A Phase I/II Double-Blind, Randomized, Controlled Study to Evaluate the Safety and Efficacy of RUT058-60

Post-surgical site infections account for approximately 20% of total healthcare-associated
infections (HAI), making surgical site infections the most common HAI in US hospitals.
Despite the routine use of prophylactic systemic antibiotics and improvements in surgical
techniques, surgical site infections continue to be associated with significant morbidity,
reduction in quality of life and overall cost following abdominal surgery.

Ruthigen is conducting this Phase I/II clinical study to evaluate the safety and potential
efficacy of RUT058-60 in preventing surgical deep incisional and organ space infection in
subjects undergoing abdominal surgery as an adjunctive therapy to prophylactic systemic
antibiotics.

Inclusion Criteria:

- Willing and able to give written informed consent to participate in the study and
authorization to release health information

- Males or females that are at least 2-years post-menopausal or surgically sterile; 18
to 75 years of age at screening

- Good general health defined as an ASA Physical Status score of moderate or 1
(healthy) or 2 (mild systemic illness), no clinically significant abnormal findings
which, in the opinion of the Investigator, would jeopardize the safety of the subject
or impact the validity of the study results. Clinical laboratory values ->/+20%
outside the normal range may be deemed acceptable

- Willing and able to follow study instructions and available to complete all study
requirements and visits

- Scheduled to undergo a planned, non-emergent abdominal surgical procedure involving
an open incision of ≥7 cm and ≤35 cm in length. Eligible surgeries include, but may
not be limited to: left hemicolectomy, right hemicolectomy, transverse colectomy,
total abdominal colectomy with ileorectal anastomosis, lower anterior surgeries,
abdominoperineal resection, Ileostomy closures and HARTMAN take down.

Exclusion Criteria:

- Tumor debulking, contaminated surgeries (e.g., extruded bowel) minimally invasive
procedures, Caesarian section and hysterectomy

- Laparoscopic appendectomy

- History of allergy or sensitivity to any components of the investigational product

- Body mass index [BMI] >40

- American Society of Anesthesiologists' (ASA) Classification of Physical Status score
≥ 3 (severe systemic illness)

- Evidence preoperatively, of any of the following: sepsis, severe sepsis, or septic
shock, or a history of delayed wound healing

- Current surgical site infection (superficial, deep incisional or organ/space)
secondary to previous laparotomy/ laparoscopy, or from any other cause

- Receiving any oral or intravenous antibiotics within 1-week prior to Baseline Day 0.
Prophylactic antibiotics for dental or other brief procedures are acceptable.
Pre-surgical administration of antibiotics is required as part of surgery
preparation.

- Preoperative evaluation suggests intra-abdominal process that might preclude full
closure of the skin

- History of chemotherapy within 4-weeks or radiation therapy within 4-weeks prior to
Baseline

- Terminal illness with life expectancy of less than 6 months from Baseline

- Current smokers, malnourished subjects, subjects with diabetes or uncontrolled serum
glucose

- History of major organ transplantation, including bone marrow transplantation

- History of laparotomy within 60-days prior to Baseline

- Preoperative pain threshold (PT) or international normalized ration (INR) >2 x upper
limit of normal

- Taking the following concomitant medications within 2 weeks prior to Baseline;
systemic steroids or other anti-inflammatory/immunosuppressive medication, or have a
history of a current immunosuppressive condition or immune
deficiency.Anti-inflammatory medications taken pro re nata (PRN) are allowed per
institution/ investigator restriction

- HIV patients or patients with Hepatitis B or C

- Prosthetic cardiac valve or joint prostheses and any potential for remote body site
infection

- Medically significant cardiac arrhythmia, or prolonged corrected QT interval (QTc)
interval >450 msec

- An ATE (MI, cerebrovascular attack [CVA], TIA), venous thromboembolic event [VTE]
(e.g., deep vein thrombosis [DVT], PE), within 12 months of Baseline

- Increased hemorrhage risk (e.g., coagulation disorders)

- Women of child bearing potential (WOCBP) or females that are pregnant, nursing, or
planning a pregnancy during the study

- Current enrollment in an investigational drug or device study or participation in
such a study within the last 30 days prior to Baseline (Day 0)

- Evidence of active uncontrolled infection or unstable or severe intercurrent medical
conditions. All subjects must be afebrile at Baseline (i.e., <38.0° Celsius [C])

- History of stage IV cancer*, other clinically significant renal, hepatic, neurologic,
hematologic, respiratory, psychiatric, cardiovascular, infectious disease,
psychological condition or social situation which, in the opinion of the
Investigator, puts the subject at significant risk, could confound the study results,
or may interfere significantly with the subject's participation in the study