Longeveron Inc

Longeveron Inc

Biotechnology

Miami, Florida 3,377 followers

Cell-Based Therapies

About us

We are a clinical-stage biotechnology company developing cellular therapies for aging-related and life-threatening conditions. Our lead investigational product is Lomecel-B™, which is derived from culture-expanded medicinal signaling cells (MSCs) that are sourced from bone marrow of young healthy adult donors. We believe that by using the same cells that promote tissue repair, organ maintenance, and immune system function, we can develop safe and effective therapies for some of the most difficult diseases and conditions associated with aging. We are currently conducting Phase 1 and 2 clinical trials in the following indications: Aging Frailty, Alzheimer’s disease, the Metabolic Syndrome, Acute Respiratory Distress Syndrome (ARDS), and hypoplastic left heart syndrome (HLHS), which is the current exception to our focus on aging. Our mission is to advance Lomecel-B™ and other cell-based product candidates into pivotal Phase 3 trials, with the goal of achieving regulatory approvals, subsequent commercialization and broad use by the healthcare community. Our philosophy is that healthy aging can be improved through regenerative medicine approaches. Life expectancy has substantially increased over the past century as a result of medical and public health advancements. However, this increase in longevity has not been paralleled by the number of years a person is expected to live in relatively good health, free of chronic disease and disabilities of aging – a period known as healthspan. As we age, we experience a profound decline, in both number and function, in our own MSCs, a decrease in immune system function, decline in blood vessel functioning, chronic inflammation and other issues. Our clinical data suggest that Lomecel-B™ addresses these conditions through multiple mechanisms of action, or MOAs, that simultaneously target key aging-related processes.

Industry
Biotechnology
Company size
11-50 employees
Headquarters
Miami, Florida
Type
Public Company
Founded
2014

Locations

Employees at Longeveron Inc

Updates

  • View organization page for Longeveron Inc, graphic

    3,377 followers

    Last week, we provided a business update and reported financial results through the first nine months of 2024. Highlights from the quarter include: - Phase 2b clinical trial (ELPIS II) evaluating Lomecel-BTM in rare pediatric disease HLHS has achieved more than 80% enrollment - Positive Type C meeting with U.S. FDA confirmed ELPIS II is pivotal and, if positive, acceptable for Biological License Application (BLA) submission for full traditional approval - Positive data from the Phase 2a clinical trial (CLEAR MIND) evaluating Lomecel-BTM in Alzheimer’s disease presented in Featured Research Oral Presentation at Alzheimer’s Association International Conference® (AAIC) - Total Revenue for the first nine months of 2024 increased 177% year-over-year to $1.8 million, primarily due to the successful initiation of contract manufacturing services and increased participant demand for the Bahamas Registry Trial - Focused expenditure management reduced first nine months Total Operating Expenses 14% year-over-year while maintaining investments in advancing the clinical pipeline - Current cash and cash equivalents are expected to be sufficient to fund Company through the fourth quarter of 2025based on the current operating budget and cash flow forecast Read the full press release: https://lnkd.in/gHt5zfpC #stemcell therapy #stemcell #HLHS #alzheimersdisease #endalz

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  • Longeveron is scheduled to report third quarter 2024 financial results tomorrow, Tuesday, November 12th, after the close of U.S. markets. Our CEO Wa’el Hashad, CFO Lisa Locklear, Founder and CSO Joshua Hare and CMO Dr. Nataliya Agafonova will host a conference call to discuss the results and provide a business update at 4:30pm ET.  For webcast access details, please visit https://lnkd.in/de4zh-Y9

    Events & Presentations

    Events & Presentations

    investors.longeveron.com

  • Positive long-term (5yr) transplant-free survival data from a multi-year follow-on study to the ELPIS I Phase 1 clinical trial evaluating stem cell therapy Lomecel-BTM in rare pediatric disease HLHS were featured in an oral presentation at the Congenital Heart Surgeons’ Society (CHSS) 51st Annual Meeting yesterday (Oct 27th).   https://lnkd.in/gs5PhRsm Key findings include: • 5-year post-Glenn procedure Kaplan-Meier survival was 100% in patients treated with Lomecel-B™ in ELPIS I, with none requiring heart transplant. This compared to 83% (95% CI= [77.4, 89.3]) transplant-free survival in the SVR trial through 5 years post-Glenn surgery, and a 5.2% (95% CI= [2.0, 8.3]) heart transplantation rate. • No Major Adverse Cardiovascular Events (MACE) were reported during the study. • No Lomecel-BTM related safety issues were reported. • These findings support the use of Lomecel-BTM as a potential adjunct to HLHS reconstruction surgery to improve transplant-free survival. #HLHS #celltherapy #stemcells #regenerativemedicine

  • Longeveron Lomecel-BTM data in Alzheimer's disease selected for Late Breaking Poster Presentation at the 17th edition of the Clinical Trials on Alzheimer’s Disease Conference (CTAD24) to be held October 29 -November 1, 2024 in Madrid, Spain. “We are excited to have been selected to present important Lomecel-B™ data at a leading forum for Alzheimer’s research and clinical investigation,” said Wa'el Hashad, CEO of Longeveron. “We believe the findings offer potential mechanistic and clinical insights in the development of cellular-based therapy for Alzheimer’s disease.”   Late Breaking Poster Presentation Date:         Tuesday, October 29, 2024, 3:00 p.m. CEST to Wednesday, October 30, 5:00 p.m. CEST Theme:    11. New Therapies and Clinical Trials Title:         LP029 “Lomecel-B inhibition of MMP14 activity predicts Lomecel-B bioactivity in the treatment of mild Alzheimer’s” The abstract of the poster 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. #CellTherapy #CTAD24 #alzheimers #endalz

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  • View organization page for Longeveron Inc, graphic

    3,377 followers

    @Longeveron #Lomecel-BTM 5-yr long-term transplant-free survival data in Hypoplastic Left Heart Syndrome #HLHS has been selected for oral presentation at the Congenital Heart Surgeons' Society (CHSS) Annual Meeting being held Oct 27-28, 2024 in Chicago. “We are extremely excited to share this 5-year long-term survival data from our ELPIS I follow-on study at the CHSS meeting this year, and to have the opportunity to present at a leading forum for congenital heart disease clinical investigation,” said Wa’el Hashad, CEO of Longeveron. “Based on the strength of the ELPIS I data, we are currently conducting the ELPIS II Phase 2b clinical trial, which is evaluating our cellular therapy Lomecel-BTM as a potential adjunct therapy for treating HLHS, and which, if positive, may serve as the foundation for a BLA submission for potential approval of Lomecel-BTM.” Oral Presentation Date:            Sunday October 27, 2024 Session:       Scientific Session II: IS STAGNATION IN TRANSPLANTATION A MYTH? ADVANCES IN PULSE, PULSELESS AND CELLS Time:             3:10 pm – 3:25 pm ET Title:              A07: “Long-term Transplant-free Survival Is Improved In Hypoplastic Left Heart Syndrome With Cell-based Therapy” #CellTherapy #CHSS

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  • View organization page for Longeveron Inc, graphic

    3,377 followers

    @Longeveron will participate in the 3rd Annual ROTH Healthcare Opportunities Conference taking place October 9, 2024 in New York City. Our CEO, Wa’el Hashad, will be speaking on the panel “Emerging Frontiers in Neuroscience” and hosting investor 1x1 meetings. The Longeveron investor presentation to be used at the conference is available at the “Events & Presentations” section of the Company’s website: https://lnkd.in/de4zh-Y9. #HLHS #Alzheimers #EndALZ #celltherapy #regenerative medicine

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  • Longeveron Inc will be in Phoenix Oct 7-9 for the @Alliance for Regenerative Medicine’s 2024 Cell and Gene Meeting on the Mesa. We look forward to connecting with senior pharma executives and investors to highlight our cellular therapy program in Alzheimer’s disease, which has generated positive data in successful Phase 1 and Phase 2a clinical trials, and our robust contract development and manufacturing services. To schedule a meeting with the Longeveron team during the conference, please use the conference partnering system, or email info@longeveron.com. #CGMesa24 #CellandGeneTherapy #CellTherapy #Alzheimers #EndALZ

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