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]

Summary of Compass Therapeutics Conference Call Company Overview - **Company**: Compass Therapeutics (CMPX) - **Location**: Boston - **Industry**: Monoclonal antibody discovery and development in oncology - **Pipeline**: Three drugs in clinical trials, with a fourth drug expected to submit for IND later this year [4][5][6] Key Programs and Developments - **Lead Program**: Tavessimig (formerly CTX009), a DLL4 VEGF A bispecific antibody - Achieved primary endpoint in a randomized study for advanced biliary tract cancer with an overall response rate of 17.1% compared to 5.3% for the control arm [4][13] - Statistically significant difference with p = 0.031 [13] - Ongoing analysis for progression-free survival (PFS) and overall survival (OS) expected later this year [14][19] - **Second Program**: Monoclonal antibody agonist of CD137 (referred to as "four seventy one") - Presented data showing responses in post-PD-1 patients, including a 28% response rate in melanoma [35][36] - Planning for an NCAM positive basket study to begin later this year [37] - **Third Program**: PD-1 PD-L1 bispecific antibody - Currently in dose escalation phase one, with no dose-limiting toxicities reported [41][42] - Expected to share phase one data at a scientific meeting in the second half of this year [42] - **Fourth Program**: VEGF PD-1 bispecific antibody - Pre-IND interaction with the FDA completed, aiming for IND submission in Q4 [49] Market Insights - **Market Size**: Estimated 23,000 patients with biliary tract cancer (BTC) in the U.S. annually, with about 15,000 expected to reach second-line therapy [30][31] - **Commercialization Strategy**: Compass is preparing to commercialize Tavessimig independently while exploring strategic partnerships [31] Competitive Landscape - No labeled second-line therapies for biliary tract cancer in the U.S., with existing treatments primarily being targeted therapies [32][33] Financials and Milestones - **Cash Position**: Approximately $113 million as of Q1, providing runway into 2027 [50] - **Key Milestones**: - PFS and OS readout from the randomized biliary tract cancer study expected in early Q4 [52] - Initiation of the basket study for "four seventy one" in April [55] - IND filing for the PD-1 VEGF bispecific expected in Q4 [55] Additional Considerations - Market reaction to the data has been mixed, with some investors expecting higher response rates [15][16] - The company emphasizes the importance of the full data set before considering accelerated approval discussions with the FDA [20][21] - The differentiation of their bispecific antibodies is highlighted, with claims of superior potency compared to competitors [47][48]