CGON - Quick Take - UGN-501 IND Clearance Reinforces Oncolytic Virus in NMIBC; Incremental Positive for CGON

Research evidence excerpt

CGON - Quick Take - UGN-501 IND Clearance Reinforces Oncolytic Virus in NMIBC; Incremental Positive for CGON

Truist Securities

Equity Research Report July 8, 2026

HEALTHCARE: Biotech CG Oncology, Inc. (CGON)

CGON - Quick Take - UGN-501 IND Clearance Reinforces Gregory Renza, M.D.

212-419-4617 Oncolytic Virus in NMIBC; Incremental Positive for CGON

Gregory.Renza@truist.com

Supawat Thongthip, Ph.D. This morning, competitor Urogen (URGN, NR) disclosed FDA IND clearance for UGN-501

212-401-4429 (formerly ICVB-1042), an oncolytic virus in non-muscle invasive bladder cancer (NMIBC).

Supawat.Thongthip@truist.com We view this news as underscoring continued landscape activity in NMIBC and

incremental validation of the oncolytic virus approach particularly in high-grade

Anish Nikhanj, Ph.D. disease - an incrementally positive readthrough for CGON's cretostimogene. We note

212-326-3106 that Creto remains meaningfully ahead in development, with the BLA submission completion

Anish.Nikhanj@truist.com in HR BCG-unresponsive NMIBC targeted by YE26 and a ph.III PIVOT-006 readout in the

IR NMIBC in the coming months (from previously 1H26). With a vote of confidence in

the oncolytic virus MoA in NMIBC and Creto's regulatory timeline intact, despite the

recent mgmt transition - we maintain our Buy rating.

Current Price (Jul. 7, $69.20

2026) Similar to Creto, UGN-501 is a genetically engineered adenovirus designed to selectively

Stock Rating BUY infect and replicate within tumor cells, leading to tumor lysis while stimulating an antitumor immune response. Notably, UGN-501/ICVB-1042 was originally developed by IconOVir Bio Unchanged

(private) as an intravenous therapy in solid tumors, though discontinued due to lack of clinical

Price Target $82.00 activity.