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Longeveron LLC is a leading global regenerative medicine company developing innovative cellular therapeutics for chronic life-threatening diseases. Their lead investigational product candidate, LMSC, is based on a specialized cell known as a mesenchymal stem cell derived from the bone marrow of healthy young adult donors. The company's allogeneic, 'off-the-shelf' product is under investigation for chronic conditions of the elderly and other life-threatening diseases with no approved therapeutics currently available, including aging frailty syndrome, Alzheimer's disease, hypoplastic left heart syndrome, and the metabolic syndrome.
Longeveron announced that the U.S. FDA granted Regenerative Medicine Advanced Therapy (RMAT) designation to Lomecel-B™ for treating mild Alzheimer’s Disease. This makes Lomecel-B™ the first cellular therapeutic candidate to receive RMAT for Alzheimer’s. The therapy is being evaluated in multiple conditions, including Alzheimer’s (Phase 2a completed), Aging-related Frailty (Phase 2b completed), and Hypoplastic Left Heart Syndrome (HLHS) (Phase 2b ongoing). The CLEAR MIND Phase 2a trial indicated that Lomecel-B™ slowed/prevented disease progression compared to placebo, meeting safety and efficacy endpoints. Full results will be presented in July 2024. RMAT designation aims to expedite the drug development process and offers benefits like FDA guidance and potential priority review.
Longeveron (NASDAQ: LGVN) has elected Neha Motwani to its Board of Directors during the Annual Meeting of Stockholders. Ms. Motwani brings over 25 years of healthcare investment banking experience, having raised approximately $7.0 billion in transactions while serving at firms like William Blair, Truist Securities, and Oppenheimer. Longeveron, a clinical-stage biotech company, is developing cellular therapies for conditions such as hypoplastic left heart syndrome (HLHS) and Alzheimer’s disease. Co-founder Joshua Hare emphasized that her expertise in biopharma operations, financing, and capital markets will significantly benefit the company as it advances its Lomecel-B™ therapy, which has shown positive results in five clinical trials across three indications.
Longeveron has announced the election of Roger Hajjar, MD, to its Board of Directors. Dr. Hajjar, an acclaimed scientist in cardiac gene therapy and current Director of the Gene and Cell Therapy Institute at Mass General Brigham, brings extensive expertise to the company. His contributions in gene therapy have initiated numerous clinical trials and his methodologies are globally implemented. This move is part of Longeveron's strategy to refresh its Board with experienced leaders to enhance its ongoing therapeutic developments, including Lomecel-B™. Dr. Hajjar's background includes 500 publications and various awards. His academic credentials include degrees from Johns Hopkins and Harvard Medical School, with significant professional contributions at Massachusetts General Hospital, Mount Sinai, and Flagship Pioneering.
Longeveron has raised $4.4 million in gross proceeds from the exercise of existing warrants to purchase 1,697,891 shares of its Class A common stock at $2.35 per share, originally issued in April 2024. The exercise was facilitated by H.C. Wainwright & Co. as the exclusive placement agent. In return, Longeveron has issued new unregistered warrants for 3,395,782 shares, exercisable at $2.50 per share for 24 months. The company plans to use the net proceeds to fund the clinical and regulatory development of Lomecel-B™ for conditions like HLHS and Alzheimer’s, as well as for general corporate purposes. The new warrants were issued in a private placement and are not registered under the Securities Act.
Longeveron, a clinical stage biotech firm listed on NASDAQ as LGVN, will participate in the Virtual Life Sciences Investor Forum on June 20, 2024. The company focuses on developing cellular therapies for critical and aging-related conditions, such as hypoplastic left heart syndrome (HLHS) and Alzheimer’s disease. The event includes a fireside chat scheduled at 10:30 a.m. ET on June 20, 2024. The webcast can be accessed via the 'Events and Presentations' section of Longeveron's website, with a replay available for 90 days.
Longeveron announced the exercise of warrants for $4.4 million in gross proceeds. These warrants, issued in April 2024, allowed the purchase of 1,697,891 Class A common stock shares at $2.35 per share. H.C. Wainwright & Co. is the offering's exclusive placement agent. In exchange for immediate cash exercise and a $0.125 fee per new warrant, Longeveron will issue new warrants for 3,395,782 Class A common stock shares at $2.50 per share, valid for 24 months. The proceeds will fund clinical and regulatory development of Lomecel-B™, regulatory approvals, capital expenditures, and general corporate purposes. The new warrants are offered under Section 4(a)(2) of the Securities Act and are not registered under state securities laws.
Longeveron announces the completion of an investigator meeting for its ELPIS II Phase 2b clinical trial evaluating Lomecel-B™ as a treatment for Hypoplastic Left Heart Syndrome (HLHS), a rare pediatric heart defect. The trial is on track to complete enrollment of 38 patients by the end of 2024. Multiple nationally recognized children's treatment centers are participating. Phase 1 results showed a 100% transplant-free survival rate up to five years, compared to a 20% historical mortality rate. The trial aims to further evaluate the safety and efficacy of Lomecel-B™.
Longeveron, a clinical stage biotechnology company (NASDAQ: LGVN), announced its participation in the Emerging Growth Virtual Conference on June 12-13, 2024. The company will present on June 12 at 1:45 p.m. ET. The presentation will be webcast and accessible via the 'Events and Presentations' section of Longeveron's website. A replay will be available for 180 days post-conference. Questions can be submitted in advance or during the event.
Longeveron announced the launch of a new contract development and manufacturing business at its 15,000 sq. ft. GMP facility. The company signed its first contract with Secretome Therapeutics, a biotechnology firm working on neonatal mesenchymal stem cell-based therapeutics. This new business line is expected to generate $4-5 million in annual revenues. Longeveron aims to leverage its expertise and capacity to advance other pharmaceutical programs. The company continues to focus on its lead therapeutic candidate, Lomecel-B, for multiple conditions, including hypoplastic left heart syndrome and Alzheimer's disease.
Longeveron (NASDAQ: LGVN), a clinical-stage regenerative medicine biotech, will attend the BIO International Convention from June 3-6, 2024, in San Diego. At the event, Longeveron's management will meet with global pharma executives to discuss partnerships and strategic opportunities for its Alzheimer's disease program. Their lead candidate, Lomecel-B™, showed promising results in the Phase 2a CLEAR MIND trial, achieving primary safety and secondary efficacy endpoints. The trial indicated Lomecel-B™ could slow or prevent disease worsening in mild Alzheimer's patients. These findings will be presented at the 2024 Alzheimer's Association International Conference.
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