Mesoblast Limited · ASX:MSB
Mesoblast — Shareholder Meeting (November 2021)
33 slides from Mesoblast's shareholder meeting presentation, Nov 29, 2021
Slide 1: Annual General Meeting Chief Executive's Presentation
For personal use only mesoblast Annual General Meeting Chief Executive’s Presentation NOVEMBER 29, 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: 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 surface For personal use only receptors, resulting in orchestration of an anti-inflammatory cascade IL-10 Breg TH1 Proliferation Mesenchymal Cytok
Slide 5: Pipeline
Pipeline For personal use only ⃰ Mesoblast has the right to use data generated by JCR Pharmaceuticals Co Ltd in Japan to support its development and commercialization plans for remestemcel-L in the US and other major healthcare markets, including for GVHD and Hypoxic Ischemic Encephalopathy # The ag
Slide 6: Financial Highlights
Financial Highlights For personal use only Successfully entered into a refinancing and expansion of our senior debt facility with Oaktree Capital Management. The new US$90 million, 5-year secured facility has a 3-year interest only period after which time 40% of the principal amortizes over two ye
Slide 7: Remestemcel-L: aGVHD and ARDS
For personal use only Remestemcel-L - Acute Graft versus Host Disease (aGVHD) - Acute Respiratory Distress Syndrome (ARDS)
Slide 8: Acute GVHD: Serious and Fatal Complication of Allogeneic BMT
Acute GVHD: Serious and Fatal Complication of Allogeneic Bone Marrow Transplantation (BMT) For personal use only PHASE 1 PHASE 2 PHASE 3 Host Tissue Damage Immune Cell Activation Inflammation and End Organ by BMT Conditioning & Cytokine Storm Damage Conditioning Activation of Macrophage regimen, Tis
Slide 9: Children with Steroid-Refractory Acute GVHD at High Risk of Treatment Failure and Death
Children with Steroid-Refractory Acute GVHD at High Risk of Treatment Failure and Death For personal use only Extremely high unmet medical need More than 2,000 allogeneic BMTs in children and adolescents in US1 Despite prophylaxis, ~50% will develop aGVHD2 First-line treatment is corticosteroi
Slide 10: Remestemcel-L: Prior Clinical Data in Children with SR-aGVHD
Remestemcel-L: Prior Clinical Data in Children with SR-aGVHD For personal use only Consistent efficacy and safety outcomes in a total of 309 children from three studies: Remestemcel-L was used as first-line therapy in a randomized controlled Phase 3 trial of 260 patients, with SR- aGVHD, including
Slide 11: Remestemcel-L Improved Dismal Survival in Children with SR-aGVHD
Remestemcel-L Improved Dismal Survival in Children with SR-aGVHD For personal use only 2 Steroid Refractory – Remestemcel-L Steroid Refractory – Best Available Therapies 1. Adapted and redrawn from Figure 2 of MacMillan, M.L. et al. Pediatric acute GVHD: clinical phenotype and response to upfront st
Slide 12: MAGIC Algorithm Probability Biomarker Score Validated Threshold
MAGIC Algorithm Probability Biomarker Score (MBS, MAP) > 0.29 is a Validated Threshold Identifying Acute GVHD Patients at High Risk of Non-Response to Treatment and Death For personal use only MAGIC MAGIC MAGIC Test Cohort Validation Cohort 1 Validation Cohort 2 100 100 100 80 80 80 60 MAP score < 0
Slide 13: Remestemcel-L Results in Greater Day 28 Response and Day 180 Survival
Remestemcel-L Treatment Results in Significantly Greater Day 28 Overall Responses and Day 180 Survival in Steroid-Refractory Patients with Baseline MAP > 0.29 For personal use only Response by baseline MAP Survival by Baseline MAP 0.8 0.8 MAP > 0.29 MAP > 0.29 67% vs 10%, p = 0.01 64% vs 10%, p = 0.
Slide 14: Remestemcel-L: Regulatory & Commercial Update for SR-aGVHD
Remestemcel-L: Regulatory & Commercial Update for SR-aGVHD For personal use only These data provide further support for the proposed anti-inflammatory mechanism of action of remestemcel-L and its immunomodulatory activity in patients with SR-aGVHD, resulting in improved survival outcomes Mesobla
Slide 15: Overview – Remestemcel-L for ARDS due to COVID-19
Overview – Remestemcel-L for ARDS due to COVID-19 For personal use only COVID-19 is a respiratory virus with a high mortality due to a severe inflammatory condition of the lungs called acute respiratory disease syndrome (ARDS) ARDS is caused by cytokine storm in lungs of patients infected with C
Slide 16: Age Associated with Reduced Naïve T Cell Response to SARS-CoV-2
Age > 65 years is Associated with Reduced Naïve T Cell Response to SARS-CoV-2, Delayed Viral Clearance and Greater Disease Severity For personal use only Naïve CD4 and CD8 T Cells reduced in age > 65 Age > 65 associated with greater COVID-19 peak disease severity SARS-CoV-2-specific CD4 T cells and
Slide 17: Clinical Experience with Remestemcel-L in COVID-19 ARDS
Clinical Experience with Remestemcel-L in COVID-19 ARDS For personal use only Emergency IND in Ventilator-Dependent COVID-19 ARDS 11 patients (10/11 were < 65 years) with moderate/severe ARDS on ventilators at Mt. Sinai Hospital in New York Patients received two infusions of remestemcel-L 2 mill
Slide 18: Greater Mortality in Control Patients Older than 65
Greater Mortality through Day 60 in Control Patients Older than 65, Consistent with Other Trials For personal use only Controls Age < 65 vs ≥ 65 (n=110) | 18
Slide 19: Greatest Mortality Reduction in Treated Patients < 65 years
Greatest Mortality Reduction Improved ARDS Severity* Seen in Remestemcel-L Treated Patients < 65 years For personal use only Modified Intent to Treat (mITT) Patients < 65 years old Treated Patients (mITT) < 65 years old (n=123) (n=123), Remestemcel-L vs Control Remestemcel-L vs Control * Measured as
Slide 20: Remestemcel-L Plus Dexamethasone Shows Synergy
Remestemcel-L Plus Dexamethasone Shows Synergy in Mortality Reduction and Improvement in ARDS Severity in Exploratory Population < 65 years old Treated Patients (mITT) < 65 years old For personal use only on Dexamethasone (n=73) Treated Patients (mITT) < 65 years old through 90-Days on Dexamethasone
Slide 21: Regulatory Pathway to Potential EUA for COVID-19 ARDS
Remestemcel-L: Regulatory Pathway to Potential EUA for COVID-19 ARDS For personal use only Mesoblast met with the FDA in regard to potential Emergency Use Authorization (EUA) for remestemcel-L in the treatment of ventilator-dependent patients with moderate or severe ARDS due to COVID-19 The FDA
Slide 22: Rexlemestrocel-L: CLBP and CHF
For personal use only Rexlemestrocel-L • Chronic Low Back Pain (CLBP) • Chronic Heart Failure (CHF)
Slide 23: Rexlemestrocel-L: A New Paradigm for Treatment of Chronic Low Back Pain
Rexlemestrocel-L: A New Paradigm for Treatment of Chronic Low Back Pain due to Degenerative Disc Disease For personal use only Back pain causes more disability than any other condition1 Burden of Inflicts substantial direct and indirect costs on the healthcare Illness system1, including excessiv
Slide 24: Single Injection Results in Two Years of Pain Reduction with Opioid Sparing
Single Injection of Rexlemestrocel-L + HA in Phase 3 Trial, Results in at Least Two Years of Pain Reduction with Opioid Sparing Activity in Patients with CLBP For personal use only Achievement of substantial and durable reductions in CLBP through 24 months across the entire evaluable study populat
Slide 25: Chronic Heart Failure: Rising Incidence & High Mortality
Chronic Heart Failure: Rising Incidence & High Mortality For personal use only Cardiovascular disease 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
Slide 26: 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 Cardiomyocyte Survival impact the heart and the systemic vascula
Slide 27: Late Breaking Presentation at American Heart Association Annual Meeting
Late Breaking Presentation at American Heart Association Annual Meeting For personal use only Data from the randomized, controlled Phase 3 trial of rexlemestrocel-L in 565 patients with NYHA class II and class III HFrEF were presented as a late breaking presentation at the AHA annual Scientific Se
Slide 28: 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 | 28
Slide 29: Rexlemestrocel-L Reduced Incidence of Non-fatal MI or Stroke
Rexlemestrocel-L Reduced Incidence of Non-fatal MI or Non-fatal Stroke Over Standard of Care Alone For personal use only | 29
Slide 30: Rexlemestrocel-L Reduced Incidence of Cardiac Death
Rexlemestrocel-L Reduced Incidence of Cardiac Death, Particularly in Patients with Inflammation For personal use only Time-to-Cardiac Death in NYHA Class II Patients | 30
Slide 31: Rexlemestrocel-L Reduced Incidence of 3-Point MACE
Rexlemestrocel-L Reduced Incidence of 3-Point MACE (Cardiac Death or MI or Stroke) in all 537 Treated Patients, and Especially in Those with Inflammation For personal use only Time-to-First-Event for Cardiac Death or Non-fatal MI or Non-fatal Stroke MPC 22/102 (21.6%) vs. CTRL 30/115 (26.1%) HR: 0.8
Slide 32: Conclusions
Conclusions For personal use only 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 added to maximal standard of care signif
Slide 33: For personal use only
For personal use only mesoblast