Mr. Michael Frank reports

REVIVE THERAPEUTICS ANNOUNCES RESULTS OF PHASE 3 CLINICAL STUDY FOR BUCILLAMINE IN THE TREATMENT OF COVID-19

Revive Therapeutics Ltd. has released the results of the company's phase 3 clinical trial (NCT04504734) evaluating the safety and efficacy of oral bucillamine in patients with mild to moderate COVID-19. The study did not achieve statistical significance on the clinical end points. The study enrolled 713 patients with mild to moderate COVID-19.

Under the 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, there were no deaths and four hospitalizations, of which three were from the placebo arm and one from the bucillamine low-dose group (300 milligrams per day). No hospitalizations occurred in the bucillamine large-dose group (600 milligrams per day), which was the dose suggested by the independent data safety monitoring board (DSMB) at the first interim analysis for the postdose selection phase of the study. The one hospitalization event in the bucillamine arm occurred in the low-dose group (300 milligrams per day), which was the dose abandoned after the first interim analysis per the DSMB's recommendation. Although the number of hospitalization events was small, it demonstrated a positive trend in the post-dose-selection phase of the study. However, based on conditional power simulation to predict, under the trend observed in the data, the estimated chance of hitting statistical significance after study enrolment completion and final analysis was only 5.48 per cent. Thus, a very low probability of the study's success and the shift in COVID-19 clinical outcomes observed throughout the pandemic, where many patients with COVID-19 were either asymptomatic or experienced mild to moderate illness and could be managed in the outpatient setting, led the DSMB to recommend that the study be halted as announced on May 12, 2023.

The company evaluated additional study end points, including the COVID-19 clinical symptoms data (cough, fever, heart rate and oxygen saturation), time to polymerase chain reaction (PCR) resolution and quantitative PCR-based assessment of SARS CoV-2 viral load. There was no significant overall improvement trend between the bucillamine and placebo arms for observed clinical symptoms and viral load data. However, based on preliminary analyses, the data demonstrated that, for patients with oxygen saturation less than 96 per cent at baseline, bucillamine had a 29.1-per-cent improvement over placebo in time to normal oxygen saturation (SpO2). In addition, for time to PCR resolution, both bucillamine and placebo arms had a median of 11 days for time to PCR negative and stay negative. However, the bucillamine arm demonstrated a slightly shorter 75-per-cent percentile of 14 days versus 15 days in placebo to achieve PCR negative. Additional analyses of the study data are continuing, which could support certain strategic decisions on pursuing the development and commercialization of bucillamine.

Based on the study's data analyzed to date, the company is committed to advancing the clinical and commercial development of bucillamine and is pursuing the following strategic initiatives:

• Bucillamine 2.0 -- reformulate bucillamine in intravenous and inhaled versions to expand on its potential therapeutic utility targeting rare disorders such as ischemia-reperfusion injury (organ transplantation), acute respiratory distress syndrome and potential medical countermeasures (terrorist attack with a biological, chemical or radiological/nuclear material or a naturally occurring emerging disease) that may come with regulatory incentives awarded by the U.S. Food and Drug Administration (FDA), such as emergency use authorization, orphan drug, fast-track and breakthrough therapy designations;
• Pharmaceutical partnerships -- work with interested pharmaceutical partners to pursue potential domestic and international regulatory approvals and new clinical studies for infectious, inflammatory and respiratory disorders;
• Government support -- seek out potential funding opportunities offered by, but not limited to, the Biomedical Advanced Research and Development Authority (BARDA) and the Administration for Strategic Preparedness and Response (ASPR) at the U.S. Department of Health and Human Services (HHS).

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 U.S. 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.