Compass Therapeutics(CMPX) - 2025 Q1 - Quarterly Results

Corporate Update and Q1 2025 Highlights Key Achievements Compass Therapeutics achieved key clinical milestones for its pipeline candidates and maintained a strong $113 million cash position - Tovecimig met its primary endpoint in the Phase 2/3 COMPANION-002 study for patients with biliary tract cancer (BTC), reinforcing its potential to address a significant treatment gap[3][5][6] - The company is advancing CTX-10726, a PD-1 x VEGF-A bispecific antibody, with an Investigational New Drug (IND) filing expected in Q4 2025 and clinical data anticipated in 2026[3][5] - CTX-8371, a PD-1 x PD-L1 bispecific, has progressed to the fourth dosing cohort in its Phase 1 study, with data expected to be shared later in 2025[3][11] - The company maintained a strong balance sheet, ending Q1 2025 with $113 million in cash and marketable securities, which is expected to fund operations into the first quarter of 2027[3][5][14] Development Pipeline Updates Tovecimig (DLL4 and VEGF-A bispecific antibody) Tovecimig demonstrated a statistically significant 17.1% ORR in BTC, with secondary endpoint data and new trials planned for 2025 Overall Response Rate (ORR) in COMPANION-002 Study | Metric | Tovecimig + Paclitaxel | Paclitaxel Alone | p-value | | :--- | :--- | :--- | :--- | | Overall Response Rate (ORR) | 17.1% | 5.3% | 0.031 | | Progressive Disease (PD) Rate | 16.2% | 42.1% | N/A | - Analyses of secondary endpoints, including progression-free survival (PFS), overall survival (OS), and duration of response (DoR), are expected in Q4 2025[3][11] - The first patient has been dosed in an Investigator Sponsored Trial (IST) at MD Anderson Cancer Center, evaluating tovecimig in the first-line setting for BTC[3][5][11] - A Phase 2 basket study of tovecimig is planned to replace the colorectal cancer study, targeting a broader set of DLL4+ cancers like gastric, ovarian, and renal[11] CTX-10726 (PD-1 x VEGF-A bispecific antibody) CTX-10726, a tetravalent PD-1 x VEGF-A bispecific, is on track for Q4 2025 IND submission and 2026 clinical data - CTX-10726 is a tetravalent bispecific antibody engineered to synergistically block VEGF-A and inhibit PD-1, showing potent preclinical activity[11] - A pre-IND meeting with the FDA was successfully completed, with an IND submission expected in Q4 2025[5][11] CTX-471 (CD137 agonist antibody) CTX-471, a CD137 agonist, showed durable responses, leading to a planned Phase 2 trial in NCAM-expressing tumors in H2 2025 - CTX-471 is a CD137 agonist antibody that binds to a unique epitope of the 4-1BB co-stimulatory molecule[11] - A Phase 2 trial of CTX-471 is planned for the second half of 2025, focusing on patients with tumors expressing NCAM (CD56)[11] CTX-8371 (PD-1 x PD-L1 bispecific antibody) CTX-8371, a PD-1 x PD-L1 bispecific, is progressing in its Phase 1 study with no DLTs, and preliminary data expected in H2 2025 - CTX-8371 is a bispecific checkpoint inhibitor that simultaneously targets PD-1 and PD-L1, featuring a unique mechanism involving the cleavage of cell surface PD-1[11] - The Phase 1 dose-escalation study has advanced to the fourth dosing cohort with no dose-limiting toxicities (DLTs) observed. Preliminary data is anticipated in H2 2025[5][11] First Quarter 2025 Financial Results Financial Performance Summary Compass Therapeutics reported a Q1 2025 net loss of $16.6 million ($0.12 per share), an increase from $10.8 million in Q1 2024 Net Loss and Net Loss per Share | Metric | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | Net Loss | $16.6 million | $10.8 million | | Net Loss per Share | $0.12 | $0.08 | Expense Analysis Operating expenses increased in Q1 2025, with R&D up 37% to $13.1 million and G&A up 51% to $4.9 million Operating Expenses | Expense Category | Q1 2025 | Q1 2024 | Change (YoY) | | :--- | :--- | :--- | :--- | | R&D Expenses | $13.1 million | $9.5 million | +37% | | G&A Expenses | $4.9 million | $3.2 million | +51% | - The increase in R&D expenses was primarily due to $2.5 million in spending on manufacturing for tovecimig and CTX-10726, plus $0.9 million in personnel costs[12] - The increase in G&A expenses was mainly attributable to a $1.3 million rise in personnel costs, which included $1.0 million related to share-based compensation[13] Cash Position Compass Therapeutics held $113 million in cash as of March 31, 2025, a decrease from $127 million at year-end 2024, with a runway into Q1 2027 - Cash and marketable securities totaled $113 million as of March 31, 2025, compared to $127 million on December 31, 2024[14] - The company anticipates its current cash position will fund operations into the first quarter of 2027[5][14] - Net cash used in operating activities during the first three months of 2025 was $13 million[14] Financial Statements Condensed Consolidated Statements of Operations The company reported a Q1 2025 net loss of $16.6 million and an operating loss of $18.0 million, with net loss per share increasing to $0.12 Condensed Consolidated Statements of Operations (In thousands, except per share data) | | Three Months Ended March 31, | | | :--- | :--- | :--- | | (In thousands, except per share data) | 2025 | 2024 | | Operating expenses: | | | | Research and development | $13,054 | $9,522 | | General and administrative | $4,912 | $3,248 | | Loss from operations | ($17,966) | ($12,770) | | Other income | $1,333 | $1,983 | | Net loss | ($16,633) | ($10,787) | | Net loss per share - basic and diluted | ($0.12) | ($0.08) | Condensed Consolidated Balance Sheets Total assets decreased to $131.5 million as of March 31, 2025, while total liabilities increased to $21.2 million and equity decreased to $110.3 million Condensed Consolidated Balance Sheets (In thousands) | | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | (In thousands) | | | | Assets | | | | Cash and cash equivalents | $41,048 | $43,483 | | Marketable securities | $71,587 | $83,239 | | Total current assets | $124,145 | $132,751 | | Total assets | $131,451 | $140,403 | | Liabilities and Stockholders' Equity | | | | Total current liabilities | $14,900 | $8,874 | | Total liabilities | $21,172 | $15,170 | | Total stockholders' equity | $110,279 | $125,233 |