Compass Therapeutics — Q3 2026 Earnings Summary

Financial Performance:

• Reported a net loss of $27.2 million ($0.15 per share) for the quarter ended September 30, 2026, compared to a net loss of $14.3 million ($0.08 per share) in the same period in 2025.
• Net loss for the nine months ended September 30, 2026, was $70.6 million ($0.38 per share), compared to $50.8 million ($0.34 per share) for the same period in 2025.
• Research and development (R&D) expenses increased to $22.0 million for the quarter (up 72% from $12.8 million in Q3 2025) and $55.0 million for the nine months (up 30% from $42.3 million in the prior year period), primarily driven by $8.6 million and $11.1 million in manufacturing costs for tovecimig, respectively.
• General and administrative (G&A) expenses rose to $6.8 million for the quarter (up 126% from $3.0 million in Q3 2025) and $21.1 million for the nine months (up 68% from $12.7 million in the prior year period), driven by increases in stock-based compensation and pre-commercialization expenses.
• Cash and marketable securities totaled $163 million as of September 30, 2026, down from $209 million as of December 31, 2025, with the decrease attributed to $48 million used in operating activities.
• The company's cash runway is expected to extend into 2028 based on current operating plans.

Guidance and Future Outlook:

• Plans to advance preparations for a Biologics License Application (BLA) submission for tovecimig in patients with biliary tract cancer (BTC) and intends to further engage with the FDA.
• Expects to provide an update on the CTX-8371 Phase 1 study later in 2026.
• Anticipates an update on the CTX-10726 dose-escalation study later in 2026.
• Initial data from the first stage of the CTX-471 Phase 2 study is expected in the second half of 2027.
• Management expressed confidence in the role of tovecimig in the BTC treatment landscape and the urgency of engaging the FDA to define the most efficient path to a BLA submission.

Business Segments and Product Lines:

• Tovecimig (DLL4 x VEGF-A bispecific antibody):
  • The Phase 2/3 COMPANION-002 study met its primary endpoint with a statistically significant improvement in Objective Response Rate (ORR) of 18.0% vs. 5.3% with paclitaxel alone (p=0.0228).
  • The study met its key secondary endpoint of Progression-Free Survival (PFS) with a median of 4.7 vs. 2.6 months (HR=0.44, p<0.0001), representing a 56% reduction in the risk of disease progression or death.
  • Median Duration of Response (DOR) was 4.9 months, and Disease Control Rate (DCR) improved to 62.2% vs. 36.8%.
  • Full COMPANION-002 data was published in the Journal of Clinical Oncology and presented at the 2026 ESMO Congress.
  • An intent-to-treat overall survival (OS) analysis showed no statistically significant difference due to high crossover rates; a crossover-adjusted analysis yielded an OS hazard ratio of 0.85 (p=0.53).
  • Enrollment continues in an investigator-sponsored trial (IST) evaluating tovecimig plus standard-of-care gemcitabine, cisplatin, and durvalumab in first-line BTC, with expansion to additional sites expected.
  • Two additional ISTs are underway in the second-line setting: tovecimig plus FOLFIRI in colorectal cancer and a combination study of tovecimig plus CTX-471 in glioblastoma.
• CTX-8371 (PD-1 x PD-L1 bispecific antibody):
  • Cohort expansions are enrolling patients with triple-negative breast cancer (n=28), non-small cell lung cancer (n=28), and Hodgkin lymphoma (n=12) in the post-checkpoint inhibitor setting.
  • Patients are dosed at either 3.0 mg/kg or 10.0 mg/kg.
• CTX-10726 (PD-1 x VEGF-A bispecific antibody):
  • Data presented at the SITC Annual Meeting demonstrated a novel mechanism where the antibody mediates VEGF-dependent cleavage of cell surface PD-1, linking tumor angiogenesis with checkpoint inhibition.
  • The Phase 1 study includes four doses (0.3, 1.0, 3.0, and 10.0 mg/kg) in patients with renal cell carcinoma, gastroesophageal cancer, hepatocellular carcinoma, and endometrial cancer.
  • Preclinical data indicated CTX-10726 exhibited more potent PD-1 blockade compared to other drugs in the class.
• CTX-471 (CD137 or 4-1BB agonist antibody):
  • A Phase 2 trial is ongoing for tumors expressing NCAM (CD56), specifically evaluating locally advanced or metastatic Grade 3 NET or NEC.
  • Stage one of the study involves dosing 18 patients at 0.3 mg/kg and 18 patients at 0.6 mg/kg.

Market and Competitive Landscape:

• The company highlights the urgent unmet medical need for patients with BTC as a driver for its regulatory strategy.
• CTX-10726 is positioned with a differentiated profile in the PD-1xVEGF field, demonstrating a mechanism not observed with pembrolizumab or bevacizumab in preclinical studies.

Risks and Challenges:

• The FDA recommended an additional study demonstrating a survival benefit before submission of a BLA for tovecimig; the company does not believe a new trial is warranted but must address this recommendation.
• The OS analysis for tovecimig was confounded by high crossover rates, resulting in no statistically significant difference in the intent-to-treat population.
• Forward-looking statements note risks related to the ability to raise additional funding, inherent uncertainties in developing product candidates, and competition in the industry.

Management Commentary and Tone:

• CEO Thomas Schuetz, MD, PhD, described the third quarter as a period of "sustained execution across our pipeline."
• Management emphasized the strength of supportive data for tovecimig and the urgency of engaging the FDA to bring the therapy to patients quickly.
• The tone regarding pipeline assets was positive, noting they are "nearing very meaningful inflection points" and expressing excitement about the differentiated potential of CTX-10726.

Other Key Points:

• The company has no revenue reported, consistent with its status as a clinical-stage biopharmaceutical company.
• Stock-based compensation expense increased by $1.8 million in the quarter and $3.8 million for the nine months.
• Pre-commercialization expenses increased by $1.5 million in the quarter and $4.6 million for the nine months.
• The company was founded in 2014 and is headquartered in Boston, Massachusetts.