Company: ARMP
Filing Date: 2025-12-01
Form Type: 424B5
Source: 0001104659-25-117382
Chunk: 11

Company: Armata Pharmaceuticals, Inc.
Filing Date: 2025-12-01
Form: 424B5
Chunk 11
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 ascending dose escalation study of the safety, tolerability, and efficacy of intravenous AP-SA02 in addition to best available
antibiotic therapy (“BAT”) compared to BAT alone (placebo) for the treatment of adults with complicated SAB. All doses of
AP-SA02 were dosed intravenously every six hours for five days. The primary clinical efficacy endpoint for the Phase 2a portion of the
diSArm study was clinical outcome (responder rate) in subjects with complicated bacteremia, measured at (i) Test of Cure (“TOC”)
for AP-SA02, defined as one week following the end of IV treatment with AP-SA02 (day 12), (ii) TOC for BAT, defined as one week following
the end of IV BAT, and (iii) end of study (“EOS”), defined as four weeks following the end of IV BAT. Clinical outcome was
evaluated by both the blinded site investigators and a blinded Clinical Efficacy Adjudication Committee (the “CEAC”) in the
intent-to-treat (“ITT”) population.

Safety and efficacy were
assessed in the ITT population, which included all subjects (n=50) who received at least one dose of AP-SA02 or placebo. The Phase 2a
study enrolled and dosed 42 patients, with 29 randomized to AP-SA02 in addition to BAT and 13 to placebo (BAT alone). Methicillin-resistant
S. aureus (“MRSA”) was the causative pathogen in ~38% of both the AP-SA02 and placebo groups.

AP-SA02 was well-tolerated
with no serious adverse events related to the study drug. Two subjects had adverse events that were possibly related to the study drug:
one with transient liver enzyme elevation and one with hypersensitivity that resolved with discontinuation of vancomycin.

<div align='center'>S-7</div>

A statistically significant increase in clinical response rate was observed at TOC for AP-SA02 (day 12) in AP-SA02 treated subjects (88%; 21/24) versus placebo (58%; 7/12) (p = 0.047) as assessed by blinded site investigators, and 83% (20/24) in the AP-SA02 group versus 58% (7/12) in the placebo group as assessed by the blinded CEAC. At TOC for BAT and at EOS, 100% of the AP-SA02 treated subjects had clinically responded