Virios Therapeutics, Inc.

Good morning, and welcome to Verios Therapeutics, Inc., fourth quarter and year-end 2020 Financial Results Conference call. At this time, all participants are in a listen-only mode. A question-and-answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. Please be advised that today's call is 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 with Vireos Therapeutics Inc. Can you proceed, Angela?

Thank you. Good morning, everyone, and thank you for joining us on today's conference call. We executed our initial public offering in December of 2020. The team was pleased to generate demand for the full offering as well as the full over allotment. with final gross proceeds of $34.5 million. The net proceeds of the IPO were approximately $31.1 million after deducting underwriting discounts, commissions, and offering expenses paid by the company. We are pleased to be with you today to discuss VarioTherapeutics' fourth quarter and year-end 2020 financial results, as well as to provide you with the progress we have already made in the past two months since the IPO. Please note that our financial results and company update press release is now available on our website. Given there are many attendees on today's call that are new to the Vireo story, we thought we'd start the call with our CEO, Greg Duncan, providing you with a brief updated corporate overview. Dr. Mike Genro, our Chief Medical Officer, will review our recent research and development progress with a particular focus on our Fibromyalgia Phase 2B program, and then I will return to review our Q4 financial results. In addition, Ralph Groswald, VP of Operations, is with us for the question and answer portion of the call. Before we would 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. 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 disclaimer in our financial results release issued this morning and the risk factors in the company's current and subsequent filings with the SEC. 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, especially during these extraordinary and challenging times. Brios Therapeutics was founded by Dr. William Pridgen, predicated on the hypothesis that several chronic pain-related disorders, including fibromyalgia and irritable bowel syndrome, may be triggered by the activation of the herpes simplex type 1 virus. As is well documented in the medical literature, the herpes simplex type 1 virus, or HSV-1 virus, as we'll refer to it on today's call, is a tissue resident virus infecting the vast majority of adults under the age of 50. In most cases, the HSV-1 virus resides in a dormant state. However, dormant HSV-1 can be activated by certain triggers, such as a major health challenge or anxiety related to job stress. Once activated, the HSV-1 virus begins to replicate, which in turn can trigger an abnormal immune response in susceptible individuals. Dr. Pridgen theorized that this cascade of HSV-1 activation followed by an abnormal immune response might be a potential root cause of the flare-ups of symptoms in diseases like fibromyalgia that can wax and wane over time. This thesis served as the genesis for various therapeutics focused on developing new combination antiviral inhibitor therapies with the end goal to improve care standards for patients suffering from chronic diseases like fibromyalgia and irritable bowel syndrome. Our lead candidate, Oral IMC1, represents a novel potential treatment approach that combines two specific mechanisms of action purposely designed to inhibit HSV1 replication, the ultimate goal of which being predicated on returning an activated or lytic HSV1 virus back to a dormant state. More specifically, The famciclovir component of IMC1 inhibits viral DNA polymerase and thus inhibits replication of the HSV1 virus itself. The celecoxib component of IMC1 inhibits the cyclooxygenase 2, or COX-2 enzyme, and to a lesser degree COX-1, enzymes that are thought to be involved in the prostaglandin pathway used by HSV to accelerate its own replication. We are unaware of any other antivirals in development for the treatment of fibromyalgia. This novel approach was a germane consideration in FDA-designated IMC1 for fast-track review for the treatment of fibromyalgia. IMC1 has also been granted a synergy patent based on the fact that neither of the individual components of IMC1 has proven effective in the management of fibromyalgia. yet the combined use of these two therapies has demonstrated significant treatment benefits in early stage clinical research. For reference, this unique mechanistic approach secured IMC-1 patent protection to 2033. To corroborate his thesis, our founder, Dr. Pridgen, conducted research in conjunction with the University of Alabama to further understand the role of HSV-1 virus activation as a potential root cause of chronic pain-related conditions. This research collaboration centered on a tissue biopsy study designed to assess the presence of active HSV-1 infection in patients with fibromyalgia and or a comorbid chronic GI disorder such as irritable bowel syndrome. This study corroborated the company's thesis by demonstrating that patients with fibromyalgia and a chronic GI disorder as well as patients with only a chronic GI disorder exhibited ongoing active HSV-1 replication. In contrast, the control patients in this study, those patients without fibromyalgia or a chronic GI disorder, exhibited almost no HSV-1 replication. This corroborative tissue biopsy evidence portends potential of IMC-1 as a treatment for fibromyalgia patients as well as patients with a chronic GI disorder, more specifically irritable bowel syndrome. Fibromyalgia was chosen as the first target for IMC-1 clinical research based on three criteria. The first reason being anchored to the pervasive dissatisfaction of fibromyalgia patients, healthcare providers, and payers with the three approved fibromyalgia medications, most notably related to poor tolerability. For reference, the three FDA-approved medications to treat fibromyalgia are Lyrica, Cymbalta, and Cervelo, all of which are CMS-mediated therapies that, in our view, have exhibited less than ideal tolerability in commercial usage. The second reason for selecting fibromyalgia for the first IMC1 proof of concept trial was predicated on less competition in the fibromyalgia research field. The third and most important consideration for targeting fibromyalgia relates to the potential to improve care for between 10 and 20 million fibromyalgia patients in the U.S. and for more than 200 million fibromyalgia patients worldwide. In the context of a large market opportunity and the clear medical need for new, safe, and effective fibromyalgia treatments, IMC-1's clinical efficacy and safety was assessed in a double-blind, placebo-controlled, multi-center trial of 143 fibromyalgia patients. The results from this Phase IIa proof-of-concept trial clearly demonstrated IMC-1's potential clinical benefits in treating fibromyalgia. In this trial, IMC-1-treated patients demonstrated statistically significant reductions in pain as well as statistically significant reductions in fatigue and improvement in patients' overall fibromyalgia symptoms. IMC-1-treated patients demonstrated improved functioning and improved overall global health status. This study also demonstrated that IMC-1-treated patients required less quote-unquote rescue therapy with low-dose opioids to control their pain when compared to placebo-treated patients. I think we'd all agree a new medication with the potential to improve fibromyalgia patients' quality of life and to reduce overall opioid use would represent a significant step forward in fibromyalgia patient care. IMC1 efficacy in treating fibromyalgia patients has generated significant excitement in the fibromyalgia research community. Additionally, the community's excitement is predicated on IMC1 exhibiting tolerability that was better than placebo in our Phase 2A trial. More specifically, patients of the placebo treatment group were three times more likely to discontinue therapy due to adverse events when compared with IMC1-treated patients. This is a rare finding, as the active treatment arm in virtually all other fibromyalgia studies exhibits a higher dropout rate due to adverse events as compared with the placebo-treated cohort. This is an especially encouraging result when viewed in the background of current patient and provider dissatisfaction with the tolerability of the three approved fibromyalgia treatments. Moving forward, the IMC-1 research programs will be managed by a seasoned executive team, complemented by a highly experienced board of directors with extensive development and commercialization experience for many category-leading medicines. This experience includes previous management responsibility for Zoloft, Viagra, Celebrex, Lipitor, Zyrtec, Lyrica, and Cervella, the latter two representing two of the three medicines approved by FDA to treat fibromyalgia. Furthermore, our chief medical officer, Dr. Mike Gendro, worked with the FDA to help define the process by which the agency reviews new drug applications for approval of fibromyalgia drugs. This is the same process used to approve Lyrica, Cybella, and Cybalta, and is still used today by FDA to guide development of new fibromyalgia drug candidates, including IMC-1. During the first quarter of this year, we assembled the full team we need to manage both the fibromyalgia Phase IIb trial and our concurrent chronic toxicology studies, and have commenced our IBS-focused research collaboration with Dr. Michael Camilleri of the Mayo Clinic. Let me turn the call over to Dr. Genro to update you on our research progress following our December IPO. Included in Mike's remarks will be an update on our top priority, our Phase IIb Fibromyalgia Trial. The Phase IIb Fibromyalgia Trial will henceforth be branded as the FORTRESS study. FORTRESS stands for Fibromyalgia Outcome Research Trial Evaluating Synergistic Suppression of HSV-1. Mike?