Virios Therapeutics, Inc.

Good morning and welcome to Vireos Therapeutics Third 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, SBP Finance Treasurer, 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 Vireo Therapeutics' third quarter financial results, as well as to provide you with an update on the operational progress we have made during the first nine 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 third quarter financial results. In addition, Ralph Goswald, our 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 of 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, 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 Vireo Therapeutics team has delivered over the past few months. Before updating you on our operational progress, I thought it might be useful to overview the Vireos Therapeutics value proposition for those new to the Vireos story and or for those attending a very quarterly update for the very first time. Vireos Therapeutics Incorporated is developing novel combination antiviral therapies to treat patients suffering from chronic debilitating diseases such as fibromyalgia, irritable bowel syndrome, and fatigue-related disorders. The focus of our lead research program is on improving clinical outcomes for patients diagnosed with fibromyalgia. The fibromyalgia patient community, and therefore market, is actually quite large, with estimates suggesting over 200 million people worldwide meet the diagnostic criteria for fibromyalgia. This large market is unfortunately very dissatisfied, largely due to the poor tolerability of the three FDA approved fibromyalgia medicines. Our lead antiviral development candidate is oral IMC-1, a dual mechanism combination antiviral therapy. IMC-1 is formulated as a tablet, dosed twice daily, and has already demonstrated statistically significant pain reduction and tolerability better than placebo in a previously completed Phase IIa fibromyalgia trial. Based on significant unmet need in the fibromyalgia treatment armamentarium, the novelty of our antiviral approach and our strong existing clinical data, IMC-1 was granted fast-track review designation by FDA, the first such designation for a fibromyalgia development candidate to the best of our knowledge. Based on the success of our Phase IIa fibromyalgia study, we commenced our ongoing fibromyalgia Phase IIb fortress trial in quarter two of this year. We refer to this trial as FORTRESS, which stands for Fibromyalgia Outcome Research Trial evaluating synergistic suppression of HSV-1. We expect to report top-line results from this ongoing trial in quarter three of 2022. Our research programs are managed by a terrific team and a board of directors who have extensive drug development and commercialization experience, including experience managing several household main medicines. Importantly, our executive team and board have been involved in the development and commercialization of two of the three previous FDA-approved medicines to treat fibromyalgia. And finally, through prudent cash management, we presently project that we have ample cash to run operations into quarter one of 2023. In short, we have a novel antiviral treatment candidate targeted towards improving care for a large, dissatisfied cohort of fibromyalgia patients. Our ongoing Phase IIb fibromyalgia program is fully funded and is being managed by a team who have successful experience developing and garnering FDA approval for previous approved fibromyalgia treatments. Within this broader context, let's move to our quarter three update. Over the past several months, the team has achieved the following key milestones. I'm very pleased to report that we have enrolled over 200 of the 460 patients we are targeting for inclusion in our landmark Phase IIb Fortress clinical trial. The primary endpoint for this trial will focus on reduction in pain, the very same endpoint that has been used to assess all previously approved FDA medicines to date. In parallel to the Fortress Phase 2b trial, our chronic toxicology studies in two species are progressing as planned. 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 program. The chronic toxicology program is timed to complete by the time the Fortress trial is completed, such that we will be able to propose a final phase three program to FDA at the conclusion of the current study. I'm also very pleased to announce that we have filed the second IMC-1 investigational new drug application with FDA. This new quote unquote IND is focused on exploring the utility of IMC-1 in treating patients diagnosed with Irritable Bowel Syndrome, which you may know as IBS. Development of this regulatory filing is the first deliverable from our IBS collaboration with Dr. Michael Camilleri of the Mayo Clinic, announced in quarter one of this year. As a precursor to exploring the clinical utility of IMC1 for treating IBS, Virios Therapeutics executed a tissue biopsy study to better understand the role of activated HSV1 in patients with chronic GI disorders. These data were actually submitted to the Digestive Disease Week Annual Scientific Congress and accepted as a quote unquote late breaker submission for presentation to the entire DDW Congress participants. Dr. Carol Duffy's presentation of these data highlighted the presence of activated replicating HSV-1 in GI biopsy tissue harvested from patients diagnosed with a chronic GI disorder. Identifying HSV-1 activation in IBS patients is the first step in providing proof of the potential of the herpes simplex 1 virus as a potential root cause of IBS, much like it is in fibromyalgia. With mechanistic data in hand, we believe the time is right to formally explore the potential clinical benefits of IMC1's synergistic antiviral effects in delivering positive clinical outcomes for IBS patients. Finally, we project that our current cast position should provide the company with operational runway into quarter one, 2023, approximately six months following the planned announcement of the top line results from a fibromyalgia phase 2B fortress trial. This has been achieved through continued prudent management of cash over the first nine months of 2021. 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 three financial results.