ORAMED PHARMACEUTICALS INC.

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 gastrointestinal tract and effectively deliver active insulin or other proteins. The formulation is not intended to modify the proteins chemically or biologically, and the dosage form is designed to be safe to ingest.

We intend to initiate, in the second half of 2026, a 60-patient, US-based clinical trial designed to validate the robustness of our oral insulin formulation in defined patient population. The trial is designed to use the smallest adequately powered patient population expected to obtain such validation in what we believe to be the shortest time possible, providing a cost-effective approach to generate additional compelling evidence and refine our patient selection criteria for future potential regulatory submissions.

The trial will be conducted by OraTech. For additional information, see note 21 to our consolidated financial statements included in this Annual Report on Form 10-K.

As part of our business strategy, we continuously review our existing pipeline and evaluate potential strategic opportunities to enhance stockholder value. Accordingly, in addition to our core pharmaceutical activities, we have made strategic investments in healthcare and life sciences companies and entered into other investment, financing, and real estate transactions, as further described below.

HTIT JV Agreement

On January 22, 2024, we along with our wholly-owned subsidiary Oramed Ltd., entered into a joint venture agreement, or the Initial JV Agreement, with Hefei Tianhui Biotech Co., Ltd. or HTIT, and its subsidiary Technowl Limited or HTIT Sub., to establish OraTech, or the “JV”. OraTech will focus on developing and commercializing products based on our oral insulin and POD™ technology, utilizing HTIT’s manufacturing capabilities.

On 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.

Transactions with Scilex

On April 14, 2025, Scilex Holding Company (“Scilex”) effected a 1-for-35 reverse stock split of its issued and outstanding common stock. The numbers below reflect the reverse split, except with respect to the Subsequent Penny Warrants that were outstanding as of the reverse stock split date, which were not adjustable under the reverse split pursuant to the terms of such warrants.

2023 Scilex Transaction

On September 21, 2023, we entered into and consummated a series of transactions, or the “2023 Scilex Transaction”, with Scilex pursuant to which Scilex issued to us:

2024 Refinancing

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 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.

Scilex received from us, in consideration 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.

As of March 26, 2026, Scilex has repaid $13,000,000 of the principal amount outstanding under the Tranche B Note, leaving a remaining principal balance of $12,000,000 with accrued interest of approximately $495,000. The Tranche B Note matures on October 8, 2026.

Royalty Purchase Agreement

In addition to the Tranche 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 Tranche B Note for the repayment of the outstanding balance under the Tranche A Note.

ZTLido Rest of the World Binding Agreement

On October 8, 2024, we and certain other institutional investors and Scilex entered into a binding term sheet, or the ROW License Term Sheet, for a license and development agreement relating to ZTlido and lidocaine products outside the United States. To implement the atransaction contemplated by the ROW License Term Sheet, we and the other institutional investors agreed to operate through a joint venture, RoyaltyVest Ltd., or RoyaltyVest, a company incorporated in the British Virgin Islands. On February 12, 2025, we were transferred 50% of the issued and outstanding shares of RoyaltyVest.

On February 22, 2025, RoyaltyVest entered into a License Agreement with Scilex (the “ZTLido License Agreement”). Under the ZTLido License Agreement, RoyaltyVest acquired exclusive rights to develop, manufacture, and commercialize lidocaine-based products, including ZTLido (lidocaine topical system 1.8%) and SP-103 (the “Product”), outside the United States. As consideration for the rights provided under the ZTLido License Agreement, (a) RoyaltyVest agreed to invest (whether through cash consideration or in-kind payment through the provision of services) $200,000 per year toward expanding the Product, (b) Scilex granted 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, 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.

Tranche B Note Consent

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.

A part of the consideration for providing the Tranche B Note Consent, on February 28, 2025, we entered into a Purchase and Sale Agreement with Scilex, Scilex Pharmaceuticals Inc. and certain other Note B Holders, pursuant to which, among other things, the applicable Note B Holders received a royalty in respect of 4% of worldwide net sales of Gloperba, Elyxyb, and related products, of which we are entitled to 50% of such royalty payments. Through RoyaltyVest, the Note B Holders, were provided the option to fund up to 50% of the cash purchase price for certain ex-US (and, as to Elyxyb, ex-Canada) product rights to Gloperba and Elyxyb and will receive proportional revenues from commercialization and licensing. As of March 31, 2025, RoyaltyVest exercised its option to Ex-U.S. product rights of Gloperba for $500,000.

Tranche B Note Deferral and Warrant Agreement

In 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 Notes. In consideration for such deferral, Scilex agreed to issue to us certain warrants to purchase shares of Scilex’s 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 of $20.00 per share, was issued to the Company pursuant to a Warrant Agreement entered by the Company and Scilex on February 19, 2026.

Scilex 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 payment was subsequently paid to 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.

For additional information regarding 2023 Scilex Transaction and 2024 Refinancing, see note 4 to our consolidated financial statements included in this Annual Report on Form 10-K.

BioXcel

In order to diversify our investments as a part of our use of cash strategy, on March 4, 2025, RoyaltyVest, participated in a registered direct offering by BioXcel Therapeutics, Inc. (Nasdaq: BTAI), or BioXcel, acquiring 188,383 shares of BioXcel’s common stock, 3,811,617 pre-funded warrants and accompanying warrants to purchase up to an additional 4,000,000 shares for a total consideration of $14,000,000. The warrants have an exercise price of $4.20 per share, are immediately exercisable, and will expire five years from the date of issuance. The pre-funded warrants have an exercise price of $0.001 per share, are immediately exercisable with no expiration 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.

As of December 31, 2025, RoyaltyVest has sold 4,000,000 shares and 2,600,000 warrants for $12,502,000. As of December 31, 2025, RoyaltyVest continues to hold 1,400,000 warrants and no longer holds any shares of BioXcel common stock.

Alpha Tau Transaction

On 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 Alpha Tau 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, Oramed Ltd. has the right and have nominated two directors to Alpha Tau’s board of directors. In addition, since the share purchase agreement date and until December 31, 2025, we purchased an additional 359,214 shares of Alpha Tau for an aggregate amount of $1,255,781. 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 its outstanding share capital.

Concurrently, we 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.

Alpha DaRT™Platform and Technology

Alpha Tau’s Alpha DaRT platform is designed to deliver highly localized alpha radiation through intratumoral insertion of radium-224 impregnated sources into solid tumors. When the radium decays, its short-lived daughters are released and disperse while emitting high-energy alpha particles aimed at destroying tumor cells while sparing surrounding healthy tissue. This approach potentially offers a novel treatment solution for patients with otherwise difficult-to-treat cancers where conventional external beam radiation may be limited.

Clinical Development Progress

Alpha Tau is currently conducting an extensive 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:

U.S. Clinical Trials:

In addition, Alpha Tau is engaged in pre-clinical research partnerships with leading academic institutions including Mayo Clinic, McGill University, Emory University, and MD Anderson Cancer Center, exploring combinations with immunotherapy. Alpha Tau has also reported encouraging interim data from a clinical study in Israel examining the combination of Alpha DaRT with checkpoint inhibitor therapeutics for patients with locally advanced or metastatic head and neck squamous cell carcinoma, and is exploring the possibility of conducting a sixth U.S. trial in this indication.

Regulatory and Commercial Progress

In addition to the ongoing FDA engagement for its U.S. clinical programs, Alpha Tau has reported that it is anticipating a response from Japan’s Ministry of Health, Labour and Welfare regarding its application for approval of Alpha DaRT in the treatment of recurrent head and neck cancer, which would mark Alpha DaRT’s first commercial approval outside of Israel if granted.

On the manufacturing front, Alpha Tau has received a 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.

Strategic Overview Rationale

Alpha Tau has demonstrated encouraging clinical progress 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.

*** Pelthos Therapeutics Inc.***

On 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.

Nano Dimension Ltd.

As of December 31, 2025, we purchased an aggregate of 5,436,791 ordinary shares, par value NIS 5.00 per share or, “Nano Ordinary Shares”, of Nano Dimension Ltd., or Nano, for an aggregate amount of approximately $8,501,000. Subsequent to December 31, 2025 and through March 26, 2026, we purchased an additional 6,401,939 of Nano ordinary shares for an aggregate purchase price of approximately $12,308,000 and we sold 1,269,987 ordinary shares of Nano for aggregate proceeds of approximately $2,606,000. Following these transactions, we hold an aggregate of 10,568,743 Nano ordinary shares, representing approximately 5.02% of its outstanding shares as of March 26, 2026, based 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 have, and intend to in the future, engage in discussions with Nano’s management, members of Nano’s board of directors, and/or other shareholders of Nano concerning, among other things, Nano’s performance, the market price of the Nano Ordinary Shares relative to the value of Nano’s assets, potential financing options for Nano, Nano’s business strategy, potential transactions and other issues for the betterment of Nano. We intend to engage in discussions with Nano and other shareholders thereof regarding the management of Nano and to recommend changes to the composition of the board of directors and expect to subsequently have further discussion with Nano’s management and board of directors covering board composition as well as a broad range of subjects relative to performance, strategic direction, shareholder value and governance of Nano.

Transactions with Lifeward

Secured Promissory Note

On November 14, 2025, in anticipation of the transactions contemplated by the Lifeward Share Purchase Agreement and the Lifeward Notes Purchase Agreement described below, we entered into a loan agreement with Lifeward Ltd. or “Lifeward” pursuant to which we provided Lifeward with a$3,000,000 secured promissory note bearing interest at 15% per annum and maturing on May 14, 2026, unless earlier repaid or converted in accordance with its terms. The note is secured by a lien on Lifeward’s cash and accounts receivable.

The principal and accrued interest under the note are convertible into Lifeward ordinary shares at a conversion price of $5.40 per share, reflecting Lifeward’s 12-for-1 reverse share split effected on February 24, 2026, which adjusted the original conversion price of $0.45 per share.

On February 12, 2026, we agreed to provide Lifeward with anadditional 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 secured by a lien on Lifeward’s cash. As of March 26, 2026, we had funded $1,025,000 under this additional note.

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

On January 12, 2026, we entered into a Share Purchase Agreement or, the “Lifeward Share Purchase Agreement” with Lifeward and OraTech pursuant to which Lifeward agreed to acquire all of the outstanding equity interests of OraTech from us or the “Share Purchase Transaction”. Prior to the closing, we transferred to Oratech all intellectual property and related assets relating to our POD™ (Protein Oral Delivery) technology platform, together with cash to fund the next planned clinical trial and related development activities. As a result, commencing on the closing date of March 25, 2026, research and development expenses will be borne by Oratech.

In 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.

The closing of the Share Purchase Transaction was subject to customary 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 connection with the transaction, Lifeward agreed 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-funded warrants and warrants described above as soon as practicable following closing, but no later than 75 days after closing, and to use commercially reasonable efforts to have such registration statement declared effective within 75 days after closing (or 105 days in the event of a full SEC review).

The Share Purchase Warrants were immediately exercisable upon issuance at an initial 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), and expire five years from the date of issuance. The exercise price is subject to customary anti-dilution adjustments.

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.

We may not exercise any portion of the Pre-Funded Warrants or Share Purchase Warrants to the extent that, after giving effect to such exercise, we and our affiliates would beneficially own more than 45.0% of the outstanding Lifeward Ordinary Shares. This limitation will automatically increase to 49.99% once (i) the Investors no longer hold any Notes and (ii) the Investors have sold all Note Shares issued or issuable upon conversion of the Notes and related warrants. We may increase the beneficial ownership limitation upon at least 61 days’ prior notice to Lifeward; provided that, for so long as certain Lifeward warrants outstanding as of the issuance date remain outstanding, any such increase will require Lifeward’s consent, which may not be unreasonably withheld, conditioned or delayed.

In connection with the execution of the Lifeward Share Purchase Agreement, we entered into a lock-up agreement for a period of 120 days after the Closing, without the prior written consent of Lifeward.

In connection with the Lifeward Share Purchase Agreement we agreed to enter into a clinical trial management or, the “Clinical Trial Management Agreement” with Oratech, pursuant to which we agreed to manage the clinical study of Oratech’s investigational oral insulin capsule product or, the “Study”, including providing clinical trial management and administrative services through study completion or, the “Services”. In consideration for the Services, OraTech will reimburse us for all reasonable out-of-pocket expenses actually incurred by us in providing the Services and payments made on behalf of OraTech to third parties and vendors, such as clinical sites, if applicable, subject to certain limitations and maximum payments as set forth in 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.

On January 12, 2026, we entered into a Securities Purchase Agreement or, the “Lifeward Notes Purchase Agreement” with Lifeward and other investors pursuant to which we agreed to purchase, in a private placement, up to $18,000,000 of senior secured convertible notes issued by Lifeward, together with accompanying warrants to purchase Lifeward Ordinary Shares.

At the initial closing, which occurred on March 25, 2026, we agreed to purchase $9,000,000 aggregate principal amount of such notes or, the “Initial Notes”. The Initial Notes bear interest at 8% per annum, payable semi-annually, and mature three years from the date of issuance. The Initial Notes are convertible into Lifeward Ordinary Shares at an initial conversion price of $5.40 per share, reflecting Lifeward’s 12-for-1 reverse share split effected on February 24, 2026 (which adjusted the original conversion price of $0.45 per share), subject to customary anti-dilution adjustments.

We 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.

The closing of the Initial Notes was subject to customary 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.

In connection with the transaction, Lifeward agreed to file a resale registration 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).

Strategic Overview Rationale

As 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.

Corner Ally Ventures

On March 1, 2026, our board approved the formation of Corner Ally Ventures or, 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 Estate Investments

On November 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 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 Board approved increasing the real estate investments to up to $30,000,000.

Profit-Sharing Loan Agreement

On September 4, 2024, we entered into a loan agreement, or the Profit-Sharing Loan Agreement, with Rabi Binyamin 4 Tama 38 Ltd. or, the “Borrower”, to finance a real estate project or, the “Rabi Binyamin Project”. According to the terms of the Profit-Sharing Loan Agreement, we agreed to loan NIS 5,500,000 (approximately $1,523,000) or, the “Loan Principal”, to the Borrower. NIS 4,700,000 (approximately $1,307,000) was loaned upon signing the Profit-Sharing Loan Agreement and an additional NIS 800,000 (approximately $237,000), or the Additional Payment, will be loaned upon certain milestones. On October 28, 2025, the Borrower met the milestones and is entitled to the additional payment.

On September 14, 2025, we loaned an additional NIS 500,000 (approximately $150,286) to the Borrower or’ the “Additional Loan”. The Additional Loan bears an annual interest of 6% and shall be repaid by December 31, 2025. According to the Additional Loan agreement, we shall be entitled to instruct the Borrower that instead of repaying the Additional Loan on the maturity date, the principal amount of the loan, as well as any accrued interest up to the date of such notice, shall be deemed to constitute a loan amount provided by us, as part of the remaining portion of the Profit-Sharing Loan Agreement. As of December 31, 2025, the Additional Loan had not been repaid. The maturity date of the Additional Loan was subsequently extended to June 30, 2026.

Upon completion of the Rabi Binyamin Project, we are entitled to receive the Loan Principal and the greater of: (i) 20% annual interest of the Loan Principal and (ii) 40% of the Rabi Binyamin Project profits.

Castel

In January 2025, we entered into an agreement to acquire a parcel of land in Mevaseret Zion, Israel for a total purchase price of NIS 5,800,000 ($1,586,000). The transaction was structured as installments payments, and as of December 31, 2025, we had paid the full purchase price. We intend to pursue value-enhancing activities in connection with the land, with the goal of increasing its potential return upon future sale.

Ruby Sapphire II Investment

On 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.

Loan to Hapisga Project

On March 24, 2025, we entered into a loan agreement with Hapisga Project – 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%.

On the same date, we entered into a loan agreement with Tova Chochma Im Nachala Ltd. or, the “Tova Chochma” in the amount of $5,000,000. The loan bears an annual interest rate of 12% with a maturity date of 12 months. In May 2025, Tova Chochma repaid an amount of $500,000. Tova Chochma can repay the loan at any time. This loan is also secured by the registration of the caveat for Hapisga Loan. The loans were granted by us in April 2025.

Research and Development

Oral Insulin and Strategic Review Process

Our proprietary flagship product, an orally ingestible insulin capsule, or ORMD-0801, allows insulin to travel from the gastrointestinal tract via the portal vein to the bloodstream, revolutionizing the manner in which insulin is delivered. It enables the passage in a more physiological manner than current delivery methods of insulin. We conducted the ORA-D-013-1 Phase 3 trial on patients with type 2 diabetes, with inadequate glycaemic control who were on two or three oral glucose-lowering agents. The primary endpoint of the trial was to evaluate the efficacy of 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 weeks. On January 11, 2023, we announced that the ORA-D-013-1 Phase 3 trial did not meet its primary or secondary endpoints.

Following 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).

We intend on initiating a 60-patient, US-based clinical trial designed to validate the robustness of our oral insulin formulation in these high-responder populations. The trial is designed to use the smallest adequately powered patient population expected to obtain such validation in what we believe to be the shortest time possible, providing a cost-effective approach to generate additional compelling evidence and refine our patient selection criteria for future potential regulatory submissions. The trial will be conducted by OraTech. For additional information, see note 21 to our consolidated financial statements included in this Annual Report on Form 10-K.

Diabetes Market Overview

Diabetes is a disease in which the body does not produce or properly use insulin. 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 589 million adults (20-79 years) worldwide suffered from diabetes in 2024 and the IDF projects this number will increase to 853 million by 2050. According to the American Diabetes Association or, the “ADA”, in 2024, the United States there were approximately 38.5 million people with diabetes. Diabetes is a leading cause of blindness, kidney failure, heart attack, stroke and amputation.

Intellectual Property and Patents

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

We maintain a proactive intellectual property strategy, which includes patent filings in multiple jurisdictions, including the United States and other commercially significant markets. We hold 21 patent applications currently pending, with respect to various compositions, methods of production and oral administration of proteins and exenatide. Expiration dates for pending patents, if granted, will fall between 2026 and 2039.

We 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.

Consistent 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.

Our patent strategy is as follows:

Trademarks and Trade Secrets

We have trademark applications 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.

We also rely on trade secrets and unpatentable know-how that we seek to protect, in part, by confidentiality 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. These agreements provide that all confidential information developed or made known to the individual during the course of the individual’s relationship with us is to be kept confidential and not disclosed to third parties except in specific limited circumstances. We also require signed confidentiality or material transfer agreements from any company that is to receive our confidential information. In the case of employees, consultants and contractors, the agreements provide that all inventions conceived by the individual while rendering services to us shall be assigned to us as the exclusive property of us. There can be no assurance, however, that all persons who we desire to sign such agreements will sign, or if they do, that these agreements will not be breached, that we would have adequate remedies for any breach, or that our trade secrets or unpatentable know-how will not otherwise become known or be independently developed by competitors.

Out-Licensed Technology

We entered into strategic agreements with Lifeward pursuant to which we agreed to sell all of the outstanding equity interests of OraTech, effectively transferring all intellectual property and related assets relating to our POD™ (Protein Oral Delivery) technology platform, together with associated development activities for the oral insulin program. In consideration, we will receive equity securities of Lifeward, including ordinary shares and warrants, as well as potential revenue-sharing payments. In addition, we will continue to support the development of the out-licensed technology by providing clinical trial management and related services for the oral insulin capsule program.

Entera Bio

In June 2010, our wholly-owned subsidiary, Oramed Ltd., entered into a joint venture agreement with Israel Canada Hotels Ltd (formerly DNA GROUP (T.R.) Ltd.) or DNA, for the establishment of Entera Bio Ltd., or Entera.

In March 2011, Oramed Ltd. sold 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.

As of December 31, 2025, Entera had not paid any royalties to Oramed 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.

HTIT

In 2015-2016, we entered into an exclusive license agreement with HTIT, as amended or, the “HTIT License Agreement”, granting HTIT commercialization rights to our oral insulin capsule, 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 net sales (subject to reduction to 8% if certain conditions are not 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 has submitted a Marketing Authorization Application to China’s regulators for the oral insulin capsule in China.

Government Regulation

The Drug Development Process

Regulatory requirements for the approval 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 each country 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 FDA requires that pharmaceutical and certain other therapeutic products undergo significant clinical experimentation and clinical testing prior to their marketing or introduction to the general public. Clinical testing, known as clinical trials or clinical studies, is either conducted internally by life science, pharmaceutical or biotechnology companies or is conducted on behalf of these companies by CROs.

The process of 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.

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:

Institutional Review Board. 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 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.

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

Phase 1. Phase 1 trials involve testing a drug or product on a limited number of healthy or patient participants, typically 24 to 100 people at a time. Phase 1 trials determine a product’s basic safety and how the product is absorbed by, and eliminated from, the body. This phase lasts an average of six months to a year.

Phase 2. Phase 2 trials involve testing of no more than 300 participants at a time who may suffer from the targeted disease or condition. Phase 2 testing typically lasts an average of one to two years. In Phase 2, the drug 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 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.

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.

Biological License Application. The results of the clinical trials for a biological product are submitted to the FDA as part of a Biological License Application or, the “BLA”. Following 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 composition, and the sponsor’s 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 United States, subject to any conditions imposed by the FDA. Approval of a BLA provides 12 years of exclusivity in the U.S. market.

Phase 4. The FDA 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 us sponsoring the new drug to gain broader market value for an approved drug.

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 (“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 drug approval process 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.

Other Regulations

Various federal, state and local laws, regulations, and recommendations relating to safe working conditions, laboratory practices, the experimental use of animals, the environment 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 U.S. Atomic Energy 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.

Competition

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.

In the diabetes treatment sector specifically, 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 products typically hold 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 may develop superior products or achieve greater market acceptance. There can be no assurance that our technology will not be rendered obsolete or noncompetitive, or that we can keep pace with technological developments, any of which could materially adversely affect our business, prospects, financial condition, and results of operations.

Employees

We believe it is imperative to attract and retain top talent for all positions in the Company. We seek to make Oramed an inclusive, diverse and safe workplace, with meaningful compensation, benefits and wellness programs and opportunities.

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, 2025, 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.

We provide competitive compensation, 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 engage, motivate and retain our employees as a cohesive unit unified in its goal to achieve the Company’s strategy and objectives.

Additional Information

Additional information about us is contained on our Internet website at www.oramed.com. Information on our website is not incorporated by reference into this report. Our Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K, and amendments to those reports filed or furnished pursuant to Section 13(a) of the Securities Exchange Act of 1934, as amended, or the Exchange Act, are available free of charge on our website under “SEC Filings” as soon as reasonably practicable after we electronically file such material with, or furnish it to, the SEC. Reports filed with the SEC are made available on its website at www.sec.gov and are also available on the website of the Israeli Securities Authority at www.magna.isa.gov.il or on the website of the Tel Aviv Stock Exchange at www.tase.co.il. The following corporate governance documents are also posted on our website: Code of Ethics, Whistleblowing Policy and the charters for each of the Audit Committee, Compensation Committee and Nominating Committee of our Board.