Dogwood Therapeutics, Inc. (DWTX) Earnings Call Transcript & Summary

Good day, and welcome to the Virios Therapeutics, Inc. Q2 2023 Earnings Update. [Operator Instructions] 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 of Virios Therapeutics. Please proceed, Angela.

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 Virios 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 involve 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 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.

Thank you, Angela, and good morning to all of you joining us on today's quarter 2 2023 earnings update. We have 3 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, IMC-1 into Phase III 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 Gendreau, on the call today to review the recently announced very encouraging results we received from our exploratory Long-COVID study sponsored by Virios 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 2 financials. Following the review of these topics, we will open up the call to questions. Let me start with an update on our IMC-1 Phase III submission to the FDA. As announced just yesterday, the Food and Drug Administration communicated that following their initial review of the Virios 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 effect study later this year, while concurrently submitting an updated Phase III 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 IMC-1 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 505(b)(2) regulatory pathway. The forthcoming Phase III fibromyalgia program proposal consists of 3 main study components. The plan is to execute 2 adequate and well-controlled studies: One is a head-to-head study comparing IMC-1 and placebo, and the second trial will be a full factorial design with each of the individual components of IMC-1, valacyclovir and celecoxib, a separate comparator arms and a long-term extension study. Based on data from the recently completed FORTRESS Phase IIb trial, we have proposed a Phase III development program targeting community-based fibromyalgia patients who 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. Gendreau, to share what we have learned from the recently completed Long-COVID study. The data from this exploratory study underpins our belief that IMC-2, a fixed-dose combination of valacyclovir 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. 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 IMC-1 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 IMC-1 to enhance our chances for Phase III success. Now switching to Long COVID, I would like to highlight the study design and 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 smeller taste and orthostatic intolerance. Prevalence estimates suggests 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 3 months after the acute COVID infection has resolved and lasting at least another 2 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 in 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 herpesviruses 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 Virios. 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 were screened, 39 were eligible for the study and enrolled into the clinical trial. 22 of those patients were assigned to receive treatment with valacyclovir and celecoxib. Those are known as the assign -- as the treatment group. And 17, were assigned to a match control group that is the patients were matched for age, gender and duration of disease, but did not receive the Val/Cel 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. All 17 control patients completed the study. Slide 3, please. The primary endpoint in this study was a reduction in fatigue over 14 weeks. The fatigue was measured with something known as the NIH PROMIS fatigue instrument. The PROMIS fatigue is an 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 that 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 Val/Cel combination had a statistically and clinically meaningful reduction in their fatigue of 7.2 points on the scale. On the PROMIS fatigue scale, a change of 3 to 4 units is considered to be clinically meaningful. So they had a better than 7-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 0.008. 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 then 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 2 domains in this measure. There's an orthostatic symptoms domain, which really directly measure the 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 the 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 9 points on the Val/Cel 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 or whatever. And again, we had over a 7-point improvement on Val/Cel 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 Val/Cel combination, which was -- this was new to us. We hadn't seen this before, and we saw that was quite an important finding with this treatment. Slide 5, 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 Val/Cel combination to the control group. At week 14, we've already showed that the NIH PROMIS fatigue T-score was improved. So the primary endpoint of fatigue was statistically improved even with these small numbers. We also measured fatigue on a 0 to 10 scale. That's where 0 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 the 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 2 different patient global impression scale. 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 2 different scales. One was a 1 to 7 scale, where 7 says I'm doing really well and 1 means I'm doing really poorly and also 0 to 10 that with the opposite direction intentionally, where 0 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've showed you the 2 orthostatic intolerance scale, so were statistically significant at end point. 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 scale 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 in the right direction and statistically significant in most cases. From a safety standpoint, treatment with Val/Cel 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 valacyclovir and Celecoxib. It doesn't look like there's any combination toxicity of 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 the valacyclovir treatment. So with that summary, let me go to Slide 6. 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 the combination of valacyclovir 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 main duration of Long-COVID related symptoms was 2 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?

Thank you, Mike. With respect to our income statement, as a development stage by technology company, we did not generate revenue during the 3 months ended June 30, 2023, or during the year ago quarter. We reported research and development expenses of $0.6 million for the second quarter ended 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 JonesTrading. 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 top 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 30, 2023, we had $4.6 million in cash as compared to $7 million as of December 31, 2022. We expect that the company's cash balance at June 30 plus the additional amount raised under the ATM agreement with JonesTrading 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?

Thanks again, Angela. Operator, we are now ready for questions.

[Operator Instructions] And the first question today is coming from David Bautz from Zacks Small-Cap Research.

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 III 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?

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 overrepresentation of these patients in our previous FORTRESS Phase IIb 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 delays. 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 buyoff, 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 III. Does that answer your question, David?

Yes. And speaking of the pK and food effect study. And just a couple of quick questions about that. What outcomes are you looking for there? Do you foresee any type of food effect on IMC-1? And then did I hear correct, is this a new formulation that you're going to be studying in that study also?

Yes. That's 2 questions there. So let me start with the second question first. So the revised IMC-1 formulation is, again, a single condition tablet. We are progressing with this new tablet in Phase III because that is the tablet that will conform to the commercial requirements. We are removing some excipients from the research formulation, small stuff, but small requests from FDA. So that new formulation is ready for both Phase III as well as for commercial launch, presuming success in the Phase III. 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(b)(2) 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 and increased time, et cetera. So as you probably know, the treatment effect size in the Phase IIb and the Phase IIa was largely similar between the 2 doses. The Phase IIb dose was about 3x larger than the Phase IIa dose. And effectively, what we're going to do is progress with the dose that's in line with those reference doses of valacyclovir and celecoxib, a dose very close to the Phase IIa dose to be most efficient as we progress into the Phase III. So 2 reasons for it: one, the efficiency, two, to make sure we're locked and loaded on a formulation that is ready for a commercial scale up, presuming success in the Phase III.

Okay. That makes sense. And then just how long is that study going to take? What are the outcomes for the food effect study, those types of things?

Yes, I was going to go on to that. I just want to make sure I answered your first one. So the 2 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 Cmax or the maximum blood concentration, which usually occurs shortly after administration of the drug. So what we want to make sure is that the Cmax, maximum exposure and the total exposure over dosing period at steady state are consistent with the dosage levels for the independent components, that's valacyclovir and celecoxib. And by doing so, we can utilize all of the safety longer-term studies that were used to originally approve both valacyclovir and celecoxib and avoid doing all those other ancillary studies. So we can have a very efficient Phase III, which is 2 adequate and more 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 III, which is good news for obviously, Virios shareholders and ideally patients moving forward.

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 Horne Center as opposed to kind of expanding out and doing a larger double-blind, placebo-controlled study at this time?

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 IMC-2 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 IMC-1 under classic double-blind, placebo controlled conditions. Simultaneously, and I say this with great hopes moving forward, we are engaging with an 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 2 academic institutions are actually evaluating and administering the funds that NIH is really recently allocated to research in Long-COVID and they are 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 nondilutive 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 2 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 can get a sense, David, that if you were 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 nondilutive funding to progress the more classic Phase IIb dose-ranging study. So really 2 shots on goal with that. And as Mike mentioned earlier, what we're really excited about here for IMC-2 is having filed this provisional patent. If that patent is granted, that will extend our intellectual property protection out to roughly 2044. So a long lead time on that method of use patent to be able to research and progress the Long-COVID program as a complement to fibromyalgia.

Okay. And so Virios is sponsoring this study at the Bateman Horne Center. Is that correct?

The Bateman Horne 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 nondilutive 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 nondilutive 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 on treatments. I think everybody realizes a 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.

The next question is coming from Sean Lee from Lay Press.

I just have 2 quick ones. First is on the upcoming new Long-COVID study. So other than being double blinded and randomized, how is it -- is there any differences between the proposed study and what has been completed so far at the Bateman Horne?

So excellent question, Sean, and thank you for joining in 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 or 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 it's 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, these combinations, be it the Phase IIa fibromyalgia trial, the Phase IIb fibromyalgia trial and now this exploratory Long-COVID trial, the impact on fatigue is robust, statistically significant and consistent across all of those 3 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 3 studies, would it make sense to potentially explore this particular combination in a broader suite of fatigue-related disorders, whether that's myalgic encephalomyelitis 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. Does that answer your question?

Yes. It answers part's of it. The other part is for the randomized study 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?

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 Long-COVID, that is consistent with other programs that FDA has endorsed [ less ] 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 recruiting in that particular trial.

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 prepared remarks, but the pK study that started later this year. What's the size and expected duration?

So the actual study itself only takes 2 to 3 weeks to run at a Phase I 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 III program. The head-to-head study is the one we're going to start with in the Phase III program as we turn into 2024.

At this time, I'll turn the call back. Over to you, Mr. Duncan for final remarks.

Thank you, Sarah. So in summary, the team and I are really very encouraged about the potential to expand our pipeline and progress IMC-1 into Phase III development as a treatment for fibromyalgia and now IMC-2 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 IMC-1 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 the 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 effect 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, to more formally assessed treatment of symptoms for patients with Long-COVID and potentially a broader fatigue syndrome using our second development candidate, IMC-2 which as you're probably well aware, but completeness is a fixed-dose combination of valacyclovir and celecoxib. As Mike also mentioned, we plan to execute the confirmatory study used IMC-2 as a treatment for Long-COVID under double-blind placebo controlled conditions. This is fully funded. We plan to commence the study starting probably 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 Virios and for attending today's earnings update. We're pleased to tell you that our pipeline now has very 2 significant opportunities, and we are committed to advancing those opportunities as expeditiously as possible with the goal of getting both IMC-1 and IMC-2 into the market to help millions of patients who suffer from fibromyalgia and/or Long-COVID sequelae. Thank you for attending today's call.

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.