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.

Summary of Compass Therapeutics FY Conference Call Company Overview - **Company**: Compass Therapeutics - **Industry**: Biotechnology, specifically focused on monoclonal antibody discovery and development in oncology - **Location**: Boston - **Current Pipeline**: Three drugs in clinical trials, with a fourth drug about to enter the clinic [2][3] Key Points and Arguments Upcoming Milestones - **Tevesemig**: A DLL4 VEGF-A bispecific antibody with a readout on secondary endpoints of progression-free survival (PFS) and overall survival (OS) expected by the end of Q1 2026 [2][3] - **PD-1, PD-L1 Bispecific Antibody**: Observed three responses in the first 15 patients treated in a phase 1 clinical trial, with cohort expansions planned for triple-negative breast cancer and non-small cell lung cancer [2][3][31] - **Fourth Drug**: A novel PD-1 VEGF-A bispecific antibody entering the clinic at the beginning of 2026 [3][4] Clinical Trial Insights - **Tevesemig Efficacy**: In a randomized study, the response rate in the combination arm (including Tevesemig) was more than triple that of the control arm, with a significant reduction in progressive disease incidence (42% in control vs. 16% in combination arm) [5][6][9] - **Survival Data**: Observations indicate fewer deaths than projected, suggesting improved overall survival [7][9][10] Market Opportunity - **Biliary Tract Cancer (BTC)**: Approximately 25,000 patients diagnosed annually in the U.S., with an estimated 15,000 patients eligible for second-line therapy, representing a multi-billion-dollar commercial opportunity [11][14] - **Duration of Therapy**: Current second-line chemotherapy duration is low single-digit months, while Tevesemig showed a median PFS of 9.4 months in a phase 2 study [12][14] Expansion Plans - **Frontline Studies**: Ongoing studies at MD Anderson to evaluate Tevesemig in combination with existing regimens, potentially increasing patient numbers by 50% [15][17] - **Additional Indications**: DLL4 expression is enriched in various malignancies, including hepatocellular, gastric, ovarian, renal cell, and colorectal cancers, indicating further expansion potential [17][18] Commercial Readiness - **Manufacturing Capability**: Compass has developed a robust commercial-ready manufacturing process for Tevesemig [20][21] - **Prescriber Awareness**: Initial pre-commercial work has begun, with plans for a full commercial launch preparation for a potential 2027 launch [20][21] Unique Mechanisms - **PD-1, PD-L1 Bispecific Antibody (8371)**: Utilizes a novel technology called StitchMabs, allowing for unique mechanisms of action, including T cell engagement and PD-1 cleavage [22][25] - **Differentiation**: The drug is positioned to have better PD-1 blockade compared to other molecules in development, with a focus on its unique mechanism [33][34] Other Important Insights - **Clinical Observations**: Notable responses in patients previously treated with other therapies, indicating potential for significant clinical impact [31] - **Future Indications**: Plans to explore additional indications for the PD-1 VEGF bispecific, including gastric cancer, hepatocellular, renal cell, and endometrial cancer [34] This summary encapsulates the critical insights and future directions for Compass Therapeutics as discussed in the conference call.

Summary of Compass Therapeutics Conference Call Company Overview - **Company**: Compass Therapeutics (NasdaqCM:CMPX) - **Industry**: Biotechnology, specifically focused on oncology and monoclonal antibody development - **Location**: Boston Key Clinical Programs Tevesemig (DLL4 VEGFA Bispecific Antibody) - **Current Status**: In a randomized trial for advanced biliary tract cancer - **Primary Endpoint Achievement**: Reported a tripling of the overall response rate compared to the control arm [4][10] - **Response Rate**: Achieved one of the highest response rates in second-line treatment for advanced biliary tract cancer [4] - **Disease Control Rate**: Significantly higher in the Tevesemig arm, suggesting potential improvements in progression-free survival (PFS) [5][10] - **Expected Data Release**: PFS and overall survival (OS) data anticipated by the end of Q1 2026 [8][11] - **Crossover Impact**: Approximately half of the control arm patients crossed over to receive Tevesemig, which may affect OS event accrual [16][22] 8371 (PD-1/PD-L1 Bispecific Antibody) - **Current Status**: Completed phase one dose escalation with no dose-limiting toxicities [5][6] - **Response Rate**: Three confirmed responses in 15 patients treated, including significant tumor reduction in a triple-negative breast cancer patient [6][7] - **Next Steps**: Moving to cohort expansions for non-small cell lung cancer and triple-negative breast cancer, with potential for approval studies in 2026 [30][32] 10726 (PD-1/VEGF Bispecific Antibody) - **Current Status**: Expected IND filing and phase one initiation in the first half of 2026 [33] - **Target Indications**: Hepatocellular cancer, gastric cancer, renal cell cancer, and endometrial cell cancer [33] Market Potential - **Biliary Tract Cancer**: Approximately 25,000 new cases annually in the U.S., with an increasing incidence projected [24] - **Eligible Patients for Tevesemig**: Estimated 15,000 patients annually in the U.S. alone, significantly larger than the platinum-resistant ovarian cancer market [24][25] - **Global Market**: Over 100,000 patients diagnosed annually across the U.S., EU, and Japan [25] Regulatory and Commercialization Strategy - **BLA Submission Timeline**: Expected in the second half of 2026, following positive interactions with the FDA [23] - **Commercialization Plans**: Preparing to launch Tevesemig independently in the U.S., with potential partnerships for ex-U.S. markets [26] Statistical Analysis and Methodology - **Statistical Techniques**: Utilizing Rank Preserving Structural Failure Time (RPSFT) for OS analysis to account for crossover patients [16][17] - **Hierarchical Testing**: Employed to control alpha spending across multiple endpoints [20] Additional Insights - **Clinical Operations**: Low patient loss to follow-up (approximately 5%) indicates strong clinical management [13] - **Future Outlook**: 2026 is anticipated to be a pivotal year for Compass Therapeutics with multiple potential approvals and market entries [32][33]