Longeveron Inc. · NASDAQ:LGVN
Longeveron — 11th Annual International Conference on Frailty & Sarcopenia Research (September 2021)
24 slides from Longeveron's conference presentation, Sep 29, 2021
Slide 1: Trial Results: Lomecel-B for Aging Frailty
Trial Results: Lomecel-B for Aging Frailty A Phase 2b, Randomized, Blinded and Placebo-Controlled Trial to Evaluate the Safety and Efficacy of Lomecel-B Infusion in Patients with Aging Frailty Jorge G. Ruiz, MD, FACP Veterans’ Successful Aging for Frail Elders (VSAFE) Associate Director for Clinical
Slide 2: Forward Looking Statements
Forward Looking Statements Certain statements in this presentation that are not historical facts are forward-looking statements that reflect management's current expectations, assumptions, and estimates of future performance and economic conditions, and involve risks and uncertainties that could cau
Slide 3: Personal Disclosures
Personal Disclosures None. 3
Slide 4: Aging Frailty: Diminishing Health, Independence and Quality of Life
Aging Frailty: Diminishing Health, Independence and Quality of Life Frailty in older adults Age-associated decline in physiological reserve, with prevalence of ~15% of individuals >65 Characterized by mobility disability, weakness, fatigue, weight loss, slowness, low activity, etc. At high risk
Slide 5: Frailty in Older Adults
Frailty in Older Adults • No approved therapies for frailty • Current interventions focus on diet and exercise (SPRINTT trial) • We report on the results of Lomecel-B on aging frailty –Enrolled 148 patients –Funded by the NIA 5 © Longeveron. CONFIDENTIAL
Slide 6: Lomecel-B is a proprietary formulation of allogeneic bone marrow-derived MSCs
Lomecel-B is a proprietary formulation of allogeneic bone marrow- derived MSCs with pleiotropic mechanisms of action 3 Potential Mechanisms of Action Pro-vascular/pro-endothelial 4 Anti-inflammatory Anti-fibrotic 2 Stimulate intrinsic 1 regenerative/repair 6
Slide 7: Lomecel-B in Aging Frailty Phase 2b Clinical Trial
Lomecel-B in Aging Frailty Phase 2b Clinical Trial • Can Lomecel-B improve physical function? • Is there a dose-response relationship with Lomecel-B? • Are there patient reported outcomes (PROs) that correlate with change in physical function? Specific • Are there biomarkers that support the mechani
Slide 8: Phase 2b Study Aging Frailty Study Design
Phase 2b Study Aging Frailty Study Design Single Infusion Follow-Up (randomized, double-blinded) (Day 90, 180, 270 days) N=29 Group 1 Placebo Primary Endpoint Clinical Screen a) Change in 6MWT (180 days) N=35 Group 2 b) Dose-Response Curve (6MWT) Major Eligibility Criteria 25M Lomecel-B Baseline • 7
Slide 9: Lomecel-B in Aging Frailty Phase 2b Clinical Trial
Lomecel-B in Aging Frailty Phase 2b Clinical Trial • Can Lomecel-B improve physical function? • Is there a dose-response relationship with Lomecel-B? • Are there patient reported outcomes that correlate with change in physical function? Specific • Are there biomarkers that support the mechanisms of
Slide 10: Lomecel-B Infusion Improved Walking Distance Over 9 Months
Lomecel-B Infusion Improved Walking Distance Over 9 Months * Change from baseline: p<0.05 ** Change from baseline: p<0.01 # Versus placebo: p<0.05 ## Versus placebo: p<0.01
Slide 11: Lomecel-B led to ~50 meter increase in walking distance (200M dose)
Lomecel-B led to ~ 50 meter increase in walking distance (200 million cell dose group) Day 270 Δ6MWT (200M vs Placebo) = 63.4 meters (CI95% 17.1 – 109.62), p=0.0077 32m MCID4 (CHF patients) 17.8m MCID2 and 20m MCID3 -30m Δ = 19% increased mortality1 (CHF patients) * Change from baseline; p<0.05 ** C
Slide 12: Lomecel-B in Aging Frailty Phase 2b Clinical Trial
Lomecel-B in Aging Frailty Phase 2b Clinical Trial • Can Lomecel-B improve physical function? • Is there a dose-response relationship with Lomecel-B? • Are there patient reported outcomes that correlate with change in physical function? Specific • Are there biomarkers that support the mechanisms of
Slide 13: Statistically-significant dose response using 6MWT at 180 days
Statistically-significant dose response using 6MWT at 180 days. 13
Slide 14: Lomecel-B in Aging Frailty Phase 2b Clinical Trial
Lomecel-B in Aging Frailty Phase 2b Clinical Trial • Can Lomecel-B improve physical function? • Is there a dose-response relationship with Lomecel-B? • Are there patient reported outcomes that correlate with change in physical function? Specific • Are there biomarkers that support the mechanisms of
Slide 15: Change in PROMIS-Physical Function correlated with change in 6MWT
Change in PROMIS-Physical Function SF-20 correlated with change in 6MWT when all Lomecel-B combined Change in 6MWT Change in PROMIS-PF 15 PROMIS-PF: Patient-Reported Outcome Measurement Information System-Physical Function
Slide 16: Lomecel-B in Aging Frailty Phase 2b Clinical Trial
Lomecel-B in Aging Frailty Phase 2b Clinical Trial • Can Lomecel-B improve physical function? • Is there a dose-response relationship with Lomecel-B? • Are there patient reported outcomes that correlate with change in physical function? Specific • Are there biomarkers that support the mechanisms of
Slide 17: Lomecel-B 200M arm showed decreased serum levels of soluble Tie2
Lomecel-B 200M arm showed decreased serum levels of soluble Tie2 (sTie2): supports pro-vascular and anti-inflammatory MOAs * Change from baseline; p<0.05 ## Versus placebo; p<0.01 17
Slide 18: Lomecel-B 200M arm showed increased VEGF-D: supports pro-vascular MOA
Lomecel-B 200M arm showed increased VEGF-D: supports pro-vascular MOA VEGF-D: Vascular endothelial growth factor-D 18
Slide 19: Lomecel-B in Aging Frailty Phase 2b Clinical Trial
Lomecel-B in Aging Frailty Phase 2b Clinical Trial • Can Lomecel-B improve physical function? • Is there a dose-response relationship with Lomecel-B? • Are there patient reported outcomes that correlate with change in physical function? Specific • Are there biomarkers that support the mechanisms of
Slide 20: Safety Findings
Safety Findings No product-related serious adverse events (SAEs) No clinically significant issues identified via laboratory evaluations Consistent with prior safety results 20
Slide 21: Lomecel-B in Aging Frailty Phase 2b Clinical Trial
Lomecel-B in Aging Frailty Phase 2b Clinical Trial • Can Lomecel-B improve physical function? • Is there a dose-response relationship with Lomecel-B? • Are there patient reported outcomes that correlate with change in physical function? Specific • Are there biomarkers that support the mechanisms of
Slide 22: Summary of Results and Objectives
Summary of Results and Objectives Significant improvement in 6MWT (functional capacity endpoint) over 9 months……….. Demonstrated dose response curve suggests biological activity……………………… Patient-reported outcomes that correlate with functional changes………………………. Biomarkers supporting mechanisms of
Slide 23: Acknowledgements
Acknowledgements We thank the many patients who volunteered for this study All the clinical sites at staff that were part of this trial • Antonio Blanco, MD: Vista Health Research – Kendall, FL • Julian Javier, MD: Advanced Research for Health Improvement – Naples, FL • Anisa Otero, MD: Vista He
Slide 24: Thank You and Panel Discussion
Thank You and Panel Discussion www.longeveron.com Nasdaq: LGVN 24