Good day, ladies and gentlemen, and welcome to Longeveron 2024 First Quarter Financial Results Earnings Call. [Operator Instructions] Please note that this conference call is being recorded. I would now like to turn the conference over to Derek Cole of Investor Relations Advisory Solutions. You may begin, sir.

Thank you, Judith. Good afternoon, everyone, and thank you for joining us today to review Longeveron's first quarter 2024 financial results and business update. After the U.S. markets closed today, we issued a press release with financial results in the first quarter, which can be found under the Investors section of the Longeveron website. On the call today are Wa'el Hashad, Chief Executive Officer; Dr. Nataliya Agafonova, Chief Medical Officer; Lisa Locklear, Chief Financial Officer; and Joshua Hare, Co-Founder, Chief Science Officer and Chairman of the Board. 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 releases 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 Wa'el Hashad, Chief Executive Officer. Wa'el?

Thank you, Derek. Good afternoon, everyone. We are pleased to update you on our progress and to share why we're confident in Longeveron's opportunity and its future. As a reminder, for those of you newer to our story, Longeveron is a regenerative medicine company developing cutting-edge cellular therapy. Our lead development compound a cellular therapy candidate called Lomecel-B, represents a pipeline and a product opportunity that is being evaluated across 3 important treatment areas. Addressing numerous unmet medical needs with U.S. market potential opportunity of approximately USD 10 billion to USD 18 billion. There are 4 main reasons that give me confidence in our ability to achieve the opportunity of Lomecel-B. The first is launch of our own foundation and a strong science. Lomecel-B is a proprietary, scalable allogeneic cellular therapy that has delivered positive initial results across 5 clinical trials. Phase I and II trials in Alzheimer's disease, Phase I and II trials in aging-related Frailty, and Phase I in hypoplastic left heart syndrome or HLHS. Second is the experience and expertise of the launch of our own team, which makes advancing this research possible across clinical development, regulatory and manufacturing. Third, is the team's dedication and commitment to advance this research -- for the fourth and most important reason, the patients. Hypoplastic left heart syndrome, Alzheimer's disease, aging Frailty, these words convey a lot of information to scientists and doctors, but they can fully express the devastating impact these disease and conditions have on the patients and their families. It is heartbreaking to see an infant after a heart surgery so early in their young lives for the lack of a memory and cognition associated with Alzheimer's. What freely drives everyone here at Longeveron, day in and day out is the patients and the opportunity to have a…

Thank you, Wa'el, and good afternoon, everyone. As Wa'el mentioned, our HLHS program is a primary focus for us as we believe it is the program with the highest probability of success and new lease term pathway to potential approval. As a reminder, for those who might not know, HLHS or hypoplastic left heart syndrome, is a rare pediatric congenital heart birth defect in which the left ventricle of the heart is either severely underdeveloped or missing. The current treatment requires infants to undergo a complex 3-stage heart reconstruction surgery process over the first 5 years of their life. Even with the comprehensive treatment, only 50% to 60% of infants survive to adolescents due to right ventricular failure. There is clearly an important unmet medical need to improve right ventricular function of these infants to positively impact both short- and long-term patient outcomes. Our ELPIS I Phase I study of Lomecel-B in infant with HLHS, demonstrated that infants in the trial experienced 100% transplant-free survival up to 5 years of age after receiving Lomecel-B during the Stage 2 surgery, compared to approximately 20% mortality rate observed from historical control data. The ELPIS I data were highly encouraging and served as the basis for ELPIS II, our ongoing Phase IIb clinical trial designed to assess the potential of Lomecel-B to improve right ventricular function and long-term outcome. ELPIS II is being conducted in collaboration with National Heart, Lung and Blood Institute through grants from the National Institutes of Health. ELPIS II remains on track to complete enrollment by the end of this year. We intend to request a Type 2 -- Type B meeting with the FDA to discuss development strategy for HLHS and expectations for the potential biologic license application or BLA approval. Moving on to our Alzheimer's disease program.…

Thank you, Nataliya, 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 now touch on some highlights. Revenues for the first quarter of 2024 were $0.5 million, up $0.2 million or 96% when compared to the first quarter of 2023, mainly as a result of increased participant demand for our Frailty and Cognitive Impairment registry trial in the Bahamas. Contract manufacturing revenue for the 3 months ended March 31, 2024, was less than $0.1 million. However, as Wa'el indicated, we believe that there is an opportunity to expand this area of business to make use of our team's significant expertise and our state-of-the-art GMP manufacturing facility. Total operating expenses for the first quarter declined 8% year-over-year. G&A expenses for the quarter increased $0.2 million to $2.2 million, while R&D expenses decreased approximately $0.6 million to approximately $2.2 million, both amounts as compared to the same period in 2023. The decrease in R&D expenses was primarily due to reduced expenses related to Alzheimer's disease, clinical trials including, and the discontinuation of the aging-related Frailty clinical trial in Japan. Our net loss decreased to approximately $4.1 million for the 3 months ended March 31, 2024, from a net loss of $4.6 million for the same period in 2023. Cash and cash equivalents and marketable securities as of March 31, 2024, were $2.3 million. In April 2024, the company completed 2 capital raises, which resulted in gross proceeds of $11.4 million. The company believes that existing cash and cash equivalents will enable it to fund its operating expenses and capital expenditure requirements into the fourth quarter of 2024. I will now hand the call over to Dr. Joshua Hare, our Chief Science Officer and Chairman of the Board, to update you on several exciting changes to our Board of Directors. Josh?

Thank you, Lisa, and good afternoon, everyone. Since the founding of this company, we have made tremendous clinical progress with Lomecel-B. That success in the clinic has not been without corporate challenges, challenges that we've been able to navigate with the assistance and guidance of a terrific Board of Directors. Recognizing Longeveron's continued growth and evolution, we've implemented a planned board refreshment process with a focus on bringing in new, relevant experienced leaders over time to add to the knowledge base and experience provided by current and departing board members. As part of this process, Jeffrey Pfeffer and Cathy Ross departed the Board and Dr. Doug Losordo, will not run for reelection at the end of his term at the upcoming Annual Shareholder Meeting next month. On behalf of the Board and company, I want to recognize and thank them for their leadership and many contributions. Their guidance and insights were instrumental in Longeveron's success to this point and we will miss their collaboration. We are delighted to have attracted several new experienced industry veterans that are interested in joining the Longeveron board. Richard Kender has been appointed to the Board filling the seat vacated by Jeffrey Pfeffer. Dr. Roger Hajjar and Neha Motwani have been nominated as candidates for the Board to replace Dr. Losordo and Cathy Ross, subject to their election at our upcoming Annual Meeting of Stockholders next month. I believe all 3 of these individuals will add tremendous value to the Board and to Longeveron. Rich Kender is a retired Senior Vice President of Business Development and Corporate Licensing at Merck & Co., Inc. He spent his entire professional career at Merck in various corporate roles of increasing responsibility and was evolved in more than 100 business development and licensing transactions. Dr. Roger Hajjar brings incredible experience as a scientist, academic and operational executive. He is an internationally recognized scientists whose cardiac gene therapy discoveries has spurred clinical trials for heart failure and whose methodologies for cardiac directed gene transfer are currently utilized by investigators around the world. So he knows quite a lot about what we are doing here at Longeveron. He was recently Head of R&D at Ring Therapeutics and was appointed as the inaugural Director of the Gene and Cell Therapy Institute at Mass General Brigham. Finally, the third board candidate, Neha Motwani, has over 25 years of healthcare investment banking experience. Most recently, having served as Managing Director, Healthcare Investment Banking at William Blair. She previously held investment banking roles of increasing responsibility with Truist Securities, Oppenheimer & Company, Stifel Financial and Cowen and Company, where collectively she completed transactions raising over $6.8 billion. I'm delighted Rich's join the Board and enthusiastically support the election of Roger and Neha at the upcoming Annual Meeting of Stockholders. I believe their experience, expertise and insights will help guide Longeveron through its next stages of growth and opportunity. Thank you all very much, and I will now turn the call back to Wa'el.

Thank you, Josh. We believe there are tremendous opportunity in our cellular therapy research and with Lomecel-B. The trend of initial clinical data from ELPIS I and CLEAR MIND reinforces that belief. Our clinical development program in HLHS and Alzheimer's disease are designed to evaluate Lomecel-B's potential in this indication in order to potentially provide new therapeutic options to patients impacted by these devastating diseases. With multiple upcoming important catalysts, we believe 2024 has the potential to be a transformational year for Longeveron. Operator, we would now like to open the call for questions from covering analysts.

[Operator Instructions] Our first question comes from Ram Selvaraju of H.C. Wainwright.

Two regulatory items, please. Firstly, with respect to the applicability of Lomecel-B in HLHS. If we look at the hypothetical scenario in which the ongoing study replicates the earlier clinical data, what perspective can you provide to us regarding the regulatory receptivity to such a result and the potential for the drug to be the subject of accelerated approval. And what other parameters, if any, might be taking into consideration here?

All right. Well, Raghuram, thank you so much for that question. I will tell you that our intention is -- right now is with -- to finalize submitting the briefing book and ask for the timely meeting. And our goal is to ask for actually the potential of getting full approval, not just accelerated approval, and our backup plan is accelerated approval. So -- but our primary target is a full approval of Lomecel-B and HLHS. The second point, I will have Nataliya probably take this one. But I want to remind you that the Phase I program was not done as a head-to-head trial, there was only 10 patients, all of them have received Lomecel-B. The Phase II program is done as a head-to-head program with 19 patients in each arm of the standard of care and the other 19 patients with adjunct therapy of Lomecel-B. With that, I will have Nataliya or Dr. Hare may comment related to the endpoints and the clinical outcome that we can drive from Phase I into Phase II.

Absolutely. And Grant (sic) [ Ragu ], I would like to echo the same comment with Wa'el that the current clinical trial ELPIS II, it's a standard of care control trial, which, as you know, probably in rare disease indication is a big benefit for seeing results in a controlled fashion. Secondly, we are exploring all kind of opportunities to design and -- design a good statistical methodology to show -- to increase probability of success. As you know, this trial is a 12-month trial and a lot of time based on the physiological changes and the condition of these children, we would need a little bit longer time. However, there are parameters, cardiac parameters, extra cardiac parameters, which can be seen within 12 months after the injection of Lomecel directly into myocardium. And they are definitely going to have a conversation about it with FDA, again, to have this dialogue to make sure that the probability of success is there.

That's very helpful. With respect to the potential future development of Lomecel-B in Alzheimer's disease, I was wondering if you could comment on the regulatory guidance that appears to indicate that impact on a single clinical efficacy endpoint, notably the ADAS-Cog scale would be considered sufficient to entertain the possibility of approval of an investigational drug product in early Alzheimer's disease patients. And I was just wondering what implications this guidance may have for the future development of Lomecel-B in the Alzheimer's disease context, along with the information that we already have, indicating that Lomecel-B may have safety advantages versus existing approved anti-Alzheimer's drugs, particularly with respect to the absence of ARIA seen so far in clinical development.

So I will take that -- I was going to say -- I will take just to add a couple of things, and I will have Nataliya give you more details as well, Raghuram on this one. As you know, there is a draft document that was circulated by the FDA looking also for inputs from all parties, including the industry into potential surrogate endpoints as well related to Alzheimer's disease. I think the agency have definitely realized that -- current, I would say, available end points to the industry is not enough, and there is a room to change or modify some of these things to help companies bring more therapies into the marketplace in a much more streamlined fashion. And of course, we are planning to provide our inputs as part of that process as well. With that being said, I will have Nataliya give you a little bit of why we still believe we are very confident about -- even with the existing guidelines for approval, we're still very optimistic about our plan, and we want to move forward there, of course. And Nataliya, feel free to add to that.

Absolutely. Raghuram, you mentioned this FDA guidelines, which actually was a really good and positive message for all of us and as well as for the community and Alzheimer’s disease. In our proof-of-concept Phase IIa study, probably the strongest result besides showing some improvement and stabilization in cognitive function, we've seen a lot of data points to show the slowing of brain volume decrease and deterioration. We also did a number of post-hoc analysis, which shows that there is a connection between the slowing of brain volume and the cognitive and functional improvement, which is a great positive finance. When we find out about these guidelines, actually, it gave us -- it gave us the more opportunities to have dialogue with FDA, have dialogue with the experts in this field to design clinical trial, having in mind that imaging biomarkers, such as the brain volume. We have a slightly different approach for Alzheimer's disease treatment. We're trying to target early Alzheimer's disease, NCI and patients with Alzheimer’s disease mild dementia, where we can prevent not only cognitive function -- not only the brain volume changes, but also cognitive function by demonstrating and by designing of combination of imaging biomarkers and clinical biomarkers. So I think we have a great potential to have a next stage Phase IIb study to implement all the brain imaging biomarkers. This definitely is a good validated clinical scales. We do have some preliminary thoughts on our next design. Definitely, cognitive and functional measures will be probably upfront. We think it may be about [ CVRSB ] maybe combination outcomes, which has been implemented before, followed by the great key secondary endpoint, which are imaging biomarkers and ADAS-Cognitive scales and MoCA scales, et cetera. So having results of our Phase IIa study really help us to navigate to the future of our design and development. And also, there are vast majority of literature rates right now speaking that there is an opportunity to design Alzheimer's disease study with image and biomarkers with less financial burden and smaller sample size. And we are trying to be very creative, but scientifically correct to explore that opportunity as well.

Ladies and gentlemen, we have reached the end of our question-and-answer session. I will now hand over to Wa'el Hashad for closing remarks.

Thank you. And I wanted to thank you all for attending today's call. We greatly appreciate your interest and support and look forward to updating you on our progress throughout the year. Thank you. Operator, you may end the call now.

Thank you. Ladies and gentlemen, that concludes today's event. Thank you for attending, and you may now disconnect your lines.