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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.
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.
Oramed Pharmaceuticals (Nasdaq: ORMP) announced the addition of Dr. Anne Peters to its Scientific Advisory Board on June 1, 2022. Dr. Peters, a leading expert in diabetes care, brings extensive experience in clinical diabetes programs and research. She has authored over 200 publications and has been involved in over 40 research studies. The company is advancing its pivotal Phase 3 studies for ORMD-0801, the first oral insulin capsule aimed at transforming diabetes treatment. This strategic appointment aims to enhance Oramed's scientific direction and development capabilities.
Oramed Pharmaceuticals (Nasdaq: ORMP) announced a significant achievement on May 24, 2022, as the US Patent and Trademark Office granted them a patent for methods and compositions aimed at treating diabetes mellitus. This patent covers oral pharmaceutical solutions that combine insulin with Glucagon-like Peptide 1 (GLP-1). Oramed is pioneering oral delivery systems to transform diabetes treatment, particularly with its lead candidate, ORMD-0801, currently in pivotal Phase 3 trials, along with the development of an oral GLP-1 analog capsule, ORMD-0901.
Oramed Pharmaceuticals (Nasdaq:ORMP) announced that CEO Nadav Kidron will present a company overview at the H.C. Wainwright Global Investment Conference on May 25, 2022, in Miami, Florida. The presentation is set for 12:00 p.m. E.T. and will be available for streaming for 90 days. Known for its oral drug delivery innovations, Oramed aims to transform diabetes treatment with its lead candidate, ORMD-0801, currently in Phase 3 trials.
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