CG Oncology (NASDAQ: CGON) widens 2025 loss but secures $903M cash and nears Phase 3 data
Rhea-AI Filing Summary
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.
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Insights
CG Oncology reports larger 2025 loss but extends cash runway and nears key cretostimogene data.
CG Oncology is still pre-commercial, so 2025 performance is dominated by investment in cretostimogene. Revenues were modest at $4.0 million, while operating costs reached $194.8 million, driving a net loss of $161.0 million. Higher R&D and G&A mainly reflect expanded trials, manufacturing and corporate infrastructure.
The balance sheet is a focal point. Year-end cash, cash equivalents and marketable securities of $742.2 million, plus additional ATM proceeds bringing this to about $903.0 million by February 26, 2026, underpin guidance that funding should last into the first half of 2029. That horizon reduces near-term financing pressure but depends on spending discipline.
Near-term value drivers center on clinical and regulatory milestones rather than current revenues. The company points to Phase 3 topline data from PIVOT-006 and Phase 2 results from CORE-008 Cohort CX in the first half of 2026, and a planned 2026 BLA submission in high-risk NMIBC. Subsequent public updates on these events will clarify clinical risk and the potential timing of any commercialization path.
8-K Event Classification
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company #ERROR! Can't render CHECKBOX b00ed4d6-bbf9-4e86-b0c2-4712c55a03ee object
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Item 2.02 Results of Operations and Financial Condition.
On February 27, 2026, CG Oncology, Inc. issued a press release announcing its financial results for the year and quarter ended December 31, 2025. A copy of the press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.
In accordance with General Instruction B.2 of Form 8-K, the information in this Current Report on Form 8-K, including Exhibit 99.1, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the Exchange Act), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, whether made before or after the date hereof, except as expressly set forth by specific reference in such filing.
Item 9.01 Financial Statements and Exhibits.
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Exhibits |
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Exhibit No. |
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Description |
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99.1 |
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Press release, dated February 27, 2026 |
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Cover Page Interactive Data File (embedded within the Inline XBRL document). |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
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CG Oncology, Inc. |
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Date: February 27, 2026 |
By: /s/ Josh Patterson |
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Name: Josh Patterson |
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Title: General Counsel and Chief Compliance Officer |
Exhibit 99.1
CG Oncology Reports 2025 Year End Financial Results and Provides Business Updates
· Well-positioned to deliver on key milestones with approximately $903.0 million cash, cash equivalents and marketable securities sufficient to fund operations into the first half of 2029
IRVINE, Calif., February 27, 2026 (GLOBE NEWSWIRE) -- CG Oncology, Inc. (NASDAQ: CGON) today reported financial results for the fourth quarter and year ended December 31, 2025, and provided business updates.
“In the coming months, we look forward to sharing topline data from PIVOT-006, the first randomized registrational trial to evaluate an investigational therapy in intermediate-risk NMIBC. We believe we have the opportunity to set the new standard in intermediate-risk NMIBC. I am extremely proud of our team for planning, enrolling and executing this important trial in record time. With cretostimogene’s unique best-in-disease profile, we remain laser-focused on advancing a comprehensive strategy designed to support an optimized product label and ensure success across additional indications—positioning cretostimogene as a potential backbone therapy for a broad range of NMIBC patients,” said Arthur Kuan, Chairman & Chief Executive Officer at CG Oncology. “We are also looking forward to sharing results from CORE-008 Cohort CX in high-risk BCG exposed from our first trial evaluating the combination of cretostimogene with gemcitabine in the coming quarter.”
Corporate Highlights
Anticipated 2026 Milestones
Fourth Quarter and Year End Financial Highlights
In addition, net proceeds of approximately $188.0 million was raised from a total of 3,623,101 shares sold in January 2026 through the Company’s ATM facility, resulting in a cash, cash equivalents, and marketable securities balance as of February 26, 2026 of approximately $903.0 million. The Company anticipates its existing cash, cash equivalents and marketable securities as of this date will be sufficient to fund operations into the first half of 2029.
About Cretostimogene Grenadenorepvec
Cretostimogene is an investigational, intravesically delivered oncolytic immunotherapy that has been studied in a clinical development program, which includes more than 600 patients with Non-Muscle Invasive Bladder Cancer (NMIBC). This program includes two Phase 3 clinical trials: BOND-003 for high-risk BCG-unresponsive NMIBC and PIVOT-006 for intermediate-risk NMIBC. CG Oncology also has a multi-cohort Phase 2 trial, CORE-008, evaluating the safety and efficacy of cretostimogene in high-risk NMIBC. Additionally, we have initiated an Expanded Access Program for cretostimogene in North America for patients who are unresponsive to BCG and meet certain program eligibility requirements. Cretostimogene is an investigational candidate, and its safety and efficacy have not been established by the FDA or any other health authority.
About CG Oncology
CG Oncology is a late-stage clinical biopharmaceutical company focused on developing and commercializing a potential backbone bladder-sparing therapeutic for patients afflicted with bladder cancer. CG Oncology sees a world where urologic cancer patients may benefit from our innovative immunotherapies to live with dignity and have an enhanced quality of life. To learn more, please visit: www.cgoncology.com.
Forward-Looking Statements
CG Oncology cautions you that statements contained in this press release regarding matters that are not historical facts are forward-looking statements. The forward-looking statements are based on our current beliefs and expectations and include, but are not limited to, statements regarding our anticipated cash runway, future results of operations and financial position; the anticipated timing and conduct of our ongoing and planned clinical trials and preclinical studies for cretostimogene, including anticipated next milestones in our development pipeline; the timing and likelihood of regulatory filings and approvals for cretostimogene; the potential therapeutic benefits of cretostimogene for high-risk and intermediate-risk NMIBC patients; and that cretostimogene has a best-in-disease product profile. Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in our business, including, without limitation: interim results of a clinical trial are not necessarily indicative of final results and one or more of the clinical outcomes may materially change as patient enrollment continues, following more comprehensive reviews of the data, and as more patient data becomes available; potential delays in the commencement, enrollment and completion of clinical trials, including the BOND-003 and PIVOT-006 trials; we may use our capital resources sooner than expected and they may be insufficient to allow us to achieve our anticipated milestones; our dependence on third parties in connection with manufacturing, shipping and clinical and preclinical testing; results from earlier clinical trials and preclinical studies not necessarily being predictive of future results; unexpected adverse side effects or inadequate efficacy of cretostimogene that may limit its development, regulatory approval, and/or commercialization; and other risks described in our filings with the Securities and Exchange Commission (SEC), including under the heading “Risk Factors” in our annual report on Form 10-K and other filings that we make with the SEC from time to time (which are available at http://www.sec.gov). You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and we undertake no obligation to update such statements to reflect events that occur or circumstances that exist after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.
Contacts:
Media
Sarah Connors
Vice President, Communications and Patient Advocacy, CG Oncology
sarah.connors@cgoncology.com
Investor Relations
Megan Knight
Vice President, Investor Relations, CG Oncology
megan.knight@cgoncology.com
CG Oncology, Inc.
Consolidated Statements of Operations and Comprehensive Loss
(In thousands, except share and per share amounts)
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Year Ended December 31, |
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2025 |
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2024 |
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(unaudited) |
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Revenues |
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Commercial and development revenue |
$ |
3,234 |
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$ |
— |
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License and collaboration revenue |
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806 |
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1,139 |
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Total revenues |
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4,040 |
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1,139 |
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Operating costs and expenses |
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Cost of sales |
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4,647 |
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— |
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Research and development |
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116,641 |
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82,102 |
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General and administrative |
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73,526 |
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33,703 |
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Total operating costs and expenses |
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194,814 |
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115,805 |
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Loss from operations |
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(190,774 |
) |
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(114,666 |
) |
Other income (expense), net: |
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Interest income, net |
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29,931 |
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26,624 |
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Other (expense) income, net |
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(152 |
) |
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3 |
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Total other income, net |
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29,779 |
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26,627 |
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Net loss and comprehensive loss |
$ |
(160,995 |
) |
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$ |
(88,039 |
) |
Net loss per share, basic and diluted |
$ |
(2.08 |
) |
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$ |
(1.41 |
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Weighted average shares of common stock outstanding, basic and diluted |
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77,303,440 |
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62,496,725 |
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CG Oncology, Inc.
Consolidated Balance Sheets
(In thousands, except share and per share amounts)
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December 31, |
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December 31, |
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2025 |
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2024 |
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(unaudited) |
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Cash, cash equivalents, and marketable securities |
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$ |
742,155 |
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$ |
741,998 |
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Total assets |
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791,592 |
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754,797 |
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Total liabilities |
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38,990 |
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21,420 |
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Total stockholders' equity |
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752,602 |
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733,377 |
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