Purple Biotech CEO Issues Letter to Shareholders Highlighting Pipeline Progress and Clinical Milestones Achieved in First Half of 2025

Core Insights - Purple Biotech Ltd. has made significant scientific advancements and operational progress in the first half of 2025, despite a challenging market environment [2][8] - The company is focused on developing first-in-class therapies to overcome tumor immune evasion and drug resistance, with a pipeline that includes CM24, NT219, and CAPTN-3 [10] Scientific Progress - CM24, an α-CEACAM1 monoclonal antibody, is advancing towards a biomarker-driven Phase 2b study targeting approximately 165 patients with second-line pancreatic ductal adenocarcinoma (PDAC) [3][7] - The Phase 2 dataset for NT219 demonstrated strong objective response rates (ORR) of 25% in the intent-to-treat group compared to 7% in the control group, and 37.5% in biomarker-enriched subgroups [7] - The overall survival (OS) hazard ratio (HR) for the intent-to-treat group was 0.81, with biomarker-enriched subgroups showing HRs of 0.05 and 0.28, indicating compelling efficacy signals [7] Upcoming Catalysts - The company plans to submit an investigational new drug (IND) application for the first development candidate from the CAPTN-3 platform in 2026, with first-in-human trials expected to follow IND approval [8] - Interim Phase 2 data for NT219 is anticipated in 2026, along with new preclinical data for next-generation assets [8] Financial Management - Purple Biotech maintained disciplined cash management in the first half of 2025, with expectations for financial runway extending into mid-2026 [8] - Additional funding will be required to support future clinical studies [8]