Longeveron Inc. develops regenerative cellular therapies centered on laromestrocel, also known as Lomecel-B, a proprietary allogeneic investigational cell therapy. The company’s clinical programs address hypoplastic left heart syndrome, Alzheimer’s disease, pediatric dilated cardiomyopathy, and aging-related frailty.
Recurring news for LGVN covers clinical-trial safety reviews, FDA interactions and designations, intellectual-property updates for mesenchymal stem cell methods, financial results, private placements, and Nasdaq-related corporate matters. Updates often focus on the ELPIS II HLHS program, laromestrocel regulatory strategy, and financing used to support clinical development.
Longeveron Inc. (NASDAQ: LGVN) announced promising results from its Phase I clinical trial of Lomecel-B for treating Hypoplastic Left Heart Syndrome (HLHS). The study reported no major adverse cardiac events or treatment-related infections within the first month post-treatment. Impressively, 100% of the infants injected with Lomecel-B remained alive and heart-transplant free after one year, a significant improvement over the historical rate of 78%. The transition to a Phase 2 trial further aims to evaluate Lomecel-B's safety and effectiveness in a controlled setting.
Longeveron Inc. (NASDAQ: LGVN) announced its participation in the H.C. Wainwright 23rd Annual Global Investor Conference, with a virtual presentation available for on-demand viewing starting September 13, 2021. Longeveron specializes in cellular therapies for chronic, aging-related conditions. Their lead product, Lomecel-B, aims to address serious disorders like Aging Frailty and Alzheimer’s disease. Following the presentation, an archived webcast will be accessible for up to 90 days on their website.
Longeveron Inc. (NASDAQ: LGVN) reported favorable outcomes from its Phase 2b trial of Lomecel-B, a therapy aimed at addressing Aging Frailty. At Day 180, patients receiving higher doses (50M, 100M, 200M) exhibited a statistically significant increase in six-minute walk test distances compared to placebo. While pairwise comparisons to placebo did not achieve significance, exploratory results at Day 270 indicated notable improvements. Longeveron plans to advance its research and discuss findings with regulatory authorities, as no serious adverse events were reported, maintaining a positive safety profile for Lomecel-B.
Longeveron Inc. (NASDAQ: LGVN) reported its Q2 2021 financial results, revealing a revenue decline to $0.5 million from $0.9 million year-over-year, primarily due to reduced grant revenue. The company achieved statistically significant results in its Phase 2b Aging Frailty trial for Lomecel-B, but did not meet primary efficacy endpoints at Day 180 compared to placebo. R&D expenses rose 205% to $2.0 million, contributing to a net loss of $5.0 million. However, cash reserves increased significantly to $16.8 million, providing runway through Q4 2022. A conference call is scheduled for today at 8:00 AM EDT.
Longeveron Inc. (NASDAQ: LGVN) announced it will release its second quarter 2021 financial results on August 13, 2021, before US market opening. Management will host a conference call at 8:00 AM to discuss these results. The call can be accessed via multiple phone lines and will be available for replay until August 19, 2021. Longeveron is focused on developing cellular therapies for chronic and life-threatening aging-related conditions, with its lead product, LOMECEL-B™, currently in Phase 1 and 2 clinical trials targeting several serious medical issues.
Longeveron Inc. (NASDAQ: LGVN) has announced the enrollment of the first patient in a Phase 2b clinical trial for Lomecel-B, aimed at infants with Hypoplastic Left Heart Syndrome (HLHS). Funded by the National Heart, Lung, and Blood Institute, this double-blind study will assess the safety and efficacy of the investigational MSC product. With a target enrollment of 38 infants across seven U.S. children's hospitals, the trial builds upon the successful Phase 1 results, which reported no major adverse events. The study aims to improve heart function post-surgery in HLHS patients.
Longeveron Inc. (NASDAQ: LGVN) announced that two abstracts for its investigational cell therapy, Lomecel-B, have been accepted for presentation at the Gerontological Society of America (GSA) 2021 Annual Scientific Meeting, scheduled for November 10-14, 2021, in Phoenix, AZ. The abstracts include:
- A Phase 2b Clinical Trial Assessing Lomecel-B Infusion in Individuals with Aging Frailty
- A Phase 1 Trial Assessing Lomecel-B Infusion in Individuals with Alzheimer’s Disease
This indicates ongoing progress in clinical trials aimed at addressing aging-related conditions.
Longeveron Inc. (NASDAQ: LGVN) announced the acceptance of an abstract for a poster presentation at the 2021 Annual Alzheimer's Association International Conference. This presentation highlights the results of their Phase 1 trial on Lomecel-B infusion in patients with mild Alzheimer’s disease. The trial met its primary endpoint of safety and feasibility, showing no Alzheimer’s Related Imaging Abnormalities (ARIA). Additionally, low-dose Lomecel-B demonstrated a reduction in cognitive decline compared to placebo, measured by the Mini Mental State Exam (MMSE). A Phase 2 trial is anticipated in the second half of 2021.
Longeveron Inc. (NASDAQ: LGVN), a clinical stage biotechnology firm, announced that CEO Geoff Green will present virtually at the World Stem Cell Summit on June 17, 2021, at 9:45 AM EDT. The 20-minute presentation will cover a corporate overview and research updates, followed by a 20-minute Q&A session. Interested participants can register for the event via the World Stem Cell Summit and the Investor Forum. Longeveron focuses on developing cellular therapies for aging-related and life-threatening conditions, with its lead product Lomecel-B currently in clinical trials for multiple indications.
Longeveron Inc. (NASDAQ: LGVN) announced that its Co-founder and Chairman, Dr. Joshua M. Hare, will be a panelist at the National Academy of Medicine’s workshop on June 15, 2021. The symposium, titled “Transformative Advances in Biological Sciences for Healthy Longevity,” aims to develop a Global Roadmap for Healthy Longevity. Longeveron is focused on cell-based therapies for aging-related diseases, with ongoing clinical trials for its lead product, Lomecel-B, targeting aging frailty and Alzheimer’s disease. Top-line data from recent trials is expected in Q3 2021.