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Biopharma Launches COVID Vaccine Program in South Africa & Mexico

Source: Streetwise Reports

December 1, 2021 (Investorideas.com Newswire) Oramed Pharmaceuticals' oral vaccine offers "convenience and safety advantages as well as coverage of emergent variant strains," noted a Nov. 29, 2021 H.C. Wainwright & Co. report.


New developments regarding Oramed Pharmaceuticals Inc.'s (ORMP:NASDAQ) COVID-19 vaccine are advancing the program outside the U.S., and the company continues making strides in testing its insulin product in types 1 and 2 diabetes, reported H.C. Wainwright & Co. analyst Ram Selvaraju in a Nov. 29 research note.

Also, H.C. Wainwright raised its 12-month price target on Israel-based Oramed to $32 per share from $17 after revising its model assumptions pertaining to the biopharma's lead drug candidates, ORMD-0801 and ORMD-0901.

Regarding its COVID-19 vaccine, Selvaraju reported that Oramed's subsidiary, Oravax Medical Inc., is preparing to begin a Phase 1 trial of its oral, virus-like particle vaccine technology in South Africa after recently receiving approval to proceed.

The vaccine "targets three SARS-CoV-2 coronavirus 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," Selvaraju pointed out.

In addition, Oravax recently formed a 50/50 joint venture with Genomma Lab to develop and commercialize Oravax's COVID-19 vaccine candidate in Mexico. Based there, Genomma is a pharmaceutical and personal care products firm.

"We believe that there remains ample room for additional vaccine approaches, particularly those that offer both convenience and safety advantages as well as coverage of emergent variant strains, as could be achieved with Oravax," Selvaraju commented. "The total COVID-19 vaccine market could approach $100 billion in 2022, in our view."

As for Oramed's flagship product, an oral insulin capsule, ORMD-0801, the biopharma "continues to achieve key milestones," Selvaraju reported.

Specifically, the company has enrolled and randomized more than three-quarters of the 675 patients to be included in its most advanced trial, the Phase 3 ORA-D-013-1. The study will continue evaluating ORMD-0801 in type 2 diabetes.

The ORMD-0801 trial consists of two components. One, ORA-D-013-1, taking place at 75 U.S. locations, will test the insulin product in patients who are taking two or three oral glucose-lowering agents.

The second component, ORA-013-2, will test ORMD-0801 in 450 patients, in the U.S., Europe and Israel, who have subpar glycemic control and are either are on a modified diet but no medication or are on Metformin as sole treatment.

As far as a timeline to market for ORMD-0801, Selvaraju outlined that commercial launch could occur in the U.S. and Europe in 2024. Leading up to that, completion of enrollment and data readout should occur for both Phase 3 studies next year. Oramed could apply for a biologics license application for the insulin product in 2023, and the U.S. Food and Drug Administration could approve it in 2024.

Also, Selvaraju noted, H.C. Wainwright expects Oramed to partner on commercialization of ORMD-0801 outside of China.

"Revenue to Oramed derived from sales of ORMD-0801 could thus drive meaningful upside to our forecasts," he added.

Disclosures:

1) Doresa Banning compiled this article for Streetwise Reports LLC and provides services to Streetwise Reports as an independent contractor. She or members of her household own securities of the following companies mentioned in the article: None. She or members of her household are paid by the following companies mentioned in this article: None.

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Important Disclaimers for H.C. Wainwright & Co., Oramed Pharma. Inc., Nov. 29, 2021

This material is confidential and intended for use by Institutional Accounts as defined in FINRA Rule 4512(c). It may also be privileged or otherwise protected by work product immunity or other legal rules.

H.C. WAINWRIGHT & CO, LLC RATING SYSTEM: H.C. Wainwright employs a three tier rating system for evaluating both the potential return and risk associated with owning common equity shares of rated firms. The expected return of any given equity is measured on a RELATIVE basis of other companies in the same sector. The price objective is calculated to estimate the potential movements in price that a given equity could reach provided certain targets are met over a defined time horizon.
Price objectives are subject to external factors including industry events and market volatility.

Investment Banking Services include, but are not limited to, acting as a manager/co-manager in the underwriting or placement of securities, acting as financial advisor, and/or providing corporate finance or capital markets-related services to a company or one of its affiliates or subsidiaries within the past 12 months.

H.C. Wainwright & Co, LLC (the "Firm") is a member of FINRA and SIPC and a registered U.S. Broker-Dealer.

I, Raghuram Selvaraju, Ph.D. , certify that 1) all of the views expressed in this report accurately reflect my personal views about any and all subject securities or issuers discussed; and 2) no part of my compensation was, is, or will be directly or indirectly related to the specific recommendation or views expressed in this research report; and 3) neither myself nor any members of my household is an officer, director or advisory board member of these companies.

A research analyst of the firm and/or the research analyst's household has a financial interest in and own the securities of BioNTech SE (including, without limitation, any option, right, warrant, future, long or short position).

As of October 31, 2021 neither the Firm nor its affiliates beneficially own 1% or more of any class of common equity securities of BioNTech SE.

Neither the research analyst nor the Firm knows or has reason to know of any other material conflict of interest at the time of publication of this research report.

None of the research analysts or the research analyst's household has a financial interest in the securities of Oramed Pharmaceuticals, Inc. (including, without limitation, any option, right, warrant, future, long or short position).

As of October 31, 2021 neither the Firm nor its affiliates beneficially own 1% or more of any class of common equity securities of Oramed Pharmaceuticals, Inc.. Affiliates of H.C. Wainwright beneficially own 1% or more of the common equity securities of Oravax Medical Inc., a joint-venture that is majority-owned by Oramed Pharmaceuticals Inc.

Neither the research analyst nor the Firm knows or has reason to know of any other material conflict of interest at the time of publication of this research report.

The research analyst principally responsible for preparation of the report does not receive compensation that is based upon any specific investment banking services or transaction but is compensated based on factors including total revenue and profitability of the Firm, a substantial portion of which is derived from investment banking services.

The firm or its affiliates received compensation from Oramed Pharmaceuticals, Inc. for non-investment banking services in the previous 12 months.

The Firm or its affiliates did not receive compensation from BioNTech SE for investment banking services within twelve months before, but will seek compensation from the companies mentioned in this report for investment banking services within three months following publication of the research report.

The Firm or its affiliates did receive compensation from Oramed Pharmaceuticals, Inc. for investment banking services within twelve months before, and will seek compensation from the companies mentioned in this report for investment banking services within three months following publication of the research report.

H.C. Wainwright & Co., LLC managed or co-managed a public offering of securities for Oramed Pharmaceuticals, Inc. during the past 12 months.

The Firm does not make a market in Oramed Pharmaceuticals, Inc. and BioNTech SE as of the date of this research report. The securities of the company discussed in this report may be unsuitable for investors depending on their specific investment objectives and financial position. Past performance is no guarantee of future results. This report is offered for informational purposes only, and does not constitute an offer or solicitation to buy or sell any securities discussed herein in any jurisdiction where such would be prohibited. This research report is not intended to provide tax advice or to be used to provide tax advice to any person. Electronic versions of H.C. Wainwright & Co., LLC research reports are made available to all clients simultaneously.

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