Longeveron Appoints Stephen Willard as CEO Ahead of Pivotal HLHS Trial Results

Longeveron Inc. (NASDAQ: LGVN) appointed Stephen H. Willard as Chief Executive Officer effective February 11, 2026, replacing interim CEO Than Powell. The appointment comes as Longeveron approaches a critical milestone with top-line results from its pivotal Phase 2b clinical trial evaluating laromestrocel for Hypoplastic Left Heart Syndrome (HLHS) expected in the third quarter of 2026.

On February 9, 2026, Longeveron Inc. announced the immediate resignation of Than Powell as Interim CEO, with Stephen H. Willard appointed as the permanent CEO, effective February 11, 2026. Powell will remain with the company to support the leadership transition and continue business development activities.

The FDA has indicated this trial could support a Biologics License Application if successful. Longeveron has previously received FDA guidance that, if successful, this trial would be deemed a pivotal trial for purposes of BLA filing. The company is preparing for a pivotal data readout from its ELPIS II trial, with a Type C meeting scheduled with the U.S. Food and Drug Administration to align on clinical efficacy endpoints. This meeting is a step toward potentially filing a Biologics License Application for its therapy aimed at Hypoplastic Left Heart Syndrome.

The Executive Chairman and Chief Science Officer stated, "I am delighted to welcome Stephen as CEO, particularly at this exciting time in Longeveron's history developing stem cell therapies addressing life threatening conditions in the most vulnerable populations - children and the elderly."

The new CEO commented, "This is an extraordinary time for Longeveron and our stem cell therapy laromestrocel. It is an exciting opportunity to be able to join a company with three development programs at the stage of pivotal clinical trials. I look forward to working with the Longeveron team to ensure the long-term success of laromestrocel while focusing on extending our capital runway, and working with potential partners to leverage our stem cell technology for the benefit of patients and shareholders."

Willard brings over 30 years of leadership experience in biotechnology and pharmaceutical companies. His previous roles include CEO positions at ICAPATH, Inc., NRx Pharmaceuticals, Inc., Cellphire, Inc., and Flamel Technologies, S.A., where he also served as CFO before becoming CEO. He formerly served as the Chairman of the Board of Directors of Flamel and formerly served on the Board of Directors of E*Trade Financial Corporation. Willard received a Bachelor of Arts degree from Williams College and a Juris Doctorate from Yale Law School.

Willard's compensation includes 200,000 shares, 200,000 restricted stock units, and a stock option for 200,000 shares, vesting quarterly over four years.

The Chair of the Board's Nominating and Corporate Governance Committee commented, "On behalf of the Board and management team, I want to thank Than for his significant contributions over the past six months, stepping in to provide effective leadership and stability through this transition. We would also like to welcome Steven to his new role. We believe his extensive strategic operations and executive leadership experience will help drive Longeveron's future success."

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 developing laromestrocel for three primary indications: Hypoplastic Left Heart Syndrome (HLHS), Alzheimer's disease (AD), and Pediatric Dilated Cardiomyopathy (DCM). Laromestrocel development programs have received five distinct 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.

In other recent developments, Longeveron Inc. announced that the Japan Patent Office has granted a patent for its potency assay methods used in assessing human mesenchymal stem cells (MSCs). This patent extends through April 2041 and applies to MSCs from various sources, including bone marrow and adipose tissue. Additionally, the United States Patent and Trademark Office has awarded Longeveron a patent for using its MSCs in treating female sexual dysfunction, which is valid through 2038. In Canada, Longeveron received a patent for its stem cell therapy, laromestrocel, targeting aging-related frailty and non-ischemic dilated cardiomyopathy, with rights secured until 2037.

Longeveron executives are also set to participate in panel discussions at the Global CardioVascular Clinical Trialists Forum in Washington, D.C., later this year. The company's focus remains on advancing its clinical programs while extending its capital runway. The micro-cap biotech is currently trading at $0.54 with a market capitalization of $11.73 million. The company reports earnings on February 27.