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     105  0 Kommentare Appendix 4c Quarterly Activity Report for Quarter Ended March 31, 2024 - Seite 2

    • During the quarter FDA granted Mesoblast a Rare Pediatric Disease (RPD) Designation for Revascor (rexlemestrocel-L) following submission of results from the randomized controlled trial in children with hypoplastic left heart syndrome (HLHS), a potentially life-threatening congenital heart condition.
    • On FDA approval of a BLA for REVASCOR for the treatment of HLHS, Mesoblast may be eligible to receive a Priority Review Voucher (PRV) that can be redeemed for any subsequent marketing application or may be sold or transferred to a third party.

    Chronic Low Back Pain – Phase 3 Program

    • Second Phase 3 trial underway for rexlemestrocel-L in the treatment of chronic low back pain (CLBP) due to inflammatory disc degeneration– a condition affecting at least seven million people in both the US and Europe alone.

    FINANCIAL REPORT

    Strengthened Balance Sheet
    Completed the pro-rata accelerated non-renounceable entitlement offer that was launched on 4 December, 2023 (Entitlement Offer). Together the entitlement offer and institutional placement raised gross proceeds of A$97 million, including A$36.7 million during the quarter on the same terms as the Entitlement Offer. As part of its active approach to efficient balance sheet management, during the quarter Mesoblast reduced debt under its five-year facility, and its minimum cash balance requirement under that facility, by US$10 million. Cash balance at the end of the quarter was A$117.0 million (US$76.4 million).1

    Cost containment strategy on-track
    Cost containment strategies and payroll reductions have been enacted by management and the Board enabling continuation of Phase 3 programs for SR-aGVHD and CLBP in the quarter whilst still achieving reductions in net operating cash spend:

    • Net operating cash spend of US$11.7 million for the quarter.
    • 28% reduction in net operating cash spend from the comparative quarter in FY2023.
    • On target to achieve a 23% ($15m) reduction in net operating spend in FY2024 compared to FY2023 which will be partially offset by investment in our commercial and clinical activities for SR-aGVHD and CLBP, respectively.

    We will maintain our focus on cutting costs and preserving cash in the remainder of the year whilst we continue to work on corporate and strategic initiatives to access commercial distribution channels, supplement costs of development, and strengthen our balance sheet.

    Other
    Fees to Non-Executive Directors were nil, consulting payments to Non-Executive Directors were US$77,217 and salary payments to full-time Executive Directors were US$228,769, detailed in Item 6 of the Appendix 4C cash flow report for the quarter.2 From 1 August 2023, Non-Executive directors have voluntarily deferred 50% cash payment of their director fees and agreed to receive the remaining 50% of their fees in equity-based incentives and Executive Directors (our Chief Executive and Chief Medical Officers) have voluntarily reduced their base salaries for FY24 by 30% in lieu of accepting equity-based incentives.

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    Appendix 4c Quarterly Activity Report for Quarter Ended March 31, 2024 - Seite 2 FDA Provides Clarity on Path to Licensure for Remestemcel-L in SR-aGVHD and Rexlemestrocel-L in End-Stage Heart FailureNEW YORK, April 29, 2024 (GLOBE NEWSWIRE) - Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular …