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As filed with the Securities and Exchange Commission on ~~January~~February 149, ~~2025~~2026

Registration No. 333-[_]

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM S-1

REGISTRATION STATEMENT UNDER

UNDER

THE SECURITIES ACT OF 1933

~~Enveric~~ENVERIC ~~Biosciences~~BIOSCIENCES, ~~Inc~~INC.

(Exact name of registrant as specified in its charter)

Delaware	~~2834~~95-4484725	~~95-4484725~~
(State or other jurisdiction of	(Primary Standard Industrial	(I.R.S. Employer
(State or Other Jurisdiction of Incorporation or Organization)	(I.R.S. Employer Identification Number)
incorporation or organization)	Classification Code Number)	Identification Number)

~~4851~~Enveric ~~Tamiami Trail N~~Biosciences, ~~Suite 200~~Inc.

~~Naples,~~245 FLFirst ~~34103~~Street, Riverview II, 18th Floor

~~(239)~~Cambridge, ~~302-1707~~MA 02142

(~~Address, including zip code, and telephone number, including area code, of registrant’s principal executive offices~~617) 444-8400

~~Joseph~~(Address, ~~Tucker~~Including Zip Code, and Telephone Number, Including Area Code, of Registrant’s Principal Executive Offices)

Joseph Tucker, Ph.D.

Chief Executive Officer

Enveric Biosciences, Inc.

~~4851~~245 ~~Tamiami~~First ~~Trail~~Street, NRiverview II, ~~Suite 200~~18th Floor

~~Naples~~Cambridge, FLMA ~~34103~~02142

(~~239~~617) ~~302~~444-~~1707~~8400

(Name, address, including zip code, and telephone number, including area code, of agent for service)

Copies to:

Bradley J. Wyatt, Esq.

~~Rasika~~Adin AJ. ~~Kulkarni~~Tarr, Esq.

~~Dickinson~~Greenberg ~~Wright~~Traurig, ~~PLLC~~LLP

~~1850~~2375 NE. ~~Central~~Camelback ~~Avenue~~Road, Suite ~~1400~~800

Phoenix, AZArizona ~~85004~~85016

(~~734~~602) ~~623~~445-~~1905~~8000

Approximate date of commencement of proposed sale to the public: As soon as practicable after ~~the~~this ~~effective~~registration ~~date~~statement ofbecomes ~~this Registration Statement~~effective.

If any of the securities being registered on this Form are to be offered on a delayed or continuous basis pursuant to Rule 415 under the Securities Act of 1933, check the following box. ☒

If this Form is filed to register additional securities for an offering pursuant to Rule 462(b) under the Securities Act, please check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. ☐

If this Form is a post-effective amendment filed pursuant to Rule 462(c) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. ☐

If this Form is a post-effective amendment filed pursuant to Rule 462(d) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. ☐

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the ~~Securities~~ Exchange Act. ~~(Check one):~~

Large accelerated filer ☐	Accelerated filer ☐
Non-accelerated filer ☒	Smaller reporting company ☒
	Emerging growth company ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 7(a)(2)(B) of the Securities Act. ☐

The ~~Registrant~~registrant hereby amends this ~~Registration~~registration ~~Statement~~statement on such date or dates as may be necessary to delay its effective date until the ~~Registrant~~registrant shall file a further amendment which specifically states that this ~~Registration~~registration ~~Statement~~statement shall thereafter become effective in accordance with Section 8(a) of the Securities Act ~~of 1933~~ or until the ~~Registration~~registration ~~Statement~~statement shall become effective on such date as the ~~Commission~~ SEC, acting pursuant to said Section 8(a), may determine.

The information in this preliminary prospectus is not complete and may be changed. ~~These~~The securities may not be sold until the registration statement filed with the Securities and Exchange Commission is effective. This preliminary prospectus is not an offer to sell these securities and weis ~~are~~ not soliciting ~~offers~~an offer to buy these securities in any jurisdiction where the offer or sale is not permitted.

~~Preliminary~~PRELIMINARY ~~Prospectus~~PROSPECTUS ~~Subject~~SUBJECT toTO ~~Completion~~COMPLETION ~~Dated~~DATED ~~January~~FEBRUARY 149, ~~2025~~2026

~~Enveric~~ENVERIC ~~Biosciences~~BIOSCIENCES, ~~Inc~~INC.

Up to ~~[●]~~328,802 Shares of Common Stock ~~and~~Underlying ~~accompanying~~the Series G Warrants Up to ~~Purchase~~328,802 upShares of Common Stock Underlying the Series H Warrants Up to ~~[●]~~23,016 Shares of Common Stock Underlying the Placement Agent Warrants

orThis prospectus relates to the issuance by us and the resale by the selling stockholders named in this prospectus (the “Selling Stockholders”) of (i) up to 328,802 shares of our Common Stock, par value $0.01 per share (“Common Stock”) that are issuable to certain Selling Stockholders upon the exercise of Series G Warrants to purchase shares of our Common Stock at a per share exercise price of $4.16 (the “Series G Warrants”) that we issued to certain Selling Stockholders in the closing of a private placement that occurred on January 28, 2026 (the “Private Placement”); (ii) up to 328,802 shares of Common Stock that are issuable to certain Selling Stockholders upon the exercise of Series H Warrants to purchase shares of our Common Stock at a per share exercise price of $4.16 (the “Series H Warrants”) that we issued to certain Selling Stockholders in a closing of the Private Placement; and (iii) up to 23,016 shares of Common Stock that are issuable to certain Selling Stockholders upon the exercise of certain Placement Agent Warrants (the “Placement Agent Warrants,” and together with the Series G Warrants and the Series H Warrants, the “January 2026 Warrants”). See “Description of Securities to be Registered – January 2026 Warrants” beginning on page 79 of this prospectus.

UpOur toregistration ~~[●]~~of ~~Pre-Funded~~the ~~Warrants~~securities tocovered ~~Purchase~~by Upthis toprospectus ~~[●]~~does ~~Shares~~not mean that either we or the Selling Stockholders will issue, offer or sell, as applicable, any of the securities being registered. The Selling Stockholders may offer, sell, or distribute all or a portion of the securities being registered publicly or through private transactions at prevailing market prices or at negotiated prices. We will not receive any of the proceeds from the sales of our Common Stock ~~and~~by ~~accompanying~~the Selling Stockholders pursuant to this prospectus. We will, however, receive the net proceeds of any January 2026 Warrants if exercised for cash. We will bear all costs, expenses and fees in connection with the registration of these securities, including with regard to ~~Purchase~~compliance with state securities or “blue sky” laws. upThe Selling Stockholders will bear all commissions and discounts, if any, attributable to their sale of shares of our Common Stock. See “Plan of Distribution” beginning on page 92 of this prospectus.

~~[●]~~Our ~~Shares~~Common Stock is listed on The Nasdaq Capital Market (“Nasdaq”) under the symbol “ENVB”. On February 4, 2026, the last reported sale price of our Common Stock on Nasdaq was $2.84 per share.

UpYou toshould ~~[●]~~read ~~Placement~~this ~~Agent~~prospectus ~~Warrants~~and toany ~~Purchase~~prospectus Upsupplement toor ~~[●]~~amendment ~~Shares~~carefully ofbefore ~~Common~~you ~~Stock~~invest in our securities.

UpOur tobusiness ~~[●]~~and ~~Shares~~investing ofin ~~Common~~our ~~Stock~~securities ~~underlying~~involve ~~the~~a ~~Warrants,~~high ~~Pre-Funded~~degree ~~Warrants~~of ~~and~~risk. ~~Placement~~See ~~Agent~~“Risk ~~Warrants~~Factors” beginning on page 12 of this prospectus.

WeNeither ~~are offering up to [●] shares of common stock, together with warrants to purchase up to [●] shares of common stock (~~the ~~“warrants”), pursuant~~Securities to this prospectus. The assumed combined public offering price for each share of common stock, together with an accompanying warrant to purchase one share of common stock, is $[●], which is equal to the last reported sale price of our common stock on the Nasdaq Capital Market on [●], 2025. The shares of common stock and ~~warrants~~Exchange ~~will~~Commission benor ~~separately~~any ~~issued,~~state ~~but~~securities ~~the~~commission ~~shares~~has ofapproved ~~common stock~~or ~~and~~disapproved ~~warrants will be issued to purchasers in the ratio~~ of ~~one~~these tosecurities ~~one.~~or ~~Each warrant will have an exercise price of $[●] per~~determined ~~share, will be exercisable beginning on the effective date of stockholder approval of the issuance of the shares upon exercise of the warrants (“Warrant Stockholder Approval”), provided however,~~ if ~~the~~this ~~Pricing~~prospectus Conditions (as defined below) are met, the warrants will be exercisable upon issuance (the “Initial Exercise Date”). The warrants will expire on the five-year anniversary of the Initial Exercise Date. As used herein, “Pricing Conditions” means that the combined offering price per share and accompanying warrant is ~~such~~truthful that the Warrant Stockholder Approval is not required under the rules of the Nasdaq Stock Market LLC (“Nasdaq”) because either (i) the offering is an at-the-market offering under Nasdaq rules and such price equals or ~~exceeds the sum of (a) the applicable “Minimum Price” per share under Nasdaq Rule 5635(d) plus (b) $0~~complete.~~125~~ ~~per~~Any ~~whole~~representation ~~share~~to ~~of common stock underlying~~ the ~~warrants or~~contrary ~~(ii) the offering~~ is a ~~discounted~~criminal ~~offering where the pricing and discount (including attributing a value of $0~~offense.~~125 per whole share underlying the warrants) meet the pricing requirements under Nasdaq’s rules.~~

WeProspectus ~~are~~dated ~~also offering up to [●] pre-funded warrants (the “pre-funded warrants”) to those purchasers whose purchase of shares of common stock in this offering would result in the purchaser~~February , ~~together with its affiliates and certain related parties, beneficially owning more than 4~~2026.99% (or, at the election of the purchaser, 9.99%) of our outstanding common stock following the consummation of this offering in lieu of the shares of our common stock that would result in ownership in excess of 4.99% (or, at the election of the purchaser, 9.99%). Each pre-funded warrant will be exercisable for one share of common stock at an exercise price of $0.0001 per share. Each pre-funded warrant is being issued together with the same warrants described above being issued with each share of common stock. The assumed combined public offering price for each such pre-funded warrant, together with an accompanying warrant to purchase one share of common stock, is [●], which is equal to the last reported sale price of our common stock on Nasdaq on [●], 2025, minus $0.0001. Each pre-funded warrant will be exercisable upon issuance and may be exercised at any time until all of the pre-funded warrants are exercised in full. The pre-funded warrants and accompanying warrants are immediately separable and will be issued separately in this offering, but the pre-funded warrants and warrants will be issued to purchasers in the ratio of one to one. This prospectus also relates to the offering of the shares of common stock issuable upon exercise of the warrants, pre-funded warrants and Placement Agent Warrants (as defined herein). For each pre-funded warrant sold, the number of shares of common stock sold will be reduced on a 1-for-1 basis.

There is no established public trading market for the warrants or the pre-funded warrants, and we do not expect a market to develop. We do not intend to apply for listing of the warrants or the pre-funded warrants on any securities exchange or other nationally recognized trading system. Without an active trading market, the liquidity of the warrants and the pre-funded warrants will be limited.

This offering will terminate on [●], 2025, unless we decide to terminate the offering (which we may do at any time in our discretion) prior to that date. We will have one closing for all the securities purchased in this offering. The combined public offering price per share of common stock (or pre-funded warrant) and accompanying warrant will be fixed for the duration of this offering.

We have engaged [●] (the “Placement Agent”), to act as our exclusive placement agent in connection with this offering. The Placement Agent has agreed to use its reasonable best efforts to arrange for the sale of the securities offered by this prospectus. The Placement Agent is not purchasing or selling any of the securities we are offering and the Placement Agent is not required to arrange the purchase or sale of any specific number of securities or dollar amount. We have agreed to pay to the Placement Agent the Placement Agent fees set forth in the table below, which assumes that we sell all of the securities offered by this prospectus. There is no minimum number of securities or amount of proceeds required as a condition to closing in this offering. In addition, because there is no escrow trust or similar arrangement and no minimum offering amount, investors could be in a position where they have invested in our company, but we are unable to fulfill all of our contemplated objectives due to a lack of interest in this offering. Further, any proceeds from the sale of securities offered by us will be available for our immediate use, despite uncertainty about whether we would be able to use such funds to effectively implement our business plan. We will bear all costs associated with the offering. See “Plan of Distribution” on page 83 of this prospectus for more information regarding these arrangements.

Our common stock is listed on Nasdaq, under the symbol “ENVB”. The last reported sale price of our common stock on Nasdaq on [●], 2025 was $[●] per share. We do not intend to list the warrants or pre-funded warrants on the NASDAQ Capital Market, any other national securities exchange or any other nationally recognized trading system.

The combined offering price per share of common stock and accompanying warrant and the combined offering price per pre-funded warrant and accompanying warrant we are offering and the exercise price and other terms of the warrants will be negotiated between us and the purchasers, in consultation with the Placement Agent based on the trading of our common stock prior to this offering, among other factors. Other factors considered in determining the offering price of the securities we are offering and the exercise price and other terms of the warrants include the history and prospects of our company, the stage of development of our business, our business plans for the future and the extent to which they have been implemented, an assessment of our management, general conditions of the securities markets at the time of the offering and such other factors as were deemed relevant. The combined offering price per share of common stock and accompanying warrant and the combined offering price per pre-funded warrant and accompanying warrant may be at a discount to the current market price of our common stock. Therefore, the recent market price used throughout this prospectus may differ substantially from the offering price.

We are a “smaller reporting company” as defined under federal securities laws and, as such, have elected to comply with certain reduced public company reporting requirements for this prospectus and may elect to comply with reduced public company reporting requirements in future filings. See “Prospectus Summary––Implications of Being a Smaller Reporting Company.”

Investing in our securities involves a high degree of risk. See the section entitled “Risk Factors” beginning on page 6 of this prospectus for a discussion of risks that should be considered in connection with an investment in our securities.

Per Share and accompanying Warrant

Per Pre-Funded Warrant and accompanying Warrant

Total

Assumed public offering price

Placement agent fees (1)

Proceeds to us, before expenses (2)

(1) We have agreed to pay the Placement Agent a total cash fee equal to 7.0% of the gross proceeds raised in this offering. We have also agreed to pay the Placement Agent a management fee equal to 1.0% of the gross proceeds raised in this offering and to reimburse the Placement Agent for its non-accountable expenses in the amount of $25,000 and for its legal fees and expenses and other out-of-pocket expenses in an amount up to $100,000, and for its clearing expenses in the amount of $15,950. In addition, we have agreed to issue to the Placement Agent, or its designees, warrants to purchase a number of shares of our common stock equal to 7.0% of the aggregate number of shares of common stock and pre-funded warrants being offered at an exercise price equal to 125% of the combined public offering price per share of common stock and accompanying warrant. We refer you to “Plan of Distribution” on page 83 of this prospectus for additional information regarding Placement Agent compensation.

(2) Because there is no minimum number of securities or amount of proceeds required as a condition to closing in this offering, the actual offering amount, Placement Agent fees, and proceeds to us, if any, are not presently determinable and may be substantially less than the total maximum offering amounts set forth above. We refer you to “Plan of Distribution” on page 83 of this prospectus for additional information regarding Placement Agent compensation.

The delivery of the securities offered hereby is expected to be made on or about _____________, 2025, subject to satisfaction of certain customary closing conditions.

Neither the Securities and Exchange Commission nor any other regulatory body has approved or disapproved of these securities or passed upon the accuracy or adequacy of this prospectus. Any representation to the contrary is a criminal offense.

The date of this prospectus is__________, 2025

TABLE OF CONTENTS

ABOUT THIS PROSPECTUS	1
PROSPECTUS SUMMARY	2
CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS	2
THE OFFERING	5
MARKET AND INDUSTRY DATA AND FORECASTS	6
RISK FACTORS	6
PROSPECTUS SUMMARY	7
CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS	34
The Offering	9
MARKET PRICE AND DIVIDEND INFORMATION	35
Risk Factor Summary	10
BUSINESS	36
RISK FACTORS	12
MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS	49
USE OF PROCEEDS	45
SECURITY OWNERSHIP AND CERTAIN BENEFICIAL OWNERS	61
MARKET PRICE, TICKER SYMBOL AND DIVIDEND INFORMATION	46
CERTAIN RELATIONSHIPS AND RELATED PARTY TRANSACTIONS	62
BUSINESS	47
MANAGEMENT	63
MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS	62
EXECUTIVE AND DIRECTOR COMPENSATION	65
CERTAIN RELATIONSHIPS AND RELATED PERSON TRANSACTIONS	67
USE OF PROCEEDS	72
MANAGEMENT	68
DILUTION	72
EXECUTIVE & DIRECTOR COMPENSATION	73
DESCRIPTION OF CAPITAL STOCK	74
DESCRIPTION OF SECURITIES TO BE REGISTERED	78
DESCRIPTION OF SECURITIES WE ARE OFFERING	78
SECURITIES ACT RESTRICTIONS ON RESALE OF ENVERIC BIOSCIENCES’ SECURITIES	87
PLAN OF DISTRIBUTION	83
SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT	88
LEGAL MATTERS	85
SELLING STOCKHOLDERS	89
EXPERTS	85
PLAN OF DISTRIBUTION	92
WHERE YOU CAN FIND MORE INFORMATION	85
LEGAL MATTERS	93
EXPERTS	93
WHERE YOU CAN FIND MORE INFORMATION	93
INDEX TO CONSOLIDATED FINANCIAL STATEMENTS	F-1

~~iii~~i

ABOUT THIS PROSPECTUS

You should ~~carefully read~~rely only on the information contained in this prospectus. ~~before~~We ~~deciding~~have not authorized anyone to ~~invest~~provide you with information other than the information that we have provided or incorporated by reference in this prospectus and your reliance on any unauthorized information or representation is at your own risk. This prospectus may be used only in jurisdictions where offers and sales of these securities are permitted. You should assume that the information contained in this prospectus is accurate only as of the date of this prospectus, and that any information we have incorporated by reference is accurate only as of the date of the document incorporated by reference, regardless of the time of delivery of this prospectus or of any sale of our securities. Our business, financial condition, results of operations and prospects may have changed since those dates. This prospectus contains market data and industry statistics and forecasts that are based on independent industry publications and other publicly available information. Although we believe these sources are reliable, we do not guarantee the accuracy or completeness of this information and we have not independently verified this information. In addition, the market and industry data and forecasts that may be included in this prospectus may involve estimates, assumptions and other risks and uncertainties and are subject to change based on various factors, including those discussed under the heading “Risk Factors” contained in this prospectus. Accordingly, investors should not place undue reliance on this information.

WeThe ~~have not~~representations, warranties and ~~the~~covenants ~~Placement~~made ~~Agent~~by ~~has~~us ~~not,~~in ~~authorized~~any ~~anyone~~agreement tothat ~~provide~~is ~~any~~filed ~~information~~as oran exhibit to ~~make~~ any ~~representations other~~document ~~than~~that ~~those~~is ~~contained~~incorporated by inreference ~~this~~herein ~~prospectus~~were ormade insolely ~~any~~for ~~free~~the ~~writing~~benefit ~~prospectuses prepared by or on behalf~~ of usthe orparties to ~~which~~such weagreement, ~~have referred~~including, ~~you.~~in Wesome ~~take~~cases, ~~no responsibility~~ for, ~~and can provide no assurance as to~~ the ~~reliability~~purpose of, ~~any other information that others~~allocating ~~may~~risk ~~give~~among ~~you.~~the ~~This~~parties ~~prospectus is an offer~~ to ~~sell~~such ~~only the securities offered hereby~~agreements, and ~~only~~should ~~under~~not ~~circumstances~~be ~~and~~deemed into ~~jurisdictions where~~be ita isrepresentation, ~~lawful~~warranty toor docovenant soto you. ~~The~~Moreover, ~~information~~such representations, ~~contained~~warranties ~~in this prospectus~~ or incovenants ~~any~~were ~~applicable~~accurate ~~free writing prospectus is current~~ only as of ~~its~~the date, ~~regardless~~when ofmade. ~~its~~Accordingly, ~~time~~such ofrepresentations, ~~delivery~~warranties orand covenants ~~any~~should ~~sale~~not ofbe ~~our~~relied ~~securities.~~on ~~Our~~as ~~business,~~accurately ~~financial~~representing ~~condition,~~the ~~results~~current state of ~~operations and~~our ~~prospects may have changed since that date~~affairs.

~~For~~To ~~investors~~the ~~outside~~extent there is a conflict between the ~~United~~information ~~States:~~contained Wein ~~have~~this ~~not~~prospectus, on the one hand, and the ~~Placement~~information ~~Agent~~contained ~~has~~in any ~~not,~~document ~~done~~incorporated ~~anything~~by ~~that~~reference ~~would~~filed ~~permit~~with ~~this offering~~the orU.S. ~~possession~~Securities orand ~~distribution~~Exchange Commission (the “SEC”) before the date of this prospectus, inon ~~any~~the ~~jurisdiction~~other ~~where~~hand, ~~action~~you ~~for~~should ~~that~~rely ~~purpose~~on isthe ~~required,~~information ~~other than~~ in ~~the~~ ~~United~~this ~~States~~prospectus. ~~Persons~~If ~~outside~~any ~~the~~statement ~~United~~in ~~States~~a ~~who~~document ~~come~~incorporated by ~~into~~reference ~~possession~~is ofinconsistent ~~this~~with ~~prospectus~~a ~~must~~statement ~~inform~~in ~~themselves~~another ~~about,~~document ~~and~~incorporated ~~observe any~~by ~~restrictions~~reference ~~relating~~having toa later date, the ~~offering~~statement ofin the document ~~securities~~having ~~and~~ the ~~distribution~~later ofdate ~~this~~modifies ~~prospectus~~or ~~outside~~supersedes the ~~United~~earlier ~~States~~statement.

~~This~~Neither we ~~prospectus~~nor ~~may~~the ~~contain~~Selling ~~references~~Stockholders tohas ~~trademarks~~authorized ~~belonging~~anyone to ~~other entities.~~provide ~~Solely~~you ~~for~~with ~~convenience,~~any ~~trademarks~~information ~~and~~or ~~trade~~to ~~names~~make ~~referred~~any torepresentations other than those contained in this prospectus, ~~including~~any ~~logos,~~post-effective ~~artwork~~amendment, ~~and~~or ~~other~~any ~~visual~~applicable ~~displays,~~prospectus ~~may~~supplement ~~appear~~prepared ~~without~~by ~~the~~or ®on behalf of us or to TMwhich ~~symbols~~we have referred you. We doand ~~not~~the ~~intend our~~Selling ~~use~~Stockholders ortake ~~display~~no responsibility for and can provide no assurance as to the reliability of, any other ~~companies’~~information ~~trade~~that ~~names~~others ormay ~~trademarks~~give toyou. ~~imply~~Neither awe, ~~relationship~~nor ~~with~~the Selling Stockholders, orwill ~~endorsement~~make oran ~~sponsorship~~offer ofto sell these securities usin byany jurisdiction where the offer or sale is not permitted. You should assume that the information appearing in this prospectus, any post-effective ~~other~~amendment ~~company~~and any applicable prospectus supplement to this prospectus is accurate only as of the date on its respective cover.

NoThis ~~dealer,~~prospectus ~~salesperson~~contains orsummaries ~~other~~of ~~person~~certain isprovisions ~~authorized~~contained toin ~~give~~some ~~any~~of ~~information~~the ordocuments todescribed ~~represent~~herein, ~~anything~~but ~~not~~reference ~~contained~~is inmade ~~this~~to ~~prospectus.~~the ~~You~~actual ~~must~~documents ~~not~~for ~~rely~~complete oninformation. ~~any~~All ~~unauthorized~~of ~~information~~the orsummaries ~~representations.~~are ~~This~~qualified ~~prospectus~~in istheir anentirety ~~offer~~by tothe ~~sell~~actual ~~only~~documents. ~~the~~Copies ~~securities~~of ~~offered~~some ~~hereby,~~of ~~but~~the ~~only~~documents ~~under~~referred ~~circumstances~~to ~~and~~herein inhave ~~jurisdictions~~been ~~where~~filed itas isexhibits ~~lawful~~ to dothe ~~so.~~registration ~~The~~statement ~~information~~of ~~contained~~which in this prospectus is a part, and ~~current~~you ~~only~~may asobtain copies of ~~its~~those ~~date~~documents as described below under “Where You Can Find More Information.”

~~This~~Unless ~~prospectus~~the ~~contains~~context ~~estimates~~otherwise ~~and~~requires, ~~other~~references ~~statistical~~in ~~data~~this ~~made~~prospectus byto ~~independent~~“Enveric” ~~parties~~“we,” “us,” “our” and bythe us“Company” ~~relating~~refer to ~~market~~Enveric ~~size~~Biosciences, ~~and~~Inc., ~~growth~~a ~~and other~~Delaware ~~data~~corporation. ~~about~~Our ~~our~~registered ~~industry.~~trademarks Wecurrently ~~obtained~~used in the ~~industry~~United ~~and~~States ~~market~~include ~~data~~Enveric, inEnveric ~~this~~Biosciences, ~~prospectus~~Next ~~from~~Generation ~~our~~Mental ~~own~~Health, ~~research~~MagicMed, asMagicMed ~~well~~Industries, asPsybrary, ~~from industry~~PsyAI, and ~~general~~our ~~publications~~logo. Solely for convenience, ~~surveys~~trademarks and ~~studies~~tradenames ~~conducted~~referred byto ~~third~~in ~~parties.~~this ~~This~~prospectus ~~data~~may ~~involves~~appear awithout ~~number~~the of® ~~assumptions~~or ~~and limitations~~™ ~~and~~symbols, ~~contains~~but ~~projections~~such ~~and~~references ~~estimates~~are ofnot ~~the~~intended ~~future~~to ~~performance~~indicate ofin any way that we will not assert, to the ~~industries~~fullest inextent ~~which~~under weapplicable law, ~~operate~~our rights, or that ~~are~~the ~~subject~~applicable owner will not assert its rights, to athese ~~high~~trademarks ~~degree of~~and ~~uncertainty~~tradenames. We ~~caution~~do ~~you~~ not tointend ~~give~~our ~~undue~~use or ~~weight~~display of other companies’ trade names or trademarks to ~~such~~imply ~~projections~~a relationship with, ~~assumptions~~or ~~and~~endorsement ~~estimates~~or sponsorship of us by, any other companies.

~~PROSPECTUS~~CAUTIONARY ~~SUMMARY~~NOTE REGARDING FORWARD-LOOKING STATEMENTS

This ~~summary~~prospectus ~~highlights~~contains ~~information~~forward-looking ~~contained~~statements ~~elsewhere~~within inthe ~~this~~meaning ~~prospectus.~~of ~~This~~Section ~~summary~~27A ~~does~~of ~~not~~the ~~contain~~Securities ~~all~~Act, and Section 21E of the Securities ~~information~~Exchange ~~that~~Act ~~you should~~of ~~consider~~1934, ~~before~~as ~~deciding~~amended to(the ~~invest~~“Exchange inAct”). Any statements about our ~~securities~~expectations, beliefs, plans, objectives, assumptions or future events or performance are not historical facts and may be forward-looking. ~~You~~These ~~should~~statements are ~~read~~often, ~~this~~but ~~entire~~are ~~prospectus~~not ~~carefully~~always, ~~including~~made through the ~~“Risk Factors”~~use ~~section~~of inwords ~~this~~or ~~prospectus.~~phrases such as “anticipate,” “believe,” “contemplate,” ~~The~~“continue,” ~~terms~~“could,” ~~the~~“estimate,” “~~Company~~expect,” “intend,” “~~Enveric~~may,” “plan,” “potential,” “~~our~~predict,” “project,” “usseek,” “should,” “target,” or“will,” “wewould,” ~~refer~~and tosimilar ~~Enveric~~expressions, ~~Biosciences~~or the negative of these terms, ~~Inc~~or similar expressions. Accordingly, these statements involve estimates, assumptions and ~~its~~uncertainties ~~subsidiaries~~which could cause actual results to differ materially from those expressed in them. Any forward-looking statements are qualified in their entirety by reference to the factors discussed throughout this prospectus, and in particular those factors referenced in the section entitled “Risk Factors.” Specific forward-looking statements in this prospectus supplement include statements regarding:

~~Business Overview~~● our belief that the industry and market data used throughout this prospectus which are based on assumptions made by us based on such data and our knowledge of our industry are reasonable; ● our belief that EB-003 is the first known compound to selectively engage both 5-HT2A and 5-HT1B receptors with the potential to deliver fast-acting, durable antidepressant and anxiolytic effects with outpatient convenience; ● our belief that our lead program, the EVM301 Series, and its lead drug candidate, EB-003, are intended to offer a first-in-class, new approach to the treatment of difficult-to-address mental health disorders, mediated by the promotion of neuroplasticity and without also inducing hallucinations in the patient; ● the advancement of EB-003 through preclinical studies and aim of initiating the first-in-human studies to asses safety and tolerability including non-hallucinogenic properties, followed by clinical trial targeting the treatment of depression or other neuropsychiatric disorders; ● our intention to assemble a team of clinical experts and principal investigators with experience across multiple mental health and central nervous system indications to be responsible for the management, monitoring, and integrity of the clinical research; ● our intention to broaden our pipeline with additional non-hallucinogenic molecules and strengthen our ability to target addiction and neuropsychiatric disorders for patients with limited options by unveiling EVM401; ● our intention to pursue development of the EVM401 Series, but primarily focus on developing our lead asset EB-003 in the EVM301 Series ● our intention to use the net proceeds from this offering for product development, working capital, and general corporate purposes; ● our plan to submit filings including Investigational New Drug (“IND”) applications and, eventually, new drug applications (NDAs) to seek approval with the U.S. Food and Drug Administration (FDA) and with responsible regulatory agencies in other jurisdictions, in connection with our product candidates; ● our belief that if we continue to pursue the development of MagicMed’s proprietary library, the Psybrary™, it will help us to identify and develop the right drug candidates needed to address mental health challenges, including depression, anxiety, and addiction disorders; ● our intention to both continue to internally develop new drug candidates with associated intellectual property and to acquire, through in-licensing, additional intellectual property from pharmaceutical and biotechnology companies and research institutions;

Enveric Biosciences is a biotechnology company dedicated to the development of novel neuroplastogenic small-molecule therapeutics for the treatment of depression, anxiety, and addiction disorders. Leveraging its unique discovery and development platform, the Psybrary™, Enveric has created a robust intellectual property portfolio of new chemical entities for specific mental health indications. Enveric’s lead program, the EVM201 Series, comprises next generation synthetic prodrugs of the active metabolite, psilocin. Recently, Enveric out-licensed this program – which consists of the EB-002 (formerly EB-373) product for the treatment of psychiatric disorders – to MycoMedica Life Sciences, who will seek to develop, manufacture, and commercialize EB-002, in exchange for certain development and milestone payments to Enveric (discussed below). Enveric is now focused on advancing its second program, the EVM301 Series – EB-003 – expected to offer a first-in-class, new approach to the treatment of difficult-to-address mental health disorders, mediated by the promotion of neuroplasticity without also inducing hallucinations in the patient.

Neuroplastogens

Following our amalgamation with MagicMed completed in September 2021, we have continued to pursue the development of MagicMed’s proprietary psychedelic derivatives library, the Psybrary™ which we believe will help us to identify and develop the right drug candidates needed to address mental health challenges, including anxiety. We synthesize novel analogues of serotonin, using a mixture of chemistry and synthetic biology, resulting in the expansion of the Psybrary™, which includes 16 patent families with over a million potential variations and hundreds of synthesized molecules.

At this stage, we have entered into non-binding term sheets with strategic partners that out-license molecules from the Psybrary™. Going forward we intend to both develop intellectual property and license intellectual property from pharmaceutical and biotechnology companies and research institutions which would cover research stage and clinical stage assets to build a pipeline of product candidates.

Our primary focus is to develop our lead asset EB-003 in the EVM301 Series. The development status of the product is shown in the table below:

Product Candidates		Targeted Indications		Partner(s)		Status		Expected Next Steps
EB-003 Third-generation psychedelic-inspired new chemical entity		Mental health indication				Pre-Clinical Development		IND Filing

For more information, see section entitled “Business” beginning on page 36 of this prospectus.

~~Recent Developments~~● the intended target for development of such conjugates is alleviating pain, specifically the pain of osteoarthritis, rheumatoid arthritis, and cancer, with the goal of achieving improved and novel therapeutic outcomes for patients; ● our belief that the licensed-in conjugates have the potential for efficacy that will differentiate their performance against target diseases over simple combination therapies of drugs and cannabinoids; ● our intention to combine innovative scientific discoveries and bio-chemical synthesis, along with accelerated clinical development plans to create, develop and progress novel therapies using psychedelic-inspired medications and similar compounds; ● our plan to submit filings including CTA, IND applications and, eventually, NDAs to seek approval with the US FDA and with responsible regulatory agencies in other jurisdictions, in connection with our product candidates; ● our intention to leverage the broad expertise of our advisors by seeking their counsel on important topics relating to our product development and clinical development programs; ● our belief that our relationships with certain academic partners have the potential to accelerate our product development, market entry, data collection, analysis and advancement of clinical trials; ● our belief that while our scientific knowledge and technology and development experience provide us with competitive advantages, we face potential competition from many different sources, including major pharmaceutical, specialty pharmaceutical and biotechnology companies, academic institutions, governmental agencies, and public and private research institutions; ● our intention to focus on the development of novel and viable psychedelic-inspired drug candidates for mental illnesses and unmet medical needs, and partner with pharmaceutical and other drug development and biotechnology companies in developing and commercializing psychedelic-inspired medicines for diverse psychological and neuropsychiatric indications, which will be fundamentally composed of the psychedelic-inspired drug candidates contained in the Psybrary™; ● our belief that while our technology, knowledge and experience as well as the scientific resources at our disposal provide us with significant competitive advantages, we face potential competition from many different sources; ● our belief that our commercial opportunities could be reduced or eliminated if our competitors develop and commercialize medicines that are safer, more effective, have fewer or less severe side effects, are more convenient or are less expensive than any product candidates that we may develop; ● our belief that regarding our Psybrary™ and the intellectual property kept and developed therein, our success depends on our ability to protect our intellectual property and our ability to achieve and maintain key partnerships aimed at the development, licensing and marketing of psychedelic-inspired medicines without infringing on the proprietary rights of others; ● our belief that our competitors may use publicly available information to gain knowledge regarding the design and progress of our development programs; ● our belief that if we fail to comply with applicable foreign regulatory requirements, we may be subject to, among other things, fines, suspension of clinical trials, suspension or withdrawal of regulatory approvals, product recalls, seizure of products, operating restrictions and criminal prosecution; and ● other factors described in the “Risk Factors” section of this prospectus.

NASDAQ Bid Price Deficiency and Reverse Split

On May 16, 2024, the Company received a letter from Nasdaq notifying the Company that for the prior 30 consecutive business days the bid price for the Company’s common stock had closed below the minimum $1.00 per share requirement for continued inclusion on Nasdaq pursuant to Nasdaq Listing Rule 5550(a)(2) (Bid Price Rule). The deficiency letter did not result in the immediate delisting of the Company’s common stock from Nasdaq. In accordance with Nasdaq Listing Rule 5810(c)(3)(A), the Company was provided an initial period of 180 calendar days, until November 12, 2024, to regain compliance with the Bid Price Rule. On November 20, 2024, Nasdaq issued a delisting notice, indicating that the Company did not satisfy the Bid Price Rule by the compliance date and that unless the Company requested an appeal of this determination before Nasdaq’s listing qualifications panel, our common stock would be scheduled for delisting from Nasdaq and trading suspended. We appealed the determination before Nasdaq’s listing qualifications panel and on December 30, 2024, the Company received an extension until May 19, 2025, to regain compliance with Bid Price Rule.

On December 12, 2024, subject to stockholder approval, the Board approved an amendment to our certificate of incorporation to, at the discretion of the Board, effect a reverse stock split of our outstanding common stock at a ratio between 1-for-10 and 1-for-100, including shares held by the Company as treasury shares, with the exact ratio within such range to be determined by the Board at its discretion. The primary goal of the reverse stock split is to increase the per share market price of our common stock to meet the Bid Price Rule for continued listing on Nasdaq. A meeting of the shareholders is called for and will be held on January 17, 2025, and subject to receipt of the stockholder approval, the Company expects to effectuate the reverse stock price prior to the consummation of this offering. However, we cannot provide any assurance that our stock price would remain over the minimum bid price under the Bid Price Rule following the reverse stock split or that we will regain compliance with the Nasdaq Bid Price Rule.

License Agreement with MycoMedica Life Sciences

On November 7, 2024, Enveric executed a licensing agreement with MycoMedica Life Sciences, PBC (“MycoMedica”), out-licensing the Company’s EVM201 program, including drug candidate EB-002. Pursuant to the terms of licensing agreement, MycoMedica will seek to develop, manufacture, and commercialize EB-002, formerly EB-373, a synthetic prodrug of the active metabolite psilocin, in treatment of neuropsychiatric disorders such as depression. MycoMedica received an exclusive, global license to the formulations, drugs, method of use, and medical devices developed by Enveric to utilize the compound. MycoMedica assumed the responsibility for all future preclinical, clinical, and commercial development on a royalty-bearing basis for all human and animal pharmaceutical applications. As part of the license agreement, Enveric received modest upfront payments, and if certain conditions are met, will receive development and sales milestones potentially totaling up to $62 million, plus tiered single digit royalties on all future sales. MycoMedica has the option during the license term to buyout its milestone and royalty payment obligations at a predetermined amount depending upon the stage of product development and commercialization at the time of the buyout. Further, MycoMedica has the right to purchase the licensed patents at a nominal amount upon a change of control of Enveric, although doing so does not relieve MycoMedica of any of its payment obligations. No royalties have been received to date.

License Agreement with Aries Science and Technology

On July 10, 2024, Akos Biosciences, Inc., a Delaware corporation (“Akos”), wholly-owned subsidiary of Enveric, entered into an exclusive license agreement with Aries Science and Technology, LLC (“Aries”) pursuant to which Akos granted Aries a license of Akos’s patented radiation dermatitis topical product. The license allows Aries to use the patented formulation to develop pharmaceutical or non-pharmaceutical products for treating radiation dermatitis suitable for administration to humans or animals. The license is exclusive (subject to certain exceptions contained in the Agreement), worldwide, royalty-bearing, and includes the right to sublicense. Enveric will be eligible to receive aggregate milestone payments of up to $61 million, as well as tiered royalties on future sales, if all conditions are met. Aries has the option during the license term, to purchase the rights to each licensed product (on a licensed product-by-licensed product basis) in the form of an exclusive (as to the applicable licensed product), fully paid, transferable right and license to the licensed product. No royalties have been received to date.

~~Registered~~This ~~Direct~~prospectus ~~Offerings~~contains forward-looking statements that are based on our management’s belief and assumptions and on information currently available to our management. These statements relate to future events or our future financial performance, and involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to be materially different from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. Numerous factors could cause our actual results to differ materially from those described in forward-looking statements, including, among other things:

~~Between March~~● ~~and~~our ~~May,~~dependence ~~2024,~~on ~~Enveric entered into a series of common stock purchase agreements (~~the ~~“Purchase~~success ~~Agreements”) for the issuance in a registered direct offering~~ of anour ~~aggregate of~~prospective ~~686,690~~product ~~shares of the Company’s common stock~~candidates, ~~par~~which ~~value~~are ~~$0.01 per share, to certain institutional investors. The issuance was made~~ in ~~exchange~~early ~~for~~stages ~~the permanent and irrevocable waiver~~ of ~~the~~development ~~variable rate transaction limitation with respect to any existing or future agreement by the Company to effect any issuance of shares~~ and ~~issue~~may ~~such shares thereunder, as contained in those certain inducement offer letters, dated December 28, 2023, between the Company and those certain institutional investors. The Company did~~ not ~~receive~~reach ~~any net proceeds in connection with the offering. The offering was made to obtain~~ a ~~waiver~~particular ofstage ~~the variable rate transaction limitation as described above and further described~~ in ~~the Purchase Agreements so the Company could utilize its equity line of credit with Lincoln Park Capital Fund~~development, ~~LLC,~~receive ~~and~~regulatory ~~enter~~approval ~~into~~or ~~any~~be ~~future~~successfully ~~agreements that involve a variable rate transaction and issue such shares thereunder.~~ commercialized;

	●	potential difficulties that may delay, suspend, or scale back our efforts to advance additional early research programs through preclinical development and investigational new drug (“IND”) application filings and into clinical development;

	●	the risk that the cost savings, synergies and growth from our combination with MagicMed Industries Inc. and the successful use of the rights and technologies acquired in the combination may not be fully realized or may take longer to realize than expected;

	●	the limited study on the effects of psychedelics and psychedelic-inspired compounds, and the chance that future clinical research studies may lead to conclusions that dispute or conflict with our understanding and belief regarding the medical benefits, viability, safety, efficacy, dosing, and social acceptance of psychedelics and psychedelic-inspired compounds;

	●	the expensive, time-consuming, and uncertain nature of clinical trials, which are susceptible to change, delays, termination, and differing interpretations;

	●	the ability to establish that potential products are efficacious or safe in preclinical or clinical trials;

	●	the fact that our current and future preclinical and clinical studies may be conducted outside the United States, and the United States Food and Drug Administration may not accept data from such studies to support any new drug applications we may submit after completing the applicable developmental and regulatory prerequisites;

	●	our ability to effectively and efficiently build, maintain and legally protect our molecular derivatives library so that it can be an essential building block from which those in the biotech industry can develop new patented products;

	●	our ability to carry out successful clinical programs;

	●	our ability to establish or maintain collaborations on the development of therapeutic candidates;

	●	our ability to obtain appropriate or necessary governmental approvals to market potential products;

	●	our ability to manufacture product candidates on a commercial scale or in collaborations with third parties;

	●	our significant and increasing liquidity needs and potential requirements for additional funding;

	●	our ability to obtain future funding for developing products and working capital and to obtain such funding on commercially reasonable terms;

	●	our ability to continue as a going concern;

	●	legislative changes related to and affecting the healthcare system, including, without limitation, changes and proposed changes to the Patient Protection and Affordable Care Act (“PPACA”);

	●	the intense competition we face, often from companies with greater resources and experience than us;

	●	our ability to retain key executives and scientists;

	●	the ability to secure and enforce legal rights related to our products, including intellectual property rights and patent protection; and

	●	our ability to maintain compliance with Nasdaq Capital Market’s continued listing requirements;

	●	political and economic instability, which may impede our development programs; and

	●	other factors and risks identified from time to time in our filings with the SEC, including in this prospectus.

We have included important factors in the cautionary statements included in this prospectus that we believe could cause actual results or events to differ materially from the forward-looking statements that we make. Our forward-looking statements do not reflect the potential impact of any future acquisitions, mergers, dispositions, joint ventures or investments we may make. No forward-looking statement is a guarantee of future performance.

You should read this prospectus, any applicable prospectus supplement, any related free-writing prospectus, and any documents incorporated by reference herein and therein completely and with the understanding that our actual future results, levels of activity, performance and events and circumstances may be materially different from what we expect. The forward-looking statements contained or incorporated by reference in this prospectus or any prospectus supplement herein and therein represent our views as of the date of this prospectus are expressly qualified in their entirety by this cautionary statement. We anticipate that subsequent events and developments will cause our views to change. However, while we may elect to update these forward-looking statements at some point in the future, we have no current intention of doing so except to the extent required by applicable law. You should, therefore, not rely on these forward-looking statements as representing our views as of any date subsequent to the date of this prospectus.

MARKET AND INDUSTRY DATA AND FORECASTS

We obtained the industry and market data used throughout this prospectus from our own internal estimates and research, as well as from independent market research, industry and general publications and surveys, governmental agencies, publicly available information and research, surveys and studies conducted by third parties. Internal estimates are derived from publicly available information released by industry analysts and third-party sources, our internal research, and our industry experience, and are based on assumptions made by us based on such data and our knowledge of our industry and market, which we believe to be reasonable. In some cases, we do not expressly refer to the sources from which this data is derived. In addition, while we believe the industry and market data included in this prospectus is reliable and based on reasonable assumptions, such data involve material risks and other uncertainties and are subject to change based on various factors, including those discussed in the section entitled “Risk Factors.” These and other factors could cause results to differ materially from those expressed in the estimates made by the independent parties or by us.

PROSPECTUS SUMMARY

The following summary highlights certain information described in greater detail elsewhere in this prospectus. This summary is not complete and does not contain all of the information you should consider or that may be important to you in making an investment decision. You should carefully read the entire prospectus, including the information under “Risk Factors,” “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and the financial statements included elsewhere in this prospectus, before making an investment in our securities. You should carefully read this entire prospectus.

The Company

We are a biotechnology company focused on developing next-generation, small-molecule neuroplastogenic therapeutics that address unmet needs in psychiatric and neurological disorders. By leveraging a differentiated drug discovery platform and a growing library of patent protected chemical structures, we are advancing a pipeline of novel compounds designed to promote neuroplasticity without hallucinogenic effects. Our lead candidate, EB-003, is the first known compound designed to selectively engage both 5-HT_2A and 5-HT_1B receptors with the potential to deliver fast-acting, durable antidepressant and anxiolytic effects with outpatient convenience.

Our lead program, the EVM301 Series, and its lead drug candidate, EB-003, are intended to offer a first-in-class, new approach to the treatment of difficult-to-address mental health disorders, mediated by the promotion of neuroplasticity and without also inducing hallucinations in the patient. EB-003 is a novel derivative of N,N-Dimethyltryptamine (“DMT”). It is currently advancing through preclinical studies with the aim of initiating first-in-human studies to assess safety and tolerability including non-hallucinogenic properties, followed by clinical trials targeting the treatment of depression or other neuropsychiatric disorders.

We intend to assemble a team of clinical experts and principal investigators with experience across multiple mental health and central nervous system indications to be responsible for the management, monitoring, and integrity of the clinical research. We plan to submit filings including IND applications and, eventually, new drug applications (“NDAs”) to seek approval with the U.S. Food and Drug Administration (the “FDA”) and with responsible regulatory agencies in other jurisdictions, in connection with our product candidates. The selection, timing, duration, and design of any prospective studies are subject to regulatory filings, approval and finalization of commercial plans. Our EB-003 program has completed short-term dose-range finding toxicology studies and is now ready to advance into IND-enabling, GLP compliant safety pharmacology, absorption, distribution, metabolism, excretition and toxicity (“ADMET”) and longer-term toxicology studies.

We unveiled an EVM401 Series on February 25, 2025, which is intended to broaden our pipeline with additional non-hallucinogenic molecules and strengthen our ability to target addiction and neuropsychiatric disorders for patients with limited options. While we intend to pursue development of the EVM401 Series, our primary focus is to develop our lead asset EB-003 in the EVM301 Series.

Recent Developments

At-the-Market Offering

On April 9, 2025, we entered into an At the Market Offering Agreement (“ATM Agreement”) with H.C. Wainwright & Co., LLC, acting as sales agent (the “Sales Agent”). On February 6, 2026, we filed a prospectus supplement so that we may issue and sell our Common Stock having an aggregate sales proceeds of up to $1,346,000 from time to time pursuant to the ATM Agreement. We will pay the Sales Agent a commission of 3.0% of the aggregate gross proceeds from each sale of our Common Stock sold pursuant to the ATM Agreement. Because there is no minimum offering amount required as a condition of this offering, the actual total public offering amount, commissions and proceeds to us, if any, are not determinable at this time. We have also agreed to reimburse the Sales Agent for certain specified expenses, including the fees and disbursements of its legal counsel, in an amount up to $100,000, which was previously paid, in addition to up to $3,500 per due diligence update session conducted in connection with each such date we file our Quarterly Reports on Form 10-Q and $5,000 per due diligence session conducted in connection with each such date we file a new registration statement or our Annual Report on Form 10-K for the Sales Agent’s counsel’s fees.

Registered Direct Offering and Concurrent Private Placement

On January 27, 2026, we entered into a securities purchase agreement with certain institutional investors (each, an “Investor”), pursuant to which we agreed to issue and sell to the Investors in a registered direct offering (the “Registered Direct Offering”), an aggregate of 328,802 shares (the “RD Shares”) of our Common Stock at a price of $4.41 per share for gross proceeds of approximately $1.5 million before the deduction of placement agent fees and offering expenses. The closing of the Registered Direct Offering occurred on January 28, 2026. The RD Shares were offered by us pursuant to a shelf registration statement on Form S-3 (File No. 333-280721), which was initially filed with the SEC on July 8, 2024, as amended on April 10, 2025, and was declared effective by the SEC on April 17, 2025, including a prospectus supplement filed with the Commission on January 28, 2026.

In the concurrent Private Placement we also agreed to issue and sell to the Investors the Series G Warrants and Series H Warrants. The Series G Warrants are exercisable immediately and will expire five (5) following the effective date of the Resale Registration Statement (defined below), and the Series H Warrants are exercisable immediately and will expire eighteen (18) months following the effective date of the Resale Registration Statement. The Series G Warrants and Series H Warrants contain customary anti-dilution adjustments to the exercise price, including for share splits, share dividends, rights offering and pro rata distributions. We agreed to file a registration statement providing for the resale of the shares issuable upon the exercise of the Series G Warrants and Series H Warrants and warrants issued to its placement agent within thirty calendar days after the closing date (the “Resale Registration Statement”).

H.C. Wainwright & Co., LLC (the “Placement Agent”) acted as the exclusive placement agent under an Engagement Letter, dated as of December 8, 2024, as amended on January 14, 2025, June 5, 2025, November 11, 2025, and December 16, 2025 (the “Engagement Letter”). Pursuant to the Engagement Letter, we agreed to pay the Placement Agent a cash fee equal to 7.0% of the aggregate gross proceeds as well as a management fee equal to 1.0% of the aggregate gross proceeds. We also agreed to pay the Placement Agent up to $35,000 for accountable expenses including the Placement Agent’s legal fees and expenses, and $10,000 for a clearing agent fee. We also issued the Placement Agent Warrants to purchase up to 23,016 shares of Common Stock to the Placement Agent (including its designees). The Placement Agent Warrants have an exercise price equal to $5.5125 per share and are exercisable for five (5) years from the commencement of sales in the Registered Direct Offering and concurrent Private Placement.

Corporate Information

~~Our~~We ~~primary~~were ~~executive~~incorporated ~~offices~~in ~~are~~Delaware ~~located~~in at1994. ~~4851~~Our ~~Tamiami~~principal ~~Trail~~corporate N,office ~~Suite~~is ~~200~~located ~~Naples,~~at FL245 ~~34103~~First ~~and~~Street, ~~our~~Riverview ~~telephone~~II, ~~number~~18th isFloor, Cambridge, Massachusetts, telephone (~~239~~619) ~~302~~444-~~1707~~8400. Our ~~website~~internet address is https://www.enveric.com./, ~~The~~and the information ~~contained~~included onin, or ~~that~~linked ~~can~~to ~~be accessed through,~~ our website is not part of this prospectus. ~~and~~We ~~should~~have ~~not~~included beour ~~considered~~website address in this prospectus solely as a textual reference. The information contained on or accessible through our website is not a part of this prospectus orand should not be relied upon in ~~deciding~~connection ~~whether~~with tomaking ~~purchase~~an ~~our~~investment ~~securities~~decision.

Psybrary and our logo are some of our trademarks used in this prospectus. This prospectus also includes trademarks, tradenames and service marks that are the property of other organizations. Solely for convenience, our trademarks and tradenames referred to in this prospectus may appear without the ® and ™ symbols, but those references are not intended to indicate, in any way, that we will not assert, to the fullest extent under applicable law, our rights or the right of the applicable licensor to these trademarks and tradenames.

Implications of Being a Smaller Reporting Company

We are a smaller reporting company as defined in ~~the~~Item ~~Exchange~~10(f)(1) ~~Act~~of Regulation S-K, and we will remain a smaller reporting company until the fiscal year following:

	●	The determination that our voting and non-voting common stock held by non-affiliates is more than $250 million measured on the last business day of our second fiscal quarter; or
	●	Our annual revenue is more than $100 million during the most recently completed fiscal year and our voting and non-voting common stock held by non-affiliates is more than $700 million measured on the last business day of our second fiscal quarter.

● The determination that our voting and non-voting Common Stock held by non-affiliates is more than $250 million measured on the last business day of our second fiscal quarter; or

● Our annual revenue is more than $100 million during the most recently completed fiscal year and our voting and non-voting Common Stock held by non-affiliates is more than $700 million measured on the last business day of our second fiscal quarter.

Smaller reporting companies are able to provide simplified executive compensation disclosure and have certain other reduced disclosure obligations, including, among other things, being required to provide only two years of audited financial statements and not being required to provide selected financial data, supplemental financial information or risk factors.

Further, as a non-accelerated filer, we will not be required to provide an auditor attestation of management’s assessment of internal control over financial reporting, which is generally required for SEC reporting companies under Sarbanes-Oxley Act Section 404(b), and, in contrast to other reporting companies, we’ll have more time to file our annual and periodic reports.

THE OFFERING

Securities we are offering		Up to [●] shares of common stock and accompanying warrants to purchase up to [●] shares of common stock, or pre-funded warrants to purchase [●] shares of common stock and accompanying warrants to purchase shares up to [●] shares of common stock. The shares of common stock, or pre-funded warrants, and in each case the accompanying warrants will be separately transferable immediately upon issuance, but the shares of common stock, or pre-funded warrants, and in each case the accompanying warrants will be issued to purchasers in the ratio of one to one. The Placement Agent has agreed to use its reasonable best efforts to arrange for the sale of the securities offered by this prospectus. The Placement Agent is not purchasing or selling any of the securities we are offering and the Placement Agent is not required to arrange the purchase or sale of any specific number of securities or dollar amount. For more information about risks involved in a best-efforts offering, see “Risks Related to this Offering” under the section entitled “Risk Factors” beginning on page 6.
Description of warrants		Each warrant is exercisable for one share of common stock, will have an exercise price of $ [●] per share, will be exercisable beginning on the effective date of the Warrant Stockholder Approval, provided however, if the Pricing Conditions are met, the warrants will be exercisable upon issuance (the “Initial Exercise Date”). The warrants will expire on the five-year anniversary of the Initial Exercise Date.
Description of the pre-funded warrants		If the issuance of shares of our common stock to a purchaser in this offering would result in such purchaser, together with its affiliates and certain related parties, beneficially owning more than 4.99% (or, at the election of the purchaser, 9.99%) of our outstanding common stock following the consummation of this offering, then such purchaser may purchase, if they so choose, in lieu of the shares of our common stock that would result in such excess ownership, a pre-funded warrant to purchase shares of our common stock for a purchase price per share of common stock subject to such pre-funded warrant equal to the per share public offering price for the common stock to be sold in this offering less $0.0001. Each pre-funded warrant will have an exercise price of $0.0001 per share, will be exercisable upon issuance and may be exercised at any time until all of the pre-funded warrants are exercised in full. Purchasers of pre-funded warrants will also receive accompanying warrants as if such purchasers were buying shares of our common stock in this offering. This prospectus also relates to the offering of the shares of common stock issuable upon exercise of these pre-funded warrants.
Term of the offering		This offering will terminate on [●], 2025 unless we decide to terminate the offering (which we may do at any time in our discretion) prior to that date.
Common stock outstanding immediately before this offering		10,388,697 shares
Common stock outstanding immediately after this offering		[●] shares, based on an assumed public offering price of $[●] per share and accompanying warrant, which was the closing price of our common stock as reported on NASDAQ on [●], 2025, and assuming no sale of any pre-funded warrants and assuming none of the warrants or placement agent warrants issued in this offering are exercised.
Use of proceeds		We currently intend to use the net proceeds from this offering for EB-003 pre-clinical development, working capital, and general corporate purposes. See “Use of Proceeds.”
Risk Factors		An investment in our securities involves a high degree of risk. See “Risk Factors” beginning on page 6 of this prospectus for a discussion of the risk factors you should carefully consider before deciding to invest in our securities.
Nasdaq listing symbol		Our common stock is listed on The Nasdaq Capital Market under the symbol “ENVB.” There is no established trading market for the warrants or pre-funded warrants and we do not expect a market to develop. In addition, we do not intend to apply for the listing of the warrants or pre-funded warrants on any national securities exchange or other trading market. Without an active trading market, the liquidity of the warrants and pre-funded warrants will be limited.

The following summary contains basic information about this offering. The summary is not intended to be complete. You should read the full text and more specific details contained elsewhere in this prospectus.

The number of shares of common stock to be outstanding after this offering is based on 10,388,697 shares outstanding as of January 10, 2025, and excludes:

Shares of Common Stock offered by the Selling Stockholders:		680,620 shares of Common Stock, consisting of: (i) an aggregate of 328,802 shares of Common Stock issuable upon the exercise of the Series G Warrants, (ii) an aggregate of 328,802 shares of Common Stock issuable upon the exercise of the Series H Warrants, and (iii) 23,016 shares of Common Stock issuable upon the exercise of the Placement Agent Warrants.

Term of the offering:		The Selling Stockholders will determine when and how they will dispose of the shares of Common Stock registered for resale under this prospectus.

Common Stock outstanding prior to this offering:		1,390,335 shares of Common Stock.

Common Stock outstanding after this offering:		2,070,955 shares of Common Stock, assuming the exercise of all the January 2026 Warrants.

Use of Proceeds:		The Selling Stockholders will receive the proceeds from the sale of shares of Common Stock offered hereby. We will not receive any proceeds from the sale of shares of Common Stock by the Selling Stockholders. We will receive the net proceeds of any January 2026 Warrants if exercised for cash. The exercise price per share is $4.16 for each of the Series G Warrants and Series H Warrants and $5.5125 for the Placement Agent Warrants. Proceeds, if any, received from such exercise will be used for product development, working capital, and general corporate purposes. No assurances can be given that any of such January 2026 Warrants will be exercised.

Trading Symbols:		Our Common Stock is listed on Nasdaq under the symbol “ENVB”.

Risk Factors:		Investing in our securities involves a high degree of risk. See “Risk Factors” on page 12 of this prospectus and the other information included in this prospectus for a discussion of factors you should consider before investing in our securities.

●Unless ~~23,082~~we ~~shares~~indicate ~~of our common stock issuable upon exercise of outstanding options granted under our equity incentive plans at a weighted average exercise price of $62.77 per share; ● 740~~otherwise,~~775~~ all ~~shares~~information ofin ~~our~~this ~~common~~prospectus ~~stock~~is ~~issuable~~based ~~upon~~on ~~vesting of restricted stock units granted~~1, ~~inclusive of 20~~390,~~526~~335 shares ~~previously~~outstanding ~~vested~~as ~~and~~of ~~unissued,~~February ~~under our equity incentive plans; and ● 844~~4,~~628~~ ~~shares~~2026. ofThe ~~our~~number ~~common stock issuable upon exercise~~ of shares outstanding ~~warrants~~as atused athroughout ~~weighted~~this ~~average~~prospectus, ~~exercise~~unless ~~price~~otherwise ofindicated, ~~$35.78 per share and 70~~excludes,~~000~~ ~~shares~~as of ~~our~~that ~~common stock issuable upon exercise of outstanding investment options at a weighted average exercise price of $10.00 per share.~~date:

~~Unless~~● ~~otherwise~~129 ~~indicated,~~shares ~~all~~of ~~information~~our ~~contained~~Common inStock ~~this~~issuable ~~prospectus~~upon ~~assumes:~~exercise of outstanding options granted under our equity incentive plans at a weighted average exercise price of $11,298.60 per share;

● 124,165 noshares ~~exercise~~ of ~~the~~our ~~outstanding~~Common ~~options,~~Stock ~~warrants,~~issuable orupon ~~pre-funded~~vesting ~~warrants, and no settlement~~ of ~~the~~ restricted stock units ~~described~~granted, ininclusive ~~the bullets above; ● no exercise~~ of ~~the~~1,810 ~~warrants~~shares orpreviously vested ~~the~~and ~~placement~~unissued, ~~agent~~under ~~warrants~~our ~~issued~~equity inincentive ~~this offering~~plans; and ~~● no sale of pre-funded warrants in this offering.~~

5● 962,124 shares of our Common Stock issuable upon exercise of outstanding warrants at a weighted average exercise price of $37.81 per share and 389 shares of our Common Stock issuable upon exercise of outstanding investment options at a weighted average exercise price of $1,800 per share.

RISK FACTOR SUMMARY

Below is a summary of material factors that make an investment in our securities speculative or risky. Importantly, this summary does not address all of the risks and uncertainties that we face. Additional discussion of the risks and uncertainties summarized in this risk factor summary, as well as other risks and uncertainties that we face, can be found under the section titled “Risk Factors” beginning on page 12 of this prospectus. The below summary is qualified in its entirety by that more complete discussion of such risks and uncertainties. If we are unable to adequately address these and other risks we face, our business, results of operations, financial condition and prospects may be harmed. You should consider carefully the risks and uncertainties described under the section titled “Risk Factors” as part of your evaluation of an investment in our securities:

●	our dependence on the success of our prospective product candidates, which are in early stages of development and may not reach a particular stage in development, receive regulatory approval or be successfully commercialized;

●	potential difficulties that may delay, suspend, or scale back our efforts to advance additional early research programs through preclinical development and IND application filings and into clinical development;

●	the risk that the cost savings, synergies and growth from our combination with MagicMed Industries Inc. and the successful use of the rights and technologies acquired in the combination may not be fully realized or may take longer to realize than expected;

●	the limited study on the effects of psychedelics, and the chance that future clinical research studies may lead to conclusions that dispute or conflict with our understanding and belief regarding the medical benefits, viability, safety, efficacy, dosing, and social acceptance of psychedelics;

●	the expensive, time-consuming, and uncertain nature of clinical trials, which are susceptible to change, delays, termination, and differing interpretations;

●	the ability to establish that potential products are efficacious or safe in preclinical or clinical trials;

●	the fact that our current and future preclinical and clinical studies may be conducted outside the United States, and the United States Food and Drug Administration may not accept data from such studies to support any new drug applications we may submit after completing the applicable developmental and regulatory prerequisites;

●	our ability to effectively and efficiently build, maintain and legally protect our molecular derivatives library so that it can be an essential building block from which those in the biotech industry can develop new patented products;

●	our ability to establish or maintain collaborations on the development of therapeutic candidates;

●	our ability to obtain appropriate or necessary governmental approvals to market potential products;

●	our ability to manufacture product candidates on a commercial scale or in collaborations with third parties;

●	our significant and increasing liquidity needs and potential requirements for additional funding;

●	our ability to obtain future funding for developing products and working capital and to obtain such funding on commercially reasonable terms;

●	our ability to continue as a going concern;

●	legislative changes related to and affecting the healthcare system, including, without limitation, changes and proposed changes to the PPACA;

●	the intense competition we face, often from companies with greater resources and experience than us;

●	our ability to retain key executives and scientists;

●	the ability to secure and enforce legal rights related to our products, including intellectual property rights and patent protection;

●	political, economic, and military instability in Israel which may impede our development programs; and

●	other factors described in the “Risk Factors” section of this prospectus.

We have included important factors in the cautionary statements included in this prospectus and, particularly in the “Risk Factors” sections of these documents, that we believe could cause actual results or events to differ materially from the forward-looking statements that we make. Our forward-looking statements do not reflect the potential impact of any future acquisitions, mergers, dispositions, joint ventures or investments we may make. No forward-looking statement is a guarantee of future performance.

You should read this prospectus completely and with the understanding that our actual future results may be materially different from what we expect. The forward-looking statements in this prospectus represent our views as of the date of this prospectus. We anticipate that subsequent events and developments will cause our views to change. However, we undertake no obligation to publicly update or revise any forward-looking statements, whether from new information, future events or otherwise, except as required by law. You should, therefore, not rely on these forward-looking statements as representing our views as of any date subsequent to the date of this prospectus.

RISK FACTORS

~~Investing~~An investment in our securities involves a high degree of risk. ~~Before~~You ~~investing~~should incarefully ~~our~~consider ~~securities,~~the ~~you~~following ~~should~~risk ~~consider~~factors, ~~carefully~~together with all of the ~~risks~~other ~~and~~information ~~uncertainties~~included in this registration statement/prospectus, before making an investment decision. The occurrence ~~discussed~~of ~~under~~one ~~“Risk~~or ~~Factors”~~more of the events or circumstances described in ~~our~~these ~~latest~~risk ~~annual~~factors, ~~report~~alone onor ~~Form~~in ~~10-K~~combination ~~and~~with ~~subsequent~~other ~~quarterly~~events ~~reports~~or oncircumstances, ~~Form~~may ~~10-Q~~have ~~and~~an ~~current~~adverse ~~reports~~effect on ~~Form~~our ~~8-K~~business, cash flows, financial condition and results of operations. You should also carefully consider ~~each of~~ the following ~~risks,~~risk ~~together~~factors ~~with~~in ~~all~~addition to the other information ~~set~~included ~~forth~~ in this registration statement/prospectus, including ~~the financial~~matters ~~statements~~addressed ~~and~~in the ~~related~~section ~~notes,~~entitled ~~before~~“Cautionary ~~making~~Note aRegarding ~~decision~~Forward-Looking ~~to buy our securities~~Statements.” IfWe ~~any~~may offace ~~the~~additional ~~following~~ risks ~~actually occur, our business~~ ~~could~~and beuncertainties ~~harmed.~~that Inare ~~that~~not ~~case,~~presently ~~the~~known ~~trading~~to ~~price~~us ofor ~~our~~that ~~common~~we ~~stock~~currently ~~could~~deem ~~decline~~immaterial, ~~and~~which ~~you~~ may ~~lose~~also ~~all~~impair orour ~~part~~business ofor ~~your investment~~financial condition.

Risks Related to this Offering and Our Securities

~~We will require substantial additional~~You ~~funding, which~~ may ~~not~~experience befuture ~~available~~dilution toas usa onresult ~~acceptable~~of ~~terms,~~future orequity atofferings ~~all,~~ and, ifother ~~not~~issuances soof ~~available, may require us to delay, limit, reduce or cease~~ our ~~operations~~securities.

We will ~~have~~not ~~used~~receive ~~and~~any weof ~~intend to use~~ the proceeds from ~~this~~the ~~offering~~sales ~~and~~of ~~any~~our ~~future~~Common ~~offerings,~~Stock ~~product~~by ~~development,~~the ~~working~~Selling ~~capital~~Stockholders ~~and~~pursuant ~~general~~to ~~corporate~~this ~~purposes~~prospectus. We will ~~require substantial additional future capital in order to complete clinical development and commercialize EB-003~~, ~~including pre-clinical~~ ~~studies~~however, ~~clinical~~receive ~~trials,~~the ~~and~~net ~~filings~~proceeds ~~with~~of ~~the~~any ~~FDA~~January ~~for~~2026 ~~approval~~Warrants ofif ~~use~~exercised ~~and~~for ~~sale~~cash.

WeIn order ~~believe~~to ~~that~~raise ~~our~~additional ~~existing~~capital, ~~cash and~~we ~~cash~~may ~~equivalents~~in ofthe ~~$2.2~~future ~~million~~offer asadditional shares of ~~December~~Common ~~31,~~Stock ~~2024~~or ~~will~~other ~~not~~securities beconvertible ~~sufficient~~into or toexchangeable ~~fund~~for our ~~planned operations,~~Common ~~without~~Stock ~~the~~prices ~~issuance~~that ofmay ~~additional~~not ~~equity~~be ~~for~~the ~~cash.~~same ~~Assuming~~as ~~that~~the ~~we receive~~price ~~net~~per ~~proceeds~~share ofpaid ~~approximately~~by ~~$[●]~~the ~~million~~investors ~~from~~in this offering. ~~(assuming~~We may annot ~~offering~~be ~~with~~able ~~gross~~to ~~proceeds~~sell ~~of approximately~~shares ~~$[●]~~or ~~million),~~other wesecurities ~~believe~~in ~~that~~any ~~the~~other ~~net~~offering ~~proceeds~~at ~~from~~a ~~this~~price ~~offering~~per ~~will~~share ~~satisfy~~that ~~our~~is ~~capital~~equal ~~needs~~to ~~for~~or ~~less~~greater than athe ~~year~~price per ~~from~~share paid by the ~~completion~~investors ofin this offering, and weinvestors ~~will~~purchasing ~~require~~shares ~~substantial~~or ~~additional~~other ~~funding~~securities ~~thereafter~~in the future could have rights superior to ~~support~~existing ~~our~~stockholders. ~~product~~The ~~development~~price ~~plan.~~per ~~Our~~share ~~estimated~~at ~~uses~~which we sell additional shares of ~~cash~~Common ~~may~~Stock or securities convertible into ~~deviate~~shares ~~from~~of ~~our~~Common ~~expectations~~Stock ~~based~~in onfuture transactions may be higher or lower than the ~~speed~~price ofper ~~our~~share ~~ability~~paid to ~~launch~~the Selling Stockholders. Our stockholders will incur dilution upon exercise of any outstanding stock options, warrants or other convertible securities or upon the ~~trial~~issuance of shares of Common Stock under our stock incentive programs.

We ~~have~~expect ~~broad~~to ~~discretion~~require additional capital in ~~how~~the wefuture ~~use~~in ~~the~~order ~~proceeds~~to ofdevelop ~~this~~our ~~offering~~product ~~and~~candidates, ~~may~~which are in early stages of development. If we do not ~~use~~obtain ~~these~~any ~~proceeds~~such ~~effectively~~additional financing, ~~which~~it ~~could~~may ~~affect~~be ~~our results~~difficult ofto ~~operations~~effectively ~~and~~realize ~~cause~~ our ~~common~~long-term ~~stock~~strategic togoals ~~decline~~and objectives.

WeOur ~~will~~current ~~have~~cash ~~considerable~~resources ~~discretion~~will innot ~~the~~be ~~application~~sufficient ofto fund the ~~net~~development ~~proceeds~~ of ~~this~~our ~~offering.~~product Wecandidates ~~intend~~through toall ~~use~~of the ~~net~~required ~~proceeds from this~~clinical ~~offering~~trials ~~for~~to ~~product~~receive ~~development,~~regulatory ~~working~~approval ~~capital~~ and ~~general corporate purposes~~commercialization. ~~As a result, investors will be relying upon management’s judgment with only limited information about our specific intentions for the use of the net proceeds of this offering.~~ If we docannot ~~not~~secure ~~invest or apply the net proceeds of~~ this ~~offering~~additional infunding ~~ways~~when ~~that~~such ~~improve~~funds ~~our~~are ~~operating results~~required, we may fail to ~~achieve~~develop ~~expected financial results, which could cause~~ our ~~stock~~product ~~price~~candidates ~~to decline. In addition, pending their use, we may invest the net proceeds from this offering in a manner that does not produce income~~ or ~~that~~be ~~loses~~forced ~~value.~~to ~~See~~forego ~~“Use~~certain ofstrategic ~~Proceeds” for further information on the anticipated use of proceeds~~opportunities.

~~Our~~Any ~~common~~additional ~~stock~~capital ~~has~~raised ~~often~~through ~~been~~the ~~thinly~~sale ~~traded,~~of soequity ~~investors may be unable to sell at~~ or ~~near~~equity-backed ~~ask~~securities ~~prices~~may ordilute atour ~~all~~stockholders’ ifownership ~~investors~~percentages and ~~need~~could toalso ~~sell shares~~result toin ~~raise~~a ~~money~~decrease orin ~~otherwise~~the ~~desire~~market tovalue ~~liquidate~~of ~~their~~our ~~shares~~equity securities.

ToThe ~~date,~~terms ~~there have been many days on which limited trading~~ of ~~our~~any ~~common stock took place. Furthermore, the stock markets, including our stock, have experienced price and volume fluctuations that have affected and continue to affect the market prices of equity~~ securities of ~~many~~issued ~~companies.~~by Weus cannot predict the extent to which investors’ interests will lead to an active trading market for our common stock or whether the market price of our common stock will be volatile. If there are wide fluctuations in ~~trading~~future ~~volumes~~capital ortransactions ~~the market prices are volatile, investors~~ may ~~have difficulty selling our common stock. We are likely to~~ be ~~too~~more ~~small~~favorable to ~~attract~~new ~~the~~investors, ~~interest of many brokerage firms~~ and ~~analysts.~~may Weinclude ~~cannot give investors any assurance that an active public trading market for our common stock will~~preferences, ~~develop~~superior orvoting berights ~~sustained. The market price of our common stock could be subject to wide fluctuations in response to quarterly variations in our revenues~~ and ~~operating~~the ~~expenses,~~issuance ~~announcements~~ of ~~new~~warrants ~~products~~ or ~~services~~other byderivative ussecurities, ~~significant~~which ~~sales~~may ofhave ~~our~~a ~~common~~further ~~stock,~~dilutive ~~including “short”~~effect ~~sales,~~on the ~~operating~~holders of ~~and~~any ~~stock price performance~~ of ~~other companies that investors may deem comparable to us, and news reports relating to trends in~~ our ~~markets~~securities orthen ~~general economic, political, and market conditions~~outstanding.

IfIn addition, we ~~are~~may ~~required~~incur tosubstantial ~~obtain~~costs ~~Warrant~~in ~~Stockholder~~pursuing ~~Approval~~future capital financing, ~~until~~including weinvestment ~~are~~banking ~~able~~fees, tolegal ~~receive~~fees, ~~such~~accounting fees, ~~approval~~securities ~~the~~law ~~warrants~~compliance ~~will~~fees, ~~not~~printing beand ~~exercisable,~~ distribution expenses and ifother wecosts. ~~are~~We ~~unable~~may also be required to ~~obtain~~recognize non-cash expenses in connection with certain securities we issue, such ~~approval~~as ~~the~~convertible notes and warrants, ~~will~~which ~~have~~may noadversely ~~value~~impact our financial condition.

If we are required to obtain Warrant Stockholder Approval, the warrants will not be exercisable until, and unless, we obtain the Warrant Stockholder Approval from our stockholders. While we intend to promptly seek stockholder approval, if required, there is no guarantee that the Warrant Stockholder Approval will ever be obtained. If we are unable to obtain the Warrant Stockholder Approval, the warrants will have no value. In addition, we will incur substantial cost, and management will devote substantial time and attention, in attempting to obtain the Warrant Stockholder Approval.12

WeThe ~~will~~trading ~~require~~price ~~additional~~of ~~capital~~our ~~funding~~Common Stock could be highly volatile, ~~the~~which ~~receipt~~could result in substantial losses for purchasers of ~~which~~our ~~may~~Common ~~impair~~Stock in this offering. Securities class action or other litigation involving the ~~value~~Company or members of our ~~common~~management ~~stock~~team could also substantially harm our business, financial condition and results of operations.

Our ~~future~~stock ~~capital~~price ~~requirements~~is ~~depend~~volatile. onThe ~~many~~stock ~~factors,~~market ~~including~~in ~~our~~general ~~research, development, sales~~ and ~~marketing~~the ~~activities.~~market Wefor ~~will~~pharmaceutical ~~need to~~and ~~raise~~biotechnology ~~additional~~companies ~~capital~~in ~~through~~particular ~~public~~have experienced orextreme ~~private~~volatility ~~equity~~that orhas ~~debt~~often ~~offerings~~been orunrelated ~~through arrangements with strategic partners or other sources in order~~ to ~~continue~~the tooperating ~~develop~~performance ~~our~~of ~~drug~~particular ~~candidates~~companies. ~~There~~As ~~can~~a beresult noof ~~assurance~~this volatility, ~~that~~you ~~additional~~may ~~capital~~not ~~will~~ be ~~available~~able ~~when needed~~to orsell onyour ~~terms~~Common ~~satisfactory~~Stock ~~to us, if~~ at ~~all.~~or Toabove the ~~extent~~public weoffering ~~raise~~price ~~additional~~and ~~capital~~you bymay ~~issuing~~lose ~~equity~~some ~~securities,~~or ~~our~~all ~~stockholders~~of your ~~may~~investment. ~~experience~~The ~~substantial~~market ~~dilution~~price ~~and~~for ~~the~~our ~~new~~Common ~~equity~~Stock ~~securities~~ may ~~have~~be ~~greater~~influenced ~~rights,~~by ~~preferences~~many orfactors, ~~privileges than our existing common stock.~~including:

6● the success of existing or new competitive products or technologies; ● regulatory actions with respect to our products or our competitors’ products and product candidates; ● announcements by us or our competitors of significant acquisitions, strategic partnerships, joint ventures, collaborations or capital commitments; ● results of clinical trials of product candidates of our competitors; ● regulatory or legal developments in the United States and other countries; ● developments or disputes concerning patent applications, issued patents or other proprietary rights; ● the recruitment or departure of key personnel; ● the extent to which we in-license, acquire or invest in other indications or product candidates; ● actual or anticipated changes in estimates as to financial results or development timelines; ● announcement or expectation of additional financing efforts; ● sales of our Common Stock by us, our insiders or other stockholders; ● variations in our financial results or those of companies that are perceived to be similar to us; ● changes in estimates or recommendations by securities analysts, if any, that cover us; ● changes in the structure of healthcare payment systems; ● market conditions in the pharmaceutical and biotechnology sectors; and ● general economic, industry and market conditions.

WeIn dothe ~~not~~past, ~~intend~~securities toclass ~~pay~~action ~~dividends~~litigation has often been brought against a company following a decline in the ~~foreseeable~~market ~~future~~price of its securities. This risk is especially relevant for pharmaceutical and biotechnology companies, which have experienced significant stock price volatility in recent years.

WeSubstantial ~~have~~future ~~never~~sales ~~paid~~or ~~cash~~other ~~dividends~~issuances onof our ~~common~~Common ~~stock~~Stock ~~and~~could ~~currently~~depress dothe ~~not~~market ~~plan~~for toour ~~pay~~Common ~~any cash dividends in the foreseeable future~~Stock.

~~Purchasers~~Sales of a substantial innumber ~~this~~of ~~offering~~shares ~~may~~of ~~experience~~our ~~immediate~~Common Stock and any future sales of a substantial ~~dilution~~number of shares of Common Stock in ~~net~~the ~~tangible~~public ~~book~~market, ~~value~~including the issuance of any shares of Common Stock issuable upon exercise of the January 2026 Warrants, or the perception by the market that those sales could occur, could cause the market price of our Common Stock to decline or could make it more difficult for us to raise funds through the sale of equity and equity-related securities in the future at a time and price that our management deems acceptable, or at all. In addition, as opportunities present themselves, we may enter into financing or similar arrangements in the future, including the issuance of debt securities, preferred stock or Common Stock, which could also depress the market for our Common Stock. We cannot predict the effect, if any, that market sales of those shares of Common Stock or the availability of those shares for sale will have on the market price of our Common Stock.

The public offering price per share of common stock and related warrants and the public offering price of each pre-funded warrant and related warrants may be substantially higher than the pro forma as adjusted net tangible book value per share of our common stock after giving effect to this offering. Assuming the sale of [●] shares of our common stock and warrants to purchase up to [●] shares of common stock at an assumed public offering price of $[●] per share, the closing sale price per share of our common stock on The Nasdaq Capital Market on [●], 2025, assuming no sale of any pre-funded warrants in this offering, no exercise of the warrants being offered in this offering and after deducting the placement agent fees and commissions and estimated offering expenses payable by us, you may incur immediate dilution in pro forma as adjusted net tangible book value. As a result of the dilution to investors purchasing securities in this offering, investors may receive significantly less than the purchase price paid in this offering, if anything, in the event of the liquidation of our company. See the section entitled “Dilution” below for a more detailed discussion of the dilution you will incur if you participate in this offering. To the extent shares are issued under outstanding options and warrants at exercise prices lower than the public offering price of our common stock in this offering, you will incur further dilution.13

~~Your~~Our ~~ownership~~stock price may be ~~diluted~~subject ifto ~~additional~~substantial ~~capital~~volatility, ~~stock~~and isstockholders ~~issued~~may tolose ~~raise~~all ~~capital,~~or toa ~~finance~~substantial ~~acquisitions~~part orof intheir ~~connection with strategic transactions~~investment.

WeOur ~~intend~~Common toStock ~~seek~~currently totrades ~~raise~~on ~~additional~~Nasdaq. ~~funds~~There ~~for~~is ~~our~~limited ~~operations~~public float, toand ~~finance~~trading ~~acquisitions~~volume orhistorically tohas ~~develop~~been ~~strategic~~low ~~relationships~~and bysporadic. ~~issuing~~As ~~equity~~a ~~or convertible debt securities in addition to the securities issued in this offering~~result, ~~which would reduce~~ the ~~percentage~~market ~~ownership of~~price for our ~~existing~~Common ~~stockholders.~~Stock ~~Our~~may ~~board~~not ofnecessarily ~~directors~~be ~~has~~a ~~the~~reliable ~~authority,~~indicator ~~without action or vote~~ of ~~the~~our ~~stockholders,~~fair tomarket ~~issue~~value. ~~all~~The orprice ~~any part~~at of which our ~~authorized~~Common ~~but~~Stock ~~unissued~~trades ~~shares~~may offluctuate ~~common~~as ora ~~preferred~~result ~~stock.~~of ~~Our~~a ~~amended~~number ~~and restated certificate~~ of ~~incorporation~~factors, asincluding ~~amended, authorizes~~the usnumber ~~to issue up to 100,000,000 shares~~ of ~~common stock and 20,000,000~~ shares ofavailable ~~preferred~~for ~~stock.~~sale ~~Future~~in ~~issuances~~the ~~of common~~market, orquarterly ~~preferred~~variations ~~stock~~in ~~would~~our ~~reduce~~operating ~~your influence over matters on which stockholders vote and would be dilutive to earnings per share. In addition~~results, ~~any~~actual ~~newly~~or ~~issued~~anticipated ~~preferred~~announcements ~~stock could have rights, preferences and privileges senior to those~~ of ~~the~~new ~~common~~releases ~~stock.~~by ~~Those~~us ~~rights, preferences~~or ~~and privileges could include~~competitors, ~~among other things,~~ the ~~establishment~~gain ~~of dividends that must be paid prior to declaring~~ or ~~paying~~loss ~~dividends or other distributions to holders~~ of ~~our~~significant ~~common stock or providing for preferential liquidation rights. These rights~~customers, ~~preferences~~ ~~and~~changes ~~privileges~~in ~~could negatively affect~~ the ~~rights~~estimates of ~~holders of~~ our ~~common~~operating ~~stock~~performance, ~~and~~market ~~the~~conditions ~~right~~in ~~to convert such preferred stock into shares of~~ our ~~common~~industry ~~stock~~and atthe aeconomy as ~~rate or price that would have~~ a ~~dilutive effect on the outstanding shares of our common stock~~whole.

There is no public market for the warrants or pre-funded warrants being offered in this offering.

There is no established public trading market for the warrants or pre-funded warrants being offered in this offering, and we do not expect one to develop. In addition, we do not intend to apply to list the warrants or pre-funded warrants on any securities exchange or nationally recognized trading system, including The Nasdaq Stock Market. Without an active market, the liquidity of the warrants and pre-funded warrants will be limited.

Holders of our warrants and pre-funded warrants will have no rights as a common stockholder until they acquire our common stock.

Until holders of our warrants and pre-funded warrants acquire shares of our common stock upon exercise of such warrants or pre-funded warrants, the holders will have no rights with respect to shares of our common stock. Upon exercise of the warrants or pre-funded warrants, holders will be entitled to exercise the rights of a common stockholder only as to matters for which the record date occurs after the exercise date.

If we do not maintain a current and effective prospectus relating to the common stock issuable upon exercise of the warrants and pre-funded warrants, public holders will only be able to exercise such warrants and pre-funded warrants on a “cashless basis.”

If we do not maintain a current and effective prospectus relating to the shares of common stock issuable upon exercise of the warrants and pre-funded warrants at the time that holders wish to exercise such warrants, they will only be able to exercise them on a “cashless basis,” and under no circumstances would we be required to make any cash payments or net cash settle such warrants to the holders. As a result, the number of shares of common stock that holders will receive upon exercise of the warrants and pre-funded warrants will be fewer than it would have been had such holders exercised their warrants or pre-funded warrants for cash. We will do our best efforts to maintain a current and effective prospectus relating to the shares of common stock issuable upon exercise of such warrants until the expiration of such warrants. However, we cannot assure you that we will be able to do so. If we are unable to do so, the potential “upside” of the holder’s investment in our company may be reduced.

The warrants are speculative in nature.

The pre-funded warrants and the warrants offered hereby do not confer any rights of common stock ownership on their holders, such as voting rights or the right to receive dividends, but rather merely represent the right to acquire shares of common stock at a fixed price. Specifically, commencing on the date of issuance, holders of pre-funded warrants and the warrants may acquire the common stock issuable upon exercise of such warrants at the stated exercise price per share. Moreover, following this offering, the market value of the warrants will be uncertain and there can be no assurance that the market value of the warrants will equal or exceed their public offering price. There can be no assurance that the market price of the common stock will ever equal or exceed the exercise price of the warrants, and consequently, whether it will ever be profitable for holders of the warrants to exercise the warrants.

This is a “best efforts” offering. No minimum amount of securities is required to be sold, and we may not raise the amount of capital we believe is required for our business plans, including our near-term business plans.

The placement agent has agreed to use their reasonable best efforts to solicit offers to purchase the securities in this offering. The placement agent has no obligation to buy any of the securities from us or to arrange for the purchase or sale of any specific number or dollar amount of the securities. There is no required minimum number of securities that must be sold as a condition to completion of this offering. Because there is no minimum offering amount required as a condition to the closing of this offering, the actual offering amount, placement agent fees and proceeds to us are not presently determinable and may be substantially less than the maximum amounts set forth above. We may sell fewer than all of the securities offered hereby, which may significantly reduce the amount of proceeds received by us, and investors in this offering will not receive a refund in the event that we do not sell an amount of securities sufficient to support our continued operations, including our near-term continued operations.

We may be required to repurchase the warrants, which may prevent or deter a third party from acquiring us.

The warrants provide that in the event of a “Fundamental Transaction” (as defined in the related warrant agreement, which generally includes any merger with another entity, the sale, transfer or other disposition of all or substantially all of our assets to another entity, or the acquisition by a person of more than 50% of our common stock), each warrant holder will have the right at any time prior to the consummation of the Fundamental Transaction to require us to repurchase the warrant for a purchase price in cash equal to the Black-Scholes value (as calculated under the warrant agreement) of the then remaining unexercised portion of such warrant on the date of such Fundamental Transaction, which may materially adversely affect our financial condition and/or results of operations and may prevent or deter a third party from acquiring us.

FINRA sales practice requirements may limit a stockholder’s ability to buy and sell our securities.

Effective June 30, 2020, the SEC implemented Regulation Best Interest requiring that “[a] broker, dealer, or a natural person who is an associated person of a broker or dealer, when making a recommendation of any securities transaction or investment strategy involving securities (including account recommendations) to a retail customer, shall act in the best interest of the retail customer at the time the recommendation is made, without placing the financial or other interest of the broker, dealer, or natural person who is an associated person of a broker or dealer making the recommendation ahead of the interest of the retail customer.” This is a significantly higher standard for broker-dealers to recommend securities to retail customers than before under FINRA “suitability rules.” FINRA suitability rules do still apply to institutional investors and require that in recommending an investment to a customer, a broker-dealer must have reasonable grounds for believing that the investment is suitable for that customer. Prior to recommending securities to their customers, broker-dealers must make reasonable efforts to obtain information about the customer’s financial status, tax status, investment objectives and other information, and for retail customers determine the investment is in the customer’s “best interest” and meet other SEC requirements. Both SEC Regulation Best Interest and FINRA’s suitability requirements may make it more difficult for broker-dealers to recommend that their customers buy speculative, low-priced securities. They may affect investing in our common stock, which may have the effect of reducing the level of trading activity in our securities. As a result, fewer broker-dealers may be willing to make a market in our common stock, reducing a stockholder’s ability to resell our common stock.

Risks Related to Our Business and Financial Condition

Our management and independent registered public accounting firm has expressed substantial doubt about our ability to continue as a going concern as of December 31, 2024. We will be unable to continue to operate for the foreseeable future without additional capital.

Our independent registered public accounting firm issued a report dated March 2528, ~~2024~~2025 in(except ~~connection~~for ~~with~~ the ~~audits~~Second ofReverse Stock Split effective ~~our~~as ~~consolidated~~of ~~financial~~October ~~statements~~23, ~~for~~2025 described in Note 1, as to which the ~~years~~date ~~ended~~is ~~December~~February 319, ~~2023~~2026), ~~and~~in connection with the audit of our consolidated financial statements as of December 31, ~~2022~~2024, which included an explanatory paragraph describing the existence of conditions that raise substantial doubt about our ability to continue as a going concern including our recurring losses, cash used in operations, and need to raise additional funds to meet our obligations and sustain our operations. In addition, the notes to our financial statements for the year ended December 31, ~~2023~~2024, included in ~~this registration~~our ~~statement~~Annual ofReport ~~which~~on ~~this~~Form ~~prospectus forms a part~~10-K, contain a disclosure describing the existence of conditions that raise substantial doubt about our ability to continue as a going concern. Our ability to continue as a going concern is dependent upon our ability to obtain substantial additional funding in connection with our continuing operations. Adequate additional financing may not be available to us in the necessary timeframe, in the amounts we require, on terms that acceptable to us, or at all. If we are unable to raise additional capital our business, prospectus, financial condition and results of operations will be materially and ~~adversely~~ adversely affected and we may be unable to continue as a going concern. If we are not able to continue as a going concern, we may have to liquidate our assets and may receive less than the value at which those assets are carried on our consolidated financial statements and/or seek protection under federal bankruptcy law, and it is likely that holders of our ~~common~~Common ~~stock~~Stock and holders of securities convertible into our ~~common~~Common ~~stock~~Stock will lose all of their investment. If we seek additional financing to fund our business activities in the future and there remains substantial doubt about our ability to continue as a going concern, investors or other financing sources may be unwilling to provide additional funding on commercially reasonable terms or at all.

As such, there is uncertainty regarding our ability to maintain liquidity sufficient to operate our business effectively, which raises substantial doubt about our ability to continue as a going concern.

We are dependent on the success of our prospective product candidates, which are in early stages of development, and there can be no assurances that any such prospects will reach a particular stage in development, receive regulatory approval or be successfully commercialized.

Our success will depend on our ability to successfully develop and commercialize our prospective product candidates through our development programs. We intend to develop at least one product candidate, EB-003, by undergoing the long, costly clinical-trial process under an IND application(s) and, eventually, obtaining FDA approval under an NDA before proceeding to market. In order to proceed with ~~development~~ development of our pharmaceutical product candidates under the NDA pathway, we must obtain the FDA’s approval of our IND application and conduct preclinical and clinical trials in compliance with the applicable IND regulations, clinical-study protocols, and other applicable ~~regulations~~ regulations and related requirements. We may never be able to develop products which are commercially viable or receive regulatory approval in the U.S. or elsewhere. There can be no assurance that the FDA or any other regulatory authority will approve of our current or future ~~product~~ product candidates.

In the United States, the FDA regulates drugs under the Federal Food, Drug and Cosmetic Act, or “FDCA,” and implementing regulations. Drugs are also subject to other federal, state and local statutes and regulations. The process of obtaining regulatory approvals and the subsequent compliance with appropriate federal, state, local and foreign statutes and regulations require the expenditure of substantial time and financial resources. The process required by the FDA before a new drug or biological product may be marketed in the United States generally involves the following:14

~~● Completion of preclinical laboratory tests, animal studies, and formulation studies according to Good Laboratory Practices and other applicable regulations; ● Submission to~~ In the ~~FDA of an IND application, which must become effective before human clinical trials may begin in the~~ United States;, ~~● Performance of adequate and well-controlled human clinical trials according to~~ the FDA’s ~~current~~regulates ~~good~~drugs ~~clinical~~under ~~practices,~~the orFederal ~~GCPs~~Food, ~~which~~Drug ~~sufficiently~~and ~~demonstrate~~Cosmetic ~~the~~Act ~~safety~~(“FDCA”) and ~~efficacy~~implementing regulations. ofDrugs ~~the~~are ~~proposed~~also ~~drug~~subject ~~or biologic for its intended uses; ● Submission~~ to ~~the~~other ~~FDA of a New Drug Application~~federal, orstate anand ~~NDA,~~local ~~for~~statutes aand ~~new~~regulations. ~~drug~~The ~~product;~~process ~~● Satisfactory completion~~ of anobtaining ~~FDA~~regulatory ~~inspection~~approvals and of the ~~manufacturing~~subsequent ~~facility or facilities where the drug or biologic is to be produced to assess~~ compliance with ~~the~~appropriate ~~FDA’s current good manufacturing practice standards~~federal, ~~or cGMP~~state, tolocal ~~assure~~and ~~that~~foreign ~~the~~statutes ~~facilities, methods~~ and ~~controls~~regulations ~~are~~require ~~adequate to preserve~~ the ~~drug’s~~expenditure orof substantial ~~biologic’s~~time ~~identity, strength, quality~~ and ~~purity;~~financial ●resources. ~~Potential~~The ~~FDA~~process ~~audit~~required ofby the ~~nonclinical~~FDA ~~and~~before ~~clinical~~a ~~trial~~new ~~sites~~drug ~~that~~or ~~generated~~biological ~~the~~product ~~data~~may inbe ~~support~~marketed of in the ~~NDA~~United orStates ~~biologics~~generally ~~license~~involves ~~application; and ● FDA review and, potentially, approval of~~ the ~~NDA.~~following:

●	Completion of preclinical laboratory tests, animal studies, and formulation studies according to Good Laboratory Practices (“GLP”) and other applicable regulations;

●	Submission to the FDA of an IND application, which must become effective before human clinical trials may begin in the United States;

●	Performance of adequate and well-controlled human clinical trials according to the FDA’s current good clinical practices (“GCPs”), which sufficiently demonstrate the safety and efficacy of the proposed drug or biologic for its intended uses;

●	Submission to the FDA of an NDA for a new drug product;

●

Satisfactory completion of an FDA inspection of the manufacturing facility or facilities where the drug or biologic is to be produced to assess compliance with the FDA’s current good manufacturing practice standards (“cCMP”) to assure that the facilities, methods and controls are adequate to preserve the drug’s or biologic’s identity, strength, quality and purity;

●	Potential FDA audit of the nonclinical and clinical trial sites that generated the data in support of the NDA or biologics license application; and

●	FDA review and, potentially, approval of the NDA.

The lengthy process of seeking required approvals and the continuing need for compliance with applicable statutes and regulations require the expenditure of substantial resources. There can be no certainty that approvals will be granted.

We may encounter difficulties that may delay, suspend or scale back our efforts to advance additional early research programs through preclinical development and IND application filings and into clinical development.

We intend to advance early research programs through preclinical development and to file an IND ~~application~~applications for human clinical trials evaluating ~~the~~ the prospective product candidates in our pipeline. The preparation and submission of IND applications requires rigorous and time-consuming preclinical testing, the results of which must be sufficiently documented to establish, among other things, the toxicity, safety, ~~manufacturing,~~ chemistry manufacturing and controls (“CMC”) and clinical ~~protocol~~protocols of the product candidates. We may experience unforeseen difficulties that could delay or otherwise prevent us from successfully executing our current development strategy. In addition, our ability to complete and file certain IND applications may depend on the support of our partners and the timely performance of their obligations under relevant collaboration agreements. If our relevant partners are not able to perform such obligations, or if they otherwise delay the progress, we may not be able to prepare and file the intended IND applications on a timely basis or at all. Any delay, suspension or reduction of our efforts to pursue our preclinical and IND strategy could have a material adverse effect on our business and cause our share price to decline.

Catastrophic events could have a material adverse effect on our business, including current plans for product development, as well as any currently ongoing preclinical studies and clinical trials and any future studies or other development or commercialization activities.

Our operations and business could be disrupted by natural disasters; industrial accidents; public health issues and global pandemics such as COVID -19; cybersecurity incidents; interruptions of service from utilities, transportation restrictions or disruptions, telecommunications, or IT systems providers; manufacturing equipment failures; geopolitical conflict; tariff wars; terrorism; or other catastrophic events.

Catastrophic events could severely impact our business, including, but not limited to, our current or future preclinical studies, clinical trials, regulatory progress, or any other development or commercialization activities, including (among others):

● delays or difficulties in enrolling patients in clinical trials, specifically since many of the patients are considered immunocompromised; ● delays or difficulties in clinical site initiation, including difficulties in recruiting clinical site investigators and clinical site staff; ● diversion of healthcare resources away from the conduct of clinical trials, including the diversion of hospitals serving as our clinical trial sites and hospital staff supporting the conduct of our clinical trials; ● interruption of key clinical trial activities, such as clinical trial site monitoring, due to limitations on travel imposed or recommended by federal or state governments, employers and others; ● limitations in employee resources that would otherwise be focused on the conduct of our clinical trials, including because of sickness of employees or their families or the desire of employees to avoid contact with large groups of people; ● delays in receiving approval from local regulatory authorities to initiate our planned clinical trials; ● delays in clinical sites receiving the supplies and materials needed to conduct our clinical trials; ● interruption in global shipping that may affect the transport of clinical trial materials, such as investigational drug product used in our clinical trials; ● changes in local regulations as part of a response to a catastrophic event which may require us to change the ways in which our clinical trials are conducted, which may result in unexpected costs, or to discontinue the clinical trials altogether; ● delays in necessary interactions with local regulators, ethics committees and other important agencies and contractors due to limitations in employee resources or forced furlough of government employees; ● delay in the timing of interactions with the FDA due to absenteeism by federal employees or by the diversion of their efforts and attention to approval of other therapeutics or other activities related; and ● refusal of the FDA to accept data from clinical trials in affected geographies outside the United States.

~~In addition,~~● achanges ~~catastrophic~~in ~~event~~local ~~could~~regulations ~~disrupt~~as ~~our~~part ~~operations~~of ~~due~~a response to ~~absenteeism~~a bycatastrophic ~~infected~~event orwhich ~~ill~~may ~~members~~require ofus ~~management~~to orchange ~~other~~the ~~employees, or~~ways ~~absenteeism~~in bywhich ~~members~~our ofclinical ~~management~~trials ~~and~~are ~~other~~conducted, ~~employees~~which ~~who~~may ~~elect~~result ~~not~~in tounexpected ~~come~~costs, or to ~~work~~discontinue ~~due~~the toclinical ~~the~~trials ~~illness~~altogether; ~~affecting~~● ~~others~~delays in ~~our office~~necessary orinteractions ~~laboratory~~with ~~facilities~~local regulators, orethics committees and other important agencies and contractors due to ~~quarantines.~~limitations Ain ~~catastrophic~~employee ~~event~~resources ~~could~~or ~~also~~forced ~~impact~~furlough ~~members~~ of ~~our~~government ~~board~~employees; of● ~~directors,~~delay ~~resulting~~ in ~~absenteeism~~the ~~from~~timing ~~meetings~~ of interactions with the ~~directors~~FDA due to absenteeism by federal employees or ~~committees~~by the diversion of ~~directors,~~their efforts and ~~making~~attention itto ~~more~~approval ~~difficult~~of toother ~~convene~~therapeutics ~~the~~or ~~quorums~~other ofactivities ~~the full~~related ~~board~~; ofand ~~directors~~● orrefusal ~~our~~of ~~committees~~the ~~needed~~FDA to ~~conduct~~accept ~~meetings~~data ~~for~~from ~~the~~clinical ~~management~~trials ofin ~~our~~affected ~~affairs~~geographies outside the United States.

In addition, a catastrophic event could disrupt our operations due to absenteeism by infected or ill members of management or other employees, or absenteeism by members of management and other employees who elect not to come to work due to the illness affecting others in our office or laboratory facilities, or due to quarantines. A catastrophic event could also impact members of our Board of Directors (the “Board”), resulting in absenteeism from meetings of the directors or committees of directors, and making it more difficult to convene the quorums of the full Board or our committees needed to conduct meetings for the management of our affairs.

We have significant and increasing liquidity needs and may require additional funding.

Research and development, management and administrative expenses and cash used for operations will continue to be significant and may increase substantially in the future in connection with new and continued research and development initiatives and our pursuit of IND ~~authorization~~application(s) for some or all of our product candidates, as is required to initiate clinical trials in human subjects in the United States. We will need to raise additional capital to fund our operations, continue to conduct clinical trials to support potential regulatory approval of marketing applications, and to fund commercialization of our current and future product candidates.

1016

The amount and timing of our future funding requirements will depend on many factors, including, but not limited to:

●	the scope, number, initiation, progress, timing, costs, design, duration, delays (if any), and results of preclinical and clinical studies for our current or future product candidates;

●	the outcome, timing and cost of regulatory reviews, approvals or other actions to meet regulatory requirements established by the FDA, and comparable foreign regulatory authorities;

●	the timing and amount of revenue generated or received, including any revenue from grants or other sources;

●	the rate of progress and cost of our clinical trials and other product development programs;

●	costs of filing, prosecuting, defending and enforcing any patent claims and other intellectual property rights associated with our current and future product candidates;

●	the effect of competing technological and market developments;

●	personnel, facilities and equipment requirements; and

●	the terms and timing of any additional collaborative, licensing, co-promotion or other arrangements that we may establish.

While we expect to fund our future capital requirements from financing arrangements, we cannot assure you that any such financing arrangements will be available to it on favorable terms, or at all. On January 27, 2026, we engaged in a registered direct offering and this concurrent Private Placement, which locked up our ability to issue securities or file registration statements for a period of 15 days following January 28, 2026, and engage in variable-rate transactions for a period of one year following January 28, 2026, each subject to limited exceptions. Even if we can raise funds from financing arrangements, the amounts raised may not be sufficient to meet our future capital requirements. Additionally, the Company does not have sufficient unreserved, authorized shares to secure an equity investment of a sufficient amount, based on the Company’s currently traded price per share, and the Company will require shareholder approval to increase the amount of authorized shares. If we are not able to raise capital, we could be required to postpone, scale back or eliminate some, or all, of our development objectives or commercialization efforts.

We depend on our current key personnel.

We have consolidated our employee base to save capital and focus on development of our ~~leading~~lead candidate EB-~~303~~003. As of the date ~~hereof,~~of the registration statement for which this prospectus forms a part, we employ five full-time employees and one part-time employee. We are highly dependent on our current management and scientific personnel, including Joseph Tucker, Peter Facchini, and Kevin Coveney. The inability to hire or retain experienced management personnel could adversely affect our ability to execute our business plan and harm our operating results. Due to the specialized scientific and managerial nature of our business, we rely heavily on our ability to attract and retain qualified scientific, technical and managerial personnel. The competition for qualified personnel in the pharmaceutical field is intense and we may be unable to continue to attract and retain qualified personnel necessary for the development of our business or to recruit suitable replacement personnel.

There has been limited study on the effects of ~~psychedelics~~psychedelic-inspired drug candidates, and future clinical research studies may lead to conclusions that dispute or conflict with our understanding and belief regarding the medical benefits, viability, safety, efficacy, dosing, and social acceptance of psychedelics.

Research relating to the medical benefits, viability, safety, efficacy, and dosing of ~~psychedelics~~psychedelic-inspired drug candidates remains in relatively early stages. There have been few clinical trials on the benefits of ~~psychedelics~~psychedelic-inspired drug candidates conducted by us or by others. Future research and clinical trials may draw opposing conclusions to statements contained in the articles, reports and studies we have relied on, or could reach different or negative conclusions regarding the medical benefits, viability, safety, efficacy, dosing or other facts and perceptions related to ~~psychedelics~~psychedelic-inspired drug candidates, which could adversely affect social acceptance of ~~psychedelics~~such molecules and the demand for our product candidates.

Our limited resources have lead us to focus on a particular candidate. As a result, we may fail to capitalize on product candidates that may be more profitable or for which there is a greater likelihood of medical and commercial success.17

AsOur ~~a result of our~~ limited ~~financial, managerial and scientific leadership~~ resources we have ~~focused~~lead onus ~~developing~~to ~~product~~focus ~~candidates~~on ~~that we~~a ~~have~~particular ~~identified~~product ~~as most likely to succeed~~candidate. As ~~such~~a result, we ~~have elected to forego or delay for the time being the development of other candidates that~~ may ~~prove to have greater potential. Our resource allocation decisions may cause us to~~ fail to capitalize on ~~viable~~product ~~medical~~candidates ~~solutions,~~that ~~therapeutic~~may ~~enhancements~~be ~~and~~more ~~commercial~~profitable ~~potentials~~or for ~~viable~~which ~~markets~~there ~~when~~is ~~our~~a ~~spending~~greater onlikelihood ~~our~~of ~~current~~medical and ~~future~~commercial ~~defined candidates with the indications specified therein may not yield any commercially viable products~~success. ~~Inaccurate evaluation of potential may result in relinquishment of valuable product candidate opportunity.~~

11As a result of our limited financial, managerial and scientific leadership resources we have focused on developing product candidates that we have identified as most likely to succeed. As such, we have elected to forego or delay for the time being the development of other candidates that may prove to have greater potential. Our resource allocation decisions may cause us to fail to capitalize on viable medical solutions, therapeutic enhancements and commercial potentials because spending on our lead candidate for one or more indications specified therein may not yield any commercially viable products. Inaccurate or limited evaluation of commercial and therapeutic potential may result in relinquishment of other valuable product candidate opportunities.

We expect to face intense competition, often from companies with greater resources and experience than us.

The ~~pharmaceutical~~ pharmaceutical industry is highly competitive, with an emphasis on proprietary products and subject to rapid change. The industry continues to expand and evolve as an increasing number of competitors and potential competitors enter the market. Many of these competitors and ~~potential~~ potential competitors have substantially greater financial, technological, managerial and research and development resources and experience ~~than~~ than us. Some of these competitors and potential competitors have more experience than us in the development of pharmaceutical products, including clinical ~~validation~~trials ~~procedures~~ and regulatory matters. In addition, our future product candidates, if successfully developed, will compete ~~with~~ with product ~~offerings~~candidates from large and well-established companies that have greater ~~marketing~~commercial ~~and~~expertise ~~sales experience and capabilities~~ than us or our collaboration partners have. Other companies with greater resources than weus may announce similar plans in the future. In addition, small or early stage companies may prove to be competitors, particularly through collaborative arrangements with large and established companies. If we are unable to compete successfully, our commercial opportunities will be reduced and our business, results of operations and financial conditions may be materially harmed. In addition, we compete with these companies in recruiting and retaining scientific personnel as well as establishing clinical trial sites and patient ~~registration~~recruitment for clinical trials.

Our current and future preclinical and clinical studies may be conducted outside the United States, and the FDA may not accept data from such studies to support any NDAs we may submit after completing the applicable developmental and regulatory prerequisites.

We are conducting, or may conduct, preclinical and/or clinical studies outside the United States. ~~For example, we have conducted preclinical studies in Israel, and plan to conduct clinical studies for one or more product candidates in Israel or other non-U.S. countries.~~ To the extent we do not conduct these clinical trials in ~~accordance~~ under an IND application, the FDA may not accept data from such trials. Although the FDA may accept data from clinical trials conducted outside the United States that are not conducted under an IND application, the FDA’s acceptance of the data is subject to certain conditions. For example, the clinical trial must be well designed and conducted and performed by qualified investigators in accordance with ethical principles and all applicable FDA regulations. The trial population must also adequately represent the intended U.S. population, and the resulting clinical trial data must be applicable to the U.S. population and U.S. medical practice in ways that the FDA deems clinically meaningful. In general, the patient population for any clinical trials conducted outside of the United States must be representative of the population for whom we intend to market the product candidate in the United States, if approved. In addition, while these clinical trials are subject to the applicable local laws, FDA acceptance of the clinical trial data will be dependent ~~upon~~ upon our ability to verify the data and our determination that the clinical trials also complied with all applicable U.S. laws and regulations. The process of obtaining regulatory approvals and the subsequent compliance with appropriate federal, state and foreign statutes and regulations requires the expenditure of substantial time and financial resources.

We cannot guarantee that the FDA will accept data from clinical trials conducted outside of the United States. If the FDA does not accept the data from such clinical trials, we would likely result in the need for additional trials and the completion of additional regulatory steps, which would be costly and time-consuming and could delay or permanently halt our development of our product candidates.

Because the results of preclinical studies and earlier clinical trials are not necessarily predictive of future results, we may not have favorable results in our planned and future clinical trials.

Successful development of therapeutic products is highly uncertain and is dependent on numerous factors, many of which are beyond our control. Drug development involves long lead times and involves many variables of uncertainty. Product candidates that appear promising in the early phases of development may fail to reach the market for several reasons including, without limitation:

● preclinical study results that may show the product to be less effective than desired (e.g., the study failed to meet our primary objectives) or to have harmful or problematic side effects; ● failure to receive the necessary regulatory approvals or a delay in receiving such approvals. Among other things, such delays may be caused by slow enrollment in clinical studies, length of time to achieve study endpoints, additional time requirements for data analysis or an IND application and later, NDA, preparation, discussions with the FDA, an FDA request for additional preclinical or clinical data or unexpected safety or ~~manufacturing~~CMC issues; ● manufacturing costs, pricing, or reimbursement issues or other factors that make the product not economical; and ● the proprietary rights of others and their competing products and technologies that may prevent the product from being commercialized.

Any positive results from our preclinical testing of our prospective product candidates may not necessarily be predictive of the results from planned or future clinical trials for such product candidates. Many companies in the pharmaceutical and biotechnology industries have suffered significant setbacks in clinical trials after achieving positive results in preclinical and early clinical development, and we cannot be certain that we will not face similar setbacks. These setbacks have been caused by, among other things, preclinical findings while clinical trials were underway or safety or efficacy observations in clinical trials, including adverse events. Moreover, our interpretation of clinical data or our conclusions based on the preclinical in vitro and in vivo models may prove inaccurate, as preclinical and clinical data can be susceptible to varying interpretations and analyses, and many companies that believed their product candidates performed satisfactorily in preclinical studies and clinical trials nonetheless failed to obtain FDA or other regulatory approvals. Similarly, undesirable side effects caused by our product candidates could cause us or regulatory authorities to limit dosage in development or interrupt, delay or halt clinical trials and could result in a more restrictive label or the delay or denial of regulatory approval by the FDA or other comparable foreign authorities. Restrictive label applications may include but are not limited to a Boxed Warning, Risk Evaluation and Mitigation Strategies, or REMS, or other limitations of use. Drug-related side effects during one clinical trial furthermore could affect patient recruitment or the ability of enrolled patients to complete the trial, result in potential product liability claims or our ability to ensure enrollment for future trials. Any of these occurrences may harm our business, financial condition and prospects significantly.

Regulatory approval is limited by the FDA to those specific indications and conditions for which clinical safety and efficacy have been demonstrated, and we may be subject to fines, penalties or injunctions if we are determined to be promoting the use of our products for unapproved or “off-label” uses.

When the FDA or comparable foreign regulatory authorities issue regulatory approval for a product candidate, the regulatory approval is limited to those specific indications for which a product is approved. If we are not able to obtain FDA approval for any desired future indications for our products and product candidates, our ability to effectively market and sell our products may be reduced and our business may be adversely affected. While physicians may choose to prescribe drugs for uses that are not described in the product’s labeling and for uses that differ from those tested in clinical studies and approved by the regulatory authorities, we are prohibited from marketing and promoting the products for indications that are not specifically approved by the FDA.

These “off-label” uses are common across medical specialties and may constitute an appropriate treatment for some patients in varied circumstances. Regulatory authorities in the United States generally do not restrict or regulate the behavior of physicians in their choice of treatment within the practice of medicine. Regulatory authorities do, however, restrict communications by pharmaceutical companies on off-label use. If the FDA determines that our promotional activities constitute promotion of an off-label use, it could request that we modify our promotional materials or subject us to regulatory or enforcement actions by other agencies, including issuance of warning letters, suspension or withdraw an approved product from the market, additional reporting requirements and/or oversight if we become subject to a corporate integrity agreement or similar agreement, any of which could significantly harm our business.

Business interruptions could delay us in the process of developing our product candidates.

Loss of our stored materials or facilities through fire, theft, or other causes could have an adverse effect on our ability to continue product development activities and to conduct our business. Even if we obtain insurance coverage to compensate us for such business interruptions, such coverage may prove insufficient to fully compensate us for the damage to our business resulting from any significant property or casualty loss.

Our employees may engage in misconduct or other improper activities, including noncompliance with regulatory standards and legal requirements.

We are exposed to the risk of employee fraud or other misconduct. Misconduct by employees could include intentional failures to comply with ~~regulations promulgated by the~~ FDA, SEC or Office of Inspector General of the Department of Health and Human Services, or regulations of any other applicable regulatory authority, failure to provide accurate information to the FDA or the SEC, comply with applicable manufacturing standards, other federal, state or foreign laws and regulations, report information or data accurately or disclose unauthorized activities. Employee misconduct could also involve the improper use of confidential or protected information, including information obtained in the course of clinical trials, or illegal pre-approval promotion of drug candidates, which could result in government investigations, enforcement actions and serious harm to our reputation. We have adopted a Corporate Code of Conduct and Ethics and Whistleblower Policy, but employee ~~misconduct~~ misconduct is not always possible to identify and deter.

The precautions we take to detect and prevent these prohibited activities may not be effective in controlling unknown or unmanaged risks or losses or in protecting us from governmental investigations or other actions or lawsuits stemming from a failure to be in compliance with such laws or regulations. If any such actions are instituted against us, and we are not successful in defending ~~our~~the Company or asserting our rights, those actions could have a significant impact on our business, including the imposition of significant fines or other sanctions.

Our proprietary information, or that of our customers, suppliers and business partners, may be lost or we may suffer security breaches.

In the ordinary course of our business, we expect to collect and store sensitive data, including valuable and commercially sensitive intellectual property, clinical trial data, our proprietary business information and that of our future customers, suppliers and business partners, and personally identifiable information of our customers, clinical trial subjects and employees, patients, in our data centers and on our networks. The secure processing, maintenance and transmission of this information is critical to our operations. Despite our security measures, our information technology and infrastructure may be vulnerable to attacks by hackers or breached due to employee error, malfeasance or other disruptions.

Any such breach could compromise our networks and the information stored there could be accessed, publicly disclosed, lost or stolen. Any such access, disclosure or other loss of information could result in legal claims or proceedings, liability under laws that protect the privacy of personal information, regulatory penalties, disrupt our operations, damage our reputation, and cause a loss of confidence in our products and our ability to conduct clinical trials, which could adversely affect our business and reputation and lead to delays in gaining regulatory approvals for our future product candidates. Although we may obtain business interruption insurance coverage in the future, our insurance might not cover all losses from any future breaches of our systems.

Failure of our information technology systems, including cybersecurity attacks or other data security incidents, could significantly disrupt the operation of our business.

Our business depends on the use of information technologies. Our ability to execute our business plan and to comply with regulators’ requirements with respect to data control and data integrity, depends, in part, on the uninterrupted performance of our information technology systems, or IT systems and the IT systems supplied by third-party service providers. Our IT systems are vulnerable to damage from a variety of sources, including telecommunications or network failures, malicious human acts, natural disasters and more sophisticated and targeted cyber-related attacks that pose a risk to the security of our information systems and networks and the confidentiality, availability and integrity of data and information. A successful cybersecurity attack or other data security incident could result in the misappropriation and/or loss of confidential or personal information, create system interruptions, or deploy malicious software that attacks our systems. It is also possible that a cybersecurity attack might not be noticed for some period of time. In addition, sustained or repeated system failures or problems arising during the upgrade of any of our IT systems that interrupt our ability to generate and maintain data could adversely affect our ability to operate our business. The occurrence of a cybersecurity attack or incident could result in business interruptions from the disruption of our IT systems, or negative publicity resulting in reputational damage with our shareholders and other stakeholders and/or increased costs to prevent, respond to or mitigate cybersecurity events. In addition, the unauthorized dissemination of sensitive personal information or proprietary or confidential information could expose us or other third-parties to regulatory fines or penalties, litigation and potential liability, or otherwise harm our business.

Security breaches, loss of data and other disruptions could compromise sensitive information related to our business, prevent it from accessing critical information or expose it to liability, which could adversely affect our business and its reputation.

In the ordinary course of our business, we expect to collect and store sensitive data, including legally protected patient health information, credit card information, personally identifiable information about our employees, intellectual property, and proprietary business information. We expect to manage and maintain this data utilizing on-site systems. This data includes a wide variety of business-critical information including research and development information, commercial information and business and financial information.

The secure processing, storage, maintenance and transmission of this critical information is vital to our operations and business strategy, and we devote significant resources to protecting such information. Although we take measures to protect sensitive information from unauthorized access or disclosure, our information technology and infrastructure may be vulnerable to attacks by hackers, or viruses, breaches or interruptions due to employee error, malfeasance or other disruptions, or lapses in compliance with privacy and security mandates. Any such virus, breach or interruption could compromise our networks and the information stored there could be accessed by unauthorized parties, publicly disclosed, lost or stolen. In the future, any such access, disclosure or other loss of information could result in legal claims or proceedings, liability under laws that protect the privacy of personal information, such as the Health Insurance Portability and Accountability Act ~~(HIPPA)~~ and European Union General Data Protection Regulation, government enforcement actions and regulatory penalties. Unauthorized access, loss or dissemination could also disrupt our operations, including our ability to process samples, provide test results, share and monitor safety data, bill payors or patients, provide customer support services, conduct research and development activities, process and prepare company financial information, manage various general and administrative aspects of our business and may damage our reputation, any of which could adversely affect our business, financial condition and results of operations.

Our operating results may vary significantly in future periods.

We are in the early stages of product development and expect to focus substantial efforts for, at least, the next several years on preclinical and clinical trials and other research and development activities. We have not obtained regulatory approval for any product candidates. Our revenues, expenses and operating results are likely to fluctuate significantly in the future. We expect to incur substantial additional operating expenses over the next several years as our research, development, and preclinical and clinical study activities increase. Our financial results are unpredictable and may fluctuate, for among other reasons, due to:

● the scope, number, progress, duration, endpoints, cost, results, and timing of our preclinical testing and clinical studies of current or potential future product candidates; ~~● our ability to obtain additional funding to develop product candidates; and ● delays in the commencement, enrollment and timing of clinical studies.~~

14● our ability to obtain additional funding to develop product candidates; and ● delays in the commencement, enrollment and timing of clinical studies.

A high portion of our costs are predetermined on an annual basis, due in part to our significant research and development costs. Thus, small declines in revenue could disproportionately affect financial results in a quarter.

~~Significant ongoing costs and obligations~~21

AsSignificant a neuro-pharmaceutical drug discovery and development platform company, the Company expects to spend substantial funds on the research, development and testing of psychedelic molecular derivatives. In addition, the Company expects to incur significant ongoing costs and ~~obligations~~ related to its investment in infrastructure and growth and for regulatory compliance, which could have a material adverse impact on the Company’s results of operations, financial condition and cash flowsobligations. The Company will also require significant additional funds if it expands the scope of current plans for research and development or if it were to acquire any other assets and advance their development. It is possible that future financing will not be available or, if available, may not be on favorable terms. The availability of financing will be affected by the achievement of the Company’s corporate goals, the results of scientific and clinical research, the need and ability to obtain regulatory approvals and the state of the capital markets generally. If adequate funding is not available, the Company may be required to delay, reduce or eliminate one or more of its research and development programs, or obtain funds through corporate partners or others who may require the Company to relinquish significant rights to its Psychedelic Derivatives or compounds or obtain funds on less favorable terms than the Company would otherwise accept. To the extent that external sources of capital become limited or unavailable or available on onerous terms, the Company’s intangible assets and its ability to continue its business plans may become impaired, and the Company’s assets, liabilities, business, financial condition and results of operations may be materially or adversely affected.

InAs ~~addition,~~a ~~future~~neuro-pharmaceutical ~~changes~~drug indiscovery ~~regulations~~and development platform company, ~~changes~~the inCompany ~~legal~~expects ~~status~~to spend substantial funds on the research, development and testing of psychedelic-inspired ~~products~~drug candidates. In addition, ~~more~~the ~~vigorous~~Company ~~enforcement~~expects ~~thereof~~to orincur ~~other~~significant ongoing costs ~~unanticipated~~and ~~events~~obligations related to its investment in infrastructure and growth and for regulatory compliance, which could ~~require~~have ~~extensive~~a ~~changes~~material toadverse impact on the Company’s results of operations, ~~increased~~financial ~~compliance~~condition ~~costs~~and cash flows. The Company will also require significant additional funds if it expands the scope of current plans for research and development or ~~give~~if ~~rise~~it were to ~~material~~acquire any other assets and advance their ~~liabilities,~~development. ~~which~~It ~~could~~is ~~have~~possible athat ~~material~~future ~~adverse~~financing ~~effect~~will not be available or, if available, may not be on favorable terms. The availability of financing will be affected by the ~~business~~achievement of the Company’s corporate goals, the results of ~~operations~~preclinical and ~~financial~~clinical research, ~~condition~~the need and ability to obtain regulatory approvals and the state of the capital markets generally. If adequate funding is not available, the Company may be required to delay, reduce or eliminate one or more of its research and development programs, or obtain funds through corporate partners or others who may require the Company to relinquish significant rights to its psychedelic-inspired drug candidates or obtain funds on less favorable terms than the Company would otherwise accept. To the extent that external sources of capital ~~The~~become limited or unavailable or available on onerous terms, the Company’s ~~efforts~~intangible assets and its ability to ~~grow~~continue its business plans may become impaired, and the Company’s assets, liabilities, business, financial condition and results of operations may be materially ~~costlier~~or ~~than~~adversely ~~expected~~affected.

WeIn ~~may~~addition, ~~rely~~future onchanges ~~third~~in ~~parties~~regulations, tochanges ~~plan~~in legal status of psychedelic and/or ~~conduct~~psychedelic-inspired ~~preclinical~~products, more vigorous enforcement thereof or other unanticipated events could require extensive changes to the Company’s operations, increased compliance costs or give rise to material liabilities, which could have a material adverse effect on the business, results of operations and ~~clinical~~financial ~~trials~~condition of the Company. The Company’s efforts to grow its business may be costlier than expected.

We may rely on third parties to ~~conduct~~plan ~~preclinical development activities~~ and ~~intends to partner with third parties who may~~ conduct ~~clinical development~~preclinical ~~activities with our Psychedelic Derivatives and other product candidates. Preclinical activities include “in vivo”~~ studies ~~providing access to specific disease models, pharmacology~~ and ~~toxicology studies, and assay development. Clinical development activities include trial design, regulatory submissions,~~ clinical ~~patient recruitment, clinical trial monitoring, clinical data management and analysis, safety monitoring and project management~~trials. If there is any dispute or disruption in its relationship with third parties, or if such third parties are unable to provide quality services in a timely manner and at a feasible cost, or if such third parties fail to meet certain development milestones, our active development programs may face delays.

~~Further,~~We may rely on third ifparties ~~any~~to ofconduct ~~these~~preclinical development activities and intend to partner with third parties ~~fails~~who tomay ~~perform~~conduct asclinical wedevelopment ~~expect~~activities with orour ifpsychedelic-inspired ~~their~~drug ~~work~~candidates. ~~fails~~Preclinical activities include “in vivo” studies providing access to specific ~~meet~~animal-based disease models, pharmacology and toxicology studies, and assay development. Clinical development activities include trial design, regulatory ~~requirements~~submissions, ~~the~~patient ~~testing~~recruitment, clinical trial monitoring, clinical data management and ~~eventual~~analysis, ~~development~~safety ofmonitoring ~~viable~~and ~~Psychedelic~~project ~~Derivative~~management. ~~drug~~If ~~candidates~~there ~~could~~is beany ~~delayed~~dispute or disruption in its relationship with third parties, ~~cancelled~~or if such third parties are unable to provide quality services in a timely manner and at a feasible cost, or ~~rendered~~if ~~ineffective~~such third parties fail to meet certain development milestones, our active development programs may face delays.

~~Our~~Further, ~~reliance~~if onany of these third ~~party~~parties ~~contract~~fails ~~manufacturers~~to perform as we expect or if their work fails to meet regulatory requirements, the testing and eventual development of viable drug candidates could be delayed, cancelled or rendered ineffective.

~~Upon~~Our ~~our~~reliance ~~completion~~on of the “in vitro” portion of the preclinical testing we intend to conduct, when only lab-grade and lab-scale psychedelic molecules are required, we intend to manufacture the required psychedelic molecules in Calgary. However, when larger quantities and higher quality psychedelic molecules are required (e.g., for animal model testing), we intend to contract with appropriate third -party contract ~~manufacturing organizations (“CMOs”) to, among other things, supply the active pharmaceutical ingredients (“API”) used in its Psychedelic Derivatives over which we may have limited control~~manufacturers. ~~We intend to rely on CMOs to supply APIs in compliance with local GMP regulations applicable to its Psychedelic Derivatives.~~

~~All~~For ~~applicable~~completion ~~jurisdictions,~~of ~~including~~the ~~Health~~“in ~~Canada,~~vitro” ~~and~~portion of the ~~FDA,~~preclinical ~~ensure~~testing ~~the~~we ~~quality~~intend ofto ~~drug~~conduct, ~~products~~when byonly ~~carefully~~lab-grade ~~monitoring~~and lab-scale drug ~~manufacturers’ compliance~~candidate ~~with~~molecules ~~GMP~~are ~~regulations.~~required, ~~The~~we ~~GMP~~intend ~~regulations~~to ~~for~~synthesize ~~drugs~~the ~~contain~~required ~~minimum~~psychedelic-related ~~requirements~~molecules ~~for~~in ~~the~~our ~~methods,~~laboratories in ~~facilities~~Calgary ~~and~~or ~~controls used~~at inother ~~manufacturing,~~third-party ~~processing~~contract ~~and~~research ~~packing~~organizations of(“CROs”) athat ~~drug~~provide ~~product.~~synthetic ~~There~~chemistry ~~can~~services. We behave nolimited ~~assurances~~control ~~that~~over ~~CMOs~~these ~~will~~third-party beCROs. ~~able~~When tolarger ~~meet~~quantities ~~our timetable~~ and ~~requirements~~higher orquality ~~carry~~psychedelic-related ~~out~~molecules ~~their~~are required ~~contractual~~(e.g., ~~obligations~~for in ~~accordance~~vivo ~~with~~animal ~~the~~toxicology ~~applicable regulations. In addition~~studies), ~~the~~we ~~API~~intend ~~they supply~~ to uscontract ~~may~~with ~~not~~appropriate ~~meet~~third-party ~~our~~contract manufacturing ~~specifications~~organizations ~~and~~(“CMOs”), ~~quality~~over ~~policies~~which ~~and~~we ~~procedures~~may orhave ~~they~~limited ~~may~~control ~~not~~to, beamong ~~able~~other tothings, supply the ~~API in commercial~~active ~~quantities.~~pharmaceutical Ifingredient we(“API”) ~~are~~of ~~unable~~our todrug ~~arrange~~candidates. ~~for~~We ~~alternative~~also ~~third-party~~intend ~~supply~~to ~~sources~~rely on ~~commercially~~CMOs ~~reasonable~~to ~~terms~~supply ~~or in a timely manner,~~APIs itand ~~may~~drug ~~delay~~products ~~the~~in ~~development~~compliance ofwith ~~its~~cCMP ~~Psychedelic~~regulations ~~Derivatives~~in ~~and could have~~ a ~~material adverse effect on our business operations and financial condition~~phase-appropriate.

15All applicable jurisdictions, including Health Canada and the FDA, ensure the quality of drug candidates by carefully monitoring drug manufacturers’ compliance with cCMP regulations. The cCMP regulations for drug candidates contain minimum requirements for the methods, facilities and controls used in manufacturing, processing and packing of APIs and drug products. There can be no assurances that CMOs will be able to meet our timetable and requirements or carry out their contractual obligations in accordance with the applicable regulations. In addition, the APIs and/or drug products that they supply to us may not meet our specifications and quality policies and procedures or they may not be able to supply the APIs and/or drug products in commercial quantities. If we are unable to arrange for alternative third-party supply sources on commercially reasonable terms or in a timely manner, it may delay the development of our drug candidates and could have a material adverse effect on our business operations and financial condition.

Further, the failure of CMOs to operate in compliance with GMP regulations could result in, among other things, certain product liability claims in the event such failure to comply results in defective products (containing our Psychedelic Derivatives) that caused injury or harm. In general, our dependence upon third parties for the supply of our APIs may adversely affect profit margins and our ability to develop and deliver viable Psychedelic Derivatives on a timely and competitive basis.22

Further, the failure of CMOs to operate in compliance with cCMP regulations could result in, among other things, certain product liability claims in the event such failure to comply results in defective products (containing our drug candidates) that caused injury or harm. In general, our dependence upon third parties for the supply of our APIs and drug products may adversely affect profit margins and our ability to develop and deliver viable drug candidates on a timely and competitive basis.

Termination or non-renewal of key licenses and agreements.

Our business is highly dependent on key licenses and agreements which expire in a short time period. Specifically, in conducting research and preclinical studies on psychedelic or psychedelic-inspired compounds in compliance with current legislation, we substantially rely on the Facchini Drug License, which ~~expires~~expired on December 31, 2025. Health Canada renews drug licenses annually and Dr. Facchini has held the Facchini Drug License since October 5, 1995 and it has been renewed each year without issue. Dr. Facchini submitted an application for renewal of his Drug License, but as of the date of this registration statement, he has yet to receive confirmation of renewal. Until Enveric obtains its own Dealer’s License or Section 56 Exemption necessary for its business, the termination, non-renewal or hindrance of use of the Facchini Drug License would have a material adverse effect on Enveric’s ability to develop ~~Psychedelic~~psychedelic-inspired ~~Derivatives~~drug candidates, conduct research or operate its business as it currently does. This could have a material adverse impact on Enveric’s financial condition.

Negative results from clinical trials or studies of others and adverse safety events involving our ~~Psychedelic~~drug ~~Derivatives~~candidates.

From time to time, studies or clinical trials on various aspects of biopharmaceutical or natural health products (“NHPs”) ~~are~~ are conducted by academic researchers, competitors or others. The results of these studies or trials, when published, may have a significant effect on the market for the biopharmaceutical or NHP that is the subject of the study. The publication of negative results of studies or clinical trials or adverse safety events related to the psychedelic compounds similar to those used by us in the development of our psychedelic-inspired ~~Psychedelic~~drug ~~Derivatives~~candidates, or the therapeutic areas in which our ~~Psychedelic~~drug ~~Derivatives~~candidates compete, could adversely affect our share price and our ability to finance future development of our ~~Psychedelic~~drug ~~Derivatives~~candidates, and our business and financial results could be materially and adversely affected.

Clinical trials of our ~~Psychedelic~~drug ~~Derivatives~~candidates may fail to demonstrate safety and efficacy to the satisfaction of regulatory authorities or not ~~otherwise~~ otherwise produce positive results.

Before we or third parties (who may license or acquire our drug candidates) are able to obtain marketing approval from regulatory authorities for the sale of products containing our ~~Psychedelic~~drug ~~Derivatives~~candidates, the completion of preclinical studies in animals and extensive clinical trials in humans to demonstrate the safety and efficacy of the ~~Psychedelic~~ ~~Derivatives~~drug candidates will be required. Clinical testing is expensive and difficult to design and implement, can take many years to complete and has uncertain outcomes. The outcome of preclinical studies and early clinical trials may not predict the success of later clinical trials, and interim results of a clinical trial do not necessarily predict final results. A number of companies in the pharmaceutical, NHP and biotechnology industries have suffered significant setbacks in advanced clinical trials due to lack of efficacy or unacceptable safety profiles, notwithstanding promising results in earlier trials. We do not know whether the clinical trials that we or third parties may conduct will demonstrate adequate efficacy and safety to result in regulatory approval to market any products containing our ~~Psychedelic Derivatives~~drug candidates in any jurisdiction. A product/compound candidate may fail for safety or efficacy reasons at any stage of the testing process. A major risk we face is the possibility that none of ~~the products containing~~ our ~~Psychedelic~~drug ~~Derivatives~~candidates will successfully gain market approval ~~from Health Canada,~~ the FDA or other regulatory authorities, resulting in our inability to derive any royalty-based revenue from them.

~~Raw materials requiring regulatory approval.~~23

Use of raw materials requires regulatory approval.

Some raw materials used by us will require regulatory approval by Health Canada and the FDA because the plant or fungi may contain a controlled substance. While we believe that we can acquire, or indirectly make use of, the requisite licenses to conduct our intended research and development activities, there is a risk that Health Canada and the FDA can either reject or require further action to approve the requisite licenses which would cause delays or result in losses for us and could result in the abandonment of a specific research programs. Raw materials and supplies are generally available in quantities to meet the needs of our business. An inability to obtain raw materials or product supply could have a material adverse impact on our business, financial condition, and results of operations.

Possible increase in costs beyond what is currently expected as a result of regulatory review.

Health Canada, ~~and~~ the FDA or other regulatory authorities in foreign jurisdictions have not yet determined whether our ~~Psychedelic~~psychedelic-inspired ~~Derivatives~~drug candidates will be scheduled as controlled substances. InBased ~~the~~on ~~event Health~~preclinical ~~Canada~~ and/or ~~the~~clinical ~~FDA~~abuse ~~determine~~liability ~~that these products are controlled substances and therefore~~studies, ~~require~~Health ~~regulatory approval~~Canada, ~~(a) our~~the ~~licensees~~FDA ~~will~~or beother ~~required~~regulatory toauthorities ~~obtain~~may ~~such~~determine ~~approval;~~that ~~and~~our ~~(b)~~products toare ~~the~~controlled ~~extent~~substances ~~that~~and ~~we produce Psychedelic Derivatives~~therefore, ~~we will~~ require ~~similar regulatory~~additional ~~approval~~regulatory controls. Such additional regulatory requirements may increase our costs and cause a delay in our operations. Further, if Health Canada, the FDA or ~~the~~other ~~FDA~~regulatory authorities require that we perform additional preclinical or clinical studies, or if we determine that additional preclinical or clinical studies are required for our ~~Psychedelic~~drug ~~Derivatives~~candidates, our expenses would further increase beyond what is currently expected and the anticipated timing of any potential approval of our ~~Psychedelic~~drug ~~Derivatives~~candidates or licensing out agreements would likely be delayed.

We have never been profitable, have no products approved for commercial sale, and to date have not generated any revenue.

We have never been profitable and we do not expect to be profitable in the foreseeable future. Neither us, nor any third-party partner, have submitted any products containing our products for approval by regulatory authorities in ~~Canada,~~ the United States or elsewhere. As of September 30, ~~2024~~2025, we had an accumulated deficit of $~~102,919,859~~112.7 million and accumulated other comprehensive losses of $~~534,998~~0. 6 million. To date, we have devoted most of our financial resources to research and development, including drug discovery research, preclinical development activities, patent application ~~filing~~filings and prosecution, and media relation efforts, as well as corporate overhead.

We ~~have~~ ~~not~~ generated ~~any~~no ~~revenues~~reportable revenues since inception through September 30, 2025, we expect to continue to incur losses for the foreseeable future, and expect these ~~losses~~ losses to increase as we continue our product development activities. If our ~~Psychedelic~~drug ~~Derivatives~~candidates and other products developed do not achieve market acceptance, we may never become profitable. As a result of the foregoing, we expect to continue to experience net losses and negative cash flows for the foreseeable future. These net losses and negative cash flows have had, and will continue to have, an adverse effect on our stockholders’ equity and working capital.

Because of the numerous risks and uncertainties associated with drug development, we are unable to accurately predict the timing or amount of increased expenses or when, or if, we will be able to achieve profitability. In addition, our expenses could increase if we are required by the FDA or ~~Health~~other ~~Canada~~regulatory authorities in foreign jurisdictions to perform preclinical studies or clinical trials in addition to those currently expected, or if there are any delays in completing our preclinical studies or the development of any of our ~~Psychedelic~~drug ~~Derivatives or other products~~candidates. The amount of future net losses will depend, in part, on the rate of future growth of our expenses and our ability to generate revenues.

We have no licensing, marketing or distribution experience and will have to invest significant resources to develop those capabilities or enter into acceptable third-party sales and marketing transactions.

We have no commercial licensing, marketing or distribution experience. To develop commercial licensing, distribution and marketing capabilities, we will have to invest significant amounts of financial and management resources, some of which will need to be committed prior to any ~~confirmation~~ confirmation that our ~~Psychedelic~~drug ~~Derivatives~~candidates will be approved by the FDA ~~and~~or ~~Health~~other ~~Canada~~regulatory ~~for~~authorities ~~Psychedelic~~in ~~Derivatives~~foreign ~~where~~jurisdictions. Where we decide to perform commercial licensing, marketing and distribution functions itself or through third parties, we could face a number of additional risks, including that we or our third-party collaborators may not be able to build and maintain an effective marketing or sales force. If we use third parties to market and ~~license~~distribute any products arising from our ~~Psychedelic~~drug ~~Derivatives~~candidates, we may have limited or no control over our commercial licensing, marketing and distribution activities on which our future revenues may depend.

We may incur substantial costs as a result of litigation or other proceedings relating to patent and other intellectual property rights.

We may from time to time seek to enforce our intellectual property rights against infringers when we determine that a successful outcome is probable and may lead to an increase in the value of the intellectual property. If we choose to enforce our patent rights against a party, then that individual or company has the right to ask the court to rule that such patents are invalid or should not be enforced. Additionally, the validity of our patents and the patents we have licensed may be challenged if a petition for post grant proceedings such as inter-partes review and post grant review is filed within the statutorily applicable time with the Canadian Intellectual Property Office or the United States Patent and Trademark Office. These lawsuits and proceedings are expensive and would consume time and resources and divert the attention of managerial and scientific personnel even if we were successful in stopping the infringement of such patents.

In addition, there is a risk that the court will decide that such patents are not valid and that we do not have the right to stop the other party from using the inventions. There is also the risk that, even if the validity of such patents is upheld, the court will refuse to stop the other party on the ground that such other party’s activities do not infringe our intellectual property rights.

17Changes in patent law and its interpretation could diminish the value of patents in general, thereby impairing our ability to protect our drug candidates.

Changes in patent law and its interpretation could diminish the value of patents in general, thereby impairing our ability to protect our Psychedelic Derivatives.

As is the case with other NHP, biotechnology and pharmaceutical companies, our success is heavily dependent on intellectual property rights, particularly patents. Obtaining and enforcing patents in the biopharmaceutical industry involves technological and legal complexity, and obtaining and enforcing biopharmaceutical patents is costly, time consuming and inherently uncertain. The Supreme Court of Canada and the U.S. Supreme Court have ruled on several patent cases in recent years, either narrowing the scope of patent protection available in certain circumstances or weakening the rights of patent owners in certain situations. In addition to increasing uncertainty with regard to our ability to obtain patents in the future, this combination of events has created uncertainty with respect to the value of patents, once obtained. Depending on decisions by the Canadian House of Representative, the Federal Court of Canada, the Canadian Intellectual Property Office, U.S. Congress, the federal courts, and the U.S. Patent and Trademark Office and international treaties entered into by these nations, the laws and regulations governing patents could change in unpredictable ways that would weaken our ability to obtain patents or to enforce patents we may obtain in the future.

Failure to manage growth

As we advance our ~~Psychedelic~~drug ~~Derivatives~~candidates through preclinical studies and early clinical development and seek business arrangements and partnerships with third parties to advance our ~~Psychedelic~~drug ~~Derivatives~~candidates through later stage clinical development, we will need to increase our ~~preclinical~~research and development personnel, scientific, management, and administrative headcount to manage these programs and ~~negotiate these arrangements~~partnerships. In addition, to meet obligations as a public company, we may need to increase our general and administrative capabilities and improve our operational and financial controls and reporting procedures. Our management, personnel and systems currently in place may not be adequate to support this future growth. In managing our growing operations, we are also subject to the risks of over-hiring and/or overcompensating our employees and over-expanding our operating infrastructure. As a result, we may be unable to manage our expenses effectively in the future, which may negatively impact our gross profit or operating expenses.

Insurance and uninsured risks

Our business is subject to a number of risks and hazards generally, including adverse preclinical ~~trial~~study results, accidents, labor ~~disputes~~ disputes and changes in the regulatory environment. Such occurrences could result in damage to assets, personal injury or death, environmental damage, delays in operations, monetary losses and possible legal liability.

Our insurance may not cover all the potential risks associated with our operations. We may also be unable to maintain insurance to cover these risks at economically feasible premiums. Insurance coverage may not be available or may not be adequate to cover any resulting liability. Moreover, insurance against risks such as environmental pollution or other hazards encountered in our operations is not generally available on acceptable terms. We might also become subject to liability for pollution or other hazards which may not be insured against or which we may elect not to insure against because of premium costs or other reasons. Losses from these events or any significant uninsured liability may require us to pay substantial amounts, which would adversely affect our financial position and results of operations.

Litigation

We may become party to litigation from time to time in the ordinary course of business which could adversely affect our business. Should any litigation in which we become involved be determined against us such a decision could adversely affect our ability to continue operating and the market price for our shares and could use significant resources. Even if we are involved in litigation and win, litigation can redirect significant company resources.

Conflicts of interest

Certain of our directors and officers do not devote their full time to the affairs of the Company and certain of our directors and officers are also directors, officers and shareholders of other biotechnology and research and development companies or other public companies in general, and as a result they may find themselves in a position where their duty to another company conflicts with their duty to the Company. There is no assurance that any such conflicts will be resolved in favor of the Company. If any such conflicts are not resolved in our favor we may be adversely affected.

The psychedelic-inspired ~~therapy~~medicines industry and market are relatively new in this industry and the market may not continue to exist or grow as anticipated.

We operate our business in a relatively new industry and market. In addition to being subject to general business risks, we must continue to build brand awareness in this industry and market through significant investments in our strategy, our operational capacity, quality assurance and compliance with regulations. In addition, there is no assurance that the industry and market will continue to exist and grow as currently estimated or anticipated or function and evolve in the manner consistent with management’s expectations and assumptions. Any event or circumstance that adversely affects the psychedelic-inspired ~~therapy~~medicines industry and market could have a material adverse effect on our business, financial conditions and results of operations.

18The psychedelic and psychedelic-inspired medicine market will face specific marketing challenges given the psychedelic products’ status as a controlled substance which resulted in past and current public perception that the products have negative health and lifestyle effects and have the potential to cause physical and social harm due to psychoactive and potentially addictive effects. Any marketing efforts by us would need to overcome this perception to build consumer confidence, brand recognition and goodwill.

The ~~psychedelic~~psychedelics-inspired ~~medicine~~medicines ~~market~~industry ~~will~~and ~~face~~market ~~specific~~are ~~marketing~~relatively ~~challenges~~new, ~~given~~and the ~~products’~~industry ~~status~~may asnot asucceed ~~controlled substance which resulted~~ in ~~past and current public perception that~~ the ~~products~~long ~~have negative health and lifestyle effects and have the potential to cause physical and social harm due to psychoactive and potentially addictive effects~~term. ~~Any marketing efforts by us would need to overcome this perception to build consumer confidence, brand recognition and goodwill.~~

We operate our business in a relatively new industry and market. The use of psychedelic-inspired medicines for medicinal purposes has shown promise in various studies and we believe that both regulators and the public have an increasing awareness and acceptance of this promising field. Nevertheless, psychedelics remain a controlled substance in the United States, Canada, and most other jurisdictions and their use for research and therapeutic purposes remains highly regulated and narrow in scope. There is no assurance that the industry and market ~~are~~will ~~relatively~~continue ~~new~~to grow as currently estimated or anticipated or function and evolve in the manner consistent with management’s expectations and assumptions. Any event or circumstance that adversely affects the psychedelic manufacturing and medicines industry and market could have a material adverse effect on our business, financial condition and results of operations. We have committed and expect to continue committing significant resources and capital to the development of psychedelic-inspired products for therapeutic uses. As a category of products, medical-grade psychedelics raw materials and psychedelic-derived APIs, and research into such substances, represent relatively untested offerings in the marketplace, and we cannot provide assurance that psychedelics as a category, or that our prospective psychedelic-inspired product candidates, in particular, will achieve market acceptance. Moreover, as a relatively new industry, ~~may~~there are not ~~succeed~~many established players in the ~~long~~psychedelic-inspired ~~term~~medicines industry whose business model we can emulate. Similarly, there is little information about comparable companies available for potential investors to review in making a decision about whether to invest in our Common Stock.

We operate our business in a relatively new industry and market. The use of psychedelics for medicinal purposes has shown promise in various studies and we believe that both regulators and the public have an increasing awareness and acceptance of this promising field. Nevertheless, psychedelics remain a controlled substance in the United States, Canada, and most other jurisdictions and their use for research and therapeutic purposes remains highly regulated and narrow in scope. There is no assurance that the industry and market will continue to grow as currently estimated or anticipated or function and evolve in the manner consistent with management’s expectations and assumptions. Any event or circumstance that adversely affects the psychedelic manufacturing and medicines industry and market could have a material adverse effect on our business, financial condition and results of operations. We have committed and expect to continue committing significant resources and capital to the development of psychedelic products for therapeutic uses. As a category of products, medical-grade psychedelics raw materials and psychedelic-derived APIs, and research into such substances, represent relatively untested offerings in the marketplace, and we cannot provide assurance that psychedelics as a category, or that our prospective products, in particular, will achieve market acceptance. Moreover, as a relatively new industry, there are not many established players in the psychedelic-based medicines industry whose business model we can emulate. Similarly, there is little information about comparable companies available for potential investors to review in making a decision about whether to invest in our common shares.26

Our psychedelic-inspired ~~product~~drug candidates may generate public controversy. Adverse publicity or public perception regarding the psychedelic ~~APIs~~-inspired APIs we intend to utilize may negatively influence our success and that of our prospective investigational therapies.

Our ability to establish and grow our business is substantially dependent on the success of the emerging market for ~~psychedelics~~psychedelic-~~based~~ inspired medicines, which will depend upon, among other matters, pronounced and rapidly changing public preferences, factors which are difficult to predict and over which we have little, if any, control. We and our clients will be highly dependent upon consumer perception of psychedelic-~~based~~inspired ~~therapies~~medicines and other products.

Therapies containing controlled substances may generate public controversy. Political and social pressures and adverse publicity could lead to delays in approval of, and increased expenses for any future therapeutic candidates we may develop. Opponents of these therapies may seek restrictions on marketing and withdrawal of any regulatory approvals. In addition, these opponents may seek to generate ~~negative~~ negative publicity in an effort to persuade the medical community to reject these therapies. For example, we may face media-communicated criticism directed at our clinical development program. Adverse publicity from ~~psilocybin~~the misuse of psilocybin, a psychedelic, may adversely affect the commercial success or market penetration achievable by our product candidates. Anti-psychedelic protests have historically occurred and may occur in the future and generate media coverage. Political pressures and adverse publicity could lead to delays in, and increased expenses for, and limit or restrict the introduction and marketing of any future therapeutic candidates.

The expansion of the use of ~~psychedelics~~psychedelic-inspired medicines in the medical industry may require new clinical research into effective medical therapies.

Research in the United States and internationally regarding the medical benefits, viability, safety, efficacy, addictiveness, dosing and social ~~acceptance~~ acceptance of psychedelic-inspired ~~and psychoactive~~ products remains in early stages. There have been relatively few clinical trials on the benefits of ~~such~~ such products. Although we believe that the articles, reports and studies support our beliefs regarding the medical benefits, viability, safety, efficacy, dosing and social acceptance of psychedelic-inspired ~~and psychoactive~~ products, future research and clinical trials may prove such statements to be incorrect, or could raise concerns regarding, and perceptions relating to, psychedelic-inspired ~~and psychoactive~~ products. Given these risks, ~~uncertainties~~ uncertainties and assumptions, readers should not place undue reliance on such articles and reports. Future research studies and clinical trials may draw opposing conclusions to those stated in this ~~prospectus~~Annual Report or reach negative conclusions regarding the medical benefits, viability, safety, efficacy, dosing, social acceptance or other facts and perceptions related to psychedelic-inspired ~~and psychoactive~~ products, which could have a material adverse effect on the demand for our ~~Psychedelic~~drug ~~Derivatives~~candidates with the potential to lead to a material adverse effect on the Company’s business, financial condition and results of operations.

19The psychedelic-inspired medicine industry is difficult to quantify and investors will be reliant on their own estimates of the accuracy of market data.

~~The~~Because the psychedelic-inspired ~~therapy~~medicine industry is ~~difficult~~in a nascent stage with uncertain boundaries, there is a lack of information about comparable companies available for potential investors to ~~quantify~~review in deciding about whether to invest in us and, few, if any, established companies whose business model we can follow or upon whose success we can build. Accordingly, investors will behave ~~reliant~~to rely on their own estimates in ofdeciding ~~the~~about ~~accuracy~~whether ofto invest in us. There can be no assurance that our estimates are accurate or that the market size is sufficiently ~~data~~large for our business to grow as projected, which may negatively impact our financial results.

Because the psychedelic therapy industry is in a nascent stage with uncertain boundaries, there is a lack of information about comparable companies available for potential investors to review in deciding about whether to invest in us and, few, if any, established companies whose business model we can follow or upon whose success we can build. Accordingly, investors will have to rely on their own estimates in deciding about whether to invest in us. There can be no assurance that our estimates are accurate or that the market size is sufficiently large for our business to grow as projected, which may negatively impact our financial results.27

The psychedelic-inspired ~~therapy~~medicine and biotechnology industries are experiencing rapid growth and increased competition.

The psychedelic-inspired ~~therapy~~medicine and biotechnology industries are undergoing rapid growth and substantial change, which has resulted in an increase in competitors, consolidation and formation of strategic relationships. Acquisitions or other consolidating transactions could harm us in a number of ways, including, without limitation, by losing strategic partners if they are acquired by or enter into ~~relationships~~ relationships with a competitor, losing customers, revenue and market share, or forcing us to expend greater resources to meet new or additional competitive threats, all of which could harm our operating results.

Additionally, the biotechnology and pharmaceutical industries are intensely competitive and subject to rapid and significant technological change. We have competitors in Canada, the United States, Europe and other jurisdictions, including, without limitation, major multinational pharmaceutical companies, established biotechnology companies, specialty pharmaceutical and generic drug companies and universities and other research institutions. Many of our competitors have greater financial and other resources, such as larger research and development staff and more experienced marketing and manufacturing organizations than we do. Large pharmaceutical companies, in particular, have extensive experience in, and substantial capital resources for, conducting research, molecular derivative development, obtaining regulatory approvals, obtaining intellectual property protection and establishing key relationships. These companies also have significantly greater sales and marketing capabilities and experience in completing collaborative transactions in our target markets with leading companies and research institutions.

Our competitors may introduce new ~~Psychedelic~~psychedelic-inspired ~~Derivatives~~medicines or develop technological advances that compete with us. We cannot predict the timing or impact of competitors introducing new ~~Psychedelic~~psychedelic-inspired ~~Derivatives~~medicines or technological advances. Such competing ~~Psychedelic~~psychedelic-inspired medicines ~~Derivatives~~ may be safer, more effective, more effectively marketed, licensed or sold or have lower prices or superior performance features than our ~~Psychedelic~~ ~~Derivatives~~psychedelic-inspired drug candidates, and this could negatively impact our business and results of operations. Established pharmaceutical ~~companies~~ companies may also invest heavily to accelerate discovery and development of novel compounds or to in-license novel compounds that could make the ~~Psychedelic~~ ~~Derivatives~~psychedelic-inspired drug candidates that we develop obsolete. As a result of all of these factors, our competitors may succeed in obtaining patent protection or discovering, developing and commercializing ~~Psychedelic~~psychedelic-inspired ~~Derivatives~~medicines before we do or may develop psychedelic-inspired ~~Psychedelic~~medicines ~~Derivatives~~ that are deemed to be more effective or gain greater market acceptance than those of the Company.

Smaller or early-stage companies may also prove to be significant competitors, particularly through collaborative transactions with large, established companies. In addition, many universities and private and public research institutes may become active in the development of novel compounds. Our competitors may succeed in developing, acquiring or licensing on an exclusive basis, technologies and ~~Psychedelic~~psychedelic-inspired ~~Derivatives that~~medicines that are more effective or less costly than any of the ~~Psychedelic~~psychedelic-inspired ~~Derivatives~~drug candidates that we are currently developing or that we may develop, which could render our ~~Psychedelic~~psychedelic-inspired ~~Derivatives~~drug candidates obsolete or non-competitive. If our competitors market ~~Psychedelic~~psychedelic-inspired medicines ~~Derivatives~~ that are more effective, safer or less expensive or that reach the market sooner than our ~~Psychedelic~~psychedelic-inspired ~~Derivatives,~~drug candidates, if any, we may not achieve commercial success. In addition, because of our limited resources, it may be difficult for us to stay abreast of the rapid changes in each technology. If we fail to stay at the forefront of technological change, we may be unable to compete effectively. Technological advances or products developed by our competitors may render our technologies or ~~Psychedelic~~psychedelic-inspired ~~Derivatives~~drug candidates obsolete, less competitive or not economical.

Changes in legislation, regulations and guidelines.

Our operations are subject to various laws, regulations and guidelines relating to, among other things, drug research, development, marketing practices, health and safety, the conduct of operations and preclinical trials. In addition to FDA ~~and~~or Health Canada restrictions on ~~the~~ the marketing of pharmaceutical products, several other types of state and federal laws have been applied to restrict certain marketing ~~practices~~ practices in the pharmaceutical and medical industries in recent years, as well as consulting or other service agreements with physicians or other potential referral sources. While to the knowledge of management, we are currently in compliance with all such laws, changes to applicable laws, regulations and guidelines may cause adverse effects to its operations. The risks to the business of the Company represented by this or similar risks are that they could significantly reduce the addressable market for our ~~Psychedelic~~psychedelic-inspired ~~Derivatives and~~drug candidates and could materially and adversely affect the business, financial condition and results of our operations.

2028

Risks Related to Regulatory Matters

Our current and prospective product candidates, and the development thereof, are or will be subject to the various federal and state laws and regulations relating to the safety and efficacy of health products, such as drugs and medical devices.

We are in the process of developing investigational new drugs for which we intend to pursue FDA approval via the NDA process. In these product candidates and synthetic molecules based on psychedelics, such as psilocybin, mescaline and MDMA, will be the active pharmaceutical ingredients.

In connection with our development and future commercialization (if applicable) of our prospective products, we, and each contemplated product candidate, are subject to the ~~Federal Food Drug and Cosmetic Act (~~FDCA). The FDCA is intended to assure the consumer, in part, that drugs and devices are safe and effective for their intended uses and that all labeling and packaging is truthful, informative, and not deceptive. The FDCA and the ~~U.S. Food and Drug Administration (~~FDA) regulations define the term “drug,” in part, by reference to its intended use, as “articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease” and “articles (other than food) intended to affect the structure or any function of the body of man or other animals.” The definition also includes components of drugs, such as active pharmaceutical ingredients. To be lawfully marketed in the United States, drugs must generally either receive premarket approval by FDA through the NDA process or conform to a “monograph” for a particular drug category, as established by FDA’s Over-the-Counter (“OTC”) Drug Review. If the FDA does not award premarket approval for our product candidates through the NDA process, this will have a material adverse effect on our business, financial condition and results of operations.

Additionally, the nature of the active ingredients we intend to utilize in our product candidates subjects us and our development and future commercialization (as applicable) activities to additional regulatory scrutiny and oversight. In connection with our development and future commercialization (if applicable) of psychedelic-based product candidates, we and each contemplated product candidate will be subject to the federal Controlled Substances Act (“CSA”) and the Controlled Substances Import and Export Act in the United States and analogous state and foreign laws.

There is no guarantee that any of our investigational drugs will ever be approved as medicines in any jurisdiction in which the Company operates, as there are currently very few FDA-approved drugs containing the psychedelic ingredients we intend to utilize as active ingredients. And, the laws and regulations generally applicable to the industry in which the Company is involved are subject to constant evolution and may change in ways currently unforeseen. Any amendment to or replacement of existing laws or regulations, including the re-classification of the substances the Company is developing or with which it is working, which are matters beyond the Company’s control, may cause the Company’s business, financial condition, results of operations and prospects to be adversely affected or may cause the Company to incur significant costs in complying with such changes or it may be unable to comply therewith. A violation of any applicable laws and regulations of the jurisdictions in which the Company operates could result in significant fines, penalties, administrative sanctions, convictions or settlements arising from civil proceedings initiated by either government entities in the jurisdictions in which the Company operates, or private citizens or criminal charges.

The psychedelic-derived therapeutic candidates we are developing or may develop in the future are subject to controlled substance laws and regulations in the United States and other countries where the product will be marketed, and failure to comply with these laws and regulations, or the cost of compliance with these laws and regulations, may adversely affect the results of our business operations and our financial condition.29

InThe ~~the~~psychedelic-inspired ~~United~~drug ~~States,~~candidates ~~psychedelics,~~we ~~such as psilocybin (and its active metabolite, psilocin), DMT, mescaline and MDMA,~~ are ~~classified~~developing ~~by the DEA as a Schedule I substances under the CSA. The DEA regulates chemical compounds as Schedule I, II, III, IV~~ or V substances. Schedule I substances by-definition have a high potential for abuse, have no currently accepted medical use in the United States, lack accepted safety for use under medical supervision, and may ~~not~~develop ~~be prescribed marketed or sold~~ in the ~~United~~future ~~States. Pharmaceutical products approved for use in the United States~~ may be listed as Schedule II, III, IV or V, with Schedule II substances considered to present the highest potential for abuse or dependence and Schedule V substances the lowest relative risk of abuse among such substances. Schedule I and II substances are subject to ~~the~~controlled ~~strictest~~substance ~~controls~~laws ~~under the CSA, including manufacturing~~ and ~~procurement quotas, security requirements~~regulations and criteria for importation. In addition, dispensing of Schedule II substances is further restricted. For example, they may not be refilled without a new prescription and may have a black box warning. Further, most, if not all, state laws in the United States ~~classify~~and ~~the psychedelic~~other ~~active~~countries ~~ingredients~~where wethe ~~intend to utilize as Schedule I controlled substances. For any~~ product ~~containing~~will ~~active ingredients that are Schedule I controlled substances to~~ be ~~available for commercial marketing in the United States~~marketed, ~~the~~and ~~product~~failure ~~must be scheduled by the DEA~~ to ~~Schedule~~comply ~~II,~~with ~~III,~~these IVlaws orand Vregulations, ~~which requires scheduling-related legislative~~ or ~~administrative action, which can further delay~~ the ~~path~~cost toof ~~market.~~compliance ~~There~~with ~~can~~these belaws noand ~~assurance that the DEA will make a favorable scheduling decision. Even assuming categorization as a Schedule II or lower controlled substance (i.e.~~regulations, ~~Schedule~~may ~~III,~~adversely IVaffect ~~or V), at~~ the ~~federal~~results ~~level,~~of ~~such~~our ~~substances~~business ~~would~~operations ~~also~~and ~~require~~our ~~scheduling~~financial ~~determinations under state laws and regulations~~condition.

21In the United States, psychedelics, such as psilocybin (and its active metabolite, psilocin), DMT, mescaline and MDMA, are classified by the Drug Enforcement Administration (“DEA”) as a Schedule I substances under the CSA. The DEA regulates chemical compounds as Schedule I, II, III, IV or V substances. Schedule I substances by-definition have a high potential for abuse, have no currently accepted medical use in the United States, lack accepted safety for use under medical supervision, and may not be prescribed marketed or sold in the United States. Pharmaceutical products approved for use in the United States may be listed as Schedule II, III, IV or V, with Schedule II substances considered to present the highest potential for abuse or dependence and Schedule V substances the lowest relative risk of abuse among such substances. Schedule I and II substances are subject to the strictest controls under the CSA, including manufacturing and procurement quotas, security requirements and criteria for importation. In addition, dispensing of Schedule II substances is further restricted. For example, they may not be refilled without a new prescription and may have a black box warning. For any product containing active ingredients that are Schedule I controlled substances to be available for commercial marketing in the United States, the product must be scheduled by the DEA to Schedule II, III, IV or V, which requires scheduling-related legislative or administrative action, which can further delay the path to market. There can be no assurance that the DEA will make a favorable scheduling decision about our psychedelic-inspired drug candidates. Even assuming categorization as a Schedule II or lower controlled substance (i.e., Schedule III, IV or V), at the federal level, such substances would also require scheduling determinations under state laws and regulations.

FDA approval is also a prerequisite to commercialization, and the controlled-substance status, currently undetermined, of our psychedelic -inspired APIs may negatively impact the FDA’s decision regarding whether to approve the applicable product candidates.

During the pre-market review process, the FDA may determine that additional data is needed for one or more of our psychedelic-inspired drug candidates, either from non-clinical or clinical studies, including with respect to whether, or to what extent, the substance has abuse potential. This may introduce a delay into the approval and any potential rescheduling process.

In addition, therapeutic candidates containing controlled substances are subject to DEA regulations relating to manufacturing, storage, distribution and physician prescription procedures, including:

● DEA registration and inspection of facilities. Facilities conducting research, manufacturing, distributing, importing or exporting, or dispensing controlled substances must be registered (licensed) to perform these activities and have the security, control, recordkeeping, reporting and inventory mechanisms required by the DEA to prevent drug loss and diversion. All these facilities must renew their registrations annually, except dispensing facilities, which must renew every three years. The DEA conducts periodic inspections of certain registered establishments that handle controlled substances. Obtaining and maintaining the necessary registrations may result in delay of the importation, manufacturing or distribution of product candidates. Furthermore, failure to maintain compliance with the CSA, particularly non-compliance resulting in loss or diversion, can result in regulatory action that could have a material adverse effect on our business, financial condition and results of operations. The DEA may seek civil penalties, refuse to renew necessary registrations, or initiate proceedings to restrict, suspend or revoke those registrations. In certain circumstances, violations could lead to criminal proceedings. ● State controlled-substances laws. Individual U.S. states have also established controlled substance laws and regulations. Though state-controlled substances laws often mirror federal law, because the states are separate jurisdictions, they may separately schedule product candidates. While some states automatically schedule a drug based on federal action, other states schedule drugs through rule making or a legislative action. State scheduling may delay commercial sale of any product for which we obtain federal regulatory approval and adverse scheduling could have a material adverse effect on the commercial attractiveness of such product. We or any partners must also obtain separate state registrations, permits or licenses in order to be able to obtain, handle, and distribute controlled substances for clinical trials or commercial sale, and failure to meet applicable regulatory requirements could lead to enforcement and sanctions by the states in addition to those from the DEA or otherwise arising under federal law. ● Clinical trials. Because some of our current and future product candidates contain Schedule I controlled substances, to conduct clinical trials in the United States prior to approval, each of our research sites must submit a research protocol to the DEA and obtain and maintain a DEA researcher registration that will allow those sites to handle and dispense such product candidates and to obtain the product from our importer. If the DEA delays or denies the grant of a researcher registration to one or more research sites, the clinical trial could be significantly delayed, and we could lose clinical trial sites. ● Importation. If any of our product candidates is approved and classified as a Schedule II, III or IV substance, an importer can only import it for commercial purposes if it obtains an importer registration and files an application for an import permit for each import. The DEA provides annual assessments/estimates to the International Narcotics Control Board, which guides the DEA in the amounts of controlled substances that the DEA authorizes to be imported. The failure to identify an importer or obtain the necessary import authority, including specific quantities, could affect the availability of our product candidates and have a material adverse effect on our business, results of operations and financial condition. In addition, an application for a Schedule II importer registration must be published in the Federal Register, and there is a waiting period for third-party comments to be submitted. It is always possible that adverse comments may delay the grant of an importer registration. ● Manufacture. If, because of a Schedule II classification or voluntarily, we were to conduct manufacturing or repackaging/relabeling in the United States, our contract manufacturers would be subject to the DEA’s annual manufacturing and procurement quota requirements. ● Distribution. If any of our product candidates is approved for marketing and scheduled under Schedule II, III or IV, we would also need to identify wholesale distributors with the appropriate DEA registrations and authority to possess and distribute or dispense such products.

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~~The psychedelic~~● ~~APIs~~State controlled-substances laws. Individual U.S. states have also established controlled substance laws and regulations. Though state-controlled substances laws often mirror federal law, because the states are separate jurisdictions, they may separately schedule product candidates. While some states automatically schedule a drug based on federal action, other states schedule drugs through rule making or a legislative action. State scheduling may delay commercial sale of any product for which we ~~intend~~obtain federal regulatory approval and adverse scheduling could have a material adverse effect on the commercial attractiveness of such product. We or any partners must also obtain separate state registrations, permits or licenses in order to ~~utilize~~be ~~are~~able ~~listed~~to asobtain, ~~Schedule~~handle, Iand distribute controlled substances ~~under~~for clinical trials or commercial sale, and failure to meet applicable regulatory requirements could lead to enforcement and sanctions by the ~~CSA~~states in addition to those from the ~~United~~DEA ~~States~~or ~~and~~otherwise arising under ~~similar controlled~~federal law. ● Clinical trials. The abuse liability potential of our psychedelic-inspired drug candidates has not yet been studied. A Human Abuse Potential study or an equivalent study may determine that, upon regulatory approval, our drug candidate will be a Schedule I controlled substance. ~~legislation~~Therefore, inany ~~other~~future ~~countries~~research or development activities with the approved drug may require submission of a preclinical or clinical protocols to the DEA and obtaining and maintaining a DEA license for each site that uses the approved drug. In that situation, if the DEA delays or denies the grant of a researcher registration to one or more research sites, future clinical trials could be significantly delayed, and ~~any~~we ~~significant~~could ~~violations~~lose clinical trial sites. ● Importation. If any of ~~these~~our ~~laws~~product candidates is approved and ~~regulations~~classified as a Schedule II, III or ~~changes~~IV substance, an importer can only import it for commercial purposes if it obtains an importer registration and files an application for an import permit for each import. The DEA provides annual assessments/estimates to the International Narcotics Control Board, which guides the DEA in the ~~laws~~ amounts of controlled substances that the DEA authorizes to be imported. The failure to identify an importer or obtain the necessary import authority, including specific quantities, could affect the availability of our product candidates and ~~regulations~~have a material adverse effect on our business, results of operations and financial condition. In addition, an application for a Schedule II importer registration must be published in the Federal Register, and there is a waiting period for third-party comments to be submitted. It is always possible that adverse comments may ~~result~~delay the grant of an importer registration. ● Manufacture. If, because of a Schedule II classification or voluntarily, we were to conduct manufacturing or repackaging/relabeling in ~~interruptions~~the United States, our contract manufacturers would be subject to the DEA’s annual manufacturing and procurement quota requirements. ● Distribution. If any of our ~~development~~product ~~activity~~candidates is approved for marketing and scheduled under Schedule II, III or ~~business~~IV, ~~continuity~~we would also need to identify wholesale distributors with the appropriate DEA registrations and authority to possess and distribute or dispense such products.

~~The~~If the psychedelic-inspired APIs and drug products that we intend to utilize ~~are~~in ~~categorized as Schedule I controlled substances under~~ the ~~CSA and are similarly categorized by most states and foreign governments. Even assuming any~~ future ~~therapeutic candidates containing such APIs~~ are ~~approved~~determined ~~and scheduled by regulatory authorities~~ to ~~allow their commercial marketing, the ingredients in such therapeutic candidates will likely continue to~~ be ~~listed under~~ Schedule I, orcontrolled substances ~~the~~under ~~state or foreign equivalent and, thus, illegal without~~ the ~~requisite~~CSA ~~regulatory~~in ~~authorizations (e.g., to allow for~~ the ~~use~~United ofStates ~~such~~and ~~substances in clinical trials~~ under ansimilar ~~IND~~controlled-substance ~~and~~legislation in ~~compliance~~other ~~with all applicable FDA~~countries, ~~DEA,~~any ~~and other regulatory~~significant ~~requirements).~~violations ~~Violations~~ of ~~any~~these ~~federal, state or foreign~~ laws and regulations ~~could result in significant fines~~, ~~penalties, administrative sanctions, convictions~~ or ~~settlements~~changes arising from civil proceedings conducted by either the federal government or private citizens, or criminal charges and penalties, including, but not limited to, disgorgement of profits, cessation of business activities, divestiture or prison time. This could have a material adverse effect on us, including on our reputation and ability to conduct business, our financial position, operating results, profitability or liquidity, the potential listing of our shares or the market price of our shares. In addition, it is difficult for us to estimate the time or resources that would be needed for the investigation or defense of any such matters or our final resolution because, in ~~part,~~ the ~~time~~laws and ~~resources that may be needed are dependent on the nature and extent of any information requested by the applicable authorities involved~~regulations, and such time or resources could be substantial. It is also illegal to aid or abet such activities or to conspire or attempt to engage in such activities. An investor’s contribution to and involvement in such activities may result in ~~federal~~interruptions ~~civil and/or criminal prosecution, including, but not limited~~ to, ~~forfeiture~~our ofdevelopment ~~his, her or its entire investment,~~activity ~~fines and/~~or ~~imprisonment~~business continuity.

The psychedelic-inspired APIs we intend to utilize have not yet been studied in preclinical or clinical abuse liability studies and may be categorized as Schedule I controlled substances under the CSA or the state or foreign equivalent and would likely be. illegal without the requisite regulatory authorizations (e.g., to allow for the use of such substances in clinical trials under an IND and in compliance with all applicable FDA, DEA, and other regulatory requirements). Violations of any federal, state or foreign laws and regulations could result in significant fines, penalties, administrative sanctions, convictions or settlements arising from civil proceedings conducted by either the federal government or private citizens, or criminal charges and penalties, including, but not limited to, disgorgement of profits, cessation of business activities, divestiture or prison time. If such were to occur, this could have a material adverse effect on us, including on our reputation and ability to conduct business, our financial position, operating results, profitability or liquidity, the potential listing of our shares or the market price of our shares. In addition, it is difficult for us to estimate the time or resources that would be needed for the investigation or defense of any such matters or our final resolution because, in part, the time and resources that may be needed are dependent on the nature and extent of any information requested by the applicable authorities involved, and such time or resources could be substantial. It is also illegal to aid or abet such activities or to conspire or attempt to engage in such activities. An investor’s contribution to and involvement in such activities may result in federal civil and/or criminal prosecution, including, but not limited to, forfeiture of his, her or its entire investment, fines and/or imprisonment.

Various federal, state, provincial and local laws govern our business in any jurisdictions in which we may operate, and to which we may export our products, including laws relating to health and safety, the conduct of our operations, and the production, storage, sale and distribution of our products. Complying with these laws requires that we comply concurrently with complex federal, state, provincial and/or local laws. These laws change frequently and may be difficult to interpret and apply. To ensure our compliance with these laws, we will need to invest significant financial and managerial resources. It is impossible for us to predict the cost of such laws or the effect they may have on our future operations. A failure to comply with these laws could negatively affect our business and harm our reputation. Changes to these laws could negatively affect our competitive position and the markets in which we operate, and there is no assurance that various levels of government in the jurisdictions in which we operate will not pass legislation or regulation that adversely impacts our business.

In addition, even if we or third parties were to conduct activities in compliance with U.S. state or local laws or the laws of other countries and regions in which we conduct activities, potential enforcement proceedings could involve significant restrictions being imposed upon us or third parties, while diverting the attention of key executives. Such proceedings could have a material adverse effect on our business, revenue, operating results and financial condition as well as on our reputation and prospects, even if such proceedings conclude successfully in our favor. In the extreme case, such proceedings could ultimately involve the criminal prosecution of our key executives, the seizure of corporate assets, and consequently, our inability to continue business operations. Strict compliance with state and local laws with respect to psilocybin and psilocin does not absolve us of potential liability under U.S. federal law, the Canadian law or EU law, nor provide a defense to any proceeding which may be brought against us. Any such proceedings brought against us may adversely affect our operations and financial performance.

Our prospective products will be subject to the various federal and state laws and regulations relating to health and safety.

We are in the process of developing investigational new drugs for which we intend to pursue FDA approval via the NDA process. In connection with our development and future commercialization (if applicable) of our products, we and each contemplated product candidate are subject to the ~~Federal Food Drug and Cosmetic Act (~~FDCA). The FDCA is intended to assure the consumer, in part, that drugs and devices are safe and effective for their intended uses and that all labeling and packaging is truthful, informative, and not deceptive. The FDCA and FDA regulations define the term “drug,” in part, by reference to its intended use, as “articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease” and “articles (other than food) intended to affect the structure or any function of the body of man or other animals.” Therefore, almost any ingested or topical or injectable product that, through its label or labeling (including internet websites, promotional pamphlets, and other marketing material), that is claimed to be beneficial for such uses will be regulated by FDA as a drug. The definition also includes components of drugs, such as active pharmaceutical ingredients. Drugs must generally either receive premarket approval by FDA through the NDA process or conform to a “monograph” for a particular drug category, as established by FDA’s ~~Over-the-Counter (~~OTC) Drug Review. If the FDA does not award premarket approval for our product candidates through the NDA process, this could have a material adverse effect on our business, financial condition and results of operations.

Clinical trials are expensive, time-consuming, uncertain and susceptible to change, delay or termination. The results of clinical trials are open to differing interpretations.

We currently have ~~two~~one ~~product~~drug ~~candidates~~candidate that ~~are~~is in preclinical development for indications such as ~~Radiation~~depression ~~Dermatitis~~ and ~~other side-effects of cancer, including~~ anxiety. We intend to develop additional drug candidates targeting other indications, including, for example, ~~pain~~ addiction and PTSD. After completing the requisite preclinical testing, submissions to the FDA (namely IND applications), internal review board (“IRB”) review, and any other applicable obligations that must be completed before clinical testing may begin in the United States, we must conduct extensive clinical trials to demonstrate the safety and efficacy of our product candidates. Clinical testing is expensive, time consuming, and uncertain as to outcome. We cannot guarantee that any clinical trials will be conducted as planned or completed on schedule, or at all. Failures in connection with one or more clinical trials can occur at any stage of testing.

The FDA and other applicable regulatory agencies may analyze or interpret the results of clinical trials differently than us. Even if the results of our clinical trials are favorable, the clinical trials for a number of our product candidates are expected to continue for several years and may take significantly longer to complete. Events that may prevent successful or timely completion of clinical development include (without limitation):

● delays in reaching a consensus with regulatory authorities on trial design; ● delays in reaching agreement on acceptable terms with prospective ~~contract~~CROs ~~research organization (“CRO”)~~ and clinical trial sites; ● delays in sourcing materials and research animals for preclinical testing and correlated testing windows at the appropriate CRO facilities; ● delays in opening clinical trial sites or obtaining required IRB or independent ethics committee approval at each clinical trial site; ● actual or perceived lack of effectiveness of any product candidate during clinical trials; ● discovery of serious or unexpected toxicities or side effects experienced by trial participants or other safety issues, such as drug interactions, including those which cause confounding changes to the levels of other concomitant medications; ● slower than expected rates of subject recruitment and enrollment rates in clinical trials; ● difficulty in retaining subjects for the entire duration of applicable clinical studies (as study subjects may withdraw at any time due to adverse side effects from the therapy, insufficient efficacy, fatigue with the clinical trial process or for any other reason); ● delays or inability in manufacturing or obtaining sufficient quantities of materials for use in clinical trials due to regulatory and manufacturing constraints; ● inadequacy of or changes in our manufacturing process or product candidate formulation; ● delays in obtaining regulatory authorizations, such as INDs and any others that must be obtained, maintained, and/or satisfied to commence a clinical trial, including “clinical holds” or delays requiring suspension or termination of a trial by a regulatory agency, such as the FDA, before or after a trial is commenced; ● changes in applicable regulatory policies and regulation, including changes to requirements imposed on the extent, nature or timing of studies; ● delays or failure in reaching agreement on acceptable terms in clinical trial contracts or protocols with prospective clinical trial sites; ● uncertainty regarding proper dosing; ● delay or failure to supply product for use in clinical trials which conforms to regulatory specification; ● unfavorable results from ongoing preclinical studies and clinical trials; ● failure of our CROs, or other third-party contractors to comply with all contractual requirements or to perform their services in a timely or acceptable manner; ● failure by us, our employees, our CROs or their employees to comply with all applicable FDA or other regulatory requirements relating to the conduct of clinical trials; ● scheduling conflicts with participating clinicians and clinical institutions; ● failure to design appropriate clinical trial protocols; ● regulatory concerns with psychedelics, ~~generally, and the potential for abuse; ● insufficient data to support regulatory approval; ● inability~~ or unwillingness of medical investigators to follow our clinical protocols; ● difficulty in maintaining contact with patients during or after treatment, which may result in incomplete data; ● any clinical holds placed on company by regulatory agencies during review process; ● delay or failure to supply psychedelic ~~product for use in clinical trials due to cross~~-~~border~~inspired ordrug ~~inter-continental~~candidates, ~~shipment~~generally, ~~or customs handling~~ and ~~processing of controlled substances; or ● difficulty finding clinical trials sites whose investigators possess~~ the ~~requisite~~potential ~~credentials~~for ~~to oversee clinical trials involving a Schedule I substance.~~abuse;

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~~Any of~~● ~~the~~insufficient ~~foregoing~~data ~~could~~to ~~have~~support aregulatory ~~material~~approval; ~~adverse~~● ~~effect~~inability onor unwillingness of medical investigators to follow our ~~business~~clinical protocols; ● difficulty in maintaining contact with patients during or after treatment, ~~financial~~which ~~condition~~may ~~and~~result ~~results~~in ofincomplete ~~operations.~~data;

~~Certain third-parties~~● weany ~~rely~~clinical holds placed on company by regulatory agencies during review process; ● delay or failure to ~~conduct~~supply ~~our~~psychedelic-inspired ~~operations~~drug ~~are~~candidate ~~subject~~for use in clinical trials due to ~~regulatory~~cross-border ~~requirements~~or inter-continental shipment or customs handling and processing of controlled substances; or ● difficulty finding clinical trials sites whose investigators possess the requisite credentials to oversee clinical trials involving a Schedule I substance, should such be required.

Certain third-parties we rely on to conduct our operations are subject to regulatory requirements.

We rely on third parties to conduct our preclinical studies and expect to use clinical studies in the future. We rely on CROs and clinical data management organizations to design, conduct, supervise and monitor our preclinical studies and clinical trials. We and our CROs are required to comply with various regulations, including GCP, which are enforced by regulatory agencies, to ensure that the health, safety and rights of patients are protected in clinical development and clinical trials, and that trial data integrity is assured. Regulatory authorities ensure compliance with these requirements through periodic inspections of trial sponsors, principal investigators and trial sites. Our reliance on third parties that we do not control does not relieve us of these responsibilities and requirements. If we or any of our CROs fail to comply with applicable requirements, the clinical data generated in our clinical trials may be deemed unreliable and the FDA or other comparable foreign regulatory authorities may require us to perform additional clinical trials before approving our marketing applications. Because we rely on third parties, our internal capacity to perform these functions is limited. Outsourcing these functions involves risk that third parties may not perform to our standards, may not produce results in a timely manner or may fail to perform at all.

We rely on third parties to supply the materials for, and manufacture, our research and development, and preclinical and clinical trial supplies and APIs, and we expect to continue to rely on third-party manufacturers if we receive regulatory approval for any product candidate. To the extent that we have existing, or enter into future, manufacturing arrangements with third parties, we will depend on these third parties to perform their obligations in a timely manner consistent with contractual and regulatory requirements, including those related to quality control and assurance.

Difficulty or delays in enrolling patients in clinical trials may result in delay or prevention of necessary regulatory approvals.

If we are unable to locate and enroll a sufficient number of eligible patients to participate in our clinical trials for our product candidates as required by the FDA or similar regulatory authorities outside the United States, we may not be able to initiate or conduct our trials. Our inability to enroll a sufficient number of patients for our trials would result in significant delays could require us to postpone or abandon clinical trials. Enrollment delays may result in increased development costs for our product candidates.

Any failure by us to comply with existing regulations could harm our reputation and operating results.

We are subject to extensive regulation by U.S. federal and state and foreign governments in each of the U.S., European and Canadian markets, in which we plan to sell our product candidates. We must adhere to all regulatory requirements, including FDA’s ~~Good Laboratory Practice (“~~GLP”), GCP, and ~~GMP~~ cCMP requirements, pharmacovigilance requirements, advertising and promotion restrictions, reporting and recordkeeping requirements, and their European equivalents. If we or our suppliers fail to comply with applicable regulations, including FDA pre-or post-approval requirements, then the FDA or other foreign regulatory authorities could sanction ~~our~~the Company. Even if a drug is approved by the FDA or other competent authorities, regulatory authorities may impose significant restrictions on a product’s indicated uses or marketing or impose ongoing requirements for potentially costly post-marketing trials.

Any of our product candidates which may be approved in the U.S. will be subject to ongoing regulatory requirements for manufacturing, labeling, packaging, storage, distribution, import, export, advertising, promotion, sampling, recordkeeping and submission of safety and other post-market information, including both federal and state requirements. In addition, manufacturers and manufacturers’ facilities are required to comply with extensive FDA requirements, including ensuring that quality control and manufacturing procedures conform to GMP. As such, we and our contract manufacturers (in the event contract manufacturers are appointed in the future) are subject to continual review and periodic inspections to assess compliance with GMP. Accordingly, we and others with whom we work will have to spend time, money and effort in all areas of regulatory compliance, including manufacturing, production, quality control and quality assurance. We will also be required to report certain adverse reactions and production problems, if any, to the FDA, and to comply with requirements concerning advertising and promotion for our products. Promotional communications with respect to prescription drugs are subject to a variety of legal and regulatory restrictions and must be consistent with the information in the product’s approved label. Similar restrictions and requirements exist in the European Union and other markets where we operate.34

25Any of our product candidates which may be approved in the U.S. will be subject to ongoing regulatory requirements for manufacturing, labeling, packaging, storage, distribution, import, export, advertising, promotion, sampling, recordkeeping and submission of safety and other post-market information, including both federal and state requirements. In addition, manufacturers and manufacturers’ facilities are required to comply with extensive FDA requirements, including ensuring that quality control and manufacturing procedures conform to cCMP. As such, we and our contract manufacturers (in the event contract manufacturers are appointed in the future) are subject to continual review and periodic inspections to assess compliance with cCMP. Accordingly, we and others with whom we work will have to spend time, money and effort in all areas of regulatory compliance, including manufacturing, production, quality control and quality assurance. We will also be required to report certain adverse reactions and production problems, if any, to the FDA, and to comply with requirements concerning advertising and promotion for our products. Promotional communications with respect to prescription drugs are subject to a variety of legal and regulatory restrictions and must be consistent with the information in the product’s approved label. Similar restrictions and requirements exist in the European Union and other markets where we operate.

If a regulatory agency discovers previously unknown problems with a product, such as adverse events of unanticipated severity or frequency, or problems with the facility where the product is manufactured, or disagrees with the promotion, marketing or labeling of the product, it may impose restrictions on that product or on us, including requiring withdrawal of the product from the market. If we fail to comply with applicable regulatory requirements, a regulatory agency or enforcement authority may:

● issue warning letters; ● impose civil or criminal penalties; ● suspend regulatory approval; ● suspend any of our ongoing clinical trials; ● refuse to approve pending applications or supplements to approved applications submitted by us; ● impose restrictions on our operations, including by requiring us to enter ininto to a Corporate Integrity Agreement or closing our contract manufacturers’ facilities, if any; or ● seize or detain products or require a product recall.

We may be subject to federal, state and foreign healthcare laws and regulations and implementation of or changes to such healthcare laws and regulations could adversely affect our business and results of operations.

If we successfully complete the requisite preclinical and clinical testing, make the required regulatory submissions and obtain any corresponding authorizations or licenses (as applicable), fulfill all other applicable development-related regulatory obligations, and, eventually, obtain FDA approval to market one or more of our current or future product candidates in the United States, we may be subject to certain healthcare laws and regulations. In both the U.S. and certain foreign jurisdictions, there have been a number of legislative and regulatory proposals to change the healthcare system in ways that could impact our ability to sell our future product candidates. If we are found to be in violation of any of these laws or any other federal, state or foreign regulations, we may be subject to administrative, civil and/or criminal penalties, damages, fines, individual imprisonment, exclusion from federal health care programs and the restructuring of our operations. Any of these could have a material adverse effect on our business and financial results. Since many of these laws have not been fully interpreted by the courts, there is an increased risk that we may be found in violation of one or more of their provisions. Any action against us for violation of these laws, even if we are ultimately successful in our defense, will cause us to incur significant legal expenses and divert our management’s attention away from the operation of our business. In addition, in many foreign countries, particularly the countries of the European Union, the pricing of prescription drugs is subject to government control.

In some foreign countries, the proposed pricing for a drug must be approved before it may be lawfully marketed. The requirements governing drug pricing vary widely from country to country. For example, some European Union jurisdictions operate positive and negative list systems under which products may only be marketed once a reimbursement price has been agreed. To obtain reimbursement or pricing approval, some of these countries may require the completion of clinical trials that compare the cost effectiveness of a particular product candidate to currently available therapies. Other member states allow companies to fix their own prices for medicines but monitor and control company profits. Such differences in national pricing regimes may create price differentials between European Union member states. There can be no assurance that any country that has price controls or reimbursement limitations for pharmaceutical products will allow favorable reimbursement and pricing arrangements for any of our products.

Historically, products launched in the European Union do not follow price structures of the U.S.. In the European Union, the downward pressure on healthcare costs in general, particularly prescription medicines, has become intense. As a result, barriers to entry of new products are becoming increasingly high and patients are unlikely to use a drug product that is not reimbursed by their government.

We may face competition from lower-priced products in foreign countries that have placed price controls on pharmaceutical products. In addition, the importation of foreign products may compete with any future product that we may market, which could negatively impact our profitability.

Specifically in the U.S., we expect that the 2010 Affordable Care Act (“ACA”), as well as other healthcare reform measures that may be adopted in the future, may result in more rigorous coverage criteria and in additional downward pressure on the price that we may receive for any approved product. There have been judicial challenges to certain aspects of the ACA and numerous legislative attempts to repeal and/or replace the ACA in whole or in part, and we expect there will be additional challenges and amendments to the ACA in the future. At this time, the full effect that the ACA will have on our business in the future remains unclear. An expansion in the government’s role in the U.S. healthcare industry may cause general downward pressure on the prices of prescription drug products, lower reimbursements or any other product for which we obtain regulatory approval, reduce product utilization and adversely affect our business and results of operations. Any reduction in reimbursement from Medicare or other government programs may result in a similar reduction in payments from private payors. Several states have adopted or are considering adopting laws that require pharmaceutical companies to provide notice prior to raising prices and to justify price increases. We expect that additional healthcare reform measures will be adopted in the future, any of which could limit the amounts that federal and state governments will pay for healthcare products and services, and in turn could significantly reduce the projected value of certain development projects and reduce our profitability. The implementation of such cost containment measures and other healthcare reforms may prevent us from being able to generate revenue, attain profitability, or commercialize any of our future product candidates for which we may receive regulatory approval.

There is a high rate of failure for drug candidates proceeding through clinical trials.

We have no products on the market. None of our prospective products or investigational candidates have ever been tested in a human subject. Our ability to achieve and sustain profitability with respect to our product candidates depends on obtaining regulatory approvals for and, if approved, successfully commercializing our product candidates, either alone or with third parties. Before obtaining regulatory approval for the commercial distribution of our product candidates, we or an existing or future collaborator must conduct extensive preclinical tests and clinical trials to demonstrate the safety, purity and potency of our product candidates.

Generally, there is a high rate of failure for drug candidates proceeding through clinical trials. We may suffer significant setbacks in our clinical trials similar to the experience of a number of other companies in the pharmaceutical and biotechnology industries, even after receiving promising results in earlier trials. Further, even if we view the results of a clinical trial to be positive, the FDA or other regulatory authorities may disagree with our interpretation of the data. In the event that we obtain negative results from clinical trials for product candidates or other problems related to potential chemistry, manufacturing and control issues or other hurdles occur and our future product candidates are not approved, we may not be able to generate sufficient revenue or obtain financing to continue our operations, our ability to execute on our current business plan may be materially impaired, and our reputation in the industry and in the investment community might be significantly damaged. In addition, our inability to properly design, commence and complete clinical trials may negatively impact the timing and results of our clinical trials and ability to seek approvals for our drug candidates.

The testing, marketing and manufacturing of any new drug product for use in the United States will require approval from the FDA. We cannot predict with any certainty the amount of time necessary to obtain such FDA approval and whether any such approval will ultimately be granted. Preclinical studies and clinical trials may reveal that one or more products are ineffective or unsafe, in which event further development of such products could be seriously delayed or terminated. Moreover, obtaining approval for certain products may require testing on human subjects of substances whose effects on humans are not fully understood or documented. Delays in obtaining FDA or any other necessary regulatory approvals of any proposed drug and failure to receive such approvals would have an adverse effect on the drug’s potential commercial success and on our business, prospects, financial condition and results of operations. In addition, it is possible that a proposed drug may be found to be ineffective or unsafe due to conditions or facts that arise after development has been completed and regulatory approvals have been obtained. In this event, we may be required to withdraw such proposed drug from the market. To the extent that our success will depend on any regulatory approvals from government authorities outside of the United States that perform roles similar to that of the FDA, uncertainties similar to those stated above will also exist.

Serious adverse events or other safety risks could require us to abandon development and preclude, delay or limit approval of our prospective products or current or future product candidates, limit the scope of any approved label or market acceptance, or cause the recall or loss of marketing approval of products that are already marketed.

If any of our prospective products or current or future product candidates, prior to or after any approval for commercial sale, cause serious or unexpected side effects, or are associated with other safety risks such as misuse, abuse or diversion, a number of potentially significant negative consequences could result, including:

●	regulatory authorities may interrupt, delay or halt clinical trials;

●	regulatory authorities may deny regulatory approval of our future product candidates;

●	regulatory authorities may require certain labeling statements, such as warnings or contraindications or limitations on the indications for use, and/or impose restrictions on distribution in the form of a Risk Evaluation and Mitigation Strategy (“REMS”) in connection with approval or post-approval;

●	regulatory authorities may withdraw their approval, require more onerous labeling statements, impose a more restrictive REMS, or require it to recall any product that is approved;

●	we may be required to change the way the product is administered or conduct additional clinical trials;

●	our relationships with our collaboration partners may suffer;

●	we could be sued and held liable for harm caused to patients; or

●	our reputation may suffer. The reputational risk is heightened with respect to those of our future product candidates that are being developed for pediatric indications.

Additionally, in light of the recent budget and staffing cuts at the FDA, the FDA may experience delays reviewing or approving our prospective products or current or future product candidates, which could impair our ability to commercialize our prospective products or current or future product candidates and have a material adverse effect on the business, financial condition and operating results of the Company.

We may voluntarily suspend or terminate our clinical trials if at any time we believe that the product candidates present an unacceptable risk to participants, or if preliminary data demonstrates that our future product candidates are unlikely to receive regulatory approval or unlikely to be successfully commercialized.

After completing preclinical testing and obtaining the requisite regulatory authorizations, as applicable, we may voluntarily suspend or terminate our clinical trials for any number of reasons, including if we believe that a product’s use, or a person’s exposure to it, may cause adverse health consequences or death. In addition, regulatory agencies, IRBs or data safety monitoring boards may at any time recommend the temporary or permanent discontinuation of our clinical trials or request that we cease using investigators in the clinical trials if they believe that the clinical trials are not being conducted in accordance with applicable regulatory requirements, or that they present an unacceptable safety risk to participants. Although we have never been asked by a regulatory agency, IRB or data safety monitoring board to temporarily or permanently discontinue a clinical trial, if we elect or are forced to suspend or terminate a clinical trial of any of our future product candidates, the commercial prospects for that product will be harmed and our ability to generate product revenue from that product may be delayed or eliminated. Furthermore, any of these events may result in labeling statements such as warnings or contraindications.

In addition, such events or labeling could prevent us or our partners from achieving or maintaining market acceptance of the affected product and could substantially increase the costs of commercializing our future product candidates and impair our ability to generate revenue from the commercialization of these products either by us or by our collaboration partners.

~~Regulatory risks related to Psychedelic Derivatives~~37

~~Successful~~Regulatory ~~execution~~risks ofrelated ~~our strategy is contingent, in part, upon compliance with regulatory requirements from time~~ to time enacted by governmental authorities and obtaining all regulatory approvals, where necessary, for the development and license of our Psychedelic Derivatives. Health Canada and the FDA have not yet determined whether our Psychedelic Derivatives will be scheduled as controlled substances. The psychedelic ~~therapy industry is a new and emerging industry with ambiguous existing regulations and uncertainty as to future regulations; We cannot predict the impact of the ever~~-~~evolving~~inspired ~~compliance~~drug regime in respect of this industry. In the event Health Canada or the FDA determine that our Psychedelic Derivatives are controlled substances and therefore, require regulatory approval, to the extent that we produce Psychedelic Derivatives, we will be required to obtain such regulatory approval.candidates

~~Further,~~Successful weexecution ~~may~~of ~~not~~our bestrategy ~~able~~is tocontingent, ~~predict~~in ~~the~~part, ~~time~~upon ~~required~~compliance with regulatory requirements from time to ~~secure~~time ~~all~~enacted ~~appropriate~~by ~~regulatory~~governmental authorities ~~approvals~~and ~~for~~obtaining ~~our~~all ~~Psychedelic~~regulatory ~~Derivatives~~approvals, orwhere necessary, for the ~~extent~~ development of ~~testing~~our ~~and~~psychedelic-inspired ~~documentation~~drug ~~that~~candidates. The ~~may,~~abuse ~~from~~liability ~~time~~potential toof ~~time,~~our bepsychedelic-inspired ~~required~~drug bycandidates ~~governmental~~has ~~authorities.~~not ~~The~~yet ~~impact~~been ofstudied ~~compliance~~in ~~regimes, any~~preclinical ~~delays~~or inclinical ~~obtaining~~studies. Therefore, Health Canada or ~~failure~~the toFDA ~~obtain~~have ~~regulatory~~not ~~approvals~~yet ~~may~~determined ~~significantly~~whether ~~delay~~our orpsychedelic-inspired ~~impact~~drug ~~the~~candidates ~~development~~will ofbe ~~markets,~~scheduled ~~our~~as controlled ~~business~~substances. ~~and~~Based ~~Psychedelic~~on ~~Derivatives,~~the ~~and~~studies ~~licensing~~Health ~~initiatives~~Canada ~~and~~or ~~could~~the ~~have~~FDA aor ~~material~~other ~~adverse~~regulatory ~~effect~~authorities onmay ~~the~~determine ~~business,~~that ~~financial~~our ~~condition~~psychedelic-inspired drug candidates are controlled substances and ~~operating~~therefore, ~~results~~would ofrequire classification as a controlled substance with all the ~~Company~~requisite controls.

Further, we may not be able to predict the time required to secure all appropriate regulatory approvals for our psychedelic-inspired drug candidates, or the extent of testing and documentation that may, from time to time, be required by governmental authorities. The impact of compliance regimes, any delays in obtaining, or failure to obtain regulatory approvals may significantly delay or impact the development of markets, our business and psychedelic-inspired drug candidates, and licensing initiatives and could have a material adverse effect on the business, financial condition and operating results of the Company.

We will incur ongoing costs and obligations related to regulatory compliance. Failure to comply with regulations may result in additional costs for corrective measures, penalties or result in restrictions on our operations. In addition, changes in regulations, more vigorous enforcement thereof or other unanticipated events could require extensive changes to our operations, increased compliance costs or give rise to material liabilities, which could have a material adverse effect on the business, financial condition and operating results of the Company.

Our management will be required to devote a substantial time to comply with public company regulations.

As a public company, we incur significant legal, accounting and other expenses that we did not incur as a private company. The Sarbanes-Oxley Act of 2002 (the “Sarbanes-Oxley Act”), the Dodd-Frank Wall Street Reform and Consumer Protection Act as well as rules implemented by the SEC and Nasdaq, impose various requirements on public companies, including those related to corporate governance practices. Our management and other personnel must devote a substantial amount of time to these requirements. Moreover, these rules and regulations increase our legal and financial compliance costs and make some activities more time consuming and costly.

The Sarbanes-Oxley Act requires, among other things, that we maintain effective internal control over financial reporting and disclosure controls and procedures. In particular, we must perform system and process evaluation and testing of our internal control over financial reporting to allow management to report on the effectiveness of our internal control over financial reporting, as required by Section 404 of the Sarbanes-Oxley Act. Our compliance with these requirements will require that we incur substantial accounting and related expenses and expend significant management efforts. We have engaged third party consultants to help satisfy the ongoing requirements of Section 404 of the Sarbanes-Oxley Act. The costs of this outsourcing may be material and there can be no assurance that such staff will be immediately available to us. Moreover, if we are not able to comply with the requirements of Section 404 of the Sarbanes-Oxley Act, or if we identify deficiencies in our internal control over financial reporting that are deemed to be material weaknesses, investors could lose confidence in the accuracy and completeness of our financial reports, the market price of our ~~common~~Common ~~stock~~Stock could decline and we could be ~~subject~~ subject to sanctions or investigations by Nasdaq, the SEC or other regulatory authorities, which could require additional financial and ~~management~~ management resources.

2838

We have identified a material weakness in our internal control over financial reporting. If we are unable to remediate the material weakness, or if we experience additional material weaknesses in the future, our business may be harmed.

Our management is responsible for establishing and maintaining adequate internal control over financial reporting and for evaluating and reporting on the effectiveness of our system of internal control. Internal control over financial reporting is a process used to provide reasonable assurance regarding the reliability of our financial reporting and the preparation of our financial statements for external purposes in accordance with generally accepted accounting principles in the United States. As a public company, we are required to comply with the Sarbanes-Oxley Act and other rules that govern public companies. In particular, we are required to certify our compliance with Section 404 of the Sarbanes-Oxley Act, which requires us to furnish annually a report by management on the effectiveness of our internal control over financial reporting.

Our management performed an assessment of the Company’s significant processes and key controls. Based on this assessment, management concluded that our internal control over financial reporting was not effective as of December 31, ~~2023~~2024 and ~~September~~December 3031, ~~2024~~ 2023 due to the material weakness related to segregation of duties. As of December 31, ~~2023~~2024 and ~~September~~December 3031, ~~2024~~2023, there were control deficiencies which constituted a material weakness in our internal control over financial reporting. Management has taken, and is taking steps to strengthen our internal control over financial reporting: we have conducted evaluation of the material weakness to determine the appropriate remedy and have established procedures for documenting disclosures and disclosure controls.

Due to the small size of ~~our~~the Company, we do not maintain sufficient segregation of duties to ensure the processing, review and authorization of all transactions including non-routine transactions. While we have taken certain actions to address the material weaknesses identified, additional measures including engaging third -party consultants may be necessary as we work to improve the overall effectiveness of our internal controls over financial reporting.

Remediation efforts place a significant burden on management and add increased pressure to our financial resources and processes. If we are unable to successfully remediate our existing material weakness or any additional material weaknesses in our internal control over financial reporting that may be identified in the future in a timely manner, the accuracy and timing of our financial reporting may be adversely affected; our liquidity, our access to capital markets, the perceptions of our creditworthiness may be adversely affected; we may be unable to maintain or regain compliance with applicable securities laws, or the listing requirements of ~~the~~ Nasdaq ~~Stock Market~~; we may be subject to regulatory investigations and penalties; investors may lose confidence in our financial reporting; our reputation may be harmed; and our stock price may decline.

Tax risk

We are subject to various taxes in either the United States, Canada and Australia, or all three, including, without limitation, the following: income taxes, payroll taxes, workers compensation, goods and services tax, sales tax, and land transfer tax. Our tax filings will be subject to audit by various taxation authorities. While we intend to base its tax filings and compliance on the advice of our tax advisors, there can be no assurance that our tax filing positions will never be challenged by a relevant taxation authority resulting in a greater than anticipated tax liability.

Risks Related to Our Intellectual Property

We may not be able to adequately protect or enforce our intellectual property rights, which could harm our competitive position.

Our success will depend, in part, on our ability to obtain and maintain additional patents, protect our trade secrets and operate without infringing on the proprietary rights of others. We rely upon a combination of patents, trade secret protection (i.e., know-how), and confidentiality agreements to protect the intellectual property of our future product candidates. The strengths of patents in the pharmaceutical field involve complex legal and scientific questions and can be uncertain. Where appropriate, we seek patent protection for certain aspects of our products and technology. Filing, prosecuting and defending patents globally can be prohibitively expensive.

Our policy is to look to patent technologies with commercial potential in jurisdictions with significant commercial opportunities. However, patent protection may not be available for some of the products or technology we are developing. If we must spend significant time and money protecting, defending or enforcing our patents, designing around patents held by others or licensing, potentially for large fees, patents or other proprietary rights held by others, our business, results of operations and financial condition may be harmed. We may not develop additional proprietary products that are patentable.

The patent positions of pharmaceutical products are complex and uncertain. The scope and extent of patent protection for our future product candidates are particularly uncertain. Although we have sought, and will continue to seek, patent protection in the U.S., Europe and other countries for our proprietary technologies, future product candidates, their methods of use, and methods of manufacture, any or all of them may not be subject to effective patent protection. If any of our products is approved and marketed for an indication for which we do not have an issued patent, our ability to use our patents to prevent a competitor from commercializing a non-branded version of our commercial products for that non-patented indication could be significantly impaired or even eliminated.

Publication of information related to our future product candidates by us or others may prevent us from obtaining or enforcing patents relating to these products and product candidates. Furthermore, others may independently develop similar products, may duplicate our products, or may design around our patent rights. In addition, any of our issued patents may be opposed and/or declared invalid or unenforceable. If we fail to adequately protect our intellectual property, we may face competition from companies who attempt to create a generic product to compete with our future product candidates. We may also face competition from companies who develop a substantially similar product to our future product candidates that is not covered by any of our patents.

Many companies have encountered significant problems in protecting, defending and enforcing intellectual property rights in foreign jurisdictions. The legal systems of certain countries, particularly certain developing countries, do not favor the enforcement of patents and other intellectual property rights, particularly those relating to pharmaceuticals, which could make it difficult for us to stop the infringement of our patents or marketing of competing products in violation of our proprietary rights generally. Proceedings to enforce our patent rights in foreign jurisdictions could result in substantial cost and divert our efforts and attention from other aspects of our business.

Our success depends on our ability to obtain additional intellectual property and operate without infringing the proprietary rights of others. Infringement claims by third parties may result in liability for damages or prevent or delay our developmental and commercialization efforts.

Our success and ability to compete depend in part on our ability to obtain additional patents, protect our trade secrets, and operate without infringing on the proprietary rights of others. If we fail to adequately protect our intellectual property, we may face competition from companies who develop a substantially similar product to our future product candidates that is not covered by any of our intellectual property. Many companies have encountered significant problems in protecting, defending, and enforcing intellectual property rights in foreign jurisdictions. The legal systems of certain countries, particularly certain developing countries, do not favor the enforcement of patents and other intellectual property rights, particularly those relating to pharmaceuticals, which could make it difficult for us to stop the infringement of our intellectual property and other proprietary rights. There is also a substantial amount of litigation, both within and outside the U.S., involving patient and other intellectual property rights in the pharmaceutical industry. We may, from time to time, be notified of claims that we are infringing upon the proprietary rights of third parties, and we cannot provide assurances that other companies will not, in the future, pursue such infringement claims against it, our commercial partners, or any third-party proprietary technologies we have licensed.

We may be unsuccessful in licensing additional intellectual property to develop new product candidates.

We may in the future seek to in-license additional intellectual property that we believe could complement or expand our product candidates or otherwise offer growth opportunities. The pursuit of such licenses may cause us to incur various expenses in identifying, investigating and pursuing suitable intellectual property. If we acquire additional intellectual property to develop new therapeutic product candidates, we may not be able to realize anticipated cost savings or synergies.

If third parties claim that intellectual property used by us infringes upon their intellectual property, our operating profits could be adversely affected.

There is a substantial amount of litigation, both within and outside the U.S., involving patent and other intellectual property rights in the pharmaceutical industry. We may, from time to time, be notified of claims that we are infringing upon patents, trademarks, copyrights or other intellectual property rights owned by third parties, and we cannot provide assurances that other companies will not, in the future, pursue such infringement claims against us, our commercial partners or any third-party proprietary technologies we have licensed. If we were found to infringe upon a patent or other intellectual property right, or if we failed to obtain or renew a license under a patent or other intellectual property right from a third party, or if a third party that we were licensing technologies from was found to infringe upon a patent or other intellectual property rights of another third party, we may be required to pay damages, including damages of up to three times the damages found or assessed, if the infringement is found to be willful, suspend the manufacture of certain products or reengineer or rebrand our products, if feasible, or we may be unable to enter certain new product markets. Any such claims could also be expensive and time-consuming to defend and divert management’s attention and resources. Our competitive position could suffer as a result. In addition, if we have declined or failed to enter into a valid non-disclosure or assignment agreement for any reason, we may not own the invention or our intellectual property, and our products may not be adequately protected. Thus, we cannot guarantee that any of our future product candidates, or our commercialization thereof, does not and will not infringe any third party’s intellectual property.

If we are not able to adequately prevent disclosure of trade secrets and other proprietary information, the value of our technology and products could be significantly diminished.

We rely on trade secrets to protect our proprietary technologies, especially where it does not believe patent protection is appropriate or obtainable. However, trade secrets are difficult to protect. We rely in part on confidentiality agreements with our current and former employees, consultants, outside scientific collaborators, sponsored researchers, contract manufacturers, vendors and other advisors to protect our trade secrets and other proprietary information. These agreements may not effectively prevent disclosure of confidential information and may not provide an adequate remedy in the event of unauthorized disclosure of confidential information. In addition, we cannot guarantee that we have executed these agreements with each party that may have or have had access to our trade secrets. Any party with whom we or they have executed such an agreement may breach that agreement and disclose our proprietary information, including our trade secrets, and we may not be able to obtain adequate remedies for such breaches.

Enforcing a claim that a party illegally disclosed or misappropriated a trade secret is difficult, expensive and time-consuming, and the outcome is unpredictable. In addition, some courts inside and outside the United States are less willing or unwilling to protect trade secrets. If any of our trade secrets were to be lawfully obtained or independently developed by a competitor, we would have no right to prevent them, or those to whom they disclose such trade secrets, from using that technology or information to compete with us. If any of our trade secrets were to be disclosed to or independently developed by a competitor or other third-party, our competitive position would be harmed.

We may not be able to protect our intellectual property rights effectively outside of the United States.

Filing, prosecuting and defending patents on all of our product candidates throughout the world would be prohibitively expensive. Therefore, we choose to file applications and/or obtained patents only in key markets. Competitors may use our technologies in jurisdictions where we have not obtained patent protection to develop their own products and, further, may be able to export otherwise infringing products to territories where we have patent protection but where enforcement is not as strong as that in the United States. These products may compete with our products in jurisdictions where we do not have any issued patents and/or our patent claims or other intellectual property rights may not be effective or sufficient to prevent them from competing.

Many companies have encountered significant problems in protecting and defending intellectual property rights in certain foreign jurisdictions. The legal systems of certain countries, particularly certain developing countries, do not favor the enforcement of patents and other intellectual property protection, particularly those relating to pharmaceuticals, which could make it difficult to stop the infringement of our patents or marketing of competing products in violation of our proprietary rights generally. Proceedings to enforce our patent rights in certain foreign jurisdictions could result in substantial cost and divert our efforts and attention from other aspects of our business and could be unsuccessful.

Our financial condition would be adversely impacted if our intangible assets become impaired

Intangibles are evaluated quarterly and are tested for impairment at least annually or when events or changes in circumstances indicate the carrying value of each segment, and collectively the Company taken as a whole, might exceed its fair value. If we determine that the value of our intangible assets is less than the amounts reflected on our balance sheet, we will be required to reflect an impairment of our intangible assets in the period in which such determination is made. An impairment of our intangible assets would result in our recognizing an expense in the amount of the impairment in the relevant period, which would also result in the reduction of our intangible assets and a corresponding reduction in our stockholders’ equity in the relevant period.

Risks Related to the Ownership of Our Common Stock

~~In the~~Our ~~event~~Common ~~that~~Stock wecould ~~fail~~be todelisted ~~regain compliance with the listing requirements of~~ from The Nasdaq Capital Market ~~or satisfy any of the listing requirements of Nasdaq, our common stock may be delisted, which could affect our market price and liquidity~~.

Our ~~common~~ ~~stock~~Common Stock is currently listed on Nasdaq. ~~For~~However, ~~continued~~we ~~listing~~cannot onassure ~~Nasdaq,~~you that we will be ~~required~~able to comply with the continued listing ~~requirements, including~~standards ~~the~~of ~~minimum market capitalization standard, the stockholders’ equity requirement, the corporate governance requirements~~Nasdaq. ~~and~~If ~~the~~we ~~minimum~~fail ~~closing~~to ~~bid~~comply ~~price~~with ~~requirement, among other requirements. As indicated earlier in this prospectus,~~ the ~~Company~~continued islisting ~~currently in~~standards ~~default~~ of Nasdaq~~’s Bid Price Rule. Also as noted earlier in this prospectus~~, ~~the~~our ~~Company~~Common isStock inmay ~~the~~become ~~process~~subject ~~of seeking a shareholder approval~~ to ~~effectuate a reverse stock split of its outstanding shares of common stock~~delisting. ~~The~~If ~~principal purpose of the reverse stock split~~Nasdaq isdelists toour ~~increase~~Common ~~the~~Stock from trading ~~price~~on ofits ~~our~~exchange ~~common~~for ~~stock~~failure to meet the ~~Bid~~continued ~~Price~~listing ~~Rule. In order to regain compliance~~standards, ~~the bid price of the Company’s common stock needs to remain at or above $1.00 per share for a minimum of 10 consecutive business days after the effective date of the reverse stock split. However,~~ we ~~cannot~~and ~~provide any assurance that~~ our ~~minimum bid price would remain over the minimum bid~~stockholders ~~price~~could ~~requirement~~face ~~following~~significant ~~the~~material ~~reverse~~adverse ~~stock~~consequences ~~split for that period~~including, orwithout ~~even if it does and we regain compliance, there is no assurance that we will not be in default of the Bid Price Rule or other continued listing requirement of Nasdaq in the future.~~limitation:

31● a limited availability of market quotations for our securities; ● a determination that our Common Stock is a “penny stock” which will require brokers trading in our Common Stock to adhere to more stringent rules and possibly result in a reduced level of trading activity in the secondary trading market for our securities; ● a limited amount of analyst coverage; and ● a decreased ability for us to issue additional securities or obtain additional financing in the future.

InThe ~~the~~market ~~event~~price ~~that we fail to regain compliance with the Bid Price Rule or satisfy any~~ of ~~the listing requirements of Nasdaq,~~ our ~~common stock~~Common Stock may be ~~delisted.~~subject Ifto ~~our~~significant ~~common~~fluctuations ~~stock~~and ~~is delisted from trading on Nasdaq~~volatility, and ~~we are not able to list~~ our ~~common~~stockholders ~~stock~~may onbe ~~another~~unable ~~exchange or~~ to ~~have~~resell ittheir ~~quoted~~shares onat ~~Nasdaq, our securities could be quoted on the OTC Bulletin Board or on the “pink sheets.” As~~ a ~~result,~~profit weand ~~could~~incur ~~face significant adverse consequences including, without limitation:~~losses.

●The amarket ~~limited~~price of ~~availability~~our ofCommon ~~market~~Stock ~~quotations~~could ~~for~~be ~~our~~subject to significant fluctuation. Market prices for securities; ●of alife ~~determination~~sciences ~~that~~and ~~our~~biopharma ~~common~~companies in ~~stock~~particular ishave ahistorically ~~“penny~~been ~~stock”~~particularly ~~which~~volatile ~~will~~and ~~require~~have ~~brokers~~shown ~~trading~~extreme inprice ~~our~~and ~~common~~volume ~~stock~~fluctuations tothat ~~adhere~~have often been unrelated or disproportionate to ~~more~~the ~~stringent~~operating ~~rules~~performance ~~and~~of ~~possibly~~those ~~result~~companies. inBroad amarket ~~reduced~~and ~~level~~industry offactors, ~~trading~~as ~~activity~~well inas ~~the~~general economic, ~~secondary~~political ~~trading~~and market ~~for~~conditions ~~our~~such ~~securities;~~as ●recessions aor ~~limited~~interest ~~amount~~rate ofchanges, ~~news~~may ~~and~~seriously ~~analyst~~affect ~~coverage~~the ~~for~~market ~~our~~price ~~Company;~~of ~~and~~our ●Common Stock, aregardless ~~decreased~~of ~~ability~~our toactual ~~issue~~operating ~~additional~~performance. ~~securities~~Some ~~(including~~of ~~pursuant~~the tofactors ~~short-form~~that ~~registration~~may ~~statements~~cause onthe ~~Form~~market ~~S-3~~price orof ~~obtain~~our ~~additional~~Common ~~financing~~Stock to influctuate ~~the~~include, ~~future).~~without limitation:

~~The market~~● ~~price~~investors ofreact negatively to the effect on our ~~common~~business ~~stock~~and ~~may~~prospects; be● ~~subject~~the toannouncement ~~significant~~of ~~fluctuations~~new ~~and~~products, ~~volatility~~new developments, ~~and~~services or technological innovations by us or our ~~stockholders~~competitors; ~~may~~● beactual ~~unable~~or toanticipated ~~resell their~~quarterly ~~shares~~increases ator adecreases ~~profit~~in revenue, gross margin or earnings, and ~~incur~~changes ~~losses.~~in our business, operations or prospects;

The market price our common stock could be subject to significant fluctuation. Market prices for securities of life sciences and biopharma companies in particular have historically been particularly volatile and have shown extreme price and volume fluctuations that have often been unrelated or disproportionate to the operating performance of those companies. Broad market and industry factors, as well as general economic, political and market conditions such as recessions or interest rate changes, may seriously affect the market price of our common stock, regardless of our actual operating performance. Some of the factors that may cause the market price of our common stock to fluctuate include, without limitation:42

● investors react negatively to the effect on our business and prospects; ● the announcement of new products, new developments, services or technological innovations by us or our competitors; ● actual or anticipated quarterly increases or decreases in revenue, gross margin or earnings, and changes in our business, operations or prospects; ● announcements relating to strategic relationships, mergers, acquisitions, partnerships, collaborations, joint ventures, capital commitments, or other events by us or our competitors; ● conditions or trends in the life sciences and biopharma industries; ● changes in the economic performance or market valuations of other life sciences and biopharma companies; ● general market conditions or domestic or international macroeconomic and geopolitical factors unrelated to our performance or financial condition; ● sale of our ~~common~~Common ~~stock~~Stock by stockholders, including executives and directors; ● volatility and limitations in trading volumes of our ~~common~~Common ~~stock~~Stock; ● volatility in the market prices and trading volumes of companies in the life sciences and biopharma industries; ● our ability to finance our business; ● ability to secure resources and the necessary personnel to pursue our plans; ● failures to meet external expectations or management guidance; ● changes in our capital structure or dividend policy, future issuances of securities, sales or distributions of large blocks of ~~common~~Common ~~stock~~Stock by stockholders; ● our cash position; ● announcements and events surrounding financing efforts, including debt and equity securities; ● analyst research reports, recommendation and changes in recommendations, price targets, and withdrawals of coverage; ● departures and additions of key personnel; ● disputes and litigation related to intellectual properties, proprietary rights, and contractual obligations; ● investigations by regulators into our operations or those of our competitors; ● changes in applicable laws, rules, regulations, or accounting practices and other dynamics; and ● other events or factors, many of which may be out of our control.

In the past, following periods of volatility in the overall market and the market prices of particular companies’ securities, securities class action litigations have often been instituted against these companies. Litigation of this type, if instituted against us, could result in substantial costs and a diversion of our management’s attention and resources. Any adverse determination in any such litigation or any amounts paid to settle any such actual or threatened litigation could require that we make significant payments.

32We may issue additional equity securities in the future, which may result in dilution to existing investors.

~~Certain~~To the extent we raise additional capital by issuing equity securities, our stockholders ~~could~~may ~~attempt~~experience substantial dilution. We may, from time to ~~influence~~time, ~~changes~~sell ~~within~~additional ~~our~~equity ~~Company~~securities ~~which~~in one or more transactions at prices and in a manner we determine. If we sell additional equity securities, existing stockholders may be materially diluted. New investors could ~~adversely~~gain ~~affect~~rights ~~our~~superior ~~operations~~to existing stockholders, such ~~financial~~as ~~condition~~liquidation and other preferences. In addition, the ~~value~~number of shares available for future grant under our ~~common~~equity compensation plans may be increased in the future. Also, the exercise or conversion of outstanding options or warrants to purchase shares of capital stock may result in dilution to our stockholders upon any such exercise or conversion.

Our stockholders may from time to time seek to acquire a controlling stake in our Company, engage in proxy solicitations, advance stockholder proposals or otherwise attempt to effect changes. Campaigns by stockholders to effect changes at publicly-traded companies are sometimes led by investors seeking to increase short-term stockholder value through actions such as financial restructuring, increased debt, special dividends, stock repurchases or sales of assets or the entire company. Responding to proxy contests and other actions by activist stockholders can be costly and time-consuming and could disrupt our operations and divert the attention of our board of directors and senior management from the operation of our business. These actions could adversely affect our operations, financial condition and the value of our common stock.43

IfCertain ~~securities~~stockholders ~~analysts~~could doattempt ~~not~~to ~~publish~~influence ~~research~~changes orwithin ~~reports~~the ~~about~~Company ~~our~~which ~~business,~~could oradversely ifaffect ~~they~~our ~~publish~~operations, ~~negative~~financial ~~evaluations,~~condition and the ~~price~~value of our ~~common~~ ~~stock~~Common ~~could decline~~Stock.

~~The~~Our stockholders ~~trading~~may ~~market~~from ~~for~~time ~~our~~to ~~common~~time ~~stock~~seek ~~will~~to ~~rely~~acquire ina ~~part~~controlling onstake in the ~~availability~~Company, ofengage ~~research~~in ~~and~~proxy ~~reports~~solicitations, ~~that~~advance ~~third-party~~stockholder ~~industry~~ proposals or ~~financial analysts~~otherwise ~~publish~~attempt ~~about~~to ~~our~~effect ~~Company~~changes. ~~There~~Campaigns ~~are~~by ~~many~~stockholders ~~large,~~to ~~publicly~~effect changes at publicly-traded companies ~~active~~are insometimes ~~the~~led ~~life sciences and biopharma industries,~~by ~~which~~investors ~~may~~seeking ~~mean~~to itincrease ~~will~~short-term bestockholder ~~less~~value ~~likely~~through ~~that~~actions wesuch ~~receive~~as ~~widespread~~financial ~~analyst~~restructuring, ~~coverage.~~increased ~~Furthermore~~debt, ifspecial ~~one~~dividends, stock repurchases or ~~more~~sales of assets or the ~~analysts~~entire ~~who~~company. ~~do cover~~Responding usto ~~downgrade~~proxy ~~our~~contests ~~stock,~~and ~~our~~other ~~stock~~actions ~~price~~by ~~would~~activist ~~likely~~stockholders ~~decline.~~can be Ifcostly ~~one~~and ortime-consuming ~~more~~and ofcould ~~these~~disrupt ~~analysts~~our ~~cease~~operations ~~coverage~~and divert the attention of our ~~Company,~~Board ~~we could~~and ~~lose~~senior ~~visibility~~management in from the ~~market,~~operation ~~which~~of inour ~~turn~~business. These actions could ~~cause~~adversely affect our ~~stock~~operations, ~~price~~financial tocondition ~~decline~~and the value of our Common Stock.

~~Anti-takeover~~If ~~provisions~~securities ~~under~~analysts ~~Delaware~~do ~~corporate~~not ~~law~~publish ~~may~~research ~~make~~or itreports ~~difficult~~about ~~for~~ our ~~stockholders~~business, ~~to replace~~ or ~~remove~~if ~~our~~they ~~board~~publish ofnegative ~~directors~~evaluations, ~~and~~the ~~could deter~~price orof ~~delay third parties from acquiring~~ our Common ~~Company,~~Stock ~~which~~could ~~may be beneficial to our stockholders~~decline.

~~Under~~The ~~our~~trading ~~Amended~~market ~~and~~for ~~Restated~~our ~~Certificate~~Common ofStock ~~Incorporation,~~will werely ~~are~~in ~~subject~~part toon the ~~anti-takeover~~availability ~~provisions~~ of ~~the~~research ~~Delaware~~and ~~General~~reports ~~Corporation Law~~that ~~(“DGCL”),~~third-party ~~including~~industry ~~Section~~or financial ~~203~~analysts ofpublish about the ~~DGCL~~Company. ~~Under~~There ~~these~~are ~~provisions,~~many ~~if anyone becomes an “interested stockholder~~large,~~” we~~ ~~may~~publicly ~~not~~traded ~~enter~~companies ~~into~~active ain ~~“business~~the ~~combination”~~life ~~with~~sciences ~~that~~and ~~person~~biopharma industries, ~~for~~which ~~three~~may ~~(3)~~mean ~~years~~it ~~without~~will ~~special~~be ~~approval,~~less ~~which~~likely ~~could discourage~~that awe ~~third~~receive ~~party~~widespread ~~from~~analyst ~~making~~coverage. aFurthermore, ~~takeover~~if ~~offer~~one ~~and could delay~~ or ~~prevent~~more ~~a change~~ of ~~control.~~the ~~For~~analysts who ~~purposes~~do ofcover ~~Section~~us ~~203~~downgrade ~~of the~~our ~~DGCL~~stock, ~~“interested~~our ~~stockholder”~~stock ~~means,~~price ~~generally,~~would ~~someone~~likely ~~owning~~decline. ~~fifteen~~If ~~percent~~one ~~(15%)~~ or more of ~~our~~these ~~outstanding~~analysts ~~voting stock~~cease orcoverage ~~an affiliate~~ of ~~ours~~the ~~that~~Company, we ~~owned~~could ~~fifteen~~lose ~~percent~~visibility ~~(15%)~~in ~~or more of our outstanding voting stock during~~ the ~~past three (3) years~~market, ~~subject~~ towhich ~~certain~~in ~~exceptions~~turn ascould ~~described~~cause inour ~~Section~~stock ~~203~~price ofto ~~the DGCL~~decline.

WeAnti-takeover provisions under Delaware corporate law may ~~not~~make beit ~~able~~difficult tofor ~~maintain~~our anstockholders ~~active~~to ~~trading~~replace ~~market~~or ~~for~~remove our ~~common~~Board ~~stock~~and could deter or delay third parties from acquiring the Company, which may be beneficial to our stockholders.

~~The~~Under ~~listing~~our Amended and Restated Certificate of ~~our~~Incorporation, ~~common~~as ~~stock~~amended on(“A&R ~~Nasdaq~~Certificate ~~does~~of Incorporation”), we are subject to the anti-takeover provisions of the Delaware General Corporation Law (“DGCL”), including Section 203 of the DGCL. Under these provisions, if anyone becomes an “interested stockholder,” we may not ~~assure~~enter ~~that~~into a ~~meaningful~~“business combination” with that person for three (3) years without special approval, ~~consistent~~which could discourage a third party from making a takeover offer and ~~liquid~~could ~~trading~~delay ~~market~~or ~~exists~~prevent a change of control. IfFor anpurposes ~~active~~of ~~market~~Section 203 of the DGCL, “interested stockholder” ~~for~~means, generally, someone owning fifteen percent (15%) or more of our ~~common~~outstanding voting stock ~~does~~or ~~continue,~~an itaffiliate ~~may~~of beours ~~difficult~~that ~~for~~owned ~~investors~~fifteen percent to(15%) ~~sell~~or ~~their~~more ~~shares~~of ~~without~~our ~~depressing~~outstanding voting stock during the ~~market~~past ~~price~~three ~~for~~(3) ~~the~~years, subject to certain exceptions as described in ~~shares~~Section or203 atof ~~all~~the DGCL.

We do not anticipate paying any cash dividends in the foreseeable future.

The current expectation is that we will retain our future earnings, if any, to fund the development and growth of our business. As a result, capital appreciation, if any, of our Common Stock will be our stockholders’ sole source of gain, if any, for the foreseeable future.

We may not be able to maintain an active trading market for our Common Stock.

The listing of our Common Stock on Nasdaq does not assure that a meaningful, consistent and liquid trading market exists. If an active market for our Common Stock does continue, it may be difficult for investors to sell their shares without depressing the market price for the shares or at all.

We maintain our cash at financial institutions, often in balances that exceed federally insured limits.

The majority of our cash is held in accounts at U.S. banking institutions that we believe are of high quality. Cash held in non-interest-bearing and interest-bearing operating accounts may exceed the Federal Deposit Insurance Corporation (“FDIC”) insurance limits. If If such banking institutions were to fail, we could lose all or a portion of those amounts held in excess of such insurance limitations. While the FDIC took control of one such banking institution, Silicon Valley Bank (“SVB”), on March 10, 2023, and the FDIC also took control of Signature Bank (“Signature Bank”) on March 12, 2023, we did not have any accounts with SVB or Signature Bank and therefore did not experience any specific risk of loss. The FDIC also announced that account holders would be made whole. Thus, we do not view the risk as material to our financial condition. However, if such a situation arises again with a financial institution we bank with, the risk of loss in excess of insurance limitations has generally increased. Any material loss that we may experience in the future could have an adverse effect on our ability to pay our operational expenses or make other payments and may require us to move our accounts to other banks, which could cause a temporary delay in making payments to our vendors and employees and cause other operational inconveniences.

We may acquire businesses or products, or form strategic alliances, in the future, and may not realize the benefits of such acquisitions.

We may acquire additional businesses or products, form strategic alliances, or create joint ventures with third parties that we believe will complement or augment our existing business. If we acquire businesses with promising markets or technologies, we may not be able to realize the benefit of acquiring such businesses if we are unable to successfully integrate them with our existing operations and company culture. We may encounter numerous difficulties in developing, manufacturing, and marketing any new products resulting from a strategic alliance or acquisition that delay or prevent us from realizing their expected benefits or enhancing our business. There is no assurance that, following any such acquisition, we will achieve the synergies expected in order to justify the transaction, which could result in a material adverse effect on our business and prospects.

3344

~~CAUTIONARY~~USE ~~NOTE~~OF ~~REGARDING FORWARD-LOOKING STATEMENTS~~PROCEEDS

~~Some~~The Selling Stockholders will receive all of the ~~information~~proceeds infrom this ~~prospectus~~offering. ~~contain~~We ~~forward-looking~~will, ~~statements~~however, ~~within~~receive the ~~meaning~~ ofnet ~~the~~proceeds ~~federal~~of ~~securities~~any ~~laws.~~January ~~You~~2026 Warrants ~~should~~if ~~not~~exercised ~~rely~~for oncash. ~~forward-looking~~Proceeds, ~~statements~~if inany, ~~this~~received ~~prospectus.~~from ~~Forward-looking~~the ~~statements~~exercise ~~typically~~of ~~are~~such ~~identified~~January by2026 ~~use~~Warrants ofwill ~~terms~~be ~~such~~used asprimarily ~~“anticipate,”~~for ~~“believe,”~~product ~~“plan~~development,” ~~“expect,”~~working ~~“future~~capital,” ~~“intend,”~~and ~~“may,”~~general corporate purposes. No assurances can be given that any of such January 2026 Warrants “will,” ~~“should,”~~be ~~“estimate,”~~exercised. ~~“predict,”~~The ~~“potential,” “continue,”~~Selling ~~and~~Stockholders ~~similar~~will ~~words,~~pay ~~although~~any ~~some~~underwriting ~~forward-looking~~discounts ~~statements~~and ~~are~~commissions ~~expressed~~and ~~differently.~~expenses ~~This~~incurred ~~prospectus~~by ~~may~~the Selling ~~also~~Stockholders ~~contain~~for ~~forward-looking~~brokerage, ~~statements~~accounting, ~~attributed~~tax toor ~~third~~legal ~~parties~~services ~~relating~~or toany ~~their~~other ~~estimates~~expenses ~~regarding~~incurred by the ~~markets~~Selling weStockholders ~~may~~in ~~enter~~disposing inof the ~~future~~shares. ~~All~~We ~~forward-looking~~will ~~statements~~bear ~~address~~all ~~matters~~other ~~that~~costs, ~~involve~~fees ~~risk~~ and ~~uncertainties,~~expenses ~~and~~incurred ~~there~~in ~~are~~effecting ~~many~~the ~~important risks,~~registration ~~uncertainties~~of ~~and~~the ~~other~~shares ~~factors~~covered ~~that~~by ~~could~~this ~~cause~~prospectus, including ~~our~~all ~~actual~~registration ~~results~~and tofiling ~~differ~~fees, ~~materially~~and ~~from~~fees ~~the~~and ~~forward-looking~~expenses ~~statements contained~~for inour ~~this~~counsel ~~prospectus~~and our independent registered public accountants.

You should also carefully consider the statements under “Risk Factors” and other sections of this prospectus, which address additional facts that could cause our actual results to differ from those set forth in the forward-looking statements. We caution investors not to place significant reliance on the forward-looking statements contained in this prospectus. We undertake no obligation to publicly update or review any forward-looking statements, whether as a result of new information, future developments or otherwise.45

34MARKET PRICE, TICKER SYMBOL AND DIVIDEND INFORMATION

MARKET PRICE AND DIVIDEND INFORMATION

Market Information

Our ~~common~~Common ~~stock~~Stock ~~trades~~is traded on the Nasdaq Capital Markets under the symbol “ENVB.”.

Holders ~~of Record~~

~~As of~~On ~~2025~~February 4, 2026 wethe Company had ~~[●]~~approximately ~~holders~~294 ofstockholders ~~record~~ of ~~our common stock~~record. The ~~actual~~ number of holders of ~~our~~record ~~common~~is ~~stock~~based ison ~~greater~~the ~~than this~~actual number of holders ~~record~~registered ~~holders~~on ~~and~~the ~~includes~~books ~~stockholders~~of ~~who~~our ~~are~~transfer ~~beneficial~~agent ~~owners,~~and ~~but~~does ~~whose~~not ~~shares~~reflect ~~are~~holders ~~held~~of shares in “street name” byor ~~brokers~~persons, orpartnerships, ~~held~~associations, bycorporations, or other ~~nominees.~~entities ~~This~~identified ~~number~~in ofsecurity ~~holders~~position oflistings ~~record~~maintained ~~also~~by ~~does~~depository ~~not include stockholders whose shares may be held in~~ trust ~~by other entities~~companies.

Dividend Policy

~~The~~We ~~Company~~have ~~has~~not ~~never~~paid ~~declared~~any orcash ~~paid~~dividends on our Common Stock to date. We expect to retain future earnings, if any, for future operations and product development and have no current plans to pay cash dividends for the foreseeable future. Any decision to declare and pay dividends in the future will be made at the discretion of the Board and will depend on, ~~its~~among ~~common~~other ~~stock~~things, our results of operations, financial condition, cash requirements, contractual restrictions and ~~has~~other nofactors ~~intention~~that the Board may deem relevant. In addition, our ability to pay dividends may be limited by covenants of any existing and future outstanding indebtedness we or our subsidiaries incur. We do sonot anticipate declaring any cash dividends to holders of our Common Stock in the foreseeable future.

35Securities Authorized for Issuance Under Equity Compensation Plans

The following table provides information as of December 31, 2025 with respect to securities that may be issued under our equity compensation plans:

Plan Category	Number of Securities to be Issued upon Exercise of Outstanding Options, Warrants and Rights		Weighted Average Exercise Price of Outstanding Options, Warrants and Rights		Number of Securities Remaining Available for Future Issuance Under Equity Compensation Plans (Excluding Securities Reflected in the First Column) (2)
Equity compensation plans approved by security holders (1)		162,470	$	11,298.60
Equity compensation plans not approved by security holders		-		-		-
Total		162,470	$	11,298.60

(1) These securities are available under the 2020 Long-Term Incentive Plan. Incentive awards may include, but are not limited to, Incentive Stock Options, Nonqualified Stock Options, Stock Appreciation Rights, Restricted Stock, Restricted Stock Units, Performance Awards, Dividend Equivalent Rights, and Other Awards.

(2) The 2020 Long-Term Incentive Plan includes an “evergreen” provision for calculating the number of shares issuable under the 2020 Long-Term Incentive Plan. In the event that the number of outstanding shares of Common Stock of the Company is increased, the number of authorized shares shall be proportionately adjusted upon the occurrence of such increase such that the quotient of (i) the number of authorized shares immediately prior to such increase and (ii) the number of shares of Common Stock outstanding immediately prior to such increase is equal to the quotient of (x) number of authorized shares immediately after such increase and (y) the number of shares of Common Stock outstanding immediately after such increase (the “Equitable Adjustment”); provided, however, that any such Equitable Adjustment is subject to and will take effect following approval of the Equitable Adjustment by the Board.

BUSINESS

~~Background~~Company Information

We were incorporated under the laws of the State of Delaware in February 1994 as Spatializer Audio Laboratories, Inc., which was a shell company immediately prior to the completion of a “reverse merger” transaction on May 26, 2015, whereby Ameri100 Acquisition, Inc., a Delaware corporation and newly created, wholly owned subsidiary, was merged with and into Ameri and Partners Inc. (“Ameri and Partners”), a Delaware corporation (the “2015 Merger”). In connection with the 2015 Merger, we changed our name to AMERI Holdings, Inc.

The Ameri business ceased to be part of the Company on December 30, 2020, pursuant to a spin-off transaction. On December 30, 2020, we completed a tender offer to purchase all of the outstanding common shares of Jay Pharma Inc., a Canada corporation, for shares of Company ~~common~~Common ~~stock~~Stock or certain preferred stock (the “Offer”), and changed our name to “Enveric Biosciences, Inc.” Our principal corporate office is located at Enveric Biosciences, Inc., 245 First Street, Riverview II, 18th Floor, Cambridge, MA 02142, telephone (617) 444-8400. Our internet address is https://www.enveric.com/, and the information included in, or linked to our website is not part of this prospectus. We have included our website address in this prospectus solely as a textual reference.

On May 24, 2021, the Company entered into an Amalgamation Agreement (the “Amalgamation Agreement”) with 1306432 B.C. Ltd., a corporation existing under the laws of the Province of British Columbia and a wholly-owned subsidiary of the Company (“HoldCo”), 1306436 B.C. Ltd., a corporation existing under the laws of the Province of British Columbia and a wholly-owned subsidiary of HoldCo (“Purchaser”), and MagicMed Industries Inc., a corporation existing under the laws of the Province of British Columbia (“MagicMed”), pursuant to which, among other things, the Company, indirectly through Purchaser, acquired all of the outstanding securities of MagicMed in exchange for securities of the Company by way of an amalgamation under the British Columbia Business Corporations Act (the “Amalgamation”), upon the terms and conditions set forth in the Amalgamation Agreement, such that, upon completion of the Amalgamation, the amalgamated corporation (“Amalco”) ~~will~~ be became an indirect wholly-owned subsidiary of the Company. The Amalgamation was completed on September 16, 2021.

On March 21, 2023, the Company established Enveric Therapeutics, an Australia-based subsidiary, to support the Company’s plans to advance its lead program, the EVM201 Series, comprised of the next generation synthetic prodrugs of the active metabolite, psilocin, towards the clinic. Enveric Therapeutics will oversee the Company’s preclinical, clinical, and regulatory activities in Australia, including ongoing interactions with the local Human Research Ethics Committees (“HREC”) and the Therapeutic Goods Administration, Australia’s regulatory authority.

Business Overview

We are a biotechnology company ~~dedicated~~focused toon ~~the~~developing ~~development~~next-generation, ~~of novel neuroplastogenic~~ small-molecule neuroplastogenic therapeutics ~~for~~that ~~the~~address ~~treatment~~unmet ~~of depression,~~needs ~~anxiety,~~in psychiatric and ~~addiction~~neurological disorders. ~~Leveraging~~By ~~our~~leveraging ~~unique~~a differentiated drug discovery platform and ~~development~~a ~~platform,~~growing ~~The~~library ~~Psybrary™~~of patent protected chemical structures, we ~~have~~are ~~created~~advancing a ~~robust~~pipeline of novel compounds designed to promote neuroplasticity without hallucinogenic effects. ~~intellectual~~Our ~~property~~lead ~~portfolio~~candidate, ofEB-003, ~~new~~is ~~chemical~~the ~~entities~~first ~~for~~known ~~specific~~compound ~~mental~~designed ~~health~~to ~~indications~~selectively engage both 5-HT2A and 5-HT1B receptors with the potential to deliver fast-acting, durable antidepressant and anxiolytic effects with outpatient convenience.

~~Enveric’s~~Our lead program, the ~~EVM201~~EVM301 Series, ~~comprises~~and ~~next~~its ~~generation~~lead ~~synthetic~~drug ~~prodrugs of the active metabolite~~candidate, ~~psilocin. Recently~~EB-003, ~~Enveric~~are ~~out-licensed this~~intended ~~program~~to –offer ~~which~~a ~~consists of the EB~~first-~~002 (formerly EB~~in-~~373)~~class, ~~product~~new ~~for~~approach to the treatment of ~~psychiatric disorders –~~ difficult-to-address ~~MycoMedica Life~~mental ~~Sciences~~health disorders, ~~who~~mediated ~~will~~by ~~seek~~the topromotion ~~develop,~~of ~~manufacture,~~neuroplasticity and ~~commercialize~~without ~~EB-002,~~also inducing hallucinations in ~~exchange~~the ~~for~~patient. ~~certain~~EB-003 ~~development~~is ~~and~~a ~~milestone payments~~novel toderivative ~~Enveric~~of ~~(discussed below)~~DMT. ~~Enveric~~It is ~~now~~currently ~~focused on~~ advancing ~~its~~through ~~second~~preclinical ~~program,~~studies with the ~~EVM301~~aim ~~Series~~of ~~– EB-003 –~~initiating ~~expected to offer a~~ first-in-~~class,~~human ~~new~~studies ~~approach~~ to ~~the~~assess ~~treatment~~safety ofand ~~difficult-to-address~~tolerability ~~mental~~including ~~health~~non-hallucinogenic ~~disorders~~properties, ~~mediated~~followed by ~~the~~clinical ~~promotion~~trials targeting ofthe ~~neuroplasticity~~treatment ~~without~~of ~~also~~depression ~~inducing~~or ~~hallucinations~~other inneuropsychiatric ~~the patient~~disorders.

We intend to assemble a team of clinical experts and principal investigators with experience across multiple mental health and central nervous system indications to be responsible for the management, monitoring, and integrity of the clinical research. We plan to submit filings including IND applications and, eventually, NDAs to seek approval with the FDA and with responsible regulatory agencies in other jurisdictions, in connection with our product candidates. The selection, timing, duration, and design of any prospective studies are subject to regulatory filings, approval and finalization of commercial plans. Our EB-003 program has completed short-term dose-range finding toxicology studies and is now ready to advance into IND-enabling, GLP compliant safety pharmacology, ADMET and longer-term toxicology studies.

Neuroplastogens

Following ~~our~~the ~~amalgamation~~Amalgamation with MagicMed ~~completed~~ in September 2021 ~~(the “Amalgamation”)~~, we have continued to pursue the development of MagicMed’s proprietary ~~psychedelic derivatives~~ library, the Psybrary™, which we believe will help us to identify and develop the right drug candidates needed to address mental health challenges, including depression, anxiety, and addiction disorders. We synthesize novel ~~analogues~~phenylalkylamines ofand ~~serotonin~~indolethylamines, using a mixture of chemistry and synthetic biology, resulting in the expansion of the Psybrary™, which currently includes 1620 patent ~~families~~ families with ~~over~~claims covering a million potential ~~variations~~molecular structures, over one thousand of which we have so far synthesized in sufficient quantities to identify and hundreds of ~~synthesized~~which ~~molecules~~we have screened for receptor binding and other relevant activities.

AtThe ~~this~~Company ~~stage,~~developed wecertain ~~have~~intellectual ~~entered~~property ~~into~~rights ~~non-binding~~around ~~term~~the ~~sheets~~trademark ~~with~~PsyAI™ ~~strategic~~for ~~partners~~potential ~~that~~use. ~~out~~On March 6, 2025, Enveric announced it is soliciting Requests-~~license~~For ~~molecules~~Proposals ~~from~~(“RFPs”) for the ~~Psybrary~~license or sale of its PsyAI™. trademark portfolio ~~Going~~as ~~forward~~a wemeans ~~intend~~of tomaximizing ~~both~~value ~~develop~~for ~~intellectual~~an ~~property~~asset ~~and~~which ~~license~~is ~~intellectual~~no ~~property~~longer ~~from~~strategic ~~pharmaceutical~~given ~~and~~the ~~biotechnology companies~~Company’s ~~and~~focus ~~research~~on ~~institutions~~drug ~~which~~development. ~~would~~This ~~cover~~limited portfolio ~~research~~of ~~stage~~US and ~~clinical~~Canadian ~~stage~~trademark assets is held by its subsidiary, Enveric Biosciences Canada, Inc. Enveric expected the period for RFPs to ~~build~~remain open until August 31, 2025, with a ~~pipeline~~decision to follow within three (3) months thereafter. No satisfactory offer for the PsyAI trademark portfolio was made during the RFP period. Accordingly, the PsyAI trademark remains an asset of ~~product~~Enveric ~~candidates~~Biosciences Canada, Inc. and is being further evaluated in view of the importance of the term “AI” in commerce.

~~Our~~At ~~primary~~this ~~focus~~stage, iswe tohave ~~develop~~entered ~~our~~into ~~lead~~several ~~asset~~non-binding EBterm sheets with strategic partners to out-~~003~~license incertain molecules from the ~~EVM301~~Psybrary™ platform. ~~Series~~Enveric Biosciences, Inc. ~~The~~licensed ~~development~~out ~~status~~its ofEVM201 ~~the~~portfolio ~~product~~to isMycoMedica ~~shown~~Life Sciences, PBC on November 7, 2024, as announced at https://www.enveric.com/news/enveric-biosciences-signs-out-licensing-agreement-with-mycomedica-life-sciences-for-eb-002/. There are no outstanding term sheets pending for any molecules in the ~~table~~Psybrary ~~below:~~platform.

~~Product~~While ~~Candidates~~we intend to pursue development of the EVM401 Series, our primary focus is to develop our lead asset EB-003 in the EVM301 Series. The development status of EB-003 is shown in the table below:

Our pipeline of product candidates and key ongoing development programs are shown in the tables below:

Product Candidates

Targeted Indications

Status

Expected Next Steps

EB-003

Psychedelic-inspired drug candidate

Mental health indication

Preclinical Development

IND Filing

Product Candidates	Targeted Indications	Status	Expected Next Steps
EB-003
Third-generation psychedelic-inspired new chemical entity	Mental health indication	Pre-Clinical Development	IND Filing

Recent Developments

License Agreement with MycoMedica Life Sciences

On November 7, 2024, Enveric executed a licensing agreement with MycoMedica, out-licensing the Company’s EVM201 program, including drug candidate EB-002. Pursuant to the terms of licensing agreement, MycoMedica will seek to develop, manufacture, and commercialize EB-002, formerly EB-373, a synthetic prodrug of the active metabolite psilocin, in treatment of neuropsychiatric disorders such as depression. MycoMedica received an exclusive, global license to the formulations, drugs, method of use, and medical devices developed by Enveric to utilize the compound. MycoMedica assumed the responsibility for all future preclinical, clinical, and commercial development on a royalty-bearing basis for all human and animal pharmaceutical applications. As part of the license agreement, Enveric received modest upfront payments, and if certain conditions are met, will receive development and sales milestones potentially totaling up to $62 million, plus tiered single digit royalties on all future sales. MycoMedica has the option during the license term to buyout its milestone and royalty payment obligations at a predetermined amount depending upon the stage of product development and commercialization at the time of the buyout. Further, MycoMedica has the right to purchase the licensed patents at a nominal amount upon a change of control of Enveric, although doing so does not relieve MycoMedica of any of its payment obligations. No royalties have been received to date.

License Agreement with Aries Science and Technology

Registered Direct Offering

Between March and May 2024, Enveric entered into a series of common stock purchase agreements (the “Purchase Agreements”) for the issuance in a registered direct offering of an aggregate of 686,690 shares of the Company’s common stock, par value $0.01 per share, to certain institutional investors. The issuance was made in exchange for the permanent and irrevocable waiver of the variable rate transaction limitation with respect to any existing or future agreement by the Company to effect any issuance of shares and issue such shares thereunder, as contained in those certain inducement offer letters, dated December 28, 2023, between the Company and those certain institutional investors. The Company did not receive any net proceeds in connection with the offering. The offering was made to obtain a waiver of the variable rate transaction limitation as described above and further described in the Purchase Agreements so the Company could utilize its equity line of credit with Lincoln Park Capital Fund, LLC, and enter into any future agreements that involve a variable rate transaction and issue such shares thereunder.

Intellectual Property

We are a party to certain license agreements as described below, ~~and~~to build a pipeline of product candidates going forward, we intend to both continue to internally develop new drug candidates with associated intellectual property and ~~license~~to acquire, through in-licensing, additional intellectual property from pharmaceutical and biotechnology companies and research institutions. ~~which~~The ~~would~~in-licensed ~~cover~~assets could include both research stage and clinical stage ~~assets~~drug ~~to build a pipeline of product~~ candidates.

The current focus of Enveric’s intellectual property is in ~~psychedelics~~neuroplastogens, including multiple portfolios of psychedelic-inspired compounds and formulations and methods of making, using, and treating mental and neurological disorders. In addition, Enveric has intellectual property related to computer assisted methods of discovering promising novel psychedelic-inspired compounds.

~~Psychedelics~~48

WePsychedelic-Inspired ~~own full rights to 20 active patent families related to psychedelic inspired compounds.~~Compounds

~~Psilocybin~~We ~~Derivatives.~~own Arights ~~portfolio~~to of19 12active patent families, related to compounds that are phenylalkylamine and indolethylamine derivatives. The 19 patent families are represented by 11a total of 24 issued United States patents and 3159 pending United States and non-United States patent applications~~, related to psilocybin derivatives, methods of making psilocybin derivatives, and methods~~ for treatment of mental disorders, such as depression, anxiety, ~~post-traumatic-stress disorder (“PTSD”)~~addiction, and other ~~psychiatric~~neuropsychiatric conditions.

~~Psilocybin~~The ~~Prodrugs.~~active ~~A portfolio of four~~ patent ~~families,~~portfolios ~~represented~~include bythe ~~six~~following ~~United~~published ~~States patents, 11 pending United States~~ and ~~non-United States~~unpublished ~~patent~~ applications ~~related to prodrugs of psilocin.~~:

37● Glycosylated Psilocybin Derivatives and Methods of Using (WO 2022/040802) ● Halogenated Psilocybin Derivatives and Methods of Using (WO2022/047579) ● Hydroxylated Psilocybin Derivatives and Methods of Using (WO2022/047580) ● Nitrated Psilocybin Derivatives and Methods of Using (WO 2022/047583) ● Aminated Psilocybin Derivatives and Methods of Using (WO2023/044556) ● Nitrilated Psilocybin Derivatives and Methods of Using (WO2022/104475) ● Carboxylated Psilocybin Derivatives and Methods of Using (WO2022/115944) ● Aldehyde and Ketone Derivatives of Psilocybin and Methods of Using (WO2022/115960) ● Prenylated Psilocybin Derivatives and Methods of Using (WO2022/155751) ● Multi-substituent Psilocybin Derivatives and Methods of Using (WO2022/170438) ● N-Heterocycle Substituted Tryptamine Derivatives and Methods of Using (WO2025/189271) ● C-4 Substituted Tryptamine Derivatives and Methods of Using (WO2023/173227) ● C-4 Carboxylic Acid Substituted Tryptamine Derivatives and Methods of Using (WO2023/173196) ● C-4 Carbonothioate Substituted Tryptamine Derivatives and Methods of Using (WO2023/173197) ● Salts of C4-Carboxylic Acid and C4-Carbonothioate-substituted Tryptamine Derivatives and Methods of Using (WO 2023/173229) ● Fused Heterocyclic Mescaline Derivatives (WO2024/026568A1) ● C1-Substituted Isopropylamine Fused Heterocyclic Mescaline Derivatives (WO2024/086933) ● Substituted N- Propylamine Fused Heterocyclic Mescaline Derivatives (WO2024/103185) ● Substituted Ethylamine Fused Heterocyclic Mescaline Derivatives (WO2024/124353)

~~Mescaline~~Cannabinoid ~~Derivatives~~Conjugates ~~– The EVM 401 Series (formerly referred to as EVM 501 Series). A portfolio of four patent families represented by five pending United States patent applications~~ and ~~four PCT applications related to mescaline derivatives and methods of treatment using mescaline derivatives.~~Formulations

We own rights held by our wholly owned subsidiary Akos Biosciences, Inc. to two active patent families related to cannabinoids. Both patent families are licensed out to unrelated third parties. One patent family relates to cannabinoid crème formulations for treatment of radiation dermatitis, is licensed to Aries Science & Technology, LLC, and comprises one United States patent, one Australian patent, and one pending European patent application. See https://www.enveric.com/news/aries-science-technology-and-enveric-biosciences-announce-licensing-agreement/. The ~~portfolios~~other ~~include~~patent ~~the~~family ~~following~~relates ~~published~~to cannabinoid conjugates in combination with COX-2 inhibitors for treatment of pain and ~~unpublished~~joint disease, is licensed under two separate licenses for pharmaceutical and non-pharmaceutical uses to Restoration Biologics, LLC, and comprises three United States patents, and three pending patent applications in the United States and other countries. A portfolio of cannabinoid conjugate technology licensed in from Diverse Biotech, Inc., is sublicensed to Restoration Biologics, LLC as part of the licenses to Restoration Biologics, LLC. See https://www.enveric.com/news/enveric-biosciences-and-restoration-biologics-announce-licensing-agreements-to-treat-joint-disease/

~~Psilocybin~~The ~~Derivatives.~~active ~~These~~cannabinoid ~~ten~~ patent ~~families~~portfolios include ~~applications and patents related to different psilocybin derivative compounds, methods for making~~ the ~~compounds,~~following ~~methods~~published ~~for modulating a 5-HT2A cell surface receptor,~~ and ~~methods~~unpublished ~~for treating psychiatric disorders~~applications:

● Glycosylated Psilocybin Derivatives and Methods of Using (WO 2022/040802) ● Halogenated Psilocybin Derivatives and Methods of Using (WO2022/047579) ● Hydroxylated Psilocybin Derivatives and Methods of Using (WO2022/047580) ● Nitrated Psilocybin Derivatives and Methods of Using (WO 2022/047583) ● Aminated Psilocybin Derivatives and Methods of Using (WO2023/044556A1) ● Nitrilated Psilocybin Derivatives and Methods of Using (WO2022/104475A1) ● Carboxylated Psilocybin Derivatives and Methods of Using (WO2022/115944) ● Aldehyde and Ketone Derivatives of Psilocybin and Methods of Using (WO2022/115960) ● Prenylated Psilocybin Derivatives and Methods of Using (WO2022/155751) ● Multi-substituent Psilocybin Derivatives and Methods of Using (WO2022/170438) ● N-Heterocycle Substituted Tryptamine Derivatives and Methods of Using (Unpublished PCT/CA2024/050312) ● Tri-Halo-Alkoxy-Substituted Tryptamine Derivatives (Unpublished PCT/CA2024/050242)

	●	Compositions for topical treatment of radiation dermatitis (WO2023154264)

	●	Cannabinoid Conjugate Molecules (WO2023150057)

Psilocybin Prodrugs. These four patent families include applications and patents related to novel tryptamine derivative compounds which serve as prodrugs for psilocin, and methods for making and using the prodrugs for treatment of psychiatric disorders.49

● C-4 Substituted Tryptamine Derivatives and Methods of Using (WO2023/173227A1) - This application relates to several groups of novel C4-substituted tryptamine derivative compounds and pharmaceutical drug formulations containing C4-ether-substituted tryptamine derivative compoundsDiverse Biotech, ~~C4-carbonic~~Inc. ~~ester~~In- ~~substituted tryptamine derivative compounds~~License, ~~C4-polyether~~sublicensed ~~substituted~~out ~~tryptamine~~to ~~derivative~~Restoration ~~compounds~~Biologics, ~~and C4-phosphate substituted tryptamine derivative compounds~~LLC. These pharmaceutical formulations may be used to treat psychiatric disorders. ● C-4 Carboxylic Acid Substituted Tryptamine Derivatives and Methods of Using (WO2023/173196A1) ● C-4 Carbanothioate Substituted Tryptamine Derivatives and Methods of Using (WO 2023/173197) ● Salts of C4-Carboxylic Acid and C4-Carbonothioate-substituted Tryptamine Derivatives and Methods of Using (WO 2023/173229)

~~Mescaline~~We ~~Derivatives~~hold –limited ~~The~~rights ~~EVM~~to ~~401~~patent ~~Series~~applications ~~(formerly~~owned ~~referred~~by toDiverse asBiotech, ~~EVM~~Inc. ~~501~~for ~~Series).~~the ~~These~~use of cannabinoids in conjugate form with five existing, standard-of-care drugs (celecoxib and four selected steroids) via Diverse Biotech’s patent ~~families~~pending ~~include~~conjugate ~~applications~~drug delivery platform. ~~related~~Rights granted by Diverse Biotech to ~~novel~~Enveric ~~mescaline~~have ~~derivative~~been ~~compounds~~assigned ~~and~~to ~~pharmaceutical~~our ~~formulations~~wholly owned subsidiary, ~~methods~~Akos Biosciences, Inc. Those rights extend to all fields of use. The intended target for ~~making~~development ~~and~~of ~~using~~such ~~those~~conjugates ~~compounds~~is ~~and~~alleviating ~~formulations~~pain, specifically the pain of osteoarthritis, rheumatoid arthritis, and ~~methods~~cancer, ~~for~~with ~~treating~~the agoal ~~neurological~~of ~~disorder~~achieving improved and novel therapeutic outcomes for patients. ~~One~~The license from Diverse Biotech is ~~published,~~paid-up and ~~three~~no ~~are~~further ~~currently~~liability ~~unpublished~~to ~~PCT~~Diverse ~~applications~~Biotech should arise from any commercialization activities by Akos Biosciences, Inc. or its sublicensees.

●The in-licensed ~~Fused~~Diverse ~~Heterocyclic~~Biotech, ~~Mescaline~~Inc. ~~Derivatives~~portfolio ~~(WO2024/026568A1)~~includes ●two C1patent families comprising two issued United States patents and 14 pending United States and non-~~Substituted~~United ~~Isopropylamine~~States ~~Fused~~applications. ~~Heterocyclic~~Those ~~Mescaline~~patents ~~Derivatives~~and ~~(WO2024/086933)~~applications ●disclose ~~Substituted~~conjugate Nchemistry that combines cannabinoids with existing drugs in conjugate form. The issued and pending claims of patents in the Diverse Biotech portfolio all appear to be for different conjugates than those for which the portfolio was originally licensed in from Diverse Biotech. Regardless, we believe that the licensed-in ~~Propylamine~~conjugates ~~Fused~~have ~~Heterocyclic~~the ~~Mescaline~~potential ~~Derivatives~~for ~~(WO2024/103185)~~efficacy ●that ~~Substituted~~will ~~Ethylamine~~differentiate ~~Fused~~their ~~Heterocylcic~~performance ~~Mescaline~~against ~~Derivatives~~target ~~(WO2024/124353)~~diseases over simple combination therapies of drugs and cannabinoids. The license extends for as long as Akos Biosciences and its sublicensee intend to develop and commercialize the licensed Agents and Products. Issued patents in the Diverse Biotech portfolio may expire as late as 2040.

Diverse Biotech, Inc. In-License

We hold limited rights to patent applications owned by Diverse Biotech, Inc. for the use of cannabinoids in conjugate form with five existing, standard-of-care drugs (celecoxib and four selected steroids) via Diverse Biotech’s patent pending conjugate drug delivery platform. Our rights extend to all fields of use. The intended target for development of such conjugates is alleviating pain, specifically the pain of osteoarthritis, rheumatoid arthritis, and cancer, with the goal of achieving improved and novel therapeutic outcomes for patients.

The in-licensed Diverse Biotech, Inc. portfolio includes two patent families comprising 2 issued and 13 pending national applications. Those patents and applications disclose conjugate chemistry that combines cannabinoids with existing drugs in conjugate form that we believe will provide differentiation in use and efficacy from combination therapy of drugs and cannabinoids. The license extends for as long as Enveric intends to develop and commercialize the licensed Agents and Products. The patent applications, should they issue, may expire as late as 2040.

Research & Development

In view of the urgent need for new and more effective mental health treatments, we intend to combine innovative scientific discoveries and bio-chemical synthesis, along with accelerated clinical development plans to create, develop and progress novel therapies using psychedelic-inspired medications and similar compounds. Our current research and development efforts are focused on developing novel molecules structurally related to certain naturally occurring psychedelics with improved pharmaceutical characteristics. Some of the naturally occurring psychedelic molecules are currently being investigated by researchers around the world as potential treatments for a broad range of psychiatric and neurologic disorders.

Clinical Studies

We are currently pursuing drug discovery and ~~pre-clinical~~preclinical activities in order to advance a number of novel psychedelic-inspired molecules towards the clinic. Enveric’s lead ~~program~~development candidate is EB-003. EB-003 is a ~~next~~novel ~~generation~~derivative ~~analog~~ of ~~N,N-Dimethyltryptamine~~DMT. It is the lead drug candidate from the EVM301 Series currently advancing through preclinical ~~development~~studies with the aim of initiating first-in-human studies, to assess safety and tolerability including non-hallucinogenic properties, followed by clinical trials targeting the treatment of depression or other neuropsychiatric disorders.

We intend to assemble a team of clinical experts and principal investigators with ~~clinical~~ experience across multiple mental health and central nervous ~~system~~ system indications to be responsible for the management, monitoring, and integrity of the clinical research.

We plan to submit filings ~~with regulatory agencies~~ including Clinical Trial Applications (“CTA”), ~~Investigational New Drug (“~~IND”) applications and, eventually, ~~new drug applications (“NDA”)~~ NDAs to seek approval with the US FDA and with responsible regulatory agencies in other jurisdictions, in connection with our product candidates. The selection, timing, duration, and design of any prospective studies are subject to regulatory filings, approval and finalization of commercial plans.

OnOur ~~December 28, 2023, we issued a press release announcing the selection of~~ EB-003 asprogram ~~the~~has ~~lead~~completed ~~development~~short-term ~~candidate~~dose-range ~~from~~finding ~~our~~toxicology ~~EVM~~studies ~~301~~and ~~Series. Our~~is ~~next~~now ~~step~~ready is to advance ~~EB-003~~ into ~~formal pre~~IND-~~clinical~~enabling, ~~studies~~GLP compliant insafety ~~support~~pharmacology, ofADMET aand ~~future~~longer-term ~~IND~~toxicology ~~filing~~studies.

Scientific Advisory Board

We have established a scientific advisory board and plan to seek advice and input from these experienced clinical leaders on matters related to our research and development programs. The members of our scientific advisory board consist of experts across a range of key disciplines relevant to our programs. We intend to continue to leverage the broad expertise of our advisors by seeking their counsel on important topics relating to our product development and clinical development programs.

Our scientific advisors are not our employees and do have commitments to, or consulting or advisory contracts with, other entities that may limit their availability to us. In addition, our scientific advisors may have arrangements with other companies to assist those companies in developing products or technologies that may compete with us. All of our scientific advisors are affiliated with other entities and devote a limited portion of their time to us.

Enveric’s current scientific advisors are set forth in the table below:

Name	Title	Specialization
Maurizio Fava, M.D.	Executive Director of the Clinical Trials Network and Institute	Clinical Research
Stephen M. Stahl, M.D., Ph.D.	Director of Psychopharmacology for the California Department of State Hospitals	Clinical Research
John Krystal, M.D.	Director of Yale Center for Clinical Investigation	Clinical Research
Michael Liebowitz, M.D.	Professor of Psychiatry; Director at Medical Research Network	Clinical Research

Maurizio Fava, M.D. has served as a Scientific Advisor of Enveric since 2022. Dr. Maurizio Fava is Chair, Mass General Brigham Academic Centers Psychiatry Department, Psychiatrist-in-Chief of the Massachusetts General Hospital (“MGH”), executive director of the Clinical Trials Network and Institute, ~~(MGH),~~ associate dean for clinical and translational research, and the Slater Family Professor of Psychiatry at Harvard Medical School. Dr. Fava is a world leader in the field of depression. He has edited eight books and authored or co-authored more than 900 original articles published in medical journals with international circulation, articles which have been cited more than 95,000 times in the literature and with an H index greater than 150. Dr. Fava founded and was director of MGH’s Depression Clinical and Research Program from 1990 until 2014. Under Dr. Fava’s direction, the Depression Clinical and Research Program became one of the most highly regarded depression programs in the country, a model for academic programs that link, in a bi-directional fashion, clinical and research work. In 2007, he also founded and is now the executive director of the MGH Psychiatry Clinical Trials Network and Institute, the first academic CRO specialized in the coordination of multi-center clinical trials in psychiatry.

39Stephen M. Stahl, M.D., Ph.D. has served as a Scientific Advisor of Enveric since 2022. Dr. Stephen Stahl has held faculty positions at Stanford University, the University of California at Los Angeles, the Institute of Psychiatry London, the Institute of Neurology London, and, currently, as Clinical Professor of Psychiatry and Neuroscience at the University of California Riverside, Adjunct Professor of Psychiatry at the University of California San Diego and as Honorary Fellow in Psychiatry at the University of Cambridge. Dr. Stahl serves as editor-in-chief of CNS Spectrums and is Senior Academic Advisor and Director of Psychopharmacology for the California Department of State Hospitals where he has a leadership role in addressing violence and decriminalization of the seriously mentally ill. Author of over 575 articles and chapters with an H index of 69, and more than 2000 scientific presentations and abstracts, Dr. Stahl is an internationally renowned clinician, researcher, and teacher in psychiatry with subspecialty expertise in psychopharmacology. Dr. Stahl has written over 50 textbooks and edited 15 others, including the best-selling and award-winning textbook, Stahl’s Essential Psychopharmacology, now in its fifth edition, and the best-selling and award-winning clinical manual, Essential Psychopharmacology Prescriber’s Guide, now in its seventh edition.

~~Stephen~~John ~~M. Stahl~~Krystal, M.D., ~~Ph.D.~~ has served as a Scientific Advisor of Enveric since 2022. Dr. ~~Stephen~~John ~~Stahl~~Krystal ~~has~~is ~~held~~the ~~faculty~~Robert ~~positions~~L. atMcNeil, ~~Stanford University~~Jr., ~~the~~Professor of ~~University~~Translational ofResearch; ~~California~~Professor atof ~~Los~~Psychiatry, ~~Angeles~~Neuroscience, ~~the~~and ~~Institute~~Psychology; Chair of ~~Psychiatry London,~~ the ~~Institute~~Department of ~~Neurology~~Psychiatry ~~London,~~at ~~and,~~Yale University; ~~currently,~~and asChief ~~Clinical Professor~~ of Psychiatry and ~~Neuroscience~~Behavioral Health at ~~the~~Yale-New ~~University~~Haven ofHospital. ~~California~~He ~~Riverside,~~is ~~Adjunct~~a ~~Professor~~graduate of ~~Psychiatry at~~ the University of ~~California~~Chicago, ~~San~~Yale ~~Diego~~School of Medicine, and asthe ~~Honorary~~Yale ~~Fellow~~Psychiatry inResidency ~~Psychiatry~~Training atProgram. ~~the~~He ~~University~~has ofpublished ~~Cambridge.~~extensively ~~Dr.~~on ~~Stahl~~neurobiology ~~serves~~and astreatment ~~editor-in-chief~~ of ~~CNS~~schizophrenia, alcoholism, ~~Spectrums~~PTSD, and isdepression. ~~Senior~~Notably, ~~Academic~~his ~~Advisor~~laboratory ~~and~~discovered ~~Director~~the rapid antidepressant effects of ~~Psychopharmacology~~ketamine ~~for~~in humans. Dr. Krystal directs/co-directs the ~~California~~Yale ~~Department~~Center offor ~~State~~Clinical ~~Hospitals~~Investigation (~~DSH~~CTSA) ~~where~~, heNIAAA ~~has~~Center afor ~~leadership~~the ~~role~~Translational inNeuroscience ~~addressing~~of ~~violence~~ Alcoholism, and ~~decriminalization~~Clinical Neuroscience Division of the ~~seriously~~National ~~mentally~~Center ~~ill~~for PTSD (VA). ~~Author~~He is a member of ~~over~~the ~~575~~U.S. ~~articles and~~National ~~chapters~~Academy ~~with~~of anMedicine; Hco-director of ~~index~~the Neuroscience Forum of ~~69,~~the ~~and~~U.S. ~~more~~National ~~than~~Academies ~~2000~~of ~~scientific~~Sciences, ~~presentations~~Engineering, and ~~abstracts,~~Medicine; ~~Dr.~~Fellow ~~Stahl~~of isthe anAmerican ~~internationally~~Association ~~renowned~~for ~~clinician,~~the ~~researcher,~~Advancement ~~and~~of ~~teacher~~Science; inand ~~psychiatry~~editor ~~with~~of ~~subspecialty~~Biological ~~expertise~~Psychiatry ~~in psychopharmacology~~(IF=13.382). Previously, Dr. ~~Stahl~~Krystal ~~has~~chaired ~~written~~the ~~over~~NIMH 50Board ~~textbooks~~of Scientific Counselors and ~~edited~~has 15served ~~others,~~as ~~including~~a member of the ~~best-selling~~NIMH ~~and~~National ~~award-winning~~Mental ~~textbook,~~Health ~~Stahl’s~~Advisory ~~Essential~~Council ~~Psychopharmacology,~~and ~~now~~the inNIAAA ~~its~~National ~~fifth~~Alcohol Advisory Council. ~~edition,~~He ~~and~~also previously served as the ~~best-selling~~president ~~and~~of ~~award-winning~~the ~~clinical~~American ~~manual,~~College ~~Essential~~of ~~Psychopharmacology~~Neuropsychopharmacology ~~Prescriber’s~~and ~~Guide,~~the ~~now~~International inCollege ~~its~~of ~~seventh edition~~Neuropsychopharmacology.

John Krystal, M.D. has served as a Scientific Advisor of Enveric since 2022. Dr. John Krystal is the Robert L. McNeil, Jr., Professor of Translational Research; Professor of Psychiatry, Neuroscience, and Psychology; Chair of the Department of Psychiatry at Yale University; and Chief of Psychiatry and Behavioral Health at Yale-New Haven Hospital. He is a graduate of the University of Chicago, Yale School of Medicine, and the Yale Psychiatry Residency Training Program. He has published extensively on the neurobiology and treatment of schizophrenia, alcoholism, PTSD, and depression. Notably, his laboratory discovered the rapid antidepressant effects of ketamine in humans. Dr. Krystal directs/co-directs the Yale Center for Clinical Investigation (CTSA), NIAAA Center for the Translational Neuroscience of Alcoholism, and Clinical Neuroscience Division of the National Center for PTSD (VA). He is a member of the U.S. National Academy of Medicine; co-director of the Neuroscience Forum of the U.S. National Academies of Sciences, Engineering, and Medicine; Fellow of the American Association for the Advancement of Science (AAAS); and editor of Biological Psychiatry (IF=13.382). Previously, Dr. Krystal chaired the NIMH Board of Scientific Counselors and has served as a member of the NIMH National Mental Health Advisory Council and the NIAAA National Alcohol Advisory Council. He also previously served as the president of the American College of Neuropsychopharmacology (ACNP) and the International College of Neuropsychopharmacology (CINP).51

Michael Liebowitz, M.D. has served as a Scientific Advisor of Enveric since 2022. Dr. Michael Liebowitz is a Professor of Psychiatry at Columbia University and New York State Psychiatric Institute (“NYSPI”) and is currently Director at Medical Research Network where he is engaged in clinical trials for depression, anxiety, binge eating, ADHD, PTSD, and borderline personality disorders. Dr. Liebowitz completed his fellowship in psychopharmacology at the Depression Evaluation Service at NYSPI, where he helped develop and validate the DSM criteria for atypical depression. Dr. Liebowitz established the Anxiety Disorders Clinic at NYSPI, the first research clinic to specialize in in anxiety disorders in the United States. Over the next two decades, Dr. Liebowitz and colleagues helped refine treatments for panic disorder, broadened the diagnostic criteria and established medication treatment for social anxiety disorder, and collaborated in clinical ~~trials~~ trials comparing medications and behavioral treatments for several anxiety disorders. Dr. Liebowitz developed the Liebowitz Social Anxiety ~~Scale~~ ~~(LSAS)~~Scale which has been the primary outcome measure for several registration programs in social anxiety disorder and is used worldwide as as a research and clinical measure.

Academic Partners

We have also established relationships with certain academic partners, who we believe have the potential to accelerate our product development, market entry, data collection, analysis and advancement of clinical trials.

Our primary academic partner is the University of Calgary which brings excellence into advancing brain and mental health research and education.

Competition

The biotechnology and pharmaceutical industries are characterized by rapidly advancing technologies, intense competition, and a strong emphasis on proprietary products. While we believe that our scientific knowledge and technology and development experience provide us with competitive advantages, we face potential competition from many different sources, including major pharmaceutical, specialty pharmaceutical and biotechnology companies, academic institutions, governmental agencies, and public and private research institutions. Any product candidates that we successfully develop and commercialize will compete with existing therapies and new therapies that may become available in the future.

40We intend to focus on the development of novel and viable psychedelic-inspired drug candidates for mental illnesses and unmet medical needs, and partner with pharmaceutical and other drug development and biotechnology companies in developing and commercializing psychedelic-inspired medicines for diverse psychological and neuropsychiatric indications, which will be fundamentally composed of the psychedelic-inspired drug candidates contained in the Psybrary™. While we believe that our technology, knowledge and experience as well as the scientific resources at our disposal provide us with significant competitive advantages, we face potential competition from many different sources. Any product candidates we successfully identify will compete not only with existing therapies but also new therapies that may become available in the future.

We intend to focus on the development of novel and viable Psychedelic Derivatives for mental illnesses and unmet medical needs, and partner with pharmaceutical and other drug development and biotechnology companies in developing and commercializing psychedelic-derived drugs for diverse psychological and neuropsychiatric indications, of which will be fundamentally composed of the Psychedelic Derivatives contained in the Psybrary™. While we believe that our technology, knowledge and experience as well as the scientific resources at our disposal provide us with significant competitive advantages, we face potential competition from many different sources. Any product candidates we successfully identify will compete not only with existing therapies but also new therapies that may become available in the future.

Our commercial opportunities could be reduced or eliminated if our competitors develop and commercialize medicines that are safer, more effective, have fewer or less severe side effects, are more convenient or are less expensive than any product candidates that we may develop. Our competitors also may obtain approval from the FDA or other regulatory agencies for their medicines more rapidly than us, which could result in our competitors establishing a strong market position before we are able to enter the market.

Regarding our Psybrary™ and the intellectual property kept and developed therein, our success depends on our ability to protect our intellectual property and our ability to achieve and maintain key partnerships aimed at the development, licensing and marketing of ~~Psychedelic Derivatives~~psychedelic-inspired medicines without infringing on the proprietary rights of others. Patent positions within the pharmaceutical field can be highly uncertain ~~and~~ and involve complex legal, scientific and factual questions for which important legal principles remain unresolved. Patents issued to us us may be challenged, invalidated or circumvented.

Government Regulation and Product Approvals

Pharmaceutical companies are subject to extensive regulation by the federal government, principally by the FDA under the ~~Federal Food, Drug and Cosmetic Act, or the~~ FDCA, and, to a lesser extent, by state and local governments. Before our prescription products may be marketed in the U.S., they must be approved by the FDA for commercial distribution. Certain OTC products must comply with applicable FDA regulations, known as OTC Monographs, in order to be marketed, but do not have the benefit of FDA review and approval before marketing. We are also subject to regulation under federal, state and local laws, including requirements regarding occupational safety, laboratory practices, environmental protection and hazardous substance control, and may be subject to other present and future local, state, federal and foreign regulations. We cannot predict the extent to which we may be affected by legislative and other regulatory developments concerning our products and the healthcare industry in general.

The FDCA and other federal and state statutes and regulations govern the testing, manufacture, quality control, export and import, labeling, storage, record keeping, approval, pricing, advertising, promotion, sale and distribution of pharmaceutical products. Noncompliance with applicable requirements both before and after approval, can subject us, our third party manufacturers and other collaborative partners to administrative and judicial sanctions, such as, among other things, warning letters, fines and other monetary payments, recall or seizure of products, criminal proceedings, suspension or withdrawal of regulatory approvals, interruption or cessation of clinical trials, total or partial suspension of production or distribution, injunctions, limitations on or the limitation of claims we can make for our products, and refusal of the government to enter into supply contracts for distribution directly by governmental agencies, or delay in approving or refusal to approve new drug applications. The FDA also has the authority to revoke or withhold approvals of new drug applications.

FDA approval is required before any “new drug,” can be marketed. Our products are new drugs and require prior FDA approval. Such approval must be based on extensive information and data submitted in a NDA, including, but not limited to, adequate and well controlled laboratory and clinical investigations to demonstrate the safety and effectiveness of the drug product for its intended use(s) as well as the manufacturing suitability of the product. In addition to providing required safety and effectiveness data for FDA approval, a drug manufacturer’s practices and procedures must comply with ~~current Good Manufacturing Practices (“cGMPs”)~~cCMPs, which apply to manufacturing, receiving, holding and shipping, and include, among other things, demonstration of product purity, consistent manufacturing and quality and at least six months of data supporting product expiration dating based on clinical registration batches. Accordingly, manufacturers must continue to expend time, money and effort in all applicable areas relating to quality assurance and regulatory compliance, including production and quality control to comply with ~~cGMPs~~cCMPs. Failure to so comply risks delays in approval of drug products and possible FDA enforcement actions, such as an injunction against shipment of products, the seizure of non-complying products, criminal prosecution and/or any of the other possible consequences described above. We are subject to periodic inspection by the FDA and the ~~Drug Enforcement Administration (“~~DEA”), which inspections may or may not be announced in advance.

41The intellectual property kept and developed in our Psybrary™ is focused solely on developing and commercializing non-hallucinogenic synthetic derivatives of psychedelic substances. While we use psychedelic-inspired compounds and classic psychedelics as our starting point for our research and identification of compounds, we do not have any direct or indirect involvement in the illegal selling, production or distribution of any substances in the jurisdictions in which we operate. Enveric is a neuro-pharmaceutical scientific company and as such we do not advocate for the legalization of psychedelic substances nor do we deal with psychedelic substances except within laboratory and clinical trial settings conducted within approved regulatory frameworks. Our products will not be commercialized prior to applicable regulatory approval and this approval will only be granted if clinical evidence of safety and efficacy for the specific intended use is successfully developed.

~~The~~Successful ~~intellectual~~execution ~~property~~of ~~kept and developed in~~ our ~~Psybrary™~~strategy is ~~focused~~in ~~solely~~part oncontingent ~~developing~~upon ~~and~~compliance ~~commercializing~~with ~~non-hallucinogenic synthetic~~regulatory ~~derivatives~~requirements ofenacted ~~psychedelic~~by ~~substances.~~governmental ~~While~~authorities ~~we use psychedelic inspired compounds~~ and obtaining ~~classic~~regulatory ~~psychedelics~~approvals ~~as our starting point~~ for ~~our~~the ~~research~~development and ~~identification~~license of ~~compounds,~~our wepsychedelic-inspired dodrug ~~not~~candidates. ~~have~~The ~~any~~psychedelic-inspired medicine ~~direct~~industry oris ~~indirect~~a ~~involvement~~new inand ~~the~~emerging ~~illegal~~industry ~~selling,~~with ~~production or~~ambiguous ~~distribution~~existing ofregulations ~~any~~and ~~substances~~uncertainty inas ~~the~~to ~~jurisdictions~~future inregulations; ~~which~~ we ~~operate.~~cannot predict ~~Enveric~~the isimpact aof ~~neuro~~the ever-~~pharmaceutical~~evolving ~~scientific~~compliance ~~company~~regime ~~and as~~in ~~such~~respect weof dothis ~~not~~industry. ~~advocate~~The ~~for~~impact ~~the legalization~~ of ~~psychedelic~~compliance ~~substances~~regimes, ~~nor~~any dodelays wein obtaining, ~~deal~~or ~~with~~failure ~~psychedelic~~to ~~substances~~obtain ~~except~~regulatory ~~within~~approvals ~~laboratory and~~may ~~clinical~~significantly ~~trial~~delay ~~settings~~or ~~conducted~~impact ~~within~~our ~~approved~~development ~~regulatory~~of ~~frameworks.~~markets, ~~Our~~our ~~products~~business, ~~will~~psychedelic-inspired medicines, ~~not~~and belicensing ~~commercialized~~initiatives ~~prior to applicable regulatory approval~~ and ~~this~~could ~~approval~~have ~~will~~a ~~only~~material beadverse ~~granted~~effect ifon ~~clinical~~our ~~evidence~~business, offinancial ~~safety~~condition and ~~efficacy~~operating ~~for the specific intended use is successfully developed~~results.

Successful execution of our strategy is in part contingent upon compliance with regulatory requirements enacted by governmental authorities and obtaining regulatory approvals for the development and license of its Psychedelic Derivatives. The psychedelic therapy industry is a new and emerging industry with ambiguous existing regulations and uncertainty as to future regulations; we cannot predict the impact of the ever-evolving compliance regime in respect of this industry. The impact of compliance regimes, any delays in obtaining, or failure to obtain regulatory approvals may significantly delay or impact our development of markets, our business, Psychedelic Derivatives, and licensing initiatives and could have a material adverse effect on our business, financial condition and operating results.53

FDA New Drug Approval Process

In the U.S., pharmaceutical products are subject to extensive regulation by the FDA. The ~~Federal~~FDCA ~~Food, Drug,~~ and ~~Cosmetic Act, or the FDCA, and~~ other federal and state statutes and regulations, govern, among other things, the research, development, testing, manufacture, storage, recordkeeping, approval, labeling, promotion and marketing, distribution, post-approval monitoring and reporting, sampling, and import and export of pharmaceutical products. Failure to comply with applicable U.S. requirements may subject a company to a variety of administrative or judicial sanctions, such as imposition of clinical holds, FDA refusal to approve pending NDAs, warning letters, product recalls, product seizures, total or partial suspension of production or distribution, injunctions, fines, refusals of government contracts, restitution, disgorgement, civil penalties and criminal prosecution.

Pharmaceutical product development in the U.S. typically involves pre-clinical laboratory and animal tests and the submission to the FDA of an IND application, which must become effective before clinical testing may commence. For commercial approval, the sponsor must submit adequate tests by all methods reasonably applicable to show that the drug is safe for use under the conditions prescribed, recommended or suggested in the proposed labeling. The sponsor must also submit substantial evidence, generally consisting of adequate, well-controlled clinical trials to establish that the drug will have the effect it purports or is represented to have under the conditions of use prescribed, recommended or suggested in the proposed labeling. In certain cases, the FDA may determine that a drug is effective based on one clinical study plus confirmatory evidence. Satisfaction of FDA pre-market approval requirements typically takes many years and the actual time required may vary substantially based upon the type, complexity and novelty of the product or disease.

Pre-clinical ~~tests~~studies include ~~laboratory~~ evaluation of ~~product chemistry~~pharmacology, ~~formulation and toxicity,~~ as well as animal ~~trials~~studies to assess the ~~characteristics and potential~~ safety and efficacy of the product candidate. The conduct of some of the pre-clinical ~~tests~~studies must comply with federal regulations and requirements, including the FDA’s ~~good~~GLP ~~laboratory practices~~ regulations and the U.S. Department of Agriculture’s (the “USDA’s”) regulations implementing the Animal Welfare Act. The results of pre-clinical ~~testing~~studies are submitted to the FDA as part of an IND application ~~along~~ along with other information, including information about ~~product chemistry~~CMC, ~~manufacturing~~ and ~~controls, and a~~ proposed clinical trial ~~protocol~~protocols. Long-term pre-clinical tests, such as animal tests of reproductive toxicity and carcinogenicity, may continue after the IND application is submitted.

A 30-day waiting period after the submission of each IND application is required prior to the commencement of clinical testing in humans. If the FDA has not imposed a clinical hold on the IND application or otherwise commented or questioned the IND application within this 30-day period, the clinical trial proposed in the IND application may begin.

Clinical trials involve the administration of the clinical protocols defined in the IND to healthy volunteers or patients under the supervision of a qualified investigator. Clinical trials must be conducted: (i) in compliance with federal regulations, (ii) in compliance with GCP ~~(“Good Clinical Practice”)~~, an international standard meant to protect the rights and health of patients and to define the roles of clinical trial sponsors, administrators and monitors, and (iii) under protocols detailing the objectives of the trial, the parameters to be used in monitoring safety and the effectiveness criteria to be evaluated. Each protocol involving testing on U.S. ~~patients~~subjects and subsequent protocol amendments must be submitted to the FDA as part of the IND application.

42The FDA may order the temporary, or permanent, discontinuation of a clinical trial at any time or impose other sanctions if it believes that the clinical trial either is not being conducted in accordance with FDA requirements or presents an unacceptable risk to the clinical trial subjects. The trial protocol and informed consent information for subjects in clinical trials must also be submitted to an IRB for approval. An IRB may also require the clinical trial at the site to be halted, either temporarily or permanently, for failure to comply with the IRB’s requirements or may impose other conditions.

The FDA may order the temporary, or permanent, discontinuation of a clinical trial at any time or impose other sanctions if it believes that the clinical trial either is not being conducted in accordance with FDA requirements or presents an unacceptable risk to the clinical trial patients. The trial protocol and informed consent information for patients in clinical trials must also be submitted to an institutional review board, or IRB, for approval. An IRB may also require the clinical trial at the site to be halted, either temporarily or permanently, for failure to comply with the IRB’s requirements or may impose other conditions.54

Clinical trials to support NDAs for marketing approval are typically conducted in three sequential phases, but the phases may overlap. In general, in Phase 1, the initial introduction of the drug into healthy human subjects or patients, the drug is tested to assess metabolism, pharmacokinetics, pharmacological actions, side effects associated with increasing doses and, if possible, early evidence on effectiveness. Phase 2 usually involves trials in a limited patient population to determine the effectiveness of the drug for a particular indication, dosage tolerance and optimum dosage, and to identify common adverse effects and safety risks.

If a compound demonstrates evidence of effectiveness and an acceptable safety profile in Phase 2 evaluations, Phase 3 trials are undertaken to obtain the additional information about clinical efficacy and safety in a larger number of patients, typically at geographically dispersed clinical trial sites, to permit the FDA to evaluate the overall benefit-risk relationship of the drug and to provide adequate information for the labeling of the drug. In most cases, the FDA requires two adequate and well-controlled Phase 3 clinical trials to demonstrate the efficacy of the drug. The FDA may, however, determine that a drug is effective based on one clinical study plus confirmatory evidence. Only a small percentage of investigational drugs complete all three phases and obtain marketing approval. In some cases, the FDA may require post-market studies, known as Phase 4 studies, to be conducted as a condition of approval in order to gather additional information on the drug’s effect in various populations and any side effects associated with long-term use. Depending on the risks posed by the drugs, other post-market requirements may be imposed.

After completion of the required clinical testing, an NDA is prepared and submitted to the FDA. The FDA approval of the NDA is required before marketing of the product may begin in the U.S. The NDA must include the results of all pre-clinical, clinical, and other testing and a compilation of data relating to the ~~product’s~~ pharmacology, ~~chemistry,~~and ~~manufacture,~~CMC ~~and~~of ~~controls~~the product candidate. The cost of preparing and submitting an NDA is substantial. Under federal law, the submission of most NDAs is additionally subject to a substantial application user fee.

The FDA has 60 days from its receipt of an NDA to determine whether the application will be accepted for filing based on the agency’s threshold determination that it is sufficiently complete to permit substantive review. Once the submission is accepted for filing, the FDA begins an in-depth review. Under the statute and implementing regulations, the FDA has 180 days (the initial review cycle) from the date of filing to issue either an approval letter or a complete response letter, unless the review period is adjusted by mutual agreement between the FDA and the applicant or as a result of the applicant submitting a major amendment. In practice, the performance goals established pursuant to the Prescription Drug User Fee Act have effectively extended the initial review cycle beyond 180 days. The FDA’s current performance goals call for the FDA to complete review of 90 percent of standard (non-priority) NDAs within 10 months of receipt and within six months for priority NDAs, but two additional months of review are added to standard and priority NDAs for a new molecular entity (“NME”).

The FDA may also refer applications for novel drug products, or drug products that present difficult questions of safety or efficacy, to an advisory committee, which is typically a panel that includes clinicians and other experts, for review, evaluation and a recommendation as to whether the application should be approved. The FDA is not bound by the recommendation of an advisory committee, but it generally follows such recommendations. Before approving an NDA, the FDA will typically inspect one or more clinical sites to assure compliance with GCP. Additionally, the FDA will inspect the facility or the facilities at which the drug is manufactured. The FDA will not approve the product unless compliance with current ~~GMP~~cCMP is satisfactory and the NDA contains data that provide substantial evidence that the drug is safe and effective in the indication studied.

After the FDA evaluates the NDA and the manufacturing facilities, it issues either an approval letter or a complete response letter. A complete response letter generally outlines the deficiencies in the submission and may require substantial additional testing, or information, in order for the FDA to reconsider the application. If, or when, those deficiencies have been addressed to the FDA’s satisfaction in a resubmission of the NDA, the FDA will issue an approval letter. The FDA has committed to reviewing 90 percent of resubmissions within two to six months depending on the type of information included.

An approval letter authorizes commercial marketing of the drug with specific prescribing information for specific indications. As a condition of NDA approval, the FDA may require a ~~risk evaluation and mitigation strategy, or~~ REMS, to help ensure that the benefits of the drug outweigh the potential risks. REMS can include medication guides, communication plans for health care professionals, and elements to assure safe use, or (“ETASU”). ETASU can include, but are not limited to, special training or certification for prescribing or dispensing, dispensing only under certain circumstances, special monitoring, and the use of patient registries. The requirement for a REMS can materially affect the potential market and profitability of the drug. Moreover, product approval may require substantial post-approval testing and surveillance to monitor the drug’s safety or efficacy. Once granted, product approvals may be withdrawn if compliance with regulatory standards is not maintained or problems are identified following initial marketing.

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Disclosure of Clinical Trial Information

Sponsors of clinical trials of certain FDA-regulated products, including prescription drugs, are required to register and disclose certain clinical trial information on a public website maintained by the U.S. National Institutes of Health. Information related to the product, patient population, phase of investigation, study sites and investigator, and other aspects of the clinical trial is made public as part of the registration. Sponsors are also obligated to disclose the results of these trials after completion. Disclosure of the results of these trials can be delayed for up to two years if the sponsor certifies that it is seeking approval of an unapproved product or that it will file an application for approval of a new indication for an approved product within one year. Competitors may use this publicly available information to gain knowledge regarding the design and progress of our development programs.

Special Protocol Assessment

A company may reach an agreement with the FDA under the Special Protocol Assessment, or “SPA”, process as to the required design and size of clinical trials intended to form the primary basis of an efficacy claim. According to its performance goals, the FDA is supposed to evaluate the protocol within 45 days of the request to assess whether the proposed trial is adequate, and that evaluation may result in discussions and a request for additional information. AAn SPA request must be made before the proposed trial begins, and all open issues must be resolved before the trial begins. If a written agreement is reached, it will be documented and made part of the administrative record. Under the FDCA and FDA guidance implementing the statutory requirement, an SPA is generally binding upon the FDA except in limited circumstances, such as if the FDA identifies a substantial scientific issue essential to determining safety or efficacy after the study begins, public health concerns emerge that were unrecognized at the time of the protocol assessment, the sponsor and the FDA agree to the change in writing, or if the study sponsor fails to follow the protocol that was agreed upon with the FDA.

Advertising and Promotion

Pre-approval promotion of investigational drug candidates is prohibited by the FDA. Therefore, sponsors must ensure that any pre-approval communications disseminated about its drug candidates do not state or imply that such candidates have been proven safe or effective for the applicable use(s) or that they have been approved for commercialization in the United States. Further, once an NDA for a given candidate is approved, if ever, the product will be subject to certain post-approval requirements. For instance, the FDA closely regulates the post-approval marketing and promotion of drugs.

Drugs may be marketed only for the approved indications and in accordance with the provisions of the approved labeling. Changes to some of the conditions established in an approved application, including changes in indications, labeling, or manufacturing processes or facilities, require submission and FDA approval of a new NDA or NDA supplement before the change can be implemented. An NDA supplement for a new indication typically requires clinical data similar to that in the original application, and the FDA uses the same procedures and actions in reviewing NDA supplements as it does in reviewing NDAs.

Adverse Event Reporting and ~~GMP~~cCMP Compliance

Adverse event reporting and submission of periodic reports is required following FDA approval of an NDA. The FDA also may require post-marketing testing, known as Phase 4 testing, may require under a REMS special communication regarding the safety of the drug or heightened surveillance to monitor the effects of an approved product, or the FDA may place conditions on an approval that could restrict the distribution or use of the product. In addition, quality-control, drug manufacture, packaging, and labeling procedures must continue to conform to ~~GMP~~cCMP, after approval. Drug manufacturers and certain of their subcontractors are required to register their establishments with the FDA and certain state agencies. Registration with the FDA subjects entities to periodic unannounced inspections by the FDA, during which the agency inspects manufacturing facilities to assess compliance with ~~GMP~~cCMP. Accordingly, manufacturers must continue to expend time, ~~money~~ money and effort in the areas of production and quality control to maintain compliance with ~~GMP~~cCMP. Regulatory authorities may withdraw ~~product~~ product approvals or request product recalls if a company fails to comply with regulatory standards, if it encounters problems following ~~initial~~ initial marketing or if previously unrecognized problems are subsequently discovered.

4456

Pediatric Exclusivity and Pediatric Use

The Best Pharmaceuticals for Children Act, or (“BPCA”,) provides NDA holders a six-month period of exclusivity attached to ~~any~~ any other exclusivity listed with the FDA — patent or non-patent — for a drug, if certain conditions are met. Conditions for pediatric exclusivity include a determination by the FDA that information relating to the use of a new drug in the pediatric population may produce health benefits in that population; a written request by the FDA for pediatric studies; and agreement by the applicant to perform the requested studies and the submission to the FDA, completion of the studies in accordance with the written request, and the acceptance by the FDA, of the reports of the requested studies within the statutory time frame. Applications under the BPCA are treated as priority applications.

In addition, under the Pediatric Research Equity Act, or (“PREA”,) NDAs or supplements to NDAs must contain data to assess ~~the~~ the safety and effectiveness of the drug for the claimed indications in all relevant pediatric subpopulations and to support dosing and ~~administration~~ administration for each pediatric subpopulation for which the drug is safe and effective, unless the sponsor has received a deferral or waiver from the FDA. Unless otherwise required by regulation, PREA does not apply to any drug for an indication for which orphan designation ~~has~~ has been granted. The sponsor or the FDA may request a deferral of pediatric studies for some or all of the pediatric subpopulations. A deferral may be granted for several reasons, including a finding that the drug is ready for approval for use in adults before pediatric ~~studies~~ studies are complete or that additional safety or effectiveness data need to be collected before the pediatric studies begin. Under PREA, ~~the~~ the FDA must send a noncompliance letter requesting a response within 45 days to any sponsor that fails to submit the required assessment, keep a deferral current or fails to submit a request for approval of a pediatric formulation.

Controlled Substances

The ~~federal Controlled Substances Act of 1970, or “~~CSA”, and its implementing regulations establish a “closed system” of regulations for controlled substances. The CSA imposes registration, security, recordkeeping and reporting, storage, manufacturing, distribution, importation and other requirements under the oversight of the ~~Drug Enforcement Agency (“~~DEA”). The DEA is the federal agency responsible for regulating controlled substances, and requires those individuals or entities that manufacture, import, export, distribute, research, or dispense controlled substances to comply with the regulatory requirements in order to prevent the diversion of controlled substances to illicit channels of commerce.

The DEA categorizes controlled substances into one of five schedules — Schedule I, II, III, IV or V — with varying qualifications for listing in each schedule. Schedule I substances by definition have a high potential for abuse, have no currently accepted medical use in treatment in the U.S., and lack accepted safety for use under medical supervision. Marijuana and psychedelics such as psilocybin, DMT, mescaline and MDMA are currently Schedule I controlled substances, which means that no preclinical or clinical studies of product candidates containing these substances may be conducted in the United States without the required DEA registration(s) and related approvals, as applicable. Pharmaceutical products having a currently accepted medical use that are otherwise approved for marketing may be listed as Schedule II, III, IV or V substances, with Schedule II substances presenting the highest potential for abuse and physical or psychological dependence, and Schedule V substances presenting the lowest relative potential for abuse and dependence.

Facilities that manufacture, distribute, import, or export any controlled substance must register annually with the DEA. The DEA registration is specific to the particular location, activity(ies) and controlled substance schedule(s). For example, separate registrations are required for importation and manufacturing activities, and each registration authorizes which schedules of controlled substances the registrant may handle. However, certain coincidental activities are permitted without obtaining a separate DEA registration, such as distribution of controlled substances by the manufacturer that produces them.

The DEA inspects all manufacturing facilities to review security, recordkeeping, reporting, and handling prior to issuing a controlled substance registration. The specific security requirements vary by the type of business activity and the schedule and quantity of controlled substances handled. The most stringent requirements apply to manufacturers of Schedules I and Schedule II substances. Required security measures commonly include background checks on employees and physical control of controlled substances through storage in approved vaults, safes and cages, and through use of alarm systems and surveillance cameras. An application for a manufacturing registration as a bulk manufacturer (not a dosage form manufacturer or a repacker/relabeler) for a Schedule I or II substance must be published in the Federal Register, and is open for 60 days to permit interested persons to submit comments, objections or requests for a hearing. A copy of the notice of the Federal Register publication is simultaneously forwarded by DEA to all those registered, or applicants for registration, as bulk manufacturers of that substance.

Once registered, manufacturing facilities must maintain records documenting the manufacture, receipt and distribution of all controlled substances. Manufacturers must submit periodic reports to the DEA of the distribution of Schedules I and II controlled substances, Schedule III narcotic substances, and other designated substances. Registrants must also report any controlled substance thefts or significant losses, and must obtain authorization to destroy or dispose of controlled substances.

As with applications for registration as a bulk manufacturer, an application for an importer registration for a Schedule I or II substance must also be published in the Federal Register, which remains open for 30 days for comments. Imports of Schedules I and II controlled substances for commercial purposes are generally restricted to substances not already available from a domestic supplier or where there is not adequate competition among domestic suppliers. In addition to an importer or exporter registration, importers and exporters must obtain a permit for every import or export of a Schedules I and II substance or Schedules III, IV and V narcotic, and submit import or export declarations for Schedules III, IV and V non-narcotics. In some cases, Schedule III non-narcotic substances may be subject to the import/export permit requirement, if necessary to ensure that the U.S. complies with its obligations under international drug control treaties.

For drugs manufactured in the U.S., the DEA establishes annually an aggregate quota for the amount of substances within Schedules I and II that may be manufactured or produced in the U.S. based on the DEA’s estimate of the quantity needed to meet legitimate medical, scientific, research and industrial needs.

The states also maintain separate controlled substance laws and regulations, including licensing, recordkeeping, security, distribution, and dispensing requirements. State Authorities, including Boards of Pharmacy, regulate use of controlled substances in each state. Failure to maintain compliance with applicable requirements, particularly as manifested in the loss or diversion of controlled substances, can result in enforcement action that could have a material adverse effect on our business, operations and financial condition. The DEA may seek civil penalties, refuse to renew necessary registrations, or initiate proceedings to revoke those registrations. In certain circumstances, violations could lead to criminal prosecution.

Europe/Rest of World Government Regulation

In addition to regulations in the U.S., we are and will be subject, either directly or through our distribution partners, to a variety of regulations in other jurisdictions governing, among other things, clinical trials and any commercial sales (including pricing and reimbursement) and distribution of our product candidates, if approved.

Whether or not we obtain FDA approval for a product, we must obtain the requisite approvals from regulatory authorities in non-U.S. countries prior to the commencement of clinical trials or marketing of the product in those countries.

In the European Union, medicinal products are subject to extensive pre- and post-marketing regulation by regulatory authorities at both the European Union and national levels. Additional rules also apply at the national level to the manufacture, import, export, storage, distribution and sale of controlled substances. In many European Union member states the regulatory authority responsible for medicinal products is also responsible for controlled substances. Responsibility is, however, split in some member states. Generally, any company manufacturing or distributing a medicinal product containing a controlled substance in the European Union will need to hold a controlled substances license from the competent national authority and will be subject to specific record-keeping and security obligations. Separate import or export certificates are required for each shipment into or out of the member state.

Clinical Trials and Marketing Approval

Whether or not we obtain FDA approval for a product, we would need to obtain the necessary approvals by the comparable regulatory authorities of foreign countries before we can commence clinical trials or marketing of the product in those countries. The approval process varies from country to country and can involve additional product testing and additional administrative review periods. The time required to obtain approval in other countries might differ from and be longer than that required to obtain FDA approval. Regulatory approval in one country does not ensure regulatory approval in another, but a failure or delay in obtaining regulatory approval in one country may negatively impact the regulatory process in others.

Certain countries outside of the U.S. have a process that requires the submission of a clinical trial application much like an IND application prior to the commencement of human clinical trials. In Europe, for example, a ~~clinical trial application, or “~~CTA”, must be submitted to the competent national health authority and to independent ethics committees in each country in which a company intends to conduct clinical trials. Once the CTA is approved in accordance with a country’s requirements and a company has received favorable ethics committee approval, clinical trial development may proceed in that country.

The requirements and process governing the conduct of clinical trials, product licensing, pricing, and reimbursement vary from country to country, even though there is already some degree of legal harmonization in the European Union member states resulting from the national implementation of underlying European Union legislation. In all cases, the clinical trials must be conducted in accordance with the International Conference on Harmonization, or (“ICH”,) guidelines on GCP and other applicable regulatory requirements.

46To obtain regulatory approval to place a drug on the market in European Union countries, Enveric must submit a marketing authorization application. This application is similar to the NDA in the U.S., with the exception of, among other things, country-specific document requirements. All application procedures require an application in the common technical document (“CTD”) format, which includes the submission of detailed information about the manufacturing and quality of the product, and nonclinical and clinical trial information. Drugs can be authorized in the European Union by using (i) the centralized authorization procedure, (ii) the mutual recognition procedure, (iii) the decentralized procedure, or (iv) national authorization procedures.

ToThe ~~obtain~~European ~~regulatory~~Commission created the centralized procedure for the approval of human drugs to ~~place~~facilitate amarketing ~~drug~~authorizations onthat ~~the~~are valid ~~market~~throughout inthe European Union ~~countries~~and, ~~Enveric~~by ~~must~~extension ~~submit~~(after anational ~~marketing~~implementing ~~authorization~~decisions) ~~application. This~~in ~~application~~Iceland, isLiechtenstein ~~similar~~and toNorway, which, together with the ~~NDA~~European inUnion Member States, comprise the UEuropean Economic Area (“EEA”).~~S.,~~ Applicants file marketing authorization applications with the ~~exception~~European ofMedicines Agency (“EMA”), ~~among~~where ~~other~~they ~~things,~~are ~~country-specific~~reviewed ~~document~~by ~~requirements.~~a relevant scientific ~~All~~committee, ~~application~~in ~~procedures~~most ~~require~~cases anthe ~~application~~Committee infor Medicinal Products for Human Use (the ~~common~~“CHMP”). ~~technical~~The ~~document,~~EMA orforwards ~~CTD,~~CHMP ~~format~~opinions to the European Commission, which ~~includes~~uses them as the ~~submission~~basis offor deciding whether to grant a marketing authorization. This procedure results ~~detailed~~in ~~information~~a ~~about~~single marketing authorization granted by the ~~manufacturing~~European ~~and~~Commission ~~quality~~that ofis valid across the ~~product~~European Union, ~~and~~as ~~nonclinical~~well ~~and~~as ~~clinical~~in ~~trial~~Iceland, Liechtenstein ~~information~~and Norway. ~~Drugs~~The ~~can~~centralized ~~be authorized~~procedure inis ~~the~~compulsory ~~European~~for ~~Union~~human bydrugs ~~using~~that are: (i) ~~the~~derived ~~centralized~~from ~~authorization~~biotechnology ~~procedure~~processes, such as genetic engineering, (ii) contain a new active substance indicated for the ~~mutual~~treatment ~~recognition~~of ~~procedure~~certain diseases, such as HIV/AIDS, cancer, diabetes, neurodegenerative diseases, autoimmune and other immune dysfunctions and viral diseases, (iii) ~~the~~officially designated “orphan ~~decentralized~~drugs” ~~procedure~~(drugs used for rare human diseases), orand (iv) ~~national~~advanced-therapy medicines, such as gene-therapy, somatic cell-therapy or tissue-engineered medicines. The centralized procedure may at the voluntary request of the applicant also be used for human drugs that do not fall within the above-mentioned categories if the CHMP agrees that the human drug (a) contains a new active substance not yet approved on November 20, 2005; (b) constitutes a significant therapeutic, scientific or technical innovation, or (c) authorization ~~procedures~~under the centralized procedure is in the interests of patients at the European Union level.

The European Commission created the centralized procedure for the approval of human drugs to facilitate marketing authorizations that are valid throughout the European Union and, by extension (after national implementing decisions) in Iceland, Liechtenstein and Norway, which, together with the European Union Member States, comprise the European Economic Area, or “EEA”. Applicants file marketing authorization applications with the EMA (European Medicines Agency), where they are reviewed by a relevant scientific committee, in most cases the Committee for Medicinal Products for Human Use (the “CHMP”). The EMA forwards CHMP opinions to the European Commission, which uses them as the basis for deciding whether to grant a marketing authorization. This procedure results in a single marketing authorization granted by the European Commission that is valid across the European Union, as well as in Iceland, Liechtenstein and Norway. The centralized procedure is compulsory for human drugs that are: (i) derived from biotechnology processes, such as genetic engineering, (ii) contain a new active substance indicated for the treatment of certain diseases, such as HIV/AIDS, cancer, diabetes, neurodegenerative diseases, autoimmune and other immune dysfunctions and viral diseases, (iii) officially designated “orphan drugs” (drugs used for rare human diseases), and (iv) advanced-therapy medicines, such as gene-therapy, somatic cell-therapy or tissue-engineered medicines. The centralized procedure may at the voluntary request of the applicant also be used for human drugs that do not fall within the above-mentioned categories if the CHMP agrees that the human drug (a) contains a new active substance not yet approved on November 20, 2005; (b) constitutes a significant therapeutic, scientific or technical innovation, or (c) authorization under the centralized procedure is in the interests of patients at the European Union level. Since the U.K. exited the E.U., it no longer falls under these regulations, however, it has been decided it will follow EMA as it is transitioning to regulations as defined by the Medicines and Healthcare products Regulatory Agency (MHRA). The MHRA has temporary arrangements in place to partially align with EU regulations around medical technology including the sale of CE-marked medical devices until June 2023 and approval of EU-authorized medicines using a mutual recognition procedure until the end of 2023.

Under the centralized procedure in the European Union, the maximum time frame for the evaluation of a marketing authorization application by the EMA is 210 days (excluding clock stops, when additional written or oral information is to be provided by the applicant in response to questions asked by the CHMP), with adoption of the actual marketing authorization by the European Commission thereafter.

Accelerated evaluation might be granted by the CHMP in exceptional cases, when a medicinal product is expected to be of a major public health interest from the point of view of therapeutic innovation, defined by three cumulative criteria: the seriousness of the disease to be treated; the absence of an appropriate alternative therapeutic approach, and anticipation of exceptional high therapeutic benefit. In this circumstance, EMA ensures that the evaluation for the opinion of the CHMP is completed within 150 days and the opinion issued thereafter.

For those medicinal products for which the centralized procedure is not available, the applicant must submit marketing authorization applications to the national medicines regulators through one of three procedures: (i) the mutual recognition procedure (which must be used if the product has already been authorized in at least one other European Union member state, and in which the European Union member states are required to grant an authorization recognizing the existing authorization in the other European Union member state, unless they identify a serious risk to public health), (ii) the decentralized procedure (in which applications are submitted simultaneously in two or more European Union member states), or (iii) national authorization procedures (which results in a marketing authorization in a single European Union member state).

Mutual Recognition Procedure

The mutual recognition procedure, or (“MRP”,) for the approval of human drugs is an alternative approach to facilitate individual national marketing authorizations within the European Union. Fundamentally, the MRP may be applied for all human drugs for which the centralized procedure is not obligatory. The MRP is applicable to the majority of conventional medicinal products, and must be used if the product has already been authorized in one or more European Union member states.

The MRP functions by building on an already-existing marketing authorization in a member state of the European Union which is used as a reference in order to obtain marketing authorizations in other European Union member states. Under the MRP, if a marketing authorization for a drug already exists in one or more member states of the European Union and subsequently marketing authorization applications are made in other European Union member states by referring to the initial marketing authorization. The member state in which the marketing authorization was first granted will then act as the reference member state. The member states where the marketing authorization is subsequently applied for act as concerned member states. The concerned member states are required to grant an authorization recognizing the existing authorization in the reference member state, unless they identify a serious risk to public health.

The MRP is based on the principle of the mutual recognition by European Union member states of their respective national marketing authorizations. Based on a marketing authorization in the reference member state, the applicant may apply for marketing authorizations in other member states. In such case, the reference member state shall update its existing assessment report about the drug in 90 days. After the assessment is completed, copies of the report are sent to all member states, together with the approved summary of product characteristics, labeling and package leaflet. The concerned member states then have 90 days to recognize the decision of the reference member state and the summary of product characteristics, labeling and package leaflet. National marketing authorizations shall be granted within 30 days after acknowledgement of the agreement.

Should any European Union member state refuse to recognize the marketing authorization by the reference member state, on the grounds of potential serious risk to public health, the issue will be referred to a coordination group. Within a time frame of 60 days, member states shall, within the coordination group, make all efforts to reach a consensus. If this fails, the procedure is submitted to an EMA scientific committee for arbitration. The opinion of this EMA Committee is then forwarded to the European Commission, for the start of the decision-making process. As in the centralized procedure, this process entails consulting various European Commission Directorates General and the Standing Committee on Human Medicinal Products.

Data Exclusivity

In the European Union, marketing authorization applications for generic medicinal products do not need to include the results of pre-clinical and clinical trials, but instead can refer to the data included in the marketing authorization of a reference product for which regulatory data exclusivity has expired. If a marketing authorization is granted for a medicinal product containing a new active substance, that product benefits from eight years of data exclusivity, during which generic marketing authorization applications referring to the data of that product may not be accepted by the regulatory authorities, and a further two years of market exclusivity, during which such generic products may not be placed on the market. The two-year period may be extended to three years if during the first eight years a new therapeutic indication with significant clinical benefit over existing therapies is approved.

Orphan Medicinal Products

The EMA’s Committee for Orphan Medicinal Products (“COMP”) may recommend orphan medicinal product designation to ~~promote~~ promote the development of products that are intended for the diagnosis, prevention or treatment of life-threatening or chronically debilitating conditions affecting not more than 5five in 10,000 persons in the European Union. Additionally, designation is granted for products ~~intended~~ intended for the diagnosis, prevention or treatment of a life-threatening, seriously debilitating or serious and chronic condition and when, without incentives, it is unlikely that sales of the product in the European Union would be sufficient to justify the necessary investment in developing the medicinal product. The COMP may only recommend orphan medicinal product designation when the product in question offers a significant clinical benefit over existing approved products for the relevant indication. Following a positive opinion by the COMP, the European Commission adopts a decision granting orphan status. The COMP will reassess orphan status in parallel with EMA review of a marketing authorization application and orphan status may be withdrawn at that stage if it no longer fulfills the orphan criteria (for instance because in the meantime a new product was approved for the indication and no convincing data are available to demonstrate a significant benefit over that product). Orphan medicinal product designation entitles a party to financial incentives such as reduction of fees or fee waivers and ten years of market exclusivity is granted following marketing authorization. During this period, the competent authorities may not accept or approve any similar medicinal product, unless it offers a significant clinical benefit. This period may be reduced to six years if the orphan medicinal product designation criteria are no longer met, including where it is shown that the product is sufficiently profitable not to justify maintenance of market exclusivity.

Pediatric Development

In the European Union, companies developing a new medicinal product must agree to a Pediatric Investigation Plan, or (“PIP”,) with the EMA and must conduct pediatric clinical trials in accordance with that PIP unless a waiver applies, for example, because the relevant disease or condition occurs only in adults. The marketing authorization application for the product must include the results of pediatric clinical trials conducted in accordance with the PIP, unless a waiver applies, or a deferral has been granted, in which case the pediatric clinical trials must be completed at a later date. Products that are granted a marketing authorization on the basis of the pediatric clinical trials conducted in accordance with the PIP are eligible for a six-month extension of the protection under a supplementary protection certificate (if the product covered by it qualifies for one at the time of approval). This pediatric reward is subject to specific conditions and is not automatically available when data in compliance with the PIP are developed and submitted.

If we fail to comply with applicable foreign regulatory requirements, we may be subject to, among other things, fines, suspension of clinical trials, suspension or withdrawal of regulatory approvals, product recalls, seizure of products, operating restrictions and criminal prosecution.

In addition, most countries are parties to the Single Convention on Narcotic Drugs 1961, which governs international trade and domestic control of narcotic substances. Countries may interpret and implement their treaty obligations in a way that creates a legal obstacle to us obtaining marketing approval for our product candidates in those countries. These countries may not be willing or able to amend or otherwise modify their laws and regulations to permit our product candidates to be marketed, or achieving such amendments to the laws and regulations may take a prolonged period of time. In that case, we would be unable to market our product candidates in those countries in the near future or perhaps at all.

Employees

We have consolidated our employee base to save capital and focus on development of our leading ~~candidate~~candidates EB-003. As of the date of ~~hereof,~~this report, we employ five full-time employees and one part-time employee. We also work with scientific advisors, consultants and service providers, mainly through academic institutions and contract research organizations.

We have never had a work stoppage and none of ~~its~~our employees are covered by collective bargaining agreements or represented by a labor union. We believe that we have good relationships with our employees.

4861

MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

References to the “Company,” “Enveric” “our,” “us,” or “we” in this section titled “Management’s Discussion and Analysis of Financial Condition and Results of Operations of Enveric” refer to Enveric Biosciences, Inc. The following discussion and analysis of our financial condition and results of operations should be read together with our financial statements and related notes appearing elsewhere in this prospectus. Some of the information contained in this discussion and analysis or set forth elsewhere in this prospectus, including information with respect to our plans and strategy for our business and related financing, includes forward-looking statements involving risks and uncertainties and should be read together with the “Risk Factors” and the “Cautionary Statement Regarding Forward-Looking Statements” sections of this prospectus. Such risks and uncertainties could cause actual results to differ materially from the results described in or implied by the forward-looking statements contained in the following discussion and analysis.

Business Overview

~~Enveric~~We ~~Biosciences~~are is a biotechnology company ~~dedicated~~focused toon ~~the~~developing ~~development~~next-generation, ~~of novel neuroplastogenic~~ small-molecule neuroplastogenic therapeutics ~~for~~that ~~the~~address ~~treatment~~unmet needs ofin ~~depression,~~psychiatric ~~anxiety,~~ and ~~addiction~~neurological disorders. ~~Leveraging~~By ~~its~~leveraging ~~unique~~a ~~discovery~~differentiated ~~and~~drug ~~development~~discovery platform, ~~the~~and ~~Psybrary™, Enveric has created~~ a ~~robust~~growing ~~intellectual~~library ~~property portfolio~~ of ~~new~~patent protected chemical ~~entities for specific mental health indications. Enveric’s lead program~~structures, ~~the~~we ~~EVM201~~are ~~Series,~~advancing ~~comprises~~a ~~next~~pipeline ~~generation~~of ~~synthetic~~novel ~~prodrugs~~compounds ofdesigned ~~the~~to ~~active~~promote ~~metabolite,~~neuroplasticity ~~psilocin.~~without ~~Recently,~~hallucinogenic ~~Enveric out-licensed~~effects. ~~this~~Our ~~program~~lead –candidate, ~~which consists of the~~ EB-~~002~~003, ~~(formerly~~is ~~EB-373) product for~~ the ~~treatment~~first ofknown ~~psychiatric~~compound ~~disorders~~designed – to ~~MycoMedica Life~~selectively ~~Sciences,~~engage ~~who~~both ~~will~~5-HT2A ~~seek to develop, manufacture,~~ and ~~commercialize EB~~5-~~002,~~HT1B ~~in exchange for certain development and milestone~~receptors ~~payments~~with ~~to Enveric (discussed below). Enveric is now focused on advancing its second program,~~ the ~~EVM301~~potential ~~Series – EB-003 – expected~~ to ~~offer~~deliver ~~a first~~fast-~~in-class~~acting, ~~new~~durable ~~approach~~antidepressant toand ~~the~~anxiolytic ~~treatment~~effects ofwith ~~difficult-to-address~~outpatient ~~mental health disorders, mediated by the promotion of neuroplasticity without also inducing hallucinations in the patient~~convenience.

~~Neuroplastogens~~Our lead program, the EVM301 Series, and our lead drug candidate, EB-003, are intended to offer a first-in-class, new approach to the treatment of difficult-to-address mental health disorders, mediated by the promotion of neuroplasticity and without also inducing hallucinations in the patient. EB-003 is a novel derivative of DMT. It is currently advancing through preclinical studies with the aim of initiating first-in-human studies to assess safety and tolerability including non-hallucinogenic properties, followed by clinical trials targeting the treatment of depression or other neuropsychiatric disorders.

~~Following~~We intend to assemble ~~our~~a ~~amalgamation~~team of clinical experts and principal investigators with ~~MagicMed~~experience ~~completed~~across inmultiple ~~September~~mental ~~2021,~~health weand ~~have~~central ~~continued~~nervous system indications to ~~pursue~~be responsible for the ~~development~~ management, monitoring, and integrity of ~~MagicMed’s~~the ~~proprietary~~clinical ~~psychedelic~~research. ~~derivatives~~We ~~library,~~plan ~~the~~to ~~Psybrary™~~submit ~~which~~filings weincluding ~~believe~~IND ~~will~~applications and, ~~help~~eventually, usNDAs to ~~identify~~seek ~~and~~approval ~~develop~~ with the ~~right~~FDA ~~drug~~and ~~candidates~~with ~~needed~~responsible toregulatory ~~address~~agencies ~~mental~~in ~~health~~other ~~challenges~~jurisdictions, ~~including~~in ~~anxiety~~connection with our product candidates. WeThe ~~synthesize~~selection, ~~novel~~timing, ~~analogues~~duration, and design of ~~serotonin~~any prospective studies are subject to regulatory filings, approval ~~using~~and afinalization ~~mixture~~ of ~~chemistry~~commercial ~~and~~plans. ~~synthetic~~Our ~~biology,~~EB-003 ~~resulting~~program inhas ~~the~~completed ~~expansion~~short-term ofdose-range ~~the~~finding ~~Psybrary™,~~toxicology ~~which~~studies ~~includes~~and 16is ~~patent~~now ~~families~~ready ~~with~~to ~~over~~advance ainto ~~million~~IND-enabling, ~~potential~~GLP ~~variations~~compliant ~~and~~safety ~~hundreds~~pharmacology, ofADMET ~~synthesized~~and ~~molecules~~longer-term toxicology studies.

AtWe ~~this~~unveiled ~~stage,~~the weEVM401 ~~have~~Series ~~entered~~on ~~into~~February ~~non-binding~~25, ~~term~~2025, ~~sheets~~which ~~with~~is ~~strategic~~intended ~~partners~~to ~~that~~broaden ~~out-license~~its ~~molecules~~pipeline ~~from~~with ~~the~~additional ~~Psybrary™.~~non-hallucinogenic molecules ~~Going~~and ~~forward~~strengthen weour ~~intend~~ability to ~~both~~target ~~develop~~addiction ~~intellectual property~~ and ~~license~~neuropsychiatric ~~intellectual~~disorders ~~property~~for ~~from~~patients ~~pharmaceutical~~with ~~and~~limited ~~biotechnology companies~~options. ~~and~~While ~~research~~we ~~institutions~~intend ~~which~~to ~~would~~pursue development ~~cover~~of ~~research~~the ~~stage~~EVM401 ~~and~~Series, ~~clinical~~our ~~stage~~primary ~~assets~~focus is to ~~build~~develop aour ~~pipeline~~lead ofasset ~~product~~EB-003 ~~candidates~~in the EVM301 Series.

Our primary focus is to develop our lead asset EB-003 in the EVM301 Series. The development status of the product is shown in the table below:

Product Candidates		Targeted Indications		Partner(s)		Status		Expected Next Steps
EB-003 Third-generation psychedelic-inspired new chemical entity		Mental health indication				Pre-Clinical Development		IND Filing

Recent Developments

~~NASDAQ~~At-the-Market ~~Bid Price Deficiency and Reverse Split~~Offering

On ~~May~~April 169, ~~2024~~2025, ~~the~~we ~~Company~~entered ~~received~~into aan ~~letter~~At ~~from Nasdaq notifying~~ the ~~Company~~Market ~~that~~Offering ~~for~~Agreement ~~the~~(“ATM ~~prior~~Agreement”) 30with ~~consecutive business days the bid price for the Company’s common stock had closed below the minimum $1~~H.00C. ~~per~~Wainwright ~~share~~& ~~requirement for continued inclusion on Nasdaq~~Co., ~~pursuant~~LLC, toacting ~~Nasdaq~~as ~~Listing~~sales ~~Rule~~agent ~~5550~~(~~a)(2)~~the ~~(Bid~~“Sales ~~Price Rule~~Agent”). ~~The~~As ~~deficiency~~of ~~letter~~September ~~did~~30, ~~not~~2025 ~~result in~~ the ~~immediate delisting of the~~ Company~~’s common~~ ~~stock~~had ~~from~~issued ~~Nasdaq. In accordance with Nasdaq Listing Rule 5810(c)(3)(A)~~110,242 shares under the ~~Company~~ATM ~~was~~Agreement ~~provided~~for annet ~~initial~~cash ~~period~~proceeds of ~~180 calendar days~~$1, ~~until November 12~~636, ~~2024, to regain compliance with the Bid Price Rule~~799. On ~~November~~February 206, ~~2024~~2026, ~~Nasdaq~~we ~~issued~~filed a ~~delisting~~prospectus ~~notice, indicating~~supplement ~~that~~so ~~the Company did not satisfy the Bid Price Rule by the compliance date and~~ that ~~unless~~we ~~the~~may ~~Company requested an appeal~~additionally ofissue ~~this~~and ~~determination~~sell ~~before Nasdaq’s listing qualifications panel,~~ our ~~common~~Common ~~stock~~Stock ~~would~~having bean ~~scheduled~~aggregate ~~for~~sales ~~delisting~~proceeds ~~from~~of ~~Nasdaq and~~up ~~trading~~to ~~suspended. We appealed the determination before Nasdaq’s listing qualifications panel and on December 30~~$1, ~~2024~~346,000 ~~the Company~~from ~~received~~time anto ~~extension~~time ~~until~~pursuant ~~May 19, 2025,~~ to ~~regain~~the ~~compliance~~ATM ~~with Bid Price Rule~~Agreement.

OnRegistered ~~December~~Direct ~~12,~~Offering 2024, subject to stockholder approval, the Board approved an amendment to our certificate of incorporation to, at the discretion of the Board, effect a reverse stock split of our outstanding common stock at a ratio between 1-for-10 and ~~1-for-100, including~~Concurrent ~~shares~~Private held by the Company as treasury shares, with the exact ratio within such range to be determined by the Board at its discretion. The primary goal of the reverse stock split is to increase the per share market price of our common stock to meet the Bid Price Rule for continued listing on Nasdaq. A meeting of the shareholders is called for and will be held on January 17, 2025, and subject to receipt of the stockholder approval, the Company expects to effectuate the reverse stock price prior to the consummation of this offering. However, we cannot provide any assurance that our stock price would remain over the minimum bid price under the Bid Price Rule following the reverse stock split or that we will regain compliance with the Nasdaq Bid Price Rule.Placement

~~License~~On ~~Agreement~~January 27, 2026, we entered into a securities purchase agreement with ~~MycoMedica~~certain ~~Life~~institutional ~~Sciences~~investors (each, an “Investor”), pursuant to which we agreed to issue and sell to the Investors in a registered direct offering (the “Registered Direct Offering”), an aggregate of 328,802 shares (the “RD Shares”) of our Common Stock at a price of $4.41 per share for gross proceeds of approximately $1.5 million before the deduction of placement agent fees and offering expenses. The closing of the Registered Direct Offering occurred on January 28, 2026.

OnIn ~~November 7, 2024, Enveric executed a licensing agreement with MycoMedica out-licensing~~ the ~~Company’s~~concurrent ~~EVM201~~Private ~~program,~~Placement ~~including drug~~we ~~candidate~~also ~~EB-002.~~agreed ~~Pursuant~~ to ~~the~~issue ~~terms~~and ofsell ~~licensing agreement, MycoMedica will seek~~ to ~~develop,~~the ~~manufacture,~~Investors ~~and commercialize EB-002, formerly EB-373, a synthetic prodrug of~~ the ~~active~~Series ~~metabolite~~G ~~psilocin,~~Warrants ~~in treatment of neuropsychiatric disorders such as depression. MycoMedica received an exclusive, global license~~ to ~~the~~purchase ~~formulations,~~up ~~drugs, method of use, and medical devices developed by Enveric~~ to ~~utilize~~an ~~the compound. MycoMedica assumed the responsibility for all future preclinical, clinical, and commercial development on a~~aggregate ~~royalty-bearing basis for all human and animal pharmaceutical applications. As part~~ of ~~the license agreement~~328,802 ~~Enveric~~shares ~~received~~of ~~modest upfront~~Common ~~payments,~~Stock and ifthe ~~certain~~Series ~~conditions~~H ~~are~~Warrants ~~met,~~purchase ~~will receive development and sales milestones potentially totaling~~ up to ~~$62~~an ~~million, plus~~aggregate tiered single digit royalties on all future sales. MycoMedica has the option during the license term to buyout its milestone and royalty payment obligations at a predetermined amount depending upon the stage of ~~product~~328,802 ~~development and~~shares ~~commercialization at the time~~ of ~~the~~Common ~~buyout. Further~~Stock, ~~MycoMedica~~each ~~has the right to purchase the licensed patents~~ at ~~a nominal amount~~an ~~upon~~exercise aprice ~~change~~ of ~~control of Enveric, although doing so does not relieve MycoMedica of any of its payment obligations~~$4.16 Noper ~~royalties have been received to date~~share.

~~License~~We ~~Agreement~~issued H.C. Wainwright & Co., LLC, as placement agent, warrants to purchase up to 23,016 shares of Common Stock with ~~Aries~~an ~~Science~~exercise price of $5.5125 per share. We also incurred legal and ~~Technology~~other offering-related fees in connection with this offering.

~~Registered Direct~~December ~~Offerings~~2025 Inducement Warrant Transaction

~~Between March~~On ~~and~~December ~~May~~11, ~~2024~~2025, ~~Enveric~~we entered into awarrant ~~series of~~exercise ~~common~~inducement ~~stock~~offer ~~purchase~~letters ~~agreements~~ (the “~~Purchase~~December ~~Agreements~~Inducement Letters”) ~~for~~with ~~the issuance in a registered direct offering of an aggregate of 458,000 shares of the Company’s common stock, par value $0.01 per share, to~~ certain institutional investors~~. The issuance was~~ ~~made~~that inheld ~~exchange~~certain ~~for~~outstanding ~~the~~warrants ~~permanent and irrevocable waiver of the variable rate transaction limitation with respect~~ to ~~any~~purchase ~~existing~~up ~~or future agreement by the Company~~ to ~~effect~~an ~~any~~aggregate ~~issuance~~ of ~~shares~~426,390 ~~and issue such~~ shares ~~thereunder,~~originally asissued ~~contained~~ in ~~those~~February ~~certain~~2025 ~~inducement offer letters, dated December 28, 2023, between the Company~~ and ~~those certain institutional investors. The Company did not receive any net proceeds in connection with the offering. The offering~~September ~~was~~2025, ~~made~~having toexercise ~~obtain~~prices ~~a waiver~~ of ~~the~~$36.00 ~~variable rate transaction limitation as described above~~ and ~~further~~$10.98 ~~described~~per inshare, ~~the~~respectively ~~Purchase~~(collectively, ~~Agreements so~~ the ~~Company~~“December ~~could~~Existing ~~utilize its equity line of credit with Lincoln Park Capital Fund, LLC, and enter into any future agreements that involve a variable rate transaction and issue such shares thereunder~~Warrants”).

50Pursuant to the December Inducement Letters, the investors agreed to exercise for cash their December Existing Warrants at a reduced exercise price of $7.05 per share and pay a purchase price of $0.125 per share in consideration for the Company’s agreement to issue in a private placement (x) new Series E Common Stock Purchase Warrants to purchase up to 426,390 shares of Common Stock and (y) new Series F Common Stock Purchase Warrants to purchase up to 426,390 shares of Common Stock. We received aggregate gross proceeds of approximately $3.1 million from the exercise of the December Existing Warrants by the investors and payment of the purchase price of $0.125 per share, before deducting placement agent fees and other offering expenses payable by us. The closing of the transactions occurred on December 12, 2025.

~~Components~~We issued H.C. Wainwright & Co., LLC, as placement agent, warrants to purchase up to 29,847 shares of ~~Operating~~Common ~~Results~~Stock with an exercise price of $9.125 per share. We also incurred legal and other offering-related fees in connection with this warrant inducement transaction.

~~Research and~~Nasdaq ~~Development~~Compliance ~~Expenses~~on Minimum Bid Price Deficiency

~~Research~~On November 12, 2025, we received ~~and~~a ~~development~~letter ~~expenses~~from ~~consist~~the ~~primarily~~Nasdaq Listing Qualifications Department of ~~costs~~Nasdaq ~~incurred~~notifying us that we regained compliance with the minimum bid price requirement set forth in in Nasdaq Listing Rule 5550(a)(2) for continued listing on The Nasdaq Capital Market. On October 22, 2025, the Company ~~research~~received ~~and~~written ~~development~~notice from the Listing Qualifications Department of ~~our~~Nasdaq ~~preclinical~~notifying ~~product~~the ~~candidates~~Company that, because the closing ~~and~~price ~~include~~for the Company’s Common Stock had fallen below $1.00 per share for 30 consecutive trading days, ~~without~~the ~~limitation:~~Company was no longer in compliance with the requirement for continued listing on Nasdaq under Nasdaq Listing Rule 5550(a)(2). On October 22, 2025, the Company had received written notice from the Listing Qualifications Department of Nasdaq notifying the Company that, because the closing price for the Company’s Common Stock had fallen below $1.00 per share for 30 consecutive trading days, the Company was no longer in compliance with the requirement for continued listing on Nasdaq under Nasdaq Listing Rule 5550(a)(2).

●October ~~employee-related~~2025 ~~expenses,~~Reverse ~~including~~Stock ~~salaries,~~Split benefits and share-based compensation expense; ● expenses incurred under agreements with contract research organizations, contract manufacturing organizations, and consultants and other entities engaged to support our product research and development activities; ● the cost of acquiring, developing and manufacturing materials and lab supplies used in research and development activities; ● facility, equipment, depreciation and other expenses, which include, without limitation direct and allocated expenses for rent, maintenance of our facilities and equipment, insurance and other supplies; ● costs associated with preclinical activities and regulatory operations, including, without limitation, patent related costs; ● consulting and professional fees associated with research and development activities.

~~We expense~~On ~~research~~October ~~and~~23, ~~development~~2025, ~~costs~~we ~~to operations as incurred. Research and development activities are central to our business model.~~effected ~~We utilize~~ a ~~combination of internal and external efforts to advance product development from early~~1-~~stage~~for-12 ~~work~~reverse tostock ~~future~~split ~~clinical~~(the ~~trial manufacturing~~“October ~~and~~2025 ~~clinical~~Reverse ~~trial~~Stock ~~support.~~Split”), ~~External~~which ~~efforts~~began ~~include~~trading ~~work~~on ~~with~~a ~~consultants~~split-adjusted ~~and~~basis ~~increasingly substantial work at CROs and~~on ~~CMOs.~~October ~~We support an internal research and development team in Calgary~~28, ~~Alberta~~2025, ~~Canada.~~pursuant Toto ~~move~~which ~~these~~every ~~programs~~12 ~~forward along~~shares of our ~~development~~issued ~~timelines,~~and aoutstanding ~~large~~shares ~~portion (approximately 75%)~~ of ~~our~~common ~~staff~~stock ~~are~~were ~~research~~reclassified ~~and~~as ~~development~~one ~~employees. In January~~share ~~2024,~~of ~~the~~common ~~Company~~stock. ~~reduced~~The ~~its~~October ~~discovery~~2025 ~~team~~Reverse inStock ~~Calgary~~Split ~~and~~had ~~was~~no ~~primarily~~impact ~~focused~~ on the ~~development~~par ofvalue ~~EB-002 and EB-003 pipeline assets (until we out-licensed EB-002 to MycoMedica Lifesciences in November~~ of ~~2024). Because~~our ofcommon ~~the~~stock ~~numerous~~or ~~risks and uncertainties associated with product development, however, we cannot determine with certainty~~ the ~~duration~~authorized ~~and~~number ~~completion costs~~ of ~~these or other current or~~ ~~future~~shares ~~preclinical~~of ~~studies~~common ~~and clinical trials~~stock. ~~The~~Unless ~~duration~~otherwise indicated, ~~costs~~all ~~and~~share ~~timing of clinical trials~~ and ~~development~~per ofshare ~~our~~information ~~product~~prior ~~candidates will~~to ~~depend~~the onOctober a2025 ~~variety~~Reverse ofStock ~~factors,~~Split date ~~including the uncertainties~~ of ~~future~~October ~~clinical and preclinical studies~~28, ~~uncertainties~~2025 in ~~clinical trial~~this ~~enrollment~~prospectus ~~rates~~supplement ~~and~~are ~~significant~~retroactively ~~and~~adjusted ~~changing~~to ~~government~~reflect ~~regulation. In addition,~~ the ~~probability~~Reverse ofStock ~~success for each product candidate will depend on numerous factors, including competition, manufacturing capability and commercial viability~~Split.

~~General and~~Nasdaq ~~Administrative~~Compliance ~~Expenses~~on Stockholders’ Equity Deficiency

~~General~~On October 23, 2025, we notified ~~and~~Nasdaq ~~administrative~~that ~~expenses~~we ~~consist~~believed ~~principally~~we ofhad ~~salaries,~~regained ~~benefits~~compliance ~~and~~with ~~related~~the ~~costs~~stockholders’ ~~such~~equity asrequirements ~~stock-based~~set ~~compensation~~forth in Nasdaq Listing Rule 5550(b)(1) for ~~personnel~~continued listing on The Nasdaq Capital Market. On October 24, 2025, we received a letter from Nasdaq determining that ~~and~~we ~~consultants~~regained conditional compliance subject to evidencing compliance upon filing our next periodic report. As detailed in ~~executive~~our Quarterly Report for the quarter ended September 30, ~~finance~~2025, ~~business~~filed ~~development,~~with ~~corporate~~the ~~communications~~SEC ~~and~~on ~~human~~November ~~resource~~14, ~~functions~~2025, ~~facility~~we ~~costs~~reported ~~not otherwise~~stockholders’ ~~included~~equity in ~~research~~excess of ~~and~~the ~~development~~required ~~expenses,~~$2.5 ~~accounting~~million and, ~~audit~~as ~~costs~~a result, ~~tax~~regained compliance ~~costs,~~with ~~SEC~~the ~~compliance~~stockholders’ ~~costs~~equity requirement. On August 26, ~~investor~~2025, ~~relation~~the ~~costs,~~Company ~~training~~had ~~and~~received ~~conference~~a ~~costs,~~deficiency ~~insurance~~letter ~~costs~~from ~~and~~the ~~legal~~Listing ~~fees~~Qualifications Department of Nasdaq notifying the Company that it was not in compliance with the minimum stockholders’ equity requirement for continued listing on Nasdaq pursuant to Nasdaq Listing Rule 5550(b)(1).

~~Impairment~~September of2025 ~~Intangible~~Inducement ~~Assets~~Warrant ~~and Goodwill~~Transaction

~~Intangible~~On September 17, 2025, the ~~assets~~Company ~~consist~~entered into warrant exercise inducement offer letters (the “September Inducement Letters”) with certain Holders of the ~~Psybrary™~~Company’s Series A Warrants and ~~Patent~~Series ~~Applications,~~B InWarrants ~~Process~~originally ~~Research~~issued ~~and~~in ~~Development~~February 2025 (the “~~IPR&D~~September Existing Warrants”), ~~and~~which ~~license agreements.~~closed ~~Psybrary™~~on ~~and~~September ~~Patent~~18, ~~Applications~~2025. ~~intangible~~Pursuant ~~assets~~to ~~are~~the ~~valued~~September ~~using~~Inducement Letters, the ~~relief~~Holders ~~from~~agreed to ~~royalty~~exercise ~~method.~~for ~~The~~cash ~~cost~~their ofSeptember ~~license agreements~~Existing isWarrants ~~amortized~~to ~~over~~purchase 202,083 shares of the ~~economic~~Company’s ~~life~~Common ofStock, in the aggregate, ~~license~~at a reduced exercise price of $10.98 ~~The~~per ~~Company~~share ~~assesses~~(from ~~the~~an ~~carrying~~original ~~value~~exercise price of ~~its~~$36.00 ~~intangible~~per ~~assets~~share), in exchange for ~~impairment~~the Company’s agreement to issue new warrants Series C Warrants and Series D Warrants to purchase up to 404,166 shares of the Company’s Common Stock under each ~~year~~series, each at an exercise price of $10.98 per share.

51The inducement warrant transaction closed on September 18, 2025. The Company received aggregate gross proceeds of $2,218,873 from the exercise of the Existing Warrants by the Holders. We issued H.C. Wainwright & Co., LLC, as placement agent warrants to purchase up to 14,146 shares of Common Stock with an exercise price of $13.7256 per share. The grant date fair value of these placement agent warrants was estimated to be $90,000 on September 18, 2025 and was charged to additional paid-in capital as issuance costs. The Company also incurred legal and other offering-related fees of $334,659, which were similarly charged to additional paid-in capital.

~~The Company performs an annual impairment test of intangible assets and goodwill as of December 31 of each fiscal year.~~63

Stock-Based Compensation

A significant portion of our operating expenses is related to stock-based compensation costs.

Stock-based compensation consists of restricted stock units (“RSU”) and options to purchase shares of the Company’s common stock. The Company follows Accounting Standards Codification (“ASC”) 718, Compensation - Stock Compensation, which addresses the accounting for stock-based payment transactions, requiring such transactions to be accounted for using the fair value method. The fair value of RSU or restricted stock awards (“RSAs”) is determined by the closing price per share of the Company’s common stock on the date of the award. The Company uses the Black-Scholes option pricing model to determine the grant date fair value of options issued.

RSU’s may contain vesting conditions that include, without limitation, any or all of the following: immediate vesting, vesting over a defined time period, vesting based on specific volume weighted average price levels being achieved by the Company’s common stock as publicly traded within specified measurement periods, and vesting based on the achievement of specific performance milestones. Options contain vesting conditions that provide for vesting over a defined time period.

The fair value of RSU’s and options, is charged to expense, on a straight line basis over the vesting periods defined in the award agreements, except for the fair value which is attributable to achievement of a specific performance milestones, which are charged to expense upon achievement of such milestones.

Change in fair value of warrant liabilities, investment options and derivative liabilities

The Company evaluates all of its financial instruments, including issued stock purchase warrants, to determine if such instruments are derivatives or contain features that qualify as embedded derivatives, pursuant to ASC 480. “Distinguishing Liabilities from Equity” (“ASC 480”) and ASC Topic 815, “Derivatives and Hedging” (“ASC 815”). The Company accounts for warrants for shares of the Company’s common stock that are not indexed to its own stock as derivative liabilities at fair value on the consolidated balance sheet. The Company adjusts this derivative liability at each reporting period, with the liability recorded on the balance sheet being equal to fair value of such liability on the relevant balance sheet date.

Fair value of derivative liabilities is determined in accordance with ASC 820-10 “Fair Value Measurement”. The fair value of the embedded derivative liabilities was determined using weighted-average scenario analysis and the fair value of warrant liabilities was determined using the Black-Scholes valuation model, both of which are level 3 methods, as defined in ASC 820-10.

The fair value of these derivative liabilities has a strong correlation to the price per share of the Company’s common stock as publicly traded. Increases in the Company’s price per share will result in increased derivative liabilities, with a corresponding other expense being recorded in the other income (expense) section of the statement of operations and comprehensive loss. Decreases in the Company’s price per share will result in decreased derivative liabilities, with a corresponding other income being recorded in the other income (expense) section of the statement of operations and comprehensive loss.

The Company accounts for the inducement to exercise warrants in accordance with ASC Subtopic 470-20-40 “Debt with Conversion and Other Options” (“ASC 470-20-40”). ASC 470-20-40 requires the recognition through earnings of an inducement charge equal to the fair value of the consideration delivered in excess of the consideration issuable under the original conversion terms.

Results of Operations

~~Comparison~~The following table sets forth information comparing the components of net loss for the three months ended September 30, ~~2024~~2025 and ~~2023~~2024:

The following table sets forth information comparing the components of net loss for the three months ended September 30, 2024 and 2023:

	For the Three Months Ended September 30,
	2025			2024
Operating expenses
General and administrative	$	1,431,157		$	1,195,661
Research and development		402,417			802,717
Depreciation and amortization		40,369			84,814
Total operating expenses		1,873,943			2,083,192

Loss from operations		(1,873,943	)		(2,083,192	)

Other income (expense)
Other expense		-			(623	)
Interest income (expense), net		274			(217	)
Total other income (expense)		274			(840	)

Net loss before income taxes	$	(1,873,669	)	$	(2,084,032	)

Income tax expense		-			-

Net loss	$	(1,873,669	)	$	(2,084,032	)

	For the Three Months Ended September 30,
	2024			2023
Operating expenses
General and administrative	$	1,235,661		$	2,080,644
Research and development		762,717			1,281,455
Depreciation and amortization		84,814			86,296
Total operating expenses		2,083,192			3,448,395
Loss from operations		(2,083,192	)		(3,448,395	)
Other income (expense)
Change in fair value of warrant liabilities		(122	)		67,822
Change in fair value of investment option liability		(501	)		562,715
Interest income (expense), net		(217	)		2,237
Total other income (expense)		(840	)		632,774
Net loss before income taxes	$	(2,084,032	)	$	(2,815,621	)
Income tax expense		—			(6,595	)
Net loss	$	(2,084,032	)	$	(2,822,216	)

General and Administrative Expenses

Our general and administrative expenses ~~decreased~~increased to $1,~~235~~431,~~661~~157 for the three months ended September 30, ~~2024~~2025 from $21,~~080~~195,~~644~~661 for the ~~three~~ three months ended September 30, ~~2023~~2024, aan ~~decrease~~increase of $~~844~~235,~~983~~496, or 4120%. This change was primarily driven by ~~decreases~~increases in ~~consulting expenses~~marketing expense of $~~138~~155,~~778~~134, ~~salaries~~Delaware ~~and~~Franchise ~~wages~~Tax of $~~263~~103,~~764~~100, and legal ~~fees~~expense of $~~192~~39,~~941~~634, ~~all~~offset aby ~~direct~~decreases ~~result of the second quarter 2023 reduction~~ in ~~force~~stock ~~and~~based nocompensation ~~longer pursuing the transfer and spin-off its cannabinoid clinical development pipeline assets to Akos~~expense ~~Biosciences,~~of ~~Inc~~$65,326.

Research and Development Expenses

Our research and development ~~expense~~expenses for the three months ended September 30, ~~2024~~2025 ~~was~~were $~~762~~402,~~717~~417 as compared to $1802,~~281,455~~717 for the three months ended September 30, ~~2023~~2024, ~~with~~for a decrease of $~~518~~400,~~738~~300, or approximately 4050%. This ~~decrease~~change was primarily driven by a decrease in CRO ~~expense~~costs of $4264,~~206~~384, salaries and wages of $~~212~~148,~~377~~103, research costs of $128,027, and product development costs of $~~208~~63,~~312~~858, partially offset by an increase in consulting fees of $197,858.

Depreciation and Amortization Expense

Depreciation and amortization expense for the three months ended September 30, ~~2024~~2025 was $8440,~~814~~369 as compared to $8684,~~296~~814 for the three months ended September 30, ~~2023~~2024, with a decrease of $144,~~482~~445, or approximately 252%, due to full amortization of the Company’s intangible assets during the first quarter of 2025.

~~Change in Fair Value of Warrant Liabilities~~64

~~Change~~The infollowing ~~fair~~table ~~value~~sets offorth ~~warrant~~information ~~liabilities~~comparing ~~for~~ the ~~three~~components ~~months ended September 30, 2024 resulted in an expense~~ of ~~$122~~net asloss ~~compared to income of $67,822~~ for the ~~three~~nine months ended September 30, ~~2023.~~2025 ~~The change in fair value of warrant liabilities is due to the exercise of 122,000 of warrants on December 28, 2023, resulting in less warrants outstanding~~ and ~~re-valued at September 30,~~ 2024, as well as, the change in the closing price of Common Stock at the end of each period, as compared to the closing price of Common Stock at the beginning of each period with a strong inverse relationship between changes in fair value of warrant liabilities and the trading price of Common Stock.:

	For the Nine Months Ended September 30,
	2025			2024
Operating expenses
General and administrative	$	4,010,313		$	4,329,565
Research and development		2,408,839			1,873,873
Depreciation and amortization		161,373			255,002
Total operating expenses		6,580,525			6,458,440

Loss from operations		(6,580,525	)		(6,458,440	)

Other income (expense)
Other income		2,565			39,386
Interest income (expense), net		144			444
Total other income (expense)		2,709			39,830

Net loss before income taxes	$	(6,577,816	)	$	(6,418,610	)

Income tax expense		-			(1,731	)

Net loss	$	(6,577,816	)	$	(6,420,341	)

Change in Fair Value of Investment Option Liability

Change in fair value of investment option liability the three months ended September 30, 2024 resulted in an expense of $501 as compared to income of $562,715 during the three months ended September 30, 2023. The change in fair value is due to the exercise of 1,000,000 investment options on December 28, 2023, resulting in less investment options re-valued at September 30, 2024 and a significant decrease in the Company’s stock price for the three months ended September 30, 2024.

Comparison for the nine months ended September 30, 2024 and 2023:

The following table sets forth information comparing the components of net loss for the nine months ended September 30, 2024 and 2023:

	For the Nine Months Ended September 30,
	2024			2023
Operating expenses
General and administrative	$	4,467,065		$	8,273,344
Research and development		1,736,373			5,531,436
Depreciation and amortization		255,002			259,300
Total operating expenses		6,458,440			14,064,080
Loss from operations		(6,458,440	)		(14,064,080	)
Other income (expense)
Change in fair value of warrant liabilities		20,722			(115,342	)
Change in fair value of investment option liability		18,664			(399,921	)
Change in fair value of derivative liability		—			727,000
Interest income, net		444			3,142
Total other income (expense)		39,830			214,879
Net loss before income taxes	$	(6,418,610	)	$	(13,849,201	)
Income tax expense		(1,731	)		(6,595	)
Net loss	$	(6,420,341	)	$	(13,855,796	)

General and Administrative Expenses

Our general and administrative expenses decreased to $4,~~467~~010,~~065~~313 for the nine months ended September 30, ~~2024~~2025 from $84,~~273~~329,~~344~~565 for the nine months ended September 30, ~~2023~~2024, a decrease of $3319,~~806~~252,~~279,~~ or 467%. This change was primarily driven by decreases in ~~consulting~~director ~~expenses of~~fees ~~$836,437, salaries and wages~~ of $1150,~~305~~252,~~710,~~ stock compensation expense of $~~623~~177,~~259~~643, ~~investor~~insurance ~~relations~~fees of $~~313~~76,~~509~~089, ~~legal fees of $487,863,~~ and accounting fees of $~~227~~62,~~200~~226, all a direct result of the second quarter 2023 reduction in force and no longer pursuing the transfer and spin-off its cannabinoid clinical development pipeline assets to Akos Biosciences, Inc., and Delaware franchise taxes of $246,144 partially offset by an increase in marketing ~~director~~expense ~~fees~~ of $~~107~~192,~~186~~763.

Research and Development Expenses

Our research and development expense for the nine months ended September 30, ~~2024~~2025 was $12,~~736~~408,~~373~~839 as compared to $51,~~531~~873,~~436~~873 for the nine months ended September 30, ~~2023~~2024 with aan ~~decrease~~increase of $3534,~~795~~966,~~063,~~ or approximately 6929%. This ~~decrease~~increase was primarily driven by aan ~~decrease~~increase ~~salaries~~in consulting ~~and~~fees ~~wages~~ of $1,~~542~~334,~~075~~313, ~~research~~and ~~costs~~a prior year gain that was realized during the nine months ended September 30, 2024 related to the Australian R&D tax incentive of $1291,~~056~~439,~~511,~~ ~~product~~offset ~~development~~by a decrease in CRO costs of $~~532~~508,~~063~~774, ~~CRO~~salaries ~~costs~~and wages of $~~128~~442,~~560~~648, ~~and~~lab ~~the~~costs ~~gain~~of ~~realized~~$49,169, ~~related~~product todevelopment ~~the~~costs ~~Australian~~of ~~R&D~~$30,974, ~~tax~~research ~~incentive~~costs of $~~291~~45,~~439~~146, and rent expense of $28,332.

Depreciation and Amortization Expense

Depreciation and amortization expense for the nine months ended September 30, ~~2024~~2025 was $~~255~~161,~~002~~373 as compared to $~~259~~255,~~300~~002 for the nine months ended September 30, ~~2023~~2024, ~~with~~for a decrease of $493,~~298~~629, or approximately 237%, primarily related to full amortization of the Company’s intangible assets in the first quarter of 2025.

~~Change~~Going inConcern, ~~Fair~~Liquidity ~~Value~~and ofCapital ~~Warrant Liabilities~~Resources

~~Change~~The inCompany ~~fair~~has ~~value~~incurred oflosses ~~warrant~~since ~~liabilities~~inception ~~for~~resulting ~~the~~in ~~nine~~an ~~months~~accumulated ~~ended~~deficit ~~September~~of 30$112,652,321 ~~2024~~as ~~resulted~~of inSeptember ~~income~~30, of2025 ~~$20,722~~and asfurther losses ~~compared~~are toanticipated ain ~~loss~~ the development of ~~$115,342~~its ~~for~~business. For the nine months ended September 30, ~~2023.~~2025, ~~The~~the ~~change~~Company inhad ~~fair~~a ~~value~~loss from operations of ~~warrant~~$6,580,525. ~~liabilities~~Further, isthe ~~due~~Company tohad ~~the~~operating ~~exercise~~cash outflows of ~~122~~$6,~~000 of~~356,680 ~~warrants~~for onthe ~~December~~nine ~~28,~~months ~~2023~~ended September 30, ~~resulting~~2025. Since ininception, ~~less~~being ~~warrants~~a ~~outstanding~~research and ~~re-valued~~development atcompany, ~~September~~the ~~30,~~Company ~~2024,~~has asnot ~~well~~yet ~~as,~~generated ~~the~~revenue ~~change in~~and the ~~closing~~Company ~~price~~has ofincurred ~~Common~~continuing losses ~~Stock~~from atits ~~the~~operations. ~~end~~The ofCompany’s ~~each~~operations ~~period,~~have asbeen ~~compared~~funded toprincipally through the ~~closing~~issuance ~~price~~ of ~~Common~~debt ~~Stock~~and atequity. These factors raise substantial doubt about the ~~beginning~~Company’s ~~of each~~ability ~~period~~to ~~with~~continue as a ~~strong~~going ~~inverse~~concern ~~relationship~~for ~~between~~a ~~changes~~period inof ~~fair~~one ~~value~~year from the date of ~~warrant~~the ~~liabilities~~registration ~~and~~statement ~~the~~for ~~trading~~which ~~price~~this ofprospectus ~~Common~~forms ~~Stock~~a part.

~~Change in Fair Value of Investment Option Liability~~65

~~Change~~In assessing the Company’s inability ~~fair~~to ~~value~~continue ofas ~~investment~~a ~~option~~going ~~liability~~concern, the ~~nine~~Company ~~months~~monitors ~~ended~~and analyzes its cash and its ability to generate sufficient cash flow in the future to support its operating and capital expenditure commitments. At September 30, ~~2024~~2025, ~~resulted~~the inCompany ~~income~~had cash of $183,~~664~~757,594 asand working ~~compared~~capital of $3,259,655. The Company’s current cash on hand is insufficient to asatisfy its operating cash needs for the 12 ~~loss~~months offollowing ~~$399,921~~the ~~during~~filing of the ~~nine~~registration ~~months~~statement ~~ended~~for ~~September~~which ~~30,~~this ~~2023~~prospectus forms a part. ~~The~~These ~~change~~conditions inraise ~~fair~~substantial doubt ~~value~~regarding isthe ~~due~~Company’s ability to continue as a going concern for a period of one year after the ~~exercise~~date of ~~1,000,000~~the ~~investment~~registration ~~options~~statement onfor ~~December~~which ~~28,~~this ~~2023,~~prospectus ~~resulting~~forms ina ~~less~~part. ~~investment~~Management’s ~~options~~plan ~~re-valued~~to atalleviate ~~September~~the ~~30,~~conditions ~~2024~~that raise substantial doubt include raising additional working capital through public or private equity or debt financings or other sources, and amay ~~significant~~include ~~decrease~~additional collaborations inwith ~~the~~third parties as well as disciplined cash spending. Adequate additional financing may not be available to us on acceptable ~~Company’s~~terms, ~~stock~~or ~~price~~at ~~for~~all. Should the ~~nine~~Company ~~months~~be ~~ended~~unable ~~September~~to 30raise sufficient additional capital, ~~2024~~the Company may be required to undertake cost-cutting measures including delaying or discontinuing certain operating activities.

~~Change~~As ina ~~Fair~~result ~~Value~~of these factors, management has concluded that there is substantial doubt about the Company’s ability to continue as a going concern for a period of ~~Derivative~~one ~~Liability~~year after the date of the registration statement for which this prospectus forms a part. The Company’s unaudited condensed consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty.

The Company’s change in fair value of derivative liability is due to the May 2023 redemption which ceased the probability of occurrence of the Akos spin-off and Akos Series A Preferred Stock redemption.

Comparison for the years ended December 31, 2023 and 2022:

The following table sets forth information comparing the components of net loss for the years ended December 31, 2023 and 2022:

	For the Years Ended December 31,
	2023			2022
Operating expenses
General and administrative	$	8,852,021		$	11,605,761
Research and development		7,252,437			8,027,773
Impairment of intangible assets and goodwill		—			7,453,662
Depreciation and amortization		343,982			327,910
Total operating expenses		16,448,440			27,415,106
Loss from operations		(16,448,440	)		(27,415,106	)
Other (expense) income
Inducement expense, net		(1,848,235	)		—
Change in fair value of warrant liabilities		94,396			4,315,236
Change in fair value of investment option liability		208,752			3,472,726
Change in fair value of derivative liability		727,000			(325,000	)
Interest income (expense), net		3,708			(5,249	)
Total other (expense) income		(814,379	)		7,457,713
Net loss before income taxes	$	(17,262,819	)	$	(19,957,393	)
Income tax (expense) benefit		(28,913	)		1,486,060
Net loss	$	(17,291,732	)	$	(18,471,333	)

Known Trends or Uncertainties

The current inflationary trend existing in the North American economic environment is considered by Management to be reasonably likely to have a material unfavorable impact on results of continuing operations. Higher rates of price inflation, as compared to recent prior levels of price inflation have caused a general increase in the cost of labor and materials. In addition, there is an increased risk of the Company experiencing labor shortages as a result of a potential inability to attract and retain human resources due to increased labor costs resulting from the current inflationary environment.

General and Administrative Expenses

Our general and administrative expenses decreased to $8,852,021 for the year ended December 31, 2023 from $11,605,761 for the year ended December 31, 2022, a decrease of $2,753,740, or 24%. This change was primarily driven by decreases in insurance expenses of $1,112,059, salaries and wages of $626,573, transaction expenses of $735,043, stock compensation expense of $351,898, marketing expense of $390,851, and legal fees of $532,563. This is offset by an increase in consulting expenses of $381,786, Delaware Franchise Tax expenses of $247,389, and accounting fees of $255,872. The decrease in insurance expense was due to a reduction in director and officer liability insurance related to the Company’s reduction in force and restructuring during the year ended December 31, 2023. The decrease in salaries and wages was due to the reduction in force during the year ended December 31, 2023. The decrease in transaction expenses was due to the expenses related to non-recurring capital raises during the year ended December 31, 2022. The decrease in stock compensation expense was due primarily to a reduction in expense related to restricted stock units as a result of forfeitures and decreased value of new grants as a result of lower stock prices. The decrease in marketing and legal expenses was due to the termination of marketing efforts surrounding the Akos cannabinoid spin-off. The increase in consulting expenses was due to increased outsourcing to contractors as a result of the reduction in force during 2023. The increase in Delaware Franchise Tax expenses was due to taxes and penalty fees related to the 2022 franchise tax return. The increase in accounting fees was due to internal control deficiency remediation efforts related to deficiencies identified in 2022 and technical accounting services related to 2023 transactions.

Research and Development Expenses

Our research and development expense for the year ended December 31, 2023 was $7,252,437 as compared to $8,027,773 for the year ended December 31, 2022 with a decrease of $775,336, or approximately 10%. This decrease was primarily driven by decreased salaries and wages of 1,608,437, product development of $443,158, and lab expenses of $321,773, and increase in tax incentive of $141,185. This is slightly offset by an increase in CRO costs of $1,674,958. The decrease in salaries and wages was primarily due to the reduction in force as a result of the cost reduction plan that the Company entered into in May 2023 and the increase in CRO costs is due to contract in Australian Subsidiary Research and Development that began in March 2023.

Impairment of intangible assets and goodwill

There was no impairment of intangible assets and goodwill for the year ended December 31, 2023 as compared to $7,453,662 for the year ended December 31, 2022, as all recognized indefinite lived intangible assets and goodwill were fully impaired as of December 31, 2022.

Depreciation and Amortization Expense

Depreciation and amortization expense for the year ended December 31, 2023 was $343,982 as compared to $327,910 for the year ended December 31, 2022, with a decrease of $16,072, or approximately 5%.

Change in Fair Value of Warrant Liabilities

Change in fair value of warrant liabilities for the year ended December 31, 2023 resulted in income of $94,396 as compared to $4,315,236 for the year ended December 31, 2022. The change in fair value of warrant liabilities is significantly influenced by the change in the closing price of common stock at the end of each period, as compared to the closing price of common stock at the beginning of each period with a strong inverse relationship between changes in fair value of warrant liabilities and the trading price of common stock. The significant decrease in the Company’s stock price during the year ended December 31, 2023 compared to the year ended December 31, 2022, resulted in the significant decrease to the change in fair value of warrant liabilities.

Change in Fair Value of Investment Option Liability

Change in fair value of investment option liability for the year ended December 31, 2023 resulted in income of $208,752 as compared to $3,472,726 for the year ended December 31, 2022. The change in fair value of investment option liability is significantly influenced by the change in the closing price of common stock at the end of each period, as compared to the closing price of common stock at the beginning of each period with a strong inverse relationship between changes in fair value of warrant liabilities and the trading price of common stock. The significant decrease in the Company’s stock price during the year ended December 31, 2023 compared to the year ended December 31, 2022, resulted in the significant decrease to the change in fair value of warrant liabilities.

Change in Fair Value of Derivative Liability

The Company’s change in fair value of derivative liability increased by $1,052,000 for the year ended December 31, 2023, due primarily to the termination of the planned spin-off of Akos and redemption of the underlying preferred stock in May 2023.

Inducement Expense

Inducement expense was $1,848,235 for the year ended December 31, 2023. The expenses recorded were related to inducement incurred related to the conversion of warrants and investment options that occurred in December 2023. The Company did not incur such expenses in the prior period.

Income Tax (Expense) Benefit

Income tax expense was $28,913 for the year ended December 31, 2023, which primarily related to state excise taxes, compared to an income tax benefit of 1,486,060 for the year ended December 31, 2022 or a change of $1,514,973. For the year ended December 31, 2022, the Company recognized a benefit for the reversal of the deferred tax liability for the indefinite lived intangible assets upon impairment, which is the primary reason for the change.

Cash Flows

Since inception, we have primarily used our available cash to fund our product development and operations expenditures.

Cash Flows for the Nine Months Ended September 30, ~~2024~~2025 and ~~2023:~~2024

The following table sets forth a summary of cash flows for the years presented:

	For the Nine Months Ended September
	For the Nine Months Ended September 30,
	2024			2023
	2025			2024
Net cash used in operating activities	$	(6,~~414~~356,~~590~~680	)	$	(126,~~343~~414,~~363~~590	)
Net cash provided by investing activities		—			11,705
Net cash provided by financing activities		7,890,361			7,210,386
Net cash provided by (used in) financing activities		7,210,386			(1,157,057	)
Effect of foreign exchange rate on changes on cash		(17,113	)		27,910
Effect of Foreign Exchange Rate on Changes on Cash		27,910			31,399
Net increase in cash	$	1,516,568		$	823,706
Net increase (decrease) in cash		823,706			(13,457,316	)

Operating Activities

Net cash used in operating activities was $6,~~414~~356,~~590~~680 during the nine months ended September 30, ~~2024~~2025, which consisted primarily of a net loss adjusted for non-cash items of $5,~~114~~960,~~009~~602, ~~and~~a andecrease ~~increase~~ in prepaid expenses and other current assets of $3132,~~674~~795, a decrease in related party payable of $232,891 and a decrease in accounts payable and accrued liabilities of $1295,~~296,907~~982.

Net cash used in operating activities was $126,~~343~~414,~~363~~590 during the nine months ended September 30, ~~2023~~2024, which consisted primarily of a net loss adjusted for non-cash items of $115,~~962~~114,~~774~~009, an increase in prepaid expenses and other current assets of $~~746~~3,~~033~~674, ~~offset~~and bya andecrease ~~increase~~ in accounts payable and accrued liabilities of $~~429~~1,~~688~~296,907.

Investing Activities

Net cash used in investing activities was $0 during the nine months ended September 30, 2024.

Net cash provided by investing activities was $11,705 during the nine months ended September 30, 2023, which consisted of proceeds from disposal of property and equipment of $16,900, offset by the purchase of property and equipment of $5,195.

Financing Activities

Net cash provided by financing activities was $7,~~210~~890,~~386~~361 during the nine months ended September 30, ~~2024~~2025, which consisted of $14,~~804~~244,~~819~~467 ~~from~~in ~~the~~net proceeds ~~received~~ from ~~the~~a ~~stock~~best ~~subscription~~efforts ~~receivable~~public offering of Common Stock, $2Pre-Funded Warrants,~~676,980~~ ~~for~~and ~~the~~Series ~~exercise~~A ofand ~~the~~Series ~~Inducement~~B Warrants, (the “Offering”), $2,~~290~~009,~~186~~095 ~~for the~~in ~~common~~proceeds ~~stock~~from ~~sold under~~ the ~~Distribution~~exercise ~~agreement, net~~ of ~~offering costs~~warrants, and $~~599~~1,~~862~~636,799 ~~for~~in ~~the~~net ~~common~~proceeds ~~stock~~from ~~sold under~~ the ~~Purchase Agreement,~~sale ~~offset~~of byCommon ~~$161,461~~Stock ~~offering~~through ~~costs previously accrued for~~ the ~~Inducement~~ATM ~~Warrants~~Agreement.

Net cash ~~used~~provided inby financing activities was $17,~~157~~210,~~057~~386 during the nine months ended September 30, ~~2023~~2024, which consisted of $1,804,819 from the ~~redemption~~net proceeds received from the stock subscription receivable, $2,676,980 for the exercise of the inducement warrants, $2,290,186 ~~redeemable~~for ~~non-controlling~~the ~~interest~~Common ~~and~~Stock ~~payment~~sold under a distribution agreement, net of ~~deferred~~offering costs, and $599,862 for the Common Stock sold under the Purchase Agreement, offset by $161,461 offering costs previously accrued for the inducement warrants.

Cash Flows for the Years Ended December 31, 2023 and 2022

The following table sets forth a summary of cash flows for the years presented:

	For the Years Ended December 31,
	2023			2022
Net cash used in operating activities	$	(14,094,411	)	$	(17,146,723	)
Net cash provided by (used in) investing activities		11,667			(584,165	)
Net cash (used in) provided by financing activities		(1,343,141	)		18,180,137
Effect of Foreign Exchange Rate on Changes on Cash		(10,022	)		(81,364	)
Net (decrease) increase in cash	$	(15,435,907	)	$	367,885

Operating Activities

Net cash used in operating activities was $14,094,411 during the year ended December 31, 2023, which consisted primarily of a net loss adjusted for non-cash items of $13,919,661, an increase in prepaid expenses of $6,857, a decrease in accounts payable and accrued liabilities of $103,848, and a decrease in right-of-use operating lease asset and obligation of $64,045.

Net cash used in operating activities was $17,146,723 during the year ended December 31, 2022, which consisted primarily of a net loss adjusted for non-cash items of $16,929,063, an increase in prepaid expenses and other current assets of $374,058, an increase in accounts payable and accrued liabilities of $263,686, and a decrease in right-of-use operating lease asset and obligation of $107,288.

Investing Activities

Net cash provided by investing activities was $11,667 during the year ended December 31, 2023, which consisted of the purchase of property and equipment, offset by proceeds from sale of property and equipment.

Net cash used in investing activities was $584,165 during the year ended December 31, 2022, which consisted of the purchase of property and equipment.

Financing Activities

Net cash used in financing activities was $1,343,141 during the year ended December 31, 2023, which consisted of $1,052,057 from the redemption of Series A Preferred Stock and $291,084 for equity distribution offering costs.

Net cash provided by financing activities was $18,180,137 during the year ended December 31, 2022, which consisted of $17,222,099 in net proceeds from the sale of common stock and warrants and warrant exercises, net of fees, and proceeds from the sale of redeemable non-controlling interest, net of offering costs, of $958,038.

Liquidity and Capital Resources

Since our inception through September 30, 2024, we have not generated revenue and have incurred significant operating losses and negative cash flow from our operations.

We are a pre-revenue biotech company that has to date, not generated any revenues. During the years ended December 31, 2023 and 2022, we raised approximately $18.2 million from the sales of common stock, warrants, preferred investment options, and redeemable non-controlling interest, and from proceeds realized from the exercise of cash warrants. These amounts were the primary source of funds upon which our operations were financed during the year ended December 31, 2023. During the year ended December 31, 2024, we raised approximately $8.0 million from the sales of common stock and warrants. The maximum amount we expect to raise in this offering is $[●], excluding the exercise of any warrants. Following this offering, we will need to raise additional capital to fund our operations and continue to support our planned development and commercialization activities.

Going Concern

The Company has incurred a loss since inception resulting in an accumulated deficit of $102,919,859 as of September 30, 2024 and further losses are anticipated in the development of its business. Further, the Company had operating cash outflows of $6,414,590 for the nine months ended September 30, 2024. For the nine months ended September 30, 2024, the Company had a loss from operations of $6,458,440. Since inception, being a research and development company, the Company has not yet generated revenue and the Company has incurred continuing losses from its operations. The Company’s operations have been funded principally through the issuance of debt and equity. These factors raise substantial doubt about the Company’s ability to continue as a going concern for a period of one year from the issuance of these unaudited condensed consolidated financial statements.

In assessing the Company’s ability to continue as a going concern, the Company monitors and analyzes its cash and its ability to generate sufficient cash flow in the future to support its operating and capital expenditure commitments. At September 30, 2024, the Company had cash of $3,111,683 and working capital of $3,499,093. The Company’s current cash on hand is insufficient to satisfy its operating cash needs for the 12 months following the filing of this registration statement. These conditions raise substantial doubt regarding the Company’s ability to continue as a going concern for a period of one year after the date the financial statements are issued. Management’s plan to alleviate the conditions that raise substantial doubt include raising additional working capital through public or private equity or debt financings or other sources, and may include additional collaborations with third parties as well as disciplined cash spending. Adequate additional financing may not be available to us on acceptable terms, or at all. Should the Company be unable to raise sufficient additional capital, the Company may be required to undertake cost-cutting measures including delaying or discontinuing certain operating activities.

As a result of these factors, management has concluded that there is substantial doubt about the Company’s ability to continue as a going concern for a period of one year after the date of this registration statement. The Company’s consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty.

Critical Accounting Estimates

Our ~~management’s~~ ~~discussion and analysis of our~~ financial ~~condition and results of operations is based on our consolidated financial~~ statements, ~~which~~ have been prepared in accordance with U.S. ~~generally accepted accounting principles (“~~GAAP~~”).~~, ~~The~~which ~~preparation of our consolidated financial statements and related disclosures~~ requires us to make estimates, assumptions and judgments that affect the reported amount of assets, liabilities, costs and expenses and related disclosures. Our critical accounting estimates are those estimates that involve a significant level of uncertainty at the time the estimate was made, and changes in them have had or are reasonably likely to have a material effect on our financial condition or results of operations. Accordingly, actual results could differ materially from our estimates. We base our estimates on past experience and other assumptions that we believe are reasonable under the circumstances, and we evaluate these estimates on an ongoing basis. Our most critical accounting ~~estimates~~estimate ~~include~~ includes determining the accruals associated with third party providers supporting research and development efforts ~~and the fair value of the inducement warrants~~.

59There have been no material changes to our critical accounting estimates as compared to the critical accounting estimates disclosed in our Annual Report on Form 10-K for the year ended December 31, 2024.

~~Accrued Research and Development Expenses~~66

AsCERTAIN ~~part~~RELATIONSHIPS ofAND ~~the~~RELATED ~~process~~PERSON of preparing our consolidated financial statements, we are required to estimate our accrued research and development expenses. This process involves reviewing purchase orders, open contracts, reconciling payments and invoices and communicating with our personnel and suppliers to identify services that have been performed on our behalf. It also includes the research and development vendors providing us milestone and percentage completion reports on the statuses within each active purchase order and contract along with estimating the level of service performed and the associated cost incurred for the services when we have not yet been invoiced or otherwise notified of the actual cost. Our vendors invoice us in various ways via advance payments, as contractual milestones are met or monthly in arrears for services performed.TRANSACTIONS

We Other ~~make~~than ~~estimates~~the ofdirector ~~our~~and ~~accrued~~executive ~~expenses~~officer ascompensation ofarrangements ~~each~~discussed ~~balance sheet date~~ in ~~our consolidated financial statements based on facts and circumstances known to us at that time. We periodically confirm~~ the ~~accuracy~~“Executive ~~of our estimates with the service providers~~ and ~~adjust~~Director ~~if necessary. The~~Compensation” ~~significant~~section ~~estimates~~ in ~~our~~this ~~accrued~~registration ~~research~~statement, ~~and~~since ~~development~~January ~~expenses~~1, ~~include~~2025 ~~the~~we ~~costs~~have ~~incurred for services performed by clinical~~not, ~~pre-clinical,~~ and ~~CMC~~there ~~vendors~~has innot ~~connection~~currently ~~with~~been ~~research~~proposed, ~~and~~any ~~development~~transaction to ~~activities for~~ which ~~we have not yet been invoiced.~~:

We contract with these vendors to conduct clinical, pre-clinical, or CMC research and development services on our behalf. We base our expenses on our estimates of the services received and efforts expended pursuant to quotes and contracts with the research and development vendors. The financial terms of these agreements are subject to negotiation, vary from contract to contract and may result in uneven payment flows. There may be instances in which payments made to our vendors will exceed the level of services provided and result in a prepayment of the research and development expense. In accruing service fees, we estimate the time period over which services will be performed and the level of effort to be expended in each period. If the actual timing of the performance of services or the level of effort varies from our estimate, we adjust the accrual or amount of prepaid expense accordingly. Non-refundable advance payments for goods and services that will be used in future research and development activities are expensed when the activity has been performed or when the goods have been received rather than when the payment is made.

	●	the amounts involved exceeded or will exceed the lesser of (i) $120,000, or (ii) 1% of the average of the Company’s total assets at December 31, 2025 and December 31, 2024; and

	●	any director, executive officer, holder of more than 5% of our voting securities, whom we refer to as our principal stockholders, or affiliates or immediate family members of our directors, executive officers and principal stockholders, had or will have a material interest.

~~Although~~Policies ~~we do not expect our estimates to be materially different from amounts actually incurred, our understanding of the status~~ and ~~timing of~~Procedures ~~services~~for ~~performed~~Related ~~relative~~Party to the actual status and timing of services performed may vary and may result in us reporting amounts that are too high or too low in any particular period. To date, there have been no material differences between our estimates of such expenses and the amounts actually incurred.Transaction

Fair Value of Inducement Warrants

The inducement warrants are measured at estimated fair value using the Black Scholes valuation model. Inherent in this model are assumptions related to expected stock price volatility, expected life, risk-free interest rate and dividend yield. We estimate the volatility of our common stock at the date of issuance based on the historical implied volatility of our own stock price that matches the expected remaining life of the warrants. The risk-free interest rate is based on the U.S. Treasury zero-coupon yield curve on the measurement date for a maturity similar to the expected remaining life of the inducement warrants. The expected life of the inducement warrants is assumed to be equivalent to their remaining contractual term. The dividend rate is based on our historical rate, which we anticipate to remain at zero. The assumptions used in calculating the estimated fair value of the inducement warrants represent our best estimates. However, these estimates involve inherent uncertainties and the application of management judgment. As a result, if factors change and different assumptions are used, the inducement warrants estimated fair value could be materially different.

SECURITY OWNERSHIP AND CERTAIN BENEFICIAL OWNERS

The following table sets forth information with respect to the beneficial ownership of our Common Stock (including shares issuable upon the exercise or conversion of securities that entitle the holders thereof to obtain Common Stock upon exercise or conversion in accordance with the terms thereof) as of January 10, 2025, by:

● each person known by us to be the beneficial owner of more than five percent of our outstanding shares of Common Stock; ● each director; ● each of our named executive officers; and ● all current directors and executive officers of the Company as a group.

Beneficial ownership is determined in accordance with the rules of the SEC, which generally attribute beneficial ownership of securities to persons who possess sole or shared voting power or investment power with respect to those securities. We deem shares of our common stock which the stockholder has the right to acquire within 60 days of January 10, 2025, whether through the vesting of restricted stock units, or RSUs, or the exercise or conversion of any stock option, convertible security, warrant or other right, to be outstanding for the purpose of computing the percentage ownership of such individual or group, but those shares are not deemed to be outstanding for the purpose of computing the percentage ownership of any other person shown in the table. The indication herein that shares are beneficially owned is not an admission on the part of the stockholder that he, she or it is a direct or indirect beneficial owner of those shares.

Except as indicated in the footnotes to this table, each beneficial owner named in the table below has sole voting and sole investment power with respect to all shares beneficially owned and each person’s address is c/o Enveric Biosciences, Inc. 4851 Tamiami Trail N., Suite 200, Naples, FL 34103. As of January 10, 2025, we had 10,388,697 shares of Common Stock outstanding.

Name of Beneficial Owner	Number of Shares of Common Stock Beneficially Owned		Percentage of Class
Officers and Directors
Joseph Tucker, Ph.D.(1)		84,410		*
Peter Facchini, Ph.D.(2)		52,003		*
Kevin Coveney(3)		21,625		*
Frank Pasqualone(4)		48,733		*
George Kegler(5)		48,053		*
Marcus Schabacker, M.D., Ph.D.(6)		48,053		*
Michael Webb(7)		47,733		*
Sheila DeWitt, Ph.D.(8)		27,845		*
All directors and current executive officers as a group of eight (8) persons(9)		378,455		3.6	%
AdvisorShares Trust(10)		599,854		5.8	%

* Represents less than 1%

(1)	Includes 31,133 shares of Common Stock and Vested and Unissued Restricted Stock Units, 36,000 Restricted Stock Units that will vest within 60 days of January 10, 2025, options to purchase 3,987 shares of Common Stock exercisable within 60 days of January 10, 2025, and warrants to purchase 13,290 shares of Common Stock exercisable within 60 days of January 10, 2025.
(2)	Includes 21,032 shares of Common Stock and Vested and Unissued Restricted Stock Units, 16,750 Restricted Stock Units that will vest within 60 days of January 10, 2025, options to purchase 1,994 shares of Common Stock exercisable within 60 days of January 10, 2025, and warrants to purchase 12,227 shares of Common Stock exercisable within 60 days of January 10, 2025.
(3)	Includes 6,625 shares of Common Stock and 15,000 Restricted Stock Units that will vest within 60 days of January 10, 2025.
(4)	All share amounts consist of Common Stock.
(5)	All share amounts consist of Common Stock.
(6)	All share amounts consist of Common Stock.
(7)	All share amounts consist of Common Stock.
(8)	All share amounts consist of Common Stock.
(9)	Includes 279,207 shares of Common Stock and Vested and Unissued Restricted Stock Units, 67,750 Restricted Stock Units vesting within 60 days of January 10, 2025, options to purchase 5,981 shares of Common Stock exercisable within 60 days of January 10, 2025, and warrants to purchase 25,517 shares of Common Stock exercisable within 60 days of January 10, 2025.
(10)	According to its most recent 13G filed with the SEC on January 6, 2025, AdvisorShares Trust (“AdvisorShares”) is an investment company organized under the laws of the State of Delaware with sole voting and dispositive power with respect to 599,854 shares. The principal address of AdvisorShares is 4800 Montgomery Lane, Suite 150, Bethesda, Maryland 20814.

CERTAIN RELATIONSHIPS AND RELATED PARTY TRANSACTIONS

In addition to the director and executive officer compensation arrangements discussed in the “Executive Officer and Director Compensation” section in this proxy statement, since January 1, 2022 we have engaged in the following transactions in which:

● the amounts involved exceeded or will exceed the lesser of (i) $120,000, or (ii) 1% of the average of the Company’s total assets at December 31, 2023 and December 31, 2022; and

● any director, executive officer, holder of more than 5% of our voting securities, whom we refer to as our principal stockholders, or affiliates or immediate family members of our directors, executive officers and principal stockholders, had or will have a material interest.

We believe that all of these transactions were on terms as favorable as could have been obtained from unrelated third parties.

Advisory Services from Dr. Sheila DeWitt

Dr. DeWitt has provided research and development services as an advisory consultant to the Company since May 2022, through DeuteRx, LLC, of which Dr. DeWitt is a President, Chief Executive Officer and Chair of its Board of Directors. These services are provided as needed on an hourly basis. As of January 10, 2025, the Company has paid approximately $220,000 to DeuteRx for its services over the last 12 months.

Consulting Agreement with David Johnson

The Company and David Johnson, the Company’s former Executive Chairman, entered into a consulting agreement on January 1, 2023 (the “January Agreement”). Pursuant to the January Agreement, Mr. Johnson agreed to provide consulting services to the Company effective January 1, 2023. Mr. Johnson earns $23,833 per month ($286,000 per annum) over the term of the January Agreement. The Company will also reimburse Mr. Johnson for such reasonable and necessary expenses incurred by him in carrying out his services under the January Agreement. The January Agreement will remain in effect until the earlier of (i) its termination pursuant to the terms of the January Agreement or (ii) the effectiveness of the spin-off of Akos Biosciences, Inc. (formerly known as Acanna Therapeutics, Inc.), a majority owned subsidiary of the Company (“Akos”) from the Company. During the term of the January Agreement, Mr. Johnson will provide services as requested by the Board. If the January Agreement is terminated without cause prior to the completion of the spin-off transaction of Akos, Company shall pay Mr. Johnson a termination fee of $286,000 over the 12 months following the termination of the January Agreement.

Policies and Procedures for Related Party Transactions

Our Audit Committee is responsible for reviewing and approving all transactions in which we are a participant and in which any parties related to us, including our executive officers, directors, beneficial owners of more than 5% of our voting securities, immediate family members of the foregoing persons, and any other persons whom our Board determines may be considered related parties, has or will have a direct or indirect material interest and that involve consideration received or receivable by these persons in excess of the lesser of (i) $120,000, and (ii) one percent of the average of the Company’s total assets at year end for the last two completed fiscal years. In reviewing and approving these transactions, our Audit Committee obtains, or directs our management to obtain on its behalf, all information that the Audit Committee believes to be material to a review of the transaction prior to its approval. It is contemplated that no related person transaction will be entered into prior to the completion of these procedures; however, where permitted, a related person transaction may be ratified upon completion of these procedures.

6267

MANAGEMENT

Executive Officers and Directors

The following table provides information regarding our executive officers and directors with their respective ages as of ~~January~~February 104, ~~2025~~ 2026:

Name	Age	Position(s)
Joseph Tucker, Ph.D.	5657	Chief Executive Officer and Director
Peter Facchini, Ph.D.	6162	Chief Innovation Officer
Kevin Coveney	6162	Chief Financial Officer
Michael D. Webb	6667	Chairman of the Board
George Kegler	6970	Director
Frank Pasqualone	6870	Director
Marcus Schabacker, M.D., Ph.D.	6162	Director
Sheila DeWitt, Ph.D.	6465	Director

Joseph Tucker, Ph.D. has served as our Chief Executive Officer and Director since September 16, 2021. Prior to joining the Company, Dr. Tucker was the Chief Executive Officer, President and Director of MagicMed Industries Inc., from its founding in May 2020 until its acquisition by the Company in September 2021. Dr. Tucker was the Executive Chairman of Willow Biosciences Inc., a TSX-listed public company, from April 2019 to March 2020. From March 2014 until April 2019, Dr. Tucker was the Chief Executive Officer, President and Director of Epimeron Inc., which amalgamated with BioCan Technologies Inc. in April 2019 to become Willow Biosciences, Inc. Between 2007 and 2014, Dr. Tucker held President, Chief Executive Officer, and Chief Financial Officer roles in several other private biotechnology companies including VirTech Bio, Inc., Taiga Bioactives Inc., SolAeroMed, Inc., and Pharmavation, Inc. From January 2001 until January 2007, Dr. Tucker was Chief Executive Officer, President and Director of Stem Cell Therapeutics, a TSX-listed public biotechnology company. Prior to leading biotechnology companies, Dr. Tucker was a healthcare analyst with two investment banks and also served in a technology commercialization capacity for a university technology transfer office. Dr. Tucker received his Ph.D. in Biochemistry and Molecular Biology from the University of Calgary. Dr. Tucker’s relevant industry experience qualifies him to be a director of the Company.

Peter Facchini, Ph.D., has served as our Chief Innovation Officer since joining the Company in September 2021. Dr. Facchini has been a Professor of Plant Biochemistry in the Department of Biological Sciences at the University of Calgary since 1995, during which he held the Canada Research Chair in Plant Metabolic Processes Biotechnology, was a 2019 Parex Resources Innovation Fellow, received the 2021 Faculty of Science Innovation Excellence Award, and was a finalist for the 2022 Alberta Science, Technology and Leadership (ASTech) award. Prior to joining the Company, Dr. Facchini co-founded and was the Chief Scientific Officer of Epimeron Inc., Willow Biosciences Inc. and MagicMed Industries Inc. Dr. Facchini has published over ~~170~~175 peer-reviewed scientific papers and co-invented innovations covered by more than 50 patents. Dr. Facchini is an international leader in the fields of natural product metabolic biochemistry and biotechnology.

Kevin Coveney has served as our Chief Financial Officer since March 13, 2023. Mr. Coveney brings to the Company over 30 years of experience in biotechnology finance and accounting. Mr. Coveney is the founder of Coveney Capital Advisors and has provided fractional CFO and consulting services to Progressive Therapeutics, Inc. from September 2022 to March 2023 and Power of Patients, LLC, from October 2022 to March 2023, respectively. Mr. Coveney previously held the position of chief financial officer at Memgen, Inc. from November 2021 to June 2022 and at Q-State Biosciences, Inc. from April 2020 to April 2021. Prior to his chief financial officer position, Mr. Coveney served as Senior Vice President of Finance, HR & IT of Vedanta Biosciences, Inc. from November 2018 to February 2020. He held various senior positions at Berg Health LLC from September 2015 to November 2018. Mr. Coveney was an Audit Partner at Braver PC (now ~~Marcum~~CBIZ) from July 2007 through October 2012. Mr. Coveney holds a Bachelor of Science degree in Management with a Concentration in Accounting from the University of Massachusetts and served as a non-commissioned officer in the United States Coast Guard.

6368

Michael D. Webb has served as a non-employee director of the Company since June 13, 2022 and has served as Chairman of the Board since November 2022. Mr. Webb is the President and Chief Executive Officer of Epion Therapeutics, Inc. and a member of its board of directors, positions he has held since 2017. He has served as a director at ~~iQure Pharma Inc. since 2022, at GMDx Genomics since 2021, at~~ Videokawa since 2018, and at DeuteRx, LLC since 2012. He has been a founder and Chief Executive Officer of biotechnology companies, taking them from seed round funding through venture financing and Nasdaq IPO. Mr. Webb began his career in Booz, Allen & Hamilton’s Chicago office, specializing in healthcare and life sciences and subsequently at CIBA-Geigy (now Novartis) where he was last a Senior Vice President. Mr. Webb holds Bachelor’s degrees in Biochemistry and Economics from the University of Kansas, summa cum laude and an MA in International Relations from Sussex University in the UK. In addition, he holds an MBA degree from Kellogg School of Management with a concentration in healthcare management. He is a past Chairman of the Massachusetts Biotechnology Council. Mr. Webb’s relevant industry experience qualifies him to be a director of the Company.

George Kegler has served as a non-employee director of the Company since December 30, 2020. Mr. Kegler was employed by Mallinckrodt Pharmaceuticals from January 2013 to June 2019, serving as the Executive Vice President and Chief Financial Officer, Interim from December 2018 to May 2019, where he had responsibility for the global finance function and was a member of the executive committee, Vice President Finance from November 2016 to November 2018, President Specialty Generics (Interim) and Vice President Finance from July 2016 to October 2016, and Vice President, Finance from January 2013 to June 2016. He has served in various consulting roles since June 2019, which ended in March 2020. Mr. Kegler has 40 years of experience in financial planning and analysis, corporate finance, controllership and business development. Previously Mr. Kegler served as the Vice President of Commercial Finance for various businesses within Mallinckrodt and was also interim President of the company’s specialty generics business. Prior to joining Mallinckrodt, he was the Chief Financial Officer for Convatec, a private equity-owned company that was purchased from Bristol-Myers Squibb. He worked in various finance roles within Bristol-Myers Squibb including commercial, international, technical operations, research & development as well as the assistant controller of internal controls. Mr. Kegler holds a bachelor’s degree in accounting from the University of Missouri, an MBA from Saint Louis University and completed the Certified Public Accountant exam in Missouri. Mr. Kegler’s experience as an officer at several companies and extensive knowledge of corporate finance qualify him to be a director of the Company.

Frank Pasqualone has served as a non-employee director of the Company since July 13, 2022. Mr. Pasqualone has served as Senior Vice President, Chief Business Officer of Theravance Biopharma, Inc. since November 2020 and joined Theravance Biopharma as Senior Vice President, Operations in June 2014 in connection with its spin-off from Innoviva. Mr. Pasqualone held the position of Senior Vice President, Operations at Innoviva since January 2014. From 2010 to 2012, he served as President of Intercontinental Region: Latin America, Middle East and Africa and also as President of Southern Europe from 2009 to 2010, at Bristol-Myers Squibb (BMS). Over a 25-year period with BMS, Mr. Pasqualone held senior management positions in the U.S. and globally. In the U.S., he was responsible for the Oncology/Virology business and led the marketing group in the Diabetes business. After leaving Bristol-Myers Squibb and prior to joining Theravance, Mr. Pasqualone was self-employed as a part-time consultant. Since October 2018, Mr. Pasqualone has served as a member of the board of trustees at Saint Francis University. Mr. Pasqualone holds an M.B.A. from University of Dayton and a B.S. in Marketing from Bowling Green State University in Ohio. Mr. Pasqualone’s relevant industry experience as an officer at several companies qualifies him to be a director of the Company.

Marcus Schabacker, M.D., Ph.D. has served as a non-employee director of the Company since December 30, 2020. Since January 2018, Dr. Schabacker has served as President and Chief Executive Officer of the ECRI Institute, a non-profit organization with 500 employees and an operating budget of $80 million focusing on advancing evidenced-based, effective healthcare globally. Prior to joining ECRI, Dr. Schabacker worked at Baxter Healthcare Corporation, serving as Corporate Vice President and Chief Scientific Officer from July 2015 to May 2017, chairman of the executive quality council from March 2014 to May 2017, Chief Scientific Officer, Medical Products from July 2014 to July 2015, and Vice President, R&D, Medical Products from March 2011 to July 2014. During his clinical years, and his time as an industry thought leader, Dr. Schabacker was focused on patient safety and enhancing patient care. For over a decade Dr. Schabacker has served on numerous boards of small and midsize companies and organizations, providing management with guidance and expertise to strategically accelerate growth and to build successful and sustainable high performing management teams. Dr. Schabacker’s medical background and relevant research and development experience qualify him to be a director of the Company.

Sheila DeWitt, Ph.D. was nominated to serve as a non-employee director of the Company by the Board on March 27, 2024. Dr. DeWitt has provided research and development services as an advisory consultant to the Company since May 2022. These services are provided as needed on an hourly basis. Since December of 2012, Dr. DeWitt has served as the President, Chief Executive Officer, and the Chair of the Board of Directors of DeuteRx, LLC. She has also served as a Director at Neuromity Therapeutics, Inc. from November 2021 to December 2023, and at RIFFIT, Inc. from March 2019 to November 2022. She also served as the President, Chief Executive Officer, and Chair of the Board of Directors at Deuteria Pharmaceuticals, Inc. from December 2010 to December 2012. Dr. DeWitt is a life sciences executive and serial entrepreneur with more than 35 years of experience in pharmaceutical and biotechnology companies including leading the start-up or turnaround of biotechnology companies or business units, orchestrating M&A transactions, and managing global R&D organizations. She earned her B.A. in Chemistry from Cornell University in 1982 and Ph.D. in Synthetic Organic Chemistry from Duke University in 1986 and has received numerous honors including Famous Organic Chemists by American Chemical Society (ACS) Organic Division (2019), “Women to Watch” by Mass High Tech (2013), and “Buzz of BIO” Pipelines of Promise for Deuteria Pharmaceuticals, Inc. (2012). Dr. DeWitt’s relevant industry experience qualifies her to be a director of the Company.69

Sheila DeWitt, Ph.D. has served as a non-employee director of the Company by the Board since May of 2024. Dr. DeWitt has provided research and development services as an advisory consultant to the Company since May 2022. These services are provided as needed on an hourly basis. Since December of 2012, Dr. DeWitt has served as the President, Chief Executive Officer, and the Chair of the Board of Directors of DeuteRx, LLC. She has also served as a Director at Neuromity Therapeutics, Inc. from November 2021 to December 2023, and at RIFFIT, Inc. from March 2019 to November 2022. She also served as the President, Chief Executive Officer, and Chair of the Board of Directors at Deuteria Pharmaceuticals, Inc. from December 2010 to December 2012. Dr. DeWitt is a life sciences executive and serial entrepreneur with more than 35 years of experience in pharmaceutical and biotechnology companies including leading the start-up or turnaround of biotechnology companies or business units, orchestrating M&A transactions, and managing global R&D organizations. She earned her B.A. in Chemistry from Cornell University in 1982 and Ph.D. in Synthetic Organic Chemistry from Duke University in 1986 and has received numerous honors including American Chemical Society (“ACS”) Hathryn C. Hach Award for Entrepreneurial Success (2025), ACS Gertrude Elion Medicinal Chemistry Award (2025), ACS Medicinal Chemistry Hall of Fame (2025) and Famous Organic Chemists ACS Organic Division (2019),. Dr. DeWitt’s relevant industry experience qualifies her to be a director of the Company.

Family Relationships

There are no family relationships among any of our directors or executive officers.

Composition of the Board ~~of Directors~~

Our ~~Amended~~A&R ~~and Restated~~ Certificate of Incorporation, as amended, and Amended and Restated Bylaws, as amended (“A&R Bylaws”), provide that our Board will consist of such number of directors as determined from time to time by resolution adopted by our Board. The size of our Board is currently fixed at six directors. Subject to any rights applicable to any then-outstanding shares of preferred stock, any vacancies or newly created directorships resulting from an increase in the authorized number of directors may be filled by a majority of the directors then in office. Stockholders vote to elect directors with a term ~~then~~ expiring each year at our annual meeting.

Director Term Limits

The Board does not currently have a term limit policy limiting the number of years a director may serve on the Board.

Board Leadership Structure

Currently, the positions of Chair of the Board and Chief Executive Officer of the Company are held by separate persons. The Board does not have a policy as to whether the roles of Chair of the Board and Chief Executive Officer should be separate or combined; however, in the event that they are combined, the independent directors may appoint an independent director to serve in a lead capacity in specific circumstances. The lead independent director would then coordinate the activities of the other non-management directors and perform such other duties and responsibilities as the Board may determine. Our Board currently believes the division of responsibility between separate individuals serving as Chair and Chief Executive Officer, respectively, is an effective approach for addressing the risks we face and increasing management accountability and improving the ability of the Board to monitor whether management’s actions are in the best interests of the Company and its stockholders. This approach is subject to the evolving needs of the Company, as the goal of the Board is to ensure the best possible management structure for the Company at any given time.

Director Independence

We are currently listed on the Nasdaq Stock Market and therefore rely on the definition of independence set forth in the Nasdaq Listing Rules (“Nasdaq Rules”). Under the Nasdaq Rules, a director will only qualify as an “independent director” if, in the opinion of our Board, that person does not have a relationship that would interfere with the exercise of independent judgment in carrying out the responsibilities of a director. Based upon information requested from and provided by each director concerning his background, employment, and affiliations, including family relationships, the Board has determined that except for Joseph Tucker, who serves as the Chief Executive Officer of the Company, and Dr. Sheila DeWitt, who acts as an advisory consultant to the Company, Mr. Webb, Mr. Kegler, Mr. Pasqualone, and Dr. Schabacker have no relationships with us that would interfere with the exercise of independent judgment and are “independent directors” as that term is defined in the Nasdaq Rules.

6470

~~EXECUTIVE~~Committees ~~AND~~of ~~DIRECTOR~~the ~~COMPENSATION~~Board

The Board delegates various responsibilities and authority to different Board committees. Committees regularly report on their activities and actions to the full Board. Currently, the Board has established an Audit Committee, a Compensation Committee, a Nominating and Governance Committee, and a Science and Technology Committee. Committee assignments are re-evaluated annually. Each of these standing committees operates under a charter that has been approved by our Board. The current charter of each of the Audit Committee, Compensation Committee, and Nominating and Governance Committee is available on our website at www.enveric.com in the “Corporate Governance” section under “Investors.”

The following table sets forth the membership of each of the Board committees listed above.

Name	Audit Committee	Compensation Committee	Nominating and Governance Committee
George Kegler	Chair	X	X
Frank Pasqualone	X	Chair	Chair
Michael Webb	X	X	-
Marcus Schabacker, M.D., Ph.D.	-	-	X

Our Science and Technology Committee, meant to oversee ongoing updates to R&D operations, is comprised of Marcus Schabacker (Chair), Michael D. Webb, and Sheila DeWitt.

Audit Committee

The members of our Audit Committee currently are George Kegler (Chair), Frank Pasqualone, and Michael Webb. Our Board has determined that all members of the Audit Committee (i) are independent directors (as currently defined in Rule 5605(a)(2) of the Nasdaq Listing Rules); (ii) meet the criteria for independence set forth in Rule 10A-3(b)(1) under the Exchange Act; (iii) have not participated in the preparation of the financial statements of the Company or any current subsidiary of the Company at any time during the past three years; and (iv) are able to read and understand fundamental financial statements. Our Board has also reviewed the education, experience, and other qualifications of each member of the Audit Committee. Based upon that review, our Board has determined that Mr. Kegler qualifies as an “audit committee financial expert” as defined in Item 407 of Regulation S-K.

The Audit Committee is governed by a written charter approved by the Board and provides assistance to the Board in fulfilling the Board’s responsibility to the Company’s stockholders relating to the Company’s accounting and financial reporting practices and system of internal control, the audit process, the quality and integrity of the Company’s financial reporting, and the Company’s process for monitoring compliance with laws and regulations and its code of conduct and ethics. The functions of the Audit Committee include, among other things:

	●	Approving and retaining the independent auditors to conduct the annual audit of our financial statements;

	●	Reviewing the proposed scope and results of the audit;

	●	Reviewing and pre-approving audit and non-audit fees and services;

	●	Reviewing accounting and financial controls with the independent auditors and our financial and accounting staff;

	●	Reviewing and approving transactions between us and our directors, officers and affiliates;

	●	Recognizing and preventing prohibited non-audit services;

	●	Establishing procedures for complaints received by us regarding accounting matters;

	●	Overseeing internal audit functions, if any; and

	●	Preparing the report of the audit committee that the rules of the SEC require to be included in our annual meeting proxy statement.

The Audit Committee is also responsible for overseeing the Company’s cybersecurity prevention efforts and incident response processes. Both our independent registered public accounting firm and internal financial personnel regularly meet privately with our Audit Committee and have unrestricted access to the Audit Committee.

The Audit Committee met four times during the year ended December 31, 2025.

Compensation Committee

The members of our Compensation Committee currently are Frank Pasqualone (Chair), George Kegler, and Michael Webb. Our Board has determined that Mr. Pasqualone, Mr. Kegler, and Mr. Webb are independent in accordance with Nasdaq Rules.

The Compensation Committee is governed by a written charter approved by the Board. Under its charter, the Compensation Committee may form, and delegate authority to, subcommittees, as appropriate. The Compensation Committee will annually review and approve corporate goals and objectives relevant to Chief Executive Officer compensation, evaluate the Chief Executive Officer’s performance in light of those goals and objectives, and recommend to the Board the Chief Executive Officer’s compensation levels based on this evaluation. The Compensation Committee will also annually review and make recommendations to the Board with respect to compensation of our non-employee directors and executive officers other than the Chief Executive Officer. The charter of the Compensation Committee also permits the Compensation Committee to engage outside consultants and to consult with our human resources department when appropriate to assist in carrying out its responsibilities. The Compensation Committee may also obtain advice and assistance from internal or external legal, accounting, or other advisers selected by the Compensation Committee. The functions of the Compensation Committee include, among other things:

	●	Reviewing and recommending the compensation arrangements for management, including the compensation for our president and chief executive officer;

	●	Establishing and reviewing general compensation policies with the objective to attract and retain superior talent, to reward individual performance and to achieve our financial goals;

	●	Administering our stock incentive plans and recommending grants under the same to the Board; and

	●	Preparing the report of the compensation committee that the rules of the SEC may require to be included in our annual meeting proxy statement.

The Compensation Committee met one time during the year ended December 31, 2025.

Nominating and Governance Committee

The members of our Nominating and Governance Committee currently are Frank Pasqualone (Chair), Marcus Schabacker, M.D., Ph.D. and George Kegler. The Board has determined that Mr. Pasqualone, Dr. Schabacker and Mr. Kegler are independent in accordance with Nasdaq Rules.

The Nominating and Governance Committee is governed by a written charter approved by the Board. The functions of the Nominating and Governance Committee include, among other things:

	●	Evaluating the current composition, organization and governance of the Board and its committees, and making recommendations for changes thereto;

	●	Reviewing each director and nominee annually;

	●	Determining desired Board member skills and attributes and conducting searches for prospective members accordingly;

	●	Evaluating nominees, and making recommendations to the Board concerning the appointment of directors to Board committees, the selection of Board committee chairs, proposal of the slate of directors for election to the Board, and the termination of membership of individual directors in accordance with the Board’s governance principles;

	●	Overseeing the process of succession planning for the Chief Executive Officer and, as warranted, other senior officers of the Company;

	●	Developing, adopting and overseeing the implementation of a code of business conduct and ethics; and

	●	Administering the annual Board performance evaluation process.

The Nominating and Governance Committee met one time during the year ended December 31, 2025.

The Board’s Role in Risk Oversight

The Board, as a whole and also at the committee level, has an active role in managing enterprise risk. The members of the Board participate in our risk oversight assessment by receiving regular reports from members of senior management on areas of material risk to us, including operational, financial, legal and regulatory, and strategic and reputational risks. The Compensation Committee is responsible for overseeing the management of risks relating to our executive compensation plans and arrangements. The Audit Committee oversees management of financial risks and cybersecurity risks, as well as our policies with respect to risk assessment and risk management. The Nominating and Governance Committee manages risks associated with the independence of the Board and potential conflicts of interest. Members of the management team report directly to the Board or the appropriate committee. The directors then use this information to understand, identify, manage, and mitigate risk. Once a committee has considered the reports from management, the chair of that committee will report on the matter to the full Board at the next meeting of the Board, or sooner if deemed necessary. This enables the Board and its committees to effectively carry out its risk oversight role.

Code of Business Conduct

We adopted a code of business conduct that applies to all of our directors, officers and employees, including our principal executive officer, principal financial officer and principal accounting officer, which is available on our website. Our code of business conduct is a “code of ethics,” as defined in Item 406(a) and (b) of Regulation S-K. We will make any legally required disclosures regarding amendments to, or waivers of, provisions of our code of ethics on our website.

EXECUTIVE & DIRECTOR COMPENSATION

Summary Compensation Table

The following table sets forth total compensation paid to the named executive officers for the years ended December 31, ~~2024~~2025 and ~~2023~~2024, comprised of (i) the individual who served as our Chief Executive Officer during the ~~2024~~2025 fiscal year, (ii) the two most highly compensated executive officers other than the Chief Executive Officer who were serving as an executive officer at the end of the ~~2024~~2025 fiscal year and whose compensation, as determined by Regulation S-K, Item 402, exceeded $100,000 and (iii) any individual who would otherwise be included in (ii) above but for the fact that such individual was not serving as an executive officer of ours at the end of the ~~2024~~2025 fiscal year. On October 28, 2025, the Company effected the Reverse Stock Split. All historical share and per share amounts reflected throughout this section have been adjusted to reflect the Reverse Stock Split.

Name and Principal Position	Year	~~Salary ($)~~	Salary		~~Bonus ($)~~	Bonus		~~Stock Awards(1) ($)~~	Stock Awards(1)			~~Non-Equity Incentive Plan Compensation ($)~~	Non-Equity Incentive Plan Compensation		~~Nonqualified Deferred Compensation Earnings ($)~~	All Other Compensation		~~All Other Compensation ($)~~	Total		~~Total ($)~~
Joseph Tucker(2)	2024		458,640						152,724.23	(3)			-			-			-			613,388.23
Joseph Tucker	2025			472,399			-			407,142	(2)			-			-			879,541
Chief Executive Officer	~~2023~~2024		~~450,785~~	458,640		-	-		~~126,280~~	~~(4)~~152,893	(3)		-	-		-	-		-	611,533		~~577,065~~
Peter Facchini, Ph.D.(5)	2024		215,268	(6)					59,260	(6)(7)												274,528
Peter Facchini, Ph.D.(8)	2025			236,089			-			31,391	(4)			-			-			267,480
Chief Innovation Officer	~~2023~~2024		~~233,272~~	~~(6)~~215,269		-	-		~~48,790~~	~~(6)(8)~~59,311	(5)		-	-		-	-		-	274,580		~~282,062~~
Kevin Coveney(9)	2024		385,000						92,900	(10)			-			-			-			477,900
Kevin Coveney	2025			396,550			-			281,895	(6)			-			-			678,445
Chief Financial Officer	~~2023~~2024		~~308,989~~	385,000		-	-		~~49,688~~	~~(11)~~93,002	(7)		-	-		-	-		-	478,002		~~358,657~~

~~(1)~~	~~Stock compensation consists of Restricted Stock Unit Award~~ (~~“RSUs”~~1) and Restricted Stock Awards (“RSAs”). RSUs and RSAs may contain vesting conditions that include, without limitation, continued employment or engagement with the Company, achievement of defined stock price levels or achievement of defined performance milestones, termination of the employee without cause, resignation of the employee for good cause or change in control. Please also note there are no assurances that such vesting conditions will be met and accordingly there are no assurances that any unvested RSUs or RSAs will become vested prior to being forfeited on the expiration date defined in the relevant award agreements. Furthermore, RSUs require that the recipient’s employment with the Company be terminated, or that a change of control occur, as a prerequisite of conversion of vested restricted stock units into shares of Common Stock.	Stock compensation consists of RSUs and RSAs. RSUs and RSAs may contain vesting conditions that include, without limitation, continued employment or engagement with the Company, achievement of defined stock price levels or achievement of defined performance milestones, termination of the employee without cause, resignation of the employee for good cause or change in control. Please also note there are no assurances that such vesting conditions will be met and accordingly there are no assurances that any unvested RSUs or RSAs will become vested prior to being forfeited on the expiration date defined in the relevant award agreements. Furthermore, RSUs require that the recipient’s employment with the Company be terminated, or that a change of control occur, as a prerequisite of conversion of vested restricted stock units into shares of Common Stock.
~~(2)~~	~~Dr. Tucker was appointed Chief Executive Officer on September 16, 2021. Effective February 1, 2023, Dr. Tucker’s annual base salary was increased from $364,000 to $458,640.~~(2)	Dr. Tucker’s 2025 stock compensation consists of an aggregate of 68,534 RSUs, valued at $407,142, with such valuation being based on the Company’s closing price per share of $15.24 and $4.67 on the RSU grant dates.
	(3)	Dr. Tucker’s 2024 stock compensation consists of an aggregate of 1,453 RSUs, valued at $152,893, with such valuation being based on the Company’s closing price per share of $153.00 and $75.60 on the RSU grant dates.
	(4)	Dr. Facchini’s 2025 stock compensation consists of an aggregate of 2,059 RSUs, valued at $31,391, with such valuation being based on the Company’s closing price per share of $15.24 on the RSU grant date.
	(5)	Dr. Facchini’s 2024 stock compensation consists of an aggregate of 500 RSUs, valued at $59,311, with such valuation being based on the Company’s closing price per share of $153.00 and $75.60 on the RSU grant dates.
	(6)	Mr. Coveney’s 2025 stock compensation consists of an aggregate of 46,377 RSUs, valued at $281,895, with such valuation being based on the Company’s closing price per share of $15.24 and $4.67 on the RSU grant dates.
	(7)	Mr. Coveney’s 2024 stock compensation consists of an aggregate of 888 RSUs, valued at $93,002, with such valuation being based on the Company’s closing price per share of $153.00 and $75.60 on the RSU grant date.
	(8)	Salaries, bonus and non-equity incentive plan compensation that were originally paid or recorded in Canadian dollars were converted to U.S. dollars using the Bloomberg average exchange rate of C$1.00 to US$0.716 for the 12-month period ended December 31, 2025 and $1.00 to US$0.694 for the 12-month period ended December 31, 2024.

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(3)	Dr. Tucker’s 2024 stock compensation consists of 100,000 RSUs, valued at $85,000, with such valuation being based on the Company’s closing price per share of $0.85 on the RSU grant date and 161,633 RSUs, valued at $67,724.23, with such valuation being based on the Company’s closing price per share of $0.419 on the RSU grant date
(4)	Dr. Tucker’s 2023 stock compensation consists of an aggregate of 44,000 RSUs, valued at $126,280, with such valuation being based on the Company’s closing price per share of $2.87 on the RSU grant date.
(5)	Dr. Facchini has served as Chief Innovation Officer since September 16, 2021.
(6)	Salaries, bonus and non-equity incentive plan compensation that were originally paid or recorded in Canadian dollars were converted to U.S. dollars using the Bloomberg exchange rate of C$1.00 to $0.694 for the 12-month period ended December 31, 2024 and C$1.00 to US$0.756 for the 12-month period ended December 31, 2023.
(7)	Dr. Facchini’s 2024 stock compensation consists of 50,000 RSUs, valued at $42,500, with such valuation being based on the Company’s closing price per share of $0.85 on the RSU grant date and 40,000 RSUs, valued at $16,760, with such valuation being based on the Company’s closing price per share of $0.419 on the RSU grant date.
(8)	Dr. Facchini’s 2023 stock compensation consists of an aggregate of 17,000 RSUs, valued at $48,790, with such valuation being based on the Company’s closing price per share of $2.87 on the RSU grant date.
(9)	Mr. Coveney has served as Chief Financial Officer since March 13, 2023.
(10)	Mr. Coveney’s 2024 stock compensation consists of 60,000 RSUs, valued at $51,000, with such valuation being based on the Company’s closing price per share of $0.85 on the RSU grant date and 100,000 RSUs, valued at $41,900, with such valuation being based on the Company’s closing price per share of $0.419 on the RSU grant date.
(11)	Mr. Coveney’s 2023 stock compensation consists of an aggregate of 26,500 RSUs, valued at $49,688, with such valuation being based on the Company’s closing price per share of $1.88 on the RSU grant date.

Narrative Disclosure to Summary Compensation Table

Tucker Employment Agreement

On May 24, 2021, Joseph Tucker, Ph.D. entered into an employment agreement (the “Tucker Employment Agreement”) with the Company pursuant to which he became the Company’s Chief Executive Officer, effective as of the September 16, 2021 closing date of the Company’s amalgamation (the “Tucker Effective Date”).

Pursuant to the Tucker Employment Agreement, Dr. Tucker was initially entitled to an annual base salary of $350,000 (“Tucker Base Salary”). Dr. Tucker also received, upon entering into the Tucker Employment Agreement, a one-time signing bonus of $100,000 and ~~1,375~~7 RSUs, of ~~which~~ which half are subject to time-based vesting and the other half are subject to market-based vesting. Pursuant to the Tucker Employment Agreement, upon entering into the agreement, Dr. Tucker also received an initial equity compensation grant of ~~15,000~~83 RSUs, of which half are subject to time-based vesting and the other half are subject to market-based vesting. The RSUs are subject to the terms and conditions of the Company’s 2020 Long-Term Incentive Plan, as amended (the “Incentive Plan”) and will vest in quarters on each of the first four anniversaries of the Tucker Effective Date. The RSUs granted based on market performance were subsequently forfeited for failure to achieve milestones.

Effective as of March 1, 2022, our Board approved an increase in annual base salary from $350,000 to $364,000 for Dr. Tucker. Beginning in calendar year 2022, Dr. Tucker became eligible to receive annual performance bonuses of up to 75% of the Tucker Base Salary, as determined from time to time by the Board. Effective as of February 1, 2023, our Board approved an increase in annual base salary from $364,000 to $458,640 for Dr. Tucker.

The Tucker Employment Agreement will remain in effect until terminated by either party. Either party may terminate the Tucker Employment Agreement upon advance written notice of termination to the other party at least 30 days prior. In addition, the Tucker Employment Agreement is subject to early termination by him or the Company in accordance with the terms of the Tucker Employment Agreement.

Pursuant to the Tucker Employment Agreement, if Dr. Tucker’s employment is terminated by the Company without Cause (as defined therein) or by Dr. Tucker for Good Reason (as defined therein), then the Company must pay Dr. Tucker, in addition to any then-accrued and unpaid obligations owed to him, 12 months of the then-current Tucker Base Salary.

The Tucker Employment Agreement also contains covenants restricting Dr. Tucker from soliciting the Company’s employees or customers for a period of 12 months after the termination of Dr. Tucker’s employment with the Company and prohibiting him from disclosure of confidential information regarding the Company at any time.

As of December 31, ~~2024~~2025, Dr. Tucker has been awarded an aggregate of ~~322~~70,~~007~~323 RSUs, of which 869,~~187~~594 ~~were forfeited to the Company for failure to satisfy certain performance conditions, and 296,508~~ remain unvested. All ~~unvested~~outstanding RSUs held by Dr. Tucker will become fully vested upon the occurrence of a Change in Control ~~or termination of service without cause or for good reason~~ (as defined in the Incentive ~~Plan~~ ~~or in the award agreement~~Plan). In addition, if we terminate Dr. Tucker’s employment without Cause or if Dr. Tucker terminates his employment for Good Reason, all outstanding RSUs subject to time-based vesting and held by Dr. Tucker will become fully vested, and all outstanding RSUs subject to market-based vesting that would have vested on the vesting date occurring on or next following Dr. Tucker’s employment termination date will become fully vested, provided that the applicable performance goal has been achieved by such date. All shares underlying vested RSUs will not be converted into issued shares until after the earlier of a Change in Control or the termination of Dr. Tucker’s employment with the Company for any reason other than a termination by the Company for Cause.

~~Coveney Employment Agreement~~74

On February 22, 2023, Kevin Coveney entered into an employment agreement (the “Coveney Employment Agreement”) with the Company pursuant to which he became the Company’s Chief Financial Officer, effective as of the March 13, 2023 (the “Coveney Effective Date”).

Pursuant to the Coveney Employment Agreement, Mr. Coveney is entitled to an annual base salary of $385,000 (“Coveney Base Salary”). Mr. Coveney also received, upon entering into the Coveney Employment Agreement 26,500 RSUs. The RSUs are subject to the terms and conditions of the Company’s 2020 Long-Term Incentive Plan, as amended (the “Incentive Plan”) and will vest in quarters on each of the first four anniversaries of the Coveney Effective Date. Mr. Coveney is also eligible to receive annual performance bonuses of up to 40% of his Base Salary based on satisfaction of performance criteria/financial results, as determined by the Board in its sole discretion.

The Coveney Employment Agreement will remain in effect until terminated by either party. Either party may terminate the Coveney Employment Agreement upon advance written notice of termination to the other party at least 30 days prior.

Pursuant to the Coveney Employment Agreement, if Mr. Coveney’s employment is terminated by the Company without Cause (as defined therein) or by Mr. Coveney for Good Reason (as defined therein), then the Company must pay Mr. Coveney, in addition to any then-accrued and unpaid obligations owed to him, 9 months of the then-current Coveney Base Salary, in exchange for release of claims.

The Coveney Employment Agreement also contains covenants restricting Mr. Coveney from soliciting the Company’s employees or customers for a period of 12 months after the termination of Mr. Coveney’s employment with the Company and prohibiting him from disclosure of confidential information regarding the Company or from disparaging the Company at any time.

As of December 31, 2024, Mr. Coveney has been awarded an aggregate of 186,500 RSUs, of which 179,875 remain unvested. All outstanding RSUs held by Mr. Coveney will become fully vested upon the occurrence of a Change in Control (as defined in the Incentive Plan). In addition, if we terminate Mr. Coveney’s employment without Cause or if Mr. Coveney terminates his employment for Good Reason, all outstanding RSUs shall immediately vest.

Facchini Employment Agreement

On May 24, 2021, Peter Facchini, Ph.D. entered into an employment agreement (the “Facchini Employment Agreement”) with the Company pursuant to which he serves as the Company’s Chief Innovation Officer, effective as of the September 16, 2021 closing date of the Company’s amalgamation (the “Facchini Effective Date”).

Pursuant to the Facchini Employment Agreement, as of the Facchini Effective Date, Dr. Facchini is entitled to a base salary of C$295,000 annually (“Facchini Base Salary”). Dr. Facchini also received a one-time signing bonus of C$50,000 and ~~11,522~~5 RSUs, based on the ~~price~~ price of the Company’s shares at the Facchini Effective Date. Half of any such RSUs are subject to time-based vesting, and the ~~remaining~~ remaining half of any such RSUs are subject to market-based vesting. ~~The~~Additionally, Dr. Facchini received 58 RSUs as equity compensation. 29 of such RSUs are subject to time-based vesting, and the remaining 29 of such RSUs are subject to market-based vesting. The RSUs are subject to the terms and conditions of the Incentive Plan. The RSUs ~~that~~ are subject to time-based vesting and shall vest in quarters on each of the first four anniversaries of the Facchini Effective Date. The RSUs granted based on market performance were subsequently forfeited for failure to achieve milestones.

The Facchini Employment Agreement will remain in effect until terminated by either party upon written notice by either party, unless the Company delivers advance written notice of termination to Dr. Facchini or Dr. Facchini delivers advance written notice of termination to the Company at least 30 days prior. In addition, the Facchini Employment Agreement is subject to early termination by him or the Company in accordance with the terms of the Facchini Employment Agreement.

Pursuant to the Facchini Employment Agreement, if Dr. Facchini’s employment is terminated by the Company without Cause (as defined in therein) or by Dr. Facchini for Good Reason (as defined therein), then the Company must pay Dr. Facchini, in addition to any then-accrued and unpaid obligations owed to him, 12 months of the then-current Facchini Base Salary.

The Facchini Employment Agreement also contains covenants restricting Dr. Facchini from soliciting the Company’s employees or customers for a period of 12 months after the termination of Dr. Facchini’s employment with the Company and prohibiting him from disclosure of confidential information regarding the Company at any time.

As of December 31, ~~2024~~2025, Dr. Facchini has been awarded an aggregate of ~~118~~2,~~521~~718 RSUs, of which 52,~~760~~414 ~~were forfeited to the Company for failure to satisfy certain performance conditions, and 104,063~~ remain unvested. All outstanding RSUs held by Dr. Facchini will become fully vested upon the occurrence of a Change in Control. In addition, all outstanding RSUs subject to time-based vesting and held by Dr. Facchini will become fully vested if we terminate Dr. Facchini’s employment without Cause or if Dr. Facchini terminates his employment for Good Reason, and all outstanding RSUs subject to market-based vesting that would have vested on the vesting date occurring on or next following Dr. Facchini’s employment termination date will become fully vested, provided that the applicable performance goal has been achieved by such date. All shares underlying vested RSUs will not be converted into issued shares until after the earlier of a Change in Control or the termination of Dr. Facchini’s employment with the Company for any reason other than a termination by the Company for Cause.

68Coveney Employment Agreement

On February 22, 2023, Kevin Coveney entered into an employment agreement (the “Coveney Employment Agreement”) with the Company pursuant to which he became the Company’s Chief Financial Officer, effective as of the March 13, 2023 (the “Coveney Effective Date”).

Pursuant to the Coveney Employment Agreement, Mr. Coveney is entitled to an annual base salary of $350,000 (“Coveney Base Salary”). Mr. Coveney also received, upon entering into the Coveney Employment Agreement 147 RSUs. The RSUs are subject to the terms and conditions of the Incentive Plan and will vest in quarters on each of the first four anniversaries of the Coveney Effective Date. Mr. Coveney is also eligible to receive annual performance bonuses of up to 40% of his Base Salary based on satisfaction of performance criteria/financial results, as determined by the Board in its sole discretion.

As of December 31, 2025, Mr. Coveney has been awarded an aggregate of 47,413 RSUs, of which 47,024 remain unvested. All outstanding RSUs held by Mr. Coveney will become fully vested upon the occurrence of a Change in Control (as defined in the Incentive Plan). In addition, if we terminate Mr. Coveney’s employment without Cause or if Mr. Coveney terminates his employment for Good Reason, all outstanding RSUs shall immediately vest.

Outstanding Equity Awards at Fiscal Year-End

The following table shows grants of stock options and ~~restricted stock units (“~~RSUs”) outstanding as of December 31, ~~2024~~2025, including both awards subject to performance conditions and time-based awards, held by each of our named executive officers.

	Option Awards										~~Stock Awards~~		Stock Awards
Name	Number of Securities Underlying Unexercised Options Exercisable (#)		Number of Securities Underlying Unexercised Options Unexercisable (#)		Equity Incentive Plan Awards: Number of Securities Underlying Unexercised Unearned Options (#)		Option Exercise Price ($)		Option Expiration Date		~~Number of Shares or Units of Stock That Have Not Vested (#)~~		Number of Shares or Units of Stock That Have Not Vested (#)		~~Market Value of Shares or Units of Stock That Have Not Vested ($)(12)~~		Market Value of Shares or Units of Stock That Have Not Vested ($)(14)
Joseph Tucker, Ph.D.		~~3,987~~23		-—		-—	$	7413,320.00	~~4/5/2026~~	4/5/2026		~~1,875~~	~~(1)~~	122	(1)	~~671.25~~	$	443
												33,000	(2)			11,814.00
														300	(2)		$	1,089
												100,000	(3)			35,800.00
														636	(3)		$	2,309
												161,633	(4)			57,864.61
														8,238	(4)		$	29,904
Peter Facchini, Ph.D		1,994		-		-	$	74.00	4/5/2026			1,313	(5)			470.05
														60,296	(5)		$	218,874
												12,750	(6)			4,564.50
Peter Facchini, Ph.D.		11		—		—	$	13,320.00		4/5/2026				47	(6)		$	171
												50,000	(7)			17,900.00
														150	(7)		$	545
												40,000	(8)			14,320.00
														157	(8)		$	570
Kevin Coveney		-		-		-		-	-			19,875	(9)			7,115.25
														2,059	(9)		$	7,474
												60,000	(10)			21,480.00
Kevin Coveney		—		—		—		—		—				73	(10)		$	265
												100,000	(11)			35,800.00
														180	(11)		$	653
														393	(12)		$	1,426
														6,179	(13)		$	22,430
														40,198	(14)		$	145,919

(1)	Represents the unvested portion of ~~15,000~~244 RSUs granted to Dr. Tucker on ~~October~~January 1325, ~~2021~~2023, each of which represents the right to receive one share of ~~common~~Common ~~stock~~Stock upon vesting. ~~50%~~The ~~of the~~ RSUs shall vest over 4 years in equal annual installments, with the first tranche tohaving ~~vest~~vested on ~~September~~January 1625, ~~2022. On December 31,~~ 2024~~, 7,500 RSUs in connection with this grant were forfeited to the Company for failure to satisfy certain performance conditions~~.
(2)	Represents the unvested portion of ~~44,000~~555 RSUs granted to Dr. Tucker on ~~January~~February 2522, ~~2023~~2024, each of which represents the right to receive one share of ~~common~~Common ~~stock~~Stock upon vesting. ~~The~~One-fourth of the RSUs ~~shall~~will vest ~~over~~upon 4the ~~years~~one-year inanniversary ~~equal~~of ~~annual~~the ~~installments,~~date ~~with~~of issuance. An additional one-thirty-sixth of the RSUs will vest each month following the first ~~tranche~~vesting todate. ~~vest~~Vesting onis ~~January~~conditioned ~~25,~~upon ~~2024~~continued employment in the Company.
(3)	Represents the unvested portion of ~~100,000~~897 RSUs granted to Dr. Tucker on ~~February~~October 229, 2024, each of which represents the right to receive one share of ~~common~~Common ~~stock~~Stock upon vesting. One-fourth of the RSUs will vest upon the one-year anniversary of the date of issuance. An additional one-thirty-sixth of the RSUs will vest each month following the first vesting date. ~~Any~~Vesting ~~remaining~~is ~~RSUs~~conditioned ~~will~~upon ~~vest~~continued onemployment ~~the~~in ~~fourth anniversary of~~ the ~~date of issuance~~Company.
(4)	Represents the unvested portion of 8,238 RSUs granted to Dr. Tucker on May 8, 2025, each of which represents the right to receive one share of Common Stock upon vesting. One-fourth of the RSUs will vest upon the one-year anniversary of the date of issuance. An additional one-thirty-sixth of the RSUs will vest each month following the first vesting date. Vesting is conditioned upon continued employment in the Company.
(5)	Represents the unvested portion of 60,296 RSUs granted to Dr. Tucker on December 23, 2025, each of which represents the right to receive one share of Common Stock upon vesting. One-fourth of the RSUs will vest upon the one-year anniversary of the date of issuance. An additional one-thirty-sixth of the RSUs will vest each month following the first vesting date. Vesting is conditioned upon continued employment in the Company
(6)	Represents the unvested portion of 94 RSUs granted to Dr. Facchini on January 25, 2023, each of which represents the right to receive one share of Common Stock upon vesting. The RSUs shall vest over 4 years in equal annual installments, with the first tranche to vest on January 25, 2024.
(7)	Represents the unvested portion of 277 RSUs granted to Dr. Facchini on February 22, 2024, each of which represents the right to receive one share of Common Stock upon vesting. One-fourth of the RSUs will vest upon the one-year anniversary of the date of issuance. An additional one-thirty-sixth of the RSUs will vest each month following the first vesting date. Vesting is conditioned upon continued employment in the Company.
(8)	Represents the unvested portion of 222 RSUs granted to Dr. Facchini on October 9, 2024, each of which represents the right to receive one share of Common Stock upon vesting. One-fourth of the RSUs will vest upon the one-year anniversary of the date of issuance. An additional one-thirty-sixth of the RSUs will vest each month following the first vesting date. Vesting is conditioned upon continued employment in the Company.
(9)	Represents the unvested portion of 2,059 RSUs granted to Dr. Facchini on May 8, 2025, each of which represents the right to receive one share of common stock upon vesting. One-fourth of the RSUs will vest upon the one-year anniversary of the date of issuance. An additional one-thirty-sixth of the RSUs will vest each month following the first vesting date. Vesting is conditioned upon continued employment in the Company.
(10)	Represents the unvested portion of 147 RSUs granted to Kevin Coveney on March 13, 2023, each of which represents the right to receive one share of Common Stock upon vesting. The RSUs shall vest over 4 years in equal annual installments, with the first tranche to vest on March 13, 2024.

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(4)	Represents the unvested portion of 161,633 RSUs granted to Dr. Tucker on October 9, 2024, each of which represents the right to receive one share of common stock upon vesting. One-fourth of the RSUs will vest upon the one-year anniversary of the date of issuance. An additional one-thirty-sixth of the RSUs will vest each month following the first vesting date. Any remaining RSUs will vest on the fourth anniversary of the date of issuance.
(11)	Represents the unvested portion of 333 RSUs granted to Kevin Coveney on February 22, 2024, each of which represents the right to receive one share of Common Stock upon vesting. One-fourth of the RSUs will vest upon the one-year anniversary of the date of issuance. An additional one-thirty-sixth of the RSUs will vest each month following the first vesting date. Vesting is conditioned upon continued employment in the Company.
(5)	Represents the unvested portion of 10,500 RSUs granted to Dr. Facchini on October 13, 2021, each of which represents the right to receive one share of common stock upon vesting. On December 31, 2024, 5,250 RSUs in connection with this grant were forfeited to the Company for failure to satisfy certain performance conditions.
(11)	Represents the unvested portion of 555 RSUs granted to Kevin Coveney on October 9, 2024, each of which represents the right to receive one share of Common Stock upon vesting. One-fourth of the RSUs will vest upon the one-year anniversary of the date of issuance. An additional one-thirty-sixth of the RSUs will vest each month following the first vesting date. Vesting is conditioned upon continued employment in the Company.
(6)	Represents the unvested portion of 17,000 RSUs granted to Dr. Facchini on January 25, 2023, each of which represents the right to receive one share of common stock upon vesting. The RSUs shall vest over 4 years in equal annual installments, with the first tranche to vest on January 25, 2024.
(12)	Represents the unvested portion of 6,179 RSUs granted to Kevin Coveney on May 8, 2025, each of which represents the right to receive one share of Common Stock upon vesting. One-fourth of the RSUs will vest upon the one-year anniversary of the date of issuance. An additional one-thirty-sixth of the RSUs will vest each month following the first vesting date. Vesting is conditioned upon continued employment in the Company.
(7)	Represents the unvested portion of 50,000 RSUs granted to Dr. Facchini on February 22, 2024, each of which represents the right to receive one share of common stock upon vesting. One-fourth of the RSUs will vest upon the one-year anniversary of the date of issuance. An additional one-thirty-sixth of the RSUs will vest each month following the first vesting date. Any remaining RSUs will vest on the fourth anniversary of the date of issuance.
(13)	Represents the unvested portion of 40,198 RSUs granted to Kevin Coveney on December 23, 2025, each of which represents the right to receive one share of Common Stock upon vesting. One-fourth of the RSUs will vest upon the one-year anniversary of the date of issuance. An additional one-thirty-sixth of the RSUs will vest each month following the first vesting date. Vesting is conditioned upon continued employment in the Company.
(8)	Represents the unvested portion of 40,000 RSUs granted to Dr. Facchini on October 9, 2024, each of which represents the right to receive one share of common stock upon vesting. One-fourth of the RSUs will vest upon the one-year anniversary of the date of issuance. An additional one-thirty-sixth of the RSUs will vest each month following the first vesting date. Any remaining RSUs will vest on the fourth anniversary of the date of issuance.
(14)	The market value of the restricted stock unit awards is based on the closing price of our Common Stock of $3.63 per share at December 31, 2025.
(9)	Represents the unvested portion of 26,500 RSUs granted to Mr. Coveney on March 13, 2023, each of which represents the right to receive one share of common stock upon vesting. The RSUs shall vest over 4 years in equal annual installments, with the first tranche to vest on March 13, 2024.
(10)	Represents the unvested portion of 60,000 RSUs granted to Mr. Coveney on February 22, 2024, each of which represents the right to receive one share of common stock upon vesting. One-fourth of the RSUs will vest upon the one-year anniversary of the date of issuance. An additional one-thirty-sixth of the RSUs will vest each month following the first vesting date. Any remaining RSUs will vest on the fourth anniversary of the date of issuance.
(11)	Represents the unvested portion of 100,000 RSUs granted to Mr. Coveney on October 9, 2024, each of which represents the right to receive one share of common stock upon vesting. One-fourth of the RSUs will vest upon the one-year anniversary of the date of issuance. An additional one-thirty-sixth of the RSUs will vest each month following the first vesting date. Any remaining RSUs will vest on the fourth anniversary of the date of issuance.
(12)	The market value of the restricted stock unit awards is based on the closing price of our common stock of $0.358 per share at December 31, 2024.

70Policies and Practices Related to the Grant of Certain Equity Awards Close in Time to the Release of Material Nonpublic Information

Equity awards are discretionary and, are generally granted to our key employees and our named executive officers under the Incentive Plan. The Company does not time the disclosure of material nonpublic information for the purpose of affecting the value of executive compensation.

Potential Payments Upon Termination of Employment or Change in Control

None of our named executive officers has a contract in place for change in control payments.

The employment agreements of Joseph Tucker, Ph.D., Peter Facchini, Ph.D. and Kevin Coveney include provisions for severance pay equal to nine to twelve months of salary upon termination by the Company without cause, as defined in the employment agreements or termination by the employee for good reason, as defined in the employment agreements.

Each of our named executive officers have also been granted RSUs under the Incentive Plan, which are currently either fully vested or contain conditions providing for vesting upon change of control. Vested RSUs are eligible for conversion to an equivalent number of shares of Common Stock upon the first occurrence of a termination of employment for any reason other than a termination by the Company for cause or an event of change of control, and all unvested RSUs shall immediately vest upon the occurrence of a termination of employment by either the Company without cause, a termination of employment by the employee for good reason or an event of change of control, and provided the Company’s compliance with all terms and conditions of the Incentive Plan, including, without limitation, the availability of shares approved by the Company’s stockholders for such issuances.

Director Compensation

The following table presents the total compensation for each person who served as a non-employee director during the fiscal year ended December 31, ~~2024~~2025. Directors who are also employees are not compensated for their service on our Board.

Name	Fees earned or paid in cash ($) (1)		Stock awards ($) (2)			Option awards ($) (3)		Nonqualifed deferred compensation earnings ($)		All other compensation ($)		Total ($)
Name (a)	Fees earned or paid in cash ($) (b)(1)		Stock awards ($) (c)			Option awards ($) (d)		Non-equity incentive plan compensation ($) (e)		Change in pension value and nonqualified deferred compensation earnings (f)		All other compensation ($) (g)		Total ($) (h)
Sheila DeWitt, Ph.D.	$	30,473		11,667			-		-		-	$	42,140
George Kegler		59,000		35,646	(3)		-		-		-		-		94,646
George Kegler		59,000		20,000			-		-		-		79,000
Frank Pasqualone (2)		65,500		35,646	(4)		-		-		-		-		101,146
Frank Pasqualone		57,500		20,000			-		-		-		77,500
Marcus Schabacker		52,000		35,646	(5)		-		-		-		-		87,646
Marcus Schabacker, M.D., Ph.D.		56,000		20,000			-		-		-		76,000
Mike Webb		175,000		35,646	(6)		-		-		-		-		210,646
Michael Webb		175,000		20,000			-		-		-		195,000
Sheila DeWitt		48,000		35,646	(7)		-		-		-		-		83,646

(1)	For the fiscal year ended December 31, 2024, each individual that serves as a non-employee director was eligible to receive (paid pro-rata in quarterly installments) an annual cash retainer in the amount of $40,000, with additional cash fees as follows: (i) $15,000 for services as the chair of the Audit Committee and $7,500 for services as a member of the Audit Committee, (ii) $10,000 for services as the chair of the Compensation Committee and $5,000 for services as a member of the Compensation Committee; (iii) $8,000 for services as the chair of the Nominating and Governance Committee and $4,000 for services as a member of the Nominating and Governance Committee; and (iv) $8,000 for services as the chair of the Science and Technology Committee and $4,000 for services as a member of the Science and Technology Committee. The remainder represents additional cash fees paid in cash in lieu of stock awards to be granted to each non-employee director.
(2)	Each non-employee director received an award of restricted stock with a value of $20,000 for their service to the Company, with such valuation being based on the closing price per share of $0.419 on the grant date. Dr. DeWitt’s award was pro-rated commensurate with the time of her service on the Board for the year 2024. The restricted stock fully vests on the first anniversary of the date of grant.
(3)	No option awards were made to our non-employee directors during 2024, and no non-employee director held any unexercised options as of December 31, 2024.

(1) For the fiscal year ended December 31, 2025, each individual that serves as a non-employee director was eligible to receive (paid pro-rata in quarterly installments) an annual cash retainer in the amount of $40,000, with additional cash fees as follows: (i) $15,000 for services as the chair of the Audit Committee and $7,500 for services as a member of the Audit Committee, (ii) $10,000 for services as the chair of the Compensation Committee and $5,000 for services as a member of the Compensation Committee; (iii) $8,000 for services as the chair of the Nominating and Governance Committee and $4,000 for services as a member of the Nominating and Governance Committee; and (iv) $8,000 for services as the chair of the Science and Technology Committee and $4,000 for services as a member of the Science and Technology Committee.

71(2) Received an additional $8,000 as compensation in January, 2026, for becoming Chair of the Nominating and Governance Committee in 2025 which would have been paid in the normal course on December 31, 2025.

~~USE~~(3) Consisting of an aggregate of 7,633 restricted OFstock ~~PROCEEDS~~shares, valued at $35,646, with such valuation being based on the Company’s closing price per share of $4.67 on the grant date.

~~We estimate that the net proceeds from the offering will be approximately $[●] million, assuming a public offering price of $[●] per share of common stock and related warrants~~ (~~which~~4) isConsisting ~~equal to the last reported sale price per share~~ of ~~our~~an ~~common~~aggregate ~~stock on The Nasdaq Capital Market, on [●], 2025), and the sale~~ of ~~all the securities offered under this prospectus~~7,633 ~~after deducting the placement~~restricted ~~agent~~stock ~~fees and estimated offering expenses payable by us~~shares, ~~assuming~~valued noat ~~sale of any pre-funded warrants. However~~$35,646, ~~because~~with ~~this~~such isvaluation abeing ~~“best efforts”~~based ~~offering~~on ~~and there is no minimum offering amount required as a condition to~~ the ~~closing of this offering, the actual offering amount, the placement agent~~Company’s ~~fees~~closing ~~and net proceeds to us are not presently determinable and may be substantially less than the maximum amounts set forth on the cover page of this prospectus. The combined public offering~~ price per share ~~(or~~of ~~pre-funded warrant)~~$4.67 ~~and~~on ~~warrants will be fixed for~~ the ~~duration~~grant ~~of this offering~~date.

~~These estimates~~(5) ~~exclude~~Consisting ~~the proceeds, if any, from the exercise~~ of ~~warrants~~an ~~issued~~aggregate ~~in this offering. If all~~ of ~~the~~7,633 ~~warrants issued in this~~restricted ~~offering~~stock ~~were~~shares, tovalued ~~be exercised in cash~~ at ~~an exercise price of~~ $~~[●] per share of common stock~~35,646, wewith ~~would~~such ~~receive~~valuation ~~additional~~being ~~proceeds of~~based ~~approximately~~on ~~$[●] million. We cannot predict when or if these warrants will be exercised. It is possible that these warrants may expire and may never be exercised. Additionally,~~ the ~~warrants~~Company’s ~~contain~~closing aprice ~~cashless~~per ~~exercise~~share ~~provision that permit exercise~~ of ~~warrants~~$4.67 on ~~a cashless basis at any time where there is no effective registration statement under~~ the ~~Securities~~grant ~~Act covering the issuance of the underlying share~~date.

~~Each $1.00 increase~~ (~~decrease~~6) inConsisting ~~the~~of ~~assumed~~an ~~public~~aggregate ~~offering price~~ of ~~$[●]~~7,633 ~~per share (the last reported price for our common stock~~restricted asstock ~~reported~~shares, onvalued ~~The~~at ~~Nasdaq Capital Market on [●]) would change our net proceeds by~~ $~~[●] million~~35,646, ~~assuming~~with ~~the~~such ~~number~~valuation ofbeing ~~shares offered~~based ~~by us, as set forth~~ on the ~~cover~~Company’s ofclosing ~~this~~price ~~prospectus,~~per ~~remains~~share ~~the same and after deducting the placement agent fees and estimated offering expenses payable by us. We may also increase or decrease the number~~ of ~~shares we are offering~~$4. ~~An increase (decrease) of 100,000~~67 inon the ~~number~~grant of shares we are offering would increase (decrease) the net proceeds to us from this offering, after deducting the placement agent fees and estimated offering expenses payable by us, by approximately $[●] million, assuming the assumed public offering price stays the samedate.

~~We intend~~(7) toConsisting ~~use~~of ~~the~~an ~~net~~aggregate ~~proceeds~~of ~~for~~7,633 ~~product~~restricted stock ~~development~~shares, ~~working~~valued ~~capital~~at ~~and~~$35,646, ~~general~~with ~~corporate~~such ~~purposes~~valuation being based on the Company’s closing price per share of $4.67 on the grant date.

As of the date of this prospectus, we cannot specify with certainty all of the particular uses for the net proceeds to us from this offering. Accordingly, our management will have broad discretion in the application of these proceeds. Net offering proceeds not immediately applied to the uses summarized above will be invested in short-term investments such as money market funds, commercial paper, U.S. treasury bills and similar securities investments pending their use.77

~~DILUTION~~DESCRIPTION OF SECURITIES TO BE REGISTERED

IfThe ~~you~~following ~~invest~~summary inof ~~our~~the ~~securities~~material interms ~~this~~of ~~offering,~~our ~~your~~Common ~~interest~~Stock ~~will~~and bedescription ~~diluted~~of ~~immediately~~certain toof ~~the~~our ~~extent~~other ofsecurities ~~the~~is ~~difference~~not ~~between~~intended ~~the~~to be ~~public~~a ~~offering~~complete ~~price~~summary ~~paid~~of by the ~~purchasers~~rights and preferences of ~~the~~our ~~shares~~Common ofStock ~~common~~or ~~stock~~such ~~(and~~other ~~pre-funded~~securities. ~~warrants)~~We ~~and~~urge ~~related~~you ~~warrants~~to ~~sold~~read inour ~~this~~A&R Certificate ~~offering~~of ~~and~~Incorporation ~~the~~in asits ~~adjusted~~entirety ~~net~~for ~~tangible~~a ~~book~~complete ~~value~~description ~~per~~of ~~shares~~the rights and preferences of ~~common~~our ~~stock~~Common ~~after~~Stock. ~~this~~See ~~offering~~“Where You Can Find More Information.”

AsWe have authorized 120,000,000 shares of ~~September~~capital 30stock, ~~2024~~par value $0.01 per share, ~~our~~of ~~net~~which ~~tangible~~100,000,000 ~~book~~are ~~value~~shares ~~was~~of ~~$[●]~~Common ~~million,~~Stock orand ~~$[●]~~20,000,000 ~~per~~are ~~share~~shares of ~~common~~“blank check” preferred stock. ~~Net~~On ~~tangible~~December

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