Laromestrocel shows promise in Alzheimer’s trial

MIAMI - Longeveron Inc. (NASDAQ:LGVN), a micro-cap biotech firm with a market capitalization of $21.94 million, has announced results from a Phase 2a clinical trial of laromestrocel (Lomecel-B™) for treating mild Alzheimer’s disease, suggesting improved cognitive function, quality of life, and brain volume in patients. According to InvestingPro data, the company has seen impressive revenue growth of 237% in the last twelve months, though it remains in development stage. The study, published in Nature Medicine, evaluated the safety and efficacy of the cell therapy, which has received U.S. FDA Regenerative Medicine Advanced Therapy (RMAT) designation.

The CLEAR MIND trial involved 48 patients aged 60-85 with mild Alzheimer’s, based on National Institutes of Health – Alzheimer’s Association criteria. Participants received either laromestrocel or a placebo. Results indicated laromestrocel was safe and well-tolerated, with no significant adverse reactions reported.

Patients treated with laromestrocel demonstrated a slower progression of the disease compared to the placebo group. The therapy also showed potential in reducing neuroinflammation and minimizing brain volume loss in areas affected by Alzheimer’s. Statistically significant improvements were noted in the Montreal Cognitive Assessment and Alzheimer’s Disease Cooperative Study Activities of Daily Living scores.

Longeveron’s Chief Medical Officer, Nataliya Agafonova, M.D., expressed optimism about the therapy’s potential, citing the importance of the results for future development paths and upcoming discussions with the FDA.

Laromestrocel is a mesenchymal stem cell therapy derived from the bone marrow of healthy adult donors, believed to have anti-inflammatory and tissue repair properties. Longeveron is pursuing laromestrocel for various conditions, including hypoplastic left heart syndrome and aging-related frailty.

The company’s focus on developing regenerative medicines aims to address medical needs that currently lack effective treatments. The recent findings provide a basis for further clinical evaluation and possible future application in Alzheimer’s disease management. InvestingPro analysis shows the company maintains a strong liquidity position with a current ratio of 7.6 and more cash than debt on its balance sheet, though it’s currently burning through cash with an EBITDA of -$15.56 million. For deeper insights into Longeveron’s financial health and growth prospects, including additional ProTips and comprehensive analysis, check out the detailed Pro Research Report available on InvestingPro.

This report is based on a press release statement from Longeveron Inc.

In other recent news, Longeveron LLC reported a substantial increase in revenue for 2024, reaching $2.4 million, which marks a 237% rise from the previous year. This surge was driven by increased demand for its cellular therapies and new contract manufacturing revenue. The company also managed to reduce its operating expenses by 13%, leading to a decreased net loss of approximately $16 million. These financial results have been met with optimism, as Longeveron’s stock experienced a significant rise in aftermarket trading.

Furthermore, Longeveron is advancing its programs for Alzheimer’s and hypoplastic left heart syndrome (HLHS), with plans to complete enrollment for its HLHS Phase 2b trial by mid-2025. The company aims to submit a Biologics License Application for its Alzheimer’s program in 2026. Analysts from firms like Roth Capital Partners and H.C. Wainwright have shown interest in these developments, asking detailed questions about the company’s clinical trials and regulatory strategies.

Longeveron has also received several FDA designations, including Fast Track and RMAT, which could potentially expedite the approval process for its therapies. While the company has not yet engaged with non-U.S. regulatory authorities for its Alzheimer’s program, it plans to focus on partnerships to further its global reach. The firm’s manufacturing capabilities are also being enhanced to meet future commercial needs, as it prepares for potential regulatory submissions.

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