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]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 For the quarterly period ended March 31, 2024 FORM 10-Q ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 ☒ QUARTERLY 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. Em ...

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, 2023 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. | Delaware | 98-0376008 | | --- | --- | | (State or Other Jurisdiction of | (I.R.S. Employer | | Incorporation or Organization) | Identification ...

Financial Performance - Revenues for the nine months ended September 30, 2023, were $1.340 million, a decrease of 33.7% from $2.022 million in the same period of 2022[27]. - The net loss attributable to stockholders for the nine months ended September 30, 2023, was $7.811 million, compared to a loss of $28.018 million for the same period in 2022, reflecting a decrease of 72.1%[27]. - Basic and diluted loss per share for the nine months ended September 30, 2023, was $0.19, down from $0.72 in the same period of 2022[27]. - The net loss for the nine months ended September 30, 2023, was $8,208, compared to a net loss of $29,028 for the same period in 2022[37]. - Basic and diluted loss per share for the three-month period ended September 30, 2023, decreased by 56% to $0.08, compared to $0.18 for the same period in 2022[165]. - The company has incurred aggregate losses of $170,892,000 from inception through September 30, 2023[169]. Assets and Liabilities - Total assets increased to $230.893 million as of September 30, 2023, compared to $161.642 million as of December 31, 2022, representing a growth of 42.7%[24]. - Total stockholders' equity decreased to $149.132 million as of September 30, 2023, from $151.812 million as of December 31, 2022, a decline of 1.8%[24]. - Cash and cash equivalents decreased significantly to $5.468 million as of September 30, 2023, from $40.464 million as of December 31, 2022[24]. - Total current liabilities rose to $78.175 million as of September 30, 2023, from $5.746 million as of December 31, 2022, an increase of 1,261.5%[24]. - As of September 30, 2023, total current assets were $175.705 million and total current liabilities were $78.175 million, resulting in a working capital surplus of $97.530 million[177]. Cash Flow - The company incurred total net cash used in operating activities of $8,877 for the nine months ended September 30, 2023, compared to $19,856 for the same period in 2022[37]. - Cash and cash equivalents at the end of the period were $5,468, down from $40,464 at the beginning of the period[37]. - Operating activities used cash of $8,877,000 in the nine-month period ended September 30, 2023, compared to $19,856,000 in the same period of 2022[179]. - Investing activities used cash of $103,035,000 in the nine-month period ended September 30, 2023, compared to cash provided by investing activities of $18,951,000 in the same period of 2022[180]. - Financing activities provided cash of $76,978,000 in the nine-month period ended September 30, 2023, compared to $6,604,000 in the same period of 2022[181]. Research and Development - Research and development expenses for the nine months ended September 30, 2023, were $7.205 million, down from $20.362 million in the prior year, indicating a reduction of 64.7%[27]. - The company has not generated significant revenues from operations and is currently incurring lower research and development expenses[42]. - Research and development expenses for the three-month period ended September 30, 2023, decreased by 82% to $957,000, compared to $5,347,000 for the same period in 2022[152]. Strategic Initiatives - The company is currently evaluating its existing pipeline and considering strategic opportunities to enhance shareholder value following the termination of two Phase 3 trials[41]. - The company entered into a Stock Purchase Agreement to acquire equity securities of Scilex for a purchase price of $105,000[44]. - A Senior Secured, Super-Priority Debtor-in-Possession Loan Agreement was entered into for $100,000, intended to be used as credit for the purchased securities[45]. - The company entered into a joint venture with Hefei Tianhui Incubator of Technologies Co. Ltd., focusing on the development and commercialization of oral insulin products, with HTIT investing $60 million and Oramed investing $10 million[134][136]. - The joint venture will initiate a Phase 3 oral insulin trial in the United States[135]. Stockholder Information - The company issued common stock, netting $2.428 million during the nine-month period ended September 30, 2023[31]. - The Company issued 1,971,447 shares under the Cantor Equity Distribution Agreement, generating aggregate net proceeds of $26,253 as of September 30, 2023[106]. - Stock-based compensation for the nine months ended September 30, 2023, was $2,845, down from $8,961 in the same period in 2022[37]. Financial Agreements and Securities - The company received a Senior Secured Promissory Note from Scilex for $101,875,000, maturing on March 21, 2025, with interest at Term SOFR plus 8.5%[120][122]. - A Senior Secured Promissory Note was issued to Oramed Pharmaceuticals Inc. by Scilex Holding Company on September 21, 2023[201]. - A Registration Rights Agreement was established between Oramed Pharmaceuticals Inc. and Scilex Holding Company on September 21, 2023[201]. - A Security Agreement was signed among Oramed Pharmaceuticals, Acquiom Agency Services LLC, and Scilex Holding Company on September 21, 2023[201]. Management and Administrative Expenses - General and administrative expenses for the nine-month period ended September 30, 2023, decreased by 43% to $6,314,000, compared to $11,085,000 for the same period in 2022[159]. - General and administrative expenses for the three-month period ended September 30, 2023, decreased by 15% to $2,599,000, compared to $3,061,000 for the same period in 2022[160]. - The President and CEO's monthly consulting fee is NIS 88,023 ($23), and he receives a gross monthly salary of NIS 46,901 ($12) from the subsidiary[111][112]. - There were no relocation expenses for the President and CEO during the nine months ended September 30, 2023, compared to $201 for the same period in 2022[109].