Cell therapy company Mesoblast (ASX:MSB) has entered into a convertible note subscription agreement with its largest shareholder, Gregory George, to issue up to US$50 million convertible notes at its discretion.
The issue of the convertible notes is linked to the US FDA's approval of Mesoblast's lead product candidate, Ryonci (remestemcel-L), for the treatment of children with steroid-refractory acute graft versus host disease (SR-aGvHD).
The company said the funding will enable it to implement its go-to-market commercial strategy. It said it expects a decision before or on the FDA's Prescription Drug User Fee Act goal date of 7 January, 2025.
Mesoblast chief executive Silviu Itescu said: "We appreciate the ongoing support from our major shareholder in ensuring that the Company is well capitalised for commercial product launch and can hit the ground running immediately following approval of RYONCIL by FDA."
Mesoblast said its go-to-market strategy includes hiring senior executives, market access, medical education, and ongoing engagement with key opinion leaders.
