Full Press Release Details
- 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
Anticipated Upcoming Milestones
Second Quarter 2025 Financial Highlights
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: www.cgoncology.com.
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 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:MediaSarah ConnorsVice President, Communications and Patient Advocacy, CG Oncology(508) 654-2277sarah.connors@cgoncology.com
Investor RelationsMegan KnightVice President, Investor Relations, CG Oncology(619) 990-3447megan.knight@cgoncology.com
| 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 |