Compass Therapeutics (CMPX) Stifel 2026 Targeted Oncology Virtual Forum summary

Clinical trial results and regulatory strategy

• Secondary endpoint data for COMPANION-002 showed significant PFS improvement with tovecimig; no numerical detriment to overall survival was observed, with crossover patients showing strong benefit.

• Median OS for tovecimig plus paclitaxel was 9.9 months, outperforming historical controls; paclitaxel alone matched standard outcomes.

• Primary endpoint of overall response rate was met, supporting a positive study outcome and plans for a Biologics License Application in the second half of the year.

• Regulatory consultants recommend seeking full approval based on strong PFS and ORR data, with Accelerated Approval as a fallback.

• Additional crossover-adjusted statistical analyses are underway to further support the regulatory submission.

FDA engagement and confirmatory studies

• FDA meeting request expected by June 1, with meeting likely in early August and feedback by Labor Day; BLA submission targeted for Q4 2026.

• Confirmatory study options include a second-line OS trial (tovecimig/paclitaxel vs. FOLFOX) and a frontline study adding tovecimig to Gem/Cis/Durva, with ongoing data collection at MD Anderson.

• Early safety data from the MD Anderson frontline study is being reported to FDA, with potential for future supportive evidence.

Pipeline updates and ASCO presentations

• CTX-8371 (PD-1/PD-L1 bispecific) data to be presented at ASCO, including full dose escalation safety and early efficacy, with deep and durable responses in multiple tumor types.

• Cohort expansions in non-small cell lung, triple-negative breast, and Hodgkin's lymphoma are enrolling well; efficacy updates expected later this year.

• Unique mechanism of CTX-8371 involves PD-1 cleavage and CD80/CD28 pathway activation, differentiating it from other checkpoint inhibitors.

• Combination studies of CTX-471 with tovecimig are planned, leveraging dual angiogenesis and checkpoint inhibition.