CG Oncology, Inc. (CGON)

Key figures

The last twelve months reported, with the latest price and balance sheet.

Revenue, last twelve months

$6.2M

Revenue growth

1030.3%

Net income, last twelve months

-$224.4M

Earnings per share

-$2.70

Operating margin

-4056.2%

Net margin

-3602.7%

Free cash flow

-$179.3M

Return on equity

-21.8%

Market value

$5.7B

Cash

$19.6M

Debt

$3.0M

Debt to equity

0.00

Shares outstanding

88.3M

Financial statements

Revenue, profit and cash flow by fiscal year, each year linked to its annual report.

By quarter

What the company said with its results

From the second quarter of 2026 results, filed 6 August 2026.

• Net loss widened to $79.1 million. Net loss was $79.1 million, or $(0.90) per share, for the quarter, against $41.4 million, or $(0.54), a year earlier. Six-month net loss was $139.3 million, or $(1.61) per share.
• Revenue of $1.2 million reported. Total revenues were $1.2 million in the quarter, mostly commercial and development revenue of $1.1 million, against nil a year earlier. Q1 2026 total revenues were $1.1 million.
• Cost of sales rose to $3.9 million. Cost of sales was $3.9 million in the quarter, against $3.0 million in Q1 2026 and no cost in the prior-year quarter. Six-month cost of sales was $6.9 million.
• Operating loss widened to $86.4 million. Loss from operations was $86.4 million, against $48.7 million a year earlier, after total operating costs of $87.6 million. Interest income, net, was $7.3 million.
• PIVOT-006 readout expected near-term. Topline data from the Phase 3 PIVOT-006 trial, testing monotherapy as adjuvant therapy in intermediate-risk NMIBC, are expected in the near-term. The prior release gave a first half 2026 window.
• BLA completion still set for 4Q’26. Completion of the BLA for HR BCG-unresponsive NMIBC with CIS is expected in 4Q’26. The prior release described the CMC module as progressing as planned.
• Further 2026 data readouts still listed. BOND-003 Cohort C and Cohort P, CORE-008 Cohort CX and Cohort A data, and durability data remain on the anticipated 2026 milestone list.
• Lancet Oncology publishes BOND-003 Cohort C. The BOND-003 Cohort C study is titled as a single-arm, phase 3 trial in high-risk, BCG-unresponsive NMIBC with carcinoma in situ. It was published in The Lancet Oncology in July.
• Court denied ANI’s post-trial motion. In July the Delaware Superior Court denied ANI’s motion for a new trial and judgment as a matter of law, rejecting ANI’s challenges to the verdict and related claims.
• Royalty provision severed, agreement intact. The jury verdict in favor of CG Oncology held that the invalidated royalty provision was properly severed and that the rest of the ANI agreement remains in force.
• R&D expense rose to $54.7 million. R&D expense was $54.7 million in the quarter, against $31.3 million a year earlier. Six-month R&D expense was $98.4 million, against $58.8 million.
• Clinical and CMC spending drove R&D. Management attributed the R&D increase primarily to clinical trial expenses, including CMC costs, and to compensation costs from increased headcount.
• G&A rose on personnel costs. G&A expense was $29.0 million in the quarter, against $17.4 million a year earlier. Management attributed the increase primarily to personnel-related expenses from headcount growth.
• Cash position at $1.0 billion. Cash, cash equivalents and marketable securities were $1.0 billion at June 30, 2026, against $1.1 billion at March 31, 2026 and $742.2 million at December 31, 2025.

Revenue by segment

As the company reports it in the segment note of its annual report.

By product, FY2025

Company events

The newest 8-K filings of 29 held.

Every filing

The newest filings with the SEC of 74 held.

Insider trades

Form 4 trades by officers, directors and 10% owners, last 12 months.

Planned insider sales

Form 144 notices, filed when the sell order goes to the broker.

Large holders

Schedule 13D and 13G filings by holders of more than 5% of the voting shares.

Short interest

Shares sold short and not yet bought back, on each FINRA settlement date.

Funds that hold it

From each fund's latest Form 13F.

264 funds held it at 30 Jun 2026: 121 added and 70 trimmed in the quarter. The largest:

Peers

Companies in the same industry.

• Amgen Inc. (AMGN): revenue $38.1B, market value $244.4B
• Gilead Sciences, Inc. (GILD): revenue $30.5B, market value $197.6B
• Moderna, Inc. (MRNA): revenue $2.2B, market value $85.4B
• argenx SE (ARGX): revenue $4.2B, market value $55.2B
• Biogen Inc. (BIIB): revenue $10.3B, market value $36.1B
• BioNTech SE (BNTX): revenue $3.2B, market value $22.1B
• Exelixis, Inc. (EXEL): revenue $2.4B, market value $16.5B
• Halozyme Therapeutics, Inc. (HALO): revenue $1.7B, market value $14.8B
• Neurocrine Biosciences Inc. (NBIX): revenue $3.4B, market value $14.8B
• Bio-Techne Corp. (TECH): revenue $1.2B, market value $11.3B

What the company does

It is in clinical development for high-risk and intermediate-risk non-muscle invasive bladder cancer (NMIBC), which the company says potentially represents up to 150,000 addressable patients. Cretostimogene is its only product candidate, and no product is approved for sale. The company is based in Irvine, California, and had 142 employees at 31 December 2025.

What it is developing

Cretostimogene is built to replicate in cells with an altered Rb-E2F gene pathway, which the company says are present in the majority of urothelial carcinomas. It carries the gene for GM-CSF, a cytokine intended to prime the immune system. It is given into the bladder through a catheter in a clinic, by a nurse or medical assistant. The company says this needs no operating room time or anesthesia and resembles the way BCG therapy is given. As of 30 January 2026, cretostimogene had been given to over 740 patients across clinical trials.

Where the trials stand

- BOND-003 Cohort C: This Phase 3 single-arm trial treats high-risk BCG-unresponsive NMIBC with carcinoma in situ. As of 23 June 2025, 75.5% of patients had a complete response at any time, and the 24-month complete response rate was 41.8% (46 out of 110 patients). No Grade 3 or higher treatment-related adverse events were reported. The company began its Biologics License Application to the U.S. Food and Drug Administration (FDA) in the fourth quarter of 2025 and says it expects to complete it in 2026. The FDA has granted Fast Track and Breakthrough Therapy designations for this use. - BOND-003 Cohort P: This exploratory cohort of up to 75 patients covers BCG-unresponsive disease with only Ta/T1 tumors. - PIVOT-006: This randomized Phase 3 trial in intermediate-risk NMIBC enrolls up to 364 patients. It compares cretostimogene after transurethral resection of the bladder tumor (TURBT) with TURBT alone. Enrollment was completed in the third quarter of 2025, and the company says it expects topline data in the first half of 2026. - CORE-008: This Phase 2 trial has Cohort A (BCG-naïve patients), Cohort B (BCG-exposed patients) and Cohort CX, which combines cretostimogene with gemcitabine. Cohort A showed a complete response in 83.7% of evaluable patients (41 of 49). - CORE-001: This completed Phase 2 trial combined cretostimogene with pembrolizumab, and 82.9% of evaluable patients had a complete response at any time.

The patients it targets

The filing cites the American Cancer Society for about 85,000 new U.S. bladder cancer diagnoses and 730,000 people living with the disease. NMIBC makes up about 75% of new diagnoses. Radical cystectomy, the complete removal of the bladder, is the guideline-recommended treatment for BCG-unresponsive disease, yet only about 6% of patients choose it. BCG has also been in short supply for over ten years, and Merck is its single manufacturer for the United States and most other markets. Based on its own research, the company sizes the segments at up to 25,000 patients for high-risk BCG-unresponsive, 50,000 for intermediate-risk, 25,000 for high-risk BCG-naïve and 50,000 for high-risk BCG-exposed disease.

How it makes and sells

The company relies on third-party manufacturers for cretostimogene. In July 2025 it obtained control of Biovire, a contract manufacturer that fills and finishes drugs and medical devices and had supplied its clinical trials. Biovire's work for other customers produces commercial and development revenue. The company is building an in-house commercial organization of field sales, marketing and market access staff for the United States. Of its employees, 85 work in research and development and 22 in commercial readiness.

- Kissei Pharmaceutical Co., Ltd. holds rights in 20 Asian countries including Japan, South Korea and India. It develops and commercializes the product there but does not manufacture it. - Lepu Biotech Co., Ltd. holds rights in mainland China, including Hong Kong and Macau.

Both agreements pay the company royalties on net sales in those territories. Its reported revenue so far comes from these licenses and from Biovire.

Competition

Cretostimogene faces BCG, which remains the standard of care, and several approved therapies for high-risk BCG-unresponsive disease. These include pembrolizumab from Merck, nadofaragene firadenovec from Ferring, the gemcitabine intravesical system TAR-200 from Johnson & Johnson, and nogapendekin alfa inbakicept from ImmunityBio. UroGen Pharma's ZUSDURI is approved for recurrent low-grade intermediate-risk disease. Other companies named as competitors include enGene, Protara Therapeutics and Relmada Therapeutics. The company names safety, efficacy, convenience and treatment cost as the key competitive factors.

Patents

The company owns eight patent families. It also relies on trade secrets for its manufacturing method.

*From CG Oncology's annual report on Form 10-K for the year ended 31 December 2025. [The filing](https://www.sec.gov/Archives/edgar/data/1991792/000119312526079498/ck0001991792-20251231.htm)*

From the company's 10-K.