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

Core Viewpoint - Scancell Holdings plc has made significant progress in developing its active immunotherapies, particularly the DNA ImmunoBody iSCIB1+ and Moditope Modi-1, showing promising clinical results in treating advanced melanoma and head and neck cancer, respectively. The company is accelerating its development plans and preparing for future regulatory studies and partnerships [10][16][21]. Clinical Development - Positive data from the Phase 2 SCOPE trial indicates that iSCIB1+ in combination with checkpoint inhibitors can potentially set a new standard for advanced melanoma treatment, with an 11-month progression-free survival (PFS) of 78% compared to 46% for standard doublet therapy [5][23][34]. - The overall response rate (ORR) for iSCIB1+ is 64%, exceeding the 48%-50% reported for existing checkpoint therapies [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, significantly higher than historical rates [43][45]. Manufacturing and Regulatory Plans - A commercial-scale GMP manufacturing process for iSCIB1+ has been developed, ensuring high-quality formulation and long-term stability, which reduces costs and improves accessibility [24][39]. - The company plans to initiate randomized studies for iSCIB1+ in 2026, with ongoing discussions with regulatory bodies in the US, UK, and Europe [25][40]. Financial Overview - For the year ending April 30, 2025, Scancell reported an operating loss of £15.0 million, a decrease from £18.3 million in 2024, with a cash balance of £16.9 million [13][62]. - The company raised £11.3 million in late 2024, contributing to a cash runway extending into the second half of 2026 [11][59]. Corporate Developments - Scancell has strengthened its leadership team with key appointments, including Phillip L'Huillier as CEO, enhancing its capabilities for late-stage development [20][57]. - The establishment of GlyMab Therapeutics Limited as a wholly owned subsidiary aims to focus on antibody assets and platforms, with a second commercial license agreement with Genmab valued at $6 million and potential milestones of up to $630 million [11][27][49].