Virios Therapeutics, Inc.

Angela Walsh, Senior Vice President of Finance and Treasurer of Vireos Therapeutics. Please proceed, Angela.

Thank you. Good morning, everyone, and thank you for joining us on today's conference call. We are pleased to be with you today to discuss Vireos Therapeutics second quarter financial results and corporate update. Please note that our financial results press release is now available on our website. Before we begin, I'd like to remind everyone that statements made during this conference call will include forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, which involved risks and insurgencies that can cause actual results to differ materially from the information expressed or implied by these forward-looking statements. For more information regarding such risks and insurgencies, please see the risk factors outlined in the company's filings with the SEC. Any forward-looking statements are made only as of today, and we disclaim any obligation to update these forward-looking statements other than as required by law. Please see the forward-looking statements section in our financial results release issued this morning for more information. It is now my pleasure to turn the call over to our CEO, Greg Duncan.

Thank you, Angela, and good morning to all of you joining us on today's quarter two 2023 earnings update. We have three specific topics to cover on today's call. First, I will begin with an update on our submission to the Food and Drug Administration, or FDA as you know it, to progress our lead development candidate, IMC1, into phase three development as a possible treatment for the millions of patients who suffer from the consequences of fibromyalgia. Second, we are very pleased to have our chief medical officer, Dr. Mike Gendro, on the call today to review the recently announced very encouraging results we received from our exploratory long COVID study sponsored by Vireo Therapeutics and conducted by the Bateman Horne Center in Salt Lake City, Utah. And finally, Angela Walsh will provide you with a summary of our quarter two financials. Following the review of these topics, we will open up the call to questions. Let me start with an update on our IMC1 phase three submission to the FDA. As announced, Just yesterday, the Food and Drug Administration communicated that following their initial review of the various therapeutics chronic toxicology program, the program studies appear adequate to support the safety of the IMC-1 dosage proposed by the company for chronic use to treat patients with fibromyalgia. With this critical feedback in hand, our goal is to initiate our proposed pharmacokinetic and food effects study later this year. while concurrently submitting an updated phase three program outline and all of the associated study protocols for final FDA review. This planned PK and food effect study in males and females will be executed as a precursor to the fibromyalgia studies with an updated IMC1 dose and formulation, which is intended to enable the company to take full advantage of all of the efficiencies afforded with the utilization of the 505B2 regulatory pathway. The forthcoming Phase III Fibromyalgia Program proposal consists of three main study components. The plan is to execute two adequate and well-controlled studies. One is a head-to-head study comparing IMC1 and placebo, and the second trial will be a full factorial design with each of the individual components of IMC1, Bamsiclovir and Celecoxib as separate comparator arms, and a long-term extension study. Based on data from the recently completed Fortress Phase 2b trial, we have proposed a Phase 3 development program targeting community-based fibromyalgia patients who have not, have not participated in prior fibromyalgia research trials. Alternatively stated, we plan to exclude or more formally screen out fibromyalgia patients who have participated in recent fibromyalgia research studies over the past several years. Following completion of the aforementioned PK study, the goal will be to begin enrollment in the first Fibromyalgia Phase III Safety and Efficacy Study in mid-2024. I would be happy to answer questions about the Phase III plan during the question and answer session of today's call. It is now my pleasure to turn the discussion over to our Chief Medical Officer, Dr. Gendro, to share what we have learned from the recently completed long COVID study. The data from this exploratory study underpins our belief that IMC2, a fixed-dose combination of valsiclovir and celecoxib, has potential to improve the symptoms or sequelae, as they are more formally known, associated with the diagnosis of long COVID. Take it away, Mike. All right.