Full Press Release Details
CG Oncology Reports First Quarter 2024 Financial Results and Provides Business Updates
Cretostimogene Monotherapy Demonstrated 75.2% Complete Response (CR) Rate at Any Time in Bacillus Calmette Guerin (BCG)-Unresponsive,
High-Risk Non-Muscle Invasive Bladder Cancer (HR-NMIBC)
First Patient Dosed in PIVOT-006 Phase 3 Clinical Trial of Cretostimogene in Intermediate-Risk
Final Results from CORE-001 Phase 2
Clinical Trial of Cretostimogene in Combination with Pembrolizumab in BCG-Unresponsive HR-NMIBC will be presented at ASCO 2024
Completed Oversubscribed and Upsized $437 Million Initial Public Offering that Extends Expected Runway Through 2027
IRVINE, Calif., May 9, 2024 (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, 2024, and provided business updates.
2024 is a transformative year for CG Oncology, with our oversubscribed and upsized $437 million IPO on NASDAQ and our recent presentation at AUA of
interim data showing a 75.2% CR rate at any time in BCG-Unresponsive HR-NMIBC from our BOND-003 Phase 3 clinical trial, which
potentially supports cretostimogene monotherapy as backbone therapy in this disease with significant unmet need, said Arthur Kuan, Chairman & Chief Executive Officer of CG Oncology. In the coming months we look forward to
sharing final results from our CORE-001 Phase 2 clinical trial of crestostimogene in combination with pembrolizumab and final results from our BOND-003 Phase 3
registrational clinical trial of cretostimogene monotherapy by the end of the year.
Corporate Highlights
Anticipated Next Milestones
First Quarter 2024 Financial Highlights
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.
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; and the timing and likelihood of regulatory filings and
approvals for cretostimogene. 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 CORE-001, 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 SEC, including under the heading Risk Factors in our annual report on Form 10-K and any subsequent filings with the SEC. 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.