Scancell reports Business Update and Financial Results for the Year Ended 30 April 2025

Core Insights - Scancell Holdings plc has reported significant clinical progress and financial results for the year ending April 30, 2025, highlighting advancements in its immunotherapy products, particularly iSCIB1+ and Modi-1, which show promising efficacy in treating advanced melanoma and head and neck cancers respectively [1][10][11]. Clinical Developments - Positive data from the Phase 2 SCOPE trial indicates that iSCIB1+ in combination with checkpoint inhibitors has a progression-free survival (PFS) of 78% at 11 months, significantly higher than the historical 12-month PFS of 46% for standard doublet therapy [5][10][22]. - The overall response rate (ORR) for iSCIB1+ is reported at 64%, exceeding the 48-50% range for existing checkpoint inhibition treatments [22][23]. - Early results from the Phase 2 ModiFY trial show that Modi-1 combined with a single checkpoint inhibitor yields an ORR of 43% in head and neck cancer, surpassing historical rates for single-agent therapies [11][44][45]. Manufacturing and Development Plans - A commercial-scale GMP manufacturing process for iSCIB1+ has been developed, ensuring high-quality formulation and long-term stability, which enhances global accessibility and reduces costs [24][40]. - The company plans to initiate randomized studies for iSCIB1+ in 2026, with ongoing discussions with potential partners for future development [10][25][41]. Financial Performance - Scancell reported an operating loss of £15.0 million for the year, a decrease from £18.3 million in the previous year, with a cash balance of £16.9 million as of April 30, 2025 [13][61]. - The company secured a second commercial license with Genmab for SC2811, which includes $6 million in upfront payments and potential milestones totaling $630 million [11][27]. Corporate Developments - The leadership team has been strengthened with key appointments, including Phillip L'Huillier as CEO, enhancing the company's capabilities for late-stage development [20][56]. - The establishment of GlyMab Therapeutics Limited as a wholly owned subsidiary aims to focus on antibody assets and platforms, providing strategic optionality for further development [11][49].