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 that the FDA has granted Rare Pediatric Disease designation for Lomecel-B, its treatment for Hypoplastic Left Heart Syndrome (HLHS), a critical congenital heart defect affecting 1,000 infants annually in the U.S. The product is currently in Phase 2 clinical trials. Phase 1 results showed that all 10 infants treated survived and had no major adverse effects. If approved, Longeveron may be eligible for a priority review voucher, potentially accelerating the market entry of Lomecel-B.
Longeveron Inc. (NASDAQ: LGVN) provided a business update and financial results for Q3 2021, reporting revenue of $0.2 million, down 89% from $1.8 million YoY, primarily due to decreased grant revenue. The net loss widened to $4.9 million, or $0.25 per share, compared to $0.9 million, or $0.06 per share, in Q3 2020. The company is advancing its lead candidate, Lomecel-B, with ongoing Phase 1 and 2 trials in various conditions, including Alzheimer’s disease and Acute Respiratory Distress Syndrome. Cash reserves increased to $19 million, sufficient to cover expenses through at least Q4 2022.
Longeveron (NASDAQ: LGVN), a clinical stage biotech firm, will release its Q3 2021 financial results on November 12, 2021, before US market open. The management will host a conference call at 8:30 a.m. ET the same day. The call can be accessed via phone or webcast, and a replay will be available until November 18, 2021. Longeveron focuses on cellular therapies for aging-related and life-threatening conditions, with its lead product Lomecel-B undergoing Phase 1 and 2 trials in various indications such as Alzheimer's disease and Metabolic Syndrome.
Longeveron Inc. (NASDAQ: LGVN) has selected Biorasi LLC as its clinical research organization to conduct a Phase 2 clinical trial evaluating its Lomecel-B infusion for Alzheimer’s Disease. This partnership aims to enhance the development of Lomecel-B, a cell-based therapy derived from medicinal signaling cells, targeting chronic aging-related conditions. The trial is expected to commence by the end of this year or early 2022, as per Kevin N. Ramdas, MD, MPH from Longeveron. Biorasi’s extensive experience in neurology studies positions them as a strong collaborator for this project.
Longeveron (NASDAQ: LGVN), a clinical-stage biotechnology company, has activated two new clinical sites for the ELPIS II Trial, which assesses Lomecel-B injections for infants with Hypoplastic Left Heart Syndrome (HLHS). The trial, now in Phase 2, aims to enroll 38 infants and is funded by the NIH's NHLBI. The newly added sites are Advocate Children’s Hospital and Primary Children’s Hospital in Utah. CEO Geoff Green emphasized the importance of these additions for timely execution and increased participation options for families.
Longeveron (NASDAQ: LGVN) announced that CEO Geoff Green will present at the Dawson James Small Cap Growth Conference on October 21, 2021, at 11:25 a.m. ET, in Jupiter, Florida. The presentation will focus on the company's progress in clinical research programs for Alzheimer’s disease, Aging Frailty, and Hypoplastic Left Heart Syndrome. Attendees can access a live webcast via the company's Investors & Media section. Longeveron is developing cell-based therapies aimed at chronic and aging-related conditions, with ongoing Phase 1 and 2 clinical trials for various indications.
Longeveron Inc. (NASDAQ: LGVN) announced positive preliminary results from its Phase 2b trial of Lomecel-B in Aging Frailty subjects. At 270 days, Lomecel-B significantly reduced the biomarker Tie-2 compared to placebo, showcasing a dose-dependent response. In particular, the high-dose group (200 million cells) exhibited a decrease of -936.85 pg/mL (p=0.0095) in sTIE-2 levels, indicating improved vascular health. Additionally, frail subjects showed improved exercise tolerance, walking an average of 47.9 meters further after 270 days. Results were presented at the International Conference for Frailty & Sarcopenia Research.
Longeveron Inc. (NASDAQ: LGVN) announced its Lomecel-B research will be highlighted in presentations and a roundtable at the 11th Annual International Conference on Frailty & Sarcopenia Research (ICFSR) from September 29 to October 2, 2021. The roundtable will cover Phase 2b study results of Lomecel-B in aging frailty. Oral presentations will focus on the safety and efficacy of Lomecel-B in aging frailty patients and the evaluation of its intravenous delivery on antibody responses. This event aims to accelerate clinical trials for aging-related treatments.
Longeveron Inc. (NASDAQ: LGVN) announced that Dr. Jorge Ruiz will present the results of the Phase 2b trial of Lomecel-B, focusing on its efficacy in treating aging frailty, at the ICFSR conference from September 29 to October 1, 2021. The study funded by the National Institute on Aging demonstrated a significant, dose-dependent improvement in walking distance among frail subjects after infusion, particularly in those receiving 200 million cells. Results indicated a 50-meter increase in walking distance at 180 days, suggesting the potential of Lomecel-B as a treatment for aging-related conditions.
Longeveron Inc. (NASDAQ: LGVN) has partnered with Kinesiometrics Inc. to leverage their digital data-driven technology for enhanced measurement of functional capacity and quality of life in clinical studies involving Lomecel-B.
Following a recent Phase 2b study that showed significant improvements in walking distance for older frail subjects post-infusion, this collaboration aims to provide real-time data collection through a mobile application. This innovation is expected to improve patient monitoring and potentially aid regulatory processes by offering detailed insights into treatment outcomes.