Oramed Pharmaceuticals Inc Stock Price, News & Analysis

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.

Oramed Pharmaceuticals (Nasdaq: ORMP) announced a webinar on November 17, 2022, at 11:00 a.m. EST, to present safety and efficacy data from its Phase 2 trial of ORMD-0801 for reducing liver fat in Type 2 Diabetes patients with NASH. The session will feature key opinion leaders, including Dr. Yaron Ilan and Dr. Joel Neutel, discussing the need for effective NASH treatment. Registered participants can access the live and archived presentations on Oramed's website.

Oramed Pharmaceuticals' subsidiary, Oravax Medical, announced positive preliminary data from its Phase 1 trial for an oral Covid-19 vaccine. The trial met both safety and immunogenicity endpoints, showing a significant antibody response in the majority of patients. No safety issues were reported. The oral vaccine utilizes a triple antigen VLP design that targets crucial SARS-CoV-2 proteins, aiming for a protective response against existing and emerging strains. This proof-of-concept trial involves 24 healthy volunteers, with results expected over a 24-week monitoring period.

Oramed Pharmaceuticals reported positive outcomes from its Phase 2 trial of ORMD-0801, an oral insulin for Type 2 Diabetes patients with NASH, conducted with 32 patients over 12 weeks. Primary endpoint met: ORMD-0801 showed safety and tolerability at 8 mg twice daily. Secondary endpoint met: Demonstrated a significant reduction in liver fat content, suggesting its potential to treat NASH effectively. The firm anticipates forthcoming results from its Phase 3 trial in January 2023, highlighting the importance of ORMD-0801 in addressing a serious unmet medical need.

Oramed Pharmaceuticals (Nasdaq: ORMP) announced that CEO Nadav Kidron will present an overview of the company at the H.C. Wainwright 24th Annual Global Investment Conference on September 13, 2022, at 3:00 p.m. ET, in New York. The presentation will highlight Oramed’s innovations in oral drug delivery systems, particularly its lead candidate, ORMD-0801, aimed at transforming diabetes treatment. The presentation will be accessible for 90 days via a provided link.