Longeveron Inc Stock Price, News & Analysis

Longeveron Inc. (NASDAQ: LGVN) announced the publication of its Phase 2b clinical trial design for Lomecel-B, aimed at addressing aging frailty in older adults, in the Journal of Frailty and Aging. This condition affects up to 15% of Americans over 65, marking a significant medical need. The publication reflects the urgency in developing therapies for frailty, a condition linked to poor outcomes in older adults. The trial focused on the safety and efficacy of Lomecel-B, developed from medicinal signaling cells, with aims to advance into pivotal Phase 3 trials.

Longeveron Inc. (LGVN) announced the initiation of its Phase 2a clinical trial for Lomecel-B, targeting Alzheimer’s disease. The trial aims to expand upon promising Phase 1 data by evaluating safety and efficacy through MRI measures and assessing inflammatory systems. The double-blind study involves 48 patients across 6 centers, emphasizing cognitive function and biomarkers. CEO Geoff Green termed this trial a significant milestone.

The previous Phase 1 study met key safety endpoints, showing favorable biomarker levels without Alzheimer’s imaging abnormalities.

Longeveron Inc. (NASDAQ: LGVN) announced that CEO Geoff Green will present and join a panel discussion at the H.C. Wainwright & Co. BioConnect 2022 Virtual Conference. The presentation will be available on-demand starting January 10, 2022, at 7:00 a.m. ET, with a panel titled “The Emerging Cell & Gene Therapy Landscape—From Hope to Reality” scheduled for January 11, 2022, from 12:00 p.m. to 1:15 p.m. ET. Longeveron focuses on developing cellular therapies for aging-related conditions, including Alzheimer’s and frailty.

Longeveron Inc. (NASDAQ: LGVN) has received Orphan Drug Designation (ODD) from the FDA for Lomecel-B, aimed at treating Hypoplastic Left Heart Syndrome (HLHS), a rare congenital heart defect affecting about 1,000 infants annually in the U.S. This designation, alongside a recently granted Rare Pediatric Disease designation, provides potential regulatory and financial benefits, including seven years of market exclusivity upon approval. Lomecel-B’s safety was highlighted in a Phase 1 trial, showing no major adverse events, as all ten infants remained alive without needing transplants 2-3.5 years post-surgery.

Longeveron, a clinical-stage biotechnology company, has successfully closed a private placement of approximately 1.17 million shares of common stock and warrants, raising an estimated $20.5 million. The warrants, exercisable at $17.50 per share and expiring in five years, will help fund clinical development for its lead product, Lomecel-B, targeting conditions like Hypoplastic Left Heart Syndrome and Alzheimer’s Disease. This private placement was facilitated by EF Hutton, and the shares are offered only to accredited investors, pending SEC registration.

On December 1, 2021, Longeveron Inc. (NASDAQ: LGVN) announced a private placement agreement to raise approximately $20.5 million from institutional investors. The company will sell around 1.17 million shares of common stock at $17.50 per share, including warrants for the same amount. The proceeds will support the clinical development of Lomecel-B, aimed at treating conditions like Hypoplastic Left Heart Syndrome and Alzheimer's Disease. The offering is expected to close by December 3, 2021.

Longeveron Inc. (NASDAQ: LGVN) has announced a clinical research agreement with Japan's National Center for Geriatrics and Gerontology (NCGG) and Juntendo University Hospital to study the safety and efficacy of Lomecel-B in older, frail Japanese subjects. This collaboration is crucial as Japan has a rapidly aging population, with 29.1% of its citizens aged 65 or older. The study aims to enroll 45 subjects and evaluate various health parameters. Previously, Lomecel-B showed promising results in U.S. trials, indicating potential for improvements in physical function and overall health.

Longeveron Inc. (NASDAQ: LGVN) announced that the FDA has granted Rare Pediatric Disease designation for Lomecel-B, its treatment for Hypoplastic Left Heart Syndrome (HLHS), a critical congenital heart defect affecting 1,000 infants annually in the U.S. The product is currently in Phase 2 clinical trials. Phase 1 results showed that all 10 infants treated survived and had no major adverse effects. If approved, Longeveron may be eligible for a priority review voucher, potentially accelerating the market entry of Lomecel-B.

Longeveron Inc. (NASDAQ: LGVN) provided a business update and financial results for Q3 2021, reporting revenue of $0.2 million, down 89% from $1.8 million YoY, primarily due to decreased grant revenue. The net loss widened to $4.9 million, or $0.25 per share, compared to $0.9 million, or $0.06 per share, in Q3 2020. The company is advancing its lead candidate, Lomecel-B, with ongoing Phase 1 and 2 trials in various conditions, including Alzheimer’s disease and Acute Respiratory Distress Syndrome. Cash reserves increased to $19 million, sufficient to cover expenses through at least Q4 2022.