Virios Therapeutics, Inc.

Good morning ladies and gentlemen, and thank you for your patience. This morning's conference call will begin soon. Please remain connected at this time. And once again, thank you for your patience. This morning's conference call will begin shortly. Thank you. Thank you. © transcript Emily Beynon Good day and welcome to the Vireos Therapeutics, Inc. Q3 earnings update. At this time, all participants have been placed on a listen-only mode. The floor will be open for questions and comments after the company presentation. It is now my pleasure to turn to proceedings over to Angela Walsh, SVP Finance and Treasurer, Vireos Therapeutics, Inc. Angela, the floor is yours.

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 a summary of our ongoing analysis of the results from our recently completed Phase IIb Fibromyalgia Trial, also known as the FORTRESS Study. 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. Then he will turn the call over to our Chief Medical Officer, Dr. Mike Genro, who will provide an update on our Fortress Study analysis. And then I will return to review our third quarter financial results. In addition, Ralph Goswald, 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 involves 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 to all of you joining us on today's quarter three earnings update. Our goals for today's discussion are threefold. First, following our announcement of the top line results in mid-September, we will provide you with a summary of what we have learned so far from our detailed examination, the FORTRESS Phase IIb Fibromyalgia study data. Second, we will outline our proposed plan and projected IMC1 development milestones for the balance of this year and into 2023. And finally, we'll provide a summary of our quarter three financials before opening up the call to receive participants' questions. On September 19th, we reported that the Fortress study demonstrated that IMC1 was safe and very well tolerated, but did not achieve statistical significance on the pre-specified primary endpoint of pain reduction. The results were confounding, particularly when viewed in the context of both mechanistic data highlighting the role of active replicating herpes infection in patients diagnosed with fibromyalgia, as well as the results of our previously successful Phase IIa fibromyalgia trial. Recall this prior Phase IIa trial clearly demonstrated IMC1's potential as a novel approach to treat the pain, fatigue, and other symptoms associated with a fibromyalgia diagnosis. In mid-September, we discussed that our preliminary top-line analysis of the data suggested an unusual bifurcation of response based on the timing of patient enrollment in the Fortress trial. By way of background, enrollment of the first 50% of patients took place from June 2021 to early November 2021. For context, this was when the Delta variant of COVID-19 was the dominant strain here in the US. Full vaccination rates were far below the levels we enjoy today. And probably most importantly, extensive quarantining was still in place in most geographies. The patients enrolled and treated with IMC1 in the first half of the study did not demonstrate a statistically significant reduction in pain when compared with patients treated with placebo during the same time period. Conversely, during the second half of the trial, which took place from November 2021 to April of this year, we enrolled the second 50% of patients into the Fortress study. This was the time period when vaccination rates had substantially improved, the less severe Omicron variant of COVID-19 became the dominant US strain, and quarantining restrictions were lessening or fully removed across many geographies here in the US essentially where we're getting back to a more normal day-to-day lifestyle. In stark contrast to the first half study enrollees, the IMC-1 treated patients enrolled during the second half of the trial, which totaled 214 patients, demonstrated a statistically significant improvement on the primary pain reduction endpoint at week 14, as well as statistically significant improvements in fatigue and fibromyalgia symptoms. The various management team believed that the likelihood of such a substantial differential response based on the timing of patient enrollment was highly unlikely to be a random occurrence. Alternatively stated, we as a team believe the positive outcomes demonstrated in the patients recruited during the second half of the Fortress study, a sample of patients that is roughly one half the size we believe was required to demonstrate statistically significant pain reduction over the full trial required deeper exploration. The Vireos management team has spent the past few weeks deeply analyzing the fortress data to better understand the factors driving the top line results. This understanding will help the team design an IMC1 development program that targets the patients who are most likely to respond to IMC1 treatment. The team has identified several factors that have both positive and negative impacts on our final study results. We have vetted these findings with multiple highly recognized fibromyalgia research thought leaders who corroborated our view that the Fortress study results were unlikely due to chance and that the positive results we observed in the Fortress trial do support the potential of IMC1. These experts supported our proposed plan to continue the development of IMC1 as a treatment for patients diagnosed with fibromyalgia. We will shortly be requesting a live meeting with FDA with the goal of progressing IMC1 development to phase three next year. It is now my distinct pleasure to turn the discussion over to our chief medical officer, Dr. R. Michael Gendro, to share what we have learned that underpins our continued belief that IMC1 can improve the treatment of fibromyalgia. Mike will also share our thoughts on the broad parameters of the plan we will propose to FDA to advance the development of IMC1 moving forward.