Key Highlights
- Capital Raised: A$260 million (US$160 million) raised through a global private placement at A$2.50 per share.
- Shareholder Support: Placement primarily backed by major shareholders in the US, UK, and Australia.
Fund Allocation
- US Commercial Launch:
- Rollout of Ryoncil® (remestemcel-L) for pediatric steroid-refractory acute graft-versus-host disease (SR-aGvHD).
- Ryoncil® is the first and only FDA-approved mesenchymal stromal cell (MSC) therapy for this condition.
- Clinical Development:
- Acceleration of a Phase 3 study for chronic low back pain (CLBP), with active recruitment underway.
- Manufacturing Expansion:
- Scale-up of commercial production to meet anticipated global demand.
- Working Capital:
- Support for corporate operations and general business activities.
CEO Commentary
Dr. Silviu Itescu, Mesoblast’s Chief Executive, said:
“We appreciate the strong support from our shareholders as we scale up production and provide hospitals with Ryoncil®, the first FDA-approved mesenchymal stromal cell therapeutic, to treat children with life-threatening SR-aGvHD.”
About Mesoblast
Mesoblast is a global leader in allogeneic cellular medicines for inflammatory diseases. The company’s proprietary mesenchymal lineage cell therapy technology targets severe inflammation, reducing immune system damage.
Key Products:
- Ryoncil®:
- Approved for pediatric SR-aGvHD.
- Development underway for adult SR-aGvHD and biologic-resistant inflammatory bowel disease.
- Rexlemestrocel-L:
- Focused on treating heart failure and CLBP.
Global Reach:
- Commercial partnerships in Japan, Europe, and China.
- Manufacturing processes ensure industrial-scale, cryopreserved, off-the-shelf cellular medicines for global availability.
Intellectual Property:
- Over 1,000 patents and applications across major markets, with protections extending through 2041.
Investor Takeaways
The capital injection positions Mesoblast to execute a transformative year, focusing on the commercial success of Ryoncil® and the advancement of its clinical pipeline. The company’s unique, patent-protected technology and FDA approval establish it as a leader in the growing cell therapy market.
Key Dates:
- Keep an eye on progress in Ryoncil® uptake and updates on the CLBP Phase 3 study.