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Compass Therapeutics (CMPX) 2025 Conference Transcript

Summary of Compass Therapeutics Conference Call Company Overview - Company: Compass Therapeutics (CMPX) - Industry: Biotechnology, specifically focused on monoclonal antibody discovery and development in oncology - Location: Boston, Massachusetts - Current Pipeline: Three drugs in clinical trials, including: - Tevesimig (DLL4 VEGF A bispecific antibody) - CT-471 (next-gen CD137 agonist antibody) - CT-172 (PD-1 PD-L1 bispecific antibody) - Upcoming: CT-10726 (VEGF PD-1 bispecific antibody) to enter the clinic later this year [4][5][6] Key Points and Arguments Tevesimig Clinical Trial - Trial Design: Randomized trial in advanced biliary tract cancer patients who have received one prior line of therapy, comparing Tevesimig plus Paclitaxel versus Paclitaxel alone [8] - Primary Endpoint: Overall response rate; key secondary endpoints include progression-free survival (PFS), overall survival (OS), and duration of response [9] - Results: - Combination arm response rate: 17.1% with a disease control rate above 60% - Control arm response rate: 5.3% with a disease control rate less than 40% - Statistically significant difference (P = 0.031) [10] - Follow-up: Median follow-up of 15 months; projections indicate mortality levels will not be reached until at least 19 months of follow-up [15] Regulatory and Future Plans - FDA Interaction: Plans to meet with the FDA post-PFS and OS data disclosure in Q4; aiming for full approval based on the current study [20][21] - BLA Submission Timeline: Anticipated in the first half of next year, with a potential launch in the second half of 2026 [25] - Safety Profile: Consistent with expectations; monitored by an independent data monitoring committee [27] Upcoming Data and Studies - MD Anderson Study: Investigator-sponsored study adding Tevesimig to frontline therapy; preliminary results expected by year-end [22] - Biomarker Analysis: Plans for retrospective analysis of DLL4 expression and genomic markers to inform future studies [30][32] PD-1 VEGF Bispecific Antibody - Development Status: IND filing planned for Q4; preclinical data suggests superior PD-1 blockade compared to competitors [41][48] - Market Interest: High interest in the bispecific space, with ongoing discussions regarding potential partnerships [50] Other Programs - CT-471: Focus on NCAM expressing tumors; plans for a basket study targeting neuroendocrine tumors and small cell lung cancer [61] - Financial Position: $113 million in cash at the end of Q1, providing runway into 2027 [64] Important but Overlooked Content - Clinical Significance: A hazard ratio less than 0.6 for OS and PFS would be considered clinically meaningful, with comparisons to existing therapies [19] - Market Dynamics: The competitive landscape for bispecific antibodies is rapidly evolving, with a focus on differentiation through unique epitopes and mechanisms of action [41][45] - Investor Focus: Key milestones include PFS and OS readouts, dose escalation study results, and IND filings, which are critical for future funding and partnerships [65]