Longeveron Inc. Common Stock 2026 Q2 Earnings Call

Good afternoon, everyone, and thank you for joining us today to review Longeveron'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 Longeveron website. On the call today are Stephen Willard, Chief Executive Officer, Dr. Joshua Hare, Co-founder, 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 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. Longeveron is approaching a series of potentially transformative milestones across our four stem cell therapy development programs that has the potential to redefine the trajectory of our business. As a reminder, we are developing laromestrocel in four indications with high unmet medical needs, hypoplastic left heart syndrome, Alzheimer's disease, pediatric dilated cardiomyopathy, and age-related frailty. We are focused on our development activities to prioritize our most important near-term catalyst, the data readout from ELPIS II, our phase IIb 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 age-related frailty, were the basis for our selection as a finalist for the XPRIZE Healthspan competition. XPRIZE Healthspan is a 7-year, $101 million global competition to revolutionize the way we approach human aging. We are extremely humbled and appreciate to have our stem cell therapy, laromestrocel, 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 healthspan. The Milestone II 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 one year or less in adults aged 50 to 90 who are free of major or life-threatening disease and disability. The top Milestone II 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 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 has been a very exciting time for laromestrocel, the patients we serve, Longeveron, and our shareholders. With that, I will turn the call over to Dr. Agafonova, our Chief Medical Officer, to touch on our clinical trial development programs.

Natalia? Thank you, Steve. Good afternoon, everyone.

As Steve mentioned, our HLHS program is the primary focus for us, with top-line results from the ELPIS II trial anticipated over the next month. We look forward to sharing those results when they're available. ELPIS II is evaluating laromestrocel 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 chambers of the heart, is either severely underdeveloped or missing. We agreed with the FDA that only the most objective measures, including all-cause mortality, cardiac transplant-free survival, event of cardiac transplantation, and well-defined measure adverse cardiac events could be informative of efficacy of ELPIS II. We have captured 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 2027 of a phase II clinical trial in pediatric dilated cardiomyopathy, or PDCM. This is a rare pediatric cardiovascular disease in which the muscle in one or more of the heart chambers become enlarged or stretched or 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 laromestrocel for potential treatment of pediatric dilated cardiomyopathy became effective in July 2025. This IND allows advancement directly into a single phase II 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. 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 $0.4 million in 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 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 ELPIS II top line results expected in September. Net loss was $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 will hand over the call to Josh Hare, our Co-founder and CSO.