Core Insights - Scancell Holdings plc has provided a business update and unaudited financial results for the six-month period ending October 31, 2025, highlighting advancements in its cancer immunotherapy products and financial performance [1]. Product Development - The lead product, iSCIB1+, demonstrated a 74% progression-free survival (PFS) at 16 months in a Phase 2 trial for advanced melanoma, showing a 24% improvement over standard care [6][16]. - The FDA has cleared an Investigational New Drug (IND) application for a Phase 3 trial of iSCIB1+ in advanced melanoma, with PFS as the primary endpoint [6][12]. - Modi-1, another candidate, is showing promise in a Phase 2 study for squamous cell cancer of the head and neck and renal cell carcinoma, with data readouts expected in H1 2026 [6][20]. - GlyMab Therapeutics Limited has been established as a subsidiary to focus on antibody assets, with positive scientific advice received for the lead antibody product, SC134, targeting small cell lung cancer [6][21]. Financial Performance - The operating loss for the six months ended October 31, 2025, was £8.9 million, an improvement from a loss of £10.5 million in the same period in 2024 [5][23]. - Research and development expenditure decreased to £6.1 million from £8.0 million in 2024, primarily due to reduced manufacturing costs [24]. - The cash balance at October 31, 2025, was £8.6 million, down from £16.9 million at April 30, 2025, with a cash runway extending to H2 2026 [10][26]. Strategic Outlook - The company plans to initiate a global Phase 3 registrational study for iSCIB1+ in 2026, with potential commercialization anticipated in 2029 [6][7]. - Continued discussions for partnerships regarding iSCIB1+ and the ImmunoBody platform are ongoing, with a focus on optimizing shareholder value [8][12]. - The company is exploring further financing options to support the Phase 3 trial and other development initiatives [8][12].