Mesoblast Ltd. Q2 FY2024 earnings call

• Clinical Pipeline: Remestemcel in pediatric and adult steroid-refractory acute graft versus host disease; Rexlemestrocel in heart disease and inflammatory back pain. Pediatric remestemcel completed pivotal Phase 3 trial with long-term survival data. Rexlemestrocel completed Phase 3 trial in inflammatory heart failure and first Phase 3 trial in chronic inflammatory low back pain.
• Intellectual Property: Leaders in mesenchymal stromal cell IP with over 1,100 patents and applications.
• Manufacturing: Commercial scale manufacturing process scalable, meets regulatory criteria, with innovations like 3D bioreactors.
• Mechanism of Action: Stromal cells deliver outcomes by engaging inflammatory cytokines and releasing mediators for anti-inflammatory responses.
• Clinical Program Milestones: Achieved deliverables like submitting potency assay data to FDA, scheduling meetings, planning adult GVHD trial, and ongoing back pain trial.
• Regulatory Updates: Upcoming FDA meeting in March for pediatric remestemcel; encouraging FDA meeting for heart failure under RMAT; RMAT designation for back pain indication.

Revenue was $3.4 million, predominantly from royalties on sales of TEMCELL in Japan. Manufacturing expenditure reduced by $6 million or 47% for the six months ended December 2023. Cash burn for operating activities in the three-month period ended December 2023 was $12.3 million, a 25% reduction from the comparative period in FY 2023. Loss after tax was reduced by 21% to $32.5 million.

• Plan to initiate pivotal Phase 3 trial for adult steroid-refractory acute GVHD in the second half of the year.
• Expect FDA formal minutes in March regarding heart failure meeting.
• Pivotal back pain trial is ongoing with screening and enrollment throughout the year.
• Anticipate continuing discussions with FDA for congenital heart disease program and other indications.

Q: Asks about pricing for pediatric remestemcel and cash runway.

A: Pricing not disclosed but referenced CAR T-cell therapies; cash burn reduced 25% relative to comparative period, expecting at least 12 months of cash with potential strategic partnerships extending runway.