Lomecel-B (laromestrocel) / Longeveron - LARVOL DELTA

Longeveron Announces Closing Of Up To $17.5 Million Public Offering (GlobeNewswire) - "The gross proceeds to the Company from the offering, before deducting the placement agent’s fees and other offering expenses payable by the Company, were approximately $5.0 million....The Company intends to use the net proceeds from the offering for funding for its ongoing clinical and regulatory development of laromestrocel for the treatment of several disease states and indications, including HLHS, Alzheimer’s disease, and pediatric DCM, obtaining regulatory approvals, advancing CMC activities to support BLA readiness, capital expenditures, working capital and other general corporate purposes."

Financing • Alzheimer's Disease • Cardiomyopathy • Respiratory Diseases

Longeveron Announces U.S. FDA Approval of IND Application for a Phase 2 Pivotal Registration Study Evaluating Laromestrocel as a Treatment of Pediatric Dilated Cardiomyopathy (DCM) (GlobeNewswire) - "Phase 2 clinical trial initiation anticipated in first half of 2026...Longeveron Inc...announced that the U.S. Food and Drug Administration (FDA) has approved the Investigational New Drug (IND) application for its stem cell therapy laromestrocel as a potential treatment for pediatric dilated cardiomyopathy (DCM). The accepted IND application provides for moving directly to a single Phase 2 pivotal registration clinical trial."

IND • New P2 trial • Cardiomyopathy

ELPISII: Evaluation of Lomecel-B™ Injection in Patients With Hypoplastic Left Heart Syndrome (HLHS): A Phase IIb Clinical Trial. (clinicaltrials.gov) - P2 | N=40 | Active, not recruiting | Sponsor: Longeveron Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Cardiovascular

ELPISII: Evaluation of Lomecel-B™ Injection in Patients With Hypoplastic Left Heart Syndrome (HLHS): A Phase IIb Clinical Trial. (clinicaltrials.gov) - P2 | N=40 | Recruiting | Sponsor: Longeveron Inc. | Trial completion date: Aug 2025 ➔ Aug 2026 | Trial primary completion date: Jun 2025 ➔ Jun 2026

Trial completion date • Trial primary completion date • Cardiovascular

Longeveron to Attend BIO International Convention 2025 (The Manila Times) - "At the conference, members of the Longeveron management team will host meetings with global pharmaceutical company executives to explore potential partnership and strategic opportunities for the Company’s Alzheimer’s disease program, which has generated positive data in successful Phase 1 and Phase 2 clinical trials."

Commercial • Alzheimer's Disease

Longeveron Announces First Quarter 2025 Financial Results and Provides Business Update (GlobeNewswire) - "Research and Development Expenses: Research and development expenses for the three months ended March 31, 2025 increased to approximately $2.5 million from approximately $2.2 million for the same period in 2024...a $0.2 million increase in amortization expense related to patent costs and a $0.1 million increase in supplies costs, partially offset by a $0.4 million decrease in clinical trial expense, primarily driven by the absence of costs related to the now-completed CLEAR MIND Alzheimer’s disease clinical trial..."

Commercial • Alzheimer's Disease

Longeveron Announces First Quarter 2025 Financial Results and Provides Business Update (GlobeNewswire) - "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."

FDA filing • Trial status • Cardiovascular

Longeveron Announces Positive Type B Meeting with U.S. FDA Regarding Pathway to BLA for Laromestrocel (Lomecel-BTM) in Alzheimer’s Disease (GlobeNewswire) - "Longeveron Inc...today announced the positive outcome of a Type B meeting with the U.S. Food and Drug Administration (FDA), supporting the advancement of laromestrocel (Lomecel-B), a proprietary, scalable, allogeneic, investigational cellular therapy, as a potential treatment for Alzheimer’s disease (AD)...The Company and the FDA reached foundational alignment on the overall study design for a proposed single, pivotal, seamless adaptive Phase 2/3 clinical trial, including proposed AD patient population, proposed placebo control, laromestrocel (Lomecel-BTM) dose selection and frequency, trial duration and trial endpoints...Contingent upon obtaining additional non-dilutive funding and/or partnering support, the Company anticipates initiating the pivotal clinical trial in the second half of 2026."

FDA event • New P2/3 trial • Alzheimer's Disease

Longeveron Announces Nature Medicine Publication of Results of Phase 2a Clinical Trial Evaluating Laromestrocel (Lomecel-B) in Alzheimer’s Disease (GlobeNewswire) - P2a | N=50 | CLEAR MIND (NCT05233774) | Sponsor: Longeveron Inc. | "Key findings include: The trial safety evaluations supported that laromestrocel (Lomecel-B) is safe and well tolerated in the study population, in both single and multiple dosing regimens, and that patients showed no incidence of hypersensitivity, infusion-related reactions, and no cases of amyloid-related imaging abnormalities (ARIA); Patients treated with laromestrocel (Lomecel-B) showed an overall slowing of disease worsening compared to placebo; Administration of laromestrocel (Lomecel-B) was associated with slowing cognitive and functional decline as demonstrated by statistically significant results in the Montreal Cognitive Assessment and statistical trending improvements compared to placebo in CDR-SB and MMSE....We look forward to our planned meeting with the FDA in March to review this data and discuss the future development path for laromestrocel (Lomecel-B) in Alzheimer’s disease."

FDA event • P2a data • Alzheimer's Disease

Allogeneic mesenchymal stem cell therapy with laromestrocel in mild Alzheimer's disease: a randomized controlled phase 2a trial. (PubMed, Nat Med) - P2 | "Larger-scale clinical trials of laromestrocel in AD are warranted. ClinicalTrials.gov registration: NCT05233774 ."

Clinical • Journal • P2a data • Alzheimer's Disease • CNS Disorders • Immunology • Inflammation

ELPISII: Evaluation of Lomecel-B™ Injection in Patients With Hypoplastic Left Heart Syndrome (HLHS): A Phase IIb Clinical Trial. (clinicaltrials.gov) - P2 | N=38 | Recruiting | Sponsor: Longeveron Inc. | Trial completion date: Aug 2026 ➔ Aug 2025 | Trial primary completion date: Jun 2026 ➔ Jun 2025

Trial completion date • Trial primary completion date • Cardiovascular

Longeveron Announces World Health Organization Approval of “laromestrocel” as International Non-proprietary Name for Stem Cell Therapy Lomecel-B (Businesswire) - "Longeveron Inc...today announced that the International Nonproprietary Names (INN) Expert Committee of the World Health Organization approved 'laromestrocel' for the non-proprietary name of the Company’s cellular therapy Lomecel-B. Commonly referred to as a generic name, each INN is a unique name used to identify pharmaceutical substances or active pharmaceutical ingredients. Lomecel-B is a proprietary, scalable, allogeneic cellular therapy being evaluated in Alzheimer’s disease and hypoplastic left heart syndrome (HLHS), a rare pediatric disease and orphan indication."

Commercial • Alzheimer's Disease • Cardiovascular

ELPISII: Evaluation of Lomecel-B™ Injection in Patients With Hypoplastic Left Heart Syndrome (HLHS): A Phase IIb Clinical Trial. (clinicaltrials.gov) - P2 | N=38 | Recruiting | Sponsor: Longeveron Inc. | Trial primary completion date: Mar 2025 ➔ Jun 2026 | Trial completion date: Aug 2025 ➔ Aug 2026

Trial completion date • Trial primary completion date • Cardiovascular

Drug Development. (PubMed, Alzheimers Dement) - P2 | "Brain MRI in this proof-of-concept study with small sample size reveals that Lomecel-B was associated with measurable neuroanatomical and neuroinflammatory improvements compared with progressive AD pathology observed in placebo. Accordingly, these findings support further development of Lomecel-B in a larger dose-finding study."

Journal • Alzheimer's Disease • CNS Disorders • Dementia • Inflammation

Drug Development. (PubMed, Alzheimers Dement) - P2 | "Together, the study achieved proof-of-concept in a small sample size. Accordingly, these findings support further development of Lomecel-B in a larger dose-finding study."

Journal • Alzheimer's Disease • CNS Disorders • Dementia

Longeveron Announces Third Quarter 2024 Financial Results and Provides Business Update (GlobeNewswire) - "Alzheimer’s disease (AD):...The Company anticipates meeting with the FDA in the first quarter of 2025 to review future clinical and regulatory strategy."

FDA event • Alzheimer's Disease

Longeveron Presents Lomecel-B Data for Alzheimer’s Disease Indication in Late Breaking Poster Presentation at the Clinical Trials on Alzheimer’s Disease Conference (CTAD24) (GlobeNewswire) - P2a | N=50 | CLEARMIND (NCT05233774) | Sponsor: Longeveron Inc. | "Longeveron Inc...today announced that its submission entitled “Lomecel-B inhibition of MMP14 activity predicts Lomecel-B bioactivity in the treatment of mild Alzheimer’s disease” was presented as a late breaking poster presentation at the 17th edition of the Clinical Trials on Alzheimer’s Disease Conference (CTAD24) taking place October 29 -November 1, 2024 in Madrid, Spain....Supernatant from Lomecel-B CLEAR MIND lots contained MMP14i activity, high levels of TIMP2 and VEGF-A protein. Patients receiving Lomecel-B lots with higher levels of MMP14i activity demonstrated enhanced responses vs. placebo on the composite Alzheimer’s disease score (CADS, the study secondary endpoint) than those who received low potency lots. Similar associations were evident with responses in the MoCA, ADCS-ADL, and left hippocampal volume."

P2a data • Alzheimer's Disease • CNS Disorders

Lomecel-B inhibition of MMP14 activity predicts Lomecel-B bioactivity in the treatment of mild Alzheimer's disease (CTAD 2024) - No abstract available

Late-breaking abstract • Alzheimer's Disease • CNS Disorders • MMP14

Longeveron Lomecel-B Data in Alzheimer’s Disease Selected for Late Breaking Poster Presentation at the Clinical Trials on Alzheimer’s Disease Conference (CTAD24) (GlobeNewswire) - "Longeveron...announced that its submission entitled 'Lomecel-B inhibition of MMP14 activity predicts Lomecel-B bioactivity in the treatment of mild Alzheimer’s disease' has been selected for a 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."

Late-breaking abstract • Alzheimer's Disease

Longeveron to Attend Alliance for Regenerative Medicine’s Cell & Gene Meeting on the Mesa (GlobeNewswire) - "At the conference, members of the Longeveron management team will host meetings with global pharmaceutical company executives to explore potential partnership and strategic opportunities for the Company’s cellular therapy program in Alzheimer’s disease (AD), which has generated positive data in successful Phase 1 and Phase 2a clinical trials, and to highlight the Company’s contract development and manufacturing business at its 15,000 square feet facility with 8 current Good Manufacturing Practice (cGMP) cleanroom suites."

Commercial • Alzheimer's Disease • CNS Disorders

A systematic review of clinical efficacy and safety of cell-based therapies in Alzheimer's disease. (PubMed, Dement Neuropsychol) - "Also, there is considerable risk of bias regarding the outcome assessment scales. Cell-based therapies are well tolerated by AD patients, which emphasizes the need for further, carefully planned randomized studies to reach evidence-based clinical recommendations in this respect."

Journal • Review • Alzheimer's Disease • Bone Marrow Transplantation • CNS Disorders • Dementia • Transplantation

Longeveron Presents Study Results from CLEAR MIND Phase 2a Clinical Trial of Lomecel-B in Mild Alzheimer’s Disease at the Alzheimer’s Association International Conference (AAIC) (GlobeNewswire) - P2a | N=50 | CLEARMIND (NCT05233774) | Sponsor: Longeveron Inc. | "The randomized, placebo-controlled Phase 2a CLEAR MIND trial evaluated a total of 48 patients (36 were treated with Lomecel-B and 12 received placebo)....The clinical trial achieved its primary safety and secondary efficacy endpoints, and the study results presented at AAIC 2024 support the therapeutic potential of Lomecel-B. Key findings include: The established safety profile of Lomecel-B for single and multiple dosing regimens was demonstrated in study data that showed no incidence of hypersensitivity, infusion-related reactions, and no cases of amyloid-related imaging abnormalities (ARIA). Patients treated with Lomecel-B showed an overall slowing of disease worsening compared to placebo....There was a statistically significant improvement relative to placebo observed in the Alzheimer’s Disease Cooperative Study Activities of Daily Living (ADCS-ADL)."

P2a data • Alzheimer's Disease

Longeveron Announces U.S. FDA Grants Fast Track Designation for Lomecel-B for the Treatment of Mild Alzheimer’s Disease (GlobeNewswire) - "Longeveron...announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to Lomecel-B for the treatment of mild Alzheimer’s Disease. Lomecel-B is a proprietary, scalable, allogeneic, investigational cellular therapy being evaluated across multiple indications, including Alzheimer’s Disease (Phase 2a completed)....The Fast Track designation and continued clinical development of Lomecel-B are based upon positive topline data reported from the Phase 2a CLEAR MIND clinical trial. Full results from the CLEAR MIND clinical trial evaluating Lomecel-B in mild Alzheimer’s Disease have been selected for a Featured Research Session oral presentation and poster presentation at AAIC, taking place July 28 - August 1, 2024..."

Fast track • P2a data • Alzheimer's Disease

Longeveron Announces U.S. FDA Grants Lomecel-B Regenerative Medicine Advanced Therapy (RMAT) Designation for the Treatment of Mild Alzheimer’s Disease (GlobeNewswire) - "Longeveron Inc...announced that the U.S. Food and Drug Administration (FDA) granted Regenerative Medicine Advanced Therapy (RMAT) designation to Lomecel-B for the treatment of mild Alzheimer’s Disease. Lomecel-B is a proprietary, scalable, allogeneic cellular investigational therapy being evaluated across multiple indications, including Alzheimer’s Disease (Phase 2a completed), Aging-related Frailty (Phase 2b completed) and hypoplastic left heart syndrome (HLHS) (Phase 2b on-going). To the Company's knowledge based on publicly available information, Lomecel-B is the first cellular therapeutic candidate to receive RMAT designation for Alzheimer’s Disease."

FDA event • Alzheimer's Disease • CNS Disorders

Results from a Phase 2a Proof-of-Concept Double-Blind, Randomized, Placebo-Controlled Trial of Lomecel-BTM in Mild Alzheimer’s Disease Dementia (AAIC 2024) - P2 | "Together, the study achieved proof-of-concept in a small sample size. Accordingly, these findings support further development of Lomecel-B in a larger dose-finding study."

Clinical • P2a data • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Dementia