Compass Therapeutics (CMPX) investor relations material

Tovecimig data and FDA path

• COMPANION-002 results were presented at ESMO and published in the Journal of Clinical Oncology on Oct. 24; crossover-adjusted survival analyses showed a hazard ratio below 1.

• Management emphasized that patients receiving tovecimig at any time lived longer; it plans to present crossover-adjusted data clearly in renewed FDA discussions.

• FDA discussions are being pursued to assess an approval path; the case will include PFS HR 0.44 and a 2025 meta-analysis linking PFS HR below 0.61 with OS benefit.

• Absent FDA feedback ruling out filing, a BLA submission is planned for H1 next year; potential confirmatory designs include second-line tovecimig plus paclitaxel vs. FOLFOX, with OS and no crossover.

• Serum and biopsy analyses are testing a possible paclitaxel-related priming effect; results may be presented at a scientific meeting early next year.

Clinical development and pipeline

• Hypertension is a key tolerability consideration for tovecimig vs. other VEGF-targeted agents; discussions with ~30 physicians at ESMO informed planned hypertension-management guidelines.

• The MD Anderson frontline study adding tovecimig to TOPAZ-1 is expanding to additional sites; goal is full enrollment next year and progress toward its 6-month PFS landmark by year-end.

• Gastric and second-line colorectal investigator-sponsored studies are expected to start soon; planned regimens include paclitaxel/tovecimig/CTX-8371 and tovecimig/FOLFIRI. A glioblastoma study is showing early signals.

• CTX-10726 dose escalation is entering cohort 3 with no dose-limiting toxicities; cohort 4 is targeted before year-end, with a status and potential efficacy update before JPM.

• CTX-8371 expansion has mid-20s patients enrolled and additional efficacy signals; an update is expected before JPM, with full enrollment targeted next year and a full dataset in H2 next year.

• CTX-471's NCAM-positive tumor study is open and recruiting; an update is expected before the end of next year.

Financial position

• Cash was $163 million, expected to fund programs well into 2028 and support multiple potential inflection points next year.