A Global Leader in Stem Cell Therapies

We are a clinical stage regenerative medicine biotechnology company developing cellular therapies for life-threatening and chronic aging-related conditions. Through patient-focused, regenerative medicine, our research and therapies are aimed at improving healthspan.

HEALTHSPAN

The number of years a person is expected to live in relatively good health, free of chronic disease and disabilities of aging; The function and ability to do activities of daily living.

“Longevity is increasing. There is heightened focus on living longer, but that comes at a cost. A key goal within the medical community is to enhance the quality of life during the aging process – to improve healthspan.

At Longeveron, we hypothesize that stem cells might reduce the difficulties associated with aging and offer improved quality of life for patients with life-threatening conditions.”

Dr. Joshua Hare
Co-founder, Chief Science Officer and Chairman

Clinical Indications

Hypoplastic Left Heart Syndrome (HLHS)

HLHS is a congenital birth defect in which the left ventricle (one of the pumping chambers of the heart) is either severely underdeveloped or missing. As a consequence, babies born with this condition have severely diminished systemic blood flow, which requires children to undergo a complex, three stage heart reconstruction surgery process over the course of the first 5 years of their lives. We are testing the ability for cell therapy to improve cardiac function in these children.

Hypoplastic Left Heart Syndrome (HLHS)

HLHS is a congenital birth defect in which the left ventricle (one of the pumping chambers of the heart) is either severely underdeveloped or missing. As a consequence, babies born with this condition have severely diminished systemic blood flow, which requires children to undergo a complex, three stage heart reconstruction surgery process over the course of the first 5 years of their lives. We are testing the ability for cell therapy to improve cardiac function in these children.

Alzheimer’s Disease

Alzheimer’s disease, which affects nearly 7 million Americans, is a neurodegenerative disorder that leads to progressive memory loss and death. There are few drugs available for treating Alzheimer’s disease, and none that affect the long-term progression of the disease. Longeveron has partnered with the Alzheimer’s Association to advance clinical research using a cell therapy approach to treating this devastating disease.

Alzheimer’s Disease

Alzheimer’s disease, which affects over 5 million Americans, is a neurodegenerative disorder that leads to progressive memory loss and death. There are few drugs available for treating Alzheimer’s disease, and none that affect the long-term progression of the disease. Longeveron has partnered with the Alzheimer’s Association to advance clinical research using a cell therapy approach to treating this devastating disease.

Aging Frailty

Can we extend the period of time that we live in relatively good health, free of chronic disease, dependence and disability, a period known as “healthspan”? Individuals with Aging Frailty are at higher risk for adverse health outcomes such as falls, fractures, loss of independence, susceptibility to infection, institutionalization, hospitalization and death. At Longeveron, we are leading the efforts to develop a regenerative medicine approach for intervention and treatment of Aging Frailty.

Aging Frailty

Can we extend the period of time that we live in relatively good health, free of chronic disease, dependence and disability, a period known as “healthspan”? Individuals with Aging Frailty are at higher risk for adverse health outcomes such as falls, fractures, loss of independence, susceptibility to infection, institutionalization, hospitalization and death. At Longeveron, we are leading the efforts to develop a regenerative medicine approach for intervention and treatment of Aging Frailty.

NEWS & MEDIA

Longeveron® Named XPRIZE Healthspan Semifinalist and Top 40 Milestone 1 Award Recipient

  • Longeveron selected as a Top 40 Semifinalist based on the feasibility of its stem cell therapy
  • Stem cell therapy laromestorcel being evaluated as potential treatment for Alzheimer’s disease and HLHS, a rare pediatric disease and orphan-designated indication

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Longeveron® Announces Second Quarter 2025 Financial Results and Provides Business Update

  • Full enrollment achieved for pivotal Phase 2b clinical trial (ELPIS II) evaluating laromestrocel as a potential adjunct treatment for HLHS, a rare pediatric disease and orphan-designated indication
  • ELPIS II top-line trial results are anticipated in the third quarter of 2026, after the final follow-up at 12-months
  • Laromestrocel Biological License Application (BLA) submission for full traditional approval for HLHS anticipated in late 2026, if ELPIS II results are positive
  • Stem cell therapy pipeline expanded with FDA approval of IND application for laromestrocel as a potential treatment for Pediatric Dilated Cardiomyopathy

Read More >>

THIRD QUARTER

Longeveron® Announces Third Quarter 2025 Financial Results and Provides Business Update

  • On track for top-line trial results in the third quarter of 2026 from pivotal Phase 2b clinical trial ELPIS II. ELPIS II is evaluating laromestrocel as a potential adjunct treatment for HLHS, a rare pediatric disease and orphan-designated indication and is fully enrolled.
  • ELPIS II may serve as foundation for a Biologics License Application (BLA) submission for full approval for HLHS, if results demonstrate sufficient evidence of efficacy

Read More >>

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Longeveron® to Report Full Year 2024 Financial Results and Host Conference Call on February 28, 2025

Conference Call and Webcast Details:

Conference Call Number: 1.877.407.0789
Conference ID: 13751432
Date: Feb 28, 2025
Time: 4:05 PM ET

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Webcast>

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Longeveron® Announces Second Quarter 2024 Financial Results and Provides Business Update

  • Positive data from the Phase 2a clinical trial (CLEAR MIND ) evaluating Lomecel-B™ in Alzheimer’s disease presented in Featured Research Oral Presentation at Alzheimer’s Association International Conference® (AAIC)
  • U.S. FDA granted Lomecel-B™ both Regenerative Medicine Advanced Therapy (RMAT) designation and Fast Track designation for the treatment of mild Alzheimer’s disease
  • Phase 2b clinical trial (ELPIS II) evaluating Lomecel-B™ in rare pediatric disease HLHS has achieved 70% enrollment with completion of enrollment targeted for the end of 2024
  • Strengthened Board of Directors with election of 3 experienced industry veterans at Annual Meeting
  • Focused expenditure management reduced first half Total Operating Expenses 22% year-over-year
  • Financing transaction and warrant exercises in July raised gross proceeds of $15.3 million to fund continued clinical development, and current cash and cash equivalents are expected to be sufficient to fund Company through the fourth quarter of 2025

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1 First Quarter

Longeveron® Announces Second Quarter 2024 Financial Results and Provides Business Update

  • Phase 2b clinical trial evaluating Lomecel-BTM in rare pediatric disease HLHS on track for completing enrollment by end of 2024
  • Data from Phase 2a clinical trial evaluating Lomecel-BTM in Alzheimer’s Disease selected for Featured Research Oral Presentation at 2024 Alzheimer’s Association International Conference
  • Completed two financings in April raising gross proceeds of $11.4 million to fund continued clinical development
  • Focused expenditure management reduced first quarter Total Operating Expenses 8% year-over-year

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Longeveron Benzinga

Our CEO Wa’el Hashad participated in an interview with Benzinga All Access to discuss recent updates and progress across our clinical development program, including Top Line Results for CLEAR MIND Alzheimer’s disease Phase 2a Trial.

Watch a replay of the interview here

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Longeveron to Present at the Annual Dawson James Small Cap Growth Conference

MIAMI, Oct. 05, 2022 (GLOBE NEWSWIRE) -- Longeveron Inc. (NASDAQ: LGVN) ("Longeveron" or "Company"), a clinical stage biotechnology company developing regenerative medicines for unmet medical needs, announced today that Chris Min, M.D., Ph.D., Interim Chief Executive Officer, and Chief Medical Officer at Longeveron, will present at the upcoming Dawson James Small Cap Growth Conference taking place in Jupiter, Florida from October 11-12, 2022.

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Group 2289

Longeveron® Announces Completion of Enrollment of Pivotal Phase 2b Clinical Trial Evaluating Laromestrocel as a Treatment for Hypoplastic Left Heart Syndrome (HLHS)

  • Top-line trial results are anticipated in the third quarter of 2026, after the final follow-up at 12-months
  • Laromestrocel Biological License Application (BLA) submission for full traditional approval for HLHS anticipated in 2026, if ELPIS II results are positive
  • U.S. FDA has awarded laromestrocel HLHS program Rare Pediatric Disease designation, Orphan drug designation, and Fast track designation
  • Laromestrocel HLHS program addresses unmet medical needs with U.S. market potential of up to $1 billion

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1 First Quarter

Longeveron® Announces First Quarter 2025 Financial Results and Provides Business Update

  • Pivotal Phase 2b clinical trial (ELPIS II) evaluating laromestrocel in HLHS, a rare pediatric disease and orphan-designated indication, has reached approximately 95% enrollment and is expected to complete enrollment in the second quarter of 2025
  • Laromestrocel Biological License Application (BLA) submission for full traditional approval for HLHS anticipated in 2026, if ELPIS II is successful
  • Results from the Phase 2a clinical trial (CLEAR MIND) evaluating laromestrocel as a potential treatment for Alzheimer’s disease were published in Nature Medicine
  • Positive FDA meeting regarding development pathway for laromestrocel in mild Alzheimer’s disease; single, pivotal Phase 2/3 adaptive design clinical trial to support potential BLA submission

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Longeveron-4th quarter-2024

Longeveron® Announces Full-Year 2024 Financial Results and Provides Business Update

  • Pivotal Phase 2b clinical trial (ELPIS II) evaluating Lomecel-B™ (laromestrocel) in Hypoplastic Left Heart Syndrome (HLHS), a rare pediatric disease and orphan-designated indication, has achieved more than 90% enrollment and is expected to complete enrollment in the second quarter of 2025
  • Lomecel-B™ Biological License Application (BLA) submission for full traditional approval anticipated in 2026, if ELPIS II is successful
  • FDA meeting anticipated late in first quarter of 2025 to discuss possible development paths for Lomecel-B™ in mild Alzheimer’s disease
  • WHO International Nonproprietary Names (INN) Expert Committee approved “laromestrocel” for the non-proprietary name of Lomecel-B™
  • Total Revenue for 2024 increased 237% year-over-year to $2.4 million, primarily due to the successful initiation of contract manufacturing services and increased participant demand for the Bahamas Registry Trial

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2 Boardroom

Longeveron Announces Board of Directors Planned Transitions:

  • Richard Kender, retired SVP of Business Development and Corporate Licensing for Merck & Co., Inc., has been appointed to the Longeveron Board
  • Dr. Roger Hajjar, former head of R&D at Ring Therapeutics, has been nominated as a candidate for the Board, subject to election at the Company’s Annual Meeting of Stockholders
  • Neha Motwani, former managing director and senior healthcare investment banker at William Blair, Truist, and Oppenheimer and Company, also has been nominated as a candidate for the Board, subject to election at the Company’s Annual Meeting of Stockholders
  • Existing directors, Dr. Joshua Hare and Ursula Ungaro, have been nominated as candidates for re-election to the Board, subject to election at the Company’s Annual Meeting of Stockholders
  • Jeffrey Pfeffer and Cathy Ross have voluntarily resigned from the Board

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Longeveron Announces Positive Top-Line Results for Lomecel-B™ in its CLEAR MIND Phase 2a Clinical Trial in the Treatment of Mild Alzheimer’s Disease

  • Primary Endpoint of Safety Met Across all Study Groups
  • Statistical Significance Met for Secondary Endpoint Composite Alzheimer’s Disease Score (CADS) for Lomecel-B™ Low-Dose and for the Pooled Lomecel-B™ Treatment Group Relative to Placebo
  • Other Doses Demonstrated Numerical Slowing/Prevention of Disease Worsening Relative to Placebo
  • Additional Biomarker Data Expected to be Announced in the Coming Weeks

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Longeveron Appoints Wa’el Hashad as Chief Executive Officer

Longeveron Inc. (NASDAQ: LGVN) (“Longeveron” or “Company”), a clinical stage biotechnology company developing regenerative medicines for rare pediatric disease, aging-related conditions, and unmet medical needs, today announced the appointment of seasoned global pharmaceutical leader Wa’el Hashad as Chief Executive Officer. Mr. Hashad will assume the role of Chief Executive Officer effective March 1, 2023. Following Mr. Hashad joining Longeveron, current Interim Chief Executive Officer Chris Min, M.D., Ph.D., will continue in his role as Chief Medical Officer.
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Meeting

Longeveron Names Jerome Bailey Vice President of Business Operations

Executive brings more than 30 years of global biopharmaceutical operations and program management experience MIAMI, Sept. 15, 2022 (GLOBE NEWSWIRE) -- Longeveron Inc. (NASDAQ: LGVN), a clinical stage biotechnology company developing regenerative medicines for unmet medical needs, today announced it has named Jerome Bailey as the company’s new vice president of business operations.

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Longeveron® Announces Nature Medicine Publication of Results of Phase 2a Clinical Trial Evaluating Laromestrocel (Lomecel-B™) in Alzheimer’s Disease

  • Phase 2a results demonstrated laromestrocel (Lomecel-B™) improved cognitive function, quality of life, and brain volume in the treatment of mild Alzheimer’s disease
  • This encouraging clinical trial data adds to the body of evidence supporting the safety of single and multiple doses of laromestrocel (Lomecel-B™) treatment for mild Alzheimer’s disease and provides indications of efficacy in combating decline of brain volume and potentially cognitive function
  • Laromestrocel (Lomecel-B™) is, to Company’s knowledge, the first cellular therapeutic candidate to receive U.S. FDA Regenerative Medicine Advanced Therapy (RMAT) designation for Alzheimer’s disease

Read More >>

REPLAY AVAILABLE FROM OUR KOL EVENT

Click here to replay our KOL event, which was held on August 16, 2023,  featuring Sunjay Kaushal, MD, PhD and Ram Kumar Subramanyan, MD, PhD, discussing the potential for Medicinal Signaling Cells (MSCs), such as those making up Longeveron’s Lomecel-B™ injection, to improve the outcome for Hypoplastic Left Heart Syndrome (HLHS) patients.

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Longeveron Welcomes Three New Prominent Board Members

Seasoned Biotechnology and Corporate Management Experts, Khoso Baluch, Jeffrey Pfeffer, and Wa’el Hashad, Elected to Board at Annual Meeting of Stockholders

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Longeveron Announces New Long-Term Survival Data from ELPIS I Trial of Lomecel-B™ for Hypoplastic Left Heart Syndrome

Children in the ELPIS I trial had 100% survival up to 5 years of age after receiving Lomecel-B TM compared to 20% mortality rate observed from historical control data

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Longeveron Announces First Patient Dosed in Phase 2 Clinical Trial of Lomecel-B™ for Aging-Related Frailty in Japan

Longeveron Inc. (NASDAQ: LGVN) ("Longeveron" or "Company"), a clinical stage biotechnology company developing regenerative medicines for unmet medical needs, today announced that the first patient has been treated with Lomecel-B™ in its Phase 2 clinical trial in patients with Aging-Related Frailty in Japan. The trial aims to enroll 45 patients and its primary objective is to evaluate safety.

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Longeveron Announces Publication of Final Data from ELPIS I Trial of Lomecel-BTM for Hypoplastic Left Heart Syndrome in Peer-Reviewed Journal

Longeveron Inc. (NASDAQ: LGVN) ("Longeveron" or "Company"), a clinical stage biotechnology company developing regenerative medicines for unmet medical needs, today announced the publication of the full results from the Company’s ELPIS I trial of Lomecel-BTM for hypoplastic left heart syndrome (HLHS) in the European Heart Journal Open. In the uncontrolled open-label Phase 1b study entitled “Intramyocardial cell-based therapy with Lomecel-B during bidirectional cavopulmonary anastomosis for hypoplastic left heart syndrome: The ELPIS phase I trial,” patients (n=10) underwent the Glenn Procedure (an open heart surgery) at approximately 4-5 months old, and received intracardiac injections of Lomecel-BTM.

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U.S. Food and Drug Administration (FDA) Grants Fast Track Designation for Longeveron’s Lomecel-B™ Product for Treatment of Hypoplastic Left Heart Syndrome (HLHS) in Infants

New designation may expedite FDA review and potential approval to address this life-threatening heart condition affecting approximately 1,000 babies per year MIAMI, Aug. 31, 2022 (GLOBE NEWSWIRE) -- Longeveron Inc. (NASDAQ: LGVN) ("Longeveron" or "Company"), a clinical stage biotechnology company developing cellular therapies for chronic aging-related and life-threatening conditions, today announced the U.S.

Read More >>

REPLAY AVAILABLE FROM OUR KOL EVENT

Click here to replay our KOL event, which was held on August 16, 2023,  featuring Sunjay Kaushal, MD, PhD and Ram Kumar Subramanyan, MD, PhD, discussing the potential for Medicinal Signaling Cells (MSCs), such as those making up Longeveron’s Lomecel-B™ injection, to improve the outcome for Hypoplastic Left Heart Syndrome (HLHS) patients.

Click Here to Watch the Replay