Longeveron Reports Q1 2024 Financial Results and Business Update
Longeveron Inc., a biotechnology company specializing in regenerative medicine, reported its financial results for the quarter ending March 31, 2024. The company, listed on NASDAQ under LGVN, focuses on cellular therapies for serious conditions related to aging. Their key investigational product, Lomecel-BTM, is under evaluation for Hypoplastic Left Heart Syndrome (HLHS) and Alzheimer’s disease.
CEO Wa’el Hashad highlighted the company’s progress in advancing its cellular therapy research, particularly through Lomecel-BTM. He expressed optimism about completing enrollment for the Phase 2b HLHS trial by the end of 2024. This follows positive results from the Phase 1 study, which led to the U.S. FDA awarding the HLHS program three significant designations: Orphan Drug, Fast Track, and Rare Pediatric Disease. These could potentially lead to a Priority Review Voucher, adding substantial value.
In April 2024, Longeveron raised $11.4 million through equity transactions to support ongoing clinical development, with contributions from board members and company insiders.
Development Programs Overview
Lomecel-BTM, Longeveron’s leading investigational therapy, is under trial for multiple conditions.
Hypoplastic Left Heart Syndrome (HLHS): This is a rare congenital heart defect affecting the left ventricle. The ongoing Phase 2b clinical trial (ELPIS II) aims to enroll 38 pediatric patients by the end of 2024. This trial is conducted in collaboration with the National Heart, Lung, and Blood Institute (NHLBI) through National Institutes of Health (NIH) grants. ELPIS II builds on positive outcomes from ELPIS I, where children treated with Lomecel-BTM showed 100% transplant-free survival up to five years, compared to a historical 20% mortality rate. Longeveron plans to discuss its HLHS development strategy and potential Biologics License Application (BLA) approval with the FDA.
Alzheimer’s Disease (AD): Alzheimer’s is a neurodegenerative disorder with limited treatment options. In a completed Phase 2a clinical trial (CLEAR MIND), Lomecel-BTM showed promise in slowing disease progression compared to a placebo. The trial met its primary safety and secondary efficacy objectives, with significant improvements in clinical and biomarker endpoints for certain Lomecel-BTM groups. These findings support further clinical development of Lomecel-BTM for mild Alzheimer’s disease. Full results from CLEAR MIND are set for presentation at the 2024 Alzheimer's Association International Conference (AAIC). Longeveron plans to meet with the FDA to discuss future clinical and regulatory strategies for this indication.
Recent Corporate Developments
In January 2024, the United States Patent and Trademark Office issued a notice of allowance for Longeveron’s patent application related to the use of allogeneic human mesenchymal stem cells as an adjuvant for vaccines in aging-related frailty patients. This patent was officially granted in May 2024 (U.S. Patent No. 11,975,068). Additionally, the company raised $11.4 million in April 2024 through two capital raises.
Financial Results for Q1 2024
For the first quarter of 2024, Longeveron reported revenues of $0.5 million, a 96% increase from $0.3 million in 2023, primarily due to higher participant demand in the Bahamas Registry Trial. Clinical trial revenue rose from $0.2 million in 2023 to $0.5 million in 2024, a 116% increase. The cost of revenue was $0.2 million, resulting in a gross profit of $0.3 million, up from $0.1 million the previous year.
General and administrative expenses rose to $2.2 million from $2.0 million, mainly due to higher professional fees. Research and development expenses dropped to $2.2 million from $2.8 million, reflecting reduced costs for Alzheimer’s and Aging-related Frailty trials and supplies. The net loss for the quarter decreased to $4.1 million from $4.6 million in 2023.
As of March 31, 2024, Longeveron had $2.3 million in cash and equivalents. With the additional $11.4 million raised in April, the company anticipates funding its operations into Q4 2024.
About Longeveron Inc.
Longeveron develops regenerative medicines to meet unmet medical needs. Its main product, Lomecel-BTM, is derived from bone marrow of young, healthy donors and has potential applications across various diseases due to its pro-vascular, pro-regenerative, anti-inflammatory, and tissue repair properties. The company is actively pursuing treatments for HLHS, Alzheimer’s disease, and Aging-related Frailty.
How to obtain the latest research advancements in the field of biopharmaceuticals?
In the Synapse database, you can keep abreast of the latest research and development advances in drugs, targets, indications, organizations, etc., anywhere and anytime, on a daily or weekly basis. Click on the image below to embark on a brand new journey of drug discovery!
