Good morning, everyone. My name is Boobalan Pachaiyappan. I'm Managing Director and Senior Biotech Analyst at ROTH Capital Partners. With me is Wa'el Hashad, Chief Executive Officer of Longeveron, and Lisa Locklear, who's the Chief Financial Officer at Longeveron. Welcome to the show. Thank you, Boobalan, for having us. Absolutely. Before we begin the discussion, I have a disclosure to make. I cover Longeveron. Our recommendation for this stock is a buy rating, and our price target for 12 months is $10. That's roughly 500% upside from what it is trading currently. Why don't we start from a high level? Can you tell us a little bit about Longeveron, your key pipeline programs, your clinical strategy, and all of that? Then we can dive deeper into HLHS. Absolutely, Boobalan. Longeveron is a cell therapy company focused on stem cell, mesenchymal stem cell to be specific. We actually produce allogeneic mesenchymal stem cells, which means it's off the shelf for any patients that can potentially use it. We believe that our stem cells have two primary mechanisms of action, which are anti-inflammatory and pro-vascular, which actually give it the opportunity to have a lot of broad application into multiple disease areas. The company was founded initially with a focus on longevity illnesses such as aging-related frailty and Alzheimer's disease. Later on, they added a rare congenital heart disease condition called hypoplastic left heart syndrome, also known in abbreviated fashion as HLHS. The technology was licensed from the University of Miami, and the company has been in existence now for 10 years. In 2021, they went public. They continue to make good advancements in all the three programs. I joined the company two years ago and prioritized the congenital heart disease, mostly because I believe, and we believe at Longeveron, it has the fastest way to commercialization. We potentially can file for a BLA next year. The other program, we're making also good progress on them, specifically Alzheimer's disease. Yeah, we're excited about where we are and where we're heading. That's kind of the high-level story about Longeveron. Great. I'm excited as well. Let's dive deeper into HLHS. One thing I've noticed is that many people, or many investors, they don't know much about HLHS. Why don't we set the foundation, tell a little bit about the disease and what the unmet needs are? I know it's almost a death sentence. You can talk a little bit more about that. We will dive deeper into how Lomecel-B or laromestrocel could be a potential drug in this indication. Absolutely. HLHS, as you said, it's a very devastating disease. For somebody that, I personally love children so much, when you see these children are born with that disease and they don't have a very high chance of even surviving till even the adolescence years, you really feel very bad for these kids. The disease itself gets diagnosed intrauterine. Before birth, the parents know that the child, and in a nutshell, the child is born without a fully developed left ventricle. The current standard of care is to do reconstructive surgeries for the heart to basically allow the right ventricle to perform the left ventricle function. This happens through three-stage surgeries. The first one takes place in the first week after birth, and then three to four months, and then three to four years subsequently. With these surgeries, the chance of living till adolescence has improved to about 50%. There is still a chance to improve on the 50% of survival. Basically, where we come, we are not really replacing these surgeries. We're just improving the odds of success for these surgeries by injecting our cells directly into the right ventricle muscle during the second surgery to improve the chance of survival without the need for a transplant for these kids. That is basically our goal. There is no current treatment for this condition. There are about 1,000 babies born every year with this condition in the U.S. There are slightly less than 10,000 worldwide with this condition. Yes, we're hoping to make a difference with that disease. Absolutely. This is a rare pediatric disease. That means you have the opportunity to be the first mover in the space. That also brings a set of challenges in terms of how you're going to run the trial and all of that. I know you're experiencing some challenges in terms of enrollment, but you're almost there at the finish line. Let's take a step back and talk about some of the initial studies you have done. ELPIS I, for instance. You recruited 10 babies, and then you did Lomecel-B administration directly into the heart, babies that were barely six months old. Right? Can you tell us what are some of the high-level takeaways from ELPIS I? Yes. We did ELPIS I, as you mentioned, Boobalan, and it had 10 patients. All of them received our cells in the second-stage surgeries. The primary endpoint was safety. Of course, it's a phase one and looking at any changes of some of the primary endpoints. We also followed these babies or kids up to five years follow-up to basically look at the survival as this is really going to translate to survival. Just to give people a context, there was a study done by the NIH. It's called the Single Ventricle Reconstruction trial. It had the largest number of patients for a follow-up. Over 200 kids were followed up. What we found in the SVR trial, this trial that was sponsored by the NIH, that kids, the mortality rate after one year from the second-stage surgery is about 10%. Five years after the second-stage surgery was about 20%. In our kids, because we followed them up for a period of five years, none of them have actually died. We had 100% survival after five years and without the need for any transplant, which is really very encouraging. That was also the foundation for why we got the Fast Track Designation and Orphan Disease Designation and Rare Pediatric Disease Designations. Of course, the safety. Of course, the safety of the product. Yes. Great. That is why we really like this technology, which is why we think this is a high watermark in HLHS treatment because nobody has ever shown data similar to what you have shown in ELPIS I. Right? Now segueing to ELPIS II, which is your registration-enabling phase IIb study. Can you tell us what is your intended clinical trial design and efficacy outcomes you are looking for? Most importantly, what is the bar to win the regulatory approval? We understand this is a rare disease, which means the FDA is more flexible in terms of what you are going to measure and all of that. If you could provide a broad commentary. Absolutely. The trial is designed as a head-to-head trial, which is usually with rare disease. You usually do not go that route because it requires more patients and it is a higher bar in general. We elected to go that route. We have the top 10 academic institutions in the country that are participating. I am going to come to that later, hopefully, in the discussion why that is important. All the top academic institutions are the sites where we are conducting the trial. It is a 38-patient trial. Nineteen are going to receive the standard of care with just surgeries without our cells, and the other 19 will receive surgeries with our cells in the second-stage surgery. We follow up these patients over a period of a year with the last readout points or the last endpoint readout will happen 12 months after they receive the cells. We are, as we announced in February 28 in our earning call, more than 90% enrolled. As you can imagine, when you have only 1,000 babies born every year with this condition, enrollment becomes very challenging. Not because people do not want to participate in the trial, but sometimes logistical challenges can happen. I mean, patients from Alaska and they are getting treated in Utah and they do not want to make the trip. Things of those nature can really affect enrollments. Despite that, we have done very good progress. As we announced, we are more than 90% enrolled in the trial. We are really in the home stretch. I really feel very confident that we will finish enrollment within the next couple of months. Q2 is what we announced, and that will be the final. I am quite confident we will get there by that. Yeah, in terms of endpoints and what we're looking for in this trial, number one, we have met with the FDA last year in August. We wanted to discuss because the initial design of the trial was based on a surrogate endpoint called right ventricular ejection fraction. The agency is also interested in more clinical endpoints. In the discussion, they have asked us to consider other alternative endpoints to improve the odds of success, things like mortality, things like hospitalization, both overall hospitalization and ICU hospitalization. They believe this could be a huge benefit. Based on this one, we have been doing a lot of simulations on our endpoints. I think we have proposed endpoints that we are taking to the FDA, but it's probably going to include some of their recommendations, the hospitalization, as well as survival in this one. We have a proposal, either a composite or win ratio, that will allow us to improve the odds of success in this trial. Yeah, it's not going to be just right ventricle. It's going to be a broader set of endpoints to improve the odds of success on this one. Absolutely. Let's say you are able to enroll the remaining three to four patients in the next two to three months. Right? Tell us, when are you planning to disclose the data and then eventually a BLA? I'll get back to PRV in a minute. All right. The plan as follows. Once we finish enrollment of the patient, the clock will take for 12 months. The last patient out that comes from the trial, we're going to need after that probably two to three weeks to make sure that we get the last piece of data, make sure that those last one or two patients we have all, we're going to clean up the rest of the data, meaning all the data are accurate and coded properly in our data set. Those last two or three patients, we'll make sure that the data, so two to three weeks probably after the data, the last patient out. It takes three, four days at most to do the database lock and top-line results. We'll announce it after that. I would say a month, five weeks at the most after the last patient out. Summer of 2026. Absolutely. Give and take. Yeah. Yes. Okay. What about potential BLA? As I mentioned, we have a Fast Track Designation. Rolling submission. We will start the rolling submission. The day we receive our top-line data, we'll file the same day. We will be ready to ask for the pre-BLA meeting. We already started writing the modules this year. We're going to be writing a lot of the general modules that we don't need to get to the data itself, like module one, for example. It's within four months. We're hoping that we finish the submission. Because there are no drugs, we anticipate to have a priority review as well, which is six plus two. We'll move as fast as we can. I mean, the team is absolutely working toward accelerating this to the fastest possible way. Okay. Let's switch gears and talk about your manufacturing and commercialization strategy. Manufacturing first. Obviously, you source these cells from healthy donors. Then you have your own proprietary processing center. I think it's in Miami, Florida. Correct. Tell us how many doses you could make per year. And then how are you planning to sort of meet the demands of HLHS? Do you think that's enough to meet the demands of the patients per year? Yes. It takes us about six weeks to make one lot in our manufacturing process. One lot, one single donation, one lot can produce 1,500 doses. Wow. That's enough for one year. That is one lot for all the US needs and beyond. We believe worldwide that we're probably going to need two to three lots per year. That should be sufficient. Of course, you need to have always extra stock, safety stock, and so on. We are currently contemplating different scenarios on the CMC because the facility that we have, while we're very excited about it, it was a clinical development facility. We do not have a lot of structure in the facility that supports commercialization, such as fill finish, for example, packaging, some of these things. We are right now evaluating whether we do accommodation or go CDMO for the commercialization to ensure the fastest possible way. I do not want this to be my bottleneck. Speed is the essence, and getting there is critical. We really have a very good plan. We also had alignment with the agency on a lot of our CMC plan, including comparability, stability, all of the requirements from a CMC. As I said, we hired also an expert in the CMC recently who you're going to meet in the upcoming meeting. His name is Devin Blass. He's a great guy. He is actually the one that did all the work for Mesoblast and many other companies. He has the expertise in this particular stem cell area. We're very fortunate to have him. We're full steam ahead on this one. In terms of commercialization, you remember I told you we're doing the study in the top 10 academic institutions. I come from a commercial background, as you know. In the commercial background, we used to say the 80/20 rule. What is that 80/20 rule? That 20% of your customer generates 80% of your business. I can tell you that those 10 institutions that we are conducting our clinical trial perform about 80% of the HLHS cases because it's very intricate surgeries. It's the Children's Hospital of Philadelphia. It's Emory. It's Boston, which is Harvard. It's all of those ones. We have a very good relationship with these investigators. They are very passionate about their work. I anticipate really it's going to be, and that's one of the reasons why I love rare diseases, is that this would be this. In terms of commercial organization, probably we're not going to need more than 15 people on the commercial side. That's including payer, marketing, sales force, everything. It's a very low investment on the commercial side. We even modeled on the most conservative, as you know, rare diseases from a pricing standpoint. They tend to be expensive. We are one-time treatment. Even on the lower end of any expectation, we still can produce a very high risk-adjusted net present value in over $500 million in risk-adjusted net present value, which is very good for a disease like that. Absolutely. Have you done any physician-based market research study to sort of gauge the pulse of the audience, whether they are looking forward to implementing Lomecel-B into the treatment paradigm as soon as it gets approved? We have not done a formal one. As I mentioned, we had several investigator meetings with these folks, and we had a lot of that discussion about the commercial opportunity and very positive feedback that came. As we get closer again, as you know, I am very mindful of our spend. I am trying to make sure to put cash. This is an important research to do. I am just waiting for the right moment to do it. Definitely, it is an important research that we plan to do. Right now, we have informal feedback. Yes. Okay. To the extent that you can tell us, what's your preliminary thinking in terms of pricing? Are you anticipating any headwinds from the reimbursement side of the equation? It's a rare disease. There's no treatment, actually. I don't see any big headwinds or any severe headwinds coming from payers. If you can tell us a little bit, that would be good. I have not, and anyone that would tell you in my stage that they have made a decision around pricing, final pricing, they're probably not telling the honesty. I will tell you this. I modeled the pricing from $500,000 to $1 million. I believe this is a range that potentially is on the conservative side. It does not mean that it could not be higher. It depends also on the clinical outcome and how strong the evidence is as well. Even on the most conservative side, I think, as I said, it is a very good risk-adjusted NPV. That is also not assuming that we are going to have the 1,000. I assumed conservatively 60% market opportunity, considering some patients may not want to take the treatments and so on. I think that is a very conservative approach to put it that way. Yeah. I wanted to make a very important note here. Even though yours is a cell therapy, it kind of behaves like a gene therapy, right? I mean, you just give them one shot into the heart during the open heart surgery. And then pretty much you're done with it. Correct. Correct? In a way, it's like behaving like a gene therapy. Technically, it's not. You have this leverage in terms of controlling your price. I'm glad you mentioned $500,000-$1 million because our pricing is exactly in the middle. I feel very confident now about my models and price targets and things like this. Thank you for that. All right. Maybe in the next five minutes or so, what we can do is we can switch gears and talk a little bit about Alzheimer's. It looks like it's a very interesting topic with all the recent acquisitions and with recent FDA approvals like donanemab, like lecanemab, and things like that. The industry's thinking is that this is a blockbuster indication. You need to have a good commercial proposal or good money and all of that to go after or to even think about a clinical development in Alzheimer's disease. You are such a very small company. What gave you the motivation to pursue a blockbuster indication like Alzheimer's? That's a great question. I can tell you, I asked myself as I joined Longeveron about that question as well. In general, as I said, the mechanism of action lends itself to diseases like Alzheimer's disease. When I first came, my question was not about whether this drug is going to be successful or not, whether do we really understand what it takes to get this drug moving forward from an investment and an amount of work. This is what happened. Six months after I joined, we got the top-line results from our phase 2a. Yes. I thought at that moment is, well, 50-patient study. It's probably not going to get a lot of results. You just put it on the shelf and move on. We got good data out of it, a good signal of efficacy on multiple elements that is very unique. Of course, you show the data to everybody. Everybody is suspicious. I think over time, when we started to submit the data and share it with both the scientific community and everybody. First, we got AAIC, Alzheimer's Association International Conference. We were one of the featured presentations on the first day of the conference, highly attended. Soon after that, we filed a clinical study report to the FDA and also requested an RMAT designation, which we got. That's a huge. Absolutely. We are the only drug for Alzheimer's that has the RMAT designation. You have seen that the data got accepted and published in Nature. Medicine. Which is a very high bar from a scientific standpoint. Again, another third-party endorsement to our data. Exactly. As we mentioned on February 28, we're also meeting this quarter with the FDA. I know it's almost there. I'm still reiterating that we, before the end of this quarter, will announce our outcome from this one, in which we are hoping that the FDA will align with our proposed strategy, which is an accelerated strategy using the RMAT designation because that's what it gives you. That would be faster and more economical than any other traditional path for any company. Hopefully, the data combined with that economic advantage that we would, if the FDA agrees with our proposal, both together will improve our odds of getting a partnership or also, and I have also a couple of other plans that we'll be discussing in case the partnership takes a little bit longer time. We believe that the Alzheimer's disease, if the FDA agrees to it, that could be presenting a good opportunity because now I don't have to do a 4,000-patient trial like what Lilly did or the lecanemab did. That would be a much faster way to get to the market. The hope is that when you meet with the agency sometime this quarter, you will formally request them whether you could bypass the phase IIB and then directly get an approval to begin the phase 3, which could be a very attractive signal for somebody to forge a partnership with you and then advise the rest of the clinical group. That's exactly it. Instead of doing two traditional trials, maybe one. Just one. Exactly. Yeah. That would be a huge economic advantage. Yes. Yeah. That's very, very exciting. I know Lisa has been patiently waiting for the last 28 minutes or so. We will have one question for Lisa. Can you tell us your cash position on the anticipated runway? How do you plan to fund the development for the rest of the or at least up until BLA filing for HLHS? Sure. We ended the year with just over $19 million, which based on where we've been operating previously would get us through the end of this year. As we've discussed, we're currently working on a plan and starting to execute for CMC and other manufacturing to really, and within the clinical area, to really ensure we're ready for the BLA. BLA readiness is our buzzword right now and where we're investing. We know that we're going to need to raise some more money before the end of the year. I mean, with the good news coming out, hopefully, of completing our enrollment, getting feedback, hopefully, from the FDA meeting that's positive, we think we'll be in a good position, whether it's through financing, through partnership opportunities, or other non-dilutive funding, which we're also considering. Yeah. Hopefully, the market will improve at that time. That would be really nice. Thank you. All right. That's all from us. Thank you so much for sharing your story with us. We congratulate you for all your future success. Yeah. Thank you very much, Boobalan, for your support. I believe in our company as well.