CG Oncology (CGON) shares climbed sharply at the 12th Annual Cantor Fitzgerald Global Healthcare Conference on September 9, with President and CEO Arthur Kuan saying the company expects data from its pivotal PIVOT-006 trial "in the very near term."
Cretostimogene, an oncolytic immunotherapy, is being developed for non-muscle invasive bladder cancer (NMIBC). PIVOT-006 is the first prospective randomized controlled trial in intermediate-risk NMIBC, enrolling patients across 90 U.S. centers. It is powered to detect a 30% relative risk reduction versus gemcitabine monotherapy.
As of August 6, Kuan told the conference that CG Oncology has hit the majority of target events in PIVOT-006. ClinicalTrials.gov previously projected a mid-2025 readout, after earlier guidance had pointed to the first half of 2024 — both timelines were subsequently revised.
"Today, I would still say that we are definitely anticipating results in the very near term," Kuan said.
Separately, 12-month complete response data for the cretostimogene-plus-gemcitabine combination program (cohort CX) are expected by the end of 2024. Cohort CX tested concurrent and sequential dosing schedules; Kuan described response rates as being in the high 80s to 90s for both regimens.
The company also has two other programs in the pipeline. BOND-003, studying BCG-unresponsive high-risk disease, carries Breakthrough Therapy Designation from the FDA and will form the basis of the initial BLA submission. Durability of response has been demonstrated from 12 to 24 months. A third phase III trial is planned for BCG-exposed high-risk disease, comparing cretostimogene plus gemcitabine against gemcitabine alone.
Kuan noted that manufacturing work for the initial BLA is largely complete, with Module 3 documentation representing the primary remaining task. He added that permanent J-code assignment typically takes about six months after drug approval.
On manufacturing, Kuan defended the company's decision to outsource fill-and-finish work to Biovire, saying: "Our shareholder base and investors early on opted in for outsourcing manufacturing. Most companies would face that challenge. We've gone through that phase already."
Shares of CG Oncology are up 114% over the past year and 73% year-to-date as of the conference, trading near Fair Value. The company carries a market capitalization of $6.4 billion and reports current revenue of $6.23 million. Its current ratio stands at 22.22, and the company holds more cash than debt. Wall Street analysts have set price targets ranging from $79 to $108.
CG Oncology's next earnings report is scheduled for November 12, 2026.
