Longeveron Results of Phase 2b Clinical Trial Demonstrating Stem Cell Therapy Improved Condition of Patients with Age-Related Frailty Published in Cell Stem Cell

MIAMI, Feb. 25, 2026 (GLOBE NEWSWIRE) -- Longeveron Inc. (NASDAQ: LGVN), a clinical stage biotechnology company developing regenerative cell therapy for life-threatening rare pediatric and chronic aging-related conditions, today announced that results of its Phase 2b clinical trial were published today in Cell Stem Cell, a Cell Press Journal. The Phase 2b results demonstrated that intravenous laromestrocel, a mesenchymal stem cell product, improved the physical condition of patients with age-related clinical frailty after nine months, compared to placebo. The full publication is available on the Cell Stem Cell website.

Laromestrocel (LOMECEL-B

) is a proprietary, scalable, allogeneic stem cell (MSC) investigational therapy that is currently being evaluated in multiple indications.

“We are highly encouraged by these Phase 2b results that demonstrate the potential of stem cell therapy to improve the condition of patients with aging-related frailty,” said Joshua M. Hare, MD, FACC, FAHA, Chief Science Officer at Longeveron. “Those with Aging Frailty are disproportionately compromised in their ability to cope with every day and acute stressors, are at high vulnerability to disease and injury, and are at increased risk for poor outcomes and death after surgery. This development area is at the core of Longeveron’s mission – advancing stem cell therapies addressing life threatening conditions in the most vulnerable populations - children and the elderly.”

The Phase 2b, randomized, dose-finding clinical trial evaluated whether laromestrocel, human bone marrow-derived allogeneic MSCs, improves physical functioning and patient self-reported outcomes in 148 ambulatory individuals with frailty (NCT03169231). Laromestorcel infusions resulted in:

• Clinically meaningful, dose-and time-dependent increases in the primary endpoint of the 6-minute walk test (6MWT) compared with placebo: 63.4m (95% confidence interval [CI]: 17.1-109.6m; p=0.0077) at month 9 and 41.3m (95% CI: -2.4-84.9m; p=0.0635) at month 6
• Increased 6MWT distance correlates with PROMIS Physical Function score
• Increasing doses of laromestrocel are associated with decreases in soluble (degraded) tyrosine kinase with immunoglobulin and epidermal growth factor homology domains (TIE-2), the cognate receptor for the angiopoietins, identifying a potential biomarker for laromestrocel responsiveness
  

These findings identify a possible stem cell therapy approach for the management of patients with hypomobility and other features of aging frailty.

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 currently pursuing three pipeline indications: hypoplastic left heart syndrome (HLHS), Alzheimer’s disease (AD), and Pediatric Dilated Cardiomyopathy (DCM). 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.

Investor and Media Contact:
Derek Cole
Investor Relations Advisory Solutions