Longeveron Inc. · NASDAQ:LGVN
Longeveron — Investor Presentation (May 2024)
24 slides from Longeveron's investor presentation, May 2024
Slide 1: Investor Presentation
A Regenerative Medicine Company Investor Presentation Nasdaq (LGVN) │ May 2024
Slide 2: Forward Looking Statements
Forward Looking Statements Certain statements in this presentation that are not historical facts are forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, which reflect management’s current expectations, assumptions, and estim
Slide 3: About Longeveron
About Longeveron • We are a mid-clinical stage company focused on development of Medicinal Signaling Cells (MSCs) for rare diseases and aging-related medical conditions with high Lomecel-B -- A Pipeline in a unmet need Product • We have conducted successful programs in Alzheimer’s Disease (AD) throu
Slide 4: Longeveron Overview
Longeveron Overview Developing Medicinal Signaling Cells (MSCs) with Therapeutic Potential in a Range of Unmet Needs Postive Mid-Stage Data for Lead Asset Lomecel-B Robust clinical pipeline in HLHS, Alzheimer’s Disease and Aging-related Frailty On-site GMP Facility for Production of Lomecel-B (not d
Slide 5: Lomecel-B: Multiple Mechanisms of Action (MOA)
Lomecel-B : Multiple Mechanisms of Action (MOA) Pro-vascular, Pro-regenerative and Anti-inflammatory: Repairs Tissue and Promotes Healing Lomecel-B Anti-inflammatory Cell-cell Interactions Exosome and MicroRNA Mitochondrial Transfer Cytokines (stem cells) Release (somatic cells) Key Advantages: • Su
Slide 6: Robust Clinical Pipeline
Robust Clinical Pipeline Indication Geography Phase 1 Phase 2 Phase 3 Milestones Hypoplastic Left Heart • ELIPIS 1 survival data U.S. presented at AHA 2023 Syndrome • ELPIS 2 actively enrolling • Positive Phase 2a data Alzheimer’s Disease U.S. announced Q4 2023 • U.S. Phase 2b Single-Dose Aging-rela
Slide 7: U.S. Opportunity: Large Markets with Unmet Medical Needs
U.S. Opportunity: Large Markets with Unmet Medical Needs Hypoplastic Left Heart Alzheimer’s Disease Aging-related Frailty Syndrome (HLHS) U.S. Patient Population 1,0003 5.8 million2 8.1 million1 U.S. Market Potential Up to $1B6 ~$5-10B5 ~$4 – 8B4 1 Company estimate based on US Census Bureau Populati
Slide 8: Lomecel-B for Hypoplastic Left Heart Syndrome (HLHS)
Lomecel-B for Hypoplastic Left Heart Syndrome (HLHS)
Slide 9: Significant Unmet Need in HLHS
Significant Unmet Need in HLHS • HLHS is a rare pediatric congenital heart defect in which the left side of the heart fails to normally develop • Affects ~1,000 babies/year in United States1 • Children with HLHS require 3 staged open-heart surgeries in order to survive • Norwood Procedure – 10 days
Slide 10: Clinical Approach to HLHS with Lomecel-B
Clinical Approach to HLHS with Lomecel-B Improving Cardiac Function through Regenerative Effect of MSCs • Dysfunction of the systemic right ventricle (RV) remains an Glenn: Redirects independent risk factor for death or heart-transplant Blood to PA (St II – 4 mo.) • Lomecel-B injected into myocardiu
Slide 11: Phase 1 Long-term Survival Data Presented at the 2023 American Heart Association
Phase 1 Long-term Survival Data Presented at the 2023 American Heart Association ELPIS I - 100% transplant-free survival for 10 patients up to 5 years post Glenn surgery • Long-term follow-up beyond the initial study ELPIS is ongoing • 5 years survival data are available • None of the 10 treated pat
Slide 12: Long-term Survival in HLHS from ELPIS I Trial of Lomecel-B
Long-term Survival in HLHS from ELPIS I Trial of Lomecel-B • Results from ELPIS I trial showed 100% survival (transplant-free) in Lomecel-B treated patients at up to 5 years • In SVR historically matched controls, 5-year mortality was ~20% 1 The NIH/NHLBI Pediatric Heart Network Single Ventricle Rec
Slide 13: ELPIS II: Phase 2b Study Design
ELPIS II: Phase 2b Study Design Phase 2b, Randomized, Multi-center study to Evaluate Lomecel-B Injection in Patients with HLHS Injections During Stage II Surgery Post Surgical Follow-Up Clinical Screening Baseline (randomized, blinded) (day 5, week 4, month 6, month 12) N=19 Eligibility Criteria • P
Slide 14: Lomecel-B for Alzheimer's Disease (AD)
Lomecel-B for Alzheimer’s Disease (AD)
Slide 15: Lomecel-B for Alzheimer's Disease
Lomecel-B for Alzheimer’s Disease Targeting CNS Inflammation • Previous therapies targeted amyloid plaques (b-secretase inhibitors and anti-amyloid antibodies) or neurofibrillary tangles (antibodies) with little evidence of disease state improvement • Inflammation is increasingly recognized as a maj
Slide 16: CLEAR MIND Phase 2a Study Design
CLEAR MIND Phase 2a Study Design Screening 4 X Infusions Final Follow Up Baseline Weeks -6 -4 0 4 8 12 16 26 39 Study Begins Randomization 1:1:1:1 Percentage of patients with at least Primary Endpoint 1 SAE 4 weeks from any infusion Group 1: Placebo Group 2: Single Dose Lomecel-BTM (25M) CADS compos
Slide 17: CLEAR MIND Phase 2a Results for Alzheimer's Disease
CLEAR MIND Phase 2a Results for Alzheimer’s Disease ▪ Results Announced Q4 2023 ▪ Lomecel-B demonstrated positive benefit/risk profile ▪ No Alzheimer’s Disease related imagine abnormalities, hypersensitivity, infusion-related reactions, interruptions of infusions, or death ▪ Pre-specified secondary
Slide 18: CLEAR MIND Phase 2a Conclusions
CLEAR MIND Phase 2a Conclusions ▪ Data suggest Lomecel-B may: ▪ Prevent disease worsening and even possibly improve cognitive function (based on the MoCa and MMSE indices) ▪ Improve quality of life based on caregiver assessment (ADRQL) ▪ Lomecel-B was also associated with reduction of loss in brain
Slide 19: Lomecel-B for Aging-related Frailty (AF)
Lomecel-B for Aging-related Frailty (AF)
Slide 20: Aging-related Frailty
Aging-related Frailty* Diminishing Health, Independence and QoL • Frailty Etiology of Aging-related Frailty ‒ Age-associated decline in reserve and function across multiple physiologic systems leading to inability to cope with stressors ‒ Characterized by mobility disability, weakness, fatigue, weig
Slide 21: Lomecel-B for Aging-related Frailty
Lomecel-B for Aging-related Frailty Completed U.S. Phase 2b Study Aging-related Frailty Study (N=143) • Designed to determine whether there was a dose response to a single infusion of Lomecel-B in Results Aging-related Frailty There was a statistically significant increase in • There were 5 treatmen
Slide 22: Experienced and Successful Leadership
Experienced and Successful Leadership Wa’el Hashad Joshua M. Hare, MD Lisa Locklear Nataliya Agafonova, MD Paul Lehr CO-FOUNDER & EVP & CHIEF FINANCIAL GENERAL COUNSEL & CHIEF EXECUTIVE OFFICER CHIEF MEDICAL OFFICER CHIEF SCIENCE OFFICER OFFICER SECRETARY › 35+ years as an executive leader › A pione
Slide 23: Longeveron Overview
Longeveron Overview Developing Medicinal Signaling Cells (MSCs) with Therapeutic Potential in a Range of Unmet Needs Postive Mid-Stage Data for Lead Asset Lomecel-B Robust clinical pipeline in HLHS, Alzheimer’s Disease and Aging-related Frailty On-site GMP Facility for Production of Lomecel-B (not d
Slide 24: Thank You
Thank You Website www.longeveron.com Chief Financial Officer Lisa Locklear llocklear@longeveron.com Investor Relations Derek Cole Investor Relations Advisory Solutions derek.cole@IRadvisory.com Social Media Converge Miami 1951 NW 7th AVENUE @LGVNSocial Suite 520 Miami, FL 33136 @Longeveron 844-470-2