Mesoblast Limited · ASX:MSB
Mesoblast — Shareholder Meeting (November 2020)
20 slides from Mesoblast's shareholder meeting presentation, Nov 24, 2020
Slide 1: Annual General Meeting
For personal use only Annual General Meeting November 24, 2020 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 |3
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 COVID-19 Acute Respiratory Distress Syndrome (ARDS) All Cause ARDS Global Other Respiratory Collaboration Pediatric & adult Remestemcel-L systemic
Slide 5: 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
Slide 6: Key Terms of Collaboration with Novartis
Key Terms of Collaboration with Novartis For personal use only Novartis will make a US$50 million upfront payment including US$25 million in equity* Mesoblast may receive: A total of US$505 million pending achievement of pre-commercialization milestones for ARDS indications; Up to an additio
Slide 7: Remestemcel-L: Potential Treatment in Severe Inflammatory Conditions
For personal use only Remestemcel-L: Potential Treatment in Severe Inflammatory Conditions
Slide 8: Immunomodulatory Activities of Remestemcel-L in Response to Inflammation
Immunomodulatory Activities of Remestemcel-L in Response to Inflammation For personal use only |8
Slide 9: 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 by BMT Conditioning & Cytokine Storm Organ Damage Conditioning Activation of CD4 regimen, Tissue Mac
Slide 10: Remestemcel-L: Consistent Clinical Outcomes in Children with SR-aGVHD
Remestemcel-L: Consistent Clinical Outcomes in Children with SR-aGVHD Consistent efficacy and safety outcomes in a total of 309 children from three studies: For personal use only − Remestemcel-L was used as first-line therapy in a randomized controlled Phase 3 trial of 260 patients, with SR-aGVHD,
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: SR-aGVHD Regulatory & Commercial Update
SR-aGVHD Regulatory & Commercial Update On August 13 2020, results from 309 children with SR-aGVHD treated with remestemcel-L were presented For personal use only to the Oncologic Drugs Advisory Committee (ODAC) of the United States Food and Drug Administration (FDA) The ODAC panel voted 9:1 tha
Slide 13: Remestemcel-L for ARDS – Major Unmet Need
Remestemcel-L for ARDS – Major Unmet Need For personal use only Multiple triggers including viral (COVID-19, influenza) or bacterial infections Typically requires extended ICU hospitalization and intervention by ventilation ~40-80% mortality in viral induced ARDS1-4 Up to 61,000 deaths per y
Slide 14: ARDS due to COVID-19, Influenza & Bacterial Infection - Pathophysiology
ARDS due to COVID-19, Influenza & Bacterial Infection - Pathophysiology For personal use only Normal alveolus Injured alveolus during the acute phase Sloughing of bronchial epithelium Alveolar airspace Inactivated surfactant Necrotic or apoptotic type I cell Epithelial basement membrane Activation
Slide 15: Promising Pilot Data in Adults & Children with COVID-19
Promising Pilot Data in Adults & Children with COVID-19 Compassionate Use Emergency IND in Ventilator-Dependent Adults with COVID-19 ARDS For personal use only 12 patients with moderate or severe ARDS received two infusions of remestemcel-L within five days at Mt. Sinai Hospital in New York City
Slide 16: Key Milestones for Remestemcel-L in COVID-19 ARDS
Key Milestones for Remestemcel-L in COVID-19 ARDS For personal use only Phase 3 multi-center, randomized, controlled trial of remestemcel-L versus placebo in ventilator- dependent patients with moderate/severe ARDS due to COVID-19 Up to 300 patients randomized 1:1 to receive placebo or two infus
Slide 17: Update on Other Phase 3 Product Candidates
For personal use only Update on Other Phase 3 Product Candidates - Heart Failure - Chronic Low Back Pain
Slide 18: REVASCOR for Advanced and End-Stage Heart Failure
REVASCOR® for Advanced and End-Stage Heart Failure For personal use only In December 2019, the Phase 3 trial in advanced heart failure surpassed the number of primary endpoint events required for trial completion − Final study visits for all surviving patients have been completed − Ongoing quality
Slide 19: 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 during Q4 CY2
Slide 20: For personal use only
For personal use only