Slide 1: Phase 2a Trial of Intravenous Bacteriophage Cocktail AP-SA02 vs. Placebo in S. aureus Bacteremia
1 A Phase 2a Randomized Double - blind, Controlled Trial of the Efficacy and Safety of an Intravenous Bacteriophage Cocktail (AP - SA02) vs. Placebo in Combination with Best Available Antibiotic Therapy (BAT) in Patients with Complicated Staphylococcus aureus Bacteremia Loren G. Miller (MD MPH, Harb
Slide 2: Forward-Looking Statements
2 This presentation contains “forward - looking” statements that involve risks, uncertainties and assumptions . If the risks or uncertainties materialize or the assumptions prove incorrect, our results may differ materially from those expressed or implied by such forward - looking statements . All s
Slide 3: Disclosures
3 Disclosures Dr. Loren Miller has received Grants/Research Support from: Armata GSK Paratek ContraFect Merck NIH A full list of disclosures is available on the IDWeek 2025 TM website
Slide 4: Phages Are a Novel Biologic Anti-Infectives
4 Phages Are a Novel Biologic Anti - Infectives Key Advantages of Phage Therapy How Phages Kill Bacteria Novel therapeutic approach Addresses ↑ ↑ ing antibiotic resistance Potential mono - or combination Rx • Alternative or addition to SOC Species - specific therapy minimizes or eliminates microbiom
Slide 5: Bacteremia Phase 1b/2a diSArm Study Design
5 Bacteremia Phase 1b/2a “diSArm” Study Design AP - SA02 5 days q6h * TOC for AP - SA02: 7 days after end of IV AP - SA02 (day 12) PFU = Plaque forming units BAT = Best available antibiotic therapy * < 72 hrs of IV BAT prior to start of AP - SA02 Screening IV BAT 14 - 56 days 28 days post IV BAT TOC
Slide 6: Phase 2a Trial Demographics & Infection Site
6 Phase 2a Trial Demographics & Infection Site Placebo (n=16)* * AP - SA02 (n=31)* Demographics 52.6 +/ - 12 54.8 +/ - 14 Age (mean) +/ - SD 10(62) 22(71) Sex Male (%) 28.5 +/ - 7.0 29.8 +/ - 7.8 BMI, mean +/ - SD 12 (75) 21 (67) White n (%) 2 (12) 8 (26) Black n (%) 5 (31) 12 (45) Hispanic n (%) 7
Slide 7: Phase 2a Trial BAT Antibiotics
7 Phase 2a Trial BAT Antibiotics Placebo (n=13) n (%) AP - SA02 (n=29) n (%) Antibiotics Used* 8 (62) 18 (62) Cefazolin 6 (46) 12 (41) Vancomycin 2(15) 9 (31) Oxacillin/nafcillin 5 (38) 5 (17) Daptomycin 1(8) 2 (7) Cefepime 0 (0) 4 (14) Ceftriaxone BAT = Best available therapy *Some subjects receive
Slide 8: Clinical Outcomes
8 Clinical Outcomes Responder defined as all these signs and symptoms resolved from screening: temperature, heart rate, respiratory rate, white b loo d cell count, systolic blood pressure, pain associated with infection site PI = Principal Investigator AC = Adjudication Committee * Blinded PI, p = 0
Slide 9: Response in Subjects With MRSA
9 Response in Subjects With MRSA Cleared Infection, No Evidence of Relapse TOC = Test of Cure BAT = Best Available Antibiotic Therapy EOS = End of Study A P - S A 0 2 ( n = 8 ) P l a c e b o ( n = 5 ) A P - S A 0 2 ( n = 6 ) P l a c e b o ( n = 4 ) A P - S A 0 2 ( n = 5 ) P l a c e b o ( n = 3 ) 0 1
Slide 10: Clinical Trends for AP-SA02 vs. Placebo
10 Clinical Trends for AP - SA02 vs. Placebo Placebo AP - SA02 Clinical Trends 19.2 (13) 11.7 (26) Time to hospital discharge: Mean Day (n) 9.3 (12) 2.7 (25) Time to initial SAB resolution: Mean Day (n ) 97.3 (13) 50.2 (26) Mean CRP Day 12 mg/L (n)
Slide 11: AP-SA02 vs. Placebo: Safety & Tolerability
11 AP - SA02 vs. Placebo: Safety & Tolerability Safety Population (N=50) Phase 2a Complicated SAB Phase 1b Uncomplicated SAB Placebo (N=13) AP - SA02 (N=29) Placebo (N=2) AP - SA02 (N=6) n (%) n (%) n (%) n (%) 12 (92) 19 (66) 2 (100) 6 (100) Any adverse events (AEs) 10 (77) 17 (59) 2 (100) 6 (100)
Slide 12: Binds, Infects, and Lyses Patient Isolates in vitro
12 AP - SA02 Binds, Infects, and Lyses Patient Isolates in vitro Genotypic mapping of ARSA0002 Phage Less Frequent Variants More Frequent Variants 3 2 1 3 2 1 Patient Isolates 4 34 3 57 54 21 01 4 26 3 65 67 16 02 7 29 2 59 58 20 03 5 20 3 55 39 17 04 30 23 27 46 05 42 51 20 46 06 60 1 3 4 3 07 100
Slide 13: Summary & Conclusion
13 Summary & Conclusion • AP - SA02 phage cocktail safe and well tolerated • In combination with BAT, AP - SA02 had an earlier and higher cure rate compared to placebo in patients with complicated SAB at day 12, post BAT, and at EOS • AP - SA02 was assessed with clinical trends of earlier resolution
Slide 14: Acknowledgments
14 *Armata is the recipient of a $26.2 million DoD award, received through the Medical Technology Enterprise Consortium (MTEC) and managed by the Naval Medical Research Command (NMRC) – Naval Advanced Medical Development (NAMD) with funding from the Defense Health Agency and Joint Warfighter Medical
Slide 15: Thank you
15 Thank you. If you would be interested in being part of the Phase 3 Trial please contact Jennifer Smith jsmith@armatapharma.com
Slide 16: Proposed Superiority Pivotal Trial Design
16 Proposed Superiority Pivotal Trial Design • Primary endpoint clinical response at day 60 (TOC) • Secondary endpoints – Clinical response at day 14 (TOC) – Time to hospital discharge – Microbiologic eradication at time 60 and 14 days – All Cause Mortality • Sample size: 406 total (203 per group) t