Financial Highlights
- Successful completion of a global private placement primarily to Mesoblast’s existing major US, UK, and Australian shareholders raising approximately US$40 million, net of transaction costs.
- In addition to cash on hand at the end of the quarter of US$48.8 million, pro-forma cash after proceeds raised in April is US$88.8 million, with up to an additional US$40 million available to be drawn down from existing financing facilities subject to certain milestones.
- Net cash usage for operating activities in the quarter was US$16.2 million; this represented an increase of US$0.7 million, or 4%, on the comparative quarter in FY2022, and a reduction of US$8.3 million, or 34%, on the comparative quarter in FY2021.
- Revenue from royalties on sales of TEMCELL® HS Inj.1 sold in Japan by our licensee for the quarter were US$1.8 million. On a constant currency basis, royalties on sales grew 4% quarter on quarter from US$2.0 million2 for the quarter ended March 31, 2023, compared with US$1.9 million for the quarter ended March 31, 2022.
Operational Highlights
Remestemcel-L
- Resubmitted to the U.S. Food and Drug Administration (FDA) the Biologics License Application (BLA) for approval of remestemcel-L in the treatment of children with steroid-refractory acute graft versus host disease (SR-aGVHD).
- The resubmission contains new information developed since the Complete Response Letter (CRL) received in September 2020, including the generation of new data and analyses which we believe provide substantial evidence of remestemcel-L’s effectiveness in pediatric SR-aGVHD.
- FDA accepted Mesoblast’s BLA resubmission for remestemcel-L, considering the resubmission to be a complete response and set a Prescription Drug User Fee Act (PDUFA) goal date of August 2, 2023.
- As part of the ongoing review of the BLA for remestemcel-L FDA scheduled a Pre-License Inspection (PLI) of Mesoblast’s cell therapy manufacturing operations at Lonza Bioscience in Singapore.
- Two studies on the remestemcel-L development program for the treatment of children with SR-aGVHD were selected by peer review and presented at the 2023 Tandem Meetings of the American Society for Transplantation and Cellular Therapy (ASTCT) and the Center for Blood and Marrow Transplant Research (CIBMTR).
- The studies are titled “The Immunomodulatory Activity of Remestemcel-L on T Cell Activation in vitro is a Direct Measure of Product Potency and Correlates with Clinical Outcomes in Pediatric Patients with Steroid-Refractory Acute GVHD” and “Long-Term Survival in Children Treated with Remestemcel-L for SR-aGVHD”. The data from both studies formed key components of Mesoblast’s recent resubmission of its remestemcel-L BLA to FDA for children with SR-aGVHD.
Rexlemestrocel-L
- FDA granted Regenerative Medicine Advanced Therapy (RMAT) designation for rexlemestrocel-L in the treatment of chronic low back pain (CLBP) associated with disc degeneration, in combination with hyaluronic acid (HA) as delivery agent for injection into the lumbar disc.
- FDA has confirmed that a 12-month reduction in pain is an approvable indication and Mesoblast will use this endpoint in its confirmatory Phase 3 trial under the RMAT designation.
- Publication of the DREAM-HF Phase 3 trial results in the premier peer-reviewed journal for cardiovascular medicine, the Journal of the American College of Cardiology (JACC). The results of the randomized, double-blind, controlled study in 537 patients showed that Mesoblast’s mesenchymal precursor cell therapy (MPCs; rexlemestrocel-L) strengthened heart function at 12 months, as measured by left ventricular ejection fraction (LVEF) and decreased cardiovascular death, myocardial infarction (MI) or stroke in patients with chronic heart failure (CHF) due to reduced ejection fraction (HFrEF) over a mean follow-up of 30 months.3
Other
Salary payments to full-time Executive Directors were US$330,756 and fees to Non-Executive Directors were US$197,365, detailed in Item 6 of the Appendix 4C cash flow report for the quarter.4
A copy of the Appendix 4C – Quarterly Cash Flow Report for the third quarter FY2023 is available on the investor page of the company’s website www.mesoblast.com.
