Longeveron Inc Stock Price, News & Analysis

Longeveron Inc. (NASDAQ: LGVN) reported significant progress in its clinical pipeline, achieving key milestones, including the completion of enrollment in its Phase 2a trial for mild Alzheimer's Disease. The FDA granted Fast Track Designation to Lomecel-BTM for infants with Hypoplastic Left Heart Syndrome (HLHS). The company’s Q3 2022 revenue totaled $0.3 million, with a net loss of $5.2 million. R&D expenses rose to $2.9 million, while G&A expenses decreased to $2.1 million. Longeveron expects its cash reserves to last into H1 2024. A conference call discussing these results is scheduled for 8:30 a.m. ET today.

Longeveron Inc. (NASDAQ: LGVN) announced the completion of enrollment in its Phase 2a clinical trial of Lomecel-B™ for mild Alzheimer’s Disease. This trial, known as the CLEAR MIND trial, aims to evaluate the safety of Lomecel-B™ through various endpoints, including serious adverse events and cognitive function measures. The trial follows positive results from a prior Phase 1b study that met its primary safety endpoint. This advancement in clinical trials highlights Longeveron’s commitment to addressing unmet medical needs in Alzheimer’s treatment.

Longeveron Inc. (NASDAQ: LGVN) is set to release its Q3 2022 financial results on November 14, 2022, prior to U.S. market opening. The company will host a conference call at 8:30 a.m. EST to discuss these results and provide a corporate update. The company is developing regenerative medicines, focusing on its lead product, Lomecel-B™, for conditions like Hypoplastic Left Heart Syndrome, Alzheimer’s Disease, and Aging Frailty. Interested parties can access the call via dial-in or through a webcast on the Longeveron website.

Longeveron Inc. (NASDAQ: LGVN) announced that Chris Min, M.D., Ph.D., its Interim CEO and Chief Medical Officer, will present at the Dawson James Small Cap Growth Conference in Jupiter, Florida, on October 12, 2022. The presentation is scheduled for 4:30 – 4:55 p.m. ET, with a live webcast available on the company's website. Longeveron focuses on developing regenerative medicines, notably Lomecel-B™, which targets Hypoplastic Left Heart Syndrome, Alzheimer’s Disease, and Aging Frailty.

Longeveron Inc. (NASDAQ: LGVN) appointed Jerome Bailey as vice president of business operations, bringing over 30 years of biopharmaceutical experience. Previously at Checkmate Pharmaceuticals, Bailey managed clinical trials across multiple therapeutic areas. CEO Chris Min highlighted Bailey's expertise as crucial for advancing their lead product, Lomecel-B™, through ongoing Phase 2 trials for Alzheimer’s and Hypoplastic Left Heart Syndrome, with a new trial in Japan on the horizon. Longeveron focuses on regenerative medicines for unmet medical needs.

Longeveron Inc. (NASDAQ: LGVN) announced that Dr. Chris Min, Interim CEO and Chief Medical Officer, will present at the H.C. Wainwright 24th Annual Global Investment Conference in New York City from September 12-14, 2022. The presentation is scheduled for September 13, 2022, from 8:30 to 9:00 a.m. ET. Interested parties can access the live webcast on Longeveron's website, with a replay available for 90 days. Longeveron focuses on cellular therapies for aging-related and life-threatening conditions, currently conducting Phase 1 and 2 clinical trials for various indications.

Longeveron Inc. (NASDAQ: LGVN) has received Fast Track Designation from the FDA for its investigational therapy Lomecel-B™. This therapy aims to treat Hypoplastic Left Heart Syndrome (HLHS), a rare congenital defect affecting about 1,000 infants annually in the U.S. Lomecel-B™ is currently undergoing a Phase 2a clinical trial. Fast Track Designation enhances interactions with the FDA, potentially accelerating approval. Notably, the ELPIS Phase 1 trial indicated 100% survival rate without heart transplants among participants.

Longeveron Inc. (NASDAQ: LGVN) announced the European Patent Office's intent to grant a patent for methods treating endothelial dysfunction with its cell therapy, Lomecel-B™. This patent, which focuses on monitoring efficacy through Vascular Endothelial Growth Factor (VEGF), reinforces Longeveron's intellectual property. The company aims to address various aging-related conditions and has received Rare Pediatric Disease Designation and Orphan Drug Designation for Lomecel-B™ targeting Hypoplastic Left Heart Syndrome. The patent is expected to expire in November 2035.

Longeveron (NASDAQ: LGVN) announced progress in its clinical trials, including a Phase 2a trial for Lomecel-B in Alzheimer’s patients, with 50% enrollment achieved. The Japanese PMDA accepted an amended trial design for Aging Frailty, potentially allowing accelerated market entry. The Phase 1/2 HERA trial noted met safety endpoints, showing promise for Lomecel-B. Financially, the company reported $27 million in cash as of June 30, 2022, sufficient to fund operations into 2024, although net losses increased to $5.6 million from $5 million year-over-year.