LGVN

Image source: The Motley Fool. Wednesday, Aug. 12, 2026 at 4:30 p.m. ET Chief Executive Officer - Stephen H. Willard Cofounder, Chief Science Officer, and Executive Chairman of the Board - Dr. Joshua Hare Chief Medical Officer - Dr. Nataliya Agafonova Chief Technology Officer - Devin Blass Chief Financial Officer - Marie Washburn Investor Relations Advisory Solutions - Derek Cole Operator: Good day, and welcome to the Longeveron's Second Quarter Financial Results Conference Call. You may press *2 to remove yourself from the queue. For participants using speaker equipment, it may be necessary to pick the handset before pressing the star keys. Please be advised that today's conference is being recorded. I would now like to hand the call over to Derek Cole of Investor Relations Advisory Solutions. Please go ahead, sir. Derek Cole: Thank you, Rochelle. Good afternoon, everyone, and thank you for joining us today to review Longeveron's second quarter financial results and business update. After The U. S. Markets closed today, we issued a press release with financial results for the second quarter which can be found under the Investors section of the Longeveron website. On the call today are Stephen H. Willard, Chief Executive officer; Dr. Joshua Hare, cofounder, chief science officer, and executive chairman of the board, Dr. Nataliya Agafonova, chief medical officer Devin Blass, chief technology officer, and Marie Washburn, 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 analysts With that, let me hand the call over to Stephen H. Willard. Chief Executive Officer. Steve? Stephen H. Willard: Thank you, Derek, and thank you all for joining us today. This is an incredibly important and exciting time for the company. Longevron is approaching a series of potentially transformative milestones across our 4 stem cell therapy development programs, that has the potential to redefine the trajectory of our business. As a reminder, we are developing Laromestrocel in 4 indications with high unmet medical needs. Hypoplastic left heart syndrome, Alzheimer's disease, pediatric dilated cardiomyopathy, and Aging-related Frailty. We have focused on our development activities to prioritize our most important near term catalyst, the data readout from ELPIS II, our phase 2 b clinical trial evaluating Laromestrocel in HLHS. We expect to report that data readout in mid September. Our approach to stem cell therapy development has garnered external recognition and validation with encouraging data from our clinical trials having been published in Nature Medicine and Cell Stem Cell. Additionally, as you hopefully saw in our announcement yesterday, published clinical trial results which indicate Laromestrocel increases 6-minute walk distance in patients with Aging-related Frailty, were the basis for our selection as a finalist for the XPRIZE health Span Competition. XPRIZE HealthSpan is a 7-year, $101 million global competition to revolutionize the way we approach human aging. We are extremely humble and appreciate to have our stem cell therapy, laramestra cell, recognized in this manner. We believe that we are the only publicly traded company to receive this honor. XPRIZE team applications were rigorously evaluated for scientific merit and clinical readiness to identify the best, most feasible, and safe approaches to increase human health span. The Milestone 2 awardees, out of more than 600 applicants across 58 countries, were selected as finalist awardees. The XPRIZE criteria was that finalist awardees must present a single or combination therapeutic approach that demonstrates feasibility and potential to restore or preserve muscular, cognitive, and immune function lost to age related degradation by at least 10 years with the ambitious goal of 20 years. And deliver their therapy in 1 year or less in adults aged 50 to 90 who are free of major or life-threatening disease and disability. The top Milestone 2 award winning teams each received $1 million to advance their therapeutic approach. Into the final phase of the competition where teams will conduct coordinated clinical trials through 2029. The grand prize will award up to $81 million to the winning team. We look forward to the next chapter of the competition as we continue to develop our stem cell therapy. That we believe has the potential to have a significant impact for patients and their families and extend healthy life. We believe the strength of our historical clinical data external validation of our programs, and hopefully, the ELPIS II data provide Longeveron with ideal timing to explore potential development and commercialization partnerships. 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. It is a very exciting time for Laramestra, the patients we serve, long term, and our shareholders. With that, I will turn the call over to Dr. Agafonova, our Chief Medical Officer, to touch on our clinical development programs. Nataliya Agafonova: Nataliya, Thank you, Steve. Good afternoon, everyone. As Steve mentioned, our HLHS program is the primary focus for us. The top line results from the ELPIS II trial anticipated over the next month. We look forward to sharing those results when they are available. ELPIS II is evaluating Laromestrocel as a potential adjunct treatment for hypoplastic left heart syndrome or HLHS. HLHS is the rare pediatric congenital heart birth defect in which the left ventricle, 1 of the pumping chambers of the heart, is either severely underdeveloped or missing. We agreed with the FDA that only the most objective measure including all cause mortality, cardiac transplant free survival, the event of cardiac transplantation, and well defined measure adverse cardiac events could be informative of efficacy of ELPIS II. We have all of these measures in ELPIS II along with some additional key measures to support an efficacy determination. We are also continuing with planning and preparation this year for a potential initiation in 3.04 thousand of a phase 2 clinical trial in pediatric dilated cardiomyopathy or PDCM. This is a rare pediatric cardiovascular disease in which the muscle in 1 or more of the heart chambers become enlarged or stretched. Or dilated with nearly 40% of children with PDCM required a heart transplant or dying within 2 years of diagnosis. Our investigational new drug IND application for Laromestrocel for potential treatment of pediatric dilated cardiomyopathy 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. I will hand the call over to Marie Washburn, our chief Financial Officer. Marie? Marie Washburn: 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 are financial results in detail. So I will touch on some highlights. Revenues for the 3 month period ended June 30, 2026 and June 30, 2025 were $0.3 million 26 revenues decreased by $29 thousand or 10%, when compared to 2025. Primarily due to the absence of contract manufacturing revenue. General and administrative expenses for the 3 months ended June 30, 2026 were $3.2 million compared to $2.6 million for the same period in 2025. The increase of $600 thousand or 23%, was primarily due to a $400 thousand increase in legal spend and $200 thousand increase in personnel costs. Research and development expenses were $3.2 million for the 3 months ended June 30, 2026. Compared to $3 million for the same period in 2025. The increase of $200 thousand or 7%, was due to higher clinical trial expenses to support the ELPIS II top line results expected in September. Net loss was $6.1 million for the 3 months ended June 30, 2026, compared to $5 million for the 3 months ended June 30, 2025. The increase of $1.1 million, or 22%, was due to the factors outlined above. Our cash and cash equivalents as of June 30, 2026 was $10.1 million. We currently anticipate our current existing cash and cash equivalents will enable us to fund our operating expenses and capital expenditures into the fourth quarter of 26 based on our current operating budget. I will hand the call over to Joshua Hare, our cofounder and CSO. Joshua? Joshua Michael Hare FACC: Thank you, Marie. Good afternoon, everyone. As we rapidly approach the availability of top-line data, from the ELPIS II Phase 2b trial in HLHS, I want to highlight some of the progress and accomplishments that underpin our belief in our allogeneic mesenchymal stem cell therapy, laromestrocel, and support its potential application across multiple high value indications. First, strong foundational science. Laramestrocel has multiple potential mechanisms of action that include anti inflammatory, provascular, and pro regenerative effects. Laramestrocel is supported by a portfolio of 52 issued patents with over 60 pending patents worldwide. We have 5 FDA expedited designations including regenerative medicine advanced therapy, or RMAT, fast track, orphan drug, and rare pediatric disease. Longevron has completed and has encouraging initial results warranting further investigation across 5 clinical trials and 3 separate indications. We have promising data from our clinical trials, that have been published in prestigious journals such as Nature Medicine, and Cell Stem Cell. We have favorable clinical trial results in Aging-related Frailty, supporting selection as a finalist out of over 600 development projects submitted worldwide for the XPRIZE HealthSpan competition which also comes with a $1 million award. We continue to make progress across our entire development pipeline and look forward to sharing the results of ELPIS II shortly. I will now turn the call back to Steven. Stephen H. Willard: 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 extraordinarily exciting time for Longeveron. We deeply appreciate the support of all of our stakeholders, and look forward to continuing collaboration and progress in the future. Operator, we would now like to open the call for questions for questions from our covering analysts. Operator: Thank you. We will now be conducting a question and answer session. If you would like to ask a question, please press *1 on your telephone. You may press *2 to remove yourself from the queue. For participants using speaker equipment, it may be necessary to pick up the handset before pressing the star keys. 1 moment while we poll for And our first question, we will hear from Raghuram Selvaraju with H. C. Wainwright. Raghuram Selvaraju: Thanks so much for taking our questions, and congratulations on all the recent progress Definitely coming up on exciting times here. Wanted to see if you could elaborate on the updated outlook for Laromestrocel in HLHS specifically as this pertains to the following 3 items. Firstly, the timeline with which you anticipate a regulatory submission could be completed for filing upon generation of positive data from ELPIS II. Secondly, where you are with respect to commercial scale up and how that dovetails with the underlying market demand that you anticipate for Laromestrocel upon potential approval in HLHS? And lastly, any updated thoughts or feedback with respect to potential pricing discussions or the relative value proposition that you anticipate would be associated with from the payer standpoint. Then just a very quick question on the Aging-related Frailty aspect. In the event that Laromestrocel ultimately received the top prize in the XPRIZE competition. How would this affect the company's strategic planning for future development of the drug? In the Aging-related Frailty indication. Thank you. Stephen H. Willard: Wow. that is quite a list of questions. Let me see if I can get to them in the order you provided. First of all, the timetable is we are eagerly looking forward to having an auction for among partners of choice in the event of good HLHS data. And a partnership will determine some of the things like pricing and that sort of thing. We anticipate we have already had conversations with major potential partners and we think they are expert at pricing and timetable and that sort of thing. We do not see any blockers if we get good HLHS data. To going to a BLA with I would remind you, priority review voucher which just recently sold for $215 million. there is also a potential priority review voucher available with regard to our PDCM. Which will be starting next year. I have discussed the timetable, the manufacturing, the pricing discussions, and then with regard to the XPRIZE, I think it is extraordinary to have a company. I mean, we are known as a company despite 12 years in the longevity space. As experts in rare pediatric orphan drugs, and that is part of our mandate. But we really have extraordinary data with regard to longevity, We will very much seek to partner in longevity prior to winning the XPRIZE and the $81 million. And I think it is a very fertile area that a lot of people are appreciating. And as I noted of the x prize winners, I believe we are the only public company, the only 1 that people can invest in terms of the cutting edge of longevity research today. Did I hit your questions, Ram? Yes. Thank you very much. Operator: And our next question, we will hear from Boobalan Pachaiyappan with ROTH Capital Partners. Boobalan Pachaiyappan: Good afternoon, everyone. Thanks for taking our questions. So we have 3 or 4 maybe wanted to start off our discussion with a focus on statistical analysis plan or SAP. To say it in short form. Because this is a hot button issue, they say. With all the adcom stuff that we witnessed a couple of weeks ago. So I am compelled to ask a few questions based on this topic, and some of them we might have discussed in the past. So where are you where are you in terms of SAP alignment with the FDA are there any last minute changes that needed to be made to the SAP or protocol prior to database unblinding. And also a sub question again on the SAP. Is the lack of SAP alignment with the FDA the reason for pushing the deadline from August to September? Stephen H. Willard: I can tell you well, actually, Nataliya, would you answer that question? Nataliya Agafonova: Yep. Yeah. Absolutely. Thank you, Boobalan, for your questions. Just to clarify that we have already substantive discussions with the FDA in alignment regarding the endpoints strategy, which include both NIH defined and sponsored defined endpoints. And we have incorporated all the agency feedback into our statistical plan, statistical approach. So this subsequently submitted, the SAP to FDA for review, and we are still waiting for their feedback. If you do not receive additional comments before database lock, we currently intend to-- with the planned database lock, conduct analysis, pre-specified analysis according to the prospectively finalized SAP. So I do not think there is anything unresolved. We so far resolved all the FDA agency's, we incorporated them into the statistical analysis plan. And of course, if we get them prior to database lock, we are happy to, you know, just to clarify some, and incorporate the details about the SAP. And second question, you are asking about August versus September. it is not going to affect anything. So we were waiting for the last patient, last visit. There were a few delays in MRI Month 12 last patient, last visit. That was the reason why we slightly delay our database. But so far, it is planned on August 31st with the top line results data array in September. Boobalan Pachaiyappan: Alright. So moving on. Let's say your former primary endpoint, which is RVEF, Let's say the RVEF was not met in your ELPIS II. But you are seeing improvements in, let's say, the length of hospitalized patients, the transplant free survival, and adverse events. And let's say you are hitting statistical significance and all of it. Can you regain the pivotal status and file a BLA based off of that? Or put it differently, what would be the minimum efficacy package that would justify a BLA submission? And there are there are a lot-- sorry. Nataliya Agafonova: No. No. Go ahead, Nataliya. So there are a lot of precedences when sponsors approved biologics had an exploratory endpoint as an exploratory endpoint. So we already know that FDA express opinion that the most clinically significant endpoints which we already incorporated in analysis, such as all cause mortality, hospitalization, etcetera. They will consider this as exploratory. However, they are happy to exercise regulatory and they requested we share results of our trial with them. for potential, you know, potential approval. So absolutely, if, in case the options you described in case of right ventricular ejection fraction does not hit statistical significance, but this 1 serves design criteria met. They absolutely do everything to regain BLA status. Yes. Stephen H. Willard: And then remember here, this is a very devastating disease. for which there are no alternative medicines available. And the FDA has been quite positive in saying they want to work with us despite the challenges we have had. And I think that we are collecting the data, which if successful, could encourage the FDA to give us the pivotal and BLA status. Boobalan Pachaiyappan: Okay. Marie, 1 last question. Let's say ELPIS II supports a BLA path. What are the remaining CMC items that need to be checked Or maybe what are the other items that need to be checked for a BLA filing? Say, sometime in 2027? Thank you. Stephen H. Willard: Devin, I will take this 1. We have made excellent progress with our CMC. We have a provider that we are working actively with to transfer the manufacturing I think everything looks to be a, you know, a go. We will be able to fine tune our program once we have a partner. But I think the partner will probably going to allow us and agree with us that we are best at handling the manufacturing of this key product. So I do not see any blockers or impediments with a positive signal from the FDA. Getting that BLA. Boobalan Pachaiyappan: Alright. Congratulations again. Stephen H. Willard: Thank you. Thank you. Operator: And our next question, we will hear from Michael Okunewitch with Max Maxim Group. Stephen H. Willard: Hi guys. Thank you so much for taking my questions. Thank you, Michael. Michael Okunewitch: I just wanted to ask a little bit about how you are going to be collecting the event space data because it is only a 12-month endpoint for LVEF. For RVEF. So is this something that you are expecting to collect over time and are planning to do as part of some longer term follow-up. Or will you have sufficient data to actually see any sort of difference on an events based outcome at the upcoming September readout? Nataliya Agafonova: Thank you, Michael. If I might address this, is it okay? Please. So Michael, great question. 1 of the long-term effect on patient outcome, we are collecting right before the database lock for each patient. Some of the patients initiated the trials 5 years ago, and we have 5 years' data. We are collecting survival status. We are collecting transplant status. This is we are going to have for all patients with different duration. Duration. depending on when a patient initiated the treatment. This is something we will collect at the end of the trial. In addition, we are planning a long-term extension trial up to the patients' age of 10. And we already share this plan with the FDA. We already submitted their questions. We are addressing them, and we already doing feasibility, etcetera. And our goal is to initiate this trial and continue following up these patients for the long term outcome up to the patients are 10 years old. With that information, it is a long term extension study for the survival status With that information, there are a lot of we kind of open up a lot of regulatory options for us. So we can go for accelerated approval with before waiting for the long term extension results or we can just go for traditional approval, still waiting for the results of the long term extension, which always reassuring. Because the most important clinically important effect is a long term survival, transplant free survival. For this patient population. Michael Okunewitch: Certainly. Thank you for that additional color on it. Are we expecting that you will have sufficient survival data to go back to FDA and potentially file for a BLA this September? Or is this something where we really need to wait and see how the data is before we can determine whether or not it will be able to serve for approval in the near term. Nataliya Agafonova: So for now, I think this has sufficient data. for yeah. We do have sufficient data to demonstrate long term outcome. And at the time of the data, we might have even the you know, additional survival data. So as we continue to collect them, we might have additional data. But at the end of this trial, like, at the end of the in September, we will have already sufficient data to demonstrate 5-year survival for some patients. Stephen H. Willard: Thank you. Michael Okunewitch: And then 1 last 1. I know this is an exploratory endpoint, but do you have sufficient patients in the study that you could get some sort of statistical power on that, on the event-based endpoints? Nataliya Agafonova: Yes. Even with missing data and we do have sufficient data if our assumptions are correct. it is still blinded, but we do have sufficient data to demonstrate significance. Michael Okunewitch: Alright. Thank you. I really appreciate your additional clarity. Congrats on all the progress. Stephen H. Willard: Thank you for getting involved. Operator: There are no further questions at this time. I would like to turn the floor back to Stephen Willard for closing remarks. Stephen H. Willard: Thank you, operator, and thank you all for attending today's call. We greatly appreciate your interest and support. And look forward to updating you in the coming weeks. Thank you. Operator, you may end the call. Operator: Thank you. This does conclude today's teleconference. We thank you for your participation. You may disconnect your lines at this time. Before you buy stock in Longeveron, consider this: The Motley Fool Stock Advisor analyst team just identified what they believe are the 10 best stocks for investors to buy now… and Longeveron wasn’t one of them. The 10 stocks that made the cut could produce monster returns in the coming years. 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Our analysts just identified a stock with the potential to be the next Nvidia. Tell us how you invest and we'll show you why it's our #1 pick. Tap here. Management is prioritizing the ELPIS II Phase 2b clinical trial for HLHS as the company's most critical near-term catalyst, with data readout expected in mid-September. The company was selected as a finalist for the XPRIZE HealthSpan competition, a recognition based on clinical data showing Laromestrocel increases 6-minute walk distance in Aging-related Frailty patients. Strategic positioning is shifting toward exploring development and commercialization partnerships to leverage the infrastructure and capital of established pharmaceutical firms. The IND for pediatric dilated cardiomyopathy (PDCM) became effective in July 2025, allowing for a direct transition into a single Phase 2 registrational trial due to the disease's severity. Revenue decreases were attributed to the absence of contract manufacturing revenue as the company focuses on its core therapeutic pipeline. Management attributes the net loss increase to higher legal spending, personnel costs, and R&D expenses specifically tied to supporting the upcoming ELPIS II results. The company anticipates that positive ELPIS II data will trigger an 'auction' among potential partners to determine pricing and commercialization timelines. Current cash and equivalents of $10.1 million are projected to fund operations into the fourth quarter of 2026 based on the current operating budget. Management plans to initiate a Phase 2 clinical trial in pediatric dilated cardiomyopathy (PDCM) in 2026. A long-term extension trial for HLHS patients is planned to follow subjects up to age 10, which may support either accelerated or traditional regulatory approval paths. The company expects to utilize a Priority Review Voucher for a potential BLA submission, noting a recent market transaction for such a voucher at $215 million. The timeline for ELPIS II top-line results was shifted from August to September due to delays in the 12-month MRI for the final patient. Longeveron is transitioning manufacturing to a third-party provider, with plans to finalize the program once a commercial partner is secured. The company holds 52 issued patents and 5 FDA expedited designations, which management views as critical defensive moats for their allogeneic mesenchymal stem cell therapy. One stock. Nvidia-level potential. 30M+ investors trust Moby to find it first. Get the pick. Tap here. Management has incorporated FDA feedback regarding NIH and sponsor-defined endpoints into the SAP and submitted it for final review. If no further comments are received before the August 31st database lock, the company will proceed with the pre-specified analysis as planned. Management stated that the FDA has expressed interest in clinically significant exploratory endpoints like all-cause mortality and transplant-free survival. Because HLHS is a devastating disease with no alternative medicines, the company believes strong trends in these secondary measures could still support a BLA submission. The company confirmed they have up to 5 years of survival and transplant status data for some patients, which they believe is sufficient to demonstrate long-term outcomes. Management asserted that even with some missing data, the study has sufficient statistical power to demonstrate significance if their efficacy assumptions are correct.

Stephen Willard On track for September 2026 top-line results from Phase 2b clinical trial (ELPIS II) evaluating laromestrocel as a potential adjunct treatment for hypoplastic left heart syndrome (HLHS), a rare pediatric disease and orphan-designated indication Longeveron selected as a Finalist and Milestone 2 Awardee for the XPRIZE Healthspan competition based on published clinical trial results which indicated laromestrocel increased 6-minute walk distance in patients with aging frailty Three new independent Directors join Longeveron’s Board of Directors Company to host conference call and webcast today at 4:30 p.m. ET MIAMI, Aug. 12, 2026 (GLOBE NEWSWIRE) -- Longeveron Inc. (NASDAQ: LGVN), a clinical stage biotechnology company developing cellular therapy for life-threatening, rare pediatric and chronic aging-related conditions, today reported financial results for the quarter ended June 30, 2026 and provided a business update. “Longeveron is approaching a series of potentially transformative milestones across our four stem cell therapy development programs that have the potential to redefine the trajectory of our business,” said Stephen H. Willard, Chief Executive Officer of Longeveron. “Our approach to stem cell therapy development has garnered external recognition and validation with positive clinical data having been published in Nature Medicine and Cell Stem Cell and also serving as the foundation for our selection as a Finalist for the XPRIZE Healthspan competition out of over 600 projects submitted worldwide. We are rapidly approaching the September top line data readout of our ELPIS II Phase 2b clinical trial evaluating laromestrocel in HLHS and look forward to sharing those results.” Development Programs Longeveron’s investigational therapeutic candidate laromestrocel (Lomecel-B®) is a proprietary, scalable, allogeneic cellular therapy being evaluated in multiple indications. Hypoplastic Left Heart Syndrome (HLHS) – a rare pediatric congenital heart birth defect in which the left ventricle (one of the pumping chambers of the heart) is either severely underdeveloped or missing. Topline results from the Phase 2b clinical trial (ELPIS II) evaluating laromestrocel as a potential adjunct therapy for HLHS are anticipated in September 2026. In May, the Company announced that the U.S. Food and Drug Administration (FDA) held a Type C meeting in late March 2026 focused on the ELPIS II Phase 2b clinical trial and upcoming data readout. Also in May, the Company announced that the independent Data Monitoring Committee (DMC) completed its final prespecified data review for ELPIS II Phase 2b clinical trial (ELPIS II). The DMC performed a risk-benefit assessment, indicated no safety concerns, and approved the study to continue as designed to completion. ELPIS II is being conducted in collaboration with the National Heart, Lung, and Blood Institute (NHLBI) through grants from the National Institutes of Health (NIH). The FDA has granted laromestrocel Orphan Drug designation, Fast Track designation, and Rare Pediatric Disease designation for the treatment of HLHS. Pediatric Dilated Cardiomyopathy (PDCM) – a rare pediatric cardiovascular disease in which the muscles in one or 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. Longeveron’s Investigational New Drug (IND) application for its stem cell therapy laromestrocel as a potential treatment for PDCM became effective in July 2025. This IND provides for moving directly to a single Phase 2 registrational clinical trial. The Company currently anticipates initiation of the Phase 2 clinical trial in 2027, with planning and preparation beginning in 2026. Alzheimer’s disease (AD) – a neurodegenerative disorder that leads to progressive memory loss and death and currently has very limited therapeutic options. In July, additional analysis of data from the Phase 2a clinical trial evaluating laromestrocel in mild AD was presented in a Poster Presentation at the 2026 Alzheimer’s Association International Conference® (AAIC®). The data indicated that laromestrocel reduced neuroinflammation in patients with mild Alzheimer’s disease. Results from the Phase 2a clinical trial (CLEAR MIND), which support the therapeutic potential of laromestrocel in the treatment of mild Alzheimer’s disease and provided evidence-based support for further clinical development, were published in the peer-reviewed journal Nature Medicine in March 2025. Positive Type B meeting with FDA regarding pathway to potential BLA submission for laromestrocel in Alzheimer’s disease held in March 2025 with tentative alignment reached on proposed trial study design, population and endpoints for a single Phase 2/3 clinical trial that, if positive, could be acceptable for BLA submission for Alzheimer’s disease. The FDA has granted laromestrocel both Regenerative Medicine Advanced Therapy (RMAT) designation and Fast Track designation for the treatment of mild Alzheimer’s disease. The Company is seeking to forge strategic collaborations and/or partnerships for the advancement of laromestrocel in addressing AD. Aging-related Frailty (AF) – a chronic condition driven by systemic physiologic decline, characterized by reduced reserve and resilience across multiple organ systems with common features including weakness, fatigue, weight loss, slowness and reduced activity. No FDA-approved therapies currently exist. Laromestrocel data from its Phase 2b clinical trial in Aging-related Frailty were published in Cell Stem Cell in February 2026. The Phase 2b results indicated that intravenous laromestrocel improved the physical condition of patients with age-related clinical frailty after nine months, compared to placebo. Corporate Updates In April, the Company announced that the China National Intellectual Property Administration granted a patent covering potency assay methods for assessing human mesenchymal stem cells (MSCs) derived from bone marrow, adipose tissue, peripheral blood, a lung, a heart, amniotic fluid, inner organs, an amniotic membrane, an umbilical cord or a placenta or differentiated from induced pluripotent stem cells (IPSCs). In May, the Company issued a CEO Letter to Shareholders highlighting corporate strategy, strategic partnering approach and 2026 key priorities. In June, the Company participated in the BIO International Convention. Members of the senior management team hosted meetings to explore potential partnership and strategic opportunities for the Company’s four stem cell development programs. In June, the Company announced that it has been granted Small or Medium-sized Enterprise (SME) status by the European Medicines Agency (EMA). The SME program is an initiative by the EMA to address the particular needs of small and medium size companies developing medicinal products in Europe. Companies that are granted SME designation are able to seek scientific advice, protocol assistance, and other information and training from dedicated EMA personnel during the clinical development process. Companies with this designation can engage in early dialogue with the EMA multidisciplinary team and discuss regulatory strategy with the goal of mitigating delay and accelerating patient access to lifesaving treatments. On August 11, 2026, the Company announced that it has been selected as a Finalist Team in the XPRIZE Healthspan global competition, a seven-year, $101 million global competition to identify therapeutic approaches to increase human healthspan. As a result, the Company will receive a $1.0 million Milestone 2 Award to be used towards the future clinical trial required in accordance with the XPRIZE competition rules, with the opportunity to compete for the XPRIZE Grand Prize of up to $81 million, subject to the successful completion of the required clinical trial and financing thereof. 2026 Second Quarter Summary Financial Results Revenues, Cost of Revenues and Gross Profit: Revenues for each of the three-month periods ended June 30, 2026 and June 30, 2025 was $0.3 million. 2026 revenues decreased by $29,000, or 10%, when compared to 2025, primarily due to the absence of contract manufacturing revenue.Clinical trial revenue, which is derived from The Bahamas Registry Trial, for each of the three-month periods ended June 30, 2026 and June 30, 2025 was $0.3 million. Contract manufacturing revenues for the three months ended June 30, 2026 and 2025, were $0 and $18,000, respectively. This decrease of $18,000, or 100%, when compared to the same period in 2025, was driven by the absence of any additional contract manufacturing services from our third-party client.Related cost of revenues were $0.1 million and $0.2 million for the three months ended June 30, 2026 and 2025, respectively. This resulted in a gross profit of approximately $0.2 million for the three months ended June 30, 2026, an increase of $36,000, or 25%, when compared to 2025. General and Administrative Expenses: General and administrative expenses for the three months ended June 30, 2026 were $3.2 million, compared to $2.6 million for the same period in 2025. The increase of $0.6 million, or 23%, was primarily due to a $0.4 million increase in legal spend and a $0.2 million increase in personnel-related costs. Research and Development Expenses: Research and development expenses were $3.2 million for the three months ended June 30, 2026, compared to $3.0 million for the same period in 2025. The increase of $0.2 million, or 7%, was due to higher clinical trial expenses to support the ELPIS II top-line results expected in September 2026. Other Income: Other income for the three months ended June 30, 2026 was $0.1 million, primarily consisting of interest earned on money market funds. Other income for the three months ended June 30, 2025, was $0.4 million, primarily consisting of $250,000 received as a recipient of a Milestone 1 Award in the XPRIZE Healthspan competition and $0.1 million of interest earned on money market funds. Net Loss: Net loss was $6.1 million for the three months ended June 30, 2026, compared to $5.0 million for the three months ended June 30, 2025. The increase of $1.1 million, or 22%, was due to the factors outlined above. Cash and cash equivalents: As of June 30, 2026, the Company had cash and cash equivalents of $10.1 million. We currently anticipate our existing cash and cash equivalents will enable us to fund our operating expenses and capital expenditure requirements into the fourth quarter of 2026, based on our current operating budget and cash flow forecast. Our operating costs will continue to be substantial for the foreseeable future in connection with our ongoing activities. We intend to seek additional financing opportunities, capital raises, as well as non-dilutive funding options to support our operating plans. Conference Call and Webcast Details: An archived replay of the webcast will be available on the “Events & Presentations” section of the Company’s website following the conference. About Longeveron Inc. Longeveron is a clinical stage biotechnology company developing regenerative medicines to address unmet medical needs. The Company’s lead investigational product is laromestrocel (Lomecel-B®), an allogeneic mesenchymal stem cell (MSC) therapy product isolated from the bone marrow of young, healthy adult donors. Laromestrocel has multiple potential mechanisms of action encompassing pro-vascular, pro-regenerative, anti-inflammatory, and tissue repair and healing effects with broad potential applications across a spectrum of disease areas. Longeveron is pursuing four pipeline indications: hypoplastic left heart syndrome (HLHS), Alzheimer’s disease, Pediatric Dilated Cardiomyopathy (DCM) and Aging-related Frailty. Laromestrocel development programs have received five distinct and important U.S. FDA designations: for the HLHS program - Orphan Drug designation, Fast Track designation, and Rare Pediatric Disease designation; and, for the AD program - Regenerative Medicine Advanced Therapy (RMAT) designation and Fast Track designation. For more information, visit www.longeveron.com or follow Longeveron on LinkedIn, X, and Instagram. Forward-Looking StatementsCertain statements in this press release that are not historical facts are forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, which reflect management’s current expectations, assumptions, and estimates of future operations, performance and economic conditions, and involve known and unknown risks, uncertainties, and other important factors that could cause actual results, performance, or achievements to differ materially from those anticipated, expressed, or implied by the statements made herein. Forward-looking statements are generally identifiable by the use of forward-looking terminology such as “anticipate,” “believe,” “contemplate,” “continue,” “could,” “estimate,” “expects,” “intend,” “looks to,” “may,” “on condition,” “plan,” “potential,” “predict,” “preliminary,” “project,” “see,” “should,” “target,” “will,” “would,” or the negative thereof or comparable terminology, although not all forward-looking statements contain these words, or by discussion of strategy or goals or other future events, circumstances, or effects. Factors that could cause actual results to differ materially from those expressed or implied in any forward-looking statements in this release include, but are not limited to, the ability of our clinical trials to demonstrate safety and efficacy of our investigational products, and other positive results; our ability to successfully transition toward a more capital-efficient, asset-light operating model; our ability to secure one or more strategic licensing partnerships for our stem cell therapy laromestrocel in our development programs; our ability to reach alignment with the FDA and other regulatory authorities on a potential path toward regulatory approval of our investigational products; receipt of trial results and other available evidence sufficient to support the Company filing a BLA following the readout of top-line results of the ELPIS II data; the timing and focus of our ongoing and future preclinical studies and clinical trials, and the reporting of data from those studies and trials; market and other conditions, our cash position and need to raise additional capital, the difficulties we may face in obtaining access to capital, and the dilutive impact it may have on our investors; our financial performance, and ability to continue as a going concern; the period over which we estimate our existing cash and cash equivalents will be sufficient to fund our future operating expenses and capital expenditure requirements; the size of the market opportunity for certain of our investigational products, including our estimates of the number of patients who suffer from the diseases we are targeting; our ability to scale production and commercialize the investigational products for certain indications; the success of competing therapies that are or may become available; the beneficial characteristics, safety, efficacy and therapeutic effects of our investigational products; our ability to obtain and maintain regulatory approval of our investigational products in the U.S. and other jurisdictions; our plans relating to the further development of our investigational products, including additional disease states or indications we may pursue; our plans and ability to obtain or protect intellectual property rights, including extensions of existing patent terms where available and our ability to avoid infringing the intellectual property rights of others; the need to hire additional personnel and our ability to attract and retain such personnel; and our estimates regarding expenses, future revenue, capital requirements and needs for additional financing. Further information relating to factors that may impact the Company’s results and forward-looking statements are disclosed in the Company’s filings with the Securities and Exchange Commission, including Longeveron’s Annual Report on Form 10-K for the year ended December 31, 2025, filed with the Securities and Exchange Commission on March 17, 2026, its Quarterly Reports on Form 10-Q, and its Current Reports on Form 8-K. The Company operates in a highly competitive and rapidly changing environment; therefore, new factors may arise, and it is not possible for the Company’s management to predict all such factors that may arise nor assess the impact of such factors or the extent to which any individual factor or combination thereof, may cause results to differ materially from those contained in any forward-looking statements. The forward-looking statements contained in this press release are made as of the date of this press release based on information available as of the date of this press release, are inherently uncertain, and the Company disclaims any intention or obligation, other than imposed by law, to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise. Investor and Media Contact:Derek ColeInvestor Relations Advisory [email protected] See accompanying notes to financial statements. See accompanying notes to financial statements. A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/cde71c09-a5f1-424d-837b-80f8786d82a5

Our analysts just identified a stock with the potential to be the next Nvidia. Tell us how you invest and we'll show you why it's our #1 pick. Tap here. Transitioned to a capital-efficient, asset-light operating model focused on securing strategic licensing partnerships for laromestrocel across all four development programs. Successfully attracted new investment capital from premier life science funds following a comprehensive review of assets and development plans. Prioritized the ELPIS II Phase IIb trial for Hypoplastic Left Heart Syndrome (HLHS) as the company's most significant near-term value catalyst. Implemented disciplined capital allocation to extend the operating runway while maintaining focus on high-impact clinical milestones. Leveraging a robust intellectual property portfolio of 52 issued patents to support independent development or partnering of multiple indications. Engaging with global pharmaceutical executives at upcoming industry conventions to explore strategic opportunities and commercial infrastructure support. Anticipate top-line results from the ELPIS II Phase IIb trial in HLHS in August 2026, which will dictate the subsequent BLA filing strategy. Plan to submit a sponsored statistical analysis plan (SAP) for ELPIS II to the FDA to align on efficacy measures before the data readout. Preparation for a single Phase II registrational clinical trial in Pediatric Dilated Cardiomyopathy (PDCM) is slated for 2026, with potential initiation in 2027. Existing cash and equivalents of $15.8 million are projected to fund operating expenses and capital requirements into the fourth quarter of 2026. Future regulatory strategy includes seeking a Type B or pre-BLA meeting in late 2026 or early 2027 depending on the strength of the HLHS data. The FDA no longer classifies ELPIS II as a 'pivotal' trial because a new primary endpoint could not be agreed upon while the trial remains blinded during an ongoing NIH-mandated interim analysis. FDA asserted that right ventricular ejection fraction (RVEF) is insufficient as a primary efficacy endpoint, requiring more objective measures like mortality and transplant-free survival. R&D expenses included a $2 million nonrecurring charge for amortization of patent costs in the prior year period, affecting year-over-year comparisons. Contract manufacturing revenue declined 84% due to reduced demand from third-party clients as the company shifts focus toward its internal pipeline. One stock. Nvidia-level potential. 30M+ investors trust Moby to find it first. Get the pick. Tap here. Management intends to immediately solicit a meeting with the FDA, likely a Type B meeting if results are overwhelmingly positive, to discuss a potential BLA filing. A pre-BLA meeting would follow in 2027 to address CMC (Chemistry, Manufacturing, and Controls) and overall filing readiness. Management believes the PDCM program is insulated from the HLHS endpoint issues because the IND already includes an agreed-upon clinical endpoint that would meet approvability criteria. While HLHS and PDCM are both rare pediatric cardiac diseases, they involve different routes of administration and distinct patient populations. The trial is currently powered to show a reduction in hospital stay duration, with a base assumption of 30 days reduced to 15 days for treated patients. The efficacy determination will rely on a composite of all-cause mortality, cardiac transplant-free survival, and major adverse cardiac events (MACE).

Image source: The Motley Fool. May 13, 2026 Chief Executive Officer — Stephen H. Willard Chief Medical Officer — Nataliya Agafonova Chief Financial Officer — Lisa Locklear Co-Founder, Chief Science Officer, and Executive Chairman — Joshua Michael Hare FACC Stephen H. Willard: 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 of CEO in February, we embarked on 2 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 catalyst. 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 Coastland Capital, Janus Henderson Investments, Logos Capital, and Matthew Perry; 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. 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 reflected 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. Longeveron will be participating in the BIO International Convention taking place in June 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 4 stem cell development programs. We are focused our development activities to prioritize our most important near term catalyst. The data readout of ELPIS 2, our phase 2 b clinical trial evaluating Laromestrocel in 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. Nataliya Agafonova: The patients we serve, Longeveron, our shareholders. With that, I will turn the call over to Dr. Agafonova our chief medical officer. To touch on our clinical development programs. Nataliya? Thank you, Steve, and good afternoon, everyone. As Steve mentioned, HLHS program is the primary focus for us, addressing an area of clear unmet medical need. ELPIS II our phase 2 clinical trial evaluating the potential of Lomecel-B in infants with HLHS is nearing completion. Enrollment of 40 patients was completed in June. Top line results from the ELPIS II trial are anticipated in August 2026. We recently completed a constructive type c meeting with the FDA on the Lomecel-B 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 ELPIS II trial is not an appropriate endpoint. To demonstrate efficacy. While agreed with the FDA regarding the insufficiency of our RVEF 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. Which the company was and remain 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 II 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 Longeveron again when the ongoing ELPIS II study is completed to discuss the study results 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 II And in that regard, the company is capturing all of these measures in ELPIS II 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 II. 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 II data. Which, as I mentioned earlier, are anticipated in August. We look forward to sharing the results of the ELPIS II clinical trial when they are available. Reaching over to pediatric dilated cardiomyopathy or PDCM. This is a rare pediatric cardiovascular disease in which the muscles in 1 or more of the heart chambers become enlarged or stretched. Dilated. This nearly 40% of children with PDCM requiring a heart transplant or dying within 2 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. Lisa Locklear: I will hand the call over to Lisa Locklear, our Chief Financial Officer. Lisa? 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 touch on some highlights. Revenues for the 3 months ended 03/31/2026, were $400 thousand and consisted of $400 thousand of clinical trial revenue and $20 thousand of contract manufacturing revenues. Revenues for the 3 months ended 03/31/2025, were $400 thousand and consisted of $300 thousand of clinical trial revenues and $100 thousand of contract manufacturing revenues. Clinical trial revenues for the 3 months ended 03/31/2026 increased $100 thousand 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 3 ended 03/31/2026, decreased $100 thousand 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 3 months ended 03/31/2026 were $2.7 million compared with $2.9 million for the same period in 2025. The $200 thousand or 7% decrease was primarily due to a $400 thousand 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 3 months ended 03/31/2026, compared to $2.5 million for the same period in 2025. The $200 thousand or 8% decrease was due to lower performance achievement related to the 2025 annual cash incentive bonuses a $2 million nonrecurring 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 II study results in August. Our net loss was $4.7 million for the 3 months ended 03/31/2026, compared to $5 million for the 3 months ended 03/31/2025. The decrease of $300 thousand or 6% was due to the factors outlined before. Our cash and cash equivalents as of 03/31/2026, 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 into 2026. Joshua Michael Hare FACC: Based on our current operating budget and cash flow forecast. I will hand the call over to Joshua Hare, our Co-Founder, Chief Science Officer and Executive Chairman. Joshua? Thank you, Lisa. Good afternoon, everyone. Laramestrocel 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, provascular, and pro regenerative effects, support its potential application across multiple high value indications. Laromestrocel benefits from having received 5 expedited designations, including regenerative medicine advanced therapy, or RMAT, Fast Track Orphan Drug, and Rare Pediatric Disease Designations. Reinforcing both the clinical promise and regulatory positioning of our program. We continue to advance a pipeline and 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 4 initial indications address market opportunities of what we estimate to be approximately $1.5+ billion, and up to $1.4 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 H. Willard: Thank you, Joshua. 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. This is 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? Operator: We would now like to open the call for questions from our covering analysts. Thank you. Ladies and gentlemen, we will now begin the question-and-answer session. Please press star and 1 on your telephone keypad. You may press star and 2 if you would like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star key. Ladies and gentlemen, we will wait for a moment while we poll for questions. We take the first question from the line of Raghuram Selvaraju from H.C. Wainwright. Analyst (Raghuram Selvaraju): Thank so 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 II and what you think are likely to be the most logical follow-up steps that you would take with the agency? Other words, you know, within what time frame would you request a potential meeting with the agency to discuss the ELPIS II results and what type, what classification of meeting would that be? Stephen H. Willard: I would say that we would do that immediately. And it would be a type c meeting. Joshua, do you have any correction to that? I am not sure. Joshua Michael Hare FACC: I would like to hear from Nataliya because if it is an end of phase 2, it could be a type b meeting. But after then, is to immediately provide the top line results to the agency and to solicit a meeting with them as soon as possible. Nataliya Agafonova: Nataliya, any Sure. Sure. I agree with that. And you know, if the so it depends on the results. If the results are really over overwhelming, we would like to come back probably the Type B meeting to discuss all the potential for the future the 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 should be done sometimes in 20 2027 because it should be, a reason why we can we can discuss all our readiness for the BLA from not just from the sense of clinical results, but also CMC, etcetera. So yeah. Analyst (Raghuram Selvaraju): 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 pros post approval assessment of laramestrocel, have changed in the wake of the most recent feedback from the FDA regarding the primary efficacy endpoint in ELPIS II. 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 about ELPIS II. Nataliya Agafonova: Sure. it is 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 I and ELPIS II 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 we are approved, then to demonstrate efficacy on transplant free survival and some other endpoints. 10 years, let's say, from when the patient reached 10 years old, later on. So that would be probably 1 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. Analyst (Raghuram Selvaraju): 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 Laromestrocel in PDCM in the wake of the most recent FDA feedback on the ELPIS II study. Nataliya Agafonova: May I just answer from clinical development. Maybe you can give business perspective. Is it okay? Stephen H. Willard: Yes, please. Go ahead. Nataliya Agafonova: Okay. So you are 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 are completely different. And I would say, the results of, HLHS trial will definitely inform in some way, inform and message We can develop some key messages, clinical messages for PDCM. But they are 2 independent diseases, and they 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 is completely 2 different, 2 different entities, 2 different diseases. And, Steve, maybe you can provide your perspective from business point of view. What happened after results of each of the tests? Stephen H. Willard: Mhmm. Sure. From a business point of view, I think this was a surprise that we had this issue with the FDA. I think it is 1 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 a 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. Nataliya Agafonova: And I would like to add that we in 2026, we are planning operationally to initiate PDCM. We are going to do feasibility, etcetera. So we are preparing for initiation of PDCM. Thank you. Joshua Michael Hare FACC: Nataliya, it might be worth mentioning what the PDCM endpoint is that we already designed for the, the approved IND. It is already a clinical endpoint that we anticipate would meet approvability criteria if met. So while there will certainly be opportunities for refinements, we do not anticipate we, 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. Nataliya Agafonova: Sure. So before Joshua, so would you like me to just mention what is what is sorry. I missed it. Joshua Michael Hare FACC: Oh, yeah. No. No. I think I was just say I just indicated, Nataliya, that we already have the chosen clinical endpoint. Agreed upon with the agency for the PDCM trial. Yep. Thank you. Yes. Thank you. Thank you very much. Operator: Thank you. We take the next question from the line of Boobalan Pachaiyappan from ROTH Partners. Please go ahead. Analyst (Boobalan Pachaiyappan): Hi, team. This is Boobalan dialing in for Boobalan. We have a couple of questions. So Mhmm. Yeah. The first question is, given that RVEF 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? Stephen H. Willard: Joshua, you want to take that? I think it is better if we have Nataliya answer that because she's completed the power analysis. Nataliya, would you like to take that question? Nataliya Agafonova: 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. And but we know even if blinded, we know that as of today, we have 2 deaths on the trial. 1 death happened prior to Glenn procedure, and another death happened after Glenn procedure. So we have these 2 events. And because it is a composite endpoint, the whole weight of the composite end point is the weighting is going to be on hospitalizations. Days in a 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, SDR data. We are using, single institution data on literature, So based on all the literature evidence, currently, patients with HLHS chest spent about 30 days in the hospital 12 months after Glenn, and that is our biggest assumption. So, of course, on our trial, we would like to do and we would like to demonstrate that these very clinically meaningful endpoints such as how many days patients spent in the hospital, it is shorter than 30 days. And we have different assumptions, 15 days, etcetera. For now, we are powering 15 days. And then as far as MACE we know what potentially we have how many events we have, but we have to adjudicate these events and but we have enough events to demonstrate some difference between standard of care and Lomecel-B at this point. Joshua Michael Hare FACC: And MACE, which is another composite endpoint. And which consists of cardiovascular mortality, hospitalization due to heart failure, thromboembolic event, and arrhythmia. So we are adjudicating these events, and we have enough sufficient events to demonstrate the difference. Nataliya Agafonova: So did I address your question? Analyst (Boobalan Pachaiyappan): 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 II study? Nataliya Agafonova: Joshua, maybe you can answer this question because you were involved in the study and you know it better. Joshua Michael Hare FACC: Yes. Thank you, and thank you for that question. We are we are excited about the child results, and they did inform our, thinking for the endpoint of ELPIS II. The reason why it is so attractive is, first of all, it is current data whereas the SVR data is somewhat dated. So the, 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 is a small study. 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 II were seen in the child study. So, again, concurrently, concurrently enrolled with ELPIS 2, so at the same time in same point in time, at the same centers with the same surgeons, And although it was a much smaller study, we did 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 II should be as well as what the constituents of MACE should be. And we are hopeful that the event rate in child will be whatever we saw in child will be similar in the ELPIS II study. Nataliya Agafonova: Thank you, Joshua. Analyst (Boobalan Pachaiyappan): 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? Know, if it is approved on an accelerated basis. Nataliya Agafonova: I would say you know, clinically relevant and outcome measures, as we spoke, transplant free survival, it is 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 is 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 2 are very, very important. And, of course, heart failure hospitalization also. So which is kind of indicator how the right ventricle is performing, etcetera. So I think those are the most significant, endpoints. And in addition, I would like to say even though FDA did not accept right ventricular ejection fraction because they believe it is not enough, evidence to consider this as a surrogate endpoint. We are still including 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 correlation with ejection fraction and clinical outcome and survival. So it is not a surrogate endpoint today. But I hope this data can inform us and maybe it is a potential for us to elevate right ventricular ejection to surrogate endpoint. Analyst (Boobalan Pachaiyappan): Thank you, Nataliya. And 1 last question from me. So after the release of ELPIS II and you know, assuming positive data, do placebo patients have an opportunity to try out Lomecel-B on a compassionate basis? Nataliya Agafonova: So we do not have any long term or we do have compassionate program, but we do not have any long term extension study where a patient can switch crossover anything like this, but maybe we have not 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 H. Willard: Yes. I mean, this whole 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. Derek, are there any other questions? Operator: No other questions. Thank you. Ladies and gentlemen, as there are no further questions from the participants, I would now hand the conference over to Stephen H. Willard for his closing comments. Stephen H. Willard: 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 4 shots on goal here. Not just 1. 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. Thank you. Operator: Ladies and gentlemen, the conference of Longeveron has now concluded. Thank you for your participation. You may now disconnect your lines. Thank you. Before you buy stock in Longeveron, consider this: The Motley Fool Stock Advisor analyst team just identified what they believe are the 10 best stocks for investors to buy now… and Longeveron wasn’t one of them. 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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 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. 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. Up Next: Transform your trading with Benzinga Edge's one-of-a-kind market trade ideas and tools. Click now to access unique insights that can set you ahead in today's competitive market. This article Longeveron Q1 2026 Earnings Call: Complete Transcript originally appeared on Benzinga.com © 2026 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.

Stephen Willard On track for August 2026 top-line results from Phase 2b clinical trial (ELPIS II) evaluating laromestrocel as a potential adjunct treatment for hypoplastic left heart syndrome, a rare pediatric disease and orphan-designated indication Closed a private placement of up to $30 million, with $15 million funded in the initial closing, led by Coastlands Capital with participation from Janus Henderson Investors and other healthcare focused funds Company to host conference call and webcast today at 4:30 p.m. ET MIAMI, May 13, 2026 (GLOBE NEWSWIRE) -- Longeveron Inc. (NASDAQ: LGVN), a clinical stage biotechnology company developing cellular therapy for life-threatening, rare pediatric and chronic aging-related conditions, today reported financial results for the quarter ended March 31, 2026 and provided a business update. “Earlier this year, we initiated a strategic repositioning of Longeveron designed to maximize shareholder value while maintaining disciplined capital allocation,” said Stephen H. Willard, Chief Executive Officer of Longeveron. “We have transitioned toward a more capital-efficient, asset-light operating model, with an increased focus on securing strategic licensing partnerships for our stem cell therapy laromestrocel in four development programs. Longeveron is approaching a series of potentially transformative milestones across these programs that have the potential to redefine the trajectory of our business, with the first catalyst, top line results from our Phase 2b clinical trial in HLHS, anticipated in August of this year.” Development Programs Longeveron’s investigational therapeutic candidate laromestrocel (Lomecel-B®) is a proprietary, scalable, allogeneic cellular therapy being evaluated in multiple indications. Hypoplastic Left Heart Syndrome (HLHS) – a rare pediatric congenital heart birth defect in which the left ventricle (one of the pumping chambers of the heart) is either severely underdeveloped or missing. Topline results from the Phase 2b clinical trial (ELPIS II) evaluating laromestrocel as a potential adjunct therapy for HLHS are anticipated in August 2026. In May, the Company announced that the U.S. Food and Drug Administration (FDA) held a Type C meeting in late March 2026 focused on the ELPIS II Phase 2b clinic trial and upcoming data readout. ELPIS II is being conducted in collaboration with the National Heart, Lung, and Blood Institute (NHLBI) through grants from the National Institutes of Health (NIH). The FDA has granted laromestrocel Orphan Drug designation, Fast Track designation, and Rare Pediatric Disease designation for the treatment of HLHS. Alzheimer’s disease (AD) – a neurodegenerative disorder that leads to progressive memory loss and death and currently has very limited therapeutic options. Laromestrocel data from the Phase 2a clinical trial (CLEAR MIND) linking neuroinflammation to clinical outcomes in patients with mild Alzheimer’s disease were presented at the 18th Clinical Trials on Alzheimer’s Disease Conference (CTAD 2025) held in December 2025. Results from the Phase 2a clinical trial (CLEAR MIND), which support the therapeutic potential of laromestrocel in the treatment of mild Alzheimer’s disease and provided evidence-based support for further clinical development, were published in the peer-reviewed journal Nature Medicine in March 2025. Positive Type B meeting with FDA regarding pathway to BLA submission for laromestrocel in Alzheimer’s disease held in March 2025 with alignment reached on proposed trial study design, population and endpoints for a single Phase 2/3 clinical trial that, if positive, could be acceptable for BLA submission for Alzheimer’s disease. The FDA has granted laromestrocel both Regenerative Medicine Advanced Therapy (RMAT) designation and Fast Track designation for the treatment of mild Alzheimer’s disease. The Company is seeking to forge strategic collaborations and/or partnerships for the advancement of laromestrocel in addressing AD. Pediatric Dilated Cardiomyopathy (PDCM) – a rare pediatric cardiovascular disease in which the muscles in one or 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. Longeveron’s Investigational New Drug (IND) application for its stem cell therapy laromestrocel as a potential treatment for PDCM became effective in July 2025. This IND provides for moving directly to a single Phase 2 registrational clinical trial. The Company currently anticipates initiation of the Phase 2 clinical trial in 2027, with planning and preparation beginning in 2026. Partnering StrategyLaromestrocel represents a pipeline in a product opportunity that has delivered positive initial results from multiple clinical trials across several indications. Our stem cell therapy development programs address life-threatening conditions in the most vulnerable populations - children and the elderly: Hypoplastic Left Heart Syndrome; Alzheimer’s disease; Pediatric Dilated Cardiomyopathy and Aging-related Frailty (AF). These four initial indications address market opportunities of what we estimate to be approximately ~$1 billion, ~$5+ billion, 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. HLHS: If the Phase 2b ELPIS II trial in HLHS is successful and the trial results and other available evidence are deemed sufficient by the FDA to support filing a BLA following the readout of the top-line results, then we would intend to pursue a potential BLA filing with the FDA and a commercialization partner. AD: We plan to leverage the strength of our Phase 2 data and clarity on the clinical pathway to a potential BLA for AD to engage with potential funding/commercialization partners. PDCM: We plan to conduct a single Phase 2 registrational clinical trial in accordance with the Investigational New Drug (IND) application which became effective in July 2025. If this trial is successful, we would then seek to partner the program for further development and potential commercialization. AF: Results from our AF Phase 2b clinical, which were published in Cell Stem Cell, further reinforce the strength and credibility of laromestrocel’s clinical data sets and provide an engagement point for discussions with potential strategic partners to further advance this important but underserved development area. Longeveron will participate in the BIO International Convention taking place June 22-25, 2026 at the San Diego Convention Center. Stephen Willard, CEO, Dr. Joshua Hare, Founder, CSO and Executive Chairman, and Than Powell, Business Development, will host meetings with global pharmaceutical company executives to explore potential partnership and strategic opportunities for the Company’s four stem cell development programs. First Quarter Corporate Updates In January, the Company announced that the Japan Patent Office granted a patent covering potency assay methods for assessing human mesenchymal stem cells (MSCs) derived from bone marrow, adipose tissue, peripheral blood, a lung, a heart, amniotic fluid, inner organs, an amniotic membrane, an umbilical cord or a placenta or differentiated from induced pluripotent stem cells (IPSCs). In February 2026, the Company announced that its Board of Directors appointed Stephen H. Willard as Chief Executive Officer. Mr. Willard has a 30+ year track record of leadership across public and private sectors as CEO of multiple biotechnology and pharmaceutical firms, with a history of delivering significant fundraises and strategic collaborations. In February 2026, the Company implemented cash-saving measures to manage cash utilization and extend cash runway. In March 2026, Mr. Richard Kender provided notice of his resignation from the Company’s Board of Directors and Audit Committee, effective immediately, due to his assuming the roles of Executive Chairman and Interim CEO of Seres Therapeutics, Inc. In March 2026, the Company completed a private placement of up to $30 million; $15 million up front with a milestone-driven potential additional $15 million related to the results of the Company’s Phase 2b ELPIS II clinical trial in HLHS and share price. The private placement was led by Coastlands Capital with participation from Janus Henderson Investors, Logos Capital and Kalehua Capital. 2026 First Quarter Summary Financial Results Revenues, Cost of Revenues and Gross Profit: Revenues for the three months ended March 31, 2026 were $0.4 million and consisted of $0.4 million of clinical trial revenues and $20,000 of contract manufacturing revenues. Revenues for the three months ended March 31, 2025 were $0.4 million and consisted of $0.3 million of clinical trial revenues and $0.1 million of contract manufacturing revenues. Clinical trial revenues for the three months ended March 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 client.Related cost of revenues was $0.1 million in each of the three months ended March 31, 2026 and 2025. This resulted in a gross profit of $0.3 million in each of the three months ended March 31, 2026 and 2025. General and Administrative Expenses: General and administrative expenses for the three months ended March 31, 2026 were $2.7 million, compared to $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 relating to 2025 annual cash incentive bonuses, partially offset by higher legal, accounting and consulting fees. Research and Development Expenses: 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 relating to 2025 annual cash incentive bonuses and a $0.2 million non-recurring charge for amortization expense related to patent costs recorded in the 2025 period, partially offset by a year over year increase in personnel and higher clinical spend as we prepare for ELPIS II study results in August. Other Income: Other income was $39,000 and $0.2 million for the three months ended March 31, 2026 and 2025, respectively, and consisted of interest earned on money market funds. The decrease in other income of $0.2 million, or 77%, was due to declining cash balance. Net Loss: Net loss was $4.7 million for the three months ended March 31, 2026, compared to $5.0 million for the three months ended March 31, 2025. The decrease of $0.3 million, or 6%, was due to the factors outlined above. Cash and cash equivalents: As of March 31, 2026, the Company had cash and cash equivalents of $15.8 million. We currently anticipate our existing cash and cash equivalents will enable us to fund our operating expenses and capital expenditure requirements into the fourth quarter of 2026, based on our current operating budget and cash flow forecast. Our operating costs will continue to be substantial for the foreseeable future in connection with our ongoing activities. We intend to seek additional financing opportunities, capital raises, as well as non-dilutive funding options to support our operating plans. An archived replay of the webcast will be available on the “Events & Presentations” section of the Company’s website following the conference. About Longeveron Inc.Longeveron is a clinical stage biotechnology company developing regenerative medicines to address unmet medical needs. The Company’s lead investigational product is laromestrocel (Lomecel-B™), an allogeneic mesenchymal stem cell (MSC) therapy product isolated from the bone marrow of young, healthy adult donors. Laromestrocel has multiple potential mechanisms of action encompassing pro-vascular, pro-regenerative, anti-inflammatory, and tissue repair and healing effects with broad potential applications across a spectrum of disease areas. Longeveron is pursuing four pipeline indications: hypoplastic left heart syndrome (HLHS), Alzheimer’s disease, Pediatric Dilated Cardiomyopathy (DCM) and Aging-related Frailty. Laromestrocel development programs have received five distinct and important FDA designations: for the HLHS program - Orphan Drug designation, Fast Track designation, and Rare Pediatric Disease designation; and, for the AD program - Regenerative Medicine Advanced Therapy (RMAT) designation and Fast Track designation. For more information, visit www.longeveron.com or follow Longeveron on LinkedIn, X, and Instagram. Forward-Looking StatementsCertain statements in this press release that are not historical facts are forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, which reflect management’s current expectations, assumptions, and estimates of future operations, performance and economic conditions, and involve known and unknown risks, uncertainties, and other important factors that could cause actual results, performance, or achievements to differ materially from those anticipated, expressed, or implied by the statements made herein. Forward-looking statements are generally identifiable by the use of forward-looking terminology such as “anticipate,” “believe,” “contemplate,” “continue,” “could,” “estimate,” “expects,” “intend,” “looks to,” “may,” “on condition,” “plan,” “potential,” “predict,” “preliminary,” “project,” “see,” “should,” “target,” “will,” “would,” or the negative thereof or comparable terminology, although not all forward-looking statements contain these words, or by discussion of strategy or goals or other future events, circumstances, or effects. Factors that could cause actual results to differ materially from those expressed or implied in any forward-looking statements in this release include, but are not limited to, the ability of our clinical trials to demonstrate safety and efficacy of our product candidates, and other positive results; our ability to successfully transition toward a more capital-efficient, asset-light operating model; our ability to secure one or more strategic licensing partnerships for our stem cell therapy laromestrocel in our development programs; the ability to reach alignment with the FDA on a potential path toward regulatory approval; receipt of trial results and other available evidence sufficient to support the Company filing a BLA following the readout of top-line results of the ELPIS II data; the timing and focus of our ongoing and future preclinical studies and clinical trials, and the reporting of data from those studies and trials;; market and other conditions, our cash position and need to raise additional capital, the difficulties we may face in obtaining access to capital, and the dilutive impact it may have on our investors; our financial performance, and ability to continue as a going concern; the period over which we estimate our existing cash and cash equivalents will be sufficient to fund our future operating expenses and capital expenditure requirements; the ability of our clinical trials to demonstrate safety and efficacy of our investigational product candidates, and other positive results; the timing and focus of our ongoing and future preclinical studies and clinical trials, and the reporting of data from those studies and trials; the size of the market opportunity for certain of our investigational product candidates, including our estimates of the number of patients who suffer from the diseases we are targeting; our ability to scale production and commercialize the investigational product candidate for certain indications; the success of competing therapies that are or may become available; the beneficial characteristics, safety, efficacy and therapeutic effects of our investigational product candidates; our ability to obtain and maintain regulatory approval of our investigational product candidates in the U.S. and other jurisdictions; our plans relating to the further development of our investigational product candidates, including additional disease states or indications we may pursue; our plans and ability to obtain or protect intellectual property rights, including extensions of existing patent terms where available and our ability to avoid infringing the intellectual property rights of others; the need to hire additional personnel and our ability to attract and retain such personnel; and our estimates regarding expenses, future revenue, capital requirements and needs for additional financing. Further information relating to factors that may impact the Company’s results and forward-looking statements are disclosed in the Company’s filings with the Securities and Exchange Commission, including Longeveron’s Annual Report on Form 10-K for the year ended December 31, 2025, filed with the Securities and Exchange Commission on March 17, 2026, its Quarterly Reports on Form 10-Q, and its Current Reports on Form 8-K. The Company operates in highly competitive and rapidly changing environment; therefore, new factors may arise, and it is not possible for the Company’s management to predict all such factors that may arise nor assess the impact of such factors or the extent to which any individual factor or combination thereof, may cause results to differ materially from those contained in any forward-looking statements. The forward-looking statements contained in this press release are made as of the date of this press release based on information available as of the date of this press release, are inherently uncertain, and the Company disclaims any intention or obligation, other than imposed by law, to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise. Investor and Media Contact:Derek ColeInvestor Relations Advisory [email protected] ---tables follow---  See accompanying notes to financial statements. See accompanying notes to financial statements. A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/cde71c09-a5f1-424d-837b-80f8786d82a5