CGON

PIVOT-006 Phase 3 topline data evaluating cretostimogene monotherapy as an adjuvant therapy in intermediate-risk NMIBC anticipated in the near-term BLA completion for HR BCG-unresponsive NMIBC expected fourth quarter 2026 Phase 3 BOND-003 Cohort C Study Results published in The Lancet Oncology, further validating the strength of the clinical evidence supporting cretostimogene Well-positioned to deliver on key milestones with approximately $1.0 billion cash, cash equivalents and marketable securities sufficient to fund operations through 2029 DALLAS, Texas, Aug. 06, 2026 (GLOBE NEWSWIRE) -- CG Oncology, Inc. (NASDAQ: CGON) today reported financial results for the second quarter ended June 30, 2026, and provided business updates. “This quarter we have made significant progress across our clinical, regulatory, manufacturing and commercial-readiness initiatives, positioning the Company for long-term success.  PIVOT-006 has accrued the vast majority of the target events, and we look forward to sharing topline results soon. We are confident in the potential of cretostimogene and are committed to delivering what we believe will be a backbone therapy for patients,” stated Arthur Kuan, Chairman & Chief Executive Officer at CG Oncology. Corporate Highlights In July, BOND-003 Cohort C Study Results were published in The Lancet Oncology validating the strength of the clinical evidence supporting cretostimogene In July, the Superior Court of the State of Delaware denied ANI’s post-trial motion for a new trial and judgment as a matter of law, upholding the jury’s verdict in favor of CG Oncology that the invalidated royalty provision was properly severed and that the remainder of the agreement with ANI remains in force, while rejecting ANI’s challenges to the verdict and related claims In May, CORE-008 Cohort CX data were presented at the Society of Urologic Oncology (SUO) session at the American Urological Association (AUA) 2026 Annual Meeting Anticipated 2026 Milestones PIVOT-006 (intermediate-risk NMIBC): Phase 3 topline data Completion of BLA submission in initial indication of HR BCG-unresponsive NMIBC with CIS with or without Ta/T1 disease in 4Q’26 BOND-003 Cohort C (HR BCG-unresponsive NMIBC with CIS with or without Ta/T1 disease), BOND-003 Cohort P (HR BCG-unresponsive NMIBC in Ta/T1 disease without CIS), CORE-008 Cohort CX (HR BCG-exposed and BCG-unresponsive NMIBC) and CORE-008 Cohort A (HR BCG-naïve NMIBC with CIS +/- Ta/T1), durability data Second Quarter Financial Highlights Cash Position: Cash, cash equivalents and marketable securities as of June 30, 2026 were $1.0 billion, compared with $1.1 billion as of March 31, 2026. The Company anticipates its existing cash, cash equivalents and marketable securities as of this date will be sufficient to fund operations through 2029. Research and Development (R&D) Expenses: R&D expenses were $54.7 million for the second quarter of 2026, as compared to $31.3 million for the prior year period. The increase was primarily due to an increase in clinical trial expenses, including CMC costs, and an increase in compensation costs due to increased headcount. General and Administrative (G&A) Expenses: G&A expenses were $29.0 million for the second quarter of 2026, as compared to $17.4 million for the prior year period. The increase was primarily attributed to an increase in personnel-related expenses, including compensation costs from increased headcount. Net Loss: Net loss was $79.1 million, or $(0.90) per share, for the second quarter of 2026, as compared to a net loss of $41.4 million, or $(0.54) per share, for the prior year period. About Cretostimogene GrenadenorepvecCretostimogene is an investigational, intravesically delivered oncolytic immunotherapy that has been studied in a clinical development program, which includes more than 600 patients with Non-Muscle Invasive Bladder Cancer (NMIBC). This program includes two Phase 3 clinical trials: BOND-003 for high-risk BCG-unresponsive NMIBC and PIVOT-006 for intermediate-risk NMIBC. CG Oncology also has a multi-cohort Phase 2 trial, CORE-008, evaluating the safety and efficacy of cretostimogene in high-risk NMIBC. Additionally, we have initiated an Expanded Access Program for cretostimogene in North America for patients who are unresponsive to BCG and meet certain program eligibility requirements. Cretostimogene is an investigational candidate, and its safety and efficacy have not been established by the FDA or any other health authority. About CG OncologyCG Oncology is a late-stage clinical biopharmaceutical company focused on developing and commercializing a potential backbone bladder-sparing therapeutic for patients afflicted with bladder cancer. CG Oncology sees a world where urologic cancer patients may benefit from our innovative immunotherapies to live with dignity and have an enhanced quality of life. To learn more, please visit: www.cgoncology.com. Forward-Looking Statements CG Oncology cautions you that statements contained in this press release regarding matters that are not historical facts are forward-looking statements. The forward-looking statements are based on our current beliefs and expectations and include, but are not limited to, statements regarding our anticipated cash runway, future results of operations and financial position; the anticipated timing and conduct of our ongoing and planned clinical trials and preclinical studies for cretostimogene, including anticipated next milestones in our development pipeline; the timing and likelihood of regulatory filings and approvals for cretostimogene; the potential therapeutic benefits of cretostimogene for high-risk and intermediate-risk NMIBC patients; and that cretostimogene has a best-in-disease product profile. Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in our business, including, without limitation: interim results of a clinical trial are not necessarily indicative of final results and one or more of the clinical outcomes may materially change as patient enrollment continues, following more comprehensive reviews of the data, and as more patient data becomes available; potential delays in the commencement, enrollment and completion of clinical trials, including the BOND-003 and PIVOT-006 trials; we may use our capital resources sooner than expected and they may be insufficient to allow us to achieve our anticipated milestones; our dependence on third parties in connection with manufacturing, shipping and clinical and preclinical testing; results from earlier clinical trials and preclinical studies not necessarily being predictive of future results; unexpected adverse side effects or inadequate efficacy of cretostimogene that may limit its development, regulatory approval, and/or commercialization; and other risks described in our filings with the Securities and Exchange Commission (SEC), including under the heading “Risk Factors” in our annual report on Form 10-K and other filings that we make with the SEC from time to time (which are available at http://www.sec.gov). You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and we undertake no obligation to update such statements to reflect events that occur or circumstances that exist after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Contacts:Media Sarah ConnorsVice President, Communications and Patient Advocacy, CG [email protected] Investor RelationsMegan KnightVice President, Investor Relations, CG [email protected]

Data reinforce durable responses, bladder preservation, low rate of disease progression, and favorable safety and tolerability in patients with high-risk, BCG-unresponsive non-muscle invasive bladder cancer DALLAS, July 27, 2026 (GLOBE NEWSWIRE) -- CG Oncology, Inc. (NASDAQ: CGON) today announced the publication of results from the pivotal Phase 3 BOND-003 Cohort C trial evaluating cretostimogene grenadenorepvec monotherapy in patients with high-risk, Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without Ta/T1 disease, in The Lancet Oncology. “Patients with BCG-unresponsive NMIBC often face the difficult decision between pursuing additional bladder-sparing therapies or undergoing a severe, life-altering cystectomy,” said Mark D. Tyson II, M.D., M.P.H., Mayo Clinic, and lead author of the publication. “The results from BOND-003 represent a potential shift in this treatment paradigm, underpinned by encouraging durability of response and bladder preservation outcomes. With a clinically meaningful median duration of response of 27.9 months, possibly among the longer duration of responses seen in this setting, paired with approximately 89% of patients maintaining their bladders at 12 months and 81% at 24 months, we are seeing evidence of sustained bladder preservation without compromising the window for further therapeutic options, if needed.” Dr. Tyson continued, “These results are particularly encouraging given BOND-003 enrolled a heavily pretreated population representative of the patients that clinicians often encounter in real-world practice. Specifically, we observed meaningful responses in patients who had already received other therapies, including intravesical gemcitabine–docetaxel or systemic pembrolizumab, underscoring cretostimogene's activity across a clinically diverse and difficult-to-treat patient population. If approved by the FDA, cretostimogene may represent an important, bladder-sparing, advancement in the bladder cancer treatment paradigm, and meaningfully improve patient outcomes.” BOND-003 Cohort C met its primary endpoint with statistical significance, exceeding historic and contemporary clinical benchmarks. Key findings and observations reported in the publication include: Robust complete response (CR) rates and durable responses in patients with high-risk BCG-unresponsive NMIBC: Favorable safety and tolerability profile: No Grade 3 or greater treatment-related adverse events or treatment-related discontinuations or deaths reported. The median time to resolution of related adverse events was 1 day (IQR 0–7). The most common TRAEs (≥10%) were bladder spasm, pollakiuria, micturition urgency, dysuria, and hematuria. Clinically meaningful progression-free survival: 96.6% of patients were free from progression to muscle invasive bladder cancer at 48 weeks and 96 weeks. Practical, office-based administration: Cretostimogene does not require prophylactic medication (e.g., anticholinergics), operating room time, additional cystoscopy, or anesthesia-dosing and aligns with existing AUA/SUNA intravesical administration policy, supporting ease of integration into both academic and community urology practice settings. “The publication of the BOND-003 Cohort C results in The Lancet Oncology represents an important milestone for CG Oncology and validates the strength of the clinical evidence supporting cretostimogene,” said Vijay Kasturi, M.D., Chief Medical Officer of CG Oncology. “The BOND-003 Cohort C data demonstrate cretostimogene’s favorable efficacy and best-in-disease durability. Importantly, we also observed a very low rate of progression to muscle-invasive bladder cancer, with only 3.4% of patients progressing during the study. These data underscore cretostimogene’s potential to become a foundational monotherapy for NMIBC and support our ongoing effort to explore its role across multiple disease settings, including adjuvant and combination approaches, aimed at addressing the needs of broader bladder cancer patient populations.” The full manuscript, titled “Intravesical cretostimogene grenadenorepvec oncolytic immunotherapy in high-risk, BCG-unresponsive, non-muscle invasive bladder cancer with carcinoma in situ (BOND-003 Cohort C): a single-arm, phase 3 trial”, is available here: https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(26)00194-4/abstract About the BOND-003 Phase 3 TrialBOND-003 (NCT04452591) is a single-arm, Phase 3, monotherapy clinical trial for the treatment of patients with high-risk BCG-unresponsive NMIBC with carcinoma in-situ (CIS) with or without Ta or T1 papillary tumors. The fully enrolled global trial with a total of 112 in North America, Australia, and the Asia-Pacific region. The primary endpoint of the trial is CR at any time, with DOR measured as a secondary endpoint. The highly pre-treated trial population includes patients with prior intravesical chemotherapy and systemic immunotherapy. About Cretostimogene GrenadenorepvecCretostimogene is an investigational, intravesically delivered oncolytic immunotherapy that has been studied in a clinical development program, which includes more than 400 patients with Non-Muscle Invasive Bladder Cancer (NMIBC). This program includes two Phase 3 clinical trials: BOND-003 for high-risk BCG-unresponsive NMIBC and PIVOT-006 for intermediate-risk NMIBC. Cretostimogene has received FDA Fast Track and Breakthrough Therapy designations. CG Oncology also has a Phase 2 trial, CORE-008, evaluating the safety and efficacy of cretostimogene in high-risk NMIBC. Additionally, we have initiated an Expanded Access Program for cretostimogene in North America for patients who are unresponsive to BCG and meet certain program eligibility requirements. Cretostimogene is an investigational candidate, and its safety and efficacy have not been established by the FDA or any other health authority. About CG OncologyCG Oncology is a late-stage clinical biopharmaceutical company focused on developing and commercializing a potential backbone bladder-sparing therapeutic for patients afflicted with bladder cancer. CG Oncology sees a world where urologic cancer patients may benefit from our innovative immunotherapies to live with dignity and have an enhanced quality of life. To learn more, please visit: www.cgoncology.com. Forward-Looking Statements CG Oncology cautions you that statements contained in this press release regarding matters that are not historical facts are forward-looking statements. The forward-looking statements are based on our current beliefs and expectations and include, but are not limited to, the potential therapeutic benefits of cretostimogene for high-risk NMIBC patients, its potential to have best-in-disease durability and tolerability, cretostimogene’s potential to become a foundational therapy for NMIBC, that cretostimogene may represent an important, bladder-sparing, advancement in bladder cancer treatment, that cretostimogene may meaningfully improve patient outcomes, and that cretostimogene offers distinct advantages over existing therapies for the treatment of high-risk, BCG-unresponsive NMIBC. Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in our business, including, without limitation: interim results of a clinical trial are not necessarily indicative of final results and one or more of the clinical outcomes may materially change as patient enrollment continues, following more comprehensive reviews of the data, and as more patient data becomes available; potential delays in the commencement, enrollment and completion of clinical trials, including the BOND-003, PIVOT-006, and CORE‑008 cohort CX trials; we may use our capital resources sooner than expected and they may be insufficient to allow us to achieve our anticipated milestones; our dependence on third parties in connection with manufacturing, shipping and clinical and preclinical testing; results from earlier clinical trials and preclinical studies not necessarily being predictive of future results; unexpected adverse side effects or inadequate efficacy of cretostimogene that may limit its development, regulatory approval, and/or commercialization; and other risks described in our filings with the Securities and Exchange Commission (SEC), including under the heading “Risk Factors” in our annual report on Form 10-K and other filings that we make with the SEC from time to time (which are available at http://www.sec.gov). You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and we undertake no obligation to update such statements to reflect events that occur or circumstances that exist after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Contacts:Media Sarah ConnorsVice President, Communications and Patient Advocacy, CG [email protected] Investor RelationsMegan KnightVice President, Investor Relations, CG [email protected]

- High CR rates at any time observed in the CIS-containing population with 85.7% and 92.3% in the ITT population and Efficacy Evaluable population, respectively - High-Grade - EFS in the overall intention-to-treat population was 96.0% at 3 months and 89.5% at 6 months - Efficacy was comparable across concurrent and sequential treatment arms and across both BCG-exposed and BCG-Unresponsive populations DALLAS, May 15, 2026 (GLOBE NEWSWIRE) -- CG Oncology, Inc. (NASDAQ: CGON) today announced positive first results from CORE‑008 Cohort CX, a Phase 2 study evaluating intravesical cretostimogene grenadenorepvec in combination with gemcitabine sequential versus concurrent treatment schedules in patients with high‑risk (HR) non‑muscle invasive bladder cancer (NMIBC). This trial includes HR NMIBC patients who are either BCG‑exposed or BCG‑unresponsive. The data, which demonstrate encouraging high-grade event-free survival (HG-EFS), high complete response (CR) rates and a well-tolerated safety profile, will be presented tomorrow at the Society of Urologic Oncology (SUO) Session at the 2026 American Urological Association (AUA) Annual Meeting in Washington, D.C. “Cohort CX was designed to assess whether combining cretostimogene with gemcitabine can further extend the strong clinical profile we have established with cretostimogene monotherapy,” said Vijay Kasturi, Chief Medical Officer of CG Oncology. “As the first prospective intravesical-only combination study of its kind, these early data demonstrate robust clinical activity across both treatment schedules, a favorable safety profile, and comparable efficacy. Importantly, the results reinforce the strategic potential of scalable intravesical-only combination regimens in high-risk NMIBC. We look forward to sharing durability data later this year.” Efficacy and Safety Analysis: As of the March 13, 2026, data cut off, the overall HG-EFS was 96.0% at 3 months and 89.5% at 6 months, with a median follow-up of 6.6 months, in the overall intent-to-treat (ITT) population. There were no statistically significant differences in HG-EFS across concurrent and sequential treatment arms. High complete response (CR) rates at any time were observed in the CIS-containing population with 85.7% (95% CI, 67.3% – 96.0%) and 92.3% (95% CI, 74.9% - 99.1%) in the ITT population with 85.7% (24/28) (95% CI, 67.3%-96.0%) and Efficacy Evaluable population with 92.3% (24/26) (95% CI, 74.9%-99.1%), respectively. Furthermore, complete response rates were maintained across the treatment arms. A favorable safety and tolerability profile was observed with no Grade 3 or greater treatment-related adverse events (TRAEs) and no deaths reported. The majority of patients were male (78.2%), white (92.7%), and over 65 years of age (81.8%), with the cohort well‑balanced across concurrent and sequential treatment arms. Out of the overall population, 65.6% of patients were BCG-exposed and 34.5% were BCG-unresponsive. More than 80% of patients were treated in community practices. “In Cohort CX, we observed consistent responses to the combination of cretostimogene and gemcitabine across both BCG-exposed and BCG-unresponsive populations,” said Trinity Bivalacqua, M.D., Ph.D., Professor of Urology at the University of Pennsylvania and lead investigator of CORE-008 Cohort CX. “These findings highlight the feasibility and encouraging clinical profile of this intravesical oncolytic immunotherapy combined with chemotherapy as a bladder-sparing approach that can be readily adopted in everyday practice. At a time when urologists face ongoing therapeutic constraints and supply challenges, expanding the intravesical treatment armamentarium has the potential to meaningfully improve care for patients across a wide range of NMIBC disease states.” About CORE‑008 CORE‑008 is a randomized, Phase 2, multi‑arm, multi‑cohort clinical trial designed to evaluate the efficacy and safety of cretostimogene grenadenorepvec in a broad population of patients with high‑risk non‑muscle invasive bladder cancer (HR NMIBC), including BCG‑naïve, BCG‑exposed, and BCG‑unresponsive disease. Cohort CX of CORE‑008 evaluates the combination of intravesical cretostimogene with gemcitabine in patients with BCG‑exposed or BCG‑unresponsive HR NMIBC. The primary endpoint of Cohort CX is high‑grade event‑free survival, defined as high‑grade recurrence or persistence, progression to T1 disease, progression to T2 or higher disease, or death from any cause. About Cretostimogene Grenadenorepvec Cretostimogene is an investigational, intravesically delivered oncolytic immunotherapy that has been studied in a clinical development program, which includes more than 400 patients with Non-Muscle Invasive Bladder Cancer (NMIBC). This program includes two Phase 3 clinical trials: BOND-003 for high-risk BCG-unresponsive NMIBC and PIVOT-006 for intermediate-risk NMIBC. CG Oncology also has a Phase 2 trial, CORE-008, evaluating the safety and efficacy of cretostimogene in high-risk NMIBC. Additionally, we have initiated an Expanded Access Program for cretostimogene in North America for patients who are unresponsive to BCG and meet certain program eligibility requirements. Cretostimogene is an investigational candidate, and its safety and efficacy have not been established by the FDA or any other health authority. About CG Oncology CG Oncology is a late-stage clinical biopharmaceutical company focused on developing and commercializing a potential backbone bladder-sparing therapeutic for patients afflicted with bladder cancer. CG Oncology sees a world where urologic cancer patients may benefit from our innovative immunotherapies to live with dignity and have an enhanced quality of life. To learn more, please visit: www.cgoncology.com. Forward-Looking Statements CG Oncology cautions you that statements contained in this press release regarding matters that are not historical facts are forward-looking statements. The forward-looking statements are based on our current beliefs and expectations and include, but are not limited to, the potential therapeutic benefits of cretostimogene for high-risk NMIBC patients, the strategic potential of combining cretostimogene with gemcitabine in high-risk NMIBC, that the combination of cretostimogene with gemcitabine will have robust clinical activity and a favorable safety profile, and that the combination of cretostimogene with gemcitabine will have the potential to meaningfully improve care for patients. Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in our business, including, without limitation: interim results of a clinical trial are not necessarily indicative of final results and one or more of the clinical outcomes may materially change as patient enrollment continues, following more comprehensive reviews of the data, and as more patient data becomes available; potential delays in the commencement, enrollment and completion of clinical trials, including the BOND-003, PIVOT-006, and CORE‑008 cohort CX trials; we may use our capital resources sooner than expected and they may be insufficient to allow us to achieve our anticipated milestones; our dependence on third parties in connection with manufacturing, shipping and clinical and preclinical testing; results from earlier clinical trials and preclinical studies not necessarily being predictive of future results; unexpected adverse side effects or inadequate efficacy of cretostimogene that may limit its development, regulatory approval, and/or commercialization; and other risks described in our filings with the Securities and Exchange Commission (SEC), including under the heading “Risk Factors” in our annual report on Form 10-K and other filings that we make with the SEC from time to time (which are available at http://www.sec.gov). You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and we undertake no obligation to update such statements to reflect events that occur or circumstances that exist after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Contacts: Media Sarah Connors Vice President, Communications and Patient Advocacy, CG Oncology [email protected] Investor Relations Megan Knight Vice President, Investor Relations, CG Oncology [email protected]

Gilead Sciences (GILD) came out with quarterly earnings of $2.03 per share, beating the Zacks Consensus Estimate of $1.89 per share. This compares to earnings of $1.81 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of +7.68%. A quarter ago, it was expected that this HIV and hepatitis C drugmaker would post earnings of $1.83 per share when it actually produced earnings of $1.86, delivering a surprise of +1.64%. Over the last four quarters, the company has surpassed consensus EPS estimates four times. Gilead, which belongs to the Zacks Medical - Biomedical and Genetics industry, posted revenues of $6.96 billion for the quarter ended March 2026, surpassing the Zacks Consensus Estimate by 0.95%. This compares to year-ago revenues of $6.67 billion. The company has topped consensus revenue estimates four times over the last four quarters. The sustainability of the stock's immediate price movement based on the recently-released numbers and future earnings expectations will mostly depend on management's commentary on the earnings call. Gilead shares have added about 11.1% since the beginning of the year versus the S&P 500's gain of 7.6%. While Gilead has outperformed the market so far this year, the question that comes to investors' minds is: what's next for the stock? There are no easy answers to this key question, but one reliable measure that can help investors address this is the company's earnings outlook. Not only does this include current consensus earnings expectations for the coming quarter(s), but also how these expectations have changed lately. Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions. Investors can track such revisions by themselves or rely on a tried-and-tested rating tool like the Zacks Rank, which has an impressive track record of harnessing the power of earnings estimate revisions. Ahead of this earnings release, the estimate revisions trend for Gilead was mixed. While the magnitude and direction of estimate revisions could change following the company's just-released earnings report, the current status translates into a Zacks Rank #3 (Hold) for the stock. So, the shares are expected to perform in line with the market in the near future. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here. It will be interesting to see how estimates for the coming quarters and the current fiscal year change in the days ahead. The current consensus EPS estimate is $2.12 on $7.42 billion in revenues for the coming quarter and $8.62 on $30.15 billion in revenues for the current fiscal year. Investors should be mindful of the fact that the outlook for the industry can have a material impact on the performance of the stock as well. In terms of the Zacks Industry Rank, Medical - Biomedical and Genetics is currently in the bottom 40% of the 250 plus Zacks industries. Our research shows that the top 50% of the Zacks-ranked industries outperform the bottom 50% by a factor of more than 2 to 1. CG Oncology, Inc. (CGON), another stock in the same industry, has yet to report results for the quarter ended March 2026. This company is expected to post quarterly loss of $0.58 per share in its upcoming report, which represents a year-over-year change of -28.9%. The consensus EPS estimate for the quarter has remained unchanged over the last 30 days. CG Oncology, Inc.'s revenues are expected to be $0.6 million, up 1100% from the year-ago quarter. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Gilead Sciences, Inc. (GILD) : Free Stock Analysis Report CG Oncology, Inc. (CGON) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

Following alignment discussions with FDA, BLA completion for HR BCG-unresponsive NMIBC is expected fourth quarter 2026 PIVOT-006 Phase 3 topline data evaluating cretostimogene monotherapy as an adjuvant therapy in intermediate-risk NMIBC anticipated first half 2026 CORE-008 Cohort CX Phase 2 first results of combination cretostimogene with gemcitabine in high-risk (HR) NMIBC BCG-exposed and BCG-unresponsive to be presented at AUA 2026 Well-positioned to deliver on key milestones with approximately $1.1 billion cash, cash equivalents and marketable securities sufficient to fund operations through 2029 DALLAS, May 08, 2026 (GLOBE NEWSWIRE) -- CG Oncology, Inc. (NASDAQ: CGON) today reported financial results for the first quarter ended March 31, 2026, and provided business updates. “We have successfully completed non-clinical and clinical modules for our first BLA submission. The remaining CMC module is progressing as planned, and we are on track to finalize our submission in the fourth quarter 2026. We are pleased to provide this additional guidance on expected BLA completion following focused filing discussions with FDA. Manufacturing inspection readiness activities continue to progress, including our commitment to sustainable long-term supply. The quality and execution of the rolling BLA has been a top priority for us, and we are confident that we are taking all appropriate measures to ensure a successful package. This has been a tremendous undertaking, and I am extremely proud of the team for their unwavering commitment,” stated Arthur Kuan, Chairman & Chief Executive Officer at CG Oncology. “We look forward to a number of meaningful near-term milestones for CG, including anticipated topline data from the Phase 3 PIVOT-006 trial in intermediate-risk NMIBC in the coming months, as well as the first results from the Phase 2 CORE-008 Cohort CX in high-risk BCG-exposed and BCG-unresponsive patients, to be presented at AUA.” Corporate Highlights CORE-008 Cohort CX data podium and poster presentation at the Society of Urologic Oncology (SUO) session at the American Urological Association (AUA) 2026 Annual Meeting on May 16. Title: First Results from CORE-008 Cohort CX- Phase 2 Study of Intravesical Cretostimogene Grenadenorepvec with Gemcitabine in Patients with High-Risk BCG-Exposed or BCG-Unresponsive Non-Muscle Invasive Bladder Cancer Strengthened Executive Leadership Team with the addition of life-science executive Jim DeTore. In April 2026, the Company appointed Jim DeTore to Chief Financial Officer. Jim brings over 30 years of life sciences expertise including executive leadership roles at Neurogastrx, Inc., Bluebird Bio, and Proteostasis Therapeutics, in each case leading the company’s financing and investor relations strategies, helping to raise over a billion dollars in equity capital. He also served as vice president of corporate finance at Ironwood Pharmaceuticals where he worked directly on several debt and equity transactions, including the company’s initial public offering. Jim received his M.B.A. and bachelor’s degree in finance from Northeastern University in Boston. Anticipated 2026 Milestones CORE-008 Cohort CX (HR BCG-exposed and BCG-unresponsive NMIBC): First results from the Phase 2 clinical trial of the combination of cretostimogene with gemcitabine in 1H’26 PIVOT-006 (intermediate-risk NMIBC): Phase 3 topline data in 1H’26 Completion of BLA submission in initial indication of HR BCG-unresponsive NMIBC with CIS with or without Ta/T1 disease in 4Q’26 BOND-003 Cohort C (HR BCG-unresponsive NMIBC in Ta/T1 disease without CIS), BOND-003 Cohort P (HR BCG-unresponsive NMIBC in Ta/T1 disease without CIS), and CORE-008 Cohort A (HR BCG-naïve NMIBC with CIS +/- Ta/T1), durability data in 2026 First Quarter Financial Highlights Cash Position: Cash, cash equivalents and marketable securities as of March 31, 2026 were $1.1 billion, compared with $742.2 million as of December 31, 2025. The March 31, 2026, cash includes net proceeds of approximately $391.4 million from a total of 6,941,407 shares sold through the Company’s at-the-market (ATM) facility in Q1 based on reverse inquiries from existing and new, high-quality funds. The Company anticipates its existing cash, cash equivalents and marketable securities as of this date will be sufficient to fund operations through 2029. Research and Development (R&D) Expenses: R&D expenses were $43.7 million for the first quarter of 2026, as compared to $27.5 million for the prior year period. The increase was primarily due to an increase in clinical trial expenses, including CMC costs, and an increase in compensation costs due to increased headcount. General and Administrative (G&A) Expenses: G&A expenses were $20.8 million for the first quarter of 2026, as compared to $14.8 million for the prior year period. The increase was primarily attributed to an increase in personnel-related expenses, including compensation costs from increased headcount, and an increase in professional and consulting fees. Net Loss: Net loss was $60.2 million, or $(0.71) per share, for the first quarter of 2026, as compared to a net loss of $34.5 million, or $(0.45) per share, for the prior year period. About Cretostimogene Grenadenorepvec Cretostimogene is an investigational, intravesically delivered oncolytic immunotherapy that has been studied in a clinical development program, which includes more than 600 patients with Non-Muscle Invasive Bladder Cancer (NMIBC). This program includes two Phase 3 clinical trials: BOND-003 for high-risk BCG-unresponsive NMIBC and PIVOT-006 for intermediate-risk NMIBC. CG Oncology also has a multi-cohort Phase 2 trial, CORE-008, evaluating the safety and efficacy of cretostimogene in high-risk NMIBC. Additionally, we have initiated an Expanded Access Program for cretostimogene in North America for patients who are unresponsive to BCG and meet certain program eligibility requirements. Cretostimogene is an investigational candidate, and its safety and efficacy have not been established by the FDA or any other health authority. About CG Oncology CG Oncology is a late-stage clinical biopharmaceutical company focused on developing and commercializing a potential backbone bladder-sparing therapeutic for patients afflicted with bladder cancer. CG Oncology sees a world where urologic cancer patients may benefit from our innovative immunotherapies to live with dignity and have an enhanced quality of life. To learn more, please visit: www.cgoncology.com. Forward-Looking Statements CG Oncology cautions you that statements contained in this press release regarding matters that are not historical facts are forward-looking statements. The forward-looking statements are based on our current beliefs and expectations and include, but are not limited to, statements regarding our anticipated cash runway, future results of operations and financial position; the anticipated timing and conduct of our ongoing and planned clinical trials and preclinical studies for cretostimogene, including anticipated next milestones in our development pipeline; the timing and likelihood of regulatory filings and approvals for cretostimogene; the potential therapeutic benefits of cretostimogene for high-risk and intermediate-risk NMIBC patients; and that cretostimogene has a best-in-disease product profile. Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in our business, including, without limitation: interim results of a clinical trial are not necessarily indicative of final results and one or more of the clinical outcomes may materially change as patient enrollment continues, following more comprehensive reviews of the data, and as more patient data becomes available; potential delays in the commencement, enrollment and completion of clinical trials, including the BOND-003 and PIVOT-006 trials; we may use our capital resources sooner than expected and they may be insufficient to allow us to achieve our anticipated milestones; our dependence on third parties in connection with manufacturing, shipping and clinical and preclinical testing; results from earlier clinical trials and preclinical studies not necessarily being predictive of future results; unexpected adverse side effects or inadequate efficacy of cretostimogene that may limit its development, regulatory approval, and/or commercialization; and other risks described in our filings with the Securities and Exchange Commission (SEC), including under the heading “Risk Factors” in our annual report on Form 10-K and other filings that we make with the SEC from time to time (which are available at http://www.sec.gov). You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and we undertake no obligation to update such statements to reflect events that occur or circumstances that exist after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. CONTACT: Contacts: Media Sarah Connors Vice President, Communications and Patient Advocacy, CG Oncology [email protected] Investor Relations Megan Knight Vice President, Investor Relations, CG Oncology [email protected]

Meridian Funds, managed by ArrowMark Partners, released its first-quarter 2026 investor letter for “Meridian Small Cap Growth Fund”. A copy of the letter is available to download here. The US equities market started 2026 with volatility driven by trade policy uncertainty and heightened geopolitical risks. Initial gains were attributed to confidence in domestic companies and the Federal Reserve easing. However, sentiment deteriorated following increased tariffs and military strikes by the U.S. and Israel against Iran. During the quarter, Meridian Small Cap Growth Fund returned -8.37% compared to the Russell 2000 Growth Index’s -2.82% return. The Fund’s relative underperformance was driven by industry allocation effects, while stock selection contributed positively. Despite the market environment, the fund prioritizes high-quality businesses characterized by durable competitive advantages, robust balance sheets, and a clear outlook for sustainable earnings growth. In addition, please check the Fund’s top five holdings to know its best picks in 2026. In its first-quarter 2026 investor letter, Meridian Small Cap Growth Fund highlighted stocks like CG Oncology, Inc. (NASDAQ:CGON). CG Oncology, Inc. (NASDAQ:CGON) is a late-stage clinical biopharmaceutical company specializing in developing cretostimogene grenadenorepvec for patients with bladder cancer. On April 20, 2026, CG Oncology, Inc. (NASDAQ:CGON) closed at $70.40 per share. One-month return of CG Oncology, Inc. (NASDAQ:CGON) was 10.28%, and its shares gained 243.75% over the past 52 weeks. CG Oncology, Inc. (NASDAQ:CGON) has a market capitalization of $5.94 billion. Meridian Small Cap Growth Fund stated the following regarding CG Oncology, Inc. (NASDAQ:CGON) in its Q1 2026 investor letter: CG Oncology, Inc. (NASDAQ:CGON) is not on our list of 40 Most Popular Stocks Among Hedge Funds Heading Into 2026. According to our database, 35 hedge fund portfolios held CG Oncology, Inc. (NASDAQ:CGON) at the end of the fourth quarter, up from 34 in the previous quarter. While we acknowledge the potential of CG Oncology, Inc. (NASDAQ:CGON) as an investment, we believe certain AI stocks offer greater upside potential and carry less downside risk. If you're looking for an extremely undervalued AI stock that also stands to benefit significantly from Trump-era tariffs and the onshoring trend, see our free report on the best short-term AI stock. In another article, we covered CG Oncology, Inc. (NASDAQ:CGON) and shared the fastest growing NASDAQ stocks to buy. In addition, please check out our hedge fund investor letters Q1 2026 page for more investor letters from hedge funds and other leading investors. READ NEXT: 33 Stocks That Should Double in 3 Years and 15 Stocks That Will Make You Rich in 10 Years. Disclosure: None. This article is originally published at Insider Monkey.

PIVOT-006 Phase 3 topline data evaluating cretostimogene monotherapy as an adjuvant therapy in intermediate-risk NMIBC expected first half 2026 CORE-008 Cohort CX Phase 2 first results of combination cretostimogene with gemcitabine in high-risk (HR) NMIBC expected first half 2026 Well-positioned to deliver on key milestones with approximately $903.0 million cash, cash equivalents and marketable securities sufficient to fund operations into the first half of 2029 IRVINE, Calif., Feb. 27, 2026 (GLOBE NEWSWIRE) -- CG Oncology, Inc. (NASDAQ: CGON) today reported financial results for the fourth quarter and year ended December 31, 2025, and provided business updates. “In the coming months, we look forward to sharing topline data from PIVOT-006, the first randomized registrational trial to evaluate an investigational therapy in intermediate-risk NMIBC. We believe we have the opportunity to set the new standard in intermediate-risk NMIBC. I am extremely proud of our team for planning, enrolling and executing this important trial in record time. With cretostimogene’s unique best-in-disease profile, we remain laser-focused on advancing a comprehensive strategy designed to support an optimized product label and ensure success across additional indications—positioning cretostimogene as a potential backbone therapy for a broad range of NMIBC patients,” said Arthur Kuan, Chairman & Chief Executive Officer at CG Oncology. “We are also looking forward to sharing results from CORE-008 Cohort CX in high-risk BCG exposed from our first trial evaluating the combination of cretostimogene with gemcitabine in the coming quarter.” Corporate Highlights Updated timeline for Phase 3 topline data from PIVOT-006 clinical trial evaluating cretostimogene as an adjuvant therapy in intermediate-risk NMIBC. In January 2026, the Company announced an expedited timeline for PIVOT-006, nearly a year ahead of schedule underscoring the excitement for cretostimogene and the significant unmet need in intermediate-risk NMIBC. PIVOT-006 is the first Phase 3 randomized trial in this patient population, encompassing the broadest range of patient types per AUA/SUO Guidelines including HG Ta solitary lesions ≤ 3cm. Presented Late-Breaking Abstracts at the Society of Urologic Oncology (SUO) 26th Annual Meeting in December 2025. Cretostimogene demonstrated HG-EFS at 3- 6- and 9-months of 95.7%, 84.6% and 80.4%, respectively, in HR BCG UR Ta/T1 disease in BOND-003 Cohort P. CORE-008 Cohort A Data in HR BCG-Naïve NMIBC demonstrates 88% CR and favorable safety. Strengthened Board of Directors with the addition of life-science executive Christina Rossi. In November 2025, the Company announced the addition of Christy Rossi, former Chief Operating Officer of Blueprint Medicines, to its board. Christy brings robust expertise in building high-performing commercial organizations, launching new medicines, and delivering impactful programs to HCPs and most importantly to patients. Anticipated 2026 Milestones PIVOT-006 (intermediate-risk NMIBC): Phase 3 topline data in 1H’26 CORE-008 Cohort CX (HR BCG-exposed and BCG-unresponsive NMIBC): First results from the Phase 2 clinical trial of the combination of cretostimogene with gemcitabine in 1H’26 Completion of BLA submission in initial indication of HR BCG-unresponsive NMIBC with CIS with or without Ta/T1 disease in 2026 BOND-003 Cohort C (HR BCG-unresponsive NMIBC in Ta/T1 disease without CIS), BOND-003 Cohort P (HR BCG-unresponsive NMIBC in Ta/T1 disease without CIS), and CORE-008 Cohort A (HR BCG-naïve NMIBC with CIS +/- Ta/T1), durability data in 2026 Fourth Quarter and Year End Financial Highlights Cash Position: Cash and cash equivalents and marketable securities as of December 31, 2025, were $742.2 million, compared with $680.3 million as of September 30, 2025. The December 31, 2025 cash includes net proceeds of approximately $98.4 million from a total of 2,343,967 shares sold through the Company’s at-the-market (ATM) facility in Q4 based on reverse inquiries from existing and new, high-quality funds. In addition, net proceeds of approximately $188.0 million was raised from a total of 3,623,101 shares sold in January 2026 through the Company’s ATM facility, resulting in a cash, cash equivalents, and marketable securities balance as of February 26, 2026 of approximately $903.0 million. The Company anticipates its existing cash, cash equivalents and marketable securities as of this date will be sufficient to fund operations into the first half of 2029. Research and Development (R&D) Expenses: R&D expenses were $30.0 million for the fourth quarter of 2025, as compared to $26.8 million for the prior year period. The increase was primarily due to an increase in clinical trial expenses, including CMC costs, and an increase in compensation costs due to increased headcount. For the full year 2025, R&D expenses were $116.6 million, which compares to $82.1 million for the full year 2024. General and Administrative (G&A) Expenses: G&A expenses were $18.0 million for the fourth quarter of 2025, as compared to $11.7 million for the prior year period. The increase was primarily attributed to an increase in personnel-related expenses, including compensation costs from increased headcount, an increase in professional and consultant fees related to legal, accounting and consulting fees, and an increase in marketing-related costs. For the full year 2025, G&A expenses were $73.5 million, which compares to $33.7 million for the full year 2024. Net Loss: Net loss attributable to common stockholders was $41.3 million, or ($0.52) per share, for the fourth quarter of 2025, as compared to $31.8 million, or ($0.46) per share, for the prior year period. For the full year 2025, net loss attributable to common stockholders was $161.0 million, or ($2.08) per share, as compared to $88.0 million, or ($1.41) per share, for the full year 2024. About Cretostimogene Grenadenorepvec Cretostimogene is an investigational, intravesically delivered oncolytic immunotherapy that has been studied in a clinical development program, which includes more than 600 patients with Non-Muscle Invasive Bladder Cancer (NMIBC). This program includes two Phase 3 clinical trials: BOND-003 for high-risk BCG-unresponsive NMIBC and PIVOT-006 for intermediate-risk NMIBC. CG Oncology also has a multi-cohort Phase 2 trial, CORE-008, evaluating the safety and efficacy of cretostimogene in high-risk NMIBC. Additionally, we have initiated an Expanded Access Program for cretostimogene in North America for patients who are unresponsive to BCG and meet certain program eligibility requirements. Cretostimogene is an investigational candidate, and its safety and efficacy have not been established by the FDA or any other health authority. About CG Oncology CG Oncology is a late-stage clinical biopharmaceutical company focused on developing and commercializing a potential backbone bladder-sparing therapeutic for patients afflicted with bladder cancer. CG Oncology sees a world where urologic cancer patients may benefit from our innovative immunotherapies to live with dignity and have an enhanced quality of life. To learn more, please visit: www.cgoncology.com. Forward-Looking Statements CG Oncology cautions you that statements contained in this press release regarding matters that are not historical facts are forward-looking statements. The forward-looking statements are based on our current beliefs and expectations and include, but are not limited to, statements regarding our anticipated cash runway, future results of operations and financial position; the anticipated timing and conduct of our ongoing and planned clinical trials and preclinical studies for cretostimogene, including anticipated next milestones in our development pipeline; the timing and likelihood of regulatory filings and approvals for cretostimogene; the potential therapeutic benefits of cretostimogene for high-risk and intermediate-risk NMIBC patients; and that cretostimogene has a best-in-disease product profile. Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in our business, including, without limitation: interim results of a clinical trial are not necessarily indicative of final results and one or more of the clinical outcomes may materially change as patient enrollment continues, following more comprehensive reviews of the data, and as more patient data becomes available; potential delays in the commencement, enrollment and completion of clinical trials, including the BOND-003 and PIVOT-006 trials; we may use our capital resources sooner than expected and they may be insufficient to allow us to achieve our anticipated milestones; our dependence on third parties in connection with manufacturing, shipping and clinical and preclinical testing; results from earlier clinical trials and preclinical studies not necessarily being predictive of future results; unexpected adverse side effects or inadequate efficacy of cretostimogene that may limit its development, regulatory approval, and/or commercialization; and other risks described in our filings with the Securities and Exchange Commission (SEC), including under the heading “Risk Factors” in our annual report on Form 10-K and other filings that we make with the SEC from time to time (which are available at http://www.sec.gov). You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and we undertake no obligation to update such statements to reflect events that occur or circumstances that exist after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Contacts: Media Sarah Connors Vice President, Communications and Patient Advocacy, CG Oncology [email protected] Investor Relations Megan Knight Vice President, Investor Relations, CG Oncology [email protected]

Two late-breaking podium presentations and three posters continue to demonstrate cretostimogene as a potential backbone therapy for a broad range of NMIBC patients IRVINE, Calif., Nov. 25, 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 announced two late breaking podium presentations on the topline results from BOND-003 Cohort P (BCG-Unresponsive in papillary-only) and first results from CORE-008 Cohort A (BCG-Naïve with carcinoma in situ) as well as three additional posters, will be presented at the Society of Urologic Oncology (SUO) 26th Annual Meeting taking place at the Sheraton Phoenix Downtown, Phoenix, AZ, from December 2 – 5, 2025. "At SUO this year, we will present important new data from across our clinical program in High-Risk BCG-Naïve NMIBC and High-Risk BCG-Unresponsive Ta/T1 disease, including results from BOND-003 Cohort P and CORE-008 Cohort A. These updates further reinforce cretostimogene’s potential as a backbone immunotherapy across the NMIBC spectrum. We are grateful to the SUO for providing a leading global forum where meaningful scientific advances can be shared on behalf of patients and their families,” said Ambaw Bellete, President & Chief Operating Officer at CG Oncology. Details on the late-breaking podium presentations and posters are as follows: Late-Breaking Podium Presentations Topline Results From BOND-003 Cohort P- a Multi-National, Single-Arm Study of Intravesical Cretostimogene Grenadenorepvec for Treatment of High-Risk, Papillary Only, BCG-Unresponsive Non-Muscle Invasive Bladder Cancer Presenter: Mark D. Tyson, M.D., Urologic Oncologist at Mayo Clinic, Scottsdale, AZ Presentation Date & Time: December 5, 2025, from 2:30-2:35 PM Mountain Standard Time Location: Sheraton Phoenix Downtown, Phoenix, AZ First Results from CORE-008 Cohort A- Phase 2 Study of Intravesical Cretostimogene Grenadenorepvec in Patients with High-Risk BCG-Naïve Non-Muscle Invasive Bladder Cancer Presenter: Trinity J. Bivalacqua, M.D., Ph.D., Urologic Oncologist at University of Pennsylvania, Philadelphia, PA Presentation Date & Time: December 5, 2025, from 2:35-2:40 PM Mountain Standard Time Location: Sheraton Phoenix Downtown, Phoenix, AZ Posters Durable 24-month outcomes from BOND-003 Cohort C: Phase 3 Study of Intravesical Cretostimogene Grenadenorepvec for High-Risk BCG-Unresponsive Non-Muscle Invasive Bladder Cancer with Carcinoma in Situ Presenter: Mark D. Tyson, M.D., Urologic Oncologist at Mayo Clinic, Scottsdale, AZ Poster Number: 53 Presentation Date & Time: December 3, 2025, from 5-6 PM Mountain Standard Time Location: Sheraton Phoenix Downtown, Phoenix, AZ Core-008 Cohort B: Evaluating Intravesical Cretostimogene Grenadenorepvec in Patients with High-Risk, BCG-Exposed Non-Muscle Invasive Bladder Cancer Trials in Progress Presenter: Trinity J. Bivalacqua, M.D., Ph.D., Urologic Oncologist at University of Pennsylvania, Philadelphia, PA Poster Number: 54 Presentation Date & Time: December 3, 2025, from 5-6 PM Mountain Standard Time Location: Sheraton Phoenix Downtown, Phoenix, AZ Design and Implementation of Patient-Centric Expanded Access Program with Cretostimogene Grenadenorepvec in Non-Muscle Invasive Bladder Cancer Unresponsive to Bacillus Calmette-Guerin Trials in Progress Presenter: Sarah P. Psutka, M.D. M.Sc., Urologic Oncologist at University of Washington, Seattle, WA Poster Number: 137 Presentation Date & Time: December 4, 2025, from 2:30 – 3:30 PM Mountain Standard Time Location: Sheraton Phoenix Downtown, Phoenix, AZ About Cretostimogene Grenadenorepvec Cretostimogene is an investigational, intravesically delivered oncolytic immunotherapy that has been studied in a clinical development program, which includes more than 400 patients with Non-Muscle Invasive Bladder Cancer (NMIBC). This program includes two Phase 3 clinical trials: BOND-003 for high-risk BCG-unresponsive NMIBC and PIVOT-006 for intermediate-risk NMIBC. CG Oncology also has a Phase 2 trial, CORE-008, evaluating the safety and efficacy of cretostimogene in high-risk NMIBC. Additionally, we have initiated an Expanded Access Program for cretostimogene in North America for patients who are unresponsive to BCG and meet certain program eligibility requirements. Cretostimogene is an investigational candidate, and its safety and efficacy have not been established by the FDA or any other health authority. About CG Oncology CG Oncology is a late-stage clinical biopharmaceutical company focused on developing and commercializing a potential backbone bladder-sparing therapeutic for patients afflicted with bladder cancer. CG Oncology sees a world where urologic cancer patients may benefit from our innovative immunotherapies to live with dignity and have an enhanced quality of life. To learn more, please visit: www.cgoncology.com. Forward-Looking Statements CG Oncology cautions you that statements contained in this press release regarding matters that are not historical facts are forward-looking statements. The forward-looking statements are based on our current beliefs and expectations and include, but are not limited to, the potential therapeutic benefits of cretostimogene for high-risk and intermediate-risk NMIBC patients, and cretostimogene’s potential as a foundational immunotherapy across the NMIBC spectrum. Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in our business, including, without limitation: interim results of a clinical trial are not necessarily indicative of final results and one or more of the clinical outcomes may materially change as patient enrollment continues, following more comprehensive reviews of the data, and as more patient data becomes available; potential delays in the commencement, enrollment and completion of clinical trials, including the BOND-003 and PIVOT-006 trials; we may use our capital resources sooner than expected and they may be insufficient to allow us to achieve our anticipated milestones; our dependence on third parties in connection with manufacturing, shipping and clinical and preclinical testing; results from earlier clinical trials and preclinical studies not necessarily being predictive of future results; unexpected adverse side effects or inadequate efficacy of cretostimogene that may limit its development, regulatory approval, and/or commercialization; and other risks described in our filings with the Securities and Exchange Commission (SEC), including under the heading “Risk Factors” in our annual report on Form 10-K and other filings that we make with the SEC from time to time (which are available at http://www.sec.gov). You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and we undertake no obligation to update such statements to reflect events that occur or circumstances that exist after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Contacts: Media Sarah Connors Vice President, Communications and Patient Advocacy, CG Oncology [email protected] Investor Relations Megan Knight Vice President, Investor Relations, CG Oncology [email protected]

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 Phase 3 studies in intermediate risk (IR) NMIBC encompassing broadest range of patients per AUA/SUO Guidelines Well-positioned to deliver on key milestones with $680.3 million cash and cash equivalents and marketable securities sufficient to fund operations into the first half of 2028 IRVINE, Calif., Nov. 14, 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 third quarter ended September 30, 2025, and provided business updates. “I am proud of the meaningful progress we have made over the last few months, most notably, the initiation of our BLA submission of cretostimogene for our lead indication of HR BCG-unresponsive NMIBC with CIS with or without Ta/T1 disease. With cretostimogene’s unique profile, we remain committed to advancing a robust clinical, regulatory, and technical strategy designed to support an optimized label and expansion into additional indications—positioning cretostimogene as a potential backbone therapy for a broad range of NMIBC patients,” said Arthur Kuan, Chairman & Chief Executive Officer at CG Oncology. “We look forward to sharing additional data from BOND-003 Cohort P and CORE-008 Cohort A before year-end.” Corporate Highlights Initiated BLA submission for cretostimogene monotherapy in HR BCG-unresponsive NMIBC with CIS with or without Ta/T1 disease. The Company initiated its rolling BLA submission for cretostimogene with complete submission expected in 2026. Cretostimogene has both Fast Track and Breakthrough Therapy Designations which are intended to accelerate the path to U.S. FDA submission. Presented Best-in-Disease Durability and Tolerability Data from BOND-003 Cohort C. In September, the Company presented best-in-disease durability and tolerability data on BOND-003 Cohort C showing 12 additional patients with HR BCG-unresponsive NMIBC with CIS with or without Ta/T1 disease were in complete response (CR) at 24 months. The robust 24-month complete response landmark rate of 41.8% (CR rate observed in 46 out of 110 patients) for cretostimogene monotherapy reaffirms the best-in-disease durability, with 90% of 12-month responders remaining disease free at 24 months. The safety profile remained consistent with no Grade 3 or greater treatment-related adverse events or deaths reported. Completed enrollment of PIVOT-006 clinical trial of cretostimogene in IR NMIBC. In September, the Company completed enrollment of PIVOT-006, approximately 10 months ahead of schedule underscoring patients’ and physicians’ interest in cretostimogene and the significant unmet need in IR NMIBC. PIVOT-006 is one of the largest randomized Phase 3 studies in this patient population and encompasses the broadest range of patient types per AUA/SUO guidelines. Anticipated Upcoming Milestones BOND-003 Cohort P (HR BCG-unresponsive NMIBC in Ta/T1 disease without CIS): Topline data from the Phase 3 clinical trial of cretostimogene monotherapy in 4Q’25 CORE-008 Cohort A (HR BCG-naïve NMIBC with CIS +/- Ta/T1): First results from the Phase 2 clinical trial of cretostimogene monotherapy in 4Q’25 CORE-008 Cohort CX (HR BCG-exposed NMIBC): Topline data from the Phase 2 clinical trial of the combination of cretostimogene with gemcitabine in 1H’26 Completion of BLA submission in initial indication, HR BCG-unresponsive NMIBC with CIS with or without Ta/T1 disease, in 2026 Third Quarter 2025 Financial Highlights Cash Position: Cash and cash equivalents and marketable securities as of September 30, 2025 were $680.3 million, compared with $661.1 million as of June 30, 2025, which includes net proceeds of approximately $48.7 million from the sale of 1,515,151 shares through the Company’s at-the-market (ATM) facility based on reverse inquiry from an existing, high-quality fund. Based on current operating plans, the Company expects its existing cash, cash equivalents and marketable securities will be sufficient to fund operations into the first half of 2028. Research and Development (R&D) Expenses: R&D expenses for the three months ended September 30, 2025 were $27.9 million compared with $19.6 million for the three months ended September 30, 2024. The increase was primarily due to an increase in clinical trial expenses and an increase in compensation costs due to increased headcount. General and Administrative (G&A) Expenses: G&A expenses for the three months ended September 30, 2025 were $23.3 million compared with $8.7 million for the three months ended September 30, 2024. The increase was primarily attributed to an increase in legal expenses and other professional fees and an increase in personnel-related expenses, including compensation costs from increased headcount. Net Loss: Net loss was $43.8 million, or ($0.57) per share, for the three months ended September 30, 2025, compared to a net loss of $20.4 million, or ($0.30) per share, for the three months ended September 30, 2024. About Cretostimogene Grenadenorepvec Cretostimogene is an investigational, intravesically delivered oncolytic immunotherapy that has been studied in a clinical development program, which includes more than 400 patients with Non-Muscle Invasive Bladder Cancer (NMIBC). This program includes two Phase 3 clinical trials: BOND-003 for high-risk BCG-unresponsive NMIBC and PIVOT-006 for intermediate-risk NMIBC. CG Oncology also has a Phase 2 trial, CORE-008, evaluating the safety and efficacy of cretostimogene in high-risk NMIBC. Additionally, we have initiated an Expanded Access Program for cretostimogene in North America for patients who are unresponsive to BCG and meet certain program eligibility requirements. Cretostimogene is an investigational candidate, and its safety and efficacy have not been established by the FDA or any other health authority. About CG Oncology CG Oncology is a late-stage clinical biopharmaceutical company focused on developing and commercializing a potential backbone bladder-sparing therapeutic for patients afflicted with bladder cancer. CG Oncology sees a world where urologic cancer patients may benefit from our innovative immunotherapies to live with dignity and have an enhanced quality of life. To learn more, please visit: www.cgoncology.com. Forward-Looking Statements CG Oncology cautions you that statements contained in this press release regarding matters that are not historical facts are forward-looking statements. The forward-looking statements are based on our current beliefs and expectations and include, but are not limited to, statements regarding our anticipated cash runway, future results of operations and financial position; the anticipated timing and conduct of our ongoing and planned clinical trials and preclinical studies for cretostimogene, including anticipated next milestones in our development pipeline; the timing and likelihood of regulatory filings and approvals for cretostimogene; the potential therapeutic benefits of cretostimogene for high-risk and intermediate-risk NMIBC patients; and that cretostimogene has best-in-disease durability and tolerability data. Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in our business, including, without limitation: interim results of a clinical trial are not necessarily indicative of final results and one or more of the clinical outcomes may materially change as patient enrollment continues, following more comprehensive reviews of the data, and as more patient data becomes available; potential delays in the commencement, enrollment and completion of clinical trials, including the BOND-003 and PIVOT-006 trials; we may use our capital resources sooner than expected and they may be insufficient to allow us to achieve our anticipated milestones; our dependence on third parties in connection with manufacturing, shipping and clinical and preclinical testing; results from earlier clinical trials and preclinical studies not necessarily being predictive of future results; unexpected adverse side effects or inadequate efficacy of cretostimogene that may limit its development, regulatory approval, and/or commercialization; and other risks described in our filings with the Securities and Exchange Commission (SEC), including under the heading “Risk Factors” in our annual report on Form 10-K, as supplemented in Part II, Item 1A, “Risk Factors” of our quarterly report on Form 10-Q for the quarter ended June 30, 2025, and other filings that we make with the SEC from time to time (which are available at http://www.sec.gov). You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and we undertake no obligation to update such statements to reflect events that occur or circumstances that exist after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Contacts: Media Sarah Connors Vice President, Communications and Patient Advocacy, CG Oncology [email protected] Investor Relations Megan Knight Vice President, Investor Relations, CG Oncology [email protected]

CG Oncology (CGON) is in the spotlight after several analysts, including Guggenheim, initiated coverage. This attention is supported by promising late-stage trial results for its lead bladder cancer therapy and anticipation of an FDA review next year. See our latest analysis for CG Oncology. Momentum has been strongly building for CG Oncology, as the stock has climbed over 66% in the past 90 days, capped by an 11.55% one-week share price return following analyst bullishness and positive clinical trial results. In summary, both short- and long-term total shareholder returns suggest investors see significant growth potential here. If biotech’s recent surge has your attention, consider exploring more healthcare standouts with our full list: See the full list for free. But with shares surging and analyst targets pointing much higher, the key question now is whether CG Oncology remains undervalued or if the market has already priced in all the company’s future growth potential. CG Oncology trades at a price-to-book (P/B) ratio of 5.1x compared to the US Biotechs industry average of 2.5x. This places the stock above sector norms and raises critical valuation questions for new investors following the recent share price surge. The price-to-book ratio is a simple metric that shows how much investors are willing to pay for a company's net assets. In biotech, this measure is particularly relevant because of the high levels of intangible investment and ongoing R&D spend, which can inflate perceived valuations relative to book value. CG Oncology's elevated P/B suggests the market is pricing in optimism for future clinical progress or potential blockbuster approvals, despite the company’s current lack of profitability and minimal revenue. Compared to the broader biotech industry average, CGON appears expensive on this basis. However, it is still considered good value relative to close peers with even higher multiples. Result: Price-to-Book of 5.1x (OVERVALUED) See what the numbers say about this price — find out in our valuation breakdown. However, major risks remain if clinical trial setbacks occur or if regulatory approval faces delays. Either of these could undermine the current growth outlook. Find out about the key risks to this CG Oncology narrative. Taking a different approach, our DCF model suggests CG Oncology is actually trading at a steep 86% discount to its estimated fair value ($44.46 compared to a fair value of $326.18). This presents a notable difference from traditional valuation multiples and raises important questions about which method best reflects future potential. Look into how the SWS DCF model arrives at its fair value. Simply Wall St performs a discounted cash flow (DCF) on every stock in the world every day (check out CG Oncology for example). We show the entire calculation in full. You can track the result in your watchlist or portfolio and be alerted when this changes, or use our stock screener to discover undervalued stocks based on their cash flows. If you save a screener we even alert you when new companies match - so you never miss a potential opportunity. You might see things differently or want to dig into the numbers yourself. Our tools let you build a personalized view in just a few minutes, so you can Do it your way. A great starting point for your CG Oncology research is our analysis highlighting 2 key rewards and 2 important warning signs that could impact your investment decision. Thousands of investors use our screeners to uncover under-the-radar opportunities before the crowd catches on. Start now and don’t let another smart move pass you by. Supercharge your portfolio with reliable income streams by checking out these 18 dividend stocks with yields > 3%, which consistently deliver yields above 3%. Step ahead of market trends and spot early movers among these 25 AI penny stocks, positioned to transform the future of artificial intelligence. Unlock unique upside potential by targeting these 3574 penny stocks with strong financials, showing strong financials and growth momentum often missed by mainstream investors. This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned. Companies discussed in this article include CGON. Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email [email protected]

CG Oncology recently reported promising developments from the BOND-003 trial with their investigational therapy, cretostimogene, showing significant efficacy in non-muscle invasive bladder cancer patients. Alongside this, the completion of enrollment in the PIVOT-006 study marks a strategic advancement in their clinical program. These events likely supported the company’s share price increase of 35% over the past month. Broad market moves, including record highs in the S&P 500 and Nasdaq, further buoyed CGON’s performance, though its specific developments in cancer research likely added significant strength to its upward momentum. We've identified 2 warning signs with CG Oncology (at least 1 which is a bit concerning) and understanding the impact should be part of your investment process. Uncover the next big thing with financially sound penny stocks that balance risk and reward. Over the past year, CG Oncology's shares have experienced a total return decline of 7.34%, contrasting with its recent short-term surge of 35% amid encouraging clinical developments. Over the same one-year period, the company underperformed both the US Biotechs industry, which returned 6.3%, and the broader US market, which achieved a 20.5% return. This underperformance is notable given the biotech sector's competitive dynamics. The announcements related to the BOND-003 trial and the completion of the PIVOT-006 study could positively influence revenue growth prospects, as these advancements may enhance the company’s market position in developing therapies for bladder cancer. However, CG Oncology remains unprofitable, with a sizable net loss reported in recent financial results. Regarding the price movement, while the current share price of US$33.47 is elevated from recent developments, it remains significantly below the consensus analyst price target of US$59, indicating potential for further growth should the company continue to develop promising therapies and improve its financial standing. Take a closer look at CG Oncology's potential here in our financial health report. This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned. Companies discussed in this article include CGON. This article was originally published by Simply Wall St. Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email [email protected]

- Announced best-in-disease durability data in BOND-003 Cohort C and promising early signal in Cohort P for cretostimogene grenadenorepvec at the American Urological Association Annual Meeting - - Initiated CORE-008 Cohort CX evaluating the combination of cretostimogene and gemcitabine in patients with high-risk (HR) BCG-exposed NMIBC - - Announced unanimous verdict that CG Oncology owes no future royalties or other payments to ANI Pharmaceuticals - IRVINE, Calif., Aug. 08, 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 second quarter ended June 30, 2025, and provided business updates. “In the second quarter, we announced best-in-disease durability and tolerability from the Phase 3 BOND-003 Cohort C registrational trial, building upon the body of evidence demonstrating the power of cretostimogene’s unique dual mechanism of action, and its potential to treat intermediate-risk and high-risk NMIBC,” said Arthur Kuan, Chairman & Chief Executive Officer at CG Oncology. “We remain laser focused on bringing forward cretostimogene, our potentially breakthrough backbone treatment to patients. The recent positive outcome of the ANI litigation allows us to continue to focus our resources and energy on delivering this innovative therapy. We are poised to initiate our BLA submission for cretostimogene in the fourth quarter of the year for the treatment of patients with HR NMIBC unresponsive to BCG.” Corporate Highlights Presented Best-in-Disease Durability and Tolerability Data in BOND-003 Cohort C and Promising Early Signal in Cohort P for Cretostimogene at a Plenary Session at the American Urological Association (AUA) Annual Meeting: On April 26th at the AUA Annual Meeting, the Company presented best-in-disease durability and tolerability data from Cohort C of the Phase 3 BOND-003 clinical trial that showed a 75.5% complete response (CR) at any time, with 34 confirmed CRs at 24 months and 9 patients pending their 24-month assessment as of the cutoff date of March 14, 2025. The 12- and 24-month CR rates are 50.7% and 42.3% by K-M estimation respectively. Median duration of response is 28 months and is ongoing. Notably, 97.3% of patients were free from progression to muscle invasive disease at 24 months. Additionally, Cohort P, which is in patients with BCG-unresponsive Ta/T1 papillary disease without carcinoma in situ (CIS), showed an estimated 90.5% high-grade recurrence-free survival at 3 and 9 months in 24 treated patients. Initiated CORE-008 Cohort CX clinical trial of cretostimogene + gemcitabine in HR BCG-exposed NMIBC: In April, the Company initiated CORE-008 Cohort CX evaluating the combination of cretostimogene and gemcitabine, given either concurrently or sequentially, in patients with HR BCG-exposed NMIBC, including patients with CIS and with or without Ta/T1 disease and patients with only Ta/T1 disease. Announced Unanimous Verdict that CG Oncology Owes No Future Royalties or Other Payments to ANI Pharmaceuticals: On July 29th, the Company announced that a jury in the Superior Court of the State of Delaware unanimously found in favor of CG Oncology on all claims in a March 2024 lawsuit brought by ANI Pharmaceuticals, Inc. (ANI). The jury unanimously rejected all of ANI’s claims for unjust enrichment damages after Judge Sheldon K. Rennie, on July 16, 2025, had ruled in favor of CG Oncology that, as a matter of law, ANI was not entitled to any royalties on future sales of cretostimogene grenadenorepvec. As a result, CG Oncology will not owe ANI a future royalty of 5% on commercial sales of cretostimogene, no damages have been awarded to ANI, and there are no further payments due to ANI under the 2010 agreement between ANI and CG Oncology. The Company will continue to vigorously defend any post-trial motions and appeals brought by ANI. Anticipated Upcoming Milestones PIVOT-006 (intermediate-risk NMIBC): Phase 3 enrollment completion in 3Q'25 Initiation of BLA submission in 4Q'25 for cretostimogene monotherapy in HR BCG-unresponsive NMIBC with CIS with or without Ta/T1 disease BOND-003 Cohort P (HR BCG-unresponsive NMIBC in Ta/T1 disease without CIS): Topline data from the Phase 3 clinical trial of cretostimogene monotherapy in 4Q'25 CORE-008 Cohort A (HR BCG-naïve NMIBC with CIS +/- Ta/T1): Topline data from the Phase 2 clinical trial of cretostimogene monotherapy in 4Q'25 CORE-008 Cohort CX (HR BCG-exposed NMIBC): Topline data from the Phase 2 clinical trial of the combination of cretostimogene with gemcitabine in 1H’26 Second Quarter 2025 Financial Highlights Cash Position: Cash and cash equivalents and marketable securities as of June 30, 2025, were $661.1 million, compared with $688.4 million as of March 31, 2025. Based on current operating plans, the Company expects its existing cash, cash equivalents and marketable securities will be sufficient to fund operations into the first half of 2028. Research and Development (R&D) Expenses: R&D expenses for the three months ended June 30, 2025 were $31.3 million compared with $18.5 million for the three months ended June 30, 2024. The increase was primarily due to an increase in clinical trial expenses and an increase in compensation costs due to increased headcount. General and Administrative (G&A) Expenses: G&A expenses for the three months ended June 30, 2025 were $17.4 million compared with $7.5 million for the three months ended June 30, 2024. The increase was primarily attributed to an increase in personnel-related expenses, including compensation costs from increased headcount and an increase in legal expenses. Net Loss: Net loss was $41.4 million, or ($0.54) per share, for the three months ended June 30, 2025, compared to a net loss of $18.9 million, or ($0.28) per share, for the three months ended June 30, 2024. About Cretostimogene Grenadenorepvec Cretostimogene is an investigational, intravesically delivered oncolytic immunotherapy that has been studied in a clinical development program, which includes more than 400 patients with Non-Muscle Invasive Bladder Cancer (NMIBC). This program includes two Phase 3 clinical trials: BOND-003 for high-risk BCG-unresponsive NMIBC and PIVOT-006 for intermediate-risk NMIBC. CG Oncology also has a Phase 2 trial, CORE-008, evaluating the safety and efficacy of cretostimogene in high-risk NMIBC. Additionally, we have initiated an Expanded Access Program for cretostimogene in North America for patients who are unresponsive to BCG and meet certain program eligibility requirements. Cretostimogene is an investigational candidate, and its safety and efficacy have not been established by the FDA or any other health authority. About CG Oncology CG Oncology is a late-stage clinical biopharmaceutical company focused on developing and commercializing a potential backbone bladder-sparing therapeutic for patients afflicted with bladder cancer. CG Oncology sees a world where urologic cancer patients may benefit from our innovative immunotherapies to live with dignity and have an enhanced quality of life. To learn more, please visit: www.cgoncology.com. Forward-Looking Statements CG Oncology cautions you that statements contained in this press release regarding matters that are not historical facts are forward-looking statements. The forward-looking statements are based on our current beliefs and expectations and include, but are not limited to, statements regarding our anticipated cash runway, future results of operations and financial position; the anticipated timing and conduct of our ongoing and planned clinical trials and preclinical studies for cretostimogene, including anticipated next milestones in our development pipeline; the timing and likelihood of regulatory filings and approvals for cretostimogene; the potential therapeutic benefits of cretostimogene for high-risk and intermediate-risk NMIBC patients; and that cretostimogene has best-in-disease durability and tolerability data. Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in our business, including, without limitation: interim results of a clinical trial are not necessarily indicative of final results and one or more of the clinical outcomes may materially change as patient enrollment continues, following more comprehensive reviews of the data, and as more patient data becomes available; potential delays in the commencement, enrollment and completion of clinical trials, including the BOND-003 and PIVOT-006 trials; we may use our capital resources sooner than expected and they may be insufficient to allow us to achieve our anticipated milestones; our dependence on third parties in connection with manufacturing, shipping and clinical and preclinical testing; results from earlier clinical trials and preclinical studies not necessarily being predictive of future results; unexpected adverse side effects or inadequate efficacy of cretostimogene that may limit its development, regulatory approval, and/or commercialization; and other risks described in our filings with the Securities and Exchange Commission (SEC), including under the heading “Risk Factors” in our annual report on Form 10-K, as supplemented in Part II, Item 1A, “Risk Factors” of our quarterly report on Form 10-Q for the quarter ended June 30, 2025, and other filings that we make with the SEC from time to time (which are available at http://www.sec.gov). You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and we undertake no obligation to update such statements to reflect events that occur or circumstances that exist after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Contacts: Media Sarah Connors Vice President, Communications and Patient Advocacy, CG Oncology (508) 654-2277 [email protected] Investor Relations Megan Knight Vice President, Investor Relations, CG Oncology (619) 990-3447 [email protected]