Compass Therapeutics (NasdaqCM:CMPX) FY Conference Transcript

Summary of Compass Therapeutics Conference Call Company Overview - Company: Compass Therapeutics (NasdaqCM:CMPX) - Industry: Biotechnology, specifically focused on oncology and monoclonal antibody development - Location: Boston Key Clinical Programs Tevesemig (DLL4 VEGFA Bispecific Antibody) - Current Status: In a randomized trial for advanced biliary tract cancer - Primary Endpoint Achievement: Reported a tripling of the overall response rate compared to the control arm [4][10] - Response Rate: Achieved one of the highest response rates in second-line treatment for advanced biliary tract cancer [4] - Disease Control Rate: Significantly higher in the Tevesemig arm, suggesting potential improvements in progression-free survival (PFS) [5][10] - Expected Data Release: PFS and overall survival (OS) data anticipated by the end of Q1 2026 [8][11] - Crossover Impact: Approximately half of the control arm patients crossed over to receive Tevesemig, which may affect OS event accrual [16][22] 8371 (PD-1/PD-L1 Bispecific Antibody) - Current Status: Completed phase one dose escalation with no dose-limiting toxicities [5][6] - Response Rate: Three confirmed responses in 15 patients treated, including significant tumor reduction in a triple-negative breast cancer patient [6][7] - Next Steps: Moving to cohort expansions for non-small cell lung cancer and triple-negative breast cancer, with potential for approval studies in 2026 [30][32] 10726 (PD-1/VEGF Bispecific Antibody) - Current Status: Expected IND filing and phase one initiation in the first half of 2026 [33] - Target Indications: Hepatocellular cancer, gastric cancer, renal cell cancer, and endometrial cell cancer [33] Market Potential - Biliary Tract Cancer: Approximately 25,000 new cases annually in the U.S., with an increasing incidence projected [24] - Eligible Patients for Tevesemig: Estimated 15,000 patients annually in the U.S. alone, significantly larger than the platinum-resistant ovarian cancer market [24][25] - Global Market: Over 100,000 patients diagnosed annually across the U.S., EU, and Japan [25] Regulatory and Commercialization Strategy - BLA Submission Timeline: Expected in the second half of 2026, following positive interactions with the FDA [23] - Commercialization Plans: Preparing to launch Tevesemig independently in the U.S., with potential partnerships for ex-U.S. markets [26] Statistical Analysis and Methodology - Statistical Techniques: Utilizing Rank Preserving Structural Failure Time (RPSFT) for OS analysis to account for crossover patients [16][17] - Hierarchical Testing: Employed to control alpha spending across multiple endpoints [20] Additional Insights - Clinical Operations: Low patient loss to follow-up (approximately 5%) indicates strong clinical management [13] - Future Outlook: 2026 is anticipated to be a pivotal year for Compass Therapeutics with multiple potential approvals and market entries [32][33]