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].

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]

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]

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]

Core Insights - CG Oncology's BOND-003 study of cretostimogene monotherapy has been selected as a late breaker for the AUA's Practice-changing, Paradigm-shifting Clinical Trials in Urology, highlighting its potential impact on bladder cancer treatment [1] - The AUA Annual Meeting will take place from April 26-29, 2025, in Las Vegas, where CG Oncology will present various updates on ongoing clinical trials related to cretostimogene [1][7] Clinical Trial Presentations - The BOND-003 Cohort C study is a Phase 3, single-arm study focusing on high-risk BCG-unresponsive non-muscle invasive bladder cancer, with a presentation scheduled for April 26, 2025 [2] - An updated analysis from the BOND-003 and CORE-001 trials will be presented, focusing on translational correlates using urinary genomic disease burden [3] - Updates to the CORE-008 trial protocol will be discussed, which evaluates intravesical cretostimogene in patients with high-risk non-muscle invasive bladder cancer [3] Additional Studies - A multi-national, single-arm study of intravesical cretostimogene for high-risk, papillary only, BCG-unresponsive non-muscle invasive bladder cancer will also be presented [4] - The PIVOT-006 study, a Phase 3 randomized trial comparing adjuvant intravesical cretostimogene versus surveillance for intermediate-risk non-muscle invasive bladder cancer, will be discussed [5] Company Overview - CG Oncology is a late-stage clinical biopharmaceutical company focused on developing and commercializing innovative therapies for bladder cancer, aiming to improve the quality of life for patients [7]

Core Insights - CG Oncology, Inc. is set to present late-breaking clinical and translational data from the BOND-003 Cohort C at the 40th Annual European Association of Urology (EAU) Congress in Madrid, Spain, from March 21-24, 2025 [1] - The presentations will focus on cretostimogene grenadenorepvec, an investigational oncolytic immunotherapy for bladder cancer patients [4][5] Presentation Details - The updated clinical results for BOND-003 Cohort C will be presented by Dr. Trinity J. Bivalacqua on March 24, 2025, from 10:45 to 12:15 CET [2] - Additional presentations will include translational correlates using urinary genomic disease burden and ongoing trials related to cretostimogene grenadenorepvec [3] Product Information - Cretostimogene grenadenorepvec is being evaluated in multiple Phase 3 clinical trials for high-risk non-muscle invasive bladder cancer (NMIBC) and intermediate-risk NMIBC [4][5] - The investigational therapy is delivered intravesically and aims to provide a bladder-sparing treatment option for patients unresponsive to Bacillus Calmette Guerin (BCG) therapy [4] Company Overview - CG Oncology is a late-stage clinical biopharmaceutical company focused on developing innovative immunotherapies for bladder cancer, aiming to enhance the quality of life for patients [6]