CGON 8-K
CG Oncology, Inc. (CGON)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
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Securities registered pursuant to Section 12(b) of the Act:
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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
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 2.02 Results of Operations and Financial Condition.
On May 8, 2026, CG Oncology, Inc. issued a press release announcing its financial results for the quarter ended March 31, 2026. 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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104 |
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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: May 8, 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 First Quarter 2026 Financial Results and Provides Business Updates
DALLAS, Texas, May 8, 2026 (GLOBE NEWSWIRE) -- CG Oncology, Inc. (NASDAQ: CGON) today reported financial results for the first quarter ended March 31, 2026, and provided business updates.
“We have successfully completed non-clinical and clinical modules for our first BLA submission. The remaining CMC module is progressing as planned, and we are on track to finalize our submission in the fourth quarter 2026. We are pleased to provide this additional guidance on expected BLA completion following focused filing discussions with FDA. Manufacturing inspection readiness activities continue to progress, including our commitment to sustainable long-term supply. The quality and execution of the rolling BLA has been a top priority for us, and we are confident that we are taking all appropriate measures to ensure a successful package. This has been a tremendous undertaking, and I am extremely proud of the team for their unwavering commitment,” stated Arthur Kuan, Chairman & Chief Executive Officer at CG Oncology.
We look forward to a number of meaningful near‑term milestones for CG, including anticipated topline data from the Phase 3 PIVOT‑006 trial in intermediate‑risk NMIBC in the coming months, as well as the
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first results from the Phase 2 CORE‑008 Cohort CX in high‑risk BCG‑exposed and BCG-unresponsive patients, to be presented at AUA.”
Corporate Highlights
Anticipated 2026 Milestones
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First Quarter Financial Highlights
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
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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
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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
Investor Relations
Megan Knight
Vice President, Investor Relations, CG Oncology
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CG ONCOLOGY, INC.
Condensed Consolidated Statements of Operations and Comprehensive Loss
(In thousands, except share and per share amounts)
(unaudited)
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Three Months Ended March 31, |
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2026 |
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2025 |
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Revenues |
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Commercial and development revenue |
$ |
1,069 |
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$ |
— |
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License and collaboration revenue |
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14 |
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52 |
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Total revenues |
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1,083 |
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52 |
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Operating costs and expenses |
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Cost of sales |
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2,962 |
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— |
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Research and development |
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43,730 |
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27,467 |
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General and administrative |
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20,780 |
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14,789 |
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Total operating costs and expenses |
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67,472 |
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42,256 |
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Loss from operations |
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(66,389 |
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(42,204 |
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Other income (expense), net: |
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Interest income, net |
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6,288 |
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7,747 |
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Other (expense) income, net |
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(101 |
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5 |
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Total other income, net |
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6,187 |
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7,752 |
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Net loss and comprehensive loss |
$ |
(60,202 |
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$ |
(34,452 |
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Net loss per share, basic and diluted |
$ |
(0.71 |
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$ |
(0.45 |
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Weighted average shares of common stock outstanding, basic and diluted |
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84,518,512 |
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76,187,621 |
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CG ONCOLOGY, INC.
Consolidated Balance Sheet Data
(In thousands)
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March 31, |
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December 31, |
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2026 |
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2025 |
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(unaudited) |
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Cash, cash equivalents, and marketable securities |
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$ |
1,076,242 |
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$ |
742,155 |
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Total assets |
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1,135,262 |
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791,592 |
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Total liabilities |
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43,483 |
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38,990 |
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Total stockholders' equity |
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1,091,779 |
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752,602 |
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