Core Insights - Biotech stocks are primarily driven by data, but share prices do not always reflect the underlying value indicated by that data [1] Company Analysis - CG Oncology, Inc. (CGON) has experienced data releases that suggest a discrepancy between its stock price and the value implied by its data [1]

Two applicants will each receive a Grant of $50,000 to support the development of outstanding clinical cancer research to improve the treatment of NMIBCApplications for the fellowship are due on February 27, 2026 SCHAUMBURG, Ill. and IRVINE, Calif., Dec. 18, 2025 (GLOBE NEWSWIRE) -- The Society of Urologic Oncology Clinical Trials Consortium (SUO-CTC), a national alliance of leading academic and community based uro-oncologists, and CG Oncology, Inc. (NASDAQ: CGON), a late-stage clinical biopharmaceutical co ...

Core Insights - CG Oncology, Inc. announced promising topline data from BOND-003 Cohort P and CORE-008 Cohort A, indicating efficacy, safety, and tolerability of cretostimogene for bladder cancer treatment [1][2][3] BOND-003 Cohort P Results - The BOND-003 trial demonstrated High-Grade Event-Free Survival (HG-EFS) rates of 95.7% at 3 months, 84.6% at 6 months, and 80.4% at 9 months among 51 evaluable patients [4][9] - No Grade 3 or greater treatment-related adverse events (TRAEs) were reported, and no patients progressed to muscle-invasive bladder cancer (MIBC) [5][9] - The study included 56 patients across 35 clinical sites in the U.S. and Japan [6] CORE-008 Cohort A Results - CORE-008 Cohort A showed an overall Complete Response (CR) rate of 83.7% in evaluable patients, with an 88.0% CR rate for optimized administration compared to 79.2% for original administration [7][10] - The safety profile was consistent with previous trials, with no serious adverse events or treatment-related discontinuations reported [8][10] Cretostimogene Overview - Cretostimogene is an investigational oncolytic immunotherapy for Non-Muscle Invasive Bladder Cancer (NMIBC), with over 400 patients involved in its clinical development [11] - The company is conducting two Phase 3 trials: BOND-003 for high-risk BCG-unresponsive NMIBC and PIVOT-006 for intermediate-risk NMIBC [11] Company Background - CG Oncology focuses on developing and commercializing bladder-sparing therapies for bladder cancer patients, aiming to improve their quality of life [12]

Core Insights - CG Oncology has appointed Christina Rossi, an experienced life sciences executive, to its Board of Directors, while Simone Song has resigned from the Board [1][2] - The company is at a pivotal moment with the initiation of the Biologics License Application (BLA) for cretostimogene, aiming for a successful launch upon FDA approval [2] - Cretostimogene is an investigational oncolytic immunotherapy being studied in over 400 patients with Non-Muscle Invasive Bladder Cancer (NMIBC) through multiple clinical trials [4] Company Overview - CG Oncology is a late-stage clinical biopharmaceutical company focused on developing a bladder-sparing therapeutic for bladder cancer patients [5] - The company aims to enhance the quality of life for urologic cancer patients through innovative immunotherapies [5] Executive Background - Christina Rossi has over 25 years of experience in the pharmaceutical and biotechnology sectors, previously serving as COO of Blueprint Medicines and holding various leadership roles at Sanofi Genzyme and Biogen [3] - Rossi's expertise includes overseeing commercial launches and optimizing operations to improve patient access to therapies [3]

Core Insights - CG Oncology is presenting new data on cretostimogene, an investigational therapy for non-muscle invasive bladder cancer (NMIBC), at the Society of Urologic Oncology (SUO) 26th Annual Meeting [1][2] - The presentations include topline results from BOND-003 Cohort P and CORE-008 Cohort A, reinforcing cretostimogene's potential as a backbone immunotherapy for NMIBC patients [2][5] Late-Breaking Podium Presentations - BOND-003 Cohort P focuses on high-risk, papillary-only, BCG-unresponsive NMIBC, with results presented by Dr. Mark D. Tyson on December 5, 2025 [3] - CORE-008 Cohort A evaluates high-risk BCG-naïve NMIBC, with initial results presented by Dr. Trinity J. Bivalacqua on December 5, 2025 [4] Posters - A poster on durable 24-month outcomes from BOND-003 Cohort C will be presented by Dr. Mark D. Tyson on December 3, 2025 [4] - Another poster on CORE-008 Cohort B, assessing intravesical cretostimogene in BCG-exposed NMIBC patients, will also be presented by Dr. Trinity J. Bivalacqua on December 3, 2025 [4] - A poster discussing a patient-centric expanded access program for cretostimogene will be presented by Dr. Sarah P. Psutka on December 4, 2025 [4] About Cretostimogene Grenadenorepvec - Cretostimogene is an investigational oncolytic immunotherapy delivered intravesically, with over 400 patients studied in its clinical development program [5] - The program includes two Phase 3 trials: BOND-003 for high-risk BCG-unresponsive NMIBC and PIVOT-006 for intermediate-risk NMIBC, along with a Phase 2 trial, CORE-008 [5] About CG Oncology - CG Oncology is a late-stage clinical biopharmaceutical company focused on developing therapies for bladder cancer, aiming to improve the quality of life for patients [6]

Clinical Trial Results - Cretostimogene achieved a 24-month complete response rate of 41.8% in high-risk Non-Muscle Invasive Bladder Cancer patients, with 46 confirmed complete responses out of 110 patients [112]. - The trial reported a 75.5% complete response rate at any time, with a median duration of response of 28 months [113]. - 96.6% of patients were free from progression to muscle invasive disease at 24 months, with no Grade 3 or greater treatment-related adverse events reported [113]. - The company initiated a BLA submission for cretostimogene in the fourth quarter of 2025, having received Fast Track and Breakthrough Therapy designations from the FDA [113]. Financial Performance - The company incurred net losses of $119.7 million for the nine months ended September 30, 2025, compared to $56.2 million for the same period in 2024 [116]. - Total revenues for the nine months ended September 30, 2025, were $1.7 million, up from $683,000 in the same period in 2024, reflecting a $1.0 million increase [146]. - Commercial and development revenue for Q3 2025 was $1.5 million, a significant increase from zero in Q3 2024, attributed to the Conversion Event in July 2025 [140]. - License and collaboration revenue recognized from agreements totaled $26.3 million since inception, with no revenue expected from cretostimogene product sales in the foreseeable future [125]. Expenses and Operating Costs - Research and development expenses for Q3 2025 were $27.9 million, an increase of $8.3 million from $19.6 million in Q3 2024, driven by higher external clinical trial costs and increased personnel-related expenses [143]. - General and administrative expenses for Q3 2025 reached $23.3 million, up $14.6 million from $8.7 million in Q3 2024, primarily due to increased professional fees and compensation costs [144]. - Total operating costs and expenses for Q3 2025 were $52.8 million, compared to $28.3 million in Q3 2024, marking a $24.5 million increase [139]. - Total research and development expenses increased to $86.7 million for the nine months ended September 30, 2025, compared to $55.3 million in 2024, marking a $31.4 million increase [151]. - General and administrative expenses rose to $55.5 million for the nine months ended September 30, 2025, up from $22.0 million in 2024, reflecting a $33.5 million increase [152]. Cash and Funding - Cash, cash equivalents, and marketable securities totaled $680.3 million as of September 30, 2025, expected to fund operations into the first half of 2028 [117][119]. - Net cash used in operating activities was $96.1 million for the nine months ended September 30, 2025, compared to $58.1 million in 2024 [161]. - Net cash provided by financing activities was $54.5 million for the nine months ended September 30, 2025, compared to $404.9 million in 2024 [166]. - The company expects existing cash resources to fund operations into the first half of 2028, based on current operating plans [157]. Investment and Financial Management - The primary objective of the company's investment activities is to preserve capital while maximizing income from investments without assuming significant risk [176]. - The company seeks to limit its exposure to interest rate risk due to the short-term duration and low risk profile of its investment portfolio [176]. - Inflation has not had a material effect on the company's business, financial condition, or results of operations for the periods covered by the Quarterly Report [177]. - The company does not currently have any off-balance sheet arrangements as defined by SEC regulations [173]. Other Financial Information - The company had an accumulated deficit of $337.7 million as of September 30, 2025, primarily due to research and development costs [116]. - Other income, net, increased to $22.4 million for the nine months ended September 30, 2025, compared to $20.4 million in 2024 [153]. - Recently issued accounting standards that may impact the company's financial position and results of operations are detailed in Note 2 of the Quarterly Report [174]. - There have been no material differences between the company's estimates of expenses and the amounts actually incurred to date [172]. - The company estimates the timing and level of effort for services performed, adjusting accruals or prepaid expenses as necessary [171].

分组1 - CG Oncology, Inc. reported a quarterly loss of $0.57 per share, consistent with the Zacks Consensus Estimate, compared to a loss of $0.30 per share a year ago [1] - The company posted revenues of $1.67 million for the quarter ended September 2025, exceeding the Zacks Consensus Estimate by 412.62%, and up from $0.04 million year-over-year [2] - CG Oncology's shares have increased approximately 31.7% since the beginning of the year, outperforming the S&P 500's gain of 14.6% [3] 分组2 - The company's earnings outlook is crucial for investors, as it includes current consensus earnings expectations for upcoming quarters and any recent changes to these expectations [4] - The trend for estimate revisions for CG Oncology was unfavorable prior to the earnings release, resulting in a Zacks Rank 4 (Sell) for the stock, indicating expected underperformance in the near future [6] - The current consensus EPS estimate for the upcoming quarter is -$0.59 on revenues of $3.37 million, and for the current fiscal year, it is -$2.15 on revenues of $2.74 million [7] 分组3 - The Medical - Biomedical and Genetics industry, to which CG Oncology belongs, is currently ranked in the top 36% of over 250 Zacks industries, suggesting a favorable outlook compared to lower-ranked industries [8]

Clinical Development - CG Oncology initiated a rolling Biologics License Application (BLA) submission for cretostimogene monotherapy in high-risk BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with complete submission expected in 2026[4] - The 24-month complete response (CR) rate for cretostimogene monotherapy in patients with HR NMIBC was 41.8%, with 90% of 12-month responders remaining disease-free at 24 months[6] - Enrollment for the PIVOT-006 clinical trial was completed approximately 10 months ahead of schedule, highlighting significant interest in cretostimogene[6] - The company expects to present additional data from BOND-003 Cohort P and CORE-008 Cohort A before year-end 2025[5] Financial Performance - Cash and cash equivalents as of September 30, 2025, were $680.3 million, sufficient to fund operations into the first half of 2028[8] - Research and Development (R&D) expenses for Q3 2025 were $27.9 million, an increase from $19.6 million in Q3 2024[8] - General and Administrative (G&A) expenses for Q3 2025 were $23.3 million, up from $8.7 million in Q3 2024, primarily due to increased legal and personnel-related expenses[8] - The net loss for Q3 2025 was $43.8 million, or ($0.57) per share, compared to a net loss of $20.4 million, or ($0.30) per share, in Q3 2024[8] - Total revenues for Q3 2025 were $1.666 million, compared to $43,000 in Q3 2024[15] - Total stockholders' equity as of September 30, 2025, was $687.6 million, down from $733.4 million as of December 31, 2024[17]

Core Insights - CG Oncology, Inc. is advancing its lead therapeutic candidate, cretostimogene, for bladder cancer, with a focus on high-risk BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) [2][6][10] - The company has initiated a rolling Biologics License Application (BLA) submission to the U.S. FDA, with complete submission expected in 2026 [6][7] - Financial results for Q3 2025 show a net loss of $43.8 million, an increase from $20.4 million in Q3 2024, attributed to rising R&D and G&A expenses [12][14] Corporate Highlights - The company reported a cash position of $680.3 million as of September 30, 2025, an increase from $661.1 million as of June 30, 2025, providing sufficient funds to support operations into the first half of 2028 [5][8] - Cretostimogene has received Fast Track and Breakthrough Therapy Designations, aimed at expediting its regulatory review process [7] Anticipated Upcoming Milestones - Topline data from the BOND-003 Cohort P trial is expected in Q4 2025, focusing on HR BCG-unresponsive NMIBC without CIS [7] - Initial results from the CORE-008 Cohort A trial are also anticipated in Q4 2025, targeting HR BCG-naïve NMIBC [7] Financial Highlights - Total revenues for Q3 2025 were $1.666 million, compared to $43,000 in Q3 2024, with commercial and development revenue of $1.508 million [14] - R&D expenses increased to $27.9 million in Q3 2025 from $19.6 million in Q3 2024, primarily due to higher clinical trial costs [12][14] - G&A expenses rose to $23.3 million in Q3 2025 from $8.7 million in Q3 2024, driven by increased legal and professional fees [12][14]

Group 1 - CG Oncology, Inc. (NASDAQ:CGON) is recognized as one of the best healthcare stocks with significant upside potential, receiving a Buy rating and a $90 price target from Guggenheim analyst Brad Canino [1] - The company is positioned favorably in the non-muscle invasive bladder cancer market, which is characterized by considerable pricing power and a substantial patient base, contributing to the optimistic outlook for CG Oncology [2] - CG Oncology's product, cretostimogene, is set to enter FDA review in 2026, noted for its "best-in-class" efficacy and safety durability, which are critical factors for its investment appeal [3] Group 2 - CG Oncology, Inc. is a clinical biopharmaceutical company focused on developing and commercializing bladder-sparing therapeutics specifically for bladder cancer, with cretostimogene currently in clinical development for Non-Muscle Invasive Bladder Cancer (NMIBC) [4] - The company is advancing its pipeline to establish a potential backbone therapy for NMIBC, emphasizing a strong tolerability profile and safety that could lead to durable, complete responses in bladder cancer patients [4]