FDA Approval of RYONCIL
RYONCIL is the first mesenchymal stromal cell therapy approved by the FDA, targeting children with steroid-refractory acute graft-versus-host disease (GVHD).
Successful Global Private Placement
Raised USD 161 million, increasing pro forma cash to approximately USD 200 million.
Reduction in Operating Cash Spend
Net operating cash spend reduced by 22%, amounting to USD 20.7 million for the first half of FY 2025.
Reversal of Inventory Provision
A USD 23 million provision against the value of inventory was reversed after FDA approval and recognized as an inventory asset.
Strong Phase 3 Trial Results for RYONCIL
RYONCIL showed a 70% overall response rate at day 28 in Phase 3 trials, significantly higher than other therapies.
Potential for RYONCIL in Inflammatory Bowel Disease
Plans to expand RYONCIL's use into inflammatory bowel disease, targeting a large unmet need population.
Promising Outcomes for Rexlemestrocel in Chronic Back Pain
Positive Phase 3 trial results showed significant pain reduction and opioid dependency reduction.
Potential Accelerated Approval Pathway for Revascor
Meetings with the FDA indicate a pathway towards accelerated approval for ischemic heart failure patients.