Mesoblast Limited · ASX:MSB
Mesoblast — Q1 FY2022 Earnings Presentation
36 slides from Mesoblast's earnings presentation, Nov 24, 2021
Slide 1: Operational Highlights & Financial Results for the Period Ended September 30, 2021
For personal use only mesoblast Operational Highlights & Financial Results for the Period Ended September 30, 2021 NOVEMBER 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: 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 5: Platform Technology – Mechanism of Action
Platform Technology – Mechanism of Action For personal use only Our mesenchymal precursor/stromal cells respond to and are activated by multiple inflammatory cytokines through surface receptors, resulting in orchestration of an anti-inflammatory cascade IL-10 Breg TH1 Proliferation Mesenchymal Cytok
Slide 6: Global IP Estate Provides Substantial Competitive Advantage
Global IP Estate Provides Substantial Competitive Advantage For personal use only ▪ Extensive patent portfolio with protection extending through 2040 in all major markets Therapeutic Areas Core commercial and ▪ Over 1,000 patents and patent applications (~80 patent families) across non-core indicati
Slide 7: Commercial-scale Manufacturing Capabilities
Commercial-scale Manufacturing Capabilities For personal use only ▪ Scalable allogeneic “off-the-shelf” cellular platforms ▪ Manufacturing meets stringent criteria of international regulatory Manufacturing Remestemcel-L agencies ▪ Robust quality assurance processes ensure final product with batch-to
Slide 8: Financial Results
For personal use only Financial Results
Slide 9: 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 10: Increased Revenues and Reduced Expenditures Resulted in Improved Loss after Tax
Increased Revenues and Reduced Expenditures Resulted in Improved Loss after Tax Revenue: Royalties from TEMCELL® HS Inj.(1) in Japan increased to $2.4m, 22% on the For personal use only Sept 30, Sept 30, previous quarter, and 90% on the comparative quarter last year. P&L for the 3 months ended 2021
Slide 11: Remestemcel-L
For personal use only Remestemcel-L - Acute Graft versus Host Disease (aGVHD) - Acute Respiratory Distress Syndrome (ARDS)
Slide 12: 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 13: 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 14: 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 15: 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 16: 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 17: Remestemcel-L Results in Greater Day 28 Response and Day 180 Survival with MAP > 0.29
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 18: 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 ▪ At the
Slide 19: 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 20: Age > 65 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 21: 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 22: 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) | 22
Slide 23: Greatest Mortality Reduction and Improved ARDS Severity in 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 24: Remestemcel-L Plus Dexamethasone Shows Synergy in Patients < 65 years
Remestemcel-L Plus Dexamethasone Shows Synergy in Mortality Reduction and Improvement in ARDS Severity in Exploratory Population < 65 years old For personal use only Treated Patients (mITT) < 65 years old on Dexamethasone (n=73) Treated Patients (mITT) < 65 years old through 90-Days on Dexamethasone
Slide 25: Remestemcel-L: 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 26: Rexlemestrocel-L - Update on Chronic Heart Failure (CHF)
For personal use only Rexlemestrocel-L - Update on Chronic Heart Failure (CHF)
Slide 27: 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 28: 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 NFkB systemic va
Slide 29: 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 30: 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
Slide 31: 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 For personal use only All Patients (n=537) HR: 1.2 p=0.4 | 31
Slide 32: 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 | 32
Slide 33: 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 | 33
Slide 34: 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 35: 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 36: Mesoblast
For personal use only mesoblast