July 29, 2024 - $Longeveron (LGVN.US)$shares surged 40.12% to $4.82 in pre-market trading on Monday. The company has reported positive findings from its Phase 2a CLEAR MIND clinical trial at the Alzheimer’s Association International Conference in Philadelphia.

Longeveron's product, Lomecel-B™️, is a cell therapy aimed at treating Alzheimer's Disease by reducing brain inflammation and slowing the disease's progression. The trial, which involved 48 older adults with mild Alzheimer's, met its primary safety goals and showed promising efficacy in slowing cognitive and functional decline. Lomecel-B™️ was well-tolerated with no serious side effects and was also associated with a reduction in brain volume loss and improvements in daily living activities and quality of life for patients, as observed by their caregivers. These results suggest Lomecel-B™️ may be a valuable future treatment for Alzheimer's Disease.

“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.”

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.

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 Lomecel-B™️, an allogeneic medicinal signaling cell (MSC) therapy product isolated from the bone marrow of young, healthy adult donors. Lomecel-B™️ 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, and Aging-related Frailty. Lomecel-BTM development programs have received five separate and distinct FDA designations: for the HLHS program - Orphan Drug designation, Fast Track designation, and Rare Pediatric Disease designation; and, for the Alzheimer’s Disease program - Regenerative Medicine Advanced Therapy (RMAT) designation and Fast Track designation.