Business
Longeveron Inc. Provides Corporate Update and Reports Fourth Quarter and Full Year 2022 Financial Results
-- Full results from ELPIS I trial published in European Heart Journal Open – -- First patient to be randomized in Japan Aging-Related Phase 2 study in Q1 –
About this update from Longeveron Inc.
[{"type":"text","content":"-- Full results from ELPIS I trial published in European Heart Journal Open – -- First patient to be randomized in Japan Aging-Related Phase 2 study in Q1 – -- Conference call scheduled for 8:30 a.m. ET today -- MIAMI, March 10, 2023 (GLOBE NEWSWIRE) -- Longeveron Inc. (NASDAQ: LGVN) (\"Longeveron\" or \"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 fourth quarter and full year of 2022. “Longeveron had a productive 2022, executing on multiple key milestones as we continued to advance Lomecel-BTM for multiple indications,” said Wa’el Hashad, Chief Executive Officer. “Earlier this year, the full data from our ELPIS I trial of Lomecel-BTM for infants with HLHS was published in European Heart Journal Open. We are excited to continue advancing this opportunity through our ongoing Phase 2 ELPIS II trial. We have also made progress with our Japan Aging-Related Phase 2 study. We look forward to building on this progress through the rest of 2023.” Business Highlights and Anticipated Milestones: Lomecel-BTM for Hypoplastic Left Heart Syndrome (HLHS): In January 2023, the full results of the ELPIS I Trial of Lomecel-BTM for hypoplastic left heart syndrome (HLHS) were published in European Heart Journal Open.Enrollment is ongoing in the ELPIS II trial, a 38-patient, randomized (1:1), blinded, controlled Phase 2 clinical trial intended to evaluate the safety and efficacy of intramyocardial injection of Lomecel-BTM in infants with HLHS who are undergoing Stage 2 surgery. Lomecel- BTM for Aging-Related Frailty: The Company has initiated Phase 2 Clinical trial of Lomecel-BTM for Aging-Related Frailty in Japan. The Phase 2 Clinical trial is a 3-arm, parallel design, randomized (1:1:1), placebo-controlled, double-blind single infusion study of two different dose levels of Lomecel-BTM. The trial is expected to enroll 45 patients and has a primary objective of evaluating safety of Lomecel-BTM as a treatment for Aging-Related Frailty. The trial is being conducted in partnership with the National Center for Geriatrics & Gerontology (NCGG;Nagoya) and Juntendo University Hospital (Tokyo). We anticipate randomizing the first patient in this study before the end of the first quarter. Lomecel-BTM for Alzheimer’s Disea...