Mesoblast Limited ((ASX:MSB, NASDAQ:MESO), global leader in allogeneic cellular medicines for inflammatory diseases, today announced it has completed a global private placement primarily to Mesoblast’s existing major US, UK, and Australian shareholders raising approximately US$40 million, net of transaction costs, at A$0.85 per share. Proceeds will be used to fund: • Launch and commercialization of the company’s lead product, remestemcel-L, in the treatment of children with steroid-refractory acute graft versus host disease (SR-aGVHD) subject to approval by the US Food & Drug Administration (FDA) of Mesoblast’s resubmitted Biologics License Application (BLA) which has a PDUFA goal date of August 2, 2023. • Ongoing manufacturing of commercial remestemcel-L product at the Lonza Biosciences facility in Singapore, where the upcoming scheduled pre-licensure inspection (PLI) will be performed by FDA. • Initiation of patient enrolment in the confirmatory Phase 3 clinical trial of rexlemestrocel-L for chronic low back pain associated with degenerative disc disease. Chief Executive Dr Silviu Itescu said “We appreciate the strong support from our major shareholders as we look forward to commercializing our platform technology and bringing the first FDA approved treatment to children with life-threatening SR-aGVHD.”
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