Welcome to our dedicated page for Oramed Pharmaceuticals news (Ticker: ORMP), a resource for investors and traders seeking the latest updates and insights on Oramed Pharmaceuticals stock.
Oramed Pharmaceuticals Inc. (NASDAQ: ORMP) is a pioneering pharmaceutical company focused on the development and commercialization of innovative oral drug delivery systems. Headquartered in the United States and Israel, Oramed aims to revolutionize the treatment of various diseases by transforming injectable therapies into oral formulations.
Oramed's flagship product, an orally ingestible insulin capsule known as ORMD-0801, is currently in Phase 2 clinical trials under the supervision of the U.S. Food and Drug Administration (FDA). This product holds significant promise for improving the quality of life for diabetes patients by eliminating the need for daily insulin injections.
The company’s proprietary Protein Oral Delivery (POD™) technology is designed to protect therapeutic proteins like insulin from the harsh conditions of the gastrointestinal tract, ensuring their effective delivery and absorption in the body. This platform technology opens up possibilities for the oral administration of a wide range of therapeutic proteins and peptides.
Oramed recently announced a strategic partnership with Hefei Tianhui Biotech Co., Ltd. (HTIT) to establish a joint venture aimed at the global commercialization of Oramed's oral insulin and POD™ pipeline. This collaboration leverages HTIT's advanced manufacturing capabilities, which include a state-of-the-art facility in Hefei, China. The initial phase of the partnership includes a $70 million investment from HTIT and a $20 million investment from Oramed, the latter consisting of both cash and shares of common stock.
Additionally, Oramed has entered a securities agreement with Scilex Holding Company, securing an 18-month Senior Secured Promissory Note valued at approximately $101.9 million. This agreement includes an interest rate of SOFR plus 8.5% and offers Oramed new warrants for up to 13 million shares of Scilex common stock.
Oramed is also branching into topical treatments through its acquisition of PeriTech Pharma Ltd.’s innovative film-forming technology. This includes over-the-counter treatments for hemorrhoids and other dermatological conditions. Oramed has secured an exclusive licensing agreement with an international consumer and pharmaceutical group, promising future royalties based on net sales.
With a robust pipeline and strategic partnerships, Oramed is well-positioned to advance its mission of improving patient care and increasing shareholder value through groundbreaking oral drug delivery solutions.
On February 9, 2023, Oramed Pharmaceuticals (Nasdaq: ORMP) provided a shareholder update, emphasizing its ongoing analysis of data from its halted Phase 3 oral insulin trials. The management and Board are currently reviewing the company's pipeline and exploring strategic alternatives to enhance shareholder value, including potential mergers or acquisitions. CEO Nadav Kidron stated the clinical team will analyze the unblinded Phase 3 data to determine the future of their oral insulin assets and platform technology. No timetable for completion has been established, nor can any assurance be given that the review will yield a transaction.
Oramed Pharmaceuticals announced negative top-line results from its Phase 3 trial (ORA-D-013-1) of ORMD-0801 for Type 2 Diabetes, involving 710 patients over 26 weeks. The trial failed to meet both primary and secondary endpoints for improving glycemic control and fasting plasma glucose levels. Consequently, Oramed plans to discontinue its oral insulin clinical activities for Type 2 Diabetes. The CEO expressed disappointment but acknowledged the prior positive trial results, indicating that future updates will follow as data is analyzed.
Oramed Pharmaceuticals (Nasdaq: ORMP) has received a new patent from the US Patent and Trademark Office titled "Methods and Compositions for Treating Diabetes," building on a previous patent from May 2022. This patent focuses on oral pharmaceutical compositions combining insulin and GLP-1 for diabetes treatment. With topline data from their first Phase 3 oral insulin trial expected soon, Oramed aims to strengthen its intellectual property portfolio in oral drug delivery.
Oramed Pharmaceuticals reported a strong performance in 2022, highlighted by the completion of enrollment in its Phase 3 oral insulin trial, ORA-D-013-1, with results expected in mid-January 2023. The Phase 2 NASH trial achieved key endpoints, confirming the safety and efficacy of ORMD-0801. A significant distribution deal was signed with Medicox for South Korea, including up to $18 million in milestone payments. Oramed also has $160 million in cash with no debt, positioning it well for future growth and FDA submissions.
Oramed Pharmaceuticals Inc. (Nasdaq: ORMP) announced a significant development with the publication of a peer-reviewed article in Diabetes, Obesity, and Metabolism. The study evaluates the safety and efficacy of ORMD-0801, an oral insulin for Type 2 Diabetes, showing statistically significant reductions in HbA1c levels over a 12-week placebo-controlled trial. The results support advancing to Phase 3 studies with an 8 mg bedtime dose. Oramed's innovative approach aims to transform diabetes treatment with oral solutions.
Oramed Pharmaceuticals (Nasdaq: ORMP) announced positive outcomes from its Phase 2 clinical trial (ORA-D-N02) for ORMD-0801, an oral insulin candidate targeting Type 2 diabetes patients with NASH. The trial achieved its primary endpoint, showing no serious adverse events. Key secondary endpoints demonstrated a reduction in liver fat, stiffness, and lipids. With 32 patients enrolled, 30 completed the trial, indicating a promising safety profile and potential efficacy. The global NASH treatment market is projected to reach $84 billion by 2029, highlighting the commercial potential of ORMD-0801.
Oramed Pharmaceuticals has signed an exclusive distribution agreement with Medicox for its oral insulin candidate, ORMD-0801, in South Korea, pending regulatory approval. This deal includes potential developmental milestones totaling up to $18 million, with $2 million already received. Oramed will also earn up to 15% royalties on gross sales. With 1 in 7 Koreans over 30 diagnosed with diabetes, the agreement taps into a significant market potential, and ORMD-0801 aims to be the first commercial oral insulin capsule. Top-line results from ongoing Phase 3 studies are expected in January 2023.
Oramed Pharmaceuticals reported its Q3 2022 financial results, highlighting important milestones in its clinical trials, including positive Phase 2 NASH data and initial results from a Phase 1 oral Covid-19 vaccine trial. As of September 30, 2022, the company had approximately $160 million in cash and investments, positioning it well for future developments. Research and development expenses decreased by 12% year-over-year to $5.35 million, while general and administrative expenses rose by 60% to $3.06 million. The loss per share decreased by 14% to $0.18.
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