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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), a clinical stage regenerative medicine biotechnology company, has announced its upcoming participation at Biotech Showcase 2025. CEO Wa'el Hashad will deliver a corporate presentation on Tuesday, January 14, 2025, from 4:00 to 4:30 p.m. PT.
The company, which focuses on developing cellular therapies for life-threatening and chronic aging-related conditions, will make the presentation available via webcast through the 'Events and Presentations' section of their website. A replay will be accessible on Longeveron's website after the conference concludes.
Longeveron (NASDAQ: LGVN), a clinical stage regenerative medicine biotechnology company, has announced its participation in the Emerging Growth Virtual Conference scheduled for December 4-5, 2024. The company will present on December 5, 2024, from 12:00 to 12:30 p.m. ET.
The presentation will be accessible through the company's website under the 'Events and Presentations' section, with the webcast replay available for 180 days following the conference. Participants can submit questions in advance to Questions@EmergingGrowth.com or during the event.
Longeveron reported Q3 2024 financial results and business updates. The company's Phase 2b ELPIS II trial for Lomecel-B™ in HLHS has reached 80% enrollment, with FDA confirming it as pivotal for BLA submission. Total revenue increased 177% to $1.8M in the first nine months of 2024. Operating expenses decreased 14% year-over-year. The company maintains $22.8M in cash, expected to fund operations through Q4 2025. Notable developments include positive Phase 2a CLEAR MIND trial data in Alzheimer's disease and successful Type C FDA meeting confirming ELPIS II's pivotal status.
Longeveron (NASDAQ: LGVN) has appointed Devin Blass as Chief Technology Officer and Senior Vice President of Chemistry, Manufacturing, and Controls, effective December 2, 2024. Blass brings over 15 years of experience in advanced therapies development and manufacturing. His appointment comes at a important time as the company prepares for a potential Biological License Application submission for HLHS, pending positive results from the ongoing ELPIS II trial. Prior to joining Longeveron, Blass served at the New York Blood Center as SVP of Comprehensive Cell Solutions and held leadership positions at Talaris Therapeutics, Bellicum Pharmaceuticals, and Mesoblast.
Longeveron (NASDAQ: LGVN), a clinical stage regenerative medicine biotechnology company, has scheduled its third quarter 2024 financial results announcement for November 12, 2024, after market close. The company will host a conference call and webcast at 4:30 p.m. ET the same day to discuss results and provide a business update. The conference call will be accessible via phone (1.877.407.0789) with Conference ID 13749428, and a webcast replay will be available on the company's website.
Longeveron presented data on Lomecel-B, their cellular therapy for mild Alzheimer's disease (AD), at the CTAD24 conference. The presentation highlighted that Lomecel-B's ability to inhibit MMP14 correlates with improved clinical outcomes in mild AD patients. Research from the Phase 2a CLEAR MIND trial showed that patients receiving Lomecel-B lots with higher MMP14 inhibitory activity demonstrated enhanced responses versus placebo on various measures, including cognitive function, quality of life, and brain volume. The findings suggest that MMP14 inhibition may protect TIE2 receptor integrity and contribute to the immunomodulatory and pro-vascular effects of Lomecel-B in mild AD treatment.
Longeveron presented long-term survival data for Lomecel-B in Hypoplastic Left Heart Syndrome (HLHS) patients at the CHSS Annual Meeting. The ELPIS I follow-on study showed 100% 5-year survival and no heart transplants needed after Glenn surgery, compared to 83% survival and 5.2% transplant rate in the Single Ventricle Reconstruction Trial. ELPIS I met its primary safety endpoint with 100% survival and transplant-free rate one year post-treatment. The ongoing ELPIS II Phase 2b trial is evaluating Lomecel-B as an adjunct therapy for HLHS versus standard care at twelve institutions.
Longeveron Inc. (NASDAQ: LGVN) announced that its submission on Lomecel-B™ has been selected for a late breaking poster presentation at the 17th Clinical Trials on Alzheimer's Disease Conference (CTAD24) in Madrid, Spain. The presentation, titled 'Lomecel-B inhibition of MMP14 activity predicts Lomecel-B bioactivity in the treatment of mild Alzheimer's disease', will be held on October 29-30, 2024.
CEO Wa'el Hashad expressed excitement about presenting important Lomecel-B™ data at this leading Alzheimer's research forum, stating that the findings offer potential mechanistic and clinical insights for developing cellular-based therapy for Alzheimer's disease. The abstract will also be included in the special CTAD edition of the Journal of Prevention of Alzheimer's Disease (JPAD), the official journal of the CTAD conference.
Longeveron Inc. (NASDAQ: LGVN) announced that its submission titled "Long-term Transplant-free Survival Is Improved In Hypoplastic Left Heart Syndrome With Cell-based Therapy" has been selected for oral presentation at the Congenital Heart Surgeons' Society (CHSS) 51st Annual Meeting. The presentation will showcase 5-year long-term survival data from the ELPIS I follow-on study, focusing on the potential of Lomecel-B™ as an adjunct therapy for treating Hypoplastic Left Heart Syndrome (HLHS).
The presentation is scheduled for Sunday, October 27, 2024, during the Scientific Session II. Longeveron's CEO, Wa'el Hashad, expressed excitement about sharing the data at this leading forum for congenital heart disease clinical investigation. The company is currently conducting the ELPIS II Phase 2b clinical trial, which may serve as the foundation for a BLA submission for potential approval of Lomecel-B™ if the results are positive.
Longeveron Inc. (NASDAQ: LGVN), a clinical stage regenerative medicine biotechnology company, announced its participation in the UBS Virtual Organ Restoration and Cell Therapy Day on October 15, 2024. The company's CEO, Wa'el Hashad, will engage in a Fireside Chat with Ash Verma, SMID-cap Biotech & Specialty Pharma Analyst at UBS Equity Research.
The virtual event is scheduled for Tuesday, October 15, 2024, from 3:00 p.m. to 3:45 p.m. ET. Interested parties can register for the event by contacting their UBS representative. Additionally, Longeveron's investor presentation is available in the 'Events & Presentations' section of the company's website.
Longeveron focuses on developing cellular therapies for life-threatening and chronic aging-related conditions, positioning itself at the forefront of regenerative medicine research.
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