An Expanded Access Program of Cretostimogene Grenadenorepvec for Treatment of NMIBC for Patients Unresponsive to BCG

Inclusion Criteria:

1. Have pathologically confirmed BCG unresponsive CIS. There is no maximum limit to the
amount of prior BCG treatment, but maintenance BCG should be administered on a
schedule consistent with standard induction-maintenance protocols. Specifically, the
definition of BCG unresponsive CIS will also require the following:

- Pathologically confirmed relapsed or persistent CIS (with or without HG Ta or
HG T1 disease)

- Completion of qualifying BCG treatment (e.g., "5+2" minimum exposure) within 15
months of the initial qualifying dose of BCG.

2. Have all Ta and/or T1 disease and all CIS resected or fulgurated, as feasible, prior
to study treatment

3. Ineligible to receive radical cystectomy (medically unfit) or refusal of radical
cystectomy according to Investigator assessment.

4. Acceptable baseline organ function

Exclusion Criteria:

1. Muscle invasive bladder cancer, locally advanced or metastatic bladder cancer.

2. Has had active autoimmune or inflammatory disease requiring systemic treatment
within 4 weeks of Day 1. Replacement therapy is not considered an excluded form of
systemic treatment and is allowed.

3. Has received systemic anticancer therapy, including investigational agents, within 4
weeks of Day 1

4. Is pregnant, currently breastfeeding or intending to breastfeed, beginning at
Screening through 1 week after the last study treatment.