Oramed’s Oravax Oral COVID-19 Vaccine to Begin Phase 1 Clinical Trial

Oramed Pharmaceuticals Inc. (Nasdaq: ORMP) (TASE: ORMP) (www.oramed,com), a clinical-stage pharmaceutical company focused on the development of oral drug delivery systems, announced that its majority-owned subsidiary, Oravax Medical Inc., has received clearance from the South African Health Products Regulatory Authority to begin patient enrollment in a first in human, Phase 1 clinical trial for its oral COVID-19 vaccine and preparations to begin the trials are now underway. South Africa was chosen because of the low incidence of the population having taken any form of COVID vaccine and because they have a world-class clinical trials infrastructure.

Oramed Pharmaceuticals Inc. has also closed $50 Million on its previously announced registered direct offering of 2,000,000 shares of the Company’s common stock, at a purchase price of $25 per share, priced at the market under Nasdaq Rules. Oramed Pharmaceuticals Inc. (Nasdaq: ORMP) (TASE: ORMP) tripled on the Nasdaq since April, rising from $ 8.45 to over $ 28.

Oravax’s virus-like particle (VLP) vaccine technology targets three SARS CoV-2 virus surface proteins, including proteins less susceptible to mutation, thus making the vaccine potentially more effective against current and future variants of the COVID-19 virus Oravax’s VLP vaccine technology is highly scalable and easily transferable.

Dr. Prabuddha Kundu, co-founder & MD at Premas Biotech said, “Oravax’s COVID-19 vaccine shall be the first of its kind going into human trials: its three antigenic proteins are designed to provide multipronged immune response against the virus and its variants. It can be administered orally to a much diverse population, spread across areas where logistics can be of concern. It has been shown to be very safe in animal studies, and additionally gives a mucosal IgA response apart from systemic response.”

Oravax’s oral COVID-19 vaccine offers an exciting potential solution to the COVID pandemic, whether as a booster or for the unvaccinated. An oral COVID-19 vaccine would eliminate several barriers to rapid, widescale distribution, potentially enabling people to administer the vaccine themselves at home.” stated Oramed CEO Nadiv Kidron. “Following this Phase 1 trial, our intention is to move forward with a Phase 2/3 trial for emergency use approval in relevant countries.” Kidron concluded.

Experts, including those at the World Health Organization, expect booster shots will be needed for both general and at-risk populations. If successful, an oral vaccine would offer enormous logistical, financial, and environmental benefits for the billions of people slated to receive them, particularly in parts of the world where access to healthcare is limited.

For more information on Oravax’s vaccine candidate, please visit
https://www.youtube.com/watch?v=rXIfr8imN6I&t=4s

About Oramed Pharmaceuticals Inc.

Oramed Pharmaceuticals Inc. (Nasdaq/TASE: ORMP) is a platform technology pioneer in the field of oral delivery solutions for drugs currently delivered via injection. Established in 2006, with offices in the United States and Israel, Oramed has developed a novel Protein Oral Delivery (PODTM) technology. Oramed is seeking to transform the treatment of diabetes through its proprietary lead candidate, ORMD0801, which is being evaluated in two pivotal Phase 3 studies and has the potential to be the first commercial oral insulin capsule for the treatment of diabetes. In addition, Oramed is developing an oral GLP-1 (Glucagon-like peptide-1) analog capsule.

For more information please visit  www.oramed.com

Oramed Company Contact: Joshua Hexter
Tel: 1-844-9-oramed  Email:  josh AT oramed.com

About Oravax Medical Inc

Oravax Medical Inc was established in 2021 by Oramed Pharmaceuticals Inc., the largest shareholder in Oravax along with Premas  Biotech, MyMD Pharmaceuticals, and certain other shareholders. The mission is to bring an oral COVID-19 vaccine to the market. Oravax combines cutting-edge vaccine technology acquired from Premas Biotech and the proprietary PODTM oral delivery technology of Oramed Pharmaceuticals Inc.

For more information please visit www.ora-vax.com

About Premas Biotech

Premas Biotech develops novel technologies and partners with global biopharmaceutical companies to build and develop novel biotherapeutic and vaccine candidates. Premas Biotech’s key focus areas are infectious diseases, cancer, metabolic disorders, and inflammation. Besides D-CryptTM, the difficult to express proteins expression platform, Premas Biotech’s leading technologies include Axtex-4DTM, an ex-vivo tissuoid generation platform, and C-QwenceTM, a fully human naive India based scFv antibody library.

For more information please visit www.premasbiotech.com

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