CGON: Remain Confident In PIVOT-006 After Updating Our Expectations To Reflect Refreshed Timing Assumptions

Research evidence excerpt

CGON: Remain Confident In PIVOT-006 After Updating Our Expectations To Reflect Refreshed Timing Assumptions

CG Oncology, Inc.

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We note that the estimate of a 30% relative risk reduction is conservative relative to BOND-003's

efficacy signal for Creto (Exhibit 1), but even so, was potentially achievable by AUA as it could

have yielded about 50% of patients having an event.

Exhibit 1 - Projected Effect Sizes and Events Across Creto and TURBT Expectations

Source: RBC Capital Markets estimates; * estimate based on 9-month data

As we've frequently seen 50% used as a typical threshold for triggering an interim analysis in

oncology trials more broadly, we think these results map to CGON potentially anticipating the

TURBT control arm reporting a 50% RFS decline by 12 months (the more favorable end of their

commentary range, derived from the ATLAS trial). As such, the delay in PIVOT's readout suggests

that Creto is either outperforming the RFS/month decline rate of 2.9, or TURBT is performing

better.

With no readout 1.5 months after AUA, we think the data is likely by mid-July. If we recalculate

the stopping criteria based on the various Creto and TURBT control arm scenarios described

above, we see that two scenarios have already crossed the threshold, while 4 other scenarios

are almost at our estimated finish line.

Exhibit 2 - We estimate an early 2H Readout Across Most Scenarios For Creto

Source: RBC Capital Markets estimates

These results suggest that CGON is likely to readout PIVOT-006 sometime over July '26, with

more remote possibilities of August and September in the event of both a highly effective Creto

response in patients along with a better than expected TURBT arm – leading to fewer overall

events.