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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 (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.
Longeveron Inc. (NASDAQ: LGVN) reported its Q1 2022 financial results, highlighting a revenue of $0.4 million, consistent with Q1 2021. Clinical trial revenue increased by 88% to $0.3 million due to reduced COVID-19 travel restrictions, while grant revenue fell 72% to $0.1 million due to the completion of prior trials. R&D expenses rose by 6% to $1.4 million, and G&A expenses increased by 16% to $2.0 million, leading to a net loss of $3.5 million. Cash and short-term investments stood at $30.6 million. The company anticipates sufficient funds to cover expenses into H1 2024.
Longeveron Inc. (NASDAQ: LGVN) announced the resignation of CEO Geoff Green, effective June 1, 2022. K. Chris Min, M.D., Ph.D., the current Chief Medical Officer, will serve as Interim CEO while a nationwide search for a permanent successor takes place. Under Green's leadership, Longeveron progressed significantly, advancing their Lomecel-B therapy into clinical trials. The company specializes in cellular therapies targeting aging-related and life-threatening conditions and is pursuing Phase 1 and 2 trials for multiple indications including Alzheimer’s disease and frailty.
Longeveron Inc. (NASDAQ: LGVN) will release its first quarter 2022 financial results on May 13, 2022, before the U.S. market opens. The management will host a conference call at 8:30 a.m. EST on the same day to discuss the results and provide corporate updates. Longeveron is focused on developing cellular therapies for aging-related and life-threatening conditions. Its lead product, Lomecel-B, is currently in Phase 1 and 2 trials addressing multiple serious conditions. For more, visit longeveron.com.
Longeveron Inc. (NASDAQ: LGVN) announces participation in key events showcasing its commitment to developing cell therapeutics for aging-related diseases. Key presentations include: April 20 - Kevin N. Ramdas discusses Lomecel-B clinical trial results at ICFSR, Boston. April 21 - Anthony Oliva presents on cognitive frailty. April 25 - Ramdas presents at the Latinos & Alzheimer’s Symposium. April 26 - Joshua Hare presents on aging and frailty at Longevity Leaders World Congress, London. The Company aims to advance its therapies into Phase 3 trials for conditions like Alzheimer's and Aging Frailty.
Longeveron Inc. (LGVN) announced a new Cooperative Research and Development Agreement (CRADA) with the U.S. Department of Veterans Affairs (VA) to add a Miami VA clinical site to its Phase 2 Alzheimer’s Disease trial. This collaboration marks the third CRADA with the VA, which also includes studies on aging frailty and Covid-19. The Phase 2 trial, named CLEAR MIND, will explore the safety and efficacy of Lomecel-B in treating mild Alzheimer’s, enrolling 48 patients. Recent peer-reviewed data indicated that Lomecel-B shows promise in slowing cognitive decline and improving quality of life.
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.
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