Longeveron Inc. (LGVN) Earnings Call Transcript

Thank you. to the Longuevaran 2026 Second Quarter Financial Results Conference call. If you would like to ask a question today, please press star 1 on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star 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. 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, Richelle. Good afternoon, everyone, and thank you for joining us today to review Longeviron's 2026 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 Longeviron website. On the call today are Steven Willard, Chief Executive Officer, Dr. Joshua Hare, Co-Founder, Chief Science Officer, and Executive Chairman of the Board, Dr. Natalia Agafenova, Chief Medical Officer, Devin Blass, Chief Technology Officer, and Marie Washburn, Chief Financial Officer. As a reminder, during this call we will 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 Steven Willard, Chief Executive Officer.

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 four stem cell therapy development programs that have the potential to redefine the trajectory of our business. As a reminder, we are developing laramester cell in poor indications with high unmet medical needs. Hypoplastic left heart syndrome, Alzheimer's disease, pediatric dilated cardiomyopathy, and age-related frailty. We have focused on our development activities to prioritize our most important near-term catalyst, the data readout from ELPAS-2, our Phase 2b clinical trial evaluating laramester cell 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 laramester cell increases six-minute walk distance in patients with age-related frailty were the basis for our selection as a finalist for the XPRIZE HealthSpan competition. XPRIZE HealthSpan is a seven-year, $101 million global competition to revolutionize the way we approach human aging. We are extremely humbled to appreciate and appreciate to have our stem cell therapy laramester cell recognized in this manner. We believe that we are the 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 healthspan. The Milestone II awardees, out of more than 600 applicants across 58 countries, were selected to receive the 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 a patient at least years with the ambitious goal of 20 years and deliver their therapy in one year or less in adults age 50 to 90 who are free of major or life-threatening disease and disability. The top milestone two award-winning teams each receive $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 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 ELPAS-2 data provide Longeviron with ideal timing to explore potential development and commercialization partnerships. 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. And it's been a very exciting time for Laramestra Cell, the patients we serve, Longeviron, 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.

Thank you, Steve. Good afternoon, everyone. As Steve mentioned, our HLHS program is the primary focus for us. The top line results from the LPS2 trial anticipated over the next month. We look forward to sharing those results when they're available. LPS2 is evaluating laromere stress cell as a potential adjunct treatment for hypoplastic left heart syndrome, or HLHS. HLHS is a rare pediatric congenital heart birth defect in which the left ventricle, one of the pumping chamber of the heart is either severely underdeveloped or missing. We agree with the FDA 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 be informative of efficacy of LPS2. We have captured all of these measures in LPS2, along with some additional key measures to support an efficacy determination. We are also continued with planning and preparation this year for a potential initiation in 2027 of a phase two clinical trial in pediatric dilated cardiomyopathy or PDCM. This is a rare pediatric cardiovascular disease in one or more of the heart chambers become enlarged or stretched or dilated. With nearly 40% of children that PDCM require a heart transplant or dying within two years of diagnosis. Our investigational new drug IND application for laramysterocell for potential treatment of pediatric dilated cardiomyopathy became effective in July 2025. This IND allows advancement directly into a single phase two registration or clinical trial, reflecting the serious nature of this rare pediatric disease and the significant at-med medical need. I will hand the call over to Marie Wasburn, our Chief Financial Officer. Marie?.

Thank you, Natalia, 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 three-month period ended June 30th, 2026. and June 30th, 2025 were 0.3 million. 2026 revenues decreased by 29,000 or 10% when compared to 2025, primarily due to the absence of contract manufacturing revenue. General and administrative expenses for the three months ended June 30th, 2026 were 3.2 million compared to 2.6 million for the same period in 2025. The increase of 0.6 million or 23% were primarily due to 0.6 million. $0.4 million increase in legal spend, and $0.2 million increase in personnel costs. Research and development expenses were $3.2 million for the three months ended, $12 million 2026 compared to 3 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 Elvis two top line results expected in September. That loss was significant. 6.1 million for the three months ended June 30th, 2026, compared to 5 million for the three months ended 2025. The increase of 1.1 million, or 22%, was due to the factors outlined above. Our cash and cash equivalents as of June 30th, 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 2026 based on our current operating budget. I'll hand over the call to Josh Hare, a co-founder in CSO.

Josh? Thank you, Marie. Good afternoon, everyone. As we rapidly approach the availability of top-line data from the ELPAS-2 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, laromestrocell, and support its potential application across multiple high-value indications. First, strong foundational science. Blaromestrocell has multiple potential mechanisms of action that include anti-inflammatory, provascular, and pro-regenerative effects. Okay. Lara Mestercel is supported by a portfolio of 52 issued patents with over 60 pending patents worldwide. We have five FDA expedited designations, including regenerative medicine advanced therapy, or RMAT, fast-track, orphan drug, and rare pediatric disease. Longeviron has completed and has encouraging initial results warranting further investigation across five clinical trials and three 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 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. Continue to make progress across our entire development pipeline and look forward to sharing the results of ELPAS II shortly. I'll 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 Longevron. 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 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 star 1 on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star 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 one moment while we pull for questions And our first question we'll hear from Ram Salivaro 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. I wanted to see if you could elaborate on the The updated outlook for laramestrocell in HLHS specifically as this pertains to the following three 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 LaramestroCell upon potential approval in HLHS. And lastly, any updated thoughts or feedback with respect to potential pricing discussions or the the relative value proposition that you anticipate lara master cell would be associated with from the payer standpoint and then just a very quick question on the age-related frailty aspect in the event that Lara Mesterfeld ultimately received the top prize, uh, in the XPRIZE competition. How would this affect the company's strategic planning for future development of the drug in the age-related frailty indication? Thank you.

Wow, that's 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've already had conversations with major potential partners. and we think they are expert at pricing and timetable and that sort of thing. We don't see any blockers if we get good HLHS data to going to a BLA. with, I would remind you, a priority review voucher, which just recently sold for $215 million. There's also a potential priority review voucher with regard to our PDCM, which will be starting next year. I've discussed the timetable, the manufacturing, the pricing discussions, and then with regard to this XPRIZE, I think it's extraordinary to have a company. 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 X Prize and the $81 million. And I think it's 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 one that people can invest in, in terms of the cutting edge of longevity research today.

Did I hit your questions, Ram? Ram Bantam- Yes, thank you very much.

And our next question we'll hear from Bubalon, Pachayam and Pitpal with Roth Capital Partners.

Hi, good afternoon, everyone. Thanks for taking our questions. So we have three or four, maybe. I 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'm compelled to ask a few questions based on this topic, and some of them we might have discussed in the past. 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 protocol prior to database unblinding? And also a sub question again on the SAP is the lack SAP alignment with the FDA, the reason for pushing the deadline from August to September.

I can tell you, actually, Natalia, would you answer that question? Natalia Ramos- Yes, absolutely. Thank you, Bobolan, for your questions. Just to clarify that we have already substantive discussions with the FDA in alignment regarding the endpoint strategy, which include both NIH-defined and and we have incorporated all the agency feedback into our statistical plan, statistical approach. So we subsequently submitted the sub to FDA for review and we're still waiting for their feedback. If we don't receive additional comments, before database lock. We currently intend to proceed with the planned database lock, conduct analysis, prespaces, the finalized sub. So I don't think there's anything unresolved. We so far resolved all the FDA agencies questions, incorporated them to statistical analysis plan and of course, if we get them prior to database lock, we're happy to, you know, just to clarify some and incorporate their details about this up. And second question you asking about August versus September is not going to affect anything, so we were wondering waiting for the last patient last year. There were a few delays in MRI month 12, and last patient, last thesis, that was the reason why we slightly delay our database, but so far it's planned on August 31st with the top line results data available in September.

All right. So, moving on. Let's say your former primary endpoint, which is RVEF, let's say the RVEF was not met in your LPS2, but you're seeing improvement in, let's say, the length of hospitalization, the transplant-free survival. and adverse events? And let's say you're hitting statistical significance in all of this. 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? Well, that's a lot to... And there are... Sorry.