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Compass Therapeutics (CMPX)

Earnings summaries and quarterly performance for Compass Therapeutics.

Recent press releases and 8-K filings for CMPX.

Compass Therapeutics discusses 2026 pipeline milestones and commercial readiness
CMPX
Product Launch
New Projects/Investments
Revenue Acceleration/Inflection
  • Compass Therapeutics expects a readout on secondary endpoints (PFS and OS) for its lead program, Tevesemig, a DLL4 VEGF-A bispecific antibody, at the end of Q1 2026. The company projects a multi-billion dollar commercial opportunity for Tevesemig in second-line biliary tract cancer, with a potential 2027 launch.
  • In its Phase 1 study for the PD-1, PD-L1 bispecific antibody (8371), three responses were observed in the first 15 patients, including near complete responses in metastatic non-small cell lung cancer and refractory triple-negative breast cancer. Cohort expansion readouts are anticipated in the second half of 2026.
  • A novel PD-1 VEGF-A bispecific antibody is scheduled to enter the clinic in early 2026, and a biomarker-driven basket study for the CD137 agonist antibody will commence in the first half of 2026.
Dec 4, 2025, 3:00 PM
Compass Therapeutics Outlines Key 2026 Clinical Milestones and Market Opportunities
CMPX
New Projects/Investments
Product Launch
Guidance Update
  • Compass Therapeutics anticipates an eventful 2026 with several key clinical milestones, including a readout on secondary endpoints (PFS and OS) for its lead program, Tevesemig, a DLL4 VEGF-A bispecific antibody, expected at the end of Q1 2026.
  • Early clinical observations for its PD-1, PD-L1 bispecific antibody (8371) show three responses in the first 15 patients treated in a Phase 1 study, including a near complete response in a patient with triple-negative breast cancer who had relapsed on prior therapies. Cohort expansions are planned for triple-negative breast cancer and non-small cell lung cancer, with a readout expected in the second half of 2026.
  • The company's novel PD-1 VEGF-A bispecific antibody is set to enter the clinic at the beginning of 2026, targeting gastric, hepatocellular, renal cell, and endometrial cancers, and is believed to offer differentiated PD-1 blockade.
  • Tevesemig, which demonstrated a more than tripled response rate in a randomized study for biliary tract cancer (BTC), represents a multi-billion-dollar commercial opportunity in second-line BTC alone, with potential for expansion into first-line and other tumor types. The company is preparing for a potential 2027 launch.
Dec 4, 2025, 3:00 PM
Piper Sandler Healthcare Conference Highlights Compass Therapeutics' and REGENX's Clinical Milestones
CMPX
New Projects/Investments
Product Launch
Guidance Update
  • Compass Therapeutics (CMPX) highlighted a 290% year-to-date stock increase and provided updates on its clinical pipeline.
  • CMPX's Tovecimig program for advanced biliary tract cancer achieved its primary endpoint for overall response rate, with PFS and OS data expected by Q1 2026, and a BLA submission anticipated in H2 2026.
  • CMPX's 8371 program, a PD-1 x PD-L1 bispecific antibody, showed three confirmed responses in 15 post-checkpoint patients in its Phase I study, with potential approval studies for triple-negative breast cancer starting in 2026.
  • REGENX announced upcoming milestones including a February PDUFA date for its RGX-121 Hunter program and top-line data for its RGX-202 Duchenne program in early Q2 2026.
Dec 2, 2025, 1:00 PM
Compass Therapeutics and REGENXBIO Provide Updates on Clinical Programs and Regulatory Timelines
CMPX
Product Launch
New Projects/Investments
Guidance Update
  • Compass Therapeutics expects PFS and OS data for its Tevesemig program in advanced biliary tract cancer by end of Q1 2026, with a potential BLA submission in H2 2026 and PDUFA in H1 2027. The company also highlighted promising Phase 1 data for its 8371 bispecific antibody, showing three confirmed responses in 15 post-checkpoint patients, and plans for two potential approval studies in 2026.
  • REGENXBIO anticipates a PDUFA date in February 2026 for its RGX-121 (Hunter program), following successful manufacturing inspections. Top-line data for its RGX-202 (Duchenne program), which has shown no serious adverse events and functional improvement in older patients, is expected in early Q2 2026.
Dec 2, 2025, 1:00 PM
Compass Therapeutics and REGENXBIO Outline Key Clinical Milestones
CMPX
New Projects/Investments
Guidance Update
Revenue Acceleration/Inflection
  • Compass Therapeutics (CMPX) anticipates PFS and OS data for Tevesemig in advanced biliary tract cancer by the end of Q1 2026, with a potential BLA submission in H2 2026 and launch in H1 2027 targeting an estimated 15,000 eligible US patients annually.
  • CMPX's 8371 (PD-1/PD-L1 bispecific antibody) demonstrated three confirmed responses in 15 post-checkpoint patients in its Phase 1 study, with plans to advance to potential approval studies for triple-negative breast cancer in H1 2026.
  • REGENXBIO anticipates a February PDUFA date for its RGX-121 Hunter program.
  • REGENXBIO also projects top-line data in early Q2 2026 for its RGX-202 Duchenne program, which has shown functional improvement in older patients and no serious adverse events in Phase 1/2.
Dec 2, 2025, 1:00 PM
Compass Therapeutics Outlines Key Clinical Catalysts for 2026 and 2027
CMPX
New Projects/Investments
Product Launch
Guidance Update
  • Compass Therapeutics anticipates a significant year in 2026, with key readouts including Progression-Free Survival (PFS) and Overall Survival (OS) data for tovecimig in advanced biliary tract cancer (BTC) in late Q1 2026. The company projects a potential $3 billion annual market in the U.S. alone for second-line BTC.
  • The company's first-in-class bispecific antibody, CTX-8371, which targets PD-1 and PD-L1, has shown promising early results with three responses out of 15 patients in the post-checkpoint inhibitor setting. Cohort expansions in non-small cell lung cancer and triple-negative breast cancer are underway, with data expected in the first half of 2026.
  • A novel PD-1 VEGF-A bispecific antibody, 10726, is slated to begin its Phase 1 study in early 2026, targeting gastric, hepatocellular, renal cell, and endometrial cancers.
  • Following successful clinical outcomes and an FDA interaction, Compass Therapeutics aims for a potential commercial launch of tovecimig in the first half of 2027.
Nov 20, 2025, 12:30 PM
Compass Therapeutics Provides Updates on Clinical Pipeline and Tovecimig Market Potential
CMPX
New Projects/Investments
Product Launch
Guidance Update
  • Compass Therapeutics expects the Progression-Free Survival (PFS) and Overall Survival (OS) readout from its randomized trial of tovecimig in advanced biliary tract cancer in late Q1 2026. The trial previously achieved its primary endpoint of overall response rate, which was statistically significant.
  • The company estimates the U.S. market for second-line biliary tract cancer to be approximately $3 billion annually, with a potential commercial launch of tovecimig in the first half of 2027.
  • The bispecific antibody CTX-8371 has demonstrated three responses out of the first 15 patients in its Phase 1 study, including confirmed partial responses in non-small cell lung cancer and metastatic triple negative breast cancer. Cohort expansions are initiating this quarter, and further data is anticipated in the first half of 2026.
  • Compass Therapeutics plans to initiate a Phase 1 study for its fourth drug, 10726 (PD-1 VEGF-A bispecific antibody), in early 2026.
Nov 20, 2025, 12:30 PM
Compass Therapeutics Provides Updates on Clinical Programs and Financial Outlook
CMPX
Guidance Update
New Projects/Investments
Product Launch
  • Top-line data for the CTX-009 COMPANION-002 trial in second-line biliary tract cancer is now guided for late Q1 2026 (March 2026), triggered by an 80% death event fraction. The primary endpoint (overall response rate) was already statistically significant.
  • The addressable market for second-line biliary tract cancer in the US is estimated at 15,000 patients annually, representing a market opportunity well north of a billion US dollars annually. The company plans to launch the drug themselves into this market.
  • Early Phase 1 data for 8371, a PD-1, PD-L1 bispecific antibody, shows three responses in three different indications among the first 15 patients, all post-checkpoint inhibitor, with no dose-limiting toxicities. Cohort expansions are initiating this quarter in triple-negative breast cancer and non-small cell lung cancer.
  • For CTX-10726, preclinical data indicates superior efficacy compared to other drugs in its class, and an Investigational New Drug (IND) submission is expected before year-end.
  • Compass Therapeutics ended Q3 with approximately $220 million in cash, providing a financial runway into 2028.
Nov 12, 2025, 9:00 PM
Compass Therapeutics Provides Clinical Pipeline Updates and Future Milestones
CMPX
New Projects/Investments
Guidance Update
Revenue Acceleration/Inflection
  • Compass Therapeutics' lead program, Tuvesimig, a DLL4 VEGFA bispecific antibody, met its primary endpoint of overall response rate in the COMPANION-002 study for advanced biliary tract cancer, with secondary endpoints (progression-free survival and overall survival) anticipated in late Q1 2026. The company estimates a commercial opportunity "well north of a billion $ annually" in the second-line BTC market in the United States alone.
  • The novel PD-1, PD-L1 bispecific (8371) showed promising Phase 1 data with three responses in post-checkpoint inhibitor patients and no dose-limiting toxicities, with cohort expansions in triple-negative breast cancer and non-small cell lung cancer starting this quarter.
  • Compass reiterated its IND filing timeline for the PD-1 VEGFA bispecific antibody (10726) for this quarter, with Phase 1 initiation early next year.
  • The CD137 agonist antibody (471) observed five responses in its Phase 1 study, and an NCAM-positive basket study is set to begin in Q1 next year.
  • The company is funded into 2028 to execute on its programs, with multiple clinical trial readouts expected in 2026.
Nov 10, 2025, 8:30 PM
Compass Therapeutics Reports Q3 2025 Financial Results and Provides Pipeline Update
CMPX
Earnings
Guidance Update
New Projects/Investments
  • Compass Therapeutics reported a net loss of $14.3 million (or $0.08 per share) for the third quarter ended September 30, 2025.
  • As of September 30, 2025, the company held $220 million in cash and marketable securities, which is expected to provide a cash runway into 2028.
  • The company anticipates reporting overall survival and progression-free survival data for tovecimig in late Q1 2026 and plans to begin cohort expansions for CTX-8371 in Q4 2025.
  • An IND filing for CTX-10726 is on track for Q4 2025, with initial Phase 1 clinical data expected in H2 2026.
Nov 5, 2025, 12:30 PM

Quarterly earnings call transcripts for Compass Therapeutics.