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CG Oncology Announces New Board Member and Board Transition

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CG Oncology (NASDAQ: CGON) appointed Christina Rossi to its Board of Directors and reported the resignation of Simone Song effective November 22, 2025. The company noted it has initiated a BLA for cretostimogene, positioning the firm to prepare for a potential commercial launch upon FDA approval.

Ms. Rossi brings >25 years of global pharma and biotech experience, including roles as Chief Operating Officer and Chief Commercial Officer at Blueprint Medicines and prior commercial leadership at Sanofi Genzyme and Biogen. The company emphasized commercial launch readiness and thanked Ms. Song for over a decade of board service.

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Positive

  • BLA initiation for cretostimogene (Nov 2025)
  • Added Christina Rossi with 25+ years commercial and launch experience

Negative

  • Board turnover: Simone Song resigned effective Nov 22, 2025

- Appoints Accomplished Life Sciences Executive Christina Rossi to its Board of Directors -

IRVINE, Calif., Nov. 26, 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 the appointment of Christina Rossi to its Board of Directors. Additionally, Simone Song, Senior Partner, ORI Capital, has resigned from the Board effective November 22, 2025.

“We are at a critical juncture in CG Oncology’s history with our recent BLA initiation for cretostimogene. Now we are laying the foundation for a successful launch upon FDA approval, which includes adding Christy to our Board of Directors. Christy has a proven track record for building high-performing commercial organizations, launching new medicines, and delivering impactful programs to HCPs and most importantly to patients. We are positioned to address the broadest range of NMIBC patients to date, thanks to the hard work and dedication of our employees and Board over the years. I want to especially thank Simone for more than a decade of service on our Board and her many contributions to our strategy and direction,” said Arthur Kuan, Chairman and Chief Executive Officer of CG Oncology.

Ms. Rossi has more than 25 years of global pharmaceutical and biotechnology experience. Most recently, she served as Chief Operating Officer of Blueprint Medicines from 2022 until its acquisition by Sanofi in 2025. Previously, she served as Chief Commercial Officer and has overseen the commercial launches of Blueprint therapies across multiple indications and geographies, including the creation of commercial infrastructure and successful market access efforts in the U.S. and Europe. Prior to joining Blueprint Medicines, she served as the Multiple Sclerosis (MS) Business Unit Head, North America, at Sanofi Genzyme. In this role, she oversaw all aspects of the financial performance of Sanofi Genzyme’s MS franchise and increased market share for existing products, led the launch of new therapies and optimized operations to accelerate patient access. Previously, Ms. Rossi served as Vice President, MS Sales, and Vice President, MS Patient and Provider Services, at Sanofi Genzyme. Prior to joining Sanofi Genzyme, she held various roles at Biogen Inc., including Head, Commercial Strategy for Eidetica Biopharma GmbH, Biogen’s biosimilar-focused venture, and U.S. Brand Leader for TYSABRI® (natalizumab). In addition, she consulted in the healthcare practice at the Boston Consulting Group. Ms. Rossi holds a B.S. in biology, cum laude, from Duke University and an M.B.A. from Harvard Business School.

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, 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; and the potential therapeutic benefits of cretostimogene for high-risk and intermediate-risk NMIBC patients. 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


FAQ

Who did CG Oncology (CGON) appoint to its board on November 26, 2025?

CG Oncology appointed Christina Rossi to its Board of Directors.

What board change did CG Oncology (CGON) announce effective November 22, 2025?

The company announced the resignation of board member Simone Song, effective November 22, 2025.

What regulatory milestone did CG Oncology (CGON) report alongside the board appointment?

CG Oncology reported initiation of a BLA for cretostimogene, noted in November 2025.

What commercial experience does Christina Rossi bring to CG Oncology (CGON)?

Ms. Rossi has >25 years in pharma/biotech, including roles as COO and CCO at Blueprint Medicines and commercial leadership at Sanofi Genzyme and Biogen.

How might Christina Rossi's appointment affect CG Oncology's (CGON) launch plans?

The company said her background supports launch preparation and commercial infrastructure ahead of potential FDA approval.

Where is CG Oncology (CGON) headquartered and what is its focus?

CG Oncology is based in Irvine, Calif. and focuses on a potential bladder-sparing therapeutic for bladder cancer.
CG Oncology, Inc.

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Biotechnology
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