PART I. FINANCIAL INFORMATION [Condensed Consolidated Financial Statements (unaudited)](index=3&type=section&id=Item%201.%20Condensed%20Consolidated%20Financial%20Statements%20(unaudited)) The company reported a $34.5 million net loss in Q1 2025, holding $688.4 million in cash and marketable securities [Condensed Consolidated Balance Sheets](index=3&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Total assets decreased to $728.2 million, with liabilities at $23.4 million and equity at $704.8 million Condensed Consolidated Balance Sheet Data (in thousands) | Account | March 31, 2025 (unaudited) | December 31, 2024 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $41,472 | $257,068 | | Marketable securities | $646,962 | $484,930 | | Total current assets | $701,192 | $754,210 | | Total assets | $728,181 | $754,797 | | **Liabilities & Stockholders' Equity** | | | | Total current liabilities | $22,642 | $21,368 | | Total liabilities | $23,423 | $21,420 | | Accumulated deficit | $(252,433) | $(217,981) | | Total stockholders' equity | $704,758 | $733,377 | | Total liabilities and stockholders' equity | $728,181 | $754,797 | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=4&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) Net loss increased to $34.5 million in Q1 2025, driven by higher R&D and G&A expenses, while revenue declined Condensed Consolidated Statements of Operations (in thousands) | Metric | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | License and collaboration revenue | $52 | $529 | | Research and development | $27,467 | $17,210 | | General and administrative | $14,789 | $5,788 | | Total operating expenses | $42,256 | $22,998 | | Loss from operations | $(42,204) | $(22,469) | | Interest income, net | $7,747 | $5,544 | | **Net loss and comprehensive loss** | **$(34,452)** | **$(16,934)** | | Net loss per share, basic and diluted | $(0.45) | $(0.36) | [Condensed Consolidated Statements of Cash Flows](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash used in operations was $29.3 million, with a $215.6 million overall decrease in cash and equivalents Summary of Cash Flows (in thousands) | Activity | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | $(29,277) | $(26,012) | | Net cash used in investing activities | $(186,769) | $(307,444) | | Net cash provided by financing activities | $450 | $402,658 | | **Net (decrease) increase in cash and cash equivalents** | **$(215,596)** | **$69,202** | | Cash and cash equivalents at end of period | $41,472 | $77,468 | [Notes to Condensed Consolidated Financial Statements](index=7&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) Notes detail the company's clinical-stage focus, 2024 IPO, collaboration agreements, and ongoing legal dispute - The company is a late-stage clinical biopharmaceutical company focused on developing and commercializing its product candidate, cretostimogene grenadenorepvec, for patients with bladder cancer[23](index=23&type=chunk) - In January 2024, the company completed its **IPO**, receiving **net proceeds of $399.6 million**[25](index=25&type=chunk) - A complaint was filed against the company by **ANI Pharmaceuticals, Inc.** on March 4, 2024, seeking a declaratory judgment regarding **royalty obligations** on 'net sales' of cretostimogene[48](index=48&type=chunk) - Total **stock-based compensation expense** was **$5.2 million** and **$1.5 million** for the three months ended March 31, 2025 and 2024, respectively[82](index=82&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=20&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses cretostimogene development, BLA submission, increased operating losses, and liquidity funding operations into 2028 - The company is a late-stage clinical biopharmaceutical company focused on developing cretostimogene for bladder cancer, with plans to initiate a **BLA submission** to the FDA in the second half of 2025[94](index=94&type=chunk)[95](index=95&type=chunk) - The company expects its existing cash, cash equivalents, and marketable securities of **$688.4 million** (as of March 31, 2025) to be **sufficient to fund operations into the first half of 2028**[99](index=99&type=chunk)[100](index=100&type=chunk)[127](index=127&type=chunk) - On March 28, 2025, the company entered into an **ATM offering agreement** with Jefferies LLC to sell up to **$250 million** of its common stock, though no sales have been made as of the report date[32](index=32&type=chunk)[125](index=125&type=chunk) [Results of Operations](index=27&type=section&id=Results%20of%20Operations) Net loss increased to $34.5 million in Q1 2025, driven by higher R&D and G&A expenses from clinical activities and headcount Comparison of Results of Operations (in thousands) | Item | Q1 2025 | Q1 2024 | Change | | :--- | :--- | :--- | :--- | | License and collaboration revenue | $52 | $529 | $(477) | | Research and development | $27,467 | $17,210 | $10,257 | | General and administrative | $14,789 | $5,788 | $9,001 | | **Net loss** | **$(34,452)** | **$(16,934)** | **$(17,518)** | - The **$10.3 million** increase in R&D expenses was primarily due to a **$5.6 million** increase in external clinical trial expenses (higher CRO fees) and a **$3.6 million** increase in compensation costs from increased headcount[121](index=121&type=chunk) - The **$9.0 million** increase in G&A expenses was mainly due to a **$5.3 million** increase in compensation costs (including a **$2.5 million** in **stock-based compensation**), a **$1.4 million** increase in professional fees, and a **$1.1 million** increase in marketing costs[122](index=122&type=chunk) [Liquidity and Capital Resources](index=28&type=section&id=Liquidity%20and%20Capital%20Resources) Liquidity from public offerings, with $688.4 million in cash and marketable securities, expected to fund operations into 2028 - As of March 31, 2025, the company had cash, cash equivalents, and marketable securities of **$688.4 million**[124](index=124&type=chunk) - **Net cash used in operating activities was $29.3 million** in Q1 2025, primarily resulting from the **net loss of $34.5 million**, offset by non-cash charges like **stock-based compensation**[132](index=132&type=chunk) - **Net cash provided by financing activities in Q1 2024 was $402.7 million**, mainly from the **IPO**, compared to **just $0.5 million** in Q1 2025 from **option exercises**[136](index=136&type=chunk)[137](index=137&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=36&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) Market risk is limited to interest rate sensitivity on $688.4 million in cash and investments, deemed insignificant due to portfolio profile - The company's **primary market risk is interest rate sensitivity** on its **$688.4 million** in cash, cash equivalents, and marketable securities[145](index=145&type=chunk) - Due to the short-term duration and low-risk profile of the investment portfolio, the company believes its **exposure to interest rate risk** is **not significant**[146](index=146&type=chunk) [Controls and Procedures](index=36&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded disclosure controls and procedures were effective as of March 31, 2025, with no material changes in internal controls - Management concluded that as of March 31, 2025, the company's **disclosure controls and procedures** were **effective** at the reasonable assurance level[149](index=149&type=chunk) - There were **no material changes** in the company's **internal control over financial reporting** during the three months ended March 31, 2025[150](index=150&type=chunk) PART II. OTHER INFORMATION [Legal Proceedings](index=37&type=section&id=Item%201.%20Legal%20Proceedings) The company is defending a legal proceeding by ANI Pharmaceuticals regarding cretostimogene royalty obligations, with a trial set for July 2025 - On March 4, 2024, **ANI Pharmaceuticals, Inc.** filed a complaint against the company seeking a declaratory judgment for **royalty payments** on 'net sales' of cretostimogene[153](index=153&type=chunk) - The company disputes the allegations and is **vigorously defending the matter**. A **trial date has been set for July 21, 2025**[153](index=153&type=chunk) [Risk Factors](index=37&type=section&id=Item%201A.%20Risk%20Factors) No material changes have occurred to the risk factors previously disclosed in the company's 2024 Annual Report on Form 10-K - There have been **no material changes** to the **risk factors** disclosed in the company's 2024 Annual Report[155](index=155&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=38&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) No unregistered equity sales; $156.0 million of IPO proceeds used for R&D, manufacturing, and pre-commercial activities for cretostimogene - The company's **IPO** in January 2024 resulted in **net proceeds of approximately $399.6 million**[158](index=158&type=chunk) - Approximately **$156.0 million** of the **IPO proceeds** have been used for **R&D, manufacturing, and pre-commercial activities** for cretostimogene[158](index=158&type=chunk) [Other Information](index=38&type=section&id=Item%205.%20Other%20Information) No Section 16 officers or directors adopted, modified, or terminated Rule 10b5-1 trading arrangements during Q1 2025 - During Q1 2025, no officers or directors adopted, modified, or terminated any **Rule 10b5-1** or similar trading arrangements[161](index=161&type=chunk) [Exhibits](index=39&type=section&id=Item%206.%20Exhibits) This section lists exhibits filed with Form 10-Q, including corporate documents, a promissory note, and CEO/CFO certifications

Financial Performance - Cash and cash equivalents and marketable securities as of March 31, 2025, were $688.4 million, down from $742.0 million as of December 31, 2024[8]. - Research and Development (R&D) expenses for Q1 2025 were $27.5 million, an increase of 60.6% compared to $17.2 million in Q1 2024[8]. - General and Administrative (G&A) expenses for Q1 2025 were $14.8 million, up from $5.8 million in Q1 2024, reflecting a 155.2% increase[8]. - Net loss for Q1 2025 was $34.5 million, or ($0.45) per share, compared to a net loss of $16.9 million, or ($0.36) per share, in Q1 2024[8]. - The company expects its existing cash and marketable securities to fund operations into the first half of 2028[8]. Clinical Trials and Research - The Phase 3 BOND-003 trial showed a 75.5% complete response rate at any time, with a 42.3% complete response rate at 24 months by Kaplan-Meier estimation[5]. - Cohort P demonstrated a promising 90.5% high-grade recurrence-free survival at 3 and 9 months in patients with BCG-unresponsive Ta/T1 disease[5]. - The CORE-008 Cohort CX trial has been initiated to evaluate the combination of cretostimogene and gemcitabine in high-risk BCG-exposed NMIBC patients[5]. Future Plans and Market Potential - The company expects to initiate its Biologics License Application (BLA) submission for cretostimogene in the second half of 2025[2]. - The company anticipates that cretostimogene could address over 70% of the market opportunity for innovative therapies in NMIBC[2].

Core Insights - CG Oncology is advancing cretostimogene as a potential backbone therapy for non-muscle invasive bladder cancer (NMIBC), with plans to submit a Biologics License Application (BLA) in the second half of 2025 [2][4] - The company reported a net loss of $34.5 million for Q1 2025, an increase from $16.9 million in Q1 2024, primarily due to rising research and development expenses [11][15] - Cash and cash equivalents as of March 31, 2025, were $688.4 million, down from $742.0 million at the end of 2024, with sufficient funds projected to last into the first half of 2028 [5] Clinical Development Updates - The BOND-003 trial showed a 24-month complete response rate of 42.3% for Cohort C, with a 75.5% complete response at any time [6][7] - Cohort P demonstrated a promising 90.5% high-grade recurrence-free survival at 3 and 9 months [6][7] - The CORE-008 trial has been initiated to evaluate the combination of cretostimogene and gemcitabine in high-risk BCG-exposed NMIBC patients [6][7] Financial Performance - Research and development expenses for Q1 2025 were $27.5 million, up from $17.2 million in Q1 2024, driven by increased clinical trial costs and headcount [11] - General and administrative expenses rose to $14.8 million in Q1 2025 from $5.8 million in Q1 2024, attributed to higher personnel-related costs and professional fees [11] - License and collaboration revenue decreased to $52,000 in Q1 2025 from $529,000 in Q1 2024 [15] Future Milestones - The company anticipates completing enrollment for the Phase 3 PIVOT-006 trial in the second half of 2025 [6][4] - The initiation of the BLA submission for cretostimogene monotherapy in HR BCG-unresponsive NMIBC is expected [6][7] - Topline data from ongoing clinical trials, including CORE-008 and BOND-003, are anticipated in the near future [6][7]

Company Overview - CG Oncology, Inc. (CGON) is expected to report flat earnings compared to the previous year, with a projected quarterly loss of $0.36 per share, indicating no change from the year-ago quarter [3][10] - Revenues are anticipated to be $0.6 million, reflecting a 13.2% increase from the same quarter last year [3] Earnings Expectations - The consensus EPS estimate has remained unchanged over the last 30 days, indicating a stable outlook from covering analysts [4] - The Zacks Earnings ESP for CG Oncology is -21.30%, suggesting a bearish sentiment among analysts regarding the company's earnings prospects [10][11] Historical Performance - In the last reported quarter, CG Oncology was expected to post a loss of $0.41 per share but actually reported a loss of $0.48, resulting in a surprise of -17.07% [12] - Over the past four quarters, the company has beaten consensus EPS estimates two times [13] Comparison with Industry Peers - Stoke Therapeutics, Inc. (STOK), another player in the Zacks Medical - Biomedical and Genetics industry, is expected to post a loss of $0.37 per share, which represents a year-over-year change of +35.1% [17] - Stoke Therapeutics has an Earnings ESP of 32.43% and a Zacks Rank of 2 (Buy), indicating a higher likelihood of beating the consensus EPS estimate [18]

Group 1: Fellowship Announcement - The Society of Urologic Oncology Clinical Trials Consortium (SUO-CTC) and CG Oncology announced the recipients of the first annual CG-SUO-CTC NMIBC Research Fellowship aimed at supporting clinical cancer research in Non-Muscle Invasive Bladder Cancer (NMIBC) [1] - The fellowship recipients, Drs. Saum Ghodoussipour and Taylor Goodstein, were recognized for their innovative research plans that have the potential to advance urology research [1] Group 2: Bladder Cancer Statistics - In 2025, it is estimated that over 84,000 individuals will be diagnosed with bladder cancer, with NMIBC accounting for approximately 75% of these cases [2] - Bladder cancer ranks as the sixth most common cancer in the United States, with men representing three-quarters of newly diagnosed cases [2] Group 3: About SUO-CTC - SUO-CTC is a clinical research network comprising over 600 members from more than 300 clinical sites across the U.S. and Canada, dedicated to advancing urology research [3] - The organization operates as a registered 501c3 not-for-profit corporation and collaborates with the Society of Urologic Oncology (SUO) [3] Group 4: About CG Oncology - CG Oncology is a late-stage clinical biopharmaceutical company focused on developing and commercializing bladder-sparing therapies for bladder cancer patients [4] - The company aims to enhance the quality of life for urologic cancer patients through innovative immunotherapies [4] Group 5: Research Focus of Fellowship Recipients - Dr. Saum Ghodoussipour's research focuses on dynamic intra-tumor heterogeneity in NMIBC [5] - Dr. Taylor Goodstein's research involves spatial transcriptomic profiling of the tumor microenvironment in BCG-unresponsive NMIBC patients treated with novel intravesical gene therapies [5]

Company Overview - CG Oncology, Inc. (CGON) shares experienced a significant increase of 25% to $27.97, following a period of 15.3% loss over the previous four weeks, indicating a strong market reaction to recent developments [1][2]. Clinical Data and Performance - The surge in CG Oncology's stock price was driven by the announcement of promising phase III data for its bladder cancer treatment, cretostimogene grenadenorepvec, presented at the American Urological Association meeting [2]. - In the BOND-003 Cohort C study, 50.7% of high-risk, BCG-unresponsive patients maintained complete responses at 12 months, and 42.3% at 24 months, showcasing the treatment's durability [2]. - Additionally, 97.3% of all treated patients were free from progression to muscle-invasive disease, and 91.6% of responders remained cystectomy-free at 24 months, with no serious treatment-related adverse events reported [2]. - Early results from Cohort P indicated a high-grade recurrence-free survival rate of 90.5% at both 3 and 9 months, further supporting the treatment's efficacy and safety [2]. Financial Expectations - The company is projected to report a quarterly loss of $0.36 per share, with revenues expected to reach $0.6 million, reflecting a 13.2% increase from the previous year [3]. - However, the consensus EPS estimate has been revised 17.2% lower over the last 30 days, which typically does not correlate with price appreciation [4]. Industry Context - CG Oncology operates within the Zacks Medical - Biomedical and Genetics industry, where another company, uniQure (QURE), has also shown a recent decline of 1.5% in its stock price [4]. - uniQure's consensus EPS estimate remains unchanged at -$1.07, representing a 21.3% increase compared to the previous year [5].

Core Insights - CG Oncology, Inc. announced positive results from the Phase 3 BOND-003 study of cretostimogene grenadenorepvec for high-risk non-muscle invasive bladder cancer (NMIBC) unresponsive to BCG treatment, presented at the 2025 American Urological Association Annual Meeting [1] Study Results - The study reported a 75.5% complete response (CR) rate at any time, with 34 confirmed CRs at 24 months and nine patients pending assessment as of March 14, 2025 [2] - The 12-month and 24-month CR rates were estimated at 50.7% and 42.3%, respectively, with a median duration of response (DOR) of 28 months [3] - 97.3% of patients were free from progression to muscle-invasive disease at 24 months [3] - In Cohort P, patients with BCG-unresponsive Ta/T1 disease without CIS showed an estimated 90.5% high-grade recurrence-free survival at 3 and 9 months [3] Safety Profile - A well-tolerated safety profile was observed, with no Grade 3 or greater treatment-related adverse events (TRAEs) or deaths reported among 110 highly pretreated patients [4] - Patients who experienced TRAEs had a median resolution time of one day, and 97.3% completed all expected treatments, indicating favorable adherence [4][5] Market Reaction - Following the announcement, CGON stock increased by 39.9%, reaching $31.30 [6]

Summary of CG Oncology (CGON) Conference Call - April 28, 2025 Company Overview - **Company**: CG Oncology - **Focus**: Development of bladder-sparing therapeutics for bladder cancer, targeting over 70% of the non-muscle invasive bladder cancer market in intermediate and high-risk categories [5][6] Key Points Discussed Clinical Development and Trials - **Programs**: Multiple programs in development, including: - **PIVOT006**: Phase III trial for intermediate risk non-muscle invasive bladder cancer, ahead of enrollment schedule, expected completion in H2 2025 [6][32] - **BORN-three**: Pivotal Phase III study for high-risk BCG unresponsive non-muscle invasive bladder cancer, showing a 75.5% complete response rate [9][13] - **CORE-eight**: Expanding potential applicability of creatostimogene in both naïve and exposed high-risk settings [6][32] Efficacy and Safety Data - **Efficacy**: - 75.5% complete response rate at any time, with ongoing complete responses at 12 months in 46% of patients [13] - 24-month complete response rate of 33.7%, with 97.3% free from progression to muscle invasive bladder cancer [14][15] - Median duration of response is 27.9 months, with 91% projected to remain in complete response at 24 months [16] - **Safety**: - Zero percent grade three or greater treatment-related adverse events, with a median time to resolution of one day [22] - High patient adherence with 97.3% completing all protocol-defined treatments [23] Competitive Landscape - **Positioning**: Creatostimogene is positioned as a backbone therapy in non-muscle invasive bladder cancer with best-in-class durability and safety [24] - **Comparative Data**: - Creatostimogene shows superior complete response rates compared to pembrolizumab (9%), nadoliterine (19%), and ANCTIVA (16%) at 24 months [14][24] Commercial Strategy - **BLA Submission**: Planned initiation in H2 2025, with breakthrough therapy designation allowing for rolling submission [39][40] - **Prelaunch Activities**: Ongoing engagement with future commercial customers and scientific exchange around clinical data [41][42] Combination Therapies - **Gemcitabine**: Selected as a combination partner for its potential to enhance efficacy and maintain a good safety profile [45] - **CORE-eight Study**: Evaluating the combination of creatostimogene and gemcitabine in high-risk BCG exposed non-muscle invasive bladder cancer [35] Future Outlook - **Expansion Potential**: Plans to expand into frontline settings for both intermediate and high-risk disease [36] - **Cash Position**: Strong balance sheet with a cash runway expected into the first half of 2028 [37] Additional Insights - **Patient Demographics**: Majority of patients in BORN-three were elderly, white, and male, with a high proportion of comorbidities [11][12] - **Regulatory Interactions**: Stable interactions with the FDA, with ongoing communication regarding the review process [62][63] - **Delivery Mechanism**: Creatostimogene can be administered by various healthcare professionals without the need for a urologist, fitting into existing workflows [25][66] This summary encapsulates the critical aspects of CG Oncology's conference call, highlighting the company's strategic direction, clinical advancements, and market positioning in the bladder cancer therapeutic landscape.

Core Insights - CG Oncology presented promising data on cretostimogene grenadenorepvec monotherapy for high-risk non-muscle invasive bladder cancer (NMIBC) at the 2025 AUA Annual Meeting, indicating its potential as a backbone therapy for bladder cancer treatment [2][6] Efficacy Data - The Phase 3 BOND-003 Cohort C study reported a robust 24-month complete response (CR) rate of 42.3% by Kaplan-Meier (K-M) estimation, with 75.5% achieving CR at any time [1][3] - 58.3% of patients demonstrated durable complete responses at 24 months, and 97.3% remained free from progression to muscle-invasive bladder cancer (MIBC) [1][3] - The median duration of response (DOR) was 28 months, with no Grade 3 or greater treatment-related adverse events reported [1][5] Safety Profile - The treatment was well-tolerated, with 97.3% of patients completing all expected treatments and a median resolution time of one day for any treatment-related adverse events [5][6] - The most common treatment-related adverse events (≥10%) included bladder spasm, pollakiuria, micturition urgency, dysuria, and hematuria [5] Study Population - The BOND-003 Cohort C study included 110 highly pretreated patients, with a median of 12 prior Bacillus Calmette Guerin (BCG) doses, some patients having received as many as 66 doses [5][6] - Cohort P data indicated a high-grade recurrence-free survival rate of 90.5% at 3 and 9 months in patients with BCG-unresponsive Ta/T1 disease [4][5] Future Outlook - CG Oncology is actively investigating the potential of cretostimogene in addressing unmet needs in bladder cancer treatment, with ongoing studies and an Expanded Access Program initiated for eligible patients [6][8]

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 [6] - The company aims to enhance the quality of life for urologic cancer patients through innovative immunotherapies [6] Clinical Trials and Developments - CG Oncology will host a conference call on April 28, 2025, to discuss results from the Phase 3 BOND-003 trial of cretostimogene monotherapy for high-risk BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) [1] - Cretostimogene is an investigational oncolytic immunotherapy being evaluated in the BOND-003 trial and is also part of another Phase 3 trial (PIVOT-006) for intermediate-risk NMIBC [4][5] - The safety and efficacy of cretostimogene have not yet been established by the FDA or any other health authority [5] Bladder Cancer Statistics - An estimated 85,000 people are expected to be diagnosed with bladder cancer in 2025, with NMIBC representing approximately 75% of newly diagnosed cases [3] - Bladder cancer is the sixth most common cancer in the United States, with men accounting for three-quarters of new diagnoses [3]