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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 has announced the election of Roger Hajjar, MD, to its Board of Directors. Dr. Hajjar, an acclaimed scientist in cardiac gene therapy and current Director of the Gene and Cell Therapy Institute at Mass General Brigham, brings extensive expertise to the company. His contributions in gene therapy have initiated numerous clinical trials and his methodologies are globally implemented. This move is part of Longeveron's strategy to refresh its Board with experienced leaders to enhance its ongoing therapeutic developments, including Lomecel-B™. Dr. Hajjar's background includes 500 publications and various awards. His academic credentials include degrees from Johns Hopkins and Harvard Medical School, with significant professional contributions at Massachusetts General Hospital, Mount Sinai, and Flagship Pioneering.
Longeveron has raised $4.4 million in gross proceeds from the exercise of existing warrants to purchase 1,697,891 shares of its Class A common stock at $2.35 per share, originally issued in April 2024. The exercise was facilitated by H.C. Wainwright & Co. as the exclusive placement agent. In return, Longeveron has issued new unregistered warrants for 3,395,782 shares, exercisable at $2.50 per share for 24 months. The company plans to use the net proceeds to fund the clinical and regulatory development of Lomecel-B™ for conditions like HLHS and Alzheimer’s, as well as for general corporate purposes. The new warrants were issued in a private placement and are not registered under the Securities Act.
Longeveron, a clinical stage biotech firm listed on NASDAQ as LGVN, will participate in the Virtual Life Sciences Investor Forum on June 20, 2024. The company focuses on developing cellular therapies for critical and aging-related conditions, such as hypoplastic left heart syndrome (HLHS) and Alzheimer’s disease. The event includes a fireside chat scheduled at 10:30 a.m. ET on June 20, 2024. The webcast can be accessed via the 'Events and Presentations' section of Longeveron's website, with a replay available for 90 days.
Longeveron announced the exercise of warrants for $4.4 million in gross proceeds. These warrants, issued in April 2024, allowed the purchase of 1,697,891 Class A common stock shares at $2.35 per share. H.C. Wainwright & Co. is the offering's exclusive placement agent. In exchange for immediate cash exercise and a $0.125 fee per new warrant, Longeveron will issue new warrants for 3,395,782 Class A common stock shares at $2.50 per share, valid for 24 months. The proceeds will fund clinical and regulatory development of Lomecel-B™, regulatory approvals, capital expenditures, and general corporate purposes. The new warrants are offered under Section 4(a)(2) of the Securities Act and are not registered under state securities laws.
Longeveron announces the completion of an investigator meeting for its ELPIS II Phase 2b clinical trial evaluating Lomecel-B™ as a treatment for Hypoplastic Left Heart Syndrome (HLHS), a rare pediatric heart defect. The trial is on track to complete enrollment of 38 patients by the end of 2024. Multiple nationally recognized children's treatment centers are participating. Phase 1 results showed a 100% transplant-free survival rate up to five years, compared to a 20% historical mortality rate. The trial aims to further evaluate the safety and efficacy of Lomecel-B™.
Longeveron, a clinical stage biotechnology company (NASDAQ: LGVN), announced its participation in the Emerging Growth Virtual Conference on June 12-13, 2024. The company will present on June 12 at 1:45 p.m. ET. The presentation will be webcast and accessible via the 'Events and Presentations' section of Longeveron's website. A replay will be available for 180 days post-conference. Questions can be submitted in advance or during the event.
Longeveron announced the launch of a new contract development and manufacturing business at its 15,000 sq. ft. GMP facility. The company signed its first contract with Secretome Therapeutics, a biotechnology firm working on neonatal mesenchymal stem cell-based therapeutics. This new business line is expected to generate $4-5 million in annual revenues. Longeveron aims to leverage its expertise and capacity to advance other pharmaceutical programs. The company continues to focus on its lead therapeutic candidate, Lomecel-B, for multiple conditions, including hypoplastic left heart syndrome and Alzheimer's disease.
Longeveron (NASDAQ: LGVN), a clinical-stage regenerative medicine biotech, will attend the BIO International Convention from June 3-6, 2024, in San Diego. At the event, Longeveron's management will meet with global pharma executives to discuss partnerships and strategic opportunities for its Alzheimer's disease program. Their lead candidate, Lomecel-B™, showed promising results in the Phase 2a CLEAR MIND trial, achieving primary safety and secondary efficacy endpoints. The trial indicated Lomecel-B™ could slow or prevent disease worsening in mild Alzheimer's patients. These findings will be presented at the 2024 Alzheimer's Association International Conference.
Longeveron (NASDAQ: LGVN) reported its Q1 2024 financials, highlighting significant progress in clinical trials for its lead candidate, Lomecel-B™. Notably, the Phase 2b trial for HLHS is on track for completion by 2024 end. Data from a Phase 2a Alzheimer's trial will be presented at the 2024 Alzheimer’s Conference, showing promising results. Financials show a 96% revenue increase to $0.5 million, driven by the Bahamas Registry Trial, and an 8% reduction in operating expenses. The company raised $11.4 million in April, bolstering its cash reserves to $2.3 million, which is expected to fund operations through Q4 2024.
Longeveron Inc. (NASDAQ: LGVN) announced planned transitions on its Board of Directors, welcoming Richard Kender, a retired Merck executive, and nominating Dr. Roger Hajjar and Neha Motwani as new board candidates. Existing directors Joshua Hare and Ursula Ungaro are up for re-election. Jeffrey Pfeffer and Cathy Ross have resigned voluntarily. These changes aim to bring in new, experienced leaders to enhance Longeveron's therapeutic development programs.
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