Every 8-K that CG Oncology, Inc. (CGON) has filed with the SEC in the last 24 months is listed below, newest first, and each one links through to the document itself with the summary and the scores our analysis gives it.
A 8-K covers material events a company has to report between its quarterly reports, so if you follow CGON and want that one kind of document rather than the whole filing history, this is the page to keep. The company's other filings, of every form, are on the full CGON filings page.
CG Oncology, Inc. reported second quarter 2026 results and expanded its equity financing capacity. For the quarter ended June 30, 2026, total revenues were $1,157 thousand and net loss was $79,056 thousand, or $0.90 per share, driven mainly by higher research and development and general and administrative expenses.
Cash, cash equivalents and marketable securities totaled approximately $1.0 billion as of June 30, 2026, which the company expects will fund operations through 2029. CG Oncology continues late‑stage development of cretostimogene grenadenorepvec, with Phase 3 PIVOT‑006 topline data anticipated in the near term and completion of a BLA for high‑risk BCG‑unresponsive NMIBC targeted for the fourth quarter of 2026. Phase 3 BOND‑003 Cohort C results were published in The Lancet Oncology, and a Delaware court denied ANI’s post‑trial motions, leaving in place a prior jury verdict favorable to CG Oncology.
Separately, CG Oncology filed Amendment No. 2 to its prospectus under an Open Market Sale Agreement with Jefferies, increasing the amount of common stock that may be sold under the at‑the‑market program by up to $500.0 million, after previously registering and selling approximately $550.0 million of shares.
CG Oncology, Inc. reported the results of its 2026 annual stockholder meeting. As of the April 7, 2026 record date, 88,009,980 shares of common stock were outstanding and entitled to vote. Stockholders elected Class II directors Christina Rossi and Victor Tong, Jr. to terms running until the 2029 annual meeting.
Stockholders also ratified Ernst & Young LLP as independent registered public accounting firm for the fiscal year ending December 31, 2026. In advisory votes, stockholders approved the compensation of named executive officers and expressed a preference for holding future advisory votes on executive pay every year, and the company will follow an annual frequency.
CG Oncology, Inc. announced that President & Chief Operating Officer Ambaw Bellete will separate from the company effective June 30, 2026, following an agreement reached on May 20, 2026. He is expected to receive severance benefits consistent with Section 4(b) of his 2025 employment agreement.
The company has begun a search for a Chief Commercial Officer and the board has appointed Arthur Kuan as President in addition to his existing roles. His background is described in CG Oncology’s definitive proxy statement filed on April 24, 2026.
CG Oncology, Inc. reported first quarter 2026 results and updated progress on its bladder cancer programs. Total revenue was $1.1 million, up from $52 thousand a year earlier, while the company recorded a net loss of $60.2 million, or $(0.71) per share.
Research and development expenses rose to $43.7 million and general and administrative expenses to $20.8 million, reflecting higher clinical and personnel costs. Cash, cash equivalents and marketable securities were $1.1 billion as of March 31, 2026, including $391.4 million of net proceeds from selling 6,941,407 shares through an at-the-market facility, which the company expects will fund operations through 2029.
CG Oncology highlighted completion of non-clinical and clinical modules for its first BLA for high‑risk BCG‑unresponsive non‑muscle invasive bladder cancer, with full submission targeted for the fourth quarter of 2026. The company anticipates topline Phase 3 PIVOT‑006 data and first Phase 2 CORE‑008 Cohort CX results in the first half of 2026.
CG Oncology, Inc. has appointed Jim DeTore as its Chief Financial Officer, effective April 13, 2026, after he served as interim principal financial and accounting officer since November 2025. He brings prior CFO experience from multiple biotechnology companies, including Neurogastrx and Bluebird Bio.
Under his new employment agreement, DeTore will receive a base salary of $520,000 and an annual target bonus equal to 45% of salary. He is also being granted stock options with a target value of $4 million and a performance stock unit award with a target value of $1 million, both granted on April 15, 2026 and vesting over time and upon achieving specific commercial and cash flow milestones.
The agreement provides severance protections, including salary, bonus, COBRA-related benefits, and equity vesting acceleration if he is terminated without cause, with enhanced benefits if this occurs in connection with a change in control.
CG Oncology, Inc. reported 2025 results showing it remains a late-stage, development-focused bladder cancer company investing heavily in cretostimogene. For 2025, total revenues were $4.0 million, up from $1.1 million in 2024, while net loss widened to $161.0 million, or $2.08 per share, compared with a $88.0 million loss, or $1.41 per share, a year earlier.
Research and development expenses rose to $116.6 million and general and administrative expenses to $73.5 million, reflecting increased clinical, personnel, and professional costs. Cash, cash equivalents and marketable securities were $742.2 million as of December 31, 2025, and approximately $903.0 million as of February 26, 2026, after at-the-market equity sales, which the company believes will fund operations into the first half of 2029.
The company highlighted upcoming milestones for cretostimogene, including Phase 3 topline data from the PIVOT-006 trial in intermediate-risk NMIBC and Phase 2 first results from CORE-008 Cohort CX in high-risk NMIBC, both expected in the first half of 2026, as well as a planned 2026 BLA submission in an initial high-risk indication.
CG Oncology, Inc. filed an amendment to its prospectus to increase its at-the-market common stock offering under a sales agreement with Jefferies LLC to an aggregate offering price of up to $550,000,000. The amendment updates a prior prospectus that covered up to $250,000,000 of common stock under the same agreement. CG Oncology has already sold 5,861,984 shares for gross proceeds of $250,000,000 under this program, and the amendment adds up to an additional $300,000,000 of common stock capacity.
CG Oncology reported new clinical timing and data for its bladder cancer programs. The company now expects topline Phase 3 PIVOT-006 data in the first half of 2026 for intermediate-risk non–muscle invasive bladder cancer, a U.S. population estimated at over 50,000 patients. Updated BOND-003 Cohort P results for cretostimogene monotherapy in BCG-unresponsive papillary-only disease showed Kaplan-Meier high-grade event-free survival of 95.7%, 84.6% and 80.4% at 3, 6 and 9 months in 51 evaluable patients, with no Grade 3 or higher treatment-related adverse events, no radical cystectomies and no progression to muscle-invasive disease. First results from CORE-008 Cohort A in high-risk, BCG-naïve patients with CIS showed an overall complete response rate of 83.7% (41 of 49), including 79.2% with the original administration and 88.0% with an optimized two-step administration, with mostly low-grade, bladder-localized adverse events and no related serious or Grade 3+ events.
CG Oncology, Inc. appointed Christina Rossi to its Board of Directors, effective November 24, 2025, as a Class II director with a term running until the 2026 annual meeting of stockholders. Her compensation follows the company’s standard non-employee director program, including an annual cash fee of $45,000, paid quarterly, and an initial grant of 20,889 stock options that vest in equal monthly installments over three years, contingent on her continued service.
The company also reported that Simone Song resigned from the Board and all committees on November 22, 2025, effective immediately. The company stated that her resignation was not due to any disagreement with CG Oncology. Ms. Song had been a member of the Audit Committee and chair of the Compensation Committee.
CG Oncology (CGON) announced a finance leadership transition. Interim principal financial and accounting officer Robert Lapetina resigned effective November 30, 2025. The company appointed Jim DeTore as interim principal financial and accounting officer effective November 17, 2025, via a Consulting Agreement with Monomoy Advisors, LLC.
The agreement pays Monomoy Advisors $32,000 for November 2025 (prorated for a partial month) and $64,000 for each month thereafter, with a minimum three‑month term and an option to extend for an additional three months. Either party may terminate for a material breach not cured within 30 days of notice or for any reason with 60 days’ prior written notice.
DeTore previously served as CFO at Neurogastrx (June 2021–June 2025), Proteostasis Therapeutics (August 2016–February 2017), and Bluebird Bio (November 2014–February 2016), and consulted for biotech and pharma companies. He is eligible for the company’s standard indemnification agreement, and there are no disclosable related‑party transactions.
CG Oncology (CGON) furnished an update on its financial results under Item 2.02. The company announced it issued a press release covering results for the quarter ended September 30, 2025, which is attached as Exhibit 99.1.
The company states the information in this report, including Exhibit 99.1, is being furnished and not filed pursuant to General Instruction B.2. The filing also lists the company’s common stock on The Nasdaq Global Select Market under the symbol CGON.
CG Oncology, Inc. filed a current report to let investors know it plans to discuss an updated corporate presentation at the 23rd Annual Morgan Stanley Global Healthcare Conference on September 9, 2025. The presentation, dated the same day, is provided as Exhibit 99.1 and is incorporated by reference in the report.
The company emphasizes that the information in the presentation is being furnished under Regulation FD and is not considered "filed" for purposes of certain liability provisions under U.S. securities laws, unless specifically incorporated into other documents. CG Oncology also notes it has no obligation to update the presentation, though future updates may be made through additional SEC filings or other public disclosures.
CG Oncology, Inc. reported updated efficacy and safety data from Cohort C of its BOND-003 Phase 3 trial of cretostimogene monotherapy in high-risk BCG-unresponsive non-muscle invasive bladder cancer. The 24-month complete response rate was 41.8%, with 46 of 110 patients in complete response, including 12 additional patients maintaining response at 24 months. Overall, 75.5% of patients achieved a complete response at any time, and the estimated 12- and 24-month duration-of-response rates were 64.1% and 58.3%, respectively, with a median duration of response of 28 months that is still ongoing.
Progression control and tolerability were notable, with 96.6% of patients free from progression to muscle invasive disease at 24 months. Cretostimogene was generally well-tolerated, with no Grade 3 or higher treatment-related adverse events or deaths, a median resolution time of one day for treatment-related side effects, and 97.3% of patients completing all expected treatments, supporting favorable adherence. Common treatment-related events included bladder spasm, pollakiuria, micturition urgency, dysuria, and hematuria.
CG Oncology, Inc. filed a current report to note that it issued a press release on August 8, 2025 announcing its financial results for the quarter ended June 30, 2025. The press release is furnished as Exhibit 99.1, meaning it is provided for informational purposes and is not treated as filed for liability purposes under the Exchange Act. The company’s common stock continues to trade on the Nasdaq Global Select Market under the symbol CGON.