Oramed Advances Oral Insulin Program with New U.S. Trial Following Subgroup Analysis
核心洞察
Oramed Pharmaceuticals is launching a 60-patient U.S. trial for its oral insulin program after identifying high-responder subgroups showing potential for over 1% HbA1c (搜索) reduction.
The company terminated its joint venture with Hefei Tianhui Biotech (搜索) and will continue oral insulin development independently to maintain full control.
Oramed's diversified investment portfolio has grown total assets to approximately $210 million by September 2025, up from $155.7 million in January 2023.
Oramed Pharmaceuticals Inc. (Nasdaq: ORMP) announced significant developments in its oral insulin program, including the launch of a new U.S. clinical trial based on promising subgroup analysis from previous Phase 2 and Phase 3 data. The company is proceeding independently after terminating a joint venture agreement, while simultaneously building a diversified investment portfolio that has generated substantial returns.
Refined Oral Insulin Strategy Shows Promise
Following extensive analysis of Phase 2 and Phase 3 trial data, Oramed identified high-responder subgroups that demonstrated particularly encouraging results. These subgroups, including participants with lower BMI and older demographics, showed the possibility of achieving over 1% reduction in HbA1c (搜索), a clinically meaningful outcome that potentially strengthens the company's regulatory and commercial positioning.
The company is initiating a 60-patient, U.S.-based trial designed to validate the robustness of its oral insulin formulation. According to CEO Nadav Kidron, "The trial was designed to use the smallest adequately powered population expected to obtain such validation in what we believe to be the shortest time possible, providing a cost-effective way to generate additional compelling evidence and refine our patient selection criteria for future potential regulatory submissions."
Independent Development Path
Oramed terminated its previously announced joint venture with Hefei Tianhui Biotech (搜索) Co. Ltd. (HTIT) due to HTIT's inability to satisfy the closing financial conditions under the agreement. The company plans to continue its oral insulin development program independently, allowing it to maintain full control and momentum on this critical program without external dependencies.
Strategic Investment Portfolio Delivers Returns
Over the past two years, Oramed has built a diversified portfolio of strategic investments in innovative biomedical companies. The company's investment in Scilex Holdings (搜索), initiated with a $99.5 million loan in September 2023, has already returned $95.5 million, with additional expected returns of over $60 million anticipated in the next 12 months, plus ongoing royalties for nine years. Total returns could reach approximately $170 million.
The company's investment in Alpha Tau Medical Ltd., which develops Alpha DaRT (Diffusing alpha-emitters Radiation Therapy) technology for cancer treatment, has shown significant appreciation. Oramed invested $37.7 million in Alpha Tau and based on the closing price of $4.51 per share on September 30, 2025, the position is valued at approximately $64.8 million, representing a $27.1 million gain.
Additional investments include BioXcel Therapeutics, where Oramed invested $7 million and realized $6.25 million through partial sales while maintaining warrant positions, and Pelthos Therapeutics (搜索), where a $1.5 million investment has grown to a $4.2 million valuation, reflecting a 180% gain.
Financial Performance and Shareholder Commitment
The company's financial position has strengthened significantly through its diversified approach. In January 2023, following a Phase 3 trial that did not meet its primary endpoints, Oramed had $155.7 million in cash and cash equivalents. By September 30, 2025, while investing $17.8 million in R&D to advance the refined oral insulin program and share buybacks, the company has grown its total cash and assets to approximately $210 million.
Despite continuing the oral insulin program independently without the previously planned spin-off, Oramed remains committed to rewarding shareholders, including plans for a one-time dividend.
Technology Platform and Future Outlook
Oramed's novel Protein Oral Delivery (POD™) technology is designed to protect drug integrity and increase absorption for drugs currently delivered via injection. The company leverages its extensive network, regulatory expertise, and business development capabilities to actively shape portfolio companies' growth trajectories and identify new opportunities.
CEO Kidron stated, "We believe Oramed stands at a unique inflection point, with our core oral insulin program showing renewed promise through our refined subgroup analysis while our investment portfolio demonstrates our ability to identify and capitalize on emerging opportunities."