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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) reported significant progress in its clinical pipeline, achieving key milestones, including the completion of enrollment in its Phase 2a trial for mild Alzheimer's Disease. The FDA granted Fast Track Designation to Lomecel-BTM for infants with Hypoplastic Left Heart Syndrome (HLHS). The company’s Q3 2022 revenue totaled $0.3 million, with a net loss of $5.2 million. R&D expenses rose to $2.9 million, while G&A expenses decreased to $2.1 million. Longeveron expects its cash reserves to last into H1 2024. A conference call discussing these results is scheduled for 8:30 a.m. ET today.
Longeveron Inc. (NASDAQ: LGVN) announced the completion of enrollment in its Phase 2a clinical trial of Lomecel-B™ for mild Alzheimer’s Disease. This trial, known as the CLEAR MIND trial, aims to evaluate the safety of Lomecel-B™ through various endpoints, including serious adverse events and cognitive function measures. The trial follows positive results from a prior Phase 1b study that met its primary safety endpoint. This advancement in clinical trials highlights Longeveron’s commitment to addressing unmet medical needs in Alzheimer’s treatment.
Longeveron Inc. (NASDAQ: LGVN) is set to release its Q3 2022 financial results on November 14, 2022, prior to U.S. market opening. The company will host a conference call at 8:30 a.m. EST to discuss these results and provide a corporate update. The company is developing regenerative medicines, focusing on its lead product, Lomecel-B™, for conditions like Hypoplastic Left Heart Syndrome, Alzheimer’s Disease, and Aging Frailty. Interested parties can access the call via dial-in or through a webcast on the Longeveron website.
Longeveron Inc. (NASDAQ: LGVN) announced that Chris Min, M.D., Ph.D., its Interim CEO and Chief Medical Officer, will present at the Dawson James Small Cap Growth Conference in Jupiter, Florida, on October 12, 2022. The presentation is scheduled for 4:30 – 4:55 p.m. ET, with a live webcast available on the company's website. Longeveron focuses on developing regenerative medicines, notably Lomecel-B™, which targets Hypoplastic Left Heart Syndrome, Alzheimer’s Disease, and Aging Frailty.
Longeveron Inc. (NASDAQ: LGVN) appointed Jerome Bailey as vice president of business operations, bringing over 30 years of biopharmaceutical experience. Previously at Checkmate Pharmaceuticals, Bailey managed clinical trials across multiple therapeutic areas. CEO Chris Min highlighted Bailey's expertise as crucial for advancing their lead product, Lomecel-B™, through ongoing Phase 2 trials for Alzheimer’s and Hypoplastic Left Heart Syndrome, with a new trial in Japan on the horizon. Longeveron focuses on regenerative medicines for unmet medical needs.
Longeveron Inc. (NASDAQ: LGVN) announced that Dr. Chris Min, Interim CEO and Chief Medical Officer, will present at the H.C. Wainwright 24th Annual Global Investment Conference in New York City from September 12-14, 2022. The presentation is scheduled for September 13, 2022, from 8:30 to 9:00 a.m. ET. Interested parties can access the live webcast on Longeveron's website, with a replay available for 90 days. Longeveron focuses on cellular therapies for aging-related and life-threatening conditions, currently conducting Phase 1 and 2 clinical trials for various indications.
Longeveron Inc. (NASDAQ: LGVN) has received Fast Track Designation from the FDA for its investigational therapy Lomecel-B™. This therapy aims to treat Hypoplastic Left Heart Syndrome (HLHS), a rare congenital defect affecting about 1,000 infants annually in the U.S. Lomecel-B™ is currently undergoing a Phase 2a clinical trial. Fast Track Designation enhances interactions with the FDA, potentially accelerating approval. Notably, the ELPIS Phase 1 trial indicated 100% survival rate without heart transplants among participants.
Longeveron Inc. (NASDAQ: LGVN) announced the European Patent Office's intent to grant a patent for methods treating endothelial dysfunction with its cell therapy, Lomecel-B™. This patent, which focuses on monitoring efficacy through Vascular Endothelial Growth Factor (VEGF), reinforces Longeveron's intellectual property. The company aims to address various aging-related conditions and has received Rare Pediatric Disease Designation and Orphan Drug Designation for Lomecel-B™ targeting Hypoplastic Left Heart Syndrome. The patent is expected to expire in November 2035.
Longeveron (NASDAQ: LGVN) announced progress in its clinical trials, including a Phase 2a trial for Lomecel-B in Alzheimer’s patients, with 50% enrollment achieved. The Japanese PMDA accepted an amended trial design for Aging Frailty, potentially allowing accelerated market entry. The Phase 1/2 HERA trial noted met safety endpoints, showing promise for Lomecel-B. Financially, the company reported $27 million in cash as of June 30, 2022, sufficient to fund operations into 2024, although net losses increased to $5.6 million from $5 million year-over-year.
Longeveron Inc. (NASDAQ: LGVN), a clinical-stage biotechnology firm, announced that an abstract detailing the Phase 2a trial of Lomecel-B in Alzheimer’s Disease has been accepted for presentation at the Alzheimer’s Association International Conference (AAIC) from July 31 to August 4, 2022. Ongoing enrollment for the trial is noted. Earlier in 2022, a peer-reviewed study confirmed the success of Lomecel-B in a Phase 1b trial, achieving its primary endpoint with good tolerability in patients. The poster presentation is scheduled for August 2, 2022.
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