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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 reported its full-year 2024 financial results, highlighting a 237% year-over-year increase in total revenue to $2.4 million. The company's pivotal Phase 2b clinical trial (ELPIS II) for Lomecel-B™ in treating Hypoplastic Left Heart Syndrome has achieved over 90% enrollment, with completion expected in Q2 2025.
Key financial metrics include a reduced net loss of $16.0 million (down 25% from 2023), with cash and equivalents of $19.2 million as of December 31, 2024. The company anticipates its current funds will support operations into Q4 2025.
Notable developments include WHO's approval of 'laromestrocel' as Lomecel-B's non-proprietary name and plans for a potential Biological License Application (BLA) submission in 2026. The company expects an FDA meeting in late Q1 2025 to discuss development paths for Lomecel-B in mild Alzheimer's disease.
Longeveron (NASDAQ: LGVN), a clinical stage regenerative medicine biotechnology company, has announced it will release its full-year 2024 financial results on Friday, February 28, 2025, after U.S. market close. The company will host a conference call and webcast at 4:30 p.m. ET the same day to discuss results and provide a business update. An archived replay will be available on the company's website following the conference.
Longeveron (NASDAQ: LGVN) announced that its cellular therapy Lomecel-B™ has received the International Non-proprietary Name (INN) 'laromestrocel' from the World Health Organization. Lomecel-B™ is being evaluated for Alzheimer's disease and hypoplastic left heart syndrome (HLHS), a rare pediatric disease.
The therapy has received multiple FDA designations, including Regenerative Medicine Advanced Therapy (RMAT) and Fast Track designation for mild Alzheimer's disease, as well as Orphan Drug designation, Fast Track designation, and Rare Pediatric Disease designation for HLHS treatment. The company has reported positive Phase 2a data in mild Alzheimer's disease and is nearing completion of enrollment for its Phase 2b HLHS clinical trial.
Longeveron (NASDAQ: LGVN), a clinical stage regenerative medicine biotechnology company, has announced its participation in the upcoming Emerging Growth Virtual Conference. The company, which focuses on developing cellular therapies for life-threatening and chronic aging-related conditions, will present on February 19, 2025, from 3:10 to 3:20 p.m. ET.
Interested parties can access the presentation through the 'Events and Presentations' section of Longeveron's website. The webcast replay will remain available for 180 days after the conference. Questions can be submitted in advance to Questions@EmergingGrowth.com or asked during the live event.
Longeveron (NASDAQ: LGVN), a clinical stage regenerative medicine biotechnology company, has announced its upcoming participation at Biotech Showcase 2025. CEO Wa'el Hashad will deliver a corporate presentation on Tuesday, January 14, 2025, from 4:00 to 4:30 p.m. PT.
The company, which focuses on developing cellular therapies for life-threatening and chronic aging-related conditions, will make the presentation available via webcast through the 'Events and Presentations' section of their website. A replay will be accessible on Longeveron's website after the conference concludes.
Longeveron (NASDAQ: LGVN), a clinical stage regenerative medicine biotechnology company, has announced its participation in the Emerging Growth Virtual Conference scheduled for December 4-5, 2024. The company will present on December 5, 2024, from 12:00 to 12:30 p.m. ET.
The presentation will be accessible through the company's website under the 'Events and Presentations' section, with the webcast replay available for 180 days following the conference. Participants can submit questions in advance to Questions@EmergingGrowth.com or during the event.
Longeveron reported Q3 2024 financial results and business updates. The company's Phase 2b ELPIS II trial for Lomecel-B™ in HLHS has reached 80% enrollment, with FDA confirming it as pivotal for BLA submission. Total revenue increased 177% to $1.8M in the first nine months of 2024. Operating expenses decreased 14% year-over-year. The company maintains $22.8M in cash, expected to fund operations through Q4 2025. Notable developments include positive Phase 2a CLEAR MIND trial data in Alzheimer's disease and successful Type C FDA meeting confirming ELPIS II's pivotal status.
Longeveron (NASDAQ: LGVN) has appointed Devin Blass as Chief Technology Officer and Senior Vice President of Chemistry, Manufacturing, and Controls, effective December 2, 2024. Blass brings over 15 years of experience in advanced therapies development and manufacturing. His appointment comes at a important time as the company prepares for a potential Biological License Application submission for HLHS, pending positive results from the ongoing ELPIS II trial. Prior to joining Longeveron, Blass served at the New York Blood Center as SVP of Comprehensive Cell Solutions and held leadership positions at Talaris Therapeutics, Bellicum Pharmaceuticals, and Mesoblast.
Longeveron (NASDAQ: LGVN), a clinical stage regenerative medicine biotechnology company, has scheduled its third quarter 2024 financial results announcement for November 12, 2024, after market close. The company will host a conference call and webcast at 4:30 p.m. ET the same day to discuss results and provide a business update. The conference call will be accessible via phone (1.877.407.0789) with Conference ID 13749428, and a webcast replay will be available on the company's website.
Longeveron presented data on Lomecel-B, their cellular therapy for mild Alzheimer's disease (AD), at the CTAD24 conference. The presentation highlighted that Lomecel-B's ability to inhibit MMP14 correlates with improved clinical outcomes in mild AD patients. Research from the Phase 2a CLEAR MIND trial showed that patients receiving Lomecel-B lots with higher MMP14 inhibitory activity demonstrated enhanced responses versus placebo on various measures, including cognitive function, quality of life, and brain volume. The findings suggest that MMP14 inhibition may protect TIE2 receptor integrity and contribute to the immunomodulatory and pro-vascular effects of Lomecel-B in mild AD treatment.