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
Anticipated Next Milestones in the Second Half of 2025
First Quarter 2025 Financial Highlights
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 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
This email address is being protected from spambots. You need JavaScript enabled to view it.
Investor Relations
Chau Cheng
Vice President, Investor Relations, CG Oncology
(949) 342-8939
This email address is being protected from spambots. You need JavaScript enabled to view it.
| CG ONCOLOGY, INC. Condensed Consolidated Balance Sheets (In thousands, except share and per share amounts) | ||||||||
| March 31, 2025 | December 31, 2024 | |||||||
| Assets | (unaudited) | |||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 41,472 | $ | 257,068 | ||||
| Marketable securities | 646,962 | 484,930 | ||||||
| Prepaid expenses and other current assets | 12,413 | 11,431 | ||||||
| Accounts receivable - other | 345 | 781 | ||||||
| Total current assets | 701,192 | 754,210 | ||||||
| Property and equipment, net | 264 | 272 | ||||||
| Note receivable, net | 25,176 | - | ||||||
| Operating lease right-of-use assets | 1,033 | 221 | ||||||
| Other assets | 516 | 94 | ||||||
| Total assets | $ | 728,181 | $ | 754,797 | ||||
| Liabilities and Stockholders’ Equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 6,731 | $ | 6,517 | ||||
| Operating lease liabilities, current portion | 255 | 186 | ||||||
| Accrued expenses and other current liabilities | 15,656 | 14,665 | ||||||
| Total current liabilities | 22,642 | 21,368 | ||||||
| Operating lease liabilities, net of current portion | 781 | 52 | ||||||
| Total liabilities | 23,423 | 21,420 | ||||||
| Commitments and contingencies (Note 5) | ||||||||
| Stockholders’ equity: | ||||||||
| Common stock, $0.0001 par value per share; 700,000,000 and 700,000,000 shares authorized as of March 31, 2025 and December 31, 2024, respectively; 76,221,289 and 76,154,783 shares issued and outstanding as of March 31, 2025 and December 31, 2024, respectively | 8 | 8 | ||||||
| Additional paid-in capital | 957,183 | 951,350 | ||||||
| Accumulated deficit | (252,433 | ) | (217,981 | ) | ||||
| Total stockholders' equity | 704,758 | 733,377 | ||||||
| Total liabilities and stockholders' equity | $ | 728,181 | $ | 754,797 | ||||
| CG ONCOLOGY, INC. Condensed Consolidated Statements of Operations and Comprehensive Loss (In thousands, except share and per share amounts) (unaudited) | ||||||||
| Three Months Ended March 31, | ||||||||
| 2025 | 2024 | |||||||
| Revenues | ||||||||
| License and collaboration revenue | $ | 52 | $ | 529 | ||||
| Operating expenses | ||||||||
| Research and development | 27,467 | 17,210 | ||||||
| General and administrative | 14,789 | 5,788 | ||||||
| Total operating expenses | 42,256 | 22,998 | ||||||
| Loss from operations | (42,204 | ) | (22,469 | ) | ||||
| Other income (expense), net: | ||||||||
| Interest income, net | 7,747 | 5,544 | ||||||
| Other income (expense), net | 5 | (9 | ) | |||||
| Total other income, net | 7,752 | 5,535 | ||||||
| Net loss and comprehensive loss | $ | (34,452 | ) | $ | (16,934 | ) | ||
| Net loss per share, basic and diluted | $ | (0.45 | ) | $ | (0.36 | ) | ||
| Weighted average shares of common stock outstanding, basic and diluted | 76,187,621 | 47,064,768 | ||||||
| Last Trade: | US$24.18 |
| Daily Change: | -0.98 -3.90 |
| Daily Volume: | 864,446 |
| Market Cap: | US$1.840B |
December 16, 2024 | |
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