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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) has partnered with Kinesiometrics Inc. to leverage their digital data-driven technology for enhanced measurement of functional capacity and quality of life in clinical studies involving Lomecel-B.
Following a recent Phase 2b study that showed significant improvements in walking distance for older frail subjects post-infusion, this collaboration aims to provide real-time data collection through a mobile application. This innovation is expected to improve patient monitoring and potentially aid regulatory processes by offering detailed insights into treatment outcomes.
Longeveron Inc. (NASDAQ: LGVN) announced promising results from its Phase I clinical trial of Lomecel-B for treating Hypoplastic Left Heart Syndrome (HLHS). The study reported no major adverse cardiac events or treatment-related infections within the first month post-treatment. Impressively, 100% of the infants injected with Lomecel-B remained alive and heart-transplant free after one year, a significant improvement over the historical rate of 78%. The transition to a Phase 2 trial further aims to evaluate Lomecel-B's safety and effectiveness in a controlled setting.
Longeveron Inc. (NASDAQ: LGVN) announced its participation in the H.C. Wainwright 23rd Annual Global Investor Conference, with a virtual presentation available for on-demand viewing starting September 13, 2021. Longeveron specializes in cellular therapies for chronic, aging-related conditions. Their lead product, Lomecel-B, aims to address serious disorders like Aging Frailty and Alzheimer’s disease. Following the presentation, an archived webcast will be accessible for up to 90 days on their website.
Longeveron Inc. (NASDAQ: LGVN) reported favorable outcomes from its Phase 2b trial of Lomecel-B, a therapy aimed at addressing Aging Frailty. At Day 180, patients receiving higher doses (50M, 100M, 200M) exhibited a statistically significant increase in six-minute walk test distances compared to placebo. While pairwise comparisons to placebo did not achieve significance, exploratory results at Day 270 indicated notable improvements. Longeveron plans to advance its research and discuss findings with regulatory authorities, as no serious adverse events were reported, maintaining a positive safety profile for Lomecel-B.
Longeveron Inc. (NASDAQ: LGVN) reported its Q2 2021 financial results, revealing a revenue decline to $0.5 million from $0.9 million year-over-year, primarily due to reduced grant revenue. The company achieved statistically significant results in its Phase 2b Aging Frailty trial for Lomecel-B, but did not meet primary efficacy endpoints at Day 180 compared to placebo. R&D expenses rose 205% to $2.0 million, contributing to a net loss of $5.0 million. However, cash reserves increased significantly to $16.8 million, providing runway through Q4 2022. A conference call is scheduled for today at 8:00 AM EDT.
Longeveron Inc. (NASDAQ: LGVN) announced it will release its second quarter 2021 financial results on August 13, 2021, before US market opening. Management will host a conference call at 8:00 AM to discuss these results. The call can be accessed via multiple phone lines and will be available for replay until August 19, 2021. Longeveron is focused on developing cellular therapies for chronic and life-threatening aging-related conditions, with its lead product, LOMECEL-B™, currently in Phase 1 and 2 clinical trials targeting several serious medical issues.
Longeveron Inc. (NASDAQ: LGVN) has announced the enrollment of the first patient in a Phase 2b clinical trial for Lomecel-B, aimed at infants with Hypoplastic Left Heart Syndrome (HLHS). Funded by the National Heart, Lung, and Blood Institute, this double-blind study will assess the safety and efficacy of the investigational MSC product. With a target enrollment of 38 infants across seven U.S. children's hospitals, the trial builds upon the successful Phase 1 results, which reported no major adverse events. The study aims to improve heart function post-surgery in HLHS patients.
Longeveron Inc. (NASDAQ: LGVN) announced that two abstracts for its investigational cell therapy, Lomecel-B, have been accepted for presentation at the Gerontological Society of America (GSA) 2021 Annual Scientific Meeting, scheduled for November 10-14, 2021, in Phoenix, AZ. The abstracts include:
- A Phase 2b Clinical Trial Assessing Lomecel-B Infusion in Individuals with Aging Frailty
- A Phase 1 Trial Assessing Lomecel-B Infusion in Individuals with Alzheimer’s Disease
This indicates ongoing progress in clinical trials aimed at addressing aging-related conditions.
Longeveron Inc. (NASDAQ: LGVN) announced the acceptance of an abstract for a poster presentation at the 2021 Annual Alzheimer's Association International Conference. This presentation highlights the results of their Phase 1 trial on Lomecel-B infusion in patients with mild Alzheimer’s disease. The trial met its primary endpoint of safety and feasibility, showing no Alzheimer’s Related Imaging Abnormalities (ARIA). Additionally, low-dose Lomecel-B demonstrated a reduction in cognitive decline compared to placebo, measured by the Mini Mental State Exam (MMSE). A Phase 2 trial is anticipated in the second half of 2021.
Longeveron Inc. (NASDAQ: LGVN), a clinical stage biotechnology firm, announced that CEO Geoff Green will present virtually at the World Stem Cell Summit on June 17, 2021, at 9:45 AM EDT. The 20-minute presentation will cover a corporate overview and research updates, followed by a 20-minute Q&A session. Interested participants can register for the event via the World Stem Cell Summit and the Investor Forum. Longeveron focuses on developing cellular therapies for aging-related and life-threatening conditions, with its lead product Lomecel-B currently in clinical trials for multiple indications.
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