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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) announced positive final results from its Phase 1 clinical trial of Lomecel-B for treating mild Alzheimer’s disease. The study met its primary safety endpoint and showed that cognitive decline was slower in patients receiving low-dose Lomecel-B compared to placebo. Notably, quality of life metrics improved, with significant differences at 26 weeks. Complete trial results will be published soon. The company is poised to initiate a Phase 2 study in the latter half of 2021, indicating a proactive approach towards potential Alzheimer's treatments.
Longeveron Inc. (NASDAQ: LGVN) reported its financial results for Q4 and full year 2020, highlighting a net loss of $1.4 million for Q4 compared to $0.5 million in Q4 2019. Revenue was $1.2 million in Q4 2020, down from $1.8 million in Q4 2019, primarily due to decreased grant revenue. However, revenue from the Bahamas Registry Trial increased by 119% year-over-year. The company secured a $29.1 million IPO and anticipates sufficient cash to support operations through Q4 2022. Upcoming results from multiple clinical trials are expected in 2021.
Longeveron (NASDAQ: LGVN), a clinical stage biotechnology company, announced a conference call on March 30, 2021, at 8:30 a.m. ET to discuss its fiscal 2020 financial results and provide a business update. The call will be accessible via telephone and a webcast. Longeveron is focused on developing cellular therapies for chronic aging-related and life-threatening conditions, with its lead product, LOMECEL-B™, targeting multiple indications including Aging Frailty and Alzheimer’s disease. An audio replay of the call will be available until April 6, 2021.
MIAMI, March 19, 2021 – Longeveron (NASDAQ: LGVN), a biotechnology company focused on cellular therapies for aging-related and life-threatening conditions, will present at the Q1 Virtual Investor Summit. The event runs from March 23-25, 2021, with Longeveron's presentation scheduled for March 24 at 10:00 am ET. This summit connects smallcap companies with investors, featuring over 100 companies and 300 investors. Longeveron is advancing its lead therapy, LOMECEL-B, aimed at conditions like Aging Frailty and Alzheimer’s disease. For more details, visit longeveron.com.
Longeveron Inc. (NASDAQ:LGVN) announced the partial exercise of its over-allotment option by underwriters in its IPO, increasing total shares sold to 2,910,000 at a public offering price of $10.00. This results in gross proceeds of $29.1 million before offering expenses. The SEC had previously declared effective a registration statement for these securities on February 11, 2021. Longeveron is focused on developing cell-based therapies for aging-related conditions and is sponsoring clinical trials for several serious health issues.
Longeveron Inc. (NASDAQ: LGVN) received FDA approval for expanded access to its investigational cell therapy, Lomecel-B, for a child with Hypoplastic Left Heart Syndrome (HLHS). The therapy aims to enhance the right ventricle's function, which is crucial for HLHS patients. Dr. Sunjay Kaushal of Ann & Robert H. Lurie Children’s Hospital will administer the treatment during surgery. Lomecel-B is derived from bone marrow and produced in Miami. The company successfully completed a Phase 1 study demonstrating safety, leading to a Phase 2 trial set for Q3 2021, progressing towards regulatory approval.
Longeveron Inc. (NASDAQ: LGVN) has amended its exclusive license agreement and formed a Collaborative Research and Development Agreement with the University of Miami. This agreement enhances access to clinical data and intellectual property related to Lomecel-B technology. Key elements include two IND applications for aging frailty and hypoplastic left heart syndrome, a patent application for treating endothelial dysfunction, and modifications to milestone payments. The partnership aims to advance Longeveron's cellular therapies aimed at chronic aging-related conditions.
Longeveron Inc. (NASDAQ: LGVN) announced an expansion of enrollment criteria for its Phase 1 RECOVER trial targeting Acute Respiratory Distress Syndrome (ARDS). The trial now includes mild ARDS patients, in addition to those with moderate and severe cases. This double-blind, placebo-controlled study will assess the safety and efficacy of Lomecel-B, a bone marrow-derived therapy, in COVID-19 or Influenza-infected ARDS patients. The study aims to mitigate severe inflammation and improve clinical outcomes. The RECOVER trial is partially funded by a TEDCO award and is set to grow its participating clinical sites.
Longeveron Inc. (NASDAQ: LGVN) has completed its Phase 2b clinical study of Lomecel-B for Aging Frailty, supported by a National Institute on Aging SBIR Grant. The study involved 149 subjects randomized to receive either Lomecel-B or a placebo, focusing on exercise tolerance and various health metrics. Top-line data is anticipated in Q3 2021. Aging Frailty affects approximately 8.1 million Americans over 65, leading to severe health complications. Lomecel-B aims to address inflammation related to this condition, and Longeveron is engaged in multiple clinical trials across various regions.
Longeveron Inc. (NASDAQ: LGVN) has completed its Phase 1 clinical trial of Lomecel-B for Hypoplastic Left Heart Syndrome (HLHS), demonstrating good tolerability with no serious adverse cardiac events reported. The trial involved 10 children undergoing the Glenn procedure. With promising safety results, the company plans to initiate a Phase 2 trial in Q3 2021, funded by a $5.6M grant from the NIH, which will assess Lomecel-B’s efficacy in 32 patients nationwide. Full Phase 1 results are expected in Q2 2021.
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