Virios Therapeutics, Inc.

Good morning and welcome to Vireo Therapeutics' second quarter 2021 financial results conference call. Please be advised that today's call is being recorded at the company's request. At this time, I'd like to turn the call over to Angela Walsh, SVP, Finance, Treasurer, Vireo 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 various therapeutics, second quarter financial results, as well as to provide you with an update on the operational progress we have made during the first six months of 2021. Please note that our financial results press release is now available on our website. We'll start today's call with our CEO, Greg Duncan, providing you with a brief update on our corporate progress during the past quarter. and then I will return to review our second quarter financial results. In addition, our Chief Medical Officer, Dr. Mike Genro and Ralph Groswald, our VP of Operations, are with us for the question and answer portion of the call. 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 uncertainties that can cause actual results to differ materially. 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 statement section in our financial results release issued this morning and the risk factors in the company's current and subsequent filings with the SEC. It is now my pleasure to turn the call over to our CEO, Greg Duncan. Greg?

Thank you very much, Angela, and good morning, everyone. We appreciate you joining us on the call today as we are very pleased to provide you with an update on the substantial progress the Varios Therapeutics team has made since our last quarterly update. In May, we dosed the first patient in our landmark Phase IIb Fibromyalgia Trial. We refer to this trial as the FORTRESS Trial, which stands for Fibromyalgia Outcome Research Trial Evaluating Synergistic Suppression of HSV-1, or herpes simplex type 1, as it's more formally known. The primary endpoint for this trial will focus on fibromyalgia patients' pain reduction, and we're using the endpoint that has been used to assess all FDA-approved fibromyalgia treatments to date. Under the expert leadership of our clinical team, I am pleased to report that all 41 sites participating in the FORTRESS trial are fully operational and actively recruiting patients. Based on this progress, we can reconfirm our prior guidance that we expect to report out top-line results from the FORTRESS Phase 2b trial in mid-2022. In parallel to the FORTRESS Phase 2b trial, our chronic toxicology studies in two species are progressing as planned. These studies will be required by regulatory authorities before we are permitted to dose study participants with IMC1 for intervals of one year or more, which we plan to do in our Phase 3 program. The chronic toxicology program is timed to complete by the time the FORTRESS study ends so that we will be able to propose a final Phase 3 program to FDA at the conclusion of our current study. And finally, we are reaffirming that our current cash should provide the company with operational runway to the end of 2022, a full six months following the planned announcement of the top-line results from the ongoing fibromyalgia Phase 2b trial. With that brief update on our operational progress, let me turn it back over to our Senior Vice President of Finance, Angela Walsh, to discuss our Q2 financial results. Angela?