OTL38 Injection for Intraoperative Imaging of Folate Receptor Positive Lung Nodules

This is a phase 2, multi-center, single dose, open-label, exploratory study in suspected lung
cancer patients scheduled to undergo endoscopic or thoracic surgery per CT/positron emission
tomography (PET) imaging based on standard of care.

Two to three hours prior to surgery, patients will be infused with OTL38. After the patient
is intubated and surgical site incised, the surgeon will locate and document all nodules
identifiable by white light, manual palpation, and Near-Infrared Imaging (NIR). This will be
documented and recorded. Surgery will be completed per surgeon's standard of care, afterwards
the area will be reviewed under standard and infrared light. All samples will be sent for
pathology and immunohistochemistry (IHC) evaluation.

Inclusion Criteria:

1. Male and Female patients 18 years of age and older

2. Confirmed diagnosis of adenocarcinoma lung cancer OR,

3. Have a primary diagnosis, or at high clinical suspicion, of lung nodule(s) warranting
surgery based on CT and/or PET imaging

4. Who are scheduled to undergo endoscopic or thoracic surgery surgery

5. 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

6. 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

7. Ability to understand the requirements of the study, provide written informed consent
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 Folate Receptor-negative lung nodules

3. Any medical condition that in the opinion of the investigators could potentially
jeopardize the safety of the patient

4. History of anaphylactic reactions or severe allergies

5. History of allergy to any of the components of OTL38, including folic acid

6. Pregnancy, or positive pregnancy test

7. Clinically significant abnormalities on electrocardiogram (ECG) at screening.

8. Presence of any psychological, familial, sociological or geographical condition
potentially hampering compliance with the study protocol and follow-up schedule

9. Impaired renal function defined as epidermal growth factor receptor (eGFR) < 50
mL/min/1.73m2

10. Impaired liver function defined as values > 3x the upper limit of normal (ULN) for
alanine aminotransferase (ALT) or aspartate aminotransferase (AST), alkaline
phosphatase (ALP), or total bilirubin.

11. Received an investigational agent in another investigational drug or vaccine trial
within 30 days prior to surgery

12. Known sensitivity to fluorescent light