Compass Therapeutics(CMPX) - 2025 Q2 - Quarterly Results

Corporate Update and Highlights Compass Therapeutics reported positive clinical trial updates for key pipeline candidates and maintained a strong cash position CEO Statement and Overall Summary Compass Therapeutics reported positive clinical trial updates for its key pipeline candidates, including tovecimig and CTX-8371, and ended the quarter with a strong cash position - The analysis for secondary endpoints (progression-free survival and overall survival) for the tovecimig Phase 2/3 trial is now guided for Q1 2026, delayed from original projections due to fewer deaths observed in the study[3] - The Phase 1 study of CTX-8371 (PD-1 x PD-L1 bispecific) has shown two deep and confirmed partial responses, prompting the initiation of expansion cohorts in non-small cell lung cancer (NSCLC) and triple-negative breast cancer (TNBC) in Q4 2025[4] - Preclinical data for CTX-10726 (PD-1 x VEGF bispecific) suggests superiority to a leading candidate, ivonescimab, with an IND submission planned for Q4 2025[4] - The company's balance sheet remains strong, ending Q2 with $101 million in cash and marketable securities, which is expected to fund operations into 2027[4][6][17] Development Pipeline Updates The company provided updates on its clinical pipeline, detailing progress for key candidates and anticipated milestones Tovecimig (DLL4 and VEGF-A bispecific antibody) The Phase 2/3 COMPANION-002 study in biliary tract cancer (BTC) successfully met its primary endpoint of overall response rate, with secondary endpoint analysis rescheduled to Q1 2026 - In April 2025, the randomized Phase 2/3 COMPANION-002 study met its primary endpoint, showing tovecimig plus paclitaxel significantly improved overall response rate compared to paclitaxel alone in BTC patients[5] - The analysis of secondary endpoints, including Overall Survival (OS) and Progression-Free Survival (PFS), is now expected in Q1 2026 because the pre-specified number of deaths (80% pooled mortality) has not yet been reached[3][6][11] - A Phase 2 basket study of tovecimig in a broader set of DLL4+ cancers (e.g., gastric, ovarian, renal) is expected to begin following the secondary endpoint data analysis from the COMPANION-002 trial[11] CTX-8371 (PD-1 x PD-L1 bispecific antibody) The Phase 1 dose-escalation study demonstrated significant anti-tumor activity, leading to planned expansion cohorts in NSCLC and TNBC in Q4 2025 - Two deep partial responses were observed in the first four dosing cohorts (n=12): a 100% reduction in target lesions for an NSCLC patient and a >90% reduction for a TNBC patient[4][6][11] - Expansion cohorts focusing on NSCLC and TNBC are planned to initiate in Q4 2025[4][11] - Detailed results from the Phase 1 dose-escalation study are expected to be reported at a medical meeting in Q4 2025, with data from the cohort expansion stage anticipated in 2026[11] CTX-10726 (PD-1 x VEGF-A bispecific antibody) Preclinical data indicates CTX-10726 is superior to ivonescimab, with an Investigational New Drug (IND) application planned for Q4 2025 - Demonstrated superior tumor control and PD-1 inhibition compared to ivonescimab in head-to-head preclinical studies[4][11] - An IND submission for CTX-10726 is expected in Q4 2025, with initial clinical data anticipated in 2026[6][11] - CTX-10726 was discovered in-house and leverages Compass's expertise in bispecific antibody drug development, including manufacturing processes which are already at commercially viable yields[4] CTX-471 (CD137 agonist antibody) Compass plans to initiate a Phase 2 trial for CTX-471, a CD137 agonist antibody, in the second half of 2025 - A Phase 2 trial of CTX-471 is expected to be initiated in the second half of 2025[11] - The trial will enroll patients with tumors expressing NCAM (CD56)[11] Financial Results Compass Therapeutics reported increased net losses in Q2 and H1 2025 due to higher R&D expenses, with cash sufficient into 2027 Second Quarter 2025 Financial Performance For the second quarter of 2025, Compass reported an increased net loss of $19.9 million ($0.14 per share), primarily driven by higher R&D expenses Net Loss Overview | Metric | Q2 2025 | Q2 2024 | Six Months 2025 | Six Months 2024 | | :--- | :--- | :--- | :--- | :--- | | Net Loss | $19.9M | $13.1M | $36.5M | $23.9M | | Net Loss per Share | $0.14 | $0.10 | $0.26 | $0.17 | Operating Expenses Total operating expenses increased in Q2 and the first six months of 2025 compared to the prior year, driven by higher R&D costs Research and Development (R&D) Expenses R&D expenses rose by 47% to $16.4 million in Q2 2025, primarily due to increased manufacturing costs for clinical trial materials R&D Expense Summary | Period | R&D Expense | Prior Year Period | % Change | | :--- | :--- | :--- | :--- | | Q2 2025 | $16.4M | $11.2M | +47% | | H1 2025 | $29.5M | $20.7M | +42% | - The increase was primarily attributable to additional manufacturing expenses for tovecimig and CTX-10726[13] General and Administrative (G&A) Expenses G&A expenses remained flat at $4.7 million for Q2 2025 but increased by 20% for the first six months due to higher share-based compensation G&A Expense Summary | Period | G&A Expense | Prior Year Period | % Change | | :--- | :--- | :--- | :--- | | Q2 2025 | $4.7M | $4.7M | 0% | | H1 2025 | $9.6M | $8.0M | +20% | Cash Position and Runway As of June 30, 2025, Compass held $101 million in cash and marketable securities, expected to fund operations into 2027 Cash and Marketable Securities | Date | Cash & Marketable Securities | | :--- | :--- | | June 30, 2025 | $101.0M | | Dec 31, 2024 | $126.7M | - The current cash position provides an anticipated cash runway into 2027[4][17] - During the first six months of 2025, $25 million of net cash was used in operating activities[17]