As filed with the ~~U.S.~~ Securities and Exchange Commission on ~~May~~September 2729, 2025.

Registration No. 333-

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM S-1

REGISTRATION STATEMENT
UNDER THE SECURITIES ACT OF 1933

MEDICUS PHARMA LTD.

(Exact name of Registrant as specified in its charter)

______________________________

Ontario, Canada	2834	~~2834~~98-1778211	~~98-1778211~~
(State or other jurisdiction of		(Primary Standard Industrial	(I.R.S. Employer
(State or other jurisdiction of incorporation or organization)	(Primary Standard Industrial Classification Code Number)	(I.R.S. Employer Identification Number)
incorporation or organization)		Classification Code Number)	Identification Number)

300 Conshohocken State Rd., Suite 200
W. Conshohocken, PA 19428
Telephone: (610) 636-0184
(Address, including zip code, and telephone number, including area code, of
Registrant's principal executive offices)

Medicus Pharma Inc.300 Conshohocken State Road, Suite 200Conshohocken, PA 19428Telephone (610) 540-7515(Name, address, including zip code, and telephone number, including area code, of agent of service)

~~(Name~~Copies to: Christopher J. CummingsPaul, ~~address~~Weiss, ~~including~~Rifkind, ~~zip~~Wharton ~~code,~~& ~~and~~Garrison ~~telephone~~LLP1285 ~~number~~Avenue of the AmericasNew York, ~~including~~NY10019-6064Telephone: ~~area~~(212) ~~code~~373-3000Facsimile: (212) 757-3990 Aaron SonshineBennett Jones LLP3400 One First Canadian PlaceP.O. Box 130, ofToronto, ~~agent~~ONM5X of1A4Telephone: ~~service~~(416) 777-6448Facsimile: (416) 863-1716

Copies to:
Christopher J. CummingsPaul, Weiss, Rifkind, Wharton & Garrison LLPToronto-Dominion Centre77 King Street West, Suite 3100P.O. Box 226, Toronto, ON M5K 1J3Telephone: (416) 504-0520Facsimile: (416) 504-0530		Aaron Sonshine Bennett Jones LLP 3400 One First Canadian Place P.O. Box 130, Toronto, ON M5X 1A4 Telephone: (416) 777-6448Facsimile: (416) 863-1716		M. Ali Panjwani, Esq.Pryor Cashman LLP7 Times SquareNew York, NY 10036Telephone: (212) 421-4100

Approximate date of commencement of proposed sale to the public: From time to time after this Registration Statement becomes effective.

Approximate date of commencement of proposed sale to the public: As soon as practicable after this registration statement becomes 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, 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, 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 earliest 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, 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 Exchange Act.

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

If an emerging growth company that prepares its financial statements in accordance with U.S. GAAP, 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 hereby amends this Registration Statement on such date or dates as may be necessary to delay its effective date until the registrant shall file a further amendment which specifically states that this Registration Statement shall thereafter become effective in accordance with Section 8(a) of the Securities Act of 1933 or until the Registration Statement shall become effective on such date as the Commission, acting pursuant to said Section 8(a), may determine.

The information in this preliminary prospectus is not complete and may be changed. These securities may not be sold until the Registration Statement filed with the U.S. Securities and Exchange Commission is effective. This preliminary prospectus is not an offer to sell nor does it seek an offer to buy these securities in any jurisdiction where the offer or sale is not permitted.

Subject to Completion,dated ~~May~~September 2729, 2025

Preliminary Prospectus

~~1,375,000~~Up ~~UnitsConsisting~~to ~~of an Aggregate of~~ 1,~~375~~397,~~000~~184 Common ~~Sharesand1,375,000 Warrants to Purchase One Common Share~~Shares

1,375,000 Common Shares Issuable upon the Exercise of the Warrants

Medicus Pharma Ltd.

WeThis ~~are~~prospectus ~~offering~~relates onto athe ~~“best~~sale ~~efforts”~~from ~~basis~~time ~~1,375,000~~to ~~units~~time ~~(each,~~of aup ~~"Unit")~~to 1,397,184 ~~each Unit consisting of one~~ common ~~share~~shares of Medicus Pharma Ltd. (the "Company"~~, "we", "us"~~), no par value, ~~and one warrant to purchase one common share~~ (~~each, a "warrant") at an assumed public offering price of $7.29 per Unit, which was~~ the ~~closing price our~~ "common shares ~~on The Nasdaq Capital Market (“Nasdaq”~~") onby May 23, 2025, for an aggregate offering of 1,375,000 common shares and 1,375,000 warrants and gross proceeds of up to approximately $10 million. The public offering price per Unit will be determined between us and the ~~agent~~selling ~~(as~~shareholders ~~defined~~identified ~~below)~~in based on market conditions at the time of pricing, and may be at a discount to the then-current market price of our common shares. Therefore, the recent market price of our common shares referenced throughout this ~~preliminary~~ prospectus ~~may not be indicative of the final offering price per Unit. Each warrant is immediately exercisable for one of our common shares at an exercise price of $ per share~~ (~~or 100% of~~ the ~~price~~"Selling ~~of each Unit sold in the offering~~Shareholders") ~~and will expire five years from the date of issuance~~. The Units will not be certificated and the common shares and warrants comprising the Units are immediately separable and will be issued separately in this offering. Pursuant to this prospectus, we are also offering the 1,375,000 common shares issuable from time to time upon the exercise of the warrants offered hereby.

~~Our~~On ~~common~~August ~~shares~~29, ~~and~~2025, ~~public~~the ~~warrants,~~Company ~~with~~completed anits ~~exercise~~previously ~~price~~announced acquisition of ~~$4.64~~Antev ~~and~~Limited ~~expiration~~("Antev") ~~date~~pursuant to that certain definitive securities exchange agreement, dated as of ~~November~~June 1529, ~~2029~~2025 (as amended, the ~~“Public~~"Definitive ~~Warrants”~~Agreement"), ~~are~~by ~~listed~~and onamong ~~Nasdaq~~the Company, ~~under~~Antev ~~the~~and ~~symbols~~certain ~~"MDCX"~~securityholders ~~and~~of Antev (the "~~MDCXW,~~Antev Vendors"), ~~respectively~~pursuant to which the Company acquired 98.6% ~~The~~of ~~warrants~~the ~~offered~~issued ~~hereby~~and ~~will~~outstanding ~~not~~shares ~~trade~~of onAntev ~~any~~for Uaggregate consideration consisting of approximately $2.S.97 ~~securities~~million ~~exchange~~in cash and we1,603,164 ~~will~~common ~~not~~shares ~~apply~~of ~~for~~the ~~listing~~Company on(the ~~any~~"Consideration ~~U.S.~~Shares") ~~securities~~(the ~~exchange~~"Antev Transaction"). ~~Therefore,~~Certain ~~without~~of anthe ~~active~~Consideration ~~trading~~Shares ~~market~~are ~~for~~ the ~~warrants,~~securities registered under the ~~liquidity~~registration statement of ~~such~~which ~~warrants~~this ~~will~~prospectus beforms ~~limited~~a part.

~~The~~We ~~closing~~are ~~prices~~not selling any securities under this prospectus and will not receive any of the proceeds from the sale of our common shares by the Selling Shareholders. Information regarding the Selling Shareholders, the number of common shares that may be sold by them and ~~Public~~the ~~Warrants~~times onand ~~Nasdaq~~manner in which they may offer and sell the common shares under this prospectus is provided under the sections titled "Selling Shareholders" and "Plan of Distribution" on ~~May~~pages 23149 and 155, ~~2025~~respectively, ~~were~~of $7this prospectus.29 We have not been informed by the Selling Shareholders that they intend to sell their common shares offered by this prospectus and $2do not know when or in what amounts, if any, the Selling Shareholders may offer the common shares for sale.41 The Selling Shareholders may sell any, ~~respectively~~all, or none of the common shares offered by this prospectus.

~~The~~Neither ~~securities will be offered at a fixed price and are expected to be issued in a single closing. We expect this offering to be completed not later than one business day following~~ the ~~commencement~~Company ofnor ~~sales~~any inSelling ~~this~~Shareholders ~~offering~~have ~~(after~~any ~~the~~current ~~effective~~arrangements ~~date~~nor ofhave ~~the~~entered ~~registration~~into ~~statement~~any ofagreements ~~which this prospectus forms a part) and that we will deliver all securities to be issued in connection~~ with ~~this~~any ~~offering via delivery versus payment or receipt versus payment~~underwriters, asbroker-dealers ~~the case may be, upon receipt of investor funds received by us. Accordingly, neither we nor the agent have made any arrangements to place investor funds in an escrow account~~ or ~~trust~~selling ~~account~~agents ~~since~~for the ~~placement agent will not receive investor funds in connection with the~~ sale of the ~~securities~~common ~~offered~~shares ~~hereunder~~hereby registered.

We have engaged Maxim Group LLC (the “agent” or “Maxim”) to act as our exclusive placement agent in connection with this offering. The agent has agreed to use its reasonable best efforts to arrange for the sale of the securities offered by this prospectus. The agent is not purchasing or selling any of the securities we are offering and the 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 agent the fees set forth in the table below, which assumes that we sell all of the securities offered by this prospectus. There is no minimum offering requirement as a condition of closing of this offering. We may sell fewer than all of the Units offered hereby, which may significantly reduce the amount of proceeds received by us. Because there is no escrow account and no minimum number of securities or amount of proceeds, investors could be in a position where they have invested in us, but we have not raised sufficient proceeds in this offering to adequately fund the intended uses of the proceeds as described in this prospectus. All proceeds from this offering will become immediately available to us and may be used as they are accepted. Purchasers of the Units will not be entitled to a refund and could lose their entire investments. See “Risk Factors” for more information regarding risks related to this offering. We will bear all costs associated with the offering. This offering will terminate on August 16, 2025, unless we decide to terminate the offering (which we may do at any time in our discretion) prior to that date. See “Plan of Distribution” for more information regarding these arrangements.______________________________

WeOur ~~are~~common anshares ~~"emerging~~are ~~growth~~listed ~~company"~~on ~~and~~The aNasdaq ~~"smaller~~Capital ~~reporting~~Market ~~company~~(the "Nasdaq"), under ~~applicable~~the ~~U.S.~~symbol ~~Securities and Exchange Commission rules and will be eligible for reduced public company disclosure requirements~~"MDCX". ~~See~~The ~~"Prospectus~~closing ~~Summary-Implications~~price of ~~Being~~our ancommon ~~Emerging~~shares ~~Growth~~on ~~Company"~~Nasdaq ~~and~~on ~~"Prospectus~~September ~~Summary-Implications~~26, of2025 ~~Being~~was ~~a Smaller Reporting Company~~$2." 63.

~~____________________________~~We are an "emerging growth company" and a "smaller reporting company" under applicable U.S. Securities and Exchange Commission ("SEC") rules and will be eligible for reduced public company disclosure requirements. See "Prospectus Summary-Implications of Being an Emerging Growth Company" and "Prospectus Summary-Implications of Being a Smaller Reporting Company."

______________________________

Investing in our securities involves risks. See "Risk Factors" beginning on page 10 of this prospectus to read about factors you should consider before buying our securities.

	Per Unit	Total
Public offering price	$	$
Placement agent fees(1)	$	$
Proceeds, before expenses	$	$

Neither the SEC nor any state securities commission has approved or disapproved of these securities or determined if this prospectus is truthful or complete. Any representation to the contrary is a criminal offense.

~~(1) We have~~The ~~engaged~~date ~~Maxim Group LLC (the “agent”) to act as placement agent for this offering, in exchange for a fee~~ of ~~7.5% of the aggregate offering price of the Units sold in~~ this ~~offering.~~prospectus ~~We have also agreed to reimburse the agent for certain expenses. For additional agent compensation information~~is , ~~see "Plan of Distribution" on page 135.~~2025

Neither the U.S. Securities and Exchange Commission nor any state securities commission has approved or disapproved of these securities or determined if this prospectus is truthful or complete. Any representation to the contrary is a criminal offense.

The agent expects to deliver the common shares and warrants against payment as set forth under "Plan of Distribution" on or about , 2025.

____________________________

Maxim Group LLCThe date of this prospectus is , 2025

TABLE OF CONTENTS

CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING STATEMENTS	iii
PROSPECTUS SUMMARY	1
THE OFFERING	67
SELECTED HISTORICAL CONSOLIDATED FINANCIAL INFORMATION	8
RISK FACTORS	10
DIVIDEND POLICY	4346
CAPITALIZATION	44
USE OF PROCEEDS	47
USE OF PROCEEDS	45
MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS	48
MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS	46
OUR BUSINESS	59
OUR BUSINESS	53
MANAGEMENT	104
MANAGEMENT	91
SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT	130
SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT	115
RELATED PARTY TRANSACTIONS	132
RELATED PARTY TRANSACTIONS	117
DESCRIPTION OF SECURITIES	134
DESCRIPTION OF SECURITIES	119
CERTAIN MATERIAL U.S. FEDERAL INCOME TAX CONSIDERATIONS	143
CERTAIN MATERIAL U.S. FEDERAL INCOME TAX CONSIDERATIONS	126
SELLING SHAREHOLDERS	149
PLAN OF DISTRIBUTION	~~135~~155
EXPERTS AND LEGAL MATTERS	~~140~~157
ENFORCEMENT OF CIVIL LIABILITIES	~~140~~158
WHERE YOU CAN FIND MORE INFORMATION	~~140~~159
INDEX TO FINANCIAL STATEMENTS	F-1

Neither we nor the ~~agent~~Selling ~~has~~Shareholders have authorized anyone to provide any information or to make any representations other than the information contained in this prospectus, any amendment or supplement to this prospectus or in any free writing prospectus prepared by or on behalf of us or to which we may have referred you. We and the ~~agent~~Selling Shareholders take no responsibility for, and can provide no assurance as to the reliability of, any other information that others may give you. We and the ~~agent~~Selling Shareholders have not authorized any other person to provide you with different or additional information. Neither we nor the ~~agent~~Selling isShareholders are making an offer to sell ~~the~~securities ~~common shares or the warrants~~ in any jurisdiction where the offer or sale is not permitted. This offering is being made in the United States and elsewhere solely on the basis of the information contained in this prospectus. You should assume that the information appearing in this prospectus is accurate only as of the date on the front cover of this prospectus, regardless of the time of delivery of this prospectus or any sale of the ~~common shares or the warrants~~securities. Our business, financial condition, results of operations and prospects may have changed since the date on the front cover of this prospectus. This prospectus is not an offer to sell or the solicitation of an offer to buy ~~the~~securities ~~common shares or the warrants~~ in any circumstances under which such offer or solicitation is unlawful.

For investors outside the United States: Neither we nor the ~~agent~~Selling ~~has~~Shareholders have done anything that would permit this offering or the possession or distribution of this prospectus in any jurisdiction where action for those purposes is required, other than in the United States. Persons outside the United States who come into possession of this prospectus must inform themselves about, and observe any restrictions relating to, this offering of ~~Units~~securities and the distribution of this prospectus outside the United States.

Unless the context otherwise requires, in this prospectus, the term(s) "we", "us", "our", "Company", "our company", "Medicus," and "our business" refer to Medicus Pharma Ltd. and our subsidiaries.

MARKET, INDUSTRY AND OTHER DATA

This prospectus contains estimates, projections and other information concerning our industry, our business, and the markets for our products. Information that is based on estimates, forecasts, projections, market research or similar methodologies is inherently subject to uncertainties, and actual events or circumstances may differ materially from events and circumstances that are assumed in this information. Unless otherwise expressly stated, we obtained this industry, business, market and other data from our own internal estimates and research as well as from reports, research surveys, studies and similar data prepared by market research firms and other third parties, industry, medical and general publications, government data, and similar sources that we believe to be reasonable and reliable.

In addition, assumptions and estimates of our and our industry's future performance are necessarily subject to a high degree of uncertainty and risk due to a variety of factors, including those described in "Risk Factors." These and other factors could cause our future performance to differ materially from our assumptions and estimates. See "Cautionary Statement Regarding Forward-Looking Statements."

TRADEMARKS AND TRADE NAMES

We own or have rights to certain trademarks that we use in conjunction with the operations of our business. Each trademark, trade name, service mark or copyright of any other company appearing or incorporated by reference in this prospectus belongs to its holder. Solely for convenience, trademarks, trade names, service marks and copyrights referred to in this prospectus may appear with or without the "©", "®" or "™" symbols, but the inclusion, or not, of such references are not intended to indicate, in any way, that we, or the applicable owner, will not assert, to the fullest extent possible under applicable law, our or their, as applicable, rights to these trademarks, trade names service marks or copyrights. We do not intend our use or display of other companies' trademarks, trade names, service marks or copyrights to imply a relationship with, or endorsement or sponsorship of us by, such other companies.

PRESENTATION OF FINANCIAL INFORMATION

Unless otherwise indicated, the consolidated financial statements and related notes included in this prospectus have been prepared in accordance with generally accepted accounting principles in the United States ("GAAP"). Our functional currency is U.S. dollars.

EXCHANGE RATE INFORMATION

In this prospectus, all dollar amounts referenced, unless otherwise indicated, are expressed in U.S. dollars and are referred to as "$". Canadian dollars are referred to as "C$". The following table sets out, for the periods indicated, the high, low, and period end indicative rates of exchange for $1.00 expressed in Canadian dollars as published by the Bank of Canada:

	Period endedMarch 31, 2025(C$)	Year endedDecember 31, 2024(C$)	Year endedDecember 31, 2023(C$)
	Six months endedJune 30, 2025(C$)	Year endedDecember 31, 2024(C$)	Year endedDecember 31, 2023(C$)
As at end of period	1.~~4376~~3643	1.4389	1.3226
Low for the period	1.~~4166~~3558	1.3316	1.3128
High for the period	1.4603	1.4416	1.3875
Average rate for the period	1.~~4352~~4094	1.3698	1.3497

~~On May 23, 2025, the daily average exchange rate for Canadian dollars in terms of the U.S. dollar, as quoted by the Bank of Canada, was $1.00 = C$1.3756.~~ii

On September 26, 2025, the daily average exchange rate for Canadian dollars in terms of the U.S. dollar, as quoted by the Bank of Canada, was $1.00 = C$1.3882.

CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING STATEMENTS

This prospectus includes forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, included in this prospectus regarding our strategy, future operations, regulatory process, future financial position, future revenue, projected costs, prospects, plans, objectives of management and expected market growth are forward-looking statements. The words "believe", "anticipate", "intend", "expect", "target", "goal", "estimate", "plan", "assume", "may", "will", "predict", "project", "would", "could" and similar expressions or the negative of such terms are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words.

The forward-looking statements in this prospectus include, but are not limited to, statements about:

• our financial results, including our ability to continue as a going concern, generate earnings and achieve and sustain profitability, which may vary significantly from forecasts and from period to period;
• the progress, timing and completion of our research, development and preclinical studies and clinical trials for our products and product candidates;
~~• the~~our ~~entry~~ability ~~into~~to ~~definitive~~successfully ~~agreements~~integrate ~~with~~Antev ~~respect~~into toour ~~the~~business ~~Antev~~and ~~Transaction~~operations, successfully develop Teverelix (as defined ~~below~~herein), ~~the~~and ~~consummation~~realize of the ~~Antev~~benefits ~~Transaction~~currently ~~and~~anticipated from the ~~expected timing thereof~~transaction;
• our ability to market, commercialize, achieve market acceptance for and sell our products and product candidates;
• our ability to develop, manage and maintain our direct sales and marketing organizations;
• our estimates regarding anticipated operating losses, future revenues, capital requirements and our needs for additional financing;
• market risks regarding consolidation in the healthcare, pharmaceutical and biotech/life sciences industry;
• the willingness of healthcare providers to purchase our products if coverage, reimbursement and pricing from third party payors for procedures using our products significantly declines;
• our ability to adequately protect our intellectual property and operate our business without infringing upon the intellectual property rights of others;
• the fact that product quality issues or product defects may harm our business;
• any product liability claims; and
• the regulatory, legal and certain operating risks that our operations subject us to.

We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements we make. We have included important factors in the cautionary statements included in this prospectus, particularly the factors described in the "Risk Factors" section of this prospectus, that 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 that we may make.

iii

You should read this prospectus and the documents that we have filed as exhibits to the registration statement of which this prospectus is a part, completely and with the understanding that our actual future results may be materially different from what we expect. We have based these forward-looking statements on our current expectations and projections about future events. These forward-looking statements are subject to risks, uncertainties and assumptions about us, including those listed in the sections of this prospectus entitled "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" and elsewhere in this prospectus.

iii

Any forward-looking statement made by us in this presentation is based on information currently available to us and speaks only as of the date on which it is made. We do not assume any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

PROSPECTUS SUMMARY

This summary highlights selected information contained elsewhere in this prospectus and is qualified in its entirety by the more detailed information and consolidated financial statements and the related notes thereto included elsewhere in this prospectus. This summary does not contain all the information you should consider before investing in our securities. You should read this entire prospectus carefully, including "Risk Factors," "Management's Discussion and Analysis of Financial Condition and Results of Operations," and our consolidated financial statements and the related notes thereto included elsewhere in this prospectus, before making an investment decision.

Overview

Our Company

We are a ~~biotech/~~clinical-stage, multi-strategy, life ~~sciences~~science and biotech company focused on investing in and accelerating the clinical development programs of novel and disruptive therapeutic assets. Currently, we are developing ~~one~~two ~~product~~products, SkinJectTM (~~the~~ "~~Product~~SkinJectTM"), with an indication for basal cell carcinoma, and Teverelix trifluoroacetate ("Teverelix", and together with SkinJectTM, the "Products").

Through our wholly owned subsidiary, SkinJect, Inc. ("SkinJect"), we focus on the development of our in-licensed drug device combination product using novel dissolvable microneedle arrays for the treatment of non-melanoma skin cancers. Our combination product candidate is a doxorubicin tip-loaded D-MNA filed with the U.S. Food and Drug Administration (the "FDA") under an Investigational New Drug Application and is regulated by the Center for Drug Evaluation and Registration (“"CDER”"), Oncology Division.

Prior to the Company's acquisition of SkinJect, our business was undertaken by SkinJect as a stand-alone entity. References to our business as conducted at a date prior to the completion of the Business Combination (as defined below) relate to the business undertakings of SkinJect.

For information on the Business Combination, see "Corporate History and Information."

We are subject to significant risks and uncertainties, including those related to our limited operating history, our lack of historical earnings, and the fact that the ~~Product~~Products isare a novel ~~technology~~technologies for which regulatory approval might not be achieved. For more information, see "Risk Factors."

Our Strategy

Our principal purpose is to advance the clinical development program of the ~~Product~~Products, which include SkinJectTM a novel, minimally invasive treatment for basal cell carcinoma and potentially other common forms of non-melanoma skin cancer and Teverelix, a next generation gonadotrophin-releasing hormone ("GnRH") antagonist that is a potentially first in market product for cardiovascular high-risk prostate cancer patients and patients with first acute urinary retention ("AUR") episodes due to enlarged prostate. We also seek to opportunistically identify, evaluate and acquire accretive assets, properties or businesses.

~~The~~SkinJectTM ~~Product~~ is considered an Investigational New Drug ("IND") by the FDA. In January 2024, we submitted to the FDA a Phase 2 IND clinical protocol to non-invasively treat basal cell carcinoma of the skin using the Product. The clinical protocol was updated in July 2024.

We may also trial ~~the~~SkinJectTM ~~Product~~ on other forms of skin cancer beyond basal cell carcinoma. Specifically, it may be trialed against squamous cell carcinoma, cutaneous T-cell lymphoma, as well as pre-cancerous lesions, among other clinical indications, subject to the Company having the capital resources available to do so, without any need to amend or expand the scope of the Company's existing licenses.

In addition, our business strategy includes the opportunistic acquisition of other accretive clinical stage life sciences and biotechnology companies. For example, in August 2025, we acquired 98.6% of the issued and outstanding shares of Antev, a UK-based late clinical-stage drug development company which is developing Teverelix.

For additional information regarding the business of the Company and the regulatory environment in which it operates, please refer to the prospectus under the heading "Our Business."

For additional information regarding the business of the Company and the regulatory environment in which it operates, please refer to the prospectus under the heading "Our Business."

Our Strengths

Our key competitive strengths include:

• A senior management team, led by Dr. Raza Bokhari, that has deep experience in medicine and pharmaceutical science as well as a proven track record in business development and entrepreneurship.
• Successful completion of a Phase 1 study of ~~the Product~~SkinJectTM.
• Potential to treat a range of other common non-melanoma skin cancers as well as pre-cancerous lesions.

Summary Risk Factors

Investing in our securities involves risk. Our ability to execute our strategy is also subject to certain risks. The risks described in "Risk Factors" in this prospectus may cause us to not realize the full benefits of our strengths or may cause us to be unable to successfully execute all or part of our strategy. Some of the more significant risks include the following:

• our financial results, including our ability to generate earnings and achieve and sustain profitability (as of ~~March~~June 3130, 2025, we had an accumulated deficit of approximately $3440.02 million, which was comprised of approximately $12.4 million of accumulated deficit of SkinJect as of September 30, 2023, the day after it became a subsidiary of the Company, and approximately $27.8 million of deficit accumulated by the Company on a consolidated basis since September 30, 2023), may vary significantly from forecasts and from period to period;
• the progress, timing and completion of our research, development and preclinical studies and clinical trials for our products and product candidates
• we may not ~~complete~~successfully ~~the~~integrate Antev ~~Transaction~~into orour ~~may~~business beand ~~delayed~~operations inor ~~completing~~successfully ~~the~~develop ~~Antev Transaction~~Teverelix;
• our ability to market, commercialize, achieve market acceptance for and sell our products and product candidates, our ability to develop, manage and maintain our direct sales and marketing organizations;
• our ability to continue as a going concern and if we are unable to obtain additional financing from outside sources and/or eventually generate enough revenues, we may be forced to curtail or discontinue our operations;
• our estimates regarding anticipated operating losses, future revenues, capital requirements and our needs for additional financing;
• market risks regarding consolidation in the healthcare, pharmaceutical and biotech/life sciences industry;
• the willingness of healthcare providers to purchase our products if coverage, reimbursement and pricing from third party payors for procedures using our products significantly declines;
• our ability to adequately protect our intellectual property and operate our business without infringing upon the intellectual property rights of others;

• the fact that product quality issues or product defects may harm our business, any product liability claims; and

• the regulatory, legal and certain operating risks that our operations subject us to.

Please see "Risk Factors" for a discussion of these and other factors you should consider before making an investment in our securities.

the fact that product quality issues or product defects may harm our business, any product liability claims; and
the regulatory, legal and certain operating risks that our operations subject us to.

Please see "Risk Factors" for a discussion of these and other factors you should consider before making an investment in our securities.

Corporate Structure

An organizational chart showing our basic corporate structure is set forth below (~~both~~SkinJect ~~subsidiaries~~and Medicus Pharma Inc. are 100% owned and Antev is 98.6% owned by Medicus Pharma Ltd.):

Corporate History and Information

Our company (formerly, Interactive Capital Partners Corporation) was incorporated pursuant to the Business Corporations Act (Ontario) on April 30, 2008 under the name Interactive Capital Partners Corporation. Prior to the Business Combination (as defined below), the Company existed as a shell company and had no business operations.

On September 29, 2023, the Company completed a business combination (the "Business Combination") with SkinJect, a company existing under the laws of Pennsylvania. The Business Combination was completed pursuant to a business combination agreement dated May 12, 2023, as amended, among the Company, SkinJect and RBx Capital, LP ("RBx"), an investment entity owned and managed by Dr. Raza Bokhari, and resulted in a reverse takeover of Interactive Capital Partners Corporation (the Company as it existed prior to the Business Combination) by the former shareholders of SkinJect, with SkinJect becoming a wholly owned operating subsidiary of the Company, and the Company being renamed "Medicus Pharma Ltd." The structure of the Business Combination is commonly used by companies seeking to become reporting issuers in Canada, as it allows the combined entity to be listed on the TSX Venture Exchange (the "TSXV") at relatively low cost while completing a concurrent equity financing. SkinJect and RBx structured the Business Combination as a reverse takeover for these reasons.

On October 11, 2023, the Company (as it exists after the Business Combination) commenced trading on the TSXV. On November 15, 2024, we completed our initial public offering in the United States and our common shares and our outstanding public warrants to purchase common shares, issued as a component of the units sold by the Company in its U.S. initial public offering with an exercise price of $4.64 and expiration date of November 15, 2029 (the "Public Warrants"), began trading on Nasdaq under the symbols "MDCX" and "MDCXW", respectively. Effective on February 21, 2025, the Company's common shares were voluntarily delisted from the TSXV. The common shares continue to be listed on Nasdaq. ~~Regulation A Offering~~

On March 10, 2025, the Company completed an offering of 1,490,000 units at $2.80 per unit pursuant to Tier II of Regulation A under the Securities Act, with each unit consisting of one common share and one warrant, each warrant with an exercise price of $2.80 and an expiration date of March 10, 2030 (the “Regulation A Warrants” and, together with the warrants and the Public Warrants, the “Warrants”). The aggregate gross proceeds to the Company from the Offering were $4,172,000.3

The Company's registered and head office is located at One First Canadian Place, 100 King Street West, Suite 3400, Toronto, Ontario M5X 1A4, Canada.

We lease U.S. office space in Conshohocken, Pennsylvania to operate the businesses of our U.S. subsidiaries, Medicus Pharma Inc. and SkinJect, Inc. We also lease office space in Weybridge, U.K. to operate the business of our subsidiary Antev.

Our website address is www.medicuspharma.com. Information contained on our website is not incorporated by reference into this prospectus, and you should not consider information contained on our website to be part of this prospectus or in deciding whether to purchase our securities.

3Recent Developments

~~Recent~~Antev ~~Developments~~Acquisition

On April 2126, 2025, the Company ~~announced~~signed ~~that~~a binding letter of intent to acquire Antev, a UK-based late clinical-stage drug development company. On June 29, 2025, the ~~Institutional~~Company, ~~Review~~Antev ~~Board~~and ~~approved~~the Antev Vendors entered into the ~~increase~~Definitive inAgreement pursuant to which the ~~number~~Company agreed to acquire all of ~~patients~~the issued and outstanding shares of Antev, on a fully diluted basis, in ~~its~~exchange ~~SKNJCT-003~~for ~~Phase~~up to 2,666,600 ~~clinical~~of ~~study~~the ~~from~~Company's 60common shares or certain cash consideration pursuant to 90a "tag offer". ~~The~~In ~~clinical~~addition ~~study~~to ~~will~~resale ~~expand~~restrictions ~~from~~prescribed ~~the~~under ~~nine~~applicable ~~clinical~~securities ~~sites~~law, incommon ~~the~~shares ~~United~~issued ~~States~~to Antev Vendors will be subject to ~~include~~a staggered lock-up and an ~~additional~~agreement ~~site~~granting certain voting rights in favor of management of the ~~United~~Company ~~States~~for 36 months. Upon the achievement of certain milestones related to potential future FDA Phase 2 and ~~two~~New ~~clinical~~Drug ~~trial~~Administration ~~sites~~approvals, as more particularly described in ~~Europe.~~the ~~The~~Definitive ~~Company~~Agreement, ~~also~~the ~~announced~~Antev ~~that~~Vendors itwill ~~has~~be ~~randomized~~entitled ~~more~~to ~~than~~receive 45up ~~participants~~to approximately $65 million in ~~the~~additional ~~study~~contingent ~~and~~consideration. This prospectus is part of the registration statement filed on ~~track~~Form toS-1 ~~submit~~pursuant to the ~~package~~Definitive ~~seeking~~Agreement ato ~~Type~~register Cfor ~~meeting~~resale ~~with~~by the ~~FDA~~Selling ~~before~~Shareholders of certain of the ~~end~~Consideration Shares from time to time. The foregoing description of the ~~second~~Definitive ~~quarter~~Agreement does not purport to be complete and is qualified in its entirety by reference to the full text of ~~2025~~the Definitive Agreement, which is filed as Exhibit 2.4 hereto and is incorporated herein by reference.

OnThe ~~April~~Antev ~~26,~~Transaction ~~2025,~~was ~~the~~completed ~~Company~~on ~~signed~~August a29, ~~binding letter of intent to acquire Antev Ltd. (“Antev”)~~2025, ~~a UK-based late clinical-stage drug development company. The Company is negotiating a definitive agreement~~ with ~~Antev pursuant to which,~~ the Company ~~will~~acquiring ~~acquire~~98.6% ~~all~~of ~~issued~~the ~~and~~Antev ~~outstanding~~ shares offor ~~Antev~~aggregate onconsideration aconsisting ~~fully~~of ~~diluted~~approximately ~~basis,~~$2.97 million in ~~exchange~~cash ~~for~~and 21,~~666~~603,~~600~~164 ~~(or~~common ~~approximately~~shares ~~19% in aggregate as~~ of the ~~date of the letter of intent) of the~~ Company’s. ~~issued~~Pursuant ~~and~~to ~~outstanding common shares (~~the “Antev Transaction~~”).~~, Inthe ~~addition~~Company tois ~~resale~~now ~~restrictions~~developing ~~prescribed under applicable securities law~~Teverelix, ~~any~~a ~~shares~~next ~~issued~~generation toGnRH ~~Antev~~antagonist, ~~shareholders will be subject to~~ a ~~9-month~~potentially ~~staggered~~first ~~lock-up and an agreement granting certain voting rights~~ in ~~favor~~market ofproduct ~~management~~for ofhigh-risk ~~the~~prostate ~~Company~~cancer ~~for~~patients 36and ~~months.~~patients ~~Antev~~with ~~shareholders~~first ~~will~~AUR beepisodes ~~entitled~~due to ~~receive~~enlarged upprostate. toTeverelix ~~$65~~is ~~million~~a inlong-acting ~~additional~~GnRH ~~contingent consideration~~antagonist. ~~The~~Unlike ~~Antev~~GnRH ~~Transaction~~agonists, iswhich ~~expected~~can tocause ~~close~~an byinitial ~~the~~surge ~~end~~in oftestosterone ~~June 2025~~levels, ~~subject~~Teverelix todirectly ~~the~~suppresses ~~completion~~sex ofhormone ~~satisfactory~~production ~~due~~without ~~diligence~~this ~~by Medicus~~surge, ~~negotiation~~potentially ofreducing ~~definitive~~cardiovascular ~~agreements,~~risks. ~~obtaining~~This ~~applicable~~mechanism ~~corporate,~~is ~~regulatory~~particularly ~~and~~beneficial ~~other~~for ~~third-party~~patients ~~approvals~~with ~~and~~existing ~~the~~cardiovascular ~~fulfillment of customary closing~~ conditions. No assurances can be made that ~~the~~we ~~parties~~ will successfully ~~negotiate~~integrate ~~and~~Antev ~~enter~~ into aour ~~definitive~~business ~~agreement,~~and oroperations ~~that the Antev Transaction will be consummated on the terms~~ or ~~timeframe~~successfully ~~currently~~develop ~~contemplated, or at all~~Teverelix.

~~Antev~~See is"Risk ~~developing~~Factors-We ~~Teverelix~~may ~~trifluoroacetate~~not ~~(“Teverelix”),~~successfully aintegrate ~~next~~Antev ~~generation~~into ~~GnRH~~our ~~antagonist, a~~business ~~potentially first in market product for high-risk prostate cancer patients~~ and ~~patients~~operations ~~with~~or ~~first~~successfully ~~acute~~develop ~~urinary retention (AUR) episodes due to enlarged prostate.~~ Teverelix ~~is a long-acting gonadotrophin-releasing hormone (GnRH) antagonist~~. Unlike GnRH agonists, which can cause an initial surge in testosterone levels, Teverelix directly suppresses sex hormone production without this surge, potentially reducing cardiovascular risks. This mechanism is particularly beneficial for patients with existing cardiovascular conditions."

~~See~~Warrant ~~“Risk~~Inducement ~~Factors—We may not complete the Antev Transaction or may be delayed in completing the Antev Transaction.”~~Agreement

On ~~May~~July 2214, 2025, ~~the~~we ~~Company~~entered ~~announced~~into ~~that~~a itwarrant ~~has~~inducement ~~received~~agreement ~~study~~with Armistice ~~may~~Capital ~~proceed~~Master ~~approval~~Fund ~~from~~Ltd. ("Armistice") (the ~~United~~"Warrant ~~Arab~~Inducement ~~Emirates~~Agreement"), ~~Department~~pursuant ofto ~~Health~~which Armistice agreed to ~~commence~~exercise ~~Phase~~existing warrants to purchase up to 1,340,000 of the Company's common shares issued on March 10, 2025 with an exercise price of $2.80 ~~clinical~~per ~~study~~Common Share (~~SKNJCT-004~~the "Regulation A Warrants"), in consideration for receiving the 2,680,000 warrants to ~~non-invasively~~purchase ~~treat~~common ~~BCC~~shares with an exercise price of $3.75 (the ~~skin~~"Private Warrants"). In accordance with the Warrant Inducement Agreement, Armistice exercised its Regulation A Warrants for cash, for gross proceeds of $3,752,000 to the Company.

On May 2, 2025, the Company entered into a securities purchase agreement (the “Purchase Agreement”) with Yorkville (as defined herein) in connection with the issuance and sale by the Company of debentures (the "Debentures") issuable in an aggregate principal amount of up to $5,000,000. Yorkville purchased and the Company issued a Debenture in the aggregate principal amount of $1,250,000 upon the signing of the Purchase Agreement, for net proceeds to the company of $1,125,000. An additional $3,750,000 is available to the Company in accordance with the Purchase Agreement at the Company’s election and upon the achievement of certain triggers. The Debentures are guaranteed by each of the Company’s subsidiaries pursuant to a global guaranty agreement (the “Guaranty”). Interest will accrue on the outstanding principal amount of each Debenture at an annual rate of 8.00%, subject to a potential increase to 18.00% per annum upon the occurrence of certain events of default. The Debentures will mature on February 2, 2026. The foregoing descriptions of the Purchase Agreement, Guaranty and Debentures do not purport to be complete and are qualified in their entirety by reference to the full text of such documents, and with respect to the Debentures, a form thereof, which are filed as exhibits hereto and are incorporated herein by reference.4

~~Implications~~Other ofCorporate ~~Being an Emerging Growth Company~~Updates

AsOn aMay ~~company~~22, ~~with~~2025, ~~less~~the ~~than~~Company ~~$1.235~~announced ~~billion~~that init ~~revenues~~has ~~during~~received ~~our~~study ~~last~~may ~~fiscal~~proceed ~~year,~~approval wefrom ~~qualify~~the asUnited anArab ~~"emerging~~Emirates ~~growth~~Department ~~company"~~of asHealth ~~that~~to ~~term~~commence isPhase ~~defined~~2 inclinical ~~the~~study ~~Jumpstart~~(SKNJCT-004) ~~Our~~to ~~Business~~non-invasively ~~Startups~~treat ~~Act~~basal ofcell ~~2012~~carcinoma (~~the~~ "~~JOBS Act~~BCC"). ~~As an emerging growth company we expect to take advantage~~ of ~~specified~~the ~~reduced reporting requirements that are otherwise applicable generally to public companies~~skin. ~~These reduced reporting requirements include, but are not limited to:~~

~~• not~~On ~~being~~June ~~required~~23, 2025, the Company announced the appointment of Andrew Smith, age 57, to ~~comply~~serve ~~with~~as the ~~auditor~~Company's ~~attestation~~Chief ~~requirements~~Operating ofOfficer ~~Section~~("COO"). ~~404~~Mr. ofSmith first joined the ~~Sarbanes-Oxley~~Company ~~Act~~as ofa ~~2002~~consultant on May 27, 2025 and transitioned to his new role as ~~amended~~COO ~~("Sarbanes-Oxley~~on ~~Act");~~June 30, 2025.

~~• reduced~~On ~~disclosure~~July ~~about~~29, ~~our~~2025, ~~executive~~the ~~compensation~~Company ~~arrangements~~and Deloitte LLP ("Deloitte") entered into an engagement letter whereby Deloitte was appointed as the exclusive lead financial adviser to the Company for the purpose of finding one or more partners for an out-licensing transaction for D-MNA for the treatment of BCC in ~~our~~adults, ~~periodic~~whether ~~reports~~by license, ~~proxy~~option, ~~statements~~or ~~and~~other ~~registration~~agreed ~~statements;~~structure ~~and~~or mechanism.

~~• an~~On ~~exemption~~August ~~from~~4, 2025, the ~~requirements~~Company toannounced ~~obtain~~that it entered into a non-binding ~~advisory~~memorandum ~~vote~~of understanding with Helix Nanotechnologies Inc. ("HelixNano"), a Boston-based biotech company focused on ~~executive~~developing ~~compensation~~an oradvanced ~~stockholder~~mRNA ~~approval~~platform to create vaccines and therapies to augment the immune system's power to fight disease, with the aim of ~~any~~forming ~~golden~~a ~~parachute~~joint ~~arrangements~~venture for the co-development and commercialization of thermostable mRNA-based vaccines utilizing each company's respective proprietary technologies. In parallel with such ongoing negotiations, Medicus and HelixNano have formalized their mutual intent to collaborate on the research, development and production of a batch of clinical-grade mRNA vaccine-loaded MNAs, which are intended for use in a Phase 1 clinical bridging study to compare the safety and preliminary efficacy of intramuscular injection vs. intradermal MNA delivery of HelixNano's vaccine candidate HN-0001, through the proposed joint venture.

WeOn ~~may~~August ~~take~~21, ~~advantage~~2025, ~~of these provisions until~~ the ~~last~~Company ~~day~~announced ofthat ~~our fiscal year following~~ the ~~fifth~~FDA ~~anniversary~~accepted of the ~~completion~~Company’s ofType ~~this~~C ~~offering.~~Meeting ~~However,~~request ifto ~~certain~~formally ~~events~~discuss ~~occur prior to~~ the ~~end of such five~~D-~~year~~MNA ~~period,~~product ~~including~~development ifand wegain ~~become~~further aalignment ~~"large~~on ~~accelerated~~the ~~filer,"~~clinical ~~our annual gross revenues exceed $1~~pathway.~~235~~ ~~billion~~In orSeptember we2025, ~~issue~~the ~~more~~FDA ~~than~~provided $1written ~~billion~~responses ofto ~~non-convertible~~the ~~debt~~Company’s inqueries, ~~any~~and ~~three-year~~agreed ~~period,~~that wethe ~~will~~Company ~~cease~~can torely beon anthe ~~emerging~~505(b)(2) ~~growth~~regulatory ~~company~~pathway ~~prior~~ to ~~the~~treat ~~end~~BCC ofusing ~~such five~~D-~~year period~~MNA.

~~The~~On ~~JOBS~~September ~~Act~~8, ~~provides~~2025, ~~that~~the anCompany ~~emerging~~announced ~~growth~~that ~~company~~its ~~can~~SKNJCT-004 ~~take~~phase ~~advantage~~2 ofclinical ~~an extended transition period for complying with new or revised accounting standards. As an emerging growth company~~study, ~~we intend~~ to ~~take~~non-invasively ~~advantage~~treat ofBCC ~~an extended transition period for complying with new or revised accounting standards as permitted by the JOBS Act. We have elected to take advantage~~ of ~~certain of~~ the reduced disclosure obligations in this prospectus and in the registration statement of which this prospectus is a part and may elect to take advantage of other reduced reporting requirements in future filings. As a resultskin, ~~the~~has ~~information~~commenced inpatient ~~this~~recruitment ~~prospectus and that we provide to our shareholders~~ in ~~the~~Cleveland ~~future~~clinic ~~may~~Abu ~~be different than what you might receive from other public reporting companies in which you hold equity interests~~Dhabi.

4On September 12, 2025, the Company announced that James Quinlan, Chief Financial Officer of the Company, will be taking a medical leave of absence from the Company commencing on such date and that Carolyn Bonner was appointed as acting Chief Financial Officer of the Company in addition to maintaining her current role as President of the Company.

~~Implications~~On September 17, 2025, the Company entered into a securities purchase agreement (the "Purchase Agreement") with Yorkville (as defined herein) in connection with the issuance and sale by the Company of ~~Being~~a debenture (the "Debenture") in the principal amount of $8.0 million. The Company used a ~~Smaller~~portion ~~Reporting~~of the proceeds from the issuance of the Debenture to fully satisfy and discharge the approximately $1.7 million remaining outstanding balance of the $5.0 million aggregate principal amount of debentures that Yorkville purchased from the Company in May and June 2025 pursuant to a purchase agreement dated May 2, 2025. The Debenture is guaranteed by each of the Company's subsidiaries pursuant to a global guaranty agreement (the "Guaranty"). Interest will accrue on the outstanding principal amount of the Debenture at an annual rate of 8.00%, subject to a potential increase to 18.00% per annum upon the occurrence of certain events of default. The Debenture will mature on September 17, 2026. The foregoing descriptions of the Purchase Agreement, Guaranty and Debenture do not purport to be complete and are qualified in their entirety by reference to the full text of such documents, which are filed as exhibits hereto and are incorporated herein by reference.

~~Additionally,~~Implications ~~we are a "smaller reporting company," meaning that the market value~~ of ~~our~~Being ~~common~~an ~~shares~~Emerging ~~held~~Growth by non-affiliates plus the proposed aggregate amount of gross proceeds to us as a result of this transaction is less than $700 million and our annual revenue is less than $100 million during the most recently completed fiscal year. As such, we are eligible for exemptions from various reporting requirements applicable to other public companies that are not smaller reporting companies, including, but not limited to, reduced disclosure obligations regarding executive compensation. We may continue to be a smaller reporting company as long as either (i) the market value of our common shares held by non-affiliates is less than $250 million or (ii) our annual revenue is less than $100 million during the most recently completed fiscal year and the market value of our common shares held by non-affiliates is less than $700 million.Company

5As a company with less than $1.235 billion in revenues during our last fiscal year, we qualify as an "emerging growth company" as that term is defined in the Jumpstart Our Business Startups Act of 2012 (the "JOBS Act"). As an emerging growth company we expect to take advantage of specified reduced reporting requirements that are otherwise applicable generally to public companies. These reduced reporting requirements include, but are not limited to:

~~THE OFFERING~~5

~~This summary highlights information presented in greater detail elsewhere in this prospectus. This summary is~~ not ~~complete~~being ~~and~~required ~~does~~to ~~not~~comply ~~contain~~with ~~all~~ the ~~information~~auditor ~~you~~attestation ~~should~~requirements ~~consider~~of ~~before~~Section ~~investing~~404 inof ~~our~~the ~~securities.~~Sarbanes-Oxley ~~You~~Act ~~should~~of ~~carefully read this entire prospectus before investing in our securities~~2002, ~~including~~as ~~"Risk~~amended ~~Factors~~("Sarbanes-Oxley ~~and our consolidated financial statements.~~ Act");

Issuer	Medicus Pharma Ltd.
Securities offered	1,375,000 Units on a “best efforts” basis, with each Unit consisting of one of our common shares and one warrant to purchase one of our common shares. Each warrant will have an exercise price of $ per share (100% of the public offering price of the Units), will be exercisable immediately and will expire five years from the date of issuance. The Units will not be certificated or issued in stand-alone form. The common shares and the warrants comprising the Units are immediately separable upon issuance and will be issued separately in this offering. Pursuant to this prospectus, we are also offering 1,375,000 common shares issuable from time to time upon the exercise of the warrants offered hereby.
Assumed public offering price	$7.29 per Unit, which is the assumed public offering price and the closing price of our common shares on Nasdaq on May 23, 2025.
Common shares to be outstanding	14,947,737 common shares (if none of the warrants issued in this offering are exercised).
Use of Proceeds	We intend to use the net proceeds from this offering to fund our Phase 2 proof of concept clinical trial for treatment of basal cell carcinoma using our doxorubicin tip loaded dissolvable microarray needle skinpatch. We may also use the net proceeds of this offering to expand our exploratory phase 2 clinical trial to a pivotal trial and/or to expand our trials to cover other non-melanoma skin diseases. We will use any remaining net proceeds for general corporate purposes and working capital. See "Use of Proceeds."
Voting rights	Each outstanding common share will be entitled to one vote on all matters submitted to a vote of shareholders.
Listings	Our common shares and Public Warrants are listed on Nasdaq under the symbols "MDCX" and "MDCXW," respectively. The warrants offered hereby will not be listed on any U.S. securities exchange.
Dividend policy	We do not anticipate that we will declare or pay dividends in the foreseeable future on our common shares. Instead, we anticipate that all of our earnings will be used for the operation and growth of our business. Any future determination to declare cash dividends would be subject to the discretion of our board of directors and would depend upon various factors, including our results of operations, financial condition and liquidity requirements, restrictions that may be imposed by applicable law and our contracts and other factors deemed relevant by our board of directors.
Risk factors	See "Risk Factors" and the other information included in this prospectus for a discussion of factors you should consider before deciding to invest in our common shares and warrants.

reduced disclosure about our executive compensation arrangements in our periodic reports, proxy statements and registration statements; and

6an exemption from the requirements to obtain a non-binding advisory vote on executive compensation or stockholder approval of any golden parachute arrangements.

~~Except~~We asmay ~~otherwise~~take ~~noted~~advantage of these provisions until the last day of our fiscal year following the fifth anniversary of the completion of this offering. However, ~~all~~if ~~information~~certain ~~contained~~events occur prior to the end of such five-year period, including if we become a "large accelerated filer," our annual gross revenues exceed $1.235 billion or we issue more than $1 billion of non-convertible debt in ~~this~~any ~~prospectus~~three-year ~~assumes:~~period, we will cease to be an emerging growth company prior to the end of such five-year period.

noThe ~~purchase~~JOBS Act provides that an emerging growth company can take advantage of ~~common~~an ~~shares~~extended transition period for complying with new or ~~warrants~~revised accounting standards. As an emerging growth company, we intend to take advantage of an extended transition period for complying with new or revised accounting standards as permitted by the JOBS Act. We have elected to take advantage of certain of the reduced disclosure obligations in this ~~offering~~prospectus byand ~~directors~~in the registration statement of which this prospectus is a part and may elect to take advantage of other reduced reporting requirements in future filings. As a result, ~~officers~~the orinformation ~~existing~~in ~~shareholders;~~this prospectus and that we provide to our shareholders in the future may be different than what you might receive from other public reporting companies in which you hold equity interests.

noImplications ~~exercise~~ of ~~our~~Being ~~outstanding~~a ~~options~~Smaller ~~(as~~Reporting ~~described herein), the Public Warrants, the Regulation A Warrants or the warrants offered in this offering.~~Company

~~The~~Additionally, ~~number~~we are a "smaller reporting company," meaning that the market value of our common shares ~~that~~held ~~will~~by benon-affiliates ~~outstanding~~plus ~~after~~the proposed aggregate amount of gross proceeds to us as a result of this ~~offering~~transaction is ~~based~~less onthan 13$700 million and our annual revenue is less than $100 million during the most recently completed fiscal year. As such,~~572~~ we are eligible for exemptions from various reporting requirements applicable to other public companies that are not smaller reporting companies,~~737~~ including, but not limited to, reduced disclosure obligations regarding executive compensation. We may continue to be a smaller reporting company as long as either (i) the market value of our common shares ~~outstanding~~held asby non-affiliates is less than $250 million or (ii) our annual revenue is less than $100 million during the most recently completed fiscal year and the market value of ~~May~~our ~~21,~~common ~~2025~~shares held by non-affiliates is less than $700 million.

~~SELECTED~~THE ~~HISTORICAL CONSOLIDATED FINANCIAL INFORMATION~~OFFERING

~~The~~This ~~following~~summary ~~tables~~highlights ~~set~~information ~~forth~~presented ~~our~~in ~~selected~~greater ~~historical~~detail ~~consolidated~~elsewhere ~~financial~~in ~~information~~this prospectus. ~~You~~This ~~should~~summary ~~read~~is ~~the~~not ~~selected~~complete ~~historical~~and ~~consolidated~~does ~~financial~~not contain all the information inyou ~~conjunction~~should ~~with~~consider ~~"Management's~~before ~~Discussion~~investing ~~and~~in ~~Analysis~~our ofsecurities. ~~Financial~~You ~~Condition~~should ~~and~~carefully ~~Results~~read ofthis ~~Operations"~~entire ~~and~~prospectus ~~our~~before ~~consolidated~~investing ~~financial~~in ~~statements~~our ~~and~~securities, ~~related~~including ~~notes~~"Risk ~~included~~Factors" ~~elsewhere~~and inour ~~this~~consolidated ~~prospectus~~financial statements.

We have derived the selected consolidated statement of operations for the three months ended March 31, 2025 and 2024 and the selected consolidated balance sheet information as of March 31, 2025 and December 31, 2024 from our interim unaudited consolidated financial statements and audited consolidated financial statements, respectively, included elsewhere in this prospectus. Our consolidated financial statements have been prepared in accordance with GAAP and our consolidated financial statements are presented in U.S. dollars, except where indicated otherwise. Our historical results are not necessarily indicative of the results that should be expected in any future period.

Issuer	Medicus Pharma Ltd.

Securities offered by the Selling Shareholder	1,397,184 common shares

Terms of the offering	Each Selling Shareholder will determine when and how it will dispose of any common shares registered under this prospectus for sale.

Common shares to be outstanding	21,865,288 common shares

Use of Proceeds	We will not receive any proceeds from the sale of the common shares offered by this prospectus by the Selling Shareholders.

Voting rights	Each outstanding common share will be entitled to one vote on all matters submitted to a vote of shareholders.

Listing	Our common shares are listed on the Nasdaq under the symbol "MDCX".

Dividend policy	We do not anticipate that we will declare or pay dividends in the foreseeable future on our common shares. Instead, we anticipate that all of our earnings will be used for the operation and growth of our business. Any future determination to declare cash dividends would be subject to the discretion of our board of directors and would depend upon various factors, including our results of operations, financial condition and liquidity requirements, restrictions that may be imposed by applicable law and our contracts and other factors deemed relevant by our board of directors.

Risk factors	See "Risk Factors" and the other information included in this prospectus for a discussion of factors you should consider before deciding to invest in our securities.

~~CONSOLIDATED~~Except ~~STATEMENT~~as OFotherwise ~~OPERATIONS~~noted, all information contained in this prospectus assumes no exercise of our outstanding options (as described herein) or warrants. The number of common shares that will be outstanding after this offering is based on 20,468,104 common shares outstanding as of September 22, 2025.

		Three Months Ended March 31,
		2025			2024
Operating expenses
General and administrative	$	3,120,060		$	1,385,981
Research and development		2,006,214			321,377
Total operating expenses		5,126,274			1,707,358
Loss from operations		(5,126,274	)		(1,707,358	)
Other income
Finance income		23,866			-
Total other income		23,866			-
Net loss and comprehensive loss for the year	$	(5,102,408	)	$	(1,707,358	)
Net loss per share attributable to common shareholders - basic and diluted	$	(0.42	)	$	(0.21	)
Weighted average number of common shares outstanding - basic and diluted		12,240,437			8,076,673

8SELECTED HISTORICAL CONSOLIDATED FINANCIAL INFORMATION

~~CONSOLIDATED~~The ~~BALANCE~~following ~~SHEET~~tables ~~DATA~~set forth our selected historical consolidated financial information. You should read the selected historical consolidated financial information in conjunction with "Management's Discussion and Analysis of Financial Condition and Results of Operations" and our consolidated financial statements and related notes included elsewhere in this prospectus

		March 31, 2025			December 31, 2024
Assets
Current assets:
Cash and cash equivalents	$	3,982,430		$	4,164,323
Prepaid expenses and other current assets		1,105,345			1,213,984
Total current assets		5,087,775			5,378,307
Operating lease right-of-use assets		245,091			268,571
Deferred issuance costs		325,000			-
Total assets	$	5,657,866		$	5,646,878
Liabilities and Shareholder's equity
Current liabilities:
Accounts payable	$	2,035,364		$	1,284,612
Accrued expenses and other current liabilities		1,062,040			762,835
Related party payable		118,215			142,459
Operating lease liability, current		120,296			116,323
Total current liabilities		3,335,915			2,306,229
Operating lease liability, non-current		174,397			205,945
Total liabilities		3,510,312			2,512,174
Shareholders' equity
Common shares, no par value; unlimited shares authorized; 13,417,561 and 11,816,721 shares issued and outstanding at March 31,2025 and December 31, 2024, respectively		32,908,702			30,518,195
Additional paid-in capital		3,245,163			1,520,412
Accumulated deficit		(34,006,311	)		(28,903,903	)
Total shareholders' equity		2,147,554			3,134,704
Total liabilities and shareholders' equity	$	5,657,866		$	5,646,878

We have derived the selected condensed consolidated statements of operations for the three and six months ended June 30, 2025 and 2024 and the selected consolidated balance sheet information as of June 30, 2025 and December 31, 2024 from our interim unaudited consolidated financial statements and audited consolidated financial statements, respectively, included elsewhere in this prospectus. Our consolidated financial statements have been prepared in accordance with GAAP and our consolidated financial statements are presented in U.S. dollars, except where indicated otherwise. Our historical results are not necessarily indicative of the results that should be expected in any future period.

9CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

RISK FACTORS

		Three months ended June 30,						Six months ended June 30,
		2025			2024			2025		2024
Operating expenses:
General and administrative	$	4,576,524		$	2,276,676		$	7,696,584		3,662,657
Research and development		1,439,564			1,277,158			3,445,778		1,598,535
Total operating expenses		6,016,088			3,553,834			11,142,362		5,261,192
Loss from operations		(6,016,088	)		(3,553,834	)		(11,142,362	)	(5,261,192	)

Other income (expense)
Interest income (expense)		40,004			(79,025	)		63,870		(79,025	)
Change in fair value of Debentures		(200,000	)		-			(200,000	)	-
Total other income (expense)		(159,996	)		(79,025	)		(136,130	)	(79,025	)
Net loss and comprehensive loss for the year	$	(6,176,084	)	$	(3,632,859	)	$	(11,278,492	)	(5,340,217	)

Net loss per share attributable to common shareholders - basic and diluted	$	(0.43	)	$	(0.44	)	$	(0.81	)	(0.66	)

Weighted average number of common shares outstanding - basic and diluted		14,284,261			8,167,993			13,853,305		8,122,333

You should carefully consider the risks described below and all other information contained in this prospectus before making an investment decision. If any of the following risks actually occur, our business, financial condition and results of operations could be materially and adversely affected. In that event, the trading price of our securities could decline, and you may lose part or all of your investment. This prospectus also contains forward-looking information that involves risks and uncertainties. Our actual results could differ materially from those anticipated in these forward-looking statements as a result of many factors, including the risks described below and elsewhere in this prospectus.8

WeCONDENSED ~~have~~CONSOLIDATED aBALANCE ~~limited operating history, which may make it difficult to evaluation our current business and predict our future performance.~~SHEETS

We have a limited operating history and, in particular, no history of earnings; we have not paid any dividends and we are unlikely to pay any dividends in the immediate or foreseeable future. Our success will depend to a large extent on the expertise, ability, judgement, discretion, integrity and good faith of our management.

		June 30, 2025			December 31, 2024
		(unaudited)
Assets
Current assets:
Cash and cash equivalents	$	9,669,546		$	4,164,323
Prepaid expenses and other current assets		1,327,185			1,213,984
Total current assets		10,996,731			5,378,307
Operating lease right-of-use assets		220,999			268,571
Deferred issuance costs		716,898			-
Total assets	$	11,934,628		$	5,646,878

Liabilities and Shareholder's equity
Current liabilities:
Accounts payable	$	1,770,178			1,284,612
Accrued expenses and other current liabilities		1,828,312			762,835
Related party payable		121,273			142,459
Operating lease liability, current		124,402			116,323
Debentures		4,700,000			-
Total current liabilities		8,544,165			2,306,229
Operating lease liability, non-current		141,753			205,945
Total liabilities		8,685,918			2,512,174



Shareholders' equity
Common shares, no par value; unlimited shares authorized; 15,936,266 and 11,816,721 shares issued and outstanding at June 30, 2025 and December 31, 2024, respectively		37,833,999			30,518,195
Additional paid-in capital		5,597,106			1,520,412
Accumulated deficit		(40,182,395	)		(28,903,903	)
Total shareholders' equity		3,248,710			3,134,704
Total liabilities and shareholders' equity	$	11,934,628		$	5,646,878

As we are at an early stage of product development, we have not generated revenues to date. We expect to spend a significant amount of capital to fund research and development and clinical trials. As a result, we expect that our operating expenses will increase significantly and, consequently, we will need to generate significant revenues to become profitable. We cannot predict when, if ever, we will be profitable. Even if we do become profitable, we may not be able to sustain or increase profitability on a quarterly or annual basis. There can be no assurances that our products will be capable of being produced in commercial quantities at reasonable costs, or be successfully marketed.9

WeRISK ~~have a novel technology with uncertain market acceptance.~~FACTORS

~~The~~You ~~Product~~should iscarefully atconsider anthe ~~early~~risks ~~stage~~described ofbelow ~~development,~~and ~~with~~all ~~uncertain~~other ~~market~~information ~~acceptance.~~contained ~~Product~~in ~~approval,~~this ~~should~~prospectus ~~this~~before bemaking ~~achieved,~~an ~~does~~investment ~~not~~decision. ~~infer~~If ~~that~~any of the ~~Product~~following ~~will~~risks ~~garner~~actually aoccur, ~~good~~our ~~market~~business, ~~price~~financial orcondition beand ~~reimbursed~~results byof ~~public~~operations orcould ~~private~~be ~~insurers.~~materially ~~Further,~~and ~~there~~adversely ~~are~~affected. noIn ~~guarantees~~ that event, the ~~Product~~trading ~~will~~price beof ~~positively~~our ~~received~~securities bycould ~~the~~decline, ~~target~~and ~~patient~~you ~~population.~~may ~~The~~lose ~~acceptability~~part or all of ~~the~~your ~~Product~~investment. toThis ~~regulators,~~prospectus ~~payors~~also ~~and~~contains ~~patients~~forward-looking ~~will~~information ~~depend~~that oninvolves ~~the~~risks ~~relative~~and ~~risk~~uncertainties. ~~versus~~Our ~~benefit~~actual ofresults ~~the~~could ~~Product~~differ asmaterially ~~proven~~from those anticipated in ~~clinical~~these ~~trials,~~forward-looking ~~the~~statements ~~acceptability~~as a result of ~~the~~many ~~price~~factors, ~~and~~including the ~~relative~~risks ~~attractiveness~~described asbelow ~~compared~~and toelsewhere ~~other~~in ~~treatments~~this prospectus.

We ~~could~~have ~~also~~a ~~suffer~~limited ~~the~~operating ~~consequences~~history, ofwhich ~~non-compliance or breaches by licensors in connection with any license agreements we~~ may ~~enter~~make ~~into~~it indifficult ~~the~~to ~~future.~~evaluation ~~Such~~our ~~non-compliance~~current orbusiness ~~breaches by such third parties could in turn result in breaches or defaults under any agreements with other collaboration partners,~~ and wepredict ~~could be found liable for damages or lose certain rights, including rights to develop and/or commercialize the Product. Loss of~~ our ~~rights to any license granted to us in the~~ future, ~~or the exclusivity rights provided therein, could harm our financial condition and operating results~~performance.

~~The~~We ~~University~~have a limited operating history and, in particular, no history of ~~Pittsburgh~~earnings; ~~may~~we ~~terminate~~have ~~our~~not ~~license~~paid ~~agreement~~any dividends and we are unlikely to pay any dividends in ~~certain~~the ~~circumstances~~immediate or foreseeable future. Our success will depend to a large extent on the expertise, ability, judgement, discretion, integrity and good faith of our management.

~~The~~As ~~License~~we ~~Agreement~~are ~~(as~~at ~~defined~~an ~~herein)~~early isstage ~~our~~of ~~main~~product ~~asset~~development, ~~and~~we ~~the~~have ~~basis~~not ~~for~~generated ~~the~~revenues ~~development~~to ~~of the Product~~date. ~~The~~We ~~University~~expect ofto ~~Pittsburgh~~spend ofa ~~the~~significant ~~Commonwealth~~amount ~~System~~ of ~~Higher~~capital ~~Education (the "University of Pittsburgh") has the right~~ to ~~terminate~~fund ~~the~~research ~~License~~and ~~Agreement~~development ifand ~~breaches~~clinical ~~are~~trials. ~~not~~As ~~cured~~a ~~within~~result, 30we ~~days~~expect ofthat our ~~receipt~~operating ofexpenses ~~notice~~will ~~thereof~~increase ~~from~~significantly ~~the~~and, ~~University~~consequently, ofwe ~~Pittsburgh~~will orneed into ~~certain~~generate ~~insolvency-related~~significant ~~situations~~revenues ~~or if we cease~~ to ~~carry~~become ~~out our business~~profitable. ~~There~~We ~~can~~cannot bepredict nowhen, ~~assurance~~if ~~that~~ever, we will be ~~able~~profitable. toEven ~~comply with the License Agreement going forward or that the University of Pittsburgh will grant any necessary waivers~~ if we ~~are unable to~~ do ~~so.~~become ~~The~~profitable, ~~obligations~~we ~~under~~may ~~the~~not ~~License~~be ~~Agreement~~able ~~principally~~to ~~require~~sustain ~~the~~or ~~trial~~increase ofprofitability ~~the Product~~ on ~~specified~~a ~~timelines.~~quarterly Ifor ~~the~~annual ~~University~~basis. ofThere ~~Pittsburgh~~can ~~were~~be tono ~~terminate~~assurances ~~the~~that ~~License Agreement~~ our ~~assets~~products ~~would~~will ~~essentially~~ be ~~rendered~~capable ~~worthless~~of ~~and~~being itproduced ~~would~~in ~~have~~commercial aquantities ~~material~~at ~~adverse~~reasonable ~~effect~~costs, onor ~~our~~be ~~ability~~successfully ~~to pursue our business objective~~marketed.

10We have a novel technology with uncertain market acceptance.

WeThe ~~may~~Products are at an early stage of development, with uncertain market acceptance. Product approval, should this be achieved, does not ~~complete~~infer that the ~~Antev~~Products ~~Transaction~~will garner a good market price or ~~may~~be reimbursed by public or private insurers. Further, there are no guarantees that the Products will be ~~delayed~~positively received by the target patient population. The acceptability of the Products to regulators, payors and patients will depend on the relative risk versus benefit of the Products as proven in ~~completing~~clinical trials, the ~~Antev~~acceptability ~~Transaction~~of the price, and the relative attractiveness as compared to other treatments.

~~The~~We ~~Antev~~could ~~Transaction~~also issuffer ~~subject to~~ the ~~completion~~consequences of ~~satisfactory~~non-compliance ~~due~~or ~~diligence~~breaches by ~~Medicus,~~licensors ~~negotiation~~in ofconnection ~~definitive~~with ~~agreements,~~any ~~obtaining~~license ~~applicable~~agreements ~~corporate,~~we ~~regulatory~~may ~~and~~enter ~~other~~into ~~third-party~~in ~~approvals and~~ the ~~fulfillment of customary closing conditions~~future. ~~There~~Such isnon-compliance noor ~~certainty~~breaches ~~and~~by ~~Medicus~~such ~~can~~third ~~provide no assurances that the~~ parties ~~will~~could ~~successfully~~in ~~negotiate~~turn ~~and~~result ~~enter~~in ~~into~~breaches ~~a definitive agreement,~~ or ~~that~~defaults ~~the~~under ~~Antev~~any ~~Transaction~~agreements ~~will~~with beother ~~consummated~~collaboration ~~on the terms or timeframe currently contemplated~~partners, orand atwe ~~all.~~could Ifbe ~~the~~found ~~Antev~~liable ~~Transaction~~for isdamages ~~not~~or ~~completed~~lose ascertain ~~contemplated~~rights, ~~Medicus could suffer adverse consequences,~~ including ~~the~~rights ~~loss~~to ofdevelop ~~investor confidence, volatility~~ and/or acommercialize ~~significant decrease in~~ the ~~market~~Products. ~~prices~~Loss of our ~~securities~~rights ~~and~~to ~~reputational~~any ~~harm.~~license Ingranted ~~addition,~~to ~~any~~us ~~delay~~ in ~~completing~~ the ~~Antev~~future, ~~Transaction could cause Medicus not to realize some~~ or ~~all of~~ the ~~benefits~~exclusivity ~~that~~rights itprovided ~~expects~~therein, tocould ~~achieve~~harm ifour ~~the~~financial ~~Antev~~condition ~~Transaction~~and isoperating ~~successfully completed within the expected timeframe~~results.

~~Our~~The ~~intellectual~~University ~~property~~of isPittsburgh ~~held~~may ~~under~~terminate ~~third-party~~our ~~licenses~~license agreement in certain circumstances.

~~Our~~The ~~intellectual~~License ~~property~~Agreement is(as ~~held~~defined ~~under~~herein) ais ~~third-party~~our ~~license~~main ~~and~~asset ~~we may require additional third-party licenses to effectively develop~~ and ~~manufacture~~the ~~our~~basis ~~key~~for ~~products~~the ordevelopment ~~future~~of ~~technologies~~SkinJectTM. ~~There~~The ~~can~~University beof noPittsburgh ~~assurance~~of ~~as to~~ the ~~availability~~Commonwealth orSystem ~~cost~~ of ~~such~~Higher ~~additional~~Education ~~licenses.~~(the A"University ~~substantial number~~ of ~~patents~~Pittsburgh") ~~have~~has ~~already~~the ~~been~~right ~~issued~~ to ~~other~~terminate ~~biotechnology and pharmaceutical companies. To~~ the ~~extent~~License ~~that~~Agreement ~~valid~~if ~~third-party~~breaches ~~patent~~are ~~rights~~not ~~cover~~cured ~~our~~within ~~products~~30 ordays ~~services,~~of ~~we or~~ our ~~strategic~~receipt ~~collaborators~~of ~~would~~notice bethereof ~~required to seek licenses~~ from the ~~holders~~University of ~~these~~Pittsburgh ~~patents~~or in ~~order~~certain toinsolvency-related ~~manufacture,~~situations ~~use~~ or ~~sell~~if ~~these~~we ~~products~~cease ~~and~~to ~~services,~~carry ~~and~~out ~~payments under them would reduce~~ our ~~profits~~business. ~~from~~There ~~these~~can ~~products~~be ~~and~~no ~~services.~~assurance Itthat iswe ~~not~~will ~~possible~~be able to ~~predict~~comply with the ~~extent~~License toAgreement ~~which~~going weforward ~~may wish~~ or bethat ~~required~~the toUniversity ~~acquire~~of ~~rights~~Pittsburgh ~~under~~will ~~such~~grant ~~patents,~~any ~~the~~necessary ~~availability~~waivers ~~and~~if ~~cost~~we ofare ~~acquiring~~unable ~~such~~to ~~rights,~~do ~~and~~so. ~~whether~~The aobligations ~~license~~under tothe ~~such~~License ~~patents~~Agreement ~~will~~principally berequire ~~available~~the ontrial ~~acceptable~~of ~~terms~~SkinJectTM oron atspecified ~~all~~timelines. ~~There~~If ~~may be patents in~~ the ~~United~~University ~~States~~of orPittsburgh inwere ~~foreign~~to ~~countries~~terminate ~~or patents issued in~~ the ~~future~~License ~~that~~Agreement ~~are~~our ~~unavailable~~assets towould ~~license~~essentially onbe ~~acceptable~~rendered ~~terms.~~worthless ~~Our~~and ~~inability~~it towould ~~obtain~~have ~~such~~a ~~licenses~~material ~~may~~adverse ~~hinder~~effect oron ~~eliminate~~our an ability to ~~manufacture~~pursue ~~and~~our ~~market~~business ~~products~~objective.

If we breach any of the agreements under which we license rights to intellectual property, we could lose license rights that are important to our business. Our current license agreement may not provide an adequate remedy for any breach by the licensor.10

~~For~~We ~~information~~may onnot ~~the~~successfully ~~License~~integrate ~~Agreement,~~Antev ~~see~~into ~~"Our~~our ~~Business~~business -and ~~Patents~~operations ~~and~~or ~~Proprietary~~successfully ~~Information~~develop Teverelix."

~~Our~~On ~~technology~~August 29, 2025, we completed the Antev Transaction and acquired 98.6% of the issued and outstanding shares of Antev. We may not be ~~successful~~able ~~for~~to successfully integrate Antev's business into our business and operations or develop its ~~intended~~assets ~~use~~acquired pursuant to the Antev Transaction, including Teverelix, and may not otherwise realize the expected benefits of the transaction. Difficulties in integrating Antev's rights into our operations may result in the Company performing differently than expected, in operation challenges or in the failure to realize anticipated benefits in the time frame or at all. Difficulties in developing Teverelix, including challenges associated with clinical trials, product approvals, bringing Teverelix to market (and receiving positive reception or obtaining favorable pricing if Teverelix is brought to market), may have an material adverse effect on our results of operations.

~~Although~~The integration of Antev and the ~~SkinJect~~development ~~Phase~~of 1Teverelix ~~study~~may ~~indicated~~result ~~that~~in material challenges, including the ~~patch~~diversion isof ~~well-tolerated,~~management's ~~there~~attention isfrom noongoing ~~guarantee~~business ~~that~~concerns, including the ~~Phase~~development 2of ~~study~~SkinJectTM; ~~will~~retaining ~~produce~~key ~~similar~~employees; ~~results~~the orpossibility ~~that~~of faulty assumptions underlying expectations regarding the ~~Product~~integration ~~will~~process ~~ultimately~~and beassociated ~~brought~~expenses; toconsolidating ~~market~~corporate orand administrative infrastructures and eliminating duplicative operations; retaining existing research, ifbusiness itand ~~does~~operational relationships; coordinating geographically separate organizations; difficulties in the assimilation of employees and corporate cultures; unanticipated issues in integrating information technology, ~~that~~communications itand ~~will~~other besystems; ~~positively~~and ~~received~~unforeseen orexpenses ~~obtain~~related ~~favorable~~to ~~pricing~~the integration. If we are not successful in integrating Antev, ~~which~~the ~~would~~benefits ~~have~~currently aanticipated ~~material~~from ~~adverse~~the ~~effect~~acquisition onof Antev, our results of operations, cash flows and financial condition may be materially adversely affected.

~~There~~Certain isof ~~substantial~~our ~~doubt~~intellectual ~~about~~property ~~the Company's ability to continue as a going concern and if the Company~~ is ~~unable~~held tounder ~~obtain~~third-party ~~additional financing from outside sources and/or eventually generate enough revenues, it may be forced to curtail or discontinue its operations~~licenses.

~~The~~Certain ~~Company's~~of ~~auditor~~our ~~has~~intellectual ~~indicated~~property inis ~~its~~held ~~report~~under ~~accompanying~~a ~~the~~third-party ~~Company's~~license ~~audited~~and ~~annual~~we ~~financial~~may ~~statements~~require ~~that~~additional ~~there~~third-party islicenses ~~substantial~~to ~~doubt~~effectively ~~about~~develop ~~the~~and ~~Company's~~manufacture ~~ability~~our tokey ~~continue~~products asor afuture ~~going concern~~technologies. ~~The~~There ~~Company~~can isbe inno ~~the~~assurance ~~preliminary~~as ~~stages~~to ofthe ~~its~~availability ~~planned~~or ~~operations~~cost ~~and~~of ~~has~~such ~~not~~additional ~~yet~~licenses. ~~determined~~A ~~whether~~substantial ~~its~~number ~~processes~~of ~~and~~patents ~~business~~have ~~plans~~already ~~are~~been ~~economically~~issued ~~viable.~~to ~~The~~other ~~continued~~biotechnology ~~operations~~and ofpharmaceutical ~~the~~companies. ~~Company~~To ~~and~~ the ~~recoverability~~extent ofthat ~~amounts~~valid ~~shown~~third-party ~~for~~patent ~~certain~~rights ~~operational~~cover ~~expenses~~our inproducts ~~the~~or ~~Company's~~services, ~~audited~~we ~~annual~~or ~~financial~~our ~~statements~~strategic ~~are~~collaborators ~~dependent~~would ~~upon~~be ~~the~~required ~~ability~~to ofseek ~~the~~licenses ~~Company~~from tothe ~~obtain~~holders ~~sufficient~~of ~~financing~~these topatents ~~commercialize~~in ~~its~~order ~~product and~~ to ~~become profitable~~manufacture, ~~all~~use ofor ~~which~~sell ~~are~~these ~~uncertain.~~products ~~Importantly~~and services, ~~the~~and ~~inclusion~~payments inunder ~~the~~them ~~Company's~~would ~~financial~~reduce ~~statements~~our ofprofits afrom ~~going~~these ~~concern~~products ~~opinion~~and ~~may~~services. ~~negatively~~It ~~impact~~is ~~the~~not ~~Company's~~possible ~~ability~~ to ~~raise~~predict ~~future financing and achieve future revenue. If~~ the ~~Company~~extent ~~is unable~~ to ~~obtain~~which ~~additional~~we ~~financing~~may ~~from~~wish ~~outside sources and/~~or ~~eventually generate enough revenues, the Company may~~ be ~~forced~~required to ~~cut~~acquire ~~costs,~~rights byunder ~~among~~such ~~other things~~patents, ~~curtailing~~the oravailability ~~discontinuing~~and ~~its~~cost ~~operations.~~of ~~These~~acquiring ~~measures~~such ~~could~~rights, ~~cause~~and ~~significant~~whether ~~delays~~a orlicense ~~entirely~~to ~~prevent~~such ~~the~~patents ~~Company's~~will ~~continued~~be ~~efforts~~available toon ~~commercialize~~acceptable ~~its~~terms ~~current~~ or ~~future~~at ~~products,~~all. ~~which~~There ~~are~~may ~~critical~~be topatents ~~the~~in ~~realization of its business plan and~~ the ~~future~~United ~~operations~~States ofor ~~the~~in ~~Company.~~foreign Ifcountries ~~any~~or ofpatents ~~these~~issued ~~events~~in ~~happens,~~ the ~~Company's~~future ~~investors~~that ~~could~~are ~~lose~~unavailable ~~all~~to orlicense ~~part~~on ofacceptable ~~their investments~~terms. InOur ~~addition,~~inability ~~the~~to ~~Company's~~obtain ~~financial~~such ~~statements~~licenses ~~do not include any adjustments that~~ may behinder ~~necessary~~or ~~should~~eliminate ~~the~~an ~~Company~~ability ~~be unable~~ to ~~continue~~manufacture asand amarket ~~going concern~~products.

~~Future~~If ~~technology~~we ~~will~~breach ~~require~~any ~~regulatory~~of ~~approval,~~the agreements under which iswe ~~costly~~license ~~and~~rights to intellectual property, we ~~may~~could ~~not~~lose belicense ~~able~~rights tothat ~~obtain~~are itimportant ~~and~~to weour ~~may~~business. ~~fail~~Our tocurrent ~~obtain~~license ~~regulatory~~agreement ~~approvals~~may ornot ~~only~~provide ~~obtain~~an ~~approvals~~adequate remedy for ~~limited~~any ~~uses~~breach orby ~~indications~~the licensor.

~~Market~~For ~~authorization~~information ofon the ~~Product~~License ~~falls~~Agreement, ~~under~~see ~~the~~"Our ~~regulatory~~Business ~~purview~~- ofPatents ~~the FDA~~ and ~~other~~Proprietary ~~equivalent regulatory bodies worldwide~~Information. There can be no assurance that these regulatory bodies will approve the Product in the manner or time frame suggested. Although we intend to work with regulatory consultants and third parties knowledgeable in the area, we cannot ensure that the Product will obtain market authorization in a timely manner, or at all. Market authorization may also be contingent on a less competitive product label, which would negatively impact revenue."

11Our technology may not be successful for its intended use.

~~Changes~~Although inthe ~~methods~~SkinJect Phase 1 study indicated that the patch is well-tolerated, there is no guarantee that the Phase 2 study will produce similar results or that SkinJectTM will ultimately be brought to market or, if it does, that it will be positively received or obtain favorable pricing, which would have a material adverse effect on our results of ~~manufacturing~~operations. In addition, there is no guarantee that the open and planned Phase 2b studies involving Teverelix will be successfully or ~~formulation~~that ~~may~~Teverelix ~~result~~will inultimately ~~additional~~be ~~costs~~brought to market, or, ~~delay~~if it does, that it will be positively received or obtain favorable pricing, which would have a material adverse effect on our business plans and results of operations.

As the Product is developed through further clinical trials towards approval and commercialization, it is common that various aspects of the development program, such as manufacturing methods and formulation, are altered along the way in an effort to optimize processes and results. Such changes carry the risk that they will not achieve these intended objectives. Any of these changes could cause the Product to perform differently and affect the results of future clinical trials conducted with the altered materials. This could delay completion of clinical trials, require the conduct of bridging clinical trials or the repetition of one or more clinical trials, increase clinical trial costs, delay approval of the Product and jeopardize our ability, or our strategic partners' ability, to commence product sales and generate revenue.11

~~The~~There ~~manufacture of the Product~~ is ~~complex.~~substantial Wedoubt orabout ~~our~~the ~~third-party~~Company's ~~manufacturers~~ability ~~may~~to ~~encounter~~continue ~~difficulties~~as ina ~~production.~~going Ifconcern weand ~~encounters~~if ~~any~~the ~~such~~Company ~~difficulties,~~is ~~our~~unable ~~ability~~ to ~~supply~~obtain ~~the~~additional ~~Product~~financing ~~for~~from ~~clinical~~outside ~~trials~~sources and/or, ifeventually ~~approved,~~generate ~~for~~enough ~~commercial~~revenues, ~~sale~~it ~~could~~may be ~~delayed~~forced to curtail or ~~halted~~discontinue ~~entirely~~its operations.

The ~~manufacture~~Company's ofauditor ~~biopharmaceutical~~has ~~products~~indicated isin ~~complex~~its ~~and~~report ~~requires~~accompanying ~~significant~~the ~~expertise~~Company's ~~and~~audited ~~capital~~annual ~~investment,~~financial ~~including~~statements that there is substantial doubt about the ~~development~~Company's ofability ~~advanced~~to ~~manufacturing~~continue ~~techniques~~as ~~and~~a ~~process~~going ~~controls~~concern. The ~~process~~Company ofis ~~manufacturing~~in the ~~Product~~preliminary isstages ~~susceptible~~of toits ~~product~~planned ~~loss~~operations ~~due~~and tohas ~~contamination,~~not ~~equipment~~yet ~~failure~~determined orwhether ~~improper~~its ~~installation~~processes orand ~~operation~~business ofplans ~~equipment,~~are ~~vendor~~economically orviable. ~~operator~~The ~~error,~~continued ~~contamination~~operations of the Company and ~~inconsistency~~the inrecoverability ~~yields,~~of ~~variability~~amounts inshown ~~product~~for ~~characteristics~~certain ~~and~~operational ~~difficulties~~expenses in ~~scaling~~ the ~~production~~Company's ~~process.~~audited ~~Even~~annual ~~minor~~financial ~~deviations~~statements ~~from~~are ~~normal~~dependent ~~manufacturing~~upon ~~processes~~the ~~could~~ability ~~result~~of inthe ~~reduced~~Company ~~production~~to ~~yields,~~obtain ~~product~~sufficient ~~defects~~financing ~~and~~to ~~other~~commercialize ~~supply~~its ~~disruptions.~~product Ifand ~~microbial,~~to ~~viral~~become orprofitable, ~~other~~all ~~contaminations~~of which are ~~discovered~~uncertain. inImportantly, the ~~Product~~inclusion or in the ~~manufacturing~~Company's ~~facilities~~financial instatements ~~which~~of ~~the~~a ~~Product~~going isconcern ~~made,~~opinion ~~such~~may ~~manufacturing~~negatively ~~facilities~~impact ~~may~~the ~~need~~Company's ability to beraise ~~closed~~future ~~for~~financing anand ~~extended~~achieve ~~period~~future ofrevenue. ~~time~~If the Company is unable to ~~investigate~~obtain additional financing from outside sources and/or ~~remedy~~eventually ~~the~~generate ~~contamination.~~enough ~~Any~~revenues, ~~adverse~~the ~~developments~~Company ~~affecting~~may ~~manufacturing~~be ~~operations~~forced ~~for~~to ~~the~~cut ~~Product~~costs, ifby ~~any~~among ~~are~~other ~~approved~~things, ~~may~~curtailing ~~result~~or indiscontinuing ~~shipment~~its operations. These measures could cause significant delays, ~~inventory~~or ~~shortages,~~entirely ~~lot~~prevent ~~failures,~~the ~~product~~Company's ~~withdrawals~~continued efforts to commercialize its current or ~~recalls~~future products, orwhich ~~other~~are ~~interruptions~~critical into the ~~supply~~realization of ~~our~~its ~~products~~business plan and the future operations of the Company. WeIf ~~may~~any ~~also~~of ~~have~~these toevents ~~take~~happens, ~~inventory~~the ~~write-offs~~Company's ~~and~~investors ~~incur~~could ~~other~~lose ~~charges~~all ~~and~~or ~~expenses~~part ~~for~~of ~~products~~their investments. In addition, the Company's financial statements do not include any adjustments that ~~fail~~may tobe ~~meet~~necessary ~~specifications,~~should ~~undertake~~the ~~costly~~Company ~~remediation~~be ~~efforts~~unable orto ~~seek~~continue ~~more~~as ~~costly~~a ~~manufacturing~~going ~~alternatives~~concern.

WeFuture ~~rely~~technology onwill ~~external~~require ~~contract~~regulatory ~~research~~approval, ~~organizations~~which is costly and we may not be able to ~~provide~~obtain ~~clinical~~it and ~~nonclinical~~we ~~research~~may ~~services~~fail ~~and~~to ~~agreements~~obtain ~~with~~regulatory ~~these~~approvals ~~organizations~~or ofonly ~~which~~obtain ~~one~~approvals ~~agreement~~for islimited ~~currently~~uses inor ~~place~~indications.

~~The~~Market ~~outsourcing~~authorization of ~~functions~~the toProducts ~~contract~~falls ~~research~~under ~~organizations involves~~ the risk that third party providers may not perform to our standards, may not produce results in a timely manner or may fail to perform at all. If any contract research organization fails to comply with applicable regulatory ~~requirements,~~purview of the ~~research~~FDA and ~~data~~other ~~generated~~equivalent ~~may be deemed unreliable to~~ regulatory ~~authorities~~bodies worldwide. ~~Additional~~There ~~pre-clinical~~can ~~and clinical trials may~~ be ~~required~~no ~~before approval of marketing applications will be given. We cannot provide~~ assurance that ~~all~~these ~~third-party~~regulatory ~~providers~~bodies will ~~meet~~approve the ~~regulatory~~Products ~~requirements~~in ~~for~~the ~~research~~manner ~~and~~or ~~pre-clinical~~time ~~trials~~frame suggested. ~~Failure~~Although ofwe ~~third-party~~intend ~~providers~~ to ~~meet~~work with regulatory ~~requirements~~consultants ~~could~~and ~~result~~third inparties ~~repeat~~knowledgeable ~~pre-clinical~~in ~~and~~the ~~clinical trials~~area, ~~which~~we ~~would~~cannot ~~delay~~ensure that the ~~regulatory~~Products ~~approval~~will ~~process~~obtain ormarket ~~result~~authorization in ~~termination~~a oftimely ~~pre-clinical~~manner, ~~and~~or ~~clinical~~at ~~trials~~all. ~~Any~~Market ofauthorization ~~the~~may ~~foregoing~~also ~~could~~be ~~have~~contingent on a ~~material~~less ~~adverse~~competitive ~~effect~~product ~~on our business~~label, ~~prospects,~~which ~~results~~would ofnegatively ~~operations~~impact ~~and financial condition~~revenue.

IfChanges wein ~~are~~methods ~~unable~~of tomanufacturing ~~establish sales and marketing capabilities~~ or ~~enter~~formulation ~~into agreements with third parties to market and sell the Product, if approved, we~~ may beresult ~~unable~~in toadditional ~~generate~~costs ~~any~~or ~~product revenue~~delay.

ToAs ~~successfully commercialize~~ the ~~Product,~~Products weare ~~will~~developed ~~need~~through tofurther ~~build~~clinical ~~out~~trials ~~sales~~towards approval and ~~marketing capabilities~~commercialization, ~~either~~it onis ~~our~~common ~~own~~that orvarious ~~with~~aspects ~~others.~~of ~~The~~the ~~establishment~~development ~~and~~program, ~~development~~such ofas ~~our~~manufacturing ~~own~~methods ~~commercial~~and ~~team~~formulation, orare ~~the~~altered ~~establishment~~along ofthe away ~~contract~~in ~~field~~an ~~force~~effort to ~~market~~optimize ~~the~~processes ~~Product will be expensive~~ and ~~time-consuming and could delay launch~~results. ~~Moreover,~~Such wechanges ~~cannot~~carry bethe ~~certain~~risk that wethey will benot ~~able~~achieve tothese ~~successfully~~intended ~~develop this capability~~objectives. WeAny ~~may~~of ~~seek~~these tochanges ~~enter~~could ~~into~~cause ~~collaborations~~the ~~with~~Products ~~other entities~~ to ~~use~~perform ~~their~~differently ~~established marketing~~ and ~~distribution~~affect ~~capabilities,~~the ~~but~~results weof ~~may~~future beclinical ~~unable~~trials toconducted ~~enter~~with ~~into~~the ~~such~~altered ~~agreements on favorable terms, if at all~~materials. IfThis ~~any~~could ~~current~~delay orcompletion ~~future~~of ~~collaborators~~clinical dotrials, ~~not~~require ~~commit~~the ~~sufficient~~conduct ~~resources~~of tobridging ~~commercialize~~clinical ~~the~~trials ~~Product,~~ or ~~we are unable to develop~~ the ~~necessary~~repetition ~~capabilities~~of onone ~~our~~or ~~own,~~more weclinical ~~may be unable to generate sufficient revenue to sustain our business. We may compete with many companies that currently have extensive~~trials, ~~experienced~~increase ~~and~~clinical ~~well-funded~~trial ~~marketing and sales operations to recruit~~costs, ~~hire,~~delay ~~train~~approval ~~and~~of ~~retain~~the ~~marketing~~Products and ~~sales~~jeopardize ~~personnel.~~our ~~Without~~ability, ~~an internal team~~ or ~~the~~our ~~support~~strategic ofpartners' aability, ~~third party~~ to ~~perform~~commence ~~marketing~~product ~~and~~ sales ~~functions,~~and wegenerate ~~may be unable to compete successfully against these more established companies~~revenue.

12The manufacture of the Products is complex. We or our third-party manufacturers may encounter difficulties in production. If we encounter any such difficulties, our ability to supply the Products for clinical trials or, if approved, for commercial sale could be delayed or halted entirely.

The manufacture of biopharmaceutical products is complex and requires significant expertise and capital investment, including the development of advanced manufacturing techniques and process controls. The processes of manufacturing the Products are susceptible to product loss due to contamination, equipment failure or improper installation or operation of equipment, vendor or operator error, contamination and inconsistency in yields, variability in product characteristics and difficulties in scaling the production process. Even minor deviations from normal manufacturing processes could result in reduced production yields, product defects and other supply disruptions. If microbial, viral or other contaminations are discovered in the Products or in the manufacturing facilities in which the Products are made, such manufacturing facilities may need to be closed for an extended period of time to investigate and remedy the contamination. Any adverse developments affecting manufacturing operations for the Products, if any are approved, may result in shipment delays, inventory shortages, lot failures, product withdrawals or recalls, or other interruptions in the supply of our products. We ~~rely~~may onalso ~~key~~have ~~personnel~~to take inventory write-offs and incur other charges and expenses for products that fail to meet specifications, undertake costly remediation efforts or seek more costly manufacturing alternatives.

Our success depends in large measure on certain key personnel, including our chief executive officer, Dr. Raza Bokhari. The loss of the services of such key personnel could have a material adverse effect on us. The contributions of these individuals to our operations have been, and are expected to continue to be, of central importance. In addition, the competition for qualified personnel in the biotech industry is intense and there can be no assurance that we will be able to continue to attract and retain all personnel necessary for the development and operation of our business. Investors must rely upon the ability, expertise, judgment, discretion, integrity and good faith of our management. Other biotechnology companies with which we compete for qualified personnel have greater financial and other resources, different risk profiles and a longer history in the industry than we do. They also may provide more diverse opportunities and better chances for career advancement. Some of these characteristics may be more appealing to high-quality candidates than those that we have to offer. If we are unable to continue to attract and retain high-quality personnel, the rate of and success with which we can develop and commercialize the Product would be limited.12

AsWe arely ~~technology-driven~~on ~~company,~~external ~~intellectual~~contract ~~input~~research ~~from~~organizations ~~key management and personnel is critical~~ to ~~achieve~~provide ~~our~~clinical ~~business objectives. Consequently, our ability to retain these individuals~~ and ~~attract~~nonclinical ~~other~~research ~~qualified individuals is critical to our success. The loss of the~~ services ofand ~~key~~agreements ~~individuals might significantly delay or prevent achievement of our business objectives. In addition, because of a relative scarcity of individuals~~ with ~~the~~these ~~high~~organizations ~~degree~~ of ~~education~~which ~~and~~one ~~scientific~~agreement ~~achievement required for our business, competition among biotech companies for qualified employees~~ is ~~intense~~currently ~~and,~~in ~~as a result, we may not be able to attract and retain such individuals on acceptable terms, or at all~~place.

~~SkinJect~~The ~~also~~outsourcing ~~has~~of ~~relationships~~functions ~~with~~to ~~scientific~~contract ~~collaborators~~research atorganizations ~~academic~~involves ~~and~~the ~~other~~risk ~~institutions~~that third party providers may not perform to our standards, ~~some~~may ofnot ~~whom~~produce ~~conduct~~results ~~research~~in ata ~~SkinJect's~~timely ~~request~~manner or ~~assist~~may ~~SkinJect~~fail into ~~formulating~~perform ~~the~~at ~~SkinJect's~~all. If any contract research ~~and~~organization ~~development~~fails ~~strategies.~~to ~~These~~comply ~~scientific~~with ~~collaborators~~applicable ~~are~~regulatory ~~not~~requirements, ~~SkinJect~~the ~~employees~~research and data generated may ~~have~~be ~~commitments~~deemed unreliable to, orregulatory ~~consulting~~authorities. orAdditional ~~advisory~~pre-clinical ~~contracts~~and ~~with,~~clinical ~~other~~trials ~~entities~~may ~~that~~be ~~may~~required ~~limit~~before ~~their~~approval ~~availability~~of tomarketing usapplications will be given. InWe ~~addition,~~cannot ~~even~~provide ~~though~~assurance ~~SkinJect's~~that ~~collaborators~~all ~~are~~third-party ~~required~~providers towill ~~sign~~meet ~~confidentiality~~the ~~agreements~~regulatory ~~prior~~requirements tofor ~~working,~~research ~~they~~and ~~may~~pre-clinical ~~have~~trials. ~~arrangements~~Failure ~~with~~of ~~other~~third-party ~~companies~~providers to ~~assist~~meet ~~such~~regulatory ~~other~~requirements ~~companies~~could result in ~~developing~~repeat ~~technologies~~pre-clinical ~~that~~and ~~may~~clinical ~~prove~~trials, ~~competitive~~which towould usdelay the regulatory approval process or result in termination of pre-clinical and clinical trials. Any of the foregoing could have a material adverse effect on our business, prospects, results of operations and financial condition.

~~Incentive~~If ~~provisions~~we ~~for~~are ~~our~~unable ~~key~~to ~~executives~~establish ~~include~~sales ~~base salary~~ and ~~the~~marketing ~~granting~~capabilities ofor ~~stock~~enter ~~options~~into ~~that~~agreements ~~vest~~with ~~over~~third ~~time,~~parties ~~designed~~ to ~~encourage~~market ~~such~~and ~~individuals~~sell tothe ~~stay with us. However~~Products, aif ~~low share price could render such agreements of little value to our key executives. In such event~~approved, ~~our~~we ~~key~~may ~~executives could~~ be ~~susceptible to being hired away by our competitors who could offer a better compensation package. If we are~~ unable to ~~attract~~generate ~~and~~any ~~retain~~product ~~key personnel our business, financial conditions and results of operations may be adversely affected~~revenue.

To successfully commercialize the Products, we will need to build out sales and marketing capabilities, either on our own or with others. The establishment and development of our own commercial team or the establishment of a contract field force to market the Products will be expensive and time-consuming and could delay launch. Moreover, we cannot be certain that we will be able to successfully develop this capability. We may seek to enter into collaborations with other entities to use their established marketing and distribution capabilities, but we may be unable to enter into such agreements on favorable terms, if at all. If any current or future collaborators do not commit sufficient resources to commercialize the Products, or we are unable to develop the necessary capabilities on our own, we may be ~~able~~unable to ~~successfully~~generate ~~execute~~sufficient revenue to sustain our business. ~~strategy~~We may compete with many companies that currently have extensive, experienced and well-funded marketing and sales operations to recruit, hire, train and retain marketing and sales personnel. Without an internal team or the support of a third party to perform marketing and sales functions, we may be unable to compete successfully against these more established companies.

The execution of our business strategy poses many challenges and is based on a number of assumptions. If we experience significant regulatory delays, supply chain disruptions, cost overruns on our programs, or if our business plan is more costly than we anticipate, certain research and development activities may be delayed or eliminated, resulting in changes or delays to our commercialization plans, or we may be compelled to secure additional funding (which may or may not be available) to execute our business strategy. We ~~cannot~~rely ~~predict with certainty future revenues or results from operations. If the assumptions~~ on ~~which~~key ~~our revenue or expenditure forecasts are based change, the benefits of our business strategy may change as well~~personnel.

WeOur ~~will~~success ~~require~~depends ~~additional~~in ~~financing~~large measure on certain key personnel, including our chief executive officer, Dr. Raza Bokhari. The loss of the services of such key personnel could have a material adverse effect on us. The contributions of these individuals to our operations have been, and are expected to continue to be, of central importance. In addition, the competition for qualified personnel in the ~~future~~biotech industry is intense and there can be no assurance that we will be able to continue to attract and retain all personnel necessary for the development and operation of our business. Investors must rely upon the ability, expertise, judgment, discretion, integrity and good faith of our management. Other biotechnology companies with which we compete for qualified personnel have greater financial and other resources, different risk profiles and a longer history in the industry than we do. They also may ~~not~~provide more diverse opportunities and better chances for career advancement. Some of these characteristics may be ~~available~~more onappealing ~~favorable~~to ~~terms~~high-quality orcandidates atthan ~~all~~those that we have to offer. If we are unable to continue to attract and retain high-quality personnel, the rate of and success with which we can develop and commercialize the Products would be limited.

~~The~~As ~~development~~a oftechnology-driven ~~our~~company, ~~business~~intellectual input from key management and personnel is ~~expected~~critical to ~~require~~achieve ~~additional~~our ~~financing~~business objectives. ~~Failure~~Consequently, our ability to ~~obtain~~retain ~~sufficient~~these ~~financing~~individuals ~~may~~and ~~result~~attract inother qualified individuals is critical to our success. The loss of the services of key individuals might significantly delay or ~~indefinite~~prevent ~~postponement~~achievement of our business ~~plans~~objectives. ~~The~~In ~~initial~~addition, ~~primary~~because ~~source~~ of ~~funding~~a ~~available~~relative toscarcity usof ~~consists~~individuals ofwith ~~equity~~the ~~financing.~~high ~~There~~degree ~~can~~of beeducation noand ~~assurance~~scientific ~~that~~achievement ~~additional~~required ~~capital~~for orour ~~other~~business, ~~types~~competition ofamong ~~financing~~biotech ~~will~~companies befor ~~available~~qualified ifemployees ~~needed~~is orintense ~~that~~and, ifas ~~available~~a result, ~~the~~we ~~terms~~may ofnot be able to attract and retain such ~~financing~~individuals ~~will~~on beacceptable ~~favorable~~terms, toor usat all.

~~The~~SkinJect ~~ongoing~~also ~~volatility in global capital markets~~ has ~~generally~~relationships ~~made~~with ~~the~~scientific ~~raising~~collaborators ofat ~~capital~~academic byand ~~equity~~other orinstitutions, ~~debt~~some ~~financing~~of ~~more~~whom ~~difficult.~~conduct ~~Access~~research toat ~~financing~~SkinJect's ~~has~~request ~~been~~or ~~negatively~~assist ~~impacted~~SkinJect byin ~~ongoing~~formulating ~~global~~the ~~economic~~SkinJect's ~~risks~~research and ~~increased~~development ~~inflation~~strategies. WeThese ~~will~~scientific ~~require~~collaborators ~~substantial~~are ~~additional~~not ~~funds~~SkinJect ~~for~~employees ~~further research~~ and ~~development, and the marketing and sale of our technology. We~~ may ~~attempt~~have commitments to, ~~raise additional funds for these purposes through public~~ or ~~private~~consulting ~~equity~~ or ~~debt~~advisory ~~financing,~~contracts ~~collaborations~~ with ~~other therapeutic companies~~, ~~government grants or~~ other ~~sources.~~entities ~~There can be no assurance~~ that ~~additional~~may ~~funding~~limit ortheir ~~partnerships~~availability ~~will be available on terms acceptable~~ to us ~~and which would foster the successful commercialization of the Product~~. IfIn ~~additional funds are raised through further issuances of equity or convertible debt securities~~addition, ~~existing~~even ~~shareholders~~though ~~could~~SkinJect's ~~suffer~~collaborators ~~significant~~are ~~dilution,~~required ~~and any new equity securities issued could have rights, preferences and privileges superior~~ to ~~those~~sign ofconfidentiality ~~the~~agreements ~~common~~prior ~~shares or terms superior~~ to ~~those of the Warrants. Any debt financing secured in the future could involve restrictive covenants relating to capital raising activities and other financial and operational matters~~working, ~~which~~they may ~~make~~have itarrangements ~~more~~with ~~difficult~~other ~~for~~companies us to ~~obtain~~assist ~~additional~~such ~~capital~~other orcompanies toin ~~pursue~~developing ~~business~~technologies ~~opportunities,~~that ~~including potential acquisitions. If adequate funds are not obtained, we~~ may beprove ~~required~~competitive to ~~reduce, curtail or discontinue operations~~us.

WeIncentive ~~have~~provisions ~~had~~for ~~negative~~our ~~operating~~key ~~cash~~executives ~~flows~~include ~~since~~base ~~inception~~salary and ~~expect~~the granting of stock options that vest over time, designed to ~~incur~~encourage ~~losses~~such ~~for~~individuals ~~the~~to ~~foreseeable~~stay ~~future~~with us. However, a low share price could render such agreements of little value to our key executives. In such event, our key executives could be susceptible to being hired away by our competitors who could offer a better compensation package. If we are unable to attract and retain key personnel our business, financial conditions and results of operations may be adversely affected.

We ~~have~~may ~~had~~not ~~negative~~be ~~cash~~able ~~flow from operating activities and have incurred operating losses since its inception. We anticipate that we will continue~~ to ~~incur~~successfully ~~losses~~execute ~~for the foreseeable future, and we expect these losses to increase as we continue~~ our ~~research~~business and development of, and seek regulatory approvals for, our product candidates, prepare for and begin to commercialize any approved product candidates and add infrastructure and personnel to support our product development efforts and operations as a public companystrategy. The net losses and negative cash flows incurred to date, together with expected future losses, have had, and likely will continue to have, an adverse effect on our shareholders' deficit and working capital. As of March 31, 2025, we had an accumulated deficit of approximately $34.0 million. The amount of future net losses will depend, in part, on the rate of future growth of our expenses and our ability to generate revenue.

ToThe ~~the~~execution ~~extent~~of ~~that~~our webusiness ~~have~~strategy ~~negative~~poses ~~operating~~many ~~cash~~challenges ~~flow~~and inis ~~future~~based ~~periods,~~on a number of assumptions. If we ~~may~~experience ~~need~~significant toregulatory ~~allocate~~delays, asupply ~~portion~~chain ofdisruptions, ~~our~~cost ~~cash~~overruns ~~reserves~~on toour ~~fund~~programs, ~~such~~or ~~negative~~if ~~cash~~our ~~flow.~~business Weplan ~~may~~is ~~also~~more becostly ~~required~~than towe ~~raise~~anticipate, ~~additional~~certain ~~funds~~research ~~through~~and ~~the~~development ~~issuance~~activities ofmay ~~equity~~be delayed or ~~debt~~eliminated, ~~securities.~~resulting ~~There~~in ~~can~~changes beor nodelays ~~assurance~~to ~~that~~our commercialization plans, or we ~~will~~may be ~~able~~compelled to ~~generate~~secure ~~positive~~additional ~~cash~~funding ~~flow~~(which ~~from~~may or may not be available) to execute our ~~operations~~business orstrategy. ~~that~~We ~~additional~~cannot ~~capital~~predict with certainty future revenues or ~~other~~results ~~types~~from ofoperations. ~~financing~~If ~~will~~the beassumptions ~~available~~on ~~when~~which ~~needed~~our revenue or onexpenditure ~~terms~~forecasts ~~favorable~~are tobased uschange, the benefits of our business strategy may change as well.

We ~~are~~will inrequire aadditional ~~highly~~financing ~~competitive~~in ~~industry~~the future, which ismay ~~continuously~~not ~~evolving~~be ~~with~~available ~~technological~~on ~~changes~~favorable terms or at all.

WeThe ~~are~~development ~~engaged~~of inour anbusiness ~~industry that~~ is ~~highly~~expected ~~competitive,~~to ~~evolving~~require ~~and~~additional ~~characterized by technological change~~financing. AsFailure ~~a result, it is difficult for us~~ to ~~predict~~obtain ~~whether,~~sufficient ~~when~~financing ~~and by whom new competing technologies or new competitors~~ may ~~enter~~result ~~the market. We face competition from companies with strong positions~~ in ~~certain~~the ~~markets~~delay weor ~~are~~indefinite ~~currently~~postponement ~~targeting, and in new markets and regions we may enter. Some~~ of ~~these~~our ~~companies~~business ~~have significantly greater financial, technical, human, research and development, and marketing resources than us~~plans. WeThe ~~cannot~~initial ~~assure~~primary ~~that~~source weof ~~will~~funding beavailable ~~able~~ to ~~compete~~us ~~effectively~~consists ~~against current and future competitors who may discover and develop products in advance~~ of usequity ~~that are more effective than those developed by us~~financing. AsThere acan ~~consequence,~~be ~~our~~no ~~current~~assurance ~~and~~that ~~future~~additional ~~technologies~~capital ~~may become obsolete~~ or ~~uncompetitive, resulting in adverse effects on revenue, margins and profitability. In addition, competition or~~ other ~~competitive~~types ~~pressures may result in price reductions, reduced margins or loss~~ of ~~market~~financing ~~share,~~will ~~any~~be ofavailable ~~which~~if ~~could~~needed ~~have a material adverse effect on our business, financial condition~~ or ~~results of operations. To the extent~~ that, ~~new~~if ~~or improved pharmaceutical drug treatments are introduced that demonstrate better long-term efficacy and safety~~available, ~~patients and physicians may further delay~~ the ~~introduction~~terms of ~~patches,~~ such asfinancing ~~the~~will ~~Product,~~be iffavorable ~~approved,~~to ~~in the skin cancer treatment continuum~~us. ~~The Product could also face competition from other formulations or devices that deliver chemotherapeutic agents on an extended basis.~~

~~Many~~The ongoing volatility in global capital markets has generally made the raising of ~~our~~capital ~~competitors~~by ~~have~~equity ~~substantially~~or ~~greater~~debt ~~financial,~~financing ~~technical~~more ~~and~~difficult. ~~other~~Access ~~resources,~~to ~~such~~financing ashas ~~larger~~been ~~research~~negatively ~~and~~impacted ~~development~~by ~~staffs~~ongoing ~~and~~global ~~experienced~~economic ~~commercial~~risks and ~~manufacturing~~increased ~~organizations~~inflation. ~~Mergers~~We will require substantial additional funds for further research and ~~acquisitions~~development, inand the ~~biotechnology~~marketing and ~~pharmaceutical~~sale ~~industries~~of our technology. We may ~~result~~attempt into ~~even~~raise ~~more~~additional ~~resources~~funds ~~being~~for ~~concentrated~~these inpurposes ~~competitors.~~through Aspublic aor ~~result~~private equity or debt financing, ~~these~~collaborations with other therapeutic companies, ~~may~~government ~~obtain~~grants ~~regulatory~~or ~~approval~~other ~~more~~sources. ~~rapidly~~There ~~than~~can webe ~~are~~no ~~able~~assurance ~~and~~that ~~may~~additional funding or partnerships will be ~~more~~available ~~effective~~on interms ~~selling~~acceptable to us and ~~marketing~~which ~~their~~would ~~products~~foster asthe ~~well~~successful commercialization of the Products. ~~Smaller~~If additional funds are raised through further issuances of equity or ~~early-stage~~convertible ~~companies~~debt ~~may~~securities, ~~also~~existing ~~prove~~shareholders tocould besuffer significant ~~competitors~~dilution, ~~particularly~~and ~~through~~any ~~collaborative~~new ~~arrangements~~equity ~~with~~securities ~~large~~issued could have rights, ~~established~~preferences ~~companies.~~and ~~Competition~~privileges ~~may~~superior ~~increase~~to ~~further~~those asof athe ~~result~~common shares or terms superior to those of ~~advances~~the Warrants. Any debt financing secured in the ~~commercial~~future ~~applicability~~could ofinvolve ~~technologies~~restrictive ~~and~~covenants ~~greater~~relating ~~availability~~to of capital ~~for~~raising ~~investment~~activities inand ~~these~~other ~~industries.~~financial ~~Our~~and ~~competitors~~operational ~~may~~matters, ~~succeed~~which inmay ~~developing,~~make ~~acquiring~~it ormore ~~licensing~~difficult onfor anus ~~exclusive~~to ~~basis~~obtain ~~drug~~additional ~~products~~capital or ~~drug~~to ~~delivery~~pursue ~~technologies~~business ~~that~~opportunities, including potential acquisitions. If adequate funds are ~~more~~not ~~effective~~obtained, orwe ~~less~~may ~~costly~~be ~~than~~required ~~the~~to ~~Product~~reduce, curtail or discontinue operations.

14We have had negative operating cash flows since inception and expect to incur losses for the foreseeable future.

We ~~believe~~have had negative cash flow from operating activities and have incurred operating losses since its inception. We anticipate that we will continue to incur losses for the foreseeable future, and we expect these losses to increase as we continue our ~~ability~~research and development of, and seek regulatory approvals for, our product candidates, prepare for and begin to ~~compete~~commercialize ~~effectively~~any ~~depends~~approved ~~upon~~product ~~many~~candidates ~~factors~~and ~~both~~add ~~within~~infrastructure and ~~beyond~~personnel to support our ~~control~~product development efforts and operations as a public company. The net losses and negative cash flows incurred to date, ~~including:~~together with expected future losses, have had, and likely will continue to have, an adverse effect on our shareholders' deficit and working capital. As of June 30, 2025, we had an accumulated deficit of approximately $40.2 million, which was comprised of approximately $12.4 million of accumulated deficit of SkinJect as of September 30, 2023, the day after it became a subsidiary of the Company, and approximately $27.8 million of deficit accumulated by the Company on a consolidated basis since September 30, 2023). The amount of future net losses will depend, in part, on the rate of future growth of our expenses and our ability to generate revenue.

~~• the usefulness, ease of use, performance and reliability of our technology compared to our competitors;~~14

• To the ~~activity~~extent ~~and~~that ~~tolerability~~we have negative operating cash flow in future periods, we may need to allocate a portion of our cash reserves to fund such negative cash flow. We may also be required to raise additional funds through the ~~Product,~~issuance ~~including~~of ~~relative~~equity or debt securities. There can be no assurance that we will be able to ~~marketed~~generate ~~products~~positive ~~and~~cash ~~product~~flow ~~candidates~~from inour ~~development~~operations byor ~~third~~that ~~parties;~~additional capital or other types of financing will be available when needed or on terms favorable to us.

~~• the~~We ~~ability~~are toin ~~distinguish~~a ~~safety~~highly ~~and~~competitive ~~efficacy~~industry ~~from~~which ~~existing,~~is ~~alternative~~continuously ~~therapies;~~evolving with technological changes.

~~• the~~We ~~timing~~are engaged in an industry that is highly competitive, evolving and characterized by technological change. As a result, it is difficult for us to predict whether, when and by whom new competing technologies or new competitors may enter the ~~Product~~market. toWe ~~complete~~face ~~clinical~~competition from companies with strong positions in certain markets we are currently targeting, and in new markets and regions we may enter. Some of these companies have significantly greater financial, technical, human, research and development, and ~~receive~~marketing resources than us. We cannot assure that we will be able to compete effectively against current and future competitors who may discover and develop products in advance of us that are more effective than those developed by us. As a consequence, our current and future technologies may become obsolete or uncompetitive, resulting in adverse effects on revenue, margins and profitability. In addition, competition or other competitive pressures may result in price reductions, reduced margins or loss of market ~~approval;~~share, any of which could have a material adverse effect on our business, financial condition or results of operations. To the extent that new or improved pharmaceutical drug treatments are introduced that demonstrate better long-term efficacy and safety, patients and physicians may further delay the introduction of patches, such as SkinJectTM, if approved, in the skin cancer treatment continuum or delay the use of Teverelix for the treatment of for the treatment of cardiovascular high-risk prostate cancer patients and patients with first AUR episodes due to an enlarged prostate. SkinJectTM could also face competition from other formulations or devices that deliver chemotherapeutic agents on an extended basis.

~~• acceptance~~Many of ~~the~~our ~~Product~~competitors byhave ~~patients~~substantially greater financial, ~~physicians~~technical and other ~~health~~resources, ~~providers~~such as larger research and development staffs and experienced commercial and manufacturing organizations. Mergers and acquisitions in the biotechnology and pharmaceutical industries may result in even more resources being concentrated in competitors. As a result, these companies may obtain regulatory approval more rapidly than we are able and may be more effective in selling and marketing their products as well. Smaller or early-stage companies may also prove to be significant competitors, particularly through collaborative arrangements with large, established companies. Competition may increase further as a result of advances in the commercial applicability of technologies and greater availability of capital for investment in these industries. Our competitors may succeed in developing, acquiring or licensing on an exclusive basis drug products or drug delivery technologies that are more effective or less costly than the Products.

• We believe that our ability to ~~monetize~~compete effectively depends upon many factors both within and beyond our ~~technology;~~control, including:

• the ~~selection~~usefulness, ease of ~~licensing~~use, ~~partners~~performance ~~for~~and reliability of our technology ~~with~~compared ~~the necessary skills and resources~~ to ~~drive~~our ~~uptake~~competitors;
~~• our~~the ~~marketing~~activity and ~~selling~~tolerability ~~efforts~~of the Products, including relative to marketed products and product candidates in development by third parties;
~~• our~~the ~~financial~~ability ~~condition~~to distinguish safety and ~~results~~efficacy offrom ~~operations~~existing, alternative therapies;
• the ~~ability~~timing for the Products to ~~maintain~~complete aclinical ~~good~~development ~~relationship~~and ~~with~~receive ~~regulatory~~market ~~authorities~~approval;
~~• the~~acceptance ~~price~~ of ~~our~~the ~~future~~Products ~~products~~by patients, ~~including~~physicians inand ~~comparison~~other tohealth ~~branded or generic competitors;~~providers,
~~• whether~~our ~~coverage~~ability ~~and~~to ~~adequate~~monetize ~~levels~~our ~~of reimbursement are available under private and governmental health insurance plans,~~technology;
~~• acquisitions~~the orselection ~~consolidations~~of ~~within~~licensing partners for our ~~industry,~~technology ~~which~~with ~~may~~the ~~result~~necessary inskills ~~more~~and ~~formidable~~resources ~~competitors~~to drive uptake;

~~• our ability to protect our intellectual property rights,~~15

• our ~~ability~~marketing ~~to attract, retain~~ and ~~motivate~~selling ~~talented employees~~efforts;
• our ~~ability~~financial tocondition ~~cost-effectively manage~~ and ~~grow~~results ~~our~~of operations; ~~and~~
~~• our~~the ~~reputation~~ability ~~and~~to ~~brand~~maintain ~~strength~~a ~~relative~~good torelationship ~~that~~with ofregulatory ~~our competitors.~~authorities;
~~Our~~the ~~future~~price ~~success~~of ~~will~~our ~~depend~~future onproducts, ~~our~~including ~~ability~~in comparison to ~~continually~~branded ~~enhance~~or ~~and~~generic ~~develop the Product.~~competitors;
~~There~~whether iscoverage ~~a broad pipeline of potential new therapies for skin cancer. The market is characterized by rapid technological change~~ and ~~the~~adequate ~~possibility~~levels of ~~frequent~~reimbursement ~~new~~are ~~product~~available ~~introductions.~~under ~~Accordingly,~~private ~~our future success depends upon our ability to enhance the Product~~ and togovernmental ~~develop,~~health ~~introduce~~insurance ~~and sell the most accurate products at competitive prices. The development of new technologies and products involves time~~plans, substantial costs and risks. Our ability to successfully develop new technologies depends in large measure on our ability to maintain a technically skilled research and development staff and to adapt to technological changes and advances in the industry.
~~The~~acquisitions success of new product introductions depends on a number of factors including the efficacy and safety as demonstrated in clinical trials, the ability to demonstrate the impact of real world evidence, timely and successful product development, the timing and market introduction of competitive products, market acceptance, the effective management of purchase commitments and inventory levels in line with anticipated product demand, the availability of pharmaceutical components in appropriate quantities and costs to meet anticipated demand, the risk that new products may have quality or ~~other~~consolidations ~~defects~~within ~~in the early stages of introduction and~~ our ~~ability to manage distribution and production issues related to new product introductions~~industry, ~~the clinical indications for~~ which ~~the~~may ~~product~~result is approved, acceptance by physicians, the medical community and patients of the product as a safe and effective treatment, the ability to distinguish safety and efficacy from existing, less expensive alternative therapies, the convenience of prescribing, administrating and initiating patients on the product, the potential and perceived advantages and/or value of the product over alternative treatments, the cost of treatment in ~~relation~~more toformidable alternative treatments, including any similar generic treatments, the availability of coverage and adequate reimbursement by third-party payors and government authorities to support the product's pricing, the prevalence and severity of adverse side effects and the effectiveness of sales and marketing efforts.competitors;
15our ability to protect our intellectual property rights,
Ifour weability ~~are unable, for any reason,~~ to ~~enhance~~attract, ~~develop,~~retain ~~introduce~~ and ~~sell~~motivate ~~new~~talented ~~products in a timely manner, or at all, in response to changing market conditions or customer requirements or otherwise, our business would be harmed.~~employees;
Ifour we are unable to differentiate the Product from existing therapies for treatment of skin cancer, or if the FDA or other applicable regulatory authorities approve generic products that compete with the Product, the ability to ~~successfully~~cost-effectively ~~commercialize~~manage ~~the~~and ~~Product~~grow ~~would~~our beoperations; ~~adversely affected.~~and
~~Although~~our ~~the~~reputation ~~Phase 1 study provides preliminary evidence of complete clinical response, it is possible that we will receive data from additional clinical trials or in a post marketing setting from physician~~ and ~~patient~~brand ~~experiences~~strength ~~with~~relative ~~the commercial product that does not continue~~ to ~~support such interpretations. It is also possible~~ that ~~the~~of ~~FDA, physicians and healthcare payers will not agree with~~ our ~~interpretation of existing and future clinical trial data~~competitors. If we are unable to demonstrate the value of the Product based on clinical data, patient experience, as well as real world evidence, the opportunity for the Product to maintain premium pricing and be commercialized successfully would be adversely affected.

~~Additionally,~~Our ~~the~~future ~~FDA~~success orwill ~~other~~depend ~~applicable~~on ~~regulatory authorities may approve other generic products that could compete with the Product if we cannot adequately protect it with~~ our ~~patent~~ability portfolio. For example, in the US, once an NDA is approved, the product covered thereby becomes a "listed drug" which can, in turn, be cited by potential competitors in support of approval of an abbreviated new drug application ("ANDA"). The Federal Food, Drug, and Cosmetic Act (the "FDCA"), FDA regulations and other applicable regulations and policies provide incentives to ~~manufacturers~~continually toenhance create modified, non-infringing versions of a drug to facilitate the approval of an ANDA or other application for generic substitutes. These manufacturers might only be required to conduct a relatively inexpensive study to show that their product has the same active ingredient(s), dosage form, strength, route of administration, conditions of use, or labeling as our product candidate and ~~that~~develop the ~~generic product is bioequivalent to us, meaning it is absorbed in the body at the same rate and to the same extent as the Product~~Products. These generic equivalents, which must meet the same quality standards as branded pharmaceuticals, would be significantly less costly than ours to bring to market and companies that produce generic equivalents are generally able to offer their products at lower prices. Thus, after the introduction of a generic competitor, a significant percentage of the sales of any branded product is typically lost to the generic product. Accordingly, competition from generic equivalents to our products would materially adversely impact our ability to successfully commercialize the Product.

AThere ~~variety~~is a broad pipeline of ~~risks~~potential ~~associated~~new therapies that may compete with ~~potential~~the ~~international~~Products. ~~business~~The ~~relationships~~market ~~could~~is ~~materially~~characterized ~~adversely~~by ~~affect~~rapid technological change and the possibility of frequent new product introductions. Accordingly, our ~~business~~future success depends upon our ability to enhance the Products and to develop, introduce and sell the most accurate products at competitive prices. The development of new technologies and products involves time, substantial costs and risks. Our ability to successfully develop new technologies depends in large measure on our ability to maintain a technically skilled research and development staff and to adapt to technological changes and advances in the industry.

WeThe ~~may~~success ~~enter~~of ~~into~~new ~~agreements~~product ~~with~~introductions ~~third~~depends ~~parties~~on ~~for~~a number of factors including the efficacy and safety as demonstrated in clinical trials, the ability to demonstrate the impact of real world evidence, timely and successful product development, the timing and ~~commercialization~~market introduction of competitive products, market acceptance, the ~~Product~~effective management of purchase commitments and inventory levels in ~~international~~line ~~markets.~~with Ifanticipated weproduct dodemand, sothe availability of pharmaceutical components in appropriate quantities and costs to meet anticipated demand, wethe ~~would~~risk bethat ~~subject~~new products may have quality or other defects in the early stages of introduction and our ability to ~~additional~~manage ~~risks~~distribution and production issues related to ~~entering~~new ~~into~~product ~~international~~introductions, ~~business~~the ~~relationships~~clinical indications for which the product is approved, acceptance by physicians, the medical community and patients of the product as a safe and effective treatment, the ability to distinguish safety and efficacy from existing, less expensive alternative therapies, the convenience of prescribing, administrating and initiating patients on the product, the potential and perceived advantages and/or value of the product over alternative treatments, the cost of treatment in relation to alternative treatments, including: any similar generic treatments, the availability of coverage and adequate reimbursement by third-party payors and government authorities to support the product's pricing, the prevalence and severity of adverse side effects and the effectiveness of sales and marketing efforts.

~~● differing~~If ~~regulatory~~we ~~requirements~~are inunable, ~~other~~for ~~countries~~any ~~including~~reason, ~~among~~to ~~others~~enhance, ~~marketing~~develop, ~~approval~~introduce and sell new products in a timely manner, ~~pricing~~or at all, ~~reimbursement~~in ~~and~~response ~~sales~~to ~~and~~changing ~~marketing~~market ~~practices;~~conditions or customer requirements or otherwise, our business would be harmed.

~~● potentially reduced protection for intellectual property rights;~~16

16If we are unable to differentiate SkinJectTM from existing therapies for treatment of skin cancer or Teverelix from therapies for high cardiovascular risk advanced prostate cancer patients or from treatment of recurrent AUR ("AURr") episodes, or if the FDA or other applicable regulatory authorities approve generic products that compete with the Products, the ability to successfully commercialize the Products would be adversely affected.

~~● potential~~It ~~for~~is ~~so-called~~possible ~~parallel~~that ~~importing,~~we ~~which~~will isreceive ~~when~~data afrom ~~local~~additional ~~seller~~clinical trials in respect of either or both of SkinJectTM and Teverelix, ~~faced~~or in a post marketing setting from physician and patient experiences with ~~higher~~the ~~local~~commercial ~~prices~~products, ~~opts~~that does not continue to ~~import~~support ~~goods~~such ~~from~~interpretations. aIt ~~foreign~~is ~~market~~also possible that the FDA, physicians and healthcare payers will not agree with ~~lower~~our ~~prices~~interpretation of existing and future clinical trial data. If we are unable to demonstrate the value of the Products based on clinical data, ~~rather~~patient ~~than~~experience, ~~buying~~as ~~them~~well ~~locally;~~as real world evidence, the opportunity for the Products to maintain premium pricing and be commercialized successfully would be adversely affected.

~~● unexpected~~Additionally, ~~changes~~the FDA or other applicable regulatory authorities may approve other generic products that could compete with the Products if we cannot adequately protect it with our patent portfolio. For example, in ~~tariffs~~the US, ~~trade~~once ~~barriers~~an ~~and~~NDA ~~regulatory~~is ~~requirements~~approved, ~~including~~ the ~~imposition~~product covered thereby becomes a "listed drug" which can, in turn, be cited by potential competitors in support of approval of an abbreviated new ~~tariffs~~drug byapplication ("ANDA"). The Federal Food, Drug, and Cosmetic Act (the U"FDCA"), FDA regulations and other applicable regulations and policies provide incentives to manufacturers to create modified, non-infringing versions of a drug to facilitate the approval of an ANDA or other application for generic substitutes.S. ~~government~~These onmanufacturers ~~imports~~might only be required to conduct a relatively inexpensive study to show that their product has the Usame active ingredient(s), dosage form, strength, route of administration, conditions of use, or labeling as our product candidate and that the generic product is bioequivalent to us, meaning it is absorbed in the body at the same rate and to the same extent as the Products.S. These generic equivalents, which must meet the same quality standards as branded pharmaceuticals, would be significantly less costly than ours to bring to market and~~/or~~ companies that produce generic equivalents are generally able to offer their products at lower prices. Thus, after the ~~imposition~~introduction of ~~retaliatory~~a ~~tariffs~~generic bycompetitor, ~~foreign~~a ~~countries;~~significant percentage of the sales of any branded product is typically lost to the generic product. Accordingly, competition from generic equivalents to our products would materially adversely impact our ability to successfully commercialize the Products.

~~● economic~~A ~~weakness,~~variety ~~including~~of ~~inflation,~~risks orassociated ~~political~~with ~~instability~~potential ininternational ~~foreign~~business ~~economies~~relationships ~~and~~could ~~markets;~~materially adversely affect our business.

~~● compliance~~We ~~with~~may ~~tax,~~enter ~~employment,~~into ~~immigration~~agreements ~~and~~with ~~labor~~third ~~laws~~parties for ~~employees~~the ~~traveling~~development and ~~working~~commercialization ~~abroad;~~of the Products in international markets. If we do so, we would be subject to additional risks related to entering into international business relationships, including:

~~● foreign~~differing ~~taxes~~regulatory requirements in other countries including, among others, marketing approval, pricing, reimbursement and sales and marketing practices;
~~● foreign~~potentially ~~currency fluctuations, which could result in increased operating expenses and~~ reduced ~~revenues,~~protection ~~and~~for ~~other~~intellectual ~~risks~~property ~~incident to doing business in another country~~rights;
~~● workforce~~potential ~~uncertainty~~for inso-called ~~countries~~parallel ~~where~~importing, ~~labor~~which ~~unrest~~ is ~~more~~when ~~common~~a ~~than~~local inseller, ~~Canada~~faced orwith ~~the~~higher ~~United~~local ~~States~~prices, opts to import goods from a foreign market with lower prices, rather than buying them locally;
~~● production~~unexpected ~~shortages~~changes ~~resulting~~in ~~from~~tariffs, ~~any~~trade ~~events~~barriers ~~affecting~~and ~~raw~~regulatory ~~material~~requirements, ~~supply~~including orthe ~~manufacturing~~imposition ~~capabilities~~of ~~abroad~~new ortariffs ~~supply~~by ~~chain~~the ~~disruptions;~~U.S. government on imports to the U.S. and/or the imposition of retaliatory tariffs by foreign countries;
~~● business~~economic ~~interruptions resulting from geo-political actions~~weakness, including ~~war and terrorism~~inflation, or ~~natural~~political ~~disasters,~~instability ~~including~~in ~~earthquakes,~~foreign ~~volcanoes,~~economies ~~typhoons, floods, tsunamis, hurricanes~~ and ~~fires.~~markets;
~~These~~compliance ~~and~~with ~~other~~tax, ~~risks~~employment, ~~may~~immigration ~~materially adversely affect our ability to develop~~ and ~~commercialize~~labor ~~products~~laws infor ~~international~~employees ~~markets~~traveling and ~~may~~working ~~harm our business.~~abroad;
~~Collaboration~~foreign ~~arrangements we may enter into in the future may not be successful.~~taxes;

We may seek future partnerships, collaborations and other strategic transactions to maximize the commercial potential of the Product. We may enter into such arrangements on a selective basis depending on the merits of retaining commercialization rights for ourself as compared to entering into selective collaboration arrangements with leading pharmaceutical or biotechnology companies, both in the United States and internationally. We face competition in seeking appropriate collaborators. Moreover, collaboration arrangements are complex and time consuming to negotiate, document and implement. We may not be successful in our efforts to establish and implement collaborations or other alternative arrangements should we choose to enter into such arrangements. The terms of any collaborations or other arrangements that we may establish may not be favorable to us.17

~~Any~~foreign ~~future~~currency ~~collaborations~~fluctuations, ~~that~~which wecould ~~enter~~result ~~into~~in ~~may~~increased ~~not~~operating beexpenses ~~successful.~~and ~~The~~reduced ~~success~~revenues, ofand ~~our~~other ~~collaboration~~risks ~~arrangements~~incident ~~will~~to ~~depend~~doing ~~heavily~~business onin ~~the~~another ~~efforts and activities of our collaborators.~~country;
~~Collaborators~~workforce ~~generally~~uncertainty ~~have~~in ~~significant~~countries ~~discretion~~where inlabor ~~determining~~unrest ~~the~~is ~~efforts~~more ~~and~~common ~~resources~~than ~~that~~in ~~they~~Canada ~~will~~or ~~apply~~the toUnited ~~these collaborations.~~States;
~~Disagreements~~production ~~between~~shortages ~~parties~~resulting tofrom aany ~~collaboration~~events ~~arrangement~~affecting ~~regarding~~raw ~~clinical~~material ~~development~~supply ~~and~~or ~~commercialization~~manufacturing ~~matters~~capabilities ~~could~~abroad ~~lead to delays in the development process~~ or ~~commercialization~~supply ofchain ~~our~~disruptions; ~~product candidate~~ and~~, in some cases, termination of the collaboration arrangement. These disagreements can be difficult to resolve if neither of the parties has final decision-making authority.~~
~~Collaborations~~business ~~with~~interruptions ~~pharmaceutical~~resulting orfrom ~~biotechnology~~geo-political ~~companies~~actions, ~~and~~including ~~other~~war ~~third~~and ~~parties~~terrorism, ~~often are terminated~~ or ~~allowed~~natural todisasters, ~~expire~~including byearthquakes, ~~the~~volcanoes, ~~other~~typhoons, ~~party.~~floods, ~~Any~~tsunamis, ~~such~~hurricanes ~~termination or expiration could adversely affect us financially~~ and ~~could harm our business reputation~~fires.

17These and other risks may materially adversely affect our ability to develop and commercialize products in international markets and may harm our business.

WeCollaboration ~~may~~arrangements ~~acquire~~we ~~businesses~~may orenter ~~products,~~into ~~or form strategic alliances~~ in the future, ~~and we~~ may not ~~realize~~be ~~the benefits of such acquisitions or alliances~~successful.

We may ~~acquire~~seek ~~additional~~future ~~businesses~~partnerships, orcollaborations ~~products,~~and ~~form~~other strategic ~~alliances~~transactions orto ~~create~~maximize ~~joint~~the ~~ventures~~commercial ~~with~~potential ~~third~~of ~~parties~~the ~~that~~Products. weWe ~~believe~~may ~~will~~enter ~~complement~~into orsuch ~~augment~~arrangements ~~our~~on ~~existing~~a ~~business.~~selective Ifbasis wedepending ~~acquire~~on ~~businesses~~the ~~with~~merits ~~promising~~of ~~markets~~retaining orcommercialization ~~technologies,~~rights wefor ~~may~~ourself ~~not~~as becompared ~~able~~ to ~~realize~~entering ~~the~~into ~~benefit~~selective ofcollaboration ~~acquiring~~arrangements ~~such~~with ~~businesses~~leading ifpharmaceutical weor ~~are~~biotechnology ~~unable~~companies, toboth ~~successfully~~in ~~integrate~~the ~~them~~United ~~with~~States ~~our existing operations~~ and ~~company culture~~internationally. We ~~may~~face ~~encounter~~competition ~~numerous difficulties~~ in ~~developing,~~seeking ~~manufacturing~~appropriate ~~and~~collaborators. ~~marketing~~Moreover, ~~any~~collaboration ~~new~~arrangements ~~products~~are ~~resulting~~complex ~~from~~and atime ~~strategic~~consuming ~~alliance~~to ornegotiate, ~~acquisition~~document ~~that~~and ~~delay or prevent us from realizing their expected benefits or enhancing our business~~implement. We ~~cannot~~may ~~assure~~not ~~you~~be ~~that,~~successful ~~following~~in ~~any~~our ~~such~~efforts ~~acquisition,~~to weestablish ~~will~~and ~~achieve~~implement ~~the~~collaborations ~~expected~~or ~~synergies~~other toalternative ~~justify~~arrangements ~~the~~should ~~transaction. In addition,~~ we ~~may~~choose ~~require~~to ~~significant~~enter ~~additional~~into ~~funds~~such toarrangements. ~~either~~The ~~acquire~~terms ~~such~~of ~~businesses~~any orcollaborations ~~products~~ or toother ~~commercialize~~arrangements ~~them,~~that ~~which~~we may ~~result~~establish inmay ~~significant~~not ~~dilution~~be favorable to ~~shareholders or the incurrence of significant indebtedness by~~ us.

WeAny dofuture collaborations that we enter into may not ~~have~~be ~~any~~successful. ~~customer~~The ~~commitments~~success of our collaboration arrangements will depend heavily on the efforts and activities of our collaborators.

WeCollaborators ~~may~~generally ~~negotiate~~have ~~clinical~~significant ~~and/or~~discretion ~~commercial~~in ~~supply~~determining ~~agreements for~~ the ~~Product~~efforts or product sub-components. At the time of this prospectus, there are no commitments from customers for the Product. Because we do not have any contracts for the Product, management may not accurately predict future revenue streams and ~~there~~resources ~~may be no assurance~~ that ~~customers~~they ~~would~~will ~~continue~~apply to ~~use~~these ~~our products, or that we would be able to replace departing potential customers with new potential customers that provide us with comparable revenue~~collaborations.

~~Our~~Disagreements ~~business~~between parties to a collaboration arrangement regarding clinical development and ~~operations~~commercialization ~~would~~matters ~~suffer~~could lead to delays in the ~~event~~development process or commercialization of ~~computer~~our ~~system~~product ~~failures~~candidate and, ~~cyberattacks~~in some cases, ortermination aof ~~deficiency~~the incollaboration ~~our~~arrangement. ~~cyber~~These ~~security~~disagreements can be difficult to resolve if neither of the parties has final decision-making authority.

~~Despite~~Collaborations ~~the~~with ~~implementation~~pharmaceutical ofor ~~security~~biotechnology ~~measures,~~companies ~~our internal computer systems,~~ and ~~those~~other ~~of the~~ third parties onoften ~~which~~are weterminated ~~rely,~~or ~~are~~allowed ~~vulnerable~~ to ~~damage~~expire ~~from~~by ~~computer~~the ~~viruses,~~other ~~unauthorized access, natural disasters, terrorism, war and telecommunication and electrical failures~~party. IfAny such antermination ~~event~~or ~~were~~expiration ~~to occur and cause interruptions in our operations, it~~ could ~~result~~adversely inaffect aus ~~material~~financially ~~disruption~~and of our commercialization or further development of our technology. To the extent that any disruption or security breach were to result in a loss of or damage to our data or applications, or inappropriate disclosure of confidential or proprietary information, we could ~~incur~~harm ~~liability and the further development or the commercialization of~~ our ~~products~~business ~~could be delayed or disrupted~~reputation.

We may ~~fail~~acquire tobusinesses ~~manage~~or ~~growth~~products, ~~successfully~~or ~~which~~form strategic alliances in the future, and we may ~~adversely~~not ~~impact~~realize ~~operating~~the ~~results~~benefits of such acquisitions or alliances.

~~Our~~We ~~failure~~may toacquire ~~manage~~additional ~~our~~businesses ~~growth~~or ~~successfully~~products, ~~may~~form ~~adversely~~strategic ~~impact~~alliances or create joint ventures with third parties that we believe will complement or augment our ~~operating~~existing ~~results~~business. ~~Our~~If ~~ability~~we toacquire ~~manage~~businesses ~~growth~~with ~~will~~promising ~~require~~markets usor technologies, we may not be able to ~~continue~~realize the benefit of acquiring such businesses if we are unable to ~~build~~successfully integrate them with our ~~operational,~~existing ~~financial~~operations and ~~management~~company ~~controls,~~culture. ~~contracting~~We ~~relationships~~may encounter numerous difficulties in developing, ~~marketing~~manufacturing and ~~business~~marketing ~~development~~any ~~plans~~new ~~and~~products ~~controls~~resulting ~~and~~from ~~reporting~~a ~~systems~~strategic ~~and~~alliance ~~procedures.~~or ~~Our~~acquisition ~~ability~~that todelay ~~manage~~or prevent us from realizing their expected benefits or enhancing our ~~growth~~business. We cannot assure you that, following any such acquisition, we will ~~also~~achieve ~~depend~~the inexpected ~~large~~synergies ~~part~~to ~~upon~~justify athe ~~number~~transaction. ofIn ~~factors~~addition, ~~including~~we ~~the~~may ~~ability~~require ~~for~~significant usadditional funds to ~~rapidly:~~either acquire such businesses or products or to commercialize them, which may result in significant dilution to shareholders or the incurrence of significant indebtedness by us.

~~• expand our internal and operational and financial controls significantly so that we can maintain control over operations;~~18

~~• attract~~We ~~and~~do ~~retain~~not ~~qualified~~have ~~technical~~any ~~personnel in order to continue to develop reliable and flexible products and provide services that respond to evolving~~ customer ~~needs;~~commitments.

~~• build~~We amay ~~sales~~negotiate ~~team~~clinical toand/or ~~keep~~commercial supply agreements for the Products or product sub-components. At the time of this prospectus, there are no commitments from customers ~~and~~for ~~channel~~the ~~partners~~Products. ~~informed~~Because ~~regarding~~we do not have any contracts for the ~~technical~~Products, ~~features~~management ~~issues~~may not accurately predict future revenue streams and ~~key~~there ~~selling~~may ~~points~~be ofno assurance that customers would continue to use our products, ~~and~~or ~~services;~~that we would be able to replace departing potential customers with new potential customers that provide us with comparable revenue.

~~• develop~~Our ~~support~~business ~~capacity~~and ~~for~~operations ~~customers~~would assuffer ~~sales~~in ~~increase;~~the ~~and~~event of computer system failures, cyberattacks, or a deficiency in our cyber security.

~~• build~~Despite athe ~~channel~~implementation ~~network~~of security measures, our internal computer systems, and those of the third parties on which we rely, are vulnerable to ~~create~~damage from computer viruses, unauthorized access, natural disasters, terrorism, war and telecommunication and electrical failures. If such an ~~expanding~~event ~~presence~~were to occur and cause interruptions in our operations, it could result in a material disruption of our commercialization or further development of our technology. To the ~~evolving~~extent ~~marketplace~~that ~~for~~any disruption or security breach were to result in a loss of or damage to our ~~products~~data or applications, or inappropriate disclosure of confidential or proprietary information, we could incur liability and ~~services~~the further development or the commercialization of our products could be delayed or disrupted.

18We may fail to manage growth successfully which may adversely impact operating results.

AnOur ~~inability~~failure to ~~achieve~~manage ~~any~~our ofgrowth ~~these~~successfully ~~objectives~~may ~~could~~adversely ~~harm~~impact our ~~business~~operating results. Our ability to manage growth will require us to continue to build our operational, financial ~~condition~~and management controls, contracting relationships, marketing and ~~results~~business ofdevelopment ~~operations~~plans and controls and reporting systems and procedures. Our ability to manage our growth will also depend in large part upon a number of factors, including the ability for us to rapidly:

~~Any~~expand ~~products~~our weinternal ~~develop~~and ~~will~~operational ~~be subject to extensive, lengthy~~ and ~~uncertain~~financial ~~regulatory~~controls ~~requirements,~~significantly ~~which~~so ~~could~~that ~~adversely~~we ~~affect~~can ~~the~~maintain ~~ability~~control toover ~~obtain regulatory approval in a timely manner, or at all.~~operations;
Itattract ~~is understood that pharmacologic therapies are subject to an extensive, lengthy~~ and ~~unpredictable~~retain ~~regulatory~~qualified ~~approval~~technical ~~process~~personnel ~~by the FDA and equivalent regulatory bodies~~ in ~~other~~order ~~countries.~~to ~~This~~continue ~~entails significant investment in time and resources, with no guarantee on the outcome or timeframe. We may encounter significant delays or excessive costs in our efforts~~ to ~~secure~~develop ~~necessary~~reliable ~~market authorizations. Even if approved, the different regulatory bodies have numerous regulations governing the manufacturing, labeling, distributing, marketing, promotion~~ and ~~advertising~~flexible ~~after product approval. The regulatory requirements governing new technologies might be subject to change, and the~~ products ~~themselves may be subject to substantial review by the FDA~~ and~~/or~~ ~~other~~provide ~~governmental~~services ~~regulatory authorities~~ that ~~could~~respond ~~prevent or delay approval of these products. Regulatory constraints ultimately imposed on our products, if approved, could limit our ability~~ to ~~commercialize,~~evolving ~~thus~~customer ~~impacting on our financial condition and results.~~needs;
~~Manufacture~~build ~~and~~a ~~marketing~~sales ofteam ~~the Product is subject~~ to ~~government~~keep ~~regulation.~~customers ~~In most countries, we will be required to complete extensive non-clinical studies~~ and ~~clinical~~channel ~~trials~~partners toinformed ~~demonstrate~~regarding the ~~safety~~technical ~~and~~features ~~efficacy~~issues ~~of the Product in order to apply for regulatory approval to market the product. Prior to marketing approval in the United States, required steps include non-clinical (animal~~ and ~~laboratory)~~key ~~testing;~~selling ~~performance~~points of adequate and well-controlled human clinical trials to establish the safety and efficacy of the Product in the intended target population; performance of a consistent and reproducible manufacturing process intended for commercial use; and successful filing and approval of an NDA. These processes are costly and the timeframe and success are uncertain and may be out of our ~~control.~~products ~~We also have no control over the extent of approval, which can be restricted to specific jurisdictions~~ and~~/or~~ ~~conditions on the product label and limit our revenues.~~services;
~~Once~~develop ~~approved,~~support wecapacity ~~will be subjected to continuing regulatory review, including adverse event reporting requirements and the FDA's general prohibition against promoting products~~ for ~~unapproved~~customers ~~uses. We may also have other forms of post approval commitments, such~~ as ~~clinical~~sales ~~trials~~increase; ~~or enhanced safety reporting~~ and commitments. Failure to comply with any post-approval requirements can have consequences including warning letters, product seizures, recalls, substantial fines, injunctions, withdrawal of approvals, operating restrictions and criminal prosecutions. Any of these enforcement actions, any unanticipated changes in existing regulatory requirements or the adoption of new requirements, or any safety issues that arise with any approved products, could negatively impact on our ability to market products and generate revenues and thus our ability to continue our operations.
Webuild ~~also may be restricted or prohibited from marketing or manufacturing~~ a ~~product,~~channel ~~even~~network after obtaining product approval, if previously unknown problems with the product or our manufacturer are subsequently discovered. Moreover, we cannot provide assurance that newly discovered or developed safety issues will not arise following any regulatory approval. If our product is used by a large patient population, serious adverse events may occur from time to ~~time~~create ~~that~~an ~~initially~~expanding ~~may~~presence ~~seem~~in ~~unconnected to~~ the ~~treatment,~~evolving ~~and~~marketplace ~~only~~for when it repeatedly occurs over a period of time does the treatment become suspect as having a causal relationship to the adverse event. Any safety issues could cause us to suspend or cease marketing of our ~~approved~~ products, ~~possibly subject us to substantial liabilities,~~ and ~~adversely affect our ability to generate revenues~~services.

WeAn ~~may~~inability ~~not~~to beachieve ~~able~~any toof ~~obtain~~these ~~marketing~~objectives ~~approval~~could harm our business, financial condition and results of operations.

~~Even~~Any ifproducts we ~~complete~~develop ~~the~~will ~~necessary~~be ~~non-clinical~~subject ~~studies~~to ~~and clinical trials~~extensive, ~~the~~lengthy ~~marketing approval process is expensive, time-consuming,~~ and uncertain ~~and~~regulatory ~~may~~requirements, ~~prevent~~which uscould ~~from~~adversely ~~obtaining~~affect ~~approvals for~~ the ~~commercialization~~ability ~~of the Product. If we are not able~~ to obtain, orregulatory ifapproval ~~there are delays~~ in ~~obtaining,~~a ~~required~~timely ~~regulatory approvals~~manner, ~~we will not be able to commercialize,~~ or ~~will~~at ~~be delayed in commercializing, the Product, and our ability to generate revenue will be materially impaired~~all.

19It is understood that pharmacologic therapies are subject to an extensive, lengthy and unpredictable regulatory approval process by the FDA and equivalent regulatory bodies in other countries. This entails significant investment in time and resources, with no guarantee on the outcome or timeframe. We may encounter significant delays or excessive costs in our efforts to secure necessary market authorizations. Even if approved, the different regulatory bodies have numerous regulations governing the manufacturing, labeling, distributing, marketing, promotion and advertising after product approval. The regulatory requirements governing new technologies might be subject to change, and the products themselves may be subject to substantial review by the FDA and/or other governmental regulatory authorities that could prevent or delay approval of these products. Regulatory constraints ultimately imposed on our products, if approved, could limit our ability to commercialize, thus impacting on our financial condition and results.

~~We rely on the protection of intellectual property rights.~~19

~~Our~~Manufacture ~~commercial~~and ~~success~~marketing ~~depends~~of tothe aProducts ~~significant~~is ~~degree~~subject ~~upon our ability~~ to ~~develop~~government ~~new~~regulation. orIn ~~improved~~most ~~technologies~~countries, ~~instruments~~we ~~and~~will ~~products,~~be ~~and~~required to ~~obtain~~complete ~~patents~~extensive ornon-clinical ~~other~~studies ~~intellectual~~and ~~property~~clinical ~~rights~~trials orto ~~statutory~~demonstrate ~~protection~~the ~~for~~safety ~~these technologies~~ and ~~products~~efficacy inof ~~Canada,~~ the ~~United~~Products ~~States~~in ~~and~~order ~~other~~to ~~countries,~~apply ~~such~~for asregulatory ~~the~~approval ~~countries~~to inmarket the ~~European~~product. ~~Union~~Prior ~~and~~to ~~Asia.~~marketing Weapproval ~~intend~~in tothe ~~patent~~United ~~concepts~~States, ~~components,~~required ~~processes,~~steps ~~industrial~~include ~~designs~~non-clinical (animal and ~~methods,~~laboratory) ~~and~~testing; ~~other~~performance ~~inventions~~of adequate and ~~technologies~~well-controlled ~~that~~human weclinical ~~considers~~trials to ~~have~~establish ~~commercial~~the ~~value~~safety orand ~~that~~efficacy ~~will~~of ~~likely~~the ~~give~~Products usin the intended target population; performance of a ~~competitive~~consistent ~~advantage.~~and ~~Despite~~reproducible ~~devoting~~manufacturing ~~resources~~process tointended ~~the~~for ~~research~~commercial use; and ~~development~~successful filing and approval of ~~proprietary~~an ~~technology,~~NDA. weThese ~~may~~processes ~~not~~are becostly ~~able~~and tothe ~~develop~~timeframe ~~new~~and ~~technology~~success ~~that~~are isuncertain ~~patentable~~and ormay ~~protectable.~~be ~~Further,~~out ~~patents~~of ~~issued~~our tocontrol. ~~us,~~We ifalso ~~any,~~have ~~could~~no becontrol ~~challenged,~~over ~~held~~the ~~invalid~~extent orof ~~unenforceable~~approval, orwhich can be ~~circumvented~~restricted ~~and~~to ~~may~~specific ~~not~~jurisdictions ~~provide~~and/or usconditions ~~with~~on ~~necessary~~the orproduct ~~sufficient~~label ~~protection~~and orlimit aour ~~competitive advantage~~revenues.

InOnce ~~addition~~approved, ~~despite~~we ~~our~~will ~~efforts to protect and maintain our patents competitors and other third parties may~~ be ~~able~~subjected to ~~design~~continuing ~~around~~regulatory ~~our patents~~review, ifincluding soadverse ~~awarded,~~event orreporting ~~develop~~requirements ~~products~~and ~~similar to our products that are not within~~ the ~~scope~~FDA's ofgeneral ~~such~~prohibition ~~patents.~~against ~~Finally,~~promoting ~~patents~~products ~~provide certain statutory protection only~~ for aunapproved ~~limited~~uses. ~~period~~We ofmay ~~time~~also ~~that~~have ~~varies~~other ~~depending~~forms ~~on the jurisdiction and type~~ of ~~patent.~~post ~~The~~approval ~~statutory protection term of our patents expire between 2030 and 2035 and~~commitments, ~~thereafter, the underlying technology of~~ such ~~patents~~as ~~will~~clinical betrials ~~allowed~~or toenhanced besafety ~~used~~reporting byand ~~any third party, including our competitors~~commitments. ~~Moreover,~~Failure ~~the inventions covered by patents may be free~~ to becomply ~~used~~with inany ~~countries~~post-approval ~~for~~requirements ~~which~~can ~~there~~have isconsequences noincluding ~~patent~~warning ~~protection.~~letters, Aproduct ~~number of our competitors and other third parties have been issued patents~~seizures, ~~or may have filed patent applications~~recalls, orsubstantial ~~may obtain additional patents or other intellectual property rights for technologies similar to those that we have developed~~fines, ~~used or commercialized~~injunctions, orwithdrawal ~~may~~of ~~develop~~approvals, ~~use~~operating orrestrictions ~~commercialize,~~and incriminal ~~the future~~prosecutions. AsAny ~~certain~~of ~~patent~~these ~~applications~~enforcement inactions, ~~the~~any ~~United~~unanticipated ~~States~~changes ~~and other countries are maintained~~ in ~~secrecy~~existing ~~for~~regulatory arequirements ~~period of time after filing, and as publication~~ or ~~public~~the ~~awareness~~adoption of new ~~technologies often lags behind actual discoveries~~requirements, weor ~~cannot~~any besafety ~~certain~~issues that wearise ~~have~~with ~~been~~any ~~the~~approved ~~first~~products, tocould ~~develop~~negatively ~~the~~impact ~~technology~~on ~~covered by~~ our ~~pending~~ability ~~patent~~to ~~applications.~~market Inproducts ~~addition,~~and ~~the~~generate ~~disclosure~~revenues inand ~~our~~thus ~~patent applications, including in respect of the utility of~~ our ~~claimed~~ability ~~inventions, may not be sufficient~~ to ~~meet~~continue ~~the statutory requirements for patentability in all cases. As a result, we can provide no assurance that~~ our ~~patent applications will result in valid or enforceable patents~~operations.

~~Prosecution~~We ~~and~~also ~~protection~~may ofbe ~~the~~restricted ~~rights~~or ~~sought~~prohibited infrom ~~patent~~marketing ~~applications~~or ~~and~~manufacturing ~~patents~~a ~~can be costly and uncertain~~product, ~~often~~even ~~involve~~after ~~complex~~obtaining ~~legal~~product ~~and~~approval, ~~factual~~if ~~issues~~previously ~~and~~unknown ~~consume~~problems ~~significant~~with ~~time and resources. In addition,~~ the ~~breadth~~product ofor ~~claims~~our ~~allowed~~manufacturer inare ~~our~~subsequently ~~future~~discovered. ~~patents~~Moreover, ~~their~~we ~~enforceability and our ability to protect and maintain them~~ cannot beprovide ~~predicted~~assurance ~~with~~that ~~any~~newly ~~certainty.~~discovered ~~The~~or ~~laws~~developed ofsafety ~~certain~~issues ~~countries~~will ~~may~~ not ~~protect~~arise ~~intellectual~~following ~~property~~any ~~rights~~regulatory toapproval. ~~the~~If ~~same~~our ~~extent~~product asis ~~the~~used ~~laws~~by ofa ~~Canada~~large orpatient ~~the~~population, ~~United~~serious ~~States~~adverse ~~Even~~events ifmay ~~our~~occur ~~patents~~from ~~are~~time ~~held~~ to betime ~~valid~~that ~~and~~initially ~~enforceable~~may inseem aunconnected ~~certain~~to ~~jurisdiction~~the treatment, ~~any~~and ~~legal~~only ~~proceedings~~when ~~that~~it werepeatedly ~~may~~occurs ~~initiate~~over ~~against~~a ~~third~~period ~~parties~~of totime ~~enforce~~does ~~such~~the ~~patents~~treatment ~~will~~become ~~likely~~suspect beas ~~expensive,~~having ~~take~~a ~~significant~~causal ~~time~~relationship ~~and~~to ~~divert~~the ~~management's~~adverse ~~attention~~event. ~~from~~Any ~~other~~safety ~~business~~issues ~~matters.~~could Wecause ~~can~~us ~~provide~~to nosuspend ~~assurance~~or ~~that~~cease ~~any~~marketing of our ~~pending~~approved ~~patent~~products, ~~applications~~possibly ~~will~~subject ~~provide~~us ~~any~~to ~~protectable~~substantial liabilities, ~~maintainable~~and oradversely ~~enforceable~~affect ~~rights~~our orability ~~competitive advantages~~ to itgenerate revenues.

~~Intellectual~~We ~~property~~may ~~rights do~~ not ~~necessarily~~be ~~address~~able ~~all potential threats~~ to ~~our~~obtain ~~competitive~~marketing ~~advantage~~approval.

~~Once~~Even ~~granted,~~if ~~patents~~we ~~may~~complete ~~remain~~the ~~open~~necessary tonon-clinical ~~invalidity~~studies ~~challenges~~and ~~including~~clinical ~~opposition~~trials, ~~interference,~~the ~~re-examination,~~marketing ~~post-grant~~approval ~~review,~~process ~~inter~~is ~~partes~~expensive, ~~review~~time-consuming, ~~nullification~~and oruncertain ~~derivation~~and ~~action~~may inprevent ~~court~~us orfrom ~~before~~obtaining ~~patent~~approvals ~~offices or similar proceedings~~ for athe ~~given~~commercialization ~~period~~of ~~after~~the ~~allowance~~Products. orIf ~~grant,~~we ~~during~~are ~~which~~not ~~time~~able ~~third~~to ~~parties~~obtain, ~~can~~or ~~raise~~if ~~objections~~there ~~against~~are ~~such~~delays ~~grant.~~in Inobtaining, ~~the~~required ~~course~~regulatory ~~of such proceedings~~approvals, ~~which~~we ~~may~~will ~~continue~~not ~~for~~be aable ~~protracted~~to ~~period of time~~commercialize, ~~the~~or ~~patent~~will ~~owner may~~ be ~~compelled~~delayed toin ~~limit~~commercializing, the ~~scope~~Products, ofand ~~the~~our ~~allowed~~ability orto ~~granted~~generate ~~claims~~revenue ~~thus~~will ~~attacked~~be ormaterially ~~may lose the allowed or granted claims altogether~~impaired.

InWe ~~addition,~~rely on the ~~degree of future~~ protection afforded by our intellectual property rights is uncertain because intellectual property rights have limitations, and may not adequately protect our business, provide a barrier to entry against our competitors or potential competitors, or permit us to maintain our competitive advantage. Moreover, if a third party has intellectual property rights that cover the practice of ~~our technology, we may not be able to fully exercise or extract value from our~~ intellectual property rights. ~~The following examples are illustrative:~~

~~● others~~Our ~~may~~commercial besuccess ~~able~~depends to ~~make~~a ~~product~~significant degree upon our ability to develop new or improved technologies, instruments and products, and to obtain patents or other intellectual property rights or statutory protection for these technologies and products in Canada, the United States and other countries, such as the countries in the European Union and Asia. We intend to patent concepts, components, processes, industrial designs and methods, and other inventions and technologies that iswe ~~similar~~considers to ~~product~~have ~~candidates~~commercial value or that will likely give us a competitive advantage. Despite devoting resources to the research and development of proprietary technology, we ~~intend~~may not be able to ~~commercialize~~develop new technology that is ~~not~~patentable ~~covered~~or byprotectable. ~~the~~Further, patents ~~that~~issued weto ~~own;~~us, if any, could be challenged, held invalid or unenforceable, or be circumvented and may not provide us with necessary or sufficient protection or a competitive advantage.

20In addition, despite our efforts to protect and maintain our patents competitors and other third parties may be able to design around our patents, if so awarded, or develop products similar to our products that are not within the scope of such patents. Finally, patents provide certain statutory protection only for a limited period of time that varies depending on the jurisdiction and type of patent. The statutory protection term of our SkinJectTM patents expire between 2030 and 2035 and the statutory term of Antev's issued U.S. patents expire in 2039 (between 2044 and 2045 with respect to certain pending patent applications that have yet to issue) and, thereafter, the underlying technology of such patents will be allowed to be used by any third party, including our competitors. Moreover, the inventions covered by patents may be free to be used in countries for which there is no patent protection. A number of our competitors and other third parties have been issued patents, or may have filed patent applications, or may obtain additional patents or other intellectual property rights for technologies similar to those that we have developed, used or commercialized, or may develop, use or commercialize, in the future. As certain patent applications in the United States and other countries are maintained in secrecy for a period of time after filing, and as publication or public awareness of new technologies often lags behind actual discoveries, we cannot be certain that we have been the first to develop the technology covered by our pending patent applications. In addition, the disclosure in our patent applications, including in respect of the utility of our claimed inventions, may not be sufficient to meet the statutory requirements for patentability in all cases. As a result, we can provide no assurance that our patent applications will result in valid or enforceable patents.

~~● we, or any collaborators might not have been the first to make or reduce to practice the inventions covered by the issued patents or pending patent applications that we own;~~20

~~● we~~Prosecution orand protection of the rights sought in patent applications and patents can be costly and uncertain, often involve complex legal and factual issues and consume significant time and resources. In addition, the breadth of claims allowed in our future patents, their enforceability and our ability to protect and maintain them cannot be predicted with any ~~collaborators~~certainty. ~~might~~The laws of certain countries may not ~~have~~protect ~~been~~intellectual property rights to the ~~first~~same extent as the laws of Canada or the United States Even if our patents are held to ~~file~~be ~~patent~~valid ~~applications~~and ~~covering~~enforceable in a certain jurisdiction, any legal proceedings that we may initiate against third parties to enforce such patents will likely be expensive, take significant time and divert management's attention from other business matters. We can provide no assurance that any of our ~~inventions;~~pending patent applications will provide any protectable, maintainable or enforceable rights or competitive advantages to it.

~~● others~~Intellectual ~~may~~property ~~independently~~rights ~~develop~~do ~~similar~~not ornecessarily ~~alternative~~address ~~technologies~~all orpotential ~~duplicate~~threats ~~any~~to of our ~~technologies~~competitive ~~without infringing our intellectual property rights;~~advantage.

~~● it~~Once isgranted, ~~possible~~patents ~~that~~may ~~our~~remain ~~pending~~open to invalidity challenges including opposition, interference, re-examination, post-grant review, inter partes review, nullification or derivation action in court or before patent ~~applications~~offices ~~will~~or ~~not~~similar ~~lead~~proceedings for a given period after allowance or grant, during which time third parties can raise objections against such grant. In the course of such proceedings, which may continue for a protracted period of time, the patent owner may be compelled to ~~issued~~limit ~~patents;~~the scope of the allowed or granted claims thus attacked or may lose the allowed or granted claims altogether.

~~● issued~~In ~~patents~~addition, ~~that~~the wedegree ~~own~~of future protection afforded by our intellectual property rights is uncertain because intellectual property rights have limitations, and may not adequately protect our business, provide a barrier to entry against our competitors or potential competitors, or permit us ~~with~~to ~~any~~maintain our competitive ~~advantages~~advantage. Moreover, orif a third party has intellectual property rights that cover the practice of our technology, we may not be ~~held~~able ~~invalid~~to fully exercise or ~~unenforceable~~extract asvalue afrom ~~result~~our ofintellectual ~~legal~~property ~~challenges;~~rights. The following examples are illustrative:

~~● our~~others ~~competitors~~may ~~might~~be ~~conduct~~able ~~research~~to ~~and~~make ~~development~~product ~~activities in the United States and other countries~~ that ~~provide~~is asimilar ~~safe~~to ~~harbor~~product ~~from~~candidates ~~patent infringement claims for certain research and development activities, as well as in countries where~~ we dointend ~~not have patent rights, and then use the information learned from such activities~~ to ~~develop~~commercialize ~~competitive~~that ~~products~~is ~~for sale in our major commercial markets; and we may~~ not ~~develop~~covered ~~additional~~by ~~proprietary~~the ~~technologies~~patents that ~~are~~we ~~patentable~~own;
~~● third~~we, ~~parties~~or ~~performing~~any ~~manufacturing~~collaborators ormight ~~testing~~not ~~for~~have usbeen ~~using~~the ~~our~~first ~~products~~to make or ~~technologies~~reduce ~~could~~to ~~use~~practice the ~~intellectual~~inventions ~~property~~covered ofby ~~others~~the ~~without~~issued ~~obtaining~~patents aor ~~proper~~pending ~~license~~patent applications that we own;
~~● parties~~we ~~may~~or ~~assert~~any ancollaborators ~~ownership~~might ~~interest~~not inhave ~~our~~been ~~intellectual~~the ~~property~~first ~~and,~~to iffile ~~successful,~~patent ~~such~~applications ~~disputes~~covering ~~may~~certain ~~preclude~~of usour ~~from exercising exclusive rights over that intellectual property~~inventions;
~~● we~~others may ~~not~~independently develop ~~additional~~similar ~~proprietary~~or alternative technologies ~~that~~or ~~are~~duplicate ~~patentable~~any of our technologies without infringing our intellectual property rights;
~~● we~~it ~~may~~is ~~not~~possible bethat ~~able~~our topending ~~obtain~~patent ~~and~~applications ~~maintain~~will ~~necessary~~not ~~licenses~~lead onto ~~commercially~~issued ~~reasonable terms, or at all~~patents; ~~and~~
~~● the~~issued patents ofthat ~~others~~we own may ~~harm~~not ~~our~~provide ~~business.~~us with any competitive advantages, or may be held invalid or unenforceable as a result of legal challenges;

Should any of these events occur, they could significantly harm our business and results of operations. We can provide no assurance that we will be successful in protecting, maintaining or enforcing our intellectual property rights. If we are not successful in protecting, maintaining or enforcing our intellectual property rights, then our business, operating results and financial condition could be materially adversely affected.21

Weour ~~may~~competitors might conduct research and development activities in the United States and other countries that provide a safe harbor from patent infringement claims for certain research and development activities, as well as in countries where we do not behave ~~able~~patent rights, and then use the information learned from such activities to ~~enforce~~develop competitive products for sale in our ~~intellectual~~major ~~property~~commercial ~~rights~~markets; ~~throughout~~and ~~the~~we ~~world.~~may not develop additional proprietary technologies that are patentable;
~~The~~third ~~laws~~parties ofperforming ~~some~~manufacturing ~~foreign~~or ~~countries~~testing dofor ~~not~~us ~~protect~~using ~~intellectual~~our ~~property~~products ~~rights~~or totechnologies ~~the~~could ~~same~~use ~~extent as~~ the ~~laws of Canada and the United States. Many companies have encountered significant problems in protecting and defending~~ intellectual property ~~rights in certain foreign jurisdictions. The legal systems~~ of ~~some~~others ~~countries,~~without ~~particularly~~obtaining ~~developing~~a ~~countries,~~proper ~~do not favor the enforcement of patents and other intellectual property protection, especially those relating to life sciences.~~license;
Toparties ~~the~~may ~~extent~~assert ~~that~~an weownership ~~have~~interest ~~obtained or are able to obtain patents or other intellectual property rights~~ in ~~any foreign jurisdictions, it may be difficult for us to stop the infringement of~~ our ~~patents or the misappropriation of other~~ intellectual property ~~rights. For example~~and, ~~some~~if ~~foreign countries have compulsory licensing laws under which a patent owner must grant licenses to third parties. In addition~~successful, ~~many~~such ~~countries~~disputes ~~limit~~may ~~the~~preclude ~~availability~~us offrom ~~certain~~exercising ~~types~~exclusive ~~of patent~~ rights ~~and~~over ~~enforceability~~that ofintellectual ~~patents against third parties, including government agencies or government contractors. In these countries, patents may provide limited or no benefit.~~property;
21we may not develop additional proprietary technologies that are patentable;
~~Proceedings~~we tomay ~~enforce~~not ~~our~~be ~~patent~~able ~~rights~~to inobtain ~~foreign jurisdictions could result in substantial costs~~ and ~~divert~~maintain ~~our~~necessary ~~efforts~~licenses ~~and~~on ~~attention~~commercially ~~from~~reasonable ~~other aspects of our business. Accordingly~~terms, ~~our~~or ~~efforts~~at toall; ~~protect our intellectual property rights in such countries may be inadequate.~~and
~~Many~~the countries, including European Union countries, India, Japan and China, have compulsory licensing laws under which a patent owner may be compelled under specified circumstances to grant licenses to third parties. In those countries, we may have limited remedies if patents ~~are infringed or if we are compelled to grant a license to a third party, which could materially diminish the value~~ of ~~those~~others ~~patents.~~may ~~This~~harm ~~could limit~~ our ~~potential revenue opportunities~~business. ~~Accordingly, our efforts to enforce our intellectual property rights around the world may be inadequate to obtain a significant commercial advantage from the intellectual property that we develop.~~

~~Guidelines~~Should ~~and~~any ~~recommendations~~of ~~published~~these byevents ~~various~~occur, ~~organizations~~they ~~can~~could ~~reduce~~significantly ~~the~~harm ~~use~~our business and results of ~~products~~operations. We can provide no assurance that we ~~may~~will ~~commercialize~~be successful in protecting, maintaining or enforcing our intellectual property rights. If we are not successful in protecting, maintaining or enforcing our intellectual property rights, then our business, operating results and financial condition could be materially adversely affected.

~~Government~~We agencies promulgate regulations and guidelines directly applicable to us and our products. In addition, professional societies, practice management groups, private health and science foundations and organizations involved in various diseases from time to time may ~~also~~not ~~publish~~be ~~guidelines~~able ~~or recommendations~~ to ~~the~~enforce healthcare and patient communities with respect to specific products. Recommendations of government agencies or these other groups or organizations may relate to such matters as usage, dosage, route of administration and use of concomitant therapies. Recommendations or guidelines that do not recognize our ~~future~~intellectual ~~products,~~property ~~suggest~~rights ~~limitations~~throughout ~~or inadequacies of our future products, or suggest~~ the ~~use of competitive or alternative products as the standard of care to be followed by patients and healthcare providers, could result in decreased use or adoption of our future products~~world.

~~Patent~~The ~~reform~~laws ~~legislation~~of insome foreign countries do not protect intellectual property rights to the same extent as the laws of Canada and the United States. Many companies have encountered significant problems in protecting and defending intellectual property rights in certain foreign jurisdictions. The legal systems of some countries, particularly developing countries, do not favor the enforcement of patents and other intellectual property protection, especially those relating to life sciences.

OnTo ~~September~~the ~~16,~~extent ~~2011,~~that ~~the~~we ~~Leahy-Smith~~have ~~America~~obtained ~~Invents~~or ~~Act~~are ~~(the~~able ~~"Leahy-Smith~~to ~~Act")~~obtain ~~was~~patents ~~signed~~or ~~into~~other ~~law.~~intellectual ~~The~~property ~~Leahy-Smith~~rights ~~Act~~in ~~includes~~any aforeign ~~number~~jurisdictions, ofit ~~significant~~may ~~changes~~be todifficult ~~U.S.~~for ~~patent~~us ~~law.~~to ~~These~~stop ~~include~~the ~~provisions~~infringement ~~that~~of ~~affect~~our patents or the ~~way~~misappropriation ~~patent~~of ~~applications~~other ~~will~~intellectual beproperty ~~prosecuted~~rights. ~~and~~For ~~may~~example, ~~also~~some ~~affect~~foreign countries have compulsory licensing laws under which a patent ~~litigation~~owner must grant licenses to third parties. In ~~particular~~addition, ~~under~~many ~~the~~countries ~~Leahy-Smith~~limit ~~Act,~~ the ~~United~~availability ~~States~~of ~~transitioned~~certain intypes ~~March~~of ~~2013~~patent torights aand ~~"first~~enforceability toof ~~file"~~patents ~~system~~against inthird ~~which~~parties, ~~the~~including ~~first~~government ~~inventor~~agencies toor ~~file~~government acontractors. ~~patent~~In ~~application~~these ~~will~~countries, bepatents ~~entitled~~may toprovide ~~the~~limited ~~patent~~or no benefit.

~~Further,~~Proceedings ~~the~~to ~~Leahy-Smith~~enforce ~~Act~~our ~~also~~patent ~~includes~~rights ~~significant changes~~ in ~~the~~foreign ~~way~~jurisdictions ~~patent~~could ~~applications~~result ~~will~~in besubstantial ~~prosecuted~~costs and ~~may~~divert ~~also~~our ~~affect~~efforts ~~patent~~and ~~litigation.~~attention ~~These~~from ~~include~~other ~~allowing~~aspects ~~third~~of ~~parties~~our ~~to submit prior art during patent prosecution by the U~~business.S. ~~Patent and Trademark Office ("USPTO")~~Accordingly, ~~and~~our ~~additional~~efforts ~~procedures~~ to ~~attack~~protect ~~the validity of a patent in post-grant proceedings including opposition, derivation, re-examination, inter partes review or interference proceedings challenging~~ our ~~patent~~intellectual ~~rights~~property ~~or the patent~~ rights ~~of others. An adverse determination~~ in ~~any~~ such ~~submission,~~countries ~~proceeding~~may orbe ~~litigation could reduce the scope or enforceability of, or invalidate, our patent rights, which could adversely affect our competitive position~~inadequate.

~~Patent~~Many ~~reform legislation in the United States~~countries, including ~~the~~European ~~Leahy-Smith~~Union ~~Act~~countries, ~~could~~India, ~~increase~~Japan ~~those uncertainties~~ and ~~costs~~China, ~~surrounding~~have ~~the~~compulsory ~~prosecution~~licensing oflaws ~~our~~under ~~patent~~which ~~applications and the enforcement or defense of our issued patents. The Leahy-Smith Act was signed into law on September 16, 2011, and includes~~ a ~~number of significant changes to U.S.~~ patent ~~law.~~owner ~~These~~may ~~include~~be ~~provisions~~compelled ~~that~~under ~~affect~~specified ~~the~~circumstances ~~way~~to ~~patent~~grant ~~applications~~licenses ~~are prosecuted, redefine prior art and provide more efficient and cost-effective avenues for competitors~~ to ~~challenge the validity of patents. These include allowing~~ third -party submission of prior art to the USPTO during patent prosecution and additional procedures to attack the validity of a patent by USPTO administered post-grant proceedings, including post-grant review, inter partes review, and derivation proceedingsparties. ~~After~~In ~~March~~those 15countries, ~~2013,~~we ~~under~~may ~~the~~have ~~Leahy-Smith~~limited ~~Act,~~remedies ~~the~~if ~~United~~patents ~~States~~are ~~transitioned~~infringed toor aif ~~first~~we ~~inventor to file system in which, assuming that the other statutory requirements~~ are ~~met,~~compelled ~~the first inventor~~ to ~~file~~grant a ~~patent~~license ~~application will be entitled~~ to ~~the patent on an invention regardless of whether~~ a third party, ~~was~~which ~~the~~could ~~first~~materially todiminish ~~invent~~ the ~~claimed~~value ~~invention.~~of ~~The~~those ~~Leahy-Smith~~patents. ~~Act~~This ~~and its implementation~~ could ~~increase~~limit ~~the~~our ~~uncertainties~~potential ~~and~~revenue ~~costs~~opportunities. ~~surrounding the prosecution of our patent applications~~Accordingly, our ~~ability~~efforts to ~~obtain~~enforce ~~future~~our ~~patents,~~intellectual ~~and~~property ~~the~~rights ~~enforcement~~around orthe ~~defense~~world ofmay ~~our~~be ~~issued~~inadequate ~~patents,~~to ~~all~~obtain ofa ~~which~~significant ~~could~~commercial ~~harm~~advantage ~~our~~from ~~business,~~the ~~financial~~intellectual ~~condition,~~property ~~results~~that ofwe ~~operations and prospects~~develop.

~~Moreover,~~Guidelines weand ~~may~~recommendations bepublished ~~subject~~by tovarious aorganizations ~~third-party~~can pre-issuance submission of prior art to the USPTO or become involved in opposition, derivation, reexamination, inter partes review, post-grant review or interference proceedings challenging our owned patent rights. An adverse determination in any such submission, proceeding or litigation could reduce the ~~scope~~use of, ~~or invalidate, our patent rights, allow third parties to commercialize our technology or~~ products ~~and~~that ~~compete~~we ~~directly~~may ~~with us, without payment to us, or result in our inability to manufacture or~~ commercialize ~~products without infringing third-party patent rights~~. In addition, if the breadth or strength of protection provided by our patents and patent applications is threatened, it could dissuade companies from collaborating with us to license, develop or commercialize current or future product candidates.

22Government agencies promulgate regulations and guidelines directly applicable to us and our products. In addition, professional societies, practice management groups, private health and science foundations and organizations involved in various diseases from time to time may also publish guidelines or recommendations to the healthcare and patient communities with respect to specific products. Recommendations of government agencies or these other groups or organizations may relate to such matters as usage, dosage, route of administration and use of concomitant therapies. Recommendations or guidelines that do not recognize our future products, suggest limitations or inadequacies of our future products, or suggest the use of competitive or alternative products as the standard of care to be followed by patients and healthcare providers, could result in decreased use or adoption of our future products.

The issuance of a patent is not conclusive as to its inventorship, scope, validity or enforceability, and our patents may be challenged in the courts or patent offices in the United States and abroad. Such challenges may result in loss of exclusivity or in patent claims being narrowed, invalidated or held unenforceable, in whole or in part, which could limit our ability to stop others from using or commercializing similar or identical technology and products, or limit the duration of the patent protection of our technology and products. Moreover, patents have a limited lifespan. In the United States, the natural expiration of a patent is generally 20 years after it is filed. The statutory protection term of our patents expire between 2030 and 2035 and, thereafter, the underlying technology of such patents will be allowed to be used by any third party, including our competitors. Various extensions may be available; however, the life of a patent, and the protection it affords, is limited. Without patent protection for our current or future product candidates, we may be open to competition from generic versions of such products. Given the amount of time required for the development, testing and regulatory review of new product candidates, patents protecting such candidates might expire before or shortly after such candidates are commercialized. As a result, our patent portfolio may not provide us with sufficient rights to exclude others from commercializing products similar or identical to ours.22

IfChanges wein dopatent ~~not~~law ~~obtain~~in ~~protection~~the ~~under~~United ~~the~~States ~~Hatch-Waxman~~and ~~Amendments~~other byjurisdictions ~~obtaining~~could ~~data~~diminish ~~exclusivity~~the value of patents in general, thereby impairing our ~~business~~ability ~~may~~to beprotect ~~harmed~~our technology and products..

~~Our~~As ~~commercial~~is ~~success~~the ~~will~~case ~~largely~~with ~~depend~~other onbiopharmaceutical companies, our ~~ability~~success tois ~~obtain~~heavily ~~market~~dependent ~~exclusivity~~on inintellectual ~~the~~property, ~~United~~particularly ~~States~~patents. Obtaining, defending, maintaining and ~~other~~enforcing ~~countries~~patents ~~with~~in ~~respect~~the tobiopharmaceutical ~~our~~industry ~~drug~~involves ~~candidates~~both technological and ~~their~~legal ~~target~~complexity ~~indications.~~and ~~Depending~~is ~~upon~~therefore ~~the timing~~costly, ~~duration~~time-consuming and ~~specifics~~inherently ofuncertain. ~~FDA~~Changes ~~marketing~~in ~~approval~~either ofthe ~~our~~patent ~~drug~~laws ~~candidates,~~or ~~certain~~interpretation of ~~our~~the ~~product~~patent ~~candidates~~laws ~~may~~in bethe ~~eligible~~United ~~for~~States ~~marketing~~could ~~exclusivity.~~increase ~~The~~the ~~FDCA~~uncertainties ~~provides~~and ~~three~~costs ~~years~~surrounding the prosecution of ~~marketing~~patent ~~exclusivity~~applications ~~for~~and anthe ~~NDA,~~enforcement or ~~supplement~~defense toof anissued ~~existing~~patents, ~~NDA~~and ifmay ~~new~~diminish ~~clinical~~our ~~investigations,~~ability ~~other~~to ~~than~~protect ~~bioavailability~~our ~~studies~~inventions, ~~that~~obtain, ~~were~~maintain, ~~conducted~~enforce orand ~~sponsored~~protect byour ~~the~~intellectual ~~applicant~~property ~~are~~rights ~~deemed~~and, bymore generally, could affect the ~~FDA~~value toof beour ~~essential~~intellectual toproperty or narrow the ~~approval~~scope of ~~the~~our ~~application,~~future ~~for~~owned ~~example~~and ~~new~~licensed ~~indications,~~patents. ~~dosages,~~Patent ~~dosage~~reform ~~forms~~legislation orin ~~strengths~~the ofUnited anStates ~~existing~~and ~~drug.~~other ~~This~~countries, ~~three~~including the Leahy-~~year~~Smith ~~exclusivity~~America ~~covers~~Invents ~~only~~Act (the ~~conditions~~"AIA"), ~~associated~~could ~~with~~increase those uncertainties and costs surrounding the ~~new~~prosecution ~~clinical~~of ~~investigations~~our ~~and~~patent ~~prohibits~~applications and the ~~FDA~~enforcement ~~from~~or ~~approving~~defense anof ~~ANDA~~our future issued patents. On September 16, or2011, the AIA was signed into law. The AIA includes a ~~505(b)(2)~~number ~~NDA~~of ~~submitted~~significant bychanges ~~another~~to ~~company~~U.S. ~~with~~patent ~~overlapping~~law. ~~conditions~~These ~~associated~~include ~~with~~provisions that affect the ~~new~~way ~~clinical~~patent ~~investigations~~applications ~~for~~will ~~the~~be ~~three-year~~prosecuted ~~period.~~and ~~Clinical~~may ~~investigation~~also ~~exclusivity~~affect ~~does~~patent ~~not~~litigation. ~~prohibit~~In particular, under the ~~FDA~~AIA, ~~from~~the ~~approving~~United ~~ANDAs~~States ~~for~~transitioned ~~drugs~~in ~~containing~~March 2013 to a "first to file" system in which the ~~original~~first ~~active~~inventor ~~agent.~~to ~~The~~file ~~three-year~~a ~~exclusivity~~patent application will ~~not~~be ~~delay~~entitled to the ~~submission~~patent. orThe ~~approval~~AIA also includes a number of ansignificant ~~NDA~~changes ~~for~~to ~~the~~U.S. ~~same~~patent ~~drug~~law. ~~However~~These include provisions that affect the way patent applications are prosecuted, anre-define ~~applicant~~prior ~~submitting~~art anand ~~NDA~~provide ~~would~~more beefficient ~~required~~and tocost-effective ~~conduct~~avenues orfor ~~obtain~~competitors ato ~~right~~challenge the validity of ~~reference~~patents. toThese ~~all~~include allowing third-party submission of prior art to the ~~preclinical~~U.S. ~~studies~~Patent and ~~adequate~~Trademark ~~and~~Office ~~well-controlled~~("USPTO") ~~clinical~~during ~~trials~~patent ~~necessary~~prosecution and additional procedures to ~~demonstrate~~attack ~~safety~~the validity of a patent by USPTO administered post-grant proceedings, PGR, IPR and ~~effectiveness~~derivation proceedings.

IfIn weaddition, the patent positions of companies in the development and commercialization of pharmaceuticals are ~~unable~~particularly touncertain. ~~obtain~~The ~~such~~U.S. ~~marketing~~Supreme ~~exclusivity~~Court ~~for~~has ~~our~~ruled ~~product~~on ~~candidates~~several patent cases in recent years, ~~our~~either ~~competitors~~narrowing ~~may~~the bescope ~~able~~of topatent ~~take~~protection ~~advantage~~available in certain circumstances or weakening the rights of ~~our~~patent ~~investment~~owners in ~~development~~certain ~~and~~situations. ~~clinical~~Depending ~~trials~~on future actions by ~~referencing~~the ~~our~~U.S. ~~clinical~~Congress, the U.S. courts, the USPTO and ~~preclinical~~the ~~data~~relevant tolaw-making ~~obtain~~bodies ~~approval~~in ofother ~~competing~~countries, ~~products~~the laws and ~~launch~~regulations ~~their~~governing ~~product~~patents ~~earlier~~could ~~than~~change in unpredictable ways that would weaken our or our licensors' ability to obtain new patents and patents that we or our licensors might ~~otherwise~~obtain bein the ~~case~~future. We cannot predict how future decisions by the courts, the U.S. Congress or the USPTO may impact the value of our patents. Any similar adverse change in the patent laws of other jurisdictions could also adversely affect our business, financial condition, results of operations and prospects.

~~Risk~~Further, the AIA also includes significant changes in the way patent applications will be prosecuted and may also affect patent litigation. These include allowing third parties to submit prior art during patent prosecution by the USPTO, and additional procedures to attack the validity of ~~reduced~~a patent in post-grant proceedings including opposition, derivation, re-examination, inter partes review or ~~eliminated~~interference proceedings challenging our patent ~~protection~~rights ~~from~~or ~~non-compliance~~the ~~with~~patent ~~regulatory~~rights ~~requirements~~of others. An adverse determination in any such submission, proceeding or litigation could reduce the scope or enforceability of, or invalidate, our patent rights, which could adversely affect our competitive position.

~~Periodic~~Patent ~~maintenance~~reform ~~fees~~legislation onin ~~any~~the ~~issued~~United ~~patent~~States, ~~are~~including ~~due~~the toAIA, becould ~~paid~~increase tothose ~~the~~uncertainties ~~USPTO~~ and ~~foreign~~costs ~~patent~~surrounding ~~agencies~~the inprosecution ~~several~~of ~~stages~~our ~~over~~patent applications and the ~~lifetime~~enforcement or defense of ~~the~~our ~~patent~~issued patents. The ~~USPTO~~AIA ~~and~~was ~~various~~signed ~~foreign~~into ~~governmental~~law ~~patent~~on ~~agencies~~September ~~require~~16, ~~compliance~~2011, ~~with~~and includes a number of ~~procedural,~~significant ~~documentary,~~changes ~~fee~~to ~~payment~~U.S. ~~and~~patent ~~other~~law. ~~similar~~These include provisions ~~during~~that affect the way patent ~~application~~applications ~~process.~~are ~~While~~prosecuted, anredefine ~~inadvertent~~prior ~~lapse~~art ~~can~~and inprovide ~~many~~more ~~cases~~efficient beand ~~cured~~cost-effective byavenues ~~payment~~for ofcompetitors ato ~~late~~challenge ~~fee~~the orvalidity byof ~~other~~patents. ~~means~~These ininclude ~~accordance~~allowing ~~with~~third ~~the~~-party ~~applicable~~submission ~~rules,~~of ~~there~~prior ~~are~~art ~~situations~~to inthe ~~which~~USPTO ~~non-compliance~~during ~~can~~patent ~~result~~prosecution inand ~~unenforceability,~~additional ~~invalidity,~~procedures ~~abandonment~~to orattack ~~lapse~~the validity of ~~the~~a patent orby ~~patent~~USPTO ~~application~~administered post-grant proceedings, ~~resulting~~including inpost-grant ~~partial~~review, orinter ~~complete~~partes ~~loss~~review, ofand ~~patent~~derivation ~~rights~~proceedings. inAfter March 15, 2013, under the ~~relevant~~AIA, ~~jurisdiction.~~the ~~Non-compliance~~United ~~events~~States ~~that~~transitioned ~~could~~to ~~result~~a first inventor to file system in ~~unenforceability~~which, ~~invalidity~~assuming that the other statutory requirements are met, ~~abandonment~~the orfirst ~~lapse~~inventor ofto file a patent orapplication ~~patent~~will ~~application~~be ~~include,~~entitled ~~but~~to ~~are~~the ~~not~~patent ~~limited~~on ~~to,~~an ~~failure~~invention toregardless ~~respond~~of towhether ~~official~~a ~~actions~~third ~~within~~party ~~prescribed~~was ~~time~~the ~~limits,~~first ~~non-payment~~to ofinvent ~~fees~~the claimed invention. The AIA and ~~failure~~its toimplementation ~~properly~~could ~~legalize~~increase the uncertainties and ~~submit~~costs ~~formal~~surrounding ~~documents.~~the Ifprosecution weof orour ~~any~~patent ~~future~~applications, ~~licensors~~our ~~fail~~ability to ~~maintain~~obtain ~~the~~future patents, and ~~patent~~the ~~applications~~enforcement ~~covering~~or ~~the~~defense ~~Product~~of our issued patents, all of which could harm our ~~competitive~~business, ~~position~~financial ~~would~~condition, beresults ~~adversely~~of ~~affected~~operations and prospects.

WeMoreover, we may ~~infringe~~be subject to a third-party pre-issuance submission of prior art to the ~~intellectual~~USPTO ~~property~~or become involved in opposition, derivation, reexamination, inter partes review, post-grant review or interference proceedings challenging our owned patent rights. An adverse determination in any such submission, proceeding or litigation could reduce the scope of, ~~others~~or invalidate, our patent rights, allow third parties to commercialize our technology or products and compete directly with us, without payment to us, or result in our inability to manufacture or commercialize products without infringing third-party patent rights. In addition, if the breadth or strength of protection provided by our patents and patent applications is threatened, it could dissuade companies from collaborating with us to license, develop or commercialize current or future product candidates.

~~Our~~The ~~commercial~~issuance ~~success~~of ~~depends~~a patent is not conclusive as to its inventorship, inscope, ~~part~~validity or enforceability, ~~upon~~and itour ~~not~~patents ~~infringing~~may be challenged in the courts or ~~violating~~patent ~~intellectual~~offices ~~property~~in ~~rights~~the ~~owned~~United byStates ~~others~~and abroad. ~~The~~Such ~~industry~~challenges may result in ~~which~~loss weof ~~compete~~exclusivity ~~has~~or ~~participants~~in ~~that~~patent ~~own~~claims being narrowed, invalidated or ~~claim~~held unenforceable, in whole or in part, which could limit our ability to ~~own~~stop others from using or commercializing similar or identical technology and products, ~~intellectual~~or ~~property~~limit the duration of the patent protection of our technology and products. WeMoreover, ~~cannot~~patents ~~determine~~have ~~with~~a ~~certainty~~limited ~~whether~~lifespan. ~~any~~In ~~existing~~the ~~third-party~~United States, the natural expiration of a patent is generally 20 years after it is filed. The statutory protection term of our patents expire between 2030 and 2035 and, orthereafter, the ~~issuance~~underlying technology of ~~any~~such ~~new~~patents will be allowed to be used by any third- party, ~~patents~~including our competitors. Various extensions may be available; however, ~~would~~the ~~require~~life usof toa ~~alter~~patent, and the protection it affords, is limited. Without patent protection for our ~~technologies~~current or future product candidates, we may be open to competition from generic versions of such products. Given the amount of time required for the development, ~~obtain~~testing ~~licenses~~and regulatory review of new product candidates, patents protecting such candidates might expire before or ~~cease~~shortly ~~certain~~after ~~activities~~such candidates are commercialized. As a result, ~~including~~our ~~the~~patent ~~sale~~portfolio ofmay ~~certain~~not provide us with sufficient rights to exclude others from commercializing products similar or identical to ours.

WeSimilarly, ~~may~~changes in patent law and regulations in other countries or jurisdictions or changes in the ~~future~~governmental ~~receive~~bodies ~~claims~~that ~~from~~enforce ~~third~~them ~~parties~~or ~~asserting~~changes ~~infringement~~in ~~and~~how ~~other~~the ~~related~~relevant ~~claims.~~governmental ~~Litigation~~authority enforces patent laws or regulations may beweaken ~~necessary~~our ability to ~~determine~~obtain new patents or to enforce patents that we have licensed or that we may obtain in the ~~scope~~future. For example, ~~enforceability~~the complexity and ~~validity~~uncertainty of ~~third-party~~European ~~intellectual~~patent ~~property~~laws ~~rights~~have oralso toincreased ~~protect~~in recent years. In Europe, ~~maintain~~in ~~and~~June ~~enforce~~2023, ~~our~~a ~~intellectual~~new ~~property~~unitary ~~rights.~~patent ~~Some~~system was introduced, which will significantly impact European patents, including those granted before the introduction of ~~our~~the ~~competitors~~system. ~~have~~Under the unitary patent system, orafter ~~are~~a ~~affiliated~~European ~~with~~patent ~~companies~~is ~~having~~granted, ~~substantially~~the ~~greater~~patent ~~resources~~proprietor ~~than~~can werequest ~~have~~unitary effect, ~~and~~thereby ~~these~~getting ~~competitors~~a ~~may~~European bepatent ~~able~~with tounitary ~~sustain~~Effect (the ~~costs~~"Unitary ofPatent"). ~~complex~~Each ~~intellectual~~Unitary ~~property~~Patent ~~litigation~~is subject to the jurisdiction of the Unitary Patent Court (the "UPC"). As the UPC is a ~~greater~~new ~~degree~~court ~~and~~system, there is no precedent for ~~longer~~the ~~periods~~court, ofincreasing ~~time~~the ~~than~~uncertainty weof ~~can~~any litigation. ~~Regardless~~Patents granted before the implementation of ~~whether~~the ~~claims~~UPC ~~that~~will ithave isthe ~~infringing~~option orof ~~violating~~opting out of the jurisdiction of the UPC and remaining as national patents orin ~~other~~the ~~intellectual~~UPC ~~property~~countries. ~~rights~~Patents ~~have~~that ~~any~~remain ~~merit~~under the jurisdiction of the UPC may be potentially vulnerable to a single UPC-based revocation challenge that, ~~those~~if ~~claims~~successful, could: invalidate the patent in all countries who are signatories to the UPC. We cannot predict with certainty the long-term effects of the new unitary patent system.

~~● adversely~~If ~~affect~~we ~~our~~do ~~relationships~~not ~~with~~obtain ~~current~~protection orunder ~~future~~the ~~distributors~~Hatch-Waxman ~~and~~Amendments ~~dealers~~by ofobtaining data exclusivity, our ~~products;~~business may be harmed.

~~● adversely~~Our ~~affect~~commercial success will largely depend on our ~~reputation~~ability to obtain market exclusivity in the United States and other countries with ~~customers;~~respect to our drug candidates and their target indications. Depending upon the timing, duration and specifics of FDA marketing approval of our drug candidates, certain of our product candidates may be eligible for marketing exclusivity. The FDCA provides three years of marketing exclusivity for an NDA, or supplement to an existing NDA if new clinical investigations, other than bioavailability studies, that were conducted or sponsored by the applicant are deemed by the FDA to be essential to the approval of the application, for example new indications, dosages, dosage forms or strengths of an existing drug. This three-year exclusivity covers only the conditions associated with the new clinical investigations and prohibits the FDA from approving an ANDA, or a 505(b)(2) NDA submitted by another company with overlapping conditions associated with the new clinical investigations for the three-year period. Clinical investigation exclusivity does not prohibit the FDA from approving ANDAs for drugs containing the original active agent. The three-year exclusivity will not delay the submission or approval of an NDA for the same drug. However, an applicant submitting an NDA would be required to conduct or obtain a right of reference to all of the preclinical studies and adequate and well-controlled clinical trials necessary to demonstrate safety and effectiveness.

~~● be time-consuming and expensive to evaluate and defend;~~24

~~● cause~~If we are unable to obtain such marketing exclusivity for our product ~~shipment~~candidates, ~~delays~~our orcompetitors ~~stoppages;~~may ~~divert~~be ~~management's~~able ~~attention~~to take advantage of our investment in development and ~~resources;~~clinical trials by referencing our clinical and preclinical data to obtain approval of competing products and launch their product earlier than might otherwise be the case.

~~● subject~~Risk usof toreduced ~~significant~~or ~~liabilities~~eliminated ~~and~~patent ~~damages;~~protection from non-compliance with regulatory requirements.

~~● require~~Periodic usmaintenance fees on any issued patent are due to ~~enter~~be ~~into~~paid ~~royalty~~to the USPTO and foreign patent agencies in several stages over the lifetime of the patent. The USPTO and various foreign governmental patent agencies require compliance with a number of procedural, documentary, fee payment and other similar provisions during the patent application process. While an inadvertent lapse can in many cases be cured by payment of a late fee or ~~licensing~~by ~~agreements;~~other means in accordance with the applicable rules, there are situations in which non-compliance can result in unenforceability, invalidity, abandonment or lapse of the patent or patent application, resulting in partial or complete loss of patent rights in the relevant jurisdiction. Non-compliance events that could result in unenforceability, invalidity, abandonment or lapse of a patent or patent application include, but are not limited to, failure to respond to official actions within prescribed time limits, non-payment of fees and failure to properly legalize and submit formal documents. If we or any future licensors fail to maintain the patents and patent applications covering the Products, our competitive position would be adversely affected.

~~● require~~We usmay toinfringe ~~cease~~the ~~certain~~intellectual ~~activities,~~property ~~including~~rights ~~the sale~~ of ~~products~~others.

IfOur itcommercial issuccess ~~determined~~depends, ~~that~~in ~~we have infringed~~part, ~~violated~~upon orit isnot infringing or violating ~~a patent or the~~ intellectual property ~~right~~rights ofowned ~~any~~by ~~other~~others. ~~person~~The orindustry ~~if we are found liable~~ in ~~respect~~which ofwe ~~any~~compete ~~other~~has ~~related~~participants ~~claim,~~that ~~then~~own, inor ~~addition~~claim to ~~being liable for potentially substantial damages~~own, ~~we may be prohibited from developing, using, distributing, selling or commercializing certain of our technologies and products unless we obtain a license from the holder of the patent or other~~ intellectual property ~~right~~. We ~~can~~cannot ~~provide~~determine nowith ~~assurance~~certainty ~~that~~whether ~~we will be able to obtain~~ any ~~such~~existing ~~license~~third-party onpatents, ~~a timely basis~~ or onthe ~~commercially~~issuance ~~favorable~~of ~~terms, or that~~ any ~~such~~new ~~licenses~~third-party ~~will be available~~patents, orwould ~~that~~require ~~workarounds~~us ~~will~~to bealter ~~feasible~~our ~~and~~technologies ~~cost-efficient.~~or Ifproducts, ~~we do not~~ obtain ~~such~~licenses ~~a license~~ or ~~find~~cease acertain ~~cost-efficient workaround~~activities, ~~our~~including ~~business,~~the ~~operating~~sale ~~results~~of ~~and~~certain financial condition could be materially adversely affected and we could be required to cease related business operations in some markets and restructure our business to focus on our continuing operations in other marketsproducts.

~~Our~~We ~~general~~may ~~liability~~in ~~insurance~~the ~~expires~~future onreceive ~~October~~claims ~~11,~~from ~~2025~~third parties asserting infringement and other related claims. ~~There~~Litigation ~~can~~may be nonecessary ~~assurance~~to ~~that~~determine the scope, enforceability and validity of third-party intellectual property rights or to protect, maintain and enforce our intellectual property rights. Some of our competitors have, or are affiliated with companies having, substantially greater resources than we ~~will~~have, and these competitors may be able to ~~renew~~sustain ~~our~~the ~~liability~~costs ~~insurance~~of oncomplex ~~favorable~~intellectual ~~terms~~property orlitigation atto ~~all~~a greater degree and for longer periods of time than we can. Regardless of whether claims that it is infringing or violating patents or other intellectual property rights have any merit, those claims could:

Weadversely ~~may~~affect ~~not~~our ~~identify~~relationships ~~relevant~~with ~~third-party~~current ~~patents~~ or ~~may~~future ~~incorrectly~~distributors ~~interpret~~and ~~the~~dealers ~~relevance, scope or expiration~~ of ~~a third-party patent, which might harm~~ our ~~ability to develop and market our~~ products.;
Weadversely ~~cannot~~affect ~~guarantee that any of~~ our ~~patent~~reputation searches or analyses, including the identification of relevant patents, the scope of patent claims or the expiration of relevant patents, are complete or thorough, nor can we be certain that we have identified each and every third-party patent and pending application in the United States and abroad that is or may be relevant to or necessary for the commercialization of our product candidates in any jurisdiction. Patent applications in the United States and elsewhere are not published until approximately 18 months after the earliest filing for which priority is claimed, with such earliest filing date being commonly referred to as the priority date. In addition, U.S. patent applications filed before November 29, 2000 and certain U.S. patent applications filed after that date that will not be filed outside the United States remain confidential until patents issue. Therefore, patent applications covering our products could have been filed by others without our knowledge. Additionally, pending patent applications that have been published can, subject to certain limitations, be later amended in a manner that could cover our product candidates or the use of our products.customers;
24be time-consuming and expensive to evaluate and defend;
~~The~~cause ~~scope~~product ofshipment adelays ~~patent claim is determined by an interpretation of the law, the written disclosure in a patent and the patent's prosecution history. Our interpretation of the relevance~~ or ~~the~~stoppages; ~~scope~~divert of a patent or a pending application may be incorrect, which may negatively impact our ability to market our products. We may incorrectly determine that our products are not covered by a third-party patent or may incorrectly predict whether a third partymanagement's ~~pending~~attention ~~application will issue with claims of relevant scope. Our determination of the expiration date of any patent in the United States or abroad that we consider relevant may be incorrect,~~ and ~~our failure to identify and correctly interpret relevant patents may negatively impact our ability to develop and market our products.~~resources;
~~If we fail to identify and correctly interpret relevant patents, we may be~~ subject to infringement claims. We cannot guarantee that we will be able to successfully settle or otherwise resolve such infringement claims. If we fail in any such dispute, in addition to being forced to pay damages, we may be temporarily or permanently prohibited from commercializing any of our products that are held to be infringing. We might, if possible, also be forced to redesign products or services so that we no longer infringe the third-party intellectual property rights. Any of these events, even if we were ultimately to prevail, could require us to ~~divert~~significant ~~substantial~~liabilities ~~financial~~ and ~~management resources that we would otherwise be able to devote to our business.~~damages;
Werequire ~~may~~us ~~become involved in lawsuits~~ to ~~protect~~enter orinto ~~enforce~~royalty ~~our patents~~ or ~~our~~licensing ~~other~~agreements; ~~intellectual property rights, which could be expensive, time consuming and unsuccessful.~~or
~~Competitors~~require may infringe or otherwise violate our patents or our other intellectual property rights. To counter infringement or unauthorized use, we may be required to file legal claims, which can be expensive and time-consuming. In addition, in an infringement proceeding, a court may decide that a patent of ours is not valid or is unenforceable or may refuse to stop the other party from using the technology at issue on the grounds that our patents do not cover the technology in question. As a result, we cannot predict with certainty how much protection, if any, will be given to our patents if we attempt to enforce them and they are challenged in court. Further, even if we prevail against an infringer in U.S. district court, there is always the risk that the infringer will file an appeal and the district court judgment will be overturned at the appeals court and/or that an adverse decision will be issued by the appeals court relating to the validity or enforceability of our patents. An adverse result in any litigation or defense proceedings could put one or more of our patents at risk of being invalidated or interpreted narrowly and could put our patent applications at risk of not issuing. The initiation of a claim against a third party may also cause the third party to bring counter claims against us such as claims asserting that our patents are invalid or unenforceable. In patent litigation in the United States, defendant counterclaims alleging invalidity or unenforceability are commonplace. Grounds for a validity challenge could be an alleged failure to ~~meet~~cease ~~any~~certain ~~of several statutory requirements~~activities, including lack of novelty, obviousness, non-enablement or lack of written description or statutory subject matter. Grounds for an unenforceability assertion could be an allegation that someone connected with prosecution of the ~~patent~~sale withheld relevant material information from the USPTO, or made a materially misleading statement, during prosecution. Third parties may also raise similar validity claims before the USPTO in post-grant proceedings such as ex parte reexaminations, inter partes review, or post-grant review, or oppositions or similar proceedings outside the United States, in parallel with litigation or even outside the context of ~~litigation~~products. The outcome following legal assertions of invalidity and unenforceability is unpredictable. We cannot be certain that there is no invalidating prior art, of which we and the patent examiner were unaware during prosecution. If a defendant were to prevail on a legal assertion of invalidity or unenforceability, we would lose at least part, and perhaps all, of any future patent protection on our current or future product candidates.

WeIf ~~may~~it ~~not~~is bedetermined ~~able~~that towe ~~detect~~have infringed, violated or ~~prevent~~is ~~misappropriation~~infringing ofor ~~our~~violating a patent or the intellectual property ~~rights~~right of any other person or if we are found liable in respect of any other related claim, ~~particularly~~then, in ~~countries~~addition ~~where~~to ~~the~~being ~~laws~~liable for potentially substantial damages, we may ~~not~~be ~~protect~~prohibited ~~those~~from ~~rights~~developing, asusing, ~~fully~~distributing, asselling inor commercializing certain of our technologies and products unless we obtain a license from the ~~United~~holder ~~States~~of the patent or other intellectual property right. ~~Our~~We ~~business~~can ~~could~~provide beno ~~harmed~~assurance ifthat inwe ~~litigation~~will ~~the~~be ~~prevailing~~able ~~party~~to ~~does~~obtain ~~not~~any ~~offer~~such uslicense on a ~~license~~timely basis or on commercially ~~reasonable~~favorable terms, or that any such licenses will be available, or that workarounds will be feasible and cost-efficient. ~~Any~~If ~~litigation~~we do not obtain such a license or ~~other~~find ~~proceedings~~a tocost-efficient ~~enforce~~workaround, our ~~intellectual~~business, ~~property~~operating ~~rights~~results ~~may~~and ~~fail,~~financial condition could be materially adversely affected and ~~even~~we ifcould ~~successful,~~be ~~may~~required ~~result~~to cease related business operations in ~~substantial~~some ~~costs~~markets and ~~distract~~restructure our ~~management~~business ~~and~~to focus on our continuing operations in other ~~employees~~markets.

Even if we establish infringement, the court may decide not to grant an injunction against further infringing activity and instead award only monetary damages, which may or may not be an adequate remedy. Furthermore, because of the substantial amount of discovery required in connection with intellectual property litigation, there is a risk that some of our confidential information could be compromised by disclosure during this type of litigation. There could also be public announcements of the results of hearings, motions or other interim proceedings or developments. If securities analysts or investors perceive these results to be negative, it could harm the price of our securities.25

25Our general liability insurance expires in October, 2025 and we are in discussions for renewal upon expiration. There can be no assurance that we will be able to renew our liability insurance on favorable terms or at all.

~~Intellectual~~We ~~property~~may ~~litigation~~not ~~could~~identify ~~cause~~relevant usthird-party topatents ~~spend~~or ~~substantial~~may ~~resources~~incorrectly ~~and~~interpret ~~distract~~the ~~our~~relevance, ~~personnel~~scope ~~from~~or ~~their~~expiration ~~normal~~of ~~responsibilities~~a ~~and~~third-party ~~have~~patent, awhich ~~harmful~~might ~~effect~~harm onour ~~the~~ability ~~success~~to ofdevelop and market our ~~business~~products.

~~Even~~We ifcannot ~~resolved~~guarantee inthat ~~our~~any ~~favor,~~of ~~litigation or other legal proceedings relating to intellectual property claims may cause us to incur significant expenses and could distract~~ our ~~technical~~patent ~~and~~searches ~~management~~or ~~personnel~~analyses, ~~from~~including ~~their~~the ~~normal~~identification ~~responsibilities.~~of Inrelevant ~~addition~~patents, ~~there could be public announcements of~~ the ~~results~~scope of ~~hearings,~~patent ~~motions~~claims or ~~other~~the ~~interim~~expiration ~~proceedings~~of orrelevant ~~developments~~patents, ~~and~~are ifcomplete ~~securities analysts~~ or ~~investors~~thorough, ~~perceive~~nor ~~these~~can ~~results~~we to be ~~negative,~~certain itthat ~~could~~we ~~adversely~~have ~~impact~~identified ~~the~~each ~~price~~and ofevery ~~our~~third-party ~~securities.~~patent ~~Such~~and ~~litigation~~pending orapplication ~~proceedings~~in ~~could~~the ~~substantially~~United ~~increase~~States ~~our operating losses~~ and ~~reduce~~abroad ~~the~~that ~~resources~~is ~~available for development activities~~ or ~~any~~may ~~future~~be ~~sales,~~relevant ~~marketing~~to or ~~distribution~~necessary ~~activities.~~for Wethe ~~may~~commercialization ~~not~~of ~~have~~our ~~sufficient~~product ~~financial~~candidates orin ~~other~~any ~~resources~~jurisdiction. toPatent ~~conduct~~applications ~~such~~in ~~litigation~~the orUnited ~~proceedings~~States ~~adequately.~~and ~~Some~~elsewhere ofare ~~our~~not ~~competitors~~published ~~may~~until beapproximately ~~able~~18 tomonths ~~sustain~~after the ~~costs~~earliest offiling ~~such~~for ~~litigation~~which orpriority ~~proceedings~~is ~~more effectively than we can because of their greater financial resources. Accordingly~~claimed, ~~despite~~with ~~our~~such ~~efforts,~~earliest wefiling ~~may~~date ~~not~~being becommonly ~~able~~referred to ~~prevent~~as ~~third~~the ~~parties~~priority ~~from infringing upon or misappropriating our intellectual property~~date. In addition, ~~the~~U.S. ~~uncertainties~~patent ~~associated~~applications ~~with~~filed ~~litigation~~before ~~could~~November ~~compromise~~29, ~~our~~2000 ~~ability~~and tocertain ~~raise~~U.S. ~~the~~patent ~~funds~~applications ~~necessary~~filed toafter ~~continue~~that ~~our~~date ~~clinical~~that ~~trials~~will ~~and~~not ~~internal~~be ~~research~~filed ~~programs.~~outside ~~Uncertainties resulting from~~ the ~~initiation~~United ~~and~~States ~~continuation~~remain ofconfidential ~~patent~~until ~~litigation~~patents orissue. ~~other~~Therefore, ~~proceedings~~patent ~~could~~applications ~~compromise~~covering our ~~ability~~products tocould ~~compete~~have inbeen ~~the~~filed ~~marketplace,~~by ~~including~~others ~~compromising~~without our ~~ability~~knowledge. toAdditionally, ~~raise~~pending ~~the~~patent ~~funds~~applications ~~necessary~~that tohave ~~continue~~been ~~our~~published ~~clinical trials~~can, ~~continue~~subject ~~our~~to ~~research~~certain ~~programs~~limitations, ~~license~~be ~~necessary~~later ~~technology~~amended ~~from~~in ~~third~~a ~~parties,~~manner orthat ~~enter~~could ~~into~~cover ~~development~~our ~~collaborations~~product ~~that~~candidates ~~would~~or ~~help~~the ususe ~~commercialize~~of our ~~product candidates, if approved~~products.

~~Because~~The scope of a patent claim is determined by an interpretation of the ~~expense~~law, the written disclosure in a patent and ~~uncertainty~~the patent's prosecution history. Our interpretation of ~~litigation~~the relevance or the scope of a patent or a pending application may be incorrect, wewhich may negatively impact our ability to market our products. We may incorrectly determine that our products are not becovered inby a ~~position~~third-party patent or may incorrectly predict whether a third party's pending application will issue with claims of relevant scope. Our determination of the expiration date of any patent in the United States or abroad that we consider relevant may be incorrect, and our failure to ~~enforce~~identify and correctly interpret relevant patents may negatively impact our ~~intellectual~~ability ~~property~~to ~~rights~~develop ~~against~~and ~~third~~market ~~parties~~our products.

~~Because~~If ofwe ~~the~~fail ~~expense~~to identify and ~~uncertainty~~correctly ofinterpret ~~litigation~~relevant patents, we may ~~conclude~~be ~~that~~subject ~~even~~to ifinfringement aclaims. ~~third~~We ~~party~~cannot isguarantee ~~infringing~~that ~~our~~we ~~issued~~will ~~patent,~~be ~~any~~able ~~patents~~to ~~that~~successfully ~~may~~settle beor ~~issued~~otherwise asresolve asuch ~~result~~infringement ofclaims. ~~our~~If ~~pending~~we orfail ~~future~~in ~~patent~~any ~~applications~~such ordispute, ~~other~~in ~~intellectual~~addition ~~property~~to ~~rights~~being forced to pay damages, ~~the~~we ~~risk-adjusted~~may ~~cost~~be temporarily or permanently prohibited from commercializing any of ~~bringing~~our ~~and~~products ~~enforcing~~that ~~such~~are aheld ~~claim~~to orbe ~~action~~infringing. ~~may~~We might, if possible, also be ~~too~~forced ~~high~~to redesign products or ~~not~~services inso ~~the~~that ~~best~~we ~~interest~~no oflonger ~~our~~infringe ~~company~~the orthird-party ~~our~~intellectual ~~shareholders~~property rights. InAny ~~such~~of ~~cases~~these events, even if we ~~may~~were ~~decide~~ultimately ~~that~~to ~~the~~prevail, ~~more~~could ~~prudent~~require ~~course~~us ofto ~~action~~divert issubstantial tofinancial ~~simply~~and ~~monitor~~management ~~the~~resources ~~situation~~that orwe ~~initiate~~would orotherwise ~~seek~~be ~~some~~able ~~other~~to ~~non-litigious~~devote ~~action~~to orour ~~solution~~business.

We may ~~need~~become toinvolved ~~license~~in ~~intellectual~~lawsuits ~~property~~to ~~from~~protect ~~third~~or ~~parties,~~enforce ~~and~~our ~~such~~patents ~~licenses~~or ~~may~~our ~~not~~other beintellectual ~~available~~property orrights, ~~may~~which ~~not~~could be ~~available~~expensive, ontime ~~commercially~~consuming ~~reasonable~~and ~~terms~~unsuccessful.

~~The~~Competitors ~~issuance~~may ofinfringe or otherwise violate our patents or our other intellectual property rights. To counter infringement or unauthorized use, we may be required to file legal claims, which can be expensive and time-consuming. In addition, in an infringement proceeding, a court may decide that a patent ~~does~~of ours is not ~~give~~valid usor ~~the~~is ~~right~~unenforceable or may refuse to ~~practice~~stop the ~~patented~~other ~~invention~~party from using the technology at issue on the grounds that our patents do not cover the technology in question. AAs ~~third~~a ~~party~~result, ~~may~~we ~~hold~~cannot ~~intellectual~~predict ~~property~~with certainty how much protection, ~~including~~if ~~patent~~any, ~~rights~~will be given to our patents if we attempt to enforce them and they are challenged in court. Further, even if we prevail against an infringer in U.S. district court, there is always the risk that ~~are~~the ~~important~~infringer will file an appeal and the district court judgment will be overturned at the appeals court and/or ~~necessary~~that an adverse decision will be issued by the appeals court relating to the ~~development~~validity or enforceability of our ~~product candidates~~patents. ~~Third~~An ~~parties~~adverse ~~may~~result ~~also~~in ~~have~~any ~~blocking~~litigation ~~patents~~or ~~that~~defense proceedings could ~~prevent~~put usone ~~from~~or ~~marketing~~more of our ~~products~~patents at risk of being invalidated or ~~practicing~~interpreted narrowly and could put our ~~own~~patent ~~patented~~applications ~~technology~~at risk of not issuing. ItThe initiation of a claim against a third party may bealso ~~necessary~~cause ~~for~~the usthird party to ~~use~~bring counter claims against us such as claims asserting that our patents are invalid or unenforceable. In patent litigation in the ~~patented~~United States, defendant counterclaims alleging invalidity or ~~proprietary~~unenforceability ~~technology~~are ofcommonplace. ~~third~~Grounds ~~parties~~for a validity challenge could be an alleged failure to ~~commercialize~~meet ~~our~~any ~~drug~~of ~~candidates~~several statutory requirements, inincluding ~~which~~lack ~~case~~of wenovelty, ~~would~~obviousness, non-enablement or lack of written description or statutory subject matter. Grounds for an unenforceability assertion could be ~~required~~an toallegation ~~obtain~~that asomeone ~~license~~connected ~~from~~with ~~these~~prosecution ~~third~~of ~~parties~~the onpatent ~~commercially~~withheld ~~reasonable~~relevant ~~terms.~~material ~~Such~~information from the USPTO, or made a ~~license~~materially misleading statement, during prosecution. Third parties may ~~not~~also beraise ~~available~~similar validity claims before the USPTO in post-grant proceedings such as ex parte reexaminations, inter partes review, or itpost-grant ~~may~~review, ~~not~~or beoppositions ~~available~~or onsimilar ~~commercially~~proceedings ~~reasonable~~outside ~~terms~~the United States, in parallel with litigation or even outside the context of litigation. The outcome following legal assertions of invalidity and unenforceability is unpredictable. We cannot be certain that there is no invalidating prior art, of which ~~case~~we ~~our~~and ~~business~~the patent examiner were unaware during prosecution. If a defendant were to prevail on a legal assertion of invalidity or unenforceability, we would belose ~~harmed~~at least part, and perhaps all, of any future patent protection on our current or future product candidates.

The risks described elsewhere pertaining to our intellectual property rights also apply to any intellectual property rights that we may in-license, and any failure by us or our potential licensors to obtain, maintain, defend and enforce these rights could harm our business. In some cases we may not have control over the prosecution, maintenance or enforcement of the patents that we may license, and may not have sufficient ability to provide input into the patent prosecution, maintenance and defense process with respect to such patents, and our potential licensors may fail to take the steps that we believe are necessary or desirable in order to obtain, maintain, defend and enforce the licensed patents.26

26We may not be able to detect or prevent misappropriation of our intellectual property rights, particularly in countries where the laws may not protect those rights as fully as in the United States. Our business could be harmed if in litigation the prevailing party does not offer us a license on commercially reasonable terms. Any litigation or other proceedings to enforce our intellectual property rights may fail, and even if successful, may result in substantial costs and distract our management and other employees.

WeEven if we establish infringement, the court may bedecide ~~subject~~not to ~~claims~~grant ~~arising~~an ~~from~~injunction ~~consultants~~against further infringing activity and instead award only monetary damages, which may or ~~contractors~~may ~~misappropriating~~not be an adequate remedy. Furthermore, because of the substantial amount of discovery required in connection with intellectual property litigation, there is a risk that some of our confidential information could be compromised by disclosure during this type of litigation. There could also be public announcements of the results of hearings, motions or other interim proceedings or developments. If securities analysts or investors perceive these results to be negative, it could harm the price of our securities.

~~Many~~Intellectual ofproperty ~~our~~litigation ~~consultants~~could ~~and~~cause ~~contractors~~us ~~were~~to ~~previously~~spend orsubstantial ~~are~~resources ~~concurrently employed at or engaged by biotechnology companies,~~ and~~/or~~ ~~other~~distract ~~pharmaceutical companies, including~~ our ~~competitors~~personnel orfrom ~~potential~~their ~~competitors,~~normal orresponsibilities ~~academic research institutions. Some of these consultants~~ and ~~contractors, including each member of our senior management or our other employees, may~~ have ~~executed~~a ~~proprietary~~harmful ~~rights,~~effect ~~nondisclosure~~on ~~and non-competition agreements in connection with such previous or concurrent employment. We may be subject to claims that we or our consultants and contractors have used or disclosed~~ the ~~intellectual~~success ~~property and other proprietary information or know-how or trade secrets~~ of ~~others in their work for us. Litigation may be necessary to defend against these claims. We are not aware of any threatened or pending claims related to these matters or concerning agreements with~~ our ~~senior management, or other of our employees, consultants and contractors, but litigation may be necessary in the future to defend against such claims~~business. If we fail in defending any such claims, in addition to paying monetary damages, we may lose valuable intellectual property rights, or personnel or access to consultants and contractors. Even if we are successful in defending against such claims, litigation could result in substantial costs and be a distraction to management.

InEven ~~addition,~~if ~~while~~resolved in our ~~policy~~favor, islitigation or other legal proceedings relating to ~~require~~intellectual property claims may cause us to incur significant expenses and could distract our ~~consultants~~technical and ~~contractors~~management ~~who~~personnel ~~may~~from their normal responsibilities. In addition, there could be ~~involved~~public inannouncements of the ~~development~~results of ~~intellectual~~hearings, ~~property~~motions toor ~~execute~~other ~~agreements~~interim ~~assigning~~proceedings ~~such~~or ~~intellectual~~developments, ~~property~~and if securities analysts or investors perceive these results to usbe negative, weit ~~may~~could beadversely ~~unsuccessful~~impact inthe ~~executing~~price ~~such~~of anour ~~agreement~~securities. ~~with~~Such ~~each~~litigation ~~party~~or ~~who~~proceedings incould ~~fact~~substantially ~~develops~~increase ~~intellectual~~our ~~property~~operating ~~that~~losses weand ~~regard~~reduce asthe ~~our~~resources ~~own~~available for development activities or any future sales, ~~which~~marketing or distribution activities. We may ~~result~~not inhave ~~claims~~sufficient byfinancial or ~~against~~other usresources ~~related~~to conduct such litigation or proceedings adequately. Some of our competitors may be able to sustain the ~~ownership~~costs of such ~~intellectual~~litigation ~~property.~~or Ifproceedings wemore ~~fail~~effectively inthan ~~prosecuting~~we orcan ~~defending~~because ~~any~~of ~~such~~their ~~claims,~~greater infinancial ~~addition~~resources. toAccordingly, ~~paying~~despite ~~monetary~~our ~~damages~~efforts, we may ~~lose~~not ~~valuable~~be able to prevent third parties from infringing upon or misappropriating our intellectual property ~~rights~~. ~~Even~~In ifaddition, wethe ~~are~~uncertainties ~~successful~~associated inwith ~~prosecuting~~litigation orcould ~~defending~~compromise ~~against~~our ~~such~~ability ~~claims,~~to raise the funds necessary to continue our clinical trials and internal research programs. Uncertainties resulting from the initiation and continuation of patent litigation or other proceedings could ~~result~~compromise our ability to compete in ~~substantial~~the ~~costs~~marketplace, ~~and~~including becompromising aour ~~distraction~~ability to raise the funds necessary to continue our ~~management~~clinical ~~and~~trials, ~~scientific~~continue ~~personnel~~our research programs, license necessary technology from third parties, or enter into development collaborations that would help us commercialize our product candidates, if approved.

~~Our~~Because ~~reliance~~of onthe ~~third~~expense ~~parties~~and ~~requires~~uncertainty usof ~~to share our trade secrets~~litigation, ~~which~~we ~~increases~~may ~~the~~not ~~possibility~~be ~~that~~in a ~~competitor~~position ~~will~~to ~~discover~~enforce ~~them or that~~ our ~~trade~~intellectual ~~secrets~~property ~~will~~rights beagainst ~~misappropriated~~third ~~or disclosed~~parties.

Because weof ~~expect~~the toexpense ~~rely on third parties to manufacture our product candidates,~~ and weuncertainty ~~expect to continue to collaborate with third parties on the development~~ of ~~our product candidates~~litigation, we ~~must,~~may atconclude ~~times,~~that ~~share~~even ~~trade secrets with them. We seek to protect our proprietary technology in part by entering into confidentiality agreements and,~~ if ~~applicable,~~a ~~material transfer agreements, consulting agreements or other similar agreements with our advisors, employees,~~ third- party ~~contractors~~is ~~and~~infringing ~~consultants prior to beginning research or disclosing proprietary information. These agreements typically limit the rights of the third parties to use or disclose~~ our ~~confidential~~issued ~~information~~patent, ~~including~~any ~~our~~patents ~~trade secrets. Despite the contractual provisions employed when working with third parties, the need to share trade secrets and other confidential information increases the risk~~ that ~~such~~may ~~trade~~be ~~secrets~~issued ~~become~~as ~~known~~a byresult ~~our competitors, are inadvertently incorporated into the technology~~ of ~~others,~~our orpending ~~are disclosed~~ or ~~used~~future inpatent ~~violation~~applications ~~of these agreements. Any disclosure, either intentional~~ or ~~unintentional,~~other byintellectual ~~our~~property ~~employees~~rights, the ~~employees~~risk-adjusted cost of ~~third~~bringing ~~parties with whom we share our facilities or third-party consultants~~ and ~~vendors~~enforcing ~~that we engage to perform research, clinical trials or manufacturing activities, or misappropriation by third parties (~~such ~~as through~~ a ~~cybersecurity~~claim ~~breach) of our trade secrets~~ or ~~proprietary~~action ~~information~~may ~~could~~be ~~enable~~too ~~competitors~~high ~~to duplicate~~ or ~~surpass our technological achievements, thus eroding our competitive position in our market. Further, adequate remedies may~~ not ~~exist~~ in the ~~event~~best interest of ~~unauthorized~~our ~~use~~company or ~~disclosure. Given that~~ our ~~proprietary~~shareholders. ~~position~~In issuch ~~based~~cases, inwe ~~part,~~may ondecide ~~our~~that ~~know-how~~the ~~and~~more ~~trade~~prudent ~~secrets,~~course ~~a competitor's discovery~~ of ~~our~~action ~~trade~~is ~~secrets~~to orsimply ~~other~~monitor ~~unauthorized~~the ~~use~~situation or ~~disclosure~~initiate ~~would~~or ~~impair~~seek ~~our~~some ~~competitive~~other ~~position~~non-litigious ~~and~~action ~~may~~or ~~harm our business and results of operations~~solution.

In addition, these agreements typically restrict the ability of our advisors, employees, third-party contractors and consultants to publish data potentially relating to our trade secrets, although our agreements may contain certain limited publication rights. Policing unauthorized use of our intellectual property is difficult, expensive and time-consuming, and we may be unable to determine the extent of any unauthorized use. Moreover, 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. Despite our efforts to protect our trade secrets, our competitors may discover our trade secrets, either through breach of our agreements with third parties, independent development or publication of information by any of our third-party collaborators. A competitor's discovery of our trade secrets would impair our competitive position and have an adverse impact on our business.27

27We may need to license intellectual property from third parties, and such licenses may not be available or may not be available on commercially reasonable terms.

IfThe weissuance of a patent does not give us the right to practice the patented invention. A third party may hold intellectual property, including patent rights, that are ~~unable~~important or necessary to ~~protect~~the development of our product candidates. Third parties may also have blocking patents that could prevent us from marketing our products or practicing our own patented technology. It may be necessary for us to use the ~~confidentiality~~patented or proprietary technology of third parties to commercialize our ~~trade~~drug ~~secrets~~candidates, ~~our~~in ~~business~~which ~~and~~case ~~competitive~~we ~~position~~would be required to obtain a license from these third parties on commercially reasonable terms. Such a license may not be available, or it may not be available on commercially reasonable terms, in which case our business would be harmed.

InThe ~~addition~~risks todescribed ~~seeking~~elsewhere ~~patents~~pertaining ~~for~~to our ~~product~~intellectual ~~candidates,~~property werights also ~~rely~~apply ~~on trade secrets, including unpatented know-how, technology and other proprietary information,~~ to ~~maintain~~any ~~our~~intellectual ~~competitive~~property ~~position.~~rights Wethat ~~seek~~we tomay ~~protect our trade secrets,~~ in ~~part~~-license, ~~by entering into non-disclosure~~ and ~~confidentiality~~any ~~agreements~~failure ~~with~~by ~~parties~~us ~~who~~or ~~have access to them, such as~~ our ~~employees,~~potential ~~corporate~~licensors ~~collaborators,~~to ~~outside scientific collaborators~~obtain, ~~contract manufacturers~~maintain, ~~consultants,~~defend ~~advisors~~ and ~~other~~enforce ~~third~~these ~~parties.~~rights Wecould ~~also~~harm ~~enter into confidentiality and invention or patent assignment agreements with~~ our ~~employees and consultants~~business. ~~Despite~~In ~~these~~some ~~efforts,~~cases ~~any of these parties may breach the agreements and disclose our proprietary information, including our trade secrets, and~~ we may not behave ~~able~~control toover ~~obtain~~the ~~adequate~~prosecution, ~~remedies~~maintenance ~~for~~or ~~such~~enforcement ~~breaches. Monitoring unauthorized uses and disclosures~~ of ~~our~~the ~~intellectual~~patents ~~property~~that ~~is difficult, and~~ we domay ~~not know whether the steps we have taken to protect our intellectual property will be effective. In addition~~license, weand may not behave ~~able~~sufficient ability to ~~obtain~~provide ~~adequate~~input ~~remedies~~into ~~for~~the ~~any~~patent ~~such breaches. Enforcing a claim that a party illegally disclosed or misappropriated a trade secret is difficult~~prosecution, ~~expensive~~maintenance and ~~time-consuming,~~defense ~~and~~process ~~the~~with ~~outcome~~respect isto ~~unpredictable.~~such ~~In addition~~patents, ~~some courts inside~~ and ~~outside~~our ~~the~~potential ~~United~~licensors ~~States~~may ~~are~~fail ~~less willing or unwilling~~ to ~~protect~~take ~~trade~~the ~~secrets.~~steps Ifthat ~~any~~we ofbelieve ~~our~~are ~~trade~~necessary ~~secrets were to be lawfully obtained~~ or ~~independently~~desirable ~~developed~~in byorder ~~a competitor, we would have no right~~ to ~~prevent them~~obtain, ~~or those to whom they communicate it~~maintain, ~~from~~defend ~~using~~and ~~that~~enforce ~~technology~~the orlicensed ~~information to compete with us~~patents. ~~If any of our trade secrets were to be disclosed to or independently developed by a competitor, our competitive position would be harmed.~~

We ~~use~~may ~~hazardous~~be ~~chemicals~~subject ~~and~~to ~~biological materials in their business. Any~~ claims ~~relating~~arising tofrom ~~improper~~consultants ~~handling, storage~~ or ~~disposal~~contractors ofmisappropriating ~~these~~intellectual ~~materials could be time consuming and costly~~property.

~~Our~~Many ~~product~~of ~~manufacturing,~~our ~~research~~consultants and ~~development,~~contractors ~~and~~were ~~testing~~previously ~~activities~~or ~~involve~~are ~~the~~concurrently ~~controlled~~employed ~~use~~at ofor ~~hazardous~~engaged ~~materials,~~by ~~including~~biotechnology ~~chemicals~~companies, and/or ~~biological~~other ~~materials.~~pharmaceutical Wecompanies, ~~cannot~~including ~~eliminate~~our ~~the~~competitors ~~risks of accidental contamination~~ or ~~the~~potential ~~accidental discharge of these materials~~competitors, or ~~any~~academic ~~resulting~~research ~~injury from such an event~~institutions. WeSome ~~may~~of bethese ~~subjected~~consultants toand ~~litigation~~contractors, ~~for~~including ~~any~~each ~~injury~~member ~~that~~of ~~results from~~ our ~~use~~senior management or ~~the~~our ~~use~~other byemployees, ~~third~~may ~~parties~~have ofexecuted ~~these~~proprietary ~~materials~~rights, nondisclosure and ~~our~~non-competition ~~liability~~agreements ~~may~~in ~~exceed~~connection ~~our~~with ~~insurance~~such ~~coverage~~previous ~~and~~or ~~our~~concurrent ~~total assets~~employment. ~~Our~~We ~~use,~~may ~~manufacture,~~be ~~storage,~~subject ~~handling~~to ~~and~~claims ~~disposal~~that ofwe ~~these~~or ~~hazardous~~our ~~materials~~consultants and ~~specified~~contractors ~~waste~~have ~~products,~~used asor ~~well~~disclosed as the ~~discharge~~intellectual ofproperty ~~pollutants into the environment~~ and ~~human~~other ~~health~~proprietary ~~and~~information ~~safety~~or ~~matters,~~know-how ~~are~~or ~~governed~~trade bysecrets ~~federal,~~of ~~state,~~others ~~provincial~~in ~~and~~their ~~local~~work ~~legislation~~for us. WeLitigation ~~are~~may ~~also~~be ~~subject~~necessary to ~~various~~defend ~~laws~~against ~~and~~these ~~regulations~~claims. ~~relating~~We toare ~~safe~~not ~~working~~aware ~~conditions,~~of ~~laboratory~~any ~~and~~threatened ~~manufacturing~~or ~~practices.~~pending ~~Our~~claims ~~operations~~related ~~may~~to ~~require~~these ~~that~~matters ~~environmental~~or ~~permits~~concerning ~~and~~agreements ~~approvals~~with beour ~~issued~~senior ~~by applicable government agencies~~management, ~~which~~or ~~can~~other beof ~~costly~~our ~~and~~employees, ~~time-consuming~~consultants ~~to attain. These regulations~~ and ~~legislation can change~~contractors, orbut ~~new~~litigation ~~ones~~may ~~come~~be ~~into~~necessary ~~place,~~in ~~due~~the to future ~~legislative~~to ordefend ~~administrative~~against ~~actions~~such claims. ~~These~~If ~~events~~we ~~could~~fail ~~cause~~in usdefending toany ~~incur~~such ~~additional~~claims, ~~expense~~in oraddition ~~restrict~~to ~~our~~paying ~~operations.~~monetary ~~Compliance with environmental laws and regulations~~damages, ~~current~~we ~~or future,~~ may belose ~~expensive~~valuable ~~and~~intellectual ~~prohibitive~~property ~~for our research~~rights, ~~development~~ or ~~production~~personnel ~~efforts.~~or ~~Failure~~access to ~~comply~~consultants ~~could~~and ~~incur~~contractors. ~~substantial~~Even ~~costs~~if ~~and~~we ~~liabilities,~~are ~~including~~successful ~~civil~~in ordefending ~~criminal~~against ~~fines~~such ~~and penalties~~claims, ~~clean-up~~litigation ~~costs~~could orresult ~~capital~~in ~~expenditures~~substantial tocosts ~~achieve~~ and ~~maintain~~be ~~compliance~~a distraction to management.

IfIn ~~product~~addition, ~~liability~~while ~~lawsuits~~our ~~are~~policy ~~brought~~is ~~against~~to usrequire ~~then~~our weconsultants and contractors who may ~~incur~~be ~~substantial~~involved ~~liabilities~~in ~~and~~the development of intellectual property to execute agreements assigning such intellectual property to us, we may be ~~required~~unsuccessful in executing such an agreement with each party who in fact develops intellectual property that we regard as our own, which may result in claims by or against us related to ~~limit~~the ~~commercialization~~ownership of ~~the~~such ~~Product~~intellectual property. If we fail in prosecuting or defending any such claims, in addition to paying monetary damages, we may lose valuable intellectual property rights. Even if ~~approved~~we are successful in prosecuting or defending against such claims, litigation could result in substantial costs and ~~any~~be ~~other~~a ~~future~~distraction ~~products~~to our management and scientific personnel.

WeOur ~~face~~reliance aon ~~potential~~third ~~risk~~parties ofrequires ~~product~~us ~~liability~~to asshare ~~a result of distribution of~~ our ~~product~~trade ~~candidate for testing and commercialization of the Product. For example~~secrets, wewhich ~~may~~increases ~~face claims if use of~~ the ~~Product~~possibility ~~allegedly~~that ~~causes~~a ~~injury~~competitor orwill isdiscover ~~found~~them ~~to be otherwise unsuitable during product testing, manufacturing, marketing~~ or ~~sale.~~that ~~Any~~our ~~such~~trade ~~product~~secrets ~~liability~~will claims may include allegations of defects in manufacturing, defects in product quality, a failure to warn of dangers inherent in the product, negligence, strict liability and a breach of warranties. Claims could also be ~~asserted~~misappropriated ~~under state consumer protection acts. If we cannot successfully defend ourself against product liability claims, we may incur substantial liabilities~~ or ~~be required to limit commercialization of the product subject to such claims~~disclosed. ~~Even successful defense would require significant financial and management resources. Regardless of the merits or eventual outcome, liability claims may result in:~~

~~● decreased~~Because ~~demand~~we ~~for~~expect ~~current~~to rely on third parties to manufacture our product candidates, and ~~future~~we ~~products;~~expect to continue to collaborate with third parties on the development of our product candidates, we must, at times, share trade secrets with them. We seek to protect our proprietary technology in part by entering into confidentiality agreements and, if applicable, material transfer agreements, consulting agreements or other similar agreements with our advisors, employees, third-party contractors and consultants prior to beginning research or disclosing proprietary information. These agreements typically limit the rights of the third parties to use or disclose our confidential information, including our trade secrets. Despite the contractual provisions employed when working with third parties, the need to share trade secrets and other confidential information increases the risk that such trade secrets become known by our competitors, are inadvertently incorporated into the technology of others, or are disclosed or used in violation of these agreements. Any disclosure, either intentional or unintentional, by our employees, the employees of third parties with whom we share our facilities or third-party consultants and vendors that we engage to perform research, clinical trials or manufacturing activities, or misappropriation by third parties (such as through a cybersecurity breach) of our trade secrets or proprietary information could enable competitors to duplicate or surpass our technological achievements, thus eroding our competitive position in our market. Further, adequate remedies may not exist in the event of unauthorized use or disclosure. Given that our proprietary position is based, in part, on our know-how and trade secrets, a competitor's discovery of our trade secrets or other unauthorized use or disclosure would impair our competitive position and may harm our business and results of operations.

~~● injury to our reputation;~~28

~~● costs~~In addition, these agreements typically restrict the ability of our advisors, employees, third-party contractors and consultants to ~~defend~~publish data potentially relating to our trade secrets, although our agreements may contain certain limited publication rights. Policing unauthorized use of our intellectual property is difficult, expensive and time-consuming, and we may be unable to determine the extent of any ~~related~~unauthorized ~~litigation;~~use. Moreover, 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. Despite our efforts to protect our trade secrets, our competitors may discover our trade secrets, either through breach of our agreements with third parties, independent development or publication of information by any of our third-party collaborators. A competitor's discovery of our trade secrets would impair our competitive position and have an adverse impact on our business.

28If we are unable to protect the confidentiality of our trade secrets, our business and competitive position would be harmed.

~~● diversion~~In addition to seeking patents for our product candidates, we also rely on trade secrets, including unpatented know-how, technology and other proprietary information, to maintain our competitive position. Trade secrets are difficult to protect, and we have limited control over the protection of ~~management's~~trade secrets used by our collaborators and suppliers. We seek to protect our trade secrets, in part, by entering into non-disclosure and confidentiality agreements with parties who have access to them, such as our employees, corporate collaborators, outside scientific collaborators, contract manufacturers, consultants, advisors and other third parties. We also enter into confidentiality and invention or patent assignment agreements with our employees and consultants. Despite these efforts, any of these parties may unintentionally or willfully breach the agreements and disclose our proprietary information, including our trade secrets, and we may not be able to obtain adequate remedies for such breaches. Monitoring unauthorized uses and disclosures of our intellectual property is difficult, and we do not know whether the steps we have taken to protect our intellectual property will be effective. In addition, we may not be able to obtain adequate remedies for any 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. We would expect any trade secret dispute to be governed by federal law, and the Defend Trade Secrets Act ("DTSA") of 2016. However, in the event we are not able to utilize the DTSA, we would then be limited to resolving such a dispute in state court. State trade secret laws in the United States vary, and state courts are sometimes less willing to protect trade secrets. In addition, some courts inside and outside the United States are less willing or unwilling to protect trade secrets. If any of our ~~resources;~~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 communicate it, 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, our competitive position would be harmed.

~~● product~~The ~~recalls,~~increasing ~~withdrawals~~use orof ~~labeling,~~artificial ~~marketing~~intelligence or("AI") ~~promotional~~and ~~restrictions;~~machine learning in drug discovery and development introduces new and evolving risks that could harm our business and competitive position.

~~● loss~~The increasing use of ~~revenue;~~AI and machine learning in drug discovery and development introduces new and evolving risks related to ownership, inventorship, and protection of intellectual property generated by or with the assistance of AI technologies. Regulatory and legal frameworks governing AI-generated inventions are still developing and may create uncertainty regarding our ability to secure and enforce rights in such inventions.

~~● inability~~We touse ~~commercialize~~hazardous ~~the~~chemicals ~~Product~~ and ~~other~~biological ~~products~~materials in their business. Any claims relating to improper handling, ifstorage ~~approved;~~or disposal of these materials could be time consuming and costly.

~~● decline~~Our inproduct manufacturing, research and development, and testing activities involve the controlled use of hazardous materials, including chemicals and biological materials. We cannot eliminate the risks of accidental contamination or the accidental discharge of these materials, or any resulting injury from such an event. We may be subjected to litigation for any injury that results from our ~~share~~use ~~price;~~or the use by third parties of these materials, and our liability may exceed our insurance coverage and our total assets. Our use, manufacture, storage, handling and disposal of these hazardous materials and specified waste products, as well as the discharge of pollutants into the environment and human health and safety matters, are governed by federal, state, provincial and local legislation. We are also subject to various laws and regulations relating to safe working conditions, laboratory and manufacturing practices. Our operations may require that environmental permits and approvals be issued by applicable government agencies, which can be costly and time-consuming to attain. These regulations and legislation can change, or new ones come into place, due to future legislative or administrative actions. These events could cause us to incur additional expense or restrict our operations. Compliance with environmental laws and regulations, current or future, may be expensive and prohibitive for our research, development or production efforts. Failure to comply could incur substantial costs and liabilities, including civil or criminal fines and penalties, clean-up costs or capital expenditures to achieve and maintain compliance.

~~● exposure to adverse publicity.~~29

~~Although~~If weproduct ~~currently~~liability ~~have~~lawsuits ~~general~~are ~~liability~~brought ~~insurance~~against inus ~~place,~~then we domay ~~not~~incur ~~know~~substantial ~~whether~~liabilities ~~the~~and ~~limits~~may ~~of the insurance will~~ be ~~sufficient~~required to ~~satisfy~~limit ~~any~~commercialization ~~claims~~of ~~should they arise. We may not have sufficient resources to pay for any liabilities resulting from a claim excluded from or beyond~~ the ~~limits of~~Products, ~~our~~if ~~insurance coverage. If we cannot successfully defend ourselves against a product liability claim~~approved, weand ~~may~~any ~~incur~~other ~~substantial~~future ~~liabilities~~products.

~~Our~~We ~~employees,~~face ~~independent~~a ~~contractors~~potential risk of product liability as a result of distribution of our product candidate for testing and commercialization of the Products. For example, ~~principal~~we ~~investigators~~may face claims if use of the Products allegedly cause injury or are found to be otherwise unsuitable during product testing, ~~consultants~~manufacturing, ~~commercial~~marketing ~~partners~~or ~~and~~sale. ~~vendors~~Any such product liability claims may ~~engage~~include allegations of defects in ~~misconduct~~manufacturing, ordefects ~~other~~in ~~improper~~product ~~activities~~quality, ~~including~~a ~~non-compliance~~failure ~~with~~to ~~regulatory~~warn ~~standards~~of ~~and~~dangers ~~requirements~~inherent ~~and~~in ~~insider~~the ~~trading~~product, ~~which~~negligence, strict liability and a breach of warranties. Claims could ~~significantly~~also ~~harm~~be ~~our~~asserted ~~business~~under state consumer protection acts. If we cannot successfully defend ourself against product liability claims, we may incur substantial liabilities or be required to limit commercialization of the product subject to such claims. Even successful defense would require significant financial and management resources. Regardless of the merits or eventual outcome, liability claims may result in:

Wedecreased ~~are~~demand ~~exposed~~for tocurrent ~~the risk that employees, independent contractors, principal investigators, consultants, commercial partners~~ and vendors may engage in fraudulent or other illegal activity, fraud or other misconduct. Misconduct by these parties could include intentional, reckless or negligent conduct or disclosure of unauthorized activities to us that violates: (i) the law and regulations of the FDA and non-U.S. regulators, including those laws that require the reporting of true, complete and accurate information to the FDA and non-U.S. regulators, (ii) healthcare fraud and abuse laws and regulations in the United States and elsewhere and (iii) laws that require the true, complete and accurate reporting of financial information or data. In particular, sales, marketing and business arrangements in the healthcare industry are subject to extensive laws and regulations intended to prevent fraud, misconduct, kickbacks, self-dealing and other abusive practices. These laws and regulations may restrict or prohibit a wide range of pricing, discounting, marketing and promotion, sales commission, customer incentive programs and other business arrangements. Misconduct in violation of these laws may also involve the improper use of information obtained in the course of clinical trials, which could result in regulatory sanctions and serious harm to our reputation. It is not always possible to identify and deter misconduct by our executives, employees, consultants and other third parties, and any precautions we take to detect and prevent this activity 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 comply with these laws or regulations. If any such actions are instituted against us, and we are not successful in defending ourself or asserting our rights, those actions could have a significant impact on our business, including the imposition of significant civil, criminal and administrative penalties, damages, monetary fines, possible exclusion from participation in national healthcare programs, contractual damages, reputational harm, diminished profits and future ~~earnings and curtailment of our operations, any of which could adversely affect our ability to operate our business and our results of operations.~~products;
Weinjury ~~may be unable~~ to ~~adequately~~our ~~prevent disclosure of trade secrets and other proprietary information.~~reputation;
Wecosts ~~rely on trade secrets~~ to ~~protect~~defend our proprietary technological advances and know-how, especially where we do not believe patent protection is appropriate or obtainable. However, trade secrets are difficult to protect. We rely in part on confidentiality agreements with our consultants, contractors, outside scientific collaborators, sponsored researchers and other advisors, including the third parties we rely on to manufacture the product, to protect our trade secrets and other proprietary information. However, any ~~party~~related ~~with whom we have executed such an agreement may breach that agreement and disclose our proprietary information, including our trade secrets.~~litigation;
~~Accordingly,~~diversion ~~these agreements may not effectively prevent disclosure~~ of ~~confidential~~management's ~~information and may not provide an adequate remedy in the event of unauthorized disclosure of confidential information. Costly and~~ time~~-consuming~~ ~~litigation could be necessary to enforce~~ and ~~determine the scope of~~ our proprietary rights. In addition, others may independently discover our trade secrets and proprietary information. Failure to obtain or maintain trade secret protection could enable competitors to use our proprietary information to develop products that compete with our products or cause additional, material adverse effects upon our competitive business position and financial results.resources;
29product recalls, withdrawals or labeling, marketing or promotional restrictions;
~~Lawsuits~~loss ~~relating~~of ~~to intellectual property infringement will be costly and time consuming.~~revenue;
Weinability ~~may be required~~ to ~~initiate~~commercialize ~~litigation~~the toProducts ~~enforce or defend our intellectual property rights. These lawsuits can be very time consuming~~ and ~~costly. There is a substantial amount of litigation involving patent and~~ other intellectual property rights in the pharmaceutical industry generally. Such litigation or proceedings could substantially increase our operating expenses and reduce the resources available for development activities or any future salesproducts, ~~marketing~~if ~~or distribution activities.~~approved;
Indecline ~~infringement litigation, any award of monetary damages we receive may not be commercially valuable. Furthermore, because of the substantial amount of discovery required~~ in ~~connection with intellectual property litigation, there is a risk that some of~~ our ~~confidential~~share ~~information~~price; and trade secrets could be compromised by disclosure during litigation. Moreover, there can be no assurance that we will have sufficient financial or other resources to file and pursue such infringement claims, which typically last for years before they are resolved. Further, any claims we assert against a perceived infringer could provoke these parties to assert counterclaims against us alleging that we have infringed their patents. Some of our competitors may be able to sustain the costs of such litigation or proceedings more effectively than we can because of their greater financial resources. Uncertainties resulting from the initiation and continuation of patent litigation or other proceedings could have a material adverse effect on our ability to compete in the marketplace.
Inexposure addition, our patents and patent applications could face other challenges, such as interference proceedings, opposition proceedings, reissue, inter partes review, re-examination proceedings, third-party submissions of prior art, and other forms of post-grant review. Any of these challenges, if successful, could result in the invalidation of, or in a narrowing of the scope or preventing the issuance of, any of our patents and patent applications subject to ~~challenge.~~adverse ~~Any of these challenges, regardless of their success, would likely be time consuming and expensive to defend and resolve and would divert our management and scientific personnel's time and attention~~publicity.

InAlthough ~~addition,~~we ~~there~~currently ~~could~~have begeneral ~~public~~liability ~~announcements~~insurance ofin place, we do not know whether the ~~results~~limits of ~~hearings,~~the ~~motions~~insurance orwill ~~other~~be ~~interim~~sufficient ~~proceedings~~to orsatisfy ~~developments,~~any ~~and~~claims ifshould ~~securities~~they ~~analysts~~arise. orWe ~~investors~~may ~~perceive~~not ~~these~~have ~~results~~sufficient resources to bepay ~~negative,~~for itany ~~could~~liabilities ~~have~~resulting from a ~~material~~claim ~~adverse~~excluded ~~effect~~from onor beyond the ~~market~~limits ~~price~~ of, our ~~securities~~insurance coverage. If we cannot successfully defend ourselves against a product liability claim, we may incur substantial liabilities.

~~Intellectual property disputes could distract our personnel from their normal responsibilities.~~30

~~Even~~Our ifemployees, ~~resolved~~independent incontractors, ~~our~~principal ~~favor~~investigators, ~~litigation~~consultants, orcommercial ~~other~~partners ~~legal~~and ~~proceedings~~vendors ~~relating to intellectual property claims~~ may ~~cause~~engage usin tomisconduct ~~incur~~or ~~significant~~other ~~expenses~~improper ~~and could distract our technical and management personnel from their normal responsibilities. In addition~~activities, ~~there~~including ~~could~~non-compliance bewith ~~public~~regulatory ~~announcements~~standards ofand ~~the~~requirements ~~results of hearings, motions or other interim proceedings or developments~~ and ifinsider ~~securities analysts or investors perceive these results to be negative~~trading, itwhich could ~~have~~significantly aharm ~~substantial adverse effect on the market price of~~ our ~~securities~~business. Such litigation or proceedings could substantially increase our operating losses and reduce the resources available for development activities or any future sales, marketing or distribution activities. We may not have sufficient financial or other resources to adequately conduct such litigation or proceedings.

~~Our~~We ~~directors~~are exposed to the risk that employees, independent contractors, principal investigators, consultants, commercial partners and vendors may ~~serve~~engage asin ~~directors~~fraudulent or other illegal activity, fraud or other misconduct. Misconduct by these parties could include intentional, reckless or negligent conduct or disclosure of unauthorized activities to us that violates: (i) the law and regulations of the FDA and non-U.S. regulators, including those laws that require the reporting of true, complete and accurate information to the FDA and non-U.S. regulators, (ii) healthcare fraud and abuse laws and regulations in the United States and elsewhere and (iii) laws that require the true, complete and accurate reporting of financial information or data. In particular, sales, marketing and business arrangements in the healthcare industry are subject to extensive laws and regulations intended to prevent fraud, misconduct, kickbacks, self-dealing and other ~~biotech~~abusive ~~companies~~practices. These laws and regulations may restrict or prohibit a wide range of pricing, discounting, marketing and promotion, sales commission, customer incentive programs and other business arrangements. Misconduct in violation of these laws may also involve the improper use of information obtained in the course of clinical trials, which could result in regulatory sanctions and serious harm to our reputation. It is not always possible to identify and deter misconduct by our executives, employees, consultants and other third parties, and any precautions we take to detect and prevent this activity 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 comply with these laws or regulations. If any such actions are instituted against us, and we are not successful in defending ourself or asserting our rights, those actions could have ~~conflicts~~a significant impact on our business, including the imposition of ~~interest~~significant civil, criminal and administrative penalties, damages, monetary fines, possible exclusion from participation in national healthcare programs, contractual damages, reputational harm, diminished profits and future earnings and curtailment of our operations, any of which could adversely affect our ability to operate our business and our results of operations.

~~Certain~~We ~~of our directors and executive officers~~ may, ~~from time to time,~~ be ~~employed~~unable by or affiliated with organizations which have entered into agreements or will enter into agreements with us. As disputes may arise between these organizations and us, or certain of these organizations may undertake or have undertaken research with our competitors, there exists the possibility for such persons to beadequately inprevent adisclosure ~~position~~ of ~~conflict.~~trade Wesecrets ~~cannot assure that any decision or recommendation made by these persons involving us will be made in accordance with his or her duties~~ and ~~obligations to deal fairly and in good faith with us and such~~ other ~~organizations~~proprietary information.

30We rely on trade secrets to protect our proprietary technological advances and know-how, especially where we do not believe patent protection is appropriate or obtainable. However, trade secrets are difficult to protect. We rely in part on confidentiality agreements with our consultants, contractors, outside scientific collaborators, sponsored researchers and other advisors, including the third parties we rely on to manufacture the product, to protect our trade secrets and other proprietary information. However, any party with whom we have executed such an agreement may breach that agreement and disclose our proprietary information, including our trade secrets.

~~Our~~Accordingly, ~~business~~these isagreements ~~affected~~may bynot ~~macroeconomic~~effectively ~~conditions~~prevent disclosure of confidential information and may not provide an adequate remedy in the event of unauthorized disclosure of confidential information. Costly and time-consuming litigation could be necessary to enforce and determine the scope of our proprietary rights. In addition, others may independently discover our trade secrets and proprietary information. Failure to obtain or maintain trade secret protection could enable competitors to use our proprietary information to develop products that compete with our products or cause additional, material adverse effects upon our competitive business position and financial results.

~~Various~~Lawsuits ~~macroeconomic~~relating factors could adversely affect our business and the results of our operations and financial condition, including changes in inflation, interest rates and foreign currency exchange rates, tariffs and trade sanctions on goods, and overall economic conditions and uncertainties, including those resulting from political instability and the current and future conditions in the global financial markets. For instance, if inflation or other factors were to ~~significantly~~intellectual ~~increase~~property ~~our~~infringement ~~business~~will ~~costs, it may not~~ be ~~feasible~~costly ~~to pass through price increases to patients. Interest rates, the liquidity of the credit markets~~ and ~~the~~time ~~volatility of the capital markets could also affect the value of our investments and our ability to liquidate our investments in order to fund our operations, if necessary~~consuming.

~~Interest~~We ~~rates~~may ~~and~~be ~~the~~required ~~ability~~ to ~~access~~initiate ~~credit~~litigation ~~markets~~to ~~could~~enforce ~~also~~or ~~adversely~~defend ~~affect~~our ~~the~~intellectual ~~ability~~property ofrights. ~~payors~~These ~~and~~lawsuits ~~distributors~~can tobe ~~purchase,~~very ~~pay~~time ~~for~~consuming and ~~effectively distribute our products if and when approved~~costly. ~~Similarly,~~There ~~these~~is ~~macroeconomic~~a ~~factors~~substantial ~~could~~amount ~~affect the ability~~ of ~~our~~litigation ~~current~~involving orpatent ~~potential~~and ~~future~~other ~~contract~~intellectual ~~manufacturers,~~property ~~sole-source~~rights orin ~~single-source~~the ~~suppliers,~~pharmaceutical orindustry ~~licensees~~generally. toSuch ~~remain~~litigation ~~in business~~ or ~~otherwise~~proceedings ~~manufacture~~could orsubstantially ~~supply~~increase our ~~products.~~operating ~~Failure~~expenses byand ~~any~~reduce ofthe ~~them~~resources toavailable ~~remain~~for indevelopment ~~business~~activities ~~could~~or ~~affect~~any ~~our~~future ~~ability~~sales, tomarketing ~~manufacture~~or ~~our~~distribution ~~products~~activities.

WeIn infringement litigation, any award of monetary damages we receive may not be ~~responsible~~commercially valuable. Furthermore, because of the substantial amount of discovery required in connection with intellectual property litigation, there is a risk that some of our confidential information and trade secrets could be compromised by disclosure during litigation. Moreover, there can be no assurance that we will have sufficient financial or other resources to file and pursue such infringement claims, which typically last for ~~corruption~~years before they are resolved. Further, any claims we assert against a perceived infringer could provoke these parties to assert counterclaims against us alleging that we have infringed their patents. Some of our competitors may be able to sustain the costs of such litigation or proceedings more effectively than we can because of their greater financial resources. Uncertainties resulting from the initiation and ~~anti-bribery~~continuation ~~law~~of ~~violations~~patent litigation or other proceedings could have a material adverse effect on our ability to compete in the marketplace.

Our business activities are subject to the to the U.S. Foreign Corrupt Practices Act (the "FCPA") and other anti-bribery and anti-corruption laws of the United States and other countries in which we operate, as well as U.S. and certain foreign export controls and trade sanctions which generally prohibit companies and company employees from engaging in bribery or other prohibited payments to foreign officials for the purpose of obtaining or retaining business.31

~~Our~~In ~~employees~~addition, orour ~~other~~patents ~~agents~~and ~~may~~patent applications could face other challenges, ~~without~~such ~~our~~as ~~knowledge~~interference ~~and~~proceedings, ~~despite~~opposition ~~our~~proceedings, ~~efforts~~reissue, ~~engage~~inter inpartes ~~prohibited~~review, ~~conduct~~re-examination ~~under~~proceedings, ~~our~~third-party ~~policies~~submissions ~~and~~of ~~procedures~~prior art, and other forms of post-grant review. Any of these challenges, if successful, could result in the ~~FCPA~~invalidation of, or ~~other~~in ~~anti-bribery~~a ~~laws~~narrowing ~~for~~of ~~which~~the wescope ~~may~~or bepreventing ~~held~~the ~~responsible.~~issuance Ifof, ~~our~~any ~~employees~~of orour ~~other~~patents ~~agents~~and ~~are~~patent ~~found~~applications subject to ~~have~~challenge. ~~engaged~~Any inof ~~such~~these ~~practices~~challenges, weregardless ~~could~~of ~~suffer~~their ~~severe~~success, ~~penalties~~would ~~and~~likely ~~other~~be ~~consequences~~time ~~that~~consuming ~~may~~and ~~have~~expensive ato ~~material~~defend ~~adverse~~and ~~effect~~resolve onand ~~our~~would ~~business,~~divert ~~financial~~our ~~condition~~management and ~~results~~scientific ofpersonnel's ~~operations~~time and attention.

WeIn ~~are~~addition, ~~subject~~there could be public announcements of the results of hearings, motions or other interim proceedings or developments, and if securities analysts or investors perceive these results to ~~foreign~~be ~~exchange~~negative, ~~risks~~it could have a material adverse effect on the market price of our securities.

AsIntellectual weproperty ~~grow~~disputes and do business in foreign markets, including the United States and Europe, it is quite possible that transactions will take place in foreign currencies. At this point we do not participate in hedging activities. Although we cannot predict the effect of possible foreign exchange losses in the future, if such losses occurred, they could ~~have~~distract ~~a material adverse effect on~~ our ~~business,~~personnel ~~results~~from oftheir ~~operation,~~normal ~~and financial condition~~responsibilities. ~~In addition, fluctuations in exchange rates could affect the pricing of our products and negatively influence customer demand.~~

WeEven ~~are~~if ~~subject~~resolved in our favor, litigation or other legal proceedings relating to ~~taxation~~intellectual ~~risks~~property claims may cause us to incur significant expenses and ~~changing~~could ~~rules~~distract byour ~~different~~technical ~~tax~~and ~~authorities~~management personnel from their normal responsibilities. In addition, there could be public announcements of the results of hearings, motions or other interim proceedings or developments and if securities analysts or investors perceive these results to be negative, it could have a substantial adverse effect on the market price of our securities. Such litigation or proceedings could substantially increase our operating losses and reduce the resources available for development activities or any future sales, marketing or distribution activities. We may not have sufficient financial or other resources to adequately conduct such litigation or proceedings.

~~Tax~~Our ~~examinations~~directors ~~are~~may ~~often~~serve ~~complex~~ as ~~tax~~directors ~~authorities may disagree with the treatment~~ of ~~items~~other ~~reported~~biotech bycompanies ~~us,~~and ~~the~~may ~~result of which could~~ have aconflicts ~~material adverse effect on our financial condition and results~~ of ~~operations~~interest.

WeCertain ~~believe~~of ~~that~~our wedirectors ~~will~~and executive officers may, from time to time, be ~~treated~~employed asby aor Uaffiliated with organizations which have entered into agreements or will enter into agreements with us.S. ~~corporation~~As disputes may arise between these organizations and us, or certain of these organizations may undertake or have undertaken research with our competitors, there exists the possibility for Usuch persons to be in a position of conflict.S. ~~federal~~We ~~income~~cannot ~~tax~~assure ~~purposes~~that any decision or recommendation made by these persons involving us will be made in accordance with his or her duties and obligations to deal fairly and in good faith with us and such other organizations.

AsOur ~~discussed~~business more fully under "U.S. Federal Income Tax Considerations," we believe that, pursuant to Section 7874 of the U.S. Internal Revenue Code of 1986, as amended (the "Code"), even though we are organized as a corporation under the laws of Ontario, Canada, the Company will be treated as a U.S. domestic corporation for all purposes of the Code. The Company will therefore be taxed as a U.S. domestic corporation for U.S. federal income tax purposes. As a result, the Company will be subject to U.S. federal income tax on its worldwide income. The Company is ~~also~~affected ~~subject~~by tomacroeconomic ~~tax in Canada~~conditions. It is unclear how the foreign tax credit rules under the Code will operate in certain circumstances, given our treatment as a U.S. domestic corporation for U.S. federal income tax purposes and the taxation of the Company in Canada. Accordingly, it is possible that we will be subject to double taxation with respect to all or part of our taxable income.

31Various macroeconomic factors could adversely affect our business and the results of our operations and financial condition, including changes in inflation, interest rates and foreign currency exchange rates, tariffs and trade sanctions on goods, and overall economic conditions and uncertainties, including those resulting from political instability and the current and future conditions in the global financial markets. For instance, if inflation or other factors were to significantly increase our business costs, it may not be feasible to pass through price increases to patients. Interest rates, the liquidity of the credit markets and the volatility of the capital markets could also affect the value of our investments and our ability to liquidate our investments in order to fund our operations, if necessary.

InInterest ~~addition,~~rates ifand the ~~Company~~ability ~~pays dividends~~ to aaccess ~~Non-U.S.~~credit ~~Holder,~~markets ascould ~~defined~~also inadversely ~~the~~affect ~~discussion under~~ the ~~heading~~ability ~~"U.S.~~of ~~Federal~~payors ~~Income~~and ~~Tax~~distributors ~~Considerations~~to purchase," itpay ~~will~~for beand ~~required~~effectively todistribute ~~withhold~~our ~~U.S.~~products ~~income~~if ~~tax~~and atwhen ~~the~~approved. ~~rate~~Similarly, ofthese ~~30%,~~macroeconomic orfactors ~~such~~could ~~lower~~affect ~~rate~~the asability ~~may~~of beour ~~provided~~current inor anpotential ~~applicable~~future ~~income~~contract ~~tax~~manufacturers, ~~treaty.~~sole-source ~~Each~~or ~~investor~~single-source issuppliers, ~~urged~~or licensees to ~~consult~~remain ~~its~~in ~~own~~business ~~tax~~or ~~adviser~~otherwise ~~regarding~~manufacture ~~the~~or ~~U.S.~~supply ~~federal~~our ~~income~~products. ~~tax~~Failure ~~position~~by any of ~~the~~them ~~Company~~to ~~and~~remain ~~the~~in ~~tax~~business ~~consequences~~could ofaffect ~~holding~~our ability to manufacture our ~~securities~~products.

~~We are subject to a number of risks and hazards, of which not all of them may be sufficiently insured for.~~32

Our business will be subject to a number of risks and hazards generally, including general liability. Such occurrences could result in damage to property, inventory, facilities, personal injury or death to end-customers or operators, damage to our properties or the properties of others, monetary losses and possible legal liability. Although we maintain insurance to protect against certain risks in such amounts as we consider to be reasonable, our insurance will not cover all the potential risks associated with our operations. We may ~~also~~ be ~~unable~~responsible tofor ~~maintain~~corruption insurance to cover these risks at economically feasible premiums. Insurance coverage may not continue to be available or may not be adequate to cover any resulting liability. We might also become subject to liability 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 may cause us to incur significant costs that could have a material adverse effect upon our financial performance and ~~results~~anti-bribery oflaw ~~operations~~violations.

~~Risks~~Our ~~related~~business activities are subject to ~~health~~the ~~epidemics~~to the U.S. Foreign Corrupt Practices Act (the "FCPA") and ~~pandemics~~other anti-bribery and anti-corruption laws of the United States and other countries in which we operate, as well as U.S. and certain foreign export controls and trade sanctions which generally prohibit companies and company employees from engaging in bribery or other prohibited payments to foreign officials for the purpose of obtaining or retaining business.

~~Unfavorable~~Our ~~global~~employees ~~conditions,~~or ~~including~~other asagents amay, ~~result~~without ofour ~~health~~knowledge and ~~safety~~despite ~~concerns~~our ~~related~~efforts, toengage ~~global~~in ~~pandemics,~~prohibited ~~could~~conduct ~~adversely~~under ~~affect~~ our ~~business,~~policies ~~financial~~and ~~condition~~procedures orand ~~results~~the ofFCPA ~~operations.~~or ~~Our~~other ~~operations~~anti-bribery ~~could~~laws befor ~~adversely~~which ~~affected~~we bymay ~~general~~be ~~conditions~~held inresponsible. ~~the~~If ~~global~~our ~~economy,~~employees ~~including~~or ~~conditions~~other ~~that~~agents are ~~outside~~found ofto ~~our~~have ~~control,~~engaged in such aspractices, ~~the~~we ~~impact~~could ofsuffer ~~health~~severe penalties and ~~safety~~other ~~concerns~~consequences ~~from~~that ~~global~~may ~~pandemics~~have ~~like~~a ~~the~~material ~~coronavirus~~adverse ~~(COVID-19)~~effect ~~outbreak.~~on ~~The~~our ~~most~~business, ~~recent global~~ financial ~~crisis~~condition ~~caused by the coronavirus outbreak has resulted in extreme volatility~~ and ~~disruptions~~results inof ~~the capital and credit markets~~operations. ~~A weak or declining economy could also strain our supply channels.~~

~~Risks~~We ~~Related~~are subject to ~~Marketing,~~foreign ~~Reimbursement,~~exchange ~~Healthcare Regulations and Ongoing Regulatory Compliance~~ risks.

~~Coverage~~As we grow and ~~reimbursement~~do ~~may~~business bein ~~limited~~foreign ormarkets, ~~unavailable~~including the United States and Europe, it is quite possible that transactions will take place in ~~certain~~foreign ~~market~~currencies. ~~segments~~At ~~for~~this point we do not participate in hedging activities. Although we cannot predict the ~~Product~~effect of possible foreign exchange losses in the future, ~~which~~if such losses occurred, they could ~~make~~have ita ~~difficult~~material ~~for~~adverse useffect toon ~~sell~~our business, results of operation, and financial condition. In addition, fluctuations in exchange rates could affect the ~~Product~~pricing ~~profitably~~of our products and negatively influence customer demand.

~~The~~We ~~success~~are ofsubject ~~the Product, if approved, depends on the availability of adequate coverage and reimbursement from third-party payors, including government agencies. There is significant uncertainty related~~ to ~~the~~taxation ~~insurance~~risks ~~coverage~~ and ~~reimbursement~~changing ofrules ~~newly approved products. Coverage may be more limited than the purposes for which a therapeutic is approved~~ by ~~the~~different ~~FDA~~tax authorities or ~~comparable~~challenges ~~regulatory~~to ~~authorities~~our intax ~~other jurisdictions~~positions.

InWe are subject to taxation in the United States, Canada and ~~some~~ other jurisdictions in which we operate. Our future income tax obligations could be affected by changes in, ~~patients~~or ~~who~~interpretations ~~are~~of, ~~provided~~tax ~~medical~~laws ~~treatment~~in ~~for~~the ~~their~~United ~~conditions~~States, ~~generally~~Canada ~~rely~~or onin ~~third-party~~other ~~payors~~jurisdictions. toChanges ~~reimburse~~in ~~all~~tax laws or ~~part~~regulations ofmay ~~the~~be ~~costs~~enacted ~~associated~~that ~~with~~could ~~their~~significantly ~~treatment~~affect our overall tax liabilities and our effective tax rate. ~~Adequate~~In ~~coverage~~addition, tax authorities could interpret or issue guidance on how provisions of certain tax laws and ~~reimbursement~~regulations will be applied or otherwise administered that is different from ~~governmental~~our ~~healthcare~~interpretation, ~~programs~~and we may be required to make adjustments to amounts that we have recorded that may adversely affect our results of operations and financial condition. Our tax reporting positions may be challenged by relevant tax authorities, ~~such~~and aswe ~~Medicare~~might incur significant expense in our efforts to defend those challenges, and ~~Medicaid~~we might be unsuccessful in those efforts. Developments in examinations and challenges might materially change our provision for taxes in the ~~United~~affected ~~States~~periods and ~~commercial~~might ~~payors~~differ ~~are~~materially ~~critical~~from toour ~~new~~historical ~~product~~tax ~~acceptance~~accruals. Any of these risks might have a materially adverse impact on our business operations, our cash flows, and our financial position or results of operations.

~~Government~~We ~~authorities~~believe ~~and~~that ~~other~~we ~~third-party~~will ~~payors,~~be ~~such~~treated as ~~private~~a ~~health insurers and health maintenance organizations, decide which drugs and treatments they will cover and the amount of reimbursement~~U.S. Incorporation ~~the United States, the principal decisions about reimbursement~~ for ~~new medicines are typically made by the Centers for Medicare & Medicaid Services (“CMS”), an agency within the United States Department of Health and Human Services~~U. ~~CMS decides whether and to what extent a new medicine will be covered and reimbursed under Medicare, and private payors often follow CMS' coverage decisions~~S. ~~Other~~federal ~~jurisdictions~~income ~~have~~tax agencies, such as the National Institute for Health and Care Excellence in the United Kingdom, that evaluate the use and cost effectiveness of therapies, which impact the utilization and price of the medicine in such jurisdictionpurposes.

32As discussed more fully under "U.S. Federal Income Tax Considerations," we believe that, pursuant to Section 7874 of the U.S. Internal Revenue Code of 1986, as amended (the "Code"), even though we are organized as a corporation under the laws of Ontario, Canada, the Company will be treated as a U.S. domestic corporation for all purposes of the Code. The Company will therefore be taxed as a U.S. domestic corporation for U.S. federal income tax purposes. As a result, the Company will be subject to U.S. federal income tax on its worldwide income. The Company is also subject to tax in Canada. It is unclear how the foreign tax credit rules under the Code will operate in certain circumstances, given our treatment as a U.S. domestic corporation for U.S. federal income tax purposes and the taxation of the Company in Canada. Accordingly, it is possible that we will be subject to double taxation with respect to all or part of our taxable income.

In ~~the United States~~addition, noif ~~uniform~~the ~~policy~~Company ofpays ~~coverage~~dividends ~~and~~to ~~reimbursement~~a ~~for products exists among third~~Non-~~party payors~~U.S. ~~As a result~~Holder, ~~obtaining~~as ~~coverage~~defined ~~and~~in ~~reimbursement~~the ~~approval~~discussion ofunder athe ~~product~~heading ~~from~~"U.S. aFederal ~~government~~Income orTax ~~other~~Considerations," ~~third-party~~it ~~payor~~will isbe arequired ~~time consuming and costly process that could require Medicus~~ to ~~provide~~withhold toU.S. ~~each~~income ~~payor~~tax ~~supporting~~at ~~scientific, clinical and cost effectiveness data for~~ the ~~use~~rate of ~~products on a payor-by-payor basis~~30%, ~~with~~or nosuch ~~assurance~~lower ~~that~~rate ~~coverage~~as ~~and~~may ~~adequate reimbursement will~~ be ~~obtained.~~provided ~~Even~~in ifan ~~Medicus~~applicable ~~obtains~~income ~~coverage~~tax ~~for~~treaty. aEach ~~given~~investor ~~product,~~is ~~the~~urged ~~resulting~~to ~~reimbursement~~consult ~~payment~~its ~~rates~~own ~~might~~tax ~~not~~adviser beregarding ~~adequate~~the ~~for~~U.S. ~~Medicus~~federal toincome ~~maintain~~tax ~~pricing~~position ~~sufficient~~of tothe ~~achieve~~Company orand ~~sustain~~the ~~profitability~~tax orconsequences ~~may~~of ~~require~~holding ~~copayments~~our ~~that patients find unacceptably high~~securities.

~~Medicus~~Our ~~intends~~ability to ~~seek~~use ~~approval~~our tonet ~~market~~operating ~~the~~losses ~~Product in different jurisdictions, which could include Canada~~ and certain other ~~selected~~attributes ~~foreign~~may ~~jurisdictions in addition to the United States. If Medicus obtains approval in any of these jurisdictions for the Product, Medicus will~~ be subject to ~~rules~~certain ~~and regulations in those jurisdictions~~limitations. Market acceptance and sales of the Product will depend significantly on the availability of adequate coverage and reimbursement from third party payors for the Product and may be affected by existing and future health care reform measures.

Our relationship with healthcare providers and physicians and third-party payors will be subject to applicable antikickback, fraud and abuse and other healthcare laws and regulations, which could expose us to criminal sanctions, civil penalties, contractual damages, reputational harm and diminished profits and future earnings.33

~~Healthcare~~Under ~~providers,~~Section ~~physicians~~382 and ~~third-party~~Section ~~payors~~383 inof the ~~United States~~Code, ~~Canada,~~if ~~and~~a ~~elsewhere~~corporation ~~play~~undergoes aan ~~primary~~"ownership ~~role~~change," in the ~~recommendation~~corporation's ~~and~~ability ~~prescription~~to ofuse ~~any~~its ~~product~~pre-change ~~candidates~~net ~~for~~operating ~~which~~losses we("NOLs") ~~obtain marketing approval. If we obtain FDA approval for any product candidates~~ and ~~begin~~other ~~commercializing~~tax ~~those products in the United States~~attributes, ~~our~~including ~~current~~research and ~~future~~development ~~arrangements~~tax ~~with healthcare providers~~credits, ~~third-party payors, customers, and others may expose us~~ to ~~broadly~~offset ~~applicable~~its ~~fraud~~post-change ~~and~~income ~~abuse~~or ~~and~~taxes ~~other~~may ~~healthcare~~be ~~laws and regulations~~limited. In ~~particular~~general, ~~the~~an ~~research~~"ownership ofchange" ~~product~~will ~~candidates,~~occur asif ~~well~~there asis ~~the~~a ~~promotion,~~cumulative ~~sales~~change ~~and~~in ~~marketing~~our ofownership ~~healthcare~~by ~~items~~"5% ~~and~~shareholders" ~~services,~~that asexceeds ~~well~~50 aspercentage ~~certain~~points ~~business~~over ~~arrangements~~a inrolling ~~the~~three-year ~~healthcare~~period. ~~industry,~~Similar ~~are~~rules ~~subject~~may toapply ~~extensive~~under state tax laws. ~~designed~~If towe ~~prevent~~have ~~fraud,~~undergone ~~kickbacks,~~previous ~~self-dealing~~ownership ~~and~~changes, ~~other~~or ~~abusive~~if ~~practices.~~we ~~These~~undergo ~~laws~~an ~~and~~ownership ~~regulations~~change ~~may~~in ~~restrict~~the orfuture, ~~prohibit~~including as a ~~wide~~result ~~range~~ of ~~pricing,~~this ~~discounting~~offering, ~~marketing~~our ~~and~~ability ~~promotion,~~to ~~structuring~~use NOLs and ~~commission(s),~~other ~~certain~~tax ~~customer~~attributes ~~incentive~~to ~~programs~~reduce ~~and~~future ~~other~~taxable ~~business~~income ormay ~~financial~~be ~~arrangements~~subject to substantial restrictions.

~~The~~We ~~applicable~~are ~~U.S.~~subject ~~federal,~~to ~~state~~a ~~and~~number ~~other~~of ~~healthcare~~risks ~~laws~~ and ~~regulations~~hazards, ~~laws~~of ~~that~~which ~~may~~not ~~affect~~all ~~our~~of ~~ability~~them tomay ~~operate~~be ~~include,~~sufficiently ~~but~~insured ~~are not limited to:~~for.

~~● the~~Our ~~federal~~business ~~Anti-Kickback~~will ~~Statute,~~be ~~which~~subject ~~prohibits,~~to ~~among~~a ~~other~~number ~~things,~~of ~~persons~~risks and ~~entities~~hazards ~~from knowingly and willfully soliciting~~generally, ~~receiving,~~including ~~offering~~general orliability. ~~paying~~Such ~~any~~occurrences ~~remuneration~~could ~~(including~~result ~~any~~in ~~kickback,~~damage ~~bribe,~~to ~~or rebate)~~property, ~~directly or indirectly~~inventory, ~~overtly or covertly~~facilities, inpersonal ~~cash~~injury or indeath ~~kind,~~ to ~~induce~~end-customers or ~~reward~~operators, ordamage into ~~return~~our ~~for,~~properties ~~either~~or the ~~referral~~properties of ~~an individual~~others, ormonetary ~~the~~losses ~~purchase,~~and ~~lease,~~possible ~~order,~~legal ~~arrangement,~~liability. orAlthough ~~recommendation~~we ofmaintain ~~any~~insurance ~~good,~~to ~~facility,~~protect ~~item~~against orcertain ~~service~~risks ~~for which payment may be made,~~ in ~~whole or in part, under a federal healthcare program,~~ such amounts as ~~the~~we ~~Medicare~~consider ~~and~~to ~~Medicaid programs. A person or entity can~~ be ~~found~~reasonable, ~~guilty~~our ofinsurance ~~violating~~will ~~the~~not ~~statute~~cover ~~without~~all ~~actual knowledge of~~ the ~~statute~~potential orrisks ~~specific~~associated ~~intent~~with toour ~~violate it~~operations. ~~The~~We ~~term~~may ~~remuneration~~also ~~has~~be ~~been~~unable ~~interpreted broadly~~ to ~~include~~maintain ~~anything~~insurance ~~of value. Further, courts have found that if "one purpose" of renumeration is~~ to ~~induce~~cover ~~referrals,~~these ~~the~~risks ~~federal~~at ~~Anti-Kickback~~economically ~~statute~~feasible ~~is violated~~premiums. ~~Violations~~Insurance ~~are~~coverage ~~subject~~may tonot ~~significant~~continue ~~civil~~to ~~and~~be ~~criminal~~available ~~fines~~or ~~and~~may ~~penalties~~not ~~for~~be ~~each~~adequate ~~violation, plus up~~ to ~~three~~cover ~~times~~any ~~the~~resulting ~~remuneration involved, imprisonment, and exclusion from government healthcare programs~~liability. InWe ~~addition,~~might aalso ~~claim~~become ~~submitted~~subject ~~for payment~~ to ~~any~~liability ~~federal~~which ~~healthcare~~may ~~program~~not ~~that~~be ~~includes~~insured ~~items~~against or ~~services~~which ~~that~~we ~~were~~may ~~made~~elect asnot ato ~~result~~insure ofagainst abecause ~~violation~~ of ~~the~~premium ~~federal~~costs ~~Anti-Kickback Statute constitutes a false~~ or ~~fraudulent~~other ~~claim for purposes of the federal False Claims Act, or FCA~~reasons. ~~The~~Losses ~~Anti-Kickback~~from ~~Statute~~these ~~has~~events ~~been~~may ~~interpreted~~cause tous ~~apply~~ to ~~arrangements~~incur ~~between~~significant ~~pharmaceutical~~costs ~~manufacturers~~that oncould ~~the~~have ~~one~~a ~~hand~~material ~~and~~adverse ~~prescribers,~~effect ~~purchasers,~~upon ~~and~~our ~~formulary~~financial ~~managers,~~performance ~~among~~and ~~others,~~results ~~on the other. There are a number~~ of ~~statutory exceptions and regulatory safe harbors protecting some common activities from prosecution;~~operations.

~~● the~~Risks ~~federal~~related ~~civil and criminal false claims laws, including the FCA, and civil monetary penalty laws which prohibit, among other things, individuals or entities from knowingly presenting, or causing~~ to behealth ~~presented,~~epidemics false, fictitious or fraudulent claims for payment to, or approval by Medicare, Medicaid, or other federal healthcare programs; knowingly making, using, or causing to be made or used, a false record or statement material to a false, fictitious or fraudulent claim or an obligation to pay or transmit money or property to the federal government; or knowingly concealing or knowingly and ~~improperly avoiding, decreasing or concealing an obligation to pay money to the federal government~~pandemics. A claim that includes items or services resulting from a violation of the federal Anti-Kickback Statute constitutes a false or fraudulent claim under the FCA. Manufacturers can be held liable under the FCA even when they do not submit claims directly to government payors if they are deemed to "cause" the submission of false or fraudulent claims. The FCA also permits a private individual acting as a "whistleblower" to bring qui tam actions on behalf of the federal government alleging violations of the FCA and to share in any monetary recovery or settlement. When an entity is determined to have violated the FCA, the government may impose civil fines and penalties for each false claim, plus treble damages, and exclude the entity from participation in Medicare, Medicaid and other federal healthcare programs;

33Unfavorable global conditions, including as a result of health and safety concerns related to global pandemics, could adversely affect our business, financial condition or results of operations. Our operations could be adversely affected by general conditions in the global economy, including conditions that are outside of our control, such as the impact of health and safety concerns from global pandemics like the coronavirus (COVID-19) outbreak. The most recent global financial crisis caused by the coronavirus outbreak has resulted in extreme volatility and disruptions in the capital and credit markets. A weak or declining economy could also strain our supply channels.

~~● the~~Risks ~~federal~~Related ~~Health Insurance Portability and Accountability Act of 1996, or HIPAA, which created additional federal criminal statutes that prohibit knowingly and willfully executing, or attempting~~ to ~~execute~~Marketing, ~~a scheme to defraud any healthcare benefit program~~Reimbursement, ~~including~~Healthcare ~~private~~Regulations third-party payors, or obtain, by means of false or fraudulent pretenses, representations, or promises, any of the money or property owned by, or under the custody or control of, any healthcare benefit program, regardless of the payor (e.g., public or private), and ~~knowingly~~Ongoing ~~and~~Regulatory willfully falsifying, concealing or covering up by any trick or device a material fact or making any materially false, fictitious or fraudulent statement or representation, or making or using any false writing or document knowing the same to contain any materially false fictitious or fraudulent statement or entry in connection with the delivery of, or payment for, healthcare benefits, items or services relating to healthcare matters. Similar to the federal Anti-Kickback Statute, a person or entity can be found guilty of violating HIPAA fraud provisions without actual knowledge of the statute or specific intent to violate it;Compliance

~~● HIPAA,~~Coverage ~~as amended by the Health Information Technology for Economic~~ and ~~Clinical~~reimbursement ~~Health~~may ~~Act~~be oflimited ~~2009,~~ or ~~HITECH,~~unavailable ~~and~~in ~~their respective implementing regulations, which impose, among other things,~~ certain ~~requirements~~market ~~relating~~segments tofor the ~~privacy~~Products, ~~security~~which ~~and~~could transmission of individually identifiable health information on certain covered healthcare providers, health plans, and healthcare clearinghouses, known as covered entities, as well as their respective "business associates," those independent contractors or agents of covered entities that create, receive, maintain, transmit or obtain protected health information in connection with providing a service on behalf of a covered entity. HITECH also created new tiers of civil monetary penalties, amended HIPAA to make ~~civil~~it ~~and~~difficult ~~criminal penalties directly applicable to business associates, and gave state attorneys general new authority to file civil actions~~ for ~~damages~~us ~~or injunctions in federal courts~~ to ~~enforce~~sell the ~~federal~~Products ~~HIPAA laws and seek attorneys' fees and costs associated with pursuing federal civil actions~~profitably. In addition, there are additional federal, state and non-U.S. laws which govern the privacy and security of health and other personal information in certain circumstances, many of which differ from each other in significant ways and may not have the same effect, thus complicating compliance efforts;

~~● the~~The ~~federal~~success ~~Physician~~of ~~Payments~~the ~~Sunshine Act~~Products, ~~created~~if ~~under the Patient Protection and Affordable Care Act~~approved, asdepends ~~amended~~on by the ~~Health~~availability ~~Care and Education Reconciliation Act~~ of ~~2010,~~adequate ~~or,~~coverage ~~collectively, the Affordable Care Act,~~ and ~~its~~reimbursement ~~implementing~~from ~~regulations,~~third-party ~~which require manufacturers of drugs~~payors, ~~devices,~~including ~~biologics~~government ~~and~~agencies. ~~medical~~There ~~supplies for which payment~~ is ~~available~~significant ~~under~~uncertainty ~~Medicare, Medicaid or the Children's Health Insurance Program (with certain exceptions) to report annually to CMS information~~ related to ~~direct~~the orinsurance ~~indirect~~coverage ~~payments~~ and ~~other~~reimbursement ~~transfers~~ of ~~value~~newly ~~made~~approved toproducts. ~~physicians~~Coverage ~~(defined~~may tobe ~~include~~more ~~doctors,~~limited ~~dentists,~~than ~~optometrists,~~the ~~podiatrists~~purposes ~~and~~for ~~chiropractors)~~which ~~and~~a ~~teaching~~therapeutic ~~hospitals,~~is asapproved ~~well as ownership and investment interests held~~ by the ~~physicians~~FDA ~~and~~or ~~their~~comparable ~~immediate~~regulatory ~~family~~authorities ~~members. Effective January 1, 2022, these reporting obligations will extend to include transfers of value made~~ in ~~the~~other ~~previous year to certain non-physician providers such as physician assistants and nurse practitioners;~~jurisdictions.

~~● federal~~In ~~consumer~~the ~~protection~~United States and ~~unfair~~some ~~competition~~other ~~laws~~jurisdictions, ~~which~~patients ~~broadly~~who ~~regulate~~are ~~marketplace~~provided ~~activities~~medical treatment for their conditions generally rely on third-party payors to reimburse all or part of the costs associated with their treatment. Adequate coverage and ~~activities~~reimbursement ~~that~~from ~~potentially~~governmental ~~harm~~healthcare ~~consumers;~~programs, such as Medicare and Medicaid in the United States and commercial payors are critical to new product acceptance.

34Government authorities and other third-party payors, such as private health insurers and health maintenance organizations, decide which drugs and treatments they will cover and the amount of reimbursement. In the United States, the principal decisions about reimbursement for new medicines are typically made by the Centers for Medicare & Medicaid Services ("CMS"), an agency within the United States

~~● analogous~~Department ~~U.S.~~of ~~state,~~Health ~~local~~ and ~~foreign~~Human ~~laws~~Services. ~~and~~CMS ~~regulations,~~decides ~~such~~whether ~~as state anti-kickback~~ and ~~false~~to ~~claims~~what ~~laws,~~extent ~~which~~a ~~may~~new ~~apply~~medicine towill ~~sales~~be orcovered ~~marketing arrangements~~ and ~~claims involving healthcare items or services~~ reimbursed byunder ~~any third-party payor~~Medicare, ~~including~~and private ~~insurers~~payors ~~and~~often ~~may~~follow beCMS' ~~broader~~coverage indecisions. ~~scope~~Other ~~than~~jurisdictions ~~their~~have ~~federal~~agencies, ~~equivalents;~~such ~~state~~as ~~and foreign laws that require pharmaceutical companies to comply with~~ the ~~pharmaceutical~~National ~~industry's~~Institute ~~voluntary~~for ~~compliance~~Health ~~guidelines~~ and ~~other~~Care ~~relevant~~Excellence ~~compliance~~in ~~guidance promulgated by~~ the ~~federal~~United government or otherwise restrict payments that may be made to healthcare providers and other potential referral sources; state and foreign laws that require drug manufacturers to report information related to payments and other transfers of value to physicians and other healthcare providersKingdom, ~~marketing expenditures or drug pricing; state and local laws~~ that ~~require~~evaluate the ~~registration~~use ~~of pharmaceutical sales representatives;~~ and ~~state~~cost ~~and~~effectiveness ~~foreign laws governing the privacy and security~~ of ~~health information~~therapies, ~~some of~~ which ~~may~~impact ~~be more stringent than those in~~ the ~~United~~utilization ~~States~~and ~~(such~~price asof the ~~European~~medicine ~~Union, which adopted the General Data Protection Regulation, which became effective~~ in ~~May~~such ~~2018) in certain circumstances, and may differ from each other in significant ways and often are not preempted by HIPAA, thus complicating compliance efforts~~jurisdiction.

The distribution of pharmaceutical products is subject to additional requirements and regulations, including extensive record-keeping, licensing, storage and security requirements intended to prevent the unauthorized sale of pharmaceutical products.34

~~The~~In ~~scope~~the ~~and~~United ~~enforcement~~States, no uniform policy of ~~each~~coverage and reimbursement for products exists among third-party payors. As a result, obtaining coverage and reimbursement approval of ~~these~~a ~~laws~~product from a government or other third-party payor is ~~uncertain~~a time consuming and ~~subject~~costly toprocess ~~rapid~~that ~~change~~could inrequire ~~the~~Medicus ~~current~~to ~~environment~~provide ofto ~~healthcare~~each ~~reform~~payor supporting scientific, ~~especially~~clinical inand ~~light~~cost ofeffectiveness data for the ~~lack~~use of ~~applicable~~products ~~precedent~~on a payor-by-payor basis, with no assurance that coverage and ~~regulations~~adequate reimbursement will be obtained. ~~Ensuring~~Even ~~business~~if ~~arrangements~~Medicus ~~comply~~obtains ~~with~~coverage ~~applicable~~for ~~healthcare~~a ~~laws~~given product, asthe ~~well~~resulting asreimbursement ~~responding~~payment torates ~~possible~~might ~~investigations~~not bybe ~~government~~adequate ~~authorities,~~for ~~can~~Medicus beto ~~time-and~~maintain ~~resource-consuming,~~pricing ~~costly,~~sufficient ~~and~~to ~~can~~achieve ~~divert~~or asustain ~~company's~~profitability ~~attention~~or ~~from~~may ~~the~~require ~~business~~copayments that patients find unacceptably high.

ItMedicus isintends ~~possible~~to ~~that~~seek ~~governmental~~approval ~~and~~to ~~enforcement~~market ~~authorities~~the ~~will~~Products ~~conclude~~in ~~that~~different ~~our business practices~~jurisdictions, ~~including~~which ~~our~~could ~~arrangements~~include ~~with~~Canada ~~physicians~~ and other ~~healthcare~~selected ~~providers,~~foreign ~~may~~jurisdictions ~~not~~in ~~comply~~addition ~~with~~to ~~current~~the orUnited ~~future statutes, regulations or case law interpreting applicable fraud and abuse or other healthcare laws and regulations~~States. If ~~our~~Medicus ~~operations~~obtains ~~are~~approval ~~found to be~~ in ~~violation of~~ any of ~~the~~these ~~laws~~jurisdictions ~~described~~for ~~above~~the ~~or any other government regulations that apply to us~~Products, weMedicus ~~may~~will be subject to ~~significant~~rules ~~sanctions, including civil, criminal~~ and ~~administrative~~regulations ~~penalties, damages, fines, disgorgement, imprisonment, reputational harm, exclusion from participation~~ in ~~federal~~those ~~and~~jurisdictions. ~~state~~Market ~~funded~~acceptance ~~healthcare programs, contractual damages~~ and ~~the~~sales ~~curtailment or restricting~~ of ~~our~~the ~~operations,~~Products aswill ~~well~~depend assignificantly ~~additional~~on ~~reporting obligations and oversight if we become subject to a corporate integrity agreement or other agreement to resolve allegations of non-compliance with these laws. Further, if any of~~ the ~~physicians~~availability ~~or other healthcare providers or entities with whom we expect to do business are found to be not in compliance with applicable laws, they may be subject to similar penalties. Any action for violation~~ of ~~these~~adequate ~~laws,~~coverage ~~even if successfully defended, could cause a pharmaceutical manufacturer to incur significant legal expenses~~ and ~~divert~~reimbursement ~~management's attention~~ from ~~the~~third ~~operation~~party ofpayors ~~the~~for ~~business. In addition,~~ the ~~approval~~Products and ~~commercialization~~may ofbe ~~any~~affected ~~product~~by ~~candidate~~existing inand ~~other~~future ~~countries~~health ~~will~~care ~~also~~reform ~~likely subject us to foreign equivalents of the healthcare laws mentioned above, among other foreign laws~~measures. ~~All of these could harm our ability to operate our business and our financial results.~~

~~Ongoing~~Our relationship with healthcare ~~legislative~~providers and ~~regulatory~~physicians ~~reform~~and ~~measures~~third-party ~~may~~payors ~~have~~will abe ~~material~~subject ~~adverse~~to ~~effect~~applicable onantikickback, ~~our~~fraud ~~business~~and abuse and ~~results~~other ofhealthcare ~~operations~~laws and regulations, which could expose us to criminal sanctions, civil penalties, contractual damages, reputational harm and diminished profits and future earnings.

~~Changes~~Healthcare providers, physicians and third-party payors in ~~U.S.~~the United States, ~~Canadian~~Canada, and ~~foreign~~elsewhere ~~regulations,~~play ~~statutes~~a orprimary role in the ~~interpretation~~recommendation and prescription of ~~existing~~any ~~regulations~~product ~~could~~candidates ~~impact~~for ~~our~~which ~~business~~we obtain marketing approval. If we obtain FDA approval for any product candidates and begin commercializing those products in the United States, our current and future byarrangements ~~requiring~~with healthcare providers, ~~for~~third-party ~~example:~~payors, ~~(i)~~customers, ~~changes~~and others may expose us to ~~our~~broadly ~~manufacturing~~applicable ~~arrangements;~~fraud ~~(ii)~~and ~~additions~~abuse orand ~~modifications~~other tohealthcare laws and regulations. In particular, the research of product ~~labeling;~~candidates, ~~(iii)~~as well as the ~~recall~~promotion, orsales ~~discontinuation~~and marketing of ~~our~~healthcare ~~products;~~items orand ~~(iv)~~services, ~~additional~~as ~~record-keeping~~well ~~requirements.~~as Ifcertain ~~any~~business ~~such~~arrangements ~~changes~~in ~~were~~the healthcare industry, are subject to beextensive ~~imposed~~laws designed to prevent fraud, ~~they~~kickbacks, ~~could~~self-dealing ~~adversely~~and ~~affect~~other ~~the~~abusive ~~operation~~practices. These laws and regulations may restrict or prohibit a wide range of ~~our~~pricing, discounting, marketing and promotion, structuring and commission(s), certain customer incentive programs and other business or financial arrangements.

InThe ~~the~~applicable United States and in some foreign jurisdictions, there have been, and likely will continue to be, a number of legislative initiatives and regulatory changes regarding the healthcare system directed at broadening the availability of healthcare, improving the quality of healthcare, and containing or lowering the cost of healthcare. For example, in March 2010, the ACA was enacted, which substantially changed the way health care is financed by both governmental and private insurers, and significantly impacted the U.S. ~~pharmaceutical industry. The ACA~~federal, ~~among~~state other things, subjects biological products to potential competition by lower-cost biosimilars, expands the types of entities eligible for the 340B drug discount program; introduced a new methodology by which rebates owed by manufacturers under the Medicaid Drug Rebate Program are calculated for drugs that are inhaled, infused, instilled, implanted or injected; increased the minimum Medicaid rebates owed by manufacturers under the Medicaid Drug Rebate Program and ~~extended~~other ~~the~~healthcare ~~rebate~~laws ~~program to individuals enrolled in Medicaid managed care organizations; established annual fees~~ and ~~taxes~~regulations onlaws ~~manufacturers~~that ofmay ~~certain~~affect ~~branded~~our ~~prescription~~ability ~~drugs; and created a new Medicare Part D coverage gap discount program, in which manufacturers must agree~~ to ~~offer~~operate ~~50% (increased to 70% pursuant to the Bipartisan Budget Act of 2018~~include, orbut ~~BBA,~~are ~~effective~~not aslimited ~~of January 2019) point-of-sale discounts off negotiated prices of applicable brand drugs~~ to ~~eligible beneficiaries during their coverage gap period, as a condition for the manufacturer's outpatient drugs to be covered under Medicare Part D.~~:

35the federal Anti-Kickback Statute, which prohibits, among other things, persons and entities from knowingly and willfully soliciting, receiving, offering or paying any remuneration (including any kickback, bribe, or rebate), directly or indirectly, overtly or covertly, in cash or in kind, to induce or reward, or in return for, either the referral of an individual, or the purchase, lease, order, arrangement, or recommendation of any good, facility, item or service for which payment may be made, in whole or in part, under a federal healthcare program, such as the Medicare and Medicaid programs. A person or entity can be found guilty of violating the statute without actual knowledge of the statute or specific intent to violate it. The term remuneration has been interpreted broadly to include anything of value. Further, courts have found that if "one purpose" of renumeration is to induce referrals, the federal Anti-Kickback statute is violated. Violations are subject to significant civil and criminal fines and penalties for each violation, plus up to three times the remuneration involved, imprisonment, and exclusion from government healthcare programs. In addition, a claim submitted for payment to any federal healthcare program that includes items or services that were made as a result of a violation of the federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the federal False Claims Act, or FCA. The Anti-Kickback Statute has been interpreted to apply to arrangements between pharmaceutical manufacturers on the one hand and prescribers, purchasers, and formulary managers, among others, on the other. There are a number of statutory exceptions and regulatory safe harbors protecting some common activities from prosecution;

Since its enactment, there have been numerous judicial, administrative, executive, and legislative challenges to certain aspects of the ACA, and our expects there will be additional challenges and amendments to the ACA in the future. For example, various portions of the ACA are currently undergoing legal and constitutional challenges in the U.S. Supreme Court. Additionally, the Trump Administration has issued various Executive Orders which eliminated cost sharing subsidies and various provisions that would impose a fiscal burden on states or a cost, fee, tax, penalty or regulatory burden on individuals, healthcare providers, health insurers, or manufacturers of pharmaceuticals or medical devices and Congress has introduced several pieces of legislation aimed at significantly revising or repealing the ACA. We cannot predict what affect further changes to the ACA would have on our business.35

Inthe ~~addition,~~federal ~~other~~civil ~~legislative changes have been proposed~~ and ~~adopted~~criminal infalse ~~the~~claims ~~United~~laws, ~~States~~including ~~since~~ the ~~ACA was enacted. For example~~FCA, onand ~~August~~civil 2,monetary ~~2011,~~penalty ~~the~~laws ~~Budget~~which ~~Control Act of 2011~~prohibit, among other things, ~~created~~individuals ~~measures~~or ~~for~~entities ~~spending~~from ~~reductions~~knowingly bypresenting, ~~Congress.~~or Acausing ~~Joint~~to ~~Select~~be ~~Committee~~presented, onfalse, ~~Deficit~~fictitious ~~Reduction,~~or ~~tasked~~fraudulent ~~with~~claims ~~recommending~~for apayment ~~targeted~~to, ~~deficit~~or ~~reduction~~approval ofby atMedicare, ~~least~~Medicaid, ~~$1.2~~or ~~trillion~~other ~~for~~federal ~~the~~healthcare ~~years~~programs; ~~2013~~knowingly ~~through~~making, ~~2021~~using, ~~was~~or ~~unable~~causing to ~~reach~~be ~~required~~made ~~goals~~or used, ~~thereby~~a ~~triggering~~false ~~the~~record ~~legislation's~~or ~~automatic~~statement ~~reduction~~material to ~~several~~a ~~government programs~~false, ~~including~~fictitious ~~aggregate~~or ~~reductions~~fraudulent ofclaim ~~Medicare~~or ~~payments~~an toobligation ~~providers of up~~ to 2%pay ~~per~~or ~~fiscal~~transmit ~~year.~~money ~~These~~or ~~reductions~~property ~~went into effect on April 1, 2013 and, due~~ to ~~subsequent~~the ~~legislative~~federal ~~amendments~~government; toor ~~the~~knowingly ~~statute,~~concealing ~~will~~or ~~remain~~knowingly inand ~~effect~~improperly ~~through 2030~~avoiding, ~~unless~~decreasing ~~additional~~or ~~Congressional~~concealing ~~action~~an isobligation ~~taken.~~to ~~However,~~pay ~~pursuant~~money to the ~~Coronavirus~~federal ~~Aid,~~government. ~~Relief~~A ~~and~~claim ~~Economic~~that ~~Security~~includes ~~Act,~~items or ~~CARES~~services ~~Act,~~resulting ~~and~~from ~~subsequent~~a ~~legislation,~~violation ~~these~~of ~~Medicare~~the ~~sequester~~federal ~~reductions~~Anti-Kickback ~~are~~Statute ~~suspended~~constitutes ~~from~~a ~~May~~false 1,or ~~2020~~fraudulent ~~through~~claim ~~March~~under ~~31, 2021 due to~~ the ~~COVID-19 pandemic~~FCA. OnManufacturers ~~January~~can 2,be ~~2013,~~held ~~the~~liable ~~American~~under ~~Taxpayer~~the ~~Relief~~FCA ~~Act~~even ofwhen ~~2012~~they ~~was~~do ~~signed~~not ~~into~~submit ~~law,~~claims ~~which,~~directly ~~among~~to ~~other~~government ~~things,~~payors ~~further~~if ~~reduced~~they ~~Medicare~~are ~~payments~~deemed to ~~several~~"cause" ~~types~~the submission of ~~providers,~~false ~~including~~or ~~hospitals~~fraudulent ~~and~~claims. ~~cancer~~The ~~treatment~~FCA ~~centers,~~also ~~and~~permits ~~increased~~a ~~the~~private ~~statute~~individual ofacting ~~limitations~~as ~~period~~a ~~for~~"whistleblower" ~~the~~to ~~government~~bring toqui ~~recover~~tam ~~overpayments~~actions toon ~~providers~~behalf ~~from~~of ~~three~~the tofederal ~~five~~government ~~years.~~alleging ~~Additionally,~~violations of the ~~BBA,~~FCA ~~among~~and ~~other~~to ~~things,~~share ~~amended~~in ~~the~~any ~~ACA,~~monetary ~~effective~~recovery ~~January~~or 1,settlement. ~~2019,~~When byan ~~increasing~~entity ~~the~~is ~~point-of-sale~~determined ~~discount~~to ~~(from~~have ~~50%~~violated ~~under~~ the ~~ACA~~FCA, tothe ~~70%)~~government ~~that~~may isimpose ~~owed~~civil byfines ~~pharmaceutical~~and ~~manufacturers~~penalties ~~who~~for ~~participate~~each infalse ~~Medicare~~claim, ~~Part~~plus Dtreble damages, and ~~closing~~exclude the ~~coverage~~entity ~~gap~~from participation in ~~most~~ Medicare ~~drug plans~~, ~~commonly~~Medicaid ~~referred~~and toother asfederal ~~the~~healthcare ~~"donut hole."~~programs;
~~Moreover,~~the ~~payment~~federal ~~methodologies~~Health ~~may~~Insurance bePortability ~~subject to changes in healthcare legislation~~ and ~~regulatory~~Accountability ~~initiatives.~~Act ~~For~~of ~~example~~1996, ~~CMS~~or ~~may develop new payment and delivery models~~HIPAA, ~~such as bundled payment models. Recently, there has been heightened governmental scrutiny over the manner in~~ which ~~manufacturers~~created ~~set~~additional ~~prices~~federal ~~for~~criminal ~~their~~statutes ~~products.~~that ~~Such~~prohibit ~~scrutiny~~knowingly ~~has resulted in several recent U.S. Congressional inquiries~~ and ~~proposed~~willfully ~~and~~executing, ~~enacted~~or ~~federal~~attempting ~~and state legislation designed~~ to, ~~among other things~~execute, ~~bring~~a ~~more~~scheme ~~transparency~~ to ~~drug~~defraud ~~pricing,~~any ~~reduce~~healthcare ~~the~~benefit ~~cost~~program, ofincluding ~~prescription~~private ~~drugs~~third-party ~~under Medicare~~payors, ~~review~~or ~~the~~obtain, ~~relationship~~by ~~between~~means ~~pricing~~of ~~and~~false ~~manufacturer~~or ~~patient~~fraudulent ~~programs~~pretenses, ~~and~~representations, ~~reform~~or ~~government program reimbursement methodologies for drugs. For example~~promises, atany ~~the~~of ~~federal level,~~ the ~~Trump~~money ~~administration's~~or ~~budget~~property ~~proposal~~owned ~~for~~by, ~~fiscal~~or ~~year~~under ~~2021~~the ~~includes~~custody aor ~~$135~~control ~~billion~~of, ~~allowance~~any tohealthcare ~~support~~benefit ~~legislative~~program, ~~proposals~~regardless ~~seeking~~of tothe ~~reduce~~payor ~~drug prices~~(e.g., ~~increase~~public ~~competition,~~or ~~lower out-of-pocket drug costs for patients~~private), and ~~increase~~knowingly ~~patient~~and ~~access~~willfully tofalsifying, ~~lower-cost~~concealing ~~generic~~or ~~and~~covering ~~biosimilar~~up ~~drugs.~~by Onany ~~March~~trick ~~10,~~or ~~2020,~~device ~~the~~a ~~Trump~~material ~~administration~~fact ~~sent~~or ~~"principles"~~making ~~for~~any ~~drug~~materially ~~pricing to Congress~~false, ~~calling~~fictitious ~~for~~or ~~legislation~~fraudulent ~~that~~statement ~~would,~~or ~~among other things~~representation, ~~cap~~or ~~Medicare~~making ~~Part~~or Dusing ~~beneficiary~~any ~~out~~false ofwriting ~~pocket~~or ~~pharmacy~~document ~~expenses,~~knowing ~~provide~~the ansame ~~option~~ to ~~cap~~contain ~~Medicare~~any ~~Part~~materially Dfalse ~~beneficiary~~fictitious ~~monthly~~or ~~out-of-pocket~~fraudulent ~~expenses,~~statement ~~and~~or ~~place~~entry ~~limits~~in onconnection ~~pharmaceutical~~with ~~price~~the ~~increases.~~delivery ~~HHS has solicited feedback on some~~ of, ~~these~~or ~~measures~~payment ~~and has implemented others under its existing authority. For example~~for, inhealthcare ~~May 2019~~benefits, ~~CMS~~items ~~issued~~or aservices ~~final~~relating ~~rule~~to ~~that~~healthcare ~~would~~matters. ~~allow~~Similar ~~Medicare~~to ~~Advantage Plans~~ the ~~option~~federal ofAnti-Kickback ~~using step therapy~~Statute, a ~~type~~person ofor ~~prior~~entity ~~authorization,~~can ~~for~~be ~~Part~~found Bguilty ~~drugs~~of ~~beginning~~violating ~~January~~HIPAA 1,fraud ~~2020.~~provisions ~~This~~without ~~final~~actual ~~rule~~knowledge ~~codified~~of ~~CMS'~~the ~~policy~~statute ~~change~~or ~~that~~specific ~~was~~intent ~~effective~~to ~~January~~violate ~~1, 2019.~~it;
~~Several~~HIPAA, ~~regulations~~as ~~have~~amended ~~also been proposed partly in response to several executive orders issued~~ by ~~President~~the ~~Trump~~Health ~~related~~Information toTechnology ~~prescription~~for ~~drug~~Economic ~~pricing~~and ~~that~~Clinical ~~seek~~Health toAct ~~implement several~~ of ~~the administration's proposals. For example~~2009, onor ~~November 20~~HITECH, ~~2020~~and ~~CMS~~their ~~issued~~respective ~~an Interim Final Rule~~ implementing ~~the Most Favored Nation~~regulations, orwhich ~~MFN~~impose, ~~Model~~among ~~under~~other ~~which~~things, ~~Medicare Part B reimbursement rates will be calculated for~~ certain ~~drugs~~requirements ~~and~~relating ~~biologicals~~to ~~based on~~ the ~~lowest~~privacy, ~~price~~security ~~drug manufacturers receive in Organization for Economic Cooperation~~ and ~~Development~~transmission ~~countries~~of ~~with~~individually aidentifiable ~~similar~~health ~~gross~~information ~~domestic~~on ~~product~~certain ~~per~~covered ~~capita.~~healthcare ~~The~~providers, ~~MFN~~health ~~Model~~plans, ~~regulations~~and ~~mandate~~healthcare ~~participation~~clearinghouses, byknown ~~identified~~as ~~Part~~covered Bentities, ~~providers~~as ~~and~~well ~~will~~as ~~apply~~their inrespective ~~all~~"business ~~U.S.~~associates," ~~states~~those ~~and~~independent ~~territories~~contractors ~~for~~or aagents ~~seven-year~~of ~~period~~covered ~~beginning~~entities ~~January~~that 1create, ~~2021~~receive, ~~and ending December 31~~maintain, ~~2027.~~transmit ~~The~~or ~~Interim~~obtain ~~Final~~protected ~~Rule~~health ~~has~~information ~~not~~in ~~been~~connection ~~finalized~~with ~~and~~providing isa ~~subject~~service ~~to revision and challenge. Additionally,~~ on ~~November~~behalf ~~20,~~of ~~2020, HHS finalized~~ a ~~regulation~~covered ~~removing~~entity. ~~the~~HITECH ~~safe~~also ~~harbor~~created ~~protection~~new ~~for~~tiers ~~price~~of ~~reductions~~civil ~~from~~monetary ~~pharmaceutical~~penalties, ~~manufacturers~~amended HIPAA to ~~plan~~make ~~sponsors~~civil ~~under~~and ~~Part~~criminal D,penalties ~~either~~ directly orapplicable ~~through~~to ~~pharmacy~~business ~~benefit managers~~associates, ~~unless~~and ~~the~~gave ~~price~~state ~~reduction~~attorneys isgeneral ~~required~~new byauthority ~~law.~~to ~~The~~file ~~rule~~civil ~~also~~actions ~~creates~~for adamages ~~new~~or ~~safe~~injunctions ~~harbor~~in ~~for~~federal ~~price~~courts ~~reductions~~to ~~reflected~~enforce at the ~~point-of-sale,~~federal asHIPAA ~~well~~laws ~~as a safe harbor for certain fixed fee arrangements between pharmacy benefit managers~~ and ~~manufacturers.~~seek ~~While~~attorneys' ~~some~~fees ~~of these~~ and ~~other~~costs ~~measures~~associated ~~may~~with ~~require~~pursuing ~~additional~~federal ~~authorization~~civil toactions. ~~become~~In ~~effective~~addition, ~~and~~there ~~the~~are ~~Biden~~additional ~~administration may reverse or otherwise change these measures~~federal, ~~Congress~~state ~~has~~and ~~indicated~~non-U.S. ~~that~~laws itwhich ~~will~~govern ~~continue~~the toprivacy ~~seek new legislative~~ and~~/or~~ ~~administrative~~security ~~measures~~of tohealth ~~control~~and ~~drug~~other ~~costs.~~personal ~~Several~~information ~~bills have been introduced~~ in ~~both~~certain ~~chambers~~circumstances, ~~but~~many ~~due~~of towhich ~~increased~~differ ~~focus~~from oneach ~~COVID-19~~other ~~relief~~in ~~efforts,~~significant itways isand may not ~~clear~~have ~~when,~~the ~~and~~same ~~if any~~effect, ~~proposed~~thus ~~legislation~~complicating ~~regarding~~compliance ~~drug costs will advance.~~efforts;
36the federal Physician Payments Sunshine Act, created under the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act of 2010, or, collectively, the Affordable Care Act, and its implementing regulations, which require manufacturers of drugs, devices, biologics and medical supplies for which payment is available under Medicare, Medicaid or the Children's Health Insurance Program (with certain exceptions) to report annually to CMS information related to direct or indirect payments and other transfers of value made to physicians (defined to include doctors, dentists, optometrists, podiatrists and chiropractors) and teaching hospitals, as well as ownership and investment interests held by the physicians and their immediate family members. Effective January 1, 2022, these reporting obligations will extend to include transfers of value made in the previous year to certain non-physician providers such as physician assistants and nurse practitioners;

At the state level, legislatures are increasingly passing legislation and implementing regulations designed to control pharmaceutical and biologic product pricing, including price or patient reimbursement constraints, discounts, restrictions on certain product access and marketing cost disclosure and transparency measures, and, in some cases, designed to encourage importation from other countries and bulk purchasing. Legally mandated price controls on payment amounts by third-party payors or other restrictions on coverage or access could harm our business, results of operations, financial condition and prospects. In addition, regional healthcare authorities and individual hospitals are increasingly using bidding procedures to determine what pharmaceutical products and which suppliers will be included in their prescription drug and other healthcare programs. This could reduce the ultimate demand for the Product or put pressure on product pricing.36

~~Our~~federal ~~expects~~consumer ~~that~~protection ~~additional state~~ and ~~federal~~unfair ~~healthcare~~competition ~~reform measures will be adopted in the future~~laws, ~~any of~~ which ~~could~~broadly ~~limit~~regulate ~~the~~marketplace ~~extent~~activities ~~to which state~~ and ~~federal~~activities ~~governments cover particular healthcare products and services and could limit the amounts~~ that ~~the~~potentially ~~federal~~harm ~~and~~consumers; ~~state governments will pay for healthcare products~~ and ~~services. This could result in reduced demand for the Product or could result in additional pricing pressures.~~
Weanalogous ~~cannot~~U.S. ~~predict~~state, ~~the~~local ~~likelihood~~and foreign laws and regulations, ~~nature~~such oras ~~extent~~state ofanti-kickback ~~government~~and ~~regulation~~false ~~that~~claims laws, which may ~~arise~~apply ~~from~~to ~~future~~sales ~~legislation~~or marketing arrangements and claims involving healthcare items or ~~administrative~~services ~~action~~reimbursed by any third-party payor, including private insurers and may be broader in scope than their federal equivalents; state and foreign laws that require pharmaceutical companies to comply with the ~~United~~pharmaceutical ~~States.~~industry's Ifvoluntary wecompliance guidelines and other relevant compliance guidance promulgated by the federal government or ~~any~~otherwise ~~third~~restrict ~~parties~~payments wethat may ~~engage~~be ~~are~~made ~~slow~~to orhealthcare ~~unable~~providers and other potential referral sources; state and foreign laws that require drug manufacturers to ~~adapt~~report information related to ~~changes~~payments inand ~~existing~~other ~~requirements~~transfers of value to physicians and other healthcare providers, marketing expenditures or drug pricing; state and local laws that require the ~~adoption~~registration of ~~new~~pharmaceutical ~~requirements~~sales orrepresentatives; ~~policies~~and state and foreign laws governing the privacy and security of health information, orsome ifof wewhich ormay ~~such~~be ~~third~~more ~~parties~~stringent ~~are~~than ~~not~~those ~~able~~in tothe ~~maintain~~United ~~regulatory~~States ~~compliance~~(such as the European Union, which adopted the ~~Product~~General ~~may~~Data ~~lose~~Protection ~~any~~Regulation, ~~regulatory~~which ~~approval~~became ~~that~~effective in May 2018) in certain circumstances, and may ~~have~~differ ~~been~~from ~~obtained~~each other in significant ways and weoften ~~may~~are not ~~achieve~~preempted orby ~~sustain~~HIPAA, ~~profitability~~thus complicating compliance efforts.

~~Risks~~The ~~Relating~~distribution of pharmaceutical products is subject to ~~this~~additional ~~Offering~~requirements and ~~our~~regulations, ~~Securities~~including extensive record-keeping, licensing, storage and security requirements intended to prevent the unauthorized sale of pharmaceutical products.

WeThe ~~may~~scope ~~experience~~and ~~fluctuations~~enforcement of each of these laws is uncertain and subject to rapid change in ~~market~~the ~~value~~current environment of healthcare reform, especially in light of the lack of applicable precedent and regulations. Ensuring business arrangements comply with applicable healthcare laws, as well as responding to possible investigations by government authorities, can be time-and resource-consuming, costly, and can divert a company's attention from the business.

~~The~~It ~~market~~is ~~price~~possible ofthat ~~publicly-traded~~governmental ~~securities~~and isenforcement ~~affected~~authorities bywill ~~many~~conclude ~~variables~~that our business practices, including our arrangements with physicians and other healthcare providers, may not ~~directly~~comply ~~related~~with tocurrent or future statutes, regulations or case law interpreting applicable fraud and abuse or other healthcare laws and regulations. If our ~~corporate~~operations ~~performance~~are found to be in violation of any of the laws described above or any other government regulations that apply to us, we may be subject to significant sanctions, including ~~the~~civil, ~~markets~~criminal and administrative penalties, damages, fines, disgorgement, imprisonment, reputational harm, exclusion from participation in ~~which~~federal weand ~~are~~state ~~traded~~funded healthcare programs, ~~the~~contractual ~~strength~~damages ofand the ~~economy~~curtailment ~~generally~~or restricting of our operations, ~~the~~as ~~global~~well ~~economic~~as ~~situation~~additional reporting obligations and ~~outlook~~oversight if we become subject to a corporate integrity agreement or other agreement to resolve allegations of non-compliance with these laws. Further, if any of the ~~availability~~physicians ~~and~~or ~~attractiveness~~other healthcare providers or entities with whom we expect to do business are found to be not in compliance with applicable laws, they may be subject to similar penalties. Any action for violation of ~~alternative~~these ~~investments~~laws, even if successfully defended, could cause a pharmaceutical manufacturer to incur significant legal expenses and divert management's attention from the ~~breadth~~operation of the ~~public~~business. ~~market~~In ~~for~~addition, the ~~securities.~~approval ~~The~~and ~~effect~~commercialization of ~~these~~any ~~and~~product candidate in other ~~factors~~countries onwill also likely subject us to foreign equivalents of the ~~market~~healthcare ~~price~~laws mentioned above, among other foreign laws. All of these could harm our ~~securities~~ability into ~~the~~operate ~~future~~our ~~cannot~~business beand ~~predicted~~our financial results.

~~Our~~Ongoing ~~securities~~healthcare ~~could~~legislative beand ~~subject~~regulatory toreform ~~large~~measures ~~price~~may have a material adverse effect on our business and ~~volume~~results ~~volatility~~of operations.

~~Market~~Changes ~~prices~~in ~~for~~U.S., ~~the~~Canadian, ~~securities~~and offoreign ~~biotechnology~~regulations, ~~companies~~statutes ~~have~~or ~~historically~~the ~~been~~interpretation ~~highly~~of ~~volatile.~~existing ~~Our~~regulations ~~securities~~could ~~have~~impact ~~and~~our ~~may~~business ~~continue~~in tothe ~~experience~~future ~~extreme~~by ~~price~~requiring, ~~and~~for ~~volume~~example: ~~volatility~~(i) ~~that~~changes ~~may result in losses~~ to ~~shareholders.~~our ~~Accordingly,~~manufacturing ~~the~~arrangements; ~~trading~~(ii) ~~price~~additions ofor ~~our~~modifications ~~securities~~to ~~could~~product belabeling; ~~subject~~(iii) tothe ~~wide~~recall ~~fluctuations~~or indiscontinuation ~~response~~of toour aproducts; ~~variety~~or of(iv) ~~factors~~additional ~~including~~record-keeping ~~announcement~~requirements. ofIf ~~material~~any ~~events~~ such as changes ~~relating~~were to ~~new~~be ~~or improved technology~~imposed, ~~drug~~they ~~safety~~could ~~concerns~~adversely ~~and~~affect ~~other~~the ~~general~~operation ~~and~~of ~~industry-specific~~our ~~economic conditions~~business.

37In the United States and in some foreign jurisdictions, there have been, and likely will continue to be, a number of legislative initiatives and regulatory changes regarding the healthcare system directed at broadening the availability of healthcare, improving the quality of healthcare, and containing or lowering the cost of healthcare. For example, in March 2010, the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act, (collectively, the "ACA") was enacted, which substantially changed the way health care is financed by both governmental and private insurers, and significantly impacted the U.S. pharmaceutical industry. The ACA, among other things, subjects biological products to potential competition by lower-cost biosimilars, expands the types of entities eligible for the 340B drug discount program; introduced a new methodology by which rebates owed by manufacturers under the Medicaid Drug Rebate Program are calculated for drugs that are inhaled, infused, instilled, implanted or injected; increased the minimum Medicaid rebates owed by manufacturers under the Medicaid Drug Rebate Program and extended the rebate program to individuals enrolled in Medicaid managed care organizations; established annual fees and taxes on manufacturers of certain branded prescription drugs; and created a new Medicare Part D coverage gap discount program, in which manufacturers must agree to offer 50% (increased to 70% pursuant to the Bipartisan Budget Act of 2018, or BBA, effective as of January 2019) point-of-sale discounts off negotiated prices of applicable brand drugs to eligible beneficiaries during their coverage gap period, as a condition for the manufacturer's outpatient drugs to be covered under Medicare Part D.

Additionally, the securities markets in the United States have recently experienced a high level of price and volume volatility. It is expected that such fluctuations in volume and price will continue to occur which may make it difficult for a shareholder to sell our securities at a price equal to or above the price at which they were purchased.37

~~Due~~Since its enactment, there have been numerous judicial, administrative, executive, and legislative challenges to certain aspects of the ~~small~~ACA, ~~size~~and our expects there will be additional challenges and amendments to the ACA in the future. For example, various portions of ~~our~~the ~~public~~ACA ~~float~~are currently undergoing legal and constitutional challenges in the U.S. Supreme Court. Additionally, ~~our~~the ~~securities~~Trump ~~may~~Administration ~~experience~~has ~~extreme~~issued ~~price~~various ~~volatility~~Executive ~~unrelated~~Orders towhich ~~our~~eliminated ~~actual~~cost sharing subsidies and various provisions that would impose a fiscal burden on states or ~~expected~~a ~~operating~~cost, ~~performance~~fee, ~~financial condition~~tax, penalty or ~~prospects~~regulatory burden on individuals, ~~making~~healthcare itproviders, ~~difficult~~health ~~for~~insurers, ~~prospective~~or ~~investors~~manufacturers toof ~~assess~~pharmaceuticals ~~the~~or ~~rapidly~~medical ~~changing~~devices ~~value~~and Congress has introduced several pieces of legislation aimed at significantly revising or repealing the ACA. We cannot predict what affect further changes to the ACA would have on our ~~securities~~business.

In addition, toother ~~the~~legislative ~~risks~~changes ~~described~~have ~~elsewhere~~been inproposed ~~this~~and ~~prospectus,~~adopted wein ~~may~~the beUnited ~~subject~~States tosince ~~extreme~~the ~~volatility~~ACA ~~that~~was isenacted. ~~unrelated~~For toexample, ~~the~~on ~~underlying~~August ~~performance~~2, of2011, ~~our~~the ~~business.~~Budget ~~Recently,~~Control ~~there~~Act ~~have~~of ~~been~~2011, ~~instances~~among ofother ~~extreme~~things, ~~share~~created ~~price~~measures ~~run-ups~~for ~~followed~~spending reductions by ~~rapid~~Congress. ~~price~~A ~~declines~~Joint ~~and~~Select ~~strong~~Committee ~~share~~on ~~price~~Deficit ~~volatility~~Reduction, tasked with recommending a ~~number~~targeted deficit reduction of ~~recent~~at ~~initial~~least ~~public~~$1.2 ~~offerings,~~trillion ~~especially~~for ~~among~~the ~~companies~~years ~~with~~2013 ~~relatively~~through ~~smaller~~2021, ~~public~~was ~~floats.~~unable Weto ~~have~~reach arequired ~~relatively~~goals, ~~small~~thereby ~~public~~triggering ~~float~~the ~~due~~legislation's automatic reduction to ~~our~~several ~~relatively~~government ~~small~~programs, ~~public~~including ~~float~~aggregate onreductions ~~Nasdaq~~of ~~and~~Medicare ~~the~~payments ~~ownership~~to ~~percentage~~providers of ~~our~~up ~~executive~~to ~~officers~~2% per fiscal year. These reductions went into effect on April 1, ~~directors~~2013 and, ~~significant~~due ~~shareholders.~~to Assubsequent alegislative ~~relatively~~amendments ~~small-capitalization~~to ~~company~~the ~~with~~statute, awill ~~relatively~~remain ~~small~~in ~~public~~effect ~~float~~through 2030, weunless ~~may~~additional ~~experience~~Congressional ~~greater~~action ~~share~~is ~~price~~taken. ~~volatility~~However, ~~extreme~~pursuant ~~price~~to ~~run-ups~~the Coronavirus Aid, ~~lower~~Relief ~~trading~~and ~~volume~~Economic Security Act, or CARES Act, and ~~less~~subsequent ~~liquidity~~legislation, ~~than~~these ~~large-capitalization~~Medicare ~~companies.~~sequester Inreductions ~~particular~~are suspended from May 1, ~~our~~2020 ~~securities~~through ~~may~~March be31, ~~subject~~2021 due to ~~rapid~~the ~~and~~COVID-19 ~~substantial~~pandemic. ~~price~~On ~~volatility~~January 2, ~~low~~2013, ~~volumes~~the American Taxpayer Relief Act of ~~trades~~2012 was signed into law, ~~and~~which, ~~large~~among ~~spreads~~other inthings, ~~bid~~further ~~and~~reduced ~~ask~~Medicare ~~prices.~~payments ~~Such~~to ~~volatility~~several types of providers, including ~~any~~hospitals ~~stock~~and ~~run-up~~cancer treatment centers, ~~may~~and beincreased ~~unrelated~~the statute of limitations period for the government to ~~our~~recover ~~actual~~overpayments orto ~~expected~~providers ~~operating~~from ~~performance~~three to five years. Additionally, ~~financial~~the ~~condition~~BBA, oramong ~~prospects~~other things, ~~making~~amended itthe ~~difficult~~ACA, ~~for~~effective ~~prospective~~January ~~investors~~1, 2019, by increasing the point-of-sale discount (from 50% under the ACA to ~~assess~~70%) that is owed by pharmaceutical manufacturers who participate in Medicare Part D and closing the ~~rapidly~~coverage ~~changing~~gap ~~value~~in ofmost ~~our~~Medicare ~~securities~~drug plans, commonly referred to as the "donut hole."

InMoreover, ~~addition~~payment methodologies may be subject to changes in healthcare legislation and regulatory initiatives. For example, ifCMS ~~the~~may ~~trading~~develop ~~volumes~~new ofpayment ~~our~~and ~~securities~~delivery ~~are~~models, ~~low~~such as bundled payment models. Recently, ~~persons~~there ~~buying~~has orbeen ~~selling~~heightened ingovernmental ~~relatively~~scrutiny ~~small~~over ~~quantities~~the ~~may~~manner ~~easily~~in ~~influence~~which manufacturers set prices offor ~~our~~their ~~securities~~products. ~~This~~Such ~~low~~scrutiny ~~volume~~has ofresulted ~~trades~~in ~~could~~several ~~also~~recent ~~cause~~U.S. ~~the~~Congressional ~~price~~inquiries ofand ~~our~~proposed ~~securities~~and enacted federal and state legislation designed to, ~~fluctuate~~among ~~greatly~~other things, ~~with~~bring ~~large~~more ~~percentage~~transparency ~~changes~~to indrug ~~price~~pricing, ~~occurring~~reduce inthe ~~any~~cost ~~trading~~of ~~day~~prescription ~~session~~drugs under Medicare, review the relationship between pricing and manufacturer patient programs, and reform government program reimbursement methodologies for drugs. ~~Holders~~For ofexample, ~~our~~at ~~securities~~the ~~may~~federal ~~also~~level, ~~not~~the beTrump ~~able~~administration's tobudget ~~readily~~proposal ~~liquidate~~for ~~their~~fiscal ~~investment~~year or2021 ~~may~~includes bea ~~forced~~$135 billion allowance to ~~sell~~support atlegislative ~~depressed~~proposals seeking to reduce drug prices, ~~due~~increase tocompetition, ~~low~~lower ~~volume~~out-of-pocket ~~trading.~~drug ~~Broad~~costs ~~market~~for ~~fluctuations~~patients, and ~~general~~increase ~~economic~~patient access to lower-cost generic and ~~political~~biosimilar ~~conditions~~drugs. ~~may~~On ~~also~~March ~~adversely~~10, ~~affect~~2020, the ~~market~~Trump ~~price~~administration ofsent ~~our~~"principles" ~~securities.~~for Asdrug apricing ~~result~~to ofCongress, ~~this~~calling ~~volatility~~for legislation that would, ~~investors~~among ~~may~~other ~~experience~~things, ~~losses~~cap onMedicare ~~their~~Part ~~investment~~D inbeneficiary ~~our~~out ~~securities.~~of Apocket ~~decline~~pharmacy inexpenses, ~~the~~provide ~~market~~an ~~price~~option to cap Medicare Part D beneficiary monthly out-of-pocket ~~our~~expenses, ~~securities~~and ~~also~~place ~~could~~limits ~~adversely~~on ~~affect~~pharmaceutical ~~our~~price ~~ability~~increases. toHHS ~~issue~~has ~~additional~~solicited ~~securities~~feedback on some of these measures and ~~our~~has ~~ability~~implemented toothers ~~obtain~~under ~~additional~~its ~~financing~~existing authority. For example, in May 2019, CMS issued a final rule that would allow Medicare Advantage Plans the ~~future~~option of using step therapy, a type of prior authorization, for Part B drugs beginning January 1, 2020. NoThis ~~assurance~~final ~~can~~rule becodified ~~given~~CMS' policy change that anwas ~~active~~effective UJanuary 1, 2019.S. ~~market~~While inthere ~~our~~had ~~securities~~been ~~will~~some ~~develop~~questions orabout bethe ~~sustained.~~Trump IfAdministration's position on the program for negotiating Medicare drug prices, CMS issued a ~~more~~public ~~active~~statement ~~market~~on ~~does~~January ~~not~~29, ~~develop~~2025, ~~holders~~declaring that lowering the cost of ~~our~~prescription ~~securities~~drugs ~~may~~is bea ~~unable~~top priority of the new administration and CMS is committed to ~~readily~~considering ~~sell~~opportunities to bring greater transparency in the ~~securities~~negotiation ~~they~~program. ~~hold~~The oreffects ~~may~~of ~~not~~the beIRA ~~able~~on toour ~~sell~~business ~~their~~is ~~securities~~not atyet ~~all~~known.

~~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.~~38

~~There~~Several isregulations nohave ~~required~~also ~~minimum~~been ~~number~~proposed ofpartly ~~Units~~in ~~that~~response ~~must~~to beseveral ~~sold~~executive asorders aissued ~~condition~~by President Trump related to ~~completion~~prescription drug pricing that seek to implement several of ~~this~~the ~~offering~~administration's proposals. ~~Because~~For ~~there~~example, ison noNovember ~~minimum~~20, ~~offering~~2020 ~~amount~~CMS ~~required~~issued asan aInterim ~~condition~~Final toRule implementing the ~~closing~~Most ofFavored ~~this~~Nation, ~~offering~~or MFN, ~~the~~Model ~~actual~~under ~~offering~~which ~~amount,~~Medicare ~~and~~Part ~~proceeds~~B toreimbursement usrates ~~are~~will ~~not~~be ~~presently~~calculated ~~determinable~~for ~~and~~certain ~~may~~drugs beand ~~substantially~~biologicals ~~less~~based ~~than~~on the ~~maximum~~lowest ~~amounts~~price ~~set~~drug ~~forth~~manufacturers receive in ~~this~~Organization ~~prospectus.~~for WeEconomic ~~may~~Cooperation ~~sell~~and ~~fewer~~Development ~~than~~countries ~~all~~with ofa ~~the~~similar ~~Units~~gross ~~offered~~domestic ~~hereby,~~product ~~which~~per ~~may~~capita. ~~significantly~~The ~~reduce~~MFN ~~the~~Model ~~amount~~regulations ofmandate ~~proceeds~~participation ~~received~~ by ~~us,~~identified Part B providers and ~~investors~~will apply in ~~this~~all ~~offering~~U.S. ~~will~~states ~~not~~and ~~receive~~territories for a ~~refund~~seven-year inperiod ~~the~~beginning ~~event~~January ~~that~~1, we2021, doand ~~not~~ending ~~sell~~December an31, ~~amount~~2027. ofThe ~~Units~~Interim ~~sufficient~~Final toRule ~~pursue~~has ~~the~~not ~~business~~been ~~goals~~finalized ~~outlined~~and inis ~~this~~subject ~~prospectus~~to revision and challenge. ~~Thus~~Additionally, weon ~~may~~November ~~not~~20, ~~raise~~2020, ~~the~~HHS ~~amount~~finalized ofa ~~capital~~regulation weremoving ~~believe~~the issafe ~~required~~harbor protection for ~~our~~price ~~business~~reductions ~~and~~from ~~may~~pharmaceutical ~~need~~manufacturers to ~~raise~~plan ~~additional~~sponsors ~~funds~~under Part D, ~~which~~either ~~may~~directly ~~not~~or bethrough ~~available~~pharmacy orbenefit ~~available~~managers, onunless ~~terms~~the ~~acceptable~~price toreduction usis required by law. ~~Despite~~The ~~this,~~rule ~~any~~also ~~proceeds~~creates ~~from~~a ~~the~~new ~~sale~~safe ofharbor for price reductions reflected at the ~~Units~~point-of-sale, ~~offered~~as bywell usas ~~will~~a besafe ~~available~~harbor for ~~our~~certain ~~immediate~~fixed ~~use,~~fee ~~and~~arrangements ~~because~~between ~~there~~pharmacy isbenefit nomanagers ~~escrow~~and ~~account~~manufacturers. While some of these and noother ~~minimum~~measures ~~offering~~may ~~amount~~require inadditional ~~this~~authorization ~~offering,~~to ~~investors~~become ~~could~~effective, and bethe inTrump aadministration ~~position~~may ~~where~~reverse ~~they~~or ~~have~~otherwise ~~invested~~change inthese usmeasures, ~~but~~Congress wehas ~~are~~indicated ~~unable~~that toit ~~fulfill~~will ~~our~~continue ~~objectives~~to ~~due~~seek tonew alegislative ~~lack~~and/or ofadministrative ~~interest~~measures into ~~this~~control ~~offering~~drug costs.

WeAt ~~will~~the ~~need~~state level, legislatures are increasingly passing legislation and implementing regulations designed to ~~raise~~control ~~additional~~pharmaceutical ~~financing~~and biologic product pricing, including price or patient reimbursement constraints, discounts, restrictions on certain product access and marketing cost disclosure and transparency measures, and, in some cases, designed to encourage importation from other countries and bulk purchasing. Legally mandated price controls on payment amounts by third-party payors or other restrictions on coverage or access could harm our business, results of operations, financial condition and prospects. In January 2024, the ~~future~~FDA authorized Florida's Agency for Health Care Administration's drug importation program, which is the first step toward Florida facilitating importation of certain prescription drugs from Canada. Authorization of other state programs may ~~dilute~~follow as other states have submitted importation program proposals. Legally mandated price controls on payment amounts by third-party payors or other restrictions could harm our ~~share~~business, ~~capital~~financial condition, results of operations and prospects. In addition, regional healthcare authorities and individual hospitals are increasingly using bidding procedures to determine what pharmaceutical products and which suppliers will be included in their prescription drug and other healthcare programs. This could reduce the ultimate demand for our drugs or put pressure on our drug pricing, which could negatively affect our business, financial condition, results of operations and prospects. In addition, regional healthcare authorities and individual hospitals are increasingly using bidding procedures to determine what pharmaceutical products and which suppliers will be included in their prescription drug and other healthcare programs. This could reduce the ultimate demand for the Products or put pressure on product pricing.

~~Our~~It ~~articles~~is ~~permit~~expected ~~the~~that ~~issuance~~additional ofstate anand ~~unlimited~~federal ~~number~~healthcare ofreform ~~common~~measures ~~shares.~~will ~~This~~be ~~offering~~adopted ~~along~~in ~~with~~the ~~any~~ future, ~~issuances~~any of ~~our~~which ~~common~~could ~~shares~~limit ~~will~~the ~~result~~extent ~~in dilution~~ to ~~the~~which ~~existing~~state ~~shareholders.~~and ~~Additionally,~~federal ~~future~~governments ~~sales~~cover ofparticular ~~our~~healthcare ~~common~~products ~~shares~~and ~~into~~services ~~the~~and ~~public~~could ~~market~~limit ~~may lower~~ the ~~market~~amounts ~~price~~that ~~for~~the ~~our~~federal ~~securities,~~and ~~which~~state ~~may~~governments ~~result~~will inpay ~~losses~~for tohealthcare ~~our~~products ~~shareholders~~and services. ~~Sales~~This ofcould ~~substantial~~result ~~amounts~~in ofreduced ~~our~~demand ~~common~~for ~~shares into~~ the ~~public~~Products ~~market,~~ or ~~even~~could ~~the~~result ~~perception~~in byadditional ~~the~~pricing ~~market that such sales may occur, may lower the market price of our securities~~pressures.

The current Trump administration is pursuing policies to reduce regulations and expenditures across government including at HHS, the FDA, CMS, and related agencies. These actions, presently directed by executive orders or memoranda from the Office of Management and Budget, may propose policy changes that create additional uncertainty for our business. Further, in June 2024, the U.S. Supreme Court reversed its longstanding approach under the Chevron doctrine, which provided for judicial deference to regulatory agencies' interpretation of statutes that are silent or ambiguous, including the FDA and CMS. As a result of this decision, we cannot be sure whether there will be increased challenges to existing agency regulations or how lower courts will apply the decision in the context of other regulatory schemes without more specific guidance from the U.S. Supreme Court. For example, this decision may result in more companies bringing lawsuits against the regulatory agencies to challenge current regulations and longstanding decisions and policies of the FDA or CMS, which could lead to uncertainties in the industry. We ~~have~~cannot nopredict ~~history~~the full impact of ~~dividends~~this decision, future judicial challenges brought against the FDA, CMS, or other regulatory agencies, or the nature or extent of government regulation that may arise from future legislation or administrative action.

To date, we have not paid any dividends on our outstanding common shares. We currently intend to retain future earnings to finance the operation, development and expansion of our business. We do not anticipate paying cash dividends on our common shares in the foreseeable future. Any decision to pay dividends on our shares will be made at the discretion of our board of directors and will depend on our earnings, financial requirements and other conditions existing at such time. See "Dividend Policy."39

~~Future~~We ~~sales~~cannot predict the likelihood, nature or extent of ~~our~~government ~~common~~regulation ~~shares~~that bymay ~~our~~arise ~~existing~~from ~~shareholders~~future ~~could~~legislation ~~cause~~or administrative action in the ~~price~~United States. If we or any third parties we may engage are slow or unable to adapt to changes in existing requirements or the adoption of ~~our~~new ~~securities~~requirements or policies, or if we or such third parties are not able to ~~decline~~maintain regulatory compliance, the Products may lose any regulatory approval that may have been obtained and we may not achieve or sustain profitability.

~~Subject~~We toare ~~compliance~~currently ~~with~~operating ~~applicable~~in ~~securities~~a ~~laws,~~period ~~our~~of ~~officers,~~global ~~directors~~economic uncertainty and ~~significant~~capital ~~shareholders~~markets ~~may~~disruption, ~~sell~~which ~~some~~has orbeen ~~all~~significantly ofimpacted ~~their~~by ~~common~~geopolitical ~~shares in the future~~instability. NoChanges ~~prediction~~and ~~can~~instability bein ~~made~~global aseconomic toconditions ~~the~~and ~~effect,~~geopolitical ifmatters ~~any,~~could ~~such~~have ~~future~~a ~~sales~~material ofadverse ~~our~~effect ~~common shares will have~~ on ~~the market price of~~ our ~~securities prevailing from time to time. However~~business, ~~the~~financial ~~future~~condition ~~sale~~and ofresults ~~a substantial number of common shares by such persons or the perception that such sales could occur, could cause the price of our securities to decline~~ofoperations.

38The United States and global markets are experiencing and may in the future experience volatility and disruption, including diminished liquidity and credit availability, declines in consumer confidence, declines in economic growth, high inflation and interest rates, increases in unemployment rates and uncertainty about economic stability. The financial markets and the global economy may also be adversely affected by the current or anticipated impact of geopolitical conflicts, including in Russia and Ukraine, the Middle East and other areas, terrorism or other events. Sanctions and enhanced export controls imposed by the United States and other countries focusing onnational security-related technologies, including biotechnology, may also adversely impact the financial markets and the global economy, and any economic countermeasures by the affected countries or others could exacerbate market and economic instability.

WeChanges in regulations and policies in the United States and the resulting political and economic uncertainty in the United States may ~~issue~~also impact us, ~~without~~the ~~shareholder~~financial ~~approval~~markets and the global economy. The U.S.has imposed increased tariffs on certain countries, ~~preferred~~focusing ~~shares~~on those with which it has the largest trade deficits. Other countries have responded, and may continue to respond, by announcing retaliatory tariffs on U.S. imports. The tariff have disrupted, and may continue to, disrupt the global markets and escalate tensions between the U.S. and other countries. The extent of the impact that such tariffs, trade policies, or new legislation or regulations will have ~~rights~~on our business specifically, or on the U.S. market and ~~preferences~~global ~~potentially~~economy ~~superior~~generally, are uncertain and in the long term, unpredictable, and could adversely affect our business, financial condition, and results of operations. In addition, the increased tariffs could impact our ability to ~~those~~commercialize future drug candidates for the U.S. market, which is relevant to our ability to generate future revenues from these activities. As a result, the continued impact of these tariffs may impair our ~~common~~plans ~~shares~~for further product development in the U.S. market as well as our ability to generate revenues.

~~Our~~The ~~articles~~United ~~permit~~States ~~the~~may ~~issuance~~also ofenact another ~~unlimited~~regulations ~~number~~or ofpolicies ~~preferred~~that ~~shares~~affect (trade with China or otherwise impact the ~~"Medicus~~pharmaceutical ~~Preferred~~industry ~~Shares")~~by inrestricting ~~one~~U.S. pharmaceutical companies from contracting withcertain countries for the development, research or ~~more~~manufacturing ~~series~~of pharmaceutical products. ~~Medicus~~In ~~Preferred~~April ~~Shares~~2025, ~~are~~the ~~entitled~~U.S. toDepartment ~~priority~~of ~~over~~Commerce ~~our~~initiated ~~common~~national ~~shares~~security ~~with~~investigations ~~respect~~into the importation ofpharmaceuticals and pharmaceutical ingredients pursuant to Section 232 of the ~~distribution~~Trade Expansion Act of ~~our~~1962, ~~assets~~whichcould result in the ~~event~~imposition of ~~any~~new ~~liquidation,~~tariffs ~~dissolution~~on orimports ~~winding~~within upthe ofpharmaceutical ~~our~~industry. ~~affairs~~Further, ~~whether~~executive ~~voluntary~~orders orwere ~~involuntary.~~signed ~~Subject~~ to ~~any~~implement ~~applicable~~Most ~~regulatory~~Favored ~~approvals,~~Nation ~~our~~drug ~~board~~pricing ofpolicies ~~directors~~designed ~~may~~to ~~set~~align ~~the~~certain ~~rights~~prescription ~~and~~drug ~~preferences~~prices ofin ~~any~~the ~~series~~U.S. ofto ~~Medicus~~lower ~~Preferred~~prices ~~Shares~~available in ~~its~~other ~~sole~~countries. ~~discretion~~Investigations ~~without~~are ~~shareholder~~being ~~approval.~~conducted ~~The~~to ~~rights~~examine price differentials and ~~preferences~~consider ofpolicy ~~those~~approaches ~~Medicus~~for ~~Preferred~~implementation, ~~Shares~~including ~~may~~through beadministrative ~~superior~~action. If such Most Favored Nation policies are implemented, changes to ~~those~~drug pricing are expected to affect the profitability of ~~our~~pharmaceutical ~~common~~and ~~shares~~biotech companies in the U.S. ~~Accordingly~~as well as in other countries, ~~the~~as ~~issuance~~a price constrained market. The details of ~~Medicus~~the ~~Preferred~~proposed ~~Shares~~policies ~~may~~are ~~adversely~~unclear, ~~affect~~and the ~~rights~~final ofterms ~~holders~~and ofimpact ~~our~~remain ~~common~~uncertain, ~~shares~~and may pose long-term risks to our business.

IfAny ~~equity~~executive ~~research~~order, ~~analysts~~legislative doaction ~~not~~or ~~publish~~potential ~~research~~sanctions oron ~~reports~~certain ~~about~~countries could materially impact our ~~business~~current ormanufacturing ifpartners. ~~they~~In ~~issue~~addition, ~~unfavorable~~natural ~~commentary~~and orman-made ~~downgrade~~disasters ~~our~~and ~~common~~global ~~shares~~health emergencies, including pandemics and epidemics, may also adversely affect the ~~price~~financial ofmarkets ~~our~~and ~~securities~~the ~~could~~global ~~decline~~economy and result in significant business disruption.

The trading market for our securities could be influenced by research and reports that industry and/or securities analysts may publish about us, our business, the market or our competitors. We do not have any control over these analysts and cannot assure that such analysts will cover us or provide favorable coverage. If any of the analysts who may cover our business change their recommendation regarding our common shares adversely, or provide more favorable relative recommendations about our competitors, the share price would likely decline. If any analysts who may cover our business were to cease coverage or fail to regularly publish reports on us, we could lose visibility in the financial markets, which in turn could cause the share price or trading volume to decline.40

AnThe ~~investment~~volatile inbusiness ~~this~~environment ~~offering~~or continued unpredictable and unstable market conditions may result in ~~uncertain~~further deterioration of the equity and credit markets, significant volatility in commodity prices, as well as supply chain interruptions and result in an economic downturn, which would make any equity or ~~adverse~~debt Ufinancing more difficult, costly and dilutive.S. ~~federal~~Failure ~~income~~to ~~tax~~secure ~~consequences~~any necessary financing in a timely manner and on favorable terms could have a material adverse effect on our growth strategy, financial performance and stock price and could require us to delay, limit, reduce, or terminate our product development or future commercialization efforts.

AnAlthough ~~investment~~our inbusiness ~~this~~has ~~offering~~not ~~may~~been ~~result~~materially inimpacted ~~uncertain~~by orthe ~~adverse~~tariffs ~~U.S.~~adopted ~~federal~~to ~~income~~date ~~tax~~or ~~consequences.~~adverse ~~For~~effects ~~instance,~~of ~~the~~geopolitical ~~allocation~~events, annatural ~~investor~~or ~~makes~~man-made ~~with~~disasters ~~respect~~or toother ~~the~~business ~~purchase~~disruptions ~~price~~to ofdate, asuch ~~unit~~matters ~~between~~may ~~the~~affect ~~common~~our ~~share~~business ~~and~~in the ~~warrant~~future ~~included~~and init ~~each~~is ~~Unit~~impossible ~~could~~to bepredict ~~challenged by~~ the ~~U.S.~~extent ~~Internal~~to ~~Revenue~~which ~~Service~~our ~~(the~~operations, ~~"IRS")~~ or ~~courts.~~those ~~Furthermore, the U.S. federal income tax consequences~~ of aour ~~cashless~~suppliers ~~exercise of warrants~~ and ~~distributions~~manufacturers, onwill ~~warrants~~be ~~are~~impacted ~~unclear~~in ~~under~~the ~~current~~short ~~law,~~ and ~~the~~long ~~adjustment~~term, toor the ~~exercise~~ways ~~price~~in ofwhich ~~the~~such ~~warrants~~matters ~~could~~may ~~give~~impact ~~rise~~our tobusiness. ~~dividend~~The ~~income~~extent toand ~~investors~~duration ~~without a corresponding payment~~ of ~~cash.~~such ~~See~~adverse ~~"U.S.~~geopolitical ~~Federal~~events, ~~Income~~natural ~~Tax~~or ~~Considerations"~~man-made ~~for~~disasters aor ~~summary~~other ofbusiness ~~the~~disruptions ~~U.S.~~and ~~federal~~actual ~~income~~or ~~tax~~perceived ~~considerations~~political ofor aneconomic ~~investment~~instability inand ~~our~~resulting ~~securities.~~market ~~Prospective~~disruptions ~~investors~~ are ~~urged~~impossible to ~~consult~~predict ~~their~~but ~~own~~could ~~tax~~be ~~advisors~~substantial. ~~with~~Any ~~respect~~such todisruptions ~~these~~may ~~and~~also ~~other~~magnify ~~tax~~the ~~consequences~~impact ~~when~~of ~~purchasing,~~other ~~holding~~risks ordescribed ~~disposing of our securities~~herein.

Risks Relating to ~~New~~this Offering and our Securities

~~There~~We ismay noexperience ~~public~~fluctuations in market ~~for the warrants being offered hereby, and we do not expect one to develop to provide you with adequate liquidity~~value.

The ~~warrants~~market ~~offered~~price ~~hereby~~of ~~will~~publicly-traded ~~not~~securities beis ~~listed~~affected onby ~~any~~many ~~Canadian~~variables ornot ~~U.S.~~directly ~~securities~~related ~~exchange.~~to ~~Consequently~~our corporate performance, ~~there~~including isthe nomarkets ~~public~~in ~~trading~~which ~~market~~we ~~for~~are traded, the ~~warrants,~~strength ~~and~~of wethe doeconomy ~~not~~generally, ~~expect~~the aglobal ~~market~~economic tosituation ~~develop.~~and ~~Accordingly~~outlook, ~~investors~~the ~~may~~availability ~~find~~and itattractiveness ~~difficult~~of toalternative ~~dispose of~~investments, orand tothe ~~obtain~~breadth ~~accurate~~of ~~quotations as to~~ the public market ~~value~~for ~~of,~~ the ~~warrants~~securities. ~~This~~The ~~lack~~effect of athese ~~trading~~and ~~market~~other ~~could~~factors ~~result~~on inthe ~~investors~~market ~~being~~price ~~unable~~of toour ~~liquidate~~securities ~~their investment~~ in the ~~warrants~~future orcannot tobe ~~sell them at a price that reflects their value~~predicted.

~~Risks~~Our ~~Related~~securities could be subject to ~~Being~~large aprice ~~Public~~and ~~Company~~volume volatility.

AsMarket aprices ~~result~~for the securities of ~~recently~~biotechnology ~~becoming~~companies ahave ~~public~~historically ~~company~~been inhighly ~~the~~volatile. ~~United~~Our ~~States,~~securities wehave ~~are~~and ~~subject~~may continue to ~~additional~~experience ~~regulatory~~extreme ~~compliance~~price ~~requirements,~~and ~~including~~volume ~~Section~~volatility ~~404~~that ofmay ~~the~~result ~~Sarbanes-Oxley~~in ~~Act~~losses to shareholders. Accordingly, ~~and~~the iftrading weprice ~~fail~~of our securities could be subject to ~~maintain~~wide anfluctuations ~~effective~~in ~~system~~response to a variety of ~~internal~~factors ~~controls,~~including weannouncement ~~may~~of ~~not~~material beevents ~~able~~such as changes relating to ~~accurately~~new ~~report~~or ~~our~~improved ~~financial~~technology, ~~results~~drug orsafety ~~prevent~~concerns ~~fraud~~and other general and industry-specific economic conditions.

~~Our~~Additionally, ~~management~~the ~~team~~securities ~~may~~markets ~~not~~in ~~successfully~~the orUnited ~~effectively~~States ~~manage~~have ~~our~~recently ~~transition~~experienced to a ~~U.S.~~high ~~public~~level ~~company~~of ~~that~~price ~~will be subject to significant regulatory oversight~~ and ~~reporting~~volume ~~obligations under U~~volatility.S. ~~and~~It ~~Canadian~~is ~~securities~~expected ~~laws.~~that ~~Our~~such ~~limited~~fluctuations ~~experience~~ in ~~dealing~~volume ~~with~~and ~~the~~price ~~increasingly~~will ~~complex~~continue ~~laws pertaining~~ to ~~U.S.~~occur ~~and~~which ~~Canadian~~may ~~public~~make ~~companies~~it ~~could~~difficult befor a ~~significant~~shareholder ~~disadvantage in that it is likely that an increasing amount of their time may be devoted~~ to ~~these~~sell ~~activities~~our ~~which~~securities ~~will~~at ~~result~~a inprice ~~less~~equal ~~time being devoted~~ to ~~the~~or ~~management~~above ~~and growth of~~ the ~~post-combination~~price ~~company.~~at Wewhich ~~may~~they ~~not~~were have adequate personnel with the appropriate level of knowledge, experience and training in the accounting policies, practices or internal control over financial reporting required of public companies in the United States and Canadapurchased.

AsDue ato ~~public company listed on Nasdaq,~~ the ~~Sarbanes-Oxley~~relatively ~~Act~~small ~~requires,~~size ~~among other things that we assess the effectiveness~~ of our ~~internal~~public ~~control~~float, ~~over~~our ~~financial~~securities ~~reporting~~may atexperience ~~the~~extreme ~~end~~price ofvolatility ~~each~~unrelated ~~fiscal~~to ~~year.~~our Weactual ~~anticipate~~or ~~being~~expected ~~first~~operating ~~required~~performance, tofinancial ~~issue~~condition, ~~management's~~or ~~assessment~~prospects, ofmaking ~~internal~~it ~~control~~difficult ~~over~~for ~~financial~~prospective ~~reporting~~investors ~~pursuant~~ to ~~Section~~assess ~~404(a) of~~ the ~~Sarbanes-Oxley~~rapidly ~~Act~~changing invalue ~~connection~~of ~~with issuing~~ our ~~consolidated financial statements as of and for the fiscal year ending December 31, 2025~~securities.

WeIn ~~have~~addition ~~started~~to the ~~process~~risks ofdescribed ~~designing~~elsewhere in this prospectus, ~~implementing~~we ~~and~~may ~~testing~~be ~~our~~subject ~~internal~~to ~~control~~extreme ~~over~~volatility ~~financial~~that ~~reporting~~is ~~required~~unrelated to ~~comply~~the ~~with~~underlying ~~Section~~performance ~~404(~~of our business. We have a) ofrelatively small public float due to our relatively small public float on the ~~Sarbanes-Oxley~~Nasdaq ~~Act.~~and ~~This~~the ~~process~~ownership ispercentage ~~time-consuming~~of our executive officers, ~~costly~~directors and ~~complicated~~significant shareholders. ~~Our~~As ~~management~~a relatively small-capitalization company with a relatively small public float, we may ~~not~~experience begreater ~~able~~share toprice ~~effectively~~volatility, ~~and~~extreme ~~timely~~price ~~implement~~run-ups, ~~controls~~lower trading volume, and ~~procedures~~less ~~that~~liquidity ~~adequately~~than ~~respond~~large-capitalization tocompanies. ~~the~~In ~~increased~~particular, ~~regulatory~~our ~~compliance~~securities may be subject to rapid and ~~reporting~~substantial ~~requirements~~price ~~that~~volatility, ~~are~~low ~~applicable~~volumes toof ustrades, asand alarge ~~public~~spreads ~~company~~in ~~listed~~bid onand ~~Nasdaq~~ask prices. IfFor weexample, ~~fail~~since toour ~~maintain~~initial ~~internal~~public ~~control~~offering ~~over~~in ~~financial~~November ~~reporting~~2024, ~~adequate~~our tocommon ~~meet~~shares ~~the~~have ~~demands~~traded ~~that~~at ~~will~~a berange ~~placed~~with ~~upon~~a ushigh asprice of $8.94 on May 20, 2025 and a ~~public~~low ~~company~~price ~~listed~~of in$1.79 ~~the~~on ~~United~~September ~~States~~4, ~~our~~2025. ~~business~~Such ~~and~~volatility, ~~reputation~~including any stock run-up, may be ~~harmed,~~unrelated ~~the~~to ~~accuracy~~our ~~and~~actual ~~timeliness~~or ofexpected ~~our~~operating performance, financial ~~reporting~~condition, ~~may~~or beprospects, ~~adversely~~making ~~affected,~~it ~~and~~difficult for prospective investors to assess the ~~price~~rapidly changing value of our ~~shares may decline~~securities.

In addition, ~~unless~~if wethe ~~still~~trading ~~qualify~~volumes asof aour ~~non-accelerated~~securities ~~filer~~are low, persons buying or selling in relatively small quantities may easily influence prices of our ~~independent~~securities. ~~registered~~This ~~public~~low ~~accounting~~volume ~~firm~~of ~~will~~trades could also cause the price of our securities to fluctuate greatly, with large percentage changes in price occurring in any trading day session. Holders of our securities may also not be ~~required~~able to ~~attest~~readily liquidate their investment or may be forced to sell at depressed prices due to low volume trading. Broad market fluctuations and general economic and political conditions may also adversely affect the ~~effectiveness~~market price of our ~~internal~~securities. ~~controls~~As ~~over~~a ~~financial~~result ~~reporting~~of ~~beginning~~this ~~with~~volatility, investors may experience losses on their investment in our ~~annual~~securities. ~~report~~A ~~following~~decline in the ~~date~~market onprice ~~which~~of weour ~~are~~securities noalso ~~longer~~could anadversely ~~"emerging~~affect ~~growth~~our ~~company,"~~ability ~~which~~to ~~may~~issue beadditional upsecurities and our ability to ~~five~~obtain ~~fiscal~~additional ~~years~~financing ~~following~~in the ~~date~~future. ofNo assurance can be given that an active market in our ~~initial~~securities ~~public~~will ~~offering~~be sustained. If an active market in our securities is not sustained, holders of our securities may be unable to readily sell the ~~United~~securities ~~States~~they hold or may not be able to sell their securities at all.

3941

IfWe wewill ~~are~~need ~~unable for any reason~~ to ~~meet~~raise ~~the~~additional ~~continued~~financing ~~listing requirements of Nasdaq, such action or inaction could result~~ in athe ~~delisting~~future ofwhich ~~our~~may ~~common~~dilute ~~shares and~~ our ~~Public~~share ~~Warrants, as applicable~~capital.

IfOur wearticles ~~fail~~permit ~~to satisfy~~ the ~~continued~~issuance ~~listing requirements~~ of ~~Nasdaq~~an ~~(for~~unlimited ~~example,~~number ~~Nasdaq~~of ~~corporate governance requirements or the minimum closing bid price requirement), such exchanges may take steps to delist our~~ common shares ~~and our Public Warrants, as applicable~~. ~~Such~~Future aissuance ~~delisting would likely have a negative effect on the price~~ of our common shares ~~and~~will ~~our~~result ~~Public~~in ~~Warrants~~dilution ~~and~~to ~~would~~the ~~impair~~existing ~~your~~shareholders. ~~ability~~Additionally, tofuture ~~sell~~sales orof ~~purchase~~ our common shares ~~and~~into ~~our~~the ~~Public~~public ~~Warrants~~market, asincluding ~~applicable,~~pursuant ~~when you wish~~ to dothis ~~so.~~prospectus, Inmay lower the ~~event~~market ofprice afor ~~delisting~~our securities, wewhich ~~can~~may ~~provide~~result noin ~~assurance~~losses ~~that any action taken by us~~ to ~~restore~~our ~~compliance~~shareholders. ~~with~~Sales ~~listing~~of ~~requirements~~substantial ~~would~~amounts ~~allow~~of our common shares ~~and~~into ~~our~~the ~~Public~~public ~~Warrants~~market, asor ~~applicable,~~even tothe ~~become~~perception ~~listed~~by ~~again, stabilize~~ the market ~~price~~that orsuch ~~improve~~sales ~~the~~may ~~liquidity of our common shares and our Public Warrants~~occur, asmay ~~applicable,~~lower ~~prevent~~the ~~such~~market ~~securities from dropping below any minimum bid~~ price ~~requirement~~of orour ~~prevent future non-compliance with Nasdaq's listing requirements~~securities.

There is a risk that we will fail to maintain an effective system of internal controls and our ability to produce timely and accurate financial statements or comply with applicable regulations could be adversely affected. We have ~~identified~~no ~~material~~history ~~weaknesses in our internal controls over financing reporting as~~ of ~~December 31, 2024, which we may not be able to remedy in a timely manner~~dividends.

AsTo adate, ~~U.S.~~we ~~public~~have ~~company,~~not wepaid ~~operate~~any individends anon ~~increasingly~~our ~~demanding~~outstanding ~~regulatory~~common ~~environment,~~shares. ~~which~~We ~~requires~~currently usintend to ~~comply~~retain ~~with~~future ~~the~~earnings ~~Sarbanes-Oxley~~to ~~Act,~~finance the ~~regulations of Nasdaq~~operation, ~~the~~development ~~rules~~ and ~~regulations~~expansion of ~~the~~our ~~SEC~~business. ~~and~~We ~~Canadian~~do ~~securities~~not ~~regulators,~~anticipate ~~expanded~~paying ~~disclosure~~cash ~~requirements,~~dividends ~~accelerated~~on ~~reporting~~our ~~requirements~~common ~~and~~shares ~~more~~in ~~complex accounting rules. Company responsibilities required by~~ the ~~Sarbanes-Oxley~~foreseeable ~~Act include establishing corporate oversight and adequate internal control over financial reporting and disclosure controls and procedures~~future. ~~Effective~~Any ~~internal~~decision ~~controls are necessary for us~~ to ~~produce~~pay ~~reliable~~dividends ~~financial~~on ~~reports~~our ~~and~~shares ~~are~~will ~~important~~be tomade ~~help~~at ~~prevent financial fraud. Prior to~~ the ~~closing~~discretion of our ~~initial~~board ~~public~~of ~~offering~~directors inand ~~the~~will ~~United~~depend ~~States,~~on ~~we have never been required to test~~ our ~~internal~~earnings, ~~controls~~financial ~~within~~requirements ~~a specified period~~ and, asother aconditions ~~result,~~existing weat ~~may~~such ~~experience~~time. ~~difficulty~~See in"Dividend ~~meeting these reporting requirements in a timely manner~~Policy."

WeSales ~~anticipate that the process~~ of ~~building~~ our ~~accounting~~common ~~and~~shares ~~financial~~by ~~functions~~the ~~and~~Selling ~~infrastructure~~Shareholders ~~may require significant additional professional fees, internal costs and management efforts. We may need to enhance and/~~or ~~implement~~by ~~a new internal system to combine and streamline the management of~~ our ~~financial, accounting, human resources and~~ other ~~functions.~~existing ~~However,~~shareholders ~~the enhancement and/or implementation of a system may result in substantial costs. Any disruptions or difficulties in implementing or using such a system~~ could ~~adversely~~cause ~~affect~~the ~~our~~price ~~controls and harm our business. Moreover, such disruption or difficulties could result in unanticipated costs and diversion~~ of ~~management's attention. In addition, we may discover additional weaknesses in~~ our ~~system~~securities of internal financial and accounting controls and procedures that could result in a material misstatement of our financial statements. Our internal control over financial reporting will not prevent or detect all errors and all fraud. A control system, no matter how well designed and operated, can provide only reasonable, not absolute, assurance that the control system's objectives will be met. Because of the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that misstatements due to ~~error or fraud will not occur or that all control issues and instances of fraud will be detected~~decline.

IfPursuant weto dothis ~~not~~prospectus, ~~able~~the toSelling ~~comply~~Shareholders ~~with~~may ~~the~~sell ~~requirements~~up ofto ~~Section~~1,397,184 ~~404~~common ofshares ~~the~~from ~~Sarbanes-Oxley~~time ~~Act~~to intime. aIn ~~timely manner~~addition, orsubject ifto wecompliance ~~are~~with ~~unable~~applicable tosecurities ~~maintain~~laws, ~~proper~~our ~~and~~officers, ~~effective~~directors ~~internal~~and ~~controls,~~significant weshareholders may ~~not~~sell besome ~~able~~or toall ~~produce~~of ~~timely~~their ~~and~~common ~~accurate~~shares ~~financial~~in ~~statements~~the future. IfNo weprediction ~~cannot~~can ~~provide~~be ~~reliable~~made ~~financial~~as ~~reports~~to orthe ~~prevent~~effect, ~~fraud~~if any, such future sales of our ~~business~~common ~~and~~shares ~~results~~will have on the market price of ~~operations~~our ~~could~~securities beprevailing ~~harmed,~~from ~~investors~~time ~~could~~to ~~lose~~time. ~~confidence~~However, inthe ~~our~~future ~~reported~~sale ~~financial~~of ~~information~~a ~~and~~substantial wenumber ~~could~~of becommon ~~subject~~shares toby ~~sanctions~~the orSelling ~~investigations~~Shareholders or by ~~Nasdaq,~~other such persons or the ~~SEC~~perception that such sales could occur, ~~Canadian~~could ~~securities~~cause ~~regulators~~the orprice ~~other~~of ~~regulatory~~our ~~authorities~~securities to decline.

~~Our~~We ~~management~~may has identified material weaknesses in our internal control over financial reporting related to lack of degree of precision in the review of materials used to record transactions in accordance with US GAAPissue, ~~and~~without ~~lack~~shareholder ~~of formalized or documented policies related to the overall IT system environment. Our management has concluded that~~approval, ~~due~~preferred toshares such material weakness, our disclosure controls and procedures were not effective as of December 31, 2024. To address our material weaknesses, we are in the process of planning to implement measures designed to improve our internal control over financial reporting and remediate the control deficiencies that led to the material weaknesses. Such changes may not, however, be effective in establishing the adequacy of our internal control over financial reporting. If the material weaknesses are not adequately remediated, or if we identify further material weaknesses in our internal controls, our failure to establish and maintain effective internal control over financial reporting could result in material misstatements in our financial statements and a failure to meet our reporting and financial obligations, each of which could have arights ~~material adverse effect on our business, results of operations, financial condition~~ and ~~the~~preferences ~~trading~~potentially ~~price~~superior ~~of our securities. In addition, investors' perceptions that our internal control over financial reporting is inadequate or that we are unable~~ to ~~produce~~those ~~accurate financial statements may materially adversely affect the price~~ of our ~~securities,~~common ~~which in turn could make it more difficult for us to obtain financing on favorable terms or at all~~shares.

40Our articles permit the issuance of an unlimited number of preferred shares (the "Medicus Preferred Shares") in one or more series. Medicus Preferred Shares are entitled to priority over our common shares with respect to the distribution of our assets in the event of any liquidation, dissolution or winding up of our affairs, whether voluntary or involuntary. Subject to any applicable regulatory approvals, our board of directors may set the rights and preferences of any series of Medicus Preferred Shares in its sole discretion without shareholder approval. The rights and preferences of those Medicus Preferred Shares may be superior to those of our common shares. Accordingly, the issuance of Medicus Preferred Shares may adversely affect the rights of holders of our common shares.

WeIf ~~have~~equity ~~and~~research ~~will~~analysts ~~continue~~do tonot ~~incur~~publish ~~increased~~research ~~costs~~or asreports aabout ~~result of~~ our ~~operation~~business asor aif ~~dual~~they ~~U.S.-Canadian~~issue ~~reporting~~unfavorable ~~company,~~commentary ~~and~~or downgrade our ~~management~~common ~~will~~shares, ~~be required to devote substantial time and resources to employing new compliance initiatives in order to comport with~~ the ~~regulatory~~price ~~requirements~~of ~~applicable~~our tosecurities ~~public~~could ~~companies~~decline.

InThe ~~connection~~trading ~~with~~market ~~recently~~for ~~becoming~~our asecurities ~~public~~could ~~company~~be ininfluenced ~~the~~by ~~US,~~research ~~we have~~ and ~~will~~reports ~~continue~~that toindustry ~~incur significant legal, accounting~~ and/or ~~other~~securities ~~expenses~~analysts ~~that~~may wepublish ~~did~~about ~~not previously incur. As a dual U.S.-Canadian public company~~us, weour ~~are subject to the reporting requirements of the Exchange Act~~business, the ~~Sarbanes-Oxley~~market ~~Act,~~or ~~the~~our ~~Dodd-Frank~~competitors. ~~Wall~~We ~~Street~~do ~~Reform~~not ~~and~~have ~~Consumer~~any ~~Protection~~control ~~Act,~~over asthese ~~well~~analysts ~~as rules adopted,~~ and tocannot beassure ~~adopted,~~that bysuch ~~the~~analysts ~~SEC, Canadian securities regulators and Nasdaq. Our management and other personnel~~ will ~~need~~cover tous ~~devote~~or aprovide ~~substantial~~favorable ~~amount of time to these compliance initiatives~~coverage. ~~Moreover,~~If weany ~~expect~~of ~~these~~the ~~rules~~analysts ~~and~~who ~~regulations~~may tocover ~~substantially increase~~ our ~~legal~~business ~~and~~change ~~financial~~their ~~compliance~~recommendation ~~costs~~regarding ~~and~~our tocommon ~~make~~shares ~~some activities more time-consuming and costly. For example~~adversely, weor ~~expect~~provide ~~these rules and regulations to make it~~ more ~~difficult~~favorable ~~and~~relative ~~more~~recommendations ~~expensive~~about ~~for~~our uscompetitors, tothe ~~obtain~~share ~~director~~price ~~and~~would ~~officer~~likely ~~liability~~decline. ~~insurance~~If ~~and~~any weanalysts who may becover ~~forced~~our tobusiness ~~accept~~were ~~reduced policy limits or incur substantially higher costs~~ to ~~maintain~~cease ~~the same or similar~~ coverage. ~~We cannot predict~~ or ~~estimate~~fail ~~the~~to ~~amount~~regularly orpublish ~~timing~~reports ofon ~~additional~~us, ~~costs~~ we ~~may~~could ~~incur~~lose tovisibility ~~respond~~in tothe ~~these~~financial ~~requirements.~~markets, ~~The~~which ~~impact~~in ofturn ~~these requirements~~ could ~~also~~cause ~~make~~the itshare ~~more~~price ~~difficult~~or ~~for~~trading usvolume to ~~attract and retain qualified persons to serve on our board of directors, our board committees or as executive officers~~decline.

~~We may be subject to securities litigation, which is expensive and could divert management attention.~~42

~~The~~Risks ~~market~~Related ~~price of our securities may be volatile, and in the past companies that have experienced volatility in the market price of their shares have been subject~~ to ~~securities~~Being ~~class~~a ~~action~~Public litigation. We may be the target of this type of litigation in the future. Litigation of this type could result in substantial costs and diversion of management's attention and resources, which could adversely impact our business. Any adverse determination in litigation could also subject us to significant liabilities.Company

As wea ~~are~~result ~~organized~~of ~~under~~recently ~~the~~becoming ~~laws of~~ a ~~Canadian~~public ~~province~~company ~~and~~in ~~certain~~the ofUnited ~~our~~States, ~~directors~~we ~~and~~are ~~officers~~subject ~~reside~~to inadditional ~~Canada~~regulatory orcompliance ~~the provinces thereof~~requirements, itincluding ~~may~~Section be404 ~~difficult~~of ~~for~~the ~~U.S.~~Sarbanes-Oxley ~~shareholders~~Act, toand ~~effect~~if ~~service~~we onfail us to ~~realize~~maintain onan ~~judgments~~effective ~~obtained~~system inof ~~the~~internal ~~United States. Similarly~~controls, itwe may not be ~~difficult~~able ~~for Canadian investors~~ to ~~enforce~~accurately ~~civil~~report ~~liabilities against~~ our ~~directors~~financial ~~and~~results ~~officers~~or ~~residing~~prevent ~~outside of Canada~~fraud.

41Our management team may not successfully or effectively manage our transition to a U.S. public company that will be subject to significant regulatory oversight and reporting obligations under U.S. and Canadian securities laws. Our limited experience in dealing with the increasingly complex laws pertaining to U.S. and Canadian public companies could be a significant disadvantage in that it is likely that an increasing amount of their time may be devoted to these activities which will result in less time being devoted to the management and growth of the post-combination company. We may not have adequate personnel with the appropriate level of knowledge, experience and training in the accounting policies, practices or internal control over financial reporting required of public companies in the United States and Canada.

WeAs ~~are~~a ~~governed~~public bycompany ~~the~~listed ~~Business~~on ~~Corporations Act (Ontario)~~Nasdaq, ~~as now enacted or as~~ the ~~same may from time to time be amended, re~~Sarbanes-~~enacted~~Oxley orAct ~~replaced ("OBCA")~~requires, ~~certain~~among ofother ~~our~~things ~~directors~~that ~~and~~we ~~officers~~assess ~~reside or are organized outside of~~ the ~~United~~effectiveness ~~States and a portion~~ of our ~~assets~~internal orcontrol ~~the~~over ~~assets~~financial ofreporting ~~these~~at ~~persons may be located outside~~ the ~~United~~end ~~States. Consequently, it may be difficult for investors who reside in the United States to effect service~~ of ~~process~~each infiscal ~~the~~year. ~~United~~We ~~States~~anticipate ~~upon~~being usfirst orrequired ~~upon such persons who are not residents of the United States, or~~ to ~~realize~~issue ~~upon~~management's ~~judgments~~assessment of ~~courts~~internal ofcontrol ~~the~~over ~~United~~financial ~~States~~reporting ~~predicated~~pursuant ~~upon~~to ~~the~~Section civil liability provisions of the U.S. federal securities laws. A judgment of a U.S. court predicated solely upon such civil liabilities may be enforceable in Canada by a Canadian court if the U.S. court in which the judgment was obtained had jurisdiction, as determined by the Canadian court, in the matter. Investors should not assume that Canadian courts: 404(ia) ~~would enforce judgments~~ of ~~U.S. courts obtained in actions against us or such persons predicated upon~~ the ~~civil~~Sarbanes-Oxley ~~liability~~Act ~~provisions of the U.S. federal securities laws or the securities or blue sky laws of any state within the United States, or (ii) would enforce,~~ in ~~original~~connection ~~actions,~~with ~~liabilities~~issuing ~~against us or such persons predicated upon the U.S. federal securities laws or any such state securities or blue sky laws. Similarly, some of~~ our ~~directors~~consolidated ~~and~~financial ~~officers~~statements ~~are~~as ~~residents~~ of ~~countries other than Canada~~ and ~~all~~for ~~or a substantial portion of~~ the ~~assets~~fiscal ofyear ~~such~~ending ~~persons~~December ~~are located outside Canada. As a result~~31, ~~it may be difficult for Canadian investors to initiate a lawsuit within Canada against these persons~~2025. In addition, it may not be possible for Canadian investors to collect from these persons judgments obtained in courts in Canada predicated on the civil liability provisions of securities legislation of certain of the provinces and territories of Canada. It may also be difficult for Canadian investors to succeed in a lawsuit in the United States based solely on violations of Canadian securities laws.

42We have started and continue the process of designing, implementing and testing our internal control over financial reporting required to comply with Section 404(a) of the Sarbanes- Oxley Act. This process is time-consuming, costly and complicated. Our management may not be able to effectively and timely implement controls and procedures that adequately respond to the increased regulatory compliance and reporting requirements that are applicable to us as a public company listed on Nasdaq. If we fail to maintain internal control over financial reporting adequate to meet the demands that will be placed upon us as a public company listed in the United States, our business and reputation may be harmed, the accuracy and timeliness of our financial reporting may be adversely affected, and the price of our shares may decline.

~~DIVIDEND~~In ~~POLICY~~addition, unless we still qualify as a non-accelerated filer, our independent registered public accounting firm will be required to attest to the effectiveness of our internal controls over financial reporting beginning with our annual report following the date on which we are no longer an "emerging growth company," which may be up to five fiscal years following the date of our initial public offering in the United States.

WeIf ~~do not anticipate that~~ we ~~will~~are ~~declare~~unable orfor ~~pay~~any ~~dividends~~reason into ~~the~~meet ~~foreseeable future on our common shares. Instead, we anticipate that all of our earnings will be used for~~ the ~~operation~~continued ~~and~~listing ~~growth~~requirements of ~~our~~Nasdaq, ~~business.~~such ~~Any~~action ~~future~~or ~~determination~~inaction tocould ~~declare~~result ~~cash~~in ~~dividends~~a ~~would~~delisting ~~be subject to the discretion~~ of our ~~board~~common ofshares ~~directors~~ and ~~would depend upon various factors, including~~ our ~~results~~Public ~~of operations~~Warrants, ~~financial~~as ~~condition and liquidity requirements, restrictions that may be imposed by~~ applicable ~~law and our contracts and other factors deemed relevant by our board of directors~~.

43If we fail to satisfy the continued listing requirements of Nasdaq (for example, Nasdaq corporate governance requirements or the minimum closing bid price requirement), such exchanges may take steps to delist our common shares and our Public Warrants, as applicable. Such a delisting would likely have a negative effect on the price of our common shares and our Public Warrants and would impair your ability to sell or purchase our common shares and our Public Warrants, as applicable, when you wish to do so. In the event of a delisting, we can provide no assurance that any action taken by us to restore compliance with listing requirements would allow our common shares and our Public Warrants, as applicable, to become listed again, stabilize the market price or improve the liquidity of our common shares and our Public Warrants, as applicable, prevent such securities from dropping below any minimum bid price requirement or prevent future non-compliance with Nasdaq's listing requirements.

~~CAPITALIZATION~~43

~~The~~There ~~following~~is ~~table~~a ~~sets~~risk ~~forth~~that we will fail to maintain an effective system of internal controls and our ~~consolidated~~ability ~~capitalization~~to produce timely and accurate financial statements or comply with applicable regulations could be adversely affected. We have identified material weaknesses in our internal controls over financing reporting as of ~~March~~December 31, ~~2025:~~2024, which we may not be able to remedy in a timely manner.

~~- on~~As ana ~~actual~~U.S. ~~basis~~public company, aswe ~~determined~~operate in ~~accordance~~an increasingly demanding regulatory environment, which requires us to comply with ~~GAAP;~~the Sarbanes-Oxley Act, the regulations of Nasdaq, the rules and regulations of the SEC and Canadian securities regulators, expanded disclosure requirements, accelerated reporting requirements and more complex accounting rules. Company responsibilities required by the Sarbanes-Oxley Act include establishing corporate oversight and adequate internal control over financial reporting and disclosure controls and procedures. Effective internal controls are necessary for us to produce reliable financial reports and are important to help prevent financial fraud. Prior to the closing of our initial public offering in the United States, we have never been required to test our internal controls within a specified period and, as a result, we may experience difficulty in meeting these reporting requirements in a timely manner.

~~- on~~We ananticipate ~~adjusted~~that ~~basis~~the process of building our accounting and financial functions and infrastructure may require significant additional professional fees, internal costs and management efforts. We may need to ~~reflect~~enhance ~~the~~and/or ~~net~~implement ~~proceeds~~a ~~from~~new ~~our~~internal ~~sale~~system to combine and streamline the management of 1our financial,~~375~~ accounting,~~000~~ ~~Units~~human inresources ~~this~~and ~~offering~~other atfunctions. However, the ~~assumed~~enhancement ~~offering~~and/or ~~price~~implementation of $7a system may result in substantial costs.29 ~~per~~Any ~~Unit~~disruptions or difficulties in implementing or using such a system could adversely affect our controls and harm our business. Moreover, ~~after~~such ~~deducting~~disruption ~~the~~or ~~underwriting~~difficulties ~~discounts~~could result in unanticipated costs and ~~commissions~~diversion of management's attention. In addition, we may discover additional weaknesses in our system of internal financial and accounting controls and procedures that could result in a material misstatement of our financial statements. Our internal control over financial reporting will not prevent or detect all errors and all fraud. A control system, no matter how well designed and operated, can provide only reasonable, not absolute, assurance that the ~~estimated~~control ~~offering~~system's ~~expenses~~objectives will be met. Because of the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that misstatements due to error or fraud will not occur or that all control issues and instances of fraud will be detected.

~~This~~If ~~table~~we ~~should~~do benot ~~read~~able into ~~conjunction~~comply with the ~~"Management's~~requirements ~~Discussion~~of ~~and~~Section ~~Analysis~~404 of ~~Financial~~the ~~Condition~~Sarbanes-Oxley Act in a timely manner, or if we are unable to maintain proper and ~~Results~~effective ofinternal ~~Operations"~~controls, we may not be able to produce timely and ~~"Use~~accurate financial statements. If we cannot provide reliable financial reports or prevent fraud, our business and results of ~~Proceeds"~~operations ~~sections~~could be harmed, asinvestors ~~well~~could aslose confidence in our ~~audited~~reported financial ~~statements~~information and we could be subject to sanctions or investigations by Nasdaq, ~~included~~the ~~elsewhere~~SEC, inCanadian ~~this~~securities ~~prospectus~~regulators or other regulatory authorities.

		As of March 31, 2025
		Actual			Adjusted
Cash	$	3,982,430		$	13,004,399
Liabilities		3,510,312			3,510,312
Shareholders' equity:
Share capital		32,908,702			41,930,671
Additional paid-in capital		3,245,163			3,245,163
Deficit		(34,006,311	)		(34,006,311	)
Total shareholders' equity		2,147,554			11,169,523
Total capitalization	$	5,657,866		$	14,679,835

For example, our management has identified material weaknesses in our internal control over financial reporting related to lack of degree of precision in the review of materials used to record transactions in accordance with US GAAP, and lack of formalized or documented policies related to the overall IT system environment. Our management has concluded that, due to such material weakness, our disclosure controls and procedures were not effective as of December 31, 2024, and that such controls and procedures remained ineffective as of June 30, 2025. To address our material weaknesses, we are in the process of planning to implement measures designed to improve our internal control over financial reporting and remediate the control deficiencies that led to the material weaknesses. Such changes may not, however, be effective in establishing the adequacy of our internal control over financial reporting. If the material weaknesses are not adequately remediated, or if we identify further material weaknesses in our internal controls, our failure to establish and maintain effective internal control over financial reporting could result in material misstatements in our financial statements and a failure to meet our reporting and financial obligations, each of which could have a material adverse effect on our business, results of operations, financial condition and the trading price of our securities. In addition, investors' perceptions that our internal control over financial reporting is inadequate or that we are unable to produce accurate financial statements may materially adversely affect the price of our securities, which in turn could make it more difficult for us to obtain financing on favorable terms or at all.

~~USE~~We OFhave ~~PROCEEDS~~and will continue to incur increased costs as a result of our operation as a dual U.S.-Canadian reporting company, and our management will be required to devote substantial time and resources to employing new compliance initiatives in order to comport with the regulatory requirements applicable to public companies.

WeIn ~~estimate~~connection ~~that~~with recently becoming a public company in the ~~net~~US, ~~proceeds~~we have and will continue to usincur ~~from~~significant ~~this~~legal, ~~offering~~accounting ~~will~~and beother ~~approximately~~expenses $9that we did not previously incur.0 ~~million~~As a dual U.S.-Canadian public company, ~~assuming~~we anare ~~offering~~subject ~~price~~to the reporting requirements of ~~$7.29~~the ~~per~~Exchange ~~Unit~~Act, ~~which~~the isSarbanes-Oxley Act, the ~~closing~~Dodd-Frank ~~price~~Wall ofStreet ~~our~~Reform ~~common~~and ~~shares~~Consumer onProtection ~~Nasdaq~~Act, onas ~~May~~well 23as rules adopted, ~~2025~~and to be adopted, ~~after~~by ~~deducting~~the ~~placement~~SEC, ~~agent~~Canadian ~~fees~~securities regulators and Nasdaq. Our management and other personnel will need to devote a substantial amount of ~~approximately~~time ~~$750~~to these compliance initiatives. Moreover,~~000~~ we expect these rules and ~~estimated~~regulations ~~offering~~to ~~expenses~~substantially ~~payable~~increase byour legal and financial compliance costs and to make some activities more time-consuming and costly. For example, we expect these rules and regulations to make it more difficult and more expensive for us to obtain director and officer liability insurance and we may be forced to accept reduced policy limits or incur substantially higher costs to maintain the same or similar coverage. We cannot predict or estimate the amount or timing of ~~approximately~~additional ~~$250~~costs we may incur to respond to these requirements. The impact of these requirements could also make it more difficult for us to attract and retain qualified persons to serve on our board of directors,~~000~~ our board committees or as executive officers.

InWe ~~addition,~~may webe ~~would~~subject ~~receive up~~ to ansecurities ~~aggregate of approximately $ million from the exercise of the warrants~~litigation, ~~assuming~~which ~~the~~is ~~exercise~~expensive inand ~~full~~could ofdivert ~~all~~management ~~such warrants for cash~~attention.

WeThe ~~intend~~market toprice ~~use~~of ~~the~~our ~~net~~securities ~~proceeds~~may ~~from~~be ~~this~~volatile, ~~offering~~and toin ~~fund~~the ~~our~~past ~~Phase~~companies 2that ~~proof~~have ofexperienced ~~concept~~volatility ~~clinical~~in ~~trial~~the ~~for~~market ~~treatment~~price of ~~basal~~their ~~cell~~shares ~~carcinoma~~have ~~using~~been ~~our~~subject ~~doxorubicin~~to ~~tip~~securities ~~loaded~~class ~~dissolvable~~action ~~microarray needle skinpatch~~litigation. We may ~~also~~be ~~use~~ the ~~net~~target ~~proceeds~~ of this ~~offering~~type toof ~~expand~~litigation ~~our~~in ~~exploratory~~the ~~phase~~future. 2Litigation ~~clinical~~of ~~trial~~this totype acould ~~pivotal~~result ~~trial~~in substantial costs and~~/or~~ todiversion ~~expand~~of ~~our~~management's ~~trials~~attention toand ~~cover~~resources, ~~other~~which ~~non-melanoma~~could ~~skin~~adversely ~~diseases.~~impact Weour ~~will~~business. ~~use~~Any ~~any~~adverse ~~remaining~~determination ~~net~~in ~~proceeds~~litigation ~~for~~could ~~general~~also ~~corporate~~subject ~~purposes~~us ~~and~~to ~~working~~significant ~~capital~~liabilities.

~~The~~As ~~amounts~~we ~~and~~are ~~timing~~organized ofunder ~~our~~the ~~actual~~laws ~~expenditures~~of ~~will~~a ~~depend~~Canadian onprovince ~~numerous factors, the timing~~ and ~~success~~certain of ~~any~~our ~~clinical~~directors ~~trials~~ and ~~preclinical~~officers ~~studies~~reside ~~we may commence~~ in ~~the~~Canada ~~future,~~or the ~~timing~~provinces ~~of regulatory submissions~~thereof, ~~the~~it ~~status~~may ofbe ~~our~~difficult ~~sales~~for ~~and~~U.S. ~~marketing~~shareholders ~~efforts,~~to ~~the~~effect ~~amounts~~service ofon ~~proceeds~~us ~~actually~~to ~~raised~~realize inon ~~this~~judgments ~~offering~~obtained ~~and~~in the ~~amount~~United ~~of cash generated by our operations~~States. ~~Because we operate in a very dynamic and highly competitive industry~~Similarly, ~~the~~it ~~actual use of proceeds~~ may ~~differ~~be ~~substantially~~difficult ~~from~~for ~~the~~Canadian ~~ranges~~investors ~~indicated~~to ~~above.~~enforce ~~Our~~civil ~~management~~liabilities ~~will~~against ~~have~~our ~~broad~~directors ~~discretion~~and toofficers ~~allocate~~residing ~~the~~outside ~~net~~of ~~proceeds from this offering~~Canada.

45We are governed by the Business Corporations Act (Ontario), as now enacted or as the same may from time to time be amended, re-enacted or replaced ("OBCA"), certain of our directors and officers reside or are organized outside of the United States and a portion of our assets or the assets of these persons may be located outside the United States. Consequently, it may be difficult for investors who reside in the United States to effect service of process in the United States upon us or upon such persons who are not residents of the United States, or to realize upon judgments of courts of the United States predicated upon the civil liability provisions of the U.S. federal securities laws. A judgment of a U.S. court predicated solely upon such civil liabilities may be enforceable in Canada by a Canadian court if the U.S. court in which the judgment was obtained had jurisdiction, as determined by the Canadian court, in the matter. Investors should not assume that Canadian courts: (i) would enforce judgments of U.S. courts obtained in actions against us or such persons predicated upon the civil liability provisions of the U.S. federal securities laws or the securities or blue sky laws of any state within the United States, or (ii) would enforce, in original actions, liabilities against us or such persons predicated upon the U.S. federal securities laws or any such state securities or blue sky laws. Similarly, some of our directors and officers are residents of countries other than Canada and all or a substantial portion of the assets of such persons are located outside Canada. As a result, it may be difficult for Canadian investors to initiate a lawsuit within Canada against these persons. In addition, it may not be possible for Canadian investors to collect from these persons judgments obtained in courts in Canada predicated on the civil liability provisions of securities legislation of certain of the provinces and territories of Canada. It may also be difficult for Canadian investors to succeed in a lawsuit in the United States based solely on violations of Canadian securities laws.

~~MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS~~45

~~This~~DIVIDEND discussion contains forward-looking statements that involve risks and uncertainties. When reviewing the discussion below, you should keep in mind the substantial risks and uncertainties that impact our business. In particular, we encourage you to review the risks and uncertainties described in "Risk Factors" in this prospectus. These risks and uncertainties could cause actual results to differ materially from those projected or implied by our forward-looking statements contained in this report. These forward-looking statements are made as of the date of this prospectus, and we do not intend, and do not assume any obligation, to update these forward-looking statements, except as required by law. All amounts are expressed in United States dollars unless otherwise stated.POLICY

~~Company~~We ~~Overview~~do not anticipate that we will declare or pay dividends in the foreseeable future on our common shares. Instead, we anticipate that all of our earnings will be used for the operation and growth of our business. Any future determination to declare cash dividends would be subject to the discretion of our board of directors and would depend upon various factors, including our results of operations, financial condition and liquidity requirements, restrictions that may be imposed by applicable law and our contracts and other factors deemed relevant by our board of directors.

The Company is a clinical stage, multi-strategy holding company focused on investing in and accelerating novel life sciences and bio-technology companies through FDA approved clinical trials. Utilizing a thesis driven collaborative process, the Company attempts to acquire and advance clinical stage assets through clinical development and commercialization. The Company looks into opportunities across all therapeutics areas where an unmet need exists for improved patient safety and efficacy. The Company is actively exploring to expand its drug development pipeline through qualified and accretive acquisitions and partnerships.46

~~The~~USE ~~Company~~OF ~~has two wholly owned subsidiaries, Medicus Pharma Inc., a company incorporated in the state of Delaware on October 12, 2023, and SkinJect.~~PROCEEDS

~~SkinJect~~This isprospectus ~~focused~~relates onto ~~the~~our ~~development~~common ofshares athat ~~novel~~may ~~drug~~be ~~delivery~~offered ~~system~~and ~~using~~sold ~~dissolvable~~from ~~microneedle~~time ~~arrays~~to ~~("MNAs")~~time ~~for~~by the ~~treatment~~Selling ~~of certain skin cancers~~Shareholders. ToAll ~~that~~of ~~end,~~ the ~~Company~~common ~~licensed~~shares ~~certain~~offered ~~technology co-developed~~ by the ~~University~~Selling ofShareholders ~~Pittsburgh~~pursuant ~~and~~to ~~Carnegie~~this ~~Mellon~~prospectus ~~University.~~will ~~The~~be ~~Company~~sold ~~established~~by ~~and~~each ~~validated~~Selling ~~fabrication~~Shareholder ~~processes~~for ~~relative~~its toown ~~the~~account. ~~MNAs,~~We ~~completed~~will ~~pre-clinical~~not ~~testing~~receive ~~and~~any ~~secured~~of ~~approval~~the toproceeds ~~proceed with clinical trials activity~~ from ~~the~~these ~~Food and Drug Administration~~sales.

The Company then completed a dose escalation study ("'SKNJCT-001") that assessed the safety of MNA patch in patients with BCC. There were no serious adverse events nor any demonstrated alterations in any clinical measurements during the trial. The conclusion of the study was that MNA patch was well tolerated with no evidence of dose limiting toxicity.47

~~The~~MANAGEMENT'S ~~Company~~DISCUSSION ~~had~~AND ~~initiated~~ANALYSIS aOF ~~clinical~~FINANCIAL ~~study~~CONDITION ~~("SKNJCT-002")~~AND ~~aimed~~RESULTS atOF evaluating clinical efficacy. The first part involved the enrollment of 15 healthy volunteers and was designed to study the penetration of placebo-containing Dynamic Mechanical Allodynia ("DMA") patches at five different anatomic locations. After the first seven health volunteers were enrolled, due to the variability of array application observed by the investigator, SkinJect made the decision to pause the trial. The study was never resumed, and it was ultimately closed without further enrollment. There were no adverse events reported in the enrolled subjects.OPERATIONS

InThis ~~January~~discussion ~~2024,~~contains ~~the~~forward-looking ~~Company~~statements ~~submitted~~that ~~the~~involve ~~clinical~~risks ~~design~~and ~~for~~uncertainties. aWhen ~~randomized,~~reviewing ~~double-blinded,~~the ~~placebo-controlled~~discussion ~~("P-MNA")~~below, ~~multi-center~~you ~~study~~should ~~("SKNJCT-003")~~keep ~~enrolling~~in upmind tothe 60substantial ~~subjects~~risks ~~presenting~~and ~~with~~uncertainties ~~nodular~~that ~~type~~impact ~~BCC~~our ofbusiness. ~~the~~In ~~skin.~~particular, ~~The~~we ~~FDA~~encourage ~~responded~~you into ~~March~~review ~~2024~~the risks and ~~requested~~uncertainties ~~additional~~described ~~clinical~~in ~~information~~"Risk Factors" in this prospectus. AThese ~~final~~risks ~~protocol~~and ~~was~~uncertainties ~~submitted~~could cause actual results to ~~the~~differ ~~FDA~~materially from those projected or implied by our forward-looking statements contained in ~~July~~this ~~2024,~~report. ~~which~~These ~~included~~forward-looking ~~the~~statements ~~information~~are ~~requested~~made byas of the ~~FDA~~date of this prospectus, ~~along~~and ~~with~~we ~~updated~~do ~~CMC~~not intend, ~~stability~~ and ~~sterility~~do ~~data.~~not Onassume ~~July~~any 31obligation, ~~2024,~~to ~~the~~update ~~FDA~~these ~~responded~~forward-looking tostatements, ~~the~~except ~~latest~~as ~~submission~~required ~~and~~by ~~requested~~law. ~~certain~~All ~~additional~~amounts ~~information~~are ~~and~~expressed ~~clarification.~~in ~~The~~United ~~Company~~States ~~has~~dollars ~~responded~~unless tootherwise ~~the~~stated. ~~FDA~~This ondiscussion is as of August 211, ~~2024.~~2025 Onand ~~August~~should ~~13,~~be ~~2024,~~read in conjunction with the Company's ~~commenced~~audited ~~activating~~consolidated ~~its~~financial ~~clinical~~statements ~~trial~~for ~~sites~~the years ended December 31, 2024 and ~~had~~2023 ~~enrolled~~and ~~over~~the ~~25%~~interim ofunaudited consolidated financial statements for the 60three ~~expected~~and ~~patients~~six bymonths ~~December~~ended June 30, 2025 and 2024.

~~The~~Company ~~Share Consolidation~~Overview

OnThe ~~June 25, 2024, the~~ Company's ~~shareholders~~is ~~approved~~a anclinical ~~amendment~~stage, tomulti-strategy ~~the~~life ~~Company's~~sciences, ~~articles~~biotech ofcompany ~~incorporation~~focused toon ~~provide~~investing ~~for~~in ~~the~~and ~~Share~~accelerating ~~Consolidation,~~clinical ordevelopment ~~reverse~~programs ~~stock split,~~ of ~~the~~novel ~~Company's issued~~ and ~~outstanding~~potentially ~~common~~disruptive ~~shares~~therapeutic atassets. ~~such~~The ~~a consolidation ratio to be determined by the~~ Company's ~~board~~looks ofinto ~~directors~~opportunities inacross ~~its sole discretion, to permit the Company to satisfy~~ all ~~conditions~~therapeutics ~~and~~areas ~~necessary~~where ~~regulatory~~an ~~approvals~~unmet toneed ~~list~~exists ~~the~~for ~~common~~improved ~~shares~~patient onsafety aand Uefficacy.S. ~~national~~The ~~securities exchange as the~~ Company's ~~board~~is ofopportunistically ~~directors~~exploring ~~may~~to ~~determine~~expand in its ~~sole~~drug ~~direction.~~development ~~Our~~pipeline ~~board~~through ofqualified ~~directors~~and ~~approved~~accretive ~~the~~acquisitions ~~Share Consolidation on October 15, 2024,~~ and ~~the Share Consolidation was completed by the Company on October 28, 2024, at the ratio of 1-for-2~~partnerships.

46The Company has two wholly owned subsidiaries, Medicus Pharma Inc., a company incorporated in the state of Delaware on October 12, 2023, and SkinJect.

~~After~~SkinJect is focused on the ~~completion~~development of ~~the~~a ~~Share~~novel ~~Consolidation~~"innovation combination product", ~~the~~as ~~number~~an ofinvestigational ~~the~~new ~~Company's~~drug, ~~issued~~using ~~and~~uniquely ~~outstanding~~designed, ~~common~~patent ~~shares~~protected ~~decreased~~doxorubicin-containing ~~from~~dissolvable ~~21,693,560~~microneedle toarrays ~~10,846,721.~~("D-MNAs") ~~The~~for ~~par~~the ~~value~~treatment of certain skin cancers. To that end, the Company's ~~common~~licensed ~~shares~~certain ~~remains~~technology ~~unchanged~~co-developed atby $0the ~~per~~University ~~share~~of ~~after~~Pittsburgh ~~the~~and ~~Share~~Carnegie ~~Consolidation~~Mellon University. The ~~Share~~Company ~~Consolidation~~established ~~was~~and validated fabrication processes relative to the D-MNAs, completed inpre-clinical ~~preparation~~testing ~~for~~and asecured ~~U.S.~~approval ~~listing~~to proceed with clinical trials activity from the FDA.

~~Initial~~The ~~Public~~Company ~~Offering~~then completed a dose escalation study ("SKNJCT-001") that assessed the safety of D-MNA patch in patients with BCC. There were no serious systemic or local adverse events nor any demonstrated alterations in any clinical measurements during the trial. The conclusion of the study was that D-MNA patch was well tolerated with no evidence of dose limiting toxicity.

OnThe ~~November~~Company ~~14,~~had ~~2024,~~initiated ~~the~~a ~~Company~~clinical ~~completed~~study ~~the~~("SKNJCT-002") ~~sale~~aimed ofat ~~970,000~~evaluating ~~Units,~~clinical ~~with~~efficacy. ~~each~~The ~~Unit~~first ~~consisting~~part involved the enrollment of ~~one~~15 ~~common~~healthy ~~share~~volunteers and ~~one~~was ~~warrant~~designed to ~~purchase~~study ~~one~~the ~~common~~penetration ~~share~~of placebo-containing Dynamic Mechanical Allodynia patches at ~~the~~five ~~price~~different ofanatomic $4locations.~~125~~ ~~per~~After ~~Unit.~~the Infirst ~~addition~~seven health volunteers were enrolled, due to the ~~underwriters~~variability ~~exercised~~of anarray ~~option~~application toobserved ~~purchase~~by ~~145~~the investigator,~~500~~ ~~warrants~~SkinJect (made the ~~"Overallotment~~decision ~~Warrants")~~to atpause athe ~~price~~trial. ofThe $0study was never resumed, and it was ultimately closed without further enrollment.01 ~~per~~There ~~warrant~~were no adverse events reported in the enrolled subjects.

~~Total~~In ~~gross~~January ~~proceeds~~2024, ~~from~~the Company submitted the ~~IPO~~clinical ~~were~~design $4for a randomized,~~002~~ double-blinded,~~705~~ placebo-controlled, ~~including~~multi-center ~~the~~study ~~proceeds~~("SKNJCT-003") ~~from~~enrolling ~~the~~up ~~Overallotment~~to ~~Warrants~~60 subjects presenting with nodular type of BCC of the skin. The ~~Company~~FDA ~~incurred~~responded ~~total~~in ~~issuance~~March ~~costs~~2024 ofand $2requested additional clinical information. A final protocol was submitted to the FDA in July 2024,~~218~~ which included the information requested by the FDA,~~014~~ along with updated chemistry, ~~including~~manufacturing ~~underwriter~~and ~~fees~~controls (CMC), stability and ~~legal~~sterility data. On July 31, 2024, the FDA responded to the latest submission and ~~other~~requested ~~professional~~certain ~~fees~~additional ~~incurred~~information ~~directly~~and ~~related~~clarification. The Company responded to the ~~issuance~~FDA on August 2, 2024 and commenced patient recruitment on August 27, 2024.

~~Regulation~~The ASKNJCT-003 ~~Offering~~Phase 2 clinical study is currently underway in nine clinical sites across United States. In March 2025, the Company announced a positively trending interim analysis for SKNJCT-003 demonstrating more the 60% clinical clearance. The interim analysis was conducted after more than 50% of the then-targeted 60 patients in the study were randomized. The findings of the interim analysis are preliminary and may or may not correlate with the findings of the study once completed. In April 2025, the investigational review board increased the number of participants in SKNJCT-003 to 90 subjects. The Company also announced expanding clinical trial sites in Europe. On July 8, 2025, the Company submitted a comprehensive package to the FDA seeking a Type C meeting during the week of October 6, 2025.

On March 10, 2025, the Company completed an offering of 1,490,000 units at $2.80 per unit pursuant to Tier II of Regulation A under the Securities Act, with each unit consisting of one common share and one Regulation A Warrant. The Regulation A Warrants have an exercise price of $2.80 and expire on March 10, 2030. The aggregate gross proceeds to the Company from the Offering were $4,172,000.48

~~Results~~In May 2025, the Company received notice that a study may proceed with approval from United Arab Emirates (UAE) Department of ~~Operations~~Health (DOH) to commence clinical study (SKNJCT-004) to non-invasively treat BCC of the skin. The study is expected to randomize 36 patients in four clinical sites in the UAE. Cleveland Clinic Abu Dhabi is the principal investigator, along with Sheikh Shakbout Medical City, Burjeel Medical City, and American Hospital of Dubai. Insights Research Organization and Solutions (IROS), a UAE-based contract research organization that is an M42 portfolio company, is coordinating the clinical study for the Company.

~~The~~In ~~following~~June ~~table~~2025, ~~outlines~~the ~~our~~Company ~~statements~~announced submission of ~~loss~~a ~~and~~product ~~comprehensive~~development ~~loss~~plan ~~for~~to the ~~three~~FDA ~~months~~to ~~ended~~treat ~~March~~external 31Squamous Cell Carcinoma (SCC) in horses. The Company, ~~2025~~in ~~and~~December 2024:, received a minor use in major species designation (MUMS) for its dissolvable doxorubicin-containing microneedle array (D-MNA) to treat external squamous cell carcinoma (SCC) in horses. MUMS is a status similar to Orphan Drug status for human drugs. It entitles the Company to an extended 7-year period of exclusive marketing following approval, provided that the Company meets all the requirements for maintaining the designation.

	Three months ended March 31,
	2025		2024
	$		$		Change
General and administrative	3,120,060		1,385,981		1,734,079
Research and development	2,006,214		321,377		1,684,837
Total operating expenses	5,126,274		1,707,358		3,418,916
Loss from operations	(5,126,274	)	(1,707,358	)	(3,418,916	)
Other income :
Finance income	23,866		-		23,866
Total other income	23,866		-		23,866
Net loss and comprehensive loss	(5,102,408	)	(1,707,738	)	(3,395,050	)
Net loss per common share (basic and diluted)	(0.42	)	(0.21	)

In June 2025, the Company entered into a definitive agreement to acquire Antev Limited, a UK-based clinical biotech company developing Teverelix, a next-generation GnRH antagonist, as first in market product for cardiovascular high-risk prostate cancer patients and patients with first acute urinary retention episodes due to enlarged prostate.

47The Share Consolidation

~~General~~On June 25, 2024, the Company's shareholders approved an amendment to the Company's articles of incorporation to provide for the Share Consolidation, or reverse stock split, of the Company's issued and ~~administrative~~outstanding common shares at such a consolidation ratio to be determined by the Company's board of directors in its sole discretion, to permit the Company to satisfy all conditions and necessary regulatory approvals to list the common shares on a U.S. national securities exchange as the Company's board of directors may determine in its sole direction. Our board of directors approved the Share Consolidation on October 15, 2024, and the Share Consolidation was completed by the Company on October 28, 2024, at the ratio of 1-for-2.

~~General~~After ~~and~~the ~~administrative~~completion ~~expenses~~of ~~for~~the Share Consolidation, the ~~three~~number ~~months~~of ~~ended~~the ~~March~~Company's 31issued and outstanding common shares decreased from 21,693,560 ~~2025~~to ~~and~~10,846,721. ~~2024~~The ~~are~~par ~~comprised~~value of: the Company's common shares remains unchanged at $0 per share after the Share Consolidation. The Share Consolidation was completed in preparation for a U.S. listing.

	Three months ended March 31,
	2025	2024
	$	$	Change
Professional fees	1,360,680	438,302	922,378
Consulting fees	284,946	455,814	(170,868	)
Salaries, wages and benefits	357,517	201,016	156,501
General office, insurance and administration expenditures	539,696	177,810	361,886
Business development and investor relations	464,944	77,086	387,858
Stock-based compensation	112,277	35,953	76,324
	3,120,060	1,385,981	1,734,079

Initial Public Offering

~~Professional~~On ~~fees~~November ~~increased~~14, ~~by $922~~2024,~~378~~ ~~for~~ the ~~three~~Company ~~months~~completed ~~ended~~its ~~March~~initial ~~31,~~public ~~2025,~~offering ~~compared~~("IPO") towith the ~~equivalent~~sale ~~period~~of in970,000 Units at the ~~prior~~price ~~year~~of $4.125 ~~The~~per ~~increase~~Unit, ~~was~~with ~~primarily~~each ~~due~~Unit to(the ~~increases~~"Unit") inconsisting ~~legal~~of ~~and~~one ~~accounting~~common ~~fees~~share ~~related~~and toone warrant (the ~~Company's~~"Public ~~operations.~~Warrants" ~~Professional~~and ~~fees~~with ~~include~~the ~~fees~~Regulation ~~incurred~~A ~~for~~Warrants ~~legal~~ and ~~accounting~~the ~~services~~June ~~that~~2030 ~~fluctuate~~Warrants, ~~from~~the ~~period~~"Warrants") to ~~period~~purchase ~~based~~one oncommon ~~the~~share ~~nature~~at of the ~~transactions~~exercise ~~the~~price ~~Company~~of ~~undertakes~~$4.64 per share. The ~~primary~~Public ~~reason~~Warrants ~~for~~expire five years from their date of issuance on November 15, 2029. In addition, the ~~increase~~underwriters isexercised ~~due~~an option to ~~increased~~purchase ~~regulatory~~145,500 ~~requirements~~Public ~~following~~Warrants (the ~~Company’s~~"Overallotment ~~initial~~Warrants") ~~public~~at ~~offering~~a ~~and~~price ~~transition~~of ~~to U~~$0.S.01 ~~domestic~~per ~~issuer status~~warrant.

~~Consulting~~Total ~~fees~~gross ~~decreased~~proceeds byfrom ~~$170,968 for~~ the ~~three~~IPO ~~months~~were ~~ended~~$4.0 ~~March 31~~million, ~~2025,~~including ~~compared to~~ the ~~equivalent~~proceeds ~~period~~from in the ~~prior~~Overallotment ~~year~~Warrants. ~~Consulting~~The ~~fees include fees paid to individuals and professional firms who provide advisory services to the~~ Company ~~and~~incurred ~~fluctuate~~total ~~from~~issuance ~~period~~costs ~~to period based on the nature~~ of ~~the transactions the Company undertakes~~$2.1 ~~The~~million, ~~primary~~including ~~reason~~underwriter ~~for~~fees, ~~the~~and ~~increase~~legal isand ~~due~~other toprofessional ~~decreased~~fees ~~business~~incurred ~~activity~~directly inrelated ~~the current year compared~~ to the ~~prior year when the Company was focused on completing the initial public offering~~issuance.

~~Salaries,~~Regulation ~~wages~~A and benefits increased by $156,501 for the three months ended March 31, 2025, compared to the equivalent period in the prior year. The increase was primarily due to an increase in headcount from the previous year.Offering

~~General~~On ~~office~~March 10, ~~insurance~~2025, ~~and~~the ~~administration~~Company ~~expenditures~~completed ~~increased~~an byoffering of 1,490,000 units at $~~361~~2.80 per unit pursuant to Tier II of Regulation A under the Securities Act,~~886~~ ~~for~~with each unit consisting of one common share and one Regulation A Warrant (the ~~three~~"Regulation ~~months~~A ~~ended~~Offering"). The Regulation A Warrants have an exercise price of $2.80 and expire on March 3110, ~~2025,~~2030. ~~compared~~The aggregate gross proceeds to the ~~equivalent~~Company ~~period~~from in the ~~prior~~Regulation ~~year~~A Offering were $4.2 ~~The~~million. ~~increase~~As ~~was~~of ~~primarily~~June ~~due~~30, to2025, 133,800 of the ~~Company~~1,490,000 ~~now~~Regulation ~~incurring~~A ~~more~~Warrants ~~significant~~have ~~insurance~~been ~~related~~exercised ~~expenses~~for ~~and~~cash, ~~general~~with ~~office~~5,000 ~~related~~being ~~expenditures~~exercised in ~~support~~the three months ended March 31, 2025, for proceeds to the Company of ~~expanded~~$374,640 ~~operations~~($14,000 of which related to the three months ended March 31, 2025).

Business development and investor relations expenses increased by $387,858 for the three months ended March 31, 2025, compared to the equivalent period in the prior year. Business development and investor relations expenses for the three months ended March 31, 2025, were primarily incurred as a result of increased marketing efforts in the current year as a result of the Company being a listed public entity on the Nasdaq.49

Stock-based compensation increased by $76,324 for the three months ended March 31, 2025, compared to the equivalent period in the prior year. Stock-based compensation changes based on the variability in the number of options granted, vesting periods of the options and the grant date fair value. During the three months ended March 31, 2025, the stock-based compensation expense relates to the vesting of share options granted during the second half of 2024.Debentures

48On May 2, 2025, the Company the Company entered into a securities purchase agreement with the Investor (as defined below), under which the Company has issued and sold three Debentures to the Investor in an aggregate principal amount totaling $5,000,000 during the three months ended June 30, 2025. The Debentures were issued at a discounted price of 90% for proceeds to the Company of $4,500,000. Interest will accrue on the outstanding principal amount of each Debenture at an annual rate of 8%, subject to a potential increase to 18% per annum upon the occurrence of certain events of default. The Debentures will mature on February 2, 2026 and are required to be repaid using proceeds from the SEPA (as defined below).

~~There~~June is2025 anPublic expected increase in general and administrative expenses associated with being a public company, including costs related to accounting, audit, legal, regulatory, and tax-related services associated with maintaining compliance with applicable securities law requirements; additional director and officer insurance costs; and investor and public relations costs.Offering

~~Research~~On June 2, 2025, the Company closed a public offering with gross proceeds of $7.0 million. The Company issued 2,260,000 units at a price of $3.10 per unit. Each unit consisted of one common share of the Company and ~~development~~one ~~("R&D")~~June 2030 Warrant. The June 2030 Warrants have an exercise price of $3.10 per share and will expire on June 2, 2030. As of June 30, 2025 no warrants have been exercised for cash.

~~Research~~Results ~~and~~of development ("R&D") costs include costs incurred under agreements with third-party contract research organizations, contract manufacturing organizations and other third parties that conduct preclinical and clinical activities on our behalf and manufacture our product candidates, and other costs associated with our R&D programs, including laboratory materials and supplies.Operations

~~R&D~~The ~~expenses~~following ~~increased~~table byoutlines ~~$1,684,837~~our ~~for~~statements ~~the~~of ~~three~~loss ~~months~~and ~~ended~~comprehensive ~~March~~loss ~~31,~~for ~~2025, compared to~~ the ~~equivalent~~three ~~periods~~and insix ~~the prior year. This increase is primarily due to costs incurred related to SKNJCT-003 which had minimal activity during the three~~ months ended ~~March~~June 3130, 2025 and 2024.:

As of March 20, 2025, the Company has commenced activating its clinical trial sites and has randomized more than 50% of the 60 patients expected to be enrolled in the study. Subsequent to March 31, 2025, the Company announced on April 21, 2025 that the Institutional Review Board approved the increase in the number of patients in the study from 60 to 90, that the clinical study will expand from the nine clinical sites in the United States to include an additional site in the United States and two clinical trial sites in Europe and that the Company has randomized more than 45 participants in the study.

	Three months ended June 30,						Six months ended June 30,
	2025		2024				2025		2024
	$		$		Change		$		$		Change
General and administrative	4,576,524		2,276,676		2,299,848		7,696,584		3,662,657		4,033,927
Research and development	1,439,564		1,277,158		162,406		3,445,778		1,598,535		1,847,243
Total operating expenses	6,016,088		3,553,834		2,462,254		11,142,362		5,261,192		5,881,170
Loss from operations	(6,016,088	)	(3,553,834	)	(2,462,254	)	(11,142,362	)	(5,261,192	)	(5,881,170	)
Other income (expense):
Interest income, net	40,004		(79,025	)	119,029		63,870		(79,025	)	142,895
Change in fair value of Debentures	(200,000	)	-		(200,000	)	(200,000	)	-		(200,000	)
Total other income (expense)	(159,996	)	(79,025	)	(80,971	)	(136,130	)	(79,025	)	(57,105	)
Net loss and comprehensive loss	(6,176,084	)	(3,632,859	)	(2,543,225	)	(11,278,492	)	(5,340,217	)	(5,938,275	)
Net loss per common share (basic and diluted)	(0.43	)	(0.44	)			(0.81	)	(0.66	)

~~We expect our R&D expenses to increase substantially for the foreseeable future as we continue with the SKNJCT-003 study and trials.~~50

~~The~~General ~~principal risks related to the Company's future performance are that the trials are unsuccessful, the Company does not receive FDA approval to proceed with the next stage of its research~~ and development, or the Company is unsuccessful in obtaining future funding needed to continue its research and development. These are customary risks for a development stage pharmaceutical Company and are less acute than for a Company with a less advanced product. Nevertheless, there can be no assurance that the Company will be able to complete its trials of the MNA, that the trials will be successful, or that the product will ultimately reach commercialization.administrative

~~Other~~General ~~income~~and administrative expenses for the three and six months ended June 30, 2025 and 2024 are comprised of:

Finance income was $23,866 and $0 for the three months ending March 31, 2025 and 2024, respectively. Finance income for the three months ended March 31, 2025 relates to interest income earned on short-term money market investments.

	Three months ended June 30,				Six months ended June 30,
	2025	2024			2025	2024
	$	$	Change		$	$	Change
Professional fees	1,944,559	621,040	1,323,519		3,305,037	1,059,342	2,245,695
Consulting fees	383,270	483,380	(100,110	)	668,216	939,194	(270,978	)
Salaries, benefits, and compensation	908,599	303,390	605,209		1,378,393	540,359	838,034
General office, insurance and administrative expenditures	724,800	716,422	8,378		1,264,698	894,232	370,466
Business development and investor relations	615,296

Filing Compare · Medicus Pharma Ltd.