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spk03: 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.
spk00: 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.
spk02: 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.
spk00: Thank you, Greg. With respect to our income statement, as a development stage biotechnology company, we did not generate revenue during the three months ended March 31, 2024, or during the year-ago quarter. We reported research and development expenses of $.3 million for the first quarter of 2024 as compared to $.5 million for the first quarter of 2023. The $0.2 million decrease was due to decreases in expenses for toxicology studies of $0.1 million and regulatory consulting costs of $0.1 million. In addition, we reported general and administrative expenses of $1 million for the first quarter of 2024 as compared to $1.1 million for the first quarter of 2023. The $0.1 million decrease quarter over quarter was due to a decrease in insurance expenses associated with being a public company. Finally, we reported a net loss of $1.3 million for the first quarter of 2024 as compared to a net loss of $1.5 million for the year-ago quarter. The lower net loss was primarily due to the decreases in research and development and operating costs that I just discussed. As of March 31st, 2024, we had $2.4 million in cash as compared to $3.3 million as of December 31st, 2023. We expect our current capital to fund operations into the fourth quarter of 2024. At this time, I will turn the call back over to Greg, who will moderate the Q&A session of the call. Greg?
spk02: Thank you, Angela. Ali, we are now ready for questions.
spk03: Thank you. Ladies and gentlemen, the floor is now open for questions. If you have any questions or comments, please press star one on your phone at this time. We ask that while posing your question, you please pick up your handset, if on speakerphone, to provide optimum sound quality. Please hold while we poll for questions. Thank you. We have a question on the line from David Bouts with Zach's Small Cap Research. Your line is live.
spk01: Hey, good morning, everyone, and thanks for taking the questions this morning. Greg, I'll start with, for the 202 study, what, can you remind us again, what kind of data are we, should we be expecting when those results are released, and do you expect them to be released basically through a press release, or is this going to be at a scientific meeting?
spk02: Hi, David, Greg here, and thank you for the question. So the design of a Phase II study, the BHC202 study, is quite similar to the prior trial, and that is by design. And it is consistent with the discussions we've had with the FDA regarding what would be required to advance a drug, potentially the first drug, to treat long COVID sequelae or symptoms as we speak to them. The primary endpoint in that study is fatigue. It is, to the best of our knowledge, the first time FDA has agreed with using fatigue as a primary endpoint, and we're excited about that for two reasons. Number one, this combination, famciclovir and valciclovir, when used with celicoxib, either as IMC1 or IMC2, as we call it, has consistently shown in both fibroclinical research and in long COVID clinical research significant reduction in fatigue. A three-point change is considered clinically meaningful. We've seen between a three and a seven-point change across all of those three studies. And as a consequence, we believe, frankly, that this may be the symptom that best responds to treatment with this particular combination. So the primary endpoint for this 12-week study is fatigue. The secondary endpoints include orthostatic intolerance. Know this as orthostatic hypotension, when people get dizzy when they get up quickly or when they move. Unfortunately, that happens for patients in this particular category with this illness all day long. And this is arguably as debilitating as the fatigue itself. So fatigue, orthostatic intolerance, pain will be assessed. We'll also look at pain, anxiety, and overall global health. So those outcomes, as I referenced in my earlier remarks, are the ones we were so excited to see improve in the first BHC, the 201 study. And that led us to progress to this double-blind placebo-controlled trial. And we are very hopeful and encouraged by past performance and are looking to read out those results in the second half of this year. It is pretty material, so I think we'll probably announce those results directly, at least top line, from Vireo Therapeutics, and certainly we'll be looking and or exploring what might be the best scientific venue, Dave, to announce those results to make sure that the entire scientific community, not just the investment community, is aware of those results.
spk01: Okay, great. And so assuming positive results, what do you envision as the next step for that program? Do you think you'll be doing a phase 2B? Do you think you can go to a phase 3? Maybe you can talk about kind of how you foresee things moving there.
spk02: Yeah, I think with positive results, and remember, the goal of this trial is to help design not necessarily the endpoints per se. Those will be consistent. We've agreed that with FDA. We want to progress with the same endpoints as the destination for assessing patient care. What this trial will do is it will allow us to assess the effect size, so how many patients will we need to see a particular effect on fatigue, orthostatic intolerance, et cetera. So the inputs from this study will dictate the design for the next study, which we believe will likely be a Phase IIb study. I'm not sure we could go directly to a Phase III, but ultimately, now that we've scoped out the parameters that are required to get a drug approved, we would certainly design the study even as a Phase 2B in a way that's consistent with Phase 3, and decide what else might be required beyond that study, which we would hope to begin executing towards the beginning of next year. That will be the rough time.
spk01: Okay. And so it sounds like you're holding off on the fibromyalgia program until you get a partner there. Do you think you could move the long COVID program on your own? Would you also want to partner that program?
spk02: Certainly we will choose the path that is most value enriching for shareholders and expeditious to get to the end points. So we feel comfortable. We can execute the IMC2 long COVID program independently. But there are companies we know that have an interest in the space. I think, David, the fatigue people had for COVID vaccines is now waning. And I think, as I referenced again in my earlier remarks, the scientific community is seeing, it seems to me, on a weekly basis, new research highlighting the role of reactivation of secondary viruses. And so I think this disease, which is really, frankly, pretty well known on Main Street, is now coming back into focus for the scientific community on Wall Street. And so our hope is that there's great interest in this in general, and we certainly wouldn't rule out potential partnership if the right economics, the efficient way to deliver value for various shareholders emerged following report out of those results.
spk01: Okay, great. Thanks for taking the questions this morning.
spk02: Of course. Of course.
spk03: Thank you. Once again, if you have any questions, please press star 1 on your telephone keypad at this time. Okay, as we have no further questions at this time, I will hand it back to Mr. Duncan for any closing comments he may have.
spk02: Thank you very much, Ali, and thank you to the team for participating, and thank you to those of you who've dialed in or clicked in on the webcast. In short, just to summarize, that BHC202 study, the three-arm study, is enrolling well. We've passed the 50% enrollment level, and we're very excited about top-line results for the second half of this year, both for various shareholders, but also because, as we articulated, there are literally millions of people who are suffering today here in the U.S., and probably tens if not hundreds of millions worldwide if that epidemiology data in other countries is the same in the U.S., patients really need something to treat this particular disease. That preliminary safety analysis of the data indicates that the combination of valcyclovir and celecoxib has been very well tolerated, and that's very consistent with what we've observed through the clinical development of both of our assets. We published our global patent earlier this year, and I'm pleased to tell you that discussions are ongoing as we seek a partner with Advanced IMC1. into phase three development for the treatment of fibromyalgia. And I should mention, as I mentioned earlier, just to close out, we continue to explore other complementary opportunities to build shareholder value. In particular, we're looking at other potential pain opportunities and our anti-infectives with a focus on antivirals to complement IMC1 and IMC2. We appreciate your time and attention this morning, and we'll report out progress on all of those matters in a very timely manner. Thank you, and have a great day.
spk03: Thank you. This concludes today's conference call. You may disconnect your lines at this time and we thank you for your participation.
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