Longeveron Q1 2026 Earnings Call: Complete Transcript

On Wednesday, Longeveron (NASDAQ:LGVN) discussed first-quarter financial results during its earnings call. The full transcript is provided below. Benzinga APIs provide real-time access to earnings call transcripts and financial data. Visit https://www.benzinga.com/apis/ to learn more. Access the full call at https://viavid.webcasts.com/starthere.jsp?ei=1759116&tp_key=638b49efbe Summary Longeveron reported revenues of $0.4 million for Q1 2026, consistent with the prior year, with clinical trial revenue increasing by 46% but contract manufacturing revenue decreasing by 84%. The company is transitioning to a capital-efficient, asset-light model and is focused on strategic licensing partnerships for its stem cell product, laramastrocel, across multiple programs. Key clinical focus is on the HLHS program, with a pivotal trial set for data readout in August 2026, and plans to advance a trial in Pediatric Dilated Cardiomyopathy in 2027. Longeveron secured investment capital from notable life sciences funds and aims to maximize shareholder value through partnerships and disciplined capital allocation. Management remains optimistic about achieving transformative milestones in 2026 and is actively pursuing strategic partnerships, particularly at the upcoming Bio International Convention. Full Transcript OPERATOR Ladies and gentlemen, greetings and welcome to the Longevron 2026 first quarter financial results and Business Update call. At this time, all participants are in listen only mode. A brief question and answer session will follow the formal presentation. If anyone requires operator assistance during the conference call, please signal the operator by pressing Star and zero on your telephone keypad. As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Derek Cole from Investor Relations at Y3 Solutions. Please go ahead. Derek Cole (Investor Relations) Thank you, operator. Good afternoon everyone and thank you for joining us today to review Longevron's 2026 first quarter financial results and business update. After the US markets today, we issued a press release with financial results for the first quarter which can be found under the Investors section of the Longevron website. On the call today are Stephen Willard, Chief Executive Officer, Joshua Hare, Co Founder, Chief Science Officer and Executive Chairman of the Board, Natalia Agafanova, Chief Medical Officer and Lisa Locklear, Chief Financial 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 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 research analysts. With that, let me hand over the call to Stephen Willard, Chief Executive Officer Stephen Willard (Chief Executive Officer) Steve thank you Derek and thank you all for joining us today. We have had an extremely productive start to this year. After I took on the role as CEO in February, we embarked on two immediate critical tasks. A comprehensive review of the Company's assets development and strategic plan and attracting new investment capital. Following this review, we have taken decisive steps to reposition the company for long term value creation, sharpen our strategic focus and align our development and capital strategy with the most impactful near term catalysts. With this reorientation, we were able to successfully attract new investment capital from several of the premier investment funds in the life sciences space including Coastlands Capital, Janice Henderson Investors, Logos Capital and Kalalau Capital. Our strategic repositioning is designed to maximize shareholder value while maintaining disciplined capital allocation. We are transitioning toward a more capital efficient asset light operating model with an increasing focus on securing strategic licensing partnerships for our stem cell product Lomecel-B across all our development programs. Hypoplastic Left Heart Syndrome or hlhs Alzheimer's Disease Pediatric Dilated cardiomyopathy or PDCM and aging-related frailty. This evolution reflects both the strength of our client data and clinical data and the growing external validation of our programs. We believe that leveraging the commercial infrastructure, capital resources and global reach of established pharmaceutical partners represents the most efficient pathway to unlock the full value of our assets. Longevron will be participating in the Bio International Convention taking place June 22nd through 25th of 2026 at the San Diego Convention Center. We will be hosting meetings with global pharmaceutical company executives to explore potential partnership and strategic opportunities for the company's four stem cell development programs. We are focused on our development activities to prioritize our most important near term catalyst, the Data readout of ELPIS2, our phase 2b clinical trial evaluating laramistracil and HLHS, expected in August. This disciplined prioritization has enabled us to extend our operating Runway while maintaining focus on value driven milestones. In 2026, we believe we are approaching a series of potentially transformative milestones that have the potential to redefine the trajectory of our business. It is an exciting time for Lomecel-B, the patients we serve, Longevron and our shareholders. With that, I will turn the call over to Dr. Agafogana, our chief Medical Officer, to touch on our clinical development programs. Natalia Agafanova (Chief Medical Officer) Natalia thank you Steve and good afternoon everyone. As Steve mentioned, our HLHS program is the primary focus for us addressing an area of clear unmet medical need. LPIs 2, our phase 2 clinical trial evaluating the potential of Lauromestracel in infants with HLHS, is nearing completion. Enrollment of 40 patients was completed in June of last year. Top line results from the ELPIS 2 trial are anticipated in August20. We recently completed a constructive Type C meeting with the FDA on the Lomecel-B Stem Cell Development Program in hlhs. In the meeting, the FDA acknowledged that HLHS is a rare disease associated with significant morbidity and mortality with a high unmet medical need for safe and effective therapies, but also asserted that the primary endpoint of right ventricle ejection fraction in the AELPIS 2 trial is not an appropriate endpoint to demonstrate efficacy. While Longeveron agreed with the FDA regarding the insufficiency of RVAF as the primary endpoint and was prepared to discuss other potentially appropriate endpoints sufficient to demonstrate efficacy, the FDA indicated that given the interim analysis mandated and conducted by the National Institute of Health NIH during the trial to which the company was and remained blinded, a new primary endpoint could not be agreed to. While the trial is still ongoing without an agreed upon primary endpoint sufficient for efficacy. The FDA no longer refers to the ELPIS 2 trial as pivotal, as had been specifically discussed with the FDA in the Company's Type C meeting in 2024. Nevertheless, the FDA expressly agreed that it is willing to meet with longeverone again when the ongoing ELPIS 2 study is completed to discuss the study result and align on a potential path forward. The FDA further indicated that only the most objective measures, including all cause mortality, cardiac transplant, free survival event of cardiac transplantation and well defined major adverse cardiac events mace could be informative of efficacy in ELPIS 2 and in that regard the company is capturing all of these measures in ELPIS 2 along with some additional key measures to support an efficacy determination. The Company intends to submit to the FDA a sponsored statistical Analysis Plan OR SAP for ELPIS 2 for the FDA's review and approval and remain optimistic that the trial results and other available evidence will be sufficient to support filing a biological license application BLA following the readout of top line results of the ELPIS 2 data, which as I mentioned earlier are anticipated in August of this year, we look forward for sharing the results of the ELPIS 2 clinical trial when they are available. Switching over to Pediatric Dilated Cardiomyopathy or PDCM. This is a rare pediatric cardiovascular disease in which the muscles in one of the more of the heart chambers become enlarged or stretched dilated. With nearly 40% of children with PDCM requiring a heart transplant or dying within two years of diagnosis. Our investigational new drug IND application for Lomecel-B as a potential treatment for PDCM became effective in July 2025. This IND allows advancement directly into a single phase 2 registrational clinical trial reflecting the serious nature of this rare pediatric disease and the significant unmet medical need. We currently anticipate planning and preparation for the study in 2026 with potential initiation of the study in 2027. I will hand the call over to Lisa Leclair, our Chief Financial Officer. Lisa Locklear (Chief Financial Officer) Lisa thank you Natalia and good afternoon everyone. This afternoon we issued a press release and filed our quarterly report on Form 10Q, which both of which present our financial results in detail, so I will touch on some highlights. Revenues for the three months ended March 31, 2026. were $0.4 million and consisted of $0.4 million of clinical trial revenue and $20,000 of contract manufacturing revenues. Revenues for the three months ended Mar. 31, 2025 were $0.4 million and consisting of $0.3 million of clinical trial revenues and 0.1 million of contract manufacturing revenues. Clinical trial revenues for the three months ended Mar.31, 2026 increased $0.1 million, or 46% when compared to the same period in 2025 as a result of greater participant demand for our Bahamas registry. Trial Contract manufacturing revenues for the three months ended March 31, 2026. decreased $0.1 million or 84% when compared to the same period in 2025, driven by reduced demand for these services from our third party clients. General and administrative expenses for the three months ended March 31st, 2026 were $2.7 million compared with 2.9 million for the same period in 2025. The 0.2 million or 7% decrease was primarily due to a $0.4 million reduction in personnel and related costs, reflecting lower performance achievement for the 2025 annual cash incentive bonuses partially offset by higher legal, accounting and consulting fees. Research and Development expenses were $2.3 million for the three months ended March 31, 2026. compared to $2.5 million for the same period in 2025. The $0.2 million or 8% decrease was due to lower performance achievement related to the 2025 annual cash incentive bonuses and a $2 million non recurring charge for amortization expense related to patent costs recorded in the 2025 period. These were partially offset by a year over year increase in personnel and higher clinical spend as we Prepare for the ELPIS 2 study results in August, our net loss was $4.7 million for the three months ended March 31, 2026. compared to $5 million for the three months ended March 31, 2025 The decrease of $0.3 million, or 6%, was due to the factors outlined before our cash and cash equivalents as of March 31, 2026. were $15.8 million. We currently anticipate our existing cash and cash equivalents will enable us to fund our operating expenses and capital expenditure requirements and into the fourth quarter of 2026 based on our current operating budget and cash flow forecast. I will hand the call over to Josh Hare, our Co Founder, Chief Science Officer and Executive Chairman. Josh Hare Josh thank you, Lisa Good afternoon everyone. Lomecel-B is an allogeneic mesenchymal stem cell therapy supported by a robust intellectual property portfolio of 52 issued patents and over 60 pending patents worldwide. Its potential mechanism of action, including anti inflammatory, pro vascular and pro regenerative effects, support its potential application across multiple high value indications. Lomecel-B benefits from having received five FDA expedited designations including Regenerative Medicine, Advanced Therapy or rmet, fast track, Orphan Drug and Rare Pediatric Disease designations, reinforcing both the clinical promise and regulatory positioning of our programs. We continue to advance a pipeline and a product strategy with multiple indications that can be independently developed, partnered or licensed, creating multiple pathways for value creation. Our stem cell therapy development programs address life threatening conditions in the most vulnerable populations, children and the elderly. Our four initial indications address market opportunities of what we estimate to be approximately 1 billion 5 plus billion and up to 1 billion and 4 billion respectively. We plan to pursue a robust partnering strategy across our development programs to accelerate potential time to market, increase capital use efficiency and leverage the greater resources of larger organizations. I will now turn the call back to Steven. Stephen Willard (Chief Executive Officer) Thank you Josh. The anticipated near term clinical data for hlhs, the strengthening of our balance sheet, the support of high quality fundamental investors and the potential for partnerships across our development programs make this an extraordinary, exciting time for Longevron. We deeply appreciate the support of all our stakeholders and look forward to continued collaborations and progress in the future. Operator we would now like to open the call for questions from our covering analysts. OPERATOR Thank you. Ladies and gentlemen, we will now begin the question and answer session. If you would like to ask a question, please press star and one on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star and two if you'd 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. Ladies and gentlemen, we will wait for a moment while we poll for questions. We take the first question from the line of Raj Salvaraju from HC Wainwright. Please go ahead. Raj Salvaraju (Equity Analyst) Thanks very much for taking my questions. Firstly, on the regulatory front, could you maybe provide us with some sense of your expectations post reporting of top line results from ELPIS 2 and what you think are likely to be the most logical follow up steps that you would take with the agency? In other words, you know, within what time frame would you request a potential meeting with the agency to discuss the Elpis 2 results and what type, what classification of meeting would that be? Natalia Agafanova (Chief Medical Officer) I would say that we would do that immediately and it would be a type C meeting. Josh, do you have any correction to that? I'm not sure. I'd like to hear from Natalia because if it's an end of phase two, it could be a type B meeting. But our plan is to immediately provide the top line results to the agency and to solicit a meeting with them as soon as possible. Natalia sure, sure. I agree with that. And you know if the so it depends on the results. If the results are really overwhelmingly positive, we would like to come back probably as a type B meeting to discuss all the potential for the future potential BLA filing. And of course we will follow up with the full clinical study report and then definitely we will plan a pre BLA meeting later on probably by the end of the year to discuss all the, you know, all the points of our path forward for the BLA. And actually pre BLA meeting should be done sometime in 2027 because it should be mission where we can discuss all our readiness for the bla not just from the stand of clinical results but also cmc et cetera. Raj Salvaraju (Equity Analyst) and then with respect to what could conceivably be the post marketing requirements for Lomecel-B if granted approval in HLHS. So this is a hypothetical scenario. Can you give us a sense of whether you think the overall regulatory positioning on what the requirements might be for post approval assessment of laramastracel have changed in the wake of the most recent feedback from the FDA regarding the primary efficacy endpoint in ELPIS 2 or if that is really a completely separate subject and has not been impacted in any way by the change in the agency's view of Elpis 2? Josh Hare Sure, it's a fantastic question. Thank you for that question. We actually thought through even in 2024 about potential post marketing requirements and we proposed long term extension study. Basically every patient who went through ELPIS 1 and ELPIS 2 study. We want to see long term, long term data, long term transplant free survival. So we proposed this design to fda, they accepted it, they like it. So most likely that would be the requirement in case if we approve them to demonstrate efficacy on transplant free survival and some other endpoint. Ten years, let's say from when the patient reached 10 years old later on. So that would be probably one of the requirements and we are preparing for that. We have design and we are implementing it operationally as we speak. We are thinking through about it. Raj Salvaraju (Equity Analyst) And at the risk of sounding iterative, I also wanted to ask about whether you feel that there is any read through or impact on your plans in PDCM based on the recent regulatory feedback that you have received. Obviously there are noteworthy differences between HLHS and PDCM, but I just wanted to see if from your perspective there is any read through to the PDCM program and you know, any additional considerations that may now be introduced as you look to Design the path forward for Larimestracel in PDCM. In the wake of the most recent FDA feedback on the Elpis 2 study. Natalia Agafanova (Chief Medical Officer) May I just answer from clinical development perspective. Maybe you can give business perspective. Is it okay? Yes, please go ahead. Okay, so you're absolutely right. When we look at the whole life cycle management, we always have to look at each indication for the same compound investigational product, even though they can be not connected and they're completely different. And I would say the results of HLHS trial will definitely inform in some way inform a message. We can develop some key messages, clinical messages for PDCM, but they are two independent diseases and the route of administration is completely different. Patient population is different. So even though we will learn from it and we even might apply some data to PDCM, it's completely Stephen Willard (Chief Executive Officer) two different entities, two different diseases. And Steve, maybe you can provide your perspective from business point of view, what happened after results of HLHS. Josh Hare Sure. From a business point of view, I think this was a surprise that we had this issue with the fda. But I think it's one that we will be able to overcome quite well because it all comes down to the data. And the FDA has been quite clear that this is very rare orphan drug disease. That is an unmet medical need. And the same is true of pdcm. And so I think we will just be careful with the FDA in terms of making sure that they are completely comfortable with our endpoints. But I think we should be in a good shape for both products. Natalia Agafanova (Chief Medical Officer) And I would like to add that in 2026 we are planning operationally to initiate PDCM. We are going to do feasibility, etc. So we are preparing for initiation of PDCM. Josh Hare Thank you, Natalia. It might be worth mentioning what the PDCM endpoint is that we already designed for approved ind. It is already a clinical endpoint that we anticipate would meet approvability criteria if met. So while there certainly will be opportunities for refinement, we don't anticipate. Rather, let me restate. We do anticipate that the endpoint already agreed upon with the FDA will ultimately be the endpoint if met, that will result in approval for PDCM. Right, Sure. So, Josh, so would you like me to just mention what was. Sorry, I missed it. Oh, yeah, no, no. I think I just indicated, Natalia, that we already have the chosen clinical endpoint agreed upon agency for the PDCM trial. Yep. Thank you. Yes, Raj Salvaraju (Equity Analyst) thank you. Thank you very much. OPERATOR Thank you. We take the next question from the line of Abubalan Pachayapan from Roth Capital Partners, please go ahead. Manasa Hi team, this is Manasa dialing in for Bhubalin and we have a couple of questions. So yeah, the first question is given that RV-EF is out of the question, let's assume a composite endpoint, you know that comprises of 12 months transplant free survival rate, the length of hospitalization and MACE. So what level of benefits do you need to show in each category to convince the FDA? Natalia Agafanova (Chief Medical Officer) Josh, you want to take that? I think it's better if we have Natalia answer that because she's completed the power analysis. Natalia, would you like to take that question? Sure, yeah. So specifically as you know when we plan the trial and now as we prepare to submit statistical analysis plan and we just received the blinded data so we are looking at all the assumptions but we know even as blinded we know that as of today we have two deaths on a trial. One death happened prior to Glenn procedure and another death happened after Glenn procedure. So we have these two events and because it's a composite endpoint, the whole weight of the composite endpoint is the weighting is going to be on hospitalization days in the hospital. Our assumptions based on literature, as you know we are pioneering this indication and there are not many precedents available and we are using single ventricle reconstruction (SVR) data, we are using single institution data on literature. So based on all the literature evidence, currently patients with HLH ESTS spent about 30 days in the hospital 12 months after Glenn. And that's our biggest assumption. So of course on our trial we would like to be do better and we would like to demonstrate that this very clinically meaningful endpoint such as how many patients spend in the hospital, it's shorter than 30 days and we have different assumptions, 15 days et cetera. For now we are powering for 15 days. And then as far as MACE we, we know what potentially we have, how many events we have, but we have to adjudicate these events. But we have enough events to demonstrate some difference between standard of care and Lomecel-B at this point. And MACE is our which is another composite endpoint and which consists of cardiovascular mortality, hospitalization due to heart failure, thromboembolic event events and arrhythmia. So we are adjudicating these events and we have enough sufficient events to demonstrate the difference. So did I address your question? Manasa Yeah, so I have a couple more. So the next thing is. So are there any specific learnings from the recently published CHILD study that you know could provide a read through for the ELPIS 2 study? Josh Hare Josh, maybe you can Answer this question because you were involved with the study and you know it better. Yes, thank you. And thank you for that question. We're excited about the CHILD results and they did inform our thinking for the endpoint of ELPIS 2. The reason why it's so attractive is first of all, it is current current data, whereas the SVR data is somewhat dated. So the CHILD study was concurrently enrolled at the same centers with the Elpis 2 patients and it did also involve standard. We also had randomization between active treatment and standard of care. So we have a standard-of-care reference, although it's a small study. Now what was quite intriguing in the CHILD study was that the rate of events was quite high in the standard of care group and all of the events that we are looking at in the ELPIS 2 were seen in the CHILD study. So again, concurrently enrolled with ELPIS 2. So at the same time in, at some point in time at the same centers with the same surgeons and although it was a much smaller study, we were able to detect meaningful differences between treated patients and standard of care patients. So we did use that as a guide in our thinking of what the endpoint for ELPIS 2 should be as well as what the constituents of MACE should be. And we are hopeful that the event rate in CHILD will be that we saw in CHILD will be similar in the ELPIS2 study. Manasa Thank you, Josh. And another question. So from a payer standpoint, what would be the greatest predictor of drug efficacy, you know, that would influence them to cover Lomecel-B, you know, if it is approved on an accelerated basis, Natalia Agafanova (Chief Medical Officer) I would say, you know, clinically relevant. And outcome measures, as we spoke, transplant-free survival, it's very important there are not too many hearts available and we would love this transplant-free survival to be as long as possible and then days in the hospital. It's also very important to demonstrate on the composite endpoint. Even though we can demonstrate composite, we have to demonstrate significance on each endpoint anyway. And I think these two are very, very important. And of course heart failure hospitalization also so which is kind of indicator how is the right ventricle is performing, et cetera. So I think those are the most significant endpoints. And in addition, I would like to say even though FDA did not accept RV-EF because they believe it's not enough evidence to consider this a surrogate endpoint, we still include in it as our secondary endpoint and we would like to do more work and once we have more long term data available, we Would like to perform this analysis of cardiac, this ejection fraction and clinical outcome and survival. So it is not surrogate in point today. But I hope this study can inform us and maybe it is a potential for us to elevate RV-EF to surrogate endpoint. Manasa Thanks, Natalia. And one last question from me. So after the release of ELPIS too and you know, assuming positive data, do placebo patients have an opportunity to try out Lomecel-B on a compassionate basis? Natalia Agafanova (Chief Medical Officer) So we don't have any long term or we do have compassionate program, but we don't have any long term extension study where a patient can switch or crossover to Lomecel-B anything like this. But we haven't discussed it yet. But I think we should. If the data are positive, I think it should be a discussion how to make it available for patients. Absolutely. Steve, would you like to add anything for compassionate use? Stephen Willard (Chief Executive Officer) Yes. I mean the whole purpose of Dr. Hare creating this company over 10 years ago was to save lives, particularly in children and the elderly. And making our drugs available for compassionate use is a priority for us. We will do everything we can to make that possible. Were there any other questions? OPERATOR Thank you ladies and gentlemen. Have there are no further questions from the participants. I would now hand the conference over to Stephen Willard for his closing comments. Stephen Willard (Chief Executive Officer) Thank you all very much for participating in this conference call and for listening to our progress. We have focused today tremendously on the data that we expect in August. It is a fundamental time for our company. But please remember that we have four shots on goal here, not just the one. And that you can expect, we hope, very interesting progress with regard to Alzheimer's disease and aging frailty as a supplement to and as a very strong carrier of the company together with our HLHS and PDCM products. Thank you once again for your time and we look forward to updating you shortly. Again, thank you. Disclaimer: This transcript is provided for informational purposes only. While we strive for accuracy, there may be errors or omissions in this automated transcription. For official company statements and financial information, please refer to the company's SEC filings and official press releases. Corporate participants' and analysts' statements reflect their views as of the date of this call and are subject to change without notice.