CG Oncology Widens Loss as Research Spending Accelerates
The bladder-cancer drug developer ended June with approximately $1.0 billion in cash and investments.
CG Oncology (CGON) widened its quarterly loss as the bladder-cancer drug developer increased spending on clinical trials, manufacturing work and personnel. Its net loss grew 91% to $79.1 million, while the loss widened to $0.90 a share from $0.54 a year earlier.
The heavier spending came as CG Oncology advanced cretostimogene toward a planned biologics-license application and awaited Phase 3 data. Research-and-development expense rose 75% to $54.7 million from $31.3 million a year earlier, primarily because of higher clinical-trial, manufacturing and compensation costs.
That investment had accelerated over the past four quarters. Research spending increased from $27.9 million in the third quarter of 2023 to $30.0 million in the fourth quarter, $43.7 million in the first quarter of 2024 and $54.7 million in the latest period. General-and-administrative expense also climbed 67% from a year earlier and rose sequentially to $29.0 million from $20.8 million, driven mainly by higher headcount and personnel costs.
More than 600 patients with non-muscle-invasive bladder cancer had received cretostimogene in its clinical-development program, up from more than 400 patients reported in January. Results from Cohort C of the Phase 3 BOND-003 study were published in The Lancet Oncology.
The timetable for topline data from the Phase 3 PIVOT-006 trial shifted from the first half of 2024 to an unspecified near-term date. CG Oncology had previously accelerated the trial by nearly a year after enrollment finished early. The company continues to expect to complete its application for cretostimogene in high-risk BCG-unresponsive disease in the fourth quarter, narrowing the general 2024 target it had provided previously.
Cash, cash equivalents and marketable securities declined from $1.1 billion at the end of March. The balance remained well above the $680.3 million reported at the end of September 2023 after a series of at-the-market financings raised about $678 million through the first quarter of 2024.
CG Oncology now expects its cash to fund operations through 2029, extending its projection from the first half of 2029 at year-end and the first half of 2028 in the third quarter of 2023. A Delaware court upheld a jury verdict severing an invalid royalty provision involving ANI while leaving the remainder of the agreement in force.