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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 that CEO Nadav Kidron will present a company overview at the Cantor Fitzgerald Global Healthcare Conference, occurring virtually from September 27-30, 2021. Kidron's presentation is scheduled for September 30, 2021, at 12:00 P.M. Eastern time. Oramed is focused on developing innovative oral drug delivery systems, notably for diabetes treatment, with their lead candidate ORMD-0801 under pivotal Phase 3 studies.
Oramed Pharmaceuticals (Nasdaq: ORMP) has achieved over 50% patient enrollment in its Phase 2 trial for ORMD-0801, an oral insulin capsule aimed at treating non-alcoholic steatohepatitis (NASH) in Type 2 diabetes patients. The trial will measure key efficacy endpoints like liver fat content and fibrosis after 12 weeks. NASH represents a significant unmet medical need, with no current approved treatments. The global NASH drug market is projected to reach $84 billion by 2029, highlighting the potential for ORMD-0801 to address this issue.
Oramed Pharmaceuticals (Nasdaq: ORMP) announced that CEO Nadav Kidron will present a company overview at the H.C. Wainwright 23rd Annual Global Investment Conference on September 13, 2021. This virtual event will start at 7:00 a.m. Eastern time and can be viewed online. Oramed is focused on oral drug delivery, particularly its lead candidate ORMD-0801, which aims to be the first commercial oral insulin capsule for diabetes treatment, currently in pivotal Phase 3 studies.
Oramed Pharmaceuticals has announced the enrollment of over 25% of its target of 450 patients in the Phase 3 ORA-D-013-2 trial for its oral insulin capsule, ORMD-0801, aimed at treating type 2 diabetes. This trial is one of two ongoing Phase 3 trials approved by the FDA. The study will assess the efficacy of ORMD-0801 in improving glycemic control compared to placebo over 26 weeks, with a secondary aim to maintain control over 52 weeks. Results from the concurrent ORA-D-013-1 trial, which enrolled nearly 65% of its 675 patients, are expected in 2022.
Oramed Pharmaceuticals Inc. (Nasdaq: ORMP) announced the publication of a study in Diabetes, Obesity, and Metabolism evaluating the efficacy and safety of its oral insulin candidate ORMD-0801 for type 2 diabetes. The trial met its primary endpoint, demonstrating that ORMD-0801 effectively managed nighttime and 24-hour glycemia levels without increasing hypoglycemia risks compared to placebo. This study supports Oramed's efforts to develop the first commercial oral insulin capsule, as it undergoes two pivotal Phase 3 trials.
On August 9, 2021, Oramed Pharmaceuticals (Nasdaq: ORMP) announced that Chief Commercial Officer Michael Rabinowitz will present a company overview at the Canaccord Genuity's 41st Annual Growth Conference, taking place virtually from August 10-12, 2021. Rabinowitz's presentation is scheduled for August 12 at 11:30 a.m. Eastern and can be viewed online. Oramed is a clinical-stage pharmaceutical company specializing in oral drug delivery systems, focusing on its lead candidate ORMD-0801, aimed at transforming diabetes treatment.
Oramed Pharmaceuticals Inc. (Nasdaq: ORMP) announced that its majority-owned company Oravax Medical will present its oral COVID-19 vaccine during a Keynote Talk at the Arena International Vaccines Virtual Conference on August 5, 2021. The presentation, led by Oramed CEO Nadav Kidron, will cover the development of the world's first triple antigen oral SARS-CoV-2 vaccine that targets three virus surface proteins. This innovative approach aims to enhance effectiveness against current and future COVID-19 variants.
Oramed Pharmaceuticals Inc. has appointed Michael Rabinowitz as the first Chief Commercial Officer to lead its commercial strategy starting August 1, 2021. This move comes as the company advances its Phase III trials for ORMD-0801, an innovative oral insulin candidate. Rabinowitz brings over 20 years of experience from Merck, where he successfully launched products globally. His appointment is seen as a strategic step towards enhancing Oramed's commercialization efforts.
Oramed Pharmaceuticals Inc. (NASDAQ: ORMP) announced significant updates regarding its majority-owned company, Oravax Medical Inc., which is advancing an oral COVID-19 vaccine utilizing proprietary protein oral delivery technology. Preclinical trials are underway against COVID-19 variants, with plans to initiate clinical trials in Israel soon. The vaccine targets multiple viral proteins to enhance its efficacy against current and future variants. Additionally, Oravax has out-licensed the rights for an injectable version of the vaccine in India to Premas Biotech, aiming to address urgent vaccination needs.
Oramed Pharmaceuticals Inc. (NASDAQ: ORMP) will join the U.S. small cap Russell 2000® and broad-market Russell 3000® Index, effective June 28, 2021. This inclusion follows the annual reconstitution and provides significant visibility among institutional investors, as approximately $10.6 trillion is benchmarked against Russell's indexes. Oramed specializes in oral drug delivery systems, aiming to innovate diabetes treatment with its lead candidate, ORMD-0801, targeting the development of the first commercial oral insulin capsule.