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

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2025 Commission File Number: 001-41925 CG Oncology, Inc. (Exact Name of Registrant as Specified in its Charter) Delaware 37-1611499 (State or other jurisdiction of incorporation or organization) (I.R.S. Employer Identification No.) OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF ...

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].

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

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]

CG Oncology (CGON) Update / Briefing April 28, 2025 08:00 AM ET Speaker0 Good morning, everyone, and thank you for standing by. Welcome to the CT Oncology Sponsor General Conference Call. At this time, all participants are in a listen only mode. Following management's prepared remarks, we will hold a Q and A session. As a reminder, this call is being recorded. Today is Monday, 04/28/2025. I would now like to turn the conference over to Sarah Connors, vice president of communication and patient advocacy at C ...

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]

Group 1 - CG Oncology, Inc. (NASDAQ: CGON) was previously noted for having promising data but was considered expensive [1] - The stock has decreased by 41% since the last analysis, prompting a reevaluation of the company's prospects [1]