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Compass Third-Quarter Net Loss Widens to $27.2 Million

Third-quarter 2026 research and development expenses rose 72% to $22.0 million as net loss widened to $27.2 million. Cash and marketable securities were $163 million at September 30, 2026, which the company said is expected to fund operations into 2028.

Compass Therapeutics (CMPX) reported a third-quarter 2026 net loss of $27.2 million, or $0.15 a share, compared with $14.3 million, or $0.08 a share, a year earlier. Research and development expenses rose 72% to $22.0 million. The clinical-stage oncology biopharmaceutical company said the FDA recommended an additional study demonstrating a survival benefit before BLA submission for tovecimig in biliary tract cancer, and that it does not believe a new trial is warranted.

The company had planned to file a BLA later in 2026 after receiving FDA feedback on COMPANION-002 data. In September 2026 it disclosed the agency’s recommendation. Compass said it is preparing to further engage the FDA and is advancing preparations for a BLA submission.

Full COMPANION-002 results were published in the Journal of Clinical Oncology and presented at the 2026 ESMO Congress. The study met its primary endpoint: tovecimig plus paclitaxel produced an overall response rate of 18.0% versus 5.3% with paclitaxel alone (p=0.0228), after one patient was adjudicated a partial response, lifting the rate from a previously reported 17.1%. Median progression-free survival was 4.7 months versus 2.6 months (HR=0.44, p<0.0001). Median duration of response was 4.9 months and disease control rate was 62.2% versus 36.8%.

The intent-to-treat overall survival analysis showed no statistically significant difference because of high crossover. A post hoc Two-Stage Estimation analysis in the JCO publication produced an OS hazard ratio of 0.85 (95% CI 0.59–1.26; p=0.53). The company said the safety profile was generally manageable and consistent with prior tovecimig studies, with no new safety signals.

Enrollment continues in an investigator-sponsored trial of tovecimig plus gemcitabine, cisplatin and durvalumab in first-line BTC, with expansion to additional sites expected. Two additional ISTs are underway in the second-line setting, including tovecimig plus FOLFIRI in colorectal cancer and a now-enrolling combination of tovecimig plus CTX-471 in glioblastoma.

CTX-8371 Phase 1 cohort expansions are enrolling 28 patients each in triple-negative breast cancer and non-small cell lung cancer and 12 in Hodgkin lymphoma, with half of the patients with each tumor type to be dosed at 3.0 mg/kg and half at 10.0 mg/kg. An update is expected later this year. CTX-10726 Phase 1 dose-escalation is enrolling across four doses in renal cell carcinoma, gastroesophageal cancer, hepatocellular carcinoma, and endometrial cancer; SITC data showed VEGF-dependent cleavage of cell-surface PD-1. Initiation of the Phase 2 trial of CTX-471 monotherapy in patients with locally advanced or metastatic Grade 3 NET or NEC is ongoing. Eligible patients must have tumors centrally confirmed to be NCAM (CD56)-positive by immunohistochemistry, have received at least one prior line of chemotherapy and have exhausted other standard-of-care options. First-stage dosing is planned at 0.3 mg/kg (n=18) and 0.6 mg/kg (n=18), with initial first-stage data expected in the second half of 2027.

Net loss for the quarter ended September 30, 2026, was $27.2 million, or $0.15 a share, compared with $14.3 million, or $0.08 a share, a year earlier.

Research and development expenses were $22.0 million, up from $12.8 million a year earlier, an increase of $9.2 million or 72%, primarily from $8.6 million of manufacturing costs related to tovecimig. General and administrative expenses were $6.8 million, up from $3.0 million, driven by $1.8 million more stock-based compensation and $1.5 million of pre-commercialization expenses.

Cash and marketable securities were $163 million at September 30, 2026, down from $180 million at the end of the second quarter. The company said the decrease from $209 million at December 31, 2025, was primarily driven by $48 million used in operating activities, and that the balance is expected to fund operations into 2028.

Chief Executive Officer Thomas Schuetz said the company is working to engage the FDA to bring tovecimig to patients with BTC as quickly as possible and that the totality of the data reinforces the urgency of that engagement.

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