Welcome to our dedicated page for Longeveron news (Ticker: LGVN), a resource for investors and traders seeking the latest updates and insights on Longeveron stock.
Longeveron Inc. (symbol: LGVN) is a clinical-stage biotechnology company at the forefront of regenerative medicine. The company is dedicated to developing innovative cellular therapeutics to address unmet medical needs related to aging and life-threatening conditions. Longeveron's lead investigational product, Lomecel-B™, is an advanced stem cell formulation derived from the bone marrow of young, healthy adult donors. This allogeneic (‘off-the-shelf’) product is currently being investigated for its potential to promote tissue repair and healing.
Lomecel-B™ is being explored for three primary indications: Hypoplastic Left Heart Syndrome (HLHS), Alzheimer's Disease (AD), and Aging-related Frailty. The unique mechanisms of action of Lomecel-B™, which include stimulating new blood vessel formation, modulating the immune system, reducing tissue fibrosis, and promoting the division of endogenous cells, make it a promising candidate for these conditions.
In its HLHS program, Longeveron has seen remarkable results. A Phase 1 trial showcased a 100% transplant-free survival rate at up to five years of age, a significant milestone considering the fatality and transplant rates historically associated with this rare pediatric disease. The ongoing Phase 2 trial aims to compare outcomes of standard care plus Lomecel-B™ vs. standard care alone, with an eye towards accelerated or final approval from the FDA based on these promising results.
For Alzheimer’s Disease, Longeveron has completed a Phase 2a CLEAR-MIND trial involving 49 patients, building on the success of its initial Phase 1 trial. Encouraging efficacy signals from this study are driving the company to seek partnerships and funding to advance this program further, addressing a vast unmet need with potential significant market opportunities.
On the financial front, Longeveron is actively managing expenses and seeking additional capital, crucial for continuing its operations and funding its ambitious pipeline. The company has undertaken measures such as a reverse stock split and filing a registration statement with the SEC to facilitate capital raising. The company’s cash resources are currently insufficient to fund operations beyond the second quarter of 2024, highlighting the urgency of securing additional financing.
CEO Wa’el Hashad, marking his first anniversary with the company, emphasizes a strategic roadmap focused on leveraging Longeveron's scientific strengths while navigating the capital market environment. The company is also exploring revenue-generating activities like contract development and manufacturing services (CDMO) to bolster its financial position.
Longeveron's commitment to responsible financial stewardship and strategic operational goals positions it as a significant player in the regenerative medicine field. The company remains dedicated to bringing Lomecel-B™ to market, potentially transforming the treatment landscape for patients suffering from devastating conditions.
Longeveron Inc. (NASDAQ: LGVN) plans to release its fourth quarter and year-end 2021 financial results on March 11, 2022, before U.S. markets open. A conference call will follow at 8:30 a.m. EST where management will discuss the results and provide a corporate update. The company focuses on cellular therapies for aging-related and life-threatening conditions, with its lead product LOMECEL-B undergoing Phase 1 and 2 trials for indications like Alzheimer’s disease and Aging Frailty.
Longeveron, a clinical stage biotechnology company focused on cellular therapies for chronic and aging-related conditions, announced that CEO Geoff Green will present at the Q1 Virtual Investor Summit on March 8, 2022, from 2:00 to 2:30 p.m. ET. The presentation will be available via a live webcast on the company's website, with an archived replay to follow. Longeveron's lead product, Lomecel-B, is derived from young adult bone marrow and aims to treat disorders linked to aging. The company seeks to advance its therapies toward regulatory approvals and commercialization.
Longeveron Inc. (NASDAQ: LGVN) appointed Todd Girolamo to its Board of Directors, bringing extensive legal, finance, and M&A experience. Girolamo is currently serving as Chief Legal Officer and Senior VP at Caladrius Biosciences. His expertise in biopharma, especially in cell and gene therapy, is expected to enhance Longeveron's clinical development efforts for its lead product, Lomecel-B, which is being tested for conditions like aging frailty and Alzheimer's. The company aims to advance its therapies towards potential regulatory approvals and commercialization.
Longeveron Inc. (NASDAQ: LGVN) will actively participate in Advanced Therapies Week at the Miami Beach Convention Center from January 25-28, 2022. Key events include:
- Panel Discussion: 'Development in Neurology and Ophthalmology' on January 26, 2022, 3:30-5:00 PM ET.
- Speaker Presentation: 'Phase 2a Clinical Trial of Lomecel-B for Alzheimer’s Disease' on January 26, 2022, 3:35 PM ET.
- Panel Discussion: 'Delivery Solutions for Gene & Cell Therapy' on January 27, 2022, 1:30-3:00 PM ET.
- Speaker Presentation: 'Technology Transfer from Pre-Clinical to cGMP Manufacturing' on January 27, 2022, 1:35 PM ET.
More details can be found on the Phacilitate Advanced Therapies Week website.
Longeveron Inc. (NASDAQ: LGVN) announced the publication of its Phase 2b clinical trial design for Lomecel-B, aimed at addressing aging frailty in older adults, in the Journal of Frailty and Aging. This condition affects up to 15% of Americans over 65, marking a significant medical need. The publication reflects the urgency in developing therapies for frailty, a condition linked to poor outcomes in older adults. The trial focused on the safety and efficacy of Lomecel-B, developed from medicinal signaling cells, with aims to advance into pivotal Phase 3 trials.
Longeveron Inc. (LGVN) announced the initiation of its Phase 2a clinical trial for Lomecel-B, targeting Alzheimer’s disease. The trial aims to expand upon promising Phase 1 data by evaluating safety and efficacy through MRI measures and assessing inflammatory systems. The double-blind study involves 48 patients across 6 centers, emphasizing cognitive function and biomarkers. CEO Geoff Green termed this trial a significant milestone.
The previous Phase 1 study met key safety endpoints, showing favorable biomarker levels without Alzheimer’s imaging abnormalities.
Longeveron Inc. (NASDAQ: LGVN) announced that CEO Geoff Green will present and join a panel discussion at the H.C. Wainwright & Co. BioConnect 2022 Virtual Conference. The presentation will be available on-demand starting January 10, 2022, at 7:00 a.m. ET, with a panel titled “The Emerging Cell & Gene Therapy Landscape—From Hope to Reality” scheduled for January 11, 2022, from 12:00 p.m. to 1:15 p.m. ET. Longeveron focuses on developing cellular therapies for aging-related conditions, including Alzheimer’s and frailty.
Longeveron Inc. (NASDAQ: LGVN) has received Orphan Drug Designation (ODD) from the FDA for Lomecel-B, aimed at treating Hypoplastic Left Heart Syndrome (HLHS), a rare congenital heart defect affecting about 1,000 infants annually in the U.S. This designation, alongside a recently granted Rare Pediatric Disease designation, provides potential regulatory and financial benefits, including seven years of market exclusivity upon approval. Lomecel-B’s safety was highlighted in a Phase 1 trial, showing no major adverse events, as all ten infants remained alive without needing transplants 2-3.5 years post-surgery.
Longeveron, a clinical-stage biotechnology company, has successfully closed a private placement of approximately 1.17 million shares of common stock and warrants, raising an estimated $20.5 million. The warrants, exercisable at $17.50 per share and expiring in five years, will help fund clinical development for its lead product, Lomecel-B, targeting conditions like Hypoplastic Left Heart Syndrome and Alzheimer’s Disease. This private placement was facilitated by EF Hutton, and the shares are offered only to accredited investors, pending SEC registration.
On December 1, 2021, Longeveron Inc. (NASDAQ: LGVN) announced a private placement agreement to raise approximately $20.5 million from institutional investors. The company will sell around 1.17 million shares of common stock at $17.50 per share, including warrants for the same amount. The proceeds will support the clinical development of Lomecel-B, aimed at treating conditions like Hypoplastic Left Heart Syndrome and Alzheimer's Disease. The offering is expected to close by December 3, 2021.
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