Mr. Michael Frank reports

REVIVE THERAPEUTICS PROVIDES UPDATE OF PHASE 3 CLINICAL STUDY FOR BUCILLAMINE IN THE TREATMENT OF COVID-19

Revive Therapeutics Ltd. has provided an update on the company's U.S. Food & Drug Administration (FDA) phase 3 clinical trial (NCT04504734) to evaluate the safety and efficacy of bucillamine, an oral drug with anti-inflammatory and anti-viral properties, in patients with mild to moderate COVID-19.

On May 10, 2023, the independent data safety monitoring board (DSMB) met to review the study's postdose selection data under the current study's protocol primary end point -- the proportion of patients meeting a composite end point of hospitalization or death from time of first dose through day 28 following randomization. The DSMB recommended that the study be halted early due to statistical significance of the primary end point likely not going to be met should the study continue toward completion. Based on the recommendation from the DSMB, the company has halted the study and will now proceed to unblind and seek an evaluation of the study's data, including the COVID-19 clinical symptoms data (cough, fever, heart rate and oxygen saturation) to determine the potential next clinical and regulatory steps for bucillamine. The company believes that, once it has completed the evaluation of the study's data, it could support further discussions with the FDA (U.S. Food and Drug Administration) on potential new clinical studies and allow the opportunity to work with potential domestic and international pharmaceutical partners to determine a suitable regulatory pathway for approval of bucillamine based on the evaluated study's data.

The company is committed to advancing the clinical and commercial development of bucillamine and plans to pursue the following activities:

• Continue discussions with the FDA on a pathway for future potential clinical studies for regulatory approval under proposed new efficacy end points based on the evaluation of the study's data;
• Work with interested pharmaceutical partners to pursue potential domestic and international regulatory approvals and new clinical studies for long COVID-19 or COVID-19 symptom related conditions and various infectious, inflammatory and respiratory disorders;
• Develop reformulation strategies of bucillamine to expand on its potential therapeutic utility targeting rare disorders that may come with regulatory incentives awarded by the FDA, such as orphan drug (ischemia-reperfusion injury, cystinuria), fast-track and breakthrough therapy designations.

At this time, the company will only provide regular updates through press releases as information becomes available.

The company is not making any express or implied claims that its product has the ability to eliminate or cure COVID-19 (SARS-CoV-2 coronavirus) at this time. There can be no assurance that the company will proceed with the clinical development and regulatory approvals of bucillamine for COVID-19 in the United States and internationally.

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.

We seek Safe Harbor.