MSB Trading - 2020, page-10823

SELL SELL SELL - What a pipeline - Only 4 weeks of games left.

Major Operational Milestones for the Next 12 Months

Remestemcel-L for SR-aGVHD and Other Inflammatory Diseases
• FDA has set a Prescription Drug User Fee Act (PDUFA) action date for RYONCIL in the
treatment of pediatric SR-aGVHD of September 30, 2020
• If approved, US launch of RYONCIL planned for Q4 2020
• Execute lifecycle extension strategy with investigator-initiated and sponsored clinical trials for
pediatric and adult systemic inflammatory diseases.

Remestemcel-L for Acute Respiratory Distress Syndrome (ARDS) in COVID-19
• Complete recruitment of Phase 3 trial
• Interim analyses planned which could result in stopping the trial early for efficacy or futility.
First interim analysis when 30% of patients reach the primary endpoint
• Expansion into additional causes of ARDS including influenza and bacterial infection
• Establish strategic partnerships for manufacturing and commercialization.

REVASCOR for Advanced and End-Stage Heart Failure
• In the Phase 3 randomized controlled trial of Revascor for advanced heart failure, final study
visits for all surviving patients have been completed, ongoing quality review of all data is being
completed at the study sites, with a data readout planned for mid-2020
• Initiate confirmatory trial in ischemic end-stage heart failure patients.

MPC-06-ID for Chronic Low Back Pain
• In the Phase 3 randomized controlled trial of MPC-06-ID for chronic low back pain due to
degenerative disc disease, final study visits for all patients have been completed, ongoing
quality review of all data is being completed at the study sites, with a data readout planned for
mid-2020
• Work together with Grünenthal to complete clinical protocol design, obtain regulatory input,
and receive clearance from European regulatory authorities to begin European Phase 3 trial.

Manufacturing
• Scale up of manufacturing to meet projected increase in capacity requirements for maturing
pipeline, including GVHD label extensions and COVID-19 ARDS
• Implement proprietary xeno-free technologies to increase yields and output
• Plan for long-term move to 3D bioreactors to reduce labor and improve manufacturing
efficiencies