Group 1 - CG Oncology Inc. has been identified as a promising stock, with Morgan Stanley raising its price target from $56 to $79 while maintaining an Overweight rating [1][3] - The company is focused on developing cretostimogene grenadenorepvec, an investigational oncolytic immunotherapy for Non-Muscle Invasive Bladder Cancer (NMIBC) [2][4] - Recent clinical trial updates show promising data from the BOND-003 Cohort C trial for high-risk NMIBC patients unresponsive to BCG treatment, and the initiation of the CORE-008 Cohort CX trial [3] Group 2 - CG Oncology's management outlook is bolstered by a strong cash position and a favorable legal outcome, expected to fund operations into the first half of 2028 [2] - Upcoming milestones include the completion of Phase 3 enrollment for the PIVOT-006 trial in Q3 and the initiation of a Biologics License Application submission for cretostimogene in Q4 [3]

Core Insights - CG Oncology, Inc. announced a robust 24-month complete response (CR) rate of 41.8% for cretostimogene monotherapy in patients with high-risk non-muscle invasive bladder cancer (NMIBC) unresponsive to Bacillus Calmette Guerin (BCG) treatment [1][2] - The study showed that 90% of 12-month responders remained disease-free at 24 months, indicating strong durability of response [2] - The safety profile of cretostimogene remains consistent, with no grade 3 or greater treatment-related adverse events (TRAEs) reported [1][3] Study Details - The Phase 3 BOND-003 Cohort C study involved 110 highly pretreated patients, making it the largest study in this patient population to date [3] - The study reported a complete response rate of 75.5% at any time and a 24-month CR rate of 41.8%, with 46 confirmed CRs as of June 23, 2025 [2][3] - The estimated duration of response (DOR) rates at 12 and 24 months were 64.1% and 58.3%, respectively, with a median DOR of 28 months [2] Patient Tolerance and Compliance - Patients tolerated cretostimogene treatment well, with a median resolution time of one day for any grade TRAEs [3] - No treatment-related discontinuation was observed, and 97.3% of patients completed all expected treatments, indicating favorable patient adherence [3] Cretostimogene Overview - Cretostimogene is an investigational, intravesically delivered oncolytic immunotherapy studied in over 400 patients with NMIBC [4] - The clinical development program includes two Phase 3 trials: BOND-003 for high-risk BCG-unresponsive NMIBC and PIVOT-006 for intermediate-risk NMIBC [4] Company Vision - CG Oncology aims to develop and commercialize innovative immunotherapies for bladder cancer patients, enhancing their quality of life [6]

Core Insights - CG Oncology has completed enrollment in its Phase 3 PIVOT-006 study, which compares adjuvant intravesical cretostimogene grenadenorepvec to surveillance in patients with intermediate-risk non-muscle invasive bladder cancer (IR NMIBC) [1][2] - The study has enrolled over 360 patients across more than 90 sites, indicating a strong interest and urgent need for new treatment options in this patient population [2][3] Company Overview - CG Oncology is a late-stage clinical biopharmaceutical company focused on developing and commercializing therapies for bladder cancer, aiming to improve the quality of life for patients [5] - The company is dedicated to addressing high unmet needs in bladder cancer treatment, particularly in intermediate-risk and high-risk NMIBC [2][4] Study Details - PIVOT-006 is a randomized, open-label trial where participants receive either cretostimogene instillations or surveillance after standard tumor removal [3] - The treatment regimen includes weekly instillations for 6 weeks, followed by weekly treatments for 3 weeks every 3 months for one year [3] Treatment Potential - Cretostimogene is an investigational oncolytic immunotherapy that selectively lyses tumor cells while activating an anti-cancer immune response, representing a novel treatment paradigm for NMIBC [2][4] - The investigational therapy has been studied in over 400 patients and is part of a broader clinical development program that includes trials for both high-risk and intermediate-risk NMIBC [4]

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].

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].

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]

Core Insights - Pelareorep shows significant clinical benefits in treating anal and pancreatic cancers, with ongoing studies demonstrating its versatility and potential to improve patient outcomes [2][9][20] - The company has entered a US$20 million share purchase agreement to support its clinical development efforts, providing a flexible funding source [6] - Financial results for Q1 2025 indicate a net loss of CAD 6.7 million, a slight improvement from CAD 6.9 million in Q1 2024, with cash and cash equivalents reported at CAD 15.3 million [10][15] Clinical Developments - Pelareorep has demonstrated promising results in multiple studies, including randomized Phase 2 studies in breast cancer and ongoing studies in pancreatic cancer and anal cancer [2][18] - The GOBLET study's interim results show an objective response rate of 33% in patients with unresectable squamous cell anal carcinoma, with some patients achieving a complete response lasting over 15 months [9] - Upcoming presentations at the ASCO Annual Meeting will highlight pelareorep's role in activating anti-tumor immunity [3][4] Financial Performance - As of March 31, 2025, the company reported CAD 15.3 million in cash and cash equivalents, projecting a cash runway through key milestones into Q3 2025 [10] - Research and development expenses decreased to CAD 4.1 million in Q1 2025 from CAD 5.7 million in Q1 2024, primarily due to lower manufacturing and clinical trial costs [10][13] - The basic and diluted loss per share improved to CAD 0.08 in Q1 2025 from CAD 0.09 in Q1 2024 [10][15] Strategic Initiatives - The company is focused on optimizing the development pathway for pelareorep, emphasizing its ability to combine with existing therapies while maintaining a favorable safety profile [2][20] - Key opinion leaders have discussed the need for new treatment options and pelareorep's potential to activate the immune system against tumors [5] - The company is advancing towards registrational studies in metastatic breast cancer and pancreatic cancer, both of which have received Fast Track designation from the FDA [20]

IRVINE, Calif., May 13, 2025 (GLOBE NEWSWIRE) -- CG Oncology, Inc. (NASDAQ: CGON), a late-stage clinical biopharmaceutical company focused on developing and commercializing a potential backbone bladder- sparing therapeutic for patients with bladder cancer, today reported financial results for the first quarter ended March 31, 2025, and provided business updates. "In 2025, we made further progress advancing cretostimogene monotherapy as a bladder-sparing backbone therapy for patients with NMIBC," said Arthur ...

Core Insights - Genelux Corporation reported a productive first quarter of 2025, establishing a strong foundation for advancing its lead product, Olvi-Vec, in various cancer indications [2][3] Pipeline Highlights - The FDA provided encouraging feedback on the OnPrime Phase 3 trial for Olvi-Vec in resistant/refractory ovarian cancer, indicating potential for traditional approval if a meaningful progression-free survival advantage is demonstrated [3] - Preliminary data from the Phase 1b/2 trial of Olvi-Vec in small cell lung cancer showed a 71% disease control rate, with significant tumor reductions observed in participants [4] - Patient enrollment is increasing in the ongoing Phase 2 trial for recurrent non-small cell lung cancer, with interim results expected in the second half of 2025 [5] Business Updates - Matthew Pulisic was appointed as the new Chief Financial Officer, bringing over 19 years of experience in the biopharmaceutical industry [6] - The company completed an underwritten offering of 3,000,000 shares at $3.50 per share, raising approximately $10.5 million to strengthen its balance sheet and extend its operational runway [7] Financial Results - As of March 31, 2025, cash, cash equivalents, and short-term investments totaled $35.1 million, expected to provide runway into the third quarter of 2026 [8] - Research and development expenses increased to $4.7 million from $4.0 million year-over-year, primarily due to higher clinical trial costs [9] - General and administrative expenses decreased to $3.1 million from $4.1 million year-over-year [10] - The net loss for the first quarter of 2025 was $7.5 million, or $0.21 per share, compared to a net loss of $7.9 million, or $0.29 per share, in the same period of 2024 [11]

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]