[PART I. FINANCIAL INFORMATION](index=3&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) Presents unaudited condensed consolidated financial statements and management's analysis of financial condition and operations [Item 1. Condensed Consolidated Financial Statements (unaudited)](index=3&type=section&id=Item%201.%20Condensed%20Consolidated%20Financial%20Statements%20%28unaudited%29) Presents unaudited condensed consolidated financial statements for periods ended June 30, 2025, and December 31, 2024 [Condensed Consolidated Balance Sheets](index=3&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Presents the company's financial position (assets, liabilities, equity) as of June 30, 2025 and December 31, 2024 | Asset/Liability Category | June 30, 2025 (in thousands) | December 31, 2024 (in thousands) | | :---------------------- | :----------------------------- | :------------------------------- | | **Assets** | | | | Cash and cash equivalents | $14,624 | $257,068 | | Marketable securities | $646,428 | $484,930 | | Total current assets | $673,030 | $754,210 | | Total assets | $701,445 | $754,797 | | **Liabilities** | | | | Total current liabilities | $30,381 | $21,368 | | Total liabilities | $31,087 | $21,420 | | **Stockholders' Equity**| | | | Accumulated deficit | $(293,859) | $(217,981) | | Total stockholders' equity | $670,358 | $733,377 | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=4&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) Details revenues, expenses, and net loss for the three and six months ended June 30, 2025 and 2024 | Metric | Three Months Ended June 30, 2025 (in thousands) | Three Months Ended June 30, 2024 (in thousands) | Six Months Ended June 30, 2025 (in thousands) | Six Months Ended June 30, 2024 (in thousands) | | :---------------------------------- | :---------------------------------------------- | :---------------------------------------------- | :-------------------------------------------- | :-------------------------------------------- | | License and collaboration revenue | $0 | $111 | $52 | $640 | | Research and development expenses | $31,331 | $18,470 | $58,799 | $35,680 | | General and administrative expenses | $17,410 | $7,494 | $32,198 | $13,282 | | Total operating expenses | $48,741 | $25,964 | $90,997 | $48,962 | | Loss from operations | $(48,741) | $(25,853) | $(90,945) | $(48,322) | | Interest income, net | $7,319 | $6,943 | $15,066 | $12,487 | | Net loss and comprehensive loss | $(41,426) | $(18,902) | $(75,878) | $(35,836) | | Net loss per share, basic and diluted | $(0.54) | $(0.28) | $(1.00) | $(0.63) | [Condensed Consolidated Statements of Redeemable Convertible Preferred Stock and Stockholders' Equity (Deficit)](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Redeemable%20Convertible%20Preferred%20Stock%20and%20Stockholders%27%20Equity%20%28Deficit%29) Outlines changes in redeemable convertible preferred stock and stockholders' equity for the periods presented - The company's redeemable convertible preferred stock converted into common stock concurrently with its IPO in January 2024[17](index=17&type=chunk)[25](index=25&type=chunk) As of June 30, 2025, and December 31, 2024, there was **no redeemable convertible preferred stock outstanding**[17](index=17&type=chunk) | Equity Item | December 31, 2024 (in thousands) | March 31, 2025 (in thousands) | June 30, 2025 (in thousands) | | :-------------------------- | :------------------------------- | :---------------------------- | :--------------------------- | | Common Stock | $8 | $8 | $8 | | Additional Paid-in Capital | $951,350 | $957,183 | $964,209 | | Accumulated Deficit | $(217,981) | $(252,433) | $(293,859) | | Total Stockholders' Equity | $733,377 | $704,758 | $670,358 | [Condensed Consolidated Statements of Cash Flows](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Summarizes cash flows from operating, investing, and financing activities for the periods presented | Cash Flow Activity | Six Months Ended June 30, 2025 (in thousands) | Six Months Ended June 30, 2024 (in thousands) | | :------------------------------------ | :-------------------------------------------- | :-------------------------------------------- | | Net cash used in operating activities | $(57,236) | $(42,132) | | Net cash used in investing activities | $(185,362) | $(343,674) | | Net cash provided by financing activities | $154 | $402,698 | | Net (decrease) increase in cash and cash equivalents | $(242,444) | $16,892 | | Cash and cash equivalents at end of period | $14,624 | $25,158 | [Notes to Condensed Consolidated Financial Statements](index=7&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) Provides detailed explanations of accounting policies, financial line items, and significant events [1. Description of Business and Basis of Presentation](index=7&type=section&id=1.%20Description%20of%20Business%20and%20Basis%20of%20Presentation) Describes the company's business, clinical stage, recent financing activities, and current financial position - CG Oncology, Inc. is a late-stage clinical biopharmaceutical company focused on developing and commercializing cretostimogene grenadenorepvec for bladder cancer[23](index=23&type=chunk) The company is at a clinical stage and does not expect significant revenues until FDA approval and commercialization[23](index=23&type=chunk) - The company completed its IPO on January 29, 2024, raising **$399.6 million** net proceeds, and a follow-on offering in December 2024, raising **$223.1 million** net proceeds[25](index=25&type=chunk) All redeemable convertible preferred stock converted to common stock with the IPO[25](index=25&type=chunk) - In February 2025, the company's subsidiary established a **$26.0 million** convertible promissory note receivable with SP Healthcare SPV I, LLC, which invested in Biovire, Inc. to acquire a contract manufacturing organization for cretostimogene[26](index=26&type=chunk) - As of June 30, 2025, the company had **$661.1 million** in cash, cash equivalents, and marketable securities, and a working capital of **$642.6 million**[31](index=31&type=chunk) It has an accumulated deficit of **$293.9 million** and incurred net losses of **$41.4 million** and **$75.9 million** for the three and six months ended June 30, 2025, respectively[31](index=31&type=chunk) - On March 28, 2025, the company entered into an Open Market Sale Agreement with Jefferies LLC to sell up to **$250.0 million** in common stock, with no sales made as of June 30, 2025[32](index=32&type=chunk) [2. Summary of Significant Accounting Policies](index=8&type=section&id=2.%20Summary%20of%20Significant%20Accounting%20Policies) Outlines key accounting policies, deferred offering costs, and evaluation of new accounting standards - The company capitalizes direct and incremental legal, professional, accounting, and other third-party fees incurred in connection with equity offerings as deferred offering costs[34](index=34&type=chunk) As of June 30, 2025, deferred offering costs were **$0.4 million**, related to a Form S-3 registration statement filed in March 2025[34](index=34&type=chunk) - The FASB issued ASU 2023-09 (Income Taxes) in December 2023, effective for annual periods beginning after December 15, 2025, requiring enhanced income tax disclosures[36](index=36&type=chunk) The company is evaluating its impact[36](index=36&type=chunk) - The FASB issued ASU No. 2024-03 (Comprehensive Income - Expense Disaggregation Disclosures) in November 2024, effective for fiscal years beginning after December 15, 2026, to improve expense disclosures[38](index=38&type=chunk) The company is evaluating its impact[38](index=38&type=chunk) [3. Fair Value Measurements](index=9&type=section&id=3.%20Fair%20Value%20Measurements) Details fair value measurements for cash equivalents and marketable securities, including their classification | Asset Category | Fair Value at June 30, 2025 (in thousands) | Fair Value at December 31, 2024 (in thousands) | | :--------------- | :--------------------------------------- | :--------------------------------------------- | | Cash equivalents | $14,291 | $256,204 | | Marketable securities | $646,428 | $484,930 | - Cash equivalents are classified as **Level 1** fair value measurements (short-term U.S. Treasury money market fund)[39](index=39&type=chunk) Marketable securities (fixed income U.S. Treasury bills) are classified as **Level 2** fair value measurements[39](index=39&type=chunk) [4. Note Receivable](index=9&type=section&id=4.%20Note%20Receivable) Describes the convertible promissory note receivable held by the company's subsidiary - The company's subsidiary, SafeGuard Healthcare, LLC, holds a **$26.0 million** convertible promissory note receivable from SPV, established in February 2025, with an **8% interest rate** and due February 3, 2029[41](index=41&type=chunk) No payments have been made as of June 30, 2025[41](index=41&type=chunk) [5. Accrued Expenses and Other Current Liabilities](index=10&type=section&id=5.%20Accrued%20Expenses%20and%20Other%20Current%20Liabilities) Presents a breakdown of accrued expenses and other current liabilities as of the reporting dates | Component | June 30, 2025 (in thousands) | December 31, 2024 (in thousands) | | :-------------------------------- | :----------------------------- | :------------------------------- | | External research and development expenses | $16,000 | $7,181 | | Personnel-related expenses | $4,561 | $5,793 | | Professional fees | $2,166 | $1,255 | | Other | $241 | $436 | | Total accrued expenses and other current liabilities | $22,968 | $14,665 | [6. Commitments and Contingencies](index=10&type=section&id=6.%20Commitments%20and%20Contingencies) Details operating lease obligations and provides an update on significant legal proceedings - As of June 30, 2025, the company had **three operating leases** for office space, with terms expiring between 2026 and 2030[45](index=45&type=chunk)[46](index=46&type=chunk) Total lease cost for the three and six months ended June 30, 2025, was **$86 thousand** and **$152 thousand**, respectively[45](index=45&type=chunk)[46](index=46&type=chunk) | Year | Lease Liabilities (in thousands) | | :--- | :------------------------------- | | 2025 | $172 | | 2026 | $324 | | 2027 | $274 | | 2028 | $227 | | 2029 | $124 | | Thereafter | $10 | | Total future minimum lease obligations | $994 | - On July 16, 2025, the Superior Court granted the company's motion for summary judgment regarding ANI Pharmaceuticals, Inc.'s royalty claim on cretostimogene sales[49](index=49&type=chunk) On July 29, 2025, a jury rejected ANI's unjust enrichment claim, meaning the company will **not owe ANI a 5% royalty or damages**[49](index=49&type=chunk) [7. License and Collaboration Agreements](index=11&type=section&id=7.%20License%20and%20Collaboration%20Agreements) Summarizes key terms and revenue recognition from the Lepu and Kissei license agreements - Under the Lepu License Agreement (March 2019), the company granted an exclusive license to Lepu Biotech Co., Ltd. for cretostimogene in mainland China, Hong Kong, and Macau[51](index=51&type=chunk) Lepu paid a **$4.5 million upfront fee** and is obligated for up to **$2.5 million** in regulatory milestones and **$57.5 million** in commercial milestones, plus high single-digit royalties on net sales[52](index=52&type=chunk)[53](index=53&type=chunk) - Under the Kissei License Agreement (March 2020, amended September 2022), the company granted an exclusive license to Kissei Pharmaceutical Co., Ltd. for cretostimogene in various Asian territories[58](index=58&type=chunk) Kissei paid a **$10.0 million upfront fee** and purchased **$30.0 million** in Series D preferred stock[59](index=59&type=chunk) Kissei is obligated for up to **$33.0 million** in development/regulatory milestones and **$67.0 million** in commercial milestones[59](index=59&type=chunk) The company is entitled to mid-twenties percentage royalties on Kissei Territory sales and pays Kissei a low-single digit royalty on sales outside the Kissei/Lepu Territories[59](index=59&type=chunk) | Revenue Source | Three Months Ended June 30, 2025 (in thousands) | Three Months Ended June 30, 2024 (in thousands) | Six Months Ended June 30, 2025 (in thousands) | Six Months Ended June 30, 2024 (in thousands) | | :--------------- | :---------------------------------------------- | :---------------------------------------------- | :-------------------------------------------- | :-------------------------------------------- | | Lepu License Agreement | $0 | $0 | $0 | $500 | | Kissei License Agreement | $0 | $100 | <$100 | $100 | | Total License and Collaboration Revenue | $0 | $111 | $52 | $640 | [8. Segment Disclosures](index=15&type=section&id=8.%20Segment%20Disclosures) Confirms the company operates as a single operating segment for financial reporting purposes - The company operates as a **single operating segment**, with its chief executive officer reviewing financial information on a consolidated basis to assess performance and allocate resources[68](index=68&type=chunk) [9. Common Stock](index=15&type=section&id=9.%20Common%20Stock) Provides information on common stock (authorized, issued, outstanding) and shares reserved for equity plans - As of June 30, 2025, the company had **76,231,859 shares** of common stock issued and outstanding, out of **700,000,000 authorized shares**[70](index=70&type=chunk) | Reserved Shares Category | June 30, 2025 | | :----------------------- | :------------ | | Stock options outstanding | 8,963,925 | | Reserved for future stock option issuances | 3,788,588 | | Reserved for future ESPP issuances | 751,077 | | Total | 13,503,590 | [10. Stock-Based Compensation](index=16&type=section&id=10.%20Stock-Based%20Compensation) Details the company's equity incentive plans and the stock-based compensation expense recognized - The company has three equity incentive plans: the 2015 Plan, 2022 Plan, and 2024 Equity Incentive Plan[75](index=75&type=chunk) The 2024 Plan replaced the 2022 Plan, with **8,246,565 shares** initially available, plus shares from prior plans that become available[76](index=76&type=chunk) | Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :-------------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Stock-based compensation expense (R&D) | $2,303 thousand | $779 thousand | $3,955 thousand | $1,322 thousand | | Stock-based compensation expense (G&A) | $4,704 thousand | $1,467 thousand | $8,203 thousand | $2,441 thousand | | Total stock-based compensation expense | $7,007 thousand | $2,246 thousand | $12,158 thousand | $3,763 thousand | - As of June 30, 2025, the company had **$79.8 million** of gross unrecognized stock-based compensation expense related to unvested options, to be recognized over a weighted average period of **3.2 years**[81](index=81&type=chunk) [11. Employee Stock Purchase Plan](index=18&type=section&id=11.%20Employee%20Stock%20Purchase%20Plan) Describes the ESPP, shares available, and related stock-based compensation expense - The 2024 Employee Stock Purchase Plan (ESPP) became effective January 11, 2024, with **812,242 shares** initially available[83](index=83&type=chunk) It allows eligible employees to purchase common stock at **85% of fair market value**[83](index=83&type=chunk) As of June 30, 2025, **751,077 shares** were available for issuance[83](index=83&type=chunk) - Stock-based compensation expense under the ESPP was approximately **$0.6 million** for the three months ended June 30, 2025, and **$1.4 million** for the six months ended June 30, 2025[84](index=84&type=chunk) [12. Debt](index=19&type=section&id=12.%20Debt) Provides an update on the company's debt obligations, including repayment of prior loans - In May 2023, the company repaid all outstanding principal and interest on its loan agreement with Silicon Valley Bank (SVB)[86](index=86&type=chunk) In March 2024, the company paid a **$0.4 million** Success Fee to SVB in connection with its IPO[87](index=87&type=chunk) As of June 30, 2025, the company has **no further debt obligations**[88](index=88&type=chunk) [13. Net Loss Per Share Attributable to Common Stockholders](index=19&type=section&id=13.%20Net%20Loss%20Per%20Share%20Attributable%20to%20Common%20Stockholders) Presents the calculation of basic and diluted net loss per share for common stockholders | Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :------------------------------------------------ | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Net loss and comprehensive loss (in thousands) | $(41,426) | $(18,902) | $(75,878) | $(35,836) | | Weighted-average common stock outstanding (basic and diluted) | 76,226,829 | 66,649,443 | 76,207,333 | 56,857,104 | | Net loss per share (basic and diluted) | $(0.54) | $(0.28) | $(1.00) | $(0.63) | - Potentially dilutive securities, including redeemable convertible preferred stock and stock options, were excluded from diluted net loss per share calculations as their effect would be **anti-dilutive**[89](index=89&type=chunk) [14. Subsequent Events](index=20&type=section&id=14.%20Subsequent%20Events) Reports significant events after the balance sheet date, including a change in control of an SPV - Subsequent to June 30, 2025, on July 20, 2025, the company obtained **control of SP Healthcare SPV I, LLC (SPV)** following the conversion of a convertible note[92](index=92&type=chunk)[93](index=93&type=chunk) The company will now consolidate SPV in its financial statements[92](index=92&type=chunk)[93](index=93&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=21&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses financial condition, operational results, liquidity, and capital resources [Overview](index=21&type=section&id=Overview) Summarizes the company's business, product development, financial performance, and funding outlook - CG Oncology is a late-stage clinical biopharmaceutical company developing cretostimogene grenadenorepvec for bladder cancer, aiming to be an alternative to Bacillus Calmette-Guérin (BCG) for high-risk Non-Muscle Invasive Bladder Cancer (NMIBC) unresponsive to BCG[99](index=99&type=chunk) - The company is building commercial operations in anticipation of potential U.S. FDA approval for cretostimogene, with a Biologics License Application (BLA) submission expected in **Q4 2025** based on the BOND-003 Cohort C Phase 3 trial data[100](index=100&type=chunk) - The company has incurred significant operating losses and negative cash flows since inception, with net losses of **$75.9 million** for the six months ended June 30, 2025, and an accumulated deficit of **$293.9 million**[103](index=103&type=chunk) - Existing cash, cash equivalents, and marketable securities of **$661.1 million** as of June 30, 2025, are estimated to fund operations into the **first half of 2028**[104](index=104&type=chunk)[105](index=105&type=chunk) [License and Collaboration Agreements](index=24&type=section&id=License%20and%20Collaboration%20Agreements) Discusses the revenue recognition and key terms of the Lepu and Kissei license agreements - The Lepu License Agreement (March 2019) grants Lepu Biotech Co., Ltd. exclusive rights for cretostimogene in mainland China, Hong Kong, and Macau[109](index=109&type=chunk) **No revenue** was recognized from this agreement for the three and six months ended June 30, 2025[109](index=109&type=chunk) - The Kissei License Agreement (March 2020, amended September 2022) grants Kissei Pharmaceutical Co., Ltd. exclusive rights for cretostimogene in various Asian territories[110](index=110&type=chunk) **Less than $0.1 million** in revenue was recognized for the six months ended June 30, 2025, and **zero** for the three months ended June 30, 2025[110](index=110&type=chunk) [Components of Our Results of Operations](index=24&type=section&id=Components%20of%20Our%20Results%20of%20Operations) Explains primary components of revenue, operating expenses, and other income (expense) impacting financial results - The company has recognized **$26.2 million** in license and collaboration revenue since inception through June 30, 2025, but has not generated product sales revenue and does not expect to in the foreseeable future[111](index=111&type=chunk) - Operating expenses consist of research and development (R&D) expenses and general and administrative (G&A) expenses[112](index=112&type=chunk) R&D expenses are primarily external costs for clinical trials and internal personnel-related expenses, all related to cretostimogene[113](index=113&type=chunk)[114](index=114&type=chunk)[117](index=117&type=chunk) - G&A expenses include personnel-related costs for executive, legal, finance, HR, and other administrative functions, as well as professional fees and allocated facilities costs[119](index=119&type=chunk) - Other income (expense), net, includes interest income from invested cash and marketable securities, and miscellaneous items like success fees[121](index=121&type=chunk)[122](index=122&type=chunk) [Results of Operations](index=27&type=section&id=Results%20of%20Operations) Analyzes the company's financial performance by comparing key metrics across different reporting periods [Comparison of the Three Months Ended June 30, 2025 and 2024](index=27&type=section&id=Comparison%20of%20the%20Three%20Months%20Ended%20June%2030%2C%202025%20and%202024) Compares the company's financial performance for the three-month periods ended June 30, 2025 and 2024 | Metric | Three Months Ended June 30, 2025 (in thousands) | Three Months Ended June 30, 2024 (in thousands) | Change (in thousands) | | :-------------------------------- | :---------------------------------------------- | :---------------------------------------------- | :-------------------- | | License and collaboration revenue | $0 | $111 | $(111) | | Research and development | $31,331 | $18,470 | $12,861 | | General and administrative | $17,410 | $7,494 | $9,916 | | Total operating expenses | $48,741 | $25,964 | $22,777 | | Loss from operations | $(48,741) | $(25,853) | $(22,888) | | Interest income, net | $7,319 | $6,943 | $376 | | Net loss and comprehensive loss | $(41,426) | $(18,902) | $(22,524) | - R&D expenses increased by **$12.9 million**, primarily due to a **$7.9 million** increase in external clinical trial expenses (higher CRO fees) and a **$3.9 million** increase in personnel-related costs (including **$1.5 million** in stock-based compensation)[125](index=125&type=chunk) - G&A expenses increased by **$9.9 million**, driven by a **$5.4 million** increase in personnel-related costs (including **$3.2 million** in stock-based compensation) and a **$3.3 million** increase in professional and consultant fees (including **$3.0 million** in legal fees)[126](index=126&type=chunk) [Comparison of the Six Months Ended June 30, 2025 and 2024](index=29&type=section&id=Comparison%20of%20the%20Six%20Months%20Ended%20June%2030%2C%202025%20and%202024) Compares the company's financial performance for the six-month periods ended June 30, 2025 and 2024 | Metric | Six Months Ended June 30, 2025 (in thousands) | Six Months Ended June 30, 2024 (in thousands) | Change (in thousands) | | :-------------------------------- | :-------------------------------------------- | :-------------------------------------------- | :-------------------- | | License and collaboration revenue | $52 | $640 | $(588) | | Research and development | $58,799 | $35,680 | $23,119 | | General and administrative | $32,198 | $13,282 | $18,916 | | Total operating expenses | $90,997 | $48,962 | $42,035 | | Loss from operations | $(90,945) | $(48,322) | $(42,623) | | Interest income, net | $15,066 | $12,487 | $2,579 | | Net loss and comprehensive loss | $(75,878) | $(35,836) | $(40,042) | - R&D expenses increased by **$23.1 million**, primarily due to a **$13.4 million** increase in external clinical trial expenses and a **$7.4 million** increase in personnel-related costs (including **$2.6 million** in stock-based compensation)[131](index=131&type=chunk) - G&A expenses increased by **$18.9 million**, mainly due to a **$10.7 million** increase in personnel-related costs (including **$5.8 million** in stock-based compensation) and a **$4.8 million** increase in professional and consultant fees[133](index=133&type=chunk) [Liquidity and Capital Resources](index=30&type=section&id=Liquidity%20and%20Capital%20Resources) Assesses the company's ability to meet financial obligations and fund future operations through available capital - The company has primarily funded operations through public offerings of common stock and redeemable convertible preferred stock, raising **$982.9 million** in gross proceeds since inception through June 30, 2025[135](index=135&type=chunk) - As of June 30, 2025, cash, cash equivalents, and marketable securities totaled **$661.1 million**, estimated to fund operations into the **first half of 2028**[135](index=135&type=chunk)[139](index=139&type=chunk) - On March 28, 2025, the company entered into an At-the-Market (ATM) offering agreement with Jefferies LLC to sell up to **$250 million** of common stock, with no sales made as of June 30, 2025[136](index=136&type=chunk) - Future funding requirements are expected to increase substantially due to ongoing R&D, regulatory approval processes, potential commercialization of cretostimogene, and costs associated with being a public company[137](index=137&type=chunk) - The company expects to finance future operations through equity offerings, debt financings, or collaborations, acknowledging potential dilution or restrictive covenants[140](index=140&type=chunk) [Cash Flows](index=33&type=section&id=Cash%20Flows) Analyzes the sources and uses of cash from operating, investing, and financing activities | Cash Flow Activity | Six Months Ended June 30, 2025 (in thousands) | Six Months Ended June 30, 2024 (in thousands) | | :------------------------------------ | :-------------------------------------------- | :-------------------------------------------- | | Net cash used in operating activities | $(57,236) | $(42,132) | | Net cash used in investing activities | $(185,362) | $(343,674) | | Net cash provided by financing activities | $154 | $402,698 | - Operating activities used **$57.2 million** in cash for the six months ended June 30, 2025, primarily due to a net loss of **$75.9 million**, partially offset by non-cash stock-based compensation and changes in operating assets and liabilities[144](index=144&type=chunk) - Investing activities used **$185.4 million** in cash for the six months ended June 30, 2025, mainly from purchases of marketable securities and the issuance of a **$26.0 million** note receivable[146](index=146&type=chunk) - Financing activities provided **$0.2 million** in cash for the six months ended June 30, 2025, primarily from stock option exercises, offset by deferred offering costs[148](index=148&type=chunk) [Critical Accounting Policies and Significant Judgments and Estimates](index=33&type=section&id=Critical%20Accounting%20Policies%20and%20Significant%20Judgments%20and%20Estimates) Highlights accounting policies requiring significant management judgment and estimation, including R&D expenses - The preparation of financial statements requires management to make estimates and judgments, particularly for R&D expenses, which involve estimating costs for services performed by vendors when invoices are not yet received[150](index=150&type=chunk)[152](index=152&type=chunk) - There have been **no material changes** to the critical accounting policies and estimates from those described in the 2024 Annual Report[151](index=151&type=chunk) [Off-Balance Sheet Arrangements](index=35&type=section&id=Off-Balance%20Sheet%20Arrangements) Confirms the absence of any off-balance sheet arrangements during the reported periods - The company did not have any **off-balance sheet arrangements** during the periods presented[155](index=155&type=chunk) [Recently Issued Accounting Standards](index=35&type=section&id=Recently%20Issued%20Accounting%20Standards) Refers to disclosures regarding new accounting standards and their potential impact on the company - A description of recently issued accounting standards that may impact the company's financial position, results of operations, and cash flows is included in **Note 2** to the condensed consolidated financial statements[156](index=156&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=35&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) Discusses the company's exposure to market risks, focusing on interest rate sensitivity and inflation impact - The company's market risk exposure is primarily limited to **interest rate sensitivity**, with **$661.1 million** in cash, cash equivalents, and marketable securities (money market funds and U.S. Treasury bills) as of June 30, 2025[157](index=157&type=chunk) - Due to the short-term duration and low-risk profile of its investment portfolio, the company believes its exposure to interest rate risk is **not significant**[158](index=158&type=chunk) - Inflation has **not had a material effect** on the company's business, financial condition, or results of operations for the periods covered[159](index=159&type=chunk) [Item 4. Controls and Procedures](index=36&type=section&id=Item%204.%20Controls%20and%20Procedures) Details disclosure controls and procedures, including management's evaluation of effectiveness and internal control changes - Management, including the principal executive officer and principal financial officer, concluded that the company's disclosure controls and procedures were **effective at a reasonable assurance level** as of June 30, 2025[161](index=161&type=chunk) - There have been **no material changes** in the company's internal control over financial reporting during the three months ended June 30, 2025[162](index=162&type=chunk) [PART II. OTHER INFORMATION](index=37&type=section&id=PART%20II.%20OTHER%20INFORMATION) Presents additional information including legal proceedings, risk factors, equity sales, and other disclosures [Item 1. Legal Proceedings](index=37&type=section&id=Item%201.%20Legal%20Proceedings) Provides an update on significant legal proceedings, specifically the lawsuit filed by ANI Pharmaceuticals - On July 16, 2025, the Superior Court granted the company's motion for summary judgment regarding ANI Pharmaceuticals, Inc.'s royalty claim on cretostimogene sales[165](index=165&type=chunk) On July 29, 2025, a jury unanimously rejected ANI's unjust enrichment claim[165](index=165&type=chunk) - As a result, the company will **not owe ANI a future royalty of 5%** on commercial sales of cretostimogene, and **no damages** were awarded to ANI[165](index=165&type=chunk) - The company expects ANI to pursue post-trial motions and appeals and will continue to vigorously defend against these claims[165](index=165&type=chunk) [Item 1A. Risk Factors](index=37&type=section&id=Item%201A.%20Risk%20Factors) Supplements previously disclosed risk factors, focusing on litigation, trade policies, and healthcare reform - The company's business could be affected by litigation, government investigations, and enforcement actions, which can be expensive, time-consuming, and cause reputational damage, as exemplified by the ANI Pharmaceuticals lawsuit[168](index=168&type=chunk)[169](index=169&type=chunk) - International trade policies, including tariffs, sanctions, and trade barriers, may adversely affect the business by increasing R&D expenses, disrupting supply chains (especially for non-U.S. suppliers of raw materials and equipment), and potentially delaying development timelines[170](index=170&type=chunk)[171](index=171&type=chunk)[172](index=172&type=chunk) - Current and future healthcare reform legislation, such as the 'One Big Beautiful Bill Act' (OBBBA) and the Inflation Reduction Act of 2022 (IRA), may increase the difficulty and cost of obtaining coverage and commercializing products, potentially reducing reimbursement and affecting pricing[175](index=175&type=chunk)[177](index=177&type=chunk)[178](index=178&type=chunk) - Changes in tax law, including recent U.S. federal tax reforms and potential future legislation, could materially adversely affect the company's financial condition, results of operations, and cash flows[182](index=182&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=42&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) Reports on unregistered sales of equity securities and details the use of IPO proceeds - There were **no recent unregistered sales** of equity securities[184](index=184&type=chunk) - The company received net proceeds of approximately **$399.6 million** from its IPO on January 29, 2024[185](index=185&type=chunk) As of June 30, 2025, approximately **$204.7 million** of these proceeds have been used for general corporate purposes, including R&D and pre-commercial activities for cretostimogene[185](index=185&type=chunk) [Item 3. Defaults Upon Senior Securities](index=42&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) This item states that there are no defaults upon senior securities - Not applicable[186](index=186&type=chunk) [Item 4. Mine Safety Disclosures](index=42&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item states that there are no mine safety disclosures - Not applicable[187](index=187&type=chunk) [Item 5. Other Information](index=42&type=section&id=Item%205.%20Other%20Information) Provides information on Rule 10b5-1 or non-Rule 10b5-1 trading arrangements by officers and directors - During the six months ended June 30, 2025, Director James J. Mulé adopted a **Rule 10b5-1 trading arrangement** on June 6, 2025, to sell **99,032 shares**, expiring June 30, 2026[188](index=188&type=chunk)[189](index=189&type=chunk) No other officers or directors adopted, modified, or terminated such arrangements[188](index=188&type=chunk)[189](index=189&type=chunk) [Item 6. Exhibits](index=43&type=section&id=Item%206.%20Exhibits) Lists exhibits filed as part of the Form 10-Q, including organizational documents, certifications, and XBRL | Exhibit Number | Exhibit Description | Filed Herewith | | :------------- | :------------------------------------------------------------------------------------------------------ | :------------- | | 3.1 | Amended and Restated Certificate of Incorporation | | | 3.2 | Amended and Restated Bylaws | | | 31.1 | Certification of Chief Executive Officer, as required by Rule 13a-14(a) or Rule 15d-14(a) | X | | 31.2 | Certification of Principal Financial Officer, as required by Rule 13a-14(a) or Rule 15d-14(a) | X | | 32.1* | Certification of Chief Executive Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 | X | | 32.2* | Certification of Principal Financial Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 | X | | 101.INS | Inline XBRL Instance Document | X | | 101.SCH | Inline XBRL Taxonomy Extension Schema with Embedded Linkbase Document | X | | 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) | | [Signatures](index=44&type=section&id=Signatures) This section contains the required signatures for the Form 10-Q report - The report was signed on **August 8, 2025**, by Arthur Kuan, Chairman and Chief Executive Officer, and Robert Lapetina, Vice President, Financial Planning & Analysis[196](index=196&type=chunk)

[Introduction](index=1&type=section&id=Introduction) CG Oncology announced Q2 2025 financial results and business updates, highlighting positive BOND-003 data, CORE-008 new cohort initiation, and a favorable ANI Pharmaceuticals lawsuit outcome [Q2 2025 Overview](index=1&type=section&id=Q2%202025%20Overview) CG Oncology announced Q2 2025 financial results and business updates, including positive BOND-003 data, CORE-008 new cohort, and a favorable ANI Pharmaceuticals lawsuit outcome - CG Oncology announced Q2 2025 financial results and business updates, highlighting positive BOND-003 clinical trial data, the initiation of a new CORE-008 cohort, and a favorable verdict in the lawsuit against ANI Pharmaceuticals[1](index=1&type=chunk) [CEO Commentary](index=1&type=section&id=CEO%20Commentary) CEO Arthur Kuan emphasized cretostimogene's durability and tolerability in BOND-003, confirming the company's focus on advancing the therapy with a planned BLA submission in Q4 - The CEO highlighted cretostimogene's "best-in-class disease durability and tolerability" in the Phase 3 BOND-003 Cohort C trial, with plans to submit a BLA in Q4 for HR NMIBC patients unresponsive to BCG[2](index=2&type=chunk) - The positive outcome of the ANI lawsuit allows the company to remain focused on delivering innovative therapies[2](index=2&type=chunk) [Corporate Highlights](index=2&type=section&id=Corporate%20Highlights) The company presented positive clinical data for BOND-003 Cohort C and P at AUA, and initiated the CORE-008 Cohort CX trial, expanding cretostimogene's indications [Clinical Development Updates](index=2&type=section&id=Clinical%20Development%20Updates) The company presented positive clinical data for BOND-003 Cohort C and P at AUA, and initiated the CORE-008 Cohort CX trial, expanding cretostimogene's indications [BOND-003 Trial Data](index=2&type=section&id=BOND-003%20Trial%20Data) BOND-003 Cohort C showed a 75.5% complete response rate at 24 months, with 97.3% of patients free from muscle-invasive disease progression; Cohort P also showed a 90.5% high-grade recurrence-free survival rate - "Best-in-class disease durability and tolerability" data for BOND-003 Cohort C was presented at the AUA annual meeting[4](index=4&type=chunk) BOND-003 Cohort C Key Data | Metric | Data | As of Date | | :--- | :--- | :--- | | Anytime Complete Response Rate (CR) | 75.5% | March 14, 2025 | | Confirmed CRs at 24 months | 34 patients | March 14, 2025 | | 12-month CR Rate (K-M estimate) | 50.7% | N/A | | 24-month CR Rate (K-M estimate) | 42.3% | N/A | | Median Duration of Response | 28 months (ongoing) | N/A | | Rate of no progression to muscle-invasive disease at 24 months | 97.3% | N/A | - BOND-003 Cohort P (patients with Ta/T1 papillary disease) showed an estimated **90.5% high-grade recurrence-free survival** at 3 and 9 months among 24 patients[4](index=4&type=chunk) [CORE-008 Trial Initiation](index=2&type=section&id=CORE-008%20Trial%20Initiation) The company initiated the CORE-008 Cohort CX clinical trial to evaluate cretostimogene combined with gemcitabine for high-risk BCG-exposed NMIBC patients - Initiated the CORE-008 Cohort CX clinical trial to evaluate cretostimogene in combination with gemcitabine for high-risk BCG-exposed NMIBC patients[4](index=4&type=chunk) [Legal and Operational Updates](index=2&type=section&id=Legal%20and%20Operational%20Updates) A Delaware Superior Court jury unanimously ruled in favor of CG Oncology, absolving them from paying future royalties or other payments to ANI Pharmaceuticals for cretostimogene sales - A Delaware Superior Court jury unanimously ruled in favor of CG Oncology, absolving them from paying a **5% royalty** or other payments to ANI Pharmaceuticals for future sales of cretostimogene[4](index=4&type=chunk) [Anticipated Upcoming Milestones](index=3&type=section&id=Anticipated%20Upcoming%20Milestones) CG Oncology announced key clinical development and regulatory milestones for upcoming quarters, including PIVOT-006 enrollment completion, BLA submission, and top-line data releases for multiple trials [Upcoming Milestones Details](index=3&type=section&id=Upcoming%20Milestones%20Details) CG Oncology announced key clinical development and regulatory milestones for upcoming quarters, including PIVOT-006 enrollment completion, BLA submission, and top-line data releases for multiple trials - PIVOT-006 (Intermediate-risk NMIBC): Phase 3 enrollment expected to complete in Q3 2025[7](index=7&type=chunk) - BLA Submission: Expected in Q4 2025 for cretostimogene monotherapy in HR BCG-unresponsive NMIBC[7](index=7&type=chunk) - BOND-003 Cohort P: Phase 3 top-line data expected in Q4 2025[7](index=7&type=chunk) - CORE-008 Cohort A: Phase 2 top-line data expected in Q4 2025[7](index=7&type=chunk) - CORE-008 Cohort CX: Phase 2 top-line data expected in H1 2026[7](index=7&type=chunk) [Second Quarter 2025 Financial Highlights](index=3&type=section&id=Second%20Quarter%202025%20Financial%20Highlights) CG Oncology's Q2 2025 financial highlights include a cash position of $661.1 million, a decrease from Q1, but sufficient to fund operations until H1 2028 [Cash Position](index=3&type=section&id=Cash%20Position) As of June 30, 2025, the company's cash, cash equivalents, and marketable securities totaled $661.1 million, down from $688.4 million on March 31, 2025, but projected to support operations until H1 2028 Cash, Cash Equivalents, and Marketable Securities | Date | Amount (Millions USD) | Change (QoQ) | | :--- | :--- | :--- | | June 30, 2025 | 661.1 | -27.3 | | March 31, 2025 | 688.4 | N/A | - The company expects its existing cash, cash equivalents, and marketable securities to be sufficient to fund operations until H1 2028[7](index=7&type=chunk) [Operating Expenses](index=3&type=section&id=Operating%20Expenses) In Q2 2025, the company's R&D and G&A expenses significantly increased year-over-year, primarily due to higher clinical trial expenditures, personnel costs, and legal fees [Research and Development (R&D) Expenses](index=3&type=section&id=Research%20and%20Development%20(R%26D)%20Expenses) Q2 2025 R&D expenses were $31.3 million, a 69.2% increase from $18.5 million in the prior year, mainly due to increased clinical trial expenditures and personnel costs Research and Development Expenses (YoY) | Period | Q2 2025 (Millions USD) | Q2 2024 (Millions USD) | YoY Change | | :--- | :--- | :--- | :--- | | R&D Expenses | 31.3 | 18.5 | +69.2% | - The increase in R&D expenses was primarily due to increased clinical trial expenditures and personnel costs[7](index=7&type=chunk) [General and Administrative (G&A) Expenses](index=3&type=section&id=General%20and%20Administrative%20(G%26A)%20Expenses) Q2 2025 G&A expenses were $17.4 million, a 132% increase from $7.5 million in the prior year, mainly due to higher personnel-related and legal fees General and Administrative Expenses (YoY) | Period | Q2 2025 (Millions USD) | Q2 2024 (Millions USD) | YoY Change | | :--- | :--- | :--- | :--- | | G&A Expenses | 17.4 | 7.5 | +132% | - The increase in G&A expenses was primarily attributable to higher personnel-related costs (including increased employee compensation) and legal fees[7](index=7&type=chunk) [Net Loss and Earnings Per Share (EPS)](index=3&type=section&id=Net%20Loss%20and%20Earnings%20Per%20Share%20(EPS)) Q2 2025 net loss was $41.4 million, or $0.54 per share, a significant increase from the $18.9 million net loss and $0.28 loss per share in the prior year Net Loss and Earnings Per Share (YoY) | Metric | Q2 2025 | Q2 2024 | YoY Change | | :--- | :--- | :--- | :--- | | Net Loss (Millions USD) | 41.4 | 18.9 | +119% | | Net Loss Per Share (USD) | (0.54) | (0.28) | +93% | [About Cretostimogene Grenadenorepvec](index=4&type=section&id=About%20Cretostimogene%20Grenadenorepvec) Cretostimogene is an investigational intravesical oncolytic immunotherapy studied in over 400 NMIBC patients across two Phase III and one Phase II clinical trials, with a North American expanded access program initiated [Cretostimogene Product Overview](index=4&type=section&id=Cretostimogene%20Product%20Overview) Cretostimogene is an investigational intravesical oncolytic immunotherapy studied in over 400 NMIBC patients across two Phase III and one Phase II clinical trials, with a North American expanded access program initiated - Cretostimogene is an investigational intravesical oncolytic immunotherapy studied in over **400 NMIBC patients**[8](index=8&type=chunk) - The drug's clinical development program includes two Phase 3 clinical trials (BOND-003 and PIVOT-006) and one Phase 2 trial (CORE-008)[8](index=8&type=chunk) - An expanded access program has been initiated in North America for patients unresponsive to BCG[8](index=8&type=chunk) [About CG Oncology](index=4&type=section&id=About%20CG%20Oncology) CG Oncology is a late-stage clinical biopharmaceutical company focused on developing and commercializing potential bladder cancer therapies, aiming to improve the lives of urologic cancer patients through innovative immunotherapies [Company Profile](index=4&type=section&id=Company%20Profile) CG Oncology is a late-stage clinical biopharmaceutical company focused on developing and commercializing potential bladder cancer therapies, aiming to improve the lives of urologic cancer patients through innovative immunotherapies - CG Oncology is a late-stage clinical biopharmaceutical company, focused on developing and commercializing potential bladder cancer therapies[9](index=9&type=chunk) - The company's vision is to enable urologic cancer patients to benefit from its innovative immunotherapies, living with dignity and improved quality of life[9](index=9&type=chunk) [Forward-Looking Statements](index=4&type=section&id=Forward-Looking%20Statements) This press release contains forward-looking statements regarding future expectations, financial condition, clinical trial timelines, regulatory approvals, and potential therapeutic benefits of cretostimogene, subject to inherent business risks and uncertainties [Disclaimer and Risks](index=4&type=section&id=Disclaimer%20and%20Risks) This press release contains forward-looking statements regarding future expectations, financial condition, clinical trial timelines, regulatory approvals, and potential therapeutic benefits of cretostimogene, subject to inherent business risks and uncertainties - This press release contains forward-looking statements regarding the company's cash flow, future operating results, clinical trial timelines, regulatory approvals, and cretostimogene's therapeutic benefits[10](index=10&type=chunk) - Actual results may differ from forward-looking statements due to risks such as clinical trial delays, insufficient capital resources, reliance on third parties, and unexpected side effects[11](index=11&type=chunk) - Investors are cautioned not to place undue reliance on these statements, and the company undertakes no obligation to update them[11](index=11&type=chunk) [Financial Statements](index=6&type=section&id=Financial%20Statements) In Q2 2025, the company reported zero license and collaboration revenue, significantly increased operating expenses, leading to an expanded net loss of $41.4 million [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) In Q2 2025, the company reported zero license and collaboration revenue, significantly increased operating expenses, leading to an expanded net loss of $41.4 million Condensed Consolidated Statements of Operations and Comprehensive Loss (Q2 2025 vs Q2 2024) | Metric (Thousands USD) | Q2 2025 | Q2 2024 | H1 2025 | H1 2024 | | :--- | :--- | :--- | :--- | :--- | | License and collaboration revenue | — | 111 | 52 | 640 | | Research and development expenses | 31,331 | 18,470 | 58,799 | 35,680 | | General and administrative expenses | 17,410 | 7,494 | 32,198 | 13,282 | | Total operating expenses | 48,741 | 25,964 | 90,997 | 48,962 | | Operating loss | (48,741) | (25,853) | (90,945) | (48,322) | | Interest income, net | 7,319 | 6,943 | 15,066 | 12,487 | | Net loss and comprehensive loss | (41,426) | (18,902) | (75,878) | (35,836) | | Net loss per share (basic and diluted) | (0.54) | (0.28) | (1.00) | (0.63) | | Weighted-average common shares outstanding | 76,226,829 | 66,649,443 | 76,207,333 | 56,857,104 | [Consolidated Balance Sheet Data](index=6&type=section&id=Consolidated%20Balance%20Sheet%20Data) As of June 30, 2025, the company reported $661.1 million in cash, cash equivalents, and marketable securities, total assets of $701.4 million, total liabilities of $31.1 million, and total stockholders' equity of $670.4 million Consolidated Balance Sheet Data (As of June 30, 2025 vs December 31, 2024) | Metric (Thousands USD) | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Cash, cash equivalents and marketable securities | 661,052 | 741,998 | | Total assets | 701,445 | 754,797 | | Total liabilities | 31,087 | 21,420 | | Total stockholders' equity | 670,358 | 733,377 | [Contacts](index=5&type=section&id=Contacts) Contact information for CG Oncology's media and investor relations is provided [Media and Investor Relations](index=5&type=section&id=Media%20and%20Investor%20Relations) Contact information for CG Oncology's media and investor relations is provided - Media Contact: Sarah Connors, Vice President, Communications & Patient Advocacy[12](index=12&type=chunk) - Investor Relations Contact: Megan Knight, Vice President, Investor Relations[12](index=12&type=chunk)

Core Insights - CG Oncology, Inc. reported positive results from the Phase 3 BOND-003 trial, highlighting the durability and tolerability of cretostimogene for bladder cancer treatment [2][6] - The company plans to submit a Biologics License Application (BLA) for cretostimogene in Q4 2025, targeting high-risk non-muscle invasive bladder cancer (NMIBC) patients unresponsive to BCG [2][11] - A recent legal victory against ANI Pharmaceuticals allows CG Oncology to focus resources on developing cretostimogene without future royalty obligations [2][5] Financial Highlights - For Q2 2025, CG Oncology reported a net loss of $41.4 million, or $0.54 per share, compared to a net loss of $18.9 million, or $0.28 per share in Q2 2024 [11][14] - Research and development expenses increased to $31.3 million in Q2 2025 from $18.5 million in Q2 2024, primarily due to higher clinical trial costs and increased headcount [11][14] - General and administrative expenses rose to $17.4 million in Q2 2025 from $7.5 million in Q2 2024, attributed to personnel-related costs and legal expenses [11][14] Cash Position - As of June 30, 2025, CG Oncology had cash and cash equivalents of $661.1 million, down from $688.4 million as of March 31, 2025 [11][16] - The company expects its current cash position to fund operations into the first half of 2028 [11] Clinical Development Updates - The company presented best-in-disease durability data from the BOND-003 trial, showing a 75.5% complete response rate at any time and a median duration of response of 28 months [6] - The CORE-008 trial was initiated to evaluate the combination of cretostimogene and gemcitabine in high-risk BCG-exposed NMIBC patients [5][6] - Anticipated milestones include the completion of Phase 3 enrollment for PIVOT-006 in Q3 2025 and topline data from various trials expected in Q4 2025 and 1H 2026 [4][11]

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].

Cretostimogene Clinical Development and Efficacy - CG Oncology's clinical development strategy targets approximately 70% of the Non-Muscle Invasive Bladder Cancer (NMIBC) market, representing a multi-billion dollar opportunity[10, 49] - In a Phase 3 registrational study for High-Risk BCG-unresponsive NMIBC, cretostimogene demonstrated a potential best-in-class efficacy with a 75% Complete Response (CR) rate at any time[10] - The 12-month Duration of Response (DoR) was 63.5%, and the 24-month DoR was 56.6%, with the median DoR exceeding 27 months and ongoing in the Phase 3 study[10] - In the BOND-003 Cohort C trial, 97.3% of patients were free from progression to MIBC at 12 months[23] - Cystectomy-Free Survival in BOND-003 Cohort C was 90% at 12 months[23] - In BOND-003 Cohort C, 50% of patients reinduced with oncolytic immunotherapy converted to CR, and 64.3% remained in durable response after conversion[28] Safety and Tolerability - Cretostimogene has a favorable safety profile with 0% Grade 3 or higher treatment-related adverse events observed in clinical trials[10, 30] - In the cretostimogene arm, 64.3% of patients experienced any grade of Treatment-Related Adverse Events (TRAEs)[31] Financial and Strategic Outlook - CG Oncology has a strong balance sheet with a cash runway expected into the first half of 2028 to drive commercialization and indication expansion[10] Market and Treatment Landscape - Physicians in top key accounts treat more than 70% of NMIBC patients by volume[46]

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]

I have my PhD in biochemistry and have worked for years analyzing clinical trials and biotech companies. It is my passion to educate everyone possible on the science behind the businesses that we invest in, and it's my mission to help you do your due diligence and not get burned by the pitfalls of investing in this space. Analyst's Disclosure:I/we have no stock, option or similar derivative position in any of the companies mentioned, and no plans to initiate any such positions within the next 72 hours. I wr ...

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]