CGON
CG OncologyCDocument history
Earnings documents stored for CGON.
Investor releaseQuarter not tagged2026-05-15CG Oncology Reports Positive First Results from CORE‑008 Cohort CX Phase 2 Trial Evaluating Intravesical Combination Therapy in High-Risk BCG-Exposed and BCG-Unresponsive Patients
GlobeNewswire
CG Oncology Reports Positive First Results from CORE‑008 Cohort CX Phase 2 Trial Evaluating Intravesical Combination Therapy in High-Risk BCG-Exposed and BCG-Unresponsive Patients
- 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...
Investor releaseQuarter not tagged2026-05-08Gilead Sciences (GILD) Tops Q1 Earnings and Revenue Estimates
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Gilead Sciences (GILD) Tops Q1 Earnings and Revenue Estimates
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...
Investor releaseQuarter not tagged2026-05-08CG Oncology Reports First Quarter 2026 Financial Results and Provides Business Updates
GlobeNewswire
CG Oncology Reports First Quarter 2026 Financial Results and Provides Business Updates
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 Le...
Investor releaseQuarter not tagged2026-04-21CG Oncology (CGON) Rallied on Pivotal Clinical Results
Insider Monkey
CG Oncology (CGON) Rallied on Pivotal Clinical Results
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...
Investor releaseQuarter not tagged2026-02-27CG Oncology Reports 2025 Year End Financial Results and Provides Business Updates
GlobeNewswire
CG Oncology Reports 2025 Year End Financial Results and Provides Business Updates
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 8...
Investor releaseQuarter not tagged2025-11-26CG Oncology to Present Results on Cretostimogene Grenadenorepvec at the Society of Urologic Oncology (SUO) 26th Annual Meeting
GlobeNewswire
CG Oncology to Present Results on Cretostimogene Grenadenorepvec at the Society of Urologic Oncology (SUO) 26th Annual Meeting
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-mont...
Investor releaseQuarter not tagged2025-11-14CG Oncology Reports Third Quarter 2025 Financial Results and Provides Business Updates
GlobeNewswire
CG Oncology Reports Third Quarter 2025 Financial Results and Provides Business Updates
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 b...
Investor releaseQuarter not tagged2025-10-10CG Oncology (CGON): Assessing Valuation Following Analyst Coverage and Positive Phase 3 Trial Results
Simply Wall St.
CG Oncology (CGON): Assessing Valuation Following Analyst Coverage and Positive Phase 3 Trial Results
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 es...
Investor releaseQuarter not tagged2025-09-11CG Oncology (CGON) Reports Promising Results In BOND-003 Trial
Simply Wall St.
CG Oncology (CGON) Reports Promising Results In BOND-003 Trial
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...
Investor releaseQuarter not tagged2025-08-08CG Oncology Reports Second Quarter 2025 Financial Results and Provides Business Updates
GlobeNewswire
CG Oncology Reports Second Quarter 2025 Financial Results and Provides Business Updates
- 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 f...
Investor releaseQuarter not tagged2025-05-13CG Oncology Reports First Quarter 2025 Financial Results and Provides Business Updates
GlobeNewswire
CG Oncology Reports First Quarter 2025 Financial Results and Provides Business Updates
- Updated BOND-003 clinical results presented at AUA showing best-in-disease durability and tolerability data for Cohort C with 24-month complete response rate of 42.3% by K-M -- Promising early signal in Cohort P with 90.5% high-grade recurrence free survival at 3 and 9 months by K-M -- New enrollment completion date for Phase 3 PIVOT-006 in intermediate-risk non-muscle invasive bladder cancer (NMIBC) expected in the second half of 2025 -- Initiated CORE-008 Cohort CX evaluating the combination of cretostimogene and gemcitabine in patients with high-risk (HR) BCG-exposed NMIBC - IRVINE, Calif., May 13, 2025 (GLOBE NEWSWIRE) -- CG Oncology, Inc. (NASDAQ: CGON), a late-stage clinical biopharmaceutical company focused on developing and commercializing a potential backbone bladder-sparing therapeutic for patients with bladder cancer, today reported financial results for the first quarter ended March 31, 2025, and provided business updates. “In 2025, we made further progress advancing cretostimogene monotherapy as a bladder-sparing backbone therapy for patients with NMIBC,” said Arthur Kuan, Chairman & Chief Executive Officer at CG Oncology. “With best-in-disease durability and tolerability data from the BOND-003 Cohort C registrational trial recently presented at AUA, we are well positioned to initiate our BLA submission in the second half of the year for the treatment of patients with HR NMIBC unresponsive to BCG. Our clinical programs have been carefully designed to address different stages of bladder cancer and tumor types. If approved, I’m confident that cretostimogene is well positioned to become backbone therapy in NMIBC, potentially addressing more than 70% of the market opportunity in need of a new and innovative therapy.” 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-...
Investor releaseQuarter not tagged2025-05-01CG Oncology, Inc. (CGON) May Report Negative Earnings: Know the Trend Ahead of Q1 Release
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CG Oncology, Inc. (CGON) May Report Negative Earnings: Know the Trend Ahead of Q1 Release
CG Oncology, Inc. (CGON) is expected to deliver flat earnings compared to the year-ago quarter on higher revenues when it reports results for the quarter ended March 2025. This widely-known consensus outlook gives a good sense of the company's earnings picture, but how the actual results compare to these estimates is a powerful factor that could impact its near-term stock price. The stock might move higher if these key numbers top expectations in the upcoming earnings report. On the other hand, if they miss, the stock may move lower. While the sustainability of the immediate price change and future earnings expectations will mostly depend on management's discussion of business conditions on the earnings call, it's worth handicapping the probability of a positive EPS surprise. This company is expected to post quarterly loss of $0.36 per share in its upcoming report, which represents no change from the year-ago quarter. Revenues are expected to be $0.6 million, up 13.2% from the year-ago quarter. The consensus EPS estimate for the quarter has remained unchanged over the last 30 days. This is essentially a reflection of how the covering analysts have collectively reassessed their initial estimates over this period. Investors should keep in mind that an aggregate change may not always reflect the direction of estimate revisions by each of the covering analysts. Estimate revisions ahead of a company's earnings release offer clues to the business conditions for the period whose results are coming out. Our proprietary surprise prediction model -- the Zacks Earnings ESP (Expected Surprise Prediction) -- has this insight at its core. The Zacks Earnings ESP compares the Most Accurate Estimate to the Zacks Consensus Estimate for the quarter; the Most Accurate Estimate is a more recent version of the Zacks Consensus EPS estimate. The idea here is that analysts revising their estimates right before an earnings release have the latest information, which could potentially be more accurate than what they and others contributing to the consensus had predicted earlier. Thus, a positive or negative Earnings ESP reading theoretically indicates the likely deviation of the actual earnings from the consensus estimate. However, the model's predictive power is significant for positive ESP readings only. A positive Earnings ESP is a strong predictor of an earnings beat, particularly...

