Virios Therapeutics, Inc.

Good morning, and welcome to the Varios Therapeutics Incorporated First Quarter 2022 Financial Results Conference Call. At this time, all participants have been placed on a listen-only mode. The floor will be open 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 Varios Therapeutics first quarter 2022 financial results, as well as to provide you with an update on the operational progress we have made during the past three 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 first 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 involve 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 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. Greg?

Thank you, Angela, and good morning, everyone. The team and I are very pleased to provide you with an update on the substantial operational progress Rheos Therapeutics Incorporated has made over the past few months. First off, I'm pleased to report that under the expert leadership of our Chief Medical Officer, Dr. Mike Gendro, our research team has now recruited 425 patients into our landmark Phase IIb Fibromyalgia Clinical Study, also known as FORTRESS. This exemplary effort keeps us on track to report top-line results from the FORTRESS study in September of this year, roughly four months from today's call. You may recall the primary endpoint for this study will focus on the therapeutic effectiveness of our lead development candidate, IMC1, a fixed-dose combination of famciclovir and Celecoftib to reduce systemic fibromyalgia-related pain. IMC-1 pain reduction effectiveness will be measured using the very same endpoint that was used in our successful Phase IIa fibromyalgia study. This pain endpoint was also used to approve the three treatments the FDA has approved to date to treat patients with fibromyalgia. We will also assess IMC-1's effects on a host of other key secondary outcomes measures related to both patient quality of care as well as safety. In parallel to our Fortress Phase 2b study, our chronic toxicology studies in two species are progressing as planned 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 3 clinical study program. the chronic toxicology program is timed to complete concurrently with our fortress trial. So we anticipate being able to propose a final phase three program to the FDA at the conclusion of our current study. As a complement to our ongoing fibromyalgia phase two B research program, this quarter we also announced that we will be progressing our second development candidate, IMC2, a combination of valciclovir and celecoxib, into clinical development. This exciting new exploratory trial will assess the potential of IMC2 to reduce fatigue and other symptoms associated with long COVID sequelae. This program is being supported through an unrestricted investigational grant to the Bateman Horne Center, a nonprofit interdisciplinary center of excellence advancing the diagnosis and treatment of chronic fatigue disorders, fibromyalgia, post-viral syndromes, and related comorbidities. For context, long COVID can be very debilitating and is estimated to affect up to 30% of patients who were previously infected with the COVID virus. This prevalence translates into well over 100 million long COVID patients on a global basis and more than 20 million cases right here in the United States. And finally, we want to convey that our current CAST position is expected to provide the company with operational runway to the end of this year, 2022. 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 quarter one financial results.