Revive Therapeutics Ltd. announced an update on the Company's U.S. Food & Drug Administration (‘FDA') Phase 3 clinical trial (the ‘Study') (NCT04504734) evaluating the safety and efficacy of Bucillamine, an oral drug with anti-inflammatory and antiviral properties, in patients with mild to moderate COVID-19. Following the independent Data Safety Monitoring Board's recommendation that the Study be halted, as announced on May 12th, 2023, the Company has initiated the following activities: Communicating the Study's closure to clinical sites, vendors, Institutional Review Board (‘IRB'), and the FDA; Evaluating the Study's data, including the COVID-19 clinical symptoms data (i.e. cough, fever, heart rate, and oxygen saturation), time to polymerase chain reaction (‘PCR') resolution, quantitative PCR-based assessment of SARS CoV-2 viral load, laboratory values (hematology and serum chemistry), and safety assessments; and Planning the Study's close-out procedures and final reporting to the FDA and IRB. The Company plans to complete its initial evaluation of the Study's data with an independent biostatistician team by the end of June.

The Company believes that once it has completed the evaluation of the Study's data, it could support further discussions with the FDA 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 endpoints 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 CO.