Thank you for joining us and welcome to our fireside chat this morning for Reviva Pharmaceuticals. My name is James Molloy, the Biotech and Specialty Pharmaceutical Analyst at AGP. Pardon my background. It's flipped around. Having some tech difficulties on my end. This morning we're talking to Laxminarayan Bhat, CEO of Reviva Pharmaceuticals. We have a buy rating, $30 price target. Reviva is developing brilaroxazine, a serotonin dopamine dual modulator being tested for CNS, inflammatory, and cardiometabolic diseases. The lead clinical program for brilaroxazine phase III RECOVER-2 trial in schizophrenia, the final confirmatory trial before expected NDA filing. RECOVER-2 is expected to start mid this year, 2026, following formal feedback from an upcoming FDA meeting to discuss the new formulation of brilaroxazine that Reviva is gonna introduce for this trial. That should extend the patent life out to 2046. We're gonna walk through all of that today. On the chat we're gonna cover the upcoming trial, the four key points around that, and then we'll take any submitted questions in the end of Q&A. Now, please feel free to submit your questions through the Zoom chat settings, or feel free to email me here at jfmalloy@allianceg.com. My email's on the screen. It's backwards. My email's up there over my shoulder. The fireside chat will run for 50 minutes. We'll have a hard stop at 11:50 A.M. Eastern Time this morning. With that, I'd like to turn it over to Lax for a brief background on himself, a brief overview of Reviva and brilaroxazine, and then we'll dive into the key topics of discussion for today. Lax, please go ahead. Thank you. Thank you, I am James Molloy and w e truly appreciate this opportunity. My background [audio distortion] A scientist by trade, the Founder and CEO of Reviva Pharmaceuticals. At Reviva, we develop novel therapies for diseases of neural dysfunction. That includes psychiatric indications and neurological conditions. The lead product, brilaroxazine, currently phase III development for schizophrenia indication. We have completed successfully the two randomized phase II, last phase II trial in 234 patients. phase III, a registrational trial in 411 patients. Also successfully completed the long-term safety t hat's the mandatory study required for approving an NDA to an indication in 450 patients. Altogether we, so far, treated close to 800+ patients in schizophrenia, and together, safety data over 900 patients. This is a kind of a overview of the clinical data. The, based on the data, what we presented in various conference and then also biomarker data for schizophrenia we recently published, for negative symptom in schizophrenia, say, based on the pharmacology and then data package generated to date. Also, in last December, we had a, you know, FDA interaction for pre-NDA meeting. Completed, the feedback already been announced. It's on our public domain, on the, our website. To summarize, the brilaroxazine is a lead candidate phase III. we are planning for second registrational trial for a schizophrenia indication. We believe that's the, kind of a major placeholder for NDA to our knowledge. As Jim highlighted, you know, beginning of this conversation, we are recently in our letter to shareholders, we highlighted few events that are unfolding this year and you can put the in a near term and then short term milestones. Happy to discuss in detail on all the points what Jim highlighted, and then also entertain any questions you may have. Thank you, Lax. Yes, there's really kind of four key topics we wanna try to cover this morning. First would be the recent move to strengthen the balance sheet with the pro forma cash stock of $23 million walkthrough. We'll walk through where Reviva they get Reviva. Second, sort of the risk-reward around changing. There's been a recent you talked about a recent change in the brilaroxazine formulation before the NDA filing. We'd like to walk through the risk-rewards of that. Third, you know, one of the particular rewards, extending the patent life of brilaroxazine out to 2046 through this new formulation, and we'll talk about some of the history. Some other companies have done a similar thing and this isn't as strange as it might seem. These are not uncommon. Sure. Not everyone can do it. Not everyone has the opportunity. Then fourth, the expected timing. The timing of the key points of phase III trial. the start, the enrollment completion, when do you expect top line, and we'll walk through that in detail. Those will be sort of the four key points I think that are key for today. To start with the balance sheet. A recent $10 million raise, I think it puts you guys up to $23 million pro forma, roughly. Sort of walk through the recent raise and where that puts you in the financial position you're in now. Yeah. You know, last month we raised $10 million. It's a small round. Again, where does it take us? As we highlighted in our last press release, the $10 million will take us to some of the, you know, catalyst what we highlighted here in our letter, shareholders letter. The most important one is the changes to the drug product and then make a switching the drug product in the clinical development. There are some studies required for that, so we are currently working on it. This is a capital strengthening balance sheet would allow us to have a slightly longer runway, i n other words, avoiding a financing hangover at the time of some catalyst what we are anticipating. We are anticipating major catalyst mid this year, FDA alignment or feedback on switching the drug product. That has, we believe, a major milestone that has a, you know, significant impact on our product development, commercial exclusivity and then n general, in total you can call it as a overall, you know, value for the product, for the brilaroxazine. That is expected sometime in mid this year. We, based next to that, once we get FDA alignment, we would like to start second registrational trial. All these events require, you know, decent amount of capital. Raising $10 million, having a in hand, a little over $12 million, all together close to $23 million cash, that would take us to beyond 2026 into Q1 2027. With the catalyst coming in mid this year, that's a major catalyst we believe, that will be, investors will view as that a positive development, whether it is raising capital, additional capital for advancing to NDA or a strategic partnership, that the FDA alignment on extend switching the drug product with the extended patent life, that would be very helpful in realizing the long-term value for brilaroxazine. That's how the $10 million will take us. Hopefully, with this strengthening the balance sheet, we will be able to achieve some of our targets, like, you know, milestones highlighted in the recent shareholders letter. Well, you mentioned it. I mean, the self-funding is an option, but you also touched upon potential partnerships. Could you walk us through, it's a key question, often comes up when I'm speaking about Reviva. Walk us through, as much as you can, of course, anything about potential partnerships that outsiders looking in can know. The interest level, number of potential partners, the size thereof. There's been a lot of, we'll get into it later, but there's been a number of acquisitions in the CNS space that does, I mean, bode very well. That's a very good question, Jim. You know, we often get lot of queries from investors and shareholders as well. You know, with the recent development, major acquisitions and especially some of the directly related to schizophrenia space, there is a strong interest in the investor community in the field. Despite having good data, why Reviva is not able to attract large amount of capital and a major pharma partnership? These questions are valid. To address that question, you know, the bottom line, when we reached out to investors and then pharma partners, one thing we repeatedly, you know, get feedback is data look good and they compare to existing therapies, whether it is a safety or efficacy, you know, we receive really good feedback from investors and then major pharma as well. One thing what we heard is patent life is short compared to kind of a other blockbuster that's currently in the market. What's that mean? Our patent life is a commercial exclusivity with the extended, you know, the compositions of matter patent expires in November 2030. Since we're a new chemical entity, we expect Hatch-Waxman Act five years extension. To my knowledge, every single drug, quarter-approved new chemical entity avail this extension. With this extension, we expect to have commercial exclusivity till 2035. For schizophrenia in all, based on our timeline, if you get brilaroxazine approved for schizophrenia, something, let's say, by end of 2028 or early 2029, commercial exclusivity till 2036, you know, for investors, major investors and pharma partners, viewed as a very, not very, what you call, favorable patent life. Not favorable patent life in the sense, going beyond schizophrenia to create value. It takes, let's say for example, some of the broader antipsychotics, good safety profile, recently approved, like ABILIFY or cariprazine. These drugs got approved beyond schizophrenia to major indications like bipolar and major depressive disorders. To go beyond schizophrenia, we need to have extended patent life and commercial exclusivity. To extending the patent life and commercial exclusivity, it's not that the cookie cutter approach. It requires, you know, lot of expertise. There are, to my knowledge, there are four things very critical in this process. As I said, it is not a kind of routinely done in the industry, but there are several examples. During the clinical development, companies have, you know, switched the drug product. For switching drug product, there are four things we need to, you know, be working on. One is deep, overall, it should have deep understanding of, you know, regulatory matters. CMC, we call it as a, in the small molecule, chemistry and formulation expertise. Clinical implication of these changes and then m ost importantly, IP. All these things we need to work out. We have been working for the last one year quietly for all these things. Now we are at a stage, we have, you know, generated a preclinical data package. They are very predictive for clinical success. With this package, you know, we are reaching out to FDA, we expect to have feedback sometime this year. Having said that, why it is not done frequently, because say, when you say that the patent exclusivity, it's typically, you know, the patent life when we file patent, typically it is an early stage of discovery stage, we file patent. The patent life, it goes for 20 years. By the time we get approval for drug, which it takes anywhere around 10- 15 years to get a new chemical entity, if it is successful, to bring it to market. If it takes 10 years, then we have 10-year patent life, if it takes 15 years, only five-year patent life will be left out. If it's a new chemical entity, we can get additional five years extended, depending upon the, how much time left out on the primary patent. All together with the extension, you know, most drugs currently in the market widely used avail around 14 years of patent life with exclusivity. Considering that you take around 10-12 years, you know, for developing a drug, and then with exclusivity, post-approval, if you can have around a 10 years exclusivity, that's a good time. In our case, we fall in around a seven years exclusivity approximately. By extending this patent life to changing the modification to the, our lead product, that would give us patent life till 2046. Of course, the patent is not granted yet, but, you know, this is something we feel very confident about it. This is routinely done in the industry because we have granted over 70 patents globally. We are very familiar with this process. This is what's coming up. This is the key, going to the second point is there's no new formulations at this late stage. This is the key at the FDA meeting that's coming up, right? This is where this is sort of the benefit risks of doing the change. The FDA, hopefully giving their bless, you see no reason why they shouldn't. Yeah. You higlighted any number of companies have done this. Can you walk through the benefit risks of what investors should be expecting here from this FDA meeting? The benefit risk, if you look at the risk is, I would say a kind of a minimal to my knowledge. Again, it depends on the investors, what they are looking for. Risk is in the short term. It takes about a year to develop. At least a year you can expect to develop this. In the short run, you know, that is a milestone can be delayed. That's what we are having currently. Investors expected quickly start a second trial. There is a delay. Now in the long run, there are a lot of benefits. Extending the patent life, it will be, it is palatable to investors and then the strategic partners, and then it is a longer runway. It maximizes the value. Most importantly, in the neuropsychiatric space, as I mentioned, with the good safety profile, broader efficacy, the drugs are developed beyond schizophrenia. Let's say for schizophrenia alone, it is around a $15 billion market by 2032, and then similar market size for bipolar and major depressive disorder. If you have extended patent life, extended commercial exclusivity, we can develop brilaroxazine using the most of the data generated, pre-clinical and clinical data generated as a safety package. You know, we don't have to repeat all those studies going after additional indication so w e can quickly go for two confirmatory studies for bipolar and major depressive disorder, and then, you know, potential NDA for these indications. This is not something new in this space, other companies have done but t he bottom line is extending the patent life and commercial exclusivity, that will open up opportunities, all these commercial opportunities. That's what, you know, we are currently doing it. Now coming to the FDA feedback. What is the expectation here in the regulatory perspective, how other companies have done in the past? Unfortunately, you don't have all this information in the public domain from other companies in detail. Yes, we do know that companies have switched drug product, but deeper insights into the process, it's difficult to get. Now, at least to our knowledge, there are, you know, multiple aspects to changing it. Let's say if the small molecule. Most the small molecule drugs currently in the market are, you know, some form of salts so t hat we call it as an API. This API further formulated into drug product, whether it is a tablet, capsule, extended release, various other form but they all starts from API. The changes can be a different salt form, and that gives a broader, strong patent coverage and then c hanges also can be, to, we call it as a polymorph. Within the salt itself, a small changes, a particular polymorph having a patent that can also be used as a patent extension. Lastly, a different formulation. Like if you have used IR formulation, or if you have used to extend it, for that gives certain benefit. All these things are prior to approval, if you can make changes, it has some benefits. Not necessarily all changes gives same extent patent life. Without going into the detail, technical detail, we have done, incorporated all these three major elements in our changes to that, you know, our brilaroxazine. We believe, you know, our patent position is very strong. This can be with the commercial exclusivity expected extension, you know, up to 2046. I recall- Yeah. ...back in the day, Intra-Cellular Therapies did a similar change on their late-stage development for CAPLYTA, which I think we've all seen on the, on the TV, the advertisements for that. They made a late change to extend their patent life as well. Yes. At least, based on the publicly available information. If you look at, you know, their patent exclusivity, if I'm correct, was till 2049, 2029. When they got extended, that went to 2040. In January 2025, the company was acquired by Johnson & Johnson. Also that extended patent life at 2040, one can expect in the CAPLYTA case, you know, going beyond schizophrenia to bipolar and major depressive disorder. They have additional 10 years patent runway that maximize the value. We are also trying to do something similar to that. Now, the which extent CAPLYTA made changes that were, is not available in the public domain. It's not only CAPLYTA. There are other few drugs in the recent past also use this approach. Again, to using this approach, you know, not every drug is possible to do but in our case, we are able to do, you know, extend the patent life. Patent already been filed, and then we are in a process of expediting the accelerated approval for this patent. With this data, pre-clinical data in this process is pretty, you know, predictable for a clinical translation. Of course, we need to generate clinical data, but they are pretty reliable for a predictive purpose. The expectation coming out of the FDA meeting. Have you disclosed publicly when the exact timing of the FDA? Yes. In the last shareholders letter to company shareholders letter, we highlighted that we are expecting around mid of this year FDA feedback, and then that would allow us to switch the drug product in the upcoming trial, and then file NDA so t hat's our plan and so that's been already been relayed to shareholders publicly. If those listeners may not know, yeah, it's usually 40 days, 45 days after the meeting for the minutes of the meeting to come out, and that's what you're, you'll be waiting for to make sure what you heard is what the FDA meant to say. Yeah. This is a, you know, well, agency, we believe, you know, this is a, maybe around a Type C meeting, and this would take around 45 days to get the feedback, maximum 60 days. Again, this is our expectation. Sometimes, you know, agency, the feedback and then the timeline, it something beyond our control. What we are predicting, these are all based on the historical data available. They are reasonable, around 45 days to a 60 days timeline. Yeah. Yeah. Yeah. The FDA certainly works on its own timelines, a government agency. Yeah. ... in line with what other companies have seen in the past and what they guide to. Let's go to the third point. We touched, again, these are all, they all kind of tie together. You touched upon it, you know, extending the patent life to 2046. The actual extension, you probably won't get to the end of this year, but the expectation is that it should be locked in. Could you talk about the implications on getting a patent out to 2046, how that changes the potential value of brilaroxazine as an asset, and the potential interest from partners, again, assuming trials will go well and it performs as expected? If you look at, again, everything is data-driven here. It's not aspirational. You know, we have generated data, clinical data. They are, to my knowledge, they are very impressive. By and large, our investor interactions also, we receive the kind of a similar feedback. Data look good. Potentially, if you can extend this one for bipolar and major depressive disorder, this could benefit patients. Now having said that, you know, extending the patent life, it would allow us to go beyond schizophrenia. For us, say, to complete the where we are now, to do the second study and then file NDA for schizophrenia, we need altogether around $50 million-$55 million to complete, including our G&A expense and wrap up the study file, submit NDA. We have currently around $23 million cash. With this, extending the patent life, that would and would be very favorable for whether it is a strategic partnership or a investors to come on board. The institutional investors, the extension of patent life for commercial exclusivity is an opportunity to, you know, expand the label claim, going for larger indications. Yes, of course it requires additional capital, but the value creation will be multifold. The, let's say if we in an ideal world or a timeline what we forecasted, if we, our plan is to start the phase II registrational trial in Q3 this year after the FDA feedback, or I would put in broadly later part of this year sometime. That would allow us to complete the study by end of this next year, and then give top-line data end of next year or early Q1 2028. It is a placeholder left out for filing an NDA, the remaining studies completed. We can quickly submit an NDA so t hat will be taken care of for schizophrenia NDA. The data generated as a package, close to 1,200 patients, 1,200+ patients, that can be utilized for developing this drug for bipolar. If we had to extend this one for bipolar, we don't have to do long-term safety and then all the toxicology package or development, even the drug development. Same drug were, you know, the, what we using for schizophrenia can be used at a different dose trying to bipolar and major depressive disorder. That's the advantage. If you look at by just quickly do registrational study for additional indication, it can get us new indication. That is, let's, for example, bipolar. That's a $15 billion market. Same thing with the MDD. Extending the patent life will open up the opportunities for going quickly. This is a additional indication. Again, this is not something we are reinventing this thing. This is a very well-worked-out regulatory approach other companies have used. What is needed is a extended patent life and a financial resource. With the extended patent life, we believe it is attractable to investors as well as a major pharma for potential partnership. That's what we would like to, we are hoping to realize, post-FDA alignment mid this year. To that end, remind listeners, Karuna was bought in March 2024 by Bristol for $14 billion to get COBENFY. Intra-Cellular was bought in January 2023 by Johnson & Johnson for $14.6 billion to get CAPLYTA. Again, they started with 1 indication, added on some other indications, similar to what you guys are planning. It's not, you guys are not paving new ground here. You're going down with some well-established paths to market. Could you talk a little about how these, those acquisitions and the potential for Reviva and brilaroxazine, how they speak to the hunger that remains for larger pharma for new CNS assets in these indications that for a long time people thought were sort of settled. They, "Oh, we got that figured out." No, that's not the case at all. Sure. You know, you gave two examples, Jim. They are, you know, two extreme ends in the sense, if you look at Karuna Therapeutics and prior to that Cerevel acquisition around a $8.9 billion at a phase II level asset. You know, Karuna Therapeutics and Cerevel, they are kind of a Wall Street driven valuation. The Intra-Cellular CAPLYTA to my knowledge, it is a more a market-driven valuation. Market-driven valuation are slightly different based on the existing sales for one indication, and a clinical stage approval for various additional indications. That's more realistic the valuation. Now, coming to Wall Street driven valuation, even if you look at Karuna Therapeutics to my knowledge, it's not just a valuation for schizophrenia. If you look at the time of Karuna Therapeutics drug got approved in 2024, so they had around a 10 years patent life. Again, the company with the $900 million, close to $900 million cash prior to acquisition. Company also started a, you know, additional indication, psychosis in Alzheimer's. The valuation, pre-market valuation is not specific to schizophrenia. Even the psychosis in Alzheimer's is also large market. Whether it realize or not down the line, that's a different aspect. The valuation is based on the, you know, pre-market or pre-commercial clinical data based or some of the indications the company intend to do. In our case, if you look at, if you have extended patent life till 2046, if you go with a, like, Intra-Cellular Therapies playbook, like, if you look at in our corporate presentation, it's on our public domain. We have compared the historical data of CAPLYTA versus our drug. Again, these are not a head-to-head comparison. To a great extent you can, you know, compare the historical data. Our data looks really very impressive, very promising. If we have, with this data, if we have extended patent life, you know, this will have a good opportunity in the valuation perspective. I don't want to put a dollar amount for our drug, the valuation. At least based on the historical data, you know, investors can come to a reasonable conclusion, what kind of valuation in the line you can expect. Well, with that, let's move over to the clinical trial design. phase III RECOVER-1 trial, 50 mg hit excellent PANSS scores. If you walk our listeners briefly through the positive data there, and then you said the RECOVER-2, the phase III trial, pending the FDA minutes, you plan to start here in the third quarter of this year. Can you walk our listeners through the similarities and differences between the RECOVER-1 and RECOVER-2 trials, and how we should look at the positive RECOVER-1 and how that may inform what we should expect from RECOVER-2? The RECOVER-1 and RECOVER-2 trial design, if you compare, they are kind of identical. Global trial, most of the clinical sites, globally in the U.S., in Asia, and in Europe, we, you know, engaged for the RECOVER-1 trial. The same sites will be re-engaged. Most of the sites will be re-engaged. We have already done all the preparatory work for initiating the RECOVER-2 trial. FDA has already reviewed the protocol and we have a, I would not say, it's not called exactly approval, consent to go ahead with the trial. We have already received FDA. It is just a switching the drug product, the old brilaroxazine drug product, the new product, which has extended patent life. The ex- FDA expectation is that when you switch a drug product in the middle of the clinical trial, or a clinical development, not in the clinical trial, sorry, clinical development. The expectation is the new product, safety profile should be comparable or better. That's the requirement. Efficacy-wise, you don't expect to have a much change. Of course, that's also a criteria. That's what we're putting. Generally, if the change is within the generally acceptable, there are a well worked out scientific, you know, methodology how you change all these things. If you are change, the changes what you make, it, if it falls in that, generally acceptable criteria, it's called GRAS criteria. If that change falls in that category, it's by and large, you know, it is a, you can make a good prediction prior to doing the clinical trial itself based on the preclinical package, whether your drug is equivalent to the previous changes, whether equivalent to the previous drug product or it even better. We feel very comfortable with the changes we made. It's very promising. Again, at this time, I don't want to reveal too much about it. Once we start phase III study, this will be on the public domain ClinicalTrials.gov. As skilled persons in this field will be able to figure out exactly what the changes we made. We feel very confident about the changes what we made, that will be, you know, equivalent or better than what we have been using in the, currently using in the trial. It'll be the 50 mg once daily, 28 days. About 400 patients for acute schizophrenia, similar to the RECOVER-1. You know, technically the way it works is say, as you know, if we have tried up to 100 mg. We have, even though we tried 50 mg phase III trial, phase II at the highest dose, we have safety profile up to 100 mg. It is very- well tolerated. There is no issue at all. Based on the profile, we, you know, we evaluated going beyond 50 mg may not add much benefit to patients. That is what we kept 50 mg. Now coming to your question with the changes what we made to the drug, with that, the new drug will be either 50 mg or 60 mg or even 40 mg equivalent. All these things will be done once we let's say if we complete the trial with the 50 mg with the new drug, that has a better profile than earlier, 50 mg. Maybe let's say just for the you know, sake of discussion, the new drug formulation, 50 mg is you know, the efficacy, if you reduce it to 40 mg, that is equivalent to our earlier drug. Still, you can go ahead and then do the 50 mg in the trial. Ultimately, when drug gets approved, the agency evaluate that one. We call it as a PK/ PD modeling and then pharmacometrics analysis combining all the studies done and t hen, FDA will make a decision what's the right dose. We expect it is to be a 50 mg top dose or equivalent. It could come down to less than 50 as well. We do not know at this time. This is routinely done in the approval process. That's not a concern. As you, as you said, you said a couple times, third quarter start again pending the FDA. Expect third quarter start potentially, you know, complete enrollment. It's a 28-day dosing, complete enrollment by fourth quarter next year. About a year and a quarter, 18 months to enroll. That's quicker than the RECOVER-1 walk-through. There was some COVID in RECOVER-1 walk-through. Why you feel good you'll be able to hit the more accelerated than the other trial timeline? You know, timeline, we put aggressive timeline. This is based on the historical as well as what we achieve, delivered to in the last trial. If you look at the last trial, efficacy trial design, it's a four weeks trial design, treatment. We delivered the data in 18 months from the first enrollment patients to the top line data approximately 18 months. That was a COVID time. Even some of our competing competitors took more than what we took to complete. Historically, four weeks trial, around 400 patients. The enrollment completed, if you historical data, if you compare with the KarXT, similar trial for schizophrenia. To my knowledge, they completed the enrollment in 12 months. We are expecting around 12 months completion of enrollment, and then give top line data in for altogether 14 months. These days, all the data captured electronically. Wrapping up the study is much faster compared to, you know, a couple of years ago. We are comfortable in predicting that timeline. Again, as I mentioned few minutes ago, the trial design is identical. We have done most of the legwork already been completed to initiate a second trial. If FDA allow us to switch the trial, that also, you know, we feel very comfortable with the regulatory feedback, but still, you know, this is the procedure what the agency feedback is very critical. With this FDA feedback, we should be able to quickly upfront the trial. There are two aspects to that. One is FDA may ask us to do a small bioequivalent study at, you know, that's a single dose study in healthy volunteers that we can be quickly wrapped up before phase III. regardless of, you know, exact timeline, once we start enrolling patients, completion of enrollment at, say, around 12 months time, and then give top line data 14 months, let's say, looks very achievable and reasonable timeline. Based on this, predictions, we put the timeline that sometime in the second half of Q3 later this year, we are expecting to enroll patients in the second trial, and then complete the study in Q4 next year, and then give top-line data end of Q4 or early Q1 in 2028 so t hat's our timeline. Would you utilize the same centers that you used in RECOVER-1 for this trial? How many centers did you use? Can you talk a little bit about the competition for patients for these trials? How easy or hard is it to get patients? Sure. You know, again, in the U.S. there are around 30 sites actively enrolled in schizophrenia trial. Every company, by every new drug developed in the last five years, you know, these are the sites involved and t hen we engaged 22 sites last trial, RECOVER-1. In this trial, we are currently planning 25 sites in the U.S. In the last trial, we put 12 sites in India, and then eight sites in Europe. We have same, eight sites in Europe, 12 sites in India. In the U.S., we are planning around 25 sites. As you know, these are the sites. If you add all together, it will come little over 40. In any trial, around 5%-10% of the sites, they underperform. That's okay. Even despite that, active sites of around 30 sites are good enough to achieve the target enrollment. The competition to enroll patients in these trials, is it relatively easy or there's a challenge? No, no. At this time, again, to my knowledge, you know, when we did the first trial, there are four companies who are doing schizophrenia trial. Two, three are efficacy studies in the four to six weeks trial, six weeks trial, four to six weeks, and there are also long-acting trials were going on. Currently, to my knowledge, there are only two companies are planning to or maybe at planning to recruit or planning for a fair. One is MapLight. It's a phase II trial upcoming to my knowledge. The other one is a LB Pharmaceuticals. They are planning or initiated a, phase III trial. other than these two companies, I don't see any other companies actively planning for large trials in U.S. Considering that, at this time, there are not much of a competition for patients pool available. The trial should run, go very quickly, to our knowledge. Now, you know, we'll talk, we'll do questions at the end, but I've been working, we're getting some questions through the Q&A on the Zoom. I've been working them in for our conversation. One of the, one thing I wanted to touch on, that came up was on the, bioequivalence study. What you'll know coming out, you'll know in July or you'll know coming out of the meeting, I suppose, if you need to do it. How, how, what's the timeline we should expect for that- Sure. ...to get that up and running and? You know, the bioequivalence study, this is a very routinely done in the industry. What we do, we have already started evaluating the bioequivalence study. In fact, when we reach out to FDA, we will have- in- hand bioequivalence study protocol. Bioequivalence study, typically, this is a very routinely done. It doesn't require any special regulatory approval, but it is just for the regulatory agency information. When we reach out to, during, for FDA feedback, this is already incorporated in that bioequivalence study design and other things. This is, again, as I said, single-dose, done in the U.S. It can be very quickly done in the U.S. Yeah. Is it a matter of a month? Couple months? No, typically it's a single days, a single dose, and then one week wash out. Typically, it takes about one month. I f you plan properly, we have already started to, you know, protocol design and other things, and then everything you keep it ready. If FDA feedback come, then we can quickly enroll patient. This is in healthy volunteers, i t's not in patient. Right. Healthy subjects, typically it is around 10 healthy volunteers. You give single dose and then collect blood samples for a week. The study is over. This is pretty quick. Of course, it's a week, you know, pre, single dose and then week blood collection. All together to wrap up, it takes around four to six weeks. Mechanistically, I mean, you'll meet with the FDA soon. You're gonna wait to get the minutes before you phase iii RECOVER-2 trial. If in that meeting you get a clear indication that you need the bioequivalence, you could get that run and done by the time you get the minutes. That's what we are hoping for. This is, it is not like a pre-NDA meeting that, at least to my knowledge, you need to wait for 30 days. This is typically evaluated by the CMC section in the FDA. This is a separate division. To, you know, often these meeting minutes are pretty quick, within a week. It's not like a pre-NDA meeting. Again, as I said, this is an agency, where we don't have any control. We need to keep always some buffer. Historical data, if you look at, you don't have to wait for. It doesn't take that, a month time to get feedback s o these are all pretty quick, you know, following meeting, we can expect feedback very quickly. Excellent. I guess in a positive, even if you were to run the bioequivalence, it may not affect your planned timeline in any way. In a bioequivalence study, it is, in a way, it is good to run, because it gives more confidence, even though it may take a week or two or maybe one month but i t secures a lot with respect to expectation in the trial outcome. Say, you know, these are all the kind of a checkbox, I would say, bioequivalence studies routinely done in the industry. You know, it doesn't take much time. Well, we're coming up on the 11:50 timeline. I'd like to thank Lax. Thank you very much for your time today, and for our listeners for joining. Any final comments before we close it out? You know, again, I, again, thanks for the opportunity. Really appreciate you taking time to organize this fireside chat. You know, as we highlighted in our shareholders letter, we have cash runway into Q1 next year. There are at least two major milestones coming up. The major milestone is a FDA alignment for switching the product. With respect to patent, as I mentioned, we already filed patent. We feel very confident about it. It just a procedural. It takes time to get approval. We are expediting it but t he FDA alignment for switching the drug product is a major milestone. With that, we have already, you know, planning for BE study and then phase III initiation. Again, as I mentioned, we already have done preliminary work for phase III study. We are very confident that following FDA meeting, quickly able to phase III study so with that these are the two major milestones. The initiation of phase III study will set a cadence or what to expect milestone-wise with the top-line data, potential NDA, and then approval. These two major milestones, FDA feedback, mid of this year phase III, these are the two major milestones, second stage for future, you know, development as well as the value creation for Reviva. Well, thank you very much. With that, we'll close the fireside chat. You may disconnect. Thank you everyone for joining us today. Thank you. Thank you, Jim.