Compass Therapeutics, Inc. (NASDAQ: CMPX) Q2 2025 Earnings | 08/11/2025

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Summary of Compass Therapeutics Q2 2025 Earnings Call – August 11, 2025

Key Highlights:

Tevesimab (DLL4/VEGFA Bispecific Antibody) in Biliary Tract Cancer (BTC):
- Fewer deaths than projected in the randomized Phase 2 trial (Companion 002), suggesting potential survival benefit.
- Median follow-up >17 months, with >20% OS rate (vs. <10% in historical ABC06 trial).
- PFS/OS analyses delayed to Q1 2026 (previously expected Q4 2025) due to slower-than-expected mortality.
- ORR was 17.1% (vs. ~6% in control), with a p-value of 0.031.
- ~50% crossover rate from control arm (paclitaxel) to Tevesimab; statistical adjustments will account for this.
CTX-8371 (PD-1/PD-L1 Bispecific Antibody):
- Unexpected deep partial responses in NSCLC (0.3 mg/kg) and triple-negative breast cancer (TNBC) (3 mg/kg) in dose escalation.
  - NSCLC patient: 59mm tumor burden resolved (initial pseudoprogression observed).
  - TNBC patient: >90% tumor reduction (52mm pericardial metastasis resolved).
- No dose-limiting toxicities in first 4 cohorts (up to 3 mg/kg).
- Cohort expansions in NSCLC/TNBC planned for late 2025, with data expected in 2026.
CTX-10726 (PD-1/VEGF Bispecific Antibody):
- Preclinical superiority vs. benchmark candidate (ivanseimab) in PD-1 blockade and tumor control.
- IND on track for Q4 2025, with Phase 1 data expected in 2026.
Financials & Milestones:
- $101M cash runway into 2027.
- Upcoming catalysts:
  - Tevesimab PFS/OS (Q1 2026) → Potential BLA filing mid-2026 (Fast Track designation).
  - CTX-8371 expansion cohorts (late 2025).
  - CTX-471 (NCAM+ solid tumors) basket trial initiation.

Q&A Highlights:

Tevesimab Survival Signal: Crossover-adjusted analysis (RPSFT method) will isolate Tevesimab’s effect. Control arm PD rate (42% at 8 weeks) suggests limited paclitaxel impact.
Regulatory Path: Post-PFS/OS data, FDA interactions will clarify approval pathway (potential accelerated approval based on ORR not ruled out).
CTX-8371 Safety: Early data suggest favorable profile; tumor-localized PD-1 blockade may reduce systemic toxicity.
CTX-10726 Strategy: Focus on indications where PD-1 + VEGF inhibition is validated (e.g., RCC, gastric cancer).

About this video

Compass Therapeutics reported its second-quarter 2025 financial results revealing a wider net loss of $19.9 million, or $0.14 per share, compared to a $13.1 million loss ($0.10 per share) in Q2 2024, missing analyst EPS expectations of -$0.12 with a 16.67% negative surprise. No revenue was recorded in the quarter, consistent with a clinical-stage biopharmaceutical company, down from $0.85 million the prior year due to absence of licensing income. Research and development expenses increased 47% to $16.4 million, reflecting intensified clinical trial activity and manufacturing scale-up primarily for lead assets. General and administrative expenses remained steady at $4.7 million. The company reported strong clinical progress, notably with its Phase 2/3 trial of tovecimig (a bispecific antibody targeting DLL4 and VEGF-A) for advanced biliary tract cancer, meeting its primary endpoint in April 2025 with fewer-than-projected deaths in the treatment group—delaying secondary outcome analysis to Q1 2026 but signaling potential efficacy. Early-stage clinical responses were also observed in CTX-8371, a PD-1/PD-L1 bispecific antibody, showing deep partial tumor reductions in certain lung and breast cancer patients with no dose-limiting toxicities, with broader cohort expansion planned by late 2025. Development of CTX-10726, a PD-1/VEGF-A bispecific, is on track with planned clinical trial initiation by year-end 2025 following promising preclinical results. Cash and marketable securities totaled $101 million as of June 30, 2025, providing a runway projected into 2027 to support ongoing trial activities and operational costs. Management did not provide formal revenue guidance, emphasizing that clinical milestones and trial data are key near-term drivers. The company’s stock surged over 20% intraday on August 11, 2025, amid enthusiasm over clinical progress despite the earnings miss. Risks include sustained operational losses, dependency on clinical trial success for future revenue generation, cash burn concerns, and the competitive oncology biotechnology landscape. Investors are advised to monitor late-stage trial data expected in 2026. About Inside Ticker: Inside Ticker delivers timely, in-depth financial news and earnings analysis to empower investors with actionable insights on global companies across sectors. For comprehensive video analysis and real-time updates, visit https://www.insideticker.com/. #CompassTherapeutics #CMPX #Q22025 #Earnings #FinancialResults #NetLoss #EPS #ClinicalTrials #Tovecimig #BispecificAntibodies #DLL4 #VEGFA #BiliaryTractCancer #CTX8371 #PD1 #PDL1 #Oncology #Biotech #CashPosition #PipelineProgress #InvestorUpdates #NASDAQ #InsideTicker

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