Virios Therapeutics, Inc.

Good morning, and welcome to the Varios Therapeutics, Inc. Second Quarter 2022 Financial Results Conference Call. At this time, all participants have been placed on a listen-only mode, and we will open the floor for your questions and comments after the presentation. 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, Senior Vice President of Finance and Treasurer for Varios 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 Vireo Therapeutics' second quarter 2022 financial results, as well as to provide you with an update on the operational progress we have made during the past six months. 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, Ralph Groswald, our Senior Vice President of Operations, is 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 from the information expressed or implied by these forward-looking statements. For more information regarding such risks and uncertainties, 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 statement 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 very much, Angela, and good morning, everyone. The team and I are exceptionally excited to provide you with an update on the substantial operational progress Rios Therapeutics Incorporated has made over the past few months. First and foremost, I'm exceptionally pleased to report that under the expert leadership of our Chief Medical Officer, Dr. Mike Gendron, in July 2022, just one month ago, our final patients completed their 16 weeks of treatment in our landmark 425-patient Phase IIb Fibromyalgia Clinical Study. This study is also known as the Fortress Study. Now that all patients have completed their participation in this study, our clinical team and our vendors are working hard to enter final data into the electronic data system to resolve any outstanding queries and to begin the cleaning process leading to database lock next month. Once the database is locked, the data will be transferred to our statistical vendor along with the unblinding codes to allow the production of the unblinded Phase IIb top-line results. We are really excited to maintain our projections to report Phase IIb fibromyalgia results next month. You'll likely recall the primary endpoint for this study will focus on the therapeutic effectiveness of our lead development candidate, IMC1, which as I'm sure you know is a fixed-dose combination of femciclovir and celecoxib to reduce systemic fibromyalgia-related pain. IMC-1 pain reduction effectiveness will be measured using the very same endpoint that was used in our previously successful Phase IIa fibromyalgia study. This pain endpoint was also used to assess the effectiveness of the three drugs for the treatment of fibromyalgia the Food and Drug Administration has approved here in the U.S. We will also assess IMC1's effects on a host of other key secondary outcomes measures related to both quality of care as well as safety. In parallel to our fortress phase 2b study, our chronic toxicology studies in two species have now completed under the direction of our Senior Vice President of Operations, Ralph Groswold. The results of 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 III clinical study program. Results from these chronic toxicology studies are an important element of the package we intend to submit to FDA to facilitate our future Phase III program discussions. As a complement to our ongoing fibromyalgia Phase IIb research program, we recently announced that we would be progressing a second development program featuring a combination of valciclovir and celecoxib into clinical development. This exciting new exploratory trial will assess the potential of this antiviral combination to reduce fatigue and other symptoms associated with long COVID sequelae. This program is being supported through an unrestricted investigational grant to the Bateman Horn Center, a nonprofit interdisciplinary center of excellence advancing the diagnosis and treatment of chronic fatigue disorders, fibromyalgia, post-viral syndromes, and related comorbidities. We project enrollment of patients for the balance of 2022 in this program with results from the program presently projected for the first half of 2023. For context, long COVID can be very debilitating. It has been estimated to affect approximately 20% of patients who were previously infected with the COVID virus. This prevalence rate translates into well over 100 million long COVID patients on a global basis. Further research will help determine how many patients infected with new variants of COVID will progress to develop long COVID sequelae. And finally, we want to convey that our current cash position is expected to provide the company with operational runway through the end of 2022. With that brief update on our operational progress, let me turn it over to our Senior Vice President, Angela Walsh, to discuss our Q2 financials.