UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM 10-K

☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the Fiscal Year Ended December 31, ~~2024~~2025

☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

Commission file number 001-35813

ORAMED PHARMACEUTICALS INC.

(Exact Name of Registrant as Specified in its Charter)

Delaware		98-0376008
(State or Other Jurisdiction of Incorporation or Organization)		(I.R.S. Employer Identification No.)

1185 Avenue of the Americas, Third Floor, New York, NY		10036
(Address of Principal Executive Offices)		(Zip Code)

844-967-2633
(Registrant’s Telephone Number, Including Area Code)

Securities registered pursuant to Section 12(b) of the Act:

Title of each class		Trading symbol		Name of each exchange on which registered
Common Stock, par value $0.012		ORMP		Nasdaq Capital Market, Tel Aviv Stock Exchange

Securities registered pursuant to Section 12(g) of the Act:

None.

(Title of class)

Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act.

Yes ☐ No ☒

Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act.

Yes ☐ No ☒

Indicate by check mark whether the registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was ~~required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.~~

required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.

Yes ☒ No ☐

Indicate by check mark whether the registrant has submitted electronically every Interactive Date File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).

Yes ☒ No ☐

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

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

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Indicate by check mark whether the registrant has filed a report on and attestation to its management’s assessment of the effectiveness of its internal control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered public accounting firm that prepared or issued its audit report. ☐

If securities are registered pursuant to Section 12(b) of the Act, indicate by check mark whether the financial statements of the registrant included in the filing reflect the correction of an error to previously issued financial statements. ☐

Indicate by check mark whether any of those error corrections are restatements that required a recovery analysis of incentive-based compensation received by any of the registrant’s executive officers during the relevant recovery period pursuant to §240.10D-1(b). ☐

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Act).

Yes ☐ No ☒

The aggregate market value of the voting and non-voting common equity held by non-affiliates as of the last business day of the registrant’s most recently completed second fiscal quarter was $~~131~~77,~~190~~659,~~607~~391 based on a price of $32.5825, being the last price at which the shares of the registrant’s common stock were sold on the Nasdaq Capital Market prior to the end of the most recently completed second fiscal quarter.

As of March 2726, ~~2025~~2026, the registrant had 40,~~850~~446,~~455~~ 179 shares of common stock issued and outstanding.

Documents Incorporated by Reference

None.

TABLE OF CONTENTS

Introduction and Use of Certain Terms		ii
Cautionary Statement Regarding Forward-Looking Statements		ii
PART I
	ITEM 1. BUSINESS	1
	ITEM 1A. RISK FACTORS	1315
	ITEM IB. UNRESOLVED STAFF COMMENTS	34
	ITEM 1B. UNRESOLVED STAFF COMMENTS	35
	ITEM 1C. CYBERSECURITY	3435
	ITEM 2. PROPERTIES	3435
	ITEM 3. LEGAL PROCEEDINGS	3435
	ITEM 4. MINE SAFETY DISCLOSURES	3435
PART II
	ITEM 5. MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES	3536
	ITEM 6. [RESERVED]	3638
	ITEM 7. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS	3638
	ITEM 7A. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK	4348
	ITEM 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA	4448
	ITEM 9. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE	4548
	ITEM 9A. CONTROLS AND PROCEDURES	4548
	ITEM 9B. OTHER INFORMATION	4649
	ITEM 9C. DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONS	4649
PART III
	ITEM 10. DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE	4750
	ITEM 11. EXECUTIVE COMPENSATION	5159
	ITEM 12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS	6471
	ITEM 13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE	6673
	ITEM 14. PRINCIPAL ACCOUNTANT FEES AND SERVICES	6673
PART IV
	ITEM 15. EXHIBITS AND FINANCIAL STATEMENT SCHEDULES	67F-1
	ITEM 16. FORM 10-K SUMMARY	7378

INTRODUCTION AND USE OF CERTAIN TERMS

As used in this Annual Report on Form 10-K, the terms “we,” “us,” “our,” the “Company,” and “Oramed” mean Oramed Pharmaceuticals Inc. and our wholly-owned subsidiaries, unless otherwise indicated. All dollar amounts refer to U.S. dollars unless otherwise indicated.

On December 31, ~~2024~~2025, the exchange rate between the New Israeli Shekel, or NIS, and the dollar, as quoted by the Bank of Israel, was NIS 3.~~647~~19 to $1.00. Unless indicated otherwise by the context, statements in this Annual Report on Form 10-K that provide the dollar equivalent of NIS amounts or provide the NIS equivalent of dollar amounts are based on such exchange rate.

CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING STATEMENTS

The statements contained in this Annual Report on Form 10-K that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws and the Israeli securities law. Words such as “expects,” “anticipates,” “intends,” “plans,” “planned expenditures,” “believes,” “seeks,” “estimates” and similar expressions or variations of such words are intended to identify forward-looking statements, but are not deemed to represent an all-inclusive means of identifying forward-looking statements as denoted in this Annual Report on Form 10-K. Additionally, statements concerning future matters are forward-looking statements. We remind readers that forward-looking statements are merely predictions and therefore inherently subject to uncertainties and other factors and involve known and unknown risks that could cause the actual results, performance, levels of activity, or our achievements, or industry results, to be materially different from any future results, performance, levels of activity, or our achievements, or industry results, expressed or implied by such forward-looking statements. Such forward-looking statements appear in “Item 1. Business” and “Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations,” as well as elsewhere in this Annual Report on Form 10-K and include, among other statements, statements regarding the following:

	●	our plan to evaluate potential strategic opportunities;

	●	our potential repurchases of shares of our common stock;

● ~~the~~our ~~possibility~~ability ~~that~~to recover the ~~anticipated~~proceeds ~~benefits~~and/or ofcollateral under the ~~2023~~Tranche ~~Scilex~~A ~~Transaction~~Note and ~~2024~~Tranche ~~Refinancing~~B Note (as defined ~~below~~herein) ~~are~~and ~~not~~related ~~realized~~agreements ~~when expected or at all, including as a result of the impact of, or problems arising~~ from, ~~the ability of~~ Scilex Holding Company, or Scilex~~, to repay the Notes and the ability of the Company to realize the value of the warrants~~;

● ~~our~~the ~~Profit~~fluctuating ~~Sharing~~market ~~Loan~~price ~~Agreement~~and ~~expose~~liquidity usof tothe ~~potential~~common ~~market,~~stock ~~liquidity,~~of ~~and~~Scilex ~~execution~~underlying ~~risks~~the warrants we hold;

● ~~the~~our JVloan ~~Agreement~~agreements ~~(as~~in ~~defined~~real ~~herein)~~estate ~~includes potential delays and~~projects, ~~indemnification liabilities~~including, ~~and~~but ~~the~~not ~~impact~~limited ofagreements ~~the~~to ~~Spin~~finance ~~Off~~a ~~(as~~real ~~defined~~estate ~~below)~~project, ~~could~~or ~~affect~~Profit ~~our~~Sharing ~~financial~~Loan ~~position~~Agreement, ~~operations,~~expose ~~and~~us ~~ability~~ to ~~realize~~potential ~~anticipated~~market, ~~benefits from the joint venture~~liquidity, ~~or OraTech~~ and ~~Spin~~execution ~~Off~~risks;

●

our various real estate investments involve significant risks and might not provide long-term value appreciation and potential income streams that we expect to receive; as we continue to evaluate our business strategy, including potential structural changes, these investments are intended to enhance financial flexibility and maximize shareholder value.

●

our exposure to potential litigation;

●

our ability to enhance value for our stockholders;

●

the expected development and potential benefits from our products;

●

the prospects of entering into additional license agreements, or other partnerships or forms of cooperation with other companies or medical institutions;

● future milestones, conditions and royalties under our license agreements;

● the potential of the Oravax Medical Inc., or Oravax, vaccine to protect against the coronavirus, or COVID-19, pandemic;

●

future milestones, conditions and royalties under our license agreements;

●

we may not realize a return on our investments in marketable securities that we own.;

●

our ability to recover the value of our investment in Lifeward, including through the senior secured convertible notes, equity consideration, warrants, and revenue-sharing payments to be received in connection with the Lifeward transactions;

●

the expected transfer and clinical development of our POD™ technology platform through OraTech Pharmaceuticals Ltd. following the closing of the Share Purchase Transaction

●

our research and development plans, including preclinical and clinical trials plans and the timing of enrollment, obtaining results and conclusion of trials;

●

our belief that our technology has the potential to deliver medications and vaccines orally that today can only be delivered via injection;

●

the competitive ability of our technology based on product efficacy, safety, patient convenience, reliability, value and patent position;

●

the potential market demand for our products;

●

our ability to obtain patent protection for our intellectual property;

●

our expectation that our research and development expenses will continue to be our major expenditure;

●

our expectations regarding our short- and long-term capital requirements;

●

our outlook for the coming months and future periods, including but not limited to our expectations regarding future revenue and expenses; and

●

information with respect to any other plans and strategies for our business.

Although forward-looking statements in this Annual Report on Form 10-K reflect the good faith judgment of our management, such statements can only be based on facts and factors known by us at the time of such statements. Consequently, forward-looking statements are inherently subject to risks and uncertainties and actual results and outcomes may differ materially from the results and outcomes discussed in or anticipated by the forward-looking statements. Factors that could cause or contribute to such differences in results and outcomes include, without limitation, those discussed herein, including those risks described in “Item 1A. Risk Factors,” and expressed from time to time in our other filings with the Securities and Exchange Commission, or SEC. In addition, historic results of scientific research, clinical and preclinical trials do not guarantee that the conclusions of future research or trials would not suggest different conclusions. Also, historic results referred to in this Annual Report on Form 10-K could be interpreted differently in light of additional research, clinical and preclinical trials results. Readers are urged not to place undue reliance on these forward-looking statements, which speak only as of the date of this Annual Report on Form 10-K. Except as required by law, we undertake no obligation to revise or update any forward-looking statements in order to reflect any event or circumstance that may arise after the date of this Annual Report on Form 10-K. Readers are urged to carefully review and consider the various disclosures made throughout the entirety of this Annual Report on Form 10-K which attempt to advise interested parties of the risks and factors that may affect our business, financial condition, results of operations and prospects.

iii

PART I

ITEM 1. BUSINESS.

Description of Business

We are a pharmaceutical company engaged in the research and development of innovative pharmaceutical solutions with a technology platform that allows for the oral delivery of therapeutic proteins. In addition, we allocate capital to strategic investments in healthcare and life sciences companies that we believe complement our long-term business objectives and technology focus.

We have developed an oral dosage form intended to withstand the harsh environment of the ~~stomach~~gastrointestinal tract and effectively deliver active ~~biological~~ insulin or other proteins. The ~~excipients in the~~ formulation ~~are~~is not intended to modify the proteins chemically or biologically, and the dosage form is designed to be safe to ingest.

OnWe ~~January~~intend ~~11,~~to ~~2023~~initiate, in ~~we announced that~~ the ~~Phase~~second 3half ~~oral~~of ~~insulin trial (ORA-D-013-1) did not meet its primary or secondary endpoints. As a result~~2026, ~~we terminated this trial and~~ a ~~parallel Phase 3~~60-patient, ~~ORA~~US-~~D-013-2~~based clinical trial. Indesigned ~~2023,~~to wevalidate ~~completed~~the anrobustness ~~analysis~~ of ~~the~~our ~~ORA-D-013-1 Phase~~oral 3insulin ~~trial~~formulation in ~~data~~defined ~~and~~patient ~~found~~population. ~~that~~The ~~subpopulations~~trial ofis ~~patients~~designed ~~with~~to ~~pooled~~use ~~specific~~the ~~parameters,~~smallest ~~such~~adequately aspowered ~~body~~patient ~~mass~~population ~~index,~~expected orto ~~BMI,~~obtain ~~baseline~~such ~~HbA1c~~validation ~~and~~in ~~age,~~what ~~responded~~we ~~well~~believe to ~~oral~~be ~~insulin.~~the ~~Based~~shortest ontime ~~this analysis~~possible, onproviding ~~September 12, 2024 we submitted~~ a ~~protocol for a revised Phase 3 (ORA~~cost-~~D-013-3)~~effective ~~clinical~~approach ~~trial~~ to ~~the~~generate ~~U.S.~~additional ~~Food~~compelling evidence and ~~Drug~~refine ~~Administration, or the FDA. We intend to initiate study during 2025. We are additionally examining~~ our ~~existing~~patient ~~pipeline~~selection ~~and~~criteria ~~have~~for ~~commenced~~future ~~an evaluation process of~~ potential ~~strategic~~regulatory ~~opportunities, with the goal of enhancing value for our stockholders~~submissions.

~~On January~~The ~~22,~~trial ~~2024,~~will webe ~~along~~conducted ~~with~~by ~~our wholly-owned subsidiary Oramed Ltd~~OraTech., ~~entered~~For ~~into~~additional ~~a joint venture agreement~~information, ~~or Initial JV Agreement,~~ ~~with~~see ~~Hefei~~note ~~Tianhui~~21 ~~Biotech~~to ~~Co.,~~our ~~Ltd.~~consolidated orfinancial ~~HTIT,~~statements ~~and~~included ~~its~~in ~~subsidiary~~this ~~Technowl~~Annual ~~Limited~~Report ~~or HTIT Sub. OraTech will focus~~ on ~~developing~~Form ~~and commercializing products based on our oral insulin and POD™ technology, utilizing HTIT’s manufacturing capabilities~~10-K.

~~On February~~As 7,part ~~2025,~~of weour ~~and~~business ~~HTIT entered into a Joint Venture Agreement~~strategy, we orcontinuously ~~the~~review JVour ~~Agreement,~~existing ~~amending~~pipeline ~~the~~and ~~Initial~~evaluate JVpotential ~~Agreement~~strategic ~~signed~~opportunities ~~on January~~to ~~22,~~enhance ~~2024.~~stockholder ~~To execute the JV Agreement, we formed OraTech Pharmaceuticals, Inc~~value., ~~or OraTech~~Accordingly, ~~which will serve as the joint venture~~ ~~entity.~~in Weaddition ~~currently~~to ~~hold~~our ~~100%~~core ofpharmaceutical ~~OraTech~~activities, ~~shares.~~we ~~OraTech~~have ~~was~~made ~~formed~~strategic toinvestments ~~advance~~in ~~the~~healthcare ~~development~~ and ~~commercialization~~life ofsciences ~~oral~~companies ~~insulin, combining our proprietary technology~~ and ~~funding with HTIT’s manufacturing capabilities. Through this partnership, OraTech will~~entered ~~have~~into ~~the~~other ~~technology~~investment, ~~resources~~financing, and ~~production~~real ~~capacity~~estate ~~to bring oral insulin to market. The agreement also outlines the spin-off of OraTech~~transactions, oras ~~the~~further ~~Spin~~described ~~Off, requiring regulatory filings and the distribution of the majority of OraTech’s shares held by us to our shareholders~~below. ~~Both we and HTIT agreed to a 120-day lock-up period post-listing, restricting share sales.~~

~~The Initial Closing, set for April 30, 2025, or the Initial Closing, includes an investment of $40,000,000 by~~ HTIT ~~and~~JV $7,500,000 by us into OraTech . Additionally, we will transfer all our intellectual property rights to OraTech. The second closing, contingent on the listing of OraTech’s shares on Nasdaq, involves a $20,000,000 investment by HTIT and an additional $7,500,000 investment by us, or the Second Closing. It is expected to close by May 31, 2025, but no later than September 1, 2025. Upon completion of the Initial Closing and the Second Closing, both HTIT and we will receive OraTech shares, resulting in ownership of 50% for each of HTIT and us, excluding the impact of the contemplated distribution of OraTech shares to our shareholders.Agreement

AsOn January 22, 2024, we along ~~part~~with ofour wholly-owned subsidiary Oramed Ltd., entered into a joint venture agreement, or the Initial JV Agreement, ~~HTIT~~with ~~will~~Hefei ~~receive~~Tianhui Biotech ~~$20~~Co.,~~000~~ Ltd. or HTIT,~~000~~ atand ~~the~~its ~~Initial~~subsidiary ~~Closing~~Technowl ~~and~~Limited ~~$10~~or HTIT Sub.,~~000~~ to establish OraTech,~~000~~ ator the ~~Second~~“JV”. ~~Closing~~OraTech ~~under~~will focus aon ~~supply~~developing ~~agreement with~~and ~~OraTech~~commercializing products based on our oral insulin and POD™ technology, utilizing HTIT’s manufacturing capabilities.

1On February 7, 2025, we and HTIT entered into a Joint Venture Agreement or, the “JV Agreement”, amending the Initial JV Agreement, to advance the development and commercialization of oral insulin by combining our proprietary technology and funding with HTIT’s manufacturing capabilities. The initial closing did not occur due to HTIT failing to satisfy the closing conditions under the JV Agreement and the supplemental agreement. Accordingly, on October 23, 2025, we provided notice of termination of the JV Agreement and the supplemental agreement.

~~2023 Scilex Transaction and 2024 Refinancing~~1

~~2023 Scilex~~Transactions ~~Transaction~~with Scilex

On ~~September~~ 21April 14, ~~2023~~2025, weScilex ~~entered~~Holding ~~into~~Company (“Scilex”) effected a 1-for-35 reverse stock split of its issued and ~~consummated~~outstanding ~~transactions,~~common ~~or,~~stock. ~~collectively,~~The ~~the~~numbers ~~2023~~below ~~Scilex~~reflect ~~Transaction,~~the ~~with~~reverse ~~Scilex~~split, ~~pursuant~~except with respect to the Subsequent Penny Warrants that were outstanding as of the reverse stock split date, which ~~Scilex~~were ~~issued~~not adjustable under the reverse split pursuant to ~~us:~~the terms of such warrants.

a. A senior secured promissory note, or the Tranche A Note, with a principal amount of $101,875,000, maturing on March 21, 2025 and bearing interest of SOFR plus 8.5%, payable in-kind. Scheduled principal payments are due on December 21, 2023, March 21, 2024, June 21, 2024, September 21, 2024, and December 21, 2024, with the balance due on March 21, 2025. In January 2025, we extended Tranche A Note maturity from March 21, 2025 to December 31, 2025. As per the Tranche A Note terms, if the Tranche A Note is not repaid in full on or prior to March 21, 2024, an exit fee of approximately $3,056,000 was. Since the Tranche A Note was not repaid by March 21, 2024, we are entitled to the above-mentioned exit fee at the maturity date of the Tranche A Note. As of March 27, 2025, Scilex ~~has repaid $69,200,000 of the amount due under the Tranche A Note and refinanced $25,000,000 as part of the 2024 Refinancing (as defined below).~~Transaction

b.On Warrants to purchase up to 4,500,000 shares of Scilex common stock with an exercise price of $0.01 per share, or the Closing Penny Warrants, and four additional warrants, or the Subsequent Penny Warrants, each for 2,125,000 shares of Scilex common stock with an exercise price of $0.01 per share. The Closing Penny Warrants vested on September 21, 2023, ~~and~~we ~~each~~entered ofinto ~~the~~and ~~Subsequent~~consummated ~~Penny~~a ~~Warrants~~series ~~vested on each~~ of ~~March 19~~ transactions, ~~2024,~~or ~~June 17, 2024, September 15, 2024 and December 14, 2024. The Closing Penny Warrants and~~ the ~~Subsequent~~“2023 ~~Penny~~Scilex ~~Warrants shall become exercisable on the earliest of (i) March 14~~Transaction”, ~~2025~~with ~~and~~Scilex ~~(ii)~~pursuant ~~the~~to ~~date on~~ which ~~the~~Scilex ~~Tranche~~issued Ato Note has been repaid in full. As of March 27, 2025, the Closing Penny Warrants and the Subsequent Penny Warrants are fully vested. On October 30, 2024, we exercised 4,500,000 Closing Penny Warrants and 2,000,000 Subsequent Penny Warrants that were exercisable at such time. As a result, we hold 6,500,000 shares of common stock of Scilex.us:

ca. ~~Transferred~~A ~~warrants~~senior secured promissory note, or the ~~Transferred~~Tranche ~~Warrants~~A Note, towith ~~purchase~~a 4principal amount of $101,~~000~~875,000, initially maturing on March 21, 2025 and bearing interest of SOFR plus 8.5%, payable in-kind. Scheduled principal payments were due quarterly from December 21, 2023, through December 21, 2024, with the remaining balance due on March 21, 2025. The maturity was subsequently extended to December 31, 2025, in exchange for 92,858 shares of Scilex common stock. ~~with~~An anexit ~~exercise~~fee ~~price~~ of approximately $113,056,000 became payable when the note was not repaid by March 21, 2024.50 ~~per~~Following ~~share~~the Option Agreement (as defined below), ~~fully~~the ~~exercisable~~maturity ~~and~~was ~~expiring~~subsequently onextended ~~November~~to 10March 31, ~~2027~~2026. OnAs ~~September~~of 20March 26, ~~2024~~2026, weScilex ~~sold~~had repaid $69,200,000 of the ~~Transferred~~amount ~~Warrants~~due ~~for~~under ~~consideration~~the ofTranche A Note and refinanced $~~300~~25,000,000 as part of the 2024 Refinancing (~~see~~as defined below). As a result, as of March 26, 2026 the outstanding principal balance of the Tranche A Note is $7,675,000 (approximately $27,884,000 ~~2025~~including weaccrued dointerest ~~not~~and ~~hold~~the ~~any~~exit ~~Transferred~~fee), ~~Warrants~~which is due by March 31, 2026.

~~On September~~b. ~~20,~~Warrants ~~2024~~to purchase up to 128,572 weshares ~~and~~of Scilex ~~entered~~common ~~into~~stock with an ~~extension~~exercise ~~agreement~~price of $0.35 per share, or the ~~Extension~~Closing ~~Agreement~~Penny Warrants, toand ~~extend~~additional warrants or, the ~~due~~“Subsequent ~~date~~Penny Warrants”, for 57,143 shares of Scilex common stock (after giving effect to the ~~September 21~~reverse stock split) and 6,500,000 ~~2024~~shares ~~payment~~of ~~under~~Scilex common stock (which such amount was not adjusted for the ~~Tranche~~reverse Astock ~~Note.~~split ~~Pursuant~~pursuant to the ~~Extension~~terms ~~Agreement~~of such warrants), ~~Scilex~~with ~~paid~~an usexercise price of $20.35 and $0.01 per share,~~000~~ respectively. During 2024,~~000~~ onwe ~~September~~exercised 23128,572 ~~2024~~Closing Penny Warrants and 57,143 ~~which payment~~Subsequent isPenny Warrants. On July 22, 2025, we entered into an option agreement, or the Option Agreement, with Scilex, granting Scilex the right to berepurchase ~~applied~~our asremaining ~~follows:~~6,500,000 ~~(i)~~Subsequent Penny Warrants for an aggregate price of $27,000,000 plus a $1,~~700~~500,000 tofee. ~~the~~In ~~payment~~two ~~due~~separate ~~under~~installments ~~the~~on ~~Tranche~~September A30, ~~Note~~2025 onand ~~March~~December 2130, 2025, Scilex exercised its right under the Option Agreement and ~~(ii)~~repurchased all warrants for total proceeds to us of $~~300~~28,500,000 ~~to purchase~~(including the ~~Transferred~~option fee) by December 31, 2025. As of December 31, 2025, we do not hold any Closing Penny Warrants asor ~~mentioned~~Subsequent ~~above~~Penny Warrants.

c. Transferred warrants to purchase 114,286 shares of Scilex common stock with an exercise price of $402.5 per share, fully exercisable and expiring on November 10, 2027 or, the “Transferred Warrants”. On September 20, 2024 ~~Refinancing~~, we sold the Transferred Warrants for $300,000 (see below). As a result, as of December 31, 2025 we do not hold any Transferred Warrants.

On October 7, 2024, we and certain institutional investors, or the Note B Holders, entered into certain agreements with Scilex, pursuant to which the Note B Holders purchased in a registered offering, or the 2024 Refinancing, (i) a new tranche B of senior secured convertible notes of Scilex in the aggregate principal amount of $50,000,000, or the Tranche B Notes, which Tranche B Notes are convertible into shares of Scilex common stock and (ii) warrants, or the Tranche B Warrants, to purchase up to 7,500,000 shares of Scilex common stock, or Tranche B Warrants. We purchased 50% of Tranche B Note and Tranche B Warrants and therefore hold an aggregate principal amount of $25,000,000 under the Tranche B Note and 3,750,000 Tranche B Warrants.2

~~Scilex received~~2024 from us, in consideration for our part in Tranche B Notes and the Tranche B Warrants issued to us, an exchange and reduction of the principal outstanding balance under the Tranche A Note of $22,500,000.Refinancing

2On October 7, 2024, we and certain institutional investors, or the Note B Holders, entered into certain agreements with Scilex, pursuant to which the Note B Holders purchased in a registered offering, or the 2024 Refinancing, (i) a new tranche B of senior secured convertible notes of Scilex in the aggregate principal amount of $50,000,000, or the Tranche B Note, which Tranche B Note is convertible into shares of Scilex common stock and (ii) warrants, or the Tranche B Warrants, to purchase up to 214,286 shares of Scilex common stock with an exercise price of $36.40. We purchased 50% of the Tranche B Note and the Tranche B Warrants, equal to an aggregate principal amount of $25,000,000 under the Tranche B Note and 107,143 Tranche B Warrants.

~~Royalty~~Scilex received from us, in ~~Purchase~~consideration ~~Agreement~~for our purchase of the Tranche B Note and the Tranche B Warrants issued to us, an exchange and reduction of the principal outstanding balance under the Tranche A Note of $22,500,000.

~~In addition,~~As onof ~~October~~March 826, ~~2024~~2026, weScilex has ~~and~~repaid ~~certain institutional investors~~$13, ~~or the RPA Purchasers~~000,000 ~~entered~~of ~~into a Purchase and Sale Agreement or~~ the ~~RPA~~principal ~~with~~amount ~~Scilex~~outstanding ~~and~~under ~~Scilex Pharmaceuticals Inc., or Scilex Pharma. Pursuant to~~ the ~~RPA,~~Tranche ~~the~~B ~~RPA Purchasers acquired the right to receive~~Note, inleaving ~~the~~a ~~aggregate,~~remaining 8%principal ofbalance ~~net sales worldwide for 10 years~~ of ~~certain purchase receivables~~$12, ~~or the Purchased Receivables with respect to ZTlido (lidocaine topical system) 1.8%~~000, ~~SP-103 (lidocaine topical system) 5.4%, and any related, improved, successor, replacement~~000 orwith ~~varying~~accrued ~~dosage~~interest ~~forms~~ of ~~the~~approximately ~~foregoing~~$495,000. WeThe ~~acquired~~Tranche ~~the~~B ~~right~~Note tomatures ~~receive~~on ~~50%~~October ~~of the Purchased Receivables~~8, ~~as more fully described in the RPA and therefore hold the right to receive 4% royalties~~2026.

~~In consideration~~Royalty ~~for~~Purchase ~~our interest in the Purchased Receivables, we exchanged and reduced $2,500,000 of the principal balance under the Tranche A Note.~~Agreement

~~Following~~In ~~the~~addition ~~refinancing~~to asthe ~~described~~Tranche ~~above~~B Note, on October 8, 2024, we and certain institutional investors, or the RPA Purchasers, entered into a Purchase and Sale Agreement, or the RPA, with Scilex and Scilex Pharmaceuticals Inc., or Scilex Pharma. Pursuant to the RPA, we acquired the right to receive 4% royalties on worldwide net sales of ZTLido, SP-103 and related products for 10 years, in exchange for a reduction of $2,500,000 in the principal balance under the Tranche A Note. In addition, Scilex used $12,500,000 of the net proceeds from the ~~proceeds of the~~ Tranche B Note for the repayment of the outstanding balance under the Tranche A Note.

ZTLido Rest of the World Binding Agreement

~~In addition,~~On on October 8, 2024, we and certain other institutional investors and Scilex entered into a binding term sheet, or the ROW License Term Sheet, ~~regarding~~for a license and development agreement, orrelating ~~the Lido License Agreement, with respect~~ to ~~services,~~ZTlido ~~compositions, products, dosages~~ and ~~formulations comprising~~ lidocaine, ~~including~~products ~~without~~outside ~~limitation,~~ the ~~product~~United ~~and~~States. ~~any~~To ~~future~~implement ~~product~~the ~~defined~~atransaction ascontemplated aby ~~“Product” under~~the ~~Scilex~~ROW ~~Pharma’s~~License ~~existing~~Term ~~(i)~~Sheet, ~~Product~~we ~~Development~~and ~~Agreement,~~the ~~dated~~other institutional asinvestors ofagreed ~~May~~to ~~11,~~operate ~~2011,~~through ~~with~~a ~~Oishi~~joint ~~Koseido Co.~~venture, RoyaltyVest Ltd., or ~~Oishi~~RoyaltyVest, ~~and~~ ~~Itochu~~a ~~Chemical~~company ~~Frontier~~incorporated ~~Corporation,~~in orthe ~~Itochu,~~British Virgin asIslands. ~~amended,~~On ~~and~~February ~~(ii)~~12, ~~the associated Commercial Supply Agreement~~2025, ~~dated~~we ~~February 16,~~were ~~2017,~~transferred ~~between~~50% ~~Scilex,~~of ~~Oishi~~the issued and ~~Itochu,~~outstanding asshares ~~amended~~of RoyaltyVest.

~~Subject to~~On ~~determination~~February of22, 2025, RoyaltyVest entered into a ~~final~~License ~~structure~~Agreement with ~~for~~Scilex (the ~~transactions~~“ZTLido ~~contemplated~~License byAgreement”). Under the ~~ROW~~ZTLido License ~~Term~~Agreement, ~~Sheet~~RoyaltyVest acquired exclusive rights to develop, wemanufacture, ~~anticipate~~and ~~that~~commercialize welidocaine-based products, including ZTLido (lidocaine topical system 1.8%) and ~~such~~SP-103 (the “Product”), ~~institutional~~outside ~~investors~~the ~~will~~United ~~hold~~States. As consideration for the ~~Lido~~rights provided under the ZTLido License Agreement, (a) RoyaltyVest agreed to invest (whether through acash ~~joint~~consideration ~~venture~~or in-kind payment through the provision of services) $200,000 per year toward expanding the Product, (b) Scilex granted RoyaltyVest a worldwide, ~~Inc.~~exclusive right, orlicense and interest to all products rights for the development, out-licensing, commercialization of any Product outside of the United States and other territories, other than certain excluded designated territories, and (c) each of RoyaltyVest and Scilex each receive 50% percent of the net revenue generated from the commercialization of the Produce outside of the United States.

~~In consideration~~Tranche ~~for~~B ~~the~~Note rights to be provided under the proposed Lido License Agreement, as more fully described in the ROW License Term Sheet, (a) RoyaltyVest will invest (whether through cash consideration or in-kind payment through the provision of services) $200,000 per year toward expanding the Product, (b) Scilex will grant RoyaltyVest a worldwide, exclusive right, license and interest to all products rights for the development, out-licensing, commercialization of any Product outside of the United States and other territories, other than certain excluded designated territories , or the ROW Territory, and (c) each of RoyaltyVest and Scilex will receive 50% percent of the net revenue (less expenses) generated from any Product in the ROW Territory. The term sheet is subject to entering into a definitive agreement (signed on February 22, 2025, see below) and subject to the consent of Oishi and Itochu to the Lido License Agreement.Consent

~~Tranche~~On January 2, 2025, we and other Tranche B Noteholders entered into deferral and consent agreements with Scilex or the Tranche B Note Consent, deferring Scilex’s first amortization payment under the Tranche B Note to October 8, 2026. In consideration, we received approximately $877,000 ($500,000 of the principal amount and $376,903 accrued interest) and 71,249 shares of Scilex common stock.

OnA ~~January~~part 2,of ~~2025,~~the weconsideration for ~~and~~providing ~~other~~the Tranche B ~~noteholders~~Note Consent, on February 28, 2025, we entered into ~~deferral~~ a Purchase and ~~consent~~Sale ~~agreements~~Agreement with Scilex, orScilex ~~the~~Pharmaceuticals Inc. ~~Tranche~~and certain other Note B ~~Consent~~Holders, ~~deferring~~pursuant ~~Scilex’s~~to ~~first~~which, ~~amortization~~among ~~payment~~other ~~under~~things, the ~~Tranche B~~applicable Note toB ~~October~~Holders 8received a royalty in respect of 4% of worldwide net sales of Gloperba, ~~2026.~~Elyxyb, Inand ~~consideration~~related products, of which we ~~received~~are ~~approximately~~entitled ~~$877~~to 50% of such royalty payments. Through RoyaltyVest,~~000~~ ~~and~~the 2Note B Holders,~~500~~ were provided the option to fund up to 50% of the cash purchase price for certain ex-US (and,~~000~~ ~~shares~~as to Elyxyb, ex-Canada) product rights to Gloperba and Elyxyb and will receive proportional revenues from commercialization and licensing. As of ~~Scilex~~March 31, ~~common~~2025, ~~stock~~RoyaltyVest exercised its option to Ex-U.S. product rights of Gloperba for $500,000.

~~In addition, as part of the Tranche B Consent and contingent upon certain conditions that were met:~~3

~~1. Scilex and the~~ Tranche B ~~Noteholders~~Note ~~agreed~~Deferral ~~to a 10-year, assignable 4% royalty on global net sales of Gloperba~~ and ~~Elyxyb~~Warrant in certain territories outside of the United States , or RoW, of which, we are entitled to 2% royalties. Gloperba, an oral liquid colchicine formulation for gout, and Elyxyb, an oral solution for acute migraine treatment, represent key assets in Scilex’s portfolio. The definitive agreement was signed on February 28, 2025.Agreement

2.In ~~The~~October 2025, the Company agreed to defer until December 31, 2025, the amortization payment due from Scilex on October 1, 2025, under the amortization schedule included in the Tranche B ~~Noteholders~~Notes. ~~have~~In ~~the~~consideration for ~~option~~such deferral, Scilex agreed to ~~fund~~issue upto us certain warrants to ~~50%~~purchase shares of ~~the~~Scilex’s ~~cash~~common stock, par value $0.0001 per share. Such commitment as memorialized in a letter agreement entered into with Scilex on December 31, 2025. The deferred amortization payment was subsequently paid to us in November 2025. A warrant to purchase 100,000 shares of Scilex common stock at an exercise price ~~for~~of ~~RoW~~$20.00 ~~product~~per ~~rights~~share, was issued to ~~Gloperba~~the ~~and~~Company ~~Elyxyb~~pursuant to ~~(excluding~~a ~~Elyxyb~~Warrant inAgreement ~~Canada)~~entered ~~and~~by ~~will~~the ~~receive~~Company ~~proportional~~and ~~revenues~~Scilex ~~from~~on ~~commercialization~~February ~~and~~19, ~~licensing~~2026.

3Scilex Warrant Agreement

In October 2025, we agreed to defer an amortization payment due from Scilex on October 1, 2025 under the amortization schedule included in the Tranche B Notes. The deferred amortization Apayment ~~Note~~was ~~Maturity~~subsequently ~~Date~~paid ~~Extension~~to ~~Amendment~~us in November 2025. In consideration for this deferral, Scilex agreed to issue to us warrants to purchase 100,000 shares of Scilex’s common stock, par value $0.0001 per share with an exercise price of $20. The warrants were issued on February 19, 2026.

~~On January~~For ~~21,~~additional ~~2025,~~information weregarding ~~entered~~2023 ~~into~~Scilex anTransaction ~~amendment~~and ~~to the Tranche A Note~~2024 Refinancing, orsee ~~the~~note ~~Tranche~~4 ~~A Extension Amendment, extending the maturity date from March 21, 2025,~~ to ~~December~~our ~~31,~~consolidated ~~2025~~financial orstatements ~~the~~included ~~Extended~~in ~~Maturity~~this ~~Date.~~Annual ~~Interest~~Report ~~will continue to accrue and be payable~~ on ~~the~~Form ~~Extended Maturity Date~~10-K. ~~In consideration of the extension, we received 3,250,000 shares of Scilex common stock.~~

~~Lidocaine License Agreement~~BioXcel

AsIn order to diversify our investments as a part of ~~the~~our ~~ROW~~use ~~License~~of ~~Term~~cash ~~Sheet~~strategy, on ~~February~~March 224, 2025, weRoyaltyVest, ~~through~~participated ~~its 50% ownership~~ in ~~RoyaltyVest,~~a ~~entered~~registered ~~into~~direct aoffering ~~license~~by ~~agreement~~BioXcel ~~with~~Therapeutics, ~~Scilex~~Inc. ~~Under~~(Nasdaq: ~~this~~BTAI), ~~agreement~~or BioXcel, ~~RoyaltyVest~~acquiring ~~acquired~~188,383 ~~exclusive~~shares ~~rights~~of toBioXcel’s ~~develop~~common stock, ~~manufacture~~3,811,617 ~~and commercialize lidocaine~~pre-~~based~~funded ~~products,~~warrants ~~including~~and ~~ZTlido~~accompanying ~~(lidocaine~~warrants ~~topical~~to ~~system~~purchase ~~1.8%)~~up ~~and~~to ~~SP-103,~~an inadditional ~~the~~4,000,000 ~~ROW~~shares ~~Territory.~~for Asa ~~part~~total consideration of ~~the arrangement~~$14,000,000. ~~RoyaltyVest~~The ~~and~~warrants ~~Scilex~~have ~~will~~an ~~each~~exercise ~~receive~~price ~~50%~~ of ~~the~~$4.20 ~~net~~per ~~profits~~share, are immediately exercisable, and will expire five years from the ~~commercialization~~date of ~~these products~~issuance. ~~Given~~The ~~our~~pre-funded warrants ~~50%~~have ~~ownership~~an inexercise ~~RoyaltyVest,~~price weof ~~effectively holds~~$0.001 aper ~~25%~~share, inare ~~the~~immediately ~~profits~~exercisable ~~generated~~with ~~under~~no ~~this~~expiration ~~agreement~~date.

BioXcel is a biopharmaceutical company leveraging artificial intelligence to develop innovative medicines in neuroscience and immuno-oncology. Its lead programs focus on treatments for agitation in neuropsychiatric disorders and other central nervous system conditions.

InAs ~~order to diversify our investments as a part~~ of ~~our~~December ~~use of cash strategy~~31, ~~on March 4,~~ 2025, RoyaltyVest wehas ~~participated~~sold ~~in a registered direct offering by BioXcel Therapeutics~~4, ~~Inc. (Nasdaq: BTAI)~~000,000 orshares ~~BioXcel,~~and ~~acquiring~~ 2,~~000~~600,000 ~~shares~~ ~~of BioXcel’s common stock and accompanying~~ warrants tofor ~~purchase up to an additional 2~~$12,~~000~~502,000 ~~shares~~. ~~The~~As ~~shares and warrants were purchased at a combined offering price~~ of ~~$3.50~~December ~~per~~31, ~~share and warrant~~2025, ~~representing~~RoyaltyVest ~~50%~~continues ofto ~~the total 4~~hold 1,~~000~~400,000 ~~shares issued in the offering. The~~ warrants ~~have an exercise price of $4.20 per share, are immediately exercisable,~~ and ~~will~~no ~~expire~~longer ~~five~~holds ~~years~~any ~~from~~shares ~~the date~~ of ~~issuance~~BioXcel common stock.

~~BioXcel is~~Alpha aTau biopharmaceutical company leveraging artificial intelligence to develop innovative medicines in neuroscience and immuno-oncology. Its lead programs focus on treatments for agitation in neuropsychiatric disorders and other central nervous system conditions.Transaction

AsOn April 24, 2025, our wholly-owned subsidiary, Oramed Ltd entered into a share purchase agreement with Alpha Tau Medical Ltd. (Nasdaq: DRTS), or Alpha Tau, a clinical-stage oncology company developing a proprietary alpha-radiation cancer therapy platform known as Alpha DaRT™. Pursuant to the agreement, Oramed Ltd. purchased 14,110,121 ordinary shares, no par value per share, of ~~March~~Alpha 27Tau in a registered direct offering at a price of $2.612 per share, for an aggregate purchase price of approximately $36,900,000. The closing of the transaction occurred on April 28, 2025. In connection with the investment, weOramed Ltd. has the right and have ~~sold~~nominated ~~869~~two directors to Alpha Tau’s board of directors. In addition,~~992~~ ~~shares~~since the share purchase agreement date and ~~continues~~until toDecember 31, 2025, we purchased an additional 359,214 shares of Alpha ~~hold~~Tau for an aggregate amount of $1,~~130~~255,~~008~~781. As of December 31, 2025 and March 26, 2026, we hold an aggregate of 14,469,335 ordinary shares of Alpha Tau, representing approximately 17% of ~~BioXcel~~its ~~common~~outstanding ~~stock~~share capital.

~~Real~~Concurrently, ~~Estate~~we ~~Transactions~~and Alpha Tau entered into a services agreement, or the Service Agreement, pursuant to which we will provide Alpha Tau with investor relations and public relations services. As consideration, Alpha Tau agreed to pay us a non-refundable fee of $3,000,000 over three years and to issue to us warrants to purchase up to 3,237,000 ordinary shares of Alpha Tau at exercise prices ranging from $3.474 to $3.90 per share. The term of the Services Agreement is three years, with limited termination rights.

~~Additionally,~~Alpha asDaRT™ aPlatform ~~part~~and ~~of our cash management strategy, we have engaged in certain real estate transactions.~~Technology

InAlpha ~~January~~Tau’s ~~2025,~~Alpha ~~we entered~~DaRT ~~into~~platform anis ~~agreement~~ designed to ~~acquire~~deliver ahighly ~~parcel~~localized ofalpha ~~land~~radiation inthrough ~~Mevaseret~~intratumoral ~~Zion,~~insertion ~~Israel~~of ~~for~~radium-224 aimpregnated ~~total~~sources ~~purchase~~into ~~price~~solid oftumors. ~~NIS 5,800,000~~When ~~(approximately~~the $1radium decays,~~586,000).~~ ~~The~~its ~~transaction~~short-lived isdaughters ~~structured~~are inreleased ~~installments,~~ and asdisperse ofwhile ~~March~~emitting ~~27,~~high-energy ~~2025,~~alpha weparticles ~~have~~aimed ~~paid~~at ~~approximately $1,210,000~~destroying ~~toward~~tumor ~~the~~cells ~~acquisition~~while ~~price.~~sparing ~~Under~~surrounding ~~the~~healthy ~~agreement,~~tissue. ~~the~~This ~~developer~~approach ispotentially ~~responsible~~offers ~~for~~a ~~executing~~novel ~~all~~treatment ~~development-related~~solution ~~activities, and~~for wepatients ~~and~~with ~~the~~otherwise difficult-to-treat ~~developer~~cancers ~~will~~where ~~share~~conventional ~~the~~external ~~profits~~beam ~~upon~~radiation ~~the~~may ~~future~~be ~~sale of the property~~limited.

On March 24, 2025, we entered into a loan agreement to finance a purchase of a real estate asset in Jerusalem, Israel in the amount of $22,650,000. The loan has a one-year maturity and is secured by a first-ranking mortgage on a property valued at approximately $800,000,000, providing significant collateral coverage. The loan bears an annual interest rate of 12%.4

~~Research and~~Clinical Development Progress

~~Oral~~Alpha Tau is currently conducting an extensive ~~Insulin~~clinical program with five concurrent FDA-approved trials in the United States, alongside additional trials in France, Italy, Israel, and planned studies in the UK:

~~Type 2 Diabetes: We conducted the ORA-D-013-1 Phase 3 trial on patients with type 2 diabetes, or T2D, with inadequate glycaemic control who were on two or three oral glucose-lowering agents~~U. The primary endpoint of the trial was to evaluate the efficacy of our oral insulin capsule, ORMD-0801, compared to placebo in improving glycaemic control as assessed by HbA1c, with a secondary efficacy endpoint of assessing the change from baseline in fasting plasma glucose at 26 weeksS. OnClinical January 11, 2023, we announced that the ORA-D-013-1 Phase 3 trial did not meet its primary or secondary endpoints. Following the results of the ORA-D-013-1 Phase 3 trial, we also terminated the ORA-D-013-2 Phase 3 trial, a second Phase 3 trial that included T2D patients with inadequate glycaemic control who were attempting to manage their condition with either diet alone or with diet and metformin. In 2023, we completed an analysis of the data from the ORA-D-013-1 Phase 3 trial and found that subpopulations of patients with pooled specific parameters, such as BMI, baseline HbA1c and age, responded well to oral insulin. These subsets exhibited an over 1% placebo adjusted, statistically significant, reduction in HbA1c. Based on this analysis, on September 12, 2024 we submitted a protocol for a revised Phase 3 (ORA-D-013-3) clinical trial to the FDA. We intend to initiate this study during 2025. We are additionally examining our existing pipeline and have commenced an evaluation process of potential strategic opportunities, with the goal of enhancing value for our stockholders.Trials:

4● ReSTART Pivotal Trial (Recurrent SCC Treatment with Alpha DaRT Radiation Therapy): A multi-center pivotal study in patients with recurrent cutaneous squamous cell carcinoma (cSCC), the second most common form of skin cancer. As of January 2026, Alpha Tau targeted completion of patient recruitment in Q1 2026 and has begun submitting modules of its Modular Pre-Market Approval (PMA) application to the FDA, with expected completion of the full submission by year-end 2026.

~~Joint Venture~~● ~~Agreement~~IMPACT Study (Intratumoral Pancreatic Alpha Combination Trial): AsA ~~mentioned~~multi-center ~~above,~~pilot onstudy ~~February~~in 7,newly-diagnosed ~~2025,~~pancreatic wecancer ~~entered~~patients ~~into~~combining JVAlpha ~~Agreement~~DaRT with ~~HTIT~~chemotherapy. ~~The~~Alpha ~~collaboration~~Tau ~~combines~~reported ~~our POD~~encouraging ~~technology~~data ~~with~~from ~~HTIT’s~~its ~~manufacturing~~first-in-human ~~capabilities~~pancreatic cancer studies in Canada and Israel, ~~creating~~including apositive ~~synergy.~~results ~~This~~presented ~~integration~~at ofthe ~~technology~~2026 ~~and~~ASCO ~~manufacturing~~Gastrointestinal ~~expertise will~~Cancers ~~enable~~Symposium. usAlpha toTau ~~ensure~~is ~~consistent,~~targeting ~~high-quality~~completion ~~production~~of atpatient ~~scale~~accrual by the end of Q1 2026, ~~setting~~with ~~new~~initial ~~standards~~results ~~for~~expected ~~oral~~by ~~protein~~year-end ~~delivery~~2026.

~~OraTech is~~● ~~backed~~GBM byFeasibility aStudy: ~~substantial~~A ~~capital~~study ~~and~~in ~~operational~~patients ~~commitment.~~with ~~These~~recurrent ~~resources~~glioblastoma ~~support~~multiforme ~~the~~(GBM), ~~initiation of~~ a ~~Phase~~highly 3aggressive ~~clinical~~malignant ~~trial~~brain ~~in the U~~tumor.S. AsAlpha ~~mentioned~~Tau ~~above,~~announced bytreatment ~~leveraging~~of ~~insights~~its ~~from~~first ~~prior~~patient ~~clinical~~at ~~studies,~~Ohio weState ~~have~~University ~~strategically~~and ~~designed~~expects ~~this~~initial ~~refined~~results ~~Phase~~around ~~3 trial to focus on key patient subpopulations that we believe have~~ the ~~highest~~end ~~potential~~of toQ4 ~~demonstrate efficacy~~2026.

~~Oral Vaccine~~● Recurrent Prostate Cancer Pilot Study: A pilot study in patients with locally recurrent prostate cancer.

~~On March~~● ~~18,~~Immunocompromised ~~2021,~~cSCC weStudy: ~~entered~~A ~~into a license agreement with Oravax, a 63% owned joint venture to commercialize oral vaccines for COVID~~multi-~~19 and~~center ~~other~~study ~~novel~~in ~~coronaviruses~~immunocompromised ~~based~~patients onwith ~~Premas Biotech Pvt~~cSCC. ~~Ltd.’s proprietary vaccine technology involving a triple antigen virus like particle.~~

In ~~October~~ ~~2022~~addition, ~~Oravax~~Alpha ~~reported~~Tau ~~positive~~is ~~preliminary~~engaged ~~Phase~~in 1pre-clinical research ~~data~~partnerships ~~for~~with ~~Cohort~~leading Aacademic ofinstitutions aincluding ~~Phase~~Mayo 1Clinic, ~~clinical~~McGill ~~trial~~University, ~~meeting~~Emory ~~primary~~University, orand ~~secondary~~MD Anderson ~~endpoints~~Cancer ofCenter, ~~safety~~exploring ~~and~~combinations ~~immunogenicity~~with immunotherapy. ~~These~~Alpha ~~results~~Tau ~~included~~has ~~significant~~also ~~antibody~~reported ~~response~~encouraging ~~(2-6~~interim ~~fold~~data ~~over~~from ~~baseline)~~a asclinical ~~measured by~~study ~~multiple~~in ~~markers~~Israel ofexamining ~~immune~~the ~~response~~combination toof ~~virus~~Alpha ~~like~~DaRT ~~particle~~with ~~vaccine~~checkpoint ~~antigens~~inhibitor ~~observed~~therapeutics infor ~~the~~patients ~~majority~~with oflocally ~~the~~advanced ~~patients~~or ~~dosed,~~metastatic head and noneck ~~safety issues~~squamous ~~were~~cell ~~observed~~carcinoma, ~~including~~and ~~mild~~is ~~symptoms.~~exploring ~~Cohort~~the Bpossibility ~~completed~~of ~~dosing~~conducting ina ~~January~~sixth ~~2023~~U. ~~Cohort B measured Immunoglobulin G, or IGG, against the spike (~~S). ~~protein,~~trial ~~showing positive IGG~~ in ~~approximately~~this ~~55% of the patients dosed~~indication. ~~We are currently evaluating our path forward for Oravax’s oral vaccines for COVID-19.~~

~~Impact of~~Regulatory ~~Current~~and ~~Events~~Commercial Progress

OnIn ~~October~~addition 7,to ~~2023,~~ the ~~State~~ongoing ofFDA ~~Israel~~engagement ~~was attacked by Hamas, a group~~for ~~designated~~its asU.S. aclinical ~~terrorist organization by the United States~~programs, ~~and~~Alpha ~~the~~Tau ~~State~~has ofreported ~~Israel subsequently declared war on Hamas. Since~~ that ~~time, Israel~~it ~~has~~is ~~been~~anticipating ~~engaged in~~ a ~~multi-front~~response ~~armed~~from ~~conflict~~Japan’s ~~with~~Ministry ~~combatants~~of ~~located in Gaza~~Health, ~~the~~Labour ~~West Bank, Syria, Iran, Lebanon~~ and ~~Yemen.~~ ~~The~~Welfare ~~situation~~regarding inits ~~the~~application ~~region~~for ~~remains~~approval ~~volatile and the possibility~~ of ~~renewed~~Alpha ~~conflicts~~DaRT ~~persist.~~in Asthe treatment of ~~March~~recurrent ~~27,~~head ~~2025,~~and weneck ~~believe that there is no immediate risk to our business operations related to these events. For further information~~cancer, ~~see~~which ~~“Item~~would ~~1A.~~mark ~~Risk Factors,”~~Alpha ~~under~~DaRT’s ~~“We~~first ~~are~~commercial ~~affected~~approval byoutside ~~the political, economic and military risks~~ of ~~having~~Israel ~~operations~~if ~~in Israel~~granted.”

~~Real~~On the manufacturing front, Alpha Tau has received ~~Estate~~a ~~Investments~~radioactive materials license for its Hudson, New Hampshire facility and is currently equipping the facility for Alpha DaRT manufacturing to support commercial readiness and scale-up operations.

OnStrategic ~~November~~Overview 7, 2024, our Board of Directors, or the Board, approved investments of up to $10,000,000 in real estate assets. This decision aligns with our strategic approach to capital allocation, leveraging opportunities in the current real estate market where we have identified attractive investment prospects. With interest rates expected to decline and valuations presenting favorable entry points, the Board believes these investments could provide long-term value appreciation and potential income streams, further strengthening our financial position. As we continues to evaluate our business strategy, including potential structural changes, these investments are intended to enhance financial flexibility and maximize shareholder value. On February 13, 2025, the Board approved increasing the real estate investments to up to $30,000,000.Rationale

~~Diabetes~~Alpha Tau has demonstrated encouraging clinical ~~Market~~progress ~~Overview~~across multiple difficult-to-treat cancer types, including pancreatic cancer, head and neck cancer, and skin cancer, with interim data showing disease control and early signals of clinical benefit. With five concurrent FDA-approved trials in the U.S., ongoing regulatory dialogue with the FDA, potential near-term regulatory approval in Japan, and advancement toward PMA submission for its pivotal skin cancer trial, Alpha Tau is entering a critical phase of clinical validation and regulatory progression. The company’s innovative alpha-radiation platform, combined with its expanding clinical footprint across multiple solid tumor types and growing manufacturing capabilities, represents what we believe to be a compelling investment opportunity in the oncology therapeutics space.

~~Diabetes is~~ aPelthos ~~disease~~Therapeutics ~~in which the body does not produce or properly use insulin~~Inc. Insulin is a hormone that causes sugar to be absorbed into cells, where the sugar is converted into energy needed for daily life. The cause of diabetes is attributed both to genetics (type 1 diabetes, or T1D) and, most often, to environmental factors such as obesity and lack of exercise (T2D). According to the International Diabetes Federation, or IDF, approximately 537 million adults (20-79 years) worldwide suffered from diabetes in 2021 and the IDF projects this number will increase to 783 million by 2045. According to the American Diabetes Association, or ADA, in 2023, the United States there were approximately 37 million people with diabetes. Diabetes is a leading cause of blindness, kidney failure, heart attack, stroke and amputation.

5On July 1, 2025, we purchased 150,000 shares of common stock of Pelthos Therapeutics Inc, or Pelthos, for an aggregate amount of $1,500,000. Subsequent to December 31, 2025 and through March 26, 2026, we sold 6,577 shares of Pelthos common stock of for aggregate proceeds of approximately $173,000. Following these sales, we hold 143,423 shares of Pelthos common stock.

~~Intellectual Property and Patents~~ 5

~~We own~~Nano aDimension ~~portfolio of patents and patent applications covering our technologies, and we are aggressively protecting these technology developments on a worldwide basis~~Ltd.

WeAs of December 31, 2025, ~~maintain~~we apurchased ~~proactive~~an ~~intellectual~~aggregate ~~property~~of ~~strategy~~5,436,791 ~~which~~ordinary ~~includes~~shares, ~~patent~~par ~~filings~~value inNIS ~~multiple~~5.00 ~~jurisdictions~~per share or, ~~including~~“Nano ~~the~~Ordinary ~~United~~Shares”, ~~States~~of Nano ~~and~~Dimension ~~other~~Ltd., ~~commercially~~or ~~significant~~Nano, ~~markets.~~for Wean ~~hold~~aggregate 26amount ~~patent~~of ~~applications~~approximately ~~currently~~$8,501,000. ~~pending~~Subsequent to December 31, ~~with~~2025 ~~respect~~and tothrough ~~various~~March ~~compositions~~26, ~~methods~~2026, we purchased an additional 6,401,939 of ~~production~~Nano ~~and~~ordinary ~~oral~~shares ~~administration~~for an aggregate purchase price of ~~proteins~~approximately $12,308,000 and ~~exenatide.~~we ~~Expiration~~sold 1,269,987 ~~dates~~ordinary shares of Nano for ~~pending~~aggregate ~~patents~~proceeds of approximately $2,606,000. ifFollowing ~~granted~~these transactions, ~~will~~we ~~fall~~hold ~~between~~an aggregate of 10,568,743 Nano ordinary shares, representing approximately 5.02% of its outstanding shares as of March 26, 2026, ~~and~~based ~~2039~~on 210,334,767 Nano Ordinary Shares outstanding as of October 14, 2025, as reported in a Report of Foreign Private Issuer on Form 6-K filed with the SEC on December 4, 2025.

We ~~hold~~ ~~140 patents~~have, ~~eight~~and ofintend ~~which~~to ~~were~~in ~~issued during~~ the ~~year ended December 31~~future, ~~2024,~~engage ~~including~~in ~~patents~~discussions ~~issued~~with ~~by the United States,~~Nano’s ~~Swiss~~management, ~~German,~~members ~~French,~~of ~~U.K.,~~Nano’s ~~Italian,~~board ~~Netherlands,~~of ~~Swedish~~directors, ~~Spanish,~~and/or ~~Australian,~~other ~~Israeli,~~shareholders ~~Japanese,~~of ~~New~~Nano ~~Zealand~~concerning, ~~South~~among ~~African,~~other ~~Russian~~things, Nano’s ~~Canadian~~performance, ~~Hong~~the ~~Kong,~~market ~~Chinese,~~price ~~European~~of ~~and~~the ~~Indian~~Nano ~~patent~~Ordinary ~~offices~~Shares ~~that~~relative ~~cover~~to athe ~~part~~value of ~~our~~Nano’s ~~technology~~assets, ~~which~~potential ~~allows~~financing options for Nano, ~~the~~Nano’s ~~oral~~business ~~delivery of~~strategy, ~~proteins;~~potential ~~patents~~transactions ~~issued~~and byother ~~the~~issues ~~Australian,~~for ~~Canadian,~~the ~~European,~~betterment ~~Austrian,~~of ~~Belgian,~~Nano. ~~French,~~We ~~German,~~intend ~~Irish,~~to ~~Italian,~~engage ~~Luxembourg,~~in ~~Monaco,~~discussions ~~Netherlands,~~with ~~Norwegian,~~Nano ~~Spanish,~~and ~~Swedish,~~other ~~Swiss,~~shareholders ~~U.K.,~~thereof ~~Israeli,~~regarding ~~New~~the ~~Zealand,~~management ~~South~~of ~~African,~~Nano ~~Russian,~~and ~~Brazilian~~to ~~and~~recommend ~~Japanese~~changes ~~patent~~to ~~offices that~~the ~~cover~~composition ~~part~~of the board of directors ~~our~~and ~~technology~~expect ~~for~~to ~~the~~subsequently ~~oral~~have ~~delivery~~further ofdiscussion ~~exenatide;~~with ~~and~~Nano’s ~~patents~~management ~~issued~~and byboard ~~the~~of ~~European,~~directors ~~Austrian,~~covering ~~Belgian,~~board ~~Denmark,~~composition ~~French,~~as ~~German,~~well ~~Irish,~~as ~~Italian,~~a ~~Luxembourg,~~broad ~~Monaco,~~range ~~Netherlands,~~of ~~Norway,~~subjects ~~Spanish,~~relative ~~Swedish,~~to ~~Swiss~~performance, ~~U.K.~~strategic ~~and~~direction, ~~Japanese~~shareholder ~~patent~~value ~~offices~~and ~~for treating~~governance ~~diabetes~~of Nano.

~~Consistent~~ Transactions with our strategy to seek protection in key markets worldwide, we have been and will continue to pursue the patent applications and corresponding foreign counterparts of such applications. We believe that our success will depend on our ability to obtain patent protection for our intellectual property.Lifeward

~~Our patent~~Secured ~~strategy~~Promissory ~~is as follows:~~Note

●On ~~Aggressively~~November ~~protect~~14, ~~all~~2025, ~~current~~in anticipation of the transactions contemplated by the Lifeward Share Purchase Agreement and ~~future~~the ~~technological~~Lifeward ~~developments~~Notes Purchase Agreement described below, we entered into a loan agreement with Lifeward Ltd. or “Lifeward” pursuant to ~~assure~~which ~~strong~~we ~~and~~provided ~~broad~~Lifeward ~~protection~~with bya ~~filing~~$3,000,000 secured ~~patents~~promissory note bearing interest at 15% per annum and/ maturing on May 14, 2026, unless earlier repaid or ~~continuations~~converted in ~~part~~accordance aswith ~~appropriate,~~its terms. The note is secured by a lien on Lifeward’s cash and accounts receivable.

●The principal ~~Protect~~and ~~technological~~accrued ~~developments~~interest atunder ~~various~~the ~~levels,~~note inare convertible into Lifeward ordinary shares at a ~~complementary~~conversion ~~manner~~price of $5.40 per share, reflecting ~~including~~Lifeward’s ~~the~~12-for-1 ~~base~~reverse ~~technology~~share split effected on February 24, as2026, ~~well~~which asadjusted ~~specific~~the ~~applications~~original conversion price of ~~the~~$0.45 ~~technology,~~per ~~and~~share.

●On ~~Establish~~February ~~comprehensive~~12, ~~coverage~~2026, inwe agreed ~~the~~to ~~United~~provide ~~States~~Lifeward with an additional secured promissory note with an initial principal amount of $525,000, which may be increased by up to an additional $975,000, bearing interest at 24% per annum and insecured ~~all~~by ~~relevant~~a ~~foreign~~lien ~~markets~~on inLifeward’s ~~anticipation~~cash. As of ~~future~~March ~~commercialization~~26, 2026, ~~opportunities~~we had funded $1,025,000 under this additional note.

~~Trademarks~~The outstanding principal and ~~Trade~~accrued ~~Secrets~~interest under the secured promissory notes are expected to be rolled into the Initial Notes issued under the Lifeward Notes Purchase Agreement described below.

~~We have~~Lifeward ~~trademark~~Share ~~applications~~Purchase pending in Israel, with Corresponding international trademark applications in Australia, Brazil, Canada, China, Colombia, the European Union, India, Indonesia, Japan, Kazakhstan, Korea, Malaysia, Mexico, New Zealand, Norway, Oman, Philippines, Russia, Singapore, Switzerland, Thailand, Turkey, Ukraine, United Arab Emirates, United Kingdom, U.S.A., Uzbekistan and Vietnam.Agreement

~~We also~~On ~~rely~~January ~~on trade secrets and unpatentable know-how that we seek to protect~~12, ~~in part~~2026, bywe ~~confidentiality~~entered ~~agreements.~~into ~~Our~~a ~~policy~~Share isPurchase ~~to require~~Agreement ~~our employees~~or, ~~consultants, contractors, manufacturers, outside scientific collaborators and sponsored researchers, our Board,~~ ~~technical review board and other advisors, to execute confidentiality agreements upon~~ the ~~commencement~~“Lifeward ofShare ~~employment~~Purchase orAgreement” ~~consulting relationships~~ with ~~us.~~Lifeward ~~These~~and ~~agreements~~OraTech ~~provide~~pursuant ~~that~~to ~~all~~which ~~confidential~~Lifeward ~~information~~agreed ~~developed or made known~~ to ~~the~~acquire ~~individual~~all ~~during the course~~ of the ~~individual’s~~outstanding ~~relationship~~equity ~~with~~interests usof isOraTech tofrom beus ~~kept~~or ~~confidential~~the ~~and~~“Share ~~not~~Purchase ~~disclosed to third parties except in specific limited circumstances~~Transaction”. We ~~also~~Prior ~~require signed confidentiality or material transfer agreements from any company that is~~ to ~~receive our confidential information. In~~ the ~~case of employees~~closing, ~~consultants~~we ~~and~~transferred to ~~contractors,~~Oratech ~~the agreements provide that~~ all ~~inventions~~intellectual ~~conceived~~property byand ~~the~~related ~~individual~~assets ~~while~~relating ~~rendering services~~ to usour ~~shall~~POD™ be(Protein ~~assigned~~Oral toDelivery) ustechnology ~~as the exclusive property of the Company. There can be no assurance~~platform, ~~however, that all persons~~together ~~who~~with wecash ~~desire~~ to ~~sign~~fund ~~such~~the ~~agreements~~next ~~will~~planned ~~sign,~~clinical ortrial ifand ~~they~~related ~~do,~~development ~~that~~activities. ~~these~~As ~~agreements~~a ~~will~~result, ~~not~~commencing beon ~~breached,~~the ~~that~~closing wedate ~~would~~of ~~have adequate~~March ~~remedies~~25, ~~for any breach~~2026, orresearch ~~that~~and ~~our~~development ~~trade~~expenses ~~secrets or unpatentable know-how~~ will ~~not otherwise become known or~~ be ~~independently~~borne ~~developed~~ by ~~competitors~~Oratech.

6In consideration for the acquisition of OraTech, Lifeward issued to us: (i) Lifeward Ordinary Shares and pre-funded warrants to purchase Lifeward Ordinary Shares representing up to 49.99% of Lifeward’s fully diluted equity capitalization at closing, subject to adjustments, which such the Lifeward Ordinary Shares issued at closing represented less than 45.0% of the outstanding Lifeward Ordinary Shares at closing; (ii) warrants to purchase Lifeward Ordinary Shares equal to the quotient of Lifeward’s net cash at closing divided by an exercise price of $5.40 per share, reflecting Lifeward’s 12-for-1 reverse share split effected on February 24, 2026 (which adjusted the original exercise price of $0.45 per share), subject to adjustments or, the “Share Purchase Warrants”; and (iii) revenue-sharing payments equal to 4% of the net revenue from Lifeward’s ReWalk Personal Exoskeleton products and related extended warranties for up to 10 years following closing, subject to certain caps and early termination upon the occurrence of specified events.

~~Out-Licensed Technology~~6

~~Entera~~The closing of the Share Purchase Transaction was subject to customary ~~Bio~~closing conditions, including the approval of Lifeward’s shareholders for the issuance of more than 19.99% of Lifeward Ordinary Shares in accordance with Nasdaq listing standards. Such shareholder approval was obtained on March 12, 2026. The closing of the Share Purchase Transaction took place on March 25, 2026.

In ~~June~~ ~~2010~~connection with the transaction, Lifeward ~~our~~agreed ~~wholly~~to file a resale registration statement with the SEC covering the Lifeward Ordinary Shares issued in the transaction and those issuable upon exercise of the pre-~~owned~~funded ~~subsidiary~~warrants and warrants described above as soon as practicable following closing, ~~Oramed~~but no ~~Ltd.~~later than 75 days after closing, ~~entered~~and ~~into~~to ause ~~joint~~commercially ~~venture~~reasonable ~~agreement~~efforts ~~with~~to ~~DNA~~have ~~GROUP~~such ~~(T.R.)~~registration ~~Ltd.~~statement ~~(formerly~~declared ~~D.N.A~~effective ~~Biomedical~~within ~~Solutions~~75 ~~Ltd.),~~days after closing (or ~~DNA,~~105 ~~for~~days in the ~~establishment~~event of ~~Entera~~a ~~Bio~~full ~~Ltd.,~~SEC ~~or Entera~~review).

~~In March~~Pre-Funded ~~2011,~~Warrants ~~Oramed~~and ~~Ltd.~~Share ~~sold~~Purchase shares of Entera to DNA, retaining 117,000 ordinary shares (after giving effect to a stock split by Entera in July 2018). In consideration for the shares sold to DNA, the Company received, among other payments, ordinary shares of DNA (see also note 3 to our audited consolidated financial statements).Warrants

~~As part~~The ofShare ~~this~~Purchase ~~agreement,~~Warrants ~~Oramed~~were ~~Ltd.~~immediately ~~entered~~exercisable ~~into~~upon ~~a patent transfer agreement, or the Patent Transfer Agreement, according to which Oramed~~issuance ~~Ltd.~~at ~~assigned~~an toinitial ~~Entera~~exercise ~~all~~price of ~~its~~$5.40 ~~rights~~per ~~to a patent application related to the oral administration of proteins that it has licensed to Entera since August 2010~~share, inreflecting ~~return for royalties of 3% of Entera~~Lifeward’s ~~net~~12-for-1 ~~revenues~~reverse ~~and~~share asplit ~~license~~effected ~~back~~on ofFebruary ~~that~~24, ~~patent application~~2026 ~~for~~(which ~~use~~adjusted inthe ~~respect~~original ofexercise ~~diabetes~~price ~~and influenza. As~~ of ~~December 31, 2024, Entera had not paid any royalties to Oramed Ltd~~$0.45 ~~During~~per ~~the years ended December 31~~share), ~~2024~~ and ~~2023,~~expire wefive ~~did~~years ~~not~~from ~~sell~~the ~~any~~date of ~~DNA’s ordinary shares~~issuance. AsThe ofexercise ~~December~~price ~~31, 2024, we held approximately~~is ~~1.4%~~subject ofto ~~DNA’s~~customary ~~outstanding~~anti-dilution ~~ordinary shares and approximately 0~~adjustments.~~3% of Entera’s outstanding ordinary shares.~~

~~HTIT~~The Pre-Funded Warrants have an exercise price of $0.0012 per share (reflecting the reverse-split adjusted price of the original $0.0001 per share), subject to customary adjustments, and will remain exercisable until exercised in full.

~~On November~~We ~~30,~~may ~~2015,~~not weexercise ~~entered~~any ~~into~~portion aof ~~Technology~~the ~~License~~Pre-Funded Warrants ~~Agreement,~~ or ~~TLA,~~Share ~~with~~Purchase ~~HTIT~~Warrants ~~and~~to ~~on December 21, 2015, these parties entered into an Amended and Restated Technology License Agreement that was further amended by~~ the ~~parties~~extent ~~on June 3~~that, ~~2016~~after ~~and~~giving ~~July~~effect ~~24, 2016, or the HTIT License Agreement. According~~ to ~~the~~such ~~HTIT License Agreement~~exercise, we ~~granted~~and ~~HTIT~~our anaffiliates ~~exclusive~~would ~~commercialization~~beneficially own ~~license~~more inthan ~~the territory~~45.0% of the ~~People’s~~outstanding ~~Republic~~Lifeward ofOrdinary ~~China, Macau and Hong Kong, related to our oral insulin capsule, ORMD-0801, or the Product~~Shares. ~~Pursuant~~ toThis ~~the~~limitation ~~HTIT License Agreement, HTIT~~ will ~~conduct,~~automatically atincrease ~~its own expense, certain pre-commercialization and regulatory activities with respect~~ to ~~our~~49.99% ~~technology~~once ~~and ORMD-0801 capsule, and will pay~~ (i) ~~royalties of 10% on net sales of~~ the ~~related commercialized products~~Investors tono belonger ~~sold~~hold byany ~~HTIT~~Notes ~~in the territory, or Royalties,~~ and (ii) anthe ~~aggregate~~Investors ofhave ~~$37,500,000,~~sold ofall ~~which~~Note ~~$3,000,000~~Shares ~~was~~issued ~~payable~~or ~~immediately, $8,000,000~~issuable ~~will be paid subject to our entry into certain agreements with certain third parties, and $26,500,000 will be payable~~ upon ~~achievement~~ conversion of ~~certain~~the ~~milestones~~Notes and ~~conditions. In the event that we will not meet certain conditions, the Royalties rate may be reduced~~related ~~to a minimum of 8%~~warrants. ~~Following~~We ~~the final expiration of our patents covering the technology in the territory in 2033, the Royalties rate~~ may beincrease ~~reduced, under certain circumstances, to 5%. The royalty payment obligation shall apply during~~ the ~~period~~beneficial ofownership ~~time~~limitation ~~beginning~~ upon ~~the~~ ~~first~~at ~~commercial~~least ~~sale~~61 ofdays’ ~~the~~prior ~~Product~~notice ~~in the territory, and ending upon the later of (i) the expiration of the last-~~to~~-expire~~ ~~licensed patents in the territory~~Lifeward; ~~and~~provided ~~(ii)~~that, 15for so ~~years~~long ~~after~~as ~~the~~certain ~~first~~Lifeward ~~commercial~~warrants ~~sale~~outstanding as of the ~~Product~~issuance indate ~~the territory. The HTIT License Agreement shall~~ remain inoutstanding, ~~effect~~any ~~until~~such ~~the~~increase ~~expiration~~will ofrequire ~~the royalty term. The HTIT License Agreement contains customary termination provisions.~~Lifeward’s ~~Through December 31~~consent, ~~2024,~~which wemay ~~received~~not ~~aggregate~~be ~~milestone~~unreasonably ~~payments of $20~~withheld,~~500,000~~ ~~out~~conditioned ofor ~~the aggregate amount of $37,500,000~~delayed.

OnIn connection with the execution ~~August~~of ~~21,~~the ~~2020~~Lifeward Share Purchase Agreement, we ~~received~~entered into a ~~letter~~lock-up ~~from~~agreement ~~HTIT,~~for ~~disputing~~a ~~certain~~period ~~pending~~of ~~payment~~120 ~~obligations~~days ofafter ~~HTIT~~the ~~under~~Closing, without the prior ~~TLA~~written consent of Lifeward.

~~Pursuant to~~Clinical ~~the~~Trial ~~terms~~Management ~~of the JV~~ Agreement, each of us, HTIT and HTIT Sub, irrevocably released and waived (i) any claims and demands against each other party in connection with the TLA; and (ii) all rights, obligations and liabilities set out and arising with respect to the performance of the TLA.

~~HTIT~~In connection with the Lifeward Share Purchase Agreement we agreed ~~has~~to ~~submitted~~enter into a ~~Marketing~~clinical ~~Authorization~~trial ~~Application~~management or, the “Clinical Trial Management Agreement” with Oratech, pursuant to ~~China’s~~which ~~regulators~~we agreed ~~for~~to manage the clinical study of Oratech’s investigational oral insulin capsule inproduct ~~China~~or, the “Study”, including providing clinical trial management and administrative services through study completion or, the “Services”. ~~Since~~In consideration for the ~~TLA~~Services, ~~was~~OraTech ~~novated~~will reimburse us for all reasonable out-of-pocket expenses actually incurred by us in providing the Services toand payments made on behalf of OraTech to third parties and vendors, ~~OraTech~~such isas ~~expected~~clinical sites, if applicable, subject to ~~receive~~certain ~~royalties~~limitations and ~~from~~maximum ~~any~~payments ~~future~~as ~~sales~~set forth in ~~China~~the Clinical Trial Management Agreement. The Clinical Trial Management Agreement will terminate upon completion of the Study unless earlier terminated in accordance with the terms set forth therein.

~~Oravax License~~Notes Securities Purchase Agreement

On ~~March~~ 18January 12, ~~2021~~2026, we entered into a ~~license~~Securities Purchase ~~agreement,~~Agreement or, the ~~Oravax~~“Lifeward ~~License~~Notes Purchase Agreement,” with ~~Oravax,~~Lifeward aand ~~63%~~other ~~owned~~investors ~~joint~~pursuant ~~venture~~ to ~~commercialize oral~~which ~~vaccines~~we ~~for~~agreed to ~~COVID-19~~purchase, ~~and~~in ~~other~~a ~~novel~~private ~~coronaviruses~~placement, ~~based~~up onto ~~Premas~~$18,000,000 ~~Biotech~~of ~~Pvt.~~senior ~~Ltd.’s~~secured ~~proprietary~~convertible ~~vaccine~~notes ~~technology involving~~issued aby ~~triple~~Lifeward, ~~antigen~~together ~~virus~~with ~~like~~accompanying ~~particle,~~warrants orto ~~the~~purchase ~~Oravax~~Lifeward ~~product~~Ordinary Shares.

~~In consideration~~At ~~for~~ the ~~grant~~initial ~~of the license under the Oravax License Agreement~~closing, wewhich ~~will~~occurred ~~receive (i) royalties equal to 7.5%~~ on ~~net~~March ~~sales~~25, as ~~defined in the Oravax License Agreement~~2026, ofwe ~~each product commercialized by Oravax, its affiliates and permitted sublicensees related~~agreed to ~~the~~purchase license during the term specified in the Oravax License Agreement, (ii) sublicensing fees equal to 15% of any non-sales-based consideration received by Oravax from a permitted sublicensee and (iii) other payments ranging between $259,000,000 toaggregate ~~$100,000,000,~~principal ~~based on~~amount ~~certain~~of ~~sales~~such ~~milestones~~notes ~~being~~or, ~~achieved~~the by“Initial ~~Oravax~~Notes”. The ~~parties~~Initial ~~further~~Notes ~~agreed~~bear tointerest ~~establish~~at 8% aper ~~development~~annum, ~~and~~payable ~~steering committee~~semi-annually, ~~which will~~and ~~consist~~mature of three ~~members,~~years offrom ~~which~~the ~~two~~date ~~members~~of ~~will~~issuance. beThe ~~appointed~~Initial byNotes ~~us,~~are ~~that~~convertible ~~will~~into ~~oversee the ongoing research, development, clinical~~Lifeward ~~and~~Ordinary ~~regulatory~~Shares ~~activity~~at ~~with~~an ~~respect~~initial toconversion ~~the~~price ~~Oravax~~of ~~product~~$5.40 Inper ~~addition~~share, wereflecting ~~agreed~~Lifeward’s to12-for-1 ~~buy~~reverse ~~and~~share ~~Oravax~~split ~~agreed~~effected ~~to issue to us 1,890,000~~on ~~shares~~February ~~of common stock of Oravax~~24, ~~representing~~2026 ~~63%~~(which ofadjusted the ~~common~~original ~~stock~~conversion ofprice ~~Oravax for the aggregate amount~~ of $~~1,500,000~~0.45 ~~Akers~~per ~~Biosciences Inc. contributed $1~~share),~~500,000~~ insubject ~~cash~~ to ~~Oravax~~customary ~~and~~anti-dilution ~~a license agreement to the Oravax product~~adjustments.

~~Medicox~~We also agreed to purchase an additional $9,000,000 ~~License~~aggregate principal amount of notes or, the “Additional Notes” and together with the Initial Notes, or, the “Notes”, together with accompanying warrants, on substantially the same terms as the Initial Notes.

~~On November~~The ~~13,~~closing ~~2022, we entered into a distribution license agreement with Medicox Co., Ltd., or Medicox, an emerging biotech company with a consortium~~ of ~~proven partnerships in~~ the ~~Republic~~Additional ofNotes ~~Korea.~~is ~~The agreement grants Medicox the exclusive license to apply for regulatory~~subject approval and distribute ORMD-0801 for ten years in the Republic of Korea. Medicox will comply with agreed distribution targets and will purchase ORMD-0801 at an agreed upon transfer price per capsule. In addition, Medicox will pay Oramed up to ~~$15,000,000~~customary inclosing ~~developmental milestones,~~conditions ~~$2,000,000 of which were received by Oramed in 2022,~~ and ~~up to 15% royalties on gross sales. Medicox will also be responsible for gaining regulatory approval in the Republic of Korea. This agreement was assigned to OraTech.~~either:

~~Government Regulation~~(i) Lifeward achieving at least a 150% increase in ReWalk unit sales compared to the trailing twelve-month period immediately preceding the Additional Closing; or

~~The Drug~~(ii) ~~Development~~the ~~Process~~closing price of Lifeward Ordinary Shares equaling or exceeding $13.80 per share, reflecting Lifeward’s 12-for-1 reverse share split (which adjusted the original $1.15 threshold), for 10 consecutive trading days immediately prior to the Additional Closing.

~~Regulatory requirements~~The ~~for~~closing ~~the approval~~ of ~~new~~the ~~drugs~~Initial ~~vary~~ Notes ~~from~~was ~~one~~subject ~~country~~ to ~~another.~~customary Inclosing ~~order to obtain approval to market our drug portfolio~~conditions, we ~~need~~including ~~to go through a different regulatory process in each country in which we apply for such approval. In some cases, information gathered during~~ the approval ~~process~~of inLifeward’s ~~one~~shareholders ~~country can be used as supporting information~~ for the ~~approval~~issuance ~~process~~of inmore than ~~another country~~19. As99% aof ~~strategic~~Lifeward ~~decision,~~Ordinary weShares ~~decided~~in toaccordance ~~first~~with ~~explore~~Nasdaq ~~the~~listing ~~FDA regulatory pathway~~standards. ~~The~~Such shareholder ~~following~~approval iswas aobtained ~~summary~~on ofMarch ~~the~~12, ~~FDA’s requirements~~2026.

~~The FDA~~In ~~requires~~connection ~~that~~with ~~pharmaceutical~~the ~~and~~transaction, ~~certain~~Lifeward agreed ~~other~~to ~~therapeutic~~file ~~products~~a ~~undergo~~resale ~~significant~~registration ~~clinical~~statement ~~experimentation~~with ~~and~~the ~~clinical~~SEC ~~testing prior~~covering tothe ~~their~~Lifeward ~~marketing~~Ordinary orShares ~~introduction~~issuable toupon conversion of the ~~general~~Notes and ~~public.~~exercise ~~Clinical~~of ~~testing,~~the ~~known~~related aswarrants ~~clinical~~within ~~trials~~30 ordays ~~clinical~~after ~~studies~~the Initial Closing, isand ~~either~~to use commercially ~~conducted~~reasonable ~~internally~~efforts byto ~~life~~have ~~science,~~the ~~pharmaceutical~~registration orstatement ~~biotechnology~~declared ~~companies~~effective within 45 days thereafter (or is75 ~~conducted~~days onin ~~behalf~~the event of ~~these~~a ~~companies~~full bySEC ~~CROs~~review).

~~The process~~Strategic ofOverview conducting clinical trials is highly regulated by the FDA, as well as by other governmental and professional bodies. Below we describe the principal framework in which clinical trials are conducted, as well as describe a number of the parties involved in these trials.Rationale

8As part of our ongoing portfolio optimization and focus on high potential innovation, during 2026 we entered into a strategic transaction with Lifeward Ltd. Under this agreement, we transferred our proprietary Protein Oral Delivery POD platform, representing years of research to enable oral administration of injectable biologics including its refined oral insulin program, to Lifeward while retaining responsibility for managing the near-term clinical development program and receiving a significant equity ownership interest in the combined company. This transaction aligns us with a revenue generating medical robotics business with established products such as ReWalk and AlterG, providing near term cash flow and diversified exposure alongside the long term upside of the POD platform. we believe that prior execution challenges at Lifeward were driven primarily by strategy and management rather than the quality of the underlying technology. With a new strategic direction and leadership team in place, we believe Lifeward is well positioned to advance the oral insulin program and fully realize the value of its combined technology platforms, ultimately delivering meaningful growth and shareholder value.

Protocols. Before commencing human clinical trials, the sponsor of a new drug or therapeutic product must submit an IND application to the FDA. The application contains, among other documents, what is known in the industry as a protocol. A protocol is the blueprint for each drug study. The protocol sets forth, among other things, the following:8

●Corner ~~Who~~Ally ~~must be recruited as qualified participants,~~Ventures

●On ~~How~~March ~~often~~1, to2026, ~~administer~~our board approved the ~~drug~~formation of Corner Ally Ventures or, ~~product~~the “Fund”, a new venture capital fund focused on investments in Israeli technology companies. We co-founded the Fund together with Corner Capital Management, LLC and, together with Ben Shapiro, are expected to serve as a major general partner of the Fund and to participate in its management and investment decision-making and may be entitled to a share of the Fund’s carried interest. We also expect to serve as an anchor limited partner and have committed to vest up to $40,000,000 in the Fund, which is expected to be funded over an anticipated four-year capital call period. The Fund’s initial closing, subject to a minimum capital commitment of $75,000,000, is expected to occur in the third quarter of 2026.

●Real ~~What~~Estate ~~tests to perform on the participants, and~~Investments

●On ~~What~~November ~~dosage~~7, 2024, our Board of Directors, or the ~~drug~~Board, orapproved ~~amount~~investments of up to $10,000,000 in real estate assets. This decision aligns with our strategic approach to capital allocation, leveraging opportunities in the ~~product~~current real estate market where we have identified attractive investment prospects. With interest rates expected to ~~give~~decline and valuations presenting favorable entry points, the Board believes these investments could provide long-term value appreciation and potential income streams, further strengthening our financial position. As we continue to evaluate our business strategy, including potential structural changes, these investments are intended to enhance financial flexibility and maximize shareholder value. On February 13, 2025, the ~~participants~~Board approved increasing the real estate investments to up to $30,000,000.

~~Institutional Review~~Profit-Sharing ~~Board.~~Loan An institutional review board is an independent committee of professionals and lay persons which reviews clinical research trials involving human beings and is required to adhere to guidelines issued by the FDA. The institutional review board does not report to the FDA, but its records are audited by the FDA. Its members are not appointed by the FDA. All clinical trials must be approved by an institutional review board. The institutional review board’s role is to protect the rights of the participants in the clinical trials. It approves the protocols to be used, the advertisements which the company or CRO conducting the study proposes to use to recruit participants, and the form of consent which the participants will be required to sign prior to their participation in the clinical trials.Agreement

~~Clinical~~On September 4, 2024, we ~~Trials.~~entered ~~Human~~into ~~clinical~~a ~~trials~~loan agreement, or ~~testing~~the ofProfit-Sharing aLoan ~~potential~~Agreement, ~~product~~with ~~are~~Rabi ~~generally~~Binyamin ~~done~~4 inTama ~~three~~38 ~~stages~~Ltd. ~~known~~or, asthe ~~Phase~~“Borrower”, to 1finance ~~through~~a ~~Phase 3~~real ~~testing~~estate project or, the “Rabi Binyamin Project”. ~~The~~According ~~names~~to the terms of the ~~phases~~Profit-Sharing ~~are~~Loan ~~derived~~Agreement, we ~~from~~agreed to loan NIS 5,500,000 (approximately $1,523,000) or, the ~~regulations~~“Loan ofPrincipal”, to the ~~FDA~~Borrower. ~~Generally~~NIS 4,700,000 ~~there~~(approximately $1,307,000) ~~are~~was ~~multiple~~loaned ~~trials~~upon ~~conducted~~signing inthe ~~each~~Profit-Sharing Loan Agreement and an additional NIS 800,000 (approximately $237,000), or the ~~phase~~Additional Payment, will be loaned upon certain milestones. On October 28, 2025, the Borrower met the milestones and is entitled to the additional payment.

~~Phase 1.~~On ~~Phase~~September 114, ~~trials~~2025, ~~involve~~we ~~testing~~loaned aan ~~drug~~additional NIS 500,000 (approximately $150,286) to the Borrower or’ ~~product~~the on“Additional aLoan”. ~~limited~~The ~~number~~Additional Loan bears an annual interest of ~~healthy~~6% orand ~~patient~~shall ~~participants~~be repaid by December 31, ~~typically~~2025. 24According to ~~100~~the ~~people~~Additional Loan agreement, we shall be entitled to instruct the Borrower that instead of atrepaying athe ~~time.~~Additional ~~Phase~~Loan 1on ~~trials~~the ~~determine~~maturity adate, ~~product’s~~the ~~basic~~principal ~~safety~~amount ~~and~~of ~~how~~the loan, as well as any accrued interest up to the ~~product~~date isof such ~~absorbed~~notice, shall be deemed to constitute a loan amount provided by us, ~~and~~as ~~eliminated~~part ~~from,~~of the ~~body~~remaining portion of the Profit-Sharing Loan Agreement. ~~This~~As ~~phase~~of ~~lasts~~December an31, ~~average~~2025, the Additional Loan had not been repaid. The maturity date of ~~six~~the ~~months~~Additional Loan was subsequently extended to June a30, ~~year~~2026.

~~Phase 2.~~Upon ~~Phase~~completion ~~2 trials involve testing~~ of ~~no more than 300 participants at a time who may suffer from~~ the ~~targeted disease or condition.~~Rabi ~~Phase~~Binyamin 2Project, ~~testing~~we ~~typically~~are ~~lasts~~entitled ~~an average of one~~ to ~~two~~receive ~~years. In Phase 2,~~ the ~~drug~~Loan isPrincipal ~~tested to determine its safety~~ and ~~effectiveness for~~the ~~treating~~greater aof: ~~specific~~(i) ~~illness~~20% orannual ~~condition.~~interest ~~Phase 2 testing also involves determining acceptable dosage levels~~ of the ~~drug.~~Loan ~~Phase~~Principal ~~2 trials may be split into Phase 2a~~ and ~~Phase 2b sub-trials. Phase 2a trials may be conducted with patient volunteers and are exploratory~~ (~~non-pivotal~~ii) ~~trials,~~40% typically designed to evaluate clinical efficacy or biological activity. Phase 2b trials are conducted with patients defined to evaluate definite dose range and evaluate efficacy. If Phase 2 trials show that a new drug has an acceptable range of ~~safety risks and probable effectiveness, a company will generally continue to review~~ the ~~substance~~Rabi inBinyamin ~~Phase~~Project ~~3 trials~~profits.

Phase 3. Phase 3 trials involve testing large numbers of participants, typically several hundred to several thousand persons. The purpose is to verify effectiveness and long-term safety on a large scale. These trials generally last two to three years. Phase 3 trials are conducted at multiple locations or sites. Like the other phases, Phase 3 requires the site to keep detailed records of data collected and procedures performed.Castel

~~Biological License~~In ~~Application.~~January ~~The~~2025, ~~results~~we ofentered into ~~the~~an ~~clinical~~agreement ~~trials for a biological product are submitted~~ to ~~the~~acquire ~~FDA as part of~~ a ~~Biological License~~parcel ~~Application, or BLA. Following the completion~~ of ~~Phase~~land ~~3 trials, assuming the sponsor of a potential product~~ in ~~the~~Mevaseret ~~United States believes it has sufficient information to support the safety and effectiveness of its product~~Zion, ~~the~~Israel ~~sponsor will generally submit a BLA to the FDA requesting that the product be approved~~ for ~~marketing. The application is~~ a ~~comprehensive,~~total ~~multi-volume~~purchase ~~filing~~price ~~that includes the results~~ of ~~all~~NIS ~~clinical trials~~5,800,000 ~~information about the drug’s composition~~($1,586,000). ~~and~~The transaction ~~the~~was ~~sponsor’s~~structured ~~plans~~as ~~for~~installments ~~producing~~payments, ~~packaging~~ and ~~labeling~~as ~~the product. The FDA’s review~~ of anDecember ~~application~~31, ~~can~~2025, ~~take~~we ahad ~~few~~paid ~~months to many years, with~~ the ~~average~~full ~~review~~purchase ~~lasting 18 months~~price. ~~Once~~We ~~approved,~~intend ~~drugs~~to ~~and~~pursue value-enhancing ~~other~~activities ~~products~~in ~~may~~connection bewith ~~marketed in~~ the ~~United States~~land, ~~subject~~with ~~to any conditions imposed by~~ the ~~FDA. Approval~~goal of aincreasing ~~BLA~~its ~~provides~~potential 12return ~~years of exclusivity in the U~~upon future sale.~~S. market.~~

~~Phase 4.~~Ruby ~~The~~Sapphire ~~FDA~~II may require that the sponsor conduct additional clinical trials following new drug approval. The purpose of these trials, known as Phase 4 trials, is to monitor long-term risks and benefits, study different dosage levels or evaluate safety and effectiveness. In recent years, the FDA has increased its reliance on these trials. Phase 4 trials usually involve thousands of participants. Phase 4 trials also may be initiated by the company sponsoring the new drug to gain broader market value for an approved drug.Investment

9On December 31, 2025, we entered into agreement and committed to invest NIS 7,000,000 (approximately $2,185,000) as a limited partner in Ruby Capital Investment Fund Sapphire II, Limited Partnership or, the “Ruby Sapphire II”, an Israeli private investment fund. Our commitment may be drawn down over time in accordance with the fund’s partnership agreement, and the investment is subject to the risks inherent in private investment funds, including illiquidity and the potential loss of invested capital. As of March 26, 2026, we had funded NIS 1,556,493 (approximately $499,000) under this commitment.

European Regulation. Similar to the U.S., a European sponsor of a biological product may submit a Marketing Approval Application to the European Medicines Agency, or EMA, for the registration of the product. The approval process in Europe consists of several stages, which together are summed up to 210 days from the time of submission of the application (net, without periods in which the sponsor provides answers to questions raised by the agency) following which, a Marketing Approval may be granted. During the approval process, the sponsor’s manufacturing facilities will be audited in order to assess Good Manufacturing Practice compliance.9

~~The drug~~Loan ~~approval~~to ~~process~~Hapisga is time-consuming, involves substantial expenditures of resources, and depends upon a number of factors, including the severity of the illness in question, the availability of alternative treatments, and the risks and benefits demonstrated in the clinical trials.Project

~~Other~~On March 24, 2025, we entered into a loan agreement with Hapisga Project ~~Regulations~~– New Talpiot Ltd. to finance a purchase of a real estate asset in Jerusalem, Israel in the amount of up to $22,650,000 or, the “Hapisga Loan”. The loan has a one-year maturity, and a caveat was registered on the property reflecting a commitment to register a first-ranking mortgage on the property which is valued at approximately NIS 3,000,000,000 (approximately $890,000,000), providing significant collateral coverage. The loan bears an annual interest rate of 12%.

~~Various federal,~~On ~~state and local laws, regulations, and recommendations relating to safe working conditions, laboratory practices,~~ the ~~experimental use~~same ~~of animals~~date, ~~the~~we ~~environment and the purchase, storage, movement, import, export, use, and disposal of hazardous or potentially hazardous~~entered ~~substances,~~into ~~including~~a ~~radioactive~~loan ~~compounds~~agreement ~~and infectious disease agents, used in connection~~ with ~~our~~Tova ~~research~~Chochma ~~are~~Im ~~applicable~~Nachala ~~to our activities~~Ltd. ~~They include~~or, ~~among others,~~ the ~~U.S.~~“Tova ~~Atomic~~Chochma” ~~Energy~~in ~~Act,~~ the ~~Clean~~amount ~~Air~~of ~~Act~~$5, ~~the Clean Water Act~~000,000. ~~the~~The ~~Occupational~~loan ~~Safety and~~bears ~~Health~~an ~~Act,~~annual ~~the~~interest ~~National~~rate ~~Environmental~~of ~~Policy~~12% ~~Act,~~with ~~the~~a ~~Toxic~~maturity ~~Substances~~date ~~Control~~of ~~Act,~~12 ~~and~~months. ~~Resources~~In ~~Conservation~~May ~~and Recovery Act~~2025, ~~national restrictions~~Tova onChochma ~~technology~~repaid ~~transfer,~~an ~~import,~~amount ~~export,~~of ~~and customs regulations~~$500,000. ~~and~~Tova ~~other present and possible future local, state, or~~Chochma ~~federal~~can ~~regulation.~~repay ~~The~~the ~~compliance~~loan ~~with~~at ~~these~~any ~~and other laws, regulations and recommendations can be~~ time~~-consuming~~. ~~and~~This ~~involve~~loan ~~substantial costs.~~is Inalso ~~addition,~~secured by the ~~extent~~registration of ~~governmental~~the ~~regulation~~caveat ~~which~~for ~~might~~Hapisga ~~result~~Loan. ~~from~~The ~~future~~loans ~~legislation~~were ~~or administrative action cannot~~granted beby ~~accurately~~us ~~predicted~~in ~~and~~April ~~may have a material adverse effect on our business, financial condition, results of operations and prospects~~2025.

~~Competition~~Research and Development

~~Competition in~~Oral ~~the~~Insulin ~~area of biomedical~~ and ~~pharmaceutical research and development is intense and significantly depends on scientific and technological~~Strategic ~~factors.~~Review These factors include the availability of patent and other protection for technology and products, the ability to commercialize technological developments and the ability to obtain regulatory approval for testing, manufacturing and marketing. Our competitors include major pharmaceutical, medical products, chemical and specialized biotechnology companies, many of which have financial, technical and marketing resources significantly greater than ours. In addition, many biotechnology companies have formed collaborations with large, established companies to support research, development and commercialization of products that may be competitive with ours. Academic institutions, governmental agencies and other public and private research organizations are also conducting research activities and seeking patent protection and may commercialize products on their own or through joint ventures. We are aware of certain other products manufactured or under development by competitors that are used for the treatment of the diseases and health conditions that we have targeted for product development. We can provide no assurance that developments by others will not render our technology obsolete or noncompetitive, that we will be able to keep pace with new technological developments or that our technology will be able to supplant established products and methodologies in the therapeutic areas that are targeted by us. The foregoing factors could have a material adverse effect on our business, prospects, financial condition and results of operations. These companies, as well as academic institutions, governmental agencies and private research organizations, also compete with us in recruiting and retaining highly qualified scientific personnel and consultants.Process

~~Competition~~Our proprietary flagship ~~within~~product, ~~our~~an ~~sector~~orally isingestible ~~increasing~~insulin capsule, soor weORMD-0801, ~~will~~allows ~~encounter~~insulin ~~competition~~to travel from ~~existing~~the ~~firms~~gastrointestinal ~~that~~tract ~~offer~~via ~~competitive~~the ~~solutions~~portal vein to the bloodstream, revolutionizing the manner in ~~diabetes~~which ~~treatment~~insulin is delivered. It enables the passage in a more physiological manner ~~solutions~~than current delivery methods of insulin. ~~These~~We ~~competitive~~conducted ~~companies~~the ~~could~~ORA-D-013-1 ~~develop~~Phase ~~products~~3 ~~that~~trial ~~are~~on ~~superior~~patients towith type 2 diabetes, with inadequate glycaemic control who were on two or ~~have~~three ~~greater~~oral ~~market~~glucose-lowering ~~acceptance,~~agents. ~~than~~The primary endpoint of the ~~products being~~trial ~~developed~~was byto ~~us.~~evaluate Wethe ~~will~~efficacy of ~~have~~ORMD-0801, compared to ~~compete~~placebo ~~against~~in ~~other~~improving ~~biotechnology~~glycaemic ~~and~~control ~~pharmaceutical~~as ~~companies~~assessed by HbA1c, with ~~greater~~a ~~market~~secondary ~~recognition~~efficacy endpoint of assessing ~~and~~the ~~greater~~change ~~financial~~from baseline in fasting plasma glucose at 26 weeks. On January 11, ~~marketing~~2023, ~~and~~we ~~other~~announced ~~resources~~that the ORA-D-013-1 Phase 3 trial did not meet its primary or secondary endpoints.

10Following the January 2023 results, we initiated a strategic review process and conducted a comprehensive analysis of the data to understand if there is a path forward for our oral insulin candidate. Accordingly, we completed a subpopulation analysis that identified patient groups with specific parameters (BMI, baseline HbA1c, and age) demonstrating an over 1% placebo-adjusted, statistically significant reduction in HbA1c. Based on these findings, on September 12, 2024, we submitted a protocol to the FDA titled, “A Double-Blinded, Placebo-controlled, Double Dummy Multi-Center Randomized, Phase 3 Study to Evaluate the efficacy and safety in subjects with Type 2 Diabetes Mellitus with Inadequate Glycemic Control on One to Three Glucose-lowering Agents” or a revised Phase 3 trial (ORA-D-013-3).

~~Our competition~~We ~~will~~intend beon ~~determined~~initiating ina ~~part~~60-patient, byUS-based ~~the~~clinical ~~potential~~trial ~~indications for which our technology is developed and ultimately approved by~~designed ~~regulatory~~to ~~authorities.~~validate ~~In addition,~~ the ~~first~~robustness ~~product~~of toour ~~reach~~oral ~~the~~insulin ~~market~~formulation in athese ~~therapeutic~~high-responder orpopulations. ~~preventive~~The ~~area~~trial is ~~often~~designed ~~at a significant competitive advantage relative~~ to ~~later~~use ~~entrants to~~ the ~~market. Accordingly, the relative speed with which we, or our potential corporate~~smallest ~~partners,~~adequately ~~can~~powered ~~develop~~patient ~~products,~~population ~~complete~~expected ~~the~~to ~~clinical~~obtain ~~trials~~such ~~and~~validation ~~approval~~in ~~processes~~what ~~and~~we ~~supply~~believe ~~commercial quantities of the products~~ to ~~the market are expected to~~ be ~~important~~the ~~competitive~~shortest ~~factors.~~time ~~Our~~possible, ~~competitive~~providing a ~~position~~cost-effective ~~will~~approach ~~also depend on our ability~~ to ~~attract~~generate ~~and retain~~additional ~~qualified~~compelling ~~scientific~~evidence and ~~other~~refine ~~personnel,~~our ~~develop~~patient ~~effective~~selection ~~proprietary~~criteria ~~products,~~for ~~develop~~future ~~and~~potential ~~implement production and marketing~~regulatory ~~plans,~~submissions. ~~obtain~~The ~~and~~trial ~~maintain~~will ~~patent~~be ~~protection~~conducted ~~and~~by ~~secure adequate capital resources~~OraTech. WeFor ~~expect~~additional ~~our technology~~information, ifsee ~~approved~~note ~~for~~21 ~~sale,~~ to ~~compete~~ ~~primarily~~our onconsolidated ~~the~~financial ~~basis~~statements included ofin ~~product~~this ~~efficacy,~~Annual ~~safety,~~Report ~~patient~~on ~~convenience,~~Form ~~reliability, value and patent position~~10-K.

We anticipated that our oral insulin capsule would be a competitive diabetes drug because of its anticipated efficacy and safety profile; however, there are other treatment options for T1D and T2D patients, such as insulin injections, insulin pumps or a combination of diet, exercise and oral medication which improve the body’s response to insulin or cause the body to produce more insulin. 10

~~Scientific Advisory~~ Diabetes ~~Board~~Market Overview

~~We maintain~~Diabetes is a ~~Scientific~~disease ~~Advisory~~in which ~~Board~~the ~~consisting~~body ofdoes ~~internationally~~not ~~recognized~~produce ~~scientists~~or ~~who~~properly ~~advise~~use usinsulin. onInsulin ~~scientific~~is ~~and~~a ~~technical~~hormone ~~aspects~~that causes sugar to be absorbed into cells, where the ofsugar ~~our~~is ~~business~~converted into energy needed for daily life. The ~~Scientific~~cause ~~Advisory~~of ~~Board~~diabetes ~~meets~~is attributed both to ~~review~~genetics ~~specific~~(type ~~projects~~1 diabetes, or T1D) and, most often, to ~~assess~~environmental ~~the~~factors ~~value~~such ofas ~~new~~obesity ~~technologies~~ and ~~developments~~lack toof usexercise (T2D). InAccording ~~addition,~~to ~~individual~~the ~~members~~International ofDiabetes ~~the~~Federation, or ~~Scientific~~IDF, ~~Advisory~~approximately ~~Board~~589 ~~meet~~million ~~with~~adults us(20-79 toyears) ~~provide~~worldwide ~~advice~~ suffered from diabetes in ~~their~~2024 ~~particular~~and ~~areas~~the ofIDF ~~expertise.~~projects ~~The~~this ~~Scientific~~number ~~Advisory~~will increase ~~Board~~to ~~consists~~853 ofmillion by 2050. According to the ~~following~~American ~~members~~Diabetes Association or, ~~information~~the ~~with~~“ADA”, ~~respect~~in ~~to whom~~2024, isthe ~~set~~United ~~forth~~States there ~~below:~~were Drapproximately 38.5 ~~Roy~~million ~~Eldor,~~people ~~Professor~~with ~~Ele~~diabetes. ~~Ferrannini,~~Diabetes ~~Dr.~~is ~~Alexander~~a ~~Fleming,~~leading ~~Professor~~cause ~~Avram~~of ~~Hershko~~blindness, ~~Dr.~~kidney ~~Julio Rosenstock~~failure, ~~Dr.~~ ~~Jay~~heart ~~Skyler~~attack, stroke and Dramputation. ~~Anne Peters.~~

~~Dr. Roy~~Intellectual ~~Eldor,~~Property ~~MD, PhD, joined the Oramed Scientific Advisory Board in July 2016. He is an endocrinologist, internist~~ and ~~researcher~~ with over twenty years of clinical and scientific experience. He is currently Director of the Diabetes Unit at the Institute of Endocrinology, Metabolism & Hypertension at the Tel-Aviv Sourasky Medical Center. Prior to that, Dr. Eldor served as Principal Scientist at Merck Research Laboratories, Clinical Research – Diabetes & Endocrinology. He previously served as a senior physician in internal medicine at the Diabetes Unit in Hadassah Hebrew University Hospital in Jerusalem, Israel; and the Diabetes Division at the University of Texas Health Science Center in San Antonio, Texas. Dr. Eldor is a recognized expert, with over 50 peer reviewed papers and book chapters, and has been a guest speaker at numerous international forums.Patents

~~Professor Ele~~We ~~Ferrannini,~~own ~~MD, joined the Oramed Scientific Advisory Board in February 2007. He is~~ a ~~past~~portfolio ~~President to the European Association for the Study~~ of ~~Diabetes (EASD), which supports scientists, physicians and students from all over the world who are interested~~patents ~~in diabetes~~ and ~~related~~patent ~~subjects~~applications incovering ~~Europe~~our and performs functions similar to that of the American Diabetes Association in the United States. Professor Ferrannini has worked with various institutions including the Department of Clinical & Experimental Medicine at the University of Pisa School of Medicinetechnologies, and ~~CNR~~we ~~(National~~are ~~Research~~aggressively ~~Council)~~protecting ~~Institute~~these oftechnology ~~Clinical~~developments ~~Physiology~~on in Pisa, Italy; and the Diabetes Division, Department of Medicine at the University of Texas Health Science Center in San Antonio, Texas. He has extensive training in internal medicine and endocrinology, and has specialized in diabetes trials. Professor Ferrannini has received a ~~Certificate~~worldwide ~~of the Educational Council for Foreign Medical Graduates from the University of Bologna, and completed a subspecialty in Diabetes and Metabolic Diseases at the University of Torino, cum laude~~basis. ~~He has published over 500 original papers and 50 book chapters and he is a “highly cited researcher,” according to the Institute for Scientific Information.~~

~~Dr. Alexander~~We ~~Fleming,~~maintain ~~MD,~~a ~~joined~~proactive ~~the Oramed Scientific Advisory Board in December 2019. Dr. Fleming, an endocrinologist, is Founder~~intellectual ~~and~~property ~~Executive Chairman of Kinexum~~strategy, awhich ~~strategic~~includes ~~advisory~~patent ~~firm.~~filings ~~From~~in ~~1986~~multiple ~~to 1998~~jurisdictions, heincluding ~~served at~~ the ~~FDA~~United asStates ~~a supervisory medical officer in the Division of Metabolism~~ and ~~Endocrine Drug Products and was responsible for landmark approvals of the first statin, metformin, and~~ other ~~endocrine~~commercially ~~and metabolic therapies~~significant markets. HeWe ~~also~~hold ~~represented~~21 ~~the~~patent ~~FDA~~applications atcurrently ~~the~~pending, ~~World~~with ~~Health~~respect ~~Organization~~to ~~and~~various oncompositions, ~~multiple~~methods ~~expert working groups~~ of ~~the~~production ~~International~~and ~~Conference~~oral ~~on Harmonization (ICH). Dr. Fleming coined the term, Metabesity, which refers to the constellation~~administration of ~~major~~proteins ~~chronic diseases~~ and ~~the aging process itself, all which share common metabolic root causes and potential preventive therapies~~exenatide. He ~~organized~~Expiration ~~the~~dates ~~first~~for ~~Congress~~pending ~~on Metabesity in London in October 2017~~patents, ~~followed~~if ~~by annual conferences. In 2020~~granted, ~~Dr.~~will ~~Fleming~~fall ~~founded the~~between ~~non-profit~~2026 ~~Kitalys Institute as a means of producing Metabesity conferences~~ and ~~advancing interventions of any kind that can improve health and healthspan~~2039.

11We hold 141 patents, one of which issued during the year ended December 31, 2025, including patents issued by the United States, Swiss, German, French, U.K., Italian, Netherlands, Swedish, Spanish, Australian, Israeli, Japanese, New Zealand, South African, Russian, Canadian, Hong Kong, Chinese, European and Indian patent offices that cover a part of our technology, which allows for the oral delivery of proteins; patents issued by the Australian, Canadian, European, Austrian, Belgian, French, German, Irish, Italian, Luxembourg, Monaco, Netherlands, Norwegian, Spanish, Swedish, Swiss, U.K., Israeli, New Zealand, South African, Russian, Brazilian and Japanese patent offices that cover part of our technology for the oral delivery of exenatide; and patents issued by the European, Austrian, Belgian, Denmark, French, German, Irish, Italian, Luxembourg, Monaco, Netherlands, Norway, Spanish, Swedish, Swiss, U.K. and Japanese patent offices for treating diabetes.

~~Professor Avram~~Consistent ~~Hershko, MD, PhD, joined the Oramed Scientific Advisory Board in July 2008. Professor Hershko served as a physician in the Israel Defense Forces from 1965 to 1967. After a post-doctoral fellowship~~ with ~~Gordon~~our ~~Tomkins at the University of San Francisco~~strategy ~~from 1969~~ to ~~1972,~~seek heprotection ~~joined the faculty of the Haifa Technion becoming a professor~~ in ~~1980.~~key Hemarkets ~~is now Distinguished Professor in the Unit of Biochemistry in the B. Rappaport Faculty of Medicine of the Technion in Haifa~~worldwide, ~~Israel.~~we ~~Professor~~have ~~Hershko’s~~been ~~main research interests concern the mechanisms by which cellular proteins are degraded, a formerly neglected field of study. Professor Hershko~~ and ~~his~~ ~~colleagues~~will ~~showed~~continue ~~that cellular proteins are degraded by a highly selective proteolytic system. This system tags proteins for destruction by linkage~~ to apursue ~~protein~~the ~~called~~patent ~~ubiquitin,~~applications ~~which had previously been identified in many tissues, but whose function was previously unknown. Subsequent work by Professor Hershko~~ and ~~many~~corresponding ~~other laboratories has shown that the ubiquitin system has a vital role in controlling~~foreign acounterparts ~~wide range~~ of ~~cellular processes,~~ such ~~as the regulation of cell division, signal transduction and DNA repair~~applications. ~~Professor~~We ~~Hershko~~believe ~~was awarded~~that ~~the~~our ~~Nobel~~success ~~Prize~~will independ ~~Chemistry~~on inour ~~2004,~~ability ~~jointly~~to ~~with~~obtain ~~his~~patent ~~former~~protection ~~PhD student Aaron Ciechanover and their colleague Irwin Rose. His many honors include the Israel Prize~~ for ~~Biochemistry~~our ~~(1994), the Gairdner Award (1999), the Lasker Prize for Basic Medical Research~~intellectual ~~(2000), the Wolf Prize for Medicine (2001) and the Louisa Gross Horwitz Award (2001)~~property. ~~Professor Hershko is a member of the Israel Academy of Sciences since 2000 and a Foreign Associate of the U.S. Academy of Sciences since 2003.~~

~~Dr. Julio~~Our ~~Rosenstock,~~patent ~~MD,~~strategy ~~joined the Oramed Scientific Advisory Board in January 2020. Dr. Rosenstock~~ is the Senior Scientific Advisor and Director of Velocity Clinical Research at Medical City, Dallas, Texas, and a Clinical Professor of Medicine at the University of Texas Southwestern Medical Center in Dallas, Texas. He is board certified in Internal Medicine, Endocrinology and Metabolism. His clinical and research activities have focused on exploring novel agents and therapeutic strategies to improve glycemic control, particularly early combination therapies in Type 2 Diabetes. Over the last 30 years, he has participated in hundreds of clinical trials and has had an active role in the development of new oral agents, incretin-related therapies and insulin formulations, often acting as ~~a lead clinical investigator~~ and scientific advisor on the design and reporting of these clinical trials. Dr. Rosenstock has been the author or co-author of 386 peer-reviewed manuscripts (H-index 124) and several hundreds of scientific abstracts and he is considered a key opinion leader in Type 2 Diabetes. He has also contributed to 13 book chapters on various topics in the field of diabetes and is considered a key opinion leader in Type 2 Diabetes.follows:

~~Dr. Jay~~● ~~Skyler,~~Aggressively ~~MD,~~protect ~~MCAP,~~all ~~FRCP,~~current ~~joined the Oramed Scientific Advisory Board in January 2020. Dr. Skyler is Professor of Medicine, Pediatrics~~ and ~~Psychology~~future intechnological ~~the~~developments ~~Division~~to ofassure ~~Endocrinology,~~strong ~~Diabetes~~ and ~~Metabolism,~~broad ~~Department~~protection ofby ~~Medicine,~~filing ~~University~~patents ~~of Miami Leonard M. Miller School of Medicine. He previously held the position of Director of the Division of Endocrinology, Diabetes~~ and/or ~~Metabolism. In~~continuations addition, Dr. Skyler is Deputy Director of Clinical Research and Academic Programs at the Diabetes Research Institute, and an Adjunct Professor of Pediatrics at the Barbara Davis Center for Childhood Diabetes at the University of Colorado in ~~Denver.~~part ~~Dr.~~as ~~Skyler’s research focuses on the clinical aspects of diabetes~~appropriate, specifically the conduct of randomized controlled clinical trials. From 1993 to 2015, he was Chairman of the National Institute of Health (NIDDK)-sponsored Diabetes Prevention Trial–- Type 1 (DPT-1) and its successor Type 1 Diabetes Trial Net, a nationwide and global network conducting clinical trials to prevent T1D.

~~Dr. Anne~~● ~~Peters,~~Protect ~~MD,~~technological ~~joined~~developments ~~the Oramed Scientific Advisory Board in June 2022. Dr. Peters is Professor of Medicine~~ at ~~the~~various ~~Keck~~levels, School of Medicine of the University of Southern California (USC) and Director of the USC Clinical Diabetes Programs. Dr. Peters earned her medical degree from the Pritzker School of Medicine at the University of Chicago and performed an internal medicine residency at Stanford University and an endocrinology fellowship at Cedars-Sinai Medical Center. She previously directed the clinical diabetes programs at Cedars-Sinai Medical Center and UCLA in ~~California.~~a ~~Her~~complementary research has focused on testing new approaches for diagnosing and treating diabetes and developing systems of care to improve outcomes in diabetic under-resourced populations. Dr. Peters has consulted for many entitiesmanner, including the ~~FDA,~~base the Centers for Disease Control and Prevention and the National Institutes of Health to help guide the development and use of treatments for diabetes. In addition to being an investigator for more than 40 research studiestechnology, ~~Dr.~~as ~~Peters~~well ~~has~~as ~~published over~~specific ~~200~~applications ~~articles, has written four books, and has given more than 500 lectures locally, nationally, and internationally. She has been on multiple guideline writing committees for the treatment~~ of ~~both type 1 and type 2 diabetes. She was a recipient of~~ the ~~ADA Outstanding Physician Clinician Award~~technology, ~~the Bernardo Houssay Award from the National Minority Quality Forum~~ and ~~received an Endocrine Society Laureate Award for Public Service.~~

12● Establish comprehensive coverage in the United States and in all relevant foreign markets in anticipation of future commercialization opportunities.

~~Employees~~Trademarks and Trade Secrets

We have trademark applications ~~believe~~pending itin isIsrael, ~~imperative~~with toCorresponding ~~attract~~international ~~and~~trademark ~~retain~~applications ~~top~~in ~~talent~~Australia, ~~for~~Brazil, ~~all~~Canada, ~~positions~~China, inColombia, the ~~Company.~~European Union, WeIndia, ~~seek~~Indonesia, toJapan, ~~make~~Kazakhstan, ~~Oramed~~Korea, anMalaysia, ~~inclusive~~Mexico, ~~diverse~~New Zealand, Norway, Oman, Philippines, Russia, Singapore, Switzerland, ~~and~~Thailand, ~~safe~~Turkey, ~~workplace~~Ukraine, ~~with~~United ~~meaningful~~Arab ~~compensation~~Emirates, ~~benefits~~United ~~and~~Kingdom, ~~wellness~~U.S.A., ~~programs~~Uzbekistan and ~~opportunities~~Vietnam.

We have experienced personnel involved in our research and development programs, as well as appropriate clinical/regulatory, quality assurance and other personnel needed to advance through clinical trials or have engaged the services of experts in the field for these requirements. As of December 31, 2024, we have contracted with thirteen individuals for employment or consulting arrangements. Of our staff, four are senior management, three are engaged in research and development work, and the remaining six are involved in corporate and administration work.11

We also rely on trade secrets ~~provide~~and ~~competitive~~unpatentable ~~compensation~~know-how that we seek to protect, ~~health~~in ~~and~~part, ~~retirement~~by ~~programs~~confidentiality ~~for~~agreements. Our policy is to require our employees, consultants, contractors, manufacturers, outside scientific collaborators and sponsored researchers, our Board, technical review board and other advisors, to execute confidentiality agreements upon the commencement of employment or consulting relationships with us. WeThese ~~offer~~agreements ~~variable~~provide that ~~pay~~all inconfidential information developed or made known to the ~~form~~individual during the course of ~~bonuses~~the ~~and~~individual’s relationship ~~stock-based~~with ~~compensation~~us ~~for~~is ~~eligible~~to ~~employees~~be kept confidential and not disclosed to third parties except in specific limited circumstances. We also ~~provide~~require signed confidentiality or material transfer agreements from any company that is to receive our ~~employees~~confidential ~~with~~information. ~~additional~~In ~~benefits~~the ~~such~~case asof ~~team-building~~employees, consultants and ~~educational~~contractors, the agreements provide that all inventions conceived by the individual while rendering services to us shall ~~offsite~~be ~~activities~~assigned ~~and~~to ~~gym~~us ~~facilities~~as the exclusive property of us. WeThere ~~believe~~can be no assurance, however, that ~~this~~all ~~provides~~persons awho ~~comprehensive~~we ~~package~~desire to ~~engage~~sign such agreements will sign, ~~motivate~~or ~~and~~if ~~retain~~they ~~our~~do, ~~employees~~that these agreements will not be breached, that we would have adequate remedies for any breach, or that our astrade asecrets ~~cohesive~~or ~~unit~~unpatentable ~~unified~~know-how inwill ~~its~~not ~~goal~~otherwise tobecome ~~achieve~~known ~~the~~or ~~Company’s~~be ~~strategy~~independently ~~and~~developed ~~objectives~~by competitors.

~~Additional Information~~Out-Licensed Technology

~~Additional information~~We ~~about~~entered usinto ~~is contained on our Internet website at www.oramed.com. Information on our website is not incorporated by reference~~strategic ~~into~~agreements ~~this~~with ~~report.~~Lifeward ~~Our~~pursuant ~~Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K, and amendments~~ to ~~those reports~~which ~~filed~~we oragreed ~~furnished pursuant~~ to ~~Section~~sell ~~13(a)~~all of the ~~Securities~~outstanding ~~Exchange~~equity ~~Act~~interests of ~~1934~~OraTech, aseffectively ~~amended,~~transferring all orintellectual ~~the~~property ~~Exchange~~and ~~Act,~~related ~~are~~assets ~~available free~~relating ofto ~~charge on~~ our ~~website~~POD™ ~~under~~(Protein ~~“SEC~~Oral ~~Filings”~~Delivery) astechnology ~~soon~~platform, astogether ~~reasonably~~with ~~practicable after we electronically file such material~~associated ~~with,~~development oractivities ~~furnish~~for itthe ~~to,~~oral ~~the~~insulin ~~SEC~~program. ~~Reports~~In ~~filed~~consideration, ~~with~~we ~~the~~will ~~SEC~~receive ~~are~~equity ~~made~~securities ~~available~~of onLifeward, ~~its~~including ~~website~~ordinary shares ~~at www.sec.gov~~ and ~~are~~warrants, ~~also~~as ~~available~~well ~~on the~~as ~~website~~potential ofrevenue-sharing ~~the~~payments. ~~Israeli~~In ~~Securities~~addition, ~~Authority~~we atwill ~~www.magna.isa.gov.il~~continue orto onsupport the ~~website~~development of the ~~Tel Aviv Stock Exchange at www.tase.co.il.~~out-licensed ~~The~~technology ~~following~~by ~~corporate~~providing ~~governance~~clinical ~~documents~~trial ~~are~~management ~~also posted on our website: Code of Ethics, Whistleblowing Policy~~ and ~~the~~related ~~charters~~services for ~~each~~ of the ~~Audit~~oral ~~Committee,~~insulin ~~Compensation~~capsule ~~Committee and Nominating Committee of our Board~~program.

~~ITEM 1A.~~Entera ~~RISK FACTORS.~~Bio

~~An investment~~In inJune ~~our securities involves a high degree of risk. You should consider carefully the following information about these risks~~2010, ~~together~~ ~~with~~our ~~the other information contained in this Annual Report on Form 10~~wholly-~~K before making an investment decision. Our business,~~owned ~~prospects~~subsidiary, ~~financial~~Oramed ~~condition and results of operations may be materially and adversely affected as a result of any of the following risks~~Ltd., ~~The~~entered ~~value~~into ~~of our securities could decline as~~ a ~~result~~joint ofventure ~~any~~agreement ofwith ~~these~~Israel ~~risks.~~Canada ~~You~~Hotels ~~could~~Ltd ~~lose~~(formerly ~~all~~DNA orGROUP ~~part of your investment in our securities~~(T. ~~Some of the statements in “Item 1A~~R.) ~~Risk Factors” are forward-looking statements~~Ltd.) ~~The~~or ~~following risk factors~~DNA, ~~are~~for ~~not~~ the ~~only~~establishment ~~risk~~of ~~factors~~Entera ~~facing~~Bio ~~the Company~~Ltd., ~~Additional risks and uncertainties not presently known to us~~ or ~~that we currently deem immaterial may also affect our business, prospects, financial condition and results of operations~~Entera.

~~Summary~~In March 2011, Oramed Ltd. ~~Risk~~sold ~~Factors~~shares of Entera to DNA and retaining 117,000 ordinary shares (after giving effect to Entera’s July 2018 stock split), and, as part of the consideration, received ordinary shares of DNA. In connection with the joint venture, Oramed Ltd entered into a patent transfer agreement pursuant to which it assigned to Entera its rights to a patent application related to the oral administration of proteins (previously licensed to Entera since August 2010), in return for royalties of 3% of Entera’s net revenues and a license back of diabetes and influenza indications.

~~Risks~~As of December 31, 2025, ~~Related~~Entera had not paid any royalties to ~~Our~~Oramed ~~Business~~Ltd. During the years ended December 31, 2025 and 2024, we did not sell any of DNA’s ordinary shares. As of December 31, 2025, we held approximately 0.2% of DNA’s outstanding ordinary shares and 0.3% of Entera’s outstanding ordinary shares.

~~● Our strategic review process may not be successful or timely.~~HTIT

●In ~~Our~~2015-2016, ~~ability~~we entered into an exclusive license agreement with HTIT, as amended or, the “HTIT License Agreement”, granting HTIT commercialization rights to ~~consummate~~our aoral ~~strategic~~insulin ~~transaction~~capsule, ~~depends~~ORMD-0801, in the People’s Republic of China, Macau, and Hong Kong. Under the agreement, HTIT conducts pre-commercialization and regulatory activities at its own expense and pays us (i) royalties of 10% on ~~our~~net ~~ability~~sales (subject to reduction ~~retain~~to ~~our~~8% ~~employees~~if ~~required~~certain toconditions ~~consummate~~are ~~such~~not ~~transaction~~met, or 5% following patent expiration in 2033), and (ii) milestone payments totaling $37,500,000, of which we have received $20,500,000. The royalty payment obligation continues from first commercial sale until the later of (i) patent expiration in the territory or (ii) 15 years after first commercial sale.

●HTIT Wehas ~~continue,~~submitted ~~and~~a inMarketing Authorization ~~the~~Application ~~future expect,~~ to ~~incur~~China’s ~~losses,~~regulators ~~and~~for wethe ~~may~~oral ~~need~~insulin ~~substantial~~capsule ~~additional capital~~ in ~~order to satisfy our business objectives~~China.

1312

●Government ~~We may be unable to protect our intellectual property rights and we may be liable for infringing the intellectual property rights of others.~~Regulation

●The ~~Our~~Drug ~~success was primarily dependent on the successful commercialization of our oral insulin capsule.~~Development Process

●Regulatory Werequirements ~~have~~for the ~~limited~~approval ~~experience~~of new drugs vary from one country to another. In order to obtain approval to market our drug portfolio, we need to go through a different regulatory process in ~~conducting~~each ~~clinical~~country ~~trials~~in which we apply for such approval. In some cases, information gathered during the approval process in one country can be used as supporting information for the approval process in another country. As a strategic decision, we decided to first explore the FDA regulatory pathway. The following is a summary of the FDA’s requirements.

●The WeFDA ~~can~~requires ~~provide~~that nopharmaceutical and ~~assurance~~certain ~~that~~other ~~our~~therapeutic products ~~will~~undergo ~~obtain~~significant ~~regulatory~~clinical ~~approval~~experimentation and clinical testing prior to their marketing or introduction ~~that~~to the ~~results~~general ofpublic. Clinical testing, known as clinical trials ~~will~~or beclinical ~~favorable~~studies, is either conducted internally by life science, pharmaceutical or biotechnology companies or is conducted on behalf of these companies by CROs.

●The Weprocess ~~may~~of ~~not~~conducting clinical ~~realize~~trials ais ~~return~~highly onregulated by the ~~ordinary~~FDA, ~~shares~~as ofwell ~~DNA~~as ~~and~~by ~~Entera~~other governmental and professional bodies. Below we describe the ~~common~~principal framework ~~stock~~in which clinical trials are conducted, as well as describe a number of ~~Scilex~~the ~~and~~parties ~~BioXcel~~involved ~~that~~in wethese ~~own~~trials.

●Protocols. ~~Because~~Before wecommencing ~~may~~human ~~from~~clinical ~~time~~trials, tothe ~~time~~sponsor of ~~maintain~~ a ~~significant~~new ~~percentage~~drug ofor ~~our~~therapeutic ~~assets~~product inmust ~~cash~~submit ~~and/or~~an ~~securities,~~IND weapplication ~~may~~to in the ~~future~~FDA. beThe ~~deemed~~application tocontains, beamong another ~~investment~~documents, ~~company~~what is ~~under~~known in the ~~Investment~~industry ~~Company~~as ~~Act~~a ofprotocol. ~~1940~~A ~~resulting~~protocol inis ~~additional~~the ~~costs~~blueprint ~~and~~for ~~regulatory~~each ~~burdens~~drug study. The protocol sets forth, among other things, the following:

● WeWho ~~may~~must ~~not~~be ~~realize~~recruited ~~the~~as ~~full~~qualified ~~benefit from our distribution license agreement with Medicox.~~participants,

● ~~The~~How ~~biotechnology~~often ~~and biopharmaceutical industries are characterized by rapid technological developments and a high degree of competition. We may be unable~~ to ~~compete~~administer ~~with~~the ~~more~~drug ~~substantial~~or ~~enterprises.~~product,

● ~~Healthcare~~What ~~policy~~tests ~~changes, including pending legislation recently adopted and further proposals still pending~~ to ~~reform~~perform on the ~~U.S. healthcare system~~participants, ~~may harm our future business.~~and

● WeWhat ~~face~~dosage ~~uncertainties~~of ~~related~~the drug or amount of the product to ~~Oravax’s~~give ~~oral~~to ~~COVID-19~~the ~~vaccine~~participants.

~~Risks~~Institutional Review Board. ~~Related~~An institutional review board is an independent committee of professionals and lay persons which reviews clinical research trials involving human beings and is required to ~~Our~~adhere ~~Real~~to ~~Estate~~guidelines ~~Investments~~issued by the FDA. The institutional review board does not report to the FDA, but its records are audited by the FDA. Its members are not appointed by the FDA. All clinical trials must be approved by an institutional review board. The institutional review board’s role is to protect the rights of the participants in the clinical trials. It approves the protocols to be used, the advertisements which we or CRO conducting the study proposes to use to recruit participants, and the form of consent which the participants will be required to sign prior to their participation in the clinical trials.

~~Risks~~Clinical Trials. Human ~~Related~~clinical totrials or testing of a potential product are generally done in three stages known as Phase 1 through Phase 3 testing. The names of the ~~Notes~~phases are derived from the regulations of the FDA. Generally, there are multiple trials conducted in each phase.

●Phase We1. ~~have~~Phase ~~lent~~1 trials involve testing a ~~substantial~~drug ~~amount~~or product on a limited number of ~~funds~~healthy or patient participants, typically 24 to ~~Scilex.~~100 Inpeople ~~the~~at ~~event~~a ~~that~~time. ~~Scilex~~Phase 1 istrials ~~unable~~determine toa ~~service~~product’s ~~its~~basic ~~obligations~~safety ~~under~~and how the ~~Note~~product ~~and~~is ~~defaults~~absorbed onby, ~~such~~and ~~Note~~eliminated from, itthe ~~could~~body. ~~have~~This aphase ~~material~~lasts an ~~adverse~~average ~~effect~~of onsix ~~our~~months ~~business~~to a year.

●Phase We2. Phase 2 trials involve testing of no more than 300 participants at a time who may ~~have~~suffer ~~difficulty~~from ~~realizing~~the targeted disease or condition. Phase 2 testing typically lasts an average of one to two years. In Phase 2, the ~~full~~drug ~~value~~is tested to determine its safety and effectiveness for treating a specific illness or condition. Phase 2 testing also involves determining acceptable dosage levels of the ~~Warrants~~drug. Phase 2 trials may be split into Phase 2a and Phase 2b sub-trials. Phase 2a trials may be conducted with patient volunteers and are exploratory (non-pivotal) trials, typically designed to evaluate clinical efficacy or biological activity. Phase 2b trials are conducted with patients defined to evaluate definite dose range and evaluate efficacy. If Phase 2 trials show that a new drug has an acceptable range of safety risks and probable effectiveness, a company will generally continue to review the substance in Phase 3 trials.

~~Risks~~Phase 3. Phase 3 trials ~~Related~~involve testing large numbers of participants, typically several hundred to ~~our~~several ~~Common~~thousand ~~Stock~~persons. The purpose is to verify effectiveness and long-term safety on a large scale. These trials generally last two to three years. Phase 3 trials are conducted at multiple locations or sites. Like the other phases, Phase 3 requires the site to keep detailed records of data collected and procedures performed.

~~● Future sales of our common stock by our existing stockholders could adversely affect our stock price.~~13

●Biological ~~Our~~License ~~failure~~Application. The results of the clinical trials for a biological product are submitted to ~~maintain~~the ~~compliance~~FDA ~~with~~as part of a Biological License Application or, the ~~Nasdaq~~“BLA”. ~~Capital~~Following ~~Market~~the completion of Phase 3 trials, assuming the sponsor of a potential product in the United States believes it has sufficient information to support the safety and effectiveness of its product, the sponsor will generally submit a BLA to the FDA requesting that the product be approved for marketing. The application is a comprehensive, multi-volume filing that includes the results of all clinical trials, information about the drug’s ~~continued~~composition, ~~listing~~and ~~requirements~~the ~~could~~sponsor’s ~~result~~plans for producing, packaging and labeling the product. The FDA’s review of an application can take a few months to many years, with the average review lasting 18 months. Once approved, drugs and other products may be marketed in the ~~delisting~~United States, subject to any conditions imposed by the FDA. Approval of ~~our~~a ~~common~~BLA ~~stock~~provides 12 years of exclusivity in the U.S. market.

●Phase As4. The FDA may require that the ~~market~~sponsor ~~price~~conduct additional clinical trials following new drug approval. The purpose of ~~our~~these ~~common~~trials, ~~stock~~known ~~may~~as ~~fluctuate~~Phase 4 ~~significantly~~trials, ~~this~~is ~~may~~to ~~make~~monitor itlong-term ~~difficult~~risks ~~for~~and ~~you~~benefits, tostudy ~~sell~~different ~~your~~dosage ~~shares~~levels or evaluate safety and effectiveness. In recent years, the FDA has increased its reliance on these trials. Phase 4 trials usually involve thousands of ~~common~~participants. ~~stock~~Phase ~~when~~4 ~~you~~trials ~~want~~also ormay be atinitiated ~~prices~~by ~~you~~us ~~find~~sponsoring ~~attractive~~the new drug to gain broader market value for an approved drug.

~~Risks~~European Regulation. Similar to ~~Related~~the U.S., a European sponsor of a biological product may submit a Marketing Approval Application to JVthe ~~Agreement~~European Medicines Agency (“EMA”), for the registration of the product. The approval process in Europe consists of several stages, which together are summed up to 210 days from the time of submission of the application (net, without periods in which the sponsor provides answers to questions raised by the agency) following which, a Marketing Approval may be granted. During the approval process, the sponsor’s manufacturing facilities will be audited in order to assess Good Manufacturing Practice compliance.

●The Ondrug ~~February~~approval 7,process is ~~2025~~time-consuming, weinvolves ~~and~~substantial ~~HTIT~~expenditures ~~entered~~of ~~into~~resources, aand JVdepends ~~Agreement~~upon ~~that~~a ~~amending~~number ~~the~~of ~~original agreement signed on January 22~~factors, ~~2024~~including or the ~~Supplemental~~severity ~~Agreement.~~of ~~If we fail to complete~~ the illness ~~transactions~~in ~~contemplated~~question, ~~under~~ the JVavailability ~~Agreement~~of asalternative ~~supplemented~~treatments, byand the ~~Supplemental~~risks ~~Agreement~~and ~~with HTIT, if such joint venture is not successful, or if we fail to realize the~~ benefits wedemonstrated ~~anticipate~~in ~~from such joint venture, we may not be able to capitalize on~~ the ~~full~~clinical ~~market potential of our drug products and technology~~trials.

●Other ~~We may not complete the transactions contemplated by the JV Agreement, as supplemented by the Supplemental Agreement.~~Regulations

●Various Wefederal, ~~may~~state ~~not~~and local ~~realize~~laws, regulations, and recommendations relating to safe working conditions, laboratory practices, the ~~anticipated~~experimental ~~benefits~~use ~~from~~of animals, the ~~Spin~~environment ~~Off~~and the purchase, storage, movement, import, export, use, and disposal of hazardous or potentially hazardous substances, including radioactive compounds and infectious disease agents, used in connection with our research are applicable to our activities. They include, among others, the ~~Spin~~U.S. ~~Off~~Atomic ~~could~~Energy ~~harm~~Act, the Clean Air Act, the Clean Water Act, the Occupational Safety and Health Act, the National Environmental Policy Act, the Toxic Substances Control Act, and Resources Conservation and Recovery Act, national restrictions on technology transfer, import, export, and customs regulations, and other present and possible future local, state, or federal regulation. The compliance with these and other laws, regulations and recommendations can be time-consuming and involve substantial costs. In addition, the extent of governmental regulation which might result from future legislation or administrative action cannot be accurately predicted and may have a material adverse effect on our business, financial condition, results of operations and prospects.

~~● Our business and assets will be less diversified following the Spin Off.~~Competition

14 We face intense competition in pharmaceutical research and development from major pharmaceutical companies, specialized biotechnology firms, academic institutions, and governmental agencies—many with substantially greater financial, technical, and marketing resources. Competition is determined by scientific and technological capabilities, patent protection, speed to market, regulatory approval, and ability to commercialize products. These entities also compete with us for qualified scientific personnel and consultants.

~~Risks~~In the diabetes treatment sector specifically, ~~Related~~we compete against well-established and rapidly evolving therapeutic options including insulin injections, insulin pumps, oral medications that improve insulin response or production, and the increasingly dominant GLP-1 receptor agonists (both injectable and oral formulations), as well as lifestyle interventions. The widespread adoption of GLP-1s for diabetes and weight management represents significant competitive pressure. First-to-market ~~Conducting~~products ~~Business~~typically inhold ~~Israel~~significant competitive advantages. Our competitive position depends on our ability to attract talent, develop effective proprietary products, obtain patent protection, and secure adequate capital. If approved, we expect our oral insulin capsule to compete primarily on efficacy, safety, patient convenience, and patent position.

●Competitors Wemay ~~are~~develop ~~affected~~superior products byor ~~the~~achieve ~~political~~greater market acceptance. There can be no assurance that our technology will not be rendered obsolete or noncompetitive, or ~~economic~~that ~~and~~we ~~military~~can ~~risks~~keep pace with technological developments, any of ~~having~~which ~~operations~~could inmaterially ~~Israel~~adversely affect our business, prospects, financial condition, and results of operations.

~~● It may be difficult to enforce a U.S. judgment against us or our officers and directors and to assert U.S. securities laws claims in Israel.~~14

~~General Risk Factors~~Employees

●We ~~Changes~~believe it is imperative to ~~tax~~attract ~~laws~~and ~~could~~retain ~~have~~top atalent ~~negative~~for ~~effect~~all onpositions usin orthe ~~our~~Company. ~~stockholders~~We seek to make Oramed an inclusive, diverse and safe workplace, with meaningful compensation, benefits and wellness programs and opportunities.

●We ~~Our~~have ~~business~~experienced personnel involved in our research and ~~operations~~development ~~would~~programs, ~~suffer~~as inwell as appropriate clinical/regulatory, quality assurance and other personnel needed to advance through clinical trials or have engaged the ~~event~~services of ~~computer~~experts ~~system~~in ~~failures~~the field for these requirements. As of December 31, ~~cyber-attacks~~2025, we have contracted with thirteen individuals for employment or ~~deficiencies~~consulting inarrangements. Of our ~~cyber-security~~staff, four are senior management, three are engaged in research and development work, and the remaining six are involved in corporate and administration work.

~~Risks~~We provide competitive compensation, ~~Related~~health and retirement programs for our employees. We offer variable pay in the form of bonuses and stock-based compensation for eligible employees. We also provide our employees with additional benefits such as team-building and educational offsite activities and gym facilities. We believe that this provides a comprehensive package to ~~Our~~engage, ~~Business~~motivate and retain our employees as a cohesive unit unified in its goal to achieve the Company’s strategy and objectives.

~~Our strategic~~Additional ~~review process may not be successful or timely.~~ Information

~~Following the~~Additional ~~results~~information ofabout us ~~the~~is ~~ORA-D-013-1~~contained ~~Phase~~on 3our ~~trial,~~Internet wewebsite ~~conducted~~at awww.oramed.com. ~~comprehensive~~Information ~~analysis~~on ofour ~~the~~website ~~data to understand if there~~ is anot ~~path~~incorporated ~~forward for~~by ~~our~~reference ~~oral~~into ~~insulin~~this ~~candidate~~report. Our WeAnnual ~~submitted~~Reports aon ~~protocol~~Form ~~ORA~~10-~~D-013-3 titled~~K, “AQuarterly ~~Double-Blinded,~~Reports ~~Placebo-controlled,~~on ~~Double~~Form ~~Dummy Multi~~10-~~center Randomized~~Q, ~~Phase~~Current 3Reports ~~Study~~on toForm ~~Evaluate~~8-K, ~~the efficacy~~ and ~~safety~~amendments into ~~subjects~~those ~~with~~reports ~~Type~~filed ~~2 Diabetes Mellitus with Inadequate~~or ~~Glycemic~~furnished ~~Control~~pursuant ~~on One~~ to ~~Three~~Section ~~Glucose-lowering~~13(a) ~~Agents”~~of to the ~~FDA~~Securities onExchange ~~September~~Act ~~12, 2024. We intend to initiate study during 2025. Concurrently, we are examining our existing pipeline and have commenced an evaluation process~~ of ~~potential strategic opportunities~~1934, ~~including~~ ~~among others, continuation~~ as ~~a stand-alone business~~amended, ~~capital raises,~~ or ~~one~~the orExchange ~~more acquisitions~~Act, ~~mergers~~are oravailable ~~business~~free ~~combinations~~of charge oron ~~other~~our ~~strategic~~website ~~transactions.~~under ~~Potential~~“SEC ~~counterparties~~Filings” inas asoon ~~strategic~~as ~~transaction~~reasonably ~~involving~~practicable usafter ~~may~~we ~~place~~electronically ~~minimal~~file orsuch nomaterial ~~value~~with, ~~on our~~or ~~assets.~~furnish ~~While~~it ~~we are devoting significant efforts~~ to ~~identify and evaluate potential strategic alternatives~~, ~~there~~the ~~can~~SEC. beReports nofiled ~~assurance that~~with ~~this~~the ~~strategic~~SEC ~~review~~are ~~process~~made ~~will~~available ~~result in us pursuing any transaction or that any transaction, if pursued, will be completed~~ on ~~attractive~~its ~~terms~~website or at ~~all~~www.sec.gov ~~Additionally,~~and ~~there~~are ~~can~~also beavailable noon ~~assurances~~the ~~that any particular course of action, business arrangement or~~website ~~transaction, or series~~ of ~~transactions,~~the ~~will~~Israeli beSecurities ~~pursued,~~Authority ~~successfully~~at ~~consummated,~~www.magna.isa.gov.il or ~~lead to any stockholder value. Any potential transaction would be dependent~~ on ~~a number of factors that may be beyond our control, including, among other things, market conditions, industry trends,~~ the ~~interest~~website of ~~third parties in a potential transaction with us, obtaining stockholder approval and~~ the ~~availability~~Tel ofAviv ~~financing to~~Stock ~~third~~Exchange ~~parties~~at ~~in a potential transaction with us on reasonable terms~~www.tase.co.il. The ~~process of reviewing alternative strategic paths may be~~following ~~time~~corporate ~~consuming,~~governance ~~may~~documents involve the dedication of significant resources and may require us to incur significant costs and expenses. It could negatively impact our ability to attract, retain and motivate employees, and expose us to potential litigation in connection with this process or any resulting transaction. If we are ~~not~~also ~~successful~~posted inon ~~setting forth a new strategic path for the Company, or if~~ our ~~plans are~~website: ~~not~~Code ~~executed~~of ~~in a timely fashion~~Ethics, ~~this~~Whistleblowing ~~may~~Policy ~~cause reputational harm with our stockholders~~ and ~~other~~the ~~stakeholders~~charters ~~and~~for ~~the~~each ~~value~~ of the ~~our~~Audit ~~securities may be adversely impacted. In addition~~Committee, ~~speculation~~Compensation ~~regarding~~Committee ~~any developments related to the review of strategic alternatives~~ and ~~perceived~~Nominating ~~uncertainties~~Committee ~~related to the future~~ of ~~the Company could cause~~ our ~~stock price to fluctuate significantly~~Board. ~~There can be no guarantee that the process of evaluating alternative strategic paths will result in our entering into or completing potential transactions within the anticipated timing or at all.~~

~~If we~~ITEM ~~are~~1A. ~~successful~~RISK ~~in completing a strategic transaction, we may be exposed to other operational and financial risks~~FACTORS.

~~Although there~~An ~~can~~investment bein noour securities ~~assurance~~involves ~~that~~ a ~~strategic~~high ~~transaction~~degree ~~will~~of ~~result~~risk. ~~from~~You ~~the~~should ~~process~~consider wecarefully ~~have~~the ~~undertaken~~following toinformation ~~identify~~about ~~and~~these ~~evaluate strategic alternatives~~risks, ~~the~~together ~~negotiation~~with ~~and~~the other ~~consummation~~information ofcontained ~~any~~in ~~such~~this ~~transaction~~Annual ~~will~~Report ~~require significant time~~ on ~~the~~Form ~~part~~10-K ofbefore ~~our~~making ~~management~~an ~~and may~~investment ~~disrupt~~decision. ~~our~~Our business., ~~The~~prospects, ~~negotiation~~financial condition and ~~consummation~~results of ~~any~~operations ~~such transaction~~ may ~~also~~be ~~require~~materially ~~more~~and ~~time~~adversely oraffected ~~greater~~as ~~cash~~a ~~resources than~~result weof ~~anticipate~~any ~~and~~of ~~expose~~the usfollowing torisks. ~~other~~The ~~operational~~value ~~and~~of our ~~financial~~securities ~~risks,~~could ~~including:~~decline ~~increased~~as ~~near-term~~a ~~and~~result ~~long-term~~of ~~expenditures; exposure~~any toof ~~unknown~~these ~~liabilities;~~risks. ~~higher~~You ~~than~~could ~~expected~~lose ~~acquisition~~all or ~~integration~~part ~~costs;~~of ~~incurrence~~your ofinvestment ~~substantial~~in ~~debt~~our orsecurities. ~~dilutive~~Some ~~issuances~~ of ~~equity~~the ~~securities~~statements toin ~~fund~~this ~~future~~“Item ~~operations;~~1A. ~~write-downs~~Risk ofFactors” ~~assets~~are ~~or goodwill or incurrence of non~~forward-~~recurring,~~looking ~~impairment or~~statements. ~~other~~The ~~charges;~~following ~~increased~~risk ~~amortization~~factors ~~expenses;~~are ~~impairment~~not ofthe only ~~relationships~~risk ~~with~~factors ~~key~~facing ~~suppliers~~the ofCompany. ~~any~~Additional ~~acquired~~risks ~~business due~~and touncertainties ~~changes~~not inpresently ~~management~~known ~~and ownership; inability~~ to ~~retain~~us ~~our~~or ~~key~~that ~~employees;~~we ~~and~~currently ~~possibility~~deem ~~of future litigation. Any~~immaterial ofmay ~~the~~also ~~above~~affect ~~risks could have a material adverse effect on~~ our business, prospects, financial condition, and ~~prospects~~results of operations.

15Summary Risk Factors

~~Our ability~~Risks toRelated ~~consummate a strategic transaction depends on our ability~~ to ~~retain~~Our ~~our employees required to consummate such transaction.~~Business

● Our ~~ability~~ ~~to consummate a~~ strategic ~~transaction~~review ~~depends~~process ~~upon our ability to retain our employees required to consummate such a transaction, the loss of whose services~~ may ~~adversely~~not ~~impact~~be ~~the~~successful ~~ability~~or ~~to consummate such transaction~~timely. Our cash conservation activities may yield unintended consequences, such as attrition and reduced employee morale, which may cause remaining employees to seek alternative employment. Our ability to successfully complete a strategic transaction depends in large part on our ability to retain certain of our remaining personnel. If we are unable to successfully retain our remaining personnel, we are at risk of a disruption to our exploration and consummation of a strategic alternative as well as business operations.

~~We may~~● ~~become~~If ~~involved~~we inare ~~securities~~successful ~~and~~in ~~stockholder~~completing ~~litigation~~a ~~that~~strategic ~~could divert management’s attention and harm the Company’s business~~transaction, ~~and~~we ~~insurance coverage~~ may ~~not~~ be ~~sufficient~~exposed to ~~cover~~other ~~all~~operational ~~costs~~ and ~~damages.~~financial risks

In the past, securities and stockholder litigation has often followed certain significant business transactions, such as the sale of a company or announcement of any other strategic transaction, or the announcement of negative events, such as negative results from clinical trials. The market price of our common stock dropped substantially when we announced the results of the ORA-D-013-1 Phase 3 trial. We may be exposed to such litigation even if no wrongdoing occurred. Litigation is usually expensive and diverts management’s attention and resources, which could adversely affect our business and cash resources and our ability to consummate a potential strategic transaction or the ultimate value our stockholders receive in any such transaction.15

~~We continue,~~● ~~and~~Our inability ~~the~~to ~~future~~consummate ~~expect,~~a strategic transaction depends on our ability to ~~incur~~retain ~~losses~~our employees required to consummate such transaction.

~~Successful evaluation~~● ~~and~~We ~~completion~~may ofbecome ~~our~~involved ~~remaining~~in ~~development~~securities ~~programs~~ and ~~our~~stockholder ~~transition~~litigation tothat ~~normal~~could ~~operations~~divert ~~are~~management’s ~~dependent~~attention ~~upon~~and ~~obtaining necessary~~harm ~~regulatory approvals from~~ the ~~FDA~~Company’s ~~prior to selling our products within the United States~~business, and ~~foreign~~insurance ~~regulatory~~coverage ~~approvals must be obtained to sell our products internationally. There can be no assurance that we will receive regulatory approval of any of our product candidates, and a substantial amount of time~~ may ~~pass~~not before we achieve a level of revenues adequate to support our operations. We expect to incur substantial expenditures in connection with our research and development programs, our strategic evaluation process, as well as the regulatory approval process with FDA and other agencies for each of our current or future product candidates during their respective developmental periods. Obtaining marketing approval will be ~~directly~~sufficient ~~dependent on our ability~~ to ~~implement~~cover ~~the~~all ~~necessary~~costs ~~regulatory steps required to obtain marketing approval in the United States~~ and ~~in other countries~~damages. ~~We cannot predict the outcome of these activities.~~

~~Based on~~● ~~our~~We ~~current~~have ~~cash~~a ~~resources~~history ~~and~~of ~~commitments,~~losses weand ~~believe~~may wenot ~~will~~ be able to ~~maintain~~sustain ~~our~~profitability current planned activities and the corresponding level of expenditures for at least the next 12 months, although no assurance can be given that we will not need additional funds prior to such time. If there are unexpected increases in ~~our operating expenses, we may need to seek additional financing during~~ the ~~next 12 months~~future.

● We ~~may~~ ~~need~~have ~~substantial~~a ~~additional~~history ~~capital~~of inlosses ~~order~~and tocan ~~satisfy~~provide no assurance as to our ~~business~~future ~~objectives~~operating results.

~~To date,~~● weWe ~~have~~rely ~~financed~~upon ~~our~~patents ~~operations~~to ~~principally~~protect ~~through~~our ~~offerings~~technology ~~of securities~~ and we may ~~require~~be ~~substantial~~unable ~~additional financing at various intervals in order~~ to ~~implement~~protect ~~any potential strategic alternative, to continue~~ our ~~remaining or potential future research and development programs, including significant requirements for operating expenses including~~ intellectual property ~~protection~~rights and enforcement, for pursuit of regulatory approvals, and for commercialization of our remaining or future products. We can provide no assurance that additional funding will be available on a timely basis, on terms acceptable to us, or at all. In the event that we ~~are unable to obtain such financing, we~~ may ~~not~~ be ~~able~~liable tofor ~~implement~~infringing the ~~actions~~intellectual weproperty ~~decide~~rights ~~to take as part~~ of ~~our strategic review process, and we will not be able to fully develop and commercialize our technology or pursue new technology~~others. ~~Our future capital requirements will depend upon many factors, including:~~

● ~~the~~Even ~~results~~if ofwe succeed in commencing a new clinical trial for our ~~strategic~~oral ~~review~~insulin ~~process~~capsule, ~~and~~there ~~any~~are ~~new~~a ~~strategic~~variety ~~direction~~of werisks ~~decide~~and uncertainties related to ~~take;~~its development.

● ~~continued~~We ~~scientific~~have ~~progress~~limited experience in ~~our~~conducting ~~research~~clinical trials and ~~development~~our ~~programs;~~clinical trials may encounter delays, suspensions or other problems.

● ~~costs~~Initial ~~and~~success ~~timing~~in ofthe ~~conducting~~completed and ongoing early-stage clinical trials ~~and~~does ~~seeking~~not ensure success in later stage trials, regulatory ~~approvals~~approval ~~and~~or ~~patent~~commercial ~~prosecutions;~~viability of a product.

● ~~competing~~We ~~technological~~can ~~and~~provide ~~market~~no ~~developments;~~assurance that our products will obtain regulatory approval or that the results of clinical trials will be favorable.

● ~~our~~We ~~ability~~are todependent ~~establish~~upon ~~additional~~third ~~collaborative~~party ~~relationships;~~suppliers of our raw materials and for other services.

● ~~effects~~We ofmay ~~commercialization~~not ~~activities~~realize ~~and~~a ~~facility~~return ~~expansions~~on ifour ~~and~~investments asin ~~required~~marketable securities that we own.

16● Because we may from time to time maintain a significant percentage of our assets in cash and/or securities, we may in the future be deemed to be an investment company under the Investment Company Act of 1940 resulting in additional costs and regulatory burdens.

~~If we~~● ~~cannot~~We ~~secure adequate financing when needed, we~~ may benot ~~required~~realize tothe ~~delay,~~full ~~scale~~benefit ~~back~~from ~~or eliminate one or more of~~ our ~~existing~~distribution ~~or planned courses of action or research and development programs, or to enter into~~ license oragreement ~~other arrangements~~ with ~~third parties to commercialize products or technologies that we would otherwise seek to develop ourselves and commercialize ourselves~~Medicox. In such event, our business, prospects, financial condition and results of operations may be adversely affected as we may be required to scale-back, eliminate, or delay development efforts or product introductions or enter into royalty, sales or other agreements with third parties in order to commercialize our products.

● We ~~have~~ aare ~~history~~highly ofdependent ~~losses~~upon ~~and~~our ~~can~~ability ~~provide~~to noenter ~~assurance~~into asagreements with collaborative partners to ~~our~~develop, ~~future~~commercialize ~~operating~~and ~~results~~market our products.

We● doThe ~~not~~biotechnology ~~have sufficient revenues from our research~~ and ~~development activities~~biopharmaceutical toindustries ~~fully~~are ~~support~~characterized ~~our~~by ~~operations.~~rapid ~~Consequently,~~technological wedevelopments ~~have incurred net losses since inception. We currently have only licensing revenues~~ and noa ~~product~~high ~~revenues,~~degree ~~and may not succeed in developing or commercializing any products which could generate product revenues. We do not expect to have any products on the market for several years. In addition, development~~ of ~~our product candidates requires a process of pre-clinical and clinical testing, during which our products could fail~~competition. ~~For example, in January 2023, the ORA-D-013-1 Phase 3 trial did not meet its primary or secondary endpoints.~~ We may ~~not~~ be ~~able~~unable to ~~enter~~compete ~~into agreements~~ with ~~one or~~ more ~~companies~~substantial ~~experienced in the manufacturing and marketing of therapeutic drugs and, to the extent that we are unable to do so, we will not be able to market our product candidates~~enterprises. Eventual profitability will depend on our success in developing, manufacturing, and marketing our product candidates or in pursuing a successful strategic alternative. As of December 31, 2024 and 2023, we had working capital of approximately $137,536,000 and approximately $109,370,000, respectively, and stockholders’ equity of approximately $146,265,000 and approximately $163,821,000, respectively. See “Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations.”

~~We rely~~● ~~upon~~Our ~~patents~~financial toposition ~~protect~~or ~~our~~results ~~technology~~could be negatively affected by product liability claims.

~~The patent~~● ~~position of biopharmaceutical and biotechnology firms is generally uncertain and involves complex legal and factual questions.~~ We do not know whether any of our current or future patent applications will result in the issuance of any patents. Even issued patents may be challenged, invalidated or circumvented. Patents may not provide a competitive advantage or afford protection against competitors with similar technology. Competitors or potential competitors may have ~~filed~~limited ~~applications~~senior ~~for,~~management orresources ~~may have received patents~~ and may ~~obtain additional~~be ~~and~~required ~~proprietary rights~~ to ~~compounds~~obtain ormore ~~processes~~resources ~~used by or competitive with ours. In addition, laws of certain foreign countries do not protect intellectual property rights~~ to ~~the~~manage ~~same~~our ~~extent as do the laws of the United States~~growth.

~~Patent litigation~~● is widespread in the biopharmaceutical and biotechnology industry and we cannot predict how this will affect our efforts to form strategic alliances, conduct clinical testing or manufacture and market any products under development. If challenged, our patents may not be held valid. We ~~could~~depend ~~also~~upon ~~become involved in interference proceedings in connection with one or more of~~ our ~~patents~~senior ormanagement ~~patent applications to determine priority of invention. If we become involved in any litigation, interference or other administrative proceedings, we will likely incur substantial expenses~~ and ~~the~~skilled ~~efforts~~personnel ~~of our technical~~ and ~~management~~their ~~personnel~~loss ~~will~~or beunavailability ~~significantly diverted. In addition, an adverse determination~~ could ~~subject~~put us ~~to significant liabilities or require us to seek licenses that may not be available on favorable terms, if~~ at ~~all. We may be restricted or prevented from manufacturing and selling our products in the event of an adverse determination in~~ a ~~judicial~~competitive ~~or administrative proceeding or if we fail to obtain necessary licenses~~disadvantage.

17● Our existing and any future joint ventures may limit our flexibility with jointly owned investments and we may not realize the benefits we expect from these arrangements.

~~We may be unable to protect our intellectual property rights and we may be liable for infringing the intellectual property rights of others.~~16

~~Our ability~~● toFluctuations ~~compete~~in ~~effectively~~interest ~~will~~rates ~~depend~~could onreduce our ability to ~~maintain~~generate ~~the~~income ~~proprietary~~on ~~nature of~~ our ~~technologies.~~loans ~~We currently hold several pending patent applications in the United States, Canada, Brazil, Europe, India, Hong Kong, Japan~~ and ~~China for our technologies covering oral administration of insulin and~~ other ~~proteins and oral administration of exenatide and proteins and 140 patents issued by the United States and various other countries’ patent offices that cover a part of our technology~~investments, which ~~allows~~could ~~for~~lead ~~the~~to oral delivery of proteins; patents issued by various patent offices that cover part of our technology for the oral delivery of exenatide; and patents issued by patent offices for treating diabetes. Further, we rely on a ~~combination~~significant ofdecrease ~~trade secrets and non-disclosure and other contractual agreements and technical measures to protect our rights~~ in our technology. We depend upon confidentiality agreements with our officers, directors, employees, consultants, and subcontractors, as well as collaborative partners, to maintain the proprietary nature of our technology. These measures may not afford us sufficient or complete protection, and others may independently develop technology similar to ours, otherwise avoid our confidentiality agreements, or produce patents that would materially and adversely affect our business, prospects, financial condition and results of operations~~. We believe that our technology is not subject to any infringement actions based upon the patents of any third parties; however~~, ~~our~~cash ~~technology~~flows ~~may in the future be found to infringe upon the rights of others. Others may assert infringement claims against us or against companies to which we have licensed our technology,~~ and if we should be found to infringe upon their patents, or otherwise impermissibly utilize their intellectual property, our ability to continue to use our technology could be materially restricted or prohibited. If this event occurs, we may be required to obtain licenses from the ~~holders~~market ofvalue ~~this intellectual property, enter into royalty agreements, or redesign our products so as not to utilize this intellectual property, each~~ of which may prove to be uneconomical or otherwise impossible. Licenses or royalty agreements required in order for us to use this technology may not be available on terms acceptable to us, or at all. These claims could result in litigation, which could materially adversely affect our ~~business, prospects, financial condition and results of operations~~investments. ~~Further, we may need to indemnify companies to which we licensed our technology in the event that such technology is found to infringe upon the rights of others.~~

~~Our commercial~~● ~~success~~Healthcare ~~will~~policy ~~also~~changes, ~~depend~~including ~~significantly~~pending onlegislation ~~our~~recently ~~ability~~adopted ~~to operate without infringing the patents~~ and ~~other~~further ~~proprietary~~proposals ~~rights of~~still ~~third~~pending ~~parties.~~to ~~Patent~~reform ~~applications are, in many cases, maintained in secrecy until patents are issued. The publication of discoveries in~~ the ~~scientific or patent literature frequently occurs substantially later than the date on which the underlying discoveries were made and patent applications are filed~~U.S. Inhealthcare ~~the event of infringement or violation of another party’s patent~~system, we may beharm ~~prevented~~our ~~from pursuing~~future ~~product development or commercialization~~business. ~~See “Item 1. Business—Description of Business— Intellectual Property and Patents.”~~

~~Our success~~● ~~was~~We ~~primarily~~are ~~dependent~~exposed onto ~~the~~fluctuations ~~successful~~in ~~commercialization~~currency ofexchange ~~our oral insulin capsule~~rates.

~~The successful~~● ~~commercialization~~Our ofvarious ~~our~~real ~~principal~~estate ~~product,~~investments ~~the~~involve ~~oral~~significant ~~insulin~~risks ~~capsule,~~and ~~was~~might ~~crucial for our success. On January 12, 2023, we announced top-line results from the phase 3 trial of our oral insulin capsule, which did~~ not ~~meet~~provide ~~its primary or secondary endpoints, and indicated that we expect to discontinue oral insulin clinical activities for T2D. At present, following the results of the ORA~~long-~~D-013-1 Phase~~term 3value ~~trial,~~appreciation ~~we conducted a comprehensive analysis of the data~~ and found that subpopulations of patients with pooled specific parameters responded well to oral insulin. Based on this analysis, we submitted a protocol for a new Phase 3 clinical trial to the FDA. . Concurrently, we are examining our existing pipeline and have commenced an evaluation process of potential ~~strategic~~income ~~opportunities.~~streams ~~Even~~that if we ~~succeed in~~expect ~~commencing a new clinical trial for our oral insulin capsule, there are a variety of risks and uncertainties related~~ to ~~its development~~receive. ~~Principally, these risks include the following:~~

● ~~Future~~We ~~clinical~~have ~~trial~~lent ~~results~~a ~~may~~substantial ~~show~~amount of funds to Scilex. In the ~~same~~event that Scilex is unable to service its obligations under the Note and defaults on such Note, it could have a material adverse effect on our business. ● If Alpha Tau fails to achieve positive clinical results asor obtain regulatory approvals, the ~~ORA-D-013-1~~value ~~Phase~~of 3our ~~trial;~~investment could decline materially, which may adversely affect our financial results.

● ~~Future~~The ~~clinical~~value ~~trial~~of ~~results may be inconsistent with previous preliminary testing results and data from~~ our ~~earlier~~investment ~~trials~~into Lifeward may ~~be inconsistent with clinical data;~~decline.

18Risks Related to our Common Stock

● ~~Even~~Future ifsales of our ~~oral~~common ~~insulin~~stock ~~capsule~~by isour ~~shown~~existing tostockholders becould ~~safe~~adversely ~~and~~affect ~~effective~~our ~~for~~stock ~~its intended purposes in future clinical trials, we may face significant or unforeseen difficulties in obtaining or manufacturing sufficient quantities or at reasonable prices;~~price.

● Our ~~ability~~failure to ~~complete~~maintain ~~the~~compliance ~~development~~with ~~and commercialization of~~ the ~~oral~~Nasdaq ~~insulin~~Capital ~~capsule~~Market’s ~~for~~continued ~~our~~listing ~~intended~~requirements ~~use~~could isresult ~~significantly~~in ~~dependent upon our ability to obtain and maintain experienced and committed partners to assist us with obtaining clinical and regulatory approvals for, and~~ the ~~manufacturing,~~delisting ~~marketing and distribution~~ of, ~~the~~our ~~oral~~common ~~insulin capsule on a worldwide basis;~~stock.

● ~~Even~~As ifthe ~~our~~market ~~oral~~price ~~insulin~~of ~~capsule~~our iscommon ~~successfully~~stock ~~developed~~may fluctuate significantly, ~~commercially~~this ~~produced~~may ~~and~~make ~~receives~~it ~~all~~difficult ~~necessary~~for ~~regulatory~~you ~~approvals,~~to ~~there~~sell isyour noshares ~~guarantee~~of ~~that~~common ~~there~~stock ~~will~~when beyou ~~market~~want ~~acceptance~~or ofat ~~our~~prices ~~product;~~you ~~and~~find attractive.

● ~~Our~~Future ~~competitors~~sales ~~may~~of ~~develop~~common ~~therapeutics~~stock or ~~other~~the ~~treatments~~issuance ~~which~~of ~~are~~securities ~~superior~~senior to our common stock or ~~less~~convertible ~~costly~~into, ~~than~~or exchangeable or exercisable for, our ~~own~~common ~~with~~stock ~~the~~could ~~result~~materially ~~that~~adversely ~~our~~affect ~~products,~~the ~~even~~trading ifprice ~~they~~of ~~are~~our ~~successfully~~common ~~developed~~stock, ~~manufactured~~ and ~~approved,~~our ~~may~~ability ~~not~~to ~~generate~~raise ~~significant~~funds ~~revenues~~in new equity offerings.

● Our ~~business~~ stockholders may beexperience ~~seriously~~significant ~~harmed~~dilution ifas ~~our analysis does not produce positive results, if we are unable to find~~ a ~~path~~result ~~forward to continue development~~ of ~~our oral insulin capsule, if we are unsuccessful in realizing new strategic opportunities or dealing with~~ any ofadditional ~~these risks,~~financing orusing ~~if we are unable to successfully commercialize~~ our ~~oral~~equity ~~insulin capsule for some other reason~~securities.

~~We have~~Risks ~~limited~~Related ~~experience~~to inConducting ~~conducting~~Business ~~clinical~~in ~~trials.~~Israel

~~Clinical trials~~● ~~must meet FDA and foreign regulatory requirements.~~ We ~~have~~are ~~limited~~affected ~~experience~~by ~~in designing, conducting and managing~~ the ~~preclinical trials and clinical trials necessary to obtain regulatory approval for our product candidates in any country. In the past~~political, weeconomic ~~entered into agreements with Integrium LLC~~ and ~~other~~military ~~consultants~~risks toof ~~assist~~having usoperations in ~~designing, conducting and managing our various clinical trials in the United States, Europe and~~ Israel. ~~Any failure of a consultant to fulfill their obligations could result in significant additional costs as well as delays in designing, consulting and completing clinical trials on our products.~~

~~Our clinical~~● ~~trials~~It may ~~encounter~~be ~~delays,~~difficult ~~suspensions~~to enforce a U.S. judgment against us or ~~other~~our ~~problems~~officers and directors and to assert U.S. securities laws claims in Israel.

We may encounter problems in clinical trials that may cause us or the FDA or foreign regulatory agencies to delay, suspend or terminate our clinical trials at any phase. These problems could include the possibility that we may not be able to conduct clinical trials at our preferred sites, enroll a sufficient number of patients for our clinical trials at one or more sites or begin or successfully complete clinical trials in a timely fashion, if at all. For example, the rate of enrollment for our Phase 1 clinical trial for our oral COVID-19 vaccine in South Africa was slower than anticipated due to several factors, including the fact that many volunteers did not qualify during screening due to prior asymptomatic COVID-19 infection and other conditions, and as a result we had to add an additional clinical site. Furthermore, we, the FDA or foreign regulatory agencies may suspend clinical trials at any time if we or they believe the subjects participating in the trials are being exposed to unacceptable health risks or if we or they find deficiencies in the clinical trial process or conduct of the investigation. If clinical trials of any of the product candidates fail, we will not be able to market the product candidate which is the subject of the failed clinical trials. The FDA and foreign regulatory agencies could also require additional clinical trials, which would result in increased costs and significant development delays. Our failure to adequately demonstrate the safety and effectiveness of a pharmaceutical product candidate under development could delay or prevent regulatory approval of the product candidate and could have a material adverse effect on our business, prospects, financial condition and results of operations. For example, see “Item 1. Business—Description of Business— Research and Development” regarding the results of the ORA-D-013-1 Phase 3 trial that did not meet its primary or secondary endpoints. Finally, the COVID-19 pandemic impacted clinical trials generally in recent years, and we experienced approximately six months of delays in clinical trials due to slow-downs of recruitment for trials generally related to COVID-19. We may experience further delays in site initiation and patient enrollment, failures to comply with study protocols, delays in the manufacture of our product candidates for clinical testing and other difficulties in starting or competing our clinical trials.17

19General Risk Factors

~~Initial success~~● inChanges ~~the~~to ~~completed~~tax ~~and~~laws ~~ongoing~~could ~~early-stage~~have ~~clinical~~a ~~trials~~negative ~~does~~effect ~~not~~on ~~ensure~~us ~~success in later stage trials, regulatory approval~~ or ~~commercial~~ ~~viability~~our ~~of a product~~stockholders.

~~Positive results~~● inOur abusiness clinical trial may not be replicated in subsequent or confirmatory trials. Additionally, success in preclinical work or early stage clinical trials does not ensure that later stage or larger scale clinical trials will be successful or that regulatory approval will be obtained. Any of our product’s failure to show sufficient efficacy in patients with the targeted indication, or if such studies are discontinued for any other reason, could negatively impact our development and ~~commercialization~~operations ~~goals~~would ~~for~~suffer ~~these products and our stock price could decline. Many companies~~ in the ~~biopharmaceutical~~event ~~industry have suffered significant setbacks in advanced clinical trials due to lack~~ of ~~efficacy~~computer orsystem ~~adverse safety profiles~~failures, ~~notwithstanding~~cyber-attacks promising results in earlier trials. As a result, preliminary and interim data should be viewed with caution until the final data are available. We have invested in clinical studies of medicines that have not met the primary clinical endpoints in their Phase 3 studies or ~~have~~deficiencies ~~been discontinued for other reasons. For example,~~ in ~~January~~ ~~2023,~~our ~~we reported that ORA~~cyber-~~D-013-1 trial did not meet its primary or secondary endpoint~~security. ~~Even if later stage clinical trials are successful, regulatory authorities may delay or decline approval of our product candidates.~~

~~There are~~● aOur ~~number~~management ofwill ~~factors~~have ~~that~~significant ~~could~~flexibility cause a clinical study to fail or be delayed, including: (i) the clinical study may produce negative or inconclusive results; (ii) regulators may require that we hold, suspend or terminate clinical research for noncompliance with regulatory requirements; (iii) we, our partners, the FDA or foreign regulatory authorities could suspend or terminate a clinical study due to adverse side effects of a product on subjects or lack of efficacy in ~~the~~using trial; (iv) we, or our partners, may decide, or regulators may require us, to conduct additional preclinical testing or clinical studies; (v) change in rates of enrollment and dropout among clinical trial participants; (vi) differences in the ~~size~~net ~~and~~proceeds ~~type~~ of the patient populations; (vii) changes in and adherence to the dosing regimen and other clinical trial protocols; and (viii) people who enroll in the clinical study may later drop out due to adverse events, a perception they are not benefiting from participating in the study, fatigue with the clinical study process or personal or other issues. The occurrence of any ofoffering ~~these events could result in significant costs and expense, have an adverse effect on our business, financial condition and results~~ of ~~operations and/or cause our stock price to decline or experience periods of volatility~~securities.

~~Clinical trials~~● ofDelaware ~~our~~law ~~products~~could ~~conducted~~discourage a change in control, or an acquisition of us by a third ~~parties~~party, ~~may~~even ~~encounter~~if ~~delays,~~the ~~suspensions~~acquisition orwould ~~other~~be ~~problems~~favorable to you, and ~~are~~thereby ~~outside~~adversely ofaffect ~~our~~existing ~~control~~stockholders.

~~Third parties~~Risks ~~who~~Related ~~conduct clinical trials of our products may encounter problems that may cause delays, suspensions or other problems at any phase. These problems could include the possibility that they may not be able~~ to ~~conduct~~Our clinical trials at their preferred sites, enroll a sufficient number of patients for their clinical trials at one or more sites or begin or successfully complete clinical trials in a timely fashion, if at all. For example, the rate of enrollment for our Phase 1 clinical trial for our oral COVID-19 vaccine in South Africa was slower than anticipated due to several factors, including the fact that many volunteers did not qualify during screening due to prior asymptomatic COVID-19 infection and other conditions, and as a result we had to add an additional clinical site. In addition, these third parties are not controlled by us and may conduct these trials in a manner in which we disagree or which may prove to be unsuccessful. Furthermore, domestic or foreign regulatory agencies may suspend clinical trials at any time if they believe the subjects participating in the trials are being exposed to unacceptable health risks or if they find deficiencies in the clinical trial process or conduct of the investigation. If such clinical trials conducted by third parties fail, it could have a material adverse effect on our business, prospects, financial condition and results of operations.Business

20Our strategic review process may not be successful or timely.

~~We can~~Following ~~provide~~the noJanuary ~~assurance~~2023 results indicating that ~~our~~the ~~products~~ORA-D-013-1 ~~will~~Phase ~~obtain~~3 ~~regulatory~~trial ~~approval~~did not meet its primary or ~~that~~secondary endpoints, we conducted a comprehensive analysis of the ~~results~~data to understand if there is a path forward for our oral insulin candidate. Concurrently, we are examining our existing pipeline and have commenced an evaluation process of ~~clinical~~potential ~~trials~~strategic ~~will~~opportunities, beincluding ~~favorable~~among others, continuation as a stand-alone business, capital raises, or one or more acquisitions, mergers or business combinations or other strategic transactions.

~~The testing,~~While ~~marketing~~we ~~and~~are ~~manufacturing~~devoting ~~of any of our products will require the approval of the FDA or regulatory agencies of other countries.~~significant Weefforts ~~cannot~~to ~~predict~~identify ~~with~~and ~~any~~evaluate ~~certainty~~potential ~~the~~strategic ~~amount~~alternatives, ofthere ~~time~~can ~~necessary~~be tono ~~obtain~~assurance ~~regulatory~~that ~~approvals,~~our ~~including~~strategic ~~from~~review ~~the~~process ~~FDA~~will ~~or other foreign~~result ~~regulatory~~in ~~authorities,~~us ~~and~~pursuing ~~whether~~ any ~~such~~transaction ~~approvals~~or ~~will~~that ~~ultimately be granted. In~~ any ~~event~~transaction, ~~review~~if ~~and~~pursued, ~~approval~~will bybe ~~the~~completed ~~regulatory bodies~~on isattractive ~~anticipated~~terms toor ~~take~~at ~~a number of years~~all. ~~Preclinical~~Additionally, ~~and~~there can ~~clinical~~be ~~trials~~no ~~may~~assurances ~~reveal~~ that ~~one~~any orparticular ~~more~~course of ~~our~~action, ~~products~~business ~~are~~arrangement ~~ineffective~~ or ~~unsafe~~transaction, inor ~~which~~series ~~event further development~~ of ~~such~~transactions, ~~products~~will ~~could~~ be ~~seriously delayed or terminated. For example~~pursued, successfully ~~in January 2023~~consummated, we ~~announced~~or ~~that~~lead ~~our~~to ~~ORA-D-013-1~~any ~~Phase~~stockholder ~~3 trial did not meet its primary or secondary endpoints~~value. AsAny apotential ~~result,~~transaction wewould ~~decided~~be todependent ~~terminate our~~on ~~ORA-D-013-2 Phase 3 trial, conducted~~ a ~~comprehensive~~number ~~analysis~~ of ~~the~~factors ~~data and found~~ that may ~~subpopulations~~be ofbeyond ~~patients~~our ~~with~~control, ~~pooled specific parameters~~including, ~~responded~~among ~~well~~other tothings, ~~oral~~market ~~insulin.~~conditions, ~~Based~~industry ~~on this analysis~~trends, wethe ~~submitted~~interest aof ~~protocol~~third ~~for~~parties in a ~~new~~potential transaction ~~Phase~~with ~~3 clinical trial to the FDA. Moreover~~us, obtaining stockholder approval ~~for~~and ~~certain products may require~~ the ~~testing~~availability onof ~~human~~financing ~~subjects~~to ofthird ~~substances~~parties ~~whose~~in ~~effects~~a onpotential ~~humans~~transaction ~~are~~with ~~not~~us ~~fully~~on ~~understood~~reasonable ~~or documented~~terms. ~~Delays~~The inprocess ~~obtaining necessary regulatory approvals~~ of ~~any~~reviewing ~~proposed~~alternative ~~product~~strategic ~~and~~paths ~~failure~~may tobe ~~receive such~~time ~~approvals~~consuming, ~~would~~may ~~have~~involve ~~an adverse effect on~~ the ~~product’s~~dedication ~~potential~~of ~~commercial~~significant resources ~~success~~ and onmay ~~our~~require ~~business,~~us ~~prospects,~~to ~~financial condition~~incur ~~and~~significant ~~results~~costs ofand ~~operations~~expenses. InIt ~~addition,~~could itnegatively isimpact ~~possible~~our ~~that~~ability ~~a product may be found~~ to beattract, ~~ineffective~~retain orand ~~unsafe due to conditions~~motivate oremployees, ~~facts which arise after development has been completed~~ and ~~regulatory~~expose ~~approvals~~us ~~have been obtained. In this event we may be required~~ to ~~withdraw~~potential ~~such~~litigation ~~product~~in ~~from~~connection ~~the~~with ~~market.~~this ~~See~~process ~~“Item~~or 1.any ~~Business—Description~~resulting ~~of Business—Government Regulation~~transaction.”

WeIf we are not successful in setting forth a new strategic path for the Company, or if our plans are ~~dependent~~not ~~upon~~executed ~~third~~in ~~party~~a ~~suppliers~~timely fashion, this may cause reputational harm with our stockholders and other stakeholders and the value of our ~~raw~~securities ~~materials~~may be adversely impacted. In addition, speculation regarding any developments related to the review of strategic alternatives and ~~for~~perceived ~~other~~uncertainties ~~services~~related to the future of the Company could cause our stock price to fluctuate significantly. There can be no guarantee that the process of evaluating alternative strategic paths will result in our entering into or completing potential transactions within the anticipated timing or at all.

~~We are~~If dependent on outside vendors for our entire supply of the oral insulin capsules and do not currently have any long-term agreements in place for the supply of oral insulin capsules, which is still necessary if we ~~decide to continue development of these projects. While we believe that there~~ are ~~numerous~~successful ~~sources of supply available, if the third party suppliers were to cease production, or otherwise fail~~in tocompleting ~~supply us with quality raw materials in sufficient quantities on~~ a ~~timely~~strategic ~~basis~~transaction, ~~and~~ we ~~were~~may ~~unable~~be toexposed ~~contract on acceptable terms for these services with alternative suppliers, our ability~~ to ~~produce~~other ~~our~~operational ~~products~~ and tofinancial ~~conduct testing and clinical trials would be materially adversely affected~~risks.

~~We rely~~Although onthere ~~suppliers,~~can ~~vendors,~~be ~~outsourcing partners, alliance partners and other third parties to research, develop, manufacture, commercialize,~~no ~~co-promote~~assurance ~~and~~that ~~sell~~a ~~our~~strategic ~~products,~~transaction ~~manage~~will ~~certain~~result ~~marketing,~~from ~~IT,~~the ~~data~~strategic ~~and~~review ~~other~~process ~~business~~we ~~unit~~have ~~and~~undertaken ~~functional~~to ~~services~~identify and ~~meet~~evaluate strategic ~~their contractual~~alternatives, ~~regulatory~~ ~~and~~the ~~other~~negotiation ~~obligations.~~and ~~Using~~consummation ~~these third parties poses a number~~ of ~~risks,~~any such ~~as:~~transaction ~~(i)~~will ~~they~~require ~~may~~significant ~~not~~time ~~perform~~on ~~to our standards or legal requirements, for example, in relation to~~ the ~~outsourcing~~part of ~~significant clinical development activities for innovative medicines~~our tomanagement ~~some~~and ~~CROs; (ii) they~~ may ~~not~~disrupt ~~produce~~our ~~reliable~~business. ~~products;~~The ~~(iii)~~negotiation ~~they~~and ~~may~~consummation ~~not perform in a timely manner; (iv) they may not maintain confidentiality~~ of ~~our~~any ~~proprietary~~such ~~information;~~transaction ~~(v) they~~ may ~~incur~~also arequire ~~significant~~more ~~cyberattack~~time or ~~business disruption; (vi) they may be~~ ~~subject~~greater tocash ~~government~~resources ~~orders~~than orwe ~~mandates~~anticipate ~~that~~and ~~require~~expose ~~them~~us to ~~give~~other ~~priority~~operational toand ~~the~~financial ~~government~~risks, ~~and~~including: ~~set~~increased ~~aside pre~~near-~~existing~~term ~~commercial orders;~~and ~~(vii)~~long-term ~~disputes~~expenditures; ~~may~~exposure ~~arise with respect~~ to ~~ownership~~unknown ofliabilities; ~~rights~~higher tothan ~~technology~~expected ~~developed~~acquisition ~~with~~or ~~our~~integration ~~partners; and (viii) disagreements could~~costs; ~~cause~~incurrence ~~delays in, or termination~~ of, ~~the~~substantial ~~research,~~debt ~~development~~ or ~~commercialization~~dilutive ofissuances ~~the product or result in litigation or arbitration. The failure~~ of ~~any~~equity ~~critical~~securities ~~third party~~ to ~~meet~~fund ~~its~~future ~~obligations;~~operations; towrite-downs ~~adequately deploy business continuity plans in the event~~ of aassets ~~crisis;~~or ~~and/~~goodwill or toincurrence ~~satisfactorily~~of ~~resolve~~non-recurring, ~~significant~~impairment ~~disagreements with us~~ or ~~address~~ other ~~factors,~~charges; ~~could~~increased ~~have~~amortization aexpenses; ~~material~~impairment ~~adverse~~of relationships ~~impact~~with ~~on our~~key ~~operations~~suppliers ~~and~~of ~~results.~~any Inacquired ~~addition,~~business ifdue ~~these~~to ~~third~~changes ~~parties~~in ~~violate,~~management orand ~~are~~ownership; ~~alleged~~inability to ~~have~~retain ~~violated, any laws or regulations, including~~our ~~the~~key ~~local~~employees; ~~pharmaceutical~~and ~~code,~~possibility ~~the U.S. Foreign Corrupt Practice Act~~ of ~~1977,~~future ~~the U~~litigation.K. ~~Bribery~~Any ~~Act~~ of ~~2010,~~ the ~~EU’s~~above ~~General~~risks ~~Data Protection~~could ~~Regulations,~~have ~~and~~a ~~other~~material ~~similar~~adverse ~~laws~~effect ~~and~~on ~~regulations~~our business, ~~during~~financial ~~the performance of their obligations for us~~condition, ~~we could suffer financial~~ and ~~reputational harm or other negative outcomes, including possible legal consequences~~prospects.

~~We may not realize a return on the ordinary shares of DNA and Entera and the common stock of Scilex and BioXcel that we own.~~18

~~DNA’s ordinary~~Our ~~shares~~ability ~~are traded on the Tel Aviv Stock Exchange and Entera’s ordinary shares and Scilex’s and BioXcel’s common stock are traded on the Nasdaq Stock Market, which are subject~~ to ~~market fluctuations. In addition, the shares of Scilex, DNA and Entera~~consummate ~~have~~a ~~historically~~strategic ~~experienced~~transaction ~~low~~depends ~~trading~~on ~~volume~~our ~~compared~~ability to ~~the~~retain ~~level~~our ofemployees ~~shares~~required ~~we hold. As a result, there is no guarantee that we will be able~~ to ~~resell~~consummate ~~those shares at the prevailing market prices or that we will realize a positive return on~~ such ~~shares~~transaction.

~~Because~~Our weability ~~may~~to ~~from time~~consummate a strategic transaction depends upon our ability to ~~time~~retain ~~maintain~~our employees required to consummate such a ~~significant~~transaction, ~~percentage~~the loss of ~~our~~whose services ~~assets~~may inadversely impact the ability to consummate such transaction. Our cash conservation activities may yield unintended consequences, such as attrition and~~/or~~ ~~securities~~reduced employee morale, wewhich may cause remaining employees to seek alternative employment. Our ability to successfully complete a strategic transaction depends in ~~the~~large ~~future~~part beon ~~deemed~~our ability to beretain ~~an investment~~certain of our remaining personnel. If we are unable ~~company under~~to ~~the Investment~~successfully ~~Company Act~~retain our remaining personnel, we are at risk of ~~1940 resulting~~a indisruption ~~additional~~to ~~costs~~our exploration and ~~regulatory~~consummation ~~burdens.~~of a strategic alternative as well as business operations.

~~Currently,~~We ~~we believe that either we are not within the definition of “Investment Company” as the term is defined under the Investment Company Act of 1940, or the 1940 Act, or, alternatively, we~~ may ~~rely~~become ~~on one or more of the 1940 Act’s exemptions. As of December 31, 2024, we held approximately 1.4% of DNA’s outstanding~~involved ~~ordinary~~in ~~shares,~~securities ~~approximately 0.3% of Entera’s outstanding ordinary shares,~~ and ~~beneficially~~stockholder ~~own~~litigation ~~approximately~~that ~~15.7%~~could ofdivert ~~BioXcel~~management’s ~~outstanding~~ ~~common~~attention ~~stock.~~and ~~Further,~~harm ~~we hold~~ the ~~Tranche A Note and Tranche B Note and in consideration of deferring Scilex~~Company’s ~~first amortization payment under the Tranche B Note to October 8~~business, ~~2026, we received, in addition to a nominal payment, 2,500,000 shares of Scilex Common Stock. We have also investments in real estate~~ and ~~real estate lending transactions as described elsewhere in this Annual~~insurance ~~Report.~~coverage Inmay ~~order~~ not to be ~~regulated~~sufficient as an investment company under the 1940 Act, unless we can qualify for an exclusion, we must ensure that we are engaged primarily in a business other than investing, reinvesting or trading in securities and that our activities do not include investing, reinvesting, owning, holding or trading “investment securities” constituting more than 40% of our total assets (exclusive of U.S. government securities and cash items) on an unconsolidated basis. We intend to ~~continue~~cover toall conduct our operations and ongoing investments into DNA, BioXcel, Entera and Scilex and our real estate transaction in a manner that will exempt us from the registration requirements of the 1940 Act. If we were to be deemed to be an investment company because of our investments, we would be required to register as an investment company under the 1940 Act. Alternatively, to continue qualifying for the exemption, we could be required to dispose of the securities holdings or other investments, which could have a material adverse effect on our business, results of operations and financial condition. The 1940 Act places significant restrictions on the capital structure and corporate governance of a registered investment company and materially restricts its ability to conduct transactions with affiliates. Compliance with the 1940 Act could also increase our operating costs. ~~Such changes could have a material adverse effect on our business, results of operations~~ and ~~financial condition~~damages.

21In the past, securities and stockholder litigation has often followed certain significant business transactions, such as the sale of a company or announcement of any other strategic transaction, or the announcement of negative events, such as negative results from clinical trials. The market price of our common stock dropped substantially when we announced the results of the ORA-D-013-1 Phase 3 trial. We may be exposed to such litigation even if no wrongdoing occurred. Litigation is usually expensive and diverts management’s attention and resources, which could adversely affect our business and cash resources and our ability to consummate a potential strategic transaction or the ultimate value our stockholders receive in any such transaction.

We ~~may~~ ~~not~~have ~~realize~~a ~~the~~history ~~full~~of ~~benefit~~losses ~~from~~and ~~our~~may ~~distribution~~not ~~license~~be ~~agreement~~able ~~with~~to ~~Medicox~~sustain profitability in the future.

~~Our~~Successful evaluation and completion of our remaining development programs ~~distribution~~and ~~license~~our ~~agreement~~transition ~~with~~to ~~Medicox~~normal ~~provides~~operations ~~that~~are ~~Medicox~~dependent ~~will~~upon ~~comply~~obtaining ~~with~~necessary ~~agreed~~regulatory ~~distribution~~approvals ~~targets~~from ~~and~~the ~~will~~FDA ~~purchase~~prior ~~ORMD-0801~~to selling our atproducts anwithin ~~agreed~~the ~~upon~~United ~~transfer~~States, ~~price~~and ~~per~~foreign ~~capsule~~regulatory ~~and~~approvals ~~pay~~must usbe upobtained to ~~$15,000,000~~sell inour ~~developmental~~products ~~milestones,~~internationally. $2There can be no assurance that we will receive regulatory approval of any of our product candidates,~~000,000~~ and a substantial amount of ~~which~~time ~~have~~may ~~already~~pass before ~~been~~we ~~received~~achieve bya uslevel of revenues adequate to support our operations. IfWe weexpect ~~are~~to ~~not~~incur ~~successful~~substantial expenditures in ~~finding~~connection awith ~~mutually~~our research ~~agreed~~and ~~way~~development toprograms, ~~continue~~which will be conducted through OraTech, our ~~collaboration~~strategic ~~following~~evaluation process, as well as the ~~results~~regulatory approval process with FDA and other agencies for each of our current or future product candidates during their respective developmental ~~the~~periods. ~~ORA-D-013-1~~Obtaining ~~Phase~~marketing 3approval ~~trial,~~will orbe ifdirectly ~~Medicox~~dependent ison ~~not~~our ~~successful~~ability into ~~independently~~implement ~~advancing~~the necessary regulatory steps required to obtain marketing approval in the ~~oral~~United ~~insulin~~States ~~candidate,~~and wein ~~may~~other ~~not~~countries. ~~realize~~ We cannot predict the ~~benefits~~outcome ~~from~~of ~~this~~these ~~collaboration~~activities.

WeBased on our current cash ~~are~~resources ~~highly~~and ~~dependent~~commitments, ~~upon~~we ~~our~~believe ~~ability~~we will be able to ~~enter~~maintain ~~into~~our ~~agreements~~current ~~with~~planned ~~collaborative~~activities ~~partners~~and tothe ~~develop~~corresponding level of expenditures for at least the next 12 months, ~~commercialize~~although ~~and~~no ~~market~~assurance can be given that we will not need additional funds prior to such time. If there are unexpected increases in our ~~products~~operating expenses, we may need to seek additional financing during the next 12 months.

~~Our long-term~~We strategy is to ultimately seek a strategic commercial partner, or partners, such as large pharmaceutical companies, with extensive experience in the development, commercialization, and marketing of insulin applications and/or other orally digestible drugs. Such planned strategic partnership, or partnerships, may ~~provide~~need ~~a marketing and sales infrastructure for our products as well as financial and operational~~substantial ~~support~~additional ~~for~~capital ~~global clinical trials, post marketing trials, label expansions and other regulatory requirements concerning future clinical development~~ in ~~the~~order ~~United States and elsewhere. We currently lack the resources~~ to ~~manufacture~~satisfy ~~any of~~ our product candidates on a large scale and we have no sales, marketing or distribution capabilities. In the event we are not able to enter into a collaborative agreement with a partner, or partners, on commercially reasonable terms, or at all, we may be unable to commercialize our products, which would have a material adverse effect upon our business, ~~prospects, financial condition and results of operations~~objectives.

~~The~~To date, we have ~~biotechnology~~financed our operations principally through offerings of securities and ~~biopharmaceutical~~we ~~industries~~may ~~are~~require ~~characterized~~substantial byadditional ~~rapid~~financing ~~technological~~at ~~developments~~various intervals in order to implement any potential strategic alternative, to continue our remaining or potential future research and development aprograms, ~~high~~including ~~degree~~significant requirements for operating expenses including intellectual property protection and enforcement, for pursuit of ~~competition~~regulatory approvals, and for commercialization of our remaining or future products. We ~~may~~can provide no assurance that additional funding will be available on a timely basis, on terms acceptable to us, or at all. In the event that we are unable to ~~compete~~obtain ~~with~~such ~~more~~financing, ~~substantial~~we ~~enterprises~~may not be able to implement the actions we decide to take as part of our strategic review process, and we will not be able to fully develop and commercialize our technology or pursue new technology. Our future capital requirements will depend upon many factors, including:

~~The biotechnology~~● and biopharmaceutical industries are characterized by rapid technological developments and a high degree of competition. As a result, our products could become obsolete before we recoup any portion of our related research and development and commercialization expenses. These industries are highly competitive, and this competition comes both from biotechnology firms and from major pharmaceutical and chemical companies. Many of these companies have substantially greater financial, marketing and human resources than we do (including, in some cases, substantially greater experience in clinical testing, manufacturing and marketing of pharmaceutical products). We also experience competition in the ~~development~~results of our ~~products~~strategic ~~from~~review ~~universities~~process and ~~other~~any ~~research institutions and compete with others in acquiring technology from such universities and institutions. We face the risk that~~ new ~~market~~strategic ~~entrants~~direction ~~and~~we ~~existing~~decide ~~competition may try~~ to replicate our business model or introduce a more innovative offering that renders our services less competitive or obsolete. In addition, our research and development efforts may target diseases and conditions for which there are existing therapies or therapies that are being developed by our competitors. Further, any products resulting from our research and development efforts might not be able to compete successfully with others’ existing and future products. See “Item 1. Business—Description of Business—Competition.”take;

~~Our financial position or results could be negatively affected by product liability claims.~~19

~~It is~~● ~~possible~~continued ~~that~~scientific weprogress will be responsible for potential product liability stemming from product research, development or manufacturing and may face an even greater risk if any product candidate that we develop is commercialized. If we cannot successfully defend ourselves against claims that products we develop independently or with our partners caused injuries, we could incur substantial liabilities. Regardless of the merit or eventual outcome of such claims, any liability claims may result in, among other things, decreased demand for any product that we may develop, loss of revenues, significant time and costs to defend the related litigation, initiation of investigations by regulators and injury to our ~~reputation~~research and ~~significant~~development negative media attention. On occasion, large judgments have been awarded in class action lawsuits based on drugs or medical treatments that had unanticipated adverse effects. Our clinical trials are covered by liability insurance, but notwithstanding such coverage, our financial position or results could be negatively affected by product liability claims.programs;

22● costs and timing of conducting clinical trials and seeking regulatory approvals and patent prosecutions;

~~We have~~● ~~limited~~competing ~~senior~~technological ~~management resources~~ and ~~may~~market ~~be required to obtain more resources to manage our growth.~~developments;

~~We expect~~● ~~the expansion of~~ our business, as well as the activities we take as a result of our strategic review process, to place a significant strain on our limited managerial, operational and financial resources. We will be required to expand our operational and financial systems significantly and to expand, train and manage our work force in order to manage the expansion of our operations. Our failure to fully integrate our new employees into our operations could have a material adverse effect on our business, prospects, financial condition and results of operations. Our ability to ~~attract~~establish ~~and~~additional ~~retain~~collaborative ~~highly~~relationships; ~~skilled personnel is critical to our operations~~ and expansion. We face competition for these types of personnel from other technology companies and more established organizations, many of which have significantly larger operations and greater financial, technical, human and other resources than we have. We may not be successful in attracting and retaining qualified personnel on a timely basis, on competitive terms or at all. If we are not successful in attracting and retaining these personnel, our business, prospects, financial condition and results of operations will be materially adversely affected. See “Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations,” “Item 1. Business—Description of Business—Employees.”

~~We depend~~● ~~upon~~effects ~~our~~of ~~senior~~commercialization ~~management~~activities and ~~skilled~~facility ~~personnel~~expansions if and ~~their~~as ~~loss or unavailability could put us at a competitive disadvantage~~required.

~~We currently~~ If ~~depend~~we ~~upon~~cannot ~~the~~secure ~~efforts~~adequate ~~and~~financing ~~abilities~~when ~~of our senior executives~~needed, aswe ~~well~~may ~~as the services of several key consultants and other~~be ~~key~~required ~~personnel,~~to ~~including Dr. Miriam Kidron~~delay, ~~our~~scale ~~Chief~~back ~~Scientific~~or ~~Officer.~~eliminate ~~The~~one ~~loss~~ or ~~unavailability~~more of ~~the~~our ~~services~~existing ofor ~~any~~planned ofcourses ~~these individuals for any significant period~~ of ~~time~~action ~~could~~or ~~have~~research aand ~~material~~development ~~adverse effect on our business~~programs, ~~prospects, financial condition and~~ ~~results~~or ofto ~~operations.~~enter Weinto dolicense ~~not~~or ~~maintain~~other ~~“key~~arrangements ~~man”~~with ~~life~~third ~~insurance~~parties ~~policies~~to ~~for~~commercialize ~~any~~products ofor ~~our~~technologies ~~senior~~that ~~executives.~~we Inwould ~~addition, recruiting~~otherwise ~~and retaining qualified scientific personnel~~ seek to ~~perform~~develop ~~future~~ourselves ~~research~~ and ~~development~~commercialize ~~work~~ourselves. ~~will~~In besuch ~~critical~~event, to our ~~success. There~~business, ~~is currently a shortage of employees with expertise in developing~~prospects, ~~manufacturing~~financial condition and ~~commercialization~~results of ~~products and related~~operations ~~clinical~~may ~~and~~be ~~regulatory~~adversely ~~affairs,~~affected ~~and~~as ~~this~~we ~~shortage~~may isbe ~~likely~~required to ~~continue.~~scale-back, ~~Competition~~eliminate, ~~for~~or ~~skilled~~delay ~~personnel~~development isefforts ~~intense~~or ~~and~~product ~~turnover~~introductions ~~rates~~or enter ~~are~~into ~~high.~~royalty, ~~Our~~sales ~~ability~~or toother ~~attract~~agreements ~~and~~with ~~retain~~third ~~qualified~~parties ~~personnel~~in ~~may~~order ~~be limited. Our inability~~ to ~~attract~~commercialize ~~and retain qualified skilled personnel would have a material adverse effect on~~ our ~~business, prospects, financial condition and results of operations~~products.

~~Our existing~~We ~~and~~have ~~any~~a ~~future~~history ~~joint~~of ~~ventures may limit our flexibility with jointly owned investments~~ losses and wecan ~~may~~provide ~~not~~no ~~realize~~assurance ~~the~~as ~~benefits~~to ~~we expect~~our ~~from~~future ~~these~~operating ~~arrangements~~results.

We do not have sufficient revenues from our research and development ~~are~~activities to fully support our operations. Consequently, we have incurred net losses since inception. We currently ~~party~~have only licensing revenues and no product revenues, and may not succeed in developing or commercializing any products which could generate product revenues. We do not expect to ~~certain~~have ~~joint~~any ~~ventures~~products on the market for several years. In addition, development of our product candidates requires a process of pre-clinical and weclinical ~~may~~testing, during which our products could fail. For example, in January 2023, the ~~future~~ORA-D-013-1 ~~sell~~Phase or3 ~~contribute~~trial did ~~additional~~not ~~assets~~meet its primary or ~~acquire,~~secondary ~~develop~~endpoints. We may not be able to enter into agreements with one or ~~recapitalize~~more companies experienced in ~~assets~~the manufacturing and marketing of therapeutic drugs and, to orthe extent that we are unable to do so, we will not be able to market our product candidates. Eventual profitability will depend on our success in ~~these~~developing, ~~joint~~manufacturing, ~~ventures~~and marketing our product candidates or ~~other~~in ~~joint~~pursuing ~~ventures~~a ~~that~~successful strategic alternative. As of December 31, 2025 and 2024, we ~~may~~had ~~enter~~working capital of approximately $114,185,000 and approximately $137,536,000, respectively, and stockholders’ equity of approximately $199,744,000 and approximately $146,265,000, respectively. See “Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations.”

~~Our participation~~We inrely ~~our~~upon ~~existing~~patents ~~joint ventures is subject~~ to protect ~~risks,~~our ~~including the following:~~technology.

●The patent position of biopharmaceutical and biotechnology firms is generally uncertain and involves complex legal and factual questions. We ~~share~~do ~~approval~~not ~~rights~~know ~~over~~whether ~~certain~~any ~~major~~of ~~decisions~~our ~~affecting~~current or future patent applications will result in the ~~ownership~~issuance of any patents. Even issued patents may be challenged, invalidated or ~~operation~~circumvented. Patents ofmay ~~the~~not ~~joint~~provide ~~ventures~~a competitive advantage or afford protection against competitors with similar technology. Competitors or potential competitors may have filed applications for, or may have received patents and ~~any~~may ~~assets~~obtain ~~owned~~additional and proprietary rights to compounds or processes used by or competitive with ours. In addition, laws of certain foreign countries do not protect intellectual property rights to the ~~joint~~same ~~ventures;~~extent as do the laws of the United States.

●Patent Welitigation ~~may~~is widespread ~~need~~in the biopharmaceutical and biotechnology industry and we cannot predict how this will affect our efforts to ~~contribute~~form strategic ~~additional~~alliances, ~~capital~~conduct clinical testing or manufacture and market any products under development. If challenged, our patents may not be held valid. We could also become involved in ~~order~~interference proceedings in connection with one or more of our patents or patent applications to ~~preserve~~determine priority of invention. If we become involved in any litigation, ~~maintain~~interference or ~~grow~~other administrative proceedings, we will likely incur substantial expenses and the ~~joint~~efforts ~~ventures~~of our technical and ~~their~~management ~~investments;~~personnel will be significantly diverted. In addition, an adverse determination could subject us to significant liabilities or require us to seek licenses that may not be available on favorable terms, if at all. We may be restricted or prevented from manufacturing and selling our products in the event of an adverse determination in a judicial or administrative proceeding or if we fail to obtain necessary licenses.

● Our joint venture investors may have economic or other business interests or goals that are inconsistent with our business interests or goals and that could affect our ability to fully benefit from the assets owned by the joint ventures;20

●We ~~Our~~may ~~joint~~be ~~venture~~unable ~~investors~~to ~~may~~protect our beintellectual ~~subject~~property torights ~~different~~and ~~laws~~we ormay ~~regulations~~be ~~than~~liable ~~us,~~for ~~which~~infringing ~~could~~the ~~create~~intellectual ~~conflicts~~property rights of ~~interest;~~others.

● Our ~~joint~~ability ~~ventures~~to ~~may~~compete ~~have~~effectively will ~~license~~depend on our ability to maintain the proprietary nature of our technologies. We currently hold several pending patent applications in the United States, Canada, Brazil, Europe, India, Hong Kong, Japan and China for our technologies covering oral administration of insulin and other ~~agreements~~proteins ~~with~~and oral administration of exenatide and proteins and 141 patents issued by the United States and various other ~~investors~~countries’ patent offices that cover a part of our technology, which allows for the oral delivery of proteins; patents issued by various patent offices that cover part of our technology for the oral delivery of exenatide; and patents issued by patent offices for treating diabetes. Further, we ~~are~~rely on a combination of trade secrets and non-disclosure and other contractual agreements and technical measures to protect our rights in our technology. We depend upon confidentiality agreements with our officers, directors, employees, consultants, and subcontractors, as well as collaborative partners, to maintain the proprietary nature of our technology. These measures may not ~~party~~afford us sufficient or complete protection, and others may independently develop technology similar to ours, otherwise avoid our confidentiality agreements, or produce patents that would materially and ~~have~~adversely noaffect ~~control~~our ~~over~~business, prospects, financial condition and results of operations. We believe that our technology is not subject to any infringement actions based upon the patents of any third parties; however, our technology may in the future be found to infringe upon the rights of others. Others may assert infringement claims against us or against companies to which we have licensed our technology, and if we should be found to infringe upon their patents, or otherwise impermissibly utilize their intellectual property, our ability to continue to use our technology could be materially restricted or prohibited. If this event occurs, we may be required to obtain licenses from the holders of this intellectual property, enter into royalty agreements, or redesign our products so as not to utilize this intellectual property, each of which may prove to be uneconomical or otherwise impossible. Licenses or royalty agreements required in order for us to use this technology may not be available on terms acceptable to us, or at all. These claims could result in litigation, which could materially adversely affect our business, prospects, financial condition and results of operations. Further, we may need to indemnify companies to which we licensed our technology in the event that such technology is found to infringe upon the rights of others.

● Our commercial success will also depend significantly on our ability to ~~sell~~operate ~~our~~without ~~interests~~infringing ~~in,~~the orpatents ~~sell~~and ~~additional~~other ~~assets~~proprietary torights of third parties. Patent applications are, ~~the~~in ~~joint~~many ~~ventures~~cases, ormaintained ~~the~~in ~~joint~~secrecy ~~ventures’~~until ~~ability~~patents toare ~~sell~~issued. ~~additional~~The ~~interests~~publication of, discoveries in the scientific or ~~assets~~patent ~~owned~~literature ~~by,~~frequently occurs substantially later than the ~~joint~~date ~~ventures~~on ~~when~~which wethe sounderlying ~~desire~~discoveries were made and patent applications are ~~subject~~filed. toIn the ~~approval~~event ~~rights~~of infringement or violation of ~~the~~another ~~other~~party’s ~~joint~~patent, ~~venture~~we ~~investors~~may ~~under~~be ~~the~~prevented ~~terms~~from ofpursuing ~~the~~product ~~agreements~~development or ~~governing~~commercialization. ~~the~~See ~~joint~~“Item ~~ventures;~~1. Business—Description of Business— Intellectual Property and Patents.”

●Even ~~Disagreements~~if ~~with~~we ~~our~~succeed ~~joint~~in commencing ~~venture~~a ~~investors~~new ~~could~~clinical ~~result~~trial infor ~~litigation~~our ororal ~~arbitration~~insulin ~~that~~capsule, ~~could~~there beare ~~expensive~~a ~~and~~variety ~~distracting~~of torisks ~~management~~ and ~~could~~uncertainties ~~delay~~related ~~important~~to ~~decisions~~its development.

23On January 12, 2023, we announced top-line results from the phase 3 trial of our oral insulin capsule, which did not meet its primary or secondary endpoints, and indicated that we expect to discontinue oral insulin clinical activities for T2D. At present, following the results of the ORA-D-013-1 Phase 3 trial, we conducted a comprehensive analysis of the data and found that subpopulations of patients with pooled specific parameters responded well to oral insulin. Based on this analysis, we submitted a protocol for a new Phase 3 clinical trial to the FDA. Concurrently, we are examining our existing pipeline and have commenced an evaluation process of potential strategic opportunities. Even if we succeed in commencing a new clinical trial for our oral insulin capsule, there are a variety of risks and uncertainties related to its development. Principally, these risks include the following:

~~Any of~~● ~~the~~Future ~~foregoing~~clinical ~~risks~~trial ~~could have a material adverse effect on our business, financial condition and~~ results ofmay ~~operations.~~show ~~Further, these, similar, enhanced or additional risks, including possible risks of~~ the ~~other~~same ~~joint~~results ~~venture~~as ~~investors having licensed assets to~~ the ~~joint~~ORA-D-013-1 ~~venture,~~Phase ~~may~~3 ~~apply to any future additional or amended joint ventures that we may enter into.~~ trial;

~~Healthcare policy~~● ~~changes,~~Future ~~including~~clinical ~~pending~~trial ~~legislation~~results ~~recently~~may ~~adopted~~be ~~and~~inconsistent ~~further~~with ~~proposals~~previous ~~still~~preliminary ~~pending~~testing toresults ~~reform~~and ~~the~~data ~~U.S.~~from ~~healthcare~~our ~~system,~~ earlier trials may ~~harm~~be ~~our~~inconsistent ~~future~~with ~~business.~~clinical data;

Healthcare costs have risen significantly over the past decade. There have been and continue to be proposals by legislators, regulators and third-party payors to keep these costs down. Certain proposals, if passed, would impose limitations on the prices we will be able to charge for the products that we are developing, or the amounts of reimbursement available for these products from governmental agencies or third-party payors. These limitations could in turn reduce the amount of revenues that we will be able to generate in the future from sales of our products and licenses of our technology.21

~~In 2010,~~● ~~the~~Even ~~federal~~if ~~government~~our ~~enacted~~oral ~~healthcare~~insulin ~~reform~~capsule ~~legislation~~is ~~that~~shown ~~has significantly impacted the pharmaceutical industry. In addition~~ to requiring most individuals to have health insurance and establishing new regulations on health plans, this legislation requires discounts under the Medicare drug benefit program and increased rebates on drugs covered by Medicaid. In addition, the legislation imposes an annual fee, which has increased annually, on sales by branded pharmaceutical manufacturers. There can be nosafe ~~assurance that our business will not be materially adversely affected by these increased rebates, fees~~ and ~~other~~effective ~~provisions.~~for Inits ~~addition,~~intended ~~these~~purposes ~~and other initiatives~~ in ~~the~~future ~~United~~clinical ~~States may continue the pressure on drug pricing~~trials, ~~especially~~we ~~under the Medicare and Medicaid programs, and~~ may ~~also~~face ~~increase regulatory~~significant ~~burdens and operating costs. The announcement~~ or ~~adoption~~unforeseen ofdifficulties ~~any such initiative could have an adverse effect on potential revenues from any product that we may successfully develop. An expansion~~ in ~~government’s~~obtaining ~~role~~or inmanufacturing ~~the~~sufficient ~~U.S.~~quantities ~~healthcare~~or ~~industry~~at ~~may lower~~reasonable ~~the future revenues for the products we are developing and adversely affect our future business, possibly materially.~~prices;

~~In September~~● ~~2017,~~Our ~~members~~ability ~~of the U.S. Congress introduced legislation with the announced intention~~ to ~~repeal~~complete ~~and replace major provisions of~~ the ~~Patient~~development ~~Protection~~ and ~~Affordable~~commercialization ~~Care Act, or the ACA. In addition to those efforts, on October 12, 2017, an executive order was issued that modified certain aspects~~ of the ~~ACA.~~oral ~~Following~~insulin ~~several~~capsule ~~years~~for ofour ~~litigation~~intended inuse ~~the~~is ~~federal~~significantly ~~courts,~~dependent inupon ~~June~~our ~~2021,~~ability ~~the~~to ~~U.S. Supreme~~obtain ~~Court~~and ~~upheld~~maintain ~~the~~experienced ~~ACA~~and ~~when~~committed itpartners ~~dismissed a legal challenge~~ to ~~the~~assist ~~ACA’s~~us ~~constitutionality.~~with ~~Further~~obtaining ~~attempts~~clinical toand ~~repeal~~regulatory ~~or to~~approvals ~~repeal~~for, and ~~replace~~ the ~~ACA may continue. In addition~~manufacturing, ~~various~~marketing ~~other healthcare reform proposals have also emerged at the federal~~ and ~~state~~ ~~level.~~distribution ~~We cannot predict what healthcare initiatives~~of, ~~if any, will be implemented at~~ the ~~federal~~oral orinsulin ~~state~~capsule ~~level,~~on ora ~~the~~worldwide ~~effect any future legislation or regulation will have on us.~~basis;

~~We are~~● ~~exposed~~Even toif ~~fluctuations~~our inoral ~~currency~~insulin ~~exchange~~capsule ~~rates.~~is successfully developed, commercially produced and receives all necessary regulatory approvals, there is no guarantee that there will be market acceptance of our product; and

~~A considerable~~● ~~amount~~Our ofcompetitors ~~our~~may ~~expenses~~develop ~~are~~therapeutics ~~generated in dollars~~ or ~~in dollar-linked currencies, but a significant portion of our expenses such as some clinical trials and payroll costs are generated in~~ other ~~currencies~~treatments ~~such~~which ~~as NIS and Euro. Most of the time, our non-dollar assets~~ are ~~not~~superior totally offset by non-dollar liabilities. Due to the foregoing and to the fact that our financial results are measured in dollars, our results could be adversely affected as a result of a strengthening or ~~weakening~~less ofcostly ~~the~~than ~~dollar compared to these other currencies. During the years ended December 31, 2019, 2020 and 2021, the dollar depreciated in relation to the NIS, which raised the dollar cost of~~ our ~~Israeli~~own ~~based~~with ~~operations and adversely affected our financial results, while during~~ the ~~year~~result ~~ended~~that ~~December 31, 2022, 2023 and 2024, the dollar increased in relation to the NIS, which reduced the dollar cost of~~ our ~~Israeli based operations costs. In addition~~products, ~~our~~ ~~results~~even ~~could also be adversely affected~~ if wethey are ~~unable~~successfully to guard against currency fluctuations in the future. Although we may in the future decide to undertake foreign exchange hedging transactions to cover a portion of our foreign currency exchange exposuredeveloped, ~~we currently~~manufactured ~~do not hedge our exposure to foreign currency exchange risks. These transactions, however, may not adequately protect us from future currency fluctuations~~ and, ~~even if they do protect us~~approved, may ~~involve operational or financing costs we would~~ not ~~otherwise~~generate ~~incur~~significant revenues.

24Our business may be seriously harmed if our analysis does not produce positive results, if we are unable to find a path forward to continue development of our oral insulin capsule, if we are unsuccessful in realizing new strategic opportunities or dealing with any of these risks, or if we are unable to successfully commercialize our oral insulin capsule for some other reason.

We ~~face~~ ~~uncertainties~~have ~~related~~limited toexperience in ~~Oravax’s~~conducting ~~oral~~clinical ~~COVID-19 vaccine~~trials.

~~We face~~Clinical ~~uncertainties~~trials ~~related~~must tomeet FDA ~~Oravax’s~~and ~~oral~~foreign ~~COVID-19~~regulatory ~~vaccine,~~requirements. ~~including~~We ~~uncertainties~~have ~~related~~limited toexperience ~~the~~in ~~risk~~designing, ~~that~~conducting ~~our~~and ~~continued~~managing ~~development programs~~the ~~may~~preclinical ~~not~~trials beand clinical ~~successful,~~trials ~~commercially~~necessary ~~viable~~to orobtain ~~receive~~regulatory approval ~~from~~for ~~regulatory~~our ~~authorities.~~product ~~Other~~candidates ~~companies~~in ~~may~~any ~~produce~~country. ~~superior or~~In ~~competitive~~the ~~oral~~past, orwe ~~other~~entered ~~products~~into ~~that~~agreements with ~~make~~Integrium ~~Oravax’s~~LLC ~~oral~~and ~~COVID-19~~other ~~vaccine~~consultants ~~not~~to ~~commercially~~assist ~~worthwhile.~~us ~~Even if we succeed~~ in ~~developing the product~~designing, ~~the~~conducting ~~demand~~and ~~for~~managing ~~any~~our ~~product~~various weclinical ~~may~~trials ~~develop~~in ~~may~~the ~~no longer exist~~United States, ~~given~~Europe ~~the~~and ~~fluid~~Israel. ~~nature~~Any failure of ~~the~~a ~~COVID-19~~consultant ~~pandemic, including possible decreased demand for vaccines due~~ to ~~weaker~~fulfill ~~strains,~~their ~~the~~obligations ~~need~~could ~~for~~result ~~different~~in ~~vaccines~~significant ~~for~~additional ~~new~~costs ~~variants~~as ~~of the virus~~well oras andelays ~~end~~in ofdesigning, ~~the~~consulting ~~pandemic~~and ~~that~~completing ~~may~~clinical ~~render~~trials ~~Oravax’s~~on ~~vaccine~~our ~~obsolete~~products.

~~Risks~~Our clinical trials may ~~Related~~encounter todelays, ~~Our~~suspensions ~~Real~~or ~~Estate~~other ~~Investments~~problems.

~~Our investments~~We may encounter problems in ~~real~~clinical ~~estate~~trials that may ~~expose~~cause us toor ~~market~~the ~~and~~FDA ~~liquidity~~or ~~risks~~foreign ~~that~~regulatory ~~could~~agencies ~~adversely~~to ~~affect~~delay, ~~our~~suspend ~~financial~~or ~~condition~~terminate ~~and~~our ~~results~~clinical trials at ofany ~~operations~~phase. OnThese ~~November~~problems 7,could ~~2024,~~include ~~our~~the ~~Board~~possibility ~~approved~~that ~~investments~~we ofmay upnot be able to ~~$10,000,000~~conduct inclinical ~~real~~trials ~~estate~~at ~~assets,~~our ~~and~~preferred ~~additional~~sites, ~~investments~~enroll ofa upsufficient tonumber ~~$20,000,000~~of Onpatients ~~February~~for ~~13,~~our ~~2025.~~clinical ~~While~~trials weat ~~believe~~one ~~these~~or ~~investments~~more ~~present~~sites ~~attractive~~or ~~opportunities,~~begin ~~the~~or ~~real~~successfully ~~estate~~complete ~~market is~~clinical ~~subject~~trials toin ~~fluctuations~~a ~~due~~timely fashion, toif ~~economic~~at ~~conditions~~all. For example, ~~interest~~the rate ~~changes,~~of ~~and~~enrollment ~~other~~for ~~external~~our ~~factors~~Phase ~~beyond~~1 clinical trial for our ~~control.~~oral ACOVID-19 ~~downturn~~ vaccine in ~~the~~South ~~real~~Africa was ~~estate~~slower ~~market~~than oranticipated andue ~~extended~~to ~~period~~several offactors, ~~declining~~including ~~property~~the ~~values~~fact ~~could~~that ~~negatively~~many ~~impact~~volunteers ~~the~~did ~~returns~~not onqualify ~~our~~during ~~investments. Additionally,~~screening ~~real~~due ~~estate~~to ~~investments~~prior asymptomatic ~~tend~~COVID-19 toinfection beand ~~relatively~~other ~~illiquid~~conditions, ~~which~~and ~~may~~as ~~limit~~a ~~our~~result ~~ability~~we had to ~~quickly~~add ~~exit~~an oradditional ~~reallocate~~clinical ~~capital~~site. In addition, clinical intrials ~~response~~conducted toby ~~market~~third ~~changes.~~parties ~~Since~~are ~~our~~not ~~approach~~controlled ~~focuses~~by onus ~~entrepreneurial~~and ~~real~~such ~~estate~~third ~~investments~~parties ~~rather~~may ~~than~~conduct ~~direct~~these ~~property~~trials ~~ownership~~in a manner in which we disagree or ~~management~~which may prove to be unsuccessful. Furthermore, we, ~~are~~the ~~also~~FDA ~~exposed~~or toforeign ~~risks~~regulatory ~~associated~~agencies ~~with~~may ~~deal~~suspend ~~execution,~~clinical ~~market~~trials ~~timing,~~at ~~and~~any time if we or they believe the ~~financial~~subjects ~~health~~participating ofin ~~investment~~the ~~partners or~~trials ~~counterparties.~~are Ifbeing ~~any~~exposed ofto ~~these~~unacceptable health risks ~~materialize,~~or if we or they ~~could~~find ~~adversely~~deficiencies in ~~affect~~the ~~our~~clinical ~~financial~~trial ~~position~~process ~~and~~or ~~ability~~conduct toof ~~generate~~the ~~anticipated returns~~investigation.

~~Risks~~If clinical trials of any of the product candidates fail, we will not ~~Related~~be able to market the ~~Notes~~product candidate which is the subject of the failed clinical trials. The FDA and foreign regulatory agencies could also require additional clinical trials, which would result in increased costs and significant development delays. Our failure to adequately demonstrate the safety and effectiveness of a pharmaceutical product candidate under development could delay or prevent regulatory approval of the product candidate and could have a material adverse effect on our business, prospects, financial condition and results of operations. For example, see “Item 1. Business—Description of Business— Research and Development” regarding the results of the ORA-D-013-1 Phase 3 trial that did not meet its primary or secondary endpoints. We may experience delays in site initiation and patient enrollment, failures to comply with study protocols, delays in the manufacture of our product candidates for clinical testing and other difficulties in starting or completing our clinical trials.

We have lent a substantial amount of funds to Scilex. In the event that Scilex is unable to service its obligations under the Note and defaults on such Note, it could have a material adverse effect on our business.22

OnInitial ~~September~~success ~~21, 2023, we were issued the Tranche A Note~~ in ~~an aggregate~~the ~~principal~~completed ~~amount~~and ofongoing ~~$101,875,000~~early-stage byclinical ~~Scilex~~trials ~~pursuant~~does tonot ~~the~~ensure ~~Scilex~~success ~~SPA. The Note originally matured on March 21, 2025 and is payable~~ in ~~six~~ ~~principal~~later ~~installments,~~stage ~~with the first installment paid on December 21~~trials, ~~2023.~~regulatory Inapproval ~~January~~or ~~2025,~~commercial ~~we extended Tranche A Note maturity~~viability ~~from March 21, 2025 to December 31, 2025. Interest under the Note accrues at a fluctuating per annum interest rate equal to the sum~~ of ~~(1)~~ ~~the greater of (x) four percent (4%) and (y) Term SOFR (as defined in the Note) and (2) eight and one half percent (8.5%), payable in-kind on~~ a ~~monthly basis~~product.

OnPositive results in a clinical ~~October~~trial 7,may ~~2024~~not be replicated in subsequent or confirmatory trials. Additionally, wesuccess ~~entered~~in ~~into~~preclinical anwork ~~agreement~~or toearly ~~refinance~~stage aclinical ~~portion~~trials does not ensure that later stage or larger scale clinical trials will be successful or that regulatory approval will be obtained. Any of our product’s failure to show sufficient efficacy in patients with the ~~Tranche~~targeted Aindication, ~~Note~~or ~~and~~if ~~pay~~such ~~off~~studies ~~certain~~are discontinued for any other ~~indebtedness~~reason, ofcould negatively impact our development and commercialization goals for these products and our stock price could ~~Scilex~~decline. WeMany ~~were~~companies ~~issued~~in anthe ~~aggregate~~biopharmaceutical ~~principal~~industry ~~amount~~have suffered significant setbacks in advanced clinical trials due to lack of ~~$25~~efficacy or adverse safety profiles,~~000~~ notwithstanding promising results in earlier trials. As a result,~~000~~ ~~under~~preliminary and interim data should be viewed with caution until the ~~Tranche~~final Bdata ~~Note~~are ~~and~~available. We have invested in clinical studies of medicines that have not met the primary clinical endpoints in their Phase 3~~,750,000~~ ~~Tranche~~studies Bor ~~Warrants~~have been discontinued for other reasons. InFor ~~addition~~example, on in ~~October~~January 82023, we ~~2024,~~reported wethat ~~entered~~ORA-D-013-1 ~~into~~trial ~~the~~did ~~RPA~~not ~~with~~meet ~~Scilex~~its toprimary ~~holds~~or ~~the~~secondary ~~right~~endpoint. toEven ~~receive~~if 4%later ~~royalties~~stage clinical trials are successful, regulatory authorities may delay or decline approval of our product candidates.

There is noare ~~guarantee~~a number of factors that ~~Scilex~~could ~~will~~cause bea ~~able~~clinical study to ~~service~~fail ~~its~~or ~~repayment~~be ~~obligations~~delayed, ~~under~~including: (i) the ~~Note.~~clinical ~~Although~~study ~~the~~may ~~Note~~produce isnegative ~~secured~~or byinconclusive ~~a first~~results; ~~priority~~(ii) ~~security~~regulators ~~interest~~may inrequire ~~and~~that ~~liens~~we onhold, ~~all~~suspend ofor ~~the~~terminate ~~assets~~clinical ofresearch ~~Scilex~~for ~~and~~noncompliance ~~its~~with ~~subsidiaries~~regulatory requirements; (iii) we, noour ~~assurance~~partners, ~~can~~the beFDA ~~made~~or ~~that~~foreign ~~Scilex~~regulatory ~~will be~~authorities ~~able~~could tosuspend ~~repay~~or ~~the~~terminate ~~Tranche~~a Aclinical ~~Note~~study ~~and~~due ~~Tranche~~to Badverse ~~Notes,~~side oreffects ~~the~~of a ~~Notes,~~product ~~when~~on ~~due~~subjects or ~~that~~lack weof ~~will~~efficacy bein ~~able~~the totrial; ~~foreclose~~(iv) onwe, ~~such~~or ~~assets~~our ~~and recover~~partners, ~~enough~~may ~~value~~decide, ~~upon~~or ~~the~~regulators ~~sale~~may ofrequire ~~such~~us, ~~assets~~ to ~~repay~~conduct additional ~~the~~preclinical ~~amounts~~testing ~~owed~~or toclinical ~~us.~~studies; In(v) ~~such~~change anin ~~event,~~rates weof ~~could~~enrollment ~~lose~~and ~~all~~dropout oramong aclinical ~~substantial~~trial participants; ~~portion~~(vi) ofdifferences ~~our~~in ~~loan~~the ~~investment.~~size ~~Additionally,~~and ~~Scilex~~type ~~has~~of ~~disclosed~~the inpatient ~~its~~populations; ~~periodic~~(vii) ~~reports~~changes ~~filed~~in ~~with~~and adherence to the ~~SEC~~dosing ~~that~~regimen ~~there~~and isother ~~substantial~~clinical ~~doubt~~trial ~~about~~protocols; ~~its~~and ~~ability~~(viii) topeople ~~continue~~who asenroll ain ~~going~~the ~~concern.~~clinical Ifstudy ~~Scilex~~may islater ~~unable~~drop out due to ~~continue~~adverse asevents, a ~~going~~perception ~~concern~~they orare ~~defaults~~not benefiting onfrom participating in the ~~Notes~~study, we ~~may~~fatigue bewith ~~unable~~the toclinical ~~recover~~study ~~some~~process or ~~all~~personal ofor ~~the~~other ~~principal~~issues. ~~amount~~The occurrence of ~~the~~any of ~~Note,~~these ~~which~~events could ~~have~~result ain ~~material~~significant costs and expense, have an adverse effect on our business, financial condition and results of operations and/or cause our stock price to decline or experience periods of volatility.

We can provide no assurance ~~may~~that ~~have~~our ~~difficulty~~products ~~realizing~~will ~~the~~obtain ~~full~~regulatory ~~value~~approval ofor that the ~~Warrants~~results of clinical trials will be favorable.

The testing, marketing and ~~Closing~~manufacturing ~~Penny~~of ~~Warrant~~any of our products will berequire ~~exercisable~~the ~~upon~~approval of the ~~earliest~~FDA or regulatory agencies of ~~(i)~~other ~~March~~countries. ~~14,~~We ~~2025,~~cannot ~~(ii)~~predict with any certainty the ~~date~~amount onof ~~which~~time necessary to obtain regulatory approvals, including from the ~~Note~~FDA ~~has~~or ~~been~~other ~~repaid~~foreign inregulatory authorities, ~~full~~and whether any such approvals will ultimately be granted. In any event, review and ~~(iii)~~approval by the ~~Management~~regulatory ~~Sale~~bodies ~~Trigger~~is ~~Date~~anticipated to ~~(as~~take ~~defined~~a ~~therein),~~number ifof ~~any,~~years. Preclinical and ~~will~~clinical ~~expire~~trials onmay ~~the~~reveal ~~date~~ that isone ~~the~~or ~~fifth~~more ~~anniversary~~of our products are ineffective or unsafe, in which event further development of ~~the~~such ~~issuance~~products ~~date~~could be seriously delayed or terminated. For ~~purposes~~example, ofin ~~the~~January ~~Penny~~2023, ~~Warrants~~we announced that our ORA-D-013-1 Phase 3 trial did not meet its primary or secondary endpoints. As a result, ~~the~~we ~~Management~~decided ~~Sale~~to ~~Trigger~~terminate ~~Date~~our isORA-D-013-2 Phase ~~generally~~3 trial, conducted a comprehensive analysis of the ~~first~~data ~~date~~and found that ~~certain~~subpopulations ~~members~~ of ~~Scilex~~patients ~~management~~with ~~engage~~pooled inspecific parameters, responded well to oral insulin. Based on this analysis, we submitted a protocol for a new Phase 3 clinical trial to the FDA. Moreover, obtaining approval for certain ~~sales~~products ormay ~~other~~require ~~similar~~the ~~transfers~~testing ofon ~~shares~~human subjects of ~~Scilex~~substances ~~Common~~whose ~~Stock~~effects on humans are not fully understood or ~~other~~documented. Delays in obtaining necessary regulatory approvals of ~~Scilex~~any proposed product and failure to receive such approvals would have an adverse effect on the product’s orpotential commercial success and on our business, prospects, financial condition ~~any~~and results of ~~its~~operations. ~~subsidiaries’~~In ~~securities~~addition, ~~subject~~it tois ~~certain~~possible ~~exceptions~~that asa ~~are~~product ~~customary~~may ~~for~~be ~~lock-up~~found ~~agreements~~to ~~executed~~be byineffective ~~directors~~or unsafe due to conditions or facts which arise after development has been completed and ~~officers~~regulatory inapprovals ~~connection~~have ~~with~~been ~~financings~~obtained. orIn ~~similar~~this ~~transactions~~event we may be required to withdraw such product from the market. See “Item 1. Business—Description of Business—Government Regulation.”

25We are dependent upon third party suppliers of our raw materials and for other services.

~~The Subsequent~~We ~~Penny~~are ~~Warrants~~dependent ~~will~~on outside ~~vest~~vendors ~~and~~for ~~become~~our ~~exercisable~~entire onsupply of the ~~date~~oral ~~that~~insulin iscapsules ~~the~~and ~~later~~do ofnot ~~(i)~~currently ~~Subsequent~~have ~~Penny~~any ~~Warrant~~long-term ~~Vesting~~agreements ~~Date, and~~in ~~(ii)~~place for the ~~earliest~~supply of ~~(A)~~oral ~~March~~insulin 14capsules, ~~2025,~~which ~~(B)~~is ~~the~~still ~~date~~necessary onif ~~which~~we ~~the~~decide ~~Note~~to ~~has~~continue ~~been~~development ~~repaid~~of inthese ~~full~~projects. ~~and~~While ~~(C)~~we believe ~~the~~that ~~Management~~there ~~Sale~~are ~~Trigger Date~~numerous sources of supply available, if ~~any.~~the ~~Each~~third ~~Subsequent~~party ~~Penny~~suppliers ~~Warrant~~were ~~will~~to ~~expire~~cease onproduction, ~~the~~or ~~date~~otherwise fail ~~that~~to issupply ~~the~~us ~~fifth~~with ~~anniversary~~quality ofraw ~~the~~materials ~~issuance~~in ~~date;~~sufficient ~~provided~~quantities ~~that, if~~on ~~the~~a ~~Notes~~timely ~~are~~basis ~~repaid~~and inwe ~~full~~were ~~prior~~unable to ~~the~~contract ~~Subsequent~~on ~~Penny~~acceptable terms ~~Warrant~~for ~~Vesting~~these ~~Date~~services ~~applicable~~with toalternative ~~such~~suppliers, ~~Subsequent~~our ~~Penny~~ability ~~Warrant,~~to ~~such Subsequent~~produce ~~Penny~~our ~~Warrant~~products ~~will~~and ~~expire~~to onconduct ~~the~~testing ~~date~~and ~~the~~clinical ~~Notes~~trials would ~~are~~be ~~repaid~~materially inadversely ~~full~~affected.

Because of the foregoing restrictions on exercisability of the Closing Penny Warrant and the Subsequent Penny Warrants, we may not be able to exercise the Warrants for shares of Scilex Common Stock at a time when it would be financially beneficial for us to do so. Accordingly, there is no guarantee that we will be able to realize the full or any value of the Warrants.23

~~Risks~~We rely on suppliers, vendors, ~~Related~~outsourcing partners, alliance partners and other third parties to research, develop, manufacture, commercialize, co-promote and sell our ~~Common~~products, ~~Stock~~manage certain marketing, IT, data and other business unit and functional services and meet their contractual, regulatory and other obligations. Using these third parties poses a number of risks, such as: (i) they may not perform to our standards or legal requirements, for example, in relation to the outsourcing of significant clinical development activities for innovative medicines to some CROs; (ii) they may not produce reliable products; (iii) they may not perform in a timely manner; (iv) they may not maintain confidentiality of our proprietary information; (v) they may incur a significant cyberattack or business disruption; (vi) they may be subject to government orders or mandates that require them to give priority to the government and set aside pre-existing commercial orders; (vii) disputes may arise with respect to ownership of rights to technology developed with our partners; and (viii) disagreements could cause delays in, or termination of, the research, development or commercialization of the product or result in litigation or arbitration. The failure of any critical third party to meet its obligations; to adequately deploy business continuity plans in the event of a crisis; and/or to satisfactorily resolve significant disagreements with us or address other factors, could have a material adverse impact on our operations and results. In addition, if these third parties violate, or are alleged to have violated, any laws or regulations, including the local pharmaceutical code, the U.S. Foreign Corrupt Practice Act of 1977, the U.K. Bribery Act of 2010, the EU’s General Data Protection Regulations, and other similar laws and regulations, during the performance of their obligations for us, we could suffer financial and reputational harm or other negative outcomes, including possible legal consequences.

~~Future sales~~We ofmay ~~our~~not ~~common~~realize ~~stock~~a byreturn on ~~our~~the ~~existing~~shares ~~stockholders~~of ~~could~~DNA, ~~adversely~~Entera, ~~affect~~Nano, ~~our~~Alpha ~~stock~~Tau ~~price~~and Pelthos that we own.

~~The market~~DNA’s ~~price~~ordinary ofshares are ~~our~~traded ~~common~~on ~~stock~~the ~~could~~Tel ~~decline~~Aviv asStock aExchange ~~result~~and ofEntera’s ~~sales~~ordinary ~~of a large number of~~ shares, ofand ~~our~~Alpha ~~common~~Tau’s ~~stock~~ordinary ~~in the market~~shares, orLifeward’s ~~the~~ordinary ~~perception that these sales could occur~~shares. WeNano’s ~~experienced a significant decline in the market price of our~~ common stock and aPelthos’s ~~significant increase~~common instock ~~trading~~are ~~volume~~traded ~~after~~on ~~announcing~~ the ~~results~~Nasdaq ofStock ~~our~~Market, ~~ORA-D-013-1~~which ~~Phase~~are 3subject to ~~trial~~market ~~in January 2023~~fluctuations. ~~Any~~In ~~strategic~~addition, ~~decision~~the weshares ~~make as a result~~ of ~~our~~DNA, ~~strategic~~Entera, ~~review~~Alpha ~~process~~Tau, ~~may~~Nano ~~also~~and ~~negatively~~Pelthos ~~affect~~have ~~our~~historically ~~common~~experienced ~~stock price or cause volatility in the market price~~relatively oflow ~~our common stock. Sales of large amounts of our securities or large variations in~~ trading volume. ~~might~~As ~~make it more difficult for us to sell equity securities in the future at~~ a ~~time~~result, ~~and~~there atis ano ~~price~~guarantee that we ~~deem~~will ~~appropriate.~~be Asable ofto ~~March~~resell ~~27,~~those ~~2025, we had outstanding 40,850,455~~ shares ofat ~~common stock, a large majority of which are freely tradable. Giving effect to~~ the ~~exercise~~prevailing inmarket ~~full~~prices ~~of all of our~~or ~~outstanding~~that ~~warrants,~~we ~~options~~will ~~and~~realize ~~restricted~~a ~~stock~~positive ~~units,~~return oron ~~RSUs,~~such ~~including those currently unexercisable or unvested, we would have outstanding 44,599,618~~ shares ~~of common stock~~.

~~Our~~Because we may from time ~~issuance~~to oftime ~~warrants,~~maintain ~~options~~a ~~and~~significant ~~RSUs~~percentage toof ~~investors,~~our ~~employees~~assets in cash and/or ~~consultants~~securities, we may ~~have~~in athe ~~negative~~future ~~effect~~be ondeemed ~~the~~to ~~trading~~be ~~prices~~an investment company under ofthe Investment ~~our common~~Company Act ~~stock~~of as1940 resulting ~~well~~in asadditional acosts ~~dilutive~~and ~~effect~~regulatory burdens.

WeCurrently, we believe that either we are not within ~~have~~the ~~issued~~definition ~~and~~of ~~may~~“Investment ~~continue~~Company” toas ~~issue~~the ~~warrants,~~term ~~options~~is defined under the Investment Company Act of 1940, ~~RSUs~~or ~~and~~the 1940 ~~convertible~~Act, ~~notes~~or, atalternatively, ~~above~~we may rely on one or ~~below~~more of the ~~current~~1940 ~~market~~Act’s ~~price~~exemptions. As of ~~March~~ 27December 31, 2025, we ~~had~~held ~~outstanding~~approximately 0.2% ~~warrants~~of ~~exercisable~~DNA’s ~~for~~outstanding ~~20,000~~ordinary shares, approximately 0.26% of ~~common~~Entera’s ~~stock~~outstanding atordinary ashares, ~~weighed~~approximately ~~average~~2.58% of ~~exercise~~Nano’s ~~price~~outstanding ofordinary $shares, approximately 4.~~13 and~~9% ~~options~~of ~~exercisable~~Pelthos’s ~~for~~outstanding ~~1,548,633~~ordinary shares ofand ~~common~~approximately ~~stock~~17% of atAlpha aTau’s ~~weighted~~outstanding ~~average~~ordinary ~~exercise~~shares, ~~price~~in ofaddition ~~$7.09.~~we Wereceived ~~also~~warrants ~~had~~to ~~outstanding~~purchase ~~RSUs for~~up ~~589~~to 3,~~781~~237,000 ordinary shares of ~~common stock~~Alpha Tau. InFurther, ~~addition~~we tohold the ~~dilutive~~Tranche ~~effect~~A ofNote aand ~~large~~Tranche ~~number~~B ofNote ~~shares~~and ofin ~~common~~consideration ~~stock~~of ~~and~~deferring aScilex’s ~~low~~first ~~exercise~~amortization payment ~~price~~under ~~for~~ the ~~warrants~~Tranche ~~and~~B ~~options~~Note to October 8, ~~there~~2026, isWe ahave ~~potential~~also ~~that~~investments ain ~~large~~real ~~number~~estate ofand ~~underlying~~real ~~shares~~estate oflending ~~common~~transactions ~~stock~~as ~~may~~described elsewhere in this Annual Report. In order not to be ~~sold~~regulated inas an investment company under the 1940 Act, unless ~~open~~we ~~market~~can atqualify ~~any~~for ~~given~~an ~~time~~exclusion, ~~which~~we ~~could~~must ~~place~~ensure ~~downward~~that ~~pressure~~we onare ~~the~~engaged primarily in a business other than investing, reinvesting or trading in securities and that our activities do not include investing, reinvesting, owning, holding or trading “investment securities” constituting more than 40% of our ~~common~~total ~~stock~~assets (exclusive of U.S. government securities and cash items) on an unconsolidated basis.

~~Because~~We intend to continue to weconduct ~~will~~our ~~not~~operations ~~pay~~and ~~cash~~ongoing ~~dividends~~investments into DNA, Entera, Nano, Pelthos, Alpha Tau, Lifeward and Scilex and our real estate transaction in a manner that will exempt us from the ~~foreseeable~~registration ~~future,~~requirements ~~investors~~of ~~may~~the ~~have~~1940 Act. If we were to ~~sell~~be ~~shares~~deemed to be an investment company because of our ~~common~~investments, ~~stock~~we inwould ~~order~~be required to ~~realize~~register ~~their~~as an investment company under the 1940 Act. Alternatively, to continue qualifying for the exemption, we could be required to dispose of the securities holdings or other investments, which could have a material adverse effect on our business, results of operations and financial condition. The 1940 Act places significant restrictions on the capital structure and corporate governance of a registered investment company and materially restricts its ability to conduct transactions with affiliates. Compliance with the 1940 Act could also increase our operating costs. Such changes could have a material adverse effect on our business, results of operations and financial condition.

We have not paid any cash dividends on our common stock and do not intend to pay cash dividends in the foreseeable future. We intend to retain future earnings, if any, for reinvestment in the development and expansion of our business. Any credit agreements which we may enter into with institutional lenders or otherwise may restrict our ability to pay dividends. Whether we pay cash dividends in the future will be at the discretion of our Board and will be dependent upon our financial condition, results of operations, capital requirements and any other factors that our Board decides is relevant.24

26We may not realize the full benefit from our distribution license agreement with Medicox.

~~Our~~On November 13, 2022, we ~~failure~~entered tointo ~~maintain~~a ~~compliance~~distribution ~~with~~license agreement or, the ~~Nasdaq~~“Medicox License ~~Capital~~Agreement” ~~Market’s~~with Medicox Co., ~~continued~~Ltd. ~~listing~~or Medicox. ~~requirements~~The Medicox License ~~could~~Agreement ~~result~~grants Medicox an exclusive license to apply for regulatory approval and distribute ORMD-0801 in the ~~delisting~~Republic of Korea. Our distribution license agreement with Medicox provides that Medicox will comply with agreed distribution targets and will purchase ORMD-0801 at an agreed upon transfer price per capsule and pay us up to $15,000,000 in developmental milestones, $2,000,000 of which have already been received by us. If we are not successful in finding a mutually agreed way to continue our ~~common~~collaboration following ~~stock~~the results of the ORA-D-013-1 Phase 3 trial, or if Medicox is not successful in independently advancing the oral insulin candidate, we may not realize the benefits from this collaboration.

~~Our common~~We ~~stock~~are ishighly ~~currently listed on the Nasdaq Capital Market. In order to maintain this listing, we must satisfy minimum financial and~~dependent ~~other~~upon ~~requirements. Nasdaq Listing Rule 5550(a)(2) requires the minimum bid price of~~ our ~~common~~ability ~~stock on the Nasdaq Capital Market~~ to ~~remain~~ ~~above~~enter ~~$1.00.~~into Ifagreements ~~the bid price of our common stock closes below $1.00 per share for 30 consecutive business days, we would be in violation of Nasdaq Listing Rule 5550(a)(2). In accordance~~ with ~~Nasdaq~~collaborative ~~Listing~~partners ~~Rule~~to ~~5810(c)(3)(A)~~develop, wecommercialize ~~would~~and ~~have~~market ~~180~~our ~~calendar days to regain compliance with the minimum bid requirement~~products.

~~While we~~Our ~~intend~~long-term strategy is to ~~engage~~ultimately inseek ~~efforts~~a tostrategic ~~maintain~~commercial ~~compliance~~partner, ~~and~~or ~~thus maintain our listing~~partners, ~~there~~such ~~can~~as belarge nopharmaceutical ~~assurance~~companies, ~~that~~with weextensive ~~will~~experience ~~continue to meet all applicable Nasdaq Capital Market requirements~~ in the ~~future~~development, ~~especially~~commercialization, inand ~~light~~marketing of ~~any~~insulin ~~strategic~~applications ~~transaction~~and/or weother ~~may~~orally ~~choose to~~digestible ~~undertake~~drugs. IfSuch ~~our~~planned ~~common~~strategic partnership, ~~stock~~or ~~were~~partnerships, ~~removed~~may ~~from~~provide ~~listing~~a ~~with~~marketing ~~the~~and ~~Nasdaq~~sales ~~Capital~~infrastructure ~~Market,~~for itour ~~may~~products beas ~~subject~~well toas ~~the~~financial ~~so-called~~and ~~“penny~~operational ~~stock”~~support ~~rules.~~for ~~The~~global ~~SEC~~clinical ~~has~~trials, ~~adopted~~post ~~regulations~~marketing ~~that~~trials, ~~define~~label aexpansions ~~“penny~~and ~~stock”~~other toregulatory berequirements ~~any~~concerning ~~equity~~future ~~security~~clinical development ~~that~~in ~~has~~the aUnited ~~market price~~States ~~per~~and ~~share~~elsewhere. ofWe ~~less~~currently ~~than~~lack ~~$5.00,~~the ~~subject~~resources to ~~certain~~manufacture ~~exceptions,~~any ~~such~~of asour ~~any~~product ~~securities~~candidates ~~listed~~ on a ~~national securities exchange, which~~large isscale ~~the~~and ~~exception on which~~ we ~~currently~~have ~~rely.~~no ~~For~~sales, ~~any~~marketing ~~transaction~~or ~~involving~~distribution acapabilities. ~~“penny~~In ~~stock,” unless exempt,~~ the ~~rules~~event ~~impose additional~~we ~~sales~~are ~~practice~~not ~~requirements~~able onto ~~broker-dealers,~~enter ~~subject~~into toa ~~certain~~collaborative ~~exceptions.~~agreement with Ifa ~~our~~partner, ~~common~~or ~~stock~~partners, ~~were~~on ~~delisted~~commercially ~~and~~reasonable ~~determined to~~terms, beor aat ~~“penny stock~~all,” awe ~~broker-dealer~~ may ~~find~~be itunable ~~more difficult~~ to ~~trade~~commercialize our ~~common~~products, ~~stock~~which ~~and an investor may find it more~~would ~~difficult~~have toa ~~acquire~~material oradverse ~~dispose~~effect ofupon our ~~common~~business, ~~stock~~prospects, onfinancial ~~the~~condition ~~secondary~~and ~~market~~results of operations.

~~If our~~The ~~common~~biotechnology ~~stock is delisted~~ and ~~there is no longer an active trading market for our shares, it may, among other things: cause stockholders~~ ~~difficulty~~biopharmaceutical inindustries ~~selling~~are ~~our~~characterized ~~shares~~by ~~without~~rapid ~~depressing~~technological ~~the~~developments ~~market~~and ~~price for the shares or selling our shares at all; substantially impair our ability to raise additional funds; result in~~ a ~~loss~~high ofdegree ~~institutional investor interest and fewer financing opportunities for us; and/or result in costly litigation, significant liabilities and diversion~~ of ~~our~~competition. ~~management’s~~We ~~time~~may ~~and~~be ~~attention and could have~~unable ato ~~material~~compete ~~adverse~~with ~~effect~~more onsubstantial ~~our financial condition, business and results of operations~~enterprises.

AThe biotechnology and biopharmaceutical ~~delisting~~industries ~~would~~are characterized by rapid technological developments and a high degree of competition. As a result, our products could become obsolete before we recoup any portion of our related research and development and commercialization expenses. These industries are highly competitive, and this competition comes both from biotechnology firms and from major pharmaceutical and chemical companies. Many of these companies have substantially greater financial, marketing and human resources than we do (including, in some cases, substantially greater experience in clinical testing, manufacturing and marketing of pharmaceutical products). We also ~~reduce~~experience ~~the~~competition ~~value~~in the development of our ~~equity~~products ~~compensation~~from ~~plans~~universities and other research institutions and compete with others in acquiring technology from such universities and institutions. We face the risk that new market entrants and existing competition may try to replicate our business model or introduce a more innovative offering that renders our services less competitive or obsolete. In addition, our research and development efforts may target diseases and conditions for which ~~could~~there ~~negatively~~are ~~impact~~existing therapies or therapies that are being developed by our ~~ability~~competitors. Further, any products resulting from our research and development efforts might not be able to ~~retain~~compete ~~employees~~successfully with others’ existing and future products. See “Item 1. Business—Description of Business—Competition.”

~~As the~~Our ~~market~~financial ~~price of our common stock may fluctuate significantly, this may make it difficult for you to sell your shares of common stock~~position ~~when~~or ~~you~~results ~~want~~could orbe atnegatively ~~prices~~affected ~~you~~by ~~find~~product ~~attractive~~liability claims.

~~The price~~It ofis ~~our~~possible ~~common~~that ~~stock~~we iswill be ~~currently~~responsible ~~listed~~for onpotential ~~the~~product ~~Nasdaq~~liability ~~Capital~~stemming ~~Market~~from ~~and~~product onresearch, ~~the~~development ~~Tel~~or ~~Aviv~~manufacturing ~~Stock~~and ~~Exchange~~may ~~and~~face ~~constantly~~an ~~changes.~~even greater Inrisk ~~recent~~if ~~years,~~any ~~the~~product ~~stock~~candidate ~~market~~that inwe ~~general~~develop ~~has~~is ~~experienced~~commercialized. ~~extreme~~If ~~price~~we ~~and~~cannot ~~volume~~successfully ~~fluctuations.~~defend Weourselves ~~expect~~against claims that ~~the~~products we ~~market~~develop ~~price~~independently of or with our ~~common~~partners ~~stock~~caused ~~will~~injuries, ~~continue~~we tocould ~~fluctuate~~incur substantial liabilities. ~~These~~Regardless ~~fluctuations~~of the merit or eventual outcome of such claims, any liability claims may result ~~from~~in, aamong ~~variety~~other things, decreased demand for any product that we may develop, loss of ~~factors~~revenues, ~~many~~significant time and costs to defend the related litigation, initiation of ~~which~~investigations ~~are~~by ~~beyond~~regulators and injury to our ~~control~~reputation and significant negative media attention. ~~For~~ ~~example~~On occasion, welarge ~~experienced~~judgments ahave ~~significant~~been ~~decline~~awarded in ~~the~~class ~~market~~action ~~price~~lawsuits ofbased on ~~our~~drugs ~~common~~or ~~stock~~medical ~~after~~treatments ~~announcing~~that ~~the~~had ~~results~~unanticipated ofadverse ~~our~~effects. ~~ORA-D-013-1~~Our clinical trials are covered by liability insurance, but notwithstanding ~~Phase~~such 3coverage, ~~trial~~our infinancial ~~January~~position ~~2023.~~or ~~These~~results ~~factors~~could ~~include:~~be negatively affected by product liability claims.

~~● market acceptance of our new strategy, once determined and announced;~~25

●We ~~clinical~~have ~~trial~~limited ~~results~~senior management resources and ~~the~~may ~~timing~~be ofrequired ~~the~~to ~~release~~obtain ofmore ~~such~~resources ~~results;~~to manage our growth.

●We expect the ~~amount~~expansion of our ~~cash~~business, as well as the activities we take as a result of our strategic review process, to place a significant strain on our limited managerial, operational and financial resources. We will be required to expand our operational and financial systems significantly and to expand, train and manage our work force in order to manage the expansion of our operations. Our failure to fully integrate our new employees into our operations could have a material adverse effect on our business, prospects, financial condition and results of operations. Our ability to ~~obtain~~attract ~~additional~~and ~~funding;~~retain highly skilled personnel is critical to our operations and expansion. We face competition for these types of personnel from other technology companies and more established organizations, many of which have significantly larger operations and greater financial, technical, human and other resources than we have. We may not be successful in attracting and retaining qualified personnel on a timely basis, on competitive terms or at all. If we are not successful in attracting and retaining these personnel, our business, prospects, financial condition and results of operations will be materially adversely affected. See “Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations,” “Item 1. Business—Description of Business—Employees.”

●We ~~announcements~~depend ofupon ~~research~~our ~~activities,~~senior management ~~business~~and ~~developments,~~skilled ~~technological~~personnel ~~innovations~~and their loss or ~~new~~unavailability ~~products~~could byput us orat ~~our~~a ~~competitors;~~competitive disadvantage.

●We ~~entering~~currently ~~into~~depend upon the efforts and abilities of our senior executives, as well as the services of several key consultants and other key personnel, including Dr. Miriam Kidron, our Chief Scientific Officer. The loss or ~~terminating~~unavailability ~~strategic~~of ~~relationships;~~the services of any of these individuals for any significant period of time could have a material adverse effect on our business, prospects, financial condition and results of operations. We do not maintain “key man” life insurance policies for any of our senior executives. In addition, recruiting and retaining qualified scientific personnel to perform future research and development work will be critical to our success. There is currently a shortage of employees with expertise in developing, manufacturing and commercialization of products and related clinical and regulatory affairs, and this shortage is likely to continue. Competition for skilled personnel is intense and turnover rates are high. Our ability to attract and retain qualified personnel may be limited. Our inability to attract and retain qualified skilled personnel would have a material adverse effect on our business, prospects, financial condition and results of operations.

●Our ~~changes~~existing inand ~~government~~any ~~regulation;~~future joint ventures may limit our flexibility with jointly owned investments and we may not realize the benefits we expect from these arrangements.

●We ~~departure~~are ofcurrently ~~key~~party ~~personnel;~~to certain joint ventures, and we may in the future sell or contribute additional assets or acquire, develop or recapitalize assets to or in these joint ventures or other joint ventures that we may enter.

●Our ~~disputes~~participation ~~concerning~~in ~~patents~~our existing orjoint ~~proprietary~~ventures ~~rights;~~is subject to risks, including the following:

27● We share approval rights over certain major decisions affecting the ownership or operation of the joint ventures and any assets owned by the joint ventures;

● ~~changes~~We may need to contribute additional capital in ~~expense~~order ~~level~~to preserve, maintain or grow the joint ventures and their investments;

● ~~future~~Our ~~sales~~joint ofventure investors may have economic or other business interests or goals that are inconsistent with our ~~equity~~business interests or ~~equity-related~~goals ~~securities~~and that could affect our ability to fully benefit from the assets owned by the joint ventures;

● ~~public~~Our ~~concern~~joint ~~regarding~~venture ~~the~~investors ~~safety,~~may ~~efficacy~~be subject to different laws or ~~other~~regulations ~~aspects~~than ofus, ~~the~~which ~~products~~could orcreate ~~methodologies~~conflicts ~~being~~of ~~developed~~interest;

● ~~activities~~Our ofjoint ~~various~~ventures ~~interest~~may ~~groups~~have orlicense ~~organizations~~and other agreements with other investors, which we are not party to and have no control over;

~~● media coverage; and~~26

● ~~status~~Our ability to sell our interests in, or sell additional assets to, the joint ventures or the joint ventures’ ability to sell additional interests of, or assets owned by, the ~~investment~~joint ~~markets.~~ventures when we so desire are subject to the approval rights of the other joint venture investors under the terms of the agreements governing the joint ventures; and

~~Future sales~~● ofDisagreements ~~common~~with ~~stock or the issuance of securities senior to~~ our ~~common~~joint ~~stock~~venture orinvestors ~~convertible~~could ~~into,~~result orin ~~exchangeable~~litigation or ~~exercisable~~arbitration ~~for, our~~that ~~common stock~~ could ~~materially~~be ~~adversely~~expensive ~~affect the trading price of our common stock,~~ and ~~our~~distracting ~~ability~~ to ~~raise~~management ~~funds~~and incould ~~new~~delay ~~equity offerings~~important decisions.

~~Future sales~~Any of ~~substantial amounts of our common stock, including pursuant to any strategic opportunity,~~ the ~~ATM~~foregoing ~~Agreement (as defined below),~~risks orcould ~~other~~have ~~equity-related~~a ~~securities~~material inadverse ~~the~~effect ~~public~~on ~~market~~our ~~or privately~~business, orfinancial ~~the~~condition ~~perception~~and ~~that~~results ~~such~~of ~~sales~~operations. ~~could~~Further, ~~occur~~these, ~~could~~similar, ~~adversely~~enhanced ~~affect~~or ~~prevailing~~additional ~~trading~~risks, ~~prices~~including ofpossible ~~our~~risks ~~common stock and could impair our ability to raise capital through future offerings~~ of ~~equity or~~the other ~~equity-related~~joint ~~securities.~~venture Weinvestors ~~anticipate~~having ~~that~~licensed weassets ~~will need~~ to ~~raise~~the ~~capital~~joint ~~through~~venture, ~~offerings~~may ~~of equity and equity related securities.~~apply ~~We can make no prediction as~~ to ~~the effect, if~~ any, ~~that~~ future ~~sales~~additional ~~of shares of our common stock~~ or ~~equity-related~~amended ~~securities,~~joint ~~or the~~ventures ~~availability~~that ofwe ~~shares~~may ofenter ~~common stock for future sale, will have on the trading price of our common stock~~into.

~~Our~~Healthcare policy changes, ~~stockholders~~including ~~may~~pending ~~experience~~legislation ~~significant~~recently ~~dilution~~adopted asand afurther ~~result~~proposals ofstill ~~any~~pending ~~additional~~to ~~financing~~reform ~~using~~the ~~our~~U.S. ~~equity~~healthcare ~~securities~~system, may harm our future business.

ToHealthcare costs have risen ~~the~~significantly ~~extent~~over ~~that~~the wepast ~~raise~~decade. ~~additional~~There ~~funds~~have bybeen ~~issuing~~and ~~equity~~continue ~~securities,~~to ~~including~~be inproposals ~~connection~~by ~~with~~legislators, ~~any~~regulators ~~strategic~~and ~~opportunity~~third-party orpayors ~~pursuant~~ to keep ~~the~~these ~~ATM~~costs ~~Agreement~~down. Certain proposals, ~~our~~if ~~stockholders~~passed, ~~may~~would ~~experience~~impose ~~significant~~limitations ~~dilution.~~on ~~Additionally,~~the prices we ~~may,~~will ~~from~~be ~~time~~able to ~~time~~charge orfor inthe ~~connection~~products ~~with~~that awe ~~strategic~~are ~~alternative~~developing, ~~issue~~or ~~additional~~the ~~shares~~amounts of ~~common~~reimbursement ~~stock~~available atfor athese ~~discount~~products from ~~the~~governmental ~~current~~agencies ~~trading~~or ~~price~~third-party ~~of our common stock~~payors. AsThese alimitations ~~result,~~could ~~our~~in ~~stockholders~~turn ~~would~~reduce ~~experience immediate dilution upon~~ the ~~purchase~~amount of ~~any~~revenues ~~shares~~that ~~of our common stock sold at such discount. In addition, as opportunities present themselves,~~ we ~~may~~will ~~enter~~be ~~into~~able ~~financing~~to orgenerate ~~similar arrangements~~ in the future, ~~including~~from ~~the~~sales ~~issuance~~ of ~~convertible debt securities, preferred stock or common stock. If we issue common stock or securities convertible into common stock,~~ our ~~common stockholders would experience additional dilution~~ products and, aslicenses aof ~~result,~~ our ~~stock price may decline~~technology.

~~Risks~~In 2010, the federal government ~~Related~~enacted healthcare reform legislation that has significantly impacted the pharmaceutical industry. In addition to JVrequiring ~~Agreement~~most individuals to have health insurance and establishing new regulations on health plans, this legislation requires discounts under the Medicare drug benefit program and increased rebates on drugs covered by Medicaid. In addition, the legislation imposes an annual fee, which has increased annually, on sales by branded pharmaceutical manufacturers. There can be no assurance that our business will not be materially adversely affected by these increased rebates, fees and other provisions. In addition, these and other initiatives in the United States may continue the pressure on drug pricing, especially under the Medicare and Medicaid programs, and may also increase regulatory burdens and operating costs. The announcement or adoption of any such initiative could have an adverse effect on potential revenues from any product that we may successfully develop. An expansion in government’s role in the U.S. healthcare industry may lower the future revenues for the products we are developing and adversely affect our future business, possibly materially.

IfIn September 2017, members weof ~~fail~~the toU.S. ~~complete~~Congress introduced legislation with the ~~transactions~~announced ~~contemplated~~intention ~~under~~to repeal and replace major provisions of the JVPatient ~~Agreement~~Protection and asAffordable ~~supplemented~~Care byAct, or the ~~Supplemental~~ACA. ~~Agreement~~In ~~with~~addition ~~HTIT~~to those efforts, ifon October 12, 2017, an executive order was issued that modified certain ~~such~~aspects ~~joint~~of ~~venture~~the isACA. ~~not~~Following ~~successful~~several years of litigation in the federal courts, orin ifJune we2021, ~~fail~~the U.S. Supreme Court upheld the ACA when it dismissed a legal challenge to ~~realize~~the ACA’s constitutionality. Further attempts to repeal or to repeal and replace the ~~benefits~~ACA may wecontinue. ~~anticipate~~In ~~from~~addition, ~~such~~various ~~joint~~other ~~venture~~healthcare reform proposals have also emerged at the federal and state level. We cannot predict what healthcare initiatives, weif ~~may~~any, ~~not~~will be ~~able to~~implemented ~~capitalize~~at onthe federal or state level, or the ~~full~~effect ~~market~~any ~~potential~~future oflegislation ~~our~~or ~~drug~~regulation will ~~products~~have ~~and~~on ~~technology~~us.

~~In joint~~We ventures, we share ownership and management of a company with one or more parties who may not have the same goals, strategies, priorities, business incentives or resources as we do and may compete with us outside the joint venture. Joint ventures are ~~intended to~~exposed be operated for the benefit of all co-owners, rather than for our exclusive benefit. Operating a business as a joint venture often requires additional organizational formalities as well as time-consuming procedures for sharing information and making decisions that must further take into consideration our partners’ interests. In joint ventures, we are required to ~~foster our relationships with our~~fluctuations ~~co-owners as well as promote the overall success of the joint venture, and if a co-owner changes, relationships deteriorate or strategic objectives diverge, our success~~ in ~~the~~currency ~~joint~~exchange ~~venture may be materially adversely affected~~rates. ~~Further, because most of the benefits from a successful joint venture are shared among the co-owners, we do not receive all the benefits from our successful joint ventures.~~

28A considerable amount of our expenses are generated in dollars or in dollar-linked currencies, but a significant portion of our expenses such as some clinical trials and payroll costs are generated in other currencies such as NIS and Euro. Most of the time, our non-dollar assets are not totally offset by non-dollar liabilities. Due to the foregoing and to the fact that our financial results are measured in dollars, our results could be adversely affected as a result of a strengthening or weakening of the dollar compared to these other currencies. During the year ended December 31, 2025, the dollar depreciated in relation to the NIS, which raised the dollar cost of our Israeli based operations and adversely affected our financial results, while during the year ended December 31, 2024, the dollar increased in relation to the NIS, which reduced the dollar cost of our Israeli based operations costs. In addition, our results could also be adversely affected if we are unable to guard against currency fluctuations in the future. Although we may in the future decide to undertake foreign exchange hedging transactions to cover a portion of our foreign currency exchange exposure, we currently do not hedge our exposure to foreign currency exchange risks. These transactions, however, may not adequately protect us from future currency fluctuations and, even if they do protect us, may involve operational or financing costs we would not otherwise incur.

In addition, because we share ownership and management with one or more parties, we may have limited control over the actions of a joint venture, particularly when we own a minority interest. As a result, we may be unable to prevent violations of applicable laws or other misconduct by a joint venture, adverse human rights or other impacts or the failure to satisfy contractual obligations by one or more parties. Moreover, a joint venture may not be subject to the same financial reporting, corporate governance or compliance approaches that we follow. To the extent another party makes decisions that negatively impact the joint venture or internal control issues arise within the joint venture, we may have to take responsive actions, or we may be subject to penalties, fines or other punitive actions or suffer reputational harm for these activities.27

~~The consummation~~Our ofinvestments ~~the~~in ~~transactions~~real ~~contemplated~~estate bymay ~~the~~expose us JVto ~~Agreement,~~market asand ~~supplemented~~liquidity byrisks ~~the~~that ~~Supplemental~~could ~~Agreement,~~adversely isaffect ~~subject~~our tofinancial ~~the~~condition ~~satisfaction or~~and ~~waiver~~results of ~~certain other closing conditions.~~operations

IfOur investments in real estate wemay doexpose ~~not~~us ~~successfully~~to ~~complete~~market ~~the~~and ~~closing~~liquidity ~~conditions,~~risks ~~this~~that ~~may~~could ~~harm~~adversely affect our ~~ability~~financial tocondition ~~complete~~and ~~the~~results ~~transactions~~of ~~contemplated~~operations. byOn ~~the JV~~November ~~Agreement~~7, as2024, ~~supplemented~~our byBoard ~~the~~approved ~~Supplemental~~investments ~~Agreement~~of up to $10,000,000 asin ~~well~~real asestate assets, and additional ~~clinical~~investments ~~trials~~of up to $20,000,000 On February 13, 2025. Following such approvals, we made investments into several real estate and ~~marketing~~related projects, including investment in Rabi Binyamin Project, purchase of ~~our~~land ~~oral~~in ~~insulin~~Mevaseret ~~candidate~~Zion, Israel, investment in Ruby Sapphire II, construction loan arranged by Lorimer Capital. To the extent our real estate investments are unsecured, or if the security interest provided by a caveat is challenged, delayed Inin ~~addition~~enforcement, ~~this~~or otherwise ineffective, we may ~~cause~~have ~~irreparable~~limited ~~harm~~or tono ~~our~~recourse ~~financial~~against ~~position~~the underlying property. As a result, such investments involve a higher degree of risk, including the potential loss of principal and ~~business~~any ~~operations~~expected returns.

~~Furthermore~~In addition,while we believe ~~there~~these ~~can~~investments bepresent noattractive ~~assurances~~opportunities, ~~that~~the ~~OraTech~~real ~~will~~estate ~~receive~~market ~~the~~is ~~necessary~~subject ~~regulatory~~to ~~approvals~~fluctuations ~~for~~due ~~the~~to ~~Phase~~economic 3conditions, ~~oral~~interest rate ~~insulin~~changes, ~~trial~~and other external factors beyond our control. A downturn in the ~~United States~~real estate market or ~~that~~an ~~our~~extended ~~drug~~period ~~products~~of ~~and~~declining property ~~our~~values ~~technology~~could ~~will~~negatively beimpact ~~developed~~the ~~and~~returns ~~commercialized~~on ~~successfully~~our investments. ~~In addition~~Additionally, ~~OraTech~~real ~~will~~estate ~~subject us~~investments tend to abe ~~number~~relatively ofilliquid, which ~~risks~~may ~~including~~limit ~~risks~~our ~~relating~~ability to ~~the~~quickly ~~lack~~exit ofor ~~full~~reallocate ~~control~~capital ofin ~~OraTech,~~response ~~potential~~to ~~disagreements~~market ~~with~~changes. ~~HTIT~~Since ~~about~~our ~~how to~~approach ~~manage~~focuses ~~OraTech~~on ~~that~~entrepreneurial real ~~may~~estate ~~result~~investments inrather ~~the~~than ~~delay~~direct orproperty ~~termination~~ownership ofor ~~the~~management, ~~commercialization~~we ofare ~~our~~also ~~products~~exposed orto ~~product~~risks ~~candidates~~associated orwith ~~that~~deal execution, ~~result~~market intiming, ~~costly~~and ~~litigation~~the orfinancial ~~arbitration~~health ~~that~~of ~~diverts~~investment ~~management~~partners ~~attention~~or ~~and~~counterparties. ~~resources,~~If ~~conflicting~~any ~~interests~~ of ~~OraTech~~these risks materialize, ~~and~~they ~~OraTech~~could adversely affect our financial position and ~~its~~ability ~~business~~to ~~not~~generate ~~being~~anticipated ~~profitable~~returns.

~~While we~~If ~~believe~~Alpha ~~that~~Tau ~~our~~fails ~~board representation, voting rights and other contractual rights with respect~~ to achieve ~~OraTech~~positive ~~will~~clinical ~~serve~~results toor ~~mitigate~~obtain ~~some of~~regulatory ~~these risks~~approvals, ~~we may have disagreements with~~ the ~~other~~value ~~directors~~of ~~and~~our ~~HTIT~~investment ~~that~~ could ~~impair~~decline ~~our~~materially, ~~ability~~which tomay ~~influence OraTech to act~~adversely inaffect aour ~~manner~~financial ~~that we believe is in the best interest of us~~results.

WeIn April 2025, we invested approximately $36.9 ~~may~~million ~~not~~in ~~complete~~Alpha Tau through the ~~transactions~~purchase ~~contemplated~~of byits ~~the~~ordinary JVshares. ~~Agreement~~The value of this investment is subject to risks and uncertainties. Alpha Tau is a clinical-stage oncology therapeutics company, asand ~~supplemented~~its byability to generate value depends largely on the ~~Supplemental~~successful ~~Agreement~~development, clinical validation, regulatory approval, and commercialization of its product candidates.

~~Pursuant to~~If ~~the~~Alpha ~~Supplemental~~Tau ~~Agreement,~~fails ~~the~~to ~~Initial~~achieve positive ~~Closing~~clinical ~~will~~results bedemonstrating ~~April 30, 2025. Subject to~~ the ~~completion~~safety and ~~satisfaction~~efficacy of ~~applicable~~its ~~closing conditions~~technologies, ~~the~~experiences ~~Second~~delays ~~Closing~~or ~~shall~~setbacks ~~occur on a date specified~~ in ~~the~~its ~~applicable~~clinical ~~closing notice~~trials, or ~~which~~encounters ~~such~~difficulties ~~date~~in ~~shall~~obtaining beregulatory noapprovals, ~~later than~~ the ~~fifth~~market ~~business~~value ~~day after the satisfaction or waiver~~ of ~~the~~Alpha ~~applicable~~Tau’s ~~closing~~ordinary ~~conditions,~~shares ~~provided,~~could ~~however,~~decline ~~that the Second Closing~~significantly. ~~shall~~Negative ~~not~~or beinconclusive ~~consummated~~clinical ~~before~~data ~~April~~may ~~30,~~materially ~~2025~~harm ~~unless~~Alpha ~~the shares of OraTech~~Tau’s ~~common~~business ~~stock~~prospects, ~~have~~financial ~~been~~condition, ~~approved for listing~~ and ~~trading on~~ability ~~the Nasdaq Stock Market prior~~ to raise ~~April~~additional 30capital, ~~2025.~~any Inof ~~the~~which ~~event~~could ~~the~~result ~~parties~~in ~~fail~~a tosubstantial ~~consummate~~decrease the ~~Second~~value ~~Closing~~of onour orinvestment. ~~before~~In ~~April 30~~addition, ~~2025,~~our ~~solely~~investment exposes ~~due~~us to ~~the~~risks ~~failure~~associated ofwith ~~not~~market ~~achieving the Listing~~volatility, ~~the~~dilution ~~parties~~from ~~agreed~~future tofinancings ~~consummate~~by ~~the~~Alpha ~~Second~~Tau, ~~Closing~~and onfactors orbeyond ~~before~~our ~~May~~control that ~~31,~~may ~~2025.~~affect ~~Notwithstanding~~Alpha ~~the~~Tau’s ~~foregoing,~~operations ~~the~~or ~~provisions~~valuation. ~~with~~Any ~~respect~~decline toin the ~~Second~~value ~~Closing~~of ~~may~~Alpha beTau’s ~~terminated~~ordinary byshares ~~either~~could ~~HTIT~~reduce orthe benefits uswe ~~if the~~expect ~~Second~~from ~~Closing~~this ~~has~~investment ~~not~~and ~~occurred~~adversely byaffect ~~September~~our 1,financial ~~2025,~~condition ~~subject~~and toresults ~~certain~~of ~~conditions~~operations.

~~There are~~We nohave ~~assurances~~lent ~~that~~a ~~the~~substantial amount ~~applicable parties will consummate either the Initial Closing or the Second Closing,~~ of ~~the~~funds ~~Spin~~to ~~Off~~Scilex. orIn ~~complete~~ the ~~closing~~event ~~conditions~~that ~~such~~Scilex ~~closings~~is ~~are~~unable ~~subject~~ to. Ifservice weits doobligations ~~not~~under ~~successfully complete such closings in a timely manner, or at all, this may harm OraTech’s ability to complete~~ the ~~transactions~~Note ~~contemplated by the JV Agreement~~ and ~~the~~defaults ~~Supplemental~~on ~~Agreement~~such Note, ~~which~~it ~~may~~could inhave ~~turn~~a ~~cause~~material ~~irreparable~~adverse ~~harm~~effect toon our ~~financial position and~~ business ~~operations~~.

29On September 21, 2023, we were issued the Tranche A Note in an aggregate principal amount of $101,875,000 by Scilex pursuant to the Scilex SPA. Interest under the Tranche A Note accrues at a fluctuating per annum interest rate equal to the sum of (1) the greater of (x) four percent (4%) and (y) Term SOFR (as defined in the Tranche A Note) and (2) eight and one half percent (8.5%), payable in-kind on a monthly basis.

On October 7, 2024, we entered into an agreement to refinance a portion of the Tranche A Note and pay off certain other indebtedness of Scilex. We were issued an aggregate principal amount of $25,000,000 under ~~may~~the ~~not~~Tranche ~~realize~~B Note and 3,750,000 Tranche B Warrants. In addition, on October 8, 2024, we entered into the ~~anticipated~~RPA ~~benefits~~with ~~from~~Scilex to holds the right ~~Spin~~to ~~Off~~receive 4% royalties. As of March 26, 2026, Scilex had repaid $69,200,000 of the Tranche A Note and $13,000,000 of the ~~Spin~~Tranche B ~~Off~~Note, ~~could~~and ~~harm~~the ~~our~~outstanding ~~business~~principal balances were $7,675,000 and $12,000,000, respectively.

We may not be able to achieve the full strategic and financial benefits expected to result from the Spin Off and such benefits may be delayed or not occur at all. The Spin Off is designed to enhance strategic and management focus, provide a distinct corporate identity, and allow us to efficiently allocate resources and deploy capital. We may not achieve these and other anticipated benefits for a variety of reasons, including the following:28

●There is no guarantee that Scilex will be able to service its repayment obligations under the ~~Spin~~Note. ~~Off~~Although the Note is secured by a first priority security interest and liens on all of the assets of Scilex and its subsidiaries, no assurance can be made that Scilex will ~~require~~be ~~significant~~able to repay the Tranche A Note and Tranche B Notes, or the Notes, when due or that we will be able to foreclose on such assets and recover enough value upon the sale of such assets to repay the amounts owed to us. In such an event, we could lose all or a substantial portion of ~~management’s~~our ~~time~~loan ~~and~~investment. ~~effort~~Additionally, ~~which~~Scilex has disclosed in its periodic reports filed with the SEC that there is substantial doubt about its ability to continue as a going concern. If Scilex is unable to continue as a going concern or defaults on the Notes, we may ~~divert~~be ~~management’s~~unable ~~attention~~to ~~from~~recover ~~operating~~some ~~and~~or ~~growing~~all of the principal amount of the Note, which could have a material adverse effect on our business;, financial condition and results of operations.

●The ~~following~~value ~~the~~of ~~Spin~~our ~~Off,~~investment into ~~OraTech~~Lifeward may ~~be more susceptible to economic downturns and other adverse events than if it was still a part of the Company;~~decline.

●Pursuant ~~following~~to the ~~Spin~~Lifeward ~~Off~~Share Purchase Agreement, ~~our~~among ~~business~~other ~~will~~customary closing beconditions, ~~less~~upon ~~diversified~~the ~~than~~closing ~~prior~~of the OraTech Share Purchase, Lifeward issued to us a number of Lifeward Ordinary Shares and pre-funded warrants equal to 49.99% of the ~~Spin~~Lifeward’s ~~Off;~~fully diluted equity capitalization, subject to certain adjustments, as of closing. The value of this investment is subject to risks and uncertainties. Lifeward is a medical device company, and its ability to generate value depends largely on the successful development, regulatory approval, and commercialization of its products. Any decline in the value of Lifeward’s ordinary shares could reduce the benefits we expect from this investment.

●In ~~following~~addition, there is no guarantee that Lifeward will be able to service its repayment obligations under the ~~Spin~~Secured ~~Off~~Promissory Note and the Notes issuable under the Lifeward Notes Purchase Agreement, ~~our~~as ~~business~~applicable. Although ~~will~~the ~~experience~~Secured Promissory Note is secured by a ~~loss~~lien ofon ~~scale~~Lifeward’s cash and ~~access~~accounts receivable, and the Initial Notes are secured by a first priority security interest and liens on all of the assets of Lifeward, no assurance can be made that Lifeward will be able to ~~certain~~repay ~~financial~~the Secured Promissory Note or the Notes, ~~managerial~~as applicable, when due or that we will be able to foreclose on such assets and ~~professional~~recover ~~resources~~enough value upon the sale of such assets to repay the amounts owed to us. In such an event, we could lose all or a substantial portion of our loan investment. Additionally, Lifeward has disclosed in its periodic reports filed with the SEC that there is substantial doubt about its ability to continue as ~~well~~a going concern. If Lifeward is unable to continue as ~~product~~a ~~and~~going ~~brand~~concern ~~power~~or ~~influence~~defaults ~~and~~on ~~recognition~~the ~~with~~Secured Promissory Note or the Notes, we may be unable to recover some ~~customers~~or ~~from~~all of the principal amount of the Secured Promissory Note or the Notes, which wecould have ~~benefited~~a inmaterial ~~the~~adverse ~~past;~~effect on our business, financial condition and results of operations.

●Risks ~~actions~~Related ~~required~~ to ~~separate the respective businesses could disrupt~~ our ~~operations;~~Common ~~and~~Stock

●Future ifsales ~~we fail to achieve some or all~~ of ~~the~~our ~~benefits~~common stock ~~expected~~by toour ~~result~~existing ~~from~~stockholders ~~the~~could ~~Spin~~adversely ~~Off,~~affect ~~or if such benefits are delayed,~~ our ~~business~~stock ~~could be harmed~~price.

~~Until~~The market price of our common stock could decline as a result of sales ~~the~~of ~~Spin~~a ~~Off~~large ~~occurs~~number of shares of our common stock in the market, or the ~~business~~perception that these sales could occur. We experienced a significant decline in the market price of ~~OraTech~~our ~~will~~common ~~remain~~stock and a significant increase in trading volume after announcing the results of our ~~business~~ORA-D-013-1 Phase ~~segment~~3 trial in January 2023. ~~Completion~~Any strategic decision we make as a result of our strategic review process may also negatively affect our common stock price or cause volatility in the ~~Spin~~market ~~Off~~price ~~remains~~of ~~subject~~our common stock. Sales of large amounts of our securities or large variations in trading volume might make it more difficult for us to sell equity securities in the ~~satisfaction~~future at a time and at a price that we deem appropriate. As of March 26, 2026, we had outstanding 40,446,179 shares of common stock, a large majority of which are freely tradable. Giving effect to the exercise in full of all of our outstanding warrants, options and restricted stock units, or ~~waiver~~RSUs, including those currently unexercisable or unvested, we would have outstanding 45,887,558 shares of ~~certain~~common ~~conditions~~stock.

Potential indemnification liabilities to HTIT pursuant to the JV Agreement, as supplemented by the Supplemental Agreement could materially and adversely affect our financial condition, results of operations, and cash flows.29

~~The JV~~Our ~~Agreement,~~issuance asof ~~supplemented by the Supplemental Agreement~~warrants, ~~among other things, provides for indemnification obligations designed to~~ ~~make~~options ~~the Company~~ and ~~the~~RSUs ~~OraTech financially responsible for certain liabilities that may exist relating~~ to ~~its~~investors, ~~business~~employees ~~activities. If we~~ and ~~the~~consultants ~~OraTech~~may ~~are~~have ~~required~~a tonegative ~~indemnify~~effect ~~HTIT~~on ~~under~~ the ~~circumstances~~trading ~~set~~prices ~~forth~~of inour ~~the~~common JVstock ~~Agreement,~~ as ~~supplemented by the Supplemental~~well ~~Agreement,~~as wea ~~may~~dilutive ~~be subject to substantial liabilities~~effect.

We ~~potentially~~ ~~could~~ have ~~received~~issued ~~better~~and ~~terms~~may ~~from~~continue ~~unaffiliated~~to ~~third~~issue ~~parties~~warrants, ~~than~~options, RSUs and convertible notes at, above or below the ~~terms~~current market price. As of March 26, 2026, we ~~received~~had outstanding warrants exercisable for 20,000 shares of common stock at a weighted average exercise price of $4.13 and options exercisable for 1,548,633 shares of common stock at a weighted average exercise price of $7.1. We also had outstanding RSUs for 1,707,383 shares of common stock. In addition to the dilutive effect of a large number of shares of common stock and a low exercise price for the warrants and options, there is a potential that a large number of underlying shares of common stock may be sold in ~~our~~the ~~agreements~~open ~~with~~market ~~OraTech~~at any given time, which could place downward pressure on the trading of our common stock.

~~The agreements~~Our wefailure ~~and~~to ~~OraTech~~maintain compliance ~~entered into in connection~~ with the ~~Spin~~Nasdaq ~~Off~~Capital have been negotiated while OraTech is still a part of our business. The terms of the agreements negotiated in the context of the Spin Off relate to, among other things, the allocation of assets, intellectual property, liabilities, rights, and other obligations between OraTech and us, among others. ArmMarket’s~~-length~~ ~~negotiations~~continued ~~between~~listing ~~OraTech and~~requirements ancould ~~unaffiliated~~result ~~third-party~~ in ~~another~~the ~~form~~delisting of ~~transaction,~~our ~~such~~common ~~as a buyer in a sale of a business transaction, may have resulted in more favorable terms to the unaffiliated third-party~~stock.

Our common stock is currently ~~business~~listed on the Nasdaq Capital Market. In order to maintain this listing, we must satisfy minimum financial and ~~assets~~other ~~will~~requirements. Nasdaq Listing Rule 5550(a)(2) requires the minimum bid price of our common stock on the Nasdaq Capital Market to remain above $1.00. If the bid price of our common stock closes below $1.00 per share for 30 consecutive business days, we would be ~~less~~in ~~diversified~~violation ~~following~~of Nasdaq Listing Rule 5550(a)(2). In accordance with Nasdaq Listing Rule 5810(c)(3)(A), we would have 180 calendar days to regain compliance with the minimum ~~Spin~~bid ~~Off~~requirement.

~~In connection~~While ~~with~~we ~~the~~intend ~~transactions~~to ~~contemplated~~engage in byefforts ~~the~~to JVmaintain ~~Agreement~~compliance, asand ~~supplemented~~thus bymaintain ~~the~~our ~~Supplemental Agreement~~listing, onthere ~~February~~can 7,be ~~2025,~~ no assurance that we ~~entered~~will ~~into~~continue ~~that~~to ~~certain~~meet ~~Asset~~all ~~Transfer~~applicable Nasdaq ~~Agreement~~Capital orMarket requirements in the ~~Asset~~future, ~~Transfer~~especially ~~Agreement~~in ~~with~~light ~~OraTech~~of ~~and~~any ~~Oramed~~strategic ~~Ltd~~transaction we may choose to undertake. If our common stock were removed from listing with the Nasdaq Capital Market, ~~pursuant~~it may be subject to ~~which, we~~the ~~and~~so-called ~~Oramed~~“penny ~~Ltd~~stock” rules. The ~~have~~SEC ~~agreed~~has toadopted ~~transfer~~regulations tothat ~~OraTech~~define ~~all~~a of“penny ~~our~~stock” ~~and~~to ~~their~~be ~~rights,~~any ~~titles,~~equity ~~and~~security ~~interests~~that inhas ~~the~~a ~~Transferred~~market ~~IP,~~price ~~Business~~per share of ~~Contracts,~~less ~~Business~~than ~~Information~~$5.00, ~~and~~subject ~~Regulatory~~to ~~Information~~certain ~~(each~~exceptions, such as ~~defined~~any insecurities ~~the~~listed ~~Asset~~on ~~Transfer~~a ~~Agreement~~national ~~and~~securities ~~collectively~~exchange, orwhich is the exception ~~Transferred~~on ~~Assets),~~which aswe ~~part~~currently ofrely. For any transaction involving a “penny stock,” unless exempt, the ~~capital~~rules ~~contribution~~impose additional sales practice requirements on broker-dealers, subject to becertain ~~made~~exceptions. If our common stock were delisted and determined to ~~OraTech~~be a “penny stock,” ina ~~consideration~~broker-dealer ~~for~~may ~~the~~find ~~issuance~~it more difficult to ustrade ofour ~~certain~~common ~~Shares~~stock and an investor may find it more difficult to acquire ~~(as~~or ~~defined~~dispose inof ~~the~~our JVcommon ~~Agreement)~~stock inon ~~OraTech~~the secondary market.

If our common stock is delisted ~~such~~and ~~Transferred~~there ~~Assets~~is ~~are~~no ~~transferred~~longer toan ~~OraTech~~active intrading ~~connection~~market ~~with~~for ~~the~~our ~~Spin~~shares, ~~Off~~it may, ~~OraTech~~among ~~will~~other ~~have~~things: ~~all~~cause ~~rights,~~stockholders ~~title~~difficulty ~~and~~in ~~interest~~selling inour ~~such~~shares ~~Transferred~~without ~~Assets,~~depressing ~~and~~the wemarket ~~will~~price nofor ~~longer~~the ~~have~~shares or selling our shares at all; ~~rights,~~substantially ~~title~~impair ~~and~~our ~~interest~~ability to raise additional funds; result in ~~such~~a ~~Transferred~~loss ~~Assets,~~of ~~meaning~~institutional ~~that~~investor ~~our~~interest ~~business~~ and ~~assets~~fewer ~~will~~financing beopportunities ~~less~~for ~~diversified~~us; ~~following~~and/or ~~the~~result ~~Spin~~in ~~Off~~costly litigation, ~~which~~significant ~~may~~liabilities inand ~~turn~~diversion ~~affect~~of our ~~operations~~management’s time and attention and could have a material adverse effect on our financial ~~position~~condition, business and results of operations.

30A delisting would also reduce the value of our equity compensation plans, which could negatively impact our ability to retain employees.

~~The financial~~As ~~position~~the ~~and~~market ~~business~~price ~~operations~~ of our ~~the~~common ~~OraTech~~stock ~~could~~may befluctuate ~~impacted~~significantly, bythis ~~HTIT’s~~may ~~ability~~make it difficult for you to ~~perform~~sell ~~its~~your ~~obligations~~shares ~~under~~of common stock when you want or ~~certain~~at ~~contracts~~prices ~~with~~you usfind attractive.

~~In connection~~The ~~with~~price ~~the~~of ~~Spin~~our ~~Off,~~common westock is ~~have~~currently ~~entered~~listed ~~into~~on athe ~~number~~Nasdaq ofCapital ~~agreements~~Market ~~with HTIT, including a supply agreement~~ and aon ~~license~~the ~~agreement that~~Tel ~~govern~~Aviv ~~our~~Stock ~~ongoing~~Exchange ~~relationship~~and ~~with~~constantly ~~HTIT~~changes. ~~Our~~In ~~success~~recent ~~depends~~years, ~~in part, on~~ the ~~maintenance~~stock market ofin ~~our~~general ~~ongoing~~has ~~relationship~~experienced ~~with~~extreme ~~HTIT, HTIT’s~~price ~~performance~~and ofvolume ~~its~~fluctuations. ~~obligations~~We ~~under~~expect ~~these~~that ~~agreements,~~the ~~including~~market ~~HTITs~~price ~~maintenance~~ of ~~the~~our ~~quality~~common ofstock ~~products~~will ~~and services~~continue ~~and~~to ~~certain~~fluctuate. ~~other~~These ~~trademarks~~fluctuations ~~and~~may ~~intellectual~~result ~~property~~from ~~that~~a wevariety ~~license~~of tofactors, ~~HTIT.~~many Ifof wewhich are ~~unable~~beyond toour ~~maintain~~control. aFor ~~good~~example, ~~relationship~~we ~~with~~experienced ~~HTIT,~~a orsignificant ifdecline ~~HTIT~~in ~~does~~the ~~not~~market ~~perform~~price ~~its~~of ~~obligations under~~ our ~~agreements~~common ~~with~~stock ~~HTIT,~~after announcing the ~~business~~results of ~~OraTech,~~our ~~its~~ORA-D-013-1 ~~operations~~Phase ~~and~~3 ~~its~~trial ~~financial~~in January ~~position~~2023. ~~may~~These befactors ~~negatively impacted.~~include:

~~The Spin~~● ~~Off~~market ~~may~~acceptance ~~expose~~of usour tonew ~~potential~~strategy, ~~liabilities~~once ~~arising~~determined ~~out of state~~ and ~~federal fraudulent conveyance laws.~~announced;

~~If we~~● ~~file~~clinical ~~for~~trial ~~insolvency~~results orand ~~bankruptcy within certain timeframes following~~ the ~~Spin~~timing ~~Off,~~of ~~a court could deem~~ the ~~Spin~~release ~~Off~~of or certain internal restructuring transactions undertaken by us in connection therewith to be a fraudulent conveyance or transfer. Fraudulent conveyances or transfers are defined to include transfers made or obligations incurred with the actual intent to hinder, delay or defraud current or future creditors or transfers made or obligations incurred for less than reasonably equivalent value when the debtor was insolvent, or that rendered the debtor insolvent, inadequately capitalized or unable to pay its debts as they become due. In such ~~circumstances, a court could void the transactions or impose substantial liabilities upon us, which could adversely affect our financial condition and our~~ results ~~of operations. Whether a transaction is a fraudulent conveyance or transfer will vary depending upon the jurisdiction whose law is being applied.~~;

~~Risks Related~~● tothe ~~Conducting~~amount ~~Business~~of incash ~~Israel~~resources and our ability to obtain additional funding;

~~We are affected by the political, economic and military risks of having operations in Israel.~~30

~~We have~~● ~~operations~~announcements ~~in the State~~ of ~~Israel,~~research ~~and we are directly affected by political~~activities, economic and security conditions in that country. Since the establishment of the State of Israel in 1948, a number of armed conflicts have taken place between Israel and its Arab neighbors and a state of hostility, varying in degree and intensity, has led to security and economic problems for Israel. In addition, acts of terrorism, armed conflicts or political instability in the region could negatively affect local business ~~conditions and harm our results of operations. We cannot predict the effect on the region of any diplomatic initiatives or political~~ developments, ~~involving~~technological ~~Israel~~innovations or ~~the~~ ~~Palestinians~~new orproducts ~~other~~by countries and territories in the Middle East. Recent political events, including political uprisings, social unrest and regime change, in various countries in the Middle East and North Africa have weakened the stability of those countries and territories, which could result in extremists coming to power. In addition, Iran has threatened to attack Israel and is widely believed to be developing nuclear weapons. Iran is also believed to have a strong influence among extremist groups in the region, such as Hamas in Gaza and Hezbollah in Lebanon. This situation has escalated in the past and may potentially escalate in the future to violent events which may affect Israel and us. On October 7, 2023, the State of Israel was attacked by and subsequently declared war on Hamas. Israel has been in an ongoing state of war with Hamas since that time. Following the attack by Hamas, Hezbollah, a terrorist organization in Lebanon has also launched missile, rocket, and shooting attacks against Israeli military sites, troops, and Israeli towns in northern Israel. In response to these attacks, the Israeli army has carried out a number of targeted strikes on sites belonging to Hezbollah in southern Lebanon and in October 2024, the Israeli military initiated a ground operation in Lebanon, primarily near the Israel-Lebanon border. As of the end of November 2024, Israel entered into a ceasefire agreement with Hezbollah, but there are no guarantees as to whether the agreement will hold or ~~whether~~our ~~further hostilities will resume.~~competitors;

~~In April~~● ~~and~~entering ~~October~~into ~~2024, Iran launched missile and unmanned aerial vehicle,~~ or ~~UAV,~~terminating ~~attacks~~strategic on Israel. Most of the missiles and UAVs were intercepted by Israel’s defense systems, with support from the United States and other countries, including regional allies, preventing significant damage and resulting in no casualties. Despite the successful interceptions, the attacks posed an elevated threat to Israel’s security.relationships;

31● changes in government regulation;

~~In December~~● ~~2024,~~departure ~~Ba’athist Syria, led by President Bashar al-Assad, collapsed during a major offensive by opposition forces made up~~ of ~~several~~key competing rebel groups. In response, the Israeli Defense Forces took control over a United Nations-designated buffer zone over Mount Hermon that separates Israel and Syria. Simultaneously, Israel conducted targeted military strikes against military assets in Syria, aiming to eliminate any chemical weapons storage sites that could be used by rebel groups and further weaken Iran’s operational capabilities in the region. While the transitional government of Syria has indicated that it is interested in reconstruction and stability rather than a continuation of conflicts with Israel, there are no guarantees that there will be no future escalation of hostilities or that Syria will not permit other neighboring countries to launch attacks at Israel from its territory.personnel;

~~It is~~● ~~possible~~disputes ~~that~~concerning ~~other~~patents terrorist organizations, including Palestinian military organizations in the West Bank, as well as other hostile countries, such as Iran, will join the hostilities. Although we believe that there is no immediate risk to our business operations related to these events, our business, prospects, financial condition and results of operations could be materially adversely affected if such hostilities involving Israel continue or ~~escalate~~proprietary or if trade or scientific cooperation between Israel and its current partners is interrupted or curtailed. Moreover, we cannot predict how this war will ultimately affect Israel’s economy in general, which may involve a downgrade in Israel’s credit rating by rating agencies (such as the recent downgrade by Moody’s of its credit rating of Israel from A1 to A2, in October 2023 and further downgrade to Baa1 with a negative outlook in September 2024, as well as the downgrade of its outlook rating from “stable” to “negative”). We may also be targeted by cyber terrorists specifically because we are an Israeli-related company.rights;

~~All adult~~● ~~male~~changes and female permanent residents of Israel, unless exempt, may be required to perform military reserve duty annually. Additionally, all such residents are subject to being called to active duty at any time under emergency circumstances, and several hundred thousand Israeli military reservists were drafted to perform immediate military service during the current war with Hamas and other hostile elements, such as Hezbollah in ~~Lebanon.~~expense Some of our employees may in the future be obligated to perform annual military reserve duty, although none were called up for reserves in the current war. If called up, such persons may be absent from their positions for a lengthy period of time. We can provide no assurance that such requirements will not have a material adverse effect on our business, prospects, financial condition and results of operations in the future, particularly if emergency circumstances occur.level;

~~It may~~● befuture ~~difficult~~sales toof ~~enforce~~our aequity ~~U.S. judgment against us~~ or ~~our~~equity-related ~~officers and directors and to assert U.S.~~ securities ~~laws claims in Israel.~~;

~~Almost all~~● ofpublic ~~our~~concern ~~directors~~regarding ~~and~~the ~~officers~~safety, ~~are~~efficacy ~~nationals and/~~or ~~residents of countries~~ other ~~than~~aspects ~~the United States. As a result, service~~ of ~~process upon us, our Israeli subsidiary and our directors and officers, may be difficult to obtain within~~ the ~~United~~products States. Furthermore, because the majority of our assets and investments, and most of our directors and officers are located outside the United States, it may be difficult for investors to enforce within the United States any judgments obtained against us or ~~any~~methodologies ~~such~~being officers or directors. Additionally, it may be difficult to assert U.S. securities law claims in original actions instituted in Israel. Israeli courts may refuse to hear a claim based on a violation of U.S. securities laws because Israel is not the most appropriate forum in which to bring such a claim. In addition, even if an Israeli court agrees to hear a claim, it may determine that Israeli law and not U.S. law is applicable to such claim. If U.S. law is found to be applicable, the content of applicable U.S. law must be proved as a fact, which can be a time-consuming and costly process. Certain matters of procedure will also be governed by Israeli law.developed;

32● activities of various interest groups or organizations;

~~Subject to~~● ~~specified~~media ~~time~~coverage; ~~limitations~~ and legal procedures, under the rules of private international law currently prevailing in Israel, Israeli courts may enforce a U.S. judgment in a civil matter, including a judgment based upon the civil liability provisions of the U.S. securities laws, as well as a monetary or compensatory judgment in a non-civil matter, provided that the following key conditions are met:

● ~~subject~~status toof ~~limited exceptions,~~ the ~~judgment~~investment ~~is final and non-appealable;~~markets.

●Future sales of common stock or the ~~judgment~~issuance ~~was~~of ~~given~~securities bysenior ato ~~court~~our ~~competent~~common ~~under~~stock ~~the~~or ~~laws~~convertible ofinto, ~~the~~or ~~state~~exchangeable inor ~~which~~exercisable for, our common stock could materially adversely affect the ~~court~~trading isprice ~~located~~of our common stock, and isour ~~otherwise~~ability ~~enforceable~~to raise funds in ~~such~~new ~~state;~~equity offerings.

●Future sales of substantial amounts of our common stock, including pursuant to any strategic opportunity, the ~~judgment~~ATM ~~was~~Agreement ~~rendered~~(as bydefined abelow), ~~court~~or ~~competent~~other ~~under~~equity-related securities in the ~~rules~~public market or privately, or the perception that such sales could occur, could adversely affect prevailing trading prices of ~~private~~our ~~international~~common ~~law~~stock ~~applicable~~and incould ~~Israel;~~impair our ability to raise capital through future offerings of equity or other equity-related securities. We anticipate that we will need to raise capital through offerings of equity and equity related securities. We can make no prediction as to the effect, if any, that future sales of shares of our common stock or equity-related securities, or the availability of shares of common stock for future sale, will have on the trading price of our common stock.

●Our ~~the~~stockholders ~~laws~~may ofexperience significant ~~the~~dilution ~~state~~as ina ~~which~~result ~~the~~of ~~judgment~~any ~~was~~additional ~~given~~financing ~~provides~~using ~~for~~our ~~the~~equity ~~enforcement of judgments of Israeli courts;~~securities.

●To ~~adequate~~the ~~service~~extent that we raise additional funds by issuing equity securities, including in connection with any strategic opportunity or pursuant to the ATM Agreement, our stockholders may experience significant dilution. Additionally, we may, from time to time or in connection with a strategic alternative, issue additional shares of ~~process~~common ~~has~~stock ~~been~~at ~~effected~~a ~~and~~discount from the ~~defendant~~current ~~has~~trading ~~had~~price of our common stock. As a ~~reasonable~~result, ~~opportunity~~our tostockholders would experience immediate dilution upon the purchase of any shares of our common stock sold at such discount. In addition, as opportunities present ~~its~~themselves, ~~arguments~~we may enter into financing or similar arrangements in the future, including the issuance of convertible debt securities, preferred stock or common stock. If we issue common stock or securities convertible into common stock, our common stockholders would experience additional dilution and, ~~evidence;~~as a result, our stock price may decline.

~~● the judgment and its enforcement are not contrary to the law, public policy, security or sovereignty of the State of Israel;~~31

●Risks ~~the~~Related ~~judgment~~to ~~was~~Conducting ~~not~~Business ~~obtained by fraud and does not conflict with any other valid judgment~~ in ~~the same matter between the same parties; and~~Israel

●We anare ~~action~~affected ~~between~~by the political, ~~same~~economic ~~parties~~and inmilitary ~~the~~risks ~~same~~of ~~matter~~having ~~was~~operations ~~not pending~~ in ~~any Israeli court at the time the lawsuit was instituted in the U~~Israel.~~S. court.~~

IfWe have operations in the State of Israel, and we are directly affected by political, economic and security conditions in that country. Since the establishment of the State of Israel in 1948, a number of armed conflicts have taken place between Israel and its Arab neighbors and a state of hostility, varying in degree and intensity, has led to security and economic problems for Israel. In addition, acts of terrorism, armed conflicts or political instability in the region could negatively affect local business conditions and harm our results of operations. We cannot predict the effect on the region of any diplomatic initiatives or political developments involving Israel or the Palestinians or other countries and territories in the Middle East. Recent political events, including political uprisings, social unrest and regime change, in various countries in the Middle East and North Africa have weakened the stability of those countries and territories, which could result in extremists coming to power. In addition, Iran has threatened to attack Israel and is widely believed to be developing nuclear weapons. Iran is also believed to have a strong influence among extremist groups in the region, such as Hamas in Gaza and Hezbollah in Lebanon. This situation has escalated in the past and may potentially escalate in the future to violent events which may affect Israel and us. On October 7, 2023, the State of Israel was attacked by and subsequently declared war on Hamas. Israel has been in an ongoing state of war with Hamas since that time. Following the attack by Hamas, Hezbollah, a terrorist organization in Lebanon has also launched missile, rocket, and shooting attacks against Israeli military sites, troops, and Israeli towns in northern Israel. In response to these ~~conditions~~attacks, ~~are~~the ~~not~~Israeli ~~met~~army has carried out a number of targeted strikes on sites belonging to Hezbollah in southern Lebanon and in October 2024, the Israeli ~~courts~~military ~~will~~initiated ~~likely~~a ~~not~~ground ~~enforce~~operation in Lebanon, primarily near the ~~applicable~~Israel-Lebanon Uborder.S. In ~~judgment~~November 2024, Israel entered into a ceasefire agreement with Hezbollah, but there are no guarantees as to whether the agreement will hold or whether further hostilities will resume.

~~General~~During 2024, Iran launched ~~Risk~~missile ~~Factors~~and unmanned aerial vehicle, or UAV, attacks on Israel. Most of the missiles and UAVs were intercepted by Israel’s defense systems, with support from the United States and other countries, including regional allies, preventing significant damage and resulting in no casualties. Despite the successful interceptions, the attacks posed an elevated threat to Israel’s security. On June 13, 2025, in light of continued nuclear threats and intelligence assessments indicating imminent attacks, Israel launched a preemptive strike directly targeting military and nuclear infrastructure inside Iran aimed to disrupt Iran’s capacity to coordinate or launch further hostilities against Israel, as well as disrupt its nuclear program. For 12 days, both sides launched attacks against one another, with Iran targeting civilian infrastructure. As a result of the escalation with Iran, Israel temporarily closed its airspace and ceased all port activity related to commercial shipments. On June 22, 2025, the U.S. military joined Israel in launching strikes directly targeting nuclear infrastructure in Iran. A U.S. brokered ceasefire took effect on June 24, 2025.

~~Changes~~On February 28, 2026, Israel and the United States commenced coordinated military strikes against targets in Iran, including military and strategic infrastructure in response to ~~tax~~ongoing ~~laws~~regional ~~could~~tensions ~~have~~and recent escalations involving Iran’s nuclear and military activities. In response, Iran launched a ~~negative~~series ~~effect~~of onretaliatory usattacks oragainst ~~our~~Israel, ~~stockholders~~targeting major cities and strategic sites, which are ongoing. While most of these attacks have been intercepted to date, some resulted in civilian casualties and damage to property. Subsequently, Hezbollah launched attacks against Israel in retaliation for the killing of Ali Hosseini Khamenei, the former Supreme Leader of Iran, and in response, Israel launched attacks against Lebanon and Israeli ground forces have entered into Southern Lebanon, and hostilities between Israel and Hezbollah are ongoing. Iran subsequently began launching retaliatory strikes against U.S. and other targets in the Gulf region. The Israeli government has raised its alert level nationwide, and the situation remains highly unstable, with ongoing exchanges of fire and heightened risk of further escalation. Regional and international responses are ongoing, and the risk of broader conflict in the Middle East has increased.

At any time, the U.S. federal or state income tax laws, or the administrative interpretations of those laws, may be amended. Federal and state tax laws are constantly under review by persons involved in the legislative process, the U.S. Internal Revenue Service, the U.S. Department of the Treasury and state taxing authorities. Changes to the tax laws, regulations and administrative interpretations, which may have retroactive application, could adversely affect us. Our stockholders are encouraged to consult with their tax advisors about the potential effects that changes in law may have on them and their ownership of our securities.32

~~Our~~In addition, in December ~~business~~2024, Ba’athist Syria, led by President Bashar al-Assad, collapsed during a major offensive by opposition forces made up of several competing rebel groups. In response, the Israeli Defense Forces took control over a United Nations-designated buffer zone over Mount Hermon that separates Israel and ~~operations~~Syria. ~~would~~Simultaneously, ~~suffer~~Israel conducted targeted military strikes against military assets in Syria, aiming to eliminate any chemical weapons storage sites that could be used by rebel groups and further weaken Iran’s operational capabilities in the ~~event~~region. While the transitional government of ~~computer~~Syria ~~system~~has ~~failures~~indicated that it is interested in reconstruction and stability rather than a continuation of conflicts with Israel, ~~cyber-attacks~~there are no guarantees that there will be no future escalation of hostilities or that ~~deficiencies~~Syria inwill ~~our~~not ~~cyber-security~~permit other neighboring countries to launch attacks at Israel from its territory.

~~Despite the~~All ~~implementation~~adult ofmale ~~security~~and ~~measures,~~female permanent ~~our~~residents ~~internal~~of ~~computer systems~~Israel, ~~and~~unless ~~those of third parties on which we rely~~exempt, ~~are~~may ~~vulnerable~~be required to ~~damage~~ ~~from~~perform ~~computer~~military ~~viruses,~~reserve ~~malware,~~duty ~~natural~~annually. ~~disasters~~Additionally, ~~terrorism,~~all ~~war,~~such ~~telecommunication and electrical failures, cyber-attacks or~~residents ~~cyber-intrusions~~are ~~over~~subject ~~the Internet, attachments~~ to ~~emails,~~being ~~persons~~called ~~inside our organization, or persons with access~~ to ~~systems~~active ~~inside our~~duty ~~organization.~~at ~~The~~any ~~risk~~time ofunder aemergency ~~security breach or disruption~~circumstances, ~~particularly~~and ~~through~~several ~~cyber-attacks~~hundred orthousand ~~cyber~~Israeli ~~intrusion,~~military ~~including by computer~~reservists ~~hackers,~~were ~~foreign~~drafted ~~governments,~~to ~~and~~perform ~~cyber~~immediate ~~terrorists,~~military ~~has~~service ~~generally~~during ~~increased as~~ the ~~number,~~current ~~intensity~~war ~~and~~with ~~sophistication~~Hamas ~~of attempted attacks~~ and ~~intrusions~~other ~~from~~hostile ~~around~~elements, ~~the~~such ~~world~~as ~~have~~Hezbollah ~~increased~~in Lebanon. IfSome ~~such~~of ~~an event were to occur and cause interruptions in~~ our ~~operations, it~~employees ~~could~~may ~~result~~ in athe ~~material~~future ~~disruption~~be ofobligated ~~our~~to ~~product~~perform ~~development~~annual ~~programs.~~military ~~For~~reserve ~~example~~duty, ~~the~~although ~~loss~~none ofwere ~~clinical~~called ~~trial~~up ~~data from completed~~for orreserves ~~ongoing~~in orthe ~~planned~~current ~~clinical~~war. ~~trials~~If ~~could~~called ~~result~~up, insuch ~~delays~~persons inmay ~~our~~be ~~clinical~~absent ~~trial~~from ~~efforts~~their ~~and~~positions ~~significantly~~for ~~increase~~a ~~our~~lengthy ~~costs~~period toof ~~recover or reproduce the data~~time. ToWe ~~the~~can ~~extent~~provide no assurance that ~~any~~such ~~disruption~~requirements orwill ~~security~~not ~~breach~~have ~~was to result in~~ a ~~loss~~material ofadverse oreffect ~~damage~~on to our ~~data or applications~~business, or ~~inappropriate disclosure of confidential or proprietary information~~prospects, wefinancial ~~could~~condition ~~incur material legal claims~~ and ~~liability, and damage~~results toof ~~our~~operations ~~reputation,~~in ~~and~~ the ~~further~~future, ~~development~~particularly ofif ~~our~~emergency ~~product~~circumstances ~~candidates could be delayed~~occur.

33Although we believe that there is no immediate risk to our business operations related to these events, our business, prospects, financial condition and results of operations could be materially adversely affected if such hostilities involving Israel continue or escalate or if trade or scientific cooperation between Israel and its current partners is interrupted or curtailed. Moreover, we cannot predict how the current conflicts in the Middle East will ultimately affect Israel’s economy in general, which may involve a downgrade in Israel’s credit rating by rating agencies (such as the recent downgrade by Moody’s of its credit rating of Israel from A1 to A2, in October 2023 and further downgrade to Baa1 with a negative outlook in September 2024, as well as the downgrade of its outlook rating from “stable” to “negative”). We may also be targeted by cyber terrorists specifically because we are an Israeli-related company. As of the date of this report, regional security risks remain elevated, and there can be no assurance that conditions will not deteriorate further during 2026.

~~We also~~It ~~maintain~~may ~~compliance~~be ~~programs~~difficult to ~~address the potential applicability of restrictions against trading while in possession of material,~~ ~~nonpublic~~enforce ~~information generally and in connection with~~ a ~~cyber-security breach~~U.S. ~~However,~~judgment aagainst ~~breakdown in existing controls and procedures around our cyber-security environment may prevent~~ us ~~from detecting, reporting~~ or ~~responding~~our toofficers ~~cyber~~and ~~incidents~~directors ~~in a timely manner~~ and ~~could~~ ~~have~~to aassert ~~material~~U.S. ~~adverse~~securities ~~effect~~laws onclaims ~~our~~in ~~financial position and value of our stock~~Israel.

~~Our~~Almost all of our directors ~~management~~and ~~will~~officers ~~have~~are ~~significant~~nationals ~~flexibility~~and/or inresidents ~~using~~of countries other than the ~~net~~United ~~proceeds~~States. As a result, service of process upon us, our Israeli subsidiary and our directors and officers, may be difficult to obtain within the United States. Furthermore, because the majority of our assets and investments, and most of our directors and officers are located outside the United States, it may be difficult for investors to enforce within the United States any ~~offering~~judgments obtained against us or any such officers or directors. Additionally, it may be difficult to assert U.S. securities law claims in original actions instituted in Israel. Israeli courts may refuse to hear a claim based on a violation of U.S. securities laws because Israel is not the most appropriate forum in which to bring such a claim. In addition, even if an Israeli court agrees to hear a claim, it may determine that Israeli law and not U.S. law is applicable to such claim. If U.S. law is found to be applicable, the content of applicable U.S. law must be proved as a fact, which can be a time-consuming and costly process. Certain matters of procedure will also be governed by Israeli law.

~~We intend~~Subject ~~generally~~ to ~~use~~specified ~~the net proceeds from any offerings of our securities for expenses related to our clinical trials, research and~~time ~~product~~limitations ~~development activities,~~ and ~~for~~legal ~~general corporate purposes~~procedures, ~~including~~under ~~general working capital purposes. Our management will have significant flexibility in applying~~ the ~~net~~rules ~~proceeds~~ of ~~any~~private ~~such~~international ~~offering~~law ~~and~~currently weprevailing ~~will~~in ~~necessarily~~Israel, beIsraeli ~~using~~courts ~~our~~may ~~capital when we decide~~enforce ona ~~new strategic initiatives~~U.S. ~~The~~judgment ~~actual~~in ~~amounts~~a ~~and~~civil ~~timing~~matter, ofincluding ~~expenditures~~a ~~will~~judgment ~~vary~~based ~~significantly~~upon ~~depending~~the oncivil aliability ~~number~~provisions of ~~factors, including~~ the ~~amount of cash used in our operations and our research and development efforts~~U.S. ~~Management’s~~securities ~~failure~~laws, toas ~~use these~~well ~~funds~~as ~~effectively~~a ~~would~~monetary ~~have~~or ancompensatory ~~adverse~~judgment ~~effect~~in ona ~~the~~non-civil ~~value~~matter, ofprovided ~~our~~that ~~common~~the ~~stock~~following ~~and~~key ~~could~~conditions ~~make~~are ~~it more difficult and costly to raise funds in the future.~~met:

~~Delaware law~~● ~~could~~subject ~~discourage~~to alimited ~~change in control~~exceptions, ~~or an acquisition of us by a third party, even if~~ the ~~acquisition~~judgment ~~would~~is befinal ~~favorable to you,~~ and ~~thereby adversely affect existing stockholders.~~non-appealable;

~~The Delaware~~● ~~General Corporation Law contains provisions that may have~~ the ~~effect~~judgment ofwas ~~making~~given ~~more difficult or delaying attempts~~ by ~~others to~~a ~~obtain~~court ~~control~~competent ofunder the ~~Company,~~laws ~~even when these attempts may be in the best interests~~ of ~~stockholders. Delaware law imposes conditions on certain business combination transactions with “interested stockholders.” These provisions and others that could be adopted in~~ the ~~future~~state ~~could deter unsolicited takeovers or delay or prevent changes~~ in ~~our control or management, including transactions in~~ which ~~stockholders~~ ~~might otherwise receive a premium for their shares of common stock over then current market prices. These provisions may also limit~~ the ~~ability~~court ofis ~~stockholders~~located toand ~~approve~~is ~~transactions~~otherwise ~~that~~enforceable ~~they may deem to be~~ in ~~their~~such ~~best interests.~~state;

~~ITEM 1B.~~● ~~UNRESOLVED~~the ~~STAFF~~judgment ~~COMMENTS.~~was rendered by a court competent under the rules of private international law applicable in Israel;

~~Not applicable.~~● the laws of the state in which the judgment was given provides for the enforcement of judgments of Israeli courts;

~~ITEM 1C.~~● ~~CYBERSECURITY.~~adequate service of process has been effected and the defendant has had a reasonable opportunity to present its arguments and evidence;

The Board recognizes the critical importance of maintaining the trust and confidence of our business partners, employees and clinical trial participants. The Audit Committee is responsible for reviewing our policies with respect to cybersecurity risks and relevant contingent liabilities and risks that may be material to the Company, including risks from third parties and business partners.33

~~We generally~~● ~~seek~~the tojudgment ~~address cybersecurity risks by implementing security measures on our internal computer systems~~ and ~~ensuring~~its ~~that~~enforcement ~~third parties~~are ~~and~~not ~~business~~contrary ~~partners~~to ~~implement~~the ~~similar measures. These security measures include firewalls~~law, ~~intrusion~~public ~~prevention and detection systems~~policy, ~~anti-malware~~security ~~functionality~~or ~~and~~sovereignty ~~access~~of ~~controls,~~the ~~which~~State ~~are~~of ~~evaluated by our external IT consultant and improved through vulnerability assessments and cybersecurity threat intelligence.~~Israel;

~~Our Chief~~● ~~Operating~~the ~~and~~judgment ~~Business~~was ~~Officer~~not isobtained ~~responsible~~by ~~for~~fraud ~~implementing~~and ~~protection~~does ~~measures~~not ~~for~~conflict ~~our~~with ~~information~~any ~~systems~~other ~~from~~valid ~~cybersecurity threats~~judgment ~~and~~in ~~promptly~~the ~~responding~~same tomatter ~~any~~between ~~cybersecurity~~the ~~incidents.~~same parties; and

~~To date,~~● ~~risks~~an ~~from~~action ~~cybersecurity~~between ~~threats~~the ~~have~~same ~~not~~parties ~~materially~~in ~~affected~~the ussame ~~and~~matter wewas do not ~~currently~~pending ~~believe~~in any ~~risks~~Israeli ~~from~~court ~~cybersecurity~~at ~~threats are~~the ~~reasonably~~time ~~likely to affect~~ the ~~Company,~~lawsuit ~~including~~was ~~our~~instituted ~~business~~in ~~strategy,~~the ~~results of operations or financial condition~~U. ~~For further information, see “Item 1A~~S. ~~Risk Factors,” under “Our business and operations would suffer in the event of computer system failures, cyber-attacks or deficiencies in our cyber-security~~court.”

~~ITEM~~If any of these conditions are not 2met, Israeli courts will likely not enforce the applicable U.S. ~~PROPERTIES~~judgment.

~~We believe~~General ~~that~~Risk our existing facilities are suitable and adequate to meet our current business requirements. In the event that we should require additional or alternative facilities, we believe that such facilities can be obtained on short notice at competitive rates.Factors

~~ITEM~~Changes to tax laws could 3.have ~~LEGAL~~a ~~PROCEEDINGS~~negative effect on us or our stockholders.

~~From time~~At toany time, wethe U.S. federal or state income tax laws, or the administrative interpretations of those laws, may ~~become~~be ~~subject~~amended. toFederal ~~litigation~~and ~~incidental~~state tax laws are constantly under review by persons involved in the legislative process, the U.S. Internal Revenue Service, the U.S. Department of the Treasury and state taxing authorities. Changes to ~~our~~the ~~business~~tax laws, regulations and administrative interpretations, which may have retroactive application, could adversely affect us. WeOur stockholders are ~~not~~encouraged ~~currently~~to aconsult ~~party~~with totheir ~~any~~tax ~~material~~advisors ~~legal~~about ~~proceedings~~the potential effects that changes in law may have on them and their ownership of our securities.

~~ITEM~~Our 4.business ~~MINE~~and ~~SAFETY~~operations ~~DISCLOSURES~~would suffer in the event of computer system failures, cyber-attacks or deficiencies in our cyber-security.

~~Not~~Despite ~~applicable~~the implementation of security measures, our internal computer systems, and those of third parties on which we rely, are vulnerable to damage from computer viruses, malware, natural disasters, terrorism, war, telecommunication and electrical failures, cyber-attacks or cyber-intrusions over the Internet, attachments to emails, persons inside our organization, or persons with access to systems inside our organization. The risk of a security breach or disruption, particularly through cyber-attacks or cyber intrusion, including by computer hackers, foreign governments, and cyber terrorists, has generally increased as the number, intensity and sophistication of attempted attacks and intrusions from around the world have increased. If such an event were to occur and cause interruptions in our operations, it could result in a material disruption of our product development programs. For example, the loss of clinical trial data from completed or ongoing or planned clinical trials could result in delays in our clinical trial efforts and significantly increase our costs to recover or reproduce the data. To the extent that any disruption or security breach was to result in a loss of or damage to our data or applications, or inappropriate disclosure of confidential or proprietary information, we could incur material legal claims and liability, and damage to our reputation, and the further development of our product candidates could be delayed.

34We also maintain compliance programs to address the potential applicability of restrictions against trading while in possession of material, nonpublic information generally and in connection with a cyber-security breach. However, a breakdown in existing controls and procedures around our cyber-security environment may prevent us from detecting, reporting or responding to cyber incidents in a timely manner and could have a material adverse effect on our financial position and value of our stock.

~~PART~~Our management will have IIsignificant flexibility in using the net proceeds of any offering of securities.

~~ITEM~~We intend generally to use 5the net proceeds from any offerings of our securities for expenses related to our clinical trials, research and product development activities, and for general corporate purposes, including general working capital purposes. ~~MARKET~~Our ~~FOR~~management ~~REGISTRANT’S~~will ~~COMMON~~have ~~EQUITY~~significant flexibility in applying the net proceeds of any such offering and we will necessarily be using our capital when we decide on new strategic initiatives. The actual amounts and timing of expenditures will vary significantly depending on a number of factors, ~~RELATED~~including ~~STOCKHOLDER~~the ~~MATTERS~~amount ~~AND~~of ~~ISSUER~~cash ~~PURCHASES~~used OFin ~~EQUITY~~our operations ~~SECURITIES~~and our research and development efforts. Management’s failure to use these funds effectively would have an adverse effect on the value of our common stock and could make it more difficult and costly to raise funds in the future.

~~Common~~Our stockholder rights ~~Stock~~plan, or “poison pill,” includes terms and conditions which could discourage a takeover or other transaction that stockholders may consider favorable.

~~Our~~On November 16, 2025, our Board declared a dividend of one common stock ispurchase ~~traded~~right (a “Right”) for each outstanding share of common stock. The dividend was paid on November 27, 2025, to the ~~Nasdaq~~stockholders ~~Capital~~of ~~Market~~record ~~and~~at the close of business on November 27, 2025. Each Right initially entitles the ~~Tel~~registered ~~Aviv~~holder to purchase from us one share of common stock at a price of $10.00 per share of common stock, subject to adjustment. The description and terms of the Rights are set forth in a Rights Agreement dated as of November 17, 2025, as the same may be amended from time to time, between us and Continental Stock ~~Exchange~~Transfer & Trust Company, as Rights agent. Until the earlier to occur of (i) 10 business days following a public announcement that a person or group of affiliated or associated persons has become a person or group of affiliated or associated persons acquires beneficial ownership of 15% or more of the outstanding shares of common stock (an “Acquiring Person”) or (ii) 10 business days (or such later date as may be determined by action of the Board prior to such time as any person or group of affiliated or associated persons becomes an Acquiring Person) following the commencement of, or public announcement of an intention to make, a tender or exchange offer the consummation of which would result in ~~each~~any ~~case~~person ~~under~~or group of affiliated or associated persons becoming an Acquiring Person (the ~~symbol~~earlier of such dates being called the “~~ORMP.~~Distribution Date”), the Rights will be evidenced, with respect to certificates representing Common Stock (or book entry shares of common stock) outstanding as of the Record Date, by such certificates (or such book entry shares). In the event that any person or group of affiliated or associated persons becomes an Acquiring Person, each holder of a Right, other than Rights beneficially owned by the Acquiring Person (which will thereupon become void), will thereafter have the right to receive upon exercise of a Right that number of shares of common stock (or cash, other assets, debt securities of the Company, or any combination thereof) having a market value of two times the exercise price of the Right.

~~Holders~~The Rights have certain anti-takeover effects, including potentially discouraging a takeover that stockholders may consider favorable. The Rights will cause substantial dilution to a person or group that attempts to acquire us on terms not approved by the board of directors.

As of March 27, 2025, there were 40,850,455 shares of our common stock issued and outstanding held of record by approximately 40 registered stockholders. We believe that a significant number of stockholders hold their shares of our common stock in brokerage accounts and registered in the name of stock depositories and are therefore not included in the number of stockholders of record.34

~~Unregistered~~Delaware law could discourage ~~Sales~~a change in control, or an acquisition of ~~Equity~~us ~~Securities~~by a third party, even if the acquisition would be favorable to you, and ~~Use~~thereby ofadversely affect ~~Proceeds~~existing stockholders.

NoThe Delaware General Corporation ~~unregistered~~Law ~~sales~~contains provisions that may have the effect of ~~equity~~making ~~securities~~more ~~were~~difficult ~~made~~or ~~during~~delaying attempts by others to obtain control of the ~~three~~Company, even ~~months~~when ~~ended~~these ~~December~~attempts 31may be in the best interests of stockholders. Delaware law imposes conditions on certain business combination transactions with “interested stockholders.” These provisions and others that could be adopted in the future could deter unsolicited takeovers or delay or prevent changes in our control or management, ~~2024~~including transactions in which stockholders might otherwise receive a premium for their shares of common stock over then current market prices. These provisions may also limit the ability of stockholders to approve transactions that they may deem to be in their best interests.

~~Issuer Purchases~~ITEM of1B. ~~Equity~~UNRESOLVED ~~Securities~~STAFF COMMENTS.

~~In June~~Not ~~2024, our Board authorized a stock buyback and retirement program pursuant to which we may, from time to time, repurchase up to $20,000,000 in maximum value of our common stock~~applicable. Share repurchases may be executed through various means, including, without limitation, open market transactions, privately negotiated transactions or otherwise in compliance with Rule 10b-18 under the Exchange Act. The stock buyback program does not obligate us to purchase any shares and expires in 12 months. The authorization for the stock buyback program may be terminated, increased or decreased by our Board in its discretion at any time.

WeITEM ~~have repurchased and retired 1,036,976 shares of our common stock under this program for approximately $2,494,000, including approximately $10,000 excise tax, at an average price of $2~~1C.36 ~~per share~~CYBERSECURITY. ~~All purchases were funded with cash on hand.~~

The ~~following~~Board ~~sets~~recognizes ~~forth~~the ~~information~~critical importance of maintaining the trust and confidence of our business partners, employees and clinical trial participants. The Audit Committee is responsible for reviewing our policies with respect to ~~repurchase~~cybersecurity risks and ~~retirement~~relevant ~~made~~contingent liabilities byand ~~the~~risks ~~Company~~that ofmay ~~its~~be ~~shares~~material ofto ~~common~~the ~~stock~~Company, ~~during~~including ~~the fourth~~risks ~~quarter~~from ~~ended~~third ~~December~~parties ~~31,~~and ~~2024:~~business partners.

Period	Total number of shares purchased		Average price paid per share		Total number of shares purchased as part of publicly announced plans or programs		Approximate dollar value of shares that may yet be purchased under the plans or programs
October 1-31, 2024		-		-		-	$	18,708,193
November 1-30, 2024		252,802	$	2.327		252,802	$	18,119,189
December 1-31, 2024		244,722	$	2.463		244,722	$	17,515,906
Total		497,524				497,524

We generally seek to address cybersecurity risks by implementing security measures on our internal computer systems and ensuring that third parties and business partners implement similar measures. These security measures include firewalls, intrusion prevention and detection systems, anti-malware functionality and access controls, which are evaluated by our external IT consultant and improved through vulnerability assessments and cybersecurity threat intelligence.

35Our Chief Operating and Business Officer is responsible for implementing protection measures for our information systems from cybersecurity threats and promptly responding to any cybersecurity incidents.

~~ITEM~~To 6date, risks from cybersecurity threats have not materially affected us and we do not currently believe any risks from cybersecurity threats are reasonably likely to affect the Company, including our business strategy, results of operations or financial condition. ~~[RESERVED]~~ For further information, see “Item 1A. Risk Factors,” under “Our business and operations would suffer in the event of computer system failures, cyber-attacks or deficiencies in our cyber-security.”

ITEM 7 2. ~~MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS~~PROPERTIES.

~~The~~Our corporate headquarters ~~following~~is ~~discussion~~located ~~and~~at ~~analysis~~1185 Avenue of ~~our~~the ~~financial~~Americas, ~~condition~~New ~~and~~York, ~~results~~NY of10036. ~~operations~~We ~~should~~currently belease ~~read~~approximately in2,842 ~~conjunction~~square ~~with~~feet ~~the~~of ~~audited consolidated~~office ~~financial~~space ~~statements~~at 20 ~~and~~Mamilla ~~the~~Street, ~~related~~Jerusalem, ~~notes~~Israel ~~included~~under ~~elsewhere~~a ~~herein~~lease ~~and~~that expires in ~~our~~August ~~audited~~31, ~~consolidated financial statements~~2030.

~~In addition~~We tobelieve that our ~~audited~~existing facilities ~~consolidated~~are ~~financial~~suitable ~~statements,~~and ~~the~~adequate ~~following~~to ~~discussion~~meet ~~contains forward-looking statements that reflect~~ our ~~plans,~~current ~~estimates~~business ~~and beliefs~~requirements. ~~Our~~In ~~actual results could differ materially from those discussed in~~ the ~~forward-looking~~event ~~statements. Factors~~ that ~~could~~we ~~cause~~should orrequire ~~contribute~~additional toor ~~these~~alternative facilities, ~~differences~~we ~~include~~believe ~~those~~that ~~discussed~~such ~~below~~facilities ~~and~~can ~~elsewhere~~be inobtained ~~this Annual Report~~ on ~~Form 10-K,~~short ~~particularly~~notice inat ~~“Cautionary~~competitive ~~Statement Regarding Forward-Looking Statements” and “Item 1A~~rates. ~~Risk Factors.”~~

~~Overview of~~ITEM ~~Operations~~3. LEGAL PROCEEDINGS.

~~We are~~From atime ~~pharmaceutical~~to ~~company~~time, ~~engaged~~we inare a ~~the~~party ~~research~~to litigation and ~~development~~subject to claims incident to the ordinary course of ~~innovative~~business. ~~pharmaceutical~~Future ~~solutions~~litigation ~~with~~may abe ~~technology~~necessary ~~platform~~to defend ~~that~~ourselves ~~allows~~by ~~for~~determining the ~~oral~~scope, ~~delivery~~enforceability, and validity of ~~therapeutic~~third-party ~~proteins~~proprietary rights or to establish our proprietary rights.

~~We have~~ITEM ~~developed an oral dosage form intended to withstand the harsh environment of the gastrointestinal tract and effectively deliver active insulin or other proteins~~4. ~~The~~MINE ~~formulation~~SAFETY ~~is not intended to modify the proteins chemically or biologically, and the dosage form is designed to be safe to ingest~~DISCLOSURES.

~~On January~~Not ~~11, 2023, we announced that the Phase 3 oral insulin trial (ORA-D-013-1) did not meet its primary or secondary endpoints~~applicable. As a result, we terminated this trial and a parallel Phase 3, ORA-D-013-2 clinical trial. In 2023, we completed an analysis of the ORA-D-013-1 Phase 3 trial data and found that subpopulations of patients with pooled specific parameters, such as BMI, baseline HbA1c and age, responded well to oral insulin. Based on this analysis, we submitted a protocol for a new Phase 3 clinical trial to the FDA. We are additionally examining our existing pipeline and have commenced an evaluation process of potential strategic opportunities, with the goal of enhancing value for our stockholders.

As detailed above, in September 2023, we entered into the 2023 Scilex Transaction, which included a senior secured promissory note (Tranche A Note) and warrants. In October 2024, we participated in the 2024 Refinancing, purchasing a portion of the Tranche B Note and acquiring royalty rights under a Purchase and Sale Agreement. Additional agreements secured the right to receive royalties from certain products of Scilex. We believe that these transactions collectively strengthened our financial position and expanded our commercial interests.35

36PART II

~~The~~Common table and discussion that follows includes a comparison of our results of operations and liquidity and capital resources for the years ended December 31, 2024 and 2023. For a comparison of our results of operations and financial condition for the year ended December 31, 2023 and the year ended December 31, 2022, see “Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations” included in our Annual Report on Form 10-K for the year ended December 31, 2023, filed with the SEC on March 6, 2024.Stock

	Year ended December 31,
	2024			2023
	(dollar amounts in thousands, except per share data)
Revenues	$	-		$	1,340
Research and development expenses		(6,324	)		(8,971	)
Sales and marketing		-			287
General and administrative expenses		(6,457	)		(8,425	)
Interest expenses		(853	)		(2,037	)
Financial income (expenses), net		(2,286	)		22,894
Income (loss) before taxes on income		(15,920	)		5,088
Taxes on income		(3,183	)		-
Net income (loss) for the year		(19,103	)		5,088
Net income (loss) attributable to Company’s stockholders		(19,060	)		5,525
Net loss attributable to non-controlling interest		(43	)		(437	)
Net income (loss) for the year		(19,103	)		5,088
Basic income (loss) per share of common stock	$	(0.48	)	$	0.14
Diluted income (loss) per share of common stock	$	(0.48	)	$	0.14
Weighted average shares of common stock outstanding used in computing basic income (loss) per share of common stock		40,828,380			40,315,068
Weighted average shares of common stock outstanding used in computing diluted income (loss) per share of common stock		40,828,380			40,566,901

Our common stock is traded on the Nasdaq Capital Market and on the Tel Aviv Stock Exchange, in each case under the symbol “ORMP.”

~~Revenues~~Holders

~~Revenues consist~~As of ~~proceeds~~March ~~related~~26, to2026, ~~the~~there were ~~Amended and Restated Technology License Agreement~~40,446,179 ~~dated~~shares ~~December~~of ~~21,~~our ~~2015,~~common ~~between~~stock usissued and ~~HTIT,~~outstanding ~~or as~~held ~~further~~of ~~amended~~record by ~~the~~approximately ~~parties~~40 onregistered ~~June~~stockholders. 3,We ~~2016~~believe that ~~and~~a ~~July~~significant ~~24,~~number ~~2016,~~of ~~the~~stockholders ~~HTIT~~hold ~~License~~their ~~Agreement,~~shares ~~that~~of ~~are~~our ~~recognized~~common onstock ain ~~cumulative basis~~brokerage ~~when~~accounts itand isregistered ~~probable that a significant reversal~~ in the ~~amount~~name of ~~cumulative~~stock depositories ~~revenue~~and ~~recognized~~are ~~will~~therefore not ~~occur,~~included ~~through~~in the ~~expected product~~number ~~submission~~of ~~date~~stockholders ~~by HTIT~~ of ~~June 2023~~record.

We did not recognize revenues for the year ended December 31, 2024, compared to revenues of approximately $1,340,000 for the year ended December 31, 2023. The decrease was due to recognition of revenues through June 30, 2023, the product submission date by HTIT.Dividend

~~Research~~On December 31, 2025, our Board of Directors declared a cash dividend of $0.25 per share of common stock, warrants and ~~Development~~RSUs, ~~Expenses~~payable to stockholders of record as of January 16, 2026. The aggregate amount of the dividend is $10,870. We do not expect that we will pay any dividends or other distributions to stockholders in the foreseeable future.

~~Research and~~Shareholder ~~development~~Rights expenses include costs directly attributable to the conduct of research and development programs, including the cost of salaries, employee benefits, costs of materials, supplies, the cost of services provided by outside contractors, including services related to our clinical trials, clinical trial expenses, the full cost of manufacturing drugs for use in research and preclinical development. All costs associated with research and development are expensed as incurred.Plan

~~Clinical~~On November 16, 2025, our ~~trial~~Board ~~costs~~declared ~~are~~a dividend of one common stock purchase right (a ~~significant~~“Right”) ~~component~~for each outstanding share of ~~research~~common stock. The dividend was paid on November 27, 2025, to the stockholders of record at the close of business on November 27, 2025. Each Right initially entitles the registered holder to purchase from us one share of common stock at a price of $10.00 per share of common stock, subject to adjustment. The description and ~~development~~terms ~~expenses~~of the Rights are set forth in a Rights Agreement dated as of November 17, 2025, as the same may be amended from time to time, between us and ~~include~~Continental ~~costs~~Stock ~~associated~~Transfer ~~with~~& ~~third-party~~Trust ~~contractors~~Company, as Rights agent. Until the earlier to occur of (i) 10 Webusiness ~~outsource~~days following a ~~substantial~~public ~~portion~~announcement that a person or group of ~~our~~affiliated ~~clinical~~or ~~trial~~associated ~~activities~~persons has become a person or group of affiliated or associated persons acquires beneficial ownership of 15% or more of the outstanding shares of common stock (an “Acquiring Person”) or (ii) 10 business days (or such later date as may be determined by action of the Board prior to such time as any person or group of affiliated or associated persons becomes an Acquiring Person) following the commencement of, ~~utilizing~~or ~~external~~public ~~entities~~announcement of an intention to make, a tender or exchange offer the consummation of which would result in any person or group of affiliated or associated persons becoming an Acquiring Person (the earlier of such dates being called the “Distribution Date”), the Rights will be evidenced, with respect to certificates representing Common Stock (or book entry shares of common stock) outstanding as ~~CROs~~of the Record Date, ~~independent~~by ~~clinical~~such ~~investigators~~certificates (or such book entry shares). In the event that any person or group of affiliated or associated persons becomes ~~and~~an Acquiring Person, each holder of a Right, other ~~third-party~~than ~~service~~Rights ~~providers~~beneficially owned by the Acquiring Person (which will thereupon become void), will thereafter have the right to ~~assist~~receive usupon ~~with~~exercise of a Right that number of shares of common stock (or cash, other assets, debt securities of the ~~execution~~Company, or any combination thereof) having a market value of ~~our~~two ~~clinical~~times ~~trials~~the exercise price of the Right.

~~Clinical activities~~Unregistered ~~which~~Sales ~~relate~~of ~~principally~~Equity toSecurities ~~clinical sites~~ and ~~other administrative functions to manage our clinical trials are performed~~ ~~primarily~~Use ~~by CROs. CROs typically perform most~~ of ~~the start-up activities for our trials, including document preparation, site identification, screening and preparation, pre-study visits, training and program management.~~Proceeds

~~Clinical trial~~No ~~and~~unregistered ~~preclinical~~sales ~~trial~~of ~~expenses include regulatory and scientific consultants’ compensation and fees, research expenses, purchase~~equity ofsecurities ~~materials,~~were ~~cost~~made ofduring ~~manufacturing of~~ the ~~oral~~three ~~insulin~~months ~~and~~ended ~~exenatide~~December ~~capsules~~31, ~~payments~~2025. ~~for~~that ~~patient~~were ~~recruitment~~not ~~and~~previously ~~treatment,~~reported asin ~~well as~~a ~~salaries~~Quarterly ~~and~~Report ~~related~~on ~~expenses~~Form 10-Q ofor ~~research~~Current ~~and~~Report ~~development~~on ~~staff~~Form 8-K.

3736

~~Research~~Issuer ~~and~~Purchases ~~development~~of ~~expenses~~Equity for the year ended December 31, 2024 decreased by 30% to approximately $6,324,000, compared to approximately $8,971,000 for the year ended December 31, 2023. The decrease was mainly due to lower expenses related to our Phase 3 trials that were terminated and was partially offset by stock-based compensation expenses and costs related to the new Phase 3 clinical trial preparations.Securities

~~Government~~In June 2024, our Board authorized a stock ~~Grants~~buyback and retirement program or, the “Buy-Back Program” pursuant to which we may, from time to time, repurchase up to $20,000,000 in maximum value of our common stock. Share repurchases may be executed through various means, including, without limitation, open market transactions, privately negotiated transactions or otherwise in compliance with Rule 10b-18 under the Exchange Act. The Buy-Back Program does not obligate us to purchase any shares and the initial term was set to expire in June 2025. On May 21, 2025, our Board authorized a one-year extension of the Buy-Back Program, which was set to expire in June 2026. The authorization for the Buy-Back Program may be terminated, increased or decreased by our Board in its discretion at any time.

~~The Government~~During of2025 ~~Israel~~and ~~encourages~~2024, ~~research~~we ~~and~~have ~~development~~repurchased ~~projects~~and retired ~~through~~shares ~~the~~of ~~IIA,~~our ~~pursuant~~common tostock under the ~~R&D~~Buy-Back ~~Law~~Program. ~~Under~~During the ~~R&D~~year ~~Law~~ended December 31, a ~~research~~2025, ~~and~~we ~~development~~repurchased ~~plan~~an ~~that~~aggregate ~~meets~~of 899,609 ~~specified~~in ~~criteria~~shares isof ~~generally~~common ~~eligible~~stock for a$2,155,000, ~~grant~~including approximately $6,000 of upexcise totax, ~~50%~~at an average price of ~~certain~~$2.39 ~~approved~~per ~~research~~share, and ~~development~~during ~~expenditures~~the year ended December 31, 2024, we repurchased an aggregate of 1,036,976 shares of common stock for $2,494,000, including $10 of excise tax, at an average price of $2.40 ~~Each~~per ~~plan~~share. ~~must~~All berepurchases ~~approved~~were byfunded ~~the~~with ~~IIA~~cash on hand.

~~From August~~On ~~2009~~October to20, ~~March 2014~~2025, ~~our~~we ~~subsidiary~~entered ~~Oramed~~into ~~Ltd.~~a ~~was~~separate ~~awarded~~stock ~~five~~repurchase ~~government~~agreement with ~~grants~~HTIT ~~amounting~~pursuant to awhich ~~total~~HTIT ~~net~~agreed ~~amount~~to ofsell ~~NIS~~to ~~8,000,000 (approximately~~us $21,~~214~~155,~~000~~367 ~~during~~shares ~~such~~of ~~period)~~common ~~from~~stock ~~the~~at ~~IIA.~~a Wepurchase ~~used~~price ~~these~~of ~~funds~~$2.23 toper ~~support~~share ~~further~~for ~~research~~an ~~and development and clinical~~aggregate ~~trials~~price of ~~our~~$2,584,000, ~~oral~~including ~~insulin~~approximately ~~capsule~~$8,000 ~~and~~of ~~oral~~excise ~~GLP-1~~tax. ~~analog~~Following ~~candidate~~such ~~during~~repurchase, the ~~period~~shares ~~from~~were ~~February~~cancelled ~~2009~~and ~~to December 2014~~retired.

~~In the~~The ~~years~~following ~~ended~~sets ~~December~~forth ~~31,~~information ~~2024~~with respect to repurchase and ~~2023,~~retirement wemade ~~did~~by ~~not~~the ~~recognize~~Company ~~any~~of ~~research~~its ~~and~~shares ~~development~~of ~~grants.~~common stock during the fourth quarter ended December 31, 2025:

Under the terms of the grants we had received from the IIA, we were obligated to pay royalties of 3% on all revenues derived from the sale of the products developed pursuant to the funded plans, including revenues from licensed ancillary services. Royalties were generally payable up to a maximum amount equaling 100% of the grants received (dollar linked) with the addition of interest at an annual rate based on the SOFR rate. On February 27, 2025, we paid approximately $2,031,000 to the IIA, and, as result, we are free of our obligations to the IIA.

Period	Total number of shares purchased		Average price paid per share		Total number of shares purchased as part of publicly announced plans or programs		Approximate dollar value of shares that may yet be purchased under the plans or programs
October 1-31, 2025		1,155,367	$	2.23		-	$	16,794,198
November 1-30, 2025		570,366	$	2.50		570,366	$	15,366,989
December 1-31, 2025		-	$	-		-	$	15,366,989
Total		1,725,733		2.32				15,366,989

The R&D Law generally requires that a product developed under a program be manufactured in Israel. However, when applying for a grant, the applicant may declare that part of the manufacturing will be performed outside of Israel or by non-Israeli residents and if the IIA is convinced that performing some of the manufacturing abroad is essential for the execution of the program, it may still approve the grant. This declaration will be a significant factor in the determination of the IIA as to whether to approve a program and the amount and other terms of the benefits to be granted. If a company wants to increase the volume of manufacturing outside of Israel after the grant has been approved, it may transfer up to 10% of the company’s approved Israeli manufacturing volume, measured on an aggregate basis, outside of Israel after first notifying the IIA thereof (provided that the IIA does not object to such transfer within 30 days). In addition, upon the approval of the IIA, a portion greater than 10% of the manufacturing volume may be performed outside of Israel. In any case of transfer of manufacturing out of Israel, the grant recipient is required to pay royalties at an increased rate, which may be substantial, and the aggregate repayment amount is increased up to 120% or 150% of the grant received (dollar linked) with the addition of interest at an annual rate based on the SOFR rate, depending on the portion of the total manufacturing volume that is performed outside of Israel. The approval we received from the IIA for the License Agreement was subject to payment of increased royalties and an increased ceiling, all in accordance with the provisions of the R&D Law. The R&D Law further permits the IIA, among other things, to approve the transfer of manufacturing rights outside of Israel in exchange for the import of different manufacturing into Israel as a substitute, in lieu of the increased royalties.37

~~The R&D~~ITEM Law also provides that know-how developed under an approved research and development program and any derivatives thereof may not be transferred or licensed to third parties in Israel without the approval of the research committee, which approval may be subject to the payment of royalties from the sale6. Such approval is not required for the sale or export of any products resulting from such research or development. The R&D Law further provides that the know-how developed under an approved research and development program and any derivatives thereof may not be transferred or licensed to any third parties outside Israel absent IIA approval which may be granted in certain circumstances as follows: (a) the grant recipient pays to the IIA a portion of the sale or license price paid in consideration for the purchase or license of such IIA-funded know-how or the price paid in consideration for the sale of the grant recipient itself, as the case may be, in accordance with certain formulas included in the tracks published under the R&D Law; (b) the grant recipient receives know-how from a third party in exchange for its IIA-funded know-how; or (c) such transfer of IIA-funded know-how is made in the context of IIA approved research and development cooperation projects or consortia.[RESERVED]

38ITEM 7. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS.

The ~~R&D~~ ~~Law~~following ~~imposes reporting requirements with respect to certain changes in the ownership of a grant recipient. The R&D Law requires~~discussion ~~the~~and ~~grant~~analysis ~~recipient to notify the IIA~~ of ~~any~~our ~~change~~financial incondition ~~control~~and ofresults ~~the recipient or a change in the holdings~~ of ~~the~~operations ~~means~~should ofbe ~~control~~read ~~of the recipient that results~~ in aconjunction ~~non-Israeli entity or person becoming an interested party in the recipient, and requires the new non-Israeli interested party to undertake to the IIA to comply~~ with the ~~R&D~~audited ~~Law.~~consolidated ~~In addition, the rules of the IIA may require the provision~~financial ofstatements additional information or representations in respect of certain such events. For this purpose, “control” is defined as the ability to direct the activities of a company other than any ability arising solely from serving as an officer or director of the company. A person is presumed to have control if such person holds 50% or more of the means of control of a company. “Means of control” refers to voting rights or the right to appoint directors or the chief executive officer. An “interested party” of a company includes a holder of 5% or more of its outstanding share capital or voting rights, its chief executive officer and ~~directors, someone who has~~ the ~~right~~related tonotes ~~appoint~~included ~~its~~elsewhere ~~chief~~herein ~~executive officer or at least one director,~~ and ain ~~company~~our ~~with~~audited ~~respect~~consolidated tofinancial ~~which any of the foregoing interested parties holds 25% or more of the outstanding share capital or voting rights or has the right to appoint 25% or more of the directors~~statements.

~~Failure to~~In ~~meet~~addition ~~the~~to ~~R&D~~our ~~Law’s~~audited consolidated ~~requirements~~financial ~~may~~statements, ~~subject~~the usfollowing todiscussion ~~mandatory~~contains ~~repayment~~forward-looking ofstatements ~~grants~~that ~~received~~reflect byour usplans, ~~(together~~estimates ~~with interest~~ and ~~penalties),~~beliefs. asOur ~~well~~actual asresults ~~expose~~could usdiffer tomaterially ~~criminal~~from ~~proceedings.~~those Indiscussed ~~addition,~~in the ~~Israeli~~forward-looking ~~government~~statements. ~~may~~Factors ~~from~~that ~~time~~could cause or contribute to ~~time~~these ~~audit~~differences ~~sales~~include ofthose ~~products which~~discussed itbelow ~~claims~~and ~~incorporate~~elsewhere ~~technology~~in ~~funded~~this ~~through~~Annual ~~IIA~~Report ~~programs~~on ~~which~~Form ~~may~~10-K, ~~lead~~particularly toin ~~additional~~“Cautionary Statement ~~royalties~~Regarding ~~being~~Forward-Looking ~~payable~~Statements” onand ~~additional products~~“Item 1A. Risk Factors.”

~~Sales and~~Overview ~~Marketing~~of ~~Expenses~~Operations

~~Sales and~~We ~~marketing~~are ~~expenses~~a ~~include~~pharmaceutical company engaged in the ~~salaries~~research and ~~related~~development ~~expenses~~of innovative pharmaceutical solutions with a technology platform that allows for the oral delivery of ~~our~~therapeutic ~~commercial~~proteins. ~~functions~~In addition, ~~consulting~~we ~~costs~~allocate capital to strategic investments in healthcare and ~~other~~life ~~general~~sciences ~~expenses~~companies that we believe complement our long-term business objectives and technology focus.

WeFor ~~did~~additional ~~not~~information regarding ~~recognize~~our ~~any sales~~business and ~~marketing expenses for the year ended December 31~~operations, ~~2024,~~please ~~compared~~refer to anItem ~~income~~1 of– ~~approximately $287,000 for the year ended December 31, 2023~~Business. ~~The income primarily resulted from the reversal of previously recognized expenses related to forfeited employee stock options, following the termination of an executive officer in fiscal year 2023.~~

~~General and~~ Reportable ~~Administrative Expenses~~Segment

~~General and~~Our ~~administrative~~single ~~expenses~~reportable ~~include~~segment ~~the~~is ~~salaries~~focused ~~and~~on ~~related expenses of our management, consulting expenses, legal~~ research and ~~professional fees,~~development ~~travel~~activities ~~expenses,~~related ~~business~~to ~~development~~our ~~expenses,~~proprietary ~~insurance~~products ~~expenses~~ and ~~other general expenses~~technologies.

~~General~~Recent and administrative expenses for the year ended December 31, 2024 decreased by 23% to approximately $6,457,000, compared to approximately $8,425,000 for the year ended December 31, 2023. This decrease was mainly due to the reversal of previously recognized expenses following the resignation of certain executive officers.Developments

~~Interest Expenses~~Scilex Warrant Agreement

~~Interest~~In ~~expenses~~October ~~were~~2025, ~~approximately~~we ~~$853~~agreed to defer an amortization payment due from Scilex on October 1,~~000~~ ~~for~~2025 under the ~~year~~amortization ~~ended~~schedule ~~December~~included in the Tranche B Notes. The deferred amortization ~~31,~~payment ~~2024,~~was ~~compared~~subsequently paid to ~~approximately~~us ~~$2,037,000~~in ~~for~~November ~~the~~2025. ~~year~~In ~~ended~~consideration ~~December~~for ~~31,~~this ~~2023~~deferral, ~~since~~Scilex ~~the~~agreed ~~Short-Term~~to ~~Borrowings~~issue ~~(as~~to ~~defined~~us ~~below)~~warrants to purchase ~~received~~100,000 ~~from~~shares ~~Discount~~of ~~Bank~~Scilex’s ~~Ltd~~common stock, par value $0.0001 ~~were~~per ~~terminated~~share ~~during~~with ~~the~~an ~~second~~exercise ~~quarter~~price of ~~2024~~$20. ~~(see~~The ~~below)~~warrants were issued on February 19, 2026.

~~Financial Income,~~Lifeward ~~Net~~Share Purchase Agreement

~~Net~~On ~~financial~~January ~~loss~~12, ~~was~~2026, ~~approximately~~we ~~$2,286,000~~entered ~~for~~into a Share Purchase Agreement or, the ~~year~~“Lifeward ~~ended~~Share Purchase Agreement” with Lifeward and OraTech pursuant to which Lifeward acquired all of the outstanding ~~December~~equity ~~31,~~interests ~~2024~~of OraTech from us or’ the “Share Purchase Transaction”. Prior to the closing, ~~compared~~we transferred to ~~approximately~~OraTech all ~~$22~~intellectual property and related assets relating to our POD™ (Protein Oral Delivery) technology platform,~~894,000~~ ~~net~~together ~~financial~~with ~~income~~cash to ~~for~~fund the ~~year~~next ~~ended~~planned ~~December~~clinical ~~31,~~trial ~~2023~~and related development activities. ~~The~~As ~~change~~a ~~was~~result, ~~mainly due~~commencing toon the ~~revaluation~~closing date of ~~the~~March ~~investments~~25, in2026, research ~~Scilex~~ and ~~lower~~development ~~interest~~expenses ~~income~~will onbe ~~deposits~~borne by Oratech.

3938

~~Liquidity~~In consideration for the acquisition of Oratech, Lifeward issued to us: (i) Lifeward Ordinary Shares and ~~Capital~~pre-funded ~~Resources~~warrants to purchase Lifeward Ordinary Shares representing up to 49.99% of Lifeward’s fully diluted equity capitalization at closing, subject to adjustments, which represents less than 45.0% of the outstanding Lifeward Ordinary Shares at closing; (ii) warrants to purchase Lifeward Ordinary Shares equal to the quotient of Lifeward’s net cash at closing divided by an exercise price of $5.40 per share, reflecting Lifeward’s 12-for-1 reverse share split effected on February 24, 2026 (which adjusted the original exercise price of $0.45 per share), subject to adjustments or, the “Share Purchase Warrants”; and (iii) revenue-sharing payments equal to 4% of the net revenue from Lifeward’s ReWalk Personal Exoskeleton products and related extended warranties for up to 10 years following closing, subject to certain caps and early termination upon the occurrence of specified events.

~~From~~The ~~our~~closing ~~inception through December 31, 2024, we have incurred losses in an aggregate amount~~ of ~~approximately~~the ~~$176,616,000.~~Share ~~During~~Purchase ~~that~~Transaction ~~period~~was ~~and~~subject ~~through~~to ~~December 31, 2024, we have financed our operations~~customary ~~through~~closing ~~several private placements of our common stock~~conditions, asincluding ~~well~~the asapproval ~~public offerings~~ of ~~our~~Lifeward’s ~~common~~shareholders ~~stock,~~for ~~raising~~the aissuance ~~total~~ of ~~approximately $255,384,000,~~more ~~net~~than ~~of transaction costs~~19.99% ~~During that period, we also received cash consideration~~ of ~~approximately~~Lifeward ~~$28,001,000~~Ordinary Shares ~~from~~in ~~the exercise~~accordance ofwith ~~warrants~~Nasdaq ~~and~~listing ~~options~~standards. WeSuch ~~expect~~shareholder toapproval ~~seek~~was ~~additional~~obtained ~~financing~~on ~~through~~March ~~similar sources in the future~~12, ~~as needed~~2026. AsThe ofclosing ~~December 31, 2024, we had approximately $54,420,000~~ of ~~available~~the ~~cash and approximately $55,281,000 of short-term bank deposits. In addition, we~~Share ~~hold~~Purchase ~~various~~Transaction oftook ~~interest~~place inon ~~certain~~March ~~investments~~25, ~~including in Scilex and others, as further detailed in this report~~2026.

~~From inception~~In ~~through~~connection ~~December~~with ~~31,~~the ~~2024~~transaction, Lifeward weagreed ~~have~~to ~~not~~file ~~generated~~a ~~significant~~resale ~~revenues~~registration ~~from~~statement ~~our~~with ~~operations.~~the ~~Although,~~SEC wecovering ~~have increased~~ the ~~research~~ ~~and~~Lifeward ~~development~~Ordinary ~~activities~~Shares ~~related~~issued toin the ~~new~~transaction ~~Phase~~and those 3issuable ~~clinical~~upon ~~trial,~~exercise ~~our~~of ~~research~~the ~~and~~pre-funded ~~development~~warrants ~~activities~~and ~~have~~warrants ~~been~~described ~~significantly reduced~~above ~~while~~as wesoon ~~conducted~~as apracticable ~~strategic~~following ~~review process~~closing, ~~following~~but ~~the~~no later ~~termination~~than of75 ~~the~~days ~~ORA-D-013-1~~after closing, and ~~ORA-D-013-2~~to ~~Phase~~use 3commercially ~~trials.~~reasonable ~~Following the~~efforts ~~preparation~~to ~~and~~have ~~expected~~such ~~initiation~~registration ofstatement ~~the~~declared ~~revised~~effective ~~phase~~within 75 3days ~~trial~~after closing (~~ORA-D-013-3)~~or we105 ~~expect~~days toin ~~increase~~the ~~our~~event ~~research~~of ~~and~~a ~~development expenses,~~full ~~either~~SEC ~~directly or through OraTech~~review).

~~Based on~~Pre-Funded ~~our~~Warrants ~~current cash resources~~ and ~~commitments,~~Share wePurchase believe we will be able to maintain our current planned activities and the corresponding level of expenditures for at least the next 12 months, although no assurance can be given that we will not need additional funds prior to such time. If there are increases in our operating expenses, we may need to seek additional financing during the next 12 months. We may also need additional funds to realize the decisions made as part of our strategic review process. We cannot predict the outcome of these activities. Warrants

~~On August~~The 8,Share ~~2023,~~Purchase weWarrants ~~borrowed~~were animmediately ~~aggregate~~exercisable ofupon ~~$99,550,000~~issuance at ~~pursuant~~an toinitial ~~loan~~exercise ~~agreements~~price ~~from~~of ~~Israel~~$5.40 ~~Discount~~per ~~Bank Ltd.~~share, orreflecting ~~the~~Lifeward’s ~~Short~~12-~~Term Borrowings.~~for-1 ~~The~~reverse ~~Short-Term~~share ~~Borrowings~~split ~~mature~~effected on ~~dates~~February ~~ranging from August 11, 2023 to May~~ 24, ~~2024, bear interest ranging from 6.66%~~2026 to(which ~~7.38%,~~adjusted ~~were~~the ~~secured~~original byexercise ~~certificates~~price of ~~deposits issued by Israel Discount Bank Ltd~~$0.45 ~~having~~per ~~an aggregate face amount of $99~~share),~~550,000. The~~ ~~net~~and ~~proceeds~~expire offive ~~the~~years ~~Short-Term~~from ~~Borrowings were used to fund~~ the ~~Tranche~~date Aof ~~Note~~issuance. The ~~Short-Term~~exercise ~~Borrowings~~price ~~were paid in one payment~~is ofsubject ~~principal~~to ~~and~~customary ~~interest at each respective maturity. As of December 31, 2024, we repaid the entire Short~~anti-~~Term~~dilution ~~Borrowings amount~~adjustments.

40The Pre-Funded Warrants have an exercise price of $0.0012 per share (reflecting the reverse-split adjusted price of the original $0.0001 per share), subject to customary adjustments, and will remain exercisable until exercised in full.

AsWe ofmay ~~December~~not ~~31,~~exercise ~~2024,~~any ~~our total~~portion ~~current~~of ~~assets~~the ~~were~~Pre-Funded Warrants ~~approximately~~or ~~$143,221,000~~Share ~~and~~Purchase ~~our~~Warrants ~~total~~to ~~current~~the ~~liabilities~~extent ~~were~~that, ~~approximately~~after ~~$5,685,000.~~giving Oneffect ~~December~~to 31such exercise, ~~2024,~~ we ~~had~~and aour ~~working~~affiliates ~~capital~~would ~~surplus~~beneficially own ofmore ~~approximately~~than ~~$137,536,000~~45.0% ~~and~~of anthe ~~accumulated~~outstanding ~~loss~~Lifeward ofOrdinary ~~approximately $176,616,000~~Shares. AsThis oflimitation ~~December 31,~~will ~~2023,~~automatically ~~our~~increase ~~total~~to ~~current~~49.99% ~~assets~~once ~~were~~(i) ~~approximately~~the ~~$162,584,000~~Investors no ~~and~~longer ~~our~~hold ~~total~~any ~~current~~Notes ~~liabilities~~and ~~were~~(ii) ~~approximately~~the ~~$53,214,000.~~Investors ~~On December~~have ~~31,~~sold ~~2023,~~all weNote ~~had~~Shares aissued ~~working~~or ~~capital~~issuable ~~surplus~~upon conversion of ~~approximately~~the ~~$109,370,000~~Notes and anrelated warrants. ~~accumulated~~We ~~loss~~may ofincrease ~~approximately~~the ~~$157,556,000. The~~beneficial ~~increase~~ownership inlimitation ~~working~~upon ~~capital~~at ~~surplus~~least ~~was~~61 ~~mainly~~days’ ~~due~~prior annotice ~~increase~~to inLifeward; ~~cash~~provided ~~and~~that, ~~cash~~for so ~~equivalents~~long ~~together~~as ~~with~~certain aLifeward ~~decrease~~warrants inoutstanding ~~short-term borrowings~~as ~~that~~of ~~was~~the ~~partially~~issuance ~~offset~~date byremain aoutstanding, ~~decrease~~any insuch ~~short-term~~increase ~~deposits~~will ~~and~~require ~~investments~~Lifeward’s consent, atwhich ~~fair~~may ~~value~~not be unreasonably withheld, conditioned or delayed.

~~During~~In ~~the~~connection ~~year~~with ~~ended~~the ~~December~~execution ~~31,~~of ~~2024,~~the ~~cash~~Lifeward ~~and~~Share ~~cash~~Purchase ~~equivalents~~Agreement, ~~increased~~we toentered ~~approximately~~into ~~$54,420,000~~a ~~from~~lock-up ~~approximately~~agreement ~~$9,055,000~~for asa period of ~~December~~120 ~~31,~~days ~~2023.~~after ~~The increase~~the ~~was~~Closing, ~~mainly~~without ~~due to~~ the prior ~~reasons~~written ~~described~~consent ~~below~~of Lifeward.

Operating activities used cash of approximately $8,412,000 in the year ended December 31, 2024, compared to approximately $10,295,000 used in the year ended December 31, 2023. Cash used in operating activities consisted mainly of changes in fair value of investments partially offset by net loss resulting from research and development and general and administrative expenses.39

~~Investing~~Clinical ~~activities~~Trial ~~provided cash~~Management of approximately $105,817,000 in the year ended December 31, 2024, compared to cash used for investing activities of approximately $73,038,000 in the year ended December 31, 2023. Cash provided by investing activities in the year ended December 31, 2024 consisted primarily of proceeds from short-term deposits and proceeds from repayments by Scilex under the Tranche A Note. Cash used by investing activities in the year ended December 31, 2023 is mainly due to our investment in Scilex and the purchase of short-term deposits, partially offset by the proceeds of short-term deposits.Agreement

~~Financing~~In ~~activities~~connection ~~used~~with ~~cash~~the ofLifeward ~~approximately~~Share ~~$52~~Purchase Agreement,~~036,000~~ inwe ~~the~~agreed ~~year~~to ~~ended~~enter ~~December~~into 31a clinical trial management or, ~~2024~~the “Clinical Trial Management Agreement” with Oratech, ~~compared~~pursuant to ~~cash~~which we agreed to manage the clinical study of ~~approximately~~Oratech’s ~~$51,978,000~~investigational ~~provided~~oral ininsulin ~~the~~capsule ~~year~~product ~~ended~~or, ~~December~~the 31“Study”, ~~2023.~~including providing ~~Cash~~clinical ~~used~~trial ~~for financing~~management ~~activities~~and inadministrative ~~the~~services ~~year~~through ~~ended~~study ~~December~~completion 31or, ~~2024~~the “Services”. In consideration for the Services, ~~consisted~~OraTech ~~primarily~~will ofreimburse ~~repayments~~us offor ~~the~~all ~~Short~~reasonable out-~~Term~~of-pocket ~~Borrowings~~expenses ~~and~~actually ~~repurchases~~incurred by us in providing the Services ofand ~~our~~payments ~~shares.~~made ~~Cash~~on ~~provided~~behalf byof ~~financing~~OraTech ~~activities~~to inthird ~~the~~parties ~~year~~and ~~ended~~vendors, ~~December~~such 31as clinical sites, ~~2023~~if applicable, ~~consisted~~subject ~~primarily~~to ofcertain limitations and maximum payments as set forth in the ~~Short-Term~~Clinical ~~Borrowings~~Trial Management Agreement. ~~Our~~ ~~primary~~The ~~financing~~Clinical ~~activities~~Trial ~~for~~Management Agreement will terminate upon completion of the ~~year~~Study ~~ended~~unless ~~December~~earlier ~~31,~~terminated ~~2024,~~in ~~were~~accordance aswith ~~follows:~~ the terms set forth therein.

●Notes ~~In March 2024, we entered into the ATM Agreement with Rodman & Renshaw LLC and StockBlock~~ Securities ~~LLC~~Purchase as sales agents, or the Agents, pursuant to which we may issue and sell in transactions that are deemed to be “at the market” offerings as defined in Rule 415 under the Securities Act of 1933, as amended, or the Securities Act, shares of our common stock, par value $0.012 per share, having a maximum aggregate offering price of up to $75,000,000 from time to time through the Agents. Any sales of shares of common stock pursuant to the ATM Agreement will be made pursuant to an effective shelf registration statement on Form S-3 (File No. 333-257926), which was declared effective by the SEC on July 26, 2021, the prospectus contained therein and a prospectus supplement related thereto dated March 18, 2024, filed with the SEC. The Agents may sell our common stock (A) in privately negotiated transactions with our consent; (B) as block transactions; or (C) by any other method permitted by law deemed to be an “at the market offering” as defined in Rule 415(a)(4) promulgated under the Securities Act, including sales made directly on The Nasdaq Capital Market or sales made into any other existing trading market for our common stock. As of December 31, 2024, no shares had been issued under the ATM Agreement.

●On InJanuary ~~June~~12, ~~2024~~2026, ~~our~~we ~~Board~~entered ~~authorized~~into a ~~stock~~Securities ~~buyback~~Purchase ~~program~~Agreement or, ~~pursuant~~the to“Lifeward ~~which~~Notes wePurchase ~~may,~~Agreement” ~~from~~with ~~time~~Lifeward ~~to time, repurchase~~ and ~~retire~~other upinvestors pursuant to ~~$20,000,000~~which inwe ~~maximum~~agreed ~~value~~to ~~of our common stock. During the year ended December 31~~purchase, ~~2024,~~in a weprivate ~~repurchased and retired 1~~placement,~~036,976~~ ~~shares~~up ofto ~~our common stock under this program for approximately~~ $218,~~494,~~000, ~~including approximately $10,~~000 ~~excise~~of ~~tax,~~senior atsecured anconvertible ~~average~~notes ~~price~~issued ofby ~~$2.36~~Lifeward, together ~~per~~with ~~share.~~accompanying ~~All~~warrants ~~repurchases~~to ~~were~~purchase ~~funded~~Lifeward ~~with~~Ordinary ~~cash on hand~~Shares.

●At Onthe ~~August~~initial 8closing, ~~2023,~~ we ~~borrowed~~purchased ~~an aggregate of~~ $999,~~550~~000,000 ~~pursuant~~aggregate toprincipal amount ~~loan~~of ~~agreements~~such ~~from~~notes ~~Israel Discount Bank Ltd.~~or, or the ~~Short-Term~~“Initial ~~Borrowings~~Notes”. The ~~Short-Term~~Initial ~~Borrowings~~Notes ~~mature~~bear oninterest ~~dates~~at ~~ranging~~8% ~~from~~per ~~August 11~~annum, ~~2023~~payable ~~to May 24~~semi-annually, ~~2024,~~and mature ~~bear~~three ~~interest~~years ~~ranging~~ from ~~6.66%~~the todate 7of issuance.~~38%,~~ ~~were~~The ~~secured~~Initial byNotes ~~certificates~~are ofconvertible ~~deposits~~into ~~issued~~Lifeward byOrdinary ~~Israel~~Shares ~~Discount~~at ~~Bank Ltd. having~~ an ~~aggregate~~initial ~~face~~conversion price ~~amount~~ of $~~99,550,000~~5.40 ~~The~~per ~~net~~share, ~~proceeds~~reflecting ofLifeward’s ~~the Short~~12-~~Term~~for-1 ~~Borrowings~~reverse ~~were~~share ~~used~~split toeffected ~~fund~~on ~~the~~February ~~Tranche~~24, A2026 ~~Note.~~(which ~~The~~adjusted ~~Short-Term~~the ~~Borrowings~~original conversion ~~were~~price ~~paid in one payment~~ of ~~principal and interest at each respective maturity~~$0.45 Asper ~~of December 31~~share), ~~2024,~~subject weto ~~repaid~~customary ~~the entire Short~~anti-~~Term~~dilution ~~Borrowings amount~~adjustments.

41We also agreed to purchase an additional $9,000,000 aggregate principal amount of notes or, the “Additional Notes” and together with the Initial Notes, or, the “Notes”, together with accompanying warrants, on substantially the same terms as the Initial Notes.

~~Trend~~The closing of the Additional Notes is subject to customary closing ~~Information~~conditions and either:

~~Following the~~(i) ~~results~~Lifeward ofachieving ~~the~~at ~~Phase~~least ~~3 trials for our oral insulin capsule candidate, ORMD-0801, we conducted~~ a ~~comprehensive analysis of the data~~150% toincrease ~~understand~~in ifReWalk ~~there~~unit issales acompared ~~path forward for our oral insulin candidate, and we worked on a protocol for a new Phase 3 clinical trial that was submitted~~ to the ~~FDA.~~trailing ~~Conducting~~twelve-month ~~this~~period ~~clinical~~immediately ~~trial,~~preceding whether independently or as part of OraTech, will require significant funds and resources. Concurrently, we are examining our existing pipeline and have commenced an evaluation process of potential strategic opportunities, with the ~~goal~~Additional ofClosing; ~~enhancing value for our stockholders. At this time, we cannot foresee how these strategic decisions will impact our financial results and operations.~~or

~~Planned~~(ii) the closing price of Lifeward Ordinary Shares equaling or exceeding ~~Expenditures~~$13.80 per share, reflecting Lifeward’s 12-for-1 reverse share split (which adjusted the original $1.15 threshold), for 10 consecutive trading days immediately prior to the Additional Closing.

~~In previous~~The ~~years,~~closing weof ~~primarily~~the ~~invested~~Initial in Notes ~~research~~was ~~and~~subject ~~development.~~to Ifcustomary weclosing ~~proceed~~conditions, toincluding ~~conduct~~the aapproval ~~new~~of ~~clinical~~Lifeward’s ~~trial~~shareholders for ~~our oral insulin candidate, we expect that in~~ the ~~upcoming~~issuance ~~years~~of ~~our~~more than ~~research~~19.99% ~~and~~of ~~development~~Lifeward ~~expenses~~Ordinary ~~will~~Shares ~~continue~~in toaccordance bewith ~~our~~Nasdaq ~~major~~listing ~~operating~~standards. ~~expense;~~Such ~~however,~~shareholder ifapproval ~~this~~was ~~clinical~~obtained ~~trial~~on isMarch ~~conducted through OraTech~~12, ~~these costs will be borne by Oratech and not by us~~2026.

~~Critical~~In connection with the transaction, Lifeward agreed to file a resale ~~Accounting~~registration ~~Estimates~~statement with the SEC covering the Lifeward Ordinary Shares issuable upon conversion of the Notes and exercise of the related warrants within 30 days after the Initial Closing, and to use commercially reasonable efforts to have the registration statement declared effective within 45 days thereafter (or 75 days in the event of a full SEC review).

Our significant accounting policies are more fully described in the notes to our accompanying consolidated financial statements. We believe that the accounting policy below is critical for one to fully understand and evaluate our financial condition and results of operations.40

~~The discussion~~Results ~~and analysis~~ of our financial condition and results of operations is based on our consolidated financial statements, which we prepared in accordance with U.S. generally accepted accounting principles, or GAAP. The preparation of our consolidated financial statements requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the consolidated financial statements, as well as the reported revenues and expenses during the reporting periods. On an ongoing basis, we evaluate such estimates and judgments. We base our estimates on historical experience and on various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions.Operations

42The table and discussion that follows includes a comparison of our results of operations and liquidity and capital resources for the years ended December 31, 2025 and December 31, 2024. For a comparison of our results of operations and financial condition for the year ended December 31, 2024 and the year ended December 31, 2023, see “Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations” included in our Annual Report on Form 10-K for the year ended December 31, 2024, filed with the SEC on March 27, 2025.

Investments at fair value: On September 21, 2023 and on October 7, 2024 we entered into the 2023 Scilex Transaction and 2024 Refinancing, respectively. We elected the fair value option for each of the components under 2023 Scilex Transaction and 2024 Refinancing in order to reduce operational complexity of bifurcating embedded derivatives. Changes in value are recorded under financial income, net and include interest income on the Notes and Royalties received.

	Year ended December 31,
	2025			2024
	(dollar amounts in thousands, except per share data)
Revenues	$	2,000		$	-
Cost of revenue		(1,987	)		-
Gross profit		13			-

Research and development expenses		(6,381	)		(6,324	)
General and administrative expenses		(8,720	)		(6,457	)
Other income, net		958			-
Interest expenses		-			(853	)
Financial income (expenses), net		89,454			(2,286	)
Income (loss) before tax expenses		75,324			(15,920	)
Tax expenses		(11,308	)		(3,183	)
Net income (loss) for the Year		64,016			(19,103	)

Net income (loss) attributable to:
Non-controlling interest		(34	)		(43	)
Company’s stockholders		64,050			(19,060	)

Basic income (loss) per share of common stock	$	1.53		$	(0.48	)
Diluted income (loss) per share of common stock	$	1.50		$	(0.48	)

Weighted average number of shares of common stock used in computing basic income (loss) per share of common stock		41,402,997			40,850,446
Weighted average number of shares of common stock used in computing diluted income (loss) per share of common stock		42,418,644			40,850,446

Determining the fair value of the components above required significant judgment with regards to the expected repayment date of the Notes which also impacts the number of Subsequent Penny Warrants to be issued to us. The total value of the 2023 Scilex Transaction (and of each of its components) was valued on a weighted average of the different scenarios.Revenues

On ~~September~~November 430, ~~2024~~2015, we entered into a ~~loan~~Technology ~~agreement~~License toAgreement, ~~finance~~with aHTIT and on December 21, 2015, the parties entered into an Amended and Restated Technology License ~~real~~Agreement ~~estate~~that ~~project~~was orfurther amended by the ~~Profit~~parties ~~Sharing~~on ~~Loan~~June 3, 2016 and July 24, 2016 or, the “HTIT License Agreement”. WeOn ~~decided~~February 7, to2025, ~~designate~~we and HTIT entered into the ~~Profit~~JV ~~Sharing~~Agreement, ~~Loan~~amending the Initial JV Agreement. asPursuant ato ~~whole~~the ~~under~~terms of the JV Agreement, we and ~~fair-value~~HTIT ~~option.~~irrevocably ~~The~~agreed ~~valuation~~to the mutual release and waiver of ~~the~~(i) ~~Profit~~any ~~Sharing~~claims ~~Loan~~and demands against each party in connection with the HTIT License Agreement, ~~was~~and ~~based~~(ii) onall ~~various~~rights, ~~project~~obligations ~~profit~~and ~~scenarios~~liabilities ~~derived~~set ~~from~~out and arising with respect to the ~~appraiser’s~~performance of the HTIT License ~~report~~Agreement.

~~ITEM~~We recognized $2,000,000 revenue ~~7A.~~related ~~QUANTITATIVE~~to ~~AND~~the ~~QUALITATIVE~~HTIT ~~DISCLOSURES~~License ~~ABOUT~~Agreement ~~MARKET~~for ~~RISK~~the year ended December 31, 2025, while there were no revenues for the year ended December 31, 2024.

~~We are exposed to a variety of risks, including changes in interest rates, foreign currency exchange rates, changes in the value of our marketable securities and inflation.~~41

AsCost of ~~December 31, 2024, we had approximately $54,420,000 in cash and cash equivalents and approximately $55,281,000 in short term bank deposits.~~Revenues

~~We aim~~On toFebruary ~~preserve~~18, ~~our financial assets~~2025, ~~maintain~~we ~~adequate~~received ~~liquidity~~approval ~~and~~from ~~maximize~~Israel ~~return~~Innovation ~~while~~Authority or, ~~minimizing~~the ~~exposure~~“IIA”, to ~~market~~transfer ~~risks.~~all ~~Such policy~~of ~~further~~our ~~provides~~IIA-funded ~~that~~technology weto ~~should~~OraTech ~~hold~~in ~~most~~accordance ofwith ~~our~~the ~~current~~terms ~~assets~~of inthe ~~bank~~JV ~~deposits~~Agreement. AsThis approval ofwas ~~today,~~granted upon the ~~currency~~condition ofthat ~~our~~we ~~financial~~pay ~~assets is~~the ~~mainly~~aggregate inIIA ~~U.S.~~grant ~~dollars~~amount, plus accrued interest, less all royalties paid to date.

~~Marketable~~On February 27, 2025, we fulfilled ~~securities~~our payment obligation by remitting approximately $2,046,000 to the IIA, and as result we have no further obligations to the IIA. $1,987,000 of the amount is recognized in cost of revenue for the year ended December 31, 2025. The amount of $59,000 was recognized in previous periods. There were no costs of revenue for the year ended December 31, 2024.

~~We own~~Research ~~1,701,357 common shares of DNA, 6,500,000 shares of Scilex Common Stock~~ and ~~117,000 ordinary shares of Entera, which are presented~~Development in our financial statements as marketable securities. Marketable securities are presented at fair value and their realization is subject to certain limitations if sold through the market, and we are therefore exposed to market risk. There is no assurance that at the time of sale of the marketable securities the price per share will be the same or higher, nor that we will be able to sell all of the securities at once given the volume of securities we hold. Entera shares and the Closing Penny Warrants are traded on Nasdaq in U.S. dollars, while DNA shares are traded on the Tel Aviv Stock Exchange in NIS. We are also exposed to changes in the market price of the Scilex, Entera and DNA shares and the Closing Penny Warrants, as well as to exchange rates fluctuations in the NIS currency compared to the U.S. dollar with respect to the DNA shares.Expenses

43Research and development expenses include costs directly attributable to the conduct of research and development programs, including the cost of salaries, employee benefits, costs of materials, supplies, the cost of services provided by outside contractors, including services related to our clinical trials, clinical trial expenses, the full cost of manufacturing drugs for use in research and preclinical development. All costs associated with research and development are expensed as incurred.

~~Interest~~Clinical trial costs are a ~~Rate~~significant ~~Risk~~component of research and development expenses and include costs associated with third-party contractors. We outsource a substantial portion of our clinical trial activities, utilizing external entities such as CROs, independent clinical investigators and other third-party service providers to assist us with the execution of our clinical trials.

~~We invest~~Clinical aactivities ~~major~~which relate ~~portion~~principally ofto ~~our~~clinical ~~cash~~sites ~~surplus~~and inother ~~bank~~administrative ~~deposits~~functions into ~~banks~~manage inour ~~Israel.~~clinical ~~Since~~trials ~~the~~are ~~bank~~performed ~~deposits~~primarily ~~typically~~by ~~carry fixed interest~~CROs. ~~rates,~~CROs ~~financial~~typically ~~income~~perform ~~over~~most of the ~~holding~~start-up ~~period~~activities isfor ~~not~~our ~~sensitive~~trials, toincluding ~~changes~~document inpreparation, ~~interest~~site ~~rates~~identification, ~~but~~screening and ~~only~~preparation, ~~the~~pre-study ~~fair value of these instruments. However~~visits, ~~our~~training ~~interest~~and ~~gains~~program ~~from future deposits may decline in the future as a result of changes in the financial markets~~management.

~~The~~Clinical trial and preclinical ~~Note~~trial ~~issued~~expenses byinclude ~~Scilex~~regulatory isand ~~based~~scientific onconsultants’ ~~the~~compensation ~~SOFR~~and ~~rate.~~fees, ~~Our~~research ~~interest~~expenses, ~~income~~purchase ~~may~~of ~~decline~~materials, incost of manufacturing of the ~~future~~oral insulin and exenatide capsules, payments for patient recruitment and treatment, as awell ~~result~~as ofsalaries aand ~~change~~related expenses inof ~~the~~research ~~SOFR~~and ~~rate~~development staff.

~~Foreign~~Research and development expenses ~~Currency~~for ~~Exchange~~the ~~Risk~~year ended December 31, 2025 decreased by 1% to approximately $6,381,000, compared to approximately $6,324,000 for the year ended December 31, 2024. The decrease was primarily attributable to lower raw materials expenses, which was partially offset by an increase in CRO expenses.

A significant portion of our expenditures, including salaries, clinical research expenses, consultants’ fees and office expenses relate to our operations in Israel. The cost of those Israeli operations, as expressed in U.S. dollars, is influenced by the extent to which any increase in the rate of inflation in Israel is not offset (or is offset on a lagging basis) by a devaluation of the NIS in relation to the U.S. dollar. If the U.S. dollar declines in value in relation to the NIS, it will become more expensive for us to fund our operations in Israel. In addition, as of December 31, 2024, we own net balances in NIS of approximately $2,078,000. Assuming a 10% appreciation of the NIS against the U.S. dollar, we would experience an exchange rate gain of approximately $231,000, while assuming a 10% devaluation of the NIS against the U.S. dollar, we would experience an exchange rate loss of approximately $189,000.42

~~The exchange~~Government ~~rate of the U.S. dollar to the NIS, based on exchange rates published by the Bank of Israel, was as follows:~~Grants

	Year ended December 31,
	2024		2023
Average rate for period		3.70		3.69
Rate at period-end		3.65		3.63

The Government of Israel encourages research and development projects through the IIA, pursuant to the R&D Law. Under the R&D Law, a research and development plan that meets specified criteria is generally eligible for a grant of up to 50% of certain approved research and development expenditures. Each plan must be approved by the IIA.

WeThe R&D Law generally dorequires that a product developed under a program be manufactured in Israel. However, when applying for a grant, the applicant may declare that part of the manufacturing will be performed outside of Israel or by non-Israeli residents and if the IIA is convinced that performing some of the manufacturing abroad is essential for the execution of the program, it may still approve the grant. This declaration will be a significant factor in the determination of the IIA as to whether to approve a program and the amount and other terms of the benefits to be granted. If a company wants to increase the volume of manufacturing outside of Israel after the grant has been approved, it may transfer up to 10% of the company’s approved Israeli manufacturing volume, measured on an aggregate basis, outside of Israel after first notifying the IIA thereof (provided that the IIA does not ~~use~~object to such transfer within 30 days). In addition, upon the approval of the IIA, a portion greater than 10% of the manufacturing volume may be performed outside of Israel. In any ~~currency~~case ~~hedging~~of ~~transactions~~transfer of ~~options~~manufacturing out orof ~~forwards~~Israel, the grant recipient is required to ~~decrease~~pay royalties at an increased rate, which may be substantial, and the ~~risk~~aggregate repayment amount is increased up to 120% or 150% of ~~financial~~the ~~exposure~~grant ~~from~~received ~~fluctuations~~(dollar inlinked) with the addition of interest at an annual rate based on ~~exchange~~the SOFR rate, depending on the portion of the Utotal manufacturing volume that is performed outside of Israel.S The approval we received from the IIA for the License Agreement was subject to payment of increased royalties and an increased ceiling, all in accordance with the provisions of the R&D Law. ~~dollar~~The ~~against~~R&D Law further permits the ~~NIS~~IIA, among other things, to approve the transfer of manufacturing rights outside of Israel in exchange for the import of different manufacturing into Israel as a substitute, in lieu of the increased royalties.

~~ITEM~~The R&D Law also provides 8that know-how developed under an approved research and development program and any derivatives thereof may not be transferred or licensed to third parties in Israel without the approval of the research committee, which approval may be subject to the payment of royalties from the sale. ~~FINANCIAL~~Such ~~STATEMENTS~~approval ~~AND~~is ~~SUPPLEMENTARY~~not ~~DATA~~required for the sale or export of any products resulting from such research or development. The R&D Law further provides that the know-how developed under an approved research and development program and any derivatives thereof may not be transferred or licensed to any third parties outside Israel absent IIA approval which may be granted in certain circumstances as follows: (a) the grant recipient pays to the IIA a portion of the sale or license price paid in consideration for the purchase or license of such IIA-funded know-how or the price paid in consideration for the sale of the grant recipient itself, as the case may be, in accordance with certain formulas included in the tracks published under the R&D Law; (b) the grant recipient receives know-how from a third party in exchange for its IIA-funded know-how; or (c) such transfer of IIA-funded know-how is made in the context of IIA approved research and development cooperation projects or consortia.

~~See~~The R&D Law imposes reporting ~~Item~~requirements 15with respect to certain changes in the ownership of ~~this~~a ~~Annual~~grant ~~Report~~recipient. onThe ~~Form~~R&D 10Law requires the grant recipient to notify the IIA of any change in control of the recipient or a change in the holdings of the means of control of the recipient that results in a non-KIsraeli entity or person becoming an interested party in the recipient, and requires the new non-Israeli interested party to undertake to the IIA to comply with the R&D Law. In addition, the rules of the IIA may require the provision of additional information or representations in respect of certain such events. For this purpose, “control” is defined as the ability to direct the activities of a company other than any ability arising solely from serving as an officer or director of the company. A person is presumed to have control if such person holds 50% or more of the means of control of a company. “Means of control” refers to voting rights or the right to appoint directors or the chief executive officer. An “interested party” of a company includes a holder of 5% or more of its outstanding share capital or voting rights, its chief executive officer and directors, someone who has the right to appoint its chief executive officer or at least one director, and a company with respect to which any of the foregoing interested parties holds 25% or more of the outstanding share capital or voting rights or has the right to appoint 25% or more of the directors.

4443

~~ITEM~~Failure to meet the R&D 9Law’s requirements may subject us to mandatory repayment of grants received by us (together with interest and penalties), as well as expose us to criminal proceedings. ~~CHANGES~~In INaddition, ~~AND~~the ~~DISAGREEMENTS~~Israeli ~~WITH~~government ~~ACCOUNTANTS~~may ONfrom ~~ACCOUNTING~~time ~~AND~~to ~~FINANCIAL~~time ~~DISCLOSURE~~audit sales of products which it claims incorporate technology funded through IIA programs which may lead to additional royalties being payable on additional products.

~~None~~Under the terms of the Company’s funding from the IIA, royalties of 3% are payable on sales of products developed from a project so funded, up to a maximum amount equaling 100%-150% of the grants received (dollar linked) with the addition of interest at an annual rate based on SOFR.

~~ITEM~~All grants were received before the year ended August 31, 2020, and 9Arecorded as a reduction of research and development expenses at that time. ~~CONTROLS~~At ~~AND~~the ~~PROCEDURES~~time the grants were received, successful development of the related projects was not assured. The total amount that was received through December 31, 2025, was approximately $2,213,000 ($2,570,000 including interest).

~~Disclosure Controls~~General and ~~Procedures~~Administrative Expenses

~~Our management,~~General ~~including our Chief Executive Officer~~ and ~~Chief~~administrative expenses ~~Financial~~include ~~Officer, evaluated~~ the ~~effectiveness~~salaries ~~of our disclosure controls~~ and ~~procedures~~related asexpenses of ~~December~~our 31management, ~~2024.~~consulting ~~Based upon that evaluation~~expenses, ~~our~~legal ~~Chief Executive Officer~~ and ~~Chief~~professional ~~Financial~~fees, ~~Officer~~travel ~~concluded~~expenses, ~~that~~business ~~our~~development ~~disclosure~~expenses, ~~controls~~insurance expenses and ~~procedures~~other ~~are~~general ~~effective~~expenses.

~~Management’s~~General and administrative ~~Annual~~expenses ~~Report~~for onthe ~~Internal~~year ~~Control~~ended ~~over~~December ~~Financial~~31, ~~Reporting~~2025 increased by 35% to approximately $8,720,000, compared to approximately $6,457,000 for the year ended December 31, 2024. The increase was mainly due to an increase in stock-based compensation expenses and an increase in professional fees, which were partially offset by a decrease in D&O insurance expenses.

~~Our management,~~Interest under the supervision of our Chief Executive Officer and Chief Financial Officer, is responsible for establishing and maintaining adequate internal control over our financial reporting, as defined in Rules 13a-15(f) and 15d-15(f) promulgated under the Exchange Act. The Company’s internal control over financial reporting is defined as a process designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with GAAP. Internal control over financial reporting includes policies and procedures that:Expenses

●There ~~pertain~~were no interest expenses for the year ended December 31, 2025, compared to approximately $853,000 for the ~~maintenance~~year ofended ~~records~~December ~~that~~31, in2024, ~~reasonable~~since ~~detail~~the ~~accurately~~Short-Term ~~and~~Borrowings (as ~~fairly~~defined ~~reflect~~below) ~~our~~received ~~transactions~~from ~~and~~Discount ~~asset~~Bank ~~dispositions;~~Ltd. were terminated during the second quarter of 2024.

●Financial ~~provide reasonable assurance that transactions are recorded as necessary to permit the preparation of our financial statements in accordance with GAAP~~Income, ~~and that our receipts and expenditures are being made only in accordance with authorizations of our management and directors; and~~Net

●Net ~~provide~~financial ~~reasonable~~income ~~assurance~~was ~~regarding~~approximately $89,454,000 for the ~~prevention~~year orended ~~timely~~December ~~detection~~31, of2025, ~~unauthorized~~compared ~~acquisition~~to approximately $3,139,000 ~~use~~net orfinancial ~~disposition~~expenses offor ~~assets~~the ~~that~~year ~~could~~ended ~~have~~December 31, a2024. ~~material~~The ~~effect~~increase onwas ~~our~~primarily ~~financial~~due ~~statements~~to the revaluation of the investment in Alpha Tau and Scilex.

~~Under the~~Tax supervision and with the participation of our management, including our Chief Executive Officer and Chief Financial Officer, we evaluated the effectiveness of our internal control over financial reporting as of December 31, 2024 based on ~~the current framework for Internal Control-Integrated Framework (2013) set forth by The Committee of Sponsoring Organizations of the Treadway Commission.~~income

~~Based on~~During ~~this~~the ~~evaluation~~year ended December 31, ~~our~~2025, ~~management~~we ~~concluded~~recognized ~~that~~tax ~~the~~expenses on ~~Company’s~~income ~~internal~~of ~~control~~approximately ~~over~~$11,308,000, ~~financial~~compared ~~reporting~~to ~~was~~tax ~~effective~~expenses ason income of approximately $3,183,000 for year ended December 31, 2024. The atincrease ain ~~reasonable~~tax ~~assurance~~expense ~~level~~is primarily attributable to deferred tax expenses of approximately $8,095,000, mainly related to our investment in Alpha Tau, while the current tax expense is primarily attributable to Scilex.

4544

~~Changes in~~Liquidity ~~Internal~~and ~~Control~~Capital ~~over Financial Reporting~~Resources

~~There were~~From noour ~~changes~~inception through December 31, 2025, we have incurred losses in an aggregate amount of approximately $123,436,000. During that period and through December 31, 2025, we have financed our ~~internal~~operations through ~~control~~several ~~over~~private ~~financial~~placements ~~reporting~~of our common stock, as well as public offerings of our common stock, raising a total of approximately $255,384,000, net of transaction costs. During that ~~occurred~~period, ~~during~~we also received cash consideration of approximately $28,001,000 from the exercise ~~quarter~~of ~~ended~~warrants ~~December~~and options. We expect to seek additional financing through similar sources in the future, as needed. As of December 31, ~~2024~~2025, ~~that~~we ~~have~~had ~~materially~~approximately $45,947,000 of available cash and approximately $10,979,000 of short-term bank deposits. In addition, we ~~affected~~hold various of interest in certain investments, orincluding ~~are~~in ~~reasonable~~Scilex, ~~likely~~Alpha toTau, ~~materially~~Hapisga ~~affect~~and others, ~~our~~as ~~internal~~further ~~control~~detailed ~~over~~in ~~financial~~this ~~reporting~~report.

~~ITEM~~From inception through December 31, 2025, we have not generated significant 9Brevenues from our operations (other than recognizing deferred revenue related to the HTIT License Agreement, as described above). ~~OTHER~~Although, we ~~INFORMATION~~have increased the research and development activities related to the new Phase 3 clinical trial, our research and development activities have been significantly reduced while we conducted a strategic review process, following the termination of the ORA-D-013-1 and ORA-D-013-2 Phase 3 trials. Following the preparation and expected initiation of the revised oral insulin clinical trial, we expect to incur increased research and development expenses in future periods, and we will need substantial additional funds. These expenses will be incurred through OraTech, as part of the Lifeward transaction. For additional information regarding see note 21 to our consolidated financial statements included in this Annual Report on Form 10-K.

~~(a)~~However, additional financing ~~Disclosure~~may ~~Pursuant~~not be available on acceptable terms, if at all, including due to ~~Item~~the ~~5.03~~difficult ofconditions ~~Form~~in ~~8-K~~the capital markets. ~~Amendments~~If we are unable to ~~Bylaws~~secure additional financing, we may be required to reduce our operations, divest certain assets, or take other measures that could materially adversely affect our reputation, business, financial condition or results of operations.

OnBased ~~March~~on ~~27, 2025, the Board amended and restated~~ our ~~by-laws,~~current ~~or the~~cash ~~Amended~~resources and ~~Restated By-Laws. The Amended and Restated By-Laws became effective as of March 27~~commitments, ~~2025.~~we ~~The~~believe ~~changes~~we towill ~~the Amended and Restated By-Laws include (i) in a contested election, a director nominee shall~~ be ~~elected~~able byto amaintain ~~plurality~~our ofcurrent ~~the votes~~planned ~~cast~~activities byand the ~~stockholders~~corresponding ~~entitled~~level ~~to vote at the election on such election~~ of ~~directors (an election shall be considered contested if,~~expenditures ~~as of the last date on which nominees~~ for ~~director may be submitted in accordance with the Amended and Restated By-laws, the nominees for election to the Board of Directors exceed the number of positions on the Board to be filled by election~~ at ~~that~~least ~~meeting); and (ii) clarification that~~ the ~~officers~~next of12 ~~the Company shall be a Chief Executive Officer, a President, a Secretary and a Treasurer~~months. This description of the amendments to the Amended and Restated By-Laws is qualified in its entirety by reference to the text of the Amended and Restated By-Laws filed as Exhibit 3.2 to this Annual Report on Form 10-K.

~~(b)~~On August 8, 2023, we borrowed ~~Termination~~an aggregate of ~~Rule~~$99,550,000 ~~10b5–1~~pursuant ~~Trading~~to ~~Arrangements~~loan agreements from Israel Discount Bank Ltd or, the “Short-Term Borrowings”. The Short-Term Borrowings mature on dates ranging from August 11, 2023 to May 24, 2024, bear interest ranging from 6.66% to 7.38%, were secured by certificates of deposits issued by Israel Discount Bank Ltd. having an aggregate face amount of $99,550,000. The net proceeds of the Short-Term Borrowings were used to fund the Tranche A Note. The Short-Term Borrowings were paid in one payment of principal and interest at each respective maturity. As of December 31, 2025, we repaid the entire Short-Term Borrowings amount.

~~Not applicable.~~ 45

~~ITEM~~As of December 31, 2025, our total current assets were approximately 9C$133,271,000 and our total current liabilities were approximately $19,086,000. ~~DISCLOSURE~~On ~~REGARDING~~December ~~FOREIGN~~31, ~~JURISDICTIONS~~2025, ~~THAT~~we ~~PREVENT~~had ~~INSPECTIONS~~a working capital surplus of approximately $114,185,000 and an accumulated loss of approximately $123,436,000. As of December 31, 2024, our total current assets were approximately $143,221,000 and our total current liabilities were approximately $5,685,000. On December 31, 2024, we had a working capital surplus of approximately $137,536,000 and an accumulated loss of approximately $176,616,000. The decrease in working capital surplus was mainly due to dividends payable together with a decrease in cash and cash equivalents and short-term deposits that was partially offset by an increase in investments at fair value and marketable securities.

~~Not~~During the year ended December ~~applicable~~31, 2025, cash and cash equivalents decreased to approximately $45,947,000 from approximately $54,420,000 as of December 31, 2024. The decrease was mainly due to the reasons described below.

46Operating activities used cash of approximately $9,145,000 in the year ended December 31, 2025, compared to approximately $8,412,000 used in the year ended December 31, 2024. Cash used in operating activities primarily consisted of research and development expenses, and general and administrative expenses.

~~PART~~Investing activities provided cash of approximately $5,443,000 in the ~~III~~year ended December 31, 2025, compared to approximately $105,817,000 provided in the year ended December 31, 2024. Cash provided by investing activities in the year ended December 31, 2025 consisted primarily of proceeds from short-term deposits and proceeds from repayments by Scilex, partially offset by purchase of short-term deposits and investments at fair value in Alpha Tau, Hapisga, Lifeward and marketable securities. Cash provided by investing activities in the year ended December 31, 2024, consisted primarily of proceeds from short-term deposits and proceeds from repayments by Scilex under the Tranche A Note.

~~ITEM~~Financing activities used 10cash of approximately $4,741,000 in the year ended December 31, 2025, compared to cash of approximately $52,036,000 used in the year ended December 31, 2024. ~~DIRECTORS~~Cash used for financing activities in the year ended December 31, ~~EXECUTIVE~~2025, ~~OFFICERS~~consisted ~~AND~~primarily ~~CORPORATE~~of ~~GOVERNANCE~~purchase of treasury shares. Cash used in financing activities in the year ended December 31, 2024, consisted primarily of repayments of the Short-Term Borrowings and repurchases of our shares.

~~Directors~~Our primary financing activities ~~and~~for ~~Executive~~the ~~Officers~~year ended December 31, 2025, were as follows:

~~The name~~● In June 2024, our Board authorized a stock buyback and ~~age~~retirement ofprogram ~~each~~pursuant to which we may, from time to time, repurchase up to $20,000,000 in maximum value of our ~~directors~~common ~~and~~stock. ~~executive~~Share ~~officers~~repurchases may be executed through various means, ~~his~~including, without limitation, open market transactions, privately negotiated transactions or ~~her~~otherwise ~~position~~in compliance with Rule 10b-18 under the Exchange Act or, the “Buy-Back Program”. The Buy-Back Program does not obligate us to purchase any shares and ~~the~~expires ~~period~~in ~~during~~12 ~~which~~months. ~~such~~The ~~person~~authorization ~~has served~~for asthe aBuy-Back ~~director~~Program may be terminated, increased or ~~executive~~decreased ~~officer~~by our Board in its discretion at any time. On May 21, 2025, our board of directors authorized a one-year extension of the ~~Company~~Buy-Back ~~are~~Program, which was set ~~forth~~to ~~below~~expire in June 2026.

Name	Age	Position	Serving Since
Nadav Kidron	50	President, Chief Executive Officer, Director and Chairman (effective as of June 30, 2022)	2006
Dr. Miriam Kidron	84	Chief Scientific Officer and Director	2006
Avraham Gabay	40	Chief Financial Officer and Treasurer	2024
Joshua Hexter	54	Chief Operating & Business Officer	2019
Daniel Aghion	43	Director	2024
Dr. Arie Mayer	68	Director	2019
Yehuda Reznick	77	Director	2024
Leonard Sank	59	Director	2007
Benjamin Shapiro	41	Director	2023

●

During 2025 and 2024, we have repurchased and retired shares of our common stock under the Buy-Back Program. In 2025, we repurchased 899,609 shares for $2,155, including $6 of excise tax, at an average price of $2.39 per share and in 2024, we repurchased 1,036,976 shares for $2,494, including $10 of excise tax, at an average price of $2.4 per share. All repurchases were funded with cash on hand.

~~Mr. Derovan,~~● ~~our~~On ~~former~~October ~~Chief~~20, ~~Legal~~2025, ~~Officer~~we ~~and~~entered ~~Secretary,~~a ~~ended~~separate ~~his~~share ~~service~~repurchase agreement with ~~the~~HTIT ~~Company~~pursuant onto ~~March~~which 5HTIT sold back to us 1,155,367 ~~2024~~shares of common stock at a purchase price of $2. ~~Mr.~~23 ~~Silberman,~~per ~~our~~share ~~former Chief~~for ~~Financial~~an ~~Officer,~~aggregate ~~Treasurer~~price ~~and~~of ~~Secretary~~$2,584,000, ~~ended~~including ~~his~~$8 ~~service~~of ~~with~~excise tax. Following such repurchase, the ~~Company~~shares onwere ~~July~~cancelled ~~11,~~and ~~2024~~retired.

~~Dr. Miriam Kidron is Mr. Nadav Kidron’s mother. There are no other directors or officers of the Company who are related by blood or marriage.~~46

~~Business Experience~~Trend Information

~~The following~~Concurrently, iswe aare ~~brief~~examining our ~~account~~existing ofpipeline ~~the education~~ and ~~business~~have ~~experience~~commenced ~~during~~an atevaluation ~~least~~process ~~the~~of ~~past~~potential ~~five~~strategic ~~years~~opportunities, ofwith ~~each~~the goal of ~~our~~enhancing ~~directors and~~value offor our ~~executive~~stockholders. ~~officers~~At ~~who~~this ~~are not also directors~~time, ~~indicating~~we ~~the~~cannot ~~principal~~foresee ~~occupation~~how ~~during~~these ~~that~~strategic ~~period,~~decisions ~~and~~will ~~the~~impact ~~name~~our ~~and~~financial ~~principal business~~results ~~of the organization in which such occupation~~ and ~~employment were carried out~~operations.

~~Mr. Nadav~~Planned Kidron was appointed President, Chief Executive Officer and director in March 2006, and Chairman of the Board effective as of June 30, 2022. He is also Chairman of the board of MDG Real Estate Global, Ltd., director of Israel Advanced Technology Industries organization and until 2016 was a director of Entera Bio Ltd. In 2009, he was a fellow at the Merage Foundation for U.S.-Israel Trade Programs for executives in the life sciences field. From 2003 to 2006, he was the managing director of the Institute of Advanced Jewish Studies at Bar Ilan University. From 2001 to 2003, he was a legal intern at Wine, Mishaiker & Ernstoff Law Offices in Jerusalem, Israel. Mr. Kidron holds an LL.B. and an International MBA from Bar Ilan University, Israel.Expenditures

~~We believe~~In ~~that~~previous Mryears, we primarily invested in research and development. If ~~Kidron’s~~we ~~qualifications~~proceed to ~~serve~~conduct ona new clinical trial for our ~~Board~~oral ~~include~~insulin ~~his~~candidate, ~~familiarity~~we ~~with~~expect that in the ~~Company~~upcoming asyears ~~its~~our ~~founder,~~research ~~his~~and ~~experience~~development inexpenses ~~capital~~will ~~markets~~continue to be our major operating expense; however, asif ~~well~~this asclinical ~~his~~trial ~~knowledge~~is conducted through OraTech, these costs will be borne by OraTech and ~~familiarity~~not by us. In addition, consistent with our broader corporate ~~management~~strategy, we may allocate capital to selected strategic initiatives and collaborations intended to support long-term growth and diversification of our business.

~~Dr. Miriam~~Critical ~~Kidron~~Accounting was appointed Chief Scientific Officer and director in March 2006. Dr. Kidron is a pharmacologist and a biochemist with a Ph.D. in biochemistry. From 1990 to 2007, Dr. Kidron was a senior researcher in the Diabetes Unit at Hadassah University Hospital in Jerusalem, Israel. Dr. Kidron was formerly a visiting professor at the Medical School at the University of Toronto (Canada), and is a member of the American, European and Israeli Diabetes Associations. Dr. Kidron is a recipient of the Bern Schlanger Award.Estimates

WeOur significant accounting ~~believe~~policies ~~that~~are ~~Dr.~~more ~~Kidron’s~~fully ~~qualifications~~described toin ~~serve~~the onnotes to our ~~Board~~accompanying ~~include~~consolidated ~~her~~financial ~~expertise~~statements. inWe ~~the~~believe ~~Company’s~~that ~~technology,~~the asaccounting itpolicy below is ~~based~~ oncritical ~~her~~for ~~research,~~one asto ~~well~~fully asunderstand ~~her experience~~ and ~~relevant~~evaluate ~~education~~our infinancial ~~the~~condition ~~fields~~and results of ~~pharmacology and diabetes~~operations.

47The discussion and analysis of our financial condition and results of operations is based on our consolidated financial statements, which we prepared in accordance with U.S. generally accepted accounting principles, or GAAP. The preparation of our consolidated financial statements requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the consolidated financial statements, as well as the reported revenues and expenses during the reporting periods. On an ongoing basis, we evaluate such estimates and judgments. We base our estimates on historical experience and on various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions.

~~Mr. Avraham~~Investments ~~Gabay was~~at ~~appointed Chief Financial Officer, Treasurer and Secretary in June 2024. Prior to his~~fair ~~appointment, Mr. Gabay served as interim chief financial officer of BiomX Inc. (NYSE American~~value: ~~PHGE)~~On ~~during~~September ~~2023.~~21, ~~From 2021 until~~ 2023~~, Mr.~~ ~~Gabay~~and ~~served~~on asOctober ~~the chief financial officer at Oravax Inc.~~7, a2024 ~~63%~~we ~~owned~~entered ~~subsidiary~~into of the ~~Company.~~2023 ~~From~~Scilex ~~2019~~Transaction ~~until~~and ~~2021~~2024 Refinancing, Mrrespectively. ~~Gabay~~ ~~was~~We ~~the~~elected ~~chief financial officer of~~ the ~~Company.~~fair ~~From~~value ~~2015~~option tofor ~~2019,~~each ~~Mr.~~of ~~Gabay served as VP Finance at Orcam Technologies Ltd. From 2014 to 2015, Mr. Gabay provided economic services in~~ the ~~advisory~~components ~~department~~under of2023 ~~KPMG~~Scilex ~~Israel,~~Transaction ~~a certified public accounting firm,~~ and ~~from 2013~~2024 toRefinancing ~~2014, he worked~~ in ~~the~~order ~~tax~~to ~~department~~reduce ~~of the law firm Gornitzky & Co. In addition, Mr. Gabay serves as a director on the~~operational ~~board~~complexity of ~~Iintoo~~bifurcating ~~Ltd.~~embedded ~~(TASE: INTO)~~derivatives. ~~Mr.~~Changes ~~Gabay holds a bachelor’s degree~~ in ~~law~~value ~~and~~are ~~accounting~~recorded ~~(magna~~under ~~cum-laude)~~financial ~~from~~income, ~~Tel-Aviv~~net ~~University~~ and isinclude ainterest ~~certified~~income on ~~public~~the ~~accountant~~Notes ~~in Israel~~ and aRoyalties ~~member of the Israeli Bar Association~~received.

~~Mr. Joshua~~Determining ~~Hexter was~~the ~~appointed Chief~~fair ~~Operating~~value ~~and~~of ~~Business~~the ~~Officer~~components inabove ~~September~~required ~~2019. Prior to his appointment,~~significant ~~Mr.~~judgment ~~Hexter~~with ~~served~~regards ~~as Chief Business Officer at BrainsWay Ltd. (Nasdaq/TASE: BWAY) from 2018~~ to ~~2019, a commercial stage medical device company focused on~~ the ~~development~~expected ~~and~~repayment ~~sale~~date of ~~non-invasive~~the ~~neuromodulation products~~Notes. ~~From~~The ~~2013~~total tovalue ~~2018, Mr. Hexter served as Chief Operating Officer and VP Business Development~~ of the ~~Company~~2023 ~~and~~Scilex ~~from~~Transaction ~~2007 to 2013, Mr. Hexter was a Director or Executive Director of BioLineRx Ltd.~~ (~~Nasdaq/TASE: BLRX), a biopharmaceutical development company dedicated to identifying, in-licensing~~ and ~~developing innovative therapeutic candidates. Prior to his employment with BioLineRx, Mr. Hexter was a member~~ of ~~the~~each ~~board~~ of ~~directors and Chief Executive Officer of~~its ~~Biosensor~~components) ~~Systems~~was ~~Design,~~valued ~~Inc.,~~on a ~~company~~weighted ~~developing~~average ~~market-driven~~of ~~biosensors. Mr. Hexter holds a bachelor’s degree from~~ the ~~University of~~different ~~Wisconsin and a master’s degree in management from Boston University~~scenarios.

Dr. Daniel Aghion became a director in January 2024. Dr. Aghion has been a neurosurgeon at Memorial Neuroscience Institute in Florida since 2016, where he treats patients with a wide array of spine disorders, including severe degenerative spine diseases, spine trauma, cancer in the spine, spine tumors, peripheral nerve surgery and more. Dr. Aghion holds a Bachelor of Science degree from the University of Michigan and an MD from the Sackler School of Medicine at Tel Aviv University. He completed his residency at Rhode Island Hospital in 2015, and a complex spine fellowship at Johns Hopkins University in Baltimore in 2016.47

WeOn September 4, 2024, we ~~believe~~entered ~~that~~into Dra loan agreement to finance a real estate project or the Profit Sharing Loan Agreement. ~~Aghion’s~~We ~~qualifications~~decided to ~~serve~~designate onthe Profit Sharing Loan Agreement as a whole under the ~~Board~~fair-value ~~include~~option. ~~his~~The ~~extensive~~valuation ~~practical~~of ~~and~~the ~~academic~~Profit ~~medical~~Sharing ~~background~~Loan Agreement was based on various project profit scenarios derived from the appraiser’s report.

~~Dr. Arie~~On ~~Mayer~~March ~~became~~24, a2025, ~~director~~we inentered into ~~December~~a ~~2019.~~loan ~~Dr.~~agreement ~~Mayer~~to isfinance ~~currently~~a ~~the~~real ~~Managing~~estate ~~Director~~project, ~~and Chairman of the Board of Sigma-Aldrich Israel Ltd~~Hapisga. ~~and~~We ~~has~~decided ~~held~~to ~~that~~designate ~~position~~the ~~since~~loan ~~January~~agreement ~~2010.~~as ~~Dr.~~a ~~Mayer~~whole ~~has~~under ~~held~~the ~~various roles with Sigma~~fair-~~Aldrich~~value ~~Israel Ltd~~option. ~~since~~The ~~1995~~valuation ~~and~~of ~~was instrumental in introducing and developing~~ the ~~Cell~~loan ~~Culture~~agreement ~~and~~was ~~Molecular~~calculated ~~Biology~~in ~~business~~accordance ~~for~~with ~~Sigma~~the ~~Aldrich Israel~~weighted ~~Ltd.~~average ~~Dr.~~expected ~~Mayer~~cashflows ~~holds a Bachelor~~ of ~~Science~~the ~~degree in chemistry from Hebrew University and a Ph~~loan.~~D. in biochemistry from Israel Institute of Technology.~~

WeOn April 24, 2025, we entered ~~believe~~into ~~that~~a ~~Dr.~~share ~~Mayer’s~~purchase ~~qualifications~~agreement and a services agreement with Alpha Tau (“Alpha Tau SPA”, “Services Agreement”). We decided to ~~serve~~designate onthe ~~our~~Alpha ~~Board~~Tau ~~include~~SPA ~~his~~and ~~experience~~the Services Agreement as ana ~~executive~~whole inunder the ~~biotechnology~~fair-value ~~industry,~~option. The valuation of the Alpha ~~with~~Tau ~~knowledge~~SPA inwas ~~managing~~determined ~~large~~using ~~organizations,~~the asclosing ~~well~~price asof ~~his~~Alpha ~~experience~~Tau’s ordinary shares, and ~~relevant~~the ~~education~~fair invalue of the ~~fields~~warrants ofissued ~~chemistry~~under ~~and~~the Services ~~biochemistry~~Agreement are calculated based on Black-Scholes model.

~~Mr. Yehuda~~On ~~Reznick~~November ~~became a director in April 2024. Mr. Reznick served as an audit partner at Kesselman & Kesselman CPA~~14, ~~a member of PricewaterhouseCoopers International Limited~~2025, ~~from~~we ~~1999~~entered ~~until~~into ~~2014.~~a ~~Prior to joining Kesselman & Kesselman, he was~~secured anote ~~tax~~with ~~and audit partner at Shachak~~Lifeward, ~~Peer~~pursuant ~~Reznick~~to ~~CPA~~which ~~for~~Lifeward ~~sixteen~~borrowed ~~years. Mr. Reznick currently serves on the board of directors of Oravax Medical Inc.~~$3, ~~an affiliate of the Company. Since 2019~~000, Mr000. ~~Reznick~~The ~~has~~valuation ~~also served on the board~~ of ~~directors of Hiron-Trade Investments & Industrial Buildings Ltd (TASE: HRON). Mr. Reznick previously served on~~ the ~~board~~note ofwas ~~directors~~determined ofusing ~~Bonus~~a ~~Biogroup~~binomial ~~Ltd (OTC: BBIXF) from 2017 to 2023~~model.

48ITEM 7A. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK.

~~We believe~~As ~~that~~a ~~Mr.~~“smaller ~~Reznick’s~~reporting ~~qualifications~~company” toas ~~serve~~defined onby Rule 12b-2 of the ~~Board~~Securities ~~include~~Exchange ~~his~~Act ~~extensive~~of ~~operational~~1934 ~~experience~~we ~~and~~are ~~his~~not ~~business~~required ~~background and~~to ~~acumen~~provide information required by this item.

~~Mr. Leonard~~ITEM ~~Sank became a director in October 2007~~8. ~~Mr.~~FINANCIAL ~~Sank~~STATEMENTS isAND aSUPPLEMENTARY South African entrepreneur and businessman, whose interests lie in entrepreneurial endeavors and initiatives, with over 30 years’ experience of playing significant leadership roles in developing businessesDATA. ~~Mr. Sank serves on the boards of a few national businesses and local non-profit charity organizations in Cape Town, where he resides.~~

~~We believe~~See ~~that~~Item ~~Mr.~~15 ~~Sank’s qualifications to serve on our Board include his years~~ of ~~experience~~this ~~in development stage businesses, as~~Annual ~~well~~Report ason ~~his~~Form ~~experience serving as a director of many entities~~10-K.

~~Mr. Benjamin~~ITEM ~~Shapiro became a director in May 2023~~9. ~~Mr.~~CHANGES ~~Shapiro~~IN isAND aDISAGREEMENTS ~~successful~~WITH ~~entrepreneur~~ACCOUNTANTS ~~and~~ON ~~business~~ACCOUNTING ~~professional who~~AND ~~co-founded~~FINANCIAL ~~The Daily Wire, a successful, industry leading, international media outlet in June 2015~~DISCLOSURE. Since May 2015, he has been host of “The Ben Shapiro Show,” a popular podcast, and he is the author of numerous New York Times best-selling books. Mr. Shapiro earned a B.A. in Political Science from UCLA in 2004, summa cum laude, and a law degree from Harvard Law School in 2007, cum laude.

~~We believe that Mr~~None. ~~Shapiro’s qualifications to serve on the Board include his extensive operational experience and his business background and acumen.~~

~~Board of~~ITEM ~~Directors~~9A. CONTROLS AND PROCEDURES.

~~There are~~Disclosure noControls ~~agreements with respect to the election of directors. Each director is currently elected for a period of one year at our annual meeting of stockholders~~ and serves until the next such meeting and until his or her successor is duly elected or until his or her earlier resignation or removal. The Board may also appoint additional directors. A director so chosen or appointed will hold office until the next annual meeting of stockholders and until his or her successor is duly elected and qualified or until his or her earlier resignation or removal.Procedures

~~The Board~~Our ~~has determined that Dr. Daniel Aghion~~management, ~~Dr.~~including our ~~Arie~~Chief ~~Mayer,~~Executive ~~Yehuda~~Officer ~~Reznick, Leonard Sank~~ and ~~Benjamin~~Chief ~~Shapiro~~Financial ~~are~~Officer, ~~independent~~evaluated ~~as defined under~~ the ~~rules~~effectiveness ~~promulgated~~of byour ~~the~~disclosure ~~Nasdaq.~~controls ~~Except for Dr. Arie Mayer~~ and ~~Mr.~~procedures ~~Reznick,~~as ~~each~~ of ~~whom serves on the board of directors of~~December ~~Oravax~~31, a2025. ~~company~~Based ~~63%~~upon ~~owned~~that ~~by us~~evaluation, ~~none~~our ofChief ~~the~~Executive ~~independent~~Officer ~~directors~~and ~~has~~Chief ~~any~~Financial ~~material~~Officer ~~relationship~~concluded ~~with~~that usour ~~besides~~disclosure ~~serving~~controls onand procedures ~~our~~are ~~Board~~effective.

We have determined that each of the directors is qualified to serve as a director of the Company based on a review of the experience, qualifications, attributes and skills of each director. In reaching this determination, we have considered a variety of criteria, including, among other things: character and integrity; ability to review critically, evaluate, question and discuss information provided, to exercise effective business judgment and to interact effectively with the other directors; and willingness and ability to commit the time necessary to perform the duties of a director.48

~~Board~~Management’s Annual Report on Internal ~~Meeting~~Control ~~Attendance~~over Financial Reporting

~~During~~Our ~~the~~management, ~~year~~under ~~ended~~the supervision ~~December~~of ~~31, 2024,~~ our ~~Board~~Chief ~~held~~Executive ~~six~~Officer ~~meetings~~ and ~~took~~Chief ~~action~~Financial byOfficer, ~~written~~is ~~consent~~responsible onfor ~~nine~~establishing ~~occasions.~~and ~~Except~~maintaining ~~Mr.~~adequate ~~Benjamin~~internal control ~~Shapiro~~over our financial reporting, ~~all~~as ofdefined ~~our~~in ~~directors~~Rules ~~attended~~13a-15(f) atand ~~least~~15d-15(f) ~~75%~~promulgated ofunder the ~~aggregate~~Exchange Act. The Company’s ~~number~~internal ofcontrol ~~meetings~~over offinancial ~~the~~reporting ~~Board~~is ~~and~~defined ~~the~~as ~~committees~~a ~~that~~process ~~were~~designed ~~held~~to ~~during~~provide ~~the~~reasonable ~~period~~assurance ~~such~~regarding ~~director~~the ~~served~~reliability onof financial reporting and the ~~Board.~~preparation ~~Board~~of ~~members~~financial ~~are encouraged~~statements tofor ~~attend~~external ~~our~~purposes ~~annual~~in ~~meetings~~accordance ofwith ~~stockholders~~GAAP. Internal control over financial reporting includes policies and procedures that:

~~Board Evaluation~~● ~~Process~~pertain to the maintenance of records that in reasonable detail accurately and fairly reflect our transactions and asset dispositions;

~~Our Board~~● isprovide ~~committed~~reasonable assurance that transactions are recorded as necessary to ~~continuous~~permit ~~improvement~~the preparation of our financial statements in accordance with GAAP, and ~~conducts~~that aour ~~board~~receipts and ~~committee~~expenditures ~~evaluation~~are ~~process~~being ~~each~~made ~~year,~~only toin ~~ensure~~accordance ~~that~~with ~~our~~authorizations ~~Board maintains~~of ~~optimal~~our ~~composition~~management and ~~functions~~directors; ~~effectively.~~and

~~As part~~● ofprovide ~~this~~reasonable ~~process,~~assurance regarding the ~~members~~prevention ofor ~~our~~timely ~~Board~~detection ~~complete a confidential written assessment~~ of ~~the~~unauthorized ~~performance~~acquisition, ~~oversight~~use ~~and~~or ~~composition~~ disposition of ~~the~~assets ~~Board and its committees~~ that iscould ~~submitted~~have toa ~~the~~material ~~Company~~effect ~~secretary.~~on ~~The~~our ~~results~~financial ~~are then reported back to the full Board~~statements. ~~After the evaluations, the Board and management work to improve upon any issues presented during the evaluation process and to identify opportunities that may lead to further improvement.~~

49Under the supervision and with the participation of our management, including our Chief Executive Officer and Chief Financial Officer, we evaluated the effectiveness of our internal control over financial reporting as of December 31, 2025 based on the current framework for Internal Control-Integrated Framework (2013) set forth by The Committee of Sponsoring Organizations of the Treadway Commission.

~~Committees~~Based on this evaluation, our management concluded that the Company’s internal control over financial reporting was effective as of December 31, 2025 at a reasonable assurance level.

~~Audit Committee~~Changes ~~and~~in ~~Audit~~Internal ~~Committee~~Control ~~Financial~~over ~~Expert~~Financial Reporting

~~The members~~There ofwere ~~our~~no ~~Audit~~changes ~~Committee~~in ~~are~~our ~~Dr.~~internal ~~Daniel~~control ~~Aghion,~~over ~~Dr.~~financial ~~Arie Mayer and Yehuda Reznick. Our Board has determined~~ reporting that ~~Mr.~~occurred ~~Reznick~~during ~~is an~~the ~~“audit~~quarter ~~committee~~ended ~~financial~~December ~~expert” as set forth in Item 407(d)(5) of Regulation S-K based on his experience as set forth above~~31, ~~and~~2025 that ~~all~~have ~~members~~materially ofaffected, ~~the~~or ~~Audit Committee~~ are ~~“independent”~~reasonably aslikely ~~defined~~to bymaterially ~~the rules of the SEC and the Nasdaq rules~~affect, ~~and regulations. The Audit Committee operates under a written charter that is posted on the “Investors” section of~~ our ~~website, www.oramed.com.~~internal ~~The~~control ~~primary~~over ~~responsibilities~~financial ~~of our Audit Committee include:~~reporting.

●ITEM ~~Overseeing~~9B. ~~the~~OTHER ~~accounting and financial reporting processes of the Company and the audits of the financial statements of the Company;~~INFORMATION.

●10b5-1 Trading ~~Appointing, compensating and retaining our registered independent public accounting firm;~~Arrangements

●During the ~~Overseeing~~fourth fiscal quarter ended December 31, 2025, none of the ~~work~~Company’s ~~performed~~directors byor ~~any~~officers ~~outside~~(as ~~accounting~~defined ~~firm;~~in Rule 16a-1(f) of the Exchange Act) adopted or terminated a “Rule 10b5-1 trading arrangement” or a “non-Rule 10b5-1 trading arrangement” (as each term is defined in Item 408(a) of Regulation S-K).

●ITEM ~~Assisting~~9C. ~~the~~DISCLOSURE ~~Board~~REGARDING inFOREIGN ~~fulfilling~~JURISDICTIONS ~~its~~THAT ~~responsibilities~~PREVENT ~~by reviewing: (i) the financial reports provided by us to the SEC, our stockholders or to the general public and (ii) our internal financial and accounting controls;~~INSPECTIONS.

●Not ~~Reviewing the Company’s policies with respect to cyber security risks and relevant contingent liabilities and risks that may be material to the Company;~~applicable.

~~● Recommending, establishing and monitoring procedures designed to improve the quality and reliability of the disclosure of our financial condition and results of operations; and~~49

●PART Reviewing major financial risk exposures and the steps management has taken to monitor and control such exposures, and discussing the guidelines and polices to govern the process by which risk assessment and management is undertaken.III

~~Our Audit~~ITEM ~~Committee~~10. ~~met~~DIRECTORS, ~~four~~EXECUTIVE ~~times~~OFFICERS ~~and~~AND ~~took~~CORPORATE ~~action by written consent on four occasions during the year ended December 31, 2024~~GOVERNANCE.

~~Compensation Committee~~Directors and Executive Officers

The ~~members~~ ofname ~~our Compensation Committee are Dr. Daniel Aghion, Yehuda Reznick~~ and ~~Leonard~~age ~~Sank.~~of ~~The~~each ~~Board has determined that all~~ of ~~the~~ ~~members~~our ofdirectors ~~the~~and ~~Compensation~~executive ~~Committee~~officers, ~~are~~his ~~“independent”~~or asher ~~defined~~position bywith ~~the~~us ~~rules~~and of the ~~SEC~~period ~~and~~during ~~Nasdaq~~which ~~rules~~such ~~and~~person ~~regulations. The~~has ~~Compensation~~served ~~Committee~~as ~~operates under~~ a ~~written~~director ~~charter~~or executive ~~that~~officer isof ~~posted on~~ the ~~“Investors”~~Company ~~section~~are ofset ~~our~~forth ~~website, www~~below.~~oramed.com. The primary responsibilities of our Compensation Committee include:~~

● Reviewing, negotiating and approving, or recommending for approval by our Board the salaries and incentive compensation of our executive officers;

Name	Age	Position	Serving Since
Nadav Kidron	51	President, Chief Executive Officer, Director and Chairman	2006
Dr. Miriam Kidron	85	Chief Scientific Officer and Director	2006
Avraham Gabay	41	Chief Financial Officer and Treasurer	2024
Joshua Hexter	55	Chief Operating & Business Officer	2019
Dr. Daniel Aghion	44	Director	2024
Dr. Arie Mayer	69	Director	2019
Yehuda Reznick	78	Director	2024
Benjamin Shapiro	42	Director	2023

●Mr. ~~Administering~~Nadav ~~our~~Kidron was appointed President, ~~equity~~Chief ~~based~~Executive ~~plans~~Officer and ~~making~~director in ~~recommendations~~March to2006, ~~our~~and Chairman of the Board effective ~~with~~as ~~respect~~of toJune ~~our~~30, ~~incentive-compensation~~2022. ~~plans~~He is also Chairman of the board of MDG Real Estate Global, Ltd., director of Alpha Tau Medical Ltd., director of Israel Advanced Technology Industries organization and ~~equity~~until 2016 was a director of Entera Bio Ltd. In 2009, he was a fellow at the Merage Foundation for U.S.-~~based~~Israel ~~plans;~~Trade Programs for executives in the life sciences field. From 2003 to 2006, he was the managing director of the Institute of Advanced Jewish Studies at Bar Ilan University. From 2001 to 2003, he was a legal intern at Wine, Mishaiker & Ernstoff Law Offices in Jerusalem, Israel. Mr. Kidron holds an LL.B. and an International MBA from Bar Ilan University, Israel.

●We ~~Making~~believe ~~recommendations~~that Mr. Kidron’s qualifications to serve on our Board include his familiarity with ~~respect~~the toCompany ~~director~~as ~~compensation;~~its founder, his experience in capital markets, as well as his knowledge and familiarity with corporate management.

●Dr. ~~Authority~~Miriam Kidron was appointed Chief Scientific Officer and director in March 2006. Dr. Kidron is a pharmacologist and a biochemist with a Ph.D. in biochemistry. From 1990 to ~~exercise~~2007, ~~all~~Dr. ~~rights~~Kidron was a senior researcher in the Diabetes Unit at Hadassah University Hospital in Jerusalem, ~~authority~~Israel. Dr. Kidron was formerly a visiting professor at the Medical School at the University of Toronto (Canada), and ~~functions~~is a member of the ~~Board~~American, ~~under~~European ~~our~~and ~~Clawback~~Israeli ~~Policy~~Diabetes Associations. Dr. Kidron is a recipient of the Bern Schlanger Award.

~~The Compensation~~We ~~Committee~~believe ~~meets~~that asDr. ~~often~~Kidron’s qualifications asto itserve ~~deems~~on ~~necessary,~~our ~~without~~Board ~~the~~include ~~presence~~her ofexpertise ~~any~~in ~~executive officer when approving compensation, except that~~ the Company’s ~~Chief Executive Officer~~technology, atas ~~the~~it ~~discretion~~is ofbased ~~the~~on ~~Compensation~~her ~~Committee~~research, ~~may~~as ~~be present during the approval~~well ~~of,~~as orher ~~deliberations~~experience ~~with~~and ~~respect~~relevant ~~to,~~education in the ~~compensation~~fields of ~~other~~pharmacology ~~executive~~and ~~officers~~diabetes. ~~The Compensation Committee may delegate any authority granted to it to one or more subcommittees of the Compensation Committee, in its sole discretion.~~

~~Our Compensation~~Mr. ~~Committee~~Avraham ~~met~~Gabay was appointed Chief ~~two~~Financial ~~times~~Officer, Treasurer and ~~took~~Secretary ~~action~~in byJune ~~written~~2024. ~~consent~~Prior onto ~~four~~his ~~occasions~~appointment, Mr. Gabay served as interim chief financial officer of BiomX Inc. (NYSE American: PHGE) during 2023. From 2021 until 2023, Mr. Gabay served as the ~~year~~chief financial ~~ended~~officer ~~December~~at 31Oravax Inc., ~~2024~~a 63% owned subsidiary of the Company. From 2019 until 2021, Mr. Gabay was the chief financial officer of the Company. From 2015 to 2019, Mr. Gabay served as VP Finance at Orcam Technologies Ltd. From 2014 to 2015, Mr. Gabay provided economic services in the advisory department of KPMG Israel, a certified public accounting firm, and from 2013 to 2014, he worked in the tax department of the law firm Gornitzky & Co. In addition, Mr. Gabay serves as a director on the board of Sade Real Estate YS Ltd. (TASE: SADE). Mr. Gabay holds a bachelor’s degree in law and accounting (magna cum-laude) from Tel-Aviv University, an MBA in healthcare innovation from Reichman University and is a certified public accountant in Israel and a member of the Israeli Bar Association.

~~Nominating~~Mr. Joshua ~~Committee~~Hexter was appointed Chief Operating and Business Officer in September 2019. Mr. Hexter has been affiliated with Oramed since 2013, initially serving as Chief Operating Officer and VP Business Development from 2013 to 2018, and returning to the Company in his current role in 2019. In the intervening period, Mr. Hexter served as Chief Business Officer at BrainsWay Ltd. (Nasdaq/TASE: BWAY) from 2018 to 2019, a commercial stage medical device company focused on the development and sale of non-invasive neuromodulation products. Prior to that, Mr. Hexter was Executive Director at BioLineRx Ltd. (Nasdaq/TASE: BLRX) from 2007 to 2013, a biopharmaceutical development company dedicated to identifying, in-licensing and developing innovative therapeutic candidates. Prior to his employment with BioLineRx, Mr. Hexter was Chief Executive Officer of Biosensor Systems Design, Inc., a company developing market-driven biosensors. Mr. Hexter holds a bachelor’s degree from the University of Wisconsin and a master’s degree in management.

~~The~~Dr. Daniel Aghion ~~members~~became ofa ~~our~~director ~~Nominating~~in ~~Committee~~January ~~are~~2024. Dr. ~~Arie~~Aghion ~~Mayer~~has ~~and~~been ~~Leonard~~a ~~Sank.~~neurosurgeon ~~The~~at ~~Board~~Memorial ~~has~~Neuroscience ~~determined~~Institute ~~that~~in ~~all~~Florida ofsince 2016, ~~the~~where ~~members~~he treats patients with a wide array of ~~the~~spine ~~Nominating Committee~~disorders, ~~are~~including ~~“independent”~~severe asdegenerative ~~defined~~spine bydiseases, ~~the~~spine ~~rules~~trauma, ofcancer in the ~~SEC~~spine, ~~and~~spine ~~Nasdaq~~tumors, ~~rules~~peripheral nerve surgery and ~~regulations~~more. ~~The~~Dr. ~~Nominating~~Aghion ~~Committee operates~~holds ~~under~~ a ~~written~~Bachelor ~~charter~~of ~~that~~Science isdegree ~~posted~~from onthe University of Michigan and an MD from the ~~“Investors”~~Sackler ~~section~~School of ~~our~~Medicine ~~website,~~at ~~www~~Tel Aviv University.~~oramed.com.~~ ~~The~~He ~~primary~~completed ~~responsibilities~~his residency at Rhode Island Hospital in 2015, and ofa ~~our~~complex ~~Nominating~~spine ~~Committee~~fellowship ~~include:~~at Johns Hopkins University in Baltimore in 2016.

●We ~~Overseeing~~believe ~~the~~that ~~composition~~Dr. ~~and~~Aghion’s qualifications ~~size~~to

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