Summary of Compass Therapeutics FY Conference Call Company Overview - **Company**: Compass Therapeutics (NasdaqCM:CMPX) - **Industry**: Oncology, specifically monoclonal antibody discovery and development - **Location**: Boston, Massachusetts - **Pipeline**: Four drugs in clinical development, with Tevesemig being the most advanced Key Points on Tevesemig - **Drug Description**: Tevesemig is a DLL4 VEGF A bispecific antibody, functioning as a next-generation angiogenesis inhibitor [1] - **Clinical Trials**: - Achieved primary endpoint in a randomized study for advanced biliary tract cancer [2] - Presented phase II data at ASCO GI showing monotherapy efficacy in advanced colorectal cancer [2] - Ongoing study COMPANION-002 comparing Tevesemig plus paclitaxel to paclitaxel alone in second-line treatment for advanced biliary tract cancer [6] - **Efficacy Data**: - Tevesemig tripled the overall response rate compared to control, with a complete response noted [7] - Significant difference in progression-free survival (PFS) observed, with 42.1% progression in control vs. 16.2% in combination arm at week eight [9] - More than 20% of patients alive at 18 months, compared to less than 10% in FOLFOX regimen [10] - **Market Opportunity**: - Estimated 25,000 new patients annually in the U.S. with biliary tract cancer, with a treatable population of approximately 15,000 [11] - Potential for over $1 billion annual market in second-line biliary tract cancer [11] - **Future Plans**: - Plans to expand indications post-approval, targeting other cancers like colorectal and gastric [12] - Potential to replace Avastin in various indications [13] Other Drug Developments - **CTX471**: - A CD137 agonist antibody showing nearly 30% response rate in post-PD1 melanoma patients [15] - Notable case of a patient with metastatic small cell lung cancer achieving a complete response after multiple therapies [16] - Planning an NCAM-positive basket study to explore efficacy further [17] - **CTX8371**: - A PD1/PDL1 bispecific antibody demonstrating unique T cell engagement and potential to convert PD1-positive T cells to PD1-negative [19] - Responses observed in patients with triple-negative breast cancer and Hodgkin's lymphoma [21] - Ongoing cohort expansions for further evaluation [21] - **CTX10726**: - A novel PD1/VEGF-A bispecific antibody entering clinical trials, showing superior preclinical efficacy compared to leading competitors [22][38] - Expected to initiate phase 1 study this quarter, with clinical data anticipated in the second half of the year [40] Commercialization Strategy - **Tevesemig**: - Plans to commercialize independently in the U.S. due to the specialized nature of the patient population [31] - Open to strategic partnerships for international markets [32] - **Infrastructure Development**: - Building commercial infrastructure over the next 12-18 months in preparation for drug launch [36] Conclusion - Compass Therapeutics is positioned for significant growth with its innovative pipeline, particularly Tevesemig, which has the potential to transform treatment for advanced biliary tract cancer and other malignancies. The company is actively preparing for commercialization and exploring further clinical opportunities across its drug portfolio.

Financial Data and Key Metrics Changes - The company reported a significant increase in the overall response rate for its lead drug, tevesimig, in the second line biliary tract cancer study, with a response rate of 17.1% compared to 5.3% for the control arm, indicating a more than tripling of the response rate [12][13] - The study also showed a statistically significant difference with a p-value of 0.031, highlighting the drug's efficacy [13] Business Line Data and Key Metrics Changes - The lead program, tevesimig, is a bispecific antibody targeting DLL4 and VEGF A, which has shown promising results in clinical trials [4][7] - The company is also advancing CTX-471, a monoclonal antibody agonist targeting CD137, which has shown a 28% response rate in a post-PD-1 patient population [22][23] Market Data and Key Metrics Changes - The company identified a significant unmet medical need in the second line biliary tract cancer market, where there are currently no labeled therapies for the majority of patients [11] - The basket study for tevesimig in DLL4 positive cancers is expected to explore a range of solid tumor indications, indicating a broad market opportunity [19] Company Strategy and Development Direction - The company aims to leverage its unique StitchMaps platform to develop next-generation antibody therapeutics, focusing on dual blockade strategies to enhance efficacy in oncology [3][7] - Future plans include a Phase II basket study for tevesimig and potential label expansion studies following its approval [19] Management's Comments on Operating Environment and Future Outlook - Management expressed enthusiasm about the upcoming readouts for progression-free survival and overall survival, indicating a positive outlook for tevesimig's clinical development [17] - The company is optimistic about the performance of the control arm in clinical trials, suggesting a potential treatment effect that could lead to fewer deaths than initially expected [17] Other Important Information - The company has fast track status for tevesimig, which could expedite its approval process, with potential approval in the second half of 2026 [19][32] - The company is also developing CTX-8371, a PD-1 PD-L1 bispecific antibody, which is currently in Phase I studies and is expected to present clinical data in the second half of the year [29] Q&A Session Summary Question: Can you provide an overview of tevesimig's clinical data? - The overall response rate for tevesimig plus paclitaxel was 17.1%, significantly higher than the 5.3% for paclitaxel alone, with a statistically significant p-value of 0.031 [12][13] Question: What is the rationale behind the DLL4 positive cancers basket study? - DLL4 notch signaling is involved in various malignancies, and the company aims to explore the efficacy of tevesimig in these cancers due to its demonstrated monotherapy activity [19] Question: What are the upcoming catalysts for the company? - Key upcoming catalysts include readouts from the tevesimig study, the initiation of several important clinical trials, and data from the CTX-471 basket study [34]