Open-Label Study to Evaluate the Efficacy and Safety of SCY-078 in Patients With Candidiasis Caused by Candida Auris (CARES)

This is a multicenter, open-label, non-comparator, single-arm study to evaluate the efficacy,
safety, tolerability and PK (for a subset of subjects) of oral SCY-078 in male and female
subjects ≥18 years of age with a documented Candida auris infection. Patients will be treated
with SCY-078 for up to 90 days.

Subjects must have a documented candidiasis, including candidemia, caused by Candida auris to
be considered for enrollment. Subjects are also eligible if they are receiving intravenous
(IV) antifungal therapy for their C. auris infection and, in the judgment of the
investigator, continued IV antifungal therapy is not feasible or desirable due to clinical or
logistical circumstances. Subjects must meet all study criteria to be eligible for inclusion.
Inclusion of each subject in the study must be approved by the Sponsor prior to enrollment.

Following a screening visit , there will be up to 11 treatment visits, a follow-up visit and
2 follow-up contacts (survival visits)

Inclusion Criteria:

- Subject must fulfill the following KEY criteria to be eligible for study admission:

1. Subject is a male or female adult ≥ 18 years of age on the day the study informed
consent form (ICF) is signed.

2. Subject has a documented candidiasis, including candidemia, caused by Candida
auris. The subject is also eligible if he/she is receiving IV antifungal therapy
for their C. auris infection and, in the judgment of the investigator, long-term
IV antifungal therapy is not feasible or desirable due to clinical or logistical
circumstances. A documented candidiasis, including candidemia, caused by Candida
auris is defined as the recovery of Candida auris by culture of a sample obtained
within the last 7 days.

3. Subject is able to tolerate medication orally or through a nasogastric (NG) tube
or percutaneous endoscopic gastrostomy (PEG) tube.

Exclusion Criteria:

- KEY exclusion criteria:

1. Subject has a fungal disease with central nervous system involvement.

2. Subject has a fungal disease of the bone and/or joint that is expected to require
>90 days of study drug treatment.

3. Subject has an inappropriately controlled fungal infection source (e.g.,
persistent catheters, devices, identified abscess) that is likely the source of
the fungal infection.

4. Subject is hemodynamically unstable and/or requiring vasopressor medication for
blood pressure support.

5. Subject has abnormal liver test parameters: AST or ALT >10 x ULN, and/or total
bilirubin >5 x ULN. Note: Subjects with unconjugated hyperbilirubinemia with
diagnosis of Gilbert's disease are not excluded.

6. Subject has an Apache score >16.

7. Subject has serum creatinine >3 times from Baseline (Screening/Treatment Day 1)
value.