LGVN.O News & Events

Longeveron entered into a definitive agreement with certain institutional and accredited investors for up to approximately $30M in gross proceeds through a private placement, priced at-the-market under Nasdaq rules. The net proceeds from the initial tranche of the financing are expected to fund the Company's current operating plans into the fourth quarter of 2026, past the anticipated pivotal Phase 2b ELPIS II clinical trial 3Q26 topline data readout. The private placement is led by Coastlands Capital, with participation from Janus Henderson Investors, along with Logos Capital and Kalehua Capital, for total gross proceeds in the initial closing of approximately $15M. H.C. Wainwright & Co. is acting as the exclusive placement agent for the private placement. At the initial closing, the Company will issue 6,013,384 shares of its Class A common stock at a purchase price of $0.52 per share and, in lieu of Class A common stock, shares of the Company's Series A Non-Voting Convertible Preferred Stock, convertible into an aggregate of 22,832,770 shares of Class A common stock, at a purchase price $1,000 for each Preferred Share. The Preferred Shares will have a conversion price of $0.52 per share and will be immediately convertible upon issuance. The Company will be eligible to receive up to an additional approximately $15M in gross proceeds in exchange for shares of Class A common stock and Preferred Shares, subject to achieving certain milestone-driven conditions related to the results of the Company's Phase 2b ELPIS II clinical trial in HLHS and share price. Additionally, at the initial closing, the Company has agreed to sell to the investors an interest in 50% of proceeds received from the potential future sale of a Rare Pediatric Disease Priority Review Voucher, to the extent received from the U.S. FDA in connection with the Company's laromestrocel program for HLHS. The initial closing of the private placement is expected to occur on or about March 11, 2026, subject to satisfaction of customary closing conditions.

Longeveron announced that results of its Phase 2b clinical trial were published today in Cell Stem Cell, a Cell Press Journal. The Phase 2b results demonstrated that intravenous laromestrocel, a mesenchymal stem cell product, improved the physical condition of patients with age-related clinical frailty after nine months, compared to placebo. The full publication is available on the Cell Stem Cell website here. The Phase 2b, randomized, dose-finding clinical trial evaluated whether laromestrocel, human bone marrow-derived allogeneic MSCs, improves physical functioning and patient self-reported outcomes in 148 ambulatory individuals with frailty. Laromestorcel infusions resulted in: Clinically meaningful, dose-and time-dependent increases in the primary endpoint of the 6-minute walk test (6MWT) compared with placebo: 63.4m at month 9 and 41.3m at month 6; Increased 6MWT distance correlates with PROMIS Physical Function score; Increasing doses of laromestrocel are associated with decreases in soluble tyrosine kinase with immunoglobulin and epidermal growth factor homology domains, the cognate receptor for the angiopoietins, identifying a potential biomarker for laromestrocel responsiveness. These findings identify a possible stem cell therapy approach for the management of patients with hypomobility and other features of aging frailty.

Longeveron announced that the company's Board of Directors has appointed Stephen Willard as CEO, effective February 11. He succeeds Than Powell who served as interim CEO prior to the Board's appointment of Willard as permanent CEO. Powell will support the leadership transition and continue his work in the company's on-going business development activities. Willard was previously CEO of Icapath, CEO of NRx Pharmaceuticals, CEO of Cellphire, and CEO of Flamel Technologies.

Longeveron supports and applauds Congress passing the Mikaela Naylon Give Kids a Chance Act. The Mikaela Naylon Give Kids a Chance Act reauthorizes the Rare Pediatric Disease Priority Review Voucher Program, which encourages the development of treatments for rare pediatric diseases. Companies pursuing treatments for rare pediatric diseases can receive a priority review voucher upon FDA approval of a therapy, and then either use it to secure a speedier FDA review of a future therapy or sell it to another company. Since August 2024, vouchers have been sold for $150-200M each. Since the program's inception, more than 60 PRVs have been awarded for 40 pediatric diseases, all at no cost to taxpayers. Longeveron is evaluating its stem cell therapy laromestrocel as a potential adjunct therapy for Hypoplastic Left Heart Syndrome, a rare pediatric congenital heart birth defect in which the left ventricle is either severely underdeveloped or missing. Even with current standard of care surgeries, only 50% of infants survive to adolescence due to right ventricular failure.