Financial Performance - Revenues for the nine months ended September 30, 2025, were $2,000,000, with a gross profit of $13,000, compared to no revenues in the same period of 2024 [25]. - Net income for the nine months ended September 30, 2025, was $54,007,000, a significant improvement from a net loss of $8,904,000 in 2024 [25]. - Basic income per share of common stock was $1.30 for the nine months ended September 30, 2025, compared to a loss of $0.22 in the same period of 2024 [25]. - The company recognized $665,000 in other income for the nine months ended September 30, 2025, compared to $0 in 2024 [208]. - Gross profit for the nine months ended September 30, 2025, was $13,000, indicating a significant increase from $0 in 2024 [208]. - Cost of revenue for the nine months ended September 30, 2025, was $1,987,000, with no costs reported for the same period in 2024 [212]. Assets and Equity - Total assets increased to $220,493,000 as of September 30, 2025, compared to $155,278,000 in 2024, representing a growth of 42% [22]. - Total stockholders' equity rose to $203,282,000 as of September 30, 2025, up from $146,265,000 in 2024, reflecting an increase of 39% [22]. - Cash and cash equivalents decreased to $52,179,000 as of September 30, 2025, from $54,420,000 in 2024, a decline of approximately 4% [22]. - Long-term liabilities increased to $12,044,000 as of September 30, 2025, compared to $4,246,000 in 2024, representing a rise of 184% [22]. Research and Development - Research and development expenses decreased to $4,393,000 for the nine months ended September 30, 2025, from $4,863,000 in 2024, indicating a reduction of approximately 10% [25]. - Research and development expenses for the three months ended September 30, 2025, decreased by 49% to approximately $1,153,000 compared to $2,242,000 in 2024 [218]. - The company has commitments to pay a total of $11,577 to a Clinical Research Organization for services related to its Phase 3 clinical trial, with $1,726 recognized in research and development expenses through September 30, 2025 [138]. Cash Flow and Investments - The total net cash used in operating activities for the nine months ended September 30, 2025, was $8,679,000, an increase from $6,501,000 in the prior year [32]. - The company reported a net cash provided by investing activities of $7,127,000 for the nine months ended September 30, 2025, compared to $90,393,000 in 2024 [32]. - The company holds investments in marketable securities, including $532 in DNA, $224 in Entera, and $4,200 in Pelthos as of September 30, 2025 [65]. - The company entered into a Profit Sharing Loan Agreement, loaning NIS 5.5 million ($1,523) to finance a real estate project, with potential returns of 20% annual interest or 40% of project profits [107][108]. Stock and Shareholder Activities - Stock-based compensation for the nine months ended September 30, 2025, was $3,708,000, compared to $2,824,000 in 2024 [32]. - The company repurchased and retired common stock amounting to $732,000 in the nine months ended September 30, 2025 [32]. - The company entered into a share repurchase agreement to buy back 1,155,367 shares at a price of $2.23 per share, totaling $2,576,000 [166]. - The Company repurchased 329,243 shares of its common stock for a total amount of $732 during the nine months ended September 30, 2025, under its stock buyback program [151]. Joint Ventures and Agreements - The company has a joint venture with Hefei Tianhui Biotech Co., Ltd. aimed at developing oral insulin, although the agreement was terminated on October 23, 2025 [37][38]. - The company entered into a binding term sheet for a license and development agreement with Scilex regarding lidocaine products, including ZTLido, with a focus on global net sales [183]. - A joint venture, RoyaltyVest Ltd., was formed to operate under the agreement, with the company holding 50% of the shares [184]. - RoyaltyVest entered into a ZTLido License Agreement with Scilex, acquiring exclusive rights to develop lidocaine-based products, sharing net profits equally [117][118]. Financial Transactions and Valuations - The fair value of the Company's investments in Scilex was $50,460, including $33,832 from notes and $14,660 from warrants as of September 30, 2025 [100]. - The fair value of the Tranche B Note was less than the aggregate unpaid principal balance by $4,086 thousand as of September 30, 2025 [94]. - The Company received $3,722 thousand in repayments from Scilex in April 2025, consisting of $3,125 thousand principal and $597 thousand accrued interest [94]. - The fair value of Alpha Tau's ordinary shares held by the Company was determined to be $4.51 as of September 30, 2025, up from $2.612 on April 24, 2025 [131]. Future Plans and Commitments - The company plans to initiate a 60-patient clinical trial in the U.S. to validate its oral insulin formulation in high-responder populations, aiming for a clinically meaningful outcome of over 1% reduction in HbA1c [172]. - The company approved real estate investments of up to $30 million to leverage opportunities in the current market [199]. - The company entered into a loan agreement for the Hapisga Project with a total amount of up to $22.65 million, secured by significant collateral [203].

Core Insights - Oramed Pharmaceuticals has made significant advancements in its operations and strategic initiatives, focusing on long-term shareholder value creation [2][8] - The company has identified high-responder subgroups in its oral insulin program, showing potential for over 1% reduction in HbA1c, which enhances its regulatory and commercial positioning [4][17] - Oramed is pursuing a 60-patient trial in the U.S. to validate its oral insulin formulation, aiming for cost-effective evidence generation [5][17] Oral Insulin Program - The oral insulin program has shown promising results in high-responder subgroups, particularly among participants with lower BMI and older demographics [4] - A new U.S.-based trial is being initiated to validate the oral insulin formulation and refine patient selection criteria for future regulatory submissions [5] Investment Portfolio - Oramed has strategically invested in various biomedical companies, including a $99.5 million loan to Scilex Holdings, which has returned $95.5 million to date, with total expected returns of approximately $170 million [7][9] - The company invested $36.9 million in Alpha Tau Medical, with a current valuation of approximately $64.8 million, reflecting a gain of $27.1 million [9][10] - Oramed has also invested $7 million in BioXcel Therapeutics and $1.5 million in Pelthos Therapeutics, with significant gains realized in both investments [12][13] Growth Initiatives - The company is actively pursuing partnerships with strong companies to unlock market potential and drive value creation [15] - Oramed's diversified investment strategy has led to substantial returns while maintaining focus on its core oral insulin program [3][17] Financial Performance - As of September 30, 2025, Oramed's total cash and assets have grown to approximately $210 million, demonstrating effective capital deployment despite investing $17.8 million in R&D [16]

Financial Performance - Revenues for the six months ended June 30, 2025, were $2,000,000, compared to $0 for the same period in 2024, indicating a significant increase[27]. - Net income for the six months ended June 30, 2025, was $5,618,000, compared to $10,738,000 for the same period in 2024, showing a decrease of 48%[27]. - Basic income per share of common stock was $0.14 for the six months ended June 30, 2025, compared to $0.26 for the same period in 2024[27]. - Financial income, net, for the six months ended June 30, 2025, was $12,808,000, compared to $19,322,000 for the same period in 2024, a decrease of 34%[27]. - The company reported a net income of $5,618,000 for the six months ended June 30, 2025, compared to $10,738,000 in the same period of 2024[204]. - The gross profit for the six months ended June 30, 2025, was $13,000, with a cost of revenue of $1,987,000[204]. Assets and Liabilities - Total assets increased to $161,684,000 as of June 30, 2025, compared to $155,278,000 as of December 31, 2024, reflecting a growth of 4%[22]. - Total current liabilities decreased to $3,693,000 as of June 30, 2025, from $5,685,000 as of December 31, 2024, a reduction of 35%[22]. - The company's accumulated deficit improved to $(170,970,000) as of June 30, 2025, from $(176,616,000) as of December 31, 2024, indicating a reduction in losses[22]. - Total stockholders' equity increased to $154,529,000 as of June 30, 2025, from $146,265,000 as of December 31, 2024, reflecting a growth of 6%[22]. Research and Development - Research and development expenses rose to $3,240,000 for the six months ended June 30, 2025, compared to $2,621,000 for the same period in 2024, an increase of 24%[27]. - Research and development expenses for the six months ended June 30, 2025, totaled $3,240,000, an increase from $2,621,000 in the same period of 2024[204]. - Research and development expenses for the three months ended June 30, 2025, decreased by 28% to approximately $1,034,000 compared to approximately $1,442,000 for the same period in 2024[215]. Cash Flow - Total net cash used in operating activities was $(7,054,000), a significant decline from $600,000 in the previous year[34]. - Total net cash used in investing activities was $(31,237,000), compared to a cash inflow of $124,653,000 in 2024[34]. - The company reported cash and cash equivalents at the end of the period of $15,797,000, down from $84,753,000 at the end of June 2024[34]. Investments and Acquisitions - The company acquired approximately 16.65% of Alpha Tau Medical Ltd. for $36,900,000 in April 2025[48]. - The company invested approximately $36.9 million to acquire 14,110,121 shares (16.65%) of Alpha Tau, with a fair value increase to $44.298 million by June 30, 2025[123][127]. - The company invested $1,500 to acquire 150,000 shares of Pelthos Therapeutics Inc. common stock[160]. - The Company entered into a loan agreement for the Hapisga Project, amounting to $22,650,000, secured by a property valued at approximately $890,000,000[202]. Joint Ventures and Partnerships - The joint venture with Hefei Tianhui Biotech Co., Ltd. (HTIT) aims to develop and commercialize oral insulin, with an initial investment of $40,000,000 from HTIT and $7,500,000 from the company[39]. - The second closing of the joint venture is contingent on Nasdaq listing approval and involves an additional investment of $20,000,000 from HTIT and $7,500,000 from the company[42]. - The company is currently evaluating alternative partners and pathways to advance its oral insulin program independently due to delays in regulatory approvals[46]. - The company has paused plans to initiate a Phase 3 clinical trial in the U.S. pending further clarity on the joint venture with HTIT[46]. Stock and Equity - The company repurchased and retired 164,000 shares of common stock during the six months ended June 30, 2025[30]. - The Company has authorized a stock buyback program allowing repurchases up to $20,000, with 163,869 shares repurchased for a total of $371 during the three and six months ended June 30, 2025[144]. - The Company granted 1,023,540 RSUs to employees with a total fair value of $2,465,430 based on the share price on the grant dates[136]. - The Company recognized stock-based compensation expense of $197 for the six months ended June 30, 2025, related to PSUs granted to executive officers[140]. Financial Instruments and Valuation - The fair value of the Tranche A Note was $13,938 million, an increase from $13,714 million as of December 31, 2024[83]. - The fair value of the Tranche B Note was $15,818 million as of June 30, 2025, compared to $18,322 million as of December 31, 2024[97]. - The Company received $3,722 million from Scilex as repayment of the Tranche B Note, which included $3,125 million of principal and $597 million of accrued interest[97]. - The fair value of the Royalty Purchase Agreement was calculated using a discount rate between 127.4% to 129.8%[96]. Regulatory and Compliance - The company is assessing the impact of the One Big Beautiful Bill Act on its consolidated financial statements[165]. - The Company has no further obligations to the Israel Innovation Authority after fulfilling a payment of $2.046 million related to IIA grants[132].

Financial Performance - Revenues for the three months ended March 31, 2025, were $2,000 thousand, compared to $0 for the same period in 2024, indicating a significant increase[28]. - The net loss for the three months ended March 31, 2025, was $7,642 thousand, compared to a net income of $1,534 thousand for the same period in 2024, marking a shift in performance[28]. - Operating loss for the three months ended March 31, 2025, was $4,500 thousand, compared to a loss of $2,962 thousand for the same period in 2024, indicating worsening operational performance[28]. - The company reported a basic loss per share of $0.19 for the three months ended March 31, 2025, compared to a profit of $0.04 per share in the same period of 2024[28]. - The Company recognized financial income (expenses) of ($3,616) for the three months ended March 31, 2025, compared to $3,552 for the same period in 2024[97]. - The company incurred aggregate losses of approximately $184,258,000 from inception through March 31, 2025[205]. Assets and Liabilities - Total assets decreased to $147,539 thousand as of March 31, 2025, from $155,278 thousand as of December 31, 2024, representing a decline of approximately 5.6%[24]. - The total stockholders' equity decreased to $139,894 thousand as of March 31, 2025, from $145,347 thousand as of December 31, 2024, a decline of about 3.7%[24]. - As of March 31, 2025, total current assets were approximately $131.5 million, with total current liabilities of approximately $5.5 million, resulting in a working capital surplus of approximately $126 million[208]. - Cash and cash equivalents increased to $74,516 thousand as of March 31, 2025, from $54,420 thousand at the end of 2024, showing a growth of approximately 37%[34]. - Total net cash used in operating activities was $3,519 thousand for the three months ended March 31, 2025, compared to $1,476 thousand for the same period in 2024, indicating increased cash outflow[34]. - As of March 31, 2025, the company had fully repaid the entire amount of $99.55 million borrowed under short-term borrowings[213]. Research and Development - Research and development expenses rose to $2,206 thousand for the three months ended March 31, 2025, up from $1,179 thousand in the same period of 2024, reflecting increased investment in R&D[28]. - Research and development expenses increased by 87% to approximately $2,206,000 for the three months ended March 31, 2025, compared to approximately $1,179,000 in 2024[198]. - The company plans to initiate a revised Phase 3 trial (ORA-D-013-3) and expects to increase research and development expenses accordingly[206]. - Research and development expenses are expected to remain the major operating expense in the upcoming years, potentially borne by OraTech if clinical trials are conducted through them[215]. Joint Ventures and Collaborations - The Company incorporated a wholly-owned subsidiary, Oramed NewCo, Inc. ("OraTech"), in Nevada on July 1, 2024, for a joint venture with Hefei Tianhui Biotech Co., Ltd. ("HTIT")[37]. - The initial closing of the JV Agreement with HTIT will involve an investment of $40,000 from HTIT and $7,500 from the Company into OraTech, with the Company transferring all its intellectual property rights[41]. - The second closing of the JV Agreement, contingent on Nasdaq listing approval, involves an additional $20,000 investment from HTIT and $7,500 from the Company[42]. - Due to U.S.-China trade tensions, HTIT is currently unable to obtain necessary regulatory approvals, causing delays in the JV Agreement closing and impacting supply and manufacturing support[45]. - The Company has paused plans to initiate the Phase 3 clinical trial in the U.S. while exploring alternative partners and pathways to advance the program independently[46]. - The closing of the JV Agreement is on hold, and plans for a Phase 3 clinical trial in the U.S. have been paused pending further clarity[153]. Financial Agreements and Investments - The Company holds a senior secured promissory note from Scilex with a principal amount of $101,875, maturing on March 21, 2025, bearing interest of SOFR plus 8.5%[70]. - The Company has the right to receive 4% royalties on net sales of ZTlido and SP-103 for 10 years, as part of the Royalty Purchase Agreement[85]. - The Company acquired 50% of the Purchased Receivables, which entitles it to 4% royalties on net sales from Scilex products[85]. - The Company entered into a Profit Sharing Loan Agreement, providing NIS 5.5 million ($1,523) to finance a real estate project, with potential returns of 20% annual interest or 40% of project profits[99]. - A loan agreement was entered into on March 24, 2025, for $22,650 to finance a real estate asset in Jerusalem, with a 12% annual interest rate[118]. - The Company entered into a loan agreement with Tova Chochma for $5,000 at an annual interest rate of 12%, with a maturity extended to up to 12 months[119]. Stock and Shareholder Activities - The Company granted 1,023,540 RSUs to employees during the three months ended March 31, 2025, with a total fair value of $2,465,430[123]. - The Company recognized stock-based compensation expense of $197 for PSUs granted to executive officers, reflecting the achievement of the first updated performance target[127]. - The Company has authorized a stock buyback program with a maximum value of $20,000, which expires in June 2025, but has not repurchased any shares under this program as of March 31, 2025[128][129]. - The company has authorized a stock buyback program with a maximum value of $20 million, which may be executed through various means over the next 12 months[220]. Market and Economic Conditions - The company faces risks related to changes in trade policy and economic conditions in the U.S., which could adversely affect its ability to consummate joint ventures[218]. - An unfavorable tariff environment may amplify macroeconomic headwinds, negatively impacting revenues, profitability, and growth prospects[219].

Core Insights - Alpha Tau Medical Ltd. has successfully closed a registered direct offering, raising approximately $36.9 million through the sale of 14,110,121 ordinary shares at a price of $2.612 per share [1][2] - The investment comes at a crucial time for Alpha Tau, which is experiencing significant growth with four active U.S. trial approvals and expansion into multiple internal organ applications [1][4] - Alpha Tau plans to utilize the net proceeds for general corporate purposes, including research and development, manufacturing expansion, and potential commercialization of its product candidates [2] Company Overview - Alpha Tau Medical Ltd. is an Israeli oncology therapeutics company founded in 2016, focusing on the research, development, and commercialization of the Alpha DaRT technology for treating solid tumors [6] - The Alpha DaRT technology involves intratumoral delivery of radium-224 to enable targeted alpha-irradiation of tumors, aiming to destroy cancer cells while sparing healthy tissue [7] Strategic Partnership - An affiliate of Oramed Pharmaceuticals has entered into an agreement to provide Alpha Tau with strategic services, including investor and public relations, over the next three years [3] - Both companies express strong confidence in the partnership, with expectations for significant advancements in clinical and commercial efforts [4]

Core Insights - Oramed Pharmaceuticals has made a strategic investment in Alpha Tau Medical, acquiring approximately 14.1 million shares at a price of $2.612 per share, aimed at supporting Alpha Tau's innovative cancer therapy technology [1][2] - The partnership combines Oramed's oral drug delivery platform with Alpha Tau's precision radiation delivery technology, enhancing both companies' capabilities in therapeutic delivery [1][3] - Oramed will provide strategic guidance and capital markets expertise to Alpha Tau through a three-year service agreement, which includes appointing two directors to Alpha Tau's Board [2][3] Company Overview - Oramed Pharmaceuticals specializes in oral delivery solutions for drugs typically administered via injection, utilizing its proprietary Protein Oral Delivery (POD™) technology to enhance drug integrity and absorption [4] - Alpha Tau Medical, founded in 2016, focuses on the research and development of the Alpha DaRT® technology for treating solid tumors, initially developed by professors from Tel Aviv University [5] Strategic Goals - The collaboration is expected to accelerate Alpha Tau's clinical trials across four indications in the U.S., expand manufacturing capacity, and enhance commercialization efforts [1][2] - Both companies share a vision of transforming therapeutic delivery methods, with Oramed focusing on oral administration and Alpha Tau on targeted radiation therapy [3]

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 or ☐ 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 | (I.R.S. Emplo ...

Core Insights - Oramed Pharmaceuticals Inc. is advancing its proprietary oral drug delivery technology through a joint venture named OraTech Pharmaceuticals, Inc. with Hefei Tianhui Biotech Co., Ltd. [4][5] - The joint venture aims to initiate a Phase 3 clinical trial in the U.S. for oral insulin, focusing on key patient subpopulations to demonstrate efficacy [6][11] - HTIT has submitted a Marketing Authorization Application for the oral insulin capsule in China, with commercialization preparations underway [7][11] - Oramed plans to distribute OraTech stock to its shareholders via a dividend, coinciding with OraTech's public trading debut on Nasdaq [8][11] - A cash dividend of approximately $0.25 per share is being evaluated to offset potential tax liabilities related to the OraTech stock distribution [9][11] - Oramed's investment in Scilex Holding Company has generated $70 million from a secured loan agreement, with additional payments expected [12][13] - The company maintains a strong financial position, supported by strategic transactions and disciplined capital allocation [13] - Future growth strategies include pursuing acquisitions and partnerships to leverage technology development [14] Joint Venture and Product Development - The OraTech joint venture combines Oramed's drug delivery technology with HTIT's manufacturing capabilities, aiming to set new standards for oral protein delivery [5][6] - OraTech is expected to receive royalties from sales in China, enhancing its revenue potential [7][11] Financial Strategies - Oramed is working on achieving Nasdaq trading status for OraTech and plans to distribute the majority of its ownership in OraTech to shareholders [8][11] - The company is also exploring cash dividends to enhance shareholder value and mitigate tax concerns [9][11] Strategic Investments - Oramed's investment in Scilex includes a royalty stream from multiple products, with expected royalties of $400,000 for Q4 2024 [12][16] - The company holds a 2% royalty on worldwide sales for ELYXYB and GLOPERBA, with additional profit-sharing arrangements [16]

Core Viewpoint - Scilex Holding Company has made an early installment payment of $13.2 million on its senior secured promissory note to Oramed Pharmaceuticals, with the remaining balance due by March 21, 2025, indicating strong financial management and commitment to debt repayment [1]. Company Overview - Scilex Holding Company is focused on acquiring, developing, and commercializing treatments for obesity, neurodegenerative diseases, cardiometabolic diseases, and non-opioid pain management products for both acute and chronic pain [1][5]. - The company is headquartered in Palo Alto, California [7][10]. Financial Actions - The early payment of $13.2 million reduces the principal balance of the Oramed Note, which will be fully retired by March 21, 2025 [1]. - This financial maneuver reflects the company's strategy to manage its liabilities effectively and enhance its balance sheet [1]. Product Portfolio - Scilex's commercial products include: - ZTlido®: A prescription lidocaine topical product for neuropathic pain relief [5]. - ELYXYB®: An FDA-approved oral solution for acute migraine treatment [5]. - Gloperba®: The first liquid oral version of colchicine for gout flare prophylaxis [5]. - The company has three product candidates in development: - SP-102 (SEMDEXA™): A viscous gel for treating lumbosacral radicular pain, with Phase 3 study completed [6]. - SP-103: A next-generation lidocaine topical system for acute pain, recently completing Phase 2 trials [6]. - SP-104: A low-dose naltrexone hydrochloride for fibromyalgia, with Phase 1 trials completed [6].

Core Insights - Oramed Pharmaceuticals has announced a $20 million stock repurchase program, reflecting confidence in its value and potential [3] - The company is actively pursuing a joint venture with Hefei Tianhui Biotech Co., Ltd. (HTIT) to develop and commercialize oral drug delivery products [6][7] - Oramed is making progress on its Phase 3 oral insulin trial and has engaged with the U.S. FDA to refine its protocol [5] Financial Updates - Oramed has received $40 million out of a total $102 million principal from Scilex Holding Company, with a $20 million installment due in September [4] - The joint venture with HTIT will involve a capital infusion of $70 million from HTIT and $25 million from Oramed [7] Strategic Initiatives - The joint venture aims to leverage HTIT's manufacturing capabilities to support the completion of the Phase 3 trial and the launch of oral insulin sales [7] - Oramed's adaptive strategy for the Phase 3 trial focuses on specific patient subgroups identified as significant responders [5] Company Overview - Oramed Pharmaceuticals specializes in oral drug delivery solutions, particularly for drugs typically administered via injection [11]