Compass Therapeutics (CMPX) Cantor Global Healthcare Conference 2025 summary

Recent achievements and clinical milestones

• Three drugs are in clinical development, with a fourth IND submission planned by year-end.

• Lead program tovecimig met its primary endpoint in a randomized trial for advanced biliary tract cancer.

• Fewer deaths than projected have been observed in the ongoing trial, with 18 months of median follow-up.

• Deep responses seen in Phase 1 for CTX-8371 in non-small cell lung and triple-negative breast cancer.

• IND for CTX-10726, a PD-1xVEGF-A bispecific, is expected in Q4, with preclinical data suggesting superiority to competitors.

Regulatory and clinical strategy

• PFS and OS data for tovecimig will be available simultaneously, projected for Q1 next year.

• The study is powered for a hazard ratio of 0.6, with meaningful improvement in PFS considered significant.

• Plan is to seek full approval, not accelerated, based on comprehensive efficacy data.

• Paclitaxel was chosen as the control arm per FDA guidance, with confidence in regulatory acceptance.

• Crossover in the trial will be statistically adjusted using the Rank Preserving Structural Failure Time method.

Safety and adverse events

• No new safety signals identified by the independent data safety monitoring committee after four reviews.

• Adverse event profile is similar to Avastin, with hypertension as the most common drug-related AE.

• Published algorithms exist for managing hypertension associated with the therapy.