Company: ARMP
Filing Date: 2025-12-01
Form Type: 424B5
Source: 0001104659-25-117382
Chunk: 37

Company: Armata Pharmaceuticals, Inc.
Filing Date: 2025-12-01
Form: 424B5
Chunk 37
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 followed for approximately
four weeks after receiving their last dose of study drug. The primary efficacy endpoint was the reduction in P. aeruginosa colony
forming units (“CFUs”) in lung sputum at one week following completion of dosing (day 17) compared to baseline. Per the statistical
analysis plan, efficacy analysis of each independent cohort showed no significant difference between subjects treated with AP-PA02 and
placebo due to small numbers of subjects in each cohort. Notably, a post-hoc intent-to-treat analysis (n=33 active and n=15 placebo; all
subjects from both cohorts) demonstrated a statistically significant reduction of P. aeruginosa CFUs in the lung at day
17 (AP-PA02 vs. placebo; P=0.05). The reduction in P. aeruginosa CFUs persisted two weeks following completion of dosing
with AP-PA02 when compared with placebo at day 24 (AP-PA02 vs. placebo; P=0.015). Additionally, paired analysis of P. aeruginosa CFU
density at baseline compared to day 10 (P=0.03), day 11 (P=0.01), day 17 (P=0.003) and day 24 (P=0.018) was significant in the AP-PA02-treated
cohort. We believe the data suggest that AP-PA02 alone is as effective as the combination therapy of phage and antibiotics in reducing P. aeruginosa CFUs in the lung. Additionally, approximately one-third of subjects treated with phage monotherapy exhibited at least
a 2-log CFU reduction in P. aeruginosa compared to no reduction in placebo treated subjects. Safety data indicate that
inhaled AP-PA02 was well-tolerated with treatment-emergent adverse events mild and self-limiting. There was one possibly related serious
adverse event that was linked to an acute pulmonary event requiring hospitalization that was responsive to antibiotics. We believe the
safety and tolerability of AP-PA02 offers a promising profile for treating chronically infected NCFB patients.

Results from the Phase 2
Tailwind study demonstrate the potential of Armata’s high-purity phage cocktail, AP-PA02, as a new monotherapy
treatment alternative for chronic pulmonary disease caused by P. aeruginosa infection, including drug-resistant
bacteria, and indicate the potential for phage therapy to reduce reliance on chronic antibiotic