Virios Therapeutics, Inc.

Good morning, and welcome to Varios Therapeutics, Inc., fourth quarter and year-end 2021 Financial Results Conference Call. At this time, all participants have been placed on the listen-only mode, and the floor will be open for 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' fourth quarter and year-end 2021 financial results, as well as to provide you with an update on the operational progress we have made during 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 fourth 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 statement section in our financial results press 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, everyone. The team and I are pleased to provide you with an update on the substantial operational progress the various therapeutics team has made over the past few months. First off, I'm very pleased to report that under the expert leadership of our chief medical officer, Dr. Mike Genro, our research team continues to recruit patients as planned into our landmark Phase 2B fibromyalgia clinical study, also known as FORTRESS. More specifically, we believe that we are well on pace to recruit over 400 patients into our ongoing FORTRESS Phase 2B study within the next 30 days. This will enable us to be fully enrolled in this landmark program by mid-April. Most importantly, this pace will allow us to remain on track to report top-line results of our fortress study program by September of this year. As you may recall, the primary endpoint for this landmark study will focus on the therapeutic effectiveness of our lead development candidate, IMC-1, a fixed-dose combination of famciclovir and celecoxib to reduce systemic fibromyalgia-related pain. IMC-1 pain reduction effectiveness will be measured using the same endpoint that was used in our successful Phase IIa fibromyalgia study. This pain endpoint was also used to approve the three treatments FDA has approved to date to treat patients with fibromyalgia. We will also assess IMC1's effectiveness 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 IIb 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 IMC-1 for intervals of one year or more, which we plan to do in our Phase III program. The chronic toxicology program is time to complete concurrently with our Fortress Phase IIb study, so we anticipate being able to propose a final Phase III program to the FDA at the conclusion of the current study. Furthermore, we recently 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 Holmes Center, a nonprofit interdisciplinary center of excellence that is 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 rate translates into well over 100 million COVID patients on a global basis and more than 20 million cases right here in the US. To put this in perspective, the US long COVID patient population is estimated to be almost double that of the existing fibromyalgia patient population. Our excitement to support the Bateman Horne Center to progress this new long COVID program is anchored to several key sentiments. This new exploratory research program represents an expansion of our combination antiviral pipeline into a second area of significant unmet need. Secondarily, this new long COVID-focused program, to the best of our knowledge, represents one of the first long COVID treatment programs in the U.S. We anticipate full enrollment in this exciting new program by quarter four of this year, with results projected in the first half of 2023. And finally, we want to reiterate that through prudent management of cash that our current cash position is expected to provide the company with operational runway through quarter one of 2023. Approximately six months following the planned announcements of our top line results from our ongoing Fortress Phase 2B study. With that update on our operational progress, let me turn it back over to our Senior Vice President of Finance, Angela Walsh, to discuss our quarter four and full year financial results.