February 27, 2024
Dear Virios (VIRI) Shareholders,
On behalf of the Virios directors and the executive team, we would like to provide a corporate progress report on several key topics as we proceed through the first quarter of 2024.
Special Shareholder Meeting: On March 1, 2024, we will hold a special shareholder meeting, whereby we are requesting your approval to execute a reverse stock split some time over the course of the next 12 months. In our outreach to shareholders in connection with the meeting, we heard concerns about whether and when the reverse stock split would be implemented, if approved, and we want to address those concerns here. Approval of this proposal does not commit the Company to the execution of a reverse stock split. It does provide maximum strategic optionality moving forward, including the ability to execute strategic transactions and to enable future fund raising.
Indeed, the Board’s unanimous view is that the implementation of the reverse stock split should be deferred until after the Company has clarity on the results of the current Long-COVID (“LC”) study being independently run via an unrestricted grant to the Bateman Horne Center. Results from this study are currently projected to be reported in the second half of 2024.
Director Fee and Management Team 10% Salary Cut: We work diligently to minimize operational expenses and deploy our cash to fund value creating research as evidenced by the fact that we operate VIRI as a public company with four full-time employees. In order to underscore the management team’s alignment as fellow shareholders and to emphasize our commitment to long-term success and value creation, all of Virios’ employees have agreed to a 10% salary compensation reduction in exchange for future vesting stock options. In addition, our directors have also agreed to a 10% reduction in cash director fees.
IMC-2 Long-COVID Development Program: We have clarity from the Food and Drug Administration (“FDA”) on the development requirements for advancing IMC-2 (combination of valacyclovir and celecoxib) into Phase 2 development as a treatment for LC symptoms. As noted above, we expect to receive top line results from the ongoing Bateman Horne Center independent investigator supported study in the second half of 2024. There continues to remain a high unmet medical need for treating LC symptoms. Recently, a USA Today Health article reported that federal estimates suggest at least 16 million Americans have LC and as many as 4 million of them are disabled by it. There are currently no FDA approved LC treatments. We are excited that IMC-2 has the potential to be one of the first approved treatments for LC and are exploring various means by which to fund execution of the important Phase 2b IMC-2 trial.
IMC-1 Fibromyalgia Development Program: We reached alignment with the FDA on the IMC-1 (combination of famciclovir and celecoxib) Phase 3 development program for treatment of fibromyalgia. We continue to be engaged with potential external entities who have an interest in partnering for this important program.
The Virios team remains committed to delivering on the promise of combination antiviral therapy to address a multitude of serious health issues and illnesses. We appreciate your support.