WHO reports 650 probable cases of acute hepatitis of unknown aetiology in children from 33 countries

Company received FDA orphan drug designation for Bucillamine in the prevention of ischemia-reperfusion injury during liver transplantation and Cannabidiol for autoimmune hepatitis

Company intends to move its head office to the US to better support growing drug programs with Bucillamine, Cannabidiol, and Psilocybin

TORONTO, May 31, 2022 – Revive Therapeutics Ltd. (“Revive” or the “Company”) (OTCQB: RVVTF) (CSE: RVV) (FRANKFURT:31R), a specialty life sciences company focused on the research and development of therapeutics for medical needs and rare disorders, today announced that in light of the growing cases of acute hepatitis in children reported by the World Health Organization (“WHO”), the Company will advance its drug pipeline for inflammatory liver disorders including Bucillamine in the prevention of ischemia-reperfusion injury during liver transplantation and Cannabidiol for autoimmune hepatitis.

As of May 26, 2022, six hundred and fifty probable cases of acute hepatitis of unknown aetiology in children have been reported to WHO from 33 countries in five WHO Regions between 5 April and 26 May 2022. The aetiology of this severe acute hepatitis remains unknown and under investigation; as the cases are more clinically severe and a higher proportion develops acute liver failure than previous reports of acute hepatitis of unknown aetiology in children. At least 38 children have required a liver transplant, nine have died, and 99 cases pending classification, according to a statement from WHO (https://www.who.int/emergencies/disease-outbreak-news/item/DON-389).

The Company has a diverse product pipeline in development for rare inflammatory liver disorders, including receiving FDA orphan drug designation for Bucillamine to prevent ischemia-reperfusion injury during liver transplantation and Cannabidiol for autoimmune hepatitis. Revive has entered into a clinical trial agreement with The Trustees of Indiana University (“TIU ”) to develop and manage a proposed Phase 2 clinical study using Cannabidiol as an adjunct therapy for difficult to treat autoimmune hepatitis. 

Revive will also explore the use of Bucillamine for liver transplantation with clinical investigators on the protocol design and regulatory pathway to obtain FDA acceptance to proceed with a clinical study under an investigational new drug application. The Company believes the use of Bucillamine during liver transplantation has the potential to be a safe and effective approach to address the unmet medical need for a novel strategy to limit or prevent ischemia-reperfusion injury. Bucillamine, a cysteine derivative that contains two donatable thiol groups, in the context of ischemia-reperfusion injury is capable of replenishing the thiol group in glutathione, thereby reactivating this endogenous defense against oxidant injury. Bucillamine also has the potential to improve graft function and patient outcome by preventing or lessening IRI.

In addition, the Company intends to move its head office to the US to better access and support growing drug programs with Bucillamine and other products.

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 awarded 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 therapeutics in various diseases and disorders. Revive’s cannabinoid pharmaceutical portfolio focuses on rare inflammatory diseases and the company was granted FDA orphan drug status designation for the use of Cannabidiol (CBD) to treat autoimmune hepatitis (liver disease) and to treat ischemia and reperfusion injury from organ transplantation. For more information, visit www.ReviveThera.com.

For more information, please contact:

Michael Frank
Chief Executive Officer
Revive Therapeutics Ltd.
Tel: 1 888 901 0036
Email: mfrank@revivethera.com
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.

Cautionary Statement

This press release contains ‘forward-looking information’ within the meaning of applicable Canadian securities legislation. These statements relate to future events or future performance. The use of any of the words “could”, “intend”, “expect”, “believe”, “will”, “projected”, “estimated” 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 belief or assumptions as to the outcome and timing of such future events. Forward looking information in this press release includes information with respect to the Company’s cannabinoids, psychedelics and infectious diseases programs. Forward-looking information is based on reasonable assumptions that have been made by Revive at the date of the information and is subject to known and unknown risks, uncertainties, and other factors that may cause actual results or events to differ materially from those anticipated in the forward-looking information. Given these risks, uncertainties and assumptions, you should not unduly rely on these forward-looking statements. The forward-looking information contained in this press release is made as of the date hereof, and Revive is not obligated 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, 2021, which has been filed on SEDAR and is available under the Company’s profile at www.sedar.com.