Here is a summary of Mesoblast Limited's Q3 2023 earnings call, which took place on May 25:
- Mesoblast has two lead candidates, remestemcel-L and rexlemestrocel-L, in its allogeneic cell therapy platform.
- Remestemcel-L is currently before the FDA with a PDUFA goal date of August 2, 2023, for pediatric steroid refractory GVHD, and has shown evidence of significant early day 100 survival benefits across multiple clinical studies.
- Mesoblast has substantial cash on hand, with $48.8 million as of March 31, 2023, and pro-forma cash of $88.8 million after a successful global private placement of $40.0 million in April.
- Results from a study performed by the CIBMTR show that remestemcel-L has long-term survival benefits for patients with acute GVHD, with survival rates of 63% at one year and 51% at two years.
- Rexlemestrocel-L has gained FDA approval for a Phase 3 trial with pain reduction as the primary endpoint and functional improvement and reduction in opioid use as secondary endpoints, and the company is also focusing on the use of its cell therapy for inflammatory heart disease.
- The company's go-to-market strategy for remestemcel-L includes targeting the highest transplant volume centers and building a small commercial team.
- The company is in discussions with various financial partners around royalty-based structures to fund future label extensions.
- The company is in discussion with members of the CIBMTR on conducting a trial on adults for its GVHD treatment, with the design of such a trial still outstanding.
This is an AI generated summary. There may be inaccuracies.
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