Comments on COO Departure

研报英文原文证据摘录

Comments on COO Departure

Biotechnology - Oncology & Rare Diseases

FLASH

FLASH: CG ONCOLOGY, INC. (CGON) May 26, 2026

Comments on COO Departure Rating:

Peer PerformCG Oncology announced the departure of the company's COO Ambaw Bellete Price:

this morning. Based on the team's reply to our question, the departure sounds more $64.25

operational in nature and is not indicative of any disruption to ongoing programs. Price Target:

NACGON noted that the change has no impact on CMC, BLA filing timing, or the

PIVOT-006 trial. We also learned that the CCO was not involved in PIVOT-006, which Source: FactSet, Wolfe Research

remains blinded and is under Vijay's team. The company appears focused on hiring a Priced as of 05/22/26

CCO with more recent and relevant launch experience to support a potentially multi-

billion dollar NMIBC launch.

Shares are weak following the news (CGON ~4% vs. XBI +1%), though we view

this as a temporary blip and would expect focus to return to the upcoming readout,

which we believe is likely to be positive. Our base case is that the control arm yields Kalpit Patel

a 12-mo RFS of 61% vs. ~72% treatment arm (HR of ~0.67). Based on investor kpatel@wolferesearch.com (646) 419-2570

inbounds, we think the Street is looking for a HR closer to 0.6 (vs. the 0.7 bar). View Kalpit’s Research

View CGON Model

We have also received inbounds on CMC. Recall, CGON narrowed the guidance from View Comp Table

2026 to 4Q26 for completion of the BLA filing. We think the transition at the fill-finish

CDMO Biovire is likely the main piece of what's taking time. This facility previously Gugangraghuraman@wolferesearch.comRaghuraman

passed a CDRH inspection cleanly — but that's a device inspection, different from the 646-419-2572

CBER pre-license inspection CG is preparing for.