CG Oncology: Takeaways from our investor dinner with CG Oncology management

研报英文原文证据摘录

CG Oncology: Takeaways from our investor dinner with CG Oncology management

Label expectations for both IR and HR setting clear

On the IR NMIBC commercial opportunity, management emphasized that the initial label

would likely reflect one year of treatment, with the option for post-marketing work to

explore extending treatment duration beyond one year. The dosing schedule is

meaningfully different by setting: IR NMIBC would require 14 doses in year one, while

BCG-UR is 18 doses in year one and up to 30 doses over three years. The company has

not anchored price, but noted price per dose should be the same across indications

(different total cost by indication based on dose count). Management believes duration

of response and safety are key differentiators, and suggested that any BCG-UR label

duration beyond 12 months would be a win, while acknowledging precedents such as

ANKTIVA with 24-month duration of response. For IR, an sBLA would require 12-month

data and a clinical write-up, with the 12-month timepoint expected sometime this year.

AUA Cohort CX data could meaningfully expand TAM

We also came away more attentive to the BCG-exposed setting, which management

framed as a meaningful TAM expansion opportunity. Management noted that BOND-003

had to turn away a meaningful number of patients who did not meet the strict BCG-

unresponsive definition, suggesting a BCG-exposed label could capture real-world

demand that currently falls outside the initial UR opportunity. Near term, the company

highlighted upcoming Cohort CX data in BCG-exposed and -UR settings at AUA, including

sequential vs concurrent administration, as an important dataset to watch and

potentially informative for the BCG-exposed strategy. At AUA, management pointed to