CG Oncology Inc (CGON) News & EventsCGONCG Oncology Inc

CG Oncology Reports Q2 Revenue of $1.16M

Reports Q2 revenue $1.16M, consensus $362,640. "This quarter we have made significant progress across our clinical, regulatory, manufacturing and commercial-readiness initiatives, positioning the Company for long-term success. PIVOT-006 has accrued the vast majority of the target events, and we look forward to sharing topline results soon. We are confident in the potential of cretostimogene and are committed to delivering what we believe will be a backbone therapy for patients," stated Arthur Kuan, Chairman & Chief Executive Officer at CG Oncology.

CG Oncology Publishes BOND-003 Trial Results, Showing Advances in Bladder Cancer Treatment

CG Oncology announced the publication of results from the pivotal Phase 3 BOND-003 Cohort C trial evaluating cretostimogene grenadenorepvec monotherapy in patients with high-risk, Bacillus Calmette-Guerin-unresponsive non-muscle invasive bladder cancer with carcinoma in situ, with or without Ta/T1 disease, in The Lancet Oncology. "Patients with BCG-unresponsive NMIBC often face the difficult decision between pursuing additional bladder-sparing therapies or undergoing a severe, life-altering cystectomy," said Mark D. Tyson II, M.D., M.P.H., Mayo Clinic, and lead author of the publication. "The results from BOND-003 represent a potential shift in this treatment paradigm, underpinned by encouraging durability of response and bladder preservation outcomes. With a clinically meaningful median duration of response of 27.9 months, possibly among the longer duration of responses seen in this setting, paired with approximately 89% of patients maintaining their bladders at 12 months and 81% at 24 months, we are seeing evidence of sustained bladder preservation without compromising the window for further therapeutic options, if needed." Dr. Tyson continued, "These results are particularly encouraging given BOND-003 enrolled a heavily pretreated population representative of the patients that clinicians often encounter in real-world practice. Specifically, we observed meaningful responses in patients who had already received other therapies, including intravesical gemcitabine-docetaxel or systemic pembrolizumab, underscoring cretostimogene's activity across a clinically diverse and difficult-to-treat patient population. If approved by the FDA, cretostimogene may represent an important, bladder-sparing, advancement in the bladder cancer treatment paradigm, and meaningfully improve patient outcomes." BOND-003 Cohort C met its primary endpoint with statistical significance, exceeding historic and contemporary clinical benchmarks.

Morgan Stanley Acts as Sole Bookrunner with Deal Range $66.87-$67.87

The deal range was $66.87-$67.87. Morgan Stanley acted as sole book running manager for the offering.