Financial Data and Key Metrics Changes - The company ended Q2 2025 with $101 million in cash, providing a runway into 2027 for executing on various programs [34] - The overall response rate for the lead program, Tivesimig, was reported at 17.1%, significantly higher than the control arm [9][10] Business Line Data and Key Metrics Changes - Tivesimig showed a tripling of the overall response rate compared to the control arm, with a p-value of 0.031 [9] - CTX-8371, the PD-1/PD-L1 bispecific antibody, reported two deep partial responses in early cohorts, indicating promising early efficacy [6][19] Market Data and Key Metrics Changes - The ongoing randomized trial for Tivesimig in patients with advanced biliary tract cancer has fewer total deaths than projected, suggesting better-than-expected survival outcomes [11][12] - The company plans to initiate cohort expansions for CTX-8371 in non-small cell lung cancer and triple-negative breast cancer later this year [33] Company Strategy and Development Direction - The company aims to file a license application for Tivesimig in 2026, following a robust interaction with the FDA [31][106] - Future studies will explore indications where both VEGF targeting and PD-1 targeting have shown effectiveness, such as renal cell and gastric cancer [79] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the potential of Tivesimig to extend overall survival in patients, despite the current lower-than-expected mortality rate [40][14] - The company is focused on advancing its pipeline, with multiple milestones expected over the next six quarters [30][31] Other Important Information - The company has fast track designation for Tivesimig, which may lead to priority review upon filing [31] - Preclinical data for CTX-10,726 showed superior tumor control compared to leading drug candidates in its class [27][29] Q&A Session Summary Question: Is there a chance that decreased deaths in the study reflect performance due to drug crossover? - Management confirmed that about half of the patients in the control arm crossed over after progression, and statistical methods will adjust for this in the overall survival analysis [39][40] Question: Can you clarify the timeline for PFS analysis? - Management indicated that the 80% event threshold will not be reached until Q1 2026, and they expect to present a priority dataset at that time [48][50] Question: What is the status of the BLA submission process? - The company is on track with its CMC process and does not foresee it being a limiting factor for BLA submission [55] Question: How confident is the company in the demographics of the study? - Management stated that randomization was stratified by key prognostic variables, which should balance demographics across treatment arms [73] Question: What are the plans for the dose expansion cohorts for CTX-8371? - The company plans a small randomized study of approximately 50 patients to explore different doses in the expansion cohorts [102]

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]