Compass Therapeutics, Inc. (CMPX)·Q2 2025 Earnings Summary

Executive Summary

• Q2 showed continued operating losses as Compass invests in its pipeline: net loss was $19.9M ($0.14/sh) vs $13.1M ($0.10/sh) in Q2’24 and $16.6M ($0.12/sh) in Q1’25; cash and marketable securities were $101M with runway into 2027 .
• Tovecimig BTC trial update was the key narrative: fewer deaths than projected delays the PFS/OS analyses to Q1’26 and may suggest an OS effect; primary ORR result previously announced (17.1% vs 5.3%, p=0.031) remains intact .
• Early CTX-8371 signals surprised positively: two deep, confirmed PRs in dose escalation (NSCLC complete resolution of target lesions; TNBC >90% target lesion reduction); cohort expansions in NSCLC and TNBC planned to start in Q4’25 .
• CTX-10726 preclinical readouts were favorable vs ivonescimab (superior PD-1 inhibition and anti-tumor activity in models); IND on track for Q4’25 with clinical data expected in 2026 .
• EPS missed S&P Global consensus (–$0.14 actual vs –$0.124 estimate), while revenue was in line (zero) as expected for a clinical-stage biotech; near-term stock catalysts center on CTX-8371 cohort expansions (Q4’25) and CTX-10726 IND (Q4’25), with major binary PFS/OS readout for tovecimig in Q1’26 .

What Went Well and What Went Wrong

What Went Well

• Fewer deaths observed in tovecimig COMPANION-002 than projected, which “may suggest that tovecimig could be affecting overall survival,” pushing PFS/OS analyses to Q1’26; CEO: “More patients are alive today than we have projected.”
• CTX-8371 dose-escalation produced two deep, confirmed PRs in refractory settings (NSCLC complete resolution of target lesions; TNBC >90% target-lesion reduction), with expansions in NSCLC/TNBC planned for Q4’25 .
• CTX-10726 showed head-to-head preclinical superiority to ivonescimab and parity vs pembrolizumab in PD-1 blockade models; IND remains on track for Q4’25 with 2026 clinical data guide .

What Went Wrong

• Operating intensity rose: R&D up 47% YoY to $16.4M in Q2 (manufacturing costs for tovecimig and CTX-10726), widening net loss to $19.9M vs $13.1M in Q2’24 .
• Key clinical catalyst delayed: PFS/OS analysis for tovecimig slipped from prior “Q4’25” expectation to “Q1’26,” deferring potential regulatory interactions and value inflection .
• No new efficacy/duration metrics yet for tovecimig beyond ORR; DoR will be analyzed after PFS/OS; management could not provide an update on the MD Anderson IST timing for initial data .

Financial Results

Income Statement – Quarterly

Notes: YoY compares Q2’25 to Q2’24; QoQ compares Q2’25 to Q1’25. R&D increased primarily due to additional manufacturing spend tied to tovecimig and CTX-10726 .

Balance Sheet / Liquidity KPIs

Results vs S&P Global Consensus (Q2 2025)

Values retrieved from S&P Global.*

Margins / Segments / KPIs

• Margins and segment reporting not meaningful given de minimis revenue; principal KPIs are R&D/G&A spend, cash runway, and program milestones .

Guidance Changes

Earnings Call Themes & Trends

Management Commentary

• “More patients are alive today than we have projected... the analyses of PFS and OS are now projected to occur in 2026.”
• “Two deep and confirmed partial responses... complete resolution of measured target lesions in a patient with non-small cell lung cancer and over 90% reduction... in a patient with triple negative breast cancer.”
• “We’re announcing... preclinical head-to-head comparisons of CTX‑10726 with ivonescimab... the best drug in this head-to-head experiment is CTX‑10726.”
• “We ended Q2 with $101 million in cash... cash runway into 2027.”

Q&A Highlights

• OS methodology and crossover: ~50% of control patients crossed over; OS primary analysis will use rank-preserving structural failure time (RPSFT) to adjust for crossover, similar to prior IDH1 BTC analyses .
• PFS powering and bar: Study 80% powered around HR ≈0.6; management noted paclitaxel arm week-8 PD rate (42.1%) suggests median PFS ~2–2.5 months, and KOL feedback indicated HR 0.6 would be “off the charts” for adoption .
• BLA readiness: CMC PPQ batches are underway; plan substantive FDA interactions post PFS/OS readout; potential for priority review under Fast Track discussed qualitatively .
• CTX-8371 expansions: Planning small randomized expansion cohorts (~50 patients) across two doses in NSCLC and TNBC starting Q4’25; early PRs occurred at 0.3 mg/kg (NSCLC) and 3.0 mg/kg (TNBC) with no DLTs to date .
• Timing sensitivity: Event rate slowed vs April projection; management now guides to Q1’26 for PFS/OS; will present a priority dataset (PFS, OS, demographics, top-line safety) with fuller data at a medical meeting .

Estimates Context

• Q2’25 EPS of $(0.14) missed S&P Global consensus of $(0.124); revenue was in line at $0 vs $0 expected .
• With operating expenses rising for manufacturing and clinical progress, upward estimate revisions to R&D and net loss for H2’25 may be warranted; topline PFS/OS in Q1’26 is the primary driver for out-quarter revenue/probability-of-success modeling .

Values retrieved from S&P Global.*

Key Takeaways for Investors

• Tovecimig survival narrative strengthened: fewer-than-expected deaths with >17 months median follow-up and pooled OS >20% suggests potential OS benefit; binary PFS/OS readout in Q1’26 is the main medium-term catalyst .
• Clinical momentum broadening: CTX-8371 signals efficacy in refractory NSCLC/TNBC with clean tolerability to date; Q4’25 expansion starts should add data velocity into 2026 .
• Pipeline leverage: CTX-10726 shows differentiated preclinical profile vs ivonescimab with IND in Q4’25; indication selection (where VEGF and PD-1 monotherapies are active) could enable efficient paths, potentially including single-arm designs in select settings .
• Cash runway into 2027 provides funding visibility through multiple value inflections (CTX-8371 expansions, CTX-10726 entry into clinic, tovecimig PFS/OS) .
• Near-term trading setup: Q4’25 newsflow (CTX‑8371 cohort initiations, potential dose-escalation data at a meeting, CTX‑10726 IND filing) could drive sentiment ahead of Q1’26 PFS/OS; watch for any interim safety/operational updates .
• Risk checks: Delay of PFS/OS to Q1’26 pushes timing; EPS miss reflects increased R&D/manufacturing spend; until survival data are shown, regulatory visibility remains limited .

Appendix: Program and Trial Highlights (for context)

• Tovecimig P2/3 BTC (2L): ORR 17.1% vs 5.3% (p=0.031) with ongoing safety consistent with prior studies; PFS/OS when ~80% OS events accrued—now guided to Q1’26 .
• CTX-8371 P1 (post PD-1/L1): Two confirmed PRs; no DLTs in first 4 cohorts; 5th cohort enrolling; expansions planned Q4’25 .
• CTX-10726 (PD-1 x VEGF-A): Preclinical superiority vs ivonescimab; IND Q4’25; clinical data in 2026 .

Citations:

• Q2’25 8-K press release, exhibits, and financials
• Q2’25 earnings call transcript
• Q1’25 8-K press release and financials
• FY’24 8-K and financial context