Compass Therapeutics reported full-year 2025 financial results and provided an update on its clinical pipeline and corporate leadership changes.

Compass Therapeutics, Inc. (Nasdaq: CMPX), a clinical-stage, oncology-focused biopharmaceutical company developing proprietary antibody-based therapeutics to treat multiple human diseases, today reported full 2025 financial results and provided a business update.

"2025 marked a year of significant progress for Compass, highlighted by our lead asset tovecimig successfully meeting the primary endpoint of overall response rate in the COMPANION-002 Phase 2/3 study in patients with biliary tract cancer. We are excited to report the results of the key secondary endpoints next month," said Thomas Schuetz, MD, PhD, Chief Executive Officer and Vice Chairman of the Board of Directors. "The upcoming tovecimig PFS/OS data release could be transformational for the company, and we are looking forward to the new option it would bring for patients with biliary tract cancer."

"Our novel PD-1 x PD-L1 checkpoint inhibitor, CTX-8371, also demonstrated strong clinical activity this past year, with three robust responses in patients with both solid tumors and hematologic malignancies, all observed in heavily pre-treated patients who received prior checkpoint inhibitor therapies. We also continued to advance our other clinical-stage assets, CTX-471 and CTX-10726."

"2026 is poised to be a defining year for Compass," Dr. Schuetz continued, "and we move forward with an expanded leadership team, welcoming Cyndi Sirard as CMO and Arjun Prasad as CCO, and promoting Bing Gong to CSO. Finally, our progress is bolstered by our strong financial position with $209 million of cash and marketable securities, providing runway into 2028."

2025 Accomplishments and 2026 Pipeline Updates:

Tovecimig (DLL4 and VEGF-A bispecific antibody)

The analyses of key secondary endpoints from the COMPANION-002 Phase 2/3 randomized study, including PFS and OS, are expected in April.

The Phase 2 study of tovecimig in a broader set of patients with DLL4+ tumor types is expected to initiate mid-2026 following a comprehensive analysis of the complete data set from the COMPANION-002 trial.

The investigator sponsored trial (IST) of tovecimig in combination with the current first-line, standard-of-care regimen of gemcitabine, cisplatin, and durvalumab in patients with BTC ( NCT05506943 ) is ongoing.

CTX-8371 (PD-1 x PD-L1 bispecific antibody)

Cohort expansions for CTX-8371 are open for enrollment in patients with TNBC (n=28) and NSCLC (n=28) in the post-checkpoint inhibitor setting. TNBC and NSCLC were selected based on the deep and durable responses previously observed in these indications in the dose escalation portion of the study. Half of the patients with each tumor type will be dosed at 3.0 mg/kg and half will be dosed at 10.0 mg/kg. Initial data from these cohort expansions, as well as available data from the Phase 1 dose-escalation portion of the study, are expected to be presented at a major medical conference in the second quarter of 2026.

Based on a previously reported response in a patient with Hodgkin lymphoma (HL), a third cohort (n=12) will be added to the expansion study in patients with HL, also at the 3.0 mg/kg and 10.0 mg/kg dose levels.

CTX-10726 (PD-1 x VEGF-A bispecific antibody)

The FDA cleared the IND submission for CTX-10726 in early 2026 and the Phase 1 study will be open for enrollment in Q1 with clinical data in the second half of the year.

The Phase 1 multiple ascending dose-escalation study will include four doses (0.3, 1.0, 3.0, and 10.0 mg/kg) in a 3+3 format. The multi-center study will enroll patients with a prioritized set of solid tumor indications, including patients with locally advanced, unresectable or metastatic renal cell carcinoma, gastroesophageal cancer, hepatocellular carcinoma, and endometrial cancer, in whom standard of care therapies have failed.

CTX-10726 is a tetravalent PD-1 x VEGF-A bispecific antibody discovered and engineered at Compass. CTX-10726 exhibits more potent PD-1 blockade compared with data reported for other drugs in the class and Compass believes it has a unique understanding of aspects of its mechanism of action that will guide development.

CTX-471 (CD137 or 4-1BB agonist antibody)

Initiation of the Phase 2 trial of CTX-471 in patients with tumors expressing NCAM (CD56) is expected in mid-2026.

Financial Results

Net loss for the year ended December 31, 2025, was $66.5 million or $0.42 per common share, compared to $49.4 million or $0.36 per common share for the same period in 2024.

Research and Development (R&D) Expenses

R&D expenses were $56.0 million for the year ended December 31, 2025, as compared to $42.3 million for the same period in 2024, an increase of $13.7 million or 32%. The increase was primarily attributable to an increase in manufacturing expenses related to tovecimig of $7.7 million and manufacturing expenses related to CTX-10726 of $5.9 million.

General and Administrative (G&A) Expenses

G&A expenses were $16.9 million for the year ended December 31, 2025, as compared to $15.1 million for the same period in 2024, an increase of $1.8 million or 12%. The increase was primarily driven by pre-commercialization expenses of $0.7 million and advisory fees of $0.5 million.

Cash Position

As of December 31, 2025, cash and marketable securities were $209 million as compared to $127 million as of December 31, 2024, an increase of $82 million, with an anticipated cash runway into 2028. During 2025, $49 million of net cash was used in operating activities, and this was offset by net proceeds from an underwritten public offering of $129 million.

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