/Longeveron Announces Presentation of Clinical Data at the 2026 Alzheimer’s Association International Conference (AAIC) that Indicate Its Cellular Therapy Laromestrocel Reduced Neuroinflammation in Patients with Alzheimer’s Disease
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Longeveron Announces Presentation of Clinical Data at the 2026 Alzheimer’s Association International Conference (AAIC) that Indicate Its Cellular Therapy Laromestrocel Reduced Neuroinflammation in Patients with Alzheimer’s Disease

GlobeNewswire
2026/07/13Calendar of Events

Longeveron Announces Presentation of Clinical Data at the 2026 Alzheimer’s Association International Conference (AAIC) that Indicate Its Cellular Therapy Laromestrocel Reduced Neuroinflammation in Patients with Alzheimer’s Disease

  • Poster Presentation at the 2026 Alzheimer’s Association International Conference (AAIC) entitled “Laromestrocel Stabilizes Brain Inflammation In Key Alzheimer’s Disease Gray And White Matter Regions As Assessed Using Free Water MRI” presented at July 13th In Person Poster Presentation Session
  • Results support a clinically relevant and long-lasting anti-inflammatory mechanism of action of laromestrocel in gray and white matter of the brain, indicate potential blood biomarker correlates with clinical outcomes, and support continued clinical development of laromestrocel for Alzheimer’s disease
  • Longeveron has received U.S. FDA RMAT designation for its Alzheimer’s disease program and has aligned on a Phase 3 study design

MIAMI, July 13, 2026 — 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 additional analysis of data from the Phase 2a clinical trial evaluating its stem cell therapy laromestrocel in mild Alzheimer’s disease (AD) is being presented in a Poster Presentation at the 2026 Alzheimer’s Association International Conference® (AAIC®), being held July 12-15, 2026 in London, United Kingdom and online.

Results presented in “Laromestrocel Stabilizes Brain Inflammation In Key Alzheimer’s Disease Gray And White Matter Regions As Assessed Using Free Water MRI” provide support for a clinically relevant and durable anti-inflammatory mechanism of action of laromestrocel in gray and white matter and indicate potential blood biomarker correlates. Importantly, the reduction on free water detected by MRI correlates with both improved clinical outcomes and the anti-atrophic responses in the brain.

A key contributor to AD brain atrophy and clinical pathology is progressive neuroinflammation, and no therapeutic to date has been successful in mitigating the destructive inflammation of AD. Brain inflammation can be indexed using free water MRI. Longeveron previously found that free water rose substantially during AD pathogenesis in the brains of individuals in the placebo group, particularly in the hippocampus, temporal lobe, and other key AD regions, but subjects treated with laromestrocel showed no increase. Together with previously published data, these results showed that laromestrocel, a human bone marrow-derived, mesenchymal stem cell therapy with anti-inflammatory and pro-vascular effects, substantially reduced brain atrophy and lowered free water in a proof of concept, randomized Phase 2a trial (CLEAR-MIND).

In this new post-hoc exploratory analysis of CLEAR-MIND results, the anti-inflammatory effect was observed to be most prominent in the hippocampus, temporal lobe, and other AD-associated areas and correlated (Spearman) with both increased brain volume and improved cognitive and quality of life scores.

Laromestrocel infusion groups were: 1) placebo, 2) 25 million cells, single dose (25Mx1), 3) 25M cells over 4 monthly doses (25Mx4) or 4) 100M cells over 4 monthly doses (100Mx4), vs placebo. Data were statistically modeled using Mixed Model Repeated Measures (MMRM). In the placebo population (N=10), free water rose over 39 weeks in key white matter regions: the fornix, sagittal stratum, uncinate fasciculus. However, free water was numerically reduced compared with placebo in all groups receiving laromestrocel (fornix at week 26: 25Mx4, N=11, p=0.058; sagittal stratum at week 39: pooled 25Mx4 and 100Mx4 treatment groups, N=21, p=0.063; uncinate fasciculus (left) at week 39: 100Mx4, N=10, p=0.064). This reduction trend in free water correlated (Spearman) with Longeveron’s recent findings showing significantly reduced free water compared with placebo at 39 weeks in key gray matter regions: hippocampus, the temporal, parietal, and occipital lobes, and medulla, and with improvements in clinical scores.

Blood plasma samples from the trial were assessed using NuLISA. Plasma NuLISA indicated a reduction compared with placebo (N=11) at 39 weeks in neurogranin, a marker of neuronal degradation (25Mx4, N=12, p=0.023), and an increase in IL-13, an anti-inflammatory cytokine that regulates brain microglia activation (25Mx1, N=12, p=0.043).

“We believe these results provide important validation of the therapeutic potential of laromestrocel in the treatment of mild Alzheimer’s disease,” said Joshua Hare, M.D., Co-founder, Chief Science Officer, and Executive Chairman at Longeveron. “We look forward to continuing partnering discussions to advance this potentially important new option for addressing Alzheimer’s disease.”

Results from the CLEAR MIND Phase 2a clinical trial, 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.

The U.S. Food and Drug Administration (FDA) has granted laromestrocel both Regenerative Medicine Advanced Therapy (RMAT) designation and Fast Track designation for the treatment of mild Alzheimer’s disease, which allow greater access to the FDA during laromestrocel’s development for Alzheimer’s disease.

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.

Investor and Media Contact

Derek Cole Investor Relations Advisory Solutions [email protected]

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/f106bde7-972a-4687-a91e-03e924f409fc

Summary

Longeveron reports new data analysis for its stem cell therapy laromestrocel in mild Alzheimer's disease at AAIC 2026.