OTL38 for Intra-operative Imaging of Folate Receptor Positive Ovarian Cancer

The Phase 3 study is to confirm the efficacy of OTL38 in combination with fluorescent light
to detect additional Folate Receptor-positive (FR+) ovarian cancer lesions not detected by
palpation and visualization under normal light in patients with FR+ ovarian cancer scheduled
to undergo primary surgical cytoreduction, interval debulking, or recurrent ovarian cancer
surgery

Inclusion Criteria:

- 1. Female patients 18 years of age and older 2. Have a primary diagnosis, or at high
clinical suspicion, of primary ovarian cancer (of epithelial type), planned for
primary surgical cytoreduction, interval debulking, or have recurrent ovarian cancer
surgery, and:

- Who are scheduled to undergo laparotomy for the debulking surgery OR

- Who are scheduled to undergo laparoscopy and pre-authorized to undergo laparotomy
for the debulking surgery if cancer is detected on the laparoscopy 3. A negative
serum pregnancy test at Screening followed by a negative urine pregnancy test on
the day of surgery or day of admission for female patients of childbearing
potential 4. Female patients of childbearing potential or less than 2 years
postmenopausal agree to use an acceptable form of contraception from the time of
signing informed consent until 30 days after study completion 5. Ability to
understand the requirements of the study, provide written informed consent for
participation in the study and authorization of use and disclosure of protected
health information, and agree to abide by the study restrictions and to return
for the required assessments

Exclusion Criteria:

- 1. Previous exposure to OTL38 2. Known FR-negative ovarian cancer 3. Planned surgical
debulking via laparoscopy or robotic surgery, with no intent of laparotomy.

4. Patients with known ovarian cancer miliary disease prior to surgery 5. Any medical
condition that, in the opinion of the investigators, could potentially jeopardize the
safety of the patient 6. History of anaphylactic reactions 7. History of allergy to
any of the components of OTL38, including folic acid 8. Pregnancy or positive
pregnancy test 9. Clinically significant abnormalities on electrocardiogram (ECG) 10.
Presence of any psychological, familial, sociological or geographical condition
potentially hampering compliance with the study protocol and follow-up schedule 11.
Impaired renal function defined as eGFR< 50 mL/min/1.73m2 12. Impaired liver function
defined as values > 3x the upper limit of normal (ULN) for alanine aminotransferase
(ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), or total
bilirubin.

13. Known Stage IV ovarian cancer with brain metastases 14. Received an
investigational agent in another clinical trial within 30 days prior to surgery 15.
Known sensitivity to fluorescent light