CTX-009 - (COMPANION-003)

Aug. 6, 2026: Compass Therapeutics (NASDAQ: CMPX) reported a pipeline update led by tovecimig (DLL4 x VEGF-A bispecific antibody) in biliary tract cancer. The company expects FDA feedback in Q3 2026 on COMPANION-002 Phase 2/3 data ahead of a potential BLA filing later in 2026. Final analysis showed the primary endpoint ORR improved to 18.0% (20/111) for tovecimig plus paclitaxel versus 5.3% for paclitaxel alone, with p=0.0228 after one case was adjudicated by blinded independent central review as a partial response. Full data were selected for an oral presentation at the 2026 ESMO Congress in October. Ongoing or initiated investigator-sponsored studies include tovecimig with gemcitabine/cisplatin/durvalumab in first-line BTC, with FOLFIRI in second-line colorectal cancer, and with CTX-471 in second-line glioblastoma.

CTX-8371 (PD-1 x PD-L1 bispecific antibody): Phase 1 expansion cohorts are enrolling in triple-negative breast cancer, NSCLC, and Hodgkin lymphoma after earlier responses; ASCO 2026 dose-escalation data were presented in June, and expansion data are expected in Q4 2026.

CTX-10726 (PD-1 x VEGF-A): first Phase 1 patients dosed; initial data expected in Q4 2026.

CTX-471 (CD137 agonist): Phase 2 in NCAM/CD56-expressing tumors is planned to start in Q3 2026.

Cash and marketable securities were $180 million at June 30, 2026, with runway expected into 2028.