Phase 2 Study of Reltecimod vs Placebo in Patients With Sepsis-associated Acute Kidney Injury

Phase 2 randomized, placebo controlled study assessing the efficacy (complete recovery from
AKI) and safety of Reltecimod in patients with suspected or confirmed abdominal sepsis
(planned or completed surgical (laparotomy or laparoscopy) or interventional radiologic
procedures for control of underlying abdominal infection within 24 hours of evaluation by
medical personnel), requiring intensive care unit (ICU) or step down unit admission and in
whom the diagnosis of Stage 2/3 acute kidney injury (AKI; as defined by Kidney Disease
Improving Global Outcomes (KDIGO) criteria) is established at initial presentation for
medical evaluation or up to 48 hours from the suspected diagnosis of abdominal sepsis.

Inclusion Criteria:

1. Has either suspected or documented diagnosis of abdominal sepsis requiring treatment
with parenteral antibiotics and planned or completed surgical (laparotomy or
laparoscopy) or interventional radiologic procedures within 24 hours of evaluation by
medical personnel. Recommended surgical or interventional radiologic procedures be
performed with 12 hours of evaluation by medical personnel.

2. Initial diagnosis of AKI Stage 2 or 3 according to KDIGO AKI criteria established
either upon presentation to medical care in those patients with suspected abdominal
sepsis or in those patients in whom the initial diagnosis of AKI is established during
the 48 hour period from the suspected diagnosis of abdominal sepsis.

3. Study medication must be administered within 6 hours of confirmation of onset of Stage
2 or 3 AKI as established at the study site, under the following criteria:

- After the decision is made by the attending surgeon at the study site for a
surgical or interventional radiology procedure for the abdominal infection OR

- After confirmed diagnosis of abdominal infection has been established by a
surgical or interventional radiology procedure

Exclusion Criteria:

1. Has known prior history of CKD with a documented estimated GFR (eGFR) < 30 mL/min

• Exception: Patients with history of CKD but no available prior eGFR who have
documented normal kidney size on ultrasound or computed tomography evaluation
(performed within 90 days of screening) will be eligible

2. Patients receiving RRT for chronic kidney disease

3. Patients that are treated with RRT for acute kidney dysfunction, starting prior to
study drug administration or in whom there is an immediate plan to initiate RRT upon
diagnosis of AKI

4. Previously diagnosed with documented AKI in the last 30 days

5. Documented primary glomerular disease or toxic tubulo-interstitial nephritis at the
time of AKI diagnosis

6. Patient is not expected to survive throughout 28 days of study due to significant
underlying medical condition

7. Any concurrent medical condition, which in the opinion of the Investigator, may
compromise the safety of the patient or the objectives of the study or the patient
will not benefit from treatment such as:

- Congestive heart failure (CHF) {New York Heart Association (NYHA) class III-IV}

- Severe chronic obstructive pulmonary disease (COPD) {GOLD stage III-IV. or
chronic hypoxemia

- Liver dysfunction {Childs-Pugh class C}

- Primary or acquired immunodeficiency or immunosuppression due to treatment with
immunosuppressive medications

- Known HIV infection with CD4 count < 200 cells/mm3 or < 14% of all lymphocytes

- Neutropenia < 1,000 cells/mm3 not due to the underlying infection

- Receiving or about to receive chemotherapy or biologic anti-cancer treatment,

- Hematological and lymphatic malignancies in the last 5 years

8. Patient has acute pancreatitis with no established source of infection, uncomplicated
appendicitis, or cholangitis or cholecystitis without peritonitis;

9. Pregnant or lactating women

10. Concurrent or previous enrollment in a clinical trial involving investigational drug
or a medical device