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].

Contacts: 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. IRVINE, Calif., June 05, 2025 (GLOBE NEWSWIRE) -- CG Oncology, Inc. (NASDA ...

CG Oncology (CGON) shares have rallied 26.5% in a month. This upsurge was observed after the company, in late April, announced superior efficacy data from some cohorts of a late-stage study of its investigational candidate, cretostimogene grenadenorepvec, which is being evaluated as a monotherapy for non-muscle invasive bladder cancer (NMIBC) patients.Cretostimogene is CG Oncology’s investigational, intravesically delivered oncolytic immunotherapy, which is being evaluated both as a monotherapy and in combi ...

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]

IRVINE, Calif., May 15, 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 that management will participate in a fireside chat at the 2025 RBC Capital Markets Global Healthcare Conference in New York, NY on Tuesday, May 20, 2025, at 11:30 am ET. Interested parties can access the live audio webcast for this confere ...

Group 1 - CG Oncology, Inc. reported a quarterly loss of $0.45 per share, which was worse than the Zacks Consensus Estimate of a loss of $0.39, and compared to a loss of $0.36 per share a year ago, indicating an earnings surprise of -15.38% [1] - The company posted revenues of $0.05 million for the quarter ended March 2025, missing the Zacks Consensus Estimate by 90.19%, and this was a decline from revenues of $0.53 million in the same quarter last year [2] - CG Oncology, Inc. shares have lost approximately 12.3% since the beginning of the year, while the S&P 500 has only declined by -0.6% [3] Group 2 - The earnings outlook for CG Oncology, Inc. is uncertain, and future stock performance will depend on management's commentary during the earnings call [4] - The current consensus EPS estimate for the upcoming quarter is -$0.53 on revenues of $0.53 million, and for the current fiscal year, it is -$1.81 on revenues of $8.24 million [7] - The Medical - Biomedical and Genetics industry, to which CG Oncology belongs, is currently ranked in the top 35% of over 250 Zacks industries, suggesting a favorable outlook compared to lower-ranked industries [8]

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 March 31, 2025 Commission File Number: 001-41925 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.) OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF ...

Corporate Highlights Exhibit 99.1 | CG Oncology Reports First Quarter 2025 Financial Results and Provides Business Updates - Updated BOND-003 clinical results presented at AUA showing best-in-disease durability and tolerability data for Cohort C with 24-month complete response rate of 42.3% by K-M - - Promising early signal in Cohort P with 90.5% high-grade recurrence free survival at 3 and 9 months by K-M - - New enrollment completion date for Phase 3 PIVOT-006 in intermediate-risk non-muscle invasive blad ...

CG Oncology, Inc. (CGON) is expected to deliver flat earnings compared to the year-ago quarter on higher revenues when it reports results for the quarter ended March 2025. This widely-known consensus outlook gives a good sense of the company's earnings picture, but how the actual results compare to these estimates is a powerful factor that could impact its near-term stock price.The stock might move higher if these key numbers top expectations in the upcoming earnings report. On the other hand, if they miss, ...

- Award recipients Honored at the American Urological Association's 2025 Annual Meeting - - Fellowship designed to support the development of outstanding clinical cancer research investigators to improve the understanding and treatment of NMIBC - SCHAUMBURG, Ill. and IRVINE, Calif., May 01, 2025 (GLOBE NEWSWIRE) -- The Society of Urologic Oncology Clinical Trials Consortium (SUO-CTC), a national alliance of leading academic and community based uro-oncologists, and CG Oncology, Inc. (NASDAQ: CGON), a late-st ...