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)
Q1 YoY Comparison
Actual vs Wall Street Consensus (Q1 2025)
Values retrieved from S&P Global.*
Clinical KPIs (BTC trial – COMPANION‑002, randomized; 2:1 tovecimig+pacl vs pacl)
Guidance Changes
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.
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 .