Reports Q1: BLA Completion In Q4 Could Set Up Coordinated HR & IR Launches

Research evidence excerpt

Reports Q1: BLA Completion In Q4 Could Set Up Coordinated HR & IR Launches

Biotechnology

CG Oncology

TD SECURITIES (USA) LLC EARNINGS UPDATE

May 11, 2026

Price: $69.62 (05/8/2026) Reports Q1: BLA Completion In Q4 Could Set

Price Target: NA Up Coordinated HR & IR Launches

BUY (1)

ESG SCORE: 57/100

Tyler Van Buren THE TD COWEN INSIGHT

646 562 1343

CG narrowed creto's BLA submission completion to Q4, citing inspection readiness. The

tyler.vanburen@tdsecurities.com

timeline could now position CG to conduct both the HR and IR launches in 2027, potentially

Sam Rollenhagen differentiating itself as the only agent to span settings. The pivotal PIVOT-006 data are

212 468 7785 expected soon in Q2, which we believe have a very high probability of success. Initial creto

samuel.rollenhagen@tdsecurities.com

+gem data will be presented at AUA.

Nicholas Lorusso

646 562 1390 Pivotal PIVOT-006 Data Are Coming By The End Of June & Should Be Positive

nick.lorusso@tdsecurities.com

CG remains on track to report the pivotal Phase III PIVOT-006 data of creto in intermediate-

Greg W. Torres, Ph.D. risk NMIBC in Q2. We expect the data will be presented after AUA in late May or June.

646 562 1351

gregory.wiessner@tdsecurities.com Given the recent enrollment completion (Sept.), we expect the topline data to focus on the

hazard ratio for the improvement of RFS, which is the primary endpoint, and potentially the 3

Key Data

and/or 6-month RFS rates. Management points to a hazard ratio of 0.7 as the bar, while our

Symbol NASDAQ: CGON

KOLs have clustered closer to 0.6. In PIVOT-006, adjuvant creto is being compared against

Beta: 0.42

a control arm of watch-and-wait following TURBT. However, with longer follow-up, it will also

52-Week Range: $73.43-$23.74