Longeveron's Alzheimer's Therapy Tapped for Key Gates-Backed Initiative

MIAMI, FL – December 29, 2025 – Longeveron Inc., a clinical-stage biotechnology company, has received a significant nod of approval for its novel Alzheimer's disease therapy, securing a coveted spot in StartUp Health's Alzheimer’s Disease Moonshot program. The company announced it will participate in the exclusive StartUp Health Apollo House networking summit during the influential JPM Healthcare Week in January 2026, an event that could prove pivotal for its future.

This selection places Longeveron (NASDAQ: LGVN) within a mission-driven community focused on accelerating breakthroughs for neurodegenerative diseases, supported by high-profile champions including the Alzheimer’s Drug Discovery Foundation (ADDF) and Gates Ventures. For a clinical-stage company navigating the notoriously challenging biotech landscape, this invitation is more than a simple acknowledgment; it's a strategic gateway to the capital and partnerships essential for bringing a new therapy to market.

The Strategic Imperative at JPM Week

The timing of this opportunity is critical. JPM Healthcare Week is the biopharma industry's premier annual event, where billions of dollars in deals are forged and the sector's trajectory for the year is set. The StartUp Health Apollo House functions as an elite nexus within this ecosystem, connecting promising founders with the funders and industry leaders who can turn scientific potential into clinical reality.

For Longeveron, the stakes are particularly high. According to its recent financial disclosures, the company's current cash and equivalents are projected to fund operations only into the first quarter of 2026. The initiation of its planned pivotal Phase 2/3 clinical trial for Alzheimer's disease is expressly contingent upon securing substantial non-dilutive funding or a strategic partnership. The meetings scheduled during JPM Week are therefore not a victory lap but a crucial fundraising mission to secure the company's future and advance its most promising program.

The backing from StartUp Health's Moonshot initiative provides powerful validation. In a field crowded with potential treatments, such an endorsement can significantly de-risk the proposition for investors, signaling that Longeveron's approach has been vetted and deemed worthy of attention by influential players dedicated to solving one of modern medicine's most intractable problems.

A New Cellular Front in the War on Alzheimer's

What sets Longeveron apart in the fiercely competitive Alzheimer's space is its unique therapeutic candidate, laromestrocel (LOMECEL-B®). Unlike the wave of recently approved anti-amyloid monoclonal antibodies that target protein plaques in the brain, laromestrocel is an allogeneic mesenchymal stem cell (MSC) therapy. This 'off-the-shelf' treatment, derived from the bone marrow of young, healthy adult donors, is designed to work through multiple mechanisms, primarily by reducing neuroinflammation and promoting the body's own regenerative processes.

This approach has already yielded impressive clinical data. The Phase 2a CLEAR MIND trial, the results of which were published in Nature Medicine in March 2025, met its primary safety endpoint, showing the therapy was well-tolerated. Critically, no cases of amyloid-related imaging abnormalities (ARIA), a concerning side effect associated with some anti-amyloid drugs, were reported.

On the efficacy front, the trial demonstrated a clear slowing of disease progression in patients with mild Alzheimer's. The data revealed statistically significant improvements in the Alzheimer's Disease Cooperative Study Activities of Daily Living (ADCS-ADL) scale, indicating a meaningful impact on patients' ability to perform daily tasks. Furthermore, MRI scans showed that patients treated with laromestrocel experienced significantly less brain volume loss in key areas like the hippocampus compared to the placebo group. This sustained anti-inflammatory and neuroprotective effect provides a strong scientific rationale for its potential as a disease-modifying therapy.

The U.S. Food and Drug Administration (FDA) has taken notice, granting laromestrocel both Regenerative Medicine Advanced Therapy (RMAT) and Fast Track designations in July 2024. These designations are reserved for promising therapies addressing serious, unmet medical needs and are designed to expedite development and review, potentially providing a quicker path to patients.

Beyond a Single Disease: A Regenerative Medicine Platform

While the Alzheimer's program is capturing headlines, Longeveron's strategic value extends further. The laromestrocel platform is not a one-trick pony but a versatile technology being applied to a range of life-threatening conditions, positioning the company as a broader player in the field of regenerative medicine.

The company's pipeline includes two other critical development programs. One targets hypoplastic left heart syndrome (HLHS), a rare and severe congenital heart defect in infants for which Longeveron has received Orphan Drug, Fast Track, and Rare Pediatric Disease designations from the FDA. Another program is focused on Pediatric Dilated Cardiomyopathy (DCM), another serious heart condition in children.

This diversified pipeline demonstrates the broad potential of the company's core MSC technology to address diseases characterized by inflammation and tissue damage. For investors, this platform approach can be appealing, as it offers multiple 'shots on goal' and mitigates the risk associated with relying on a single, albeit large, indication like Alzheimer's disease. The ability of the same core product to address disparate and underserved patient populations underscores the potential for a wide-ranging impact.

As Longeveron's leadership prepares for the high-stakes meetings at JPM Healthcare Week, they will be armed with a compelling story that combines promising clinical data in Alzheimer's, strong regulatory validation from the FDA, and the long-term vision of a multi-faceted regenerative medicine platform. The coming weeks will be crucial in determining if this narrative can attract the financial fuel needed to propel its innovative science from the laboratory to the clinic for patients in desperate need of new hope.