# EDGAR Filing Document

**Accession Number:** 0001991792
**File Stem:** 0001991792-25-000004
**Filing Date:** 2025-9
**Character Count:** 19021
**Document Hash:** bac064913740c89a795c86f263ae8328
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0001991792-25-000004.hdr.sgml**: 20250905

**ACCESSION NUMBER**: 0001991792-25-000004

**CONFORMED SUBMISSION TYPE**: 8-K

**PUBLIC DOCUMENT COUNT**: 12

**CONFORMED PERIOD OF REPORT**: 20250905

**ITEM INFORMATION**: Regulation FD Disclosure

**ITEM INFORMATION**: Other Events

**ITEM INFORMATION**: Financial Statements and Exhibits

**FILED AS OF DATE**: 20250905

**DATE AS OF CHANGE**: 20250905

**FILER**: 

**COMPANY DATA:**
- **COMPANY CONFORMED NAME:** CG Oncology, Inc.
- **CENTRAL INDEX KEY:** 0001991792
- **STANDARD INDUSTRIAL CLASSIFICATION:** BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836]
- **ORGANIZATION NAME:** 03 Life Sciences
- **EIN:** 371611499
- **STATE OF INCORPORATION:** DE
- **FISCAL YEAR END:** 1231

**FILING VALUES:**
- **FORM TYPE:** 8-K
- **SEC ACT:** 1934 Act
- **SEC FILE NUMBER:** 001-41925
- **FILM NUMBER:** 251294996

**BUSINESS ADDRESS:**
- **STREET 1:** 400 SPECTRUM CENTER DRIVE
- **STREET 2:** SUITE 2040
- **CITY:** IRVINE
- **STATE:** CA
- **ZIP:** 92618
- **BUSINESS PHONE:** (949) 419-6203

**MAIL ADDRESS:**
- **STREET 1:** 400 SPECTRUM CENTER DRIVE
- **STREET 2:** SUITE 2040
- **CITY:** IRVINE
- **STATE:** CA
- **ZIP:** 92618

?xml version='1.0' encoding='ASCII'? 8-K

**UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549**

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## FORM 8-K

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**CURRENT REPORT**

**Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934**

**Date of Report (Date of earliest event reported):** September 05, 2025<br>

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CG Oncology, Inc.

**(Exact name of Registrant as Specified in Its Charter)**

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| | | |
|:---|:---|:---|
| Delaware | 001-41925 | 37-1611499 |
| **(State or Other Jurisdiction<br>of Incorporation)** | **(Commission File Number)** | **(IRS Employer<br>Identification No.)** |
| 400 Spectrum Center Drive<br>Suite 2040 |  |  |
| Irvine**,** California |  | 92618 |
| **(Address of Principal Executive Offices)** |  | **(Zip Code)** |

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**Registrant's Telephone Number, Including Area Code:** (949) 409-3700<br>

N/A<br>

**(Former Name or Former Address, if Changed Since Last Report)**

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Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

☐Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

**Securities registered pursuant to Section 12(b) of the Act:**

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| | | |
|:---|:---|:---|
| **<br>Title of each class** | **Trading<br>Symbol(s)** | **<br>Name of each exchange on which registered** |
| Common Stock, par value $0.0001 per share | CGON | The Nasdaq Global Select Market |

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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. ☐

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**Item 7.01 Regulation FD Disclosure.**

On September 5, 2025, CG Oncology, Inc. (the "***Company***") issued a press release entitled "CG Oncology Continues to Demonstrate Best-in-Disease Durability and Tolerability in BOND-003 Cohort C; Additional 12 Patients in Complete Response at 24 Months". The full text of the press release is attached as Exhibit 99.1 to this Current Report on Form 8-K.

On September 5, 2025, the Company posted an updated corporate presentation on the Company's website. Investors may access the presentation by visiting the "Investor Relations" section of the Company's website at www.cgoncology.com. The Company plans to use its website to disseminate future updates to its corporate presentation and does not intend to file or furnish a Form 8-K alerting investors each time the presentation is updated.

The information furnished under this Item 7.01 shall not be deemed "filed" for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or subject to the liabilities of that section. The information shall not be deemed incorporated by reference into any other filing with the Securities and Exchange Commission made by the Company, regardless of any general incorporation language in such filing.

By furnishing the information in this Item 7.01, the Company makes no admission as to the materiality of Item 7.01 in this report or the presentation available on the Company's website. The information contained in the corporate presentation is summary information that is intended to be considered in the context of the Company's filings with the Securities and Exchange Commission and other public announcements that the Company makes, by press release or otherwise, from time to time. The Company undertakes no duty or obligation to publicly update or revise the information contained in this Item 7.01, although it may do so from time to time as its management believes is appropriate or as required by applicable law. Any such updating may be made through the filing of other reports or documents with the Securities and Exchange Commission, through press releases, by updating its website or through other public disclosure.

**Item 8.01 Other Events.**

On September 5, 2025, the Company reported updated data from Cohort C of the BOND-003 Phase 3 clinical trial evaluating the efficacy and safety of cretostimogene as monotherapy in patients with high-risk BCG-unresponsive non-muscle invasive bladder cancer (NMIBC). These updated data showed 12 additional patients with NMIBC were in complete response (CR) at 24 months. The 24-month complete response landmark rate of 41.8% (CR rate observed in 46 out of 110 patients) for cretostimogene monotherapy reaffirms the best-in-disease durability that the Company announced at the American Urological Association Annual Meeting in April 2025. The study reported 75.5% CR at any time and 41.8% at 24 months with 46 confirmed CRs as of the cutoff date of June 23, 2025. The estimated 12- and 24-month duration of response (DOR) rates are 64.1% and 58.3%, respectively. Median DOR is 28 months and is ongoing. Notably, 96.6% of patients were free from progression to muscle invasive disease at 24 months. Cretostimogene has been generally well-tolerated in the trial as of the cutoff date of June 23, 2025. There were no Grade 3 or greater treatment-related adverse events (TRAEs) or deaths reported. Patients who experienced TRAEs of any grade had a median resolution time of one day. No treatment-related discontinuation of cretostimogene was observed, and 97.3% of patients completed all expected treatments, demonstrating favorable patient adherence and compliance. The most common TRAEs (≥10%) were bladder spasm, pollakiuria, micturition urgency, dysuria, and hematuria.

**Forward Looking Statements** 

The Company cautions you that statements contained in this report 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: the potential therapeutic benefits of cretostimogene for high-risk and intermediate-risk NMIBC patients and its potential to have best-in-disease durability and tolerability and to meaningfully improve patient outcomes, and the importance of the data as they relate to addressing bladder cancer. Actual results may differ from those set forth in this report due to the risks and uncertainties inherent in our business, including, without limitation: additional patient data related to cretostimogene that continues to become available may be inconsistent with the data produced as of the data cutoff, and further analysis of existing data and analysis of new data may lead to conclusions different from those established as of the date hereof; 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; potential delays in the commencement, enrollment and completion of clinical trials; competitive developments with respect to current and other investigational NMIBC treatments may adversely affect the commercial opportunity of cretostimogene; 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, as supplemented in Part II, Item 1A, "Risk Factors" of our quarterly report on Form 10-Q for the quarter ended June 30, 2025, 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.

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**Item 9.01 Financial Statements and Exhibits.** 

(d) Exhibits

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| | |
|:---|:---|
| Exhibit No. | Description |
| 99.1 | [<u>Press release, dated September 5, 2025</u>](ck0001991792-ex99_1.htm) |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document). |

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**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.** |
| Date: September 5, 2025 | By: <u>/s/ Josh Patterson</u> |
|  | Name: Josh Patterson |
|  | Title: General Counsel and Chief Compliance Officer |

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## Exhibit 99.1

**Exhibit 99.1**

![img89521117_0.jpg](img89521117_0.jpg)

**CG Oncology Continues to Demonstrate Best-in-Disease Durability and Tolerability in BOND-003 Cohort C; Additional 12 Patients in Complete Response at 24 Months** 

- Robust 24-month complete response (CR) rate of 41.8% observed for cretostimogene monotherapy in patients with high-risk non-muscle invasive bladder cancer (NMIBC) who are unresponsive to Bacillus Calmette Guerin (BCG) treatment -

- 90% of 12-month responders remained disease free at 24 Months -

- Safety profile remains consistent -

IRVINE, Calif., September 5, 2025 (GLOBE NEWSWIRE) -- CG Oncology, Inc. (NASDAQ: CGON), a late-stage clinical biopharmaceutical company focused on developing and commercializing a potential backbone bladder-sparing therapeutic for patients with bladder cancer, today announced updated data on BOND-003 Cohort C showing 12 additional patients with high risk non-muscle invasive bladder cancer (HR NMIBC) were in complete response (CR) at 24 months. The robust 24-month complete response landmark rate of 41.8% (CR rate observed in 46 out of 110 patients) for cretostimogene monotherapy reaffirms the best-in-disease durability that the Company announced at the American Urological Association Annual Meeting in April 2025. Cretostimogene's safety profile also remains consistent with no grade 3 or greater treatment-related adverse events (TRAEs) or deaths reported. Trinity J. Bivalacqua, MD, PhD, Urologic Oncology at Penn Medicine, and Co-Director, Genitourinary Cancer Service Line, Abramson Cancer Center, will present these updated data tomorrow, September 6, 2025, at the New England Section of the American Urological Association's 94th annual meeting in Boston, Massachusetts.

"Based on the latest data cut, I remain very encouraged that if approved, cretostimogene will represent an important, bladder-sparing advancement in the management of high risk non-muscle invasive bladder cancer in patients who have disease that is unresponsive to BCG," said Trinity J. Bivalacqua, MD, PhD. "In my clinical experience, bladder cancer patients are seeking treatment options that offer durable and

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sustained results. The latest data from the BOND-003 Cohort C study demonstrates that if a patient is a responder at 12 months, there is a 90 percent chance they will remain in response at 24 months. This is unprecedented in the high-risk, heavily pretreated NMIBC patient population and very meaningful for those battling this difficult disease."

"The data from our Phase 3 BOND-003 Cohort C registrational trial underscores cretostimogene's potential to become a breakthrough backbone treatment for bladder cancer patients," said Ambaw Bellete, President & Chief Operating Officer at CG Oncology. "We are eager to bring this innovative treatment to a broad range of NMIBC patients, and we are making great strides towards that goal as we prepare to initiate our BLA submission for cretostimogene in our initial indication for the treatment of patients with HR NMIBC unresponsive to BCG in the fourth quarter of this year."

The Phase 3 BOND-003 Cohort C study is in patients with high-risk NMIBC unresponsive to Bacillus Calmette Guerin (BCG) treatment with carcinoma in situ (CIS) with or without Ta or T1 disease. The study reported 75.5% CR at any time and 41.8% at 24 months with 46 confirmed CRs as of the cutoff date of June 23, 2025. The estimated 12- and 24-month duration of response (DOR) rates are 64.1% and 58.3%, respectively. Median DOR is 28 months and is ongoing. Notably, 96.6% of patients were free from progression to muscle invasive disease at 24 months.

A total of 110 highly pretreated patients are efficacy evaluable in the BOND-003 Cohort C study, which makes it the largest study in this patient population to date. These patients received a median of 12 prior BCG doses, some as high as 66. Prior intervening therapy also included intravesical chemotherapy (41.1%) and systemic immunotherapy (6.3%). Despite their highly pretreated conditions, patients tolerated cretostimogene treatment well. There were no Grade 3 or greater TRAEs or deaths reported. Patients who experienced TRAEs of any grade had a median resolution time of one day. No treatment-related discontinuation of cretostimogene was observed, and 97.3% of patients completed all expected treatments, demonstrating favorable patient adherence and compliance. The most common TRAEs (≥10%) were bladder spasm, pollakiuria, micturition urgency, dysuria, and hematuria.

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**About Cretostimogene Grenadenorepvec**

Cretostimogene is an investigational, intravesically delivered oncolytic immunotherapy that has been studied in a clinical development program, which includes more than 400 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 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, the potential therapeutic benefits of cretostimogene for high-risk and intermediate-risk NMIBC patients, its potential to have best-in-disease durability and tolerability, and that cretostimogene offers distinct advantages over existing therapies for the treatment of HR BCG-UR NMIBC. 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: additional patient data related to cretostimogene that continues to become available may be inconsistent with the data produced as of the data cutoff, and further analysis of existing data and analysis of new data may lead to conclusions different from those established as of the date hereof; results from earlier clinical trials and preclinical studies not necessarily being predictive of future results; unexpected adverse side effects or

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inadequate efficacy of cretostimogene that may limit its development, regulatory approval, and/or commercialization; potential delays in the commencement, enrollment and completion of clinical trials; competitive developments with respect to current and other investigational NMIBC treatments may adversely affect the commercial opportunity of cretostimogene; 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, as supplemented in Part II, Item 1A, "Risk Factors" of our quarterly report on Form 10-Q for the quarter ended June 30, 2025, 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<br>

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