Welcome back, everyone. Next, we have Longeveron Inc. It trades on the Nasdaq under the symbol LGVN. It's a clinical stage biotech company developing regenerative medicines to address unmet medical needs. Please welcome its CEO and director, Wa'el Hashad. Welcome, Wa'el. Hi, Ana. Thank you so much for having me today to share the Longeveron story and tell everyone here about the exciting work that we're doing. First, before I start our presentation today, I just wanted to put the forward-looking statement, and you can find a complete version and take the time to read it on our website. So, Longeveron, in a high level, it's a cellular therapy company for aging-related and life-threatening conditions. We have our lead asset. It's called Lomecel-B. And this product has multiple positive initial results in five clinical trials across three indications. And I will get into more details in just a minute. The clinical pipeline is in a condition called hypoplastic left heart syndrome. And I will go in details of that condition in a minute. It's also abbreviated as HLHS. Also, we're studying our product in Alzheimer's disease and aging-related frailty. All of these three conditions represent a great market opportunity, both in the U.S. and worldwide. The FDA has granted the HLHS program with three important designations. The first is a Rare Pediatric Disease designation. That designation comes with a priority review voucher available to us to use upon approval. We also have an Orphan Drug designation and fast-track designation as well. The FDA has granted the Alzheimer's disease program with two important designations. The first is the Regenerative Medicine Advanced Therapy designation, also known as RMAT designation. For those of you who are not familiar with this type of designation, it's very similar to breakthrough designation for traditional drugs. We also have a fast-track designation for the Alzheimer's disease program. We have cash and cash equivalents to fund our company through the fourth quarter of 2025. We provided this in our latest guidance on November 12 when we announced our third quarter earnings call. We do not carry any debt in our books. We have a proven management and scientific and manufacturing CMC team. The cellular therapy or the Lomecel-B, it's an allogeneic donor-derived medicinal signaling cells, also known as mesenchymal stem cells, isolated from bone marrow of healthy young adults aged 18 to 45. We take these cells and we expand them in a controlled culture environment. We produce billions of these cells under the laboratory-controlled condition that I just mentioned. After a specific number of expansion cycles, we call them passages in our facility or our work in our labs, these cells are harvested and separated into specific doses. These doses can range from very small doses and unique in the case of HLHS or all the way to the highest dose that we have produced that per dose is 100 million cells. Lomecel-B, as I said, is currently under development in three indications: Hypoplastic Left Heart Syndrome. We finished phase 1, and currently we are going in the middle of a phase 2b clinical trial. We also finished phase 1 and 2a for Alzheimer's disease and finished phase 1 and 2b for aging-related frailty. Why does Lomecel-B produce the desired effect, or what is the mechanism of action behind this one? We believe that Lomecel-B, these cells can act in multiple functions. One of them is anti-inflammatory effect. The second one is exosome and microRNA release, which can lead to a better outcome for the diseases that we're targeting, mitochondrial transfer, and cell-to-cell interaction. Currently, as I said, we have concluded phase two in both Alzheimer's disease and aging-related frailty, and we're currently enrolling in our phase 2B for hypoplastic left heart syndrome in the U.S. All of these indications represent a great market opportunity, so hypoplastic left heart syndrome, it's a rare pediatric disease. There are about 1,000 babies born with this condition up to every year, and that represents just in the U.S. of about $1 billion market opportunity, as well as equivalent to that worldwide as well from an opportunity standpoint. In Alzheimer's, there are about 5.8 million patients right now that suffer from Alzheimer's disease in the U.S., a much larger population outside of the U.S., and that represents a market opportunity of $5 to 10 billion by itself. Aging-related frailty is about 8.1 million patient population in the U.S. That by itself represents about $4 to 8 billion market opportunity just in the U.S. Let's go and review each one of those conditions in a little bit more detail. Hypoplastic Left Heart Syndrome, or HLHS. What is this condition? As you can see from this diagram or this graphic of normal heart versus the HLHS heart, these kids are born with undeveloped left ventricle. You can see the normal heart on the left-hand side. On the right-hand side, you can see that the left ventricle is not fully developed. The current standard of care that is taking place is that these kids undergo after birth, immediately after birth, into three procedures. The first one is called the Norwood procedure. It takes place within the first 10 days of life. The second one is called the Glenn procedure. It takes about three-to-four months after birth. The last one is called Fontan procedure. It happens about three to four years after birth. These three surgeries, basically what they do is they reconstruct the heart or re-plumb the heart, allow the right ventricle to perform the left ventricle function. However, as you can see from the picture of the normal heart and the HLHS heart, the wall thickness of the right ventricle is much thinner than the left ventricle in the normal heart. As a result of these reconstructive surgeries, which is really vital for the survival of these patients, unfortunately, it has improved the outcome. But yet, still, there is a time where the right ventricle fails to perform that heavy load or heavy lift that the left ventricle is supposed to do. The technology that we are developing, the cells, is meant to be injected directly onto the right ventricle to improve the outcome for these surgeries. We are not replacing the surgeries. We're just ensuring that the surgeries become more successful and that the right ventricle will be able to perform that left ventricle function without failing. How do we know that? There are two ways that we can measure that. One, it's called surrogate endpoints, which is the amount of blood ejected by the right ventricle or ejection fraction. We measure that if there is an improvement versus the standard of care, the surgeries alone, by giving our cells directly into the heart. Then the second one is, of course, can these patients survive for a longer period and without the need for a transplant? What happened in the second surgery during the Glenn procedures? We inject our cells directly, as I mentioned, into the right ventricle. You can see here on this diagram, the glowing dots represent where these cells are injected on the right ventricle. Over the experience that we had, we had our phase 1. We studied 10 patients. All of them have received cells. We followed them up for a period of five years. Over the five-year period, we have not seen any patients die, nor did we see any patient needing a transplant for that period of five years. Now, because this was not a controlled trial, we wanted to compare this to the standard of care. We compared this data to the largest cohort of these patients that was collected by the NIH, which is about 200-plus patients. It's called the Single Ventricle Reconstruction trial dataset. From that, you can see here in the red line that the survival of these kids with these surgeries happened to be at 90% or 10% mortality after one year from the Glenn procedure and up to 20% mortality that happened or deaths that happened after five years. That is compared to the blue line in our phase I, where you can see that all the patients in our phase I trial, or also known as ELPIS I, have survived up to five years without the need of transplant. We presented this data in last year's American Heart Association meeting. You can see here the poster that was presented. We also presented the complete five-year follow-up last October, just two months ago, at the Congenital Heart Disease Conference and was presented by Dr. Sanjay Kaushal. That led us first to get all the designations that I mentioned, which is, again, as a reminder, it's the Rare Pediatric Disease designation, the Orphan Drug designation, and Fast Track designation, and also encouraged us to continue the development of this program. So, we embarked on the second phase of development, which is called ELPIS II. And that's a phase 2b study. This one, we are doing a head-to-head trial. This is a much larger study. It is 38 patients. 19 will receive just the surgeries or the standard of care. The other 19 patients will receive surgeries plus our cells injected during the second stage of surgery. And we followed these patients up for about one year after receiving the cells. And we're going to measure three important things. We measure the right ventricular ejection fraction, which is the amount of blood being ejected by the right ventricle, as well as the survival at 12 months, as well as the hospitalization at the length of hospitalization during that follow-up period from the surgeries. These trials are done at the top academic institutions in the country, Boston Children's Hospital, which is Harvard, Lurie, Northwestern, Children's Hospital Los Angeles, part of USC, Children's Hospital of Atlanta, Emory, University of Texas, Children's Hospital of Philadelphia, University of Utah. So, these are the top academic centers. This trial is also supported by a grant from the National Heart, Lung, and Blood Institute, which is part of the NIH. We're very excited. We currently enrolled 80% of the trial or more than 80% of the trial. 31 out of the 38 patients are enrolled. And we expect to finish the enrollment, or we're driving to finish the enrollment as soon as possible. You know, if not by the end of this year, it will most likely happen in the first quarter of next year. We had a very successful meeting with the FDA in August of this year. And we wanted to confirm several assumptions here. The first, we wanted to confirm that our current study will be acceptable by the FDA for Biological License Application, also known as a BLA, and that supports the approval for full traditional approval. And we were able to get alignment from the FDA on that first point. The second thing is we agreed with the FDA on the primary and secondary endpoints. And we also agreed on the CMC and the potency assay plan requirement for this approval. So, overall, we feel like we have what we need, and we are working on getting ready for a BLA submission once the study finishes out, which we anticipate to be early 2026. The second program that I would like to touch base quickly on is our Alzheimer's disease program, and as I mentioned, we are targeting this. We believe that Lomecel-B has a very good effect. As you remember from the mechanism of action, I said it has an anti-inflammatory effect, and as everybody knows, Alzheimer's disease is characterized by a high degree of inflammation. And that was the theory behind our development of Lomecel-B in that indication. The FDA has granted us two designations, as I mentioned, the RMAT, the Regenerative Medicine Advanced Therapy designation, and the Fast Track designation. We have done two trials. The second one is the phase 2a, which was the basis for these two designations. This was a head-to-head trial versus placebo, and we studied a single dose of 20 million cells, and we also studied multiple doses of 25 million cells and multiple doses of 100 million cells. Basically, what we did is we gave the patients four doses every four weeks, so one dose every four weeks for the first 12 months, and then we followed the patient for a period of up to 39 weeks. The primary endpoints were looking at safety, so we were looking at any serious adverse events that happened within one month from any of the administration of the doses, and then the secondary endpoints were the composite Alzheimer's disease score, which looks at both clinical and functional and surrogate endpoints altogether. We also had some exploratory endpoints looking at cognitive tests and MRI biomarkers. What is the outcome from this trial? The trial results were presented last July at the Alzheimer's Association International Conference in Philadelphia. It was one that was selected as a featured research oral presentation during that meeting. We demonstrated a positive benefit-risk profile. Patients treated by Lomecel-B, they showed overall slowing of the progression or prevention of the disease worsening compared to placebo. The trial achieved its primary safety and secondary endpoints, showing statistically significant improvement in the pre-specified clinical and biomarker endpoints. We established the safety profile for Lomecel-B, which we feel very good about. Now we have more than 540 patients that have received the drug. We have very solid safety datasets. Our administration of Lomecel-B was associated with slowing cognitive and functional decline and also demonstrated statistically significant results in the Montreal Cognitive Assessment, and there were trends in the CDR-SB and MMSE, which is a Mini-Mental State Exam, and those are two important tests that actually are the basis for approval, and I want to remind everyone, this trial was fairly small in size, so the fact that we were able to demonstrate significant outcomes and trends was very encouraging. There was also a statistically significant improvement in functional outcomes, such as the Alzheimer's Disease Cooperative Study Activity of Daily Living, ADCS, Activity of Daily Living, ADL. It's also worth noting that we have shown a slowing in the brain shrinkage by 49%. That also was very highly significant and was very worth noting as well from the results standpoint. The results of the ClearMind trial, that's the name of the trial, support the therapeutic potential for the product to pursue it further, and the company is working right now and preparing for a meeting with the FDA in the first quarter of next year to review the clinical and regulatory path for Lomecel-B and Alzheimer's disease. And we are definitely looking for a possible partnership and non-dilutive funding to support the further development of the program. As everybody knows, this is a large study and it's going to require significant investment, and we believe the best path forward is through partnership and non-dilutive funding. Finally, I would like to quickly touch base on the third program, which is aging-related frailty. It's a disease that affects a large population. It contributes to a lot of the poor clinical outcome in other areas as well. It's an area with high unmet need. There is no drug currently approved in this area. We have done our phase 2b. That was a large study. It had 143 patients. We injected multiple doses, 25, 50, 100, and 200 million cells. The bottom line is we used a test. It's a patient-reported outcome test. It's called the Six-Minute Walk Test. It's how many steps people can do within six minutes. We have shown a significant improvement after nine months from a single infusion of Lomecel-B compared to placebo. With that, we are very encouraged. For prioritization, we put this on the back burner right now in order to focus on the first two opportunities because we believe they have a much faster path to get to the market than the aging-related frailty. As a reminder, from a financial position, our cash and cash equivalents as of the end of the third quarter of 2024 was $22.8 million. Our cash runway will take us through the first quarter of 2025, and the number of shares outstanding is about 14.8 million shares, and we have also 6.8 million warrants outstanding as well. We have a proven management team, and we are very excited. We just added one new member to our executive team. His name is Devin Blass, and he just started this week to lead the CMC function, but you can see from this group that we have a very solid group of leaders that has significant experience under their belt, bringing products to the market and advancing our therapies to the market. In summary, I want to start with the first slide and say that we are a cellular therapy company developing it for aging-related and life-threatening conditions. Our product, Lomecel-B, has had five positive initial results across these three indications. Our clinical pipeline in HLHS, Alzheimer's, and aging-related frailty represents a large U.S. market opportunity and outside of the U.S. as well. The FDA has granted the HLHS program three important designations: Rare Pediatric Disease designation, Orphan Drug designation, and Fast Track. For Alzheimer's, we have two important designations: Regenerative Medicine Advanced Therapy, RMAT, and Fast Track designation. Our cash and cash equivalents can fund the company through the fourth quarter of next year. We have no debt. We have a proven management and scientific manufacturing team. If you definitely want to reach to us, feel free to reach to ourselves here through these emails. And you can find the whole presentation available on our website. Ana, back to you. Thank you so much. OK. And I appreciate this overview and update. You made a lot of progress. So, talk a little bit about 2025. What does that look like? So, we are very excited about 2025. So, as I mentioned during the presentation, we met with the FDA in August of this year for the HLHS program, which we believe is our top priority. And we believe it's the fastest way to get to the market. We have the potential to file for a BLA early in 2026 once the trial results. And because we have Fast Track designation, that allows us also to do a rolling submission, which can also accelerate that process significantly. So, what is our plan? 2025 is all about BLA enabling activities. It's all about getting our manufacturing readiness process, our clinical readiness process. BLA is a significant undertaking. And we don't want to wait till we see the trial results. So, next year, it's all going to be about preparing and enabling our BLA activities. So, once we finish the trial and get the results, we'll be ready to file it with the agency. And you've explained that Longeveron is applying its stem cell therapy approach to HLHS and Alzheimer's disease. So, will you talk a little bit about the medical need in these areas? Sure. HLHS is a condition, as I mentioned, that affects about 1,000 babies every year. With the surgeries that are currently available to these patients, it gives them the opportunity to live into adulthood. But many of them still don't make it. And that represents a great opportunity. It also adds a huge burden on the health care system because many of these kids end up at a certain stage of their life needing a transplant. So, as long as you can delay that process or improve the outcome, that's definitely a significant improvement that we are hoping to achieve with our trial. The second thing is that from a commercial opportunity, this disease is managed by less than 50 physicians around the country. So, you really don't need a huge infrastructure to support the commercialization of this drug, and these drugs, if you follow rare diseases, it is usually in the range of $2 to 3 million treatment per year. Remember, our treatment is only a one-time treatment. So, even in the lower end, that represents a huge commercial opportunity with a great return on investment, and there is no other drug in the market. I mean, when we talk to a lot of the parents of these children, they are absolutely hoping that we are able to make it to the market so they give their children an opportunity for a better life and better outcome. As for the Alzheimer's disease, the Alzheimer's disease is a huge market. As the population continues to age, the growth in the population with Alzheimer's disease is growing at an exponential rate. Currently, and thanks to medical advancement of many companies, there are two or three drugs that are all approved, but they are all in one mechanism of action. We know that Alzheimer's disease is a multifaceted disease that is affected by many other things, and there is a need for other modalities. We are hoping that we can bring this to add to the armamentarium of the physicians who are treating this disease. What are the market sizes for each of those areas? Right now, it is estimated to, as I said, for the rare disease market, we believe that we can get about $1 billion, up to $1 billion of market opportunity. That's peak sales for HLHS. For Alzheimer's disease, the market opportunity is huge. It could be north of $10 billion. It's going to continue to grow even with the presence of more drugs into the market. The population growth actually will allow these drugs to be able to be utilized significantly. This number as well does not include patients outside of the U.S., which is also a significant population. I mean, if you add Alzheimer's across the entire world, it is approaching close to 35 million patients worldwide suffering from that disease. So, large opportunity in both areas as well. And how comfortable are you with the regulatory pathway for the HLHS and the Alzheimer's indications? Yeah. So, being a cell therapy, we go and get reviewed by a division at the FDA. It's called the CBER division, the Center for Biologics Evaluation and Research Division. And that is specialized for cell and gene therapy. This division is, in relative terms, a new division. And that's why we wanted to meet with the FDA regarding this because we didn't want to take any assumptions. And that's why we decided to meet with them and discuss the HLHS in August of this year. We plan to discuss the Alzheimer's disease program early next year as well to get alignment on the path forward and make sure that our work is going to meet the expectation. I have to say from the meeting, we found that both that division at the FDA have been very cooperative. They gave us good advice. I think, in general, we feel very confident that we'll be able to meet all the requirements and bring those products to the market. A question about the status of Longeveron's longevity participation in the Bahamas. Can you give us an update? Yes. So, we wanted to give, as you know, and even here in the U.S., as part of the RMAT designation, there is always a good opportunity for the company to provide what we call an expanded access program. The opportunity in The Bahamas, when the Bahamas Ministry of Health approached Longeveron asking if we can establish something similar to an expanded access program under their watch, under their control, which we agreed to. So, we actually allow patients under, and we collect all the safety data for these patients. We monitor them. We follow them. And all of this. But if any patient needs therapy that is needed and aligned with the protocol that was established and agreed upon by the Ministry of Health of The Bahamas, is that they can go and get treatment over there. And, as I said, we follow up with these patients. And it helps us also establish a good safety data set from our product as well. And all of this data is used for our application for our BLA as well. Similar companies like Mesoblast are valued at $10-$12 above Longeveron. Why is your stock hovering at around $2? That is a very good thing. We really see this as a big opportunity for investors. I know every company, when you talk to them, everyone is going to, of course, go and say our work is more advanced. First, I would say that both companies, both Mesoblast, for example, or Capricor, or any of these companies, they have a little bit longer history than us in being there. They were ahead of the company when they formed. I will tell you this, Ana. I mean, you look at the amount of designation. I mean, these designations don't come without a good review from the agency. I would say that we have really done very good work so far. I absolutely believe there is a huge opportunity. That was one of the reasons why I joined Longeveron about a year and a half ago, or a little bit over a year and a half ago, because I believe there is more to be done. There is more value on the upside in this company than what stands at the $2 range. The question is, we just have to tell our story and support it with all the evidence. I'm quite confident about what the future is going to be like for Longeveron. Fantastic. Thank you so much for your time today. We look forward to seeing you in 2025. All right. Sounds good. Thank you for having me. I appreciate the opportunity. All right, everyone, stay with us. We'll be right back.