Mesoblast Limited · ASX:MSB
Mesoblast — 18th Global CardioVascular Clinical Trialists Forum (CVCT) 2021
17 slides from Mesoblast's conference presentation, Dec 7, 2021
Slide 1: DREAM HF Trial: Rexlemestrocel-L in Treatment of Heart Failure with Reduced Ejection Fraction
ASX: MSB; Nasdaq: MESO 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 Exhibit 99.2
Slide 2: Cautionary Note Regarding Forward-Looking Statements
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, levels of activity, perf
Slide 3: Our Mission
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 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 increasing2 Chronic heart failur
Slide 5: Mesenchymal precursor cells key mechanisms of action in the heart
Mesenchymal precursor cells (MPC) key mechanisms of action thought to beneficially impact the heart and the systemic vasculature: Reduction in cardiac and systemic inflammation Reversal of endothelial dysfunction Induction of microvascular network within viable heart muscle Reduction in heart muscle
Slide 6: DREAM-HF Trial: Overview
DREAM-HF Trial: Overview 18 to ≤80 years of age 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 coronary artery bypass graft surgery
Slide 7: Clinically Significant Endpoints in Persistent HFrEF
Clinically Significant Endpoints in Persistent HFrEF 1. Mortality (cardiovascular death, all-cause cardiac death, cardiac death from pump failure) 2. Irreversible Morbidity (non-fatal myocardial infarction, non-fatal cerebrovascular accident) 3. Non-fatal Decompensated HFrEF Morbidity Events (non-fa
Slide 8: Rexlemestrocel-L Did Not Further Reduce Hospitalization for Worsening HF Symptoms
Rexlemestrocel-L Did Not Further Reduce Frequency of Hospitalization for Worsening HF Symptoms Over Maximal Standard of Care 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 | 9 Time-to-First-Event for Cardiovascular Death or Non-fatal MI or Non-fatal Stroke
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: Greatest Treatment Effect in Patients with Micro- or Macro- Vascular Disease (Myocardial Ischemia and/or Diabetes) 10 1 Chronic HF of ischemic etiology includes epic
Slide 11: Myocardial Ischemia and/or Diabetes in Controls Identifies Subgroup with Worse Outcomes
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 11 3-Point TTFE Composite IMM MACE (n=276 Control Patients) Myocardial Ischemia &/or Diabetes (n=192) vs. Non-Ischemia/Non-Diabe
Slide 12: Rexlemestrocel-L Reduced Risk of MACE in Ischemic and/or Diabetic 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% Ischemic &/or Diabetic Patients (n=385) Non-Ischemic/Non-Diabetic Patients (n=152) Kaplan-Meier log rank statistics
Slide 13: Pre-Specified Hypotheses
Pre-Specified Hypotheses 1Pellicori P, Zhang J, Cuthert J, et.al. High sensitivity C-reactive protein in chronic heart failure: patient characteristics, phenotypes, and mode of death. Cardiovasc Res 2020;116:91-100 hs-CRP is a validated biomarker for risk of vascular disease, accelerated atheroscler
Slide 14: Composite 3-Point MACE and Inflammation
Composite 3-Point MACE and Inflammation Kaplan-Meier log rank statistics 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%
Slide 15: Investigational Agents Evaluated for Cardiovascular Risk Reduction: Comparison
Investigational Agents Evaluated for Cardiovascular Risk Reduction Using 3-Point IMM MACE*: Comparison With Rexlemestrocel-L in Patients With Myocardial Ischemia &/or Diabetes * TTFE Composite for Cardiovascular Death or Non-fatal MI or Non-fatal Stroke Wang CCL et al. Circulation 2019; 139: 1741-17
Slide 16: Conclusion & Key Next Steps
Conclusion & Key Next Steps | 16 Transendocardial delivery of 150 million allogeneic MPCs (rexlemestrocel-L) was safe and did not elicit any clinically meaningful immune-related responses Over a mean follow-up of 30 months, a single rexlemestrocel-L dose on top of maximal standard of care significan
Slide 17: IX mesoblast *,
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