Compass Therapeutics (CMPX) investor relations material

Clinical trial results and regulatory strategy

• Secondary endpoint data for COMPANION-002 showed significant improvement in PFS with tovecimig; median OS for tovecimig plus paclitaxel was 9.9 months versus 6.1 months for paclitaxel alone, aligning with historical controls.

• The primary endpoint of overall response rate was met, supporting a positive study outcome and a strong case for FDA approval.

• Plans are underway for a Biologics License Application submission in the second half of the year, with FDA meetings expected in August and feedback by Labor Day.

• Additional crossover-adjusted statistical analyses are being conducted to further clarify the impact on overall survival.

• Confirmatory trial options include a second-line OS trial versus FOLFOX or a frontline study with Gem/Cis/Durva, with ongoing data collection to inform design.

Pipeline updates and upcoming data

• CTX-8371 (PD-1/PD-L1 bispecific) data will be presented at ASCO, including full dose escalation safety and early efficacy, with durable responses in Hodgkin's lymphoma and triple-negative breast cancer.

• Cohort expansions in non-small cell lung, triple-negative breast, and Hodgkin's lymphoma are enrolling well, with safety data expected at ASCO and efficacy updates later in the year.

• The unique mechanism of CTX-8371 involves PD-1 cleavage and dual checkpoint/angiogenesis inhibition, with translational work ongoing to further elucidate its action.

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

• CTX-10726 (PD-1/VEGF-A bispecific) phase I is targeting indications with established checkpoint or angiogenesis inhibitor efficacy, with dose escalation data expected in the second half of the year.

Financial position and execution

• Cash balance of $195 million at end of Q1 provides runway into 2028, supporting planned launches, cohort expansions, and full phase I programs for multiple assets.

• Resources are allocated to advance four clinical-stage drugs, with a focus on delivering transformational data and preparing for a potential U.S. launch of tovecimig next year.