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Compass Therapeutics, Inc. (CMPX)·Q3 2025 Earnings Summary

Executive Summary

  • Q3 2025 EPS of $(0.08) beat Wall Street consensus of $(0.14), with no revenue recognized; net loss was $14.3M driven by higher R&D and lower G&A versus prior year . EPS estimate values retrieved from S&P Global.*
  • Management highlighted a continued trend of decreased pooled mortality in the Phase 2/3 COMPANION-002 trial of tovecimig in BTC; OS and PFS analyses now expected in late Q1 2026, and management sees potential to support a first BLA filing in H2 2026 .
  • CTX-8371 Phase 1 dose escalation fully enrolled; a new response observed in a third indication and no DLTs to date; cohort expansions in NSCLC/TNBC expected to begin in Q4 2025, with topline data targeted for H1 2026 .
  • Balance sheet strengthened by August financing; cash and marketable securities reached $220M at quarter-end, extending runway into 2028; net cash used in operations was $35.9M for the first nine months of 2025 .
  • Additional Q3 press release: CTX-10726 preclinical poster at SITC showed superior anti-tumor activity vs ivonescimab across models; IND filing remains on track for Q4 2025, initial Phase 1 data expected in 2026 .

What Went Well and What Went Wrong

What Went Well

  • “We have made strong progress across our clinical pipeline... expect to report the OS and PFS data in late Q1 2026... could support our first BLA filing in the second half of 2026.” – CEO Thomas Schuetz .
  • CTX-8371: new response in a third indication in the fifth cohort; no dose-limiting toxicities at any dose level; cohort expansions in NSCLC/TNBC to begin in Q4 2025; topline Phase 1 data expected H1 2026 .
  • CTX-10726: strong preclinical data including superior tumor control vs ivonescimab; IND on track for Q4 2025; Phase 1 clinical data expected in H2 2026; SITC 2025 poster presented .

What Went Wrong

  • Secondary endpoint analyses timing for tovecimig (OS/PFS) delayed from prior guidance (Q4 2025) to late Q1 2026 due to fewer OS events than modeled; while indicative of improved survival, it pushes the catalyst into next quarter .
  • R&D expenses increased 49% YoY to $12.8M in Q3 2025, mainly from manufacturing and IND-enabling costs related to CTX-10726; nine-month R&D was $42.3M vs $29.3M in 2024 (+44%) .
  • Net loss widened YoY to $14.3M (from $10.5M), despite G&A declining due to a $1.1M stock comp credit; highlights continuing investment intensity ahead of key 2026 milestones .

Financial Results

MetricQ3 2024Q1 2025Q2 2025Q3 2025
License Revenue ($USD Millions)$0.0 $0.0 $0.0 $0.0
R&D Expenses ($USD Millions)$8.6 $13.1 $16.4 $12.8
G&A Expenses ($USD Millions)$3.6 $4.9 $4.7 $3.0
Total Operating Loss ($USD Millions)$(12.2) $(18.0) $(21.1) $(15.8)
Other Income ($USD Millions)$1.8 $1.3 $1.2 $1.6
Net Loss ($USD Millions)$(10.5) $(16.6) $(19.9) $(14.3)
Diluted EPS ($USD)$(0.08) $(0.12) $(0.14) $(0.08)
Weighted Avg Shares (Millions)137.6 138.2 138.3 168.8
Balance Sheet MetricDec 31, 2024Mar 31, 2025Jun 30, 2025Sep 30, 2025
Cash & Equivalents ($USD Millions)$43.5 $41.0 $22.9 $46.2
Marketable Securities ($USD Millions)$83.2 $71.6 $78.1 $173.7
Cash + Securities ($USD Millions)$127.0 $113.0 $101.0 $220.0
Total Stockholders’ Equity ($USD Millions)$125.2 $110.3 $93.2 $209.6
Results vs Estimates (Q3 2025)ActualConsensus
EPS ($USD)$(0.08) $(0.14)*
EPS – # of Estimates11*
Revenue ($USD Millions)$0.0 $0.0*
Revenue – # of Estimates10*

Values retrieved from S&P Global.*

KPIs (clinical and operational)

KPIQ1 2025Q2 2025Q3 2025
Tovecimig Phase 2/3 ORR (primary endpoint)17.1% vs 5.3% control; p=0.031 Maintained; fewer deaths observed than projected Maintained; OS/PFS analyses expected late Q1 2026
CTX-8371 Phase 1 responsesAdvanced to 4th cohort; no DLTs Two deep PRs (NSCLC 100% target lesion resolution; TNBC >90% reduction); no DLTs; expansions planned Q4 2025 New response in a third indication; no DLTs; expansions to begin Q4 2025; topline H1 2026
CTX-10726 IND timingPre-IND complete; IND expected Q4 2025 IND expected Q4 2025; superior preclinical vs ivonescimab IND on track Q4 2025; SITC data showed superiority vs ivonescimab
Cash runwayInto Q1 2027 Into 2027 Into 2028

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Tovecimig OS/PFS analyses (COMPANION-002)Secondary endpointsQ4 2025 (guided prior) Late Q1 2026 Delayed
Cash runwayCorporateInto 2027 Into 2028 Extended
CTX-8371 cohort expansions (NSCLC/TNBC)Phase 1Begin Q4 2025 Begin Q4 2025 Maintained
CTX-10726 IND filingINDQ4 2025 Q4 2025 Maintained
First BLA filing (tovecimig)RegulatoryMid-2026 (slides) H2 2026 (press release language) Maintained/clarified

Earnings Call Themes & Trends

Note: A Q3 2025 earnings call transcript was not available; themes reflect Q1/Q2 earnings materials and Q3 press releases, with supplemental investor conferences in September.

TopicPrevious Mentions (Q1/Q2)Current Period (Q3)Trend
BTC survival signals and timingGuided Q4 2025 for OS/PFS; primary ORR met; fewer deaths than modeled Continued decreased mortality; OS/PFS now late Q1 2026; BLA potential H2 2026 Timing delayed; survival signal strengthening
CTX-8371 efficacy/safetyProgress to 4th cohort; two deep responses; no DLTs; expansions planned Q4 2025 New response in third indication; fifth cohort fully enrolled; no DLTs; topline H1 2026 Positive efficacy, differentiated safety profile
CTX-10726 preclinical momentumPre-IND complete; IND Q4 2025; superiority vs ivonescimab in models SITC poster shows superior anti-tumor activity vs ivonescimab; IND on track Q4 2025 Building momentum toward clinic
Financing/runwayCash $113M/$101M; runway into 2027 $220M cash+securities; runway into 2028; $138M oversubscribed financing Strengthened balance sheet
Market opportunity in BTCMassive unmet need; ~25k US patients annually Reinforced ~25k US incidence; aiming 2L SoC positioning Narrative consistent, commercial rationale intact

Management Commentary

  • “Based on a continuing trend of lower mortality... we expect to report the OS and PFS data in late Q1 2026... could support our first BLA filing in the second half of 2026.” – Thomas Schuetz, CEO .
  • “There have been no dose-limiting toxicities (DLTs) observed at any dose level, suggesting that CTX-8371 may have a differentiated safety profile... cohort expansions in NSCLC and TNBC are expected to begin in Q4 2025.” – Thomas Schuetz .
  • “All these plans are fully supported by our upsized and oversubscribed $138 million financing... [which] extends the runway into 2028.” – Company statement .
  • “We believe that the fact that there are more patients alive and those patients are living longer suggests that we could be seeing a treatment effect as measured by overall survival.” – Thomas Schuetz at a September investor event .

Q&A Highlights

Note: No Q3 earnings call transcript available. The following Q&A themes reflect September investor conference discussions.

  • OS/PFS timing update rationale: Fewer deaths observed versus initial modeling led to pushing OS/PFS analyses to Q1 2026; management views this as encouraging for a survival benefit .
  • Financing and runway: $138M upsized financing extends runway through transformational milestones, including OS/PFS, BLA filing, CTX-8371 expansions, and CTX-10726 first-in-human study .
  • BTC market sizing and positioning: ~25k US BTC incidence annually; tovecimig + paclitaxel seeks to become second-line standard of care in a setting with no labeled therapies for ~80–85% of patients .

Estimates Context

  • Q3 2025 EPS beat: Actual $(0.08) vs consensus $(0.14); 11 EPS estimates. Revenue was $0.0 vs $0.0 consensus; estimates reflect biotech model with limited near-term revenue. Values retrieved from S&P Global.*
  • Potential revisions: The EPS beat was aided by lower quarter-over-quarter R&D versus Q2 and a G&A credit from returned unvested equity ($1.1M), which may not recur; analysts may recalibrate quarterly opex cadence but are likely to keep 2026 milestone-driven valuation focus intact .

Key Takeaways for Investors

  • Clinical de-risking continues: Statistically significant ORR in BTC and improving pooled survival trends underpin a credible registrational path; OS/PFS analyses in late Q1 2026 are the next major value inflection .
  • Pipeline depth adds optionality: CTX-8371 shows multi-indication activity with a clean safety profile so far; cohort expansions in NSCLC/TNBC commence in Q4 2025; topline Phase 1 data in H1 2026 can broaden the story beyond BTC .
  • CTX-10726 is advancing: Strong SITC preclinical poster and head-to-head superiority vs ivonescimab support IND filing in Q4 2025 and clinical proof-of-concept in 2026 .
  • Balance sheet robust: $220M in cash and marketable securities extends runway into 2028, reducing financing overhang ahead of multiple 2026 catalysts .
  • Near-term trading setup: Expect news flow on CTX-8371 expansions and CTX-10726 IND; primary trading catalyst remains OS/PFS readout in late Q1 2026; any interim survival or safety updates could move sentiment .
  • Medium-term thesis: If OS/PFS are positive, management plans H2 2026 BLA filing for tovecimig, with second-line BTC positioning and potential basket study expansion into DLL4+ tumors, supporting a multi-program oncology platform valuation .
  • Risk factors: Delay risk around event-driven analyses; opex intensity continues; binary clinical milestones dominate valuation; however, diversified pipeline and extended runway mitigate single-asset risk .