Business
Longeveron Inc. Provides Corporate Update and Reports First Quarter 2023 Financial Results
-- New long-term survival data disclosed from ELPIS I trial of Lomecel-BTM for Hypoplastic Left Heart Syndrome; Data reinforce potential mortality benefit --
About this update from Longeveron Inc.
[{"type":"text","content":"-- New long-term survival data disclosed from ELPIS I trial of Lomecel-BTM for Hypoplastic Left Heart Syndrome; Data reinforce potential mortality benefit -- -- First patient dosed in Phase 2 clinical trial of Lomecel-BTM for Aging-Related Frailty in Japan -- -- Conference call scheduled for 8:30 a.m. ET today -- MIAMI, May 12, 2023 (GLOBE NEWSWIRE) -- Longeveron Inc. (NASDAQ: LGVN) (\"Longeveron\" or the \"Company\"), a clinical stage biotechnology company developing regenerative medicines for unmet medical needs, today provided a business update and reported its financial results for the first quarter ended March 31, 2023. “In 2023, we have continued to make steady progress advancing Lomecel-BTM, our lead investigational product, across three clinical programs,” said Wa’el Hashad, Chief Executive Officer. “Since joining the Company in March, I am very excited about the progress of Lomecel-BTM in HLHS, a rare and life-threatening congenital heart disease. Earlier this week, we provided long-term follow-up data from our ELPIS I trial of Lomecel-BTM for infants with HLHS, which showed a 100% survival rate up to 5 years. Also notably, the first patient was treated with Lomecel-BTM in our Phase 2 clinical trial in patients with Aging-Related Frailty in Japan. We plan to continue to execute on key milestones across our three clinical programs, and from our Phase 2a CLEAR MIND trial for Alzheimer’s Disease, we expect to announce topline results by the end of this year.” First Quarter Business Updates: Lomecel-BTM for Hypoplastic Left Heart Syndrome (HLHS): Earlier this week, Longeveron announced new long-term follow-up data from the ELPIS I trial of Lomecel-BTM for patients with HLHS. Data showed 100% survival rate at up to five years after receiving Lomecel-BTM compared to 20% mortality at five years observed in historical controlled trial.Longeveron has fully activated all seven clinical sites and expects to add one more site. The Company continues to enroll patients in its ELPIS II trial, a 38-patient, randomized (1:1) blinded, controlled Phase 2a clinical trial intended to evaluate the safety and efficacy of intramyocardial injection of Lomecel-BTM in infants with HLHS who are undergoing Stage II reconstructive cardiac surgery.Lomecel-BTM for HLHS has previously received Fast Track, Rare Pediatric Disease, and Orphan Drug Designa...