A Phase 1 Safety Study of SANGUINATE™ In Patients With Acute Severe Anemia.

Data collection for each patient during the in-patient portion of the study will be required
for up to a maximum of 14 days while under critical care, with additional collection of
safety-related findings at 7 days and 14 days after the last infusion of SANGUINATE. Each
patient will thus have up to 28 days participation in the trial.

A minimum of 100 subjects are to be enrolled and to receive at least one infusion of
SANGUINATE, with 14-day follow-up after the last infusion.

Because of the life-threatening effects of severe anemia, it is expected that all patients
in this trial will receive care within a critical care facility (may be called intensive
care or some similar name), wherein all patients will have real-time monitoring of vital
signs and ECG (e.g., by telemetry) before, during, and after all study drug infusions.

Inclusion Criteria:

1. The patient would otherwise receive RBC transfusion for treatment of severe anemia
but cannot (hemolytic/allosensitized or no compatible blood) or will not
(religious/personal objection) receive RBCs

2. Hemoglobin ≤ 5 g/dL, or hemoglobin ≤ 7 g/dL following a decline of ≥ 5 g/dL over less
than 7 days

3. Age ≥ 18 years

4. Receiving or willing to receive supplemental iron therapy (unless contraindicated)

5. Receiving or willing to receive erythropoiesis-stimulating agent (EPO) therapy

6. Patient or legally authorized representative provided consent to participate

7. Investigator determination that the patient is an appropriate candidate for study
enrollment

Exclusion Criteria:

1. Hemoglobin ≤ 2 g/dL

2. Presence of severe trauma (e.g., Injury Severity Score (ISS)/New Injury Severity
Score (NISS) Score ≥ 25)

3. Unable to provide sufficient blood sample volume for screening assessments; or

4. Pregnant; or

5. Investigator determination that the patient is not an appropriate candidate for study
enrollment