Lomecel-B (laromestrocel) / Longeveron - LARVOL DELTA

Longeveron Announces Presentation of Clinical Data at the 2026 Alzheimer’s Association International Conference (AAIC) that Indicate Its Cellular Therapy Laromestrocel Reduced Neuroinflammation in Patients with Alzheimer’s Disease (The Manila Times) - "In this new post-hoc exploratory analysis of CLEAR-MIND results, the anti-inflammatory effect was observed to be most prominent in the hippocampus, temporal lobe, and other AD-associated areas and correlated (Spearman) with both increased brain volume and improved cognitive and quality of life scores...However, free water was numerically reduced compared with placebo in all groups receiving laromestrocel (fornix at week 26: 25Mx4, N=11, p=0.058; sagittal stratum at week 39: pooled 25Mx4 and 100Mx4 treatment groups, N=21, p=0.063; uncinate fasciculus (left) at week 39: 100Mx4, N=10, p=0.064)...Blood plasma samples from the trial were assessed using NuLISA. Plasma NuLISA indicated a reduction compared with placebo (N=11) at 39 weeks in neurogranin, a marker of neuronal degradation (25Mx4, N=12, p=0.023), and an increase in IL-13, an anti-inflammatory cytokine that regulates brain microglia activation (25Mx1, N=12, p=0.043)."

P2a data • Alzheimer's Disease

Laromestrocel Stabilizes Brain Inflammation In Key Alzheimer's Disease Gray And White Matter Regions As Assessed Using Free Water MRI (AAIC 2026) - No abstract available

Alzheimer's Disease • CNS Disorders • Inflammation

New Phase 2a Clinical Data Analysis of Stem Cell Therapy Laromestrocel in Mild Alzheimer's Disease Accepted for Poster Presentation at the 2026 Alzheimer's Association International Conference (Investing News Network (INN))

P2a data • Alzheimer's Disease

Development Programs: Hypoplastic Left Heart Syndrome (HLHS) (GlobeNewswire) - "Topline results from the Phase 2b clinical trial (ELPIS II) evaluating laromestrocel as a potential adjunct therapy for HLHS are anticipated in August 2026."

P2b data • Cardiovascular

Development Programs:…Alzheimer’s disease (AD) (GlobeNewswire) - "The Company is seeking to forge strategic collaborations and/or partnerships for the advancement of laromestrocel in addressing AD."

Licensing / partnership • Alzheimer's Disease

Longeveron’s Investigational New Drug (IND) application for its stem cell therapy laromestrocel as a potential treatment for PDCM became effective in July 2025 (GlobeNewswire) - "This IND provides for moving directly to a single Phase 2 registrational clinical trial. The Company currently anticipates initiation of the Phase 2 clinical trial in 2027, with planning and preparation beginning in 2026."

New P2 trial • Cardiomyopathy • Cardiovascular

Mesenchymal Stem-cell Therapy in Mild-to-moderate Alzheimer’s Disease: Safety, Cognitive Efficacy, and Biomarker Signals from Controlled Human Trials (AAN 2026) - "Other studies (Lomecel-B/LMSCs) found MSCs safe without dose-limiting toxicity...Cognitive outcomes were heterogeneous with isolated short-term gains, and imaging/biomarker signals suggest slower atrophy and vascular modulation. Evidence remains limited; larger, biomarker-driven phase II/III RCTs are needed to confirm efficacy."

Biomarker • Clinical • Alzheimer's Disease • CNS Disorders

Randomized phase 2b dose-escalation trial of stem cell therapy with laromestrocel for aging frailty. (PubMed, Cell Stem Cell) - P2b | "Increased 6MWT distance correlates with PROMIS Physical Function score, and increasing doses of laromestrocel are associated with decreases in soluble (degraded) tyrosine kinase with immunoglobulin and epidermal growth factor homology domains (TIE2), the cognate receptor for the angiopoietins, identifying a potential biomarker of laromestrocel responsiveness. These findings identify a stem cell therapy approach for the management of patients with hypomobility and other features of aging frailty."

Journal • P2b data • Geriatric Disorders • EGF

Longeveron Granted FDA Type C Meeting Ahead Of Pivotal ELPIS II Data For HLHS (Nasdaq) - "ELPIS II topline results are expected in Q3 2026, and the company aims to ensure that the dataset- if positive- will be acceptable for a full traditional BLA submission."

FDA event • P2b data • Cardiovascular

Therapeutic Efficacy of Mesenchymal Stem Cells (MSCs) on Alzheimer's Disease: Review of Clinical Results. (PubMed, Tissue Eng Regen Med) - "The analysis of 17 clinical trials and 5 relevant clinical outcomes showed that MSCs therapy if feasible and generally safe in AD patients. There are indications of potential therapeutic benefits such as improved cognitive function or quality of life measures in some AD patients. However, its therapeutic efficacy has not been proven definitely due to small size of subjects, variations in dosage, MSCs source, and administration scheme (route, timing, and frequency). Larger subject sizes and well-controlled trials are needed to provide more conclusive evidence."

Journal • Review • Alzheimer's Disease • CNS Disorders

Reduced brain neuroinflammation after laromestrocel treatment in mild AD: results from the CLEAR MIND study (CTAD 2025) - No abstract available

Inflammation

Longeveron New MRI Biomarker Data Linking Neuroinflammation to Clinical Outcomes in Patients with Mild Alzheimer’s Disease Presented at the Clinical Trials on Alzheimer’s Disease Conference (CTAD 2025) (GlobeNewswire) - "Patients receiving laromestrocel exhibited a durable reduction in free water fraction compared with placebo (N=11) at week 39 for several brain regions, including hippocampus (Group 4: p=0.004, N=8; Group 3: p=0.037, N=8), which showed a dose response, and also temporal cortex (Group 3: p=0.032, N=8), occipital cortex (Group 3: p=0.003, N=8), and parietal cortex (Group 3: p=0.038, N=8). This new result was accompanied by clinical benefit as wells as reduced brain atrophy, as demonstrated in our study. Of the 14 brain regions, 13 (all but frontal) showed pooled treatment group responses (Groups 2, 3, and 4 combined) in the direction of improvement (reduction in free water) by week 39."

P2a data • Alzheimer's Disease

Longeveron…announced that its submission entitled 'Reduced brain neuroinflammation after laromestrocel treatment in mild AD: results from the CLEAR MIND study' has been selected for a poster presentation at the 18th Clinical Trials on Alzheimer’s Disease Conference (CTAD 2025)… (GlobeNewswire)

P2a data • 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 stem cell therapy program in Alzheimer’s disease (AD): Positive data from successful Phase 1 and Phase 2a AD clinical trials."

Clinical • Trial status • Alzheimer's Disease

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