-Virios’ IMC-1 Phase 3 Proposed Program is Considered Acceptable based on Initial FDA Feedback Pending Review of the Final Chronic Toxicology Program Results-

-Final Toxicology Results to be Submitted to FDA in May 2023-

-Company will Provide Material Updates on Further FDA Guidance as Process Proceeds for This Important FDA “Fast-track” Designated Program-

Virios Therapeutics, Inc. (Nasdaq: VIRI) (the “Company”), a development-stage biotechnology company focused on advancing novel, combination antiviral therapies to treat debilitating chronic diseases, including fibromyalgia (“FM”), announced a program summary based on initial feedback from the U.S. Food & Drug Administration (“FDA”) on its Phase 3 FM program proposal featuring its lead development candidate IMC-1. IMC-1 is a novel, proprietary, fixed dose combination of famciclovir and celecoxib designed to synergistically suppress herpes virus replication, with the end goal of reducing virally promoted fibromyalgia disease symptoms.

Key IMC-1 Phase 3 Program Proposal Highlights

• The proposed Phase 3 program consists of four primary components: two adequate and well-controlled clinical studies, one of which would be a full factorial design with each of the individual components of IMC-1 (famciclovir and celecoxib) as separate comparator arms, a long-term safety trial, and a pharmacokinetic/food effect study.
• Based on data from the recently completed FORTRESS Phase 2b trial, the Company proposed a Phase 3 development program targeting community-based FM patients, who have not participated in prior FM trials.
• Initial FDA feedback was that the Company’s Phase 3 proposal is acceptable, subject to review of the final results from its recently completed chronic toxicology program. The Company will submit the final toxicology reports and associated data in May 2023.
• An updated IMC-1 Phase 3 program proposal, responsive to FDA guidance, will also be provided once FDA completes its review of the chronic toxicology reports.

There is significant unmet medical need in the FM patient community, as reflected by the fact that existing treatments do not work for all patients and no new pharmaceutical treatments have been approved by FDA to treat FM over the past decade. The Company will provide material progress updates as it continues to work with FDA with the goal of advancing IMC-1 into Phase 3 development as a potential new treatment option for the FM patient community.