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 September 30, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _____________________ to _____________________ Commission File Number: 001-41925 CG Oncology, Inc. Indicate by check mark whether the registrant (1) has fil ...

CG Oncology, Inc. (CGON) came out with a quarterly loss of $0.57 per share in line with the Zacks Consensus Estimate. This compares to a loss of $0.3 per share a year ago. These figures are adjusted for non-recurring items. A quarter ago, it was expected that this company would post a loss of $0.49 per share when it actually produced a loss of $0.54, delivering a surprise of -10.2%.Over the last four quarters, the company has not been able to surpass consensus EPS estimates.CG Oncology, Inc., which belongs ...

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]

Initiated rolling Biologics License Application (BLA) submission to U.S. FDA for cretostimogene monotherapy in high-risk (HR) BCG-unresponsive non-muscle invasive bladder cancer (NMIBC)Demonstrated continued best-in-disease durability and tolerability in BOND-003 Cohort C with robust 24-month complete response (CR) rate of 41.8% observed for cretostimogene monotherapy in patients with HR NMIBC unresponsive to Bacillus Calmette Guerin (BCG)Completed enrollment of PIVOT-006, one of the largest randomized Phas ...

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]

Core Insights - CG Oncology Inc. (NASDAQ:CGON) is recognized as a promising investment opportunity, with Guggenheim analyst Brad Canino initiating coverage with a Buy rating and a price target of $90, citing the significant patient population and pricing power in the non-muscle invasive bladder cancer market [1][3] - The company is developing cretostimogene grenadenorepvec, an investigational oncolytic immunotherapy aimed at providing bladder-sparing treatment for non-muscle invasive bladder cancer (NMIBC) [2][4] - CG Oncology has initiated the CORE-008 Cohort CX trial to evaluate the combination of cretostimogene and gemcitabine in high-risk NMIBC patients, with key upcoming milestones including the completion of Phase 3 enrollment for the PIVOT-006 trial in Q3 and the initiation of a Biologics License Application (BLA) submission for cretostimogene in Q4 [3] Company Overview - CG Oncology is a late-stage clinical biopharmaceutical company focused on developing and commercializing bladder-sparing therapeutics for bladder cancer patients [4]

Key Points - Several biotech stocks experienced notable after-hours gains on October 9, driven by new data and corporate developments [1] Company Summaries Palisade Bio Inc. (PALI) - Shares traded at $2.26 in after-hours, reflecting a 7.62% gain from the prior close of $2.10, which was up 5% on the day [1] - The company cancelled its special meeting of stockholders due to lack of quorum, withdrawing all proposals from consideration [2] Healthcare Triangle Inc. (HCTI) - Shares traded at $2.88 in after-hours, up 4.35% from the regular session close of $2.76, which was down 17.86% [3] - The company signed a non-binding Letter of Intent to acquire Teyame.AI, projected to generate $34 million in revenue for fiscal year 2025 [4] Nutriband Inc. (NTRB) - Shares traded at $8.25 in after-hours, up 4.30% from the regular session close of $7.91, which was down 6.94% [5] - The company filed a provisional patent application with the USPTO to strengthen its intellectual property for its AVERSA abuse deterrent transdermal [5] Karyopharm Therapeutics Inc. (KPTI) - Shares traded at $6.08 in after-hours, up 4.46% from the regular session close of $5.82, which had declined 1.36% [6] - The company announced financing transactions expected to provide $100 million in financial flexibility, extending its cash runway into Q2 2026 [6] Editas Medicine Inc. (EDIT) - Shares traded at $4.22 in after-hours, up 3.43% from the regular session close of $4.08, which was down 1.69% [7] - The company presented new preclinical proof-of-concept data for its therapy EDIT-401, showing a 90% LDL-C reduction in non-human primates and mice [7] CG Oncology Inc. (CGON) - Shares traded at $45.40 in after-hours, up 2.11% from the regular session close of $44.46, which gained 9.21% [8] - No official news releases or filings were issued during the day [8]

In my last coverage of CG Oncology, Inc. (NASDAQ: CGON ), I had a shift in sentiment from "Hold" to "Buy" based on key catalysts that we could look forward to in 2025. Since then, theI have my PhD in biochemistry and have worked for years analyzing clinical trials and biotech companies. It is my passion to educate everyone possible on the science behind the businesses that we invest in, and it's my mission to help you do your due diligence and not get burned by the pitfalls of investing in this space.Analys ...

Core Viewpoint - CG Oncology is a clinical-stage biotech company focused on developing treatments for non-muscle invasive bladder cancer (NMIBC), with a recent bullish research report boosting its share price significantly [1][2][3]. Company Overview - CG Oncology is currently concentrated on one type of cancer, NMIBC, and has a promising drug candidate, cretostimogene, which has shown efficacy and safety in clinical trials [3][4]. - The company has received a buy rating from Guggenheim with a price target of $90 per share, indicating a potential for more than double the current share price [2]. Market Potential - There is a large addressable market for NMIBC treatments, and a successful drug could provide significant pricing power for CG Oncology [4]. - The company is expected to seek FDA approval for its investigational drug next year, which adds to the optimism surrounding its prospects [5].

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]