Compass Therapeutics (NasdaqCM:CMPX) FY Conference Transcript

Summary of Compass Therapeutics FY Conference Call Company Overview - Company: Compass Therapeutics (NasdaqCM:CMPX) - Location: Boston - Focus: Monoclonal antibody discovery and development in oncology - Pipeline: Three drugs currently in clinical trials, including a DLL4 VEGFA bispecific antibody for advanced biliary tract cancer [2][3] Key Points on Clinical Programs Tuvesimig and Biliary Tract Cancer (BTC) - Market Opportunity: Approximately 25,000 new BTC cases diagnosed annually in the U.S. Only 15%-20% of patients have actionable mutations for targeted therapy. The remaining 80%-85% lack approved second-line therapies, presenting a significant commercial opportunity exceeding $1 billion annually in the U.S. [4][5] - COMPANION-002 Study: - Focuses on Tuvesimig (DLL4 VEGFA bispecific) combined with paclitaxel versus paclitaxel alone in second-line BTC patients. - Achieved a statistically significant increase in overall response rate (p-value of 0.031) and a notable reduction in progressive disease rates at week eight (42.1% in control vs. 16.2% in combination arm) [6][7]. - Safety data monitored by a data safety monitoring committee showed no new safety signals [8]. - Future readouts for progression-free survival (PFS) and overall survival (OS) expected in late Q1 2026 [9][10]. Regulatory Considerations - The FDA required paclitaxel as the control arm for the study, despite FOLFOX being in NCCN guidelines [14]. - Historical precedent from the Tibsovo study suggests that positive PFS results could support regulatory filings even without significant OS improvements [10][11]. Other Pipeline Developments PD-1, PD-L1 Bispecific Antibody (8371) - Mechanism: Acts as a next-generation checkpoint inhibitor, converting PD-1 positive T cells to PD-1 negative T cells, enhancing T cell engagement [17][18]. - Phase One Data: No dose-limiting toxicities observed across 15 patients, with three responses noted in post-checkpoint inhibitor patients [19][20]. - Cohort Expansion: Plans to expand cohorts in triple negative breast cancer and non-small cell lung cancer [21]. CD137 Agonist (471) - Phase One Study: Enrolled 60 patients across 17 tumor types, with five responses observed. A complete response was noted in a small cell lung cancer patient [25][26]. - Future Plans: An NCAM-positive basket study is set to begin in Q1 2026, with multiple clinical readouts anticipated in 2026 [26]. Financial and Operational Outlook - Compass Therapeutics is funded through 2028 to support ongoing clinical programs and development efforts [26]. Conclusion - Compass Therapeutics is positioned to capitalize on significant market opportunities in oncology, particularly in biliary tract cancer, with promising clinical data supporting its lead programs. The company is actively preparing for future regulatory submissions and expanding its clinical pipeline.