Longeveron Inc.

Follow the formal presentation. Should anyone require operator assistance during the conference, please press star zero on your telephone keypad. As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Derek Cole of Investor Relations Advisory Solutions. Thank you. You may begin.

Thank you, operator. Good afternoon, everyone, and thank you for joining us today to review Longevron's 2025 first quarter financial results and business updates. After the U.S. markets closed today, we issued a press release with financial results for Q1 2020, which can be found under the investor section of the Longevron website. On the call today are Wael Hashad, Chief Executive Officer, Joshua O'Hare, Co-Founder, Chief Science Officer and Chairman of the Board, Natalia Agafonova, Chief Medical Officer, Lisa Locklear, Chief Financial Officer, and Devin Blass, Chief Technology Officer. As a reminder, during this call, we will be making forward-looking statements. These statements are subject to certain risks and uncertainties that could cause actual results to differ materially from these statements. Any such statements should be considered in conjunction with cautionary statements in our press release and risk factors discussed in the company's filings with the Securities and Exchange Commission, which we encourage you to review. Following the company's prepared remarks, we will open the call to questions from covering analysts. With that, let me hand the call over to Dr. Joshua Hare, founder and chairman of the board. Josh?

Thank you, Derek. Good afternoon, everyone, and thank you very much for joining us today. We greatly appreciate your interest in Longeviron. We are very pleased to update you on our continued successful progress advancing stem cell therapy with our lead product, Laromester Cell, for multiple chronic indications. Simply put, this period of the past two years to next year is the most exciting time in the company's history. Ten years ago, when I co-founded the company, our stem cell therapy vision was an academic idea. Today, we can see the possibility of our first BLA submission seeking approval for laromestrocell for HLHS. This directly reflects our mission, seeking to help patients and families through the application of stem cell research. In Alzheimer's disease, we've generated incredibly important clinical data supporting the therapeutic potential of laromestrocell in this devastating neurodegenerative disorder that leads to progressive memory loss and death and currently has very limited therapeutic options. This data has been accepted for presentation at multiple leading industry conferences and was published in the prestigious peer-reviewed journal Nature Medicine in the April 2025 issue. We were honored to also have the opportunity to discuss these phase two results in a recent article in Neurology Today. Our motivation and dedication to advancing stem cell therapy research has only been further invigorated by the reception to this data from the thought leader community. The next 12 to 18 months are potentially transformational period for Longevron with multiple critical milestones. and we are incredibly excited about the opportunity for this progress and to share the developments with you. I will now hand the call over to Wael. Wael?

Thank you, Josh. As Josh stated so well, this is a very exciting time for the company. We continue to focus on diligent, efficient execution of our strategic plan for Longevron and Leromaster Cell. In February of this year, we achieved milestone when the International Non-Proprietary Name Expert Committee of the World Health Organization approved Laromaster Cell as a non-proprietary name for Lomacil B. This is an important step in the development and potential future commercialization of our cell therapy, Laromaster Cell. We will be using the name Laromaster Cell going forwards when referencing our cell therapy and reduce the usage of LomaCellB. As a reminder, for those of you newer to our story, Longevrone is a regenerative medicine company developing cutting-edge cellular therapy. Our stem cell therapy, Lettermaster Cell, has delivered several positive initial results across five clinical trials in three indications. phase one and two in Alzheimer's disease, phase one and two in aging-related frailty, and phase one in hypoplastic left heart syndrome, or HLHS, a rare pediatric and orphan disease. The company's development program for these three initial indications addressed U.S. market opportunities of approximately five-plus billion 4-plus billion, and up to 1 billion, respectively. Our strategic plan is built on the strengths of the science underlying our stem cell therapy lateral mast cell. Our goals for 2025 center on efficient, effective execution of that strategic plan with emphasis on three primary operational goals. Alphas II, which is the Phase IIb study for HLHS completion, HLHS BLA preparedness and commercializational readiness, pursuing strategic collaboration for the Alzheimer's disease program. HLHS is a key strategic priority for us. We believe the HLHS program has high probability of success and the shortest path to potential regulatory approval and future commercialization across our pipeline. We are currently nearing completion of enrollment of the ELPIS II Phase IIb study, evaluating bladder mast cell as a potential adjunct treatment to the standard of care for HLHS patients. ELPIS II has achieved approximately 95% enrollment and we expect to complete enrollment in the second quarter of this year, which is the current existing quarter now. The determination by the U.S. Food and Drug Administration at our meeting in August of last year that ALPS-2 is pivotal significantly accelerated the potential regulatory path for lateral mast cell. And if supported by clinical data from the clinical trial, would allow us to initiate a rolling submission of a BLA with the Food and Drug Administration in 2026. With the potential for BLA submission on the horizon, we hired Devin Blass as our Chief Technology Officer. He has over 15 years of distinguished experience in the development and manufacturing of advanced therapies, and is leading the company's technological and manufacturing strategies. He will be providing a brief commentary on our HLHS BLA preparedness activities. The lateral mast cell Alzheimer's disease program continues to garner important recognition and support. As Dr. Hare mentioned, results from ClearMind Phase IIA clinical trial evaluating lateral mast cell in mild Alzheimer's disease were published in Nature Medicine in March of this year and featured in an interview with Dr. Hare in Neurology Today in April. Data from this trial were previously presented as a featured research oral presentation at the 2024 Alzheimer's Association International Conference held at the end of July of 2024 as a late-breaking and also presented as a late-breaking poster presentation at the 17th edition of the Clinical Trials on Alzheimer's Disease Conference CTAD 24 in October. In March of this year, we held Type B meetings with the FDA to discuss the regulatory pathway for potential BLA or lateral mast cell in mild Alzheimer's disease. we reach foundational alignment on the overall study design for the proposed single, pivotal, seamless, adaptive Phase 2-3 clinical trial to support an accelerated path to potential approval. The FDA agreed to consider a BLA submission based on a positive interim results from this planned single study. With this regulatory clarity in hand, we are focused on seeking partnership opportunities and or non-dilutive funding for the Alzheimer's disease program. I'm incredibly pleased with the progress we are making to advancing lateral mast cell as a cellular therapy for multiple indications with important unmet medical needs. We are now approaching multiple potential transformational milestones over the next 12 to 18 months And I am thoroughly excited by the opportunity for Larimax Rochelle, Longevron, patients, and shareholders. With that, I will turn the call to Dr. Agassinova to provide update on our clinical development program. Natalia?

Natalia Agassinova Thank you, , and good afternoon, everyone. Our lead investigational product is laramistra cells, a stem cell therapy derived from culture-expanded mesenchymal stem cells, MSCs, that are sourced from the bone marrow of young, healthy adult donors. The number of functional MSCs in the body declines as we age, which has driven interest in their use for aging-related conditions. Their unique properties, including the ability to reduce inflammation, promote tissue repair and regeneration, modulate immune response, and improve vascularization, also support their application in some rare cardiovascular disease conditions with high unmet medical needs. We believe that by using the same cells that promote tissue repair, organ maintenance, and immune system function, we can develop safe and effective therapies for some of the most difficult diseases and conditions. Based on positive initial data, lateral menstrual cell development programs have received five FDA designations. For the HLHS program, orphan drug designation, fast drug designation, and rare pediatric disease designation. And for the Alzheimer's disease program, regenerative medicine advanced therapy, or RMAT designation, and fast-track designation, each of which offer benefit for the program development and regulatory processes. As Yael mentioned, our HLHS program is the primary focus for us, with a near-term pathway to potential approval in an area of clear unmet medical need. HLHS is a rare pediatric disease in which the left ventricle, one of the pumping chambers of the heart, is either severely underdeveloped or missing. Because the left ventricle is the chamber that normally pumps the blood to the body, infants born with this condition have a profound reduction in blood flow and thus cannot get the normal supply of oxygen to their organs. In order for the children to survive, they must undergo a complicated three-stage heart reconstruction surgery over the course of the five years of their lives. Despite the surgical reconstruction, only 50% of the affected children survived to age 15 without heart transplantation. Our program is designed to boost, improve the heart function in these children with the goal of potentially enhancing their survival. In our Phase I clinical study, LPS-1, in four-month-old infants with HLHS, we observed 100% transplant-free survival up to five years following treatment. This contrasts with an approximately 20% mortality rate observed in the historical control data. Five-year post-treatment long-term survival data from the LPS1 Phase 1 clinical trial was presented at the Congenital Heart Surgeon Society's 51st Annual Meeting in October 2024. We are currently conducting the Phase IIb Clinical Trial, LPS II, evaluating the potential of larynestrus cells to improve right ventricular function and long-term outcomes in pediatric patients with HLHS. LPS II is being conducted in collaboration with the National Heart, Lung, and Blood Institute through grants from the National Institute of Health. We expect to complete enrollment of the trial before the end of the second quarter. We will then focus on supporting our investigative sites through completion of 12-month primary endpoint follow-up period and preparation for the data collection and analysis at the end of the study to support potential BLA submission readiness. If results from LPS2 are positive, we would be positioned to initiate a rolling BLA submission with the FDA in 2026. And now, we hand the call over to Devin Blass, our Chief Technology Officer. Devin?

Thank you, Natalia. Good afternoon. It's a pleasure to join the call for the first time with everyone. As YL mentioned, my background is in the manufacture and development of advanced therapies, which is why I'm delighted to have joined Longevron at this transformational period in the company's development of cellular therapies. This year, we will see a significant focus on organizational readiness for the potential BLA filing for HLHS in 2026. The biological license application is a formal request for marketing approval submitted to the FDA for a biologic, somewhat analogous to the process of submitting a new drug application for a small molecule therapy. BLAs are evaluated by the Center for Biologics Evaluation and Research, or SBIR, an entity distinct from the Center for Drug Evaluation and Research, or SPDR. In a relatively short period of time, we have developed a strategic plan to ensure BLA readiness. Should ELVIS II generate positive results? Our CMC, or Chemistry Manufacturing and Controls Plan, is focused on meeting our BLA timeline without delays at the lowest cost, and we are evaluating all strategic options to achieve that outcome. This includes exploring commercial manufacturing options for LeMessurCell, either by enhancing our facilities and internal capabilities to meet commercial readiness, or, alternatively, contracting the commercial manufacturer of LeMessurCell for HLHS to a CDMO. Our CMC plan identifies the necessary tasks and outlines the substantial amount of work required to achieve BLA readiness, ensuring we are well prepared to submit all of the necessary CMC components of the application in a timely manner. While there is obviously a lot of work to accomplish ahead of any potential filing, we are off to a strong start and making consistent progress every day. Our goal is to substantially advance BLA readiness this year shorten the timeline from clinical trial data readout to BLA submission. I will hand the call over to Lisa Locklear, our Chief Financial Officer, to discuss our financial results for the first quarter. Lisa?

Thank you, Devin, and good afternoon, everyone. This afternoon, we issued a press release and filed our quarterly report on Form 10-Q, both of which present our financial results in detail, so I will touch on some highlights. Revenues for the first quarter of 2025 and 2024 were $0.4 million and $0.5 million, respectively. This represents a decrease of $0.1 million, or 30%, in 2025 compared to 2024, driven primarily by a decreased participant demand for our Bahamas registry trial, partially offset by an increase of our manufacturing services contract revenue. Clinical trial revenue from the Bahamas registry trial in the first quarter of 2025 was $0.3 million, a decrease of $0.2 million from the first quarter of 2024, as I said, due to decreased participant demand. Contract manufacturing revenue for the first three months ended March 31st, 2025 and 2024 was $0.1 million and $33,000 respectively, reflecting an increase of approximately $0.1 million due to increased activity from our manufacturing services contract. General and administrative expenses for the three months ended March 31st, 2025 increased to approximately $2.9 million compared to $2.2 million for the same period in 2024. The increase of approximately $0.7 million, or 34%, was primarily related to an increase in personnel-related costs, including equity-based compensation. Research and development expenses for the three months ended March 31st, 2025 increased 13% to approximately $2.5 million from approximately $2.2 million for the same period in 2024. Our net loss for the quarter increased to approximately $5.0 million from $4 million for the same period in 2024. Our cash and cash equivalents as of March 31st, 2025 were $14.3 million. We currently believe our existing cash and cash equivalents will fund our operating expenses and capital expenditure requirements late into the third quarter of 2025 based on our current operating budget and cash flow forecast. Following our successful Type C meeting with the FDA in August 2024 regarding the HLHS regulatory pathway, we have begun ramping up our BLA enabling activities. We currently anticipate a potential BLA filing with the FDA in 2026 if the current ELPAS II trial in HLHS is successful. The company's operating expenses and capital expenditure requirements will increase throughout calendar 2025 as a result of these BLA-enabling activities. We expect that our current operating plan will require increased spending and additional capital investments to support these initiatives, and we intend to seek additional financing, capital raises, and or non-dilutive funding options to support them. Additionally, Following a positive type B meeting with the FDA in March 2025 with respect to the Alzheimer's disease regulatory pathway, we are focused on seeking partnership opportunities and or non-dilutive funding for the Alzheimer's disease program, including a proposed single, pivotal, seamless adaptive phase two slash three clinical trial. There are a lot of important things happening right now for Longevron, and we are excited for these opportunities and to keep you updated on our progress. I will now hand the call back to YL.

Thank you, Lisa. Longevrone has made tremendous progress in two important stem cell development programs, HLHS, Alzheimer's disease. We are now approaching multiple potentially transformational milestones, including completion of pivotal Phase IIb clinical trial in HLHS, our first potential BLA submission for HLHS, and based on the strengths of a Phase IIa clinical data, potential partnering for Alzheimer's disease programs. Our team's expertise and industry experience enabled the organization to accomplish so much with a small team and fewer resources. And I am incredibly proud of their efforts and accomplishments on behalf of patients and shareholders. We deeply appreciate the support of all the stakeholders and look forward to continued collaboration and progress in the future. Operator, we would now like to open the call for questions from our covering analyst.

Thank you. We will now 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 your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. One moment, please, while we poll for questions. The first question is from Bubalan Pachayapan from Roth Capital. Please go ahead.

Good afternoon, everyone, and congrats on the progress. So we have three questions. So firstly, I wanted to talk a little bit about HLHS markets. So this is primarily for me to get some clarity the way I look at the market. So you've said in the past roughly 1,000 babies are born every year in the U.S. that have HLHS. So even if you assume 15% mortality, we still have 850 babies who need to undergo the stage 2 surgery every year within four to six months after the Norwood procedure. So my question is, do all stage 1 survivors will ultimately qualify to receive lateral menstrual cells Or is there a reason why certain stage 1 surviving patients would not want laromestrofil? As you can imagine, the reason I'm asking this question is because I want to understand whether some of the enrollment challenges you're facing would ultimately impact your commercial adoption.

All right. So, Bobalan, that's a great question, and I may have several members of the team to answer this one. I'll answer the last part, which is regarding the enrollment challenges. I really believe that while everybody sees it and everybody loves to see more prediction, I think we have actually done a very good job as a company in enrolling in an orphan disease compared to other products. I mean, we are almost 95% enrolled. If you do the math, that means that we have one patient left. which we are confident we're going to get this quarter, and we finished the enrollment. And enrolling 44% of the annual population in the study, that's a sizable population for an orphan disease. And the fact that we were able to enroll it in a matter of less than three years, actually, it's a very good achievement. So in that front, I know it has been challenging, and I know everybody would like to see more clarity. I really believe that we have done a very good job in their government. As for the market, the market opportunity is very big because we have our exclusion criteria does not exclude a lot of patients, but I will have Dr. Hare or Natalia answer exactly who are the patients are excluded, and I will come back and talk about the market opportunity as well. Josh?

Hi, Will. Yes, I just wanted to make a comment on the trial as well. I think that I want to emphasize that not only is this trial excellently conducted, but it is going to be the most rigorous trial conducted in babies with congenital heart disease for cell therapy. because of the rigorous design and size of the patient population. With regard to the market, I think that the majority of children who go to the stage two surgery, the Glenn procedure, will be considered for inclusion in this treatment once approved. I think there are very few reasons to not consider treating a child once they make it to stage two if the product is approved via BLA.

Yeah, so Bobalan, to be more specific and tell you how we're even forecasting our market for the market and the commercial opportunity. We anticipated 1,000 babies that are born with this condition every year. Many of them actually end up going directly because, as you know, the first stage surgery happened within the first week of birth. And even if 90% of them survived to the second stage surgery, that leaves about 900 patients every year. Within those 900 patients, we assumed the following. The only exclusion criteria is if these patients have a comorbidity with a valve problem with tricuspid valve issues, that population that has that comorbidity is less than 10%. So here is another out of that 900, it can take out about 10% of the population that leave you with 800. Those 800 patients, we assume that some of them, for whatever reasons they choose electively, that they would not want to have the therapy. So our penetration assume about 65%, two-thirds of the market will have, which we believe that represents a very good sizable opportunity for us in the marketplace. And this is the most conservative pricing estimate will be north of half a billion dollars just in the US. And that's not including any patient from outside the US.

All right. Great. Thanks for the detailed answer. I just wanted to move to the second question. And I also have a follow-up. So my second question about the FDA, you know, there's been, FDA has been in the news many times during the last few months for many reasons, and one of which is leadership changes of the CBER division. And this is the division you'll be ultimately dealing with when you approach your BLA filing and potentially for the PRV. So my question is, look, have you seen any indication or whatsoever, any signals whatsoever, you know, that basically makes you believe your BLA will be impacted by either leadership changes or by policy changes at the FDA.

So to be direct, we have not seen anything. I mean, the most recent interaction with the FDA was in March 13, of course, before the naming of the new CBER director. But the interaction has been very supportive. The FDA has been very collaborative. The team has remained very supportive of our plans. And we have minutes, again, that we have agreed. So there is nothing here to allow us to assume otherwise from any information that we have. I also want to tell you that regardless of any leadership change, our philosophy as long as we have to be buttoned up in our application, and that's why we're having a head start. Regardless, we want to absolutely submit the best possible BLA, ready with all the information that is needed to absolutely pass through the drug approval and get that approval on the first one.

All right, great. And one last question, and this is for Devin. Devin, nice to meet you. So as you're contemplating manufacturing in-house versus contracting a CRO, so I was wondering if you could provide some commentary on your current capacity and potentially your plans to scale your operations, assuming you're ultimately going to be responsible for manufacturing as you think about transitioning to a pre-commercial company. So if you can lay out some of your, you know, the current plans and maybe potentially the investments that might be necessary to rapidly advance towards commercialization stage, that would be helpful. And also in this regard, if you can tell us, you know, if there is any bottlenecks that would limit your freedom to operate, because when you go to commercial, I wanted to better understand, you know, whether you're hinging or someone else's patents. So any commentary would be helpful.

Of course. So regarding our... our capacity. So the one lot of laramester cell we believe is enough to produce at least 1,500 doses for this product. So with the commercial markets and the number of babies that are born this year, we believe that the current yield sizes are one that would be able to supply the drug commercially. And that's with our current manufacturing process. The investments that we'll be making is primarily in ramping up our GNP systems, looking at facilities which could include a CDMO that has commercial capabilities and capable of receiving a BLA. Additionally, we are ramping up on internal staff as well, experts who have gone through this process before to ensure a timely BLA.

All right, that's it from me. Thank you, team, and advance congrats to wrap-up LPS2 enrollment.

Thank you, Paul Barlan.

The next question is from Ram Salvaraju from H.C. Wainwright. Please go ahead.

Thanks so much for taking my questions, and again, congrats on all the progress so far. Looking forward to your wrap-up of the enrollment process with LPS2. Two quick things. Firstly, I was wondering if you could provide us with some feedback, some color on the applicability of value-based pricing to determine the best possible pricing paradigm for Laramestra Cell in HLHS. And in particular, you know, if value-based pricing is applicable, if it is applicable, you know, in what context, you know, how might this factor into how pricing is ultimately determined? And if you look at recent drug launches in the rare and ultra-rare disease space, are there any that are currently ongoing or that we expect later this year that might provide appropriate precedent benchmarks for the pricing of laramestacel in HLHF if ultimately approved? And then the second one is a very minor one, but I was wondering if you could comment on the timing with which would need to secure regulatory approval in order to be eligible for a PRV, assuming that the PRV program overall is not reauthorized by Congress. Thank you.

All right.

So, Ram, let me answer the two questions. Regarding the PRV, right now, the current PRV expires in September of next year. And I don't think that if it doesn't get renewed, this means that it will expire before we get a market authorization for ladder master cell. However, I absolutely know, and I sit, as you know, on the board of the California Life Science and actually engage with a lot of the members of the Congress, both on the two sides of the aisle, And I can tell you there is a big support on both sides of the aisle to support the program or the initiative. It's called Give a Kid a Chance Act. And I believe once the Congress start to put all their priorities and budgets and things like that, it will get reauthorized for an extension. And in this case, we will be eligible to get it. So that's regarding that. the PRV and what is the likelihood and full transparency. And we are working, and again, as I said, this is a very top priority for us. And we are part of Bio and CLS and Bio Florida and many other organizations, and they know how important that is. Regarding the value-based pricing and the reference pricing. So the only product that is currently the closest product to our product in the area of disease is the product that was approved for mesoblast or GVHD, graft-versus-host disease, which is also an orphan disease as well. The cost of therapy, I believe, as they have announced, and again, I'm just speaking out of their own disclosure, is about $1.5 million for the course of treatment. So if you use this as a benchmark at the closest, you can grow your pricing, as I said, We have not made a final pricing decision on any of these things, but we are one-time use only, so there is no chronic utilization. And we believe that we can command a good premium, especially that we're looking for saving lives. I mean, mortality is one of the endpoints that we're looking for, or survival. And we're also looking for things that can really provide a significant value to the healthcare system, such as hospitalization costs and other areas as well. So overall, we believe that we will be able to have a very good story around value-based pricing if we need it. And I believe that even on the most conservative estimate, as I mentioned, of pricing drugs in the field that we are operating with, which we have seen it north all the way up to $3 million per course of treatment, I believe that we'll be able to generate a substantial revenue for the company.

Thank you very much. The next question is for Michael Okunowich from Maxim Group.

Please go ahead.

Hey guys, thanks so much for taking my questions today, and congrats on all the progress you've made.

Thank you, Michael.

So I guess to start things off, I'd like to see if you could talk a little bit about what sort of a sales force you would need in ATLHS, and in particular, among those 12 centers that are running the ELPAS-2 study, how much of the volume of the Glenn surgery actually passes through these centers?

All right. That's a great question. And I'm honestly, I'm so excited in this call to start to see that we're getting commercial question because that's, that's what we're excited about here also on Longevity. So to answer your question is, I will tell you, Michael, I came from the commercial world and we used to say there is a rule called 80-20. So 20% of our customers generate 80% of our business. And I would tell you that 12 centers that we have used in our clinical trials, they actually conducted the majority, almost 80% of these surgeries. So that's a big plus for us is that we are actually conducting a trial in high volume centers. This is a very specialized surgery or set of surgeries, as you know, And having those relationships established and the experience with the drug will give us a huge benefit. The number of surgeons who are or pediatric cardiac surgeons who perform these surgeries in the U.S. is they are about less than 50 on my last count. And we anticipate a need for more than four or five Salesforce across the United States. But the entire commercial organization will not exceed 12 to 15 people, and that assumes managed market support, marketing support, patient services support, and all of that. So it's a very focused organization, and that's the beauty of operating in orphan diseases. You really don't need large resources to be able to service the patients who suffer from these diseases.

Yeah, thank you. That's certainly a good answer to hear. And then just talking a little bit about the plans for scaling out your manufacturing, I'd like to get a sense of how much the stage of partnering discussions in all timers might impact the decision to go for a CDMO or to build out in-house, or is that not really a factor here?

Devin can add this. We absolutely know for a fact that we cannot manufacture for Alzheimer's within our existing facility because the plan that we aligned with the FDA on is that we're going to do a pivotal phase two, three, as you heard in our call today. which is a great plan because that is probably the fastest and most accelerated path that the FDA agreed to in that area, which we're really excited about. But that also means that the clinical trial materials, even for that study, will have to be produced in a commercial-level facility, which in this case we know it cannot be our existing facility, and either CDMO or we're going to have to – see if the partnering discussion lead to a partner with a facility that they can support that. But definitely not going to happen in our facility in Miami. Do the decisions of the CDMO for HLHS and Alzheimer's are tied together? To a very remote, I think we're looking at them as two distinct criteria. But definitely one of, if we're going to move the CDMO route for HLHS, We definitely, that's one of the questions that we have it on the table. Can this in the future also help us at a larger scale with Alzheimer's disease? Devin, do you want to add any comments on this?

Just to reiterate that, you know, while we're looking at multiple different options, the CDMO option is one of them. And the CDMOs that we have been looking at do have The capability to for a larger scale manufacturing for an indication like Alzheimer's.

All right, thank you for that. Then 1 last 1 for me and I'll hop back in the queue.

I'd like to see if you could help me understand a little bit more what the adaptive protocol might look like for the Alzheimer's study. Would that be something like a phase two portion that confirms powering and then a phase three portion for approval? Or would it just be one single straight through protocol?

Yeah, so I'll give you the high level and Messiah can get into the details. So the agreement with the FDA is that we're going to do one single study. This study will have about 1,600 patients or 1,650. And the first portion of the study, which we call it phase two adaptive, will have 600 patients. It will be a three-arm study, one placebo and two different dosing regimen for lateral mast cell. And at the end of the period of the 600, we're going to do an interim analysis looking at the same primary endpoints that we would use for the end of the study. If that interim analysis at the 600 is positive, the FDA agreed that they will give us an approval based on the 600 with the principle to continue the study for the 1650 to get larger patient set after the approval is complete. So that's the plan that we agreed to with the FDA. And Natalia, feel free to give more details or answer any additional question from Michael.

Absolutely, Wael. Just to add what Wael mentioned already, the idea of adaptive design, yes, is to do seamless. So we are not interrupting phase two. We are moving directly to phase three. And the approval, traditional approval, is based on interim analysis when 50% of participants complete all 72 weeks of treatment. And we are talking about, as I mentioned, 600 patients and 200 patients per arm. And now decisions will be made based on the conditional power. At that time, we have opportunities either to go for approval, traditional approval, if there is evidence of efficacy, or We can choose another dose for the complete trial. We can also decide whether or not the trial is going to work. And then the trial is going to continue in case we approve It is conditioned to complete the trial until all patients on the study complete 72 weeks of treatment with the full analysis at the end of the trial. So this is the opportunity to have, first of all, to have one trial, operationally seamless. We don't have to do all this operational feasibility, et cetera. It's going to be continuous treatment. And also to have, this is an opportunity to have a traditional approval sooner. So, yeah.

All right. Thank you very much for the additional color. And once again, congrats on all the progress you've made over the past several quarters.

Thanks, Michael. There are no further questions at this time. I would like to turn the floor back over to Wael Hashad for closing comments.

All right. Well, thank you, operator, and thank you all for attending our call today. We greatly appreciate your interest and support and look forward to updating you on our progress. Thank you.

This concludes today's teleconference. You may disconnect your lines at this time. Thank you for your participation.