UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 CG Oncology, Inc. (Exact Name of Registrant as Specified in its Charter) Delaware 37-1611499 (State or other jurisdiction of incorporation or organization) (I.R.S. Employer Identification No.) ...

Exhibit 99.1 CG Oncology Reports Second Quarter 2025 Financial Results and Provides Business Updates - Announced best-in-disease durability data in BOND-003 Cohort C and promising early signal in Cohort P for cretostimogene grenadenorepvec at the American Urological Association Annual Meeting - - Initiated CORE-008 Cohort CX evaluating the combination of cretostimogene and gemcitabine in patients with high-risk (HR) BCG-exposed NMIBC - - Announced unanimous verdict that CG Oncology owes no future royalties ...

Core Viewpoint - CG Oncology achieved a significant legal victory against ANI Pharmaceuticals, with a jury ruling in favor of CG Oncology on all claims, allowing the company to avoid future royalty payments on its investigational therapy, cretostimogene grenadenorepvec [1][2]. Company Overview - CG Oncology is a late-stage clinical biopharmaceutical company focused on developing and commercializing innovative immunotherapies for bladder cancer patients [4]. - The company aims to enhance the quality of life for urologic cancer patients through its therapies [4]. Product Information - Cretostimogene grenadenorepvec is an investigational, intravesically delivered oncolytic immunotherapy currently in clinical development for bladder cancer, specifically targeting Non-Muscle Invasive Bladder Cancer (NMIBC) [3]. - The clinical development program for cretostimogene includes over 400 patients and consists of two Phase 3 trials (BOND-003 and PIVOT-006) and one Phase 2 trial (CORE-008) [3]. - An Expanded Access Program for cretostimogene has been initiated in North America for patients unresponsive to BCG [3].

Attacking Bladder Cancer for a Better Tomorrow Disclaimer and Forward-Looking Statements We caution you that this presentation contains forward-looking statements about us and our industry. All statements other than statements of historical tacts contained in presentation, including statements regarding our luture results of operations and financial position, business strategy, research and development plans, the anticipated tim design and conduct of our ongoing and planned clinical studies for cretostimoge ...

Cretostimogene Clinical Programs & Efficacy - Cretostimogene targets over 70% of the Non-Muscle Invasive Bladder Cancer (NMIBC) market[10] - In High-Risk BCG-Unresponsive NMIBC CIS, Cretostimogene monotherapy (BOND-003 Cohort C) achieved a 12-month Complete Response (CR) rate of 46.4% (51 out of 110 patients) and an estimated 24-month CR rate of 42.3%[30] - In High-Risk BCG-Unresponsive NMIBC Ta/T1 (BOND-003 Cohort P), Cretostimogene demonstrates a 90.5% High Grade Recurrence-Free Survival (HG-RFS) rate at 3, 6, and 9 months[16, 54] - In CORE-008 CX (Cretostimogene in combination with gemcitabine), the Overall Complete Response was 75%[61] Safety & Durability - Cretostimogene demonstrates best-in-disease durability data, with a median Duration of Response (DoR) exceeding 28 months and ongoing in HR BCG-UR NMIBC[12, 38] - 97.3% of patients treated with Cretostimogene were free from progression to MIBC at 24 months[14, 32] - 91.6% of responders avoided radical cystectomy by month 24[14, 32] - Cretostimogene has a favorable safety profile, with 0% Grade ≥ 3 treatment-related Adverse Events (AEs) reported[12, 43, 45] Trial Updates & Market Position - The Phase 3 trial of adjuvant Cretostimogene for Intermediate Risk NMIBC (PIVOT-006) is expected to fully enroll ahead of schedule in 2H'25[15, 55] - Cretostimogene is positioned as a backbone therapy in NMIBC, with ease of delivery and administration for patients, physicians, and practice providers[12, 50]

Financial Data and Key Metrics Changes - The company has approximately $688 million in cash as of Q1, which is expected to last through the first half of 2028, covering existing programs and initial launch activities [77][79]. Business Line Data and Key Metrics Changes - The company is preparing to file a Biologics License Application (BLA) this year, targeting the BCG unresponsive high-risk population, which consists of about 15,000 patients annually [3][37]. - In a trial called BON-three, the company reported a 75.5% complete response rate at any time, with a durable response rate of 65% at one year and 58% at two years [7][8]. Market Data and Key Metrics Changes - In the U.S., there are 85,000 new bladder cancer patients diagnosed each year, with 75% being non-muscle invasive, and 70% of those being in the intermediate and high-risk categories [37]. - The company is addressing a growing number of patients in the BCG exposed category, estimated to be well over 30,000 to 50,000 patients [37]. Company Strategy and Development Direction - The company aims to revolutionize the treatment landscape for non-muscle invasive bladder cancer, focusing on both intermediate and high-risk populations [5]. - The strategy includes simplifying the administration process from a five-step to a two-step process, which is expected to save time and improve patient throughput [23][24]. Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the upcoming BLA filing, emphasizing the importance of demonstrating a minimum duration of response of at least twelve months [22]. - The company is optimistic about its unique position in the market due to the ongoing BCG shortage, which allows for faster enrollment in clinical trials [41]. Other Important Information - The company has generated data showing consistent response rates in patients who have had prior chemotherapy, which will be leveraged in discussions with providers [53]. - The company is focused on building relationships with key accounts, particularly in high-volume centers, to prepare for the commercial launch [73][75]. Q&A Session Summary Question: What is the current cash position and runway guidance? - The company has about $688 million in cash, which is expected to last through the first half of 2028, covering all existing programs and commercial preparations [77][79]. Question: What are the key endpoints for the papillary population study? - The benchmark for the papillary population is a recurrence-free survival rate of about 40% at twelve months, with the company aiming to exceed this in their studies [66]. Question: How does the company plan to prepare for a potential approval? - The commercial leadership team is already in place, focusing on building relationships with key accounts and preparing for the launch [73].

Company Overview - CG Oncology, Inc. is a late-stage clinical biopharmaceutical company focused on developing and commercializing a potential backbone bladder-sparing therapeutic for bladder cancer patients [3] - The company aims to enhance the quality of life for urologic cancer patients through innovative immunotherapies [3] Upcoming Event - Arthur Kuan, Chairman & CEO of CG Oncology, will participate in a fireside chat at the Goldman Sachs 46th Annual Global Healthcare Conference on June 10, 2025, at 11:20 am ET [1] - Interested parties can access the live audio webcast from the Investor Relations section of the company's website, with a replay available for approximately 90 days after the event [2]

Core Insights - CG Oncology's shares have increased by 26.5% over the past month following the announcement of positive efficacy data from a late-stage study of cretostimogene grenadenorepvec for non-muscle invasive bladder cancer (NMIBC) patients [1] Company Overview - Cretostimogene is an investigational oncolytic immunotherapy delivered intravesically, being evaluated as both a monotherapy and in combination therapies across various mid- and late-stage studies for different bladder cancer indications [2] Study Results - The Phase III BOND-003 Cohort C study included high-risk NMIBC patients unresponsive to Bacillus Calmette-Guérin (BCG) therapy, showing a complete response (CR) rate of 75.5% at any time point, with 34 confirmed CRs at 24 months [3][4] - The study reported a CR of 46.4% at 12 months and 33.7% at 24 months, with a median duration of response of 28 months [4] - 97.3% of patients remained free from progression to muscle-invasive disease, and 91.6% of responders remained cystectomy-free at 24 months [4] - In Cohort P of the BOND-003 study, cretostimogene achieved a high-grade recurrence-free survival rate of 90.5% at both three and nine months among 24 treated patients [7] - The treatment was well tolerated, with all treatment-related adverse events being mild to moderate, and 97.3% of patients completed all planned treatments [8] Competitive Landscape - CG Oncology faces competition from Johnson and Johnson (JNJ), which is seeking FDA approval for TAR-200, an investigational drug-device combination targeting the same NMIBC patient population [9] - JNJ's TAR-200 has received Breakthrough Therapy designation from the FDA for this indication [10] - Other competitors include ImmunityBio's Anktiva and Merck's Keytruda, which are approved for high-risk NMIBC but utilize different mechanisms of action compared to cretostimogene [11]

Summary of CG Oncology (CGON) 2025 Conference Call Company Overview - CG Oncology is focused on patients with urological cancer, aiming to enhance their quality of life through innovative therapies [3][4] - The company is developing its first potential backbone bladder-sparing therapy, credostimogene, for non-muscle invasive bladder cancer [3][4] Core Product Insights - **Credostimogene**: An oncolytic immunotherapy designed specifically for bladder cancer treatment [4] - Recent data from the pivotal trial BON3 cohort C showed promising results in patients with high-risk non-muscle invasive bladder cancer who failed standard care (BCG) [4][6] - **Durability and Tolerability**: Credostimogene demonstrated a 46% complete response (CR) rate at 12 months and a 34% CR rate at 24 months, indicating strong disease durability compared to standard therapies [6][7] Competitive Landscape - Credostimogene is positioned favorably against existing therapies like TAR200, N803, and pembrolizumab, with discussions highlighting its superior clinical metrics [7][8] - A significant metric is cystectomy-free survival, with 97.3% of patients remaining free from progression to muscle-invasive disease at 24 months [7] Mechanism of Action - Credostimogene operates through two mechanisms: oncolysis, which selectively targets and kills cancer cells, and immune priming, which enhances the immune response [9][10] Clinical Trial Progress - The PIVOT-six trial is expected to conclude six months ahead of schedule due to heightened interest from clinicians and patients [12] - Six ongoing clinical programs are being conducted in major community centers [12] Regulatory and Commercialization Strategy - CG Oncology plans to initiate its filing in the second half of 2025, focusing on an optimized package insert for commercial success [15][18] - The company is actively engaging with regulatory agencies to refine its submission strategy [15][18] Administration and Workflow - Credostimogene is administered intravesically, similar to BCG treatment, with a streamlined process that takes about one hour [20][23] - The product is manufactured in the US, utilizing single-use bioreactors for optimized production [28][29] Market Potential and Strategy - The market for BCG unresponsive disease includes approximately 15,000 new patients annually, with a 60/40 split between carcinoma in situ and T1 disease [36] - The company is learning from previous product launches in the same category to enhance its market entry strategy [31][32] Financial Position - CG Oncology raised funds in December, providing a financial runway into the first half of 2028 to support clinical trials and commercialization efforts [43][44] Conclusion - CG Oncology is well-positioned to address the unmet needs in the bladder cancer treatment landscape with its innovative therapy, credostimogene, and is actively preparing for regulatory submission and market entry [44]

Company Overview - CG Oncology, Inc. is a late-stage clinical biopharmaceutical company focused on developing and commercializing a potential backbone bladder-sparing therapeutic for bladder cancer patients [3] - The company aims to enhance the quality of life for urologic cancer patients through innovative immunotherapies [3] Upcoming Event - Management will participate in a fireside chat at the 2025 RBC Capital Markets Global Healthcare Conference in New York on May 20, 2025, at 11:30 am ET [1] - Interested parties can access the live audio webcast from the Investor Relations section of the company's website, with a replay available for approximately 90 days post-event [2]