Mesoblast Limited · ASX:MSB
Mesoblast — 18th Global CardioVascular Clinical Trialists Forum (CVCT) 2021
17 slides from Mesoblast's conference presentation, Dec 6, 2021
Slide 1: DREAM HF Trial: Rexlemestrocel-L in Treatment of HFrEF
For personal use only mesoblast DREAM HF Trial: Rexlemestrocel-L (MPCs) in the Treatment of Heart Failure with Reduced Ejection Fraction (HFrEF) Presentation at the 18th Global CardioVascular Clinical Trialists Forum (CVCT), Washington DC DECEMBER 2021 ASX: MSB; Nasdaq: MESO
Slide 2: Cautionary Note Regarding Forward-Looking Statements
For personal use only CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS This presentation includes forward-looking statements that relate to future events or our future financial performance and involve known and unknown risks, uncertainties and other factors that may cause our actual results, le
Slide 3: Our Mission
For personal use only Our Mission Mesoblast is committed to bringing to market innovative cellular medicines to treat serious and life-threatening illnesses
Slide 4: Chronic Heart Failure: Rising Incidence & High Mortality
Chronic Heart Failure: Rising Incidence & High Mortality For personal use only Cardiovascular disease (CVD) remains the leading cause of death in the United States1 Heart failure affects 6.5 million patients in the US and 26 million patients globally. As populations age, the prevalence is increa
Slide 5: Proposed Mechanism of Action of Intra-Cardiac MPC Administration
Proposed Mechanism of Action of Intra-Cardiac MPC Administration in Treatment of both Heart Failure & Large Vessel Atherosclerosis For personal use only Mesenchymal precursor cells (MPC) key mechanisms of action thought to beneficially impact the heart and the systemic vasculature: Reduction in ca
Slide 6: DREAM-HF Trial: Overview
DREAM-HF Trial: Overview only 18 to ≤80 years of age Inclusion Criteria NYHA class II / III, LVEF ≤ 40% Receiving optimal medical therapies for heart failure at stable and tolerated doses for at least 1 month before study intervention No option for percutaneous coronary intervention or coron
Slide 7: Clinically Significant Endpoints in Persistent HFrEF
Clinically Significant Endpoints in Persistent HFrEF For personal use only 3-Point Composite MACE Pre-Specified Endpoints Endpoint 1. Mortality (cardiovascular death, all-cause cardiac death, 4. Irreversible Morbidity or cardiac death from pump failure) Mortality: IMM (cardiovascular/cardiac death,
Slide 8: Rexlemestrocel-L Did Not Further Reduce Hospitalization for Worsening HF
Rexlemestrocel-L Did Not Further Reduce Frequency of Hospitalization for Worsening HF Symptoms Over Maximal Standard of Care For personal use only All Patients (n=537) HR: 1.2 p=0.4 |8
Slide 9: Rexlemestrocel-L Reduced Incidence of 3-Point Composite MACE
Rexlemestrocel-L Reduced Incidence of 3-Point Composite MACE (CV Death, MI or Stroke) Compared to Controls Across All 537 Treated Patients Time-to-First-Event for Cardiovascular Death or For personal use only Non-fatal MI or Non-fatal Stroke |9
Slide 10: Evaluation of Rexlemestrocel-L on 3-Point IMM MACE in High-Risk Populations
Evaluation of Rexlemestrocel-L on 3-Point IMM MACE in Pre-Specified Patient Populations With Reproducibly High-Risk for Poor Outcomes: For personal use only Greatest Treatment Effect in Patients with Micro- or Macro- Vascular Disease (Myocardial Ischemia and/or Diabetes) 1 Chronic HF of ischemic eti
Slide 11: Myocardial Ischemia and/or Diabetes in Controls Identifies Worse-Outcome Subgroup
Myocardial Ischemia &/or Diabetes in Control Patients in DREAM-HF Trial Identifies Subgroup with Worse Outcomes, as Measured by 3-Point IMM MACE, than other HFrEF Controls For personal use only 3-Point TTFE Composite IMM MACE (n=276 Control Patients) Myocardial Ischemia &/or Diabetes (n=192) vs. Non
Slide 12: Reduced Risk of 3-Point MACE in High-Risk Patients by 36%
Rexlemestrocel-L Reduced Risk of 3-Point TTFE Composite IMM MACE in High-Risk Patients with Myocardial Ischemia &/or Diabetes by 36% For personal use only Ischemic &/or Diabetic Patients Non-Ischemic/Non-Diabetic Patients (n=385) (n=152) Kaplan-Meier log rank statistics | 12
Slide 13: Pre-Specified Hypotheses
Pre-Specified Hypotheses For personal use only hs-CRP is a validated biomarker for risk of vascular disease, accelerated atherosclerosis, myocardial infarction, and heart failure severity Cut-points of <2mg/L, ≥ 2 mg/L, ≥ 3mg/l, and ≥ 4mg/L were pre-specified for sensitivity analyses in the DREA
Slide 14: Composite 3-Point MACE and Inflammation
Composite 3-Point MACE and Inflammation For personal use only In Patients with Myocardial Ischemia and/or Diabetes with hsCRP≥2 mg/L Rexlemestrocel-L Reduced Risk of TTFE for 3-Point MACE by 54% Kaplan-Meier log rank statistics | 14
Slide 15: Investigational Agents Evaluated for Cardiovascular Risk Reduction
Investigational Agents Evaluated for Cardiovascular Risk Reduction Using 3-Point IMM MACE*: Comparison With Rexlemestrocel-L in Patients With Myocardial Ischemia &/or Diabetes For personal use only * TTFE Composite for Cardiovascular Death or Non-fatal MI or Non-fatal Stroke Wang CCL et al. Circulat
Slide 16: Conclusion & Key Next Steps
Conclusion & Key Next Steps 1. Transendocardial delivery of 150 million allogeneic MPCs (rexlemestrocel-L) was safe and did not elicit For personal use only any clinically meaningful immune-related responses 2. Over a mean follow-up of 30 months, a single rexlemestrocel-L dose on top of maximal stan
Slide 17: For personal use only
For personal use only mesoblast
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