Oramed Pharmaceuticals Inc Stock Price, News & Analysis

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.

Oramed Pharmaceuticals announced that its Phase 3 trial, ORA-D-013-2, has reached over 50% enrollment of the targeted 450 patients for its oral insulin capsule, ORMD-0801, aimed at treating type 2 diabetes. This trial follows the completion of enrollment for the larger ORA-D-013-1 trial, which involved 710 patients. The trials mark the first Phase 3 oral insulin studies conducted under FDA oversight. The primary goal of ORA-D-013-2 is to assess the efficacy of ORMD-0801 compared to placebo in improving glycemic control over a 26-week period.

Oramed Pharmaceuticals Inc. (Nasdaq: ORMP) announced that it will provide a company overview and updates at the Canaccord Genuity Annual Growth Conference in Boston, Massachusetts, from August 8-11, 2022. The presentation is scheduled for August 10 at 4:30 p.m. E.T. and will be webcasted, with a link available on the Oramed website 48 hours prior. Oramed focuses on oral drug delivery systems and aims to revolutionize diabetes treatment with its lead candidate, ORMD-0801, currently in pivotal Phase 3 studies.

Oramed Pharmaceuticals reported a strong financial position with $169 million in cash and no debt as of March 31, 2022. The company expects pivotal Phase 3 oral insulin data in January 2023 and Phase 2 NASH data soon. ORMD-0801 aims to revolutionize type 2 diabetes treatment, offering a non-injection method beneficial to patients. Additionally, Oravax's Phase 1 clinical trial for an oral COVID-19 vaccine is underway in South Africa, with top-line data expected later this year. Oramed feels well-positioned for upcoming milestones despite broader market challenges.