Longeveron Announces 2025 Full Year Financial Results and Provides Business Update

• On track for third quarter 2026 top-line trial results from anticipated 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 may serve as foundation for a Biologics License Application (BLA) submission for full approval for HLHS, if results demonstrate sufficient evidence of efficacy
• 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, March 17, 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 year ended December 31, 2025 and provided a business update.

“I am excited to have joined Longeveron at a pivotal moment in the Company’s history,” said Stephen H. Willard, Chief Executive Officer of Longeveron. “With a strong foundation in stem cell science and multiple positive clinical trials with our stem cell therapy across several indications, Longeveron is well positioned to be a leader in advancing stem cell treatments for the benefit of patients and their families. We continue to focus on delivering top-line trial results in the third quarter of 2026 for our anticipated pivotal Phase 2b clinical trial evaluating laromestrocel as a potential treatment for HLHS, a rare pediatric congenital heart defect, and we remain on track to do just that. We plan to focus on a robust partnering strategy across our development programs. We believe this strategy can enable us to build on our stem cell scientific acumen, be more efficient in our use of and need for capital, and leverage the greater resources of larger organizations for mutual success. Lastly, I am delighted to welcome what I believe are two of the premier investment funds in the life sciences space, Coastlands Capital and Janus Henderson Investors, as key shareholders. We appreciate their support, investment and shared vision for advancing stem cell science.”

Corporate Strategy Update
Laromestrocel 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 (HLHS), a rare pediatric disease; Alzheimer’s disease (AD); and Pediatric Dilated Cardiomyopathy (PDCM). These three initial indications address market opportunities of what we estimate to be approximately ~$1 billion, ~$5+ billion and up to ~$1 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 pivotal Phase 2b ELPIS II trial in HLHS is successful, we believe the timing would be optimal to seek a potential BLA and 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 pivotal Phase 2 registrational clinical trial in accordance with the PDCM 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.
• Pediatric Priority Review Vouchers (PRVs): The HLHS development program has been granted Rare Pediatric Disease designation by the FDA, which makes it eligible to receive a PRV upon approval of a BLA. Companies can either use the PRV to secure a speedier FDA review of a future therapy or sell it to another company. Since August 2024, vouchers have been sold for $150-205 million each. In the March 2026 private placement, the Company agreed to pursue a sale of a PRV received for HLHS, if granted, and to provide to the investors a 50% interest in the proceeds received (after deducting necessary, documented third-party fees or charges) from the potential future sale of the PRV.

Development Programs
Longeveron’s investigational therapeutic candidate is laromestrocel (Lomecel-B™), 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 trial results for the anticipated pivotal Phase 2b clinical trial (ELPIS II) evaluating laromestrocel as a potential adjunct therapy for HLHS are anticipated in the third quarter of 2026.
• In January, the Company announced that the U.S. Food and Drug Administration (FDA) has granted Longeveron a Type C meeting at the end of March 2026 to gain alignment on the clinical efficacy data endpoints and statistical analysis plan (SAP) to support a potential BLA.
• Laromestrocel BLA submission for full approval for HLHS, if ELPIS II results demonstrate sufficient evidence of efficacy, anticipated in 2027.
• 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, pivotal 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 pivotal registrational clinical trial.
• The Company currently anticipates initiation of the pivotal Phase 2 clinical trial in 2027, with planning and preparation beginning in 2026.

Corporate Updates

• In October, the Company announced that George Paletta, Jr., MD, MBA, was appointed to the Longeveron Board of Directors. Dr. Paletta is a nationally and internationally recognized orthopedic surgeon and the former head team doctor for the St. Louis Cardinals. Dr. Paletta is a developer of ambulatory surgical centers (ASCs), and has participated in the selling of two ASCs with deal values totaling almost $1 billion.
• In November, the Company announced that the United States Patent and Trademark Office (USPTO) granted a patent covering administration of laromestrocel for the treatment of patients with symptoms of Aging-related Frailty.
• In December, the Company announced that the Canadian Intellectual Property Office (CIPO) granted a patent covering administration of laromestrocel for the treatment of patients with symptoms of Aging-related Frailty and also for the treatment of non-ischemic dilated cardiomyopathy (NIDCM).
• In December, the Company announced that the USPTO granted a patent covering administration of laromestrocel for the treatment of female patients with sexual dysfunction and improvement in sexual quality of life.
• In January, the Company announced that the Japan Patent Office (JPO) 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 upfront 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.

2025 Full Year Summary Financial Results

• Revenues: Revenues for the year ended December 31, 2025 were $1.2 million and consisted of $1.0 million of clinical trial revenue and $0.2 million of contract manufacturing revenue. Revenues for the year ended December 31, 2024 were $2.4 million and consisted of $1.4 million of clinical trial revenue, $0.5 million of contract manufacturing lease revenue, and $0.5 million of contract manufacturing revenue. 2025 revenues decreased $1.2 million, or 50%, when compared to 2024, as a result of lower participant demand for our Bahamas Registry Trial and reduced demand for contract manufacturing services from our third-party client.
• Cost of Revenues and Gross Profit: Cost of revenues was $0.4 million and $0.5 million for the years ended December 31, 2025 and 2024, respectively. This resulted in a gross profit of approximately $0.8 million for the year ended December 31, 2025, a decrease of $1.1 million, or 57%, when compared with a gross profit of $1.9 million for 2024.
• General and Administrative Expenses: General and administrative expenses for the year ended December 31, 2025 increased to approximately $12.0 million compared to $10.3 million for the same period in 2024. The increase of approximately $1.8 million, or 17%, was primarily related to an increase in personnel and related costs in 2025 as we increased headcount year over year and accrued severance costs for our former CEO.
• Research and Development Expenses: Research and development expenses for the year ended December 31, 2025 increased to approximately $12.0 million from approximately $8.1 million for the same period in 2024. This increase of $3.9 million, or 48%, was primarily driven by a $2.2 million increase in personnel and related costs, including equity-based compensation, $1.4 million increase in CMC costs associated with technology transfer, including non-clinical manufacturing batches that advance our readiness for future commercial production as part of our BLA-enabling efforts, and a $0.2 million increase in amortization expense related to patent costs.
• Other Income (Expense): Other income for the year ended December 31, 2025 was $0.6 million, consisting of $0.4 million of interest earned on money market funds and $0.3 million of cash received as a recipient of a Milestone 1 Award in the XPRIZE Healthspan competition, partially offset by a $0.1 million loss on the disposal of assets. Other income for the year ended December 31, 2024 was $0.5 million, consisting primarily of interest earned on money market funds and marketable securities.
• Net Loss: Net loss increased to approximately $22.7 million for the year ended December 31, 2025 from a net loss of $16.0 million for the same period in 2024. The increase in the net loss of $6.7 million, or 41%, was for reasons outlined above.
• Cash and cash equivalents as of December 31, 2025, the Company had cash and cash equivalents of $4.7 million and working capital of approximately $1.4 million. With the completion of the recent private placement that raised approximately $15 million in initial gross proceeds, 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 Statements
Certain 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 future restoration of executive compensation levels; our intention and ability to repay certain compensation amounts to executives or rehire employees currently furloughed; the grant of certain equity awards; 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 Cole
Investor Relations Advisory Solutions
[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