Revive Therapeutics Announces Updated Type-C Meeting to Discuss Amended Phase 3 Clinical Study Protocol Agreement for Bucillamine in the Treatment of COVID-19

Revive Therapeutics Ltd.

TORONTO, Nov. 24, 2022 (GLOBE NEWSWIRE) — Revive Therapeutics Ltd. (“Revive” or the “Company”) (OTCQB: RVVTF) (CSE: RVV) (FRANKFURT: 31R), a specialized life sciences company focused on the research and development of therapies for the medical needs and rare diseases, today announced that it will submit the Type C meeting application package to the United States Food & Drug Administration (“FDA”) by mid-December 2022, which will outline the plan for global development and pre-dose screening data supporting the Company’s latest revised Phase 3 clinical trial endpoints (the “Study”) (NCT04504734) to assess the safety and efficacy of the bucillamine, an oral medication with anti-inflammatory and antiviral properties, in patients with mild to moderate COVID-19. Following submission of the Type C meeting request package, the Company expects to hear from the FDA on a firm date for the meeting.

The company makes no express or implied representation that its product has the ability to eliminate or cure COVID-19 (coronavirus SARS-2) at this time.

About Revive Therapeutics Ltd.

Revive is a life sciences company focused on the research and development of therapeutics for infectious diseases and rare disorders, and it is prioritizing drug development efforts to take advantage of several regulatory incentives granted by the FDA such as Orphan Drug, Fast Track, Breakthrough Therapy and Rare Pediatric Disease Designations. Currently, the company is exploring the use of bucillamine for the potential treatment of infectious diseases, with an initial focus on severe influenza and COVID-19. With its acquisition of Psilocin Pharma Corp., Revive is advancing the development of psilocybin-based therapies in various diseases and disorders. Revive’s cannabinoid pharmaceutical portfolio focuses on rare inflammatory diseases and the company has been granted orphan drug status by the FDA for the use of cannabidiol (CBD) to treat autoimmune hepatitis (liver disease) and to treat ischemia and reperfusion injury resulting from organ transplantation. For more information, visit www.ReviveThera.com.

For more information please contact:

Michael Franck
Chief executive officer
Revive Therapeutics Ltd.
Tel: 1 888 901 0036
E-mail: [email protected]
Website: www.revivethera.com

Neither the Canadian Securities Exchange nor its regulation services provider has reviewed or accepts responsibility for the adequacy or accuracy of this release.

Caution

This press release contains “forward-looking information” within the meaning of applicable Canadian securities laws. These statements relate to future events or future performance. Use of any of the words “could”, “intend”, “expect”, “believe”, “will”, “project”, “estimate” and similar expressions and statements relating to matters that are not historical facts are intended to identify forward-looking information and are based on Revive’s current beliefs or assumptions about the outcome and timing of such future events. Forward-looking information in this press release includes information regarding the Company’s cannabinoid, psychedelic and infectious disease programs. Forward-looking information is based on reasonable assumptions made by Revive as of the date of the information and is subject to known and unknown risks, uncertainties and other factors that may cause actual results or events differ significantly from those anticipated in the report. forward-looking information. Given these risks, uncertainties and assumptions, you should not place undue reliance on these forward-looking statements. The forward-looking information contained in this press release is made as of the date hereof, and Revive is under no obligation to update or revise any forward-looking information, whether as a result of new information, future events or otherwise, except as required by applicable securities laws. The foregoing statements expressly qualify any forward-looking information contained herein. Reference is made to the risk factors disclosed under the heading “Risk Factors” in the Company’s Annual MD&A for the fiscal year ended June 30, 2022, which has been filed on SEDAR and is available under the Company’s profile. Company at www.sedar.com.

. Revive Therapeutics announces a update meeting type for discuss laccord modified protocol the clinical study phase for bucillamine in treatment COVID19

NEXT COVID-19 cases rise in Florida after Thanksgiving holiday