Business
Longeveron Provides Corporate Update and Reports Fourth Quarter and Full Year 2020 Financial Results
MIAMI, March 30, 2021 (GLOBE NEWSWIRE) -- Longeveron Inc. (NASDAQ: LGVN) ("Longeveron" or "Company"), a clinical stage biotechnology company developing
About this update from Longeveron Inc.
[{"type":"text","content":"MIAMI, March 30, 2021 (GLOBE NEWSWIRE) -- Longeveron Inc. (NASDAQ: LGVN) (\"Longeveron\" or \"Company\"), a clinical stage biotechnology company developing cellular therapies for chronic aging-related and life-threatening conditions, today reported its financial results for the quarter and full year ended December 31, 2020 and provided a business update. Primary Accomplishments in 2020: Received approval from U.S. Food and Drug Administration (FDA) to proceed with Phase 1 clinical trial for Acute Respiratory Distress Syndrome (ARDS) related to either COVID-19 or Influenza infection. This trial initiated in mid-2020 and continues to enroll subjects.Received a $650,000, two-year Maryland Stem Cell Research Fund TEDCO Grant Award for ARDS COVID-19/Influenza Phase 1 trial.Treated two COVID-19-related ARDS subjects with Lomecel-B infusion under FDA-approved expanded access (“compassionate use”) protocol.Lomecel-B approved for Phase 2 Aging Frailty clinical trial by Japanese Pharmaceutical and Medical Devices Agency (PMDA) through a Clinical Trial Notification (CTN) application filed by Japan’s National Center for Geriatrics & Gerontology.Successfully completed Phase 1 trial in subjects with Alzheimer’s Disease. Preliminary top-line results were included in the Company’s S-1 Registration Statement filed with the SEC in February 2021. Final results will be announced in the second quarter of 2021, and a Phase 2 trial is expected to commence in the second half of 2021.Lomecel-B Phase 2 HLHS program awarded a $4.5M multiyear grant award from the National Heart, Lung and Blood Institute (NHLBI).Revenue increased in 2020 from both grants and clinical trial (Bahamas Registry Trial) revenue sources, compared to 2019. Highlights from Q1 2021: Completed $29.1 million Initial Public Offering, including partial exercise of over-allotment, and concurrent listing on Nasdaq.Successfully completed 150 subject Phase 2b clinical study of Lomecel-B infusion for Aging Frailty, with top-line trial results anticipated in the third quarter of 2021.Successfully completed Phase 1 clinical study of Lomecel-B intramyocardial injection in Hypoplastic Left Heart Syndrome (HLHS) subjects, with full results expected in the second quarter of 2021, and Phase 2 trial expected to commence in second half of 2021.Granted expanded access (“compassionate use”) approval by ...