Company: ARMP
Filing Date: 2025-12-01
Form Type: 424B5
Source: 0001104659-25-117382
Chunk: 8

Company: Armata Pharmaceuticals, Inc.
Filing Date: 2025-12-01
Form: 424B5
Chunk 8
---
ologic plausibility of a bacterial specific mechanism of action and creating the opportunity for phage as a therapeutic alternative
to inhaled antibiotics. This study was supported by the Cystic Fibrosis Foundation (the “CFF”), which granted us a Therapeutics
Development Award of $5.0 million. We received the full award’s amount, including the final payment of $0.3 million, in January 2024.
Following the promising Phase 1b/2a results of favorable safety and tolerability profile and plausible mechanism of action, an additional
confirmatory Phase 2 trial was initiated in non-cystic fibrosis bronchiectasis (“NCFB”) patients with similar chronic pulmonary
disease with infections due to P. aeruginosa.

Clinical Development of AP-PA02 in Non-Cystic Fibrosis Bronchiectasis: Completed Phase 2 Study

On February 22, 2022, Armata announced that
it had received from the FDA the approval to proceed for our IND application for AP-PA02, in a second indication, NCFB. On December 19,
2024, Armata announced encouraging results from the completed “Tailwind” study – a Phase 2 multicenter, double-blind,
randomized, placebo-controlled study to evaluate the safety, phage kinetics, and efficacy of inhaled AP-PA02 in subjects with NCFB and
chronic pulmonary P. aeruginosa infection. Data indicated that inhaled AP-PA02 provides a durable reduction of P. aeruginosa in the lung, with a favorable safety and tolerability profile. The Tailwind study was conducted in two
cohorts running in parallel: subjects in one cohort (cohort A) received inhaled AP-PA02 as monotherapy, while subjects in another cohort
(cohort B) received inhaled AP-PA02 in combination with inhaled anti-pseudomonal antibiotic treatment. Subjects in both cohorts were dosed
at home by nebulization with study drug administered every 12 hours for 10 days and were 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