Appendix 4C Quarterly Activity Report for Quarter Ended June 30, 2023

NEW YORK, July 30, 2023 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today provided an activity report for the fourth quarter ended June 30, 2023.

Activities Report

• Cash balance at the end of the quarter was US$71.3 million, with up to an additional US$40 million available to be drawn down from existing financing facilities subject to certain milestones.
• Revenue from royalties on sales of TEMCELL HS Inj.¹ sold in Japan by our licensee for the quarter were US$2.0 million.
• Net cash usage for operating activities in the quarter was US$16.3 million of which US$7.2 million (44.2%) was for manufacturing activities ahead of potential product launch; this compared to US$13.9 million in the comparative quarter in FY2022, of which US$4.9 million was for manufacturing activities.
• Biologics License Application (BLA) resubmission for remestemcel-L in the treatment of children with steroid-refractory acute graft versus host disease (SR-aGVHD) was accepted by the U.S. Food and Drug Administration (FDA) on March 7, 2023 with a Prescription Drug User Fee Act (PDUFA) goal date of August 2, 2023. The Company has worked closely with FDA during the course of the review period and remains in ongoing dialogue with FDA.
• As part of its ongoing review of the BLA, FDA has conducted the Pre-License Inspection (PLI) of the manufacturing process for remestemcel-L, and this did not result in the issuance of any Form 483.
  

Other
Fees and consulting payments to Non-Executive Directors were US$308,097, and salary payments to full-time Executive Directors were US$328,392, detailed in Item 6 of the Appendix 4C cash flow report for the quarter.²

A copy of the Appendix 4C – Quarterly Cash Flow Report for the fourth quarter FY2023 is available on the investor page of the company’s website www.mesoblast.com.

About Mesoblast
Mesoblast is a world leader in developing allogeneic (off-the-shelf) cellular medicines for the treatment of severe and life-threatening inflammatory conditions. The Company has leveraged its proprietary mesenchymal lineage cell therapy technology platform to establish a broad portfolio of late-stage product candidates which respond to severe inflammation by releasing anti-inflammatory factors that counter and modulate multiple effector arms of the immune system, resulting in significant reduction of the damaging inflammatory process.