Mesoblast Limited · ASX:MSB

Mesoblast — Healthcare Conference (January 2021)

35 slides from Mesoblast's conference presentation, Jan 12, 2021

1. Slide 1: Rexlemestrocel-L for Cardiovascular Diseases

   For personal use only Rexlemestrocel-L for Cardiovascular Diseases Heart Failure Phase 3 Trial Top Line Results January 2021 ASX: MSB; Nasdaq: MESO

2. 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

3. 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 |3

4. Slide 4: Product Pipeline

   Product Pipeline For personal use only MESOBLAST PRODUCT THERAPEUTIC PHASE 1/2 PHASE 3 REGISTRATION COMMERCIAL COMMERCIAL CANDIDATE AREA RIGHTS PARTNERS Acute GVHD - Pediatric Global * ex-Japan Pediatric & adult Acute GVHD - Adult Remestemcel-L (RYONCILTM) systemic Acute Respiratory Distress Syndrom

5. Slide 5: Platform Technology – Mechanism of Action

   Platform Technology – Mechanism of Action Our mesenchymal precursor/stromal cells respond to and are activated by multiple inflammatory cytokines through For personal use only surface receptors, resulting in orchestration of an anti-inflammatory cascade IL-10 Breg TH1 Mesenchymal Proliferation Cytok

6. Slide 6: Global IP Estate Provides Substantial Competitive Advantage

   Global IP Estate Provides Substantial CompetitiveAdvantage For personal use only  Extensive patent portfolio with protection extending through 2040 in all major markets  Over 1,100 patents and patent applications (82 patent families) across all major jurisdictions Therapeutic Areas  Covers compos

7. Slide 7: Commercial Scale Manufacturing Capability

   Commercial Scale Manufacturing Capability Manufacturing Remestemcel-L For personal use only  Scalable allogeneic “off-the-shelf” cellular platforms  Manufacturing meets stringent criteria of international regulatory agencies  Robust quality assurance processes ensure final product with batch-to-b

8. Slide 8: Overview of Collaboration with Novartis for Remestemcel-L

   Overview of Collaboration with Novartis for Remestemcel-L For personal use only  Worldwide license and collaboration agreement with Novartis for the development, manufacture and commercialization of remestemcel-L*  Initial focus is on the treatment of acute respiratory distress syndrome (ARDS) and

9. Slide 9: SR-aGVHD Regulatory & Commercial Update

   SR-aGVHD Regulatory & Commercial Update For personal use only  On August 13 2020, results from 309 children with steroid refractory acute graft versus host disease (SR-aGVHD) treated with remestemcel-L were presented to the Oncologic Drugs Advisory Committee (ODAC) of the United States Food and Dru

10. Slide 10: MPC-06-ID for Chronic Low Back Pain

    MPC-06-ID for Chronic Low Back Pain For personal use only  Phase 3 trial of MPC-06-ID for chronic low back pain in 404 patients: − Final study visits for all patients have been completed − Ongoing quality review of all data is being completed at the study sites − Data readout expected shortly  Con

11. Slide 11: DREAM HF Phase 3 Trial in Chronic Heart Failure - Mechanism of Action

    For personal use only DREAM HF - Phase 3 Trial in Chronic Heart Failure - Rexlemestrocel-L Mechanism of Action

12. Slide 12: 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

13. Slide 13: Myocardial Infarction & Stroke in Chronic Heart Failure: Current Unmet Needs

    Myocardial Infarction & Stroke in Chronic Heart Failure: Current Unmet Needs For personal use only  Each year in the United States approx. 805,000 people suffer from a myocardial infarction (heart attack) and approx. 795,000 people experience a new or recurrent stroke1  A major consequence of a he

14. Slide 14: 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

15. Slide 15: Rexlemestrocel-L for Chronic Heart Failure: Treatment Algorithm

    Rexlemestrocel-L for Chronic Heart Failure For personal use only Treatment Algorithm in Progressive Heart Failure Progressive Vascular (Endothelial) Dysfunction and Heart Failure Early  ACEI or ARB Mesoblast Target Market  Statins Chronic Heart Failure1  Beta blockers  Re-vascularization or valv

16. Slide 16: DREAM HF Phase 3 Trial: Rexlemestrocel-L vs Sham Clinical Outcomes

    For personal use only DREAM HF - Phase 3 Trial in Chronic Heart Failure - Rexlemestrocel-L vs Sham Clinical Outcomes

17. Slide 17: DREAM HF: Overview of Phase 3 Trial

    DREAM HF: Overview of Phase 3 Trial For personal use only  Mesoblast’s allogeneic cell therapy rexlemestrocel-L has a dual mechanism of action that involves immunomodulation and improvement in blood vessel integrity/function  DREAM-HF Phase 3 trial was designed to evaluate whether rexlemestrocel-L

18. Slide 18: DREAM HF: Patient Flow

    DREAM HF: Patient Flow For personal use only 1,167 patients assessed for eligibility Intent-to-Treat (ITT) 565 patients randomized Randomized • 283 to MPCs Patient Population • 282 to Control N = 565 Pts. 28 randomized but not treated • 18 randomized to MPCs • 10 randomized to Control 537 randomized

19. Slide 19: DREAM HF: Baseline FAS Summary Data by NYHA Class II or III

    DREAM HF: Baseline FAS Summary Data by NYHA CLASS II or III For personal use only | 19

20. Slide 20: DREAM HF: Baseline FAS Summary Data by NYHA Class II or III

    DREAM HF: Baseline FAS Summary Data by NYHA CLASS II or III For personal use only | 20

21. Slide 21: DREAM HF: Recurrent Hospitalization Events and Non-Fatal Ischemic MACE

    For personal use only DREAM HF - Recurrent Decompensated Heart Failure Hospitalization Events - Non-Fatal Ischemic MACE (Heart attacks or Strokes)

22. Slide 22: Rexlemestrocel-L Did Not Reduce Non-Fatal Heart Failure MACE

    Rexlemestrocel-L Did Not Reduce Non-Fatal Heart Failure MACE (Recurrent Decompensated Heart Failure Events or High-Grade Arrhythmias) For personal use only All Patients (n=537) HR: 1.2 p=0.4 | 22

23. Slide 23: Rexlemestrocel-L Significantly Reduced Incidence of Ischemic MACE by 60%

    Rexlemestrocel-L Significantly Reduced Incidence of Ischemic MACE (MI, Stroke) by 60% Relative to Controls (n=537 Patients) For personal use only Absence of Ischemic MACE All Patients (n=537) REX 5% vs Controls 13%, p=0.002 REX Effect Size: ↓60% Days from Day 0 Treatment | 23

24. Slide 24: Elevated Baseline CRP Levels Predict Rexlemestrocel-L Benefit

    Elevated Baseline CRP Levels Predict Rexlemestrocel-L Benefit on Incident Heart Attacks or Strokes … Consistent with Anti-Inflammatory MOA For personal use only Myocardial Infarction or Cerebrovascular Accident ALL TTFE ANALYSIS REX Effect Compared with 60% Controls P-value 0.002 COVARIATES Ischemic

25. Slide 25: Ischemic MACE Reduced by 57% & 67% in NYHA Class II & III

    Rexlemestrocel-L Significantly Reduced Incidence of Ischemic MACE (MI, Stroke) by 57% & 67% Relative to Controls In NYHA Class II & III, respectively For personal use only Absence of Ischemic MACE Absence of Ischemic MACE NYHA II NYHA III REX 6% vs Controls 14%, p=0.05 REX 4% vs Controls 12%, p=0.01

26. Slide 26: Significantly Reduced Hospitalization Rates from Non-Fatal MI or Stroke

    Rexlemestrocel-L Significantly Reduced Hospitalization Rates from Non-Fatal MI or Stroke in All Patients, with Similar Effect Size in NYHA Class II and Class III Patients For personal use only REX vs CONTROL REX vs CONTROL REX vs CONTROL NYHA CLASS II NYHA CLASS III (N=537) (N=206) (N=331) Rate Rati

27. Slide 27: DREAM HF: Death From Cardiac Causes (CV Death)

    For personal use only DREAM HF - Death From Cardiac Causes (CV Death)

28. Slide 28: High Baseline CRP and NT-proBNP Predict Benefit on Cardiac Death

    High Baseline CRP and NT-proBNP are Significant Predictors of Rexlemestrocel-L Treatment Benefit on Cardiac Death For personal use only Cardiac Death ALL Class II Class III COVARIATES* NYHA Class II P = 0.0430 NYHA Class III P = 0.4630 hsCRP>2 P = 0.1634 P = 0.0062 hsCRP>3 P = 0.0122 hsCRP>4 P = 0.0

29. Slide 29: Rexlemestrocel-L Reduced Cardiac Death by 60% in NYHA Class II Patients

    Rexlemestrocel-L Reduced Cardiac Death by 60% in NYHA Class II Patients For personal use only Absence of Cardiac Death NYHA II (n=206) REX 8% vs Controls 20%, p=0.037 REX Effect Size: ↓60% Days from Day 0 Treatment | 29

30. Slide 30: DREAM HF: Three-Point MACE (CV Death, MI or Stroke)

    For personal use only DREAM HF - Three-Point MACE (CV Death, MI or Stroke)

31. Slide 31: Significantly Reduced 3-Point Composite MACE Across All 537 Patients

    Rexlemestrocel-L Significantly Reduced 3-Point Composite MACE (CV Death, MI or Stroke) Compared to Controls Across All 537 Patients For personal use only Absence of Cardiac Death or Non-fatal Ischemic MACE All Patients (n=537) REX 20.6% vs Controls 30%, p=0.027 REX effect size: ↓30% Days from Day 0

32. Slide 32: Significantly Reduced 3-Point Composite MACE in 206 NYHA Class II Patients

    Rexlemestrocel-L Significantly Reduced 3-Point Composite MACE (CV Death, MI or Stroke) in 206 NYHA Class II Patients For personal use only Absence of Cardiac Death or Non- fatal Ischemic MACE NYHA II (n=206) REX 13% vs Controls 29%, p=0.009 REX effect size: ↓ 55% Days from Day 0 Treatment | 32

33. Slide 33: Rexlemestrocel-L for Chronic Heart Failure: Treatment Algorithm

    Rexlemestrocel-L for Chronic Heart Failure For personal use only Treatment Algorithm in Progressive Heart Failure Progressive Vascular (Endothelial) Dysfunction and Heart Failure Early  ACEI or ARB Mesoblast Target Market  Statins Chronic Heart Failure1  Beta blockers  Re-vascularization or valv

34. Slide 34: Rexlemestrocel-L Phase 3 Trial Conclusions

    Rexlemestrocel-L Phase 3 Trial Conclusions For personal use only  Rexlemestrocel-L may provide a major breakthrough in reducing heart failure progression and mortality when used early (class II disease), and may provide durable protection from heart attacks or strokes in high-risk patients  60% re

35. Slide 35: For personal use only

    For personal use only

Mesoblast — Healthcare Conference (January 2021) on 6ix