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CG Oncology Reports 2025 Year End Financial Results and Provides Business Updates

CGON
  • CG Oncology reported financial results for the fourth quarter and year ended December 31, 2025, alongside business updates.
  • Topline data from the Phase 3 PIVOT-006 trial for cretostimogene monotherapy in intermediate-risk NMIBC is expected in the first half of 2026.
  • First results from the CORE-008 Cohort CX Phase 2 trial evaluating cretostimogene combined with gemcitabine in high-risk NMIBC are also expected in the first half of 2026.
  • The company announced an expedited timeline for PIVOT-006 data, nearly a year ahead of schedule.
  • Late-breaking abstracts presented in December 2025 showed 3-, 6-, and 9-month high-grade recurrence-free survival rates of 95.7%, 84.6%, and 80.4% respectively for BOND-003 Cohort P.
  • CORE-008 Cohort A data demonstrated an 88% complete response rate in high-risk BCG-naïve NMIBC with favorable safety.
  • The Board of Directors was strengthened by adding Christina Rossi, former COO of Blueprint Medicines, in November 2025.
  • Key 2026 milestones include completing a BLA submission for high-risk BCG-unresponsive NMIBC, presenting durability data for multiple cohorts, and releasing Phase 3 top-line data.
  • Cash, cash equivalents, and marketable securities totaled $742.2 million as of December 31, 2025, rising to approximately $903.0 million as of February 26, 2026, following $188.0 million in ATM proceeds.
  • The current cash position is sufficient to fund operations into the first half of 2029.
  • Research and development expenses were $30.0 million in Q4 2025 and $116.6 million for the full year 2025, reflecting increased clinical trial and personnel costs.
  • General and administrative expenses were $18.0 million in Q4 2025 and $73.5 million for the full year 2025, driven by higher personnel, professional fees, and marketing costs.
  • Net loss for Q4 2025 was $41.3 million ($0.52 per share), compared to $31.8 million for the same period in 2024.
  • Full-year 2025 net loss was $161.0 million ($2.08 per share), compared to $88.0 million in 2024.