UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM _____________________ TO _____________________ Commission File Number 001-41925 CG Oncology, Inc. (State or other jurisdiction of incorporation or organization) 40 ...

Exhibit 99.1 CG Oncology Reports 2025 Year End Financial Results and Provides Business Updates IRVINE, Calif., February 27, 2026 (GLOBE NEWSWIRE) -- CG Oncology, Inc. (NASDAQ: CGON) today reported financial results for the fourth quarter and year ended December 31, 2025, and provided business updates. "In the coming months, we look forward to sharing topline data from PIVOT-006, the first randomized registrational trial to evaluate an investigational therapy in intermediate-risk NMIBC. We believe we have th ...

Core Insights - CG Oncology, Inc. reported financial results for Q4 and the full year 2025, highlighting a net loss of $161.0 million for the year, compared to a loss of $88.0 million in 2024, indicating increased operational costs and investments in R&D [12][14]. Financial Highlights - Cash and cash equivalents as of December 31, 2025, were $742.2 million, up from $680.3 million as of September 30, 2025, bolstered by net proceeds of approximately $98.4 million from shares sold in Q4 [5][8]. - R&D expenses for Q4 2025 were $30.0 million, an increase from $26.8 million in Q4 2024, with full-year R&D expenses totaling $116.6 million compared to $82.1 million in 2024 [12]. - G&A expenses for Q4 2025 were $18.0 million, up from $11.7 million in the prior year, with full-year G&A expenses reaching $73.5 million compared to $33.7 million in 2024 [12]. Clinical Development Updates - The company anticipates topline data from the PIVOT-006 Phase 3 trial evaluating cretostimogene in intermediate-risk NMIBC in the first half of 2026, which is nearly a year ahead of schedule [6][7]. - Results from the CORE-008 Cohort CX trial, assessing the combination of cretostimogene with gemcitabine in high-risk NMIBC, are also expected in the first half of 2026 [6][7]. - Cretostimogene has shown promising efficacy in previous trials, with high-grade event-free survival rates of 95.7%, 84.6%, and 80.4% at 3, 6, and 9 months, respectively, in high-risk BCG unresponsive NMIBC [7]. Corporate Developments - The company strengthened its Board of Directors by adding Christina Rossi, a life-science executive with extensive experience in commercial organizations and new medicine launches [7]. - CG Oncology has initiated an Expanded Access Program for cretostimogene in North America for patients unresponsive to BCG [9].

IRVINE, Calif., Feb. 23, 2026 (GLOBE NEWSWIRE) -- CG Oncology, Inc. (NASDAQ: CGON) today announced that Arthur Kuan, Chairman & Chief Executive Officer, and Ambaw Bellete, President & Chief Operating Officer, will present at the TD Cowen 46th Annual Health Care Conference on Monday, March 2, 2026, at 3:10 pm ET. The conference is taking place at the Boston Marriott Copley Place in Boston, MA. Interested parties may access the live audio webcast for this conference from the Investor Relations section of the ...

Connecticut-based Braidwell reported selling 1,412,746 shares of CG Oncology (NASDAQ:CGON) in its February 17, 2026, SEC filing, an estimated $58.46 million trade based on quarterly average pricing. What happened According to a February 17, 2026, SEC filing, Braidwell reduced its position in CG Oncology by 1,412,746 shares during the fourth quarter of 2025. The estimated transaction value was $58.46 million, based on the stock’s average closing price in the quarter. The fund’s quarter-end value in CG Onc ...

Core Viewpoint - CG Oncology is focused on developing a bladder-sparing therapeutic for bladder cancer patients, targeting a market of approximately 150,000 patients annually in the U.S. [2] Company Overview - The incidence of bladder cancer in the U.S. is about 85,000 patients per year, with a prevalence exceeding 700,000 patients [3] - 75% of bladder cancer patients are classified as non-muscle invasive, which is characterized by frequent recurrences that can lead to progression and metastatic disease [3] Strategic Focus - CG Oncology is concentrating on the non-muscle invasive bladder cancer segment, specifically targeting intermediate risk and high-risk populations [4] - The company has invested in two pivotal Phase III trials, with one expected to read out results in the first half of this year [4]

Summary of CG Oncology FY Conference Call Company Overview - **Company**: CG Oncology (NasdaqGS:CGON) - **Focus**: Developing a bladder-sparing therapeutic for bladder cancer patients, specifically targeting the non-muscle invasive bladder cancer (NMIBC) segment, which includes approximately 150,000 patients per year in the U.S. [2][3] Industry Insights - **Bladder Cancer Statistics**: - Incidence: Approximately 85,000 new cases annually in the U.S. - Prevalence: Over 700,000 patients, with 75% being non-muscle invasive [2] - Recurrence rates are high, often leading to progression and metastatic disease [2] Core Strategies and Trials - **Target Market**: Focus on intermediate-risk and high-risk populations within NMIBC [2][3] - **Pivotal Trials**: - **PIVOT-006**: Expected data readout in the first half of 2026, targeting 25,000 patients in the BCG-unresponsive segment [3][4] - **BOND-003**: Phase 3 monotherapy trial already read out, currently under BLA process [3] - **CORE-008, Cohort CX**: Combination trial of Credo plus gemcitabine, with data expected in the first half of 2026 [4][5] Product Profile - **Credo**: An oncolytic immunotherapy with a dual mechanism of action, selectively killing cancer cells and triggering a potent anti-tumor immune response [7][8] - **Clinical Data**: - 75.5% complete response rate in over 110 patients with BCG-unresponsive disease [10] - 46.4% observed complete response rate at 12 months and 42% at 24 months [10] - 96.4% progression-free survival from muscle-invasive disease at 24 months [10] - 90% of patients who achieve a complete response at 12 months remain in response at 24 months [11] Competitive Positioning - **Differentiation**: Credo shows superior efficacy and safety compared to existing therapies, with no significant grade three side effects reported [12][22] - **Market Opportunity**: The intermediate-risk population represents a potential 50,000 patients per year opportunity for CG Oncology [14] Commercial Strategy - **Pre-launch Activities**: Engaging with key accounts and conducting clinical research to prepare for market entry [20][21] - **Field Force**: Plans to deploy a lean field force of 75 to cover 300 network sites that account for 70% of BCG and TURBT volume [20] - **Manufacturing Capacity**: Current capacity of 50,000 vials per year, with plans to scale up to meet anticipated demand [22] Financial Outlook - **Cash Position**: As of Q3, CG Oncology reported $680 million, providing a runway into the first half of 2028 without revenue projections [41] Pricing Strategy - **Market Pricing**: Competitors' pricing ranges from $200,000 to $690,000 per year for BCG-unresponsive disease [43] - **Pricing Considerations**: Factors include efficacy, safety, treatment length, and access for physicians and patients [43][45] Future Directions - **Regulatory Submissions**: Ongoing BLA submission for high-risk BCG-unresponsive indication, with a focus on de-risking the submission process [33][34] - **Expansion Plans**: Interest in conducting randomized trials for the BCG-exposed population, which has been underserved due to the BCG shortage [48] Conclusion - CG Oncology is positioned to make a significant impact in the bladder cancer treatment landscape with its innovative therapy, Credo, and is preparing for a strategic market entry backed by strong clinical data and a solid financial foundation [22][41]

Core Insights - CG Oncology (CGON) shares have increased nearly 32% in the past week following the announcement of earlier-than-expected top-line data from the phase III PIVOT-006 study, now anticipated in the first half of 2026 [1][8] - Over the last six months, CGON shares have surged 112.8%, significantly outperforming the industry growth of 22.9% [3] Study Details - The phase III PIVOT-006 study is assessing the efficacy of adjuvant intravesical cretostimogene grenadenorepvec against active surveillance in over 360 adult patients with intermediate-risk non-muscle invasive bladder cancer (IR NMIBC) post-tumor resection [2] - The primary endpoint is recurrence-free survival (RFS), with secondary endpoints including RFS at specific intervals and progression-free survival [2] Regulatory and Development Updates - CG Oncology has reported positive durability and response data from the phase III BOND-003 study for high-risk NMIBC patients unresponsive to Bacillus Calmette Guerin, with the FDA granting Fast Track and Breakthrough Therapy designations in December 2023 [6] - A rolling biologics license application submission is underway, expected to be completed in 2026 [6] - A separate phase II CORE-008 study is also evaluating the safety and effectiveness of cretostimogene in high-risk NMIBC [7] Market Context - With no FDA-approved therapies available for IR NMIBC patients post-surgery, the accelerated timeline for the phase III study and positive late-stage data have bolstered expectations for regulatory approval, enhancing investor confidence [9]

Core Insights - CG Oncology is a biopharmaceutical company focused on developing innovative cancer therapies, particularly for bladder cancer treatments [1] - The company has received a "Strong Buy" rating due to its pipeline progress and upcoming catalysts in 2026 [3] Market Performance - Morgan Stanley set a price target of $93 for CGON, indicating a potential increase of about 71.59% from its current trading price of $54.20 [2][6] - The stock has experienced a significant rise of 29.26%, with a change of $12.27, reflecting strong market interest [2] Key Developments - CG Oncology completed the rolling Biologics License Application (BLA) for cretostimogene, targeting high-risk BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) [3][6] - The early completion of enrollment in the phase 3 PIVOT-006 trial for intermediate-risk NMIBC has accelerated the timeline for topline data to the first half of 2026, positioning the company for a potential first FDA approval in this segment [4][6] Financial Metrics - CGON's market capitalization is approximately $4.06 billion, with a trading volume of 6,958,295 shares on the NASDAQ exchange [5] - The stock has fluctuated between a low of $43.25 and a high of $57.40 today, with a 52-week range of $14.80 to $57.40, indicating its volatile yet promising nature [5]

Group 1 - The article discusses CG Oncology and its potential positive Phase 3 outcome that could lead to a Biologics License Application (BLA) for Cretostimogene [2] - The author, Terry Chrisomalis, has extensive experience in the biotech sector and runs the Biotech Analysis Central service, which provides in-depth analysis of pharmaceutical companies [2] - Biotech Analysis Central offers a library of over 600 articles, a model portfolio of small and mid-cap stocks, and various analysis tools for healthcare investors [2] Group 2 - The article does not provide any specific financial data or performance metrics related to CG Oncology or its products [1][3][4]