Mesoblast is using its proprietary mesenchymal lineage cell technology platform to develop and commercialize innovative allogeneic cellular medicines to treat complex inflammatory diseases resistant to conventional standard of care.

The Company’s portfolio of Phase 3 product candidates are:

• RYONCIL™ (remestemcel-L) for steroid-refractory acute graft versus host disease (acute GVHD) in children
• Remestemcel-L for moderate to severe acute respiratory distress syndrome (ARDS) due to COVID-19 infection
• REVASCOR^® for advanced chronic heart failure
• MPC-06-ID for chronic low back pain due to degenerative disc disease

Mesoblast’s Biologics License Application (BLA) for RYONCIL for the treatment of children with steroid-refractory acute GVHD has been accepted for priority review by the United States Food and Drug Administration (FDA). The FDA has set a Prescription Drug User Fee Act (PDUFA) action date of September 30, 2020, and if approved, Mesoblast will make RYONCIL immediately available in the United States.

The Company also has a promising emerging pipeline and next generation technologies.

Innovative technology platform

Mesoblast’s novel allogeneic product candidates are based on rare (approximately 1:100,000 in bone marrow) mesenchymal lineage cells that respond to tissue damage, secreting mediators that promote tissue repair and modulate immune responses.

Mesenchymal lineage cells are collected from the bone marrow of healthy adult donors and proprietary processes are utilized to expand them to a uniform, well characterized, and highly reproducible cell population. This enables manufacturing at industrial scale for commercial purposes. Another key feature of Mesoblast’s cells is they can be administered to patients without the need for donor–recipient matching or recipient immune suppression.