Overview

Overview

Mesoblast is a world leader in developing innovative cellular medicines.

Mesoblast (ASX:MSB; Nasdaq:MESO) has entered 2019 with the most mature cell therapy product pipeline and technology platform in the regenerative medicine industry.

Two commercial products have already been approved and marketed by the Company’s licensees in Japan and in Europe. Mesoblast has one product candidate which has successfully completed Phase 3 and is approaching commercialization in the United States (U.S.), another product candidate having achieved clinical outcomes in line with the U.S. Food and Drug Administration (FDA) guidance for a registrable clinical indication for market authorization, and two additional Phase 3 assets with blockbuster potential.

Mesoblast’s royalty income and milestone payments from licensees continues to grow, the Company has sufficient cash to achieve key commercial milestones, and access to additional non-dilutive sources of capital from strategic financial institutions whose extensive due diligence provides further third party validation of the strength of the product portfolio and patent estate.

Substantial Commercialization Opportunities

Lead product candidates under investigation are:

  • Remestemcel-L for acute graft versus host disease
  • Revascor for advanced and end-stage heart failure
  • MPC-06-ID for chronic low back pain due to degenerative disc disease

Additionally, Mesoblast has a promising emerging pipeline of products and next generation technologies.

Innovative technology

Mesoblast is developing immuno-selected, culture expanded cellular medicines based on mesenchymal precursor cells (MPCs) and their progeny, mesenchymal stem cells (MSCs). Rare mesenchymal lineage cells (approximately 1:100,000 of bone marrow cells) are found around blood vessels and are central to blood vessel maintenance, repair and regeneration. Preclinical studies have shown that these cells respond to damaged-tissue, secreting mediators that promote tissue repair and modulate immune responses. This mechanism of action enables the targeting of multiple disease pathways in a number of complex diseases where inflammation plays a central role and are resistant to conventional standard of care. A key feature of Mesoblast’s patented mesenchymal lineage cells is that they are administered without the need for donor–recipient matching or recipient immune suppression, and therefore are often referred to as ‘off-the-shelf’ cellular medicines.

Evidence-based Science and Translational Medicine

Mesoblast's approach to product development is to ensure rigorous scientific investigations are performed with well-characterized cell populations in order to understand mechanisms of action for each indication. Extensive preclinical translational studies guide clinical trials that are structured to meet stringent criteria set by international regulatory agencies.

Share Price :    as of Mar 22, 2019