Core Insights - Compass is a monoclonal antibody discovery and development company focused on oncology, based in Boston [1] - The company currently has three drugs in clinical trials and a fourth drug set to enter the clinic [1] - 2026 is anticipated to be a significant year for the company with important updates expected [1] Drug Development Updates - The lead program, Tovecimig, is a DLL4xVEGF-A bispecific antibody, with readouts on secondary endpoints of progression-free survival and overall survival expected by the end of Q1 2026 [1] - In the second half of 2025, the company observed significant efficacy in a Phase I clinical trial of a PD-1, PD-L1 bispecific antibody, with three responses noted in the first 15 patients treated [2] - The company plans to expand cohorts for patients with triple-negative breast cancer and non-small cell lung cancer based on the observed efficacy [2]

Core Insights - The company has seen a significant stock price increase of 290% year-to-date, outperforming the XBI index which is up 30% [1] - The company is focused on monoclonal antibody discovery and development in oncology, with three drugs currently in clinical trials [2] Clinical Programs Overview - The most advanced program is a DLL4 VEGF-A bispecific antibody named tovecimig, which is in a randomized trial for patients with advanced biliary tract cancer [3] - The company reported achieving the primary endpoint in a randomized trial, with the overall response rate more than tripling compared to the control arm [3]

Summary of Compass Therapeutics Conference Call Company Overview - **Company**: Compass Therapeutics (NasdaqCM:CMPX) - **Location**: Boston - **Industry**: Biotechnology, specifically monoclonal antibody discovery and development in oncology - **Current Pipeline**: Three drugs in clinical trials: - Tovecimig (DLL4 VEGF-A bispecific antibody) - CTX-471 (next generation CD137 agonist antibody) - CTX-8371 (first-in-class bispecific antibody targeting PD-1 and PD-L1) - **Upcoming Drug**: 10726 (novel PD-1 VEGF-A bispecific antibody) entering the clinic soon [4][5][52] Key Points and Arguments Clinical Trials and Drug Efficacy - **Tovecimig**: - Currently in a randomized trial for advanced biliary tract cancer, achieving a statistically significant primary endpoint of overall response rate, tripling the response rate compared to control [6][7] - Secondary endpoints include progression-free survival (PFS) and overall survival (OS), with analyses expected in late Q1 2026 [6][8] - Clinically meaningful hazard ratios for PFS and OS are anticipated to be less than 0.7, with specific assumptions for control and treatment arms [7][8] - **CTX-8371**: - Demonstrated promising results with three confirmed responses in a small cohort, including significant tumor reductions in patients with non-small cell lung cancer and triple-negative breast cancer [41][42] - Cohort expansions planned based on initial positive responses [43] - **10726**: - Preclinical work completed, IND submission planned, with a phase one study to begin early next year targeting multiple cancer types [49][50] Market Potential - **Biliary Tract Cancer**: - Approximately 25,000 new cases diagnosed annually in the U.S., with about 15,000 patients eligible for second-line therapy [30] - Potential market size for second-line therapies estimated at nearly $3 billion annually in the U.S. alone [32] Competitive Landscape - Limited activity in mutation-agnostic approaches for biliary tract cancer, with most recent approvals being mutation-specific [33] - Akeso's frontline BTC program is noted, but results are not expected until early 2030s [33] Regulatory Considerations - Discussions with the FDA suggest that achieving favorable trends in OS alongside positive PFS results could facilitate a productive dialogue regarding approval [25][26] Future Catalysts - Key upcoming events include: - PFS and OS readout for tovecimig in late Q1 2026 - Phase one initiation for 10726 - Cohort expansion for CTX-8371 - Basket study for CTX-471 [52] Additional Important Information - **Crossover in Trials**: Approximately half of the control arm patients crossed over to the active arm, which necessitated the use of statistical methods to adjust for this in analyses [12][13] - **Market Research**: Comprehensive third-party market research conducted to understand treatment regimens and patient demographics [27][30] - **Pricing Strategy**: Recent oncology drug launches priced around $36,000 to $40,000 per month, with conservative estimates suggesting a potential annual cost of $200,000 per patient [31][32] This summary encapsulates the critical insights from the conference call, highlighting the company's pipeline, market potential, competitive landscape, and future catalysts.