Open-Label Study to Evaluate Efficacy and Safety of SCY-078 in Patients With Refractory or Intolerant Fungal Diseases

This is a multicenter, open label, non-comparator, single arm study to evaluate the efficacy
and safety of SCY-078 in patients ≥ 18 years of age with a documented invasive and/or severe
fungal disease that has been intolerant or refractory (rIFI) to Standard of Care (SoC)
antifungal treatment. Patients will be treated with SCY-078 for up to 90 days.

Subjects must have a proven or probable fungal disease and meet all study criteria to be
considered for enrollment. Eligible subjects must also have documented evidence of failure
of, intolerance to, or toxicity related to a currently approved SoC antifungal treatment.

Subjects will also be considered for enrollment if they have an eligible fungal disease and,
in the judgement of the investigator, the subject cannot receive approved oral antifungal
options (e.g. susceptibility of the organism or risk for drug-drug interactions) and a
continued IV antifungal therapy is not desirable or feasible due to clinical or logistical
circumstances.

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

Inclusion Criteria:

1. Be ≥ 18 years of age with a documented eligible invasive and/or severe fungal disease
that is refractory or intolerant to Standard-of-Care treatment

2. Be able to tolerate medication orally or through a nasogastric (NG) tube or
percutaneous endoscopic gastrostomy (PEG) tube

3. Must be able to understand and sign a written informed consent form (ICF), which must
be obtained prior to treatment and any study-related procedures.

4. Be able to understand and sign a consent or authorization form which shall permit the
use, disclosure and transfer of the subject's personal health information. (e.g., in
the U.S. HIPAA Authorization form).

5. Be able to understand and follow all study-related procedures including study drug
administration.

6. Agree to use a medically acceptable method of contraception while receiving
protocol-assigned product.

Exclusion Criteria:

1. An invasive fungal disease with CNS, cardiac or eye involvement.

2. A life expectancy < 3 days.

3. Subjects has a known or estimated creatinine clearance of <20 mL/min by Cockroft
Gault. Estimated creatinine clearance = [(140-age) x weight in Kg]/[72x serum
creatinine in mg/dL) [x 0.85 if female]. Subjects undergoing dialysis.

4. Subject with abnormal liver test parameters: aspartate aminotransferase (AST), alanine
aminotransferase (ALT) >10 x the upper limit of normal (ULN), and/or total bilirubin >
5 x ULN. Patients with unconjugated hyperbilirubinemia with diagnosis of Gilbert's
disease are not excluded.

5. There is inappropriate fungal infection source control e.g., persistent catheters,
devices, identified abscess likely to be the source of the fungal infection.

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

7. Subject requires treatment with the prohibited medications.

8. Subject with a known hypersensitivity to SCY-078 drug under study.

9. Subject with < 500 absolute neutrophils per mL at baseline. NOTE: Patients with an
absolute neutrophil count (ANC) < 500/mm3 who are receiving G-CSF are allowed to
enroll if the patient is expected to recover from the severe neutropenia (ANC <
500/mm3) in 3 to 5 days after starting with G-CSF treatment and if the patient is
expected to meet inclusion/exclusion criteria at the time of reevaluation.

10. Subject is pregnant or lactating.

11. Subject has used an investigational drug within 30 days prior to the baseline visit.

12. Any other condition or laboratory abnormality that, in the judgment of the
investigator, would put the subject at unacceptable risk for participation in the
study or may interfere with the assessments included in the study.

13. Prolonged QTc (Fridericia's correction: QTc = QT/RR0.33) > 480 findings on the
baseline ECG or other abnormalities deemed clinically significant by the investigator
that would put the subject at unacceptable risk for participation in the study.