Mesoblast (MSB) Registration filing summary

Company overview and business model

• Develops allogeneic, off-the-shelf cellular medicines targeting severe inflammatory conditions using proprietary mesenchymal lineage cell therapy technology.

• RYONCIL (remestemcel-L) received FDA approval in December 2024 for pediatric steroid-refractory acute graft versus host disease, the first FDA-approved MSC therapy.

• Pipeline includes therapies for adult SR-aGvHD, biologic-resistant inflammatory bowel disease, heart failure, and chronic low back pain, with commercial partnerships in Japan, Europe, and China.

• Holds over 1,000 patents/applications, providing protection through at least 2041 in major markets.

• Manufactures industrial-scale, cryopreserved cell therapies that do not require donor-recipient matching or immune suppression.

Financial performance and metrics

• As of June 30, 2024: cash and cash equivalents of $62.96 million, current borrowings of $13.86 million, non-current borrowings of $100.48 million.

• Issued capital of $1.31 billion, reserves of $78.3 million, accumulated losses of $908.76 million, total equity of $480.36 million, and total capitalization of $594.7 million.

• Has incurred operating losses since inception and anticipates continued substantial losses; has never generated revenue from product sales.

Use of proceeds and capital allocation

• Will not receive proceeds from the resale of ADSs by shareholders.

• Proceeds from the January 2025 private placement (~A$260 million) allocated to US commercial launch of RYONCIL, acceleration of Phase 3 CLBP study, expansion of commercial manufacturing, and general corporate purposes.