Oramed(ORMP) - 2025 Q4 - Annual Report

Clinical Trials and Research - The company plans to initiate a 60-patient clinical trial in the second half of 2026 to validate its oral insulin formulation, aiming for a cost-effective approach to regulatory submissions[26] - The ORA-D-013-1 Phase 3 trial for the oral insulin capsule did not meet its primary or secondary endpoints, leading to a strategic review and a revised Phase 3 trial submission to the FDA[90][91] - The results of the ORA-D-013-1 Phase 3 trial did not meet primary or secondary endpoints, leading to a comprehensive analysis and submission of a new protocol for a Phase 3 clinical trial to the FDA[152] - The ORA-D-013-1 trial did not meet its primary or secondary endpoints, leading to the termination of the ORA-D-013-2 Phase 3 trial[160] - Alpha Tau is conducting five concurrent FDA-approved clinical trials in the U.S. and additional trials in France, Italy, Israel, and planned studies in the UK[52] - The company reported encouraging interim data from a clinical study in Israel combining Alpha DaRT with checkpoint inhibitors for head and neck cancer patients[53] - Alpha Tau anticipates a response from Japan's Ministry of Health regarding its application for Alpha DaRT in recurrent head and neck cancer, which would be its first commercial approval outside of Israel[54] - Alpha Tau is targeting completion of patient recruitment for the ReSTART pivotal trial by Q1 2026 and expects full PMA submission by year-end 2026[58] Financial Transactions and Investments - In the 2023 Scilex Transaction, the company received a senior secured promissory note with a principal amount of $101,875,000, maturing on March 31, 2026, with an interest rate of SOFR plus 8.5%[32] - The company acquired the right to receive 4% royalties on worldwide net sales of ZTLido and related products for 10 years, in exchange for a $2,500,000 reduction in the Tranche A Note[38] - The company participated in a registered direct offering by BioXcel, acquiring shares and warrants for a total consideration of $14,000,000[46] - The company purchased 14,110,121 shares of Alpha Tau Medical Ltd. at a price of $2.612 per share, for an aggregate purchase price of approximately $36,900,000[48] - The company has the right to nominate two directors to Alpha Tau's board and will receive a non-refundable fee of $3,000,000 over three years for providing investor relations services[49] - The company has approved investments of up to $10 million in real estate assets and an additional $20 million, with investments made in various projects including the Rabi Binyamin Project and land in Mevaseret Zion, Israel[180] - The company committed to invest NIS 7,000,000 (approximately $2,185,000) in the Ruby Sapphire II Investment Fund, with NIS 1,556,493 (approximately $499,000) funded as of March 26, 2026[87] - The company has purchased 150,000 shares of Pelthos Therapeutics Inc. for $1,500,000 and currently holds 143,423 shares after selling some[57] - The company has entered into a secured promissory note with Lifeward for $3,000,000 at 15% interest, maturing on May 14, 2026[61] - Lifeward issued shares and warrants to Alpha Tau in exchange for acquiring OraTech, with revenue-sharing payments of 4% from Lifeward's ReWalk products for up to 10 years[66] - The company invested approximately $36.9 million in Alpha Tau, a clinical-stage oncology therapeutics company, with the investment's value dependent on successful clinical results and regulatory approvals[182] Market and Competitive Landscape - The diabetes market is projected to grow from approximately 589 million adults with diabetes in 2024 to 853 million by 2050, highlighting significant market potential[93] - The company faces intense competition in the diabetes treatment sector from established therapeutic options, including GLP-1 receptor agonists[122] - The biotechnology and biopharmaceutical industries are characterized by rapid technological developments and high competition, which may hinder the company's ability to compete[130] - The biotechnology industry is characterized by rapid technological developments and high competition, which may affect the company's ability to recoup R&D expenses[168] Financial Condition and Risks - The company has incurred net losses since inception and currently has only licensing revenues with no product revenues, indicating a challenging path to profitability[146] - The company expects to incur substantial expenditures related to research and development programs, which will be conducted through its strategic evaluation process[142] - The company may require substantial additional financing to implement potential strategic alternatives and continue research and development programs[144] - The company has a history of losses and cannot assure future operating results, with no products expected to be on the market for several years[146] - The company may face significant operational and financial risks if a strategic transaction is pursued, including increased expenditures and potential litigation[138] - The company may need to delay or scale back its research and development programs if adequate financing is not secured[145] - The company is dependent on third-party suppliers for raw materials and services, which poses risks to its operations[130] - The company is dependent on third-party suppliers for oral insulin capsules and lacks long-term agreements for supply[161] - The approval process for new drugs can take several months to years, with an average review lasting 18 months[116] Corporate Governance and Compliance - The company has contracted with thirteen individuals for employment or consulting arrangements, with a focus on retaining top talent[125] - The company must maintain compliance with Nasdaq listing requirements, including a minimum bid price of $1.00 per share, to avoid delisting[191] - The company has implemented anti-takeover Rights that may discourage favorable acquisitions, potentially causing substantial dilution to unauthorized acquirers[215] - Delaware law may complicate or delay changes in control or acquisitions, even if they are in the best interests of stockholders[217] - The company prioritizes cybersecurity, with measures including firewalls, intrusion detection systems, and access controls to mitigate risks[220] - The Chief Operating and Business Officer is responsible for cybersecurity protection measures and incident response[221] - The company maintains compliance programs to address potential cyber-security breaches, which could materially affect its financial position if not managed effectively[210] External Factors and Economic Conditions - The company is subject to political, economic, and military risks due to its operations in Israel, which could negatively impact its business[199] - Recent political events have led to a downgrade of Israel's credit rating from A1 to A2 in October 2023, and further to Baa1 with a negative outlook in September 2024[204] - The company is exposed to currency exchange rate fluctuations, with significant expenses in non-dollar currencies affecting financial results, particularly with the dollar's depreciation against the NIS in 2025[178] Shareholder Considerations - Stockholders may experience significant dilution if the company raises additional funds by issuing equity securities[197] - The company anticipates needing to raise capital through equity offerings, which may adversely affect the trading price of its common stock[196] - The company has outstanding 40,446,179 shares of common stock as of March 26, 2026, which could be affected by future sales from existing stockholders[189] - The company experienced a significant decline in stock price following the announcement of the ORA-D-013-1 Phase 3 trial results in January 2023[195] - The management has significant flexibility in using the net proceeds from any securities offerings, which could impact the company's future financial health[211]