Phase 1b/2a, Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study of Safety, Tolerability, and Efficacy of Intravenous AP-SA02 as an Adjunct to Best Available Antibiotic Therapy for the Treatment of Adults With Bacteremia Due to Staphylococcus Aureus
Phase: PHASE1
Conditions: Bacteremia, Staphylococcus Aureus, Staphylococcus Aureus Bacteremia, Bacteremia Staph, Bacteremia Due to Staphylococcus Aureus
Sponsor: Armata Pharmaceuticals, Inc.

CLINICAL STUDY PROTOCOL 
Phase 1b/2a, Randomized, Double-Blind, Placebo-Controlled, 
Multiple Ascending Dose Escalation Study of the Safety, 
Tolerability, and Efficacy of Intravenous AP-SA02 as an Adjunct to 
Best Available Antibiotic Therapy Compared to Best Available 
Antibiotic Therapy Alone for the Treatment of Adults With 
Bacteremia Due to Staphylococcus aureus 
Investigational Product: AP-SA02 
Protocol Number: AP-SA02-101 
EudraCT Number: 2021-001190-22 
Sponsor: 
Armata Pharmaceuticals, Inc. 
5005 McConnell Avenue 
Los Angeles, CA 90066
United States  
Telephone: +1-310-665-2928 
Version Number: 4.0 
Date:  25 July 2024 
Confidentiality Statement 
This clinical study protocol and the information contained herein is the confidential and 
exclusive property of Armata Pharmaceuticals, Inc., subject to the confidentiality obligations 
contained in the Clinical Study Agreement between Armata Pharmaceuticals, Inc. and your 
institution relating to this study. 

Armata Pharmaceuticals, Inc. 
Clinical Study Protocol AP-SA02-101 
 
Armata Pharmaceuticals, Inc. 
Confidential & Proprietary 
Page 2 of 78 
Version 4.0, 25 July 2024 
SIGNATURE PAGE 
STUDY TITLE: Phase 1b/2a, Randomized, Double-Blind, Placebo-Controlled, Multiple 
Ascending Dose Escalation Study of the Safety, Tolerability, and Efficacy of Intravenous 
AP-SA02 as an Adjunct to Best Available Antibiotic Therapy Compared to Best Available 
Antibiotic Therapy Alone for the Treatment of Adults With Bacteremia Due to 
Staphylococcus aureus 
 
We, the undersigned, have read this protocol and agree that it contains all necessary information 
required to conduct the study. 
Signature 
 
 
 
 
 
 
 
Date 
 
Deborah Birx, MD 
Chief Executive Officer 
Armata Pharmaceuticals, Inc. 
 
Mina Pastagia, MD 
Chief Medical Officer 
Armata Pharmaceuticals, Inc. 
July 31, 2024
31July2024

Armata Pharmaceuticals, Inc. 
Clinical Study Protocol AP-SA02-101 
Armata Pharmaceuticals, Inc. 
Confidential & Proprietary 
Page 3 of 78 
Version 4.0, 25 July 2024 
INVESTIGATOR AGREEMENT 
By signing below I agree that: 
I have read this protocol. I approve this document and I agree that it contains all necessary details 
for carrying out the study as described. I will conduct this study in accordance with the protocol 
inclusive of the design and specific provisions of this protocol and will complete the study within 
the time designated in this protocol. I will provide copies of this protocol to study personnel under 
my supervision. I will discuss this material with them to ensure they are fully informed about the 
study product and study procedures. I will let them know that this information is confidential and 
proprietary to Armata Pharmaceuticals, Inc., that it may not be further disclosed to third parties, 
and is subject to the confidentiality obligations contained in the Clinical Study Agreement. 
I understand that the study may be terminated or enrollment suspended at any time by Armata 
Pharmaceuticals, Inc. with or without cause, or by my institution in accordance with the terms of 
the Clinical Study Agreement. 
I agree to conduct this study in full accordance with all applicable laws and regulations, including 
Food and Drug Administration Regulations, Institutional Review Board/Ethic Committee 
Regulations, and International Council for Harmonisation Guidelines for Good Clinical Practices. 
 
 
 
 
 
 
______________________________________________  
____________________ 
Investigator’s Signature 
 
 
 
 
 
Date 
 
 
 
______________________________________________ 
Investigator’s Printed Name 
 

Armata Pharmaceuticals, Inc. 
Clinical Study Protocol AP-SA02-101 
 
Armata Pharmaceuticals, Inc. 
Confidential & Proprietary 
Page 4 of 78 
Version 4.0, 25 July 2024 
SYNOPSIS 
TITLE: Phase 1b/2a, Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose 
Escalation Study of the Safety, Tolerability, and Efficacy of Intravenous AP-SA02 as an Adjunct 
to Best Available Antibiotic Therapy Compared to Best Available Antibiotic Therapy Alone for 
the Treatment of Adults With Bacteremia Due to Staphylococcus aureus 
PROTOCOL NUMBER: AP-SA02-101 
INVESTIGATIONAL PRODUCT: AP-SA02 
PHASE: 1b/2a 
INDICATION: Bacteremia due to Staphylococcus aureus (SA) 
OBJECTIVES: 
Phase 1b  
The objective of Phase 1b is to evaluate the safety and tolerability of multiple ascending 
intravenous (IV) doses of AP-SA02 or placebo as an adjunct to best available therapy (BAT) 
compared to BAT alone in subjects with SA bacteremia (SAB). 
Phase 2a 
The objective of Phase 2a is to evaluate the efficacy, safety, and tolerability of multiple doses of 
AP-SA02 or placebo as an adjunct to BAT compared to BAT alone in subjects with complicated 
SAB. 
POPULATION: 
Subjects who meet all inclusion criteria and none of the exclusion criteria during the 3-day 
screening period will be considered eligible for enrollment in the study. 
Inclusion Criteria  
Inclusion criteria for Phase 1b and 2a 
Subjects who meet all of the following criteria will be eligible to participate in the study: 
1. Is able and willing to provide written informed consent or have consent provided by a legally 
authorized representative (LAR); 
2. Is a hospitalized male or female adult subject aged 18 years or older at time of consent;  
3. Has SAB identified from at least 1 blood culture or from a rapid diagnostic test within 72 hours 
of randomization. Time of positive blood culture starts from when specimen is collected for 
blood culture; 

Armata Pharmaceuticals, Inc. 
Clinical Study Protocol AP-SA02-101 
 
Armata Pharmaceuticals, Inc. 
Confidential & Proprietary 
Page 5 of 78 
Version 4.0, 25 July 2024 
4. Has a plan for source control within 3 days after randomization to be completed within 7 days 
of randomization if relevant (eg, abscess drainage, washout or debridement of infected 
material) or has source already controlled; 
5. If a female of childbearing potential (FCBP), the subject must agree to use a highly effective 
method of birth control (defined as those, alone or in combination, that result in a low failure 
rate [ie, less than 1% per year]) from Day 1 through 60 days following the last dose of study 
drug;  
Note: FCBP must have a negative serum pregnancy test within 72 hours prior to 
randomization. An FCBP is any female, regardless of sexual orientation, who meets the 
following criteria: has not undergone a hysterectomy or bilateral oophorectomy, or has not 
been naturally postmenopausal for at least 12 consecutive months (ie, has had menses at any 
time in the preceding 12 consecutive months). 
6. If a male subject, the subject must agree to use barrier contraception (ie, condoms) from Day 1 
through 60 days following the last dose of study drug;  
Additional inclusion criteria for Phase 2a only 
7. Has at least 1 of the following signs/symptoms at or within 72 hours prior to randomization: 
a. Documented temperature ≥38.0ºC (100.4ºF) or ≤36.0°C (96.8°F) measured orally, 
≥38.5ºC (101.3ºF) or ≤36.5°C (97.7°F) measured tympanically, or ≥39ºC (102.2ºF) or 
≤37°C (98.6°F) measured rectally; 
b. Heart rate >90 beats per minute; 
c. Respiratory rate >20 breaths per minute; 
d. White blood cell count ≥12.0 × 109 cells/L or ≤0.4 × 109 cells/L, or ≥10% immature 
neutrophils;  
e. Systolic blood pressure <90 mmHg; and/or 
f. Pain associated with focal site of infection. 
8. Has at least 1 of the following: 
a. At the time of positive SA blood culture was undergoing chronic intermittent hemodialysis 
or peritoneal dialysis; 
b. Positive blood culture for SA after 2 or more days on anti-staphylococcal antibiotic 
treatment; 
c. Temperature ≥38.0°C (100.4°F) at ≥72 hours after initial blood culture; 
d. SAB associated with signs or symptoms of metastatic foci and/or hematogenous seeding, 
including, but not limited to, septic thrombophlebitis, osteomyelitis (not including 
osteomyelitis associated with hardware or prosthetic joint infection), deep soft tissue 
abscess, 
septic 
arthritis/bacterial 
native 
joint 
infection, 
septic 
pulmonary 
emboli/infarction, visceral soft tissue abscess, or empyema confirmed by physical 
examination, imaging, or culture; and/or 

Armata Pharmaceuticals, Inc. 
Clinical Study Protocol AP-SA02-101 
 
Armata Pharmaceuticals, Inc. 
Confidential & Proprietary 
Page 6 of 78 
Version 4.0, 25 July 2024 
e. Presence of right-sided SAB endocarditis (native valve) by modified Duke criteria, with 
no clinical evidence of cerebral foci requiring at least 28 days of anti-SA antibiotic 
treatment. 
Exclusion Criteria 
Exclusion criteria for Phase 1b and 2a 
Subjects who meet any of the following criteria will be excluded from participation in the study: 
1. Has concomitant growth of organisms besides SA in a blood culture, excluding 
coagulase-negative staphylococci (eg, Staphylococcus epidermidis) and other species when 
considered by the primary team to represent contaminants; 
2. Has, in the 7 days prior to randomization, a positive culture with SA that has a known 
minimum inhibitory concentration to daptomycin >1 mcg/mL or vancomycin >2 mcg/mL; 
3. Has received treatment with any potentially effective (anti-SA) systemic antibiotic for more 
than 72 hours within 7 days prior to randomization; 
  
Note: Subjects who have received >72 hours of antibiotics and have documented resistance to 
administered therapy or persistent SAB on 2  blood cultures obtained over 72 hours may be 
considered for the study with Sponsor or Medical Monitor approval.  
4. Has known or suspected left-sided infectious endocarditis by modified Duke criteria; 
5. Has a suspected endovascular source of bacteremia including, but not limited to, perivalvular 
abscess, left ventricular assist device (cardiac pacemaker or automatic implantable 
cardioverter-defibrillator [AICD]), AICD wire, arteriovenous graft, prosthetic valves, or valve 
rings; 
Note: A subject with a suspected endovascular source of infection may be considered if that 
source is planned to be removed within 72 hours of randomization. 
6. Has a known or suspected brain abscess;  
Note: A subject with epidural abscess may be included if they do not require surgical 
intervention and have minimal neurologic deficits. 
 
7. Community acquired pneumonia, nosocomial pneumonia due to pathogens other than S. 
aureus. 
 Note: patients with pneumonia due to S. aureus are eligible for enrollment. 
; 
8. Has osteomyelitis that is associated with hardware or prosthetic joint infection; 
Note: A subject with a suspected osteomyelitis with hardware or prosthetic joint infection may 
be considered if that source is planned to be removed within 72 hours of randomization.  
9. Has refractory shock with persistent hypotension (ie, mean arterial pressure <60 mmHg) that 
is unresponsive to fluids and vasopressors at Screening; 

Armata Pharmaceuticals, Inc. 
Clinical Study Protocol AP-SA02-101 
 
Armata Pharmaceuticals, Inc. 
Confidential & Proprietary 
Page 7 of 78 
Version 4.0, 25 July 2024 
10. Has a known allergy to phage products; 
11. Is a female subject who is pregnant or breastfeeding; 
12. In the Investigator’s opinion, the subject is unable to understand and comply with protocol 
requirements, instructions, and protocol-stated restrictions and is unlikely to complete the 
study as planned;  
13. Is currently enrolled in another investigational interventional trial and has received any 
investigational treatment within 28 days prior to consent or will continue to receive any 
investigational treatment during the study; 
14. Has anticipated requirement for effective systemic bacterial therapy unrelated to the treatment 
of SAB or other planned use of systemic antibacterial therapy (eg, treatment of acne vulgaris); 
Note: Prophylactic antibiotics for operative dental procedures and chronic suppressive oral 
antibiotic therapy after completion of a minimum of 14 days (uncomplicated SAB) or 28 days 
(complicated SAB) to 56 days of BAT are permitted.  
15. Has, at Screening, 1 or more of the following laboratory abnormalities: 
 
a. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >5 × upper limit of 
normal (ULN) if total bilirubin <2 × ULN; and/or 
b. ALT or AST >2.5 × ULN if total bilirubin is >2 × ULN.  
16. Has, in the opinion of the Investigator, an acute or chronic medical condition (eg, seizure 
disorder in status epilepticus, acute coronary syndrome, end-stage renal disease with no plan 
to dialyze, metastatic malignancy, chronic severe liver disease, or other disease) or other 
finding that is clinically significant that could put the subject at risk or harm by participating 
in the study; 
17. Has, in the opinion of the Investigator, evidence of a concurrent medical illness that is 
immediately life-threatening, has life-expectancy of less than 3 months, or is likely to elect 
palliative care within 3 months;  
18. Has any known previous exposure to AP-SA02 or prior participation in Study AP-SA02-101; 
19. History of AIDS (human immunodeficiency virus positive with an AIDS-defining condition 
and/or CD4 count <200 cells/mm3) or chronic severe liver disease due to hepatitis B virus 
(HBV) or C virus (HCV), confirmed by medical history or  recent test results (within 90 days 
prior to Screening). If neither of these options are feasible to confirm disease status, rapid 
testing should be performed by the Investigator.  
Additional exclusion criteria for Phase 1b only 
20. Has all of the following signs/symptoms at or within 24 hours prior to randomization: 
a. Documented temperature ≥38.0ºC (100.4ºF) or ≤36.0°C (96.8°F) measured orally, 
≥38.5ºC (101.3ºF) or ≤36.5°C (97.7°F) measured tympanically, or ≥39ºC (102.2ºF) or 
≤37°C (98.6°F) measured rectally; 
b. Heart rate >90 beats per minute; 

Armata Pharmaceuticals, Inc. 
Clinical Study Protocol AP-SA02-101 
 
Armata Pharmaceuticals, Inc. 
Confidential & Proprietary 
Page 8 of 78 
Version 4.0, 25 July 2024 
c. Respiratory rate >20 breaths per minute;  
d. White blood cell count ≥12.0 × 109 cells/L or ≤0.4 × 109 cells/L, or ≥10% immature 
neutrophils; and 
e.  Systolic blood pressure <90 mmHg. 
STUDY DESIGN AND DURATION: 
Adult hospitalized subjects who have a positive blood culture for SA and require a minimum of 
14 days (uncomplicated SAB) or 28 days (complicated SAB) and a maximum of 56 days of IV 
antibiotic therapy may be eligible for this study. Prior to any study screening evaluations, the 
subject (or LAR) must sign an informed consent form. Subjects will be assessed for all inclusion 
and exclusion criteria, source and distal sites(s) of infection, presence of endocarditis, significant 
comorbidities, and National Early Warning Score 2 (NEWS2) score. Screening assessments will 
be completed from Day -3 to Day -1. After all eligibility criteria are met, the subject will be 
randomized. Subjects not fulfilling the eligibility criteria and not randomized may be rescreened 
for participation if their eligibility characteristics change. Screening procedures that fall within the 
screening window do not need to be repeated.  
Blinded study drug will be initiated on Day 1 and administered every 6 hours through Day 5. The 
BAT must be planned for a minimum of 14 days (uncomplicated SAB) or 28 days (complicated 
SAB) and a maximum of 56 days (inclusive of the days on BAT prior to study 
enrollment/randomization) based on the clinical presentation of the subject and the clinical 
judgment of the Investigator. Visits from Day 1 through Day 7 should be performed in an inpatient 
location.  
All subjects will receive antibiotics that are chosen by the Investigator and are per local standard 
of care. If subjects with methicillin-susceptible SA isolates are intolerant to beta-lactam therapy, 
an alternative antibiotic considered to be BAT, is acceptable. The BAT will have been started 
before randomization in most subjects. 
Summary of Study Design 
This is a first-in-human, prospective, Phase 1b/2a, randomized, double-blind, placebo-controlled, 
multiple ascending dose (MAD) study to assess the safety, tolerability, and efficacy of multiple 
IV doses of AP-SA02 as an adjunctive therapy to BAT and compared to BAT alone for the 
treatment of SAB. This multiple dose escalation design will assess the safety and tolerability, as 
well as the efficacy, of various dosing cohorts with phage pharmacokinetics (PK) to identify a 
dose and duration of dosing that offers the best therapeutic potential benefit.  
In Phase 1b, a standard MAD design for safety and tolerability will begin by randomizing subjects 
in Phase 1b Cohort 1 to receive either approximately 2 × 109 plaque-forming units (PFU) or 
placebo in addition to BAT. A Data Review Committee (DRC) will convene to review the data 
from Phase 1b Cohorts and during Phase 2a, as needed. The DRC will review emerging safety 
data throughout the study to determine if it is safe and appropriate to continue the study with the 
currently planned dose levels for the subsequent cohorts, or if further refinement of the proposed 
dose levels or dosing duration is warranted. The planned dose levels and dosing duration after 
Phase 1b Cohort 1 may be modified and/or additional cohorts may be added based on emerging 
information from the current study as well as other ongoing studies. The highest total daily dose 

Armata Pharmaceuticals, Inc. 
Clinical Study Protocol AP-SA02-101 
 
Armata Pharmaceuticals, Inc. 
Confidential & Proprietary 
Page 9 of 78 
Version 4.0, 25 July 2024 
will not exceed 8 × 1011 PFU and no more than 40 additional subjects will be added without a 
protocol amendment. The DRC will also determine how to advance the cohorts (serially or 
simultaneously). The DRC can receive unblinded data, if requested and deemed necessary to 
adequately complete their review. Further details regarding the role, responsibilities, and 
procedures of the DRC will be provided in the DRC Charter. 
The planned enrollment in each of the Phase 1b cohorts is 4 subjects per cohort (AP-SA02 to 
placebo 3:1); however, this may be modified after DRC review. Subjects in Phase 1b Cohort 1 
will receive IV bolus infusion doses of blinded study drug every 6 hours for 5 study days (a total 
of 20 doses) in an inpatient location in addition to BAT. Following 5 days of dosing with study 
drug, additional study visits will be conducted at the End of Treatment (EOT) for study drug 
(Day 5), at the Test of Cure (TOC) for study drug (Day 12), TOC for BAT (7 days [±1 day] after 
the end of BAT), and at End of Study (EOS) (28 days after the end of BAT). Subsequent cohorts 
(eg, planned Phase 1b Cohort 2 or additional cohorts [up to 3]) will proceed similarly; however, 
the duration of dosing may be modified after the DRC review of the preceding cohort. 
In Phase 2a, approximately 42 subjects will receive IV bolus infusion doses of blinded study drug 
every 6 hours, for no more than 14 days as determined by analysis during or after Phase 1b, in 
addition to BAT. Following 5 days of dosing with study drug, additional study visits will be 
conducted at EOT for study drug (Day 5), TOC for study drug (Day 12), TOC for BAT (7 days 
[±1 day] after the end of BAT), and EOS (28 days after the end of BAT). If the study drug EOT 
is extended after the DRC review, the study drug TOC visit will occur 7 days after the last day of 
dosing and the study drug EOS visit will occur 28 days after the end of BAT.  
The following dose cohorts are planned: 
Phase 1b 
• Cohort 1 (AP-SA02 to placebo 3:1): 
o Planned approximately 2 × 109 PFU (1 × 109 PFU/phage) administered via IV bolus 
infusion every 6 hours for a period of 5 days;  
• Cohort 2 (AP-SA02 to placebo 3:1): 
o Planned approximately 2 × 1010 PFU (1 × 1010 PFU/phage) administered via IV bolus 
infusion every 6 hours for a period of 5 days; and 
Note: The dose, frequency, and duration may be modified after DRC review. Maximum dosing 
duration will be no more than 14 days. 
• Additional cohort(s) (up to 3) as determined after DRC review. 
Phase 2a 
• Phase 2a (AP-SA02 to placebo 2:1): 
o Dose and duration are to be determined based on safety and tolerability from or after Phase 
1b, administered via IV bolus infusion. 

Armata Pharmaceuticals, Inc. 
Clinical Study Protocol AP-SA02-101 
 
Armata Pharmaceuticals, Inc. 
Confidential & Proprietary 
Page 10 of 78 
Version 4.0, 25 July 2024 
Note: The dose, frequency, and duration may be modified after DRC review. Maximum dosing 
duration will be no more than 14 days. 
 
A DRC will be convened to review all blinded safety data through TOC for study drug (Day 12) 
to recommend dose escalation. Safety stopping rules, including the number of dose-limiting 
toxicities, are prespecified in the protocol. The DRC can receive unblinded data, if requested and 
deemed necessary to adequately complete their review. Upon completion of Phase 1b Cohort 2, 
Phase 2a may be initiated and may be an expansion of one of the previous cohorts. 
Based on these evaluations and DRC recommendation, the Sponsor will determine if additional 
methicillin-resistant SA (MRSA) subjects will need to be enrolled in order to ensure adequate 
distribution of MRSA subjects between treatment arms. 
In Phase 2a, subjects will be randomized in a 2:1 ratio to receive AP-SA02 or placebo. 
Randomization will be stratified by methicillin susceptibility/resistance. Subjects will be on BAT 
for a minimum of 28 days to 56 days (complicated SAB) and followed through 28 days after the 
end of BAT, for a total of 56 to 84 days in the study. The BAT must be planned for a minimum 
of 28 days and a maximum of 56 days, inclusive of the days on BAT started prior to study 
enrollment/randomization. The EOT for BAT will be defined based on the prespecified duration 
of therapy at the time of enrollment. The prespecified duration of BAT at Screening may be 
increased within 7 days after randomization with duration of BAT no more than 56 days in the 
event that new/additional clinical information warrants a longer duration of therapy; this must be 
documented in the subject’s source chart and electronic case report form (eCRF). All changes 
made to the subject’s BAT and the reason for such changes must be documented on the appropriate 
eCRF. 
DATA REVIEW COMMITTEE: 
The DRC will be comprised of members with pertinent expertise who will review emerging 
blinded safety data at appropriate times throughout the study, as described in this protocol and as 
set forth in the DRC Charter. 
The DRC will convene throughout the study to review blinded safety data to recommend if it is 
safe and appropriate to continue the study as planned. The DRC will convene to recommend if 
dose selection and/or dose duration are appropriate prior to dose escalation during or after Phase 
1b. Additionally, the DRC can receive unblinded data, if requested and deemed necessary to 
adequately complete their review. Further details regarding the roles, responsibilities, and 
procedures of the DRC will be provided in the DRC Charter.  
In addition, ad hoc reviews of blinded safety data will be performed throughout the study by 
appropriate study personnel and the Medical Monitor. The DRC can convene for ad hoc meetings 
if deemed necessary by the Sponsor or Medical Monitor through ongoing trend reviews or if a 
study stopping rule has been met. 
DOSAGE FORMS AND ROUTE OF ADMINISTRATION: 
AP-SA02 is a proprietary multi-phage therapeutic candidate.
 
 

Armata Pharmaceuticals, Inc. 
Clinical Study Protocol AP-SA02-101 
 
Armata Pharmaceuticals, Inc. 
Confidential & Proprietary 
Page 11 of 78 
Version 4.0, 25 July 2024 
 
The dose level of AP-SA02 to be administered to each subject will 
be determined based on the cohort assignment. Dosage (in PFU) per cohort is shown in the table 
below. The dose level to be tested in the Phase 1b additional cohort(s) (up to 3) and Phase 2a will 
be based on the observed safety and tolerability in the prior dosed subjects. 
Phase 
Cohort 
Each Dose  
(Approximate 
PFU/phage) 
Each Dose 
(Approximate Total 
PFU) 
Total Daily Dose 
(Approximate Total 
PFU) 
Total Dose Over 5 Days
(Approximate Total 
PFU) 
Phase 1b 
1 
1 × 109 
2 × 109 
8 × 109 
4 × 1010 
2 
1 × 1010 
2 × 1010 
8 × 1010 
4 × 1011 
Phase 2a 
TBD 
TBD 
TBD 
TBD 
PFU = plaque-forming units; TBD = to be determined.  
Placebo will be a sterile dilution buffer used for active AP-SA02
 
AP-SA02 or placebo will be administered via IV bolus infusion every 6 hours for 5 consecutive 
days in an inpatient location, unless the dose, frequency, or duration is modified after DRC review. 
In addition, all subjects will receive at least 14 days (uncomplicated SAB) or 28 days (complicated 
SAB) and up to 56 days of BAT. BAT will be administered at the discretion of the Investigator. 
ENDPOINTS:  
Phase 1b Multiple Ascending Dose Safety  
The primary endpoint is safety. Safety will be evaluated by presenting summaries of the following: 
• Treatment-emergent adverse events (TEAEs), which are defined as adverse events (AEs) 
occurring after the first dose of study drug through TOC for study drug (Day 12) or through 
EOS for serious AEs (SAEs); 
• Vital signs; and 
• Clinical laboratory evaluations.  
The endpoints listed for Phase 2a may be assessed as secondary endpoints in the safety cohorts; 
however, these cohorts are exploratory and not powered for any efficacy variable. 
Phase 2a  
The Phase 2a endpoints are the following:  
• Time to reach a NEWS2 score ≤2 maintained for at least 24 hours or hospital discharge 
(whichever comes first) for subjects on active drug versus placebo in the Microbiological 
Intent-to-Treat (MITT) Population; 
• Clinical Improvement or response at TOC for study drug (Day 12) in the MITT Population; 
• Proportion of subjects reaching a NEWS2 score ≤2 maintained for at least 24 hours or hospital 
discharge (whichever comes first) for subjects on active drug versus placebo at TOC for study 
drug (Day 12) in the MITT Population;  
• Microbiological outcome at EOT for study drug (Day 5); 

Armata Pharmaceuticals, Inc. 
Clinical Study Protocol AP-SA02-101 
 
Armata Pharmaceuticals, Inc. 
Confidential & Proprietary 
Page 12 of 78 
Version 4.0, 25 July 2024 
• Clinical Improvement or response at TOC for BAT (7 days [±1 day] after the end of BAT); 
• Clinical Improvement or response at EOS (28 days after the end of BAT); 
• Time to death; 
• NEWS2 score while hospitalized by study day; 
• Late composite efficacy, as defined by the following: 
o Survival at EOS (Days 39 to 81); and 
o No evidence of microbiological failure, as defined by either of the following: 
 Blood cultures that remain positive for SA ≥7 days from randomization; or 
 Isolation of SA from the blood or another sterile site (eg, joint fluid, tissue) >14 days 
from randomization. 
• Microbiological failure or relapse by any of the following: 
o Blood cultures that remain positive for SA ≥7 days from randomization;  
o Isolation of SA from the blood or another sterile site (eg, joint fluid, tissue) >14 days from 
randomization; or  
o Blood culture positive for SA >72 hours after the first blood cultures showing 
clearance (CL) of SAB (defined as 2 consecutive days with negative SA blood cultures). 
• Time to resolution of SAB; 
• Time to hospital discharge (and time to hospital discharge readiness); 
• Need for and duration of intensive care unit stay; 
• Need for and duration of endotracheal mechanical ventilation; 
• Need for and duration of noninvasive pressure ventilation (eg, Continuous Positive Airway 
Pressure, Bilevel Positive Airway Pressure); 
• PK of AP-SA02 with IV administration; 
• Relationship between AP-SA02 exposures and safety and efficacy endpoints; 
• Immunogenicity of AP-SA02 at EOS; 
• Time to resolution of any signs and/or symptoms of bacteremia present at Screening; 
• Time to resolution of any signs/symptoms related to focal site of SA infection (eg, joint pain; 
redness; swelling; weight-bearing, back pain; weight-bearing, skin redness; drainage) from 
randomization on Day 1; 
• TEAEs, which are defined as AEs occurring after the first dose of study drug through TOC 
for study drug (Day 12) or through EOS for SAEs; 
• Proportion of subjects with acute kidney injury, defined as stage 1 or higher using modified 
Risk-Injury-Failure-Loss-End-stage renal disease criteria at any time within the first 7 days or 
new need for renal replacement therapy between Day 1 and EOS; 

Armata Pharmaceuticals, Inc. 
Clinical Study Protocol AP-SA02-101 
 
Armata Pharmaceuticals, Inc. 
Confidential & Proprietary 
Page 13 of 78 
Version 4.0, 25 July 2024 
• Vital signs;  
• Clinical laboratory evaluations; 
• Change in C-reactive protein (CRP) from baseline to EOS; 
• Change in interleukin-10 from baseline through TOC for study drug (Day 12); 
• Change in SA isolate sensitivity to AP-SA02 between initiation of study drug and the last 
isolation of SA from a sterile site (blood, joint fluid, tissue); 
• Change in SA isolate susceptibilities to anti-staphylococcal antibiotics from baseline; 
• Change in SA isolate susceptibility to BAT from baseline; and 
• Clinical and microbiological outcomes by foci of infection. 
CLINICAL EFFICACY ADJUDICATION COMMITTEE: 
The Clinical Efficacy Adjudication Committee (CEAC) will consist of a group of independent 
clinical experts blinded to treatment allocation and not associated with study conduct. Data 
obtained for subjects who receive study drug may be reviewed independently by CEAC members. 
The CEAC members will give their opinion on the diagnosis and classification of the SAB, the 
adequacy of BAT, the adequacy of source control, and/or the response assessment (overall success 
or failure). For deaths occurring during the study, a blinded assessment of the attribution of death 
to SAB or to another cause may be performed by the CEAC members. 
STUDY EVALUATIONS:  
Safety 
Safety will be assessed by monitoring AEs, vital signs, laboratory data (chemistries, hematology, 
and coagulation), immunogenicity evaluation, physical examinations, electrocardiograms, and 
radiologic imaging per standard of care (eg, echocardiogram). 
Pharmacokinetics 
PK samples for AP-SA02 will be collected from subjects enrolled at predetermined/qualified PK 
sites on the following days and times, and evaluated based on AP-SA02 levels as measured by 
venous blood samples:  
• Day 1: pre-dose (-60 minutes) and , 0.5 hours (±15 minutes), 1 hour (±15 minutes), and 3 
hours (±15 minutes) post first dose of the day; 
• Days 2 to 4: 1 sample 1 hour (30 minutes) post first dose of the study day ; 
• Day 5:  1 hour (±15 minutes) post last dose of the day; and 
• Day 6: 24 hours (±30 minutes) post last dose.  
PK parameters of AP-SA02 will be assessed from subjects enrolled at predetermined/qualified PK 
sites with serial PK sampling, including maximum observed plasma concentration (Cmax), time to 
reach Cmax (Tmax), terminal elimination half-life (t½), CL, volume of distribution (Vz), area under 
the plasma concentration time curve (AUC) from time 0 to the last quantifiable time (AUC0-t), and 

Armata Pharmaceuticals, Inc. 
Clinical Study Protocol AP-SA02-101 
 
Armata Pharmaceuticals, Inc. 
Confidential & Proprietary 
Page 14 of 78 
Version 4.0, 25 July 2024 
AUC from time 0 to infinity (AUC0-∞). Additional details regarding PK analysis methodology will 
be described in the Statistical Analysis Plan (SAP). 
Pharmacodynamics 
Pharmacodynamics will be evaluated based on the following: 
• Time to resolution of signs/symptoms of bacteremia present at Screening; 
• Time to resolution of bacteremia based on blood cultures; and/or 
• Change in CRP from baseline. 
STATISTICAL ANALYSES: 
Predefined or post-hoc statistical analysis for all subjects may be performed to compare the 
treatment groups that are randomized based on the following: 
• MRSA subjects (subgroup will be for Phase 2a only); 
• Blood cultures positive for SA on Day -1 prior to study drug administration; and 
• Source control achieved (eg, abscess drainage, catheter or intravascular device removal, 
washout of infected joint). 
Note: The final SAP will finalize the subgroup analyses. 
Analysis Populations 
The following analysis populations will be defined for the Phase 1b and Phase 2a cohorts:  
• Intent-to-Treat (ITT): all randomized subjects regardless of whether or not study drug is 
received; 
• Phage-Sensitive ITT: all randomized subjects who receive both BAT and study drug, and 
whose SA isolate is sensitive to at least 1 of the phage components that comprise the study 
drug; 
• Safety: all randomized subjects who receive at least 1 dose of study drug; 
• MITT: all subjects in the ITT Population with baseline SAB and who receive at least 1 dose 
of study drug; and 
• PK: all subjects (enrolled at predetermined/qualified PK sites) who have at least 1 PK sample 
drawn. 
An SAP will be prepared and finalized before database lock and analyses of data. Summary data 
will be tabulated and presented by treatment group. 
SAMPLE SIZE DETERMINATION: 
The study will enroll approximately 50 eligible subjects. Enrollment may be expanded up to a 
total of approximately 100 subjects to ensure that at least 8 treated and 4 placebo Phase 2a subjects 
are MRSA subjects and to account for additional subjects and cohorts that may be enrolled based 
on DRC review and Sponsor input based on emerging data. To ensure that at least 8 treated and 

Armata Pharmaceuticals, Inc. 
Clinical Study Protocol AP-SA02-101 
 
Armata Pharmaceuticals, Inc. 
Confidential & Proprietary 
Page 15 of 78 
Version 4.0, 25 July 2024 
4 placebo Phase 2a subjects are MRSA subjects, no more than approximately 70 non-MRSA 
subjects will be enrolled without a protocol amendment.  
The Phase 1b MAD safety cohorts will follow a standard 3 + 1 design for 2 cohorts (n = 4 for each 
cohort for a total of 8 subjects). However, additional cohorts (up to 3) may be added or existing 
cohorts expanded per recommendation of the DRC or Sponsor decision. The total sample size in 
Phase 1b may be increased up to a total of 20 subjects without a protocol amendment in 
consultation with the DRC.  
Phase 2a will have an initial sample size of approximately n = 42 with a study drug to placebo 
allocation of 2:1 in order to enroll at least 38 subjects meeting the MITT Population criteria with 
the assumption that approximately 90% of randomized subjects will satisfy the MITT Population 
criteria. This will provide at least 80% power to detect a difference of 50% in the proportion of 
subjects in each treatment arm, with a 30% placebo portion meeting all conditions for Clinical 
Improvement or response at TOC for study drug (Day 12) in the MITT Population with a type 1 
error rate of 0.05 (1-sided) using Fisher’s exact test. Additional subjects may be included in 
Phase 2a after a protocol amendment. 
SITES: Approximately 30 to 35 sites globally  
SPONSOR: 
Armata Pharmaceuticals, Inc. 
5005 McConnell Avenue 
Marina del Rey, CA 90066 
United States  
Telephone: +1-310-665-2928 

Armata Pharmaceuticals, Inc. 
Clinical Study Protocol AP-SA02-101 
Armata Pharmaceuticals, Inc. 
Confidential & Proprietary 
Page 16 of 78 
Version 4.0, 25 July 2024 
TABLE OF CONTENTS 
Signature Page ................................................................................................................................ 2 
Investigator Agreement ................................................................................................................... 3 
Synopsis .......................................................................................................................................... 4 
Table of Contents .......................................................................................................................... 16 
List of Tables ................................................................................................................................ 20 
List of Figures ............................................................................................................................... 21 
List of Abbreviations and Definition of Terms............................................................................. 22 
1 Introduction and Background Information ............................................................................. 24 
1.1 
Introduction ................................................................................................................... 24 
1.1.1 Staphylococcus aureus Bacteremia ................................................................... 24 
1.1.2 Phage as Antimicrobials .................................................................................... 25 
1.1.2.1 Mechanisms of action of phages ......................................................... 25 
1.1.3 Staphylococcus aureus Phage Product, AP-SA02 ............................................ 26 
1.2 
Rationale ........................................................................................................................ 26 
1.3 
Risk/Benefit ................................................................................................................... 26 
1.3.1 Benefits .............................................................................................................. 26 
1.3.1.1 Known benefits ................................................................................... 26 
1.3.1.2 Potential benefits ................................................................................. 26 
1.3.2 Risks .................................................................................................................. 27 
1.3.2.1 Known risks ........................................................................................ 27 
1.3.2.2 Potential risks ...................................................................................... 27 
1.3.3 Overall Risk/Benefit Assessment ...................................................................... 27 
1.4 
Intent to Benefit ............................................................................................................. 27 
2 Study Objectives ..................................................................................................................... 29 
2.1 
Phase 1b ......................................................................................................................... 29 
2.2 
Phase 2a ......................................................................................................................... 29 
3 Study Description.................................................................................................................... 30 
3.1 
Summary of Study Design ............................................................................................ 30 
3.2 
Data Review Committee ............................................................................................... 33 
3.3 
Study Indication ............................................................................................................ 33 

Armata Pharmaceuticals, Inc. 
Clinical Study Protocol AP-SA02-101 
Armata Pharmaceuticals, Inc. 
Confidential & Proprietary 
Page 17 of 78 
Version 4.0, 25 July 2024 
4 Selection and Withdrawal of Subjects .................................................................................... 34 
4.1 
Inclusion Criteria ........................................................................................................... 34 
4.2 
Exclusion Criteria .......................................................................................................... 35 
4.3 
Stopping Criteria ........................................................................................................... 37 
4.3.1 Criteria for Potential Interruption or Discontinuation of Study Drug in 
Individual Subjects ............................................................................................ 37 
4.3.2 Criteria for Ad Hoc Data Review Committee Review of Study ....................... 38 
4.4 
Withdrawal or Modification of Individual Subject Study Participation ....................... 39 
4.4.1 Termination of the Study ................................................................................... 39 
5 Study Treatments .................................................................................................................... 40 
5.1 
Treatment Groups .......................................................................................................... 40 
5.2 
Rationale for Dosing ..................................................................................................... 40 
5.3 
Randomization and Blinding ......................................................................................... 41 
5.4 
Breaking the Blind ........................................................................................................ 41 
5.5 
Drug Supplies ................................................................................................................ 41 
5.5.1 Formulation and Packaging ............................................................................... 41 
5.5.2 Study Drug Preparation and Dispensing ........................................................... 42 
5.5.3 Study Drug Administration ............................................................................... 42 
5.5.4 Treatment Compliance ...................................................................................... 42 
5.5.5 Storage and Accountability ............................................................................... 42 
5.6 
Prior and Concomitant Medications and/or Procedures ................................................ 43 
5.6.1 Excluded Medications and/or Procedures ......................................................... 43 
5.6.2 Documentation of Prior and Concomitant Medication Use .............................. 43 
6 Study Procedures .................................................................................................................... 44 
7 Efficacy Assessments .............................................................................................................. 45 
7.1 
Phase 1b Multiple Ascending Dose Safety Endpoints .................................................. 45 
7.2 
Phase 2a Endpoints ........................................................................................................ 45 
7.3 
Efficacy Outcome Assessments .................................................................................... 47 
7.4 
National Early Warning Score 2 ................................................................................... 47 
7.5 
Anti-Phage Antibodies .................................................................................................. 49 
7.6 
Phage Clearance ............................................................................................................ 49 
7.7 
Blood Cultures ............................................................................................................... 49 

Armata Pharmaceuticals, Inc. 
Clinical Study Protocol AP-SA02-101 
Armata Pharmaceuticals, Inc. 
Confidential & Proprietary 
Page 18 of 78 
Version 4.0, 25 July 2024 
7.7.1 Criteria for Positive Blood Culture for Eligibility ............................................ 50 
7.7.2 Cultures From Sterile Sites ............................................................................... 50 
7.8 
Microbiological Outcome ............................................................................................. 50 
7.9 
Pharmacokinetic Assessments ....................................................................................... 51 
7.10 Pharmacodynamic Assessments .................................................................................... 51 
8 Safety Assessments ................................................................................................................. 52 
8.1 
Adverse Events .............................................................................................................. 52 
8.1.1 Adverse (Drug) Reaction .................................................................................. 53 
8.1.2 Unexpected Adverse Drug Reaction ................................................................. 53 
8.1.3 Assessment of Adverse Events by the Investigator .......................................... 53 
8.2 
Serious Adverse Events ................................................................................................. 54 
8.3 
Serious Adverse Event Reporting − Procedures for Investigators ................................ 55 
8.4 
Pregnancy Reporting ..................................................................................................... 55 
8.5 
Expedited Reporting ...................................................................................................... 56 
8.6 
Special Situation Reports .............................................................................................. 56 
8.7 
Clinical Laboratory Evaluations .................................................................................... 57 
8.8 
Acute Kidney Injury ...................................................................................................... 57 
8.9 
Vital Signs ..................................................................................................................... 58 
8.10 Electrocardiogram ......................................................................................................... 58 
8.11 Physical Examination .................................................................................................... 58 
9 Statistics .................................................................................................................................. 59 
9.1 
Analysis Populations ..................................................................................................... 59 
9.2 
Statistical Methods ........................................................................................................ 59 
9.2.1 Analysis of Phase 2a Endpoints ........................................................................ 59 
9.2.2 Analysis of Safety ............................................................................................. 59 
9.2.3 Analysis of Pharmacokinetics ........................................................................... 60 
9.2.4 Analysis of Pharmacodynamics ........................................................................ 60 
9.2.5 Clinical Efficacy Adjudication Committee ....................................................... 60 
9.2.6 Sample Size Determination ............................................................................... 60 
10 Data Management and Record Keeping ................................................................................. 61 
10.1 Data Management ......................................................................................................... 61 
10.1.1 Data Handling ................................................................................................... 61 

Armata Pharmaceuticals, Inc. 
Clinical Study Protocol AP-SA02-101 
Armata Pharmaceuticals, Inc. 
Confidential & Proprietary 
Page 19 of 78 
Version 4.0, 25 July 2024 
10.1.2 Computer Systems ............................................................................................. 61 
10.1.3 Data Entry ......................................................................................................... 61 
10.1.4 Medical Information Coding ............................................................................. 61 
10.1.5 Data Validation ................................................................................................. 61 
10.2 Record Keeping ............................................................................................................. 61 
10.3 End of Study .................................................................................................................. 62 
11 Investigator Requirements and Quality Control ..................................................................... 63 
11.1 Ethical Conduct of the Study ........................................................................................ 63 
11.2 Institutional Review Board/Independent Ethics Committee ......................................... 63 
11.3 Informed Consent .......................................................................................................... 63 
11.4 Subject Card .................................................................................................................. 64 
11.5 Study Monitoring Requirements ................................................................................... 64 
11.6 Disclosure of Data ......................................................................................................... 64 
11.7 Retention of Records ..................................................................................................... 64 
11.8 Publication Policy ......................................................................................................... 65 
11.9 Financial Disclosure ...................................................................................................... 65 
11.10 Insurance and Indemnity ............................................................................................... 65 
11.11 Legal Aspects ................................................................................................................ 65 
12 Study Administrative Information .......................................................................................... 66 
12.1 Protocol Amendments ................................................................................................... 66 
13 References ............................................................................................................................... 67 
Appendix A: Schedule of Procedures ........................................................................................... 70 
Appendix B: Clinical Laboratory Analytes .................................................................................. 74 
Appendix C: Modified Duke Criteria for Diagnosis of Infective Endocarditis ............................ 76 
Appendix D: Risk-Injury-Failure-Loss-End-Stage Renal Disease Criteria .................................. 78 

Armata Pharmaceuticals, Inc. 
Clinical Study Protocol AP-SA02-101 
Armata Pharmaceuticals, Inc. 
Confidential & Proprietary 
Page 20 of 78 
Version 4.0, 25 July 2024 
LIST OF TABLES 
Table 1. 
Dosage per Cohort ...................................................................................................... 40 
Table 2. 
Definition of Clinical Outcome .................................................................................. 47 
Table 3. 
National Early Warning Score 2 Scoring System ....................................................... 48 
Table 4. 
National Early Warning Score 2 Thresholds and Clinical Risk ................................. 49 
Table 5. 
Microbiological Outcome ........................................................................................... 51 
Table 6. 
Modified Duke Criteria for Diagnosis of Infective Endocarditis: Definitions of 
Definite, Possible, and Rejected Endocarditis ............................................................ 76 
Table 7. 
Modified Duke Criteria for Diagnosis of Infective Endocarditis: Definitions for Major 
and Minor Criteria ....................................................................................................... 77 
Table 8. 
Definition of Risk-Injury-Failure-Loss-End-Stage Renal Disease Criteria ................ 78 
 
 
 

Armata Pharmaceuticals, Inc. 
Clinical Study Protocol AP-SA02-101 
Armata Pharmaceuticals, Inc. 
Confidential & Proprietary 
Page 21 of 78 
Version 4.0, 25 July 2024 
LIST OF FIGURES 
Figure 1. Lytic Cycle of Bacteriophages .................................................................................... 26 
Figure 2. Study Schema.............................................................................................................. 31 
Figure 3. Study Cohort Progression ........................................................................................... 32 
 

Armata Pharmaceuticals, Inc. 
Clinical Study Protocol AP-SA02-101 
 
Armata Pharmaceuticals, Inc. 
Confidential & Proprietary 
Page 22 of 78 
Version 4.0, 25 July 2024 
LIST OF ABBREVIATIONS AND DEFINITION OF TERMS  
Abbreviation 
Definition 
AE 
Adverse event 
AICD 
Automatic implantable cardioverter-defibrillator 
AIDS 
Acquired immunodeficiency syndrome 
AKI 
Acute kidney injury 
ALT 
Alanine aminotransferase 
AST 
Aspartate aminotransferase 
AUC 
Area under the plasma concentration-time curve 
AUC0-∞ 
Area under the plasma concentration-time curve from time 0 to 
infinity 
AUC0-t 
Area under the plasma concentration-time curve from time 0 to the 
last quantifiable time 
BAT 
Best available therapy 
CEAC 
Clinical Efficacy Adjudication Committee 
CFR 
Code of Federal Regulations 
CL 
Clearance 
Cmax 
Maximum observed plasma concentration 
CRA 
Clinical Research Associate 
CRO 
Contract Research Organization 
CRP 
C-reactive protein 
CTA 
Clinical trial authorisation 
CTCAE 
Common Terminology Criteria for Adverse Events 
DRC 
Data Review Committee 
ECG 
Electrocardiogram 
eCRF 
Electronic case report form 
EDC 
Electronic data capture 
EIU 
Exposure In Utero 
EOS 
End of Study 
EOT 
End of Treatment 
ETOT 
Early Termination of Treatment 
FCBP 
Female of childbearing potential 
FDA 
Food and Drug Administration 
GCP 
Good Clinical Practice 
HEENT 
Head, eyes, ears, nose, and throat 
ICF 
Informed consent form 
ICH 
International Council for Harmonisation 
IEC 
Independent Ethics Committee 

Armata Pharmaceuticals, Inc. 
Clinical Study Protocol AP-SA02-101 
 
Armata Pharmaceuticals, Inc. 
Confidential & Proprietary 
Page 23 of 78 
Version 4.0, 25 July 2024 
Abbreviation 
Definition 
IL 
Interleukin 
IRB 
Institutional Review Board 
ITT 
Intent-to-Treat 
IV 
Intravenous(ly) 
LAR 
Legally authorized representative 
MAD 
Multiple ascending dose 
MITT 
Microbiological Intent-to-Treat 
MRSA 
Methicillin-resistant Staphylococcus aureus 
MSSA 
Methicillin-susceptible Staphylococcus aureus 
NEWS2 
National Early Warning Score 2 
OHRO 
Office of Human Research Oversight 
PFU 
Plaque-forming units 
PK 
Pharmacokinetic(s) 
RIFLE 
Risk-Injury-Failure-Loss-End-stage renal disease 
SA 
Staphylococcus aureus 
SAB 
Staphylococcus aureus bacteremia 
SAE 
Serious adverse event 
SAP 
Statistical Analysis Plan 
SUSAR 
Suspected Unexpected Serious Adverse Reaction 
t½  
Terminal elimination half-life 
TEAE 
Treatment-emergent adverse event 
Tmax 
Time to reach maximum observed plasma concentration 
TOC 
Test of Cure 
ULN 
Upper limit of normal 
Vz 
Volume of distribution 
 

Armata Pharmaceuticals, Inc. 
Clinical Study Protocol AP-SA02-101 
Armata Pharmaceuticals, Inc. 
Confidential & Proprietary 
Page 24 of 78 
Version 4.0, 25 July 2024 
1 
INTRODUCTION AND BACKGROUND INFORMATION  
1.1 
Introduction 
Armata Pharmaceuticals, Inc. (Armata, the Sponsor) is developing a proprietary multi-phage 
therapeutic candidate (AP-SA02) for the treatment of Staphylococcus aureus (SA) 
bacteremia (SAB). The intended route of clinical administration is intravenous (IV) and will be 
administered as an adjunct to best available antibiotic therapy. 
1.1.1 
Staphylococcus aureus Bacteremia 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 

Armata Pharmaceuticals, Inc. 
Clinical Study Protocol AP-SA02-101 
Armata Pharmaceuticals, Inc. 
Confidential & Proprietary 
Page 25 of 78 
Version 4.0, 25 July 2024 
 
 
 
1.1.2 
Phage as Antimicrobials 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1.1.2.1 
Mechanisms of action of phages 
 
 
 
 
 

Armata Pharmaceuticals, Inc. 
Clinical Study Protocol AP-SA02-101 
Armata Pharmaceuticals, Inc. 
Confidential & Proprietary 
Page 26 of 78 
Version 4.0, 25 July 2024 
Figure 1. Lytic Cycle of Bacteriophages 
 
Schematic representation of virulent phage infection, replication, and lysis of bacterial host cells. 
DNA = deoxyribonucleic acid.  
Source: Barbu EM, Cady KC, Hubby B. Phage therapy in the era of synthetic biology. Cold Spring Harb Perspect Biol. 
2016;8(10):a023879  
1.1.3 
Staphylococcus aureus Phage Product, AP-SA02  
Based on a comprehensive series of in vitro and in vivo studies assessing antimicrobial potential 
and bioavailability, AP-SA02 is an optimized product comprised of lytic phages with desirable 
therapeutic properties. In addition to infecting over 95% of SA clinical isolates, AP-SA02 is highly 
selective for SA, active against SA biofilms, viable in relevant biological fluids, and is cooperative 
with current standard of care antibiotics. Please see the Investigator’s Brochure for details.  
1.2 
Rationale 
This is a Phase 1b/2a first-in-human study evaluating multiple doses of AP-SA02 as an adjunct to 
best available therapy (BAT) in adults with SAB. The aim of this study is to examine the safety 
and tolerability of multiple ascending IV doses of AP-SA02 (Phase 1b). The study is also designed 
to evaluate the efficacy, safety, and tolerability of multiple doses of AP-SA02 as an adjunct to 
BAT compared to BAT alone (Phase 2a). 
These data will be used to support further clinical development of AP-SA02 for treatment of SAB. 
1.3 
Risk/Benefit 
1.3.1 
Benefits 
1.3.1.1 
Known benefits 
The clinical benefit of AP-SA02 remains to be established. 
1.3.1.2 
Potential benefits 
Subjects participating in this study might have a benefit regarding the clinical course of their SA 
infection. Results from the proposed study may be useful in developing a new antimicrobial 
therapy for SA infection. 
•••••• 
• 
1 
• 
---
V1Nlentpnage 
life cycte 
• • ,, 

Armata Pharmaceuticals, Inc. 
Clinical Study Protocol AP-SA02-101 
Armata Pharmaceuticals, Inc. 
Confidential & Proprietary 
Page 27 of 78 
Version 4.0, 25 July 2024 
1.3.2 
Risks 
1.3.2.1 
Known risks 
No clinical studies have been performed and, as a consequence, adverse drug reactions have not 
been identified. 
1.3.2.2 
Potential risks 
All therapies have the potential to cause adverse experiences. The risks associated with blood 
sampling for safety or pharmacokinetic (PK) purposes are limited and the volume of blood needed 
is well below the acceptable limits for adults. Study intervention will be provided in addition to, 
not in replacement of, standard of care supportive and symptomatic therapy. 
1.3.3 
Overall Risk/Benefit Assessment 
Based on the available data and proposed safety measures, the overall benefit/risk assessment for 
AP-SA02 clinical studies is deemed acceptable for the reasons described below.  
Several safety measures will be implemented to potentially minimize the risk to subjects, 
including:  
• Utilization of selection criteria which exclude subjects who may potentially be at higher risk 
of experiencing an adverse event (AE); 
• Females of childbearing potential (FCBPs) must agree to use a highly effective method of birth 
control from Day 1 through 60 days following the last dose of study drug;  
• Males must agree to use barrier contraception (ie, condoms) from Day 1 through 60 days 
following the last dose of study drug; 
• Utilization of discontinuation and withdrawal criteria. Subjects who prematurely discontinue 
study intervention for any reason (except withdrawal of consent) will be asked to continue with 
their remaining study visits and assessment schedule; 
• At several time points throughout the study (see the Schedule of Procedures in Appendix A), 
safety parameters, including AEs, vital signs, clinical laboratory evaluations (chemistries, 
hematology, and coagulation), immunogenicity evaluations, physical examinations, 
electrocardiograms (ECGs), vital signs, and radiological imaging per standard of care 
(eg, echocardiogram) will be assessed; 
• Follow-up visits are scheduled after the last intake of study drug, or after withdrawal, for final 
study-related assessments; and 
• A Data Review Committee (DRC) will monitor and review data on a regular basis to ensure 
the continuing safety of the participants enrolled in this study. 
1.4 
Intent to Benefit 
All subjects will receive additional safety monitoring as required per the protocol, in addition to 
the standard of care they would receive and will still receive, if they did not participate in the 
clinical study. While standard of care varies by institution, the additional safety monitoring all 

Armata Pharmaceuticals, Inc. 
Clinical Study Protocol AP-SA02-101 
Armata Pharmaceuticals, Inc. 
Confidential & Proprietary 
Page 28 of 78 
Version 4.0, 25 July 2024 
study subjects will receive per the AP-SA02-101 protocol includes, but is not limited to, the 
following:  
• Daily blood cultures and use of a rapid diagnostic at sites with this capability in which it is not 
standard of care;  
• Increased vital sign monitoring (temperature, heart rate, and blood pressure);  
• Additional blood chemistry, hematology, coagulation, C-reactive protein (CRP), interleukin 
(IL)-10, and procalcitonin testing;  
• Additional oversight from local study physician(s), nurses, and research staff, as well as 
physicians and medical personnel at the Sponsor and Clinical Research Organization; and 
• Continued follow-up and monitoring after hospital discharge.   
Due to variation in standard of care at each institution, participation in this clinical study provides 
every subject with a personalized and thorough hospital experience provided for by the designated 
study clinical team in addition to the standard of care team, with continued oversight following 
discharge through EOS (28 days after the end of BAT). With a clear mechanism of follow-up 
defined in the study protocol, subjects or legally authorized representatives (LARs) can discuss 
post-hospitalization status with their study physician allowing identification of SAB-related 
sequelae. Post-hospitalization follow-up, and close monitoring while hospitalized, may lead to 
better outcomes for all subjects enrolled in the study.   
 

Armata Pharmaceuticals, Inc. 
Clinical Study Protocol AP-SA02-101 
Armata Pharmaceuticals, Inc. 
Confidential & Proprietary 
Page 29 of 78 
Version 4.0, 25 July 2024 
2 
STUDY OBJECTIVES 
2.1 
Phase 1b 
The objective of Phase 1b is to evaluate the safety and tolerability of multiple ascending IV doses 
of AP-SA02 or placebo as an adjunct to BAT compared to BAT alone in subjects with SAB. 
2.2 
Phase 2a 
The objective of Phase 2a is to evaluate the efficacy, safety, and tolerability of multiple doses of 
AP-SA02 or placebo as an adjunct to BAT compared to BAT alone in subjects with complicated 
SAB. 

Armata Pharmaceuticals, Inc. 
Clinical Study Protocol AP-SA02-101 
Armata Pharmaceuticals, Inc. 
Confidential & Proprietary 
Page 30 of 78 
Version 4.0, 25 July 2024 
3 
STUDY DESCRIPTION 
Adult hospitalized subjects who have a positive blood culture for SA and require a minimum of 
14 days (uncomplicated SAB) or 28 days (complicated SAB) and a maximum of 56 days of IV 
antibiotic therapy may be eligible for this study. Prior to any study screening evaluations, the 
subject (or LAR) must sign an informed consent form (ICF). Subjects will be assessed for all 
inclusion and exclusion criteria, source and distal site(s) of infection, presence of endocarditis, 
significant comorbidities, and National Early Warning Score 2 (NEWS2) score. Screening 
assessments will be completed from Day -3  to Day -1. After all eligibility criteria are met, the 
subject will be randomized. Subjects not fulfilling the eligibility criteria and not randomized may 
be rescreened for participation if their eligibility characteristics change. Screening procedures that 
fall within the screening window do not need to be repeated. 
Blinded study drug will be initiated on Day 1 and administered every 6 hours through Day 5. The 
BAT must be planned for a minimum of 14 days (uncomplicated SAB) or 28 days (complicated 
SAB) and a maximum of 56 days (inclusive of the days on BAT prior to study 
enrollment/randomization) based on the clinical presentation of the subject and the clinical 
judgment of the Investigator. Visits from Day 1 through Day 7 should be performed in an inpatient 
location.  
All subjects will receive antibiotics that are chosen by the Investigator and are per local standard 
of care. If subjects with MSSA isolates are intolerant to beta-lactam therapy, an alternative 
antibiotic considered to be BAT, is acceptable. The BAT may have been started before 
randomization in most subjects. 
3.1 
Summary of Study Design 
This is a first-in-human, prospective, Phase 1b/2a, randomized, double-blind, placebo-controlled, 
multiple ascending dose (MAD) study to assess the safety, tolerability, and efficacy of multiple IV 
doses of AP-SA02 as an adjunctive therapy to BAT and compared to BAT alone for the treatment 
of SAB. This multiple dose escalation design will assess the safety and tolerability, as well as the 
efficacy, of various dosing cohorts with phage PK to identify a dose and duration of dosing that 
offers the best therapeutic potential benefit.  
In Phase 1b, a standard MAD design for safety and tolerability will begin by randomizing subjects 
in Phase 1b Cohort 1 to receive either approximately 2 × 109 plaque-forming units (PFU) or 
placebo in addition to BAT. A DRC will convene to review the data from Phase 1b Cohorts and 
during Phase 2a, as needed. The DRC will review emerging safety data throughout the study to 
determine if it is safe and appropriate to continue the study with the currently planned dose levels 
for the subsequent cohorts, or if further refinement of the proposed dose levels or dosing duration 
is warranted. The planned dose levels and dosing duration after Phase 1b Cohort 1 may be modified 
and/or additional cohorts may be added based on emerging information from the current study as 
well as other ongoing studies. The highest total daily dose will not exceed 8 × 1011 PFU and no 
more than 40 additional subjects will be added without a protocol amendment. The DRC will also 
determine how to advance the cohorts (serially or simultaneously). The DRC can receive 
unblinded data, if requested and deemed necessary to adequately complete their review. Further 
details regarding the role, responsibilities, and procedures of the DRC will be provided in the DRC 
Charter. 

Armata Pharmaceuticals, Inc. 
Clinical Study Protocol AP-SA02-101 
 
Armata Pharmaceuticals, Inc. 
Confidential & Proprietary 
Page 31 of 78 
Version 4.0, 25 July 2024 
The planned enrollment in each of the Phase 1b cohorts is 4 subjects per cohort (AP-SA02 to 
placebo 3:1); however, this may be modified after DRC review. Subjects in Phase 1b Cohort 1 will 
receive IV bolus infusion doses of blinded study drug every 6 hours for 5 study days (a total of 
20 doses) in an inpatient location in addition to BAT. Following 5 days of dosing with study drug, 
additional study visits will be conducted at the End of Treatment (EOT) for study drug (Day 5), at 
the Test of Cure (TOC) for study drug (Day 12), TOC for BAT (7 days [±1 day] after the end of 
BAT), and at End of Study (EOS) (28 days after the end of BAT). Subsequent cohorts (eg, planned 
Phase 1b Cohort 2 or additional cohorts [up to 3]) will proceed similarly; however, the duration of 
dosing may be modified after the DRC review of the preceding cohort. 
Figure 2 shows the study schema. 
Figure 2. Study Schema 
 
Note: EOT for IV BAT is dependent on the duration of the Investigator prespecified antibiotic therapy (14 days [uncomplicated 
SAB] or 28 days [complicated SAB] to 56 days). 
1. 
The screening period will be up tp 3 days. 
BAT = best available therapy; D/d = day; EOS = End of Study; EOT = End of Treatment; hrs = hours; IV = intravenous(ly); 
q6h = every 6 hours; SAB = Staphylococcus aureus bacteremia; Scr = Screening. 
In Phase 2a, approximately 42 subjects will receive IV bolus infusion doses of blinded study drug 
every 6 hours, for no more than 14 days as determined by analysis during or after Phase 1b, in 
addition to BAT. Following 5 days of dosing with study drug, additional study visits will be 
conducted at EOT for study drug (Day 5), TOC for study drug (Day 12), TOC for BAT (7 days 
[±1 day] after the end of BAT), and EOS (28 days after the end of BAT). If the study drug EOT is 
extended after the DRC review, the study drug TOC visit will occur 7 days after the last day of 
dosing and the study drug EOS visit will occur 28 days after the end of BAT.  
The following dose cohorts are planned: 
Phase 1b 
• Cohort 1 (AP-SA02 to placebo 3:1): 
o Planned approximately 2 × 109 PFU (1 × 109 PFU/phage) administered via IV bolus 
infusion every 6 hours for a period of 5 days;  
Test of Cure 
7 days after end 
of study drug 
(D12) 
EOT Study Drug 
(DS) 
Ser 2 days1 
} 
IV BAT 14-56 days 
<72 hrs of IV BAT 
prior to start of 
study drug 
Study Drug 
(Sd q6h) 
2 sets of blood cultures on D1; 
daily blood cultures thereafter 
until negative 2 consecutive days 
) 
Test of Cure 
EOS 
7 days after end 
28 days after 
of IV BAT 
end of IV BAT 
1- 018-60) 
(~D39-81) 
28 days post IV BAT 
! 
! 
Blood 
Blood 
Culture 
Culture 

Armata Pharmaceuticals, Inc. 
Clinical Study Protocol AP-SA02-101 
 
Armata Pharmaceuticals, Inc. 
Confidential & Proprietary 
Page 32 of 78 
Version 4.0, 25 July 2024 
• Cohort 2 (AP-SA02 to placebo 3:1): 
o Planned approximately 2 × 1010 PFU (1 × 1010 PFU/phage) administered via IV bolus 
infusion every 6 hours for a period of 5 days; and 
Note: The dose, frequency, and duration may be modified after DRC review. Maximum dosing 
duration will be no more than 14 days. 
Additional cohort(s) (up to 3) as determined after DRC review. 
Phase 2a 
• Phase 2a (AP-SA02 to placebo 2:1): 
o Dose and duration are to be determined based on safety and tolerability from or after Phase 
1b, administered via IV bolus infusion. 
• Note: The dose, frequency, and duration may be modified after DRC review. Maximum dosing 
duration will be no more than 14 days. 
Figure 3 shows the study cohort progression. 
Figure 3. Study Cohort Progression 
 
*Enrollment may be expanded up to a total of approximately 100 subjects to ensure that at least 8 treated and 4 placebo Phase 2a 
subjects are MRSA subjects and to account for additional subjects and cohorts that may be enrolled based on DRC review and 
Sponsor input based on emerging data. 
DRC = Data Review Committee; MRSA = methicillin-resistant Staphylococcus aureus; n = number. 
A DRC will be convened to review all blinded safety data through TOC for study drug (Day 12) 
to recommend dose escalation. Safety stopping rules, including the number of dose-limiting 
Phase 1b 
Total Planned Enrolled* 
n~so (active:placebo) 
Cohort 1 
n=4(3:1) 
Cohort2 
n=4(3:1) 
.. .. .. .. 
.... •· .. 
.. ---------, 
·~, 
\ 
I 
I 
I 
I 
I 
I 
: 
Additional 
: 
: 
Cohort(s) 
: 
I 
I 
) 
... , ________ ., 
Phase 2a 
n=42 (2:1) 

Armata Pharmaceuticals, Inc. 
Clinical Study Protocol AP-SA02-101 
Armata Pharmaceuticals, Inc. 
Confidential & Proprietary 
Page 33 of 78 
Version 4.0, 25 July 2024 
toxicities, are prespecified in Section 4.3. The DRC can receive unblinded data, if requested and 
deemed necessary to adequately complete their review. Upon completion of Phase 1b Cohort 2, 
Phase 2a may be initiated and may be an expansion of one of the previous cohorts. 
Based on these evaluations and DRC recommendation, the Sponsor will determine if additional 
MRSA subjects will need to be enrolled in order to ensure adequate distribution of MRSA subjects 
between treatment arms. 
In Phase 2a, subjects will be randomized in a 2:1 ratio to receive AP-SA02 or placebo. 
Randomization will be stratified by methicillin susceptibility/resistance. Subjects will be on BAT 
for a minimum of 28 days to 56 days (complicated SAB) and followed through 28 days after the 
end of BAT, for a total of 56 to 84 days in the study. The BAT must be planned for a minimum of 
28 days and a maximum of 56 days, inclusive of the days on BAT started prior to study 
enrollment/randomization. The EOT for BAT will be defined based on the prespecified duration 
of therapy at the time of enrollment. The prespecified duration of BAT at Screening may be 
increased within 7 days after randomization with duration of BAT no more than 56 days in the 
event that new/additional clinical information warrants a longer duration of therapy; this must be 
documented in the subject’s source chart and electronic case report form (eCRF). All changes 
made to the subject’s BAT and the reason for such changes must be documented on the appropriate 
eCRF. 
3.2 
Data Review Committee 
The DRC will be comprised of members with pertinent expertise who will review emerging 
blinded safety data at appropriate times throughout the study, as described in this protocol and as 
set forth in the DRC Charter. 
The DRC will convene throughout the study to review blinded safety data to recommend if it is 
safe and appropriate to continue the study as planned. The DRC will convene to recommend if 
dose selection and/or dose duration are appropriate prior to dose escalation during or after Phase 
1b. Additionally, the DRC can receive unblinded data, if requested and deemed necessary to 
adequately complete their review. Further details regarding the roles, responsibilities, and 
procedures of the DRC will be provided in the DRC Charter.  
In addition, ad hoc reviews of blinded safety data will be performed throughout the study by 
appropriate study personnel and the Medical Monitor. The DRC can convene for ad hoc meetings 
if deemed necessary by the Sponsor or Medical Monitor through ongoing trend reviews or if a 
study stopping rule has been met; see Section 4.3. 
3.3 
Study Indication 
The indication for this study is the treatment of bacteremia due to SA. 

Armata Pharmaceuticals, Inc. 
Clinical Study Protocol AP-SA02-101 
 
Armata Pharmaceuticals, Inc. 
Confidential & Proprietary 
Page 34 of 78 
Version 4.0, 25 July 2024 
4 
SELECTION AND WITHDRAWAL OF SUBJECTS 
Subjects who meet all inclusion criteria and none of the exclusion criteria during the 2-day (or 
3-day upon discussion with the Medical Monitor or Sponsor) screening period will be considered 
eligible for enrollment in the study. 
4.1 
Inclusion Criteria  
Inclusion criteria for Phase 1b and 2a 
Subjects who meet all of the following criteria will be eligible to participate in the study: 
1. Is able and willing to provide written informed consent or have consent provided by an LAR; 
2. Is a hospitalized male or female adult subject aged 18 years or older at time of consent;  
3. Has SAB identified from at least 1 blood culture or from a rapid diagnostic test within 72 hours 
of randomization. Time of positive blood culture starts from when specimen is collected for 
blood culture;  
4. Has a plan for source control within 3 days after randomization to be completed within 7 days 
of randomization if relevant (eg, abscess drainage, washout or debridement of infected 
material) or has source already controlled; 
5. If an FCBP, the subject must agree to use a highly effective method of birth control (defined 
as those, alone or in combination, that result in a low failure rate [ie, less than 1% per year]) 
from Day 1 through 60 days following the last dose of study drug;  
Note: FCBP must have a negative serum pregnancy test within 72 hours prior to randomization. 
An FCBP is any female, regardless of sexual orientation, who meets the following criteria: has 
not undergone a hysterectomy or bilateral oophorectomy, or has not been naturally 
postmenopausal for at least 12 consecutive months (ie, has had menses at any time in the 
preceding 12 consecutive months). 
6. If a male subject, the subject must agree to use barrier contraception (ie, condoms) from Day 1 
through 60 days following the last dose of study drug;  
Additional inclusion criteria for Phase 2a only 
7. Has at least 1 of the following signs/symptoms at or within 72 hours prior to randomization: 
a. Documented temperature ≥38.0°C (100.4°F) or ≤36.0°C (96.8°F) measured orally, 
≥38.5°C (101.3°F) or ≤36.5°C (97.7°F) measured tympanically, or ≥39°C (102.2°F) or 
≤37°C (98.6°F) measured rectally; 
b. Heart rate >90 beats per minute; 
c. Respiratory rate >20 breaths per minute; 
d. White blood cell count ≥12.0 × 109 cells/L or ≤0.4 × 109 cells/L, or ≥10% immature 
neutrophils;  
e. Systolic blood pressure <90 mmHg; and/or 
f. Pain associated with focal site of infection. 

Armata Pharmaceuticals, Inc. 
Clinical Study Protocol AP-SA02-101 
 
Armata Pharmaceuticals, Inc. 
Confidential & Proprietary 
Page 35 of 78 
Version 4.0, 25 July 2024 
8. Has at least 1 of the following: 
a. At the time of positive SA blood culture was undergoing chronic intermittent hemodialysis 
or peritoneal dialysis; 
b. Positive blood culture for SA after 2 or more days on anti-staphylococcal antibiotic 
treatment; 
c. Temperature ≥38.0°C (100.4°F) at ≥72 hours after initial blood culture; 
d. SAB associated with signs or symptoms of metastatic foci and/or hematogenous seeding, 
including, but not limited to, septic thrombophlebitis, osteomyelitis (not including 
osteomyelitis associated with hardware or prosthetic joint infection), deep soft tissue 
abscess, septic arthritis/bacterial native joint infection, septic pulmonary emboli/infarction, 
visceral soft tissue abscess, or empyema confirmed by physical examination, imaging, or 
culture; and/or 
e. Presence of right-sided SAB endocarditis (native valve) by modified Duke criteria 
(Appendix C), with no clinical evidence of cerebral foci requiring at least 28 days of 
anti-SA antibiotic treatment. 
4.2 
Exclusion Criteria 
Exclusion criteria for Phase 1b and 2a 
Subjects who meet any of the following criteria will be excluded from participation in the study: 
1. Has concomitant growth of organisms besides SA in a blood culture, excluding 
coagulase-negative staphylococci (eg, Staphylococcus epidermidis) and other species when 
considered by the primary team to represent contaminants; 
2. Has, in the 7 days prior to randomization, a positive culture with SA that has a known minimum 
inhibitory concentration to daptomycin >1 mcg/mL or vancomycin >2 mcg/mL; 
3. Has received treatment with any potentially effective (anti-SA) systemic antibiotic for more 
than 72 hours within 7 days prior to randomization; 
 
Note: Subjects who have received >72 hours of antibiotics and have documented resistance to 
administered therapy or persistent SAB on 2 blood cultures obtained over 72 hours may be 
considered for the study with Sponsor or Medical Monitor approval. 
4. Has known or suspected left-sided infectious endocarditis by modified Duke criteria 
(Appendix C); 
5. Has a suspected endovascular source of bacteremia including, but not limited to, perivalvular 
abscess, left ventricular assist device (cardiac pacemaker or automatic implantable 
cardioverter-defibrillator [AICD]), AICD wire, arteriovenous graft, prosthetic valves, or valve 
rings;  
Note: A subject with a suspected endovascular source of infection may be considered if that 
source is planned to be removed within 72 hours of randomization. 

Armata Pharmaceuticals, Inc. 
Clinical Study Protocol AP-SA02-101 
Armata Pharmaceuticals, Inc. 
Confidential & Proprietary 
Page 36 of 78 
Version 4.0, 25 July 2024 
6. Has a known or suspected brain abscess;  
Note: A subject with epidural abscess may be included if they do not require surgical 
intervention and have minimal neurologic deficits. 
 
7. Community acquired pneumonia, nosocomial pneumonia due to pathogens other than S. 
aureus.  
Note: patients with pneumonia due to S. aureus are eligible for enrollment;  
8. Has osteomyelitis that is associated with hardware or prosthetic joint infection; 
Note: A subject with a suspected osteomyelitis with hardware or prosthetic joint infection may 
be considered if that source is planned to be removed within 72 hours of randomization. 
9. Has refractory shock with persistent hypotension (ie, mean arterial pressure <60 mmHg) that 
is unresponsive to fluids and vasopressors at Screening; 
10. Has a known allergy to phage products; 
11. Is a female subject who is pregnant or breastfeeding; 
12. In the Investigator’s opinion, the subject is unable to understand and comply with protocol 
requirements, instructions, and protocol-stated restrictions and is unlikely to complete the 
study as planned;  
13. Is currently enrolled in another investigational interventional trial and has received any 
investigational treatment within 28 days prior to consent or will continue to receive any 
investigational treatment during the study; 
14. Has anticipated requirement for effective systemic bacterial therapy unrelated to the treatment 
of SAB or other planned use of systemic antibacterial therapy (eg, treatment of acne vulgaris); 
Note: Prophylactic antibiotics for operative dental procedures and chronic suppressive oral 
antibiotic therapy after completion of a minimum of 14 days (uncomplicated SAB) or 28 days 
(complicated SAB) to 56 days of BAT are permitted. 
15. Has, at Screening, 1 or more of the following laboratory abnormalities: 
a. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >5 × upper limit of 
normal (ULN) if total bilirubin <2 × ULN; and/or 
b. ALT or AST >2.5 × ULN if total bilirubin is >2 × ULN.  
16. Has, in the opinion of the Investigator, an acute or chronic medical condition (eg, seizure 
disorder in status epilepticus, acute coronary syndrome, end-stage renal disease with no plan 
to dialyze, metastatic malignancy, chronic severe liver disease, or other disease) or other 
finding that is clinically significant that could put the subject at risk or harm by participating 
in the study; 
17. Has, in the opinion of the Investigator, evidence of a concurrent medical illness that is 
immediately life-threatening, has life-expectancy of less than 3 months, or is likely to elect 
palliative care within 3 months; 

Armata Pharmaceuticals, Inc. 
Clinical Study Protocol AP-SA02-101 
 
Armata Pharmaceuticals, Inc. 
Confidential & Proprietary 
Page 37 of 78 
Version 4.0, 25 July 2024 
18. Has any known previous exposure to AP-SA02 or prior participation in Study AP-SA02-101; 
19. History of AIDS (human immunodeficiency virus positive with an AIDS-defining condition 
and/or CD4 count <200 cells/mm3) or chronic severe liver disease due to hepatitis B virus 
(HBV) or C virus (HCV) within 90 days prior to Screening.  
Additional exclusion criteria for Phase 1b only 
20. Has all of the following signs/symptoms at or within 24 hours prior to randomization: 
a. Documented temperature ≥38.0°C (100.4°F) or ≤36.0°C (96.8°F) measured orally, 
≥38.5°C (101.3°F) or ≤36.5°C (97.7°F) measured tympanically, or ≥39°C (102.2°F) or 
≤37°C (98.6°F) measured rectally; 
b. Heart rate >90 beats per minute; 
c. Respiratory rate >20 breaths per minute;  
d. White blood cell count ≥12.0 × 109 cells/L or ≤0.4 × 109 cells/L, or ≥10% immature 
neutrophils; and 
e. Systolic blood pressure <90 mmHg.  
4.3 
Stopping Criteria 
The DRC will oversee the safety and tolerability of AP-SA02 during the study and determine if it 
is acceptable to continue. However, safety and tolerability data will be reviewed on an ongoing 
basis by the Medical Monitor and stopping rules will be applicable starting with dosing of the first 
subject. 
4.3.1 
Criteria for Potential Interruption or Discontinuation of Study Drug in Individual 
Subjects 
In the event that any of the following criteria are encountered, the Investigator should review the 
AE with the Medical Monitor as soon as feasible. The Investigator will hold the next infusion 
pending that review has been completed. The Investigator and Medical Monitor in consultation 
with the Sponsor will decide whether to continue to hold study treatment pending additional 
information or to discontinue study treatment.  
• ≥Grade 3 AE or clinically significant laboratory abnormality per Common Terminology 
Criteria for AEs (CTCAE) version 5.0 considered attributable to AP-SA02 (confirmed by 
unblinding). If the event or laboratory test is not listed in the CTCAE, the event or laboratory 
test should be graded by applying the CTCAE guidelines detailed in Section 8.1.3; or 
Note: Clinically significant laboratory abnormalities classified per above should be confirmed 
with a repeat test within 24 hours.  
• Clinical signs or symptoms of severe allergic or anaphylactic reaction. 
• Any SAE considered to be at least possibly related to AP-SA02 (confirmed by unblinding). 
Any subject who prematurely discontinues from study drug should continue to be followed per 
protocol for safety and key efficacy endpoints. Study staff should make every effort to complete 
the full panel of assessments scheduled for Early Termination of Treatment (ETOT). The reason 

Armata Pharmaceuticals, Inc. 
Clinical Study Protocol AP-SA02-101 
 
Armata Pharmaceuticals, Inc. 
Confidential & Proprietary 
Page 38 of 78 
Version 4.0, 25 July 2024 
and date of discontinuation will be documented in the eCRF and the subject should continue to 
complete all safety assessments at subsequent study visits. 
4.3.2 
Criteria for Ad Hoc Data Review Committee Review of Study 
In the event that any of the following criteria are encountered, the DRC may, as described in the 
DRC Charter, convene to review available data and make recommendations, including but not 
limited to, if the cohort should stop or pause the study, enrollment, or treatment and/or make 
recommendations to modify the protocol (ie, decrease or change the dose of study drug, modify 
safety monitoring): 
Phase 1b criteria 
• If any unacceptable toxicity (as determined by the Investigator or Sponsor’s Medical Monitor) 
occurs; 
• If ≥1 serious AE (SAE) considered attributable to AP-SA02 (confirmed by unblinding) occurs; 
or 
• If ≥2 of all treated subjects experience similar SAEs or Grade 3 (CTCAE version 5.0) AEs 
meeting the following criteria: 
o Onset between start of dosing and 7 days after last dose; and 
o Considered attributable to AP-SA02 (confirmed by unblinding). 
Note: All ≥Grade 3 (CTCAE version 5.0) laboratory abnormalities should be confirmed with 
a repeat test within 24 hours. 
Phase 2a criteria 
• If  ≥1 serious AE (SAE) considered at least possibly attributable to AP-SA02 (confirmed by 
unblinding) occurs; or 
• If ≥2 of all treated subjects experience the same or similar adverse events that are  Grade 3 or 
higher meeting the following criteria:  
o Onset between start of dosing and 28 days after last dose; and 
o Considered attributable to AP-SA02 (confirmed by unblinding). 
Note: All ≥Grade 3 (CTCAE version 5.0) laboratory abnormalities should be confirmed with 
a repeat test within 24 hours. 
Further enrollment of subjects and dosing of the investigational product should be halted until a 
safety review of the event is completed. If the DRC recommends, and the Sponsor then 
implements, stopping study treatment and, subsequently, the Sponsor, independent of or following 
a DRC recommendation, proposes to restart the study, a substantial amendment will be submitted 
to regulatory agencies, Institutional Review Board (IRB)/Independent Ethics Committee (IEC), 
and Office of Human Research Oversight (OHRO). The study will not restart until the amendment 
has been approved by regulatory agencies and IRB/IECs. These requirements are not applicable if 
the Sponsor pre-emptively pauses study treatment for subject safety pending DRC review and the 
DRC recommends resuming study treatments and/or any study modifications recommended do 
not represent substantial protocol changes.  

Armata Pharmaceuticals, Inc. 
Clinical Study Protocol AP-SA02-101 
Armata Pharmaceuticals, Inc. 
Confidential & Proprietary 
Page 39 of 78 
Version 4.0, 25 July 2024 
4.4 
Withdrawal or Modification of Individual Subject Study Participation 
Participation of a subject in this clinical study will be discontinued if: 
• The subject or LAR withdraws consent or requests discontinuation from the study for any 
reason; or 
• The subject becomes pregnant. 
The Investigator may with concurrence of Medical Monitor or Sponsor discontinue or modify a 
subject’s study participation for any of the following reasons:  
• Occurrence of any AE (whether or not attributed to study treatment), medical condition, or 
circumstance that does not allow the subject to adhere to the requirements of the protocol or 
continued participation is not in the best interest of the subject; or 
• Subject failure to comply with protocol requirements or study-related procedures. 
Subjects will be considered lost to follow-up if, after completing study treatment, they fail to attend 
a required visit or are unresponsive despite 3 attempts to reach them by telephone, text message, 
email, and/or regular postal mail. Such subjects may, with the concurrence of the Sponsor, be 
terminated from study participation and notification sent by registered mail to the last known 
address. These contact attempts will be documented in both the study record and the subject’s 
medical record.  
Subjects who discontinue prematurely from the study or whose participation is modified will be 
strongly encouraged to complete the full panel of safety assessments scheduled for the ETOT. The 
reason for subject withdrawal must be documented in the eCRF. 
Withdrawn or lost to follow-up subjects may be replaced to ensure adequate numbers of evaluable 
subjects at the discretion of the Sponsor. Subjects who discontinue for study drug-related safety or 
tolerability reasons will not be replaced.  
4.4.1 
Termination of the Study 
The Sponsor may terminate the study at any time and for any reason, including but not limited to 
recommendation by the DRC, new non-clinical information regarding the study treatment, or if 
required by regulatory authorities.  
Depending on the circumstances, termination procedures may or may not include completion of 
study treatment as assigned for all subjects who have received at least 1 dose. After a subject 
receives their last treatment, all EOS treatment safety evaluations will be completed. 

Armata Pharmaceuticals, Inc. 
Clinical Study Protocol AP-SA02-101 
 
Armata Pharmaceuticals, Inc. 
Confidential & Proprietary 
Page 40 of 78 
Version 4.0, 25 July 2024 
5 
STUDY TREATMENTS 
5.1 
Treatment Groups 
The dose level of AP-SA02 to be administered to each subject will be determined based on the 
cohort assignment. Table 1 shows the dosage (in PFU) per cohort. The dose level to be tested in 
the Phase 1b additional cohort(s) (up to 3) and Phase 2a will be based on the observed safety and 
tolerability in the prior dosed subjects. 
Table 1. 
Dosage per Cohort 
Phase  
Cohort 
Each Dose  
(Approximate 
PFU/phage) 
Each Dose 
(Approximate Total 
PFU) 
Total Daily Dose 
(Approximate Total 
PFU) 
Total Dose Over 5 Days 
(Approximate Total 
PFU) 
Phase 1b 
1 
1 × 109 
2 × 109 
8 × 109 
4 × 1010 
2 
1 × 1010 
2 × 1010 
8 × 1010 
4 × 1011 
Phase 2a 
TBD 
TBD 
TBD 
TBD 
PFU = plaque-forming units; TBD = to be determined.  
5.2 
Rationale for Dosing 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Armata Pharmaceuticals, Inc. 
Clinical Study Protocol AP-SA02-101 
Armata Pharmaceuticals, Inc. 
Confidential & Proprietary 
Page 41 of 78 
Version 4.0, 25 July 2024 
 
 
 
5.3 
Randomization and Blinding 
Subjects in Phase 1b will be randomized in a 3:1 ratio in a blinded manner to receive AP-SA02 or 
placebo. For Phase 2a, subjects will be randomized in a 2:1 ratio in a blinded manner to receive 
AP-SA02 or placebo.  
Subjects will be randomized using a centralized randomization system, according to a 
computer-generated randomization list, and stratified by methicillin susceptibility/resistance for 
Phase 2a only. Dosing should occur as soon as possible after randomization. Treatment group 
assignment will be blinded to the subjects, site study team, Sponsor study team, Contract Research 
Organization (CRO) study team, and Investigators. 
5.4 
Breaking the Blind 
Unblinding at the request of the Investigator should occur only in the event of severe AE or SAE 
that is reasonably assessed as treatment related and for which it is necessary to know the treatment 
assignment to determine an appropriate course of therapy for the subject. If the Investigator must 
identify the treatment assignment of an individual subject, the Investigator or qualified designee 
should request the treatment assignment from the centralized randomization system. They should 
not attempt to get this information from the site’s unblinded study team. The Investigator is advised 
to not reveal the treatment assignment to any other site, Sponsor, or CRO personnel.  
Whenever possible, prior to proceeding with unblinding, the Investigator will contact the Sponsor 
to discuss the need to break the blind. The Investigator will notify the Sponsor as soon as is 
practical in the event of the study blind being broken and will document the reason. In the event 
this is not possible, the Investigator should contact the Sponsor as soon as possible to discuss the 
event without revealing the treatment assignment. The Investigator must document the subject 
identification, the date and time of breaking the blind, and must clearly explain the reasons for 
breaking the blind. 
Medically necessary care should not be delayed for unblinding information (ie, the Investigator 
should treat the subject based on the subject’s signs/symptoms without waiting for the unblinding 
process to be completed). 
Subjects who are unblinded and discontinue study drug should continue to complete all safety 
assessments at subsequent study visits. 
5.5 
Drug Supplies 
5.5.1 
Formulation and Packaging 
 
 
 
  

Armata Pharmaceuticals, Inc. 
Clinical Study Protocol AP-SA02-101 
Armata Pharmaceuticals, Inc. 
Confidential & Proprietary 
Page 42 of 78 
Version 4.0, 25 July 2024 
Study drug will be labeled according to local regulatory requirements.  
Placebo will be a sterile dilution buffer used for active AP-SA02
 
5.5.2 
Study Drug Preparation and Dispensing 
 
 
 
 
5.5.3 
Study Drug Administration 
AP-SA02 or placebo will be administered via IV bolus infusion every 6 hours for 5 consecutive 
days in an inpatient location, unless the dose, frequency, or duration is modified after DRC 
review. For a delayed dosing administration, if the dose is delayed by <2 hours, the original 
schedule, relative to the first dose of study drug should be kept. If dose administration is delayed 
by >2 hours, the next dose, and all subsequent doses, should be based on the timing of the 
delayed dose and subjects should receive all study drug doses, even if this extends the treatment 
period. Sites should complete dose administration within ± 30 mins of the scheduled dose 
administration time. In addition, all subjects will receive at least 14 days (uncomplicated SAB) 
or 28 days (complicated SAB) and up to 56 days of BAT. BAT will be administered at the 
discretion of the Investigator.  
Subjects must be directly observed during study drug/placebo administration by clinical personnel. 
The first dose of study drug on Day 1 must occur as close as possible to the time of randomization. 
5.5.4 
Treatment Compliance 
Details of the date and time when the study drug is administered, along with any deviation from 
the procedure described in this protocol, will be recorded in the subject’s source documents and 
the eCRF. 
5.5.5 
Storage and Accountability 
 
 
  
 
 
 
 
 
 
 
The Investigator will agree to not supply the study drug to any person other than the 
sub-Investigators, designated study staff, and the subjects participating in the study. 

Armata Pharmaceuticals, Inc. 
Clinical Study Protocol AP-SA02-101 
Armata Pharmaceuticals, Inc. 
Confidential & Proprietary 
Page 43 of 78 
Version 4.0, 25 July 2024 
The Investigator will return or destroy all study drugs according to the Pharmacy Manual. The list 
of destroyed vials must be recorded. The Investigator must agree to neither dispense the study drug 
from, nor store it at, any study site other than the study site agreed upon with the Sponsor. Details 
on study drug accountability and destruction will be included in the Pharmacy Manual. 
5.6 
Prior and Concomitant Medications and/or Procedures 
5.6.1 
Excluded Medications and/or Procedures 
The following medications and/or procedures are prohibited: 
• Any investigational treatment within 28 days of Screening; and  
• Anticipated requirement for effective systemic bacterial therapy unrelated to the treatment of 
SAB or other planned use of systemic antibacterial therapy (eg, treatment of acne vulgaris). 
Note: Prophylactic antibiotics for operative dental procedures and chronic suppressive oral 
antibiotic therapy after completion of a minimum of 14 days (uncomplicated SAB) or 28 days 
(complicated SAB) to 56 days of BAT are permitted.  
5.6.2 
Documentation of Prior and Concomitant Medication Use 
Any treatment given in addition to the study drug during the study will be regarded as a 
concomitant medication and must be recorded on the appropriate eCRF. 
Any relevant medications received in the 28 days prior to randomization must be recorded on the 
appropriate eCRF, along with the reason for use, dates of administration, and dosages. 
Concomitant medications, including over-the-counter medications and herbal supplements, should 
be kept to a minimum during the study. However, if these are considered necessary for the subject’s 
welfare and are unlikely to interfere with the study drug, they may be given at the discretion of the 
Investigator and recorded in the subject’s source documents and the eCRF. 

Armata Pharmaceuticals, Inc. 
Clinical Study Protocol AP-SA02-101 
Armata Pharmaceuticals, Inc. 
Confidential & Proprietary 
Page 44 of 78 
Version 4.0, 25 July 2024 
6 
STUDY PROCEDURES 
Study procedures will follow the Schedule of Procedures (Appendix A). 

Armata Pharmaceuticals, Inc. 
Clinical Study Protocol AP-SA02-101 
Armata Pharmaceuticals, Inc. 
Confidential & Proprietary 
Page 45 of 78 
Version 4.0, 25 July 2024 
7 
EFFICACY ASSESSMENTS 
7.1 
Phase 1b Multiple Ascending Dose Safety Endpoints 
The primary endpoint is safety. Safety will be evaluated by presenting summaries of the following: 
• Treatment-emergent AEs (TEAEs), which are defined as AEs occurring after the first dose of 
study drug through TOC for study drug (Day 12) or through EOS for SAEs; 
• Vital signs; and 
• Clinical laboratory evaluations.  
The endpoints listed in Section 7.2 for Phase 2a may be assessed as secondary endpoints in the 
safety cohorts; however, these cohorts are exploratory and not powered for any efficacy variable. 
7.2 
Phase 2a Endpoints 
The Phase 2a endpoints are the following: 
• Time to reach a NEWS2 score ≤2 maintained for at least 24 hours or hospital discharge 
(whichever comes first) for subjects on active drug versus placebo in the Microbiological 
Intent-to-Treat (MITT) Population; 
• Clinical Improvement or response at TOC for study drug (Day 12) in the MITT Population; 
• Proportion of subjects reaching a NEWS2 score ≤2 maintained for at least 24 hours or hospital 
discharge (whichever comes first) for subjects on active drug versus placebo at TOC for study 
drug (Day 12) in the MITT Population;  
• Microbiological outcome at EOT for study drug (Day 5); 
• Clinical Improvement or response at TOC for BAT (7 days [±1 day] after the end of BAT); 
• Clinical Improvement or response at EOS (28 days after the end of BAT); 
• Time to death; 
• NEWS2 score while hospitalized by study day; 
• Late composite efficacy, as defined by the following: 
o Survival at EOS (Days 39 to 81); and 
o No evidence of microbiological failure, as defined by either of the following: 
 Blood cultures that remain positive for SA ≥7 days from randomization; or 
 Isolation of SA from the blood or another sterile site (eg, joint fluid, tissue) >14 days 
from randomization. 

Armata Pharmaceuticals, Inc. 
Clinical Study Protocol AP-SA02-101 
Armata Pharmaceuticals, Inc. 
Confidential & Proprietary 
Page 46 of 78 
Version 4.0, 25 July 2024 
• Microbiological failure or relapse by any of the following: 
o Blood cultures that remain positive for SA ≥7 days from randomization;  
o Isolation of SA from the blood or another sterile site (eg, joint fluid, tissue) >14 days from 
randomization; or  
o Blood culture positive for SA >72 hours after the first blood cultures showing CL of SAB 
(defined as 2 consecutive days with negative SA blood cultures). 
• Time to resolution of SAB; 
• Time to hospital discharge (and time to hospital discharge readiness); 
• Need for and duration of intensive care unit stay; 
• Need for and duration of endotracheal mechanical ventilation; 
• Need for and duration of noninvasive pressure ventilation (eg, Continuous Positive Airway 
Pressure, Bilevel Positive Airway Pressure); 
• PK of AP-SA02 with IV administration; 
• Relationship between AP-SA02 exposures and safety and efficacy endpoints; 
• Immunogenicity of AP-SA02 at EOS; 
• Time to resolution of any signs and/or symptoms of bacteremia present at Screening; 
• Time to resolution of any signs/symptoms related to focal site of SA infection (eg, joint pain; 
redness; swelling; weight-bearing, back pain; weight-bearing, skin redness; drainage) from 
randomization on Day 1; 
• TEAEs, which are defined as AEs occurring after the first dose of study drug through TOC for 
study drug (Day 12) or through EOS for SAEs; 
• Proportion of subjects with acute kidney injury (AKI), defined as stage 1 or higher using 
modified Risk-Injury-Failure-Loss-End-stage renal disease (RIFLE) criteria (Appendix D) at 
any time within the first 7 days or new need for renal replacement therapy between Day 1 and 
EOS; 
• Vital signs; 
• Clinical laboratory evaluations; 
• Change in CRP from baseline to EOS; 
• Change in IL-10 from baseline through TOC for study drug (Day 12); 
• Change in SA isolate sensitivity to AP-SA02 between initiation of study drug and the last 
isolation of SA from a sterile site (blood, joint fluid, tissue); 
• Change in SA isolate susceptibilities to anti-staphylococcal antibiotics from baseline; 
• Change in SA isolate susceptibility to BAT from baseline; and 
• Clinical and microbiological outcomes by foci of infection. 

Armata Pharmaceuticals, Inc. 
Clinical Study Protocol AP-SA02-101 
 
Armata Pharmaceuticals, Inc. 
Confidential & Proprietary 
Page 47 of 78 
Version 4.0, 25 July 2024 
7.3 
Efficacy Outcome Assessments 
Clinical outcome will be assessed at TOC for study drug, TOC for BAT, and EOS, and will be 
based on the definitions in Table 2. The signs and symptoms of SAB include the following: 
• Documented temperature ≥38.0°C (100.4°F) or ≤36.0°C (96.8°F) measured orally, ≥38.5°C 
(101.3°F) or ≤36.5°C (97.7°F) measured tympanically, or ≥39°C (102.2°F) or ≤37°C (98.6°F) 
measured rectally; 
• Heart rate >90 beats per minute; 
• Respiratory rate >20 breaths per minute; 
• White blood cell count ≥12.0 × 109 cells/L or ≤0.4 × 109 cells/L, or ≥10% immature 
neutrophils;  
• Systolic blood pressure <90 mmHg; and/or 
• Pain associated with focal site of infection. 
Note: On Day 7, the Investigator will provide an assessment of whether additional imaging is 
needed for potential metastatic infection based on clinical signs/symptoms of SA infection.  
Table 2. 
Definition of Clinical Outcome 
Clinical Outcome 
Definition 
Improvement or 
response (meets all 
criteria) 
• 
The subject is alive;  
• 
Eradication of SAB based on blood cultures obtained through Day 7; 
• 
No new metastatic foci including and after Day 7 or complications of SAB; and 
• 
Resolution of SAB-related clinical signs and symptoms that were present at baseline. 
No response (meets 
1 or more criteria) 
• 
Death due to any cause; 
• 
Persistence of bacteremia based on blood cultures obtained through Day 7 or recurrence 
of SAB; 
• 
Development of new metastatic foci after Day 7 or other complications related to SA; 
or 
• 
Persistence, worsening, or recurrence of attributable signs and symptoms of SAB which 
were present at baseline. 
Indeterminate 
Study data not available for the evaluation of efficacy due to lost to follow-up, withdrawal 
of consent, or missing data.  
SA = Staphylococcus aureus; SAB = Staphylococcus aureus bacteremia.  
7.4 
National Early Warning Score 2 
Table 3 presents the NEWS2 scoring system. A NEWS2 score will be recorded once per day (and 
should be repeated if there is a change in clinical status) from Day 1 through Day 7 and TOC 
for study drug (Day 12). NEWS2 is an aggregate scoring system derived from 6 physiologic 
parameters: 
• Respiration rate; 
• Oxygen saturation; 
• Systolic blood pressure; 
• Pulse rate; 

Armata Pharmaceuticals, Inc. 
Clinical Study Protocol AP-SA02-101 
Armata Pharmaceuticals, Inc. 
Confidential & Proprietary 
Page 48 of 78 
Version 4.0, 25 July 2024 
• Level of consciousness or new confusion; and  
• Temperature. 
Table 3. 
National Early Warning Score 2 Scoring System 
 
Consciousness definitions: alert, fully awake (spontaneous opening of eyes, will to respond to voice, has motor function); CVPU: 
new Confusion, responds to Voice with eyes, voice or motor (event if limited response); responds to a Pain stimulus (likely only 
withdrawal if not respond to voice); Unresponsive (commonly referred to as unconscious) does not give any eye, voice, or motor 
response to voice or pain.  
CVPU = Confusion, Voice, Pain, Unresponsive; SpO2 = oxygen saturation.  
Source: Royal College of Physicians. National Early Warning Score (NEWS) 2: Standardising the assessment of acute-illness 
severity in the NHS. Royal College of Physicians; 2017. Accessed 23 March 2021.  
https://www.rcplondon.ac.uk/projects/outputs/national-early-warning-score-news-2 
Table 4 presents the NEWS2 thresholds and associated clinical risk. The aggregate score 
represents the risk of death from sepsis and indicates the urgency of the response: 
• 0 to 4: low risk (a score of 3 in any individual parameter is low-medium); 
• 5 to 6: medium risk; or 
• 7 or more: high risk. 
Physiological 
parameter 
Respiration rate 
(per minute) 
SpO2 Scale 1 ( % ) 
SpO2 Scale 2 ( % ) 
Air or oxygen? 
Systolic blood 
pressure (mmHg) 
Pulse (per minute) 
Consciousness 
Temperature (°C) 
Score 
3 
I 
2 
I , 
I 
o 
I , 
I 
2 
I 
3 
s8 
9- 11 
12- 20 
21- 24 
:i,25 
s91 
92-93 
94- 95 
;;-:96 
s83 
84- 85 
86- 87 
88-92 
93-94 on 
95-96 on 
:i,97on 
;,:93 on air 
oxygen 
oxygen 
oxygen 
Oxygen 
Air 
s90 
91- 100 
101- 110 
11 1- 219 
:i,220 
s40 
41-50 
51-90 
91-110 
111-130 
:i,131 
Alert 
CVPU 
s35.0 
35.1-36.0 
36.1-38.0 
38.1-39.0 
:i,39.1 

Armata Pharmaceuticals, Inc. 
Clinical Study Protocol AP-SA02-101 
Armata Pharmaceuticals, Inc. 
Confidential & Proprietary 
Page 49 of 78 
Version 4.0, 25 July 2024 
Table 4. 
National Early Warning Score 2 Thresholds and Clinical Risk 
 
NEW = National Early Warning.  
Source: Royal College of Physicians. National Early Warning Score (NEWS) 2: Standardising the assessment of acute-illness 
severity in the NHS. Royal College of Physicians; 2017. Accessed 23 March 2021. 
 https://www.rcplondon.ac.uk/projects/outputs/national-early-warning-score-news-2 
7.5 
Anti-Phage Antibodies  
Serum samples will be collected prior to the first dose on Day 1, Day 7, TOC for study drug 
(Day 12), and EOS to determine if titers of anti-phage antibodies are detectable.  
7.6 
Phage Clearance 
Urine for phage CL will be collected prior to the first dose on Day 1, Day 7, TOC for study drug 
(Day 12), TOC for BAT, and ETOT. Date and time will be recorded for each urine sample 
collection at the designated time points. 
7.7 
Blood Cultures 
Blood cultures and susceptibility testing will be performed by a local microbiology laboratory per 
the laboratory’s standard procedures and standard of care at Screening, daily from Day 1 through 
Day 7 as indicated in the Schedule of Procedures (Appendix A). Blood cultures should be collected 
regardless of clinical indication at Day 1, EOT for study drug (Day 5), Day 7, TOC for study drug 
(Day 12), TOC for BAT, and EOS. Isolates of SA from positive blood cultures for standard of care 
blood cultures used to assess eligibility as well as from study cultures will be sent to the central 
microbiology laboratory for confirmations of identification and susceptibility testing. 
Two sets of blood cultures, preferably from 2 different sites, 30 minutes apart will be drawn on 
Day 1 as close to the start of study drug administration as possible, unless blood cultures have 
already been sent that day for Screening or clinical care. Thereafter, 1 set of blood cultures is 
acceptable. Blood cultures should be collected from a peripheral venipuncture site when possible 
until 2 consecutive days of negative blood cultures are obtained or otherwise as clinically 
indicated. Repeat blood cultures will also be obtained at EOT for study drug (Day 5), Day 7, each 
of the TOC (BAT and study drug) and the EOS Visits to evaluate for microbiological cure and 
sustained cure. 
Subjects’ SA blood culture isolates will be classified as MSSA or MRSA. 
NEW score 
I 
Clinical risk 
I 
Aggregate score 0-Lt 
Low 
Red score 
Low- medium 
Score of 3 in any individual parameter 
Aggregate score 5-6 
Medium 
Aggregate score 7 or more 
High 

Armata Pharmaceuticals, Inc. 
Clinical Study Protocol AP-SA02-101 
Armata Pharmaceuticals, Inc. 
Confidential & Proprietary 
Page 50 of 78 
Version 4.0, 25 July 2024 
7.7.1 
Criteria for Positive Blood Culture for Eligibility 
For study eligibility, subjects must have blood culture positive for SA determined by rapid 
diagnostic or conventional method from blood culture specimens collected within 72 hours prior 
to randomization. Time of positive blood culture starts from when specimen is collected for blood 
culture. The site microbiological laboratory is encouraged to use a Food and Drug Administration 
(FDA)-cleared, European Conformity-in vitro diagnostic certified, or Sponsor-approved rapid 
diagnostic test to identify SA if it is available at the site. Subjects may be enrolled based on a 
positive result from a rapid diagnostic test, but confirmation of SA by conventional culture 
methods will be the required objective measure for SA in the study analyses for efficacy. Subjects 
who are enrolled based on a positive rapid diagnostic test, but have negative blood culture result 
for SA, will discontinue study drug if the Investigator decides to discontinue antibiotic treatment 
of SAB. In the event subjects will complete the EOT for the study drug safety evaluations and 
have additional safety follow-up 7 days after last dose in person, if feasible, or by phone.  
The study site’s local microbiology laboratory will perform identification and in vitro 
susceptibility testing to standard of care antibiotics according to local practices for all blood 
cultures positive for SA. The Investigator should ensure that all SA isolates obtained from all 
cultures performed during the study period (and wherever possible, the isolate from the initial 
positive culture for SA) are sent to the central microbiology laboratory, as described in the 
Laboratory Manual. The local microbiology laboratory will be required to prepare SA isolates for 
shipment to the central microbiology laboratory as outlined in the Laboratory Manual. Although 
only SA isolates should be sent to the central microbiology laboratory, all organisms isolated from 
blood cultures performed during the study should be recorded in the electronic data capture (EDC) 
system. The central microbiology laboratory will confirm the identification and perform in vitro 
susceptibility testing and phage susceptibility of isolates in batches for the purposes of the final 
study analysis; the central microbiology laboratory will not be providing results to the sites. Further 
evaluation to identify the potential mechanism of resistance may be performed. 
7.7.2 
Cultures From Sterile Sites 
Specimens from sterile sites (eg, joint fluid, tissue) will be collected as clinically indicated and 
sent to the site’s local microbiology laboratory for culture and susceptibility per standard practice. 
Results of the cultures will be entered into the EDC system. Isolates of all SA isolates will be sent 
to the central microbiology laboratory for confirmation of identification and susceptibility testing 
as outlined in the Laboratory Manual.  
7.8 
Microbiological Outcome  
Microbiological response will be determined programmatically as 1 of the following outcomes 
based on the results of blood cultures and/or urine cultures at EOT for study drug (Day 5), TOC 
for study drug (Day 12), TOC for BAT, and EOS. A microbiological favorable assessment will 
include eradication and presumed eradications, as detailed in Table 5. 

Armata Pharmaceuticals, Inc. 
Clinical Study Protocol AP-SA02-101 
 
Armata Pharmaceuticals, Inc. 
Confidential & Proprietary 
Page 51 of 78 
Version 4.0, 25 July 2024 
Table 5. 
Microbiological Outcome  
Category 
Criteria 
Eradication 
Blood cultures negative for SA for 2 consecutive days.  
Presumed eradication 
Follow-up blood cultures were not done (or were technically uninterpretable) and the 
subject has responded clinically, as defined in Table 2. 
Persistence 
Follow-up blood cultures do not meet the criteria for eradication and are positive for SA 
either daily or every other day.  
Presumed persistence 
Follow-up blood cultures were not done (or were technically uninterpretable) and the 
subject has not responded clinically, as defined in Table 2. 
Recurrence 
A positive blood culture for SAB at any time after documented eradication or presumed 
eradication.  
SA = Staphylococcus aureus; SAB = Staphylococcus aureus bacteremia. 
7.9 
Pharmacokinetic Assessments 
PK samples for AP-SA02 will be collected from subjects enrolled at predetermined/qualified PK 
sites on the following days and times, and evaluated based on AP-SA02 levels as measured by 
venous blood samples:  
• Day 1: pre-dose (-60 minutes) and , 0.5 hours (±15 minutes), 1 hour (±15 minutes), and 3 hours 
(±15 minutes) post first dose of the day; 
• Days 2 to 4: 1 sample 1 hour (30 minutes) post first dose of the study day;  
• Day 5:  1 hour (±15 minutes) post last dose of the day; and 
• Day 6: 24 hours (±30 minutes) post last dose.  
PK parameters of AP-SA02 will be assessed from subjects enrolled at predetermined/qualified PK 
sites with serial PK sampling, including maximum observed plasma concentration (Cmax), time to 
reach Cmax (Tmax), terminal elimination half-life (t½), CL, volume of distribution (Vz), area under 
the plasma concentration-time curve (AUC) from time 0 to the last quantifiable time (AUC0-t), and 
AUC from time 0 to infinity (AUC0-∞). Additional details regarding PK analysis methodology will 
be described in the Statistical Analysis Plan (SAP). 
7.10 
Pharmacodynamic Assessments 
Pharmacodynamics will be evaluated based on the following: 
• Time to resolution of signs/symptoms of bacteremia present at Screening; 
• Time to resolution of bacteremia based on blood cultures; and/or 
• Change in CRP from baseline. 

Armata Pharmaceuticals, Inc. 
Clinical Study Protocol AP-SA02-101 
Armata Pharmaceuticals, Inc. 
Confidential & Proprietary 
Page 52 of 78 
Version 4.0, 25 July 2024 
8 
SAFETY ASSESSMENTS 
Safety will be assessed by monitoring AEs, vital signs, laboratory data (chemistries, hematology, 
and coagulation), immunogenicity evaluation, physical examinations, ECGs, and radiologic 
imaging per standard of care (eg, echocardiogram). 
8.1 
Adverse Events 
An AE is defined as any untoward medical occurrence in a clinical investigation subject 
administered a pharmaceutical product, which does not necessarily have a causal relationship with 
this treatment. An AE can therefore be any unfavorable and/or unintended sign (including an 
abnormal laboratory finding), symptom, or disease temporally associated with the use of an 
investigational medicinal product, whether or not related to the investigational medicinal product. 
All AEs, including observed or volunteered problems, complaints, or symptoms, are to be recorded 
on the appropriate eCRF. 
AEs, which include clinical laboratory test variables, will be monitored and documented from the 
time of informed consent. Subjects should be instructed to report any AE that they experience to 
the Investigator, whether or not they think the event is due to study treatment. Beginning at 
Screening, Investigators should make an assessment for AEs at each visit and record the event on 
the appropriate AE eCRF. 
Wherever possible, a specific disease or syndrome rather than individual associated signs and 
symptoms should be identified by the Investigator and recorded on the eCRF. However, if an 
observed or reported sign or symptom is not considered a component of a specific disease or 
syndrome by the Investigator, it should be recorded as a separate AE on the eCRF. Additionally, 
the condition that led to a medical or surgical procedure (eg, surgery, endoscopy, tooth extraction, 
or transfusion) should be recorded as an AE, not the procedure itself.  
Any medical condition already present at Screening should be recorded as medical history and not 
be reported as an AE unless the medical condition or signs or symptoms present at baseline changes 
in severity, frequency, or seriousness at any time during the study. In this case, it should be reported 
as an AE. 
Clinically significant abnormal laboratory or other examination (eg, ECG) findings that are 
detected during the study or are present at Screening and significantly worsen during the study 
should be reported as AEs, as described below. The Investigator will exercise his or her medical 
and scientific judgment in deciding whether an abnormal laboratory finding or other abnormal 
assessment is clinically significant. Clinically significant abnormal laboratory values occurring 
during the clinical study will be followed until repeat tests return to normal, stabilize, or are no 
longer clinically significant. Abnormal test results that are determined to be an error should not be 
reported as an AE. Laboratory abnormalities or other abnormal clinical findings (eg, ECG 
abnormalities) should be reported as an AE if any of the following are applicable: 
• If an intervention is required as a result of the abnormality; 
• If action taken with the study drug is required as a result of the abnormality; or 
• Based on the clinical judgment of the Investigator. 

Armata Pharmaceuticals, Inc. 
Clinical Study Protocol AP-SA02-101 
 
Armata Pharmaceuticals, Inc. 
Confidential & Proprietary 
Page 53 of 78 
Version 4.0, 25 July 2024 
8.1.1 
Adverse (Drug) Reaction 
All noxious and unintended responses to a medicinal product related to any dose should be 
considered an adverse drug reaction. “Responses” to a medicinal product means that a causal 
relationship between a medicinal product and an AE is at least a reasonable possibility, ie, the 
relationship cannot be ruled out. 
8.1.2 
Unexpected Adverse Drug Reaction 
An Unexpected Adverse Drug Reaction is defined as an adverse reaction, the nature or severity of 
which is not consistent with the applicable product information. For AP-SA02, the reference safety 
information is included in the Investigator’s Brochure currently in force. The reference safety 
information will be reviewed yearly and the periodicity of the review will be harmonized with the 
reporting period of the Development Safety Update Report. 
8.1.3 
Assessment of Adverse Events by the Investigator 
The severity of all AEs should be graded according to the CTCAE version 5.0. For those AE terms 
not listed in the CTCAE, the following grading system should be used: 
Assessment of severity 
The severity of all AEs should be graded according to the CTCAE version 5.0. For those AE terms 
not listed in the CTCAE, the following grading system should be used: 
• CTCAE Grade 1: Mild; asymptomatic or mild symptoms; clinical or diagnostic observations 
only; intervention not indicated; 
• CTCAE Grade 2: Moderate; minimal local or noninvasive intervention indicated; limiting 
age-appropriate instrumental activities of daily living; 
• CTCAE Grade 3: Severe or medically significant but not immediately life-threatening; 
hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care 
activities of daily living; 
• CTCAE Grade 4: Life-threatening consequences; urgent intervention indicated; or 
• CTCAE Grade 5: Death related to the AE. 
Assessment of causality 
The relationship of an AE to the administration of the study drug is to be assessed according to the 
following definitions: 
No (unrelated, not related, unlikely to be related) – The time course between the administration of 
study drug and the occurrence or worsening of the AE rules out a causal relationship and another 
cause (concomitant drugs, therapies, complications, etc) is suspected. 
Yes (possibly, probably, or definitely related) – The time course between the administration of 
study drug and the occurrence or worsening of the AE is consistent with a causal relationship and 
no other cause (concomitant drugs, therapies, complications, etc) can be identified. 
The definition implies a reasonable possibility of a causal relationship between the event and the 
study drug. This means that there are facts (evidence) or arguments to suggest a causal relationship. 

Armata Pharmaceuticals, Inc. 
Clinical Study Protocol AP-SA02-101 
Armata Pharmaceuticals, Inc. 
Confidential & Proprietary 
Page 54 of 78 
Version 4.0, 25 July 2024 
The following factors should also be considered: 
• The temporal sequence from study drug administration- 
The event should occur after the study drug is given. The length of time from study drug 
exposure to event should be evaluated in the clinical context of the event. 
• Underlying, concomitant, intercurrent diseases- 
Each report should be evaluated in the context of the natural history and course of the disease 
being treated and any other disease the subject may have. 
• Concomitant drug- 
The other drugs the subject is taking or the treatment the subject receives should be examined 
to determine whether any of them might be recognized to cause the event in question. 
• Known response pattern for this class of study drug- 
Clinical and/or preclinical data may indicate whether a particular response is likely to be a 
class effect. 
• Exposure to physical and/or mental stresses- 
The exposure to stress might induce adverse changes in the recipient and provide a logical and 
better explanation for the event. 
• The pharmacology and PK of the study drug- 
The known pharmacologic properties (absorption, distribution, metabolism, and excretion) of 
the study drug should be considered. 
8.2 
Serious Adverse Events 
An AE or adverse reaction is considered serious if, in the view of either the Investigator or Sponsor, 
it results in any of the following outcomes: 
• Death; 
• A life-threatening AE; 
Note: An AE or adverse reaction is considered “life-threatening” if, in view of either the 
Investigator or Sponsor, its occurrence places the subject at immediate risk of death. It does 
not include an event that, had it occurred in a more severe form, might have caused death. 
• Requires hospitalization or prolongation of existing hospitalizations; 
Note: Any hospital admission with at least 1 overnight stay will be considered an inpatient 
hospitalization. An emergency room or urgent care visit without hospital admission will not 
be recorded as an SAE under this criterion, nor will hospitalization for a procedure scheduled 
or planned before signing of informed consent, or elective treatment of a preexisting condition 
that did not worsen from baseline. However, unexpected complications and/or prolongation of 
hospitalization that occur during elective surgery should be recorded as AEs and assessed for 
seriousness. Admission to the hospital for social or situational reasons (ie, no place to stay, live 

Armata Pharmaceuticals, Inc. 
Clinical Study Protocol AP-SA02-101 
 
Armata Pharmaceuticals, Inc. 
Confidential & Proprietary 
Page 55 of 78 
Version 4.0, 25 July 2024 
too far away to come for hospital visits, respite care) will not be considered inpatient 
hospitalizations.  
• A persistent or significant disability/incapacity or substantial disruption of the ability to 
conduct normal life functions; 
• A congenital anomaly/birth defect; or 
• An important medical event. 
Note: Important medical events that do not meet any of the above criteria may be considered 
an SAE when, based upon appropriate medical judgment, they may jeopardize the subject and 
may require medical or surgical intervention to prevent 1 of the outcomes listed above. 
Examples of such medical events include allergic bronchospasm requiring intensive treatment 
in an emergency room or at home, blood dyscrasias or convulsions that do not result in 
inpatient hospitalizations, or the development of drug dependency. 
8.3 
Serious Adverse Event Reporting − Procedures for Investigators 
Initial reports 
All SAEs occurring from the time of informed consent until end of study must be reported to 
Clinical Safety within 24 hours of the knowledge of the occurrence. 
To report the SAE, complete the SAE form electronically in the EDC system for the study. When 
the form is completed, 
 Safety personnel will be notified electronically by the EDC 
system and will retrieve the form. If the event meets serious criteria and it is not possible to access 
the EDC system, send an email to 
 Safety at 
 
 
 (contact information listed in Section 8.6) within 24 hours of 
awareness. When the EDC system becomes available, the SAE information must be entered within 
24 hours of the system becoming available. 
Follow-up reports 
The Investigator must continue to follow the subject until the SAE has subsided or until the 
condition becomes chronic in nature, stabilizes (in the case of persistent impairment), or the subject 
dies. 
Within 24 hours of receipt of follow-up information, the Investigator must update the SAE form 
electronically in the EDC system for the study and submit any supporting documentation 
(eg, subject discharge summary or autopsy reports) to 
Clinical Safety via fax or email. 
If it is not possible to access the EDC system, refer to the procedures outlined above for initial 
reporting of SAEs. 
8.4 
Pregnancy Reporting 
If a subject becomes pregnant during the study or within the safety follow-up period defined in the 
protocol, the Investigator is to stop dosing with study drug immediately and the subject should be 
withdrawn from the study. ETOT procedures should be implemented at that time.  
A pregnancy is not considered to be an AE or SAE; however, it must be reported to 
 
Clinical Safety within 24 hours of knowledge of the event. 
 Clinical Safety will then 

Armata Pharmaceuticals, Inc. 
Clinical Study Protocol AP-SA02-101 
Armata Pharmaceuticals, Inc. 
Confidential & Proprietary 
Page 56 of 78 
Version 4.0, 25 July 2024 
provide the Investigator/site the Exposure In Utero (EIU) form for completion. The 
Investigator/site must complete the EIU form and fax/email it back to 
 Clinical Safety.  
If the female partner of a male subject becomes pregnant while the subject is receiving study drug 
or within the safety follow-up period defined in the protocol, the Investigator should notify 
Clinical Safety as described above.  
The pregnancy should be followed until the outcome of the pregnancy, whenever possible. Once 
the outcome of the pregnancy is known, the EIU form should be completed and faxed/emailed to 
Clinical Safety. If the outcome of the pregnancy meets the criteria for immediate 
classification as an SAE (ie, postpartum complication, spontaneous abortion, stillbirth, neonatal 
death, or congenital anomaly), the Investigator should follow the procedures for reporting an SAE. 
8.5 
Expedited Reporting 
The Sponsor/designee will report all relevant information about Suspected Unexpected Serious 
Adverse Reactions (SUSARs) that are fatal or life-threatening as soon as possible to the FDA, 
applicable competent authorities in all the Member States concerned, to the Central Ethics 
Committee, OHRO, and other designated officials as needed (Department of Defense) and in any 
case no later than 7 days after knowledge by the Sponsor/designee of such a case. Relevant 
follow-up information will subsequently be communicated within an additional 8 days.  
All other SUSARs will be reported to the FDA, applicable competent authorities concerned, and 
to the Central Ethics Committee concerned as soon as possible but within a maximum of 15 days 
of first knowledge by the Sponsor/designee.  
The Sponsor/designee will also report any additional expedited safety reports required in 
accordance with the timelines outlined in country-specific legislation.  
The Sponsor/designee will also inform all Investigators as required per local regulation. 
The requirements above refer to the requirements relating to investigational drug product. 
8.6 
Special Situation Reports 
Special situation reports include reports of overdose, misuse, abuse, medication error, and reports 
of adverse reactions associated with product complaints. 
• Overdose: Refers to the administration of a quantity of a medicinal product given per 
administration or cumulatively (accidentally or intentionally), which is above the maximum 
recommended dose according to the protocol. Clinical judgment should always be applied. In 
cases of a discrepancy in the drug accountability, overdose will be established only when it is 
clear that the subject has taken additional dose(s) or the Investigator has reason to suspect that 
the subject has taken additional dose(s).  
• Misuse: Refers to situations where the medicinal product is intentionally and inappropriately 
used in a way that is not in accordance with the protocol instructions or local prescribing 
information and may be accompanied by harmful physical and/or psychological effects.  
• Abuse: Is defined as persistent or sporadic, intentional excessive use of a medicinal product, 
which is accompanied by harmful physical or psychological effects. 

Armata Pharmaceuticals, Inc. 
Clinical Study Protocol AP-SA02-101 
Armata Pharmaceuticals, Inc. 
Confidential & Proprietary 
Page 57 of 78 
Version 4.0, 25 July 2024 
• Medication error: Is any unintentional error in the prescribing, dispensing, or administration 
of a medicinal product by a healthcare professional, patient, or consumer, respectively. The 
administration or consumption of the unassigned treatment and administration of an expired 
product are always reportable as medication errors, cases of subjects missing doses of 
investigational product are not considered reportable as medication error. 
• Product complaint: Is defined as any written, electronic, or oral communication that alleges 
deficiencies related to the identity, quality, durability, reliability, safety, effectiveness, or 
performance of a drug or device after it is released for distribution. A special situations form 
will only be completed if a complaint is associated with an adverse drug reaction.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
8.7 
Clinical Laboratory Evaluations 
Blood samples for chemistry, hematology, coagulation, CRP, and procalcitonin will be obtained 
at Screening, daily from Day 1 through EOT for study drug (Day 5), Day 7, TOC for study drug 
(Day 12), TOC for BAT, and EOS. Clinical laboratory assessments will be performed post-dose 
after the second infusion on Day 1. All standard blood tests will be analyzed centrally by a certified 
clinical laboratory and details on the collection and processing of central laboratory samples can 
be found in the Laboratory Manual. 
Following study drug dosing, the Investigator will review laboratory values for those outside of 
normal range and will be required to conduct clinically appropriate follow-up procedures. Clinical 
significance of the values outside of normal ranges will be assessed by the Investigator. 
The analytes listed in Appendix B will be measured at Screening, daily from Day 1 through EOT 
for study drug (Day 5), Day 7, TOC for study drug (Day 12), TOC for BAT, and EOS. 
8.8 
Acute Kidney Injury 
AKI will be measured at Day 1 and EOS. AKI will be defined as stage 1 or higher using modified 
RIFLE criteria (Appendix D) at any time within the first 7 days or new need for renal replacement 
therapy between Day 1 and EOS. 

Armata Pharmaceuticals, Inc. 
Clinical Study Protocol AP-SA02-101 
Armata Pharmaceuticals, Inc. 
Confidential & Proprietary 
Page 58 of 78 
Version 4.0, 25 July 2024 
8.9 
Vital Signs 
Vital signs will be measured at Screening, prior to infusion (-1 hour window) daily on Day 1 
through Day 7, TOC for study drug (Day 12), TOC for BAT, and EOS. Vital signs will include 
temperature, heart rate, and blood pressure. Vital signs will be obtained at every visit unless the 
subject has been discharged and visits are being performed remotely. During the Treatment Period, 
vital signs should be obtained prior to each infusion (-1 hour window). Wherever possible, vital 
signs will be obtained after at least 5 minutes resting in a supine or sitting position. If more than 
1 measurement is taken on a given day, the highest value for temperature should be recorded in 
the eCRF.  
8.10 
Electrocardiogram 
A 12-lead ECG will be conducted at Screening, post first dose on Day 1, Day 3, EOT for study 
drug (Day 5), TOC for study drug (Day 12), TOC for BAT, and EOS. The Investigator will 
evaluate ECGs for abnormal results and document the clinical significance of these, reporting as 
AEs or medical history where appropriate. 
8.11 
Physical Examination 
A complete physical examination will be performed at Screening, Day 7, TOC for study drug 
(Day 12), TOC for BAT, and EOS. A targeted physical examination will be performed daily from 
Day 1 through Day 6.  
A complete physical examination will include evaluation of head, eyes, ears, nose, and 
throat (HEENT), neck, lungs, heart, chest, abdomen, extremities, neurologic status, skin for 
evidence of emboli, palpation for signs of pain, and any other notable conditions. A targeted 
physical examination will include evaluation for complications of bacteremia, HEENT, lungs, 
heart, skin for any evidence of septic emboli, and palpation for signs of pain. Pain on a physical 
examination should trigger diagnostic testing for metastatic foci of infection. 
 

Armata Pharmaceuticals, Inc. 
Clinical Study Protocol AP-SA02-101 
Armata Pharmaceuticals, Inc. 
Confidential & Proprietary 
Page 59 of 78 
Version 4.0, 25 July 2024 
9 
STATISTICS 
9.1 
Analysis Populations 
The following analysis populations will be defined for the Phase 1b and Phase 2a cohorts:  
• Intent-to-Treat (ITT): all randomized subjects regardless of whether or not study drug is 
received; 
• Phage-Sensitive ITT: all randomized subjects who receive both BAT and study drug, and 
whose SA isolate is sensitive to at least 1 of the phage components that comprise the study 
drug; 
• Safety: all randomized subjects who receive at least 1 dose of study drug; 
• MITT: all subjects in the ITT Population with baseline SAB and who receive at least 1 dose of 
study drug; and 
• PK: all subjects (enrolled at predetermined/qualified PK sites) who have at least 1 PK sample 
drawn. 
An SAP will be prepared and finalized before database lock and analyses of data. Summary data 
will be tabulated and presented by treatment group. 
9.2 
Statistical Methods 
Predefined or post-hoc statistical analysis for all subjects may be performed to compare the 
treatment groups that are randomized based on the following:  
• MRSA subjects (subgroup will be for Phase 2a only); 
• Blood cultures positive for SA on Day -1 prior to study drug administration; and 
• Source control achieved (eg, abscess drainage, catheter or intravascular device removal, 
washout of infected joint). 
Note: The final SAP will finalize the subgroup analyses. 
9.2.1 
Analysis of Phase 2a Endpoints 
Phase 2a endpoints will be summarized descriptively for each treatment arm using appropriate 
proportions and means depending on the data type along with the 95% confidence interval. No 
formal hypothesis testing is planned. 
Additional details will be described in the SAP.  
9.2.2 
Analysis of Safety 
Safety will be assessed by monitoring AEs, vital signs, laboratory data (chemistries, hematology, 
and coagulation), immunogenicity evaluation, physical examinations, ECGs, and radiologic 
imaging per standard of care (eg, echocardiogram). 

Armata Pharmaceuticals, Inc. 
Clinical Study Protocol AP-SA02-101 
Armata Pharmaceuticals, Inc. 
Confidential & Proprietary 
Page 60 of 78 
Version 4.0, 25 July 2024 
9.2.3 
Analysis of Pharmacokinetics 
PK samples for AP-SA02 will be collected from subjects enrolled at predetermined/qualified PK 
sites per protocol and evaluated based on AP-SA02 levels as measured by venous blood samples.  
PK parameters of AP-SA02 will be assessed from subjects enrolled at predetermined/qualified PK 
sites with serial PK sampling, including Cmax, Tmax, t½, CL, Vz, AUC0-t, and AUC0-∞. Additional 
details regarding PK analysis methodology will be described in the SAP.  
9.2.4 
Analysis of Pharmacodynamics 
Pharmacodynamics will be evaluated based on the following: 
• Time to resolution of signs/symptoms of bacteremia present at Screening; 
• Time to resolution of bacteremia based on blood cultures; and/or 
• Change in CRP from baseline. 
9.2.5 
Clinical Efficacy Adjudication Committee 
The Clinical Efficacy Adjudication Committee (CEAC) will consist of a group of independent 
clinical experts blinded to treatment allocation and not associated with study conduct. Data 
obtained for subjects who receive study drug may be reviewed independently by CEAC members. 
The CEAC members will give their opinion on the diagnosis and classification of the SAB, the 
adequacy of BAT, the adequacy of source control, and/or the response assessment (overall success 
or failure). For deaths occurring during the study, a blinded assessment of the attribution of death 
to SAB or to another cause may be performed by the CEAC members. 
9.2.6 
Sample Size Determination 
The study will enroll approximately 50 eligible subjects. Enrollment may be expanded up to a total 
of approximately 100 subjects to ensure that at least 8 treated and 4 placebo Phase 2a subjects are 
MRSA subjects and to account for additional subjects and cohorts that may be enrolled based on 
DRC review and Sponsor input based on emerging data. To ensure that at least 8 treated and 
4 placebo Phase 2a subjects are MRSA subjects, no more than approximately 70 non-MRSA 
subjects will be enrolled without a protocol amendment. 
The Phase 1b MAD safety cohorts will follow a standard 3 + 1 design for 2 cohorts (n = 4 for each 
cohort for a total of 8 subjects). However, additional cohorts (up to 3) may be added or existing 
cohorts expanded per recommendation of the DRC or Sponsor decision. The total sample size in 
Phase 1b may be increased up to a total of 20 subjects without a protocol amendment in 
consultation with the DRC.  
Phase 2a will have an initial sample size of approximately n = 42 with a study drug to placebo 
allocation of 2:1 in order to enroll at least 38 subjects meeting the MITT Population criteria with 
the assumption that approximately 90% of randomized subjects will satisfy the MITT Population 
criteria. This will provide at least 80% power to detect a difference of 50% in the proportion of 
subjects in each treatment arm, with a 30% placebo portion meeting all conditions for Clinical 
Improvement or response at TOC for study drug (Day 12) in the MITT Population with a type 1 
error rate of 0.05 (1-sided) using Fisher’s exact test. Additional subjects may be included in 
Phase 2a after a protocol amendment. 

Armata Pharmaceuticals, Inc. 
Clinical Study Protocol AP-SA02-101 
Armata Pharmaceuticals, Inc. 
Confidential & Proprietary 
Page 61 of 78 
Version 4.0, 25 July 2024 
10 
DATA MANAGEMENT AND RECORD KEEPING 
10.1 
Data Management 
10.1.1 
Data Handling 
Data will be recorded at the site on eCRFs and reviewed by the CRA during monitoring visits. The 
CRAs will verify data recorded in the EDC system with source documents. All corrections or 
changes made to any study data must be appropriately tracked in an audit trail in the EDC system. 
An eCRF will be considered complete when all missing, incorrect, and/or inconsistent data have 
been accounted for. 
10.1.2 
Computer Systems 
Data will be processed using a validated computer system conforming to regulatory requirements. 
10.1.3 
Data Entry 
Data must be recorded using the EDC system as the study is in progress. All site personnel must 
log into the system using their secure username and password in order to enter, review, or correct 
study data. These procedures must comply with Title 21 of the Code of Federal Regulations (CFR) 
(21 CFR Part 11) and other appropriate international regulations. All passwords will be strictly 
confidential. 
10.1.4 
Medical Information Coding 
For medical information, the following thesauri will be used: 
• Medical Dictionary for Regulatory Activities (latest) for medical history and AEs; and 
• World Health Organization Drug Dictionary for prior and concomitant medications. 
10.1.5 
Data Validation 
Validation checks programmed within the EDC system, as well as supplemental validation 
performed via review of the downloaded data, will be applied to the data in order to ensure 
accurate, consistent, and reliable data. Data identified as erroneous, or data that are missing, will 
be referred to the investigative site for resolution through data queries. 
The eCRFs must be reviewed and electronically signed by the Investigator. 
10.2 
Record Keeping 
Records of subjects, source documents, monitoring visit logs, eCRFs, inventory of study product, 
regulatory documents, and other Sponsor correspondence pertaining to the study must be kept in 
the appropriate study files at the site. Source data are defined as all information in original records 
and certified copies of original records of clinical findings, observations, or other activities in a 
clinical study necessary for the evaluation and reconstruction of the clinical study. Source data are 
contained in source documents (original records or certified copies). These records will be retained 
in a secure file for the period as set forth in the Clinical Study Agreement. Prior to transfer or 
destruction of these records, the Sponsor must be notified in writing and be given the opportunity 
to further store such records.  

Armata Pharmaceuticals, Inc. 
Clinical Study Protocol AP-SA02-101 
Armata Pharmaceuticals, Inc. 
Confidential & Proprietary 
Page 62 of 78 
Version 4.0, 25 July 2024 
10.3 
End of Study 
The end of the study is defined as the date of the last protocol-specified visit/assessment (including 
telephone contact) for the last subject in the study. 
 

Armata Pharmaceuticals, Inc. 
Clinical Study Protocol AP-SA02-101 
Armata Pharmaceuticals, Inc. 
Confidential & Proprietary 
Page 63 of 78 
Version 4.0, 25 July 2024 
11 
INVESTIGATOR REQUIREMENTS AND QUALITY CONTROL  
11.1 
Ethical Conduct of the Study 
Good Clinical Practice (GCP) is an international ethical and scientific quality standard for 
designing, conducting, recording, and reporting studies that involve human subjects. Compliance 
with this standard provides public assurance that the rights, safety, and wellbeing of study subjects 
are protected, consistent with the principles that have their origin in the Declaration of Helsinki, 
and that the clinical study data are credible. 
11.2 
Institutional Review Board/Independent Ethics Committee 
The IRB/IEC and OHRO will review all appropriate study documentation in order to safeguard 
the rights, safety, and wellbeing of subjects. The study will only be conducted at sites where 
IRB/IEC approval has been obtained. The protocol, Investigator’s Brochure, ICF, advertisements 
(if applicable), written information given to the subjects, safety updates, annual progress reports, 
and any revisions to these documents will be provided to the IRB/IEC by the Investigator. 
Federal regulations and International Council for Harmonisation (ICH) Guidelines require that 
approval be obtained from an IRB/IEC prior to participation of subjects in research studies. Prior 
to study onset, the protocol, any protocol amendments, ICFs, advertisements to be used for subject 
recruitment, and any other written information regarding this study to be provided to a subject or 
subject’s legal guardian must be approved by the IRB/IEC. 
No drug will be released to the site for dosing until written IRB authorization has been received 
by the Sponsor and the Clinical Study Agreement has been signed by the institution. 
For sites in the European Union, it is the responsibility of the Sponsor or their designee 
 to obtain the approval of the responsible ethics committees according to the national 
regulations.  
The study will only start in the respective sites once the respective committee’s written approval 
has been given. 
11.3 
Informed Consent 
The ICF and any changes to the ICF made during the course of the study must be agreed to by the 
Sponsor or designee and the IRB prior to its use and must be in compliance with all ICH GCP, 
local regulatory requirements, and legal requirements, as set forth in the Clinical Study Agreement. 
The Investigator must ensure that each study subject or LAR is fully informed about the nature 
and objectives of the study and possible risks associated with participation and must ensure that 
the subject has been informed of his/her rights to privacy. The Investigator will obtain written 
informed consent from each subject or LAR before any study-specific activity is performed and 
should document in the source documentation that consent was obtained prior to enrollment in the 
study. The original signed copy of the ICF must be maintained by the Investigator and is subject 
to inspection by a representative of the Sponsor, their representatives, auditors, the IRB, and/or 
regulatory agencies. A copy of the signed ICF will be given to the subject or LAR. 

Armata Pharmaceuticals, Inc. 
Clinical Study Protocol AP-SA02-101 
Armata Pharmaceuticals, Inc. 
Confidential & Proprietary 
Page 64 of 78 
Version 4.0, 25 July 2024 
11.4 
Subject Card 
For sites in the European Union, on enrollment in the study, the subject will receive a subject card 
to be carried at all times. The subject card will state that the subject is participating in a clinical 
research study, type of treatment, number of treatments received, and contact details in case of an 
SAE. 
11.5 
Study Monitoring Requirements 
It is the responsibility of the Investigator to ensure that the study is conducted in accordance with 
the protocol, ICH GCP, Directive 2001/20/EC, applicable regulatory requirements, and the 
Declaration of Helsinki, and that valid data are entered into the eCRFs. 
To achieve this objective, the CRA’s duties are to aid the Investigator and, at the same time, the 
Sponsor in the maintenance of complete, legible, well organized and easily retrievable data. Before 
the enrollment of any subject in this study, the Sponsor or their designee will review with the 
Investigator and site personnel the following documents: protocol, Investigator’s Brochure, eCRFs 
and procedures for their completion, informed consent process, and the procedure for reporting 
SAEs. 
The Investigator will permit the Sponsor or their designee to monitor the study as set forth in the 
Clinical Study Agreement, and as frequently as deemed necessary to determine that data recording 
and protocol adherence are satisfactory. During the monitoring visits, information recorded on the 
eCRFs will be verified against source documents and requests for clarification or correction may 
be made. After the eCRF data are entered by the site, the CRA will review the data for safety 
information, completeness, accuracy, and logical consistency. Computer programs that identify 
data inconsistencies may be used to help monitor the clinical study. If necessary, requests for 
clarification or correction will be sent to Investigators. The Investigator and his/her staff will be 
expected to cooperate with the CRA and provide any missing information, whenever possible. If 
planned onsite monitoring visits are not possible because of Coronavirus Disease 2019, remote 
monitoring may occur, if allowed by local and federal legal and regulatory requirements.  
All monitoring activities will be reported and archived. In addition, monitoring visits will be 
documented at the investigational site by signature and date on the study-specific monitoring log. 
11.6 
Disclosure of Data 
Data generated by this study must be available for inspection by the FDA, the Sponsor or their 
designee, applicable foreign health authorities, and the IRB as appropriate. Such data may be used 
only as set forth in the Clinical Study Agreement. Subjects or their LAR may request their medical 
information be given to their personal physician or other appropriate medical personnel 
responsible for their welfare. 
Subject medical information obtained during the study is confidential and disclosure to third 
parties other than those noted above is prohibited. 
11.7 
Retention of Records 
To enable evaluations and/or audits from regulatory authorities or the Sponsor, the Investigator 
will keep records, including the identity of all participating subjects (sufficient information to link 
records, eg, eCRFs and hospital records), all original signed ICFs, copies of all eCRFs, SAE forms, 

Armata Pharmaceuticals, Inc. 
Clinical Study Protocol AP-SA02-101 
Armata Pharmaceuticals, Inc. 
Confidential & Proprietary 
Page 65 of 78 
Version 4.0, 25 July 2024 
source documents, and detailed records of treatment disposition. The records should be retained 
by the Investigator according to specifications in the ICH guidelines, local regulations, or as 
specified in the Clinical Study Agreement, whichever is longer. The Investigator must obtain 
written permission from the Sponsor before disposing of any records, even if retention 
requirements have been met. 
If the Investigator relocates, retires, or for any reason withdraws from the study, the Sponsor should 
be prospectively notified. The study records must be transferred to an acceptable designee, such 
as another Investigator, another institution, or to the Sponsor. 
11.8 
Publication Policy 
 
 
 
 
 
11.9 
Financial Disclosure 
 
 
 
11.10 
Insurance and Indemnity 
 
 
 
 
11.11 
Legal Aspects 
 
 
  

Armata Pharmaceuticals, Inc. 
Clinical Study Protocol AP-SA02-101 
Armata Pharmaceuticals, Inc. 
Confidential & Proprietary 
Page 66 of 78 
Version 4.0, 25 July 2024 
12 
STUDY ADMINISTRATIVE INFORMATION 
12.1 
Protocol Amendments 
Any amendments to the study protocol will be communicated to the Investigators by 
 or 
the Sponsor. All protocol amendments will undergo the same review and approval process as the 
original protocol. A protocol amendment may be implemented after it has been approved by the 
IRB, unless immediate implementation of the change is necessary for subject safety. In this case, 
the situation must be documented and reported to the IRB within 5 working days. 

Armata Pharmaceuticals, Inc. 
Clinical Study Protocol AP-SA02-101 
Armata Pharmaceuticals, Inc. 
Confidential & Proprietary 
Page 67 of 78 
Version 4.0, 25 July 2024 
13 
REFERENCES 
 
1. 
CDC Data & Reports. Accessed November 18, 2019. 
2. 
Diekema DJ, Pfaller MA, Schmitz FJ, et al. Survey of infections due to Staphylococcus 
species: frequency of occurrence and antimicrobial susceptibility of isolates collected in 
the United States, Canada, Latin America, Europe, and the Western Pacific region for the 
SENTRY 
Antimicrobial 
Surveillance 
Program, 
1997-1999. 
Clin 
Infect 
Dis. 
2001;32 (suppl 2):S114-S132. 
3. 
van Hal SJ, Jensen SO, Vaska VL, et al. Predictors of mortality in Staphylococcus aureus 
bacteremia. Clin Microbiol Rev. 2012;25(2):362-386. 
4. 
Kalil AC, Van Schooneveld TC, Fey PD, et al. Association between vancomycin minimum 
inhibitory concentration and mortality among patients with Staphylococcus aureus 
bloodstream 
infections: 
a 
systematic 
review 
and 
meta-analysis. 
JAMA. 
2014;312(15):1552-1564. 
5. 
Mylotte JM, McDermott C, Spooner JA. Prospective study of 114 consecutive episodes of 
Staphylococcus aureus bacteremia. Rev Infect Dis. 1987;9(5):891-907. 
6. 
Shurland S, Zhan M, Bradham DD, et al. Comparison of mortality risk associated with 
bacteremia due to methicillin-resistant and methicillin-susceptible Staphylococcus aureus. 
Infect Control Hosp Epidemiol. 2007;28(3):273-279. 
7. 
Laupland KB, Ross T, Gregson DB. Staphylococcus aureus bloodstream infections: risk 
factors, outcomes, and the influence of methicillin resistance in Calgary, Canada, 
2000-2006. J Infect Dis. 2008;198(3):336-343. 
8. 
Wang FD, Chen YY, Chen TL, et al. Risk factors and mortality in patients with nosocomial 
Staphylococcus aureus bacteremia. Am J Infect Control. 2008;36(2):118-122. 
9. 
Kaech C, Elzi L, Sendi P, et al. Course and outcome of Staphylococcus aureus bacteraemia: 
a retrospective analysis of 308 episodes in a Swiss tertiary-care centre. Clin Microbiol 
Infect. 2006;12(4):345-352. 
10. 
Lodise TP, Graves J, Evans A, et al. Relationship between vancomycin MIC and failure 
among patients with methicillin-resistant Staphylococcus aureus bacteremia treated with 
vancomycin. Antimicrob Agents Chemother. 2008;52(9):3315-3320. 
11. 
Cosgrove SE, Sakoulas G, Perencevich EN, et al. Comparison of mortality associated with 
methicillin-resistant and methicillin-susceptible Staphylococcus aureus bacteremia: a 
meta-analysis. Clin Infect Dis. 2003;36(1):53-59. 
12. 
Hassoun A, Linden PK, Friedman B. Incidence, prevalence, and management of MRSA 
bacteremia across patient populations – a review of recent developments in MRSA 
management and treatment. Crit Care. 2017;21(1):211. 
13. 
Liu C, Bayer A, Cosgrove SE, et al. Clinical practice guidelines by the Infectious Diseases 
Society of America for the treatment of methicillin-resistant Staphylococcus aureus 
infections in adults and children: executive summary. Clin Infect Dis. 2011;52(3):285-292. 
14. 
Fowler VG, Olsen MK, Corey GR, et al. Clinical identifiers of complicated Staphylococcus 
aureus bacteremia. Arch Intern Med. 2003;163(17):2066-2072. 
15. 
Corey GR. Staphylococcus aureus bloodstream infections: definitions and treatment. Clin 
Infect Dis. 2009;48 (suppl 4):S254-S259. 
 

Armata Pharmaceuticals, Inc. 
Clinical Study Protocol AP-SA02-101 
Armata Pharmaceuticals, Inc. 
Confidential & Proprietary 
Page 68 of 78 
Version 4.0, 25 July 2024 
 
16. 
Holland TL, Raad I, Boucher HW, et al. Effect of algorithm-based therapy vs usual care 
on clinical success and serious adverse events in patients with staphylococcal bacteremia: 
a randomized clinical trial. JAMA. 2018;320(12):1249-1258. 
17. 
Jernigan JA, Farr BM. Short-course therapy of catheter-related Staphylococcus aureus 
bacteremia: a meta-analysis. Ann Intern Med. 1993;119(4):304-311. 
18. 
Kullar R, Davis SL, Levine DP, et al. Impact of vancomycin exposure on outcomes in 
patients with methicillin-resistant Staphylococcus aureus bacteremia: support for 
consensus guidelines suggested targets. Clin Infect Dis. 2011;52(8):975-981. 
19. 
Jacob JT, DiazGranados CA. High vancomycin minimum inhibitory concentration and 
clinical outcomes in adults with methicillin-resistant Staphylococcus aureus infections: a 
meta-analysis. Int J Infect Dis. 2013;17(2):e93-e100. 
20. 
Holubar M, Meng L, Deresinski S. Bacteremia due to methicillin-resistant Staphylococcus 
aureus: new therapeutic approaches. Infect Dis Clin North Am. 2016;30(2):491-507. 
21. 
Mendes RE, Tsakris A, Sader HS, et al. Characterization of methicillin-resistant 
Staphylococcus aureus displaying increased MICs of ceftaroline. J Antimicrob Chemother. 
2012;67(6):1321-1324. 
22. 
Ikeda-Dantsuji Y, Hanaki H, Nakae T, et al. Emergence of linezolid-resistant mutants in a 
susceptible-cell population of methicillin-resistant Staphylococcus aureus. Antimicrob 
Agents Chemother. 2011;55(5):2466-2468. 
23. 
Morales G, Picazo JJ, Baos E, et al. Resistance to linezolid is mediated by the cfr gene in 
the first report of an outbreak of linezolid-resistant Staphylococcus aureus. Clin Infect Dis. 
2010;50(6):821-825. 
24. 
Molina-Manso D, del Prado G, Ortiz-Pérez A, et al. In vitro susceptibility to antibiotics of 
staphylococci in biofilms isolated from orthopaedic infections. Int J Antimicrob Agents. 
2013;41(6):521-523. 
25. 
Ceri H, Olson ME, Stremick C, et al. The Calgary Biofilm Device: new technology for 
rapid determination of antibiotic susceptibilities of bacterial biofilms. J Clin Microbiol. 
1999;37(6):1771-1776. 
26. 
Pearl S, Gabay C, Kishony R, et al. Nongenetic individuality in the host-phage interaction. 
PLoS Biol. 2008;6(5):e120. 
27. 
Shen Y, Köller T, Kreikemeyer B, et al. Rapid degradation of Streptococcus pyogenes 
biofilms by PlyC, a bacteriophage-encoded endolysin. J Antimicrob Chemother. 
2013;68(8):1818-1824. 
28. 
Tamma PD, Avdic E, Li DX, et al. Association of adverse events with antibiotic use in 
hospitalized patients. JAMA Intern Med. 2017;177(9):1308-1315. 
29. 
Clokie MR, Millard AD, Letarov AV, et al. Phages in nature. Bacteriophage. 
2011;1(1):31-45. 
30. 
Bragg R, van der Westhuizen W, Lee JY, et al. Bacteriophages as potential treatment 
option for antibiotic resistant bacteria. Adv Exp Med Biol. 2014;807:97-110. 
31. 
Chan BK, Turner PE, Kim S, et al. Phage treatment of an aortic graft infected with 
Pseudomonas aeruginosa. Evol Med Public Health. 2018;2018(1):60-66. 
 

Armata Pharmaceuticals, Inc. 
Clinical Study Protocol AP-SA02-101 
Armata Pharmaceuticals, Inc. 
Confidential & Proprietary 
Page 69 of 78 
Version 4.0, 25 July 2024 
 
32. 
Schooley RT, Biswas B, Gill JJ, et al. Development and use of personalized 
bacteriophage-based therapeutic cocktails to treat a patient with a disseminated resistant 
Acinetobacter 
baumannii 
infection. 
Antimicrob 
Agents 
Chemother. 
2017;61(10):e00954-17. 
33. 
Dedrick RM, Guerrero-Bustamante CA, Garlena RA, et al. Engineered bacteriophages for 
treatment of a patient with a disseminated drug-resistant Mycobacterium abscessus. Nat 
Med. 2019;25(5):730-733. 
34. 
Dissanayake U, Ukhanova M, Moye ZD, et al. Bacteriophages reduce pathogenic 
Escherichia coli counts in mice without distorting gut microbiota. Front Microbiol. 
2019;10:1984. 
35. 
Cieplak T, Soffer N, Sulakvelidze A, et al. A bacteriophage cocktail targeting Escherichia 
coli reduces E. coli in simulated gut conditions, while preserving a non-targeted 
representative commensal normal microbiota. Gut Microbes. 2018;9(5):391-399. 
36. 
Denou E, Bruttin A, Barretto C, et al. T4 phages against Escherichia coli diarrhea: potential 
and problems. Virology. 2009;388(1):21-30. 
37. 
Parasion S, Kwiatek M, Gryko R, et al. Bacteriophages as an alternative strategy for 
fighting biofilm development. Pol J Microbiol. 2014;63(2):137-145. 
38. 
Harper DR, Parracho HM, Walker J, et al. Bacteriophages and biofilms. Antibiotics 
(Basel). 2014;3(3):270-284. 
39. 
Barbu EM, Cady KC, Hubby B. Phage therapy in the era of synthetic biology. Cold Spring 
Harb Perspect Biol. 2016;8(10):a023879. 
40. 
Petrovic Fabijan A, Lin RCY, Ho J, et al. Safety of bacteriophage therapy in severe 
Staphylococcus aureus infection. Nat Microbiol. 2020;5(3):465-472. 

Armata Pharmaceuticals, Inc. 
Clinical Study Protocol AP-SA02-101 
Armata Pharmaceuticals, Inc. 
Confidential & Proprietary 
Page 70 of 78 
Version 4.0, 25 July 2024 
APPENDIX A: SCHEDULE OF PROCEDURES 

Armata Pharmaceuticals, Inc. 
Clinical Study Protocol AP-SA02-101 
 
Armata Pharmaceuticals, Inc. 
Confidential & Proprietary 
Page 71 of 78 
Version 4.0, 25 July 2024 
 
Screening 
Treatment Perioda 
TOC for Study
Drug 
TOC for 
BAT 
EOSb 
ETOT 
Visit 
Day (±Visit Window) 
-3 to -1c 
1  
2  
3  
4  
5  
6  
7 
12 
(±1 day)d 
18-60 
(±1 day)e 
39-81  
(±1 day) 
U 
Informed consentf 
X 
 
 
 
 
 
 
 
 
 
 
 
Inclusion/exclusion criteriag 
X 
 
 
 
 
 
 
 
 
 
 
 
Demographic information 
X 
 
 
 
 
 
 
 
 
 
 
 
Medical/surgical historyh 
X 
 
 
 
 
 
 
 
 
 
 
 
Prior/concomitant medications 
Xi 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Weight and heightj 
X 
 
 
 
 
 
 
 
 
 
 
 
Complete physical examinationk,l  
X 
 
 
 
 
 
 
X 
X 
X 
X 
X 
Targeted physical examinationl,m  
 
X 
X 
X 
X 
X 
X 
 
 
 
 
 
Vital signsn 
X 
Xo 
Xo 
Xo 
Xo 
Xo 
X 
X 
X 
X 
X 
X 
NEWS2 scorep 
 
X 
X 
X 
X 
X 
X 
X 
X 
 
 
X 
Blood culturesq 
X 
X 
Xr 
Xr 
Xr 
X 
Xr 
X 
X 
X 
X 
Xr 
Sterile site cultures 
Xs 
Xs 
Xs 
Xs 
Xs 
Xs 
Xs 
Xs 
Xs 
Xs 
Xs 
Xs 
Infectious disease consultation 
 
Xt 
 
 
 
 
 
 
 
 
 
 
Signs/symptoms of SA infectionu 
X 
X 
X 
X 
X 
X 
X 
Xv 
X 
X 
X 
X 
Assessment of clinical outcome 
 
 
 
 
 
X 
 
 
X 
X 
X 
X 
Ultrasound 
 
Xw 
 
 
 
 
 
 
 
 
 
 
ECHO 
 
Xx 
 
 
 
 
 
 
 
 
 
 
Source controly 
 
X 
 
 
 
 
 
 
 
 
 
 
AKI assessmentz 
 
X 
 
 
 
 
 
 
 
 
X 
 
Serum for AP-SA02 anti-phage antibodies 
 
Xaa 
 
 
 
 
 
X 
X 
 
X 
 
IL-10 
X 
Xff 
X 
X 
X 
X 
X 
X 
X 
 
 
X 
Serology testingbb 
X 
 
 
 
 
 
 
 
 
 
 
 
Pregnancy testcc 
X 
X 
 
 
 
 
 
 
 
X 
X 
X 
12-lead ECG 
X 
Xdd 
 
X 
 
X 
 
 
X 
X 
X 
X 
Clinical laboratory evaluationsee  
X 
Xff 
X 
X 
X 
X 
 
X 
X 
X 
X 
X 
Urinalysiskk 
X 
X 
 
 
 
X 
 
X 
X 
X 
X 
X 
PK blood samplinggg 
 
X 
X 
X 
X 
X 
X 
X 
 
 
 
 
Urine samples for phage CLhh, kk 
 
X 
 
 
 
 
 
X 
X 
X 
 
X 
Randomization 
 
X 
 
 
 
 
 
 
 
 
 
 
Study drug administrationii 
 
X 
X 
X 
X 
X 
 
 
 
 
 
 
Adverse eventsjj 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Note: Blood samples may be collected and stored for future assessments. 
a. 
Daily visits will be performed at an inpatient location. Study days may not correspond exactly with calendar days during the Treatment Period. Additional dosing days will 
repeat procedures on Days 2 to 4, depending on the number of days added. The final day of dosing will mirror Day 5.  

Armata Pharmaceuticals, Inc. 
Clinical Study Protocol AP-SA02-101 
Armata Pharmaceuticals, Inc. 
Confidential & Proprietary 
Page 72 of 78 
Version 4.0, 25 July 2024 
b. 
EOS will occur 28 days after the end of BAT. 
c. 
The screening period will be up to 3 days. Subjects should be randomized as soon as possible after confirmation of study eligibility and can be randomized on the same calendar 
day as Screening.  
d. 
TOC for study drug will occur on Day 12. A ±1 day window will be allowed if the subject is discharged. 
e. 
TOC for BAT will occur 7 days (±1 d) after the end of BAT. 
f. 
Signed informed consent by the subject (or LAR) must be obtained before any study-related procedures are performed. 
g. 
Subjects must continue to meet eligibility criteria at randomization. 
h. 
Relevant medical/surgical history will be collected. Any updates since the Screening Visit will be assessed at randomization.  
i. 
All relevant medications received in the 28 days prior to randomization must be recorded. 
j. 
Height will be collected at the Screening Visit only and will be used to calculate body mass index. 
k. 
A complete physical examination will include evaluation of HEENT, neck, lungs, heart, chest, abdomen, extremities, neurologic status, skin for evidence of emboli, palpation 
for signs of pain, and any other notable conditions.  
l. 
Pain on a physical examination should trigger diagnostic testing for metastatic foci of infection. 
m. A targeted physical examination will include evaluation for complications of bacteremia, HEENT, lungs, heart, skin for any evidence of septic emboli, and palpation for signs 
of pain. 
n. 
Vital signs will include temperature, heart rate, and blood pressure. Vital signs will be obtained at every visit unless the subject has been discharged and visits are being 
performed remotely. Wherever possible, vital signs will be obtained after at least 5 minutes resting in a supine or sitting position. If more than 1 measurement is taken on a 
given day, the highest value for temperature should be recorded in the eCRF.  
o. 
During the Treatment Period, vital signs should be obtained prior to each infusion (-1 hour window). 
p. 
A NEWS2 score will be recorded once per day (and should be repeated if there is a change in clinical status) from Day 1 through Day 7 and TOC for study drug (Day 12). 
NEWS2 is an aggregate scoring system derived from 6 physiologic parameters: respiration rate; oxygen saturation; systolic blood pressure; pulse rate; level of consciousness 
or new confusion, and temperature. The NEWS2 score will be calculated programmatically from the NEWS2 parameters entered in the eCRF; additional NEWS2 assessments 
should be repeated that day if indicated due to a change in clinical status. 
q. 
Two sets of blood cultures, preferably from 2 different sites, 30 minutes apart will be drawn on Day 1 as close to the start of study drug administration as possible, unless blood 
cultures have already been sent that day for Screening or clinical care. Thereafter, 1 set of blood cultures is acceptable. Blood cultures should be collected from a peripheral 
venipuncture site when possible until 2 consecutive days of negative blood cultures are obtained or otherwise clinically indicated. Repeat blood cultures will also be obtained 
at EOT for study drug (Day 5), Day 7, each of the TOC (BAT and study drug) and the EOS Visits, regardless of clinical indication, to evaluate for microbiological cure and 
sustained cure. See Section 7.7 for additional details. 
r. 
Blood cultures will be drawn on these days, only if necessary, until 2 consecutive days of negative blood cultures are obtained or if clinically indicated. 
s. 
Sterile site cultures will be collected on these days as clinically indicated.  
t. 
All subjects will receive an infectious disease consultation within 2 days of randomization unless consultation was obtained prior to enrollment. If consultation can only be 
obtained after 2 days of randomization, this is permissible, but must be documented. Sites without access to an infectious diseases specialist must discuss with the Medical 
Monitor or Sponsor if the subject can be included in the study. If the Investigator specialty is infectious disease, a separate consultation is not required.  
u. 
Signs/symptoms related to focal site of SA infection (eg, joint pain; redness; swelling; weight-bearing, back pain; weight-bearing, skin redness; drainage) will be assessed at 
Screening, daily from Day 1 through Day 7, at TOC for study drug (Day 12), TOC for BAT, and EOS. 
v. 
Investigator will provide an assessment of whether additional imaging is needed for potential metastatic infection based on clinical signs/symptoms of SA infection.  
w. All subjects with an intravascular catheter present at admission that is not thought to be infected and is not planned on being removed within 3 days of randomization should 
receive an ultrasound to evaluate for the presence of an intravascular clot within 2 days of randomization unless this was done within 7 days prior to Screening. 
x. 
All subjects will receive a TTE and/or TEE ECHO within 3 days of randomization unless this was done within 7 days prior to Screening. Subjects with endocarditis should 
have a follow-up TTE or TEE between Days 7 and 14. All effort should be made to perform this before administration of study drug.  
y. 
All work-up for distant sites of metastatic infection and all decisions regarding source control procedures will be performed as per primary team. IV catheters known or suspected 
to be infected must be removed or changed as soon as possible within 72 hours after randomization. Sites should identify source control within 3 days; potential source or 
evidence of ongoing infection after 7 days may be considered a clinical failure. 
z. 
AKI will be defined as stage 1 or higher using modified RIFLE criteria at any time within the first 7 days or new need for renal replacement therapy between Day 1 and EOS. 

Armata Pharmaceuticals, Inc. 
Clinical Study Protocol AP-SA02-101 
 
Armata Pharmaceuticals, Inc. 
Confidential & Proprietary 
Page 73 of 78 
Version 4.0, 25 July 2024 
aa. Serum for AP-SA02 anti-phage antibodies will be performed prior to the first dose.  
bb. HIV antibody, HBsAg, and HCV antibody testing will be performed at Screening, only if status is unknown.  
cc. FCBPs only must have a negative serum pregnancy test within 72 hours prior to randomization. Results can be from a local laboratory and will be confirmed at the central 
laboratory. 
dd. A 12-lead ECG will be performed post first dose of the day. 
ee. Assessments include chemistries, hematology, coagulation, CRP, and procalcitonin. See Appendix B for a list of clinical laboratory analytes.  
ff. 
Clinical laboratory assessments and IL-10 will be performed post-dose after the second infusion. 
gg. Venous blood samples for PK analysis of AP-SA02 levels will be collected from subjects enrolled at predetermined/qualified PK sites on Day 1 (pre-dose [-60 minutes] and  
0.5 hours [±15 minutes], 1 hour [±15 minutes], 3 hours [±15 minutes] post first dose of the day), Days 2 to 4 (1 sample 1 hour [30 minutes] post  first dose of the study day, 
Day 5 ( 1 hour [±15 minutes] post last dose of the day), Day 6 (24 hours [±30 minutes] post last dose).  
hh. Urine for phage CL will be collected prior to the first dose on Day 1, Day 7, TOC for study drug (Day 12), TOC for BAT, and ETOT. Date and time will be recorded for each 
urine sample collection at the designated time points. 
ii. 
AP-SA02 or placebo will be administered via IV bolus infusion every 6 hours for 5 consecutive days in an inpatient location, unless the dose, frequency, or duration is modified 
after DRC review. In addition, all subjects will receive at least 14 days (uncomplicated SAB) or 28 days (complicated SAB) and up to 56 days of BAT. BAT will be administered 
at the discretion of the Investigator. Subjects must be directly observed during study drug/placebo administration by clinical personnel. The first dose of study drug on Day 1 
must occur as close as possible to the time of randomization.  
jj. 
Adverse events will be collected from the time of informed consent. 
kk. It is expected that subjects enrolled who are also receiving dialysis (hemodialysis or peritoneal dialysis) may produce little or no urine. In such cases, urine for urinalysis or 
urine for phage clearance may not be available for collection at some or any of the timepoints listed in the protocol. Protocol deviations will not be issued for missed urine 
collections due to anuria. 
AKI = acute kidney injury; BAT = best available therapy; CL = clearance; CRP = C-reactive protein; DRC = Data Review Committee; ECG = electrocardiogram; 
ECHO = echocardiogram; eCRF = electronic case report form; EOS = End of Study; ETOT = Early Termination of Treatment; FCBP = female of childbearing potential; 
HBsAg = hepatitis B surface antigen; HCV = hepatitis C virus; HEENT = head, eyes, ears, nose, and throat; HIV = human immunodeficiency virus; IL = interleukin; 
IV = intravenous(ly); LAR = legally authorized representative; NEWS2 = National Early Warning Score 2; PK = pharmacokinetic(s); RIFLE = Risk-Injury-Failure-Loss-End-stage 
renal disease; SA = Staphylococcus aureus; SAB = Staphylococcus aureus bacteremia; TEE = transesophageal; TOC = Test of Cure; TTE = transthoracic; U = unscheduled. 

Armata Pharmaceuticals, Inc. 
Clinical Study Protocol AP-SA02-101 
Armata Pharmaceuticals, Inc. 
Confidential & Proprietary 
Page 74 of 78 
Version 4.0, 25 July 2024 
APPENDIX B: CLINICAL LABORATORY ANALYTES 
Standard Safety Chemistry Panel 
Alanine aminotransferase 
Albumin 
Alkaline phosphatase 
Amylase 
Aspartate aminotransferase 
Bicarbonate 
Blood urea nitrogen 
Calcium 
Chloride 
Creatine kinase 
Creatinine 
Direct bilirubin 
Estimated glomerular filtration rate [1] 
Gamma-glutamyl transferase 
Glucose 
Inorganic phosphorus 
Lactate dehydrogenase 
Lipase 
Potassium 
Sodium 
Total bilirubin 
Total protein 
Uric acid 
 
1. 
Estimated glomerular filtration rate will be calculated using the Cockcroft-Gault method. 
 
Hematology 
Hematocrit 
Hemoglobin 
Platelets 
Red blood cell count 
White blood cell count and differential [1] 
 
1. 
Manual microscopic review will be performed only if white blood cell count and/or differential values are out of 
reference range. 
 
Coagulation 
Activated partial thromboplastin time 
International normalized ratio 
Prothrombin time  
 
 
Serology 
Hepatitis B surface antigen 
Hepatitis C virus antibody 
Human immunodeficiency virus antibody 
 
 
Pregnancy Test 
Serum β-human chorionic gonadotropin pregnancy test [1] 
1. 
Within 72 hours prior to randomization for females of childbearing potential. 
 

Armata Pharmaceuticals, Inc. 
Clinical Study Protocol AP-SA02-101 
Armata Pharmaceuticals, Inc. 
Confidential & Proprietary 
Page 75 of 78 
Version 4.0, 25 July 2024 
Additional Tests 
C-reactive protein 
Interleukin-10 
Procalcitonin 
 
 
Urinalysis 
Bilirubin 
Blood 
Glucose 
Ketones 
Leukocyte esterase 
Microscopy [1] 
Nitrite 
pH 
Protein 
Specific gravity 
Urobilinogen 
 
1. 
Microscopy will be performed only as needed based on positive dipstick test results. 
 

Armata Pharmaceuticals, Inc. 
Clinical Study Protocol AP-SA02-101 
 
Armata Pharmaceuticals, Inc. 
Confidential & Proprietary 
Page 76 of 78 
Version 4.0, 25 July 2024 
APPENDIX C: MODIFIED DUKE CRITERIA FOR DIAGNOSIS OF 
INFECTIVE ENDOCARDITIS 
Table 6. 
Modified Duke Criteria for Diagnosis of Infective Endocarditis: Definitions of 
Definite, Possible, and Rejected Endocarditis 
Criteria 
Definition 
Definite IE 
• 
Pathologic criteria: 
o 
Pathologic lesions – Vegetation or intracardiac abscess demonstrating active endocarditis 
on histology; OR 
o 
Microorganism – Demonstrated by culture or histology of a vegetation or intracardiac 
abscess. 
• 
Clinical criteria: 
o 
Using specific definitions listed in Table 7: 
 
2 major clinical criteria; OR 
 
1 major and 3 minor clinical criteria; OR 
 
5 minor clinical criteria. 
Possible IE1 
• 
Presence of 1 major and 1 minor clinical criteria; OR 
• 
Presence of 3 minor clinical criteria. 
Rejected IE 
• 
A firm alternate diagnosis is made; OR 
• 
Resolution of clinical manifestations occurs after ≤4 days of antibiotic therapy; OR 
• 
No pathologic evidence of infective endocarditis is found at surgery or autopsy after antibiotic 
therapy for ≤4 days; OR 
• 
Clinical criteria for possible or definite IE not met. 
1. 
The category of possible IE represents a modification from the previously published Duke criteria. 
IE = infective endocarditis.  
Source: Li JS, Sexton DJ, Mick N, et al. Proposed modifications to the Duke criteria for the diagnosis of infective endocarditis. 
Clin Infect Dis. 2000;30(4):633-638 
Note: Duke criteria will be captured in the eCRF data for subjects in Phase 2a.  

Armata Pharmaceuticals, Inc. 
Clinical Study Protocol AP-SA02-101 
 
Armata Pharmaceuticals, Inc. 
Confidential & Proprietary 
Page 77 of 78 
Version 4.0, 25 July 2024 
Table 7. 
Modified Duke Criteria for Diagnosis of Infective Endocarditis: Definitions for 
Major and Minor Criteria  
Criteria 
Definition 
Major 
• 
Positive blood cultures for IE (1 of the following): 
o 
Typical microorganisms consistent with IE from 2 separate blood cultures: 
 
SA; 
 
Viridans streptococci; 
 
Streptococcus gallolyticus (formerly Streptococcus bovis), including nutritional 
variant strains (Granulicatella spp and Abiotrophia defectiva); 
 
HACEK group – Haemophilus aphrophilus (subsequently called Aggregatibacter 
aphrophilus 
and 
Aggregatibacter 
paraphrophilus), 
Actinobacillus 
actinomycetemcomitans 
(subsequently 
called 
Aggregatibacter 
actinomycetemcomitans), 
Cardiobacterium 
hominis, 
Eikenella 
corrodens, 
Kingella kingae; 
 
Community-acquired enterococci in the absence of a primary focus. 
o 
Persistently positive blood culture: 
 
For organisms that are typical causes of IE – at least 2 positive blood cultures from 
blood samples drawn >12 hours apart; 
 
For organisms that are more commonly skin contaminants – 3 or a majority of 
≥4 separate blood cultures (with first and last drawn at least 1 hour apart). 
o 
Single positive blood culture for Coxiella burnetii or phase 1 IgG antibody titer >1:800.* 
• 
Evidence of endocardial involvement (1 of the following): 
o 
Echocardiogram positive for IE: 
 
Vegetation (oscillating intracardiac mass on a valve or on supporting structures, in 
the path of regurgitant jets, or on implanted material, in the absence of an alternative 
anatomic explanation); OR 
 
Abscess; OR 
 
New partial dehiscence of prosthetic valve. 
o 
New valvular regurgitation: 
 
Increase in or change in preexisting murmur not sufficient. 
Minor 
• 
Predisposition – IV drug use or presence of a predisposing heart condition (prosthetic heart 
valve or a valve lesion associated with significant regurgitation or turbulence of blood flow); 
• 
Fever – temperature ≥38.0°C (100.4°F); 
• 
Vascular phenomena – major arterial emboli, septic pulmonary infarcts, mycotic aneurysm, 
intracranial hemorrhage, conjunctival hemorrhages, or Janeway lesions; 
• 
Immunologic phenomena – glomerulonephritis, Osler nodes, Roth spots, or rheumatoid 
factor; 
• 
Microbiologic evidence – positive blood cultures that do not meet major criteria OR serologic 
evidence of active infection with organism consistent with IE. 
Note: Echocardiographic minor criteria eliminated.* 
Modifications from the previously published Duke criteria are noted by an asterisk (*). 
IE = infective endocarditis; IgG = immunoglobulin G; IV = intravenous(ly); SA = Staphylococcus aureus; spp = species.  
Source: Li JS, Sexton DJ, Mick N, et al. Proposed modifications to the Duke criteria for the diagnosis of infective endocarditis. 
Clin Infect Dis. 2000;30(4):633-638 

Armata Pharmaceuticals, Inc. 
Clinical Study Protocol AP-SA02-101 
 
Armata Pharmaceuticals, Inc. 
Confidential & Proprietary 
Page 78 of 78 
Version 4.0, 25 July 2024 
APPENDIX D: RISK-INJURY-FAILURE-LOSS-END-STAGE RENAL 
DISEASE CRITERIA 
Table 8. 
Definition of Risk-Injury-Failure-Loss-End-Stage Renal Disease Criteria 
Term 
Definition 
Risk (R) 
Increased creatinine 1.5 × or GFR decrease >25% 
Injury (I) 
Increased creatinine 2 × or GFR decrease >50% 
Failure (F) 
Increased creatinine level 3 ×, GFR decrease >75%, or creatinine level ≥4 mg/dL 
Loss (L) 
Persistent acute renal failure or complete loss of function for >4 weeks 
ESKD (E) 
ESKD for >3 months 
ESKD = end-stage kidney disease; GFR = glomerular filtration rate. 
Source: Hartzell JD, Neff R, Ake J, et al. Nephrotoxicity associated with intravenous colistin (colistimethate sodium) treatment 
at a tertiary care medical center. Clin Infect Dis. 2009;48(12):1724-1728