Mesoblast Limited reports positive key highlights in Q1, including FDA application for Ryoncil®
From GlobeNewswire: 2024-10-30 19:11:00
Mesoblast Limited reported key highlights for the first quarter, including the filing of a Biologics License Application with the FDA for Ryoncil® in the treatment of children with steroid-refractory acute graft versus host disease. The company also secured strategic financing and focused on cost control, with a net operating spend down 26% from the prior quarter.
Mesoblast’s Ryoncil® and Revascor® have shown promising results in clinical trials. Ryoncil® may receive FDA approval by January 7, 2025, for treating children with steroid-refractory acute GvHD. Revascor® has received Rare Pediatric Disease Designation for treating hypoplastic left heart syndrome. The company plans to discuss regulatory approval with the FDA for these treatments.
Mesoblast is also advancing its rexlemestrocel-L product for various conditions, including chronic low back pain and chronic heart failure. FDA supports an accelerated approval pathway for rexlemestrocel-L in end-stage heart failure patients with LVADs, and the company is conducting a Phase 3 trial for chronic low back pain. The company’s financial management strategy has led to a reduction in net operating cash spend and a strong cash balance of $51.1 million as of September 30, 2024.
To ensure readiness for commercial launch, Mesoblast has entered a convertible note subscription agreement for up to $50 million following FDA approval of Ryoncil®. The company’s disciplined financial approach has allowed it to make significant progress on key programs while controlling costs. Non-Executive Directors deferred 50% of cash payment in equity-based incentives, and Executive Directors voluntarily reduced their base salaries by 30% in FY25.
Mesoblast’s innovative cellular medicines are designed to address severe inflammatory conditions by modulating the immune system. The company has a strong global intellectual property portfolio and proprietary manufacturing processes for scalable, off-the-shelf cellular therapies. Mesoblast is developing treatments for a range of conditions, including inflammatory diseases, heart failure, and low back pain. Investors can access the company’s financial reports on its website for more details.
Read more at GlobeNewswire:: Appendix 4C Quarterly Activity Report for Quarter Ended