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, off-the-shelf cellular medicines with defined pharmaceutical release criteria.

Financial performance and metrics

• As of June 30, 2024: cash and cash equivalents of $62.96 million, total capitalization of $594.7 million, and accumulated losses of $908.76 million.

• Issued capital of $1.31 billion (1,141,784,114 ordinary shares outstanding as of June 30, 2024).

• January 2025 private placement raised approximately A$260 million from institutional and professional investors.

Use of proceeds and capital allocation

• Proceeds from the January 2025 private placement will fund the US commercial launch of RYONCIL, accelerate Phase 3 clinical development in chronic low back pain, expand commercial manufacturing, and support working capital and general corporate purposes.