Latest news with #CGOncology
Yahoo
08-08-2025
- Business
- Yahoo
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 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 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. 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: Forward-Looking StatementsCG 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 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 Oncology(508) Investor RelationsMegan KnightVice President, Investor Relations, CG Oncology(619) CG ONCOLOGY, INC. Condensed Consolidated Statements of Operations and Comprehensive Loss(In thousands, except share and per share amounts)(unaudited) Three Months EndedJune 30, Six Months EndedJune 30, 2025 2024 2025 2024 Revenues License and collaboration revenue $ — $ 111 $ 52 $ 640 Operating expenses Research and development 31,331 18,470 58,799 35,680 General and administrative 17,410 7,494 32,198 13,282 Total operating expenses 48,741 25,964 90,997 48,962 Loss from operations (48,741 ) (25,853 ) (90,945 ) (48,322 ) Other income (expense), net: Interest income, net 7,319 6,943 15,066 12,487 Other expense (income), net (4 ) 8 1 (1 ) Total other income, net 7,315 6,951 15,067 12,486 Net loss and comprehensive loss $ (41,426 ) $ (18,902 ) $ (75,878 ) $ (35,836 ) Net loss per share, basic and diluted $ (0.54 ) $ (0.28 ) $ (1.00 ) $ (0.63 ) Weighted average shares of common stock outstanding, basicand diluted 76,226,829 66,649,443 76,207,333 56,857,104 CG ONCOLOGY, INC. Consolidated Balance Sheet Data(In thousands) June 30,2025(unaudited) December 31,2024 Cash, cash equivalents, and marketable securities $ 661,052 $ 741,998 Total assets 701,445 754,797 Total liabilities 31,087 21,420 Total stockholders' equity 670,358 733,377 Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
31-07-2025
- Business
- Yahoo
CG Oncology, Inc. (CGON) Reports 75.5% Complete Response in Bladder Cancer Trial
We recently compiled a list of CG Oncology, Inc. stands sixth on our list. CG Oncology, Inc. (NASDAQ:CGON) is a late-stage clinical biopharmaceutical company developing bladder-sparing immunotherapies, with a primary focus on cretostimogene grenadenorepvec, a targeted oncolytic virus therapy for bladder cancer. Their lead program targets high-risk, BCG-unresponsive non-muscle invasive bladder cancer (NMIBC), an area with limited options beyond invasive surgery. Recent data from the Phase 3 BOND-003 trial, presented in June 2025, revealed a 75.5% complete response rate, with 42.3% of patients maintaining that response at 24 months. Impressively, 97.3% remained free of progression to muscle-invasive disease, and 91.6% avoided cystectomy. The therapy was also well-tolerated, with no grade 3 or higher treatment-related adverse events reported. Cretostimogene stands out as a potential new standard for NMIBC, offering durable cancer control without surgery and preserving patients' quality of life. Its promising results have sparked interest in combining it with other therapies like pembrolizumab, further expanding its therapeutic potential. A healthcare specialist in the laboratory testing an Oncology-related product. CG Oncology, Inc. (NASDAQ:CGON) continues to expand its clinical footprint with trials targeting both BCG-naïve and previously treated patients. A Biologics License Application (BLA) is expected soon, supported by strong Phase 2 combination data published in Nature Medicine. The business is also offering expanded access programs, broadening patient reach before full regulatory approval. While we acknowledge the potential of GOOGL 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. READ NEXT: The Best and Worst Dow Stocks for the Next 12 Months and 10 Unstoppable Stocks That Could Double Your Money. Disclosure: None. Sign in to access your portfolio
Yahoo
06-07-2025
- Business
- Yahoo
Morgan Stanley Lifts PT on CG Oncology (CGON) to $56, Keeps an Overweight Rating
CG Oncology, Inc. (NASDAQ:CGON) is one of the 13 Best Pharma Stocks to Buy According to Wall Street Analysts. On June 17, Morgan Stanley raised the firm's price target on CG Oncology, Inc. (NASDAQ:CGON) to $56 from $52, while maintaining an Overweight rating on the shares. A researcher in a laboratory examining a vial of oncolytic herpes simplex virus, demonstrating the company's commitment to finding a cure for cancer. The firm told investors in a research note that although the non-muscle invasive bladder cancer space has undergone recent and anticipated approvals, the space is comprehensive enough to accommodate multiple players. It thus considers cretostimogene to be meaningfully differentiated by its safety data and durability, along with having 'best-in-disease potential' that supports an optimistic rating for the company. CG Oncology, Inc. (NASDAQ:CGON) is a clinical biopharmaceutical company that develops and commercializes bladder-sparing therapeutics for bladder cancer. Its product cretostimogene is initially in clinical development for the treatment of Non-Muscle Invasive Bladder Cancer (NMIBC). While we acknowledge the potential of 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. READ NEXT: The Best and Worst Dow Stocks for the Next 12 Months and 10 Unstoppable Stocks That Could Double Your Money. Disclosure: None.
Business Insider
15-05-2025
- Business
- Business Insider
Analysts Are Bullish on These NA Stocks: American Healthcare REIT, Inc. (AHR), CG Oncology, Inc. (CGON)
There's a lot to be optimistic about in the NA sector as 2 analysts just weighed in on American Healthcare REIT, Inc. (AHR – Research Report) and CG Oncology, Inc. (CGON – Research Report) with bullish sentiments. Confident Investing Starts Here: American Healthcare REIT, Inc. (AHR) RBC Capital analyst Michael Carroll maintained a Buy rating on American Healthcare REIT, Inc. on May 13 and set a price target of $39.00. The company's shares closed last Wednesday at $34.19. According to Carroll is a 5-star analyst with an average return of 7.4% and a 59.6% success rate. Carroll covers the NA sector, focusing on stocks such as Easterly Government Properties, Diversified Healthcare Trust, and First Industrial Realty. American Healthcare REIT, Inc. has an analyst consensus of Strong Buy, with a price target consensus of $37.00, representing a 7.7% upside. In a report issued on April 28, Jefferies also initiated coverage with a Buy rating on the stock with a $37.00 price target. CG Oncology, Inc. (CGON) RBC Capital analyst Gregory Renza maintained a Buy rating on CG Oncology, Inc. on May 13 and set a price target of $68.00. The company's shares closed last Wednesday at $24.17, close to its 52-week low of $23.91. According to Renza is a 4-star analyst with an average return of 7.7% and a 40.3% success rate. Renza covers the Healthcare sector, focusing on stocks such as Perspective Therapeutics, Verrica Pharmaceuticals, and ACADIA Pharmaceuticals. The word on The Street in general, suggests a Strong Buy analyst consensus rating for CG Oncology, Inc. with a $60.25 average price target, implying a 150.1% upside from current levels. In a report issued on May 2, J.P. Morgan also initiated coverage with a Buy rating on the stock with a $41.00 price target.
Yahoo
13-05-2025
- Business
- Yahoo
CG Oncology, Inc. (CGON) Reports Q1 Loss, Lags Revenue Estimates
CG Oncology, Inc. (CGON) came out with a quarterly loss of $0.45 per share versus the Zacks Consensus Estimate of a loss of $0.39. This compares to loss of $0.36 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of -15.38%. A quarter ago, it was expected that this company would post a loss of $0.41 per share when it actually produced a loss of $0.48, delivering a surprise of -17.07%. Over the last four quarters, the company has surpassed consensus EPS estimates two times. CG Oncology, Inc. , which belongs to the Zacks Medical - Biomedical and Genetics industry, posted revenues of $0.05 million for the quarter ended March 2025, missing the Zacks Consensus Estimate by 90.19%. This compares to year-ago revenues of $0.53 million. The company has not been able to beat consensus revenue estimates 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. CG Oncology, Inc. Shares have lost about 12.3% since the beginning of the year versus the S&P 500's decline of -0.6%. While CG Oncology, Inc. Has underperformed 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 CG Oncology, Inc. 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 current fiscal year change in the days ahead. The current consensus EPS estimate is -$0.53 on $0.53 million in revenues for the coming quarter and -$1.81 on $8.24 million 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 top 35% 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. Atara Biotherapeutics (ATRA), another stock in the same industry, has yet to report results for the quarter ended March 2025. This drug developer is expected to post quarterly loss of $3.07 per share in its upcoming report, which represents a year-over-year change of +46.6%. The consensus EPS estimate for the quarter has remained unchanged over the last 30 days. Atara Biotherapeutics' revenues are expected to be $0.2 million, down 99.3% 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 CG Oncology, Inc. (CGON) : Free Stock Analysis Report Atara Biotherapeutics, Inc. (ATRA) : Free Stock Analysis Report This article originally published on Zacks Investment Research ( Zacks Investment Research Sign in to access your portfolio
