– Featured Research Session oral presentation highlights findings that show Lomecel-B improved cognitive function, quality of life, and brain volume in the treatment of mild Alzheimer's Disease –

– Study meets its key objectives to advance data supporting favorable benefit/risk profile, support target engagement, and provide additional support for the efficacy profile of Lomecel-B –

– Therapeutic potential demonstrated in MRI biomarker results showing 49% reduction in brain volume loss and improvement in inflammation featured in poster presentation –

MIAMI, July  28, 2024  (GLOBE NEWSWIRE) -- Longeveron Inc. (NASDAQ: LGVN), a clinical stage regenerative medicine biotechnology company developing cellular therapies for life-threatening and chronic aging-related conditions, announced that its positive Phase 2a clinical trial data and biomarker results were featured in two presentations, including a Featured Research Session oral presentation, at the Alzheimer's Association International Conference (AAIC), taking place July 28 – August 1, 2024, in Philadelphia and online.

"As a medicinal signaling cell therapy that has multiple potential mechanisms of action to address inflammatory responses in the brain, Lomecel-B offers potential to address the underlying pathology of Alzheimer's Disease without the limitations of previous therapies," said Wa'el Hashad, Chief Executive Officer at Longeveron. "We are very encouraged by the safety profile and efficacy evidence that support the differentiated therapeutic potential of Lomecel-B and lay the foundation for its future clinical development. We're pleased to connect with the Alzheimer's community at AAIC 2024 and contribute to the growing body of evidence that fuels the continued development of novel therapeutics for this devastating disease."

The randomized, placebo-controlled Phase 2a CLEAR MIND trial evaluated a total of 48 patients (36 were treated with Lomecel-B and 12 received placebo) who were 60-85 years old and had a diagnosis of mild Alzheimer's Disease in accordance with National Institutes of Health – Alzheimer's Association (NIA-AA) criteria, a Mini-Mental State Examination (MMSE) score of 18-24, and a brain MRI and positron emission tomography (PET) scan consistent with Alzheimer's Disease. The clinical trial achieved its primary safety and secondary efficacy endpoints, and the study results presented at AAIC 2024 support the therapeutic potential of Lomecel-B. Key findings include:

• The established safety profile of Lomecel-B for single and multiple dosing regimens was demonstrated in study data that showed no incidence of hypersensitivity, infusion-related reactions, and no cases of amyloid-related imaging abnormalities (ARIA).

• Patients treated with Lomecel-B showed an overall slowing of disease worsening compared to placebo.

• Positive efficacy results were demonstrated via a change from baseline at week 39 of the trial at prespecified levels using the Composite Alzheimer's Disease Score (CADS) – a secondary outcome measure that combines information across cognitive, functional capacity, and brain MRI domains.

• Administration of Lomecel-B was associated with slowing cognitive and functional decline as demonstrated by statistically significant results in the Montreal Cognitive Assessment and statistical trending improvements compared to placebo in CDR-SB and MMSE.

• There was a statistically significant improvement relative to placebo observed in the Alzheimer's Disease Cooperative Study Activities of Daily Living (ADCS-ADL).

• Lomecel-B minimized the loss in brain volume in areas associated with Alzheimer's Disease (TBV, Hippocampus, Ventricles, Thalamus), statistically significant for left hippocampal volume relative to placebo. Along with positive changes in brain volumes, there was 20-30% reduction in left and right ventricular enlargement, respectively.

• Diffusion tensor imaging MRI supports the concept that Lomecel-B has the potential to reduce neuroinflammation compared to placebo.

• Lomecel-B treated patients demonstrated a numerical improvement relative to placebo in quality of life observed by caregivers and measured by the Alzheimer's Disease Related Quality of Life (ADRQOL) and Quality of life AD (QOL-AD) scales.

"In recent years, we've seen an enhanced industry focus on bringing novel Alzheimer's Disease therapeutics to market to treat the millions of people who suffer each year," said Nataliya Agafonova, M.D., Chief Medical Officer at Longeveron. "The emergence of new Alzheimer's Disease therapies has demonstrated that we are increasingly capable of treating a condition once deemed untreatable, and the next step in this endeavor is to develop a therapeutic that is both safe and effective in treating this disease. The results from the Phase 2a CLEAR MIND trial are highly encouraging and demonstrate the potential of Lomecel-B to fulfill this need, and I look forward to its continued development."

"We believe these results provide important validation of both the safety and therapeutic potential of Lomecel-B in the treatment of mild Alzheimer's Disease and suggest, with further clinical evaluation, that this cellular therapy has the potential to have a positive impact on patients afflicted with this devastating disease," said Joshua Hare, M.D., Co-founder, Chief Science Officer, and Chairman at Longeveron. "We look forward to meeting the FDA to review this data and discuss the future development path for Lomecel-B in Alzheimer's Disease."

The FDA has granted Lomecel-B 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 Lomecel-BTM's development for Alzheimer's Disease.

About Lomecel-B
Lomecel-B is a living cell product made from specialized cells isolated from the bone marrow of young healthy adult donors. These specialized cells, known as medicinal signaling cells (MSCs), are essential to our endogenous biological repair mechanism. MSCs have been shown to perform a number of complex functions in the body, including the formation of new tissue. They also have been shown to respond to sites of injury or disease and secrete bioactive factors that are immunomodulatory and regenerative. We believe that Lomecel-B may have multiple potential mechanisms of action that may lead to anti-inflammatory, pro-vascular regenerative responses, and therefore may have broad application for a range of rare and aging related diseases.