
Longeveron Inc. (LGVN) Q4 2025 Earnings Call Transcript
Longeveron Inc. (LGVN) Q4 2025 Earnings Call Transcript
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Longeveron Inc. (LGVN) Q4 2025 Earnings Call Transcript

Longeveron reported financial results for the year ended December 31, 2025 and provided a business update. Results from pivotal P2 trial anticipated 3Q26.

Tuesday's move higher precedes an earnings print where analysts are looking for an EPS loss of 38 cents on estimated revenue of $106,200. This revenue target represents a sharp decline from the $603,000 reported in the year ago quarter.

$15 million upfront with a milestone-driven potential additional $15 million related to the Company's anticipated pivotal clinical trial in Hypoplastic Left Heart Syndrome (HLHS) priced at the market under Nasdaq rules Private placement led by Coastlands Capital with participation from Janus Henderson Investors and other healthcare focused funds Initial proceeds extend cash runway into 4Q26, past the anticipated pivotal Phase 2b ELPIS II clinical trial 3Q26 topline data readout MIAMI, March 11, 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 announced the closing of its previously announced private placement for up to approximately $30 million in gross proceeds, priced at-the-market under Nasdaq rules. The net proceeds from the initial tranche of the financing are expected to fund the Company's current operating plans into the fourth quarter of 2026, past the anticipated pivotal Phase 2b ELPIS II clinical trial 3Q26 topline data readout.

The clinical-stage biotech company, which specializes in cellular therapies for rare pediatric and aging-related conditions, secured the funding to advance its lead candidate, laromestrocel.

/PRNewswire/ -- USANewsGroup.com News Commentary - The global cell therapy market is projected to surpass $8.2 billion in 2026, driven by a wave of clinical

Results of Phase 2b clinical trial demonstrating stem cell therapy improved condition of patients with aging frailty published in Cell Stem Cell journal.

Mr. Willard has a 30+ year track record of leadership across public and private sectors as CEO of multiple biotechnology and pharmaceutical firms, with an impressive history of delivering significant fundraises and strategic collaborations Corporate focus on delivering top-line results from the pivotal Phase 2b clinical trial in Hypoplastic Left Heart Syndrome (HLHS), anticipated in the third quarter of 2026 Than Powell stepped down as interim CEO; will remain with the Company to support the leadership transition and continue his work in the Company's on-going business development activities MIAMI, Feb. 13, 2026 (GLOBE NEWSWIRE) -- Longeveron Inc. (NASDAQ: LGVN), a clinical stage regenerative medicine biotechnology company developing cellular therapies for life-threatening, rare pediatric and chronic aging-related conditions, today announced that the Company's Board of Directors has appointed Stephen H. Willard as Chief Executive Officer, effective February 11, 2026.

Longeveron supports the passing of the Mikaela Naylon Give Kids a Chance Act which reauthorizes the Rare Pediatric Disease Priority Review Voucher Program.

The patent relates to 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) Patent issuance contributes to Longeveron's growing international patent portfolio protecting its clinical programs and products Laromestrocel, Longeveron's proprietary mesenchymal stem cell therapy, has delivered positive initial results across five clinical trials in three indications, including Hypoplastic Left Heart Syndrome, Alzheimer's disease and Aging-related Frailty MIAMI, Jan. 29, 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 announced that the Japan Patent Office (JPO) has 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). Japan Patent No.

ELPIS II top-line trial results are anticipated in the third quarter of 2026 Laromestrocel Biological License Application (BLA) submission for full traditional approval for HLHS anticipated if ELPIS II results are positive U. S. FDA has awarded laromestrocel HLHS program Rare Pediatric Disease designation, Orphan Drug designation, and Fast Track designation Laromestrocel HLHS program has the potential to address an unmet medical need with significant U.

Shares of Longeveron Inc. (NASDAQ: LGVN - Get Free Report) fell 4.1% during trading on Tuesday. The stock traded as low as $0.52 and last traded at $0.5482. 171,988 shares changed hands during mid-day trading, a decline of 44% from the average session volume of 305,300 shares. The stock had previously closed at $0.5719. Wall

Longeveron, Selected as a StartUp Health Alzheimer's Disease Moonshot Company, Will Participate in StartUp Health Apollo House During JPM Week 2026.

The patent relates to methods of administering therapeutically effective amounts of isolated allogeneic mesenchymal stem cells (MSCs) to female patients with sexual dysfunction in order to increase sexual quality of life Female sexual dysfunction is an extremely common unmet medical need which can have a major impact on quality of life in otherwise healthy women Longeveron anticipates entering into licensing or partnering agreements for the potential development and commercialization of stem cell therapy for this indication MIAMI, Dec.

The patent relates to methods of administering therapeutically effective amounts of isolated allogeneic mesenchymal stem cells (MSCs) to patients with aging-related frailty with inflammaging and also to treat patients with non-ischemic dilated cardiomyopathy Non-ischemic dilated cardiomyopathy is a progressive disorder with no current cure, often leading to heart transplantation No approved treatments for aging-related frailty, a syndrome affecting older individuals that impairs human Healthspan, and is characterized by weakness, low physical activity, slowed motor performance, exhaustion, and unintentional weight loss Laromestrocel, a mesenchymal stem cell therapy, has delivered positive initial results across two clinical trials in aging-related frailty MIAMI, Dec. 02, 2025 (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 announced that the Canadian Intellectual Property Office (CIPO) has granted a patent covering administration of laromestrocel (LOMECEL-B®), the Company's proprietary mesenchymal stem cells (MSCs), for the treatment of patients with symptoms of aging-related frailty and also for the treatment of non-ischemic dilated cardiomyopathy (NIDCM). Canadian Patent No.

Results obtained in the Phase 2 placebo-controlled CLEAR-MIND clinical trial showed that treatment with stem cell therapy laromestrocel was associated with a reduction in MRI measured neuroinflammation compared to placebo across multiple key brain regions, including key Alzheimer's disease-associated regions, most notably in the hippocampus Reduction in hippocampal neuroinflammation, measured using MRI assessed free water, correlated strongly with preservation of hippocampal volume and with clinical outcomes Findings suggest a sustained anti-inflammatory effect of laromestrocel, reinforcing its proposed mechanism of action in the treatment of mild Alzheimer's disease MIAMI, Dec. 01, 2025 (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 announced that its submission entitled “Reduced brain neuroinflammation after laromestrocel treatment in mild AD: results from the CLEAR MIND study” is being presented in a poster presentation at the 18th Clinical Trials on Alzheimer's Disease Conference (CTAD 2025) being held December 1-4, 2025 in San Diego, CA. “Laromestrocel, a stem cell therapy that has multiple potential mechanisms of action to address inflammatory responses in the brain, offers the potential to address the underlying pathology of Alzheimer's disease,” said Joshua Hare, M.D.

MIAMI, Nov. 19, 2025 (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 announced that its submission entitled “Reduced brain neuroinflammation after laromestrocel treatment in mild AD: results from the CLEAR MIND study” has been selected for a poster presentation at the 18th Clinical Trials on Alzheimer's Disease Conference (CTAD 2025) to be held December 1-4, 2025 in San Diego, CA. “We are excited to have been selected to present important laromestrocel data at this leading forum for Alzheimer's research and clinical investigation,” said Joshua Hare, Co-founder, Chief Science Officer and Executive Chairman of Longeveron.

The patent relates to methods of administering therapeutically effective amounts of isolated allogeneic mesenchymal stem cells (MSCs) to patients with aging-related frailty with inflammaging No approved treatments for aging-related frailty, a syndrome affecting older individuals that impairs human Healthspan, and is characterized by weakness, low physical activity, slowed motor performance, exhaustion, and unintentional weight loss Laromestrocel, a mesenchymal stem cell therapy, has delivered positive initial results across two clinical trials in aging-related frailty MIAMI, Nov. 12, 2025 (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 announced that the United States Patent and Trademark Office (USPTO) has granted a patent covering administration of the Company's proprietary Mesenchymal Stem Cells (MSCs) for the treatment of patients with symptoms of aging-related frailty. U.S. Patent No.

Longeveron Inc. ( LGVN ) Q3 2025 Earnings Call November 4, 2025 4:30 PM EST Company Participants Than Powell - Interim CEO & Director Nataliya Agafonova - Chief Medical Officer Devin Blass - CTO & Senior VP of Chemistry, Manufacturing, and Controls Lisa Locklear - CFO, Executive VP & Treasurer Joshua Hare - Co-Founder, Chief Science Officer & Executive Chairman Conference Call Participants Derek Cole Raghuram Selvaraju - H.C. Wainwright & Co, LLC, Research Division Boobalan Pachaiyappan - ROTH Capital Partners, LLC, Research Division Michael Okunewitch - Maxim Group LLC, Research Division Presentation Operator Greetings, and welcome to the Longeveron 2025 Q3 Financial Results and Business Update Call.

Laromestrocel is a proprietary, scalable, allogeneic cellular therapy being evaluated to improve the clinical outcomes of children with HLHS Full enrollment achieved for pivotal Phase 2b clinical trial (ELPIS II) evaluating laromestrocel as a potential adjunct treatment for HLHS, a rare pediatric disease and orphan-designated indication ELPIS II top-line trial results are anticipated in the third quarter of 2026 MIAMI, Oct. 27, 2025 (GLOBE NEWSWIRE) -- Longeveron Inc. (NASDAQ: LGVN), a clinical stage biotechnology company developing cellular therapies for life-threatening, rare pediatric and chronic aging-related conditions, today announced that Joshua M. Hare, MD, FACC, FAHA, Longeveron's Co-founder, Chief Science Officer and Executive Chairman was interviewed on National Public Radio's (NPR) BioTech Nation with Dr. Moira Gunn.