Mesoblast Reports US$182M Cash, Ryoncil Sales Begin with 15 Kits Sold

Commercial Launch of Ryoncil Marks a Milestone

Mesoblast Limited (ASX:MSB; Nasdaq:MESO) has taken a significant step forward by making Ryoncil (remestemcel-L) commercially available in the United States as of March 28, 2025. This launch follows the FDA’s approval of Ryoncil as the first mesenchymal stromal cell (MSC) therapy for any indication in the US, specifically targeting steroid-refractory acute graft versus host disease (aGVHD) in children. The therapy is now covered by Federal Medicaid, with 15 infusion kits already purchased to initiate or continue treatment courses.

Operationally, Mesoblast has onboarded ten priority transplant centers, with plans to add ten more this quarter. The deployment of nine key account managers aims to accelerate engagement with the remaining 35 priority centers, which collectively represent 80% of pediatric transplants in the US. The company’s MyMesoblast™ patient access hub facilitates insurance navigation and financial assistance, underscoring its commitment to broad patient access.

Robust Financial Position Supports Growth

Mesoblast reported a net operating cash outflow of US$12.7 million for the quarter, ending with a strong cash balance of US$182 million (A$290 million). This financial strength was bolstered by a recent global private placement raising A$260 million (US$161 million), primarily from existing institutional investors across the US, UK, and Australia. The company’s solid liquidity positions it well to expand Ryoncil’s indications to other pediatric inflammatory diseases and adult acute GVHD.

Advancing Pipeline and Regulatory Engagement

Beyond Ryoncil, Mesoblast is actively progressing its pipeline. A Type B meeting with the FDA is scheduled this quarter to discuss accelerated approval pathways for Revascor (rexlemestrocel-L) in ischemic chronic heart failure with reduced ejection fraction (HFrEF) and persistent inflammation. The FDA has previously indicated eligibility for accelerated approval based on existing trial data, with a confirmatory trial planned post-approval.

Meanwhile, the Phase 3 confirmatory trial for rexlemestrocel-L in chronic low back pain due to degenerative disc disease is underway across multiple US sites. This 300-patient randomized, placebo-controlled study targets a 12-month primary endpoint of pain reduction, with secondary measures including quality of life and opioid cessation, a critical focus given the opioid crisis linked to discogenic back pain.

Corporate Developments and Governance

Mesoblast has strengthened its board with the appointments of Dr. Gregory George and Ms. Lyn Cobley, enhancing governance as the company scales commercial operations. Additionally, Mesoblast was added to the S&P/ASX 200 Index effective March 6, 2025, reflecting its growing market presence.

The company continues to manage costs prudently, with executive and non-executive directors voluntarily reducing cash compensation in favor of equity incentives, aligning leadership interests with long-term shareholder value.

Looking Ahead

With Ryoncil’s US launch underway and a strong cash runway, Mesoblast is poised to expand its commercial footprint and advance its promising pipeline. Upcoming FDA interactions and clinical trial readouts will be pivotal in shaping the company’s trajectory in the regenerative medicine space.