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spk04: Angela Walsh, Senior Vice President of Finance and Treasurer of Vireos Therapeutics. Please proceed, Angela.
spk00: 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 Vireos Therapeutics second quarter financial results and 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 insurgencies 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 insurgencies, 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 statements 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.
spk03: Thank you, Angela, and good morning to all of you joining us on today's quarter two 2023 earnings update. We have three specific topics to cover on today's call. First, I will begin with an update on our submission to the Food and Drug Administration, or FDA as you know it, to progress our lead development candidate, IMC1, into phase three development as a possible treatment for the millions of patients who suffer from the consequences of fibromyalgia. Second, we are very pleased to have our chief medical officer, Dr. Mike Gendro, on the call today to review the recently announced very encouraging results we received from our exploratory long COVID study sponsored by Vireo Therapeutics and conducted by the Bateman Horne Center in Salt Lake City, Utah. And finally, Angela Walsh will provide you with a summary of our quarter two financials. Following the review of these topics, we will open up the call to questions. Let me start with an update on our IMC1 phase three submission to the FDA. As announced, Just yesterday, the Food and Drug Administration communicated that following their initial review of the various therapeutics chronic toxicology program, the program studies appear adequate to support the safety of the IMC-1 dosage proposed by the company for chronic use to treat patients with fibromyalgia. With this critical feedback in hand, our goal is to initiate our proposed pharmacokinetic and food effects study later this year. while concurrently submitting an updated phase three program outline and all of the associated study protocols for final FDA review. This planned PK and food effect study in males and females will be executed as a precursor to the fibromyalgia studies with an updated IMC1 dose and formulation, which is intended to enable the company to take full advantage of all of the efficiencies afforded with the utilization of the 505B2 regulatory pathway. The forthcoming Phase III Fibromyalgia Program proposal consists of three main study components. The plan is to execute two adequate and well-controlled studies. One is a head-to-head study comparing IMC1 and placebo, and the second trial will be a full factorial design with each of the individual components of IMC1, Bamsiclovir and Celecoxib as separate comparator arms, and a long-term extension study. Based on data from the recently completed Fortress Phase 2b trial, we have proposed a Phase 3 development program targeting community-based fibromyalgia patients who have not, have not participated in prior fibromyalgia research trials. Alternatively stated, we plan to exclude or more formally screen out fibromyalgia patients who have participated in recent fibromyalgia research studies over the past several years. Following completion of the aforementioned PK study, the goal will be to begin enrollment in the first Fibromyalgia Phase III Safety and Efficacy Study in mid-2024. I would be happy to answer questions about the Phase III plan during the question and answer session of today's call. It is now my pleasure to turn the discussion over to our Chief Medical Officer, Dr. Gendro, to share what we have learned from the recently completed long COVID study. The data from this exploratory study underpins our belief that IMC2, a fixed-dose combination of valsiclovir and celecoxib, has potential to improve the symptoms or sequelae, as they are more formally known, associated with the diagnosis of long COVID. Take it away, Mike. All right.
spk02: Thank you, Greg, and good morning. Before we dig into the long COVID data and the company's initial thoughts on our development plan, let me convey that the team and I look forward to initiating our PK study with an updated formulation of IMC1 for fibromyalgia while finalizing the protocols and procedures required for the Phase III development program as a treatment for fibromyalgia. We believe the safety and efficacy results from our previous FORTRESS trial, along with the chronic toxicology program results, have enabled us to define a fibromyalgia clinical trial program and a formulation and dose of IMC1 to enhance our chances for phase three success. Now, switching to long COVID, I would like to highlight the study design in the encouraging open label long COVID data we announced in July. First, I think it would be useful to provide some background on the illness itself. This includes the criteria by which a patient is diagnosed with long COVID and the symptoms underpinning the significant morbidity associated with this illness. Long COVID is also referred to as post-acute sequelae of COVID-19 or PASC. PASC symptoms may include severe fatigue, post-exertional malaise, brain fog, dizziness, sleep disruption, loss of smell or taste, and orthostatic intolerance. Prevalence estimates suggest as many as 65 million people worldwide suffer from PASC. It's more common in females and in patients with preexisting conditions such as asthma, chronic obstructive pulmonary disease, hypertension, and depression. The World Health Organization diagnostic criteria are based on a continuation of or development of new symptoms three months after the acute COVID infection has resolved and lasting at least another two months without another explanation. We know that COVID acute infections can activate an immune response. In some cases, severe COVID infections can lead to an exhausted immune response. In cases where the immune system is now exhausted or ineffective, we believe the lack of routine immune surveillance functions can lead to reactivation of latent herpesviruses that the patient was previously infected with. Our hypothesis is that late viral reactivation leads to further dysregulation of the immune system persistent inflammation, and what we refer to as the PASC symptoms or long COVID. This hypothesis is consistent with what has been suggested by the mechanistic task force working on the recovery initiative at the NIH. Recovery stands for researching COVID to enhance recovery. This hypothesis that reactivated herpes viruses are involved in at least some of the symptomatology associated with long COVID served as a genesis for an open-label, single-center, investigator-initiated study conducted by the Bateman Horne Center under an unrestricted investigational grant provided by Vireos. Bateman Horne is a nonprofit, interdisciplinary center of excellence advancing the diagnosis and treatment of chronic fatigue disorders, including ME-CFS, fibromyalgia, post-viral syndromes, and related illnesses. Now, given that, let me walk through some of the data showing the results from this Bateman-Horne study. Slide 2 shows what's known as a consort diagram for the study. That is the flow of patients through the study. So, the Bateman-Horne Center recruited patients for the study. They screened 46 potentially eligible long COVID patients that were recruited either from their own internal cohort of patients they are monitoring or They had advertised from other treatment centers in the Salt Lake City area. Of those 46 who were screened, 39 were eligible for the study and enrolled into the clinical trial. Twenty-two of those patients were assigned to receive treatment with Valcyclovir and Celecoxib. Those are known as the treatment group. And 17 were assigned to a matched control group. That is, the patients were matched for age, gender, and duration of disease, but did not receive the Val-Celi combination. The treatment group, 20 patients completed the 14 weeks of treatment. One patient withdrew the study due to adverse events that were possibly related to treatment. And one was terminated from the study by the investigator for noncompliance with the protocol. control patients completed the study. Slide three, please. The primary endpoint in this study was reduction in fatigue over 14 weeks. The fatigue was measured with something known as the NIH PROMIS fatigue instrument. The PROMIS fatigue is a instrument that was developed by the NIH to measure various aspects of fatigue in patients. It measures physical fatigue, mental fatigue. It's a self-report. The patients complete these at clinic visits and provide feedback on overall how they believe their fatigue is doing over time. And we look at the change from their starting point or their baseline value. And what we saw after 14 weeks of treatment was that the patients receiving the valselli combination had a statistically and clinically meaningful reduction in their fatigue of 7.2 points on this scale on the promise fatigue scale a change of three to four units is considered to be clinically meaningful so they had a better than seven point reduction in their fatigue level whereas the control group or the standard of care group had a pretty much no real change in their fatigue level over the 14 weeks. That was statistically significant at .008. And as I said previously, it's also clinically meaningful. So this is something patients really could experience and realize they were getting some benefit from. Next slide. Another important outcome measure we used in the study was this orthostatic intolerance. Orthostatic intolerance is a, Common finding in long COVID patients and in ME-CFS patients that is related to autonomic dysfunction, a normal event when a patient goes from sitting to standing or lying down to standing is your body compensates for changes in blood pressure to maintain blood flow to the brain. And when we have autonomic dysfunction, sometimes those reflexes are not, don't work quite right, and you get symptoms as if you're going to faint. You can get tunnel vision. You can get changes in blood pressure and heart rate. You get sweating. You just don't feel right. These are related to these orthostatic dysfunction. And so, since we see this as a common side effect in patients with long COVID, we measured, we used an instrument that measures orthostatic symptoms. And there's two domains to this measure. There's an orthostatic symptoms domain, which really directly measures these symptoms. And there's an activity limitation domain, which looks at what you can or can't do or what are impacted by these symptoms. And on this scale that was applied to all the patients in this study, we saw a statistically significant improvement in symptoms shown on the left, this graph on the left, of over nine points on the valacella combination. And the control group actually got a little bit worse over time. So that was highly statistically significant. And the scale on the right is the orthostatic activity limitations. That is things you can no longer do because you're worried about the symptoms or you feel like you're going to fall down, lose consciousness, whatever. And again, we had over seven point improvement on Valsali on this domain versus, again, the control group got worse and that was statistically significant as well. So both of these measures that are hallmarks of both ME-CFS and long COVID patients, were improved by the valacella combination, which was, this was new to us. We hadn't seen this before, and we found that was quite an important finding with this treatment. Slide five, please. So here's a summary of all the outcome measures that showed some effect in this small clinical trial. And this is comparing the valacella combination to the control group. At week 14, we've already showed that the NIH PROMIS fatigue T-score was improved so that the primary endpoint of fatigue was statistically improved even with these small numbers. We also measured fatigue on a zero to 10 scale. That's where zero was I have no fatigue anymore and 10 was it's worst possible fatigue. The patients completed this at home every week through a survey. And what we saw over 14 weeks is they also reported improvement on this scale as well as on the PROMIS scale. At the same time, they were doing this 0 to 10 fatigue scale. They were doing a 0 to 10 pain scale at home weekly and, well, not as predominant effect as the fatigue. We also did see statistical improvement in their pain, self-rated pain on a weekly basis as well. Patients completed two different patient global impression scales. This is a patient global impression is asking them how they think they're doing overall since beginning the study. That is, general overall health. We had two different scales. One was a one to seven scale where seven says I'm doing really well and one means I'm doing really poorly. And also a zero to 10 that went the opposite direction intentionally where zero means I've got the best possible health and 10 means my health is the worst it could be. And on both of those scales completed at clinic visits, patients reported statistically better results on treatment than on the control group. We showed you the two orthostatic intolerance scales who are statistically significant at endpoint. And we also had something called the hospital anxiety and depression scale in this study. So it has a domain for depression symptoms and a domain for anxiety symptoms. The depression symptoms trended towards statistical significance, but certainly went in the right direction. And the anxiety seal actually was statistically significant at week 14 as well in the treatment group versus control. So that was all very encouraging that we have all the study endpoints going the right direction and statistically significant in most cases. From a safety standpoint, treatment with the valcella combination was generally well tolerated. And what we saw in terms of safety profile and any adverse events was really consistent with what we already know about valcyclovir and salicoxib. Doesn't look like there's any combination toxicity to them. And nausea was far and away the most common adverse event, which is a known effect of Celecoxib in particular. Most common adverse event in the routine care or the control group was headaches and muscle pain. There were no serious adverse events in the study. And we only had, as I mentioned, one treated patient discontinued due to adverse events, which were possibly related to Valsali treatment. So with that summary, let me go to slide six and outline the next steps. So we have filed a provisional method of use patent for treating long COVID with this combination, focusing on fatigue and orthostatic intolerance. And if that should issue, we would have very good patent coverage for quite a while. We are proposing a follow-on study with the Bateman Horne Center to essentially replicate these results using a double-blinded placebo-controlled design. and we also are preparing a pre-IND meeting request to meet with the FDA and ask for their guidance on a development plan for a long COVID indication with an anticipated meeting with the FDA later this year. So with that, I would like to say in summary that female patients who were diagnosed with long COVID and who were treated open-label with a combination of valcyclovir and celecoxib for 14 weeks exhibited clinically and statistically significant improvements in fatigue, pain, general well-being, and symptoms related to autonomic dysfunction as compared to a control cohort of female long COVID patients matched by age, gender, length of illness, who were then treated with routine care. The statistically significant improvements in long COVID symptoms and general health status were particularly encouraging given that the mean duration of Long COVID-related symptoms was two years for both the treated and controlled cohort prior to enrollment in this study. I would be happy to answer further questions about our data analysis and our development plans during the Q&A session. Let me turn the program back to our SVP of Finance and Treasurer, Angela Walsh, to discuss our Q2 2023 financials. Angela?
spk00: Thank you, Mike. With respect to our income statement, as a development stage by technology company, we did not generate revenue during the three months into June 30, 2023, or during the year-ago quarter. We reported research and development expenses of $.6 million for the second quarter into June 30, 2023, as compared to $2.4 million for the year-ago quarter. The decrease in research and development expenses from the year-ago quarter was primarily due to a decrease in clinical trial expenses of $1.7 million related to our completed fortress study and a decrease in expenses related to our chronic toxicology program of $0.2 million, which was offset by an increase in drug development and manufacturing costs of $0.1 million. We reported general and administrative expenses of $0.9 million for the second quarter of 2023 as compared to $1.3 million for the year-ago quarter. The decrease from the year-ago quarter was primarily due to decreases in expenses associated with being a public company of $0.2 million, legal and accounting fees of $0.1 million, and salaries and related costs of $0.1 million. Finally, we reported a net loss of $1.4 million for the second quarter of 2023 as compared to a net loss of $3.7 million for the year-ago quarter. The lower net loss was primarily due to lower research and development costs as well as operational costs that I just mentioned. In July 2023, we entered into a capital-on-demand sales agreement with the Jones Trading. This type of agreement often referred to as an at-the-market or ATM agreement, provides a public company with the ability to raise capital as needed at the prevailing market stock price. It is a common practice for biotechnology companies to have this type of agreement in place since compared to alternative financing methods, it typically provides a lower cost of capital, less dilution over time, and flexibility as there is no specific requirement or obligation to raise any amount of funds. As of June 30th, 2023, we had $4.6 million in cash as compared to $7 million as of December 31st, 2022. We expect that the company's cash balance at June 30th plus the additional amount raised under the ATM agreement with Jones Trading to be sufficient to fund operating expenses and capital requirements for at least the next 12 months. I will now turn the discussion back to Greg to wrap up and moderate the Q&A session. Greg?
spk03: Thanks again, Angela. Operator, we are now ready for questions.
spk04: Thank you. At this time, we will be conducting a question and answer session. If you would like to ask a question, please press star 1 on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star 2 if you would like to remove yourself from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. Once again, please press star one if you wish to ask your question. And one moment while we poll for questions. And the first question today is coming from David Bouts from Zach's Small Cap Research. David, your line is live.
spk05: Hey, good morning, everybody. Greg, I was wondering if you could start talking about the fibromyalgia market a little bit, and I think how it relates to the patient population that you're going to be targeting in the phase three trial, where you're going to be limiting it to patients who haven't been in prior fibromyalgia studies. And do you foresee any effect on a potential label for the drug by limiting that patient population if IMC-1 ends up to be approved?
spk03: Hi, David. Good morning and thank you for the question. I think it's a very good question. The short answer is the number of patients who've been involved in prior clinical studies is actually a very small fraction of the total universe, probably low single digits. So I don't think this materially impacts our commercial opportunity if for some reason we were labeled as hasn't been studied in patients with prior research experience, so to speak. We believe the over-representation of these patients in our previous Fortress Phase 2b trial was largely a function of the COVID quarantine environment. And under normal conditions, we should be able to recruit this study using both classic advertising, social media outreach, without undue delay. So I think there's going to be very minimal impact on the overall commercial opportunity. I would also say, as you probably heard through the course of today's discussion, we will be advancing the pharmacokinetic study in both males and females with the potential, presuming FDA buy-off, that we can actually study both genders moving forward. So, in fact, I think there's probably a net positive relative to the broad label, potentially, if we progress with both males and females in the phase three. Does that answer your question, David?
spk05: Yes, thank you. And speaking of the TK and food effect study. Just a couple quick questions about that. What outcomes are you looking for there? Do you foresee any type of food effect on IMC1? And then did I hear correctly, is this a due formulation that you're going to be studying in that study also?
spk03: Yeah, so that's two questions there. So let me start with the second question first. So the revised IMC1 IMC-1 formulation is, again, a single combination tablet. We are progressing with this new tablet in phase three because that is the tablet that will conform to commercial requirements. We are removing some excipients from the research formulation, small stuff, but, you know, small requests from FDA. So that new formulation is ready for both phase three as well as for commercial launch, presenting success in the phase three. The reason we're progressing this new formulation with a new dose, which is closer to the Phase IIa dose, is because we want to take advantage of all of the efficiencies under the 505 regulatory pathway, as I mentioned in my earlier remarks. This avoids a whole host of other ancillary Phase III programs that nobody cares about but are costly in increased time, et cetera. So, as you probably know, the treatment effect size in the Phase IIb And the phase 2A was largely similar between the two doses. The phase 2B dose was about three times larger than the phase 2A dose. And effectively, what we're going to do is progress with a dose that's in line with those reference doses of famciclovir and celecoxib, a dose very close to the phase 2A dose, to be most efficient as we progress into the phase 3. So two reasons for it. One, the efficiency. Two, to make sure we're locked and loaded on a formulation that is ready for commercial scale-up, presuming success in the phase 3.
spk05: Okay, that makes sense. And then, yeah, just how long is that study going to take? What are the outcomes for the food effect study, those types of things?
spk03: Yeah, I was going to go on to that. I just want to make sure I answered your first one. So the two things we're studying in this pharmacokinetic study using the new formulation are both total exposure as measured by classic area under the curve, how much exposure is there from the new dosage compared to the reference doses, as well as what is the C-max, or the maximum blood concentration, which usually occurs shortly after administration of the drug. So what we want to make sure is that the C-max, maximum exposure, and the total exposure of a dosing period at steady state are consistent with the dosage levels for the independent components, that's Stamciclovir and Celecoxib. And by doing so, we can utilize all of the safety and longer-term studies that were used to originally approve both famciclovir and celicoxib and avoid doing all those other ancillary studies so we can have a very efficient phase three, which is two adequate and well-controlled trials, and patients from those trials can be rolled into a long-term extension. That gives us the most efficient way to progress this phase three, which is good news for obviously virio, shareholders, and ideally patients moving forward.
spk05: Okay. And lastly, about long COVID, I'm curious if you could talk about why you decided to do another single center study with the Bateman Horn Center as opposed to kind of expanding out and doing a larger double-blind placebo-controlled study at this time.
spk03: Very good question, David. So the shorter answer is we're doing both. I think you'd agree. I mean, you need to look no further than today's headlines. COVID is here to stay. And so we are commencing the double-blind, placebo-controlled IMC2 program in long COVID, which is fully funded. It doesn't require us to raise additional capital. This is a very efficient progression. So we can now study IMC1 under classic double-blind, placebo-controlled conditions. Simultaneously, and I say this with great hopes moving forward, we are engaging with NIH, who you're very familiar with, but also the NHLBI, which is working with NIH The NHLBI is the National Heart, Lung, and Blood Institute, for those that are not familiar. Those two academic institutions are actually evaluating and administering the funds that NEH really recently allocated to research in long COVID, and they're evaluating different options moving forward. We've engaged with them. We have some meetings set up this fall to talk with them about the study that Mike provided the top-line highlights with. all of which is to say we're looking to see if we can't secure some non-dilutive funding options for the broader Phase II dose-ranging study that is the next step in the more classic development process. So it's really two shots on goal here. We will provide updates on the progress on both as we get into fall and close in on the end of the year. But suffice it to say, hopefully you get a sense, David, that if you're excited about fibromyalgia, which we all are, obviously anybody on the call is, We now have a second program as a complement to the fibromyalgia program, and we're leaving no stone unturned. We'd like to progress the confirmatory trial and see if we can secure either partnership or non-dilutive funding to progress the more classic phase 2B dose ranging study. So really two shots on goal with that. And as Mike mentioned earlier, what we're really excited about here for IMC2 is having filed this provisional patent If that patent is granted, that will extend our intellectual property protection out to roughly 2044. So long lead time on that method of use patent to be able to research and progress the long COVID program as a compliment to fibromyalgia.
spk05: Okay. And so Vireos is sponsoring this study at the Bateman Horn Center. Is that correct?
spk03: The Bateman Horn Center program is funded. So we do not need to raise any additional capital to run that program. We will look towards partnership and potentially non-dilutive funding through NHLBI and NIH under the RECOVER umbrella to potentially fund that mixed confirmatory dose ranging study because we'd like to look at multiple doses in that secondary trial. That would require partnership or non-dilutive funding. But as you probably have seen under recent headlines, both scientific and lay press, There was a lot of information about characterizing long COVID, and I think NIH and NHLBI are now repurposing their focus to focus more in on treatments. I think everybody realizes long COVID is here to stay, and as a consequence, long COVID is here as a result of this continuing new pathogens, new, I think it's the E5 variation now that we're on, something of that ilk. This is going to be like the flu, and I think long COVID will follow these new versions of COVID. So this could be very timely and very, very helpful for patients.
spk05: Okay, great. Thanks for taking the questions this morning.
spk03: Of course.
spk04: Of course. Thank you, David. Thank you. The next question is coming from Shawn Lee from HC Wainwright. Shawn, your line is live.
spk01: Good morning, Greg, and thanks for taking my questions. I just have two quick ones. First is on the upcoming new long COVID study. So, other than being double-blind and randomized, how is it, is there any differences between the proposed study and what has been completed so far ?
spk03: So, excellent question, Sean, and thank you for joining and for your question. As Mike outlined, the original exploratory trial was open-label. in its approach, and I think you'd probably agree, executing at the same center, same conditions, same outcomes under double-blind conditions is a higher hurdle rate. And so we are looking to validate that particular finding, and we'll commence that program this fall that is fully funded. So what we'd like to do is actually validate that study under more classic double-blind placebo-controlled conditions. At the same time, as we referenced, we do think a more classic Phase IIb And who knows where the conversations with FDA goes. We need to talk to them about what outcomes they think are important here, how they would like us to explore different doses for long COVID. One of the other questions which we didn't mention but I think is important to reference in the context of your question, Sean, is we will also ask the FDA about broader fatigue opportunities. If you look historically, at these combinations, be it the phase 2A fibromyalgia trial, the phase 2B fibromyalgia trial, and now this exploratory long COVID trial, the impact on fatigue is robust, statistically significant, and consistent across all of those three studies. And so we do think it's early days, but our initial thought process is given the robustness, consistency, and concordance of this signal across all three studies, would it make sense to potentially explore this particular combination in a broader suite of fatigue-related disorders, whether that's myalgic encephalitis or chronic fatigue syndrome, it's more classically known, or some other form of fatigue also represents an opportunity. So that pre-IND meeting will certainly be mostly focused on long COVID, but we do think there is a potential to expand that research given the consistency of the signal to potentially other fatigue-related disorders.
spk01: Does that answer your question? Yeah, I answered part of it. The other part is for the randomized study that's happening, in terms of endpoints and patient enrollment, patient selection, I mean, and also study size, is there any differences compared to the previously completed study?
spk03: The sample sizes in the forward double-blind on COVID program will be a little bit larger. That is specifically a goal. I think we will also ensure patients have a diagnosis of COVID that precedes their long COVID. That is consistent with other programs that FDA has endorsed, blessed moving forward. If you look at some of the other long COVID-related research history, they want a confirmed diagnosis. But suffice it to say, we'll be using the same dose, the same center. We'll have a broader catchment area. to recruit this program, but this program will actually be a little bit larger, but will benefit from more bells and whistles relative to advertising, social media outreach, et cetera, to potentially accelerate recruitment in that particular trial.
spk01: I see. Great. That sounds very exciting and definitely looking forward to the results of this next one. My second question is on the proposed fibromyalgia study I may have missed it in the preparing marks, but the PK study that's to start later this year, what's the size and the expected duration?
spk03: The actual study itself only takes two to three weeks to run at a phase one center. The size will be probably 20-ish patients per arm, 15 to 20 patients per arm. And effectively what you're studying is the levels of the combination product versus the independent components. And so it's a relatively efficient study to run. Our goal is to actually commence that study this year to be ready to begin outreach on the more formal phase three program, the head-to-head studies, the one we're going to start with in the phase three program as we turn into 2024.
spk01: Great. That's all I need to know. Thanks again for taking my questions.
spk03: Of course. Thank you very much again, Sean, for your interest in Vireos and for participating on today's call. It looks like... Thank you. I will turn the call back.
spk04: No other... Yep. Over to you, Mr. Duncan, for final remarks.
spk03: Thank you, sir. So in summary, the team and I are really very encouraged about the potential to expand our pipeline and progress IMC1 into Phase 3 development, as a treatment for fibromyalgia, and now IMC2 into Phase II development as a possible treatment for long COVID. In short, we're now complementing the fibromyalgia program with a very robust long COVID program, which has very significant commercial potential on its own merits. This year, more specifically, our goal is to initiate the IMC1 pharmacokinetic and food effect study, as I just referenced in the Q&A. Later this year, using the dose and formulation, we plan to progress into both Phase III and into commercial scale-up, presenting success in Phase III. And at the same time, we'll be submitting the final outline and the study protocols for final FDA blessing. We have time to do that without delaying the start to the Phase III program as we run the PK and food effects study. As Mike shared, we are extraordinarily encouraged by the clinically and statistically significant improvements in fatigue, pain, and symptoms of autonomic dysfunction. that were observed in a long COVID study. As you can see in the popular press, COVID is not going away. It is here to stay. And if you think about orthostatic hypertension in the population that's most at risk for both COVID and long COVID, a fall could lead to hip fracture and a whole series of very significant health consequences. So getting it right for these patients with long COVID, controlling their fatigue, controlling their autonomic dysfunction, could be a very, very significant upgrade in the standard of care and health for these particular patients. We anticipate meeting with the FDA in the second half of this year to discuss opening a new investigational drug application, as Mike referenced, for more formally assessed treatments of symptoms for patients with long COVID and potentially a broader fatigue syndromes using our second development candidate, IMC2, which, as you are probably well aware, but for completeness, is a fixed-dose combination of valciclovir and celicoxib. As Mike also mentioned, we plan to execute the confirmatory study and use IMC2 as a treatment for long COVID under double-blind placebo-controlled conditions. This study is fully funded. We plan to commence the study starting early fall. We will work closely with the FDA, as you would well imagine, to determine our next steps in advancing both of these very promising programs and look forward to providing consistent updates over the course of the second half of this year. We want to thank you all for your interest in Vireos and for attending today's earnings update. and we're pleased to tell you that our pipeline now has very two significant opportunities, and we are committed to advancing those opportunities as expeditiously as possible with the goal of getting both IMC1 and IMC2 into the market to help millions of patients who suffer from fibromyalgia and or long COVID sequelae. Thank you for attending today's call.
spk04: Thank you. This does conclude today's conference. You may disconnect your lines at this time, and have a wonderful day. Thank you for your participation.
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