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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, a clinical-stage biotechnology company, has successfully closed a private placement of approximately 1.17 million shares of common stock and warrants, raising an estimated $20.5 million. The warrants, exercisable at $17.50 per share and expiring in five years, will help fund clinical development for its lead product, Lomecel-B, targeting conditions like Hypoplastic Left Heart Syndrome and Alzheimer’s Disease. This private placement was facilitated by EF Hutton, and the shares are offered only to accredited investors, pending SEC registration.
On December 1, 2021, Longeveron Inc. (NASDAQ: LGVN) announced a private placement agreement to raise approximately $20.5 million from institutional investors. The company will sell around 1.17 million shares of common stock at $17.50 per share, including warrants for the same amount. The proceeds will support the clinical development of Lomecel-B, aimed at treating conditions like Hypoplastic Left Heart Syndrome and Alzheimer's Disease. The offering is expected to close by December 3, 2021.
Longeveron Inc. (NASDAQ: LGVN) has announced a clinical research agreement with Japan's National Center for Geriatrics and Gerontology (NCGG) and Juntendo University Hospital to study the safety and efficacy of Lomecel-B in older, frail Japanese subjects. This collaboration is crucial as Japan has a rapidly aging population, with 29.1% of its citizens aged 65 or older. The study aims to enroll 45 subjects and evaluate various health parameters. Previously, Lomecel-B showed promising results in U.S. trials, indicating potential for improvements in physical function and overall health.
Longeveron Inc. (NASDAQ: LGVN) announced that the FDA has granted Rare Pediatric Disease designation for Lomecel-B, its treatment for Hypoplastic Left Heart Syndrome (HLHS), a critical congenital heart defect affecting 1,000 infants annually in the U.S. The product is currently in Phase 2 clinical trials. Phase 1 results showed that all 10 infants treated survived and had no major adverse effects. If approved, Longeveron may be eligible for a priority review voucher, potentially accelerating the market entry of Lomecel-B.
Longeveron Inc. (NASDAQ: LGVN) provided a business update and financial results for Q3 2021, reporting revenue of $0.2 million, down 89% from $1.8 million YoY, primarily due to decreased grant revenue. The net loss widened to $4.9 million, or $0.25 per share, compared to $0.9 million, or $0.06 per share, in Q3 2020. The company is advancing its lead candidate, Lomecel-B, with ongoing Phase 1 and 2 trials in various conditions, including Alzheimer’s disease and Acute Respiratory Distress Syndrome. Cash reserves increased to $19 million, sufficient to cover expenses through at least Q4 2022.
Longeveron (NASDAQ: LGVN), a clinical stage biotech firm, will release its Q3 2021 financial results on November 12, 2021, before US market open. The management will host a conference call at 8:30 a.m. ET the same day. The call can be accessed via phone or webcast, and a replay will be available until November 18, 2021. Longeveron focuses on cellular therapies for aging-related and life-threatening conditions, with its lead product Lomecel-B undergoing Phase 1 and 2 trials in various indications such as Alzheimer's disease and Metabolic Syndrome.
Longeveron Inc. (NASDAQ: LGVN) has selected Biorasi LLC as its clinical research organization to conduct a Phase 2 clinical trial evaluating its Lomecel-B infusion for Alzheimer’s Disease. This partnership aims to enhance the development of Lomecel-B, a cell-based therapy derived from medicinal signaling cells, targeting chronic aging-related conditions. The trial is expected to commence by the end of this year or early 2022, as per Kevin N. Ramdas, MD, MPH from Longeveron. Biorasi’s extensive experience in neurology studies positions them as a strong collaborator for this project.
Longeveron (NASDAQ: LGVN), a clinical-stage biotechnology company, has activated two new clinical sites for the ELPIS II Trial, which assesses Lomecel-B injections for infants with Hypoplastic Left Heart Syndrome (HLHS). The trial, now in Phase 2, aims to enroll 38 infants and is funded by the NIH's NHLBI. The newly added sites are Advocate Children’s Hospital and Primary Children’s Hospital in Utah. CEO Geoff Green emphasized the importance of these additions for timely execution and increased participation options for families.
Longeveron (NASDAQ: LGVN) announced that CEO Geoff Green will present at the Dawson James Small Cap Growth Conference on October 21, 2021, at 11:25 a.m. ET, in Jupiter, Florida. The presentation will focus on the company's progress in clinical research programs for Alzheimer’s disease, Aging Frailty, and Hypoplastic Left Heart Syndrome. Attendees can access a live webcast via the company's Investors & Media section. Longeveron is developing cell-based therapies aimed at chronic and aging-related conditions, with ongoing Phase 1 and 2 clinical trials for various indications.
Longeveron Inc. (NASDAQ: LGVN) announced positive preliminary results from its Phase 2b trial of Lomecel-B in Aging Frailty subjects. At 270 days, Lomecel-B significantly reduced the biomarker Tie-2 compared to placebo, showcasing a dose-dependent response. In particular, the high-dose group (200 million cells) exhibited a decrease of -936.85 pg/mL (p=0.0095) in sTIE-2 levels, indicating improved vascular health. Additionally, frail subjects showed improved exercise tolerance, walking an average of 47.9 meters further after 270 days. Results were presented at the International Conference for Frailty & Sarcopenia Research.
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