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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) has appointed Dr. K. Chris Min as Chief Medical Officer, effective April 4, 2022. Dr. Min will oversee global clinical development and regulatory strategy, particularly focusing on advancing Lomecel-B through pivotal trials. He brings over a decade of industry experience, including roles at Enterin and Cerevel Therapeutics. The company aims to progress Lomecel-B's development for conditions like Alzheimer's and Hypoplastic Left Heart Syndrome, with clinical trials expanding to Asia.
Longeveron Inc. (NASDAQ: LGVN) announced positive results from a Phase 1 trial of Lomecel-B for Alzheimer's disease, published in Alzheimer’s & Dementia. The study met its primary safety endpoint, showing that Lomecel-B was well tolerated, with no serious side effects observed. Preliminary findings suggest Lomecel-B may slow cognitive decline and improve patient quality of life. A Phase 2 trial has commenced, exploring single vs. multiple doses. The study indicates a potential for Lomecel-B to address multiple Alzheimer’s pathology features, as highlighted by encouraging changes in cognitive and brain health assessments.
Longeveron, a clinical-stage biotechnology company, presented at the Second Euro-Geroscience Conference on March 24-25, 2022, focusing on cellular therapies for aging-related conditions. Notable presentations included "Targeting Frailty with Stem Cells" and results for LOMECEL-B as a geroscience therapeutic candidate. Longeveron's lead product, derived from medicinal signaling cells, aims to treat conditions such as Aging Frailty and Alzheimer's. The company is advancing toward pivotal Phase 3 trials with regulatory approval in view.
Longeveron Inc. (NASDAQ: LGVN), a clinical-stage biotechnology company, announced that CEO Geoff Green will present at the Oppenheimer 32nd Annual Healthcare Conference on March 16, 2022. The virtual presentation is scheduled from 2:00 to 2:30 p.m. ET and will be accessible via Longeveron's website. The company specializes in cellular therapies targeting chronic, aging-related, and life-threatening conditions, focusing on its lead product, LOMECEL-B™. Longeveron is currently conducting Phase 1 and 2 trials for various conditions, including Alzheimer’s disease and Aging Frailty.
Longeveron (NASDAQ: LGVN) reported significant advancements in clinical trials for Lomecel-B, focusing on Hypoplastic Left Heart Syndrome, Alzheimer’s Disease, and COVID-related Acute Respiratory Distress Syndrome. The company received FDA designations for HLHS and raised $20.5 million in a private placement to support ongoing research. Despite a decline in revenue from $1.3 million in 2021 to $5.6 million in 2020, Longeveron expects sufficient cash to fund operations into 2024. Multiple data publications and a conference call to discuss results are scheduled for March 11, 2022.
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.
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