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CT

Compass Therapeutics, Inc. (CMPX)·Q1 2025 Earnings Summary

Executive Summary

  • Q1 2025 delivered a clear clinical win: tovecimig (DLL4 x VEGF-A) met the primary endpoint in randomized Phase 2/3 BTC, with 17.1% ORR vs 5.3% for paclitaxel (p=0.031), and markedly lower PD rates (16.2% vs 42.1%) .
  • Financially, Compass reported GAAP net loss of $16.6M and diluted EPS of -$0.12; R&D rose 37% YoY to $13.1M and G&A rose 51% YoY to $4.9M; cash and marketable securities ended at $113M with runway into 2027 .
  • Versus Wall Street, EPS modestly missed consensus (-$0.12 actual vs -$0.111 consensus*), while revenue was in line (no revenue; consensus $0*) [GetEstimates].
  • Near-term catalysts: prespecified analyses of PFS, OS, and DoR expected in Q4; ongoing FDA interactions and BLA-ready CMC work, plus front-line BTC IST enrolling at MD Anderson .

What Went Well and What Went Wrong

What Went Well

  • Tovecimig met the primary endpoint (ORR) in BTC with statistically significant and clinically meaningful improvement (17.1% vs 5.3% ORR; p=0.031), plus markedly lower PD rates (16.2% vs 42.1%) .
  • Management highlighted rigorous BICR review and RECIST 1.1 compliance, noting confirmatory scans are not required in randomized trials; scans were centrally reviewed, “as rigorous as you can get” .
  • Strong balance sheet and runway: $113M cash/marketable securities; runway into 2027 supports execution across programs (tovecimig, CTX‑471, CTX‑8371, CTX‑10726) .

What Went Wrong

  • EPS missed consensus slightly (-$0.12 vs -$0.111*) amid higher spend; R&D up $3.6M YoY (manufacturing for tovecimig and CTX‑10726 +$2.5M; additional personnel +$0.9M), G&A up $1.7M YoY (personnel +$1.3M incl. $1.0M SBC) [GetEstimates].
  • Investor expectations may have been for higher ORR enabling accelerated approval immediately; management acknowledged the market’s mixed reaction and emphasized totality of data including forthcoming PFS/OS .
  • OS analysis delayed due to fewer-than-modeled events; median follow-up >14 months with OS analysis likely in early Q4, pushing timelines for full dataset disclosure .

Financial Results

Current vs Prior Two Quarters (chronological: oldest → newest)

MetricQ3 2024Q4 2024Q1 2025
Licensing Revenue ($USD Millions)$0.00 $0.85 $0.00 (no revenue line presented)
R&D Expense ($USD Millions)$8.61 $13.03 $13.05
G&A Expense ($USD Millions)$3.63 $3.54 $4.91
Other Income ($USD Millions)$1.76 $1.54 $1.33
Net Loss ($USD Millions)$10.48 $15.03 $16.63
Diluted EPS ($USD)$(0.08) $(0.11) $(0.12)
Cash & Marketable Securities ($USD Millions)$135.40 $126.72 (Cash $43.48; Mkt Sec $83.24) $112.64 (Cash $41.05; Mkt Sec $71.59)

Q1 YoY Comparison

MetricQ1 2024Q1 2025
R&D Expense ($USD Millions)$9.52 $13.05
G&A Expense ($USD Millions)$3.25 $4.91
Net Loss ($USD Millions)$10.79 $16.63
Diluted EPS ($USD)$(0.08) $(0.12)

Actual vs Wall Street Consensus (Q1 2025)

MetricConsensusActual
EPS ($USD)$(0.111)*$(0.12)
Revenue ($USD Millions)$0.00*$0.00 (no revenue recognized)

Values retrieved from S&P Global.*

Clinical KPIs (BTC trial – COMPANION‑002, randomized; 2:1 tovecimig+pacl vs pacl)

KPITovecimig + PaclitaxelPaclitaxel Alonep‑value
Overall Response Rate (ORR)17.1% 5.3% 0.031
Progressive Disease (PD) Rate16.2% 42.1% N/A

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Cash RunwayThrough Q1 2027“Runway into 2027” (Q4 2024) “Runway into 2027; ended Q1 with $113M” Maintained
BTC Trial Secondary Endpoints (PFS/OS/DoR)Readout TimingTop-line ORR end of Q1 2025; secondary endpoints TBD Analyses expected Q4 2025 (OS likely early Q4) Updated timeline
Front-line BTC IST (MD Anderson)EnrollmentIST initiation Q1 2025 First patient dosed; actively enrolling Progressed
CTX‑10726 (PD‑1 x VEGF‑A)INDIND by YE 2025 Pre‑IND completed; IND filing expected Q4 2025 Confirmed timeline
CTX‑8371 (PD‑1 x PD‑L1)Phase 1 DataPreliminary data 2H 2025 Fourth dosing cohort; data expected 2H 2025 Maintained
CTX‑471 (CD137)Phase 2 StartMid‑2025 initiation Basket in NCAM/CD56 tumors expected 2H 2025 Slight schedule detail

Earnings Call Themes & Trends

Note: A Q1 2025 earnings call transcript was not available in the repository. Management commentary from the May 8, 2025 Citizens JMP Life Sciences Conference is used for current-period narrative.

TopicPrevious Mentions (Q3 2024, Q4 2024)Current Period (Q1 2025)Trend
BTC efficacy (tovecimig)Top-line ORR readout targeted for end Q1 2025; trial fully enrolled ORR 17.1% vs 5.3% (p=0.031); PD rate much lower; awaiting PFS/OS/DoR in Q4 Positive; building to full dataset
Regulatory strategyDesigning randomized trial; no immediate AA claims FDA interactions continuing; AA not imminent; focus on totality incl. PFS/OS; BLA‑ready CMC underway Clarifying path; data-driven
Market opportunity (BTC)Emphasized unmet need; front-line SOC includes IO ~23k U.S. BTC patients; ~15k likely 2L; multi‑billion market; few targeted options for ~85% of patients Expanding TAM framing
Manufacturing/CMCAdvancing programs; runway supports execution U.S.-based CMO; CMC aligned with clinical timelines toward year-end Operational readiness
PD‑1 x VEGF‑A (CTX‑10726)IND by YE 2025 Pre‑IND done; IND Q4 2025; claims higher PD‑1 blockade potency vs peers On track; differentiation
CD137 (CTX‑471)Durable responses; NCAM/CD56 biomarker correlation NCAM+ basket study starting; monotherapy responses in post‑PD‑1 patients reiterated Biomarker-led expansion
PD‑1 x PD‑L1 (CTX‑8371)Dose escalation cohorts; no DLTs Fourth cohort; unique MoA includes PD‑1 cleavage; data 2H 2025 Progressing; mechanistic differentiation

Management Commentary

  • “These positive data reinforce the potential for tovecimig to fill a striking gap in the treatment paradigm for patients with BTC. We expect to share analyses of the secondary endpoints, including PFS, OS and DoR, in the fourth quarter of this year.” — CEO Thomas Schuetz .
  • On RECIST 1.1 rigor: “In randomized trials… a second scan is not required… What it does suggest is… blinded independent central readers. All of the scans that we had from the study were confirmed by blinded independent central review.” — CEO .
  • On OS timeline and effect: “We have more than 14 months of median follow-up… OS analysis would not occur probably till the beginning of Q4… It’s quite likely that we’re seeing a treatment effect just based on cumulative mortality.” — CEO .
  • On market size: “23,000 patients with BTC estimated in the United States in 2025… about two‑thirds… make it to second-line therapy… fully penetrated market is a multi‑billion dollar annual market.” — CEO .
  • On pipeline cadence and cash: “Finished Q1 with about $113 million in cash… runway… into 2027… key milestones… PFS and OS readout… basket study for 471… phase one data for 8371… IND filing for 10726.” — CEO .

Q&A Highlights

  • Investor concern on ORR magnitude and AA timing: Management acknowledged mixed market reaction and emphasized totality of evidence and forthcoming PFS/OS before AA discussions .
  • Regulatory and CMC readiness: Engaging FDA; BLA‑ready CMC work in progress; U.S.‑based contract manufacturer; timelines aligned with clinical milestones .
  • Competitive landscape: No labeled second‑line BTC therapy in U.S.; targeted options (FGFR2, IDH1, HER2) cover ~15% of patients, leaving ~85% without labeled therapy .
  • TAM and commercialization: Multi‑billion potential; preparing to commercialize, while evaluating strategic options .
  • Mechanistic differentiation: CTX‑8371 engages cells and cleaves PD‑1 on exhausted T‑cells; CTX‑10726 designed for more potent PD‑1 blockade than peers .

Estimates Context

  • Q1 2025 EPS was slightly below consensus (actual $(0.12) vs $(0.111)), reflecting higher R&D and G&A; revenue inline at $0 [GetEstimates] .
  • With upcoming PFS/OS/DoR in Q4, estimates may need to incorporate potential PFS benefit and timing of regulatory interactions; spending likely remains elevated with IND and CMC activities .

Values retrieved from S&P Global.*

Key Takeaways for Investors

  • Tovecimig delivered a statistically significant ORR benefit and materially lower PD rates in randomized BTC; PFS/OS will be the major de‑risking catalysts in Q4 .
  • Near‑term narrative hinges on strength of PFS/OS; a positive PFS could reset expectations and support regulatory dialogue and potential filing strategy .
  • EPS modestly missed consensus; spending is appropriately ramping for CMC and IND activities, supported by $113M cash and runway into 2027 .
  • BTC TAM is larger than often assumed; lack of labeled 2L options positions tovecimig favorably if PFS/OS reinforce ORR .
  • Additional shots on goal: CTX‑471 biomarker‑driven basket, CTX‑8371 Phase 1 readout 2H, CTX‑10726 IND in Q4 with potential potency differentiation .
  • Trading lens: Expect volatility around Q4 readouts and any FDA updates; upside skew if PFS/OS are robust and CMC remains on track .
  • Medium‑term thesis: Platform benefits across angiogenesis‑IO and next‑gen checkpoints; capital runway supports multi‑program execution into 2027 .

Document Availability Note

  • Q1 2025 8‑K 2.02 press release read in full .
  • A Q1 2025 earnings call transcript was not found; management’s May 8, 2025 Citizens JMP Life Sciences Conference transcript was read in full and used for current‑period commentary .
  • Prior quarter materials (Q4 2024 and Q3 2024 8‑Ks) read in full for trend analysis .