Longeveron Inc. (LGVN) Q2 2026 Earnings Report, Transcript and Summary

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.

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?

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, 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?

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?

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.

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.

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.

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.

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.

And our next question, we will hear from Boobalan Pachaiyappan with ROTH Capital Partners.

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?

I can tell you well, actually, Nataliya, would you answer that question?

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.

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.

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.

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.

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.

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.

Alright. Congratulations again.

Thank you. Thank you.

And our next question, we will hear from Michael Okunewitch with Max Maxim Group.

Hi guys. Thank you so much for taking my questions. Thank you, Michael.

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?

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.

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.

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.

Thank you.

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?

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.

Alright. Thank you. I really appreciate your additional clarity. Congrats on all the progress.

Thank you for getting involved.

There are no further questions at this time. I would like to turn the floor back to Stephen Willard for closing remarks.

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.

Thank you. This does conclude today's teleconference. We thank you for your participation. You may disconnect your lines at this time.