Summary of Compass Therapeutics FY Conference Call Company Overview - **Company**: Compass Therapeutics (NasdaqCM:CMPX) - **Location**: Boston - **Focus**: Monoclonal antibody discovery and development in oncology - **Pipeline**: Three drugs currently in clinical trials, including a DLL4 VEGFA bispecific antibody for advanced biliary tract cancer [2][3] Key Points on Clinical Programs Tuvesimig and Biliary Tract Cancer (BTC) - **Market Opportunity**: Approximately 25,000 new BTC cases diagnosed annually in the U.S. Only 15%-20% of patients have actionable mutations for targeted therapy. The remaining 80%-85% lack approved second-line therapies, presenting a significant commercial opportunity exceeding $1 billion annually in the U.S. [4][5] - **COMPANION-002 Study**: - Focuses on Tuvesimig (DLL4 VEGFA bispecific) combined with paclitaxel versus paclitaxel alone in second-line BTC patients. - Achieved a statistically significant increase in overall response rate (p-value of 0.031) and a notable reduction in progressive disease rates at week eight (42.1% in control vs. 16.2% in combination arm) [6][7]. - Safety data monitored by a data safety monitoring committee showed no new safety signals [8]. - Future readouts for progression-free survival (PFS) and overall survival (OS) expected in late Q1 2026 [9][10]. Regulatory Considerations - The FDA required paclitaxel as the control arm for the study, despite FOLFOX being in NCCN guidelines [14]. - Historical precedent from the Tibsovo study suggests that positive PFS results could support regulatory filings even without significant OS improvements [10][11]. Other Pipeline Developments PD-1, PD-L1 Bispecific Antibody (8371) - **Mechanism**: Acts as a next-generation checkpoint inhibitor, converting PD-1 positive T cells to PD-1 negative T cells, enhancing T cell engagement [17][18]. - **Phase One Data**: No dose-limiting toxicities observed across 15 patients, with three responses noted in post-checkpoint inhibitor patients [19][20]. - **Cohort Expansion**: Plans to expand cohorts in triple negative breast cancer and non-small cell lung cancer [21]. CD137 Agonist (471) - **Phase One Study**: Enrolled 60 patients across 17 tumor types, with five responses observed. A complete response was noted in a small cell lung cancer patient [25][26]. - **Future Plans**: An NCAM-positive basket study is set to begin in Q1 2026, with multiple clinical readouts anticipated in 2026 [26]. Financial and Operational Outlook - Compass Therapeutics is funded through 2028 to support ongoing clinical programs and development efforts [26]. Conclusion - Compass Therapeutics is positioned to capitalize on significant market opportunities in oncology, particularly in biliary tract cancer, with promising clinical data supporting its lead programs. The company is actively preparing for future regulatory submissions and expanding its clinical pipeline.

Financial Data and Key Metrics Changes - For the first half of 2025, the company reported total revenue of $4.9 million, primarily driven by collaborations with AstraZeneca and Sanofi, as well as governmental funding for research expenditures [28] - Operating expenses reached $30.3 million, with R&D expenses at $20.5 million, reflecting a 29% decrease compared to the prior year, while G&A expenses remained stable at $9.8 million [28] - As of June 30, 2025, the company had $70.4 million in cash, cash equivalents, and financial assets, providing a cash runway until the end of the third quarter of 2026 [28] Business Line Data and Key Metrics Changes - The company is focusing investments on three high-value clinical assets: IPH4502, Lacutamab, and Monalizumab, which are expected to create meaningful value [4][30] - IPH4502 is currently in phase one development, with enrollment progressing well and expected to complete by the end of Q1 2026 [11][14] - Lacutamab is close to completing the phase three protocol, with potential accelerated approval in Sézary syndrome anticipated by 2027 [21][25] Market Data and Key Metrics Changes - The company identified approximately 1,000 Sézary syndrome patients in the U.S., with around 300 new cases each year, representing a significant market opportunity for Lacutamab [24][25] - The total agreement with AstraZeneca for Monalizumab is worth up to $1.275 billion, with $450 million already received in upfront and milestone payments [27] Company Strategy and Development Direction - The company has made a strategic decision to streamline its organization and focus on high-value clinical assets to drive forward programs that can make a significant difference [4][30] - The company is actively working with investors and partners to secure funding for the phase three trial of Lacutamab, while also exploring options for IPH4502 [38][39] Management Comments on Operating Environment and Future Outlook - Management expressed confidence in the strategic refocus and the potential of the clinical pipeline to deliver value for patients and shareholders [30] - The restructuring plan is fully embedded into the cash runway, ensuring financial visibility through the end of Q3 2026 [54] Other Important Information - The Chief Scientific Officer, Eric Vivier, will transition to a role as an advisor to the R&D Committee of the Board of Directors, ensuring continued collaboration [5] - The company is exploring the potential of IPH4502 in urothelial cancer patients who have become refractory to enfortumab vedotin, with a focus on addressing high unmet medical needs [41] Q&A Session Summary Question: What should we take away on the potential of targeting NK cells now that ANKET® assets are not included in your prioritization today? - Management clarified that while NK cells are not the main priority, they are still working on NK cell engagers and will base future decisions on clinical data [32][33] Question: Any commentary on where Sanofi is with the assets that they currently are developing? - Management indicated that Sanofi continues to progress the BCMA-targeted ANKET® and updates are expected soon [37] Question: Regarding the phase three start for Lacutamab, should we still assume that unless you have a partner signed up ahead of the start of the study, it'll still be a wait and watch? - Management confirmed they are actively working with investors and partners to keep options open for moving forward with Lacutamab [38] Question: Based on the preclinical data that you have generated so far, what potential indications do you think IPH4502 will be effective? - Management highlighted a focus on urothelial cancer patients who are refractory to enfortumab vedotin, with potential for accelerated market approval [41] Question: Can you provide an initial estimate of the investment requirements if you decide to go to trial without a partner? - Management stated they would not normally communicate specific costs but indicated it would be similar to other oncology phase 3 trials [56]