Virios Therapeutics, Inc.

Good morning and welcome to the Vireos Therapeutics Incorporated first quarter 2024 earnings call. At this time, all participants have been placed on a listen-only mode. 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 Vireos Therapeutics. Please proceed, Angela.

Good morning, everyone, and thank you for joining us on today's conference call. We are pleased to be with you today to discuss various therapeutics first quarter financial results and to provide a corporate update. Please note that our financial results press release is now available on our website. 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 involved 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 four linking statements other than as required by law. Please see the four linking statements section in our financial results press release issued this morning for more information. Now, it is my pleasure to turn the call over to our CEO, Greg Duncan.

Thank you very much, Angela. The team and I are excited to convey a few key progress highlights from the first three months of this year as the first part of today's update. Let's start with the ongoing, investigator-initiated Bateman-Horne Center Long COVID Phase 2 study. Clearly, this ongoing study is important to bariotherapeutic shareholders. However, we can't forget it's also important to the millions of patients who are suffering from the symptoms of long COVID illness. It seems each week, new research highlights the growing burden of long COVID illness. Recently published scientific literature demonstrate a growing belief that reactivation of previously dormant herpes viruses, the target of our therapies, notably in Epstein-Barr virus and herpes simplex 1, may be triggering long COVID illness in at least a portion of those suffering from long COVID sequelae. The Center for Disease Control, or CDC, as you may know it, estimates that approximately 7% of the US population representing approximately 23 million U.S. citizens, have suffered from long COVID symptoms at some point since the beginning of the pandemic. The CDC further estimates that 3.4% of U.S. adults are presently, right now, suffering from active long COVID sequelae, representing 11.2 million potential patient targets. That's patient targets here just in the U.S. Unfortunately, there are no FDA-approved long COVID treatments. We believe Valsiclovir and Celecoxib, or IMC2 as we call it, has the potential to be a market-leading option to address this major need for millions of patients worldwide. The ongoing BHC202 study is a three-arm study comparing two dose levels of the Valsiclovir-Celecoxib combination versus placebo and over 12 weeks to treat their symptoms of long COVID illness. I'm pleased to report that patient enrollment is going well and has surpassed the 50% enrollment level. Encouragingly, and consistent with prior research, a planned preliminary safety analysis of the BAC202 study data indicates that the combination of valciclovir and celecoxib has been very well tolerated to date with no serious adverse events reported and only a few transient or temporary treatment-emergent adverse events being reported throughout the study. This Phase II trial follows on from the previous proof-of-concept study results we reported last year, featuring the combination of alcyclovir and celicoxib as a potential new treatment for long COVID. In this study, as you may recall, IMC-2 demonstrated clinical and statistical improvement in long COVID patients' fatigue, orthostatic intolerance, anxiety, and pain, as well as an improvement in overall health as compared with age, gender, duration of illness, and previously vaccinated match control patients. These results are particularly important for several reasons, most notably given the current dearth of treatments available to address patients' long COVID symptoms. Furthermore, we believe these data validate our approach to addressing the reactivation of secondary herpes viruses rather than targeting the SARS-CoV-2 virus itself as a unique approach to treating long COVID patient symptoms. This approach and these data may explain why treatments like Paxlovid that specifically target the SARS-CoV-2 virus have failed to date to exhibit benefits in treating long COVID symptoms. We also now know that the risk of developing long COVID increases with each acute infection and that COVID vaccines do not prevent do not prevent patients from progressing to long COVID illness. In short, there's a major need to advance new therapies like IMC2 in the hopes of addressing this emerging health problem. Topline results from this landmark study are expected in the second half of 2024, and in our view, represent a significant value inflection opportunity for various shareholders on the near-term horizon. On a related long COVID program note, Varios' global patent for IMC2 covering combination antiviral treatment of both long COVID as well as Alzheimer's disease was recently published. This enables the company to streamline the process for obtaining patent protection globally. If ultimately granted, this will provide us with intellectual property protection for use of IMC2 in both treating long COVID and Alzheimer's disease until approximately 2044. Moving beyond the IMC2 long COVID program, I also wanted to share that discussions are ongoing as we seek a partner to advance our second development candidate, IMC1, a fixed-dosage combination of famciclovir and salicoxib into Phase III development for the treatment of fibromyalgia. In particular, we are evaluating opportunities with partners who are focused on developing and commercializing non-opioid pain treatments. And finally, The company continues to actively explore complementary opportunities that can build shareholder value through strategic partnerships, collaborations, or other forms of transactions. In particular, we are assessing both pain and anti-infective development candidates as potential complements to our focus with IMC1 and IMC2. Now, I will turn it back over to Angela to discuss our quarter one financial update.