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CG Oncology (CGON) Q3 2025 Financial Results Summary

QuoteReporter

4 min read
CG Oncology (CGON) Q3 2025 Financial Results Summary

CG Oncology (CGON) Q3 2025 Financial Results Summary

On November 14, 2025, CG Oncology, Inc. (NASDAQ: CGON) released its financial results for the third quarter ending September 30, 2025, alongside significant business updates.

Financial Highlights

  • Cash Position:
  • Cash and cash equivalents, along with marketable securities, totaled $680.3 million as of September 30, 2025, an increase of 2.7% from $661.1 million on June 30, 2025.
  • Approximately $48.7 million net proceeds from the sale of 1,515,151 shares were raised through the Company’s at-the-market facility.

  • Research and Development (R&D) Expenses:

  • R&D expenses for Q3 2025 were $27.9 million, a rise of 42.4% compared to $19.6 million for the same quarter in 2024.

  • General and Administrative (G&A) Expenses:

  • G&A expenses reached $23.3 million in Q3 2025, compared to $8.7 million in Q3 2024, reflecting a significant increase of 168.4%.

  • Net Loss:

  • The net loss for the third quarter was $43.8 million, or ($0.57) per share, which is a 114% increase from a net loss of $20.4 million or ($0.30) per share in Q3 2024.

Revenue Summary

  • Total Revenues:
  • Revenues for Q3 2025 were $1.67 million, a substantial increase from $43,000 in Q3 2024.
  • The revenue included $1.51 million from commercial and development activities and $158,000 from license and collaboration agreements, compared to $43,000 last year.

Operational Insights

  • Cretostimogene Highlights:
  • Biologics License Application (BLA): The company has initiated a rolling BLA submission to the U.S. FDA for cretostimogene monotherapy in high-risk BCG-unresponsive non-muscle invasive bladder cancer (NMIBC).
  • Best-in-Disease Data: Presenting data from BOND-003 Cohort C, CG Oncology reported a 41.8% complete response rate at 24 months in patients treated with cretostimogene, maintaining 90% of 12-month responders being disease-free.
  • Enrollment Completion: The company successfully completed enrollment in the PIVOT-006 study approximately 10 months ahead of schedule, demonstrating robust interest from patients and physicians.

Future Outlook

  • CG Oncology anticipates several key milestones in the coming quarters:
  • Release of topline data from the BOND-003 Cohort P in Q4 2025.
  • Initial results from the CORE-008 Cohort A in Q4 2025.
  • Completion of the BLA submission expected by 2026.

Share Repurchase & Dividends

  • The company did not declare any quarterly dividends or announce any share repurchase plans during this reporting period.

Summary Table of Key Metrics

Metric Q3 2025 Q3 2024 Change (%)
Cash & Cash Equivalents $680.3 million $661.1 million +2.7%
R&D Expenses $27.9 million $19.6 million +42.4%
G&A Expenses $23.3 million $8.7 million +168.4%
Net Loss $43.8 million $20.4 million +114%
Total Revenues $1.67 million $43,000 +~3,870%

CG Oncology continues to advance its clinical programs while managing its operational expenditures, positioning itself for potential growth paths as it progresses through regulatory submissions and clinical trials. The financial results reflect not only a commitment to innovation in the field of bladder cancer therapeutics but also the challenges associated with high development costs.

Here are the extracted tables in Markdown format:

CG ONCOLOGY, INC. Condensed Consolidated Statements of Operations and Comprehensive Loss (In thousands, except share and per share amounts) (unaudited)

Three Months Ended September 30, 2025 Three Months Ended September 30, 2024 Nine Months Ended September 30, 2025 Nine Months Ended September 30, 2024
Revenues $1,508 $— $1,508 $—
License and collaboration revenue 158 43 210 683
Total revenues 1,666 43 1,718 683
Operating costs and expenses
Cost of sales 1,577 1,577
Research and development 27,884 19,622 86,683 55,302
General and administrative 23,334 8,716 55,532 21,998
Total operating costs and expenses 52,795 28,338 143,792 77,300
Loss from operations (51,129) (28,295) (142,074) (76,617)
Other income (expense), net:
Interest income, net 7,421 7,892 22,487 20,379
Other (expense) income, net (100) (2) (99) (3)
Total other income, net 7,321 7,890 22,388 20,376
Net loss and comprehensive loss (43,808) (20,405) (119,686) (56,241)
Net loss per share, basic and diluted (0.57) (0.30) (1.57) (0.93)
Weighted average shares of common stock outstanding, basic and diluted 76,729,726 67,143,744 76,383,376 60,311,003

CG ONCOLOGY, INC. Consolidated Balance Sheet Data (In thousands)

September 30, 2025 December 31, 2024
Cash, cash equivalents, and marketable securities $680,263 $741,998
Total assets 729,913 754,797
Total liabilities 42,270 21,420
Total stockholders’ equity 687,643 733,377

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