Company: ARMP
Filing Date: 2025-08-13
Form Type: S-3
Source: 0001104659-25-077648
Chunk: 7

Company: Armata Pharmaceuticals, Inc.
Filing Date: 2025-08-13
Form: S-3
Chunk 7
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 the approval to proceed from the U.S. Food and Drug Administration (the
“FDA”) for our Investigational New Drug (“IND”) application for AP-PA02. In the first quarter of 2023, we announced
positive topline results from the completed “SWARM-P.a.” study – a Phase 1b/2a, multicenter, double-blind, randomized,
placebo-controlled, single ascending dose and multiple ascending dose clinical trial to evaluate the safety and tolerability of inhaled
AP-PA02 in subjects with cystic fibrosis and chronic pulmonary P. aeruginosainfection. Data indicate that AP-PA02 was
well-tolerated with a treatment emergent adverse event profile similar to placebo. Pharmacokinetics findings confirm that AP-PA02 can
be effectively delivered to the lungs through nebulization with minimal systemic exposure, with single ascending doses and multiple ascending
doses resulting in a proportional increase in exposure as measured in induced sputum. AP-PA02 exposures were generally consistent across
subjects. Additionally, bacterial levels of P. aeruginosain the sputum measured at several timepoints suggest improvement
in bacterial load reduction for subjects treated with AP-PA02 at the end of treatment as compared to placebo after ten days of dosing.
In addition, a correlation was seen between increasing phage dose (higher AP-PA02 exposures) and reduction in the bacterial load, supporting
the biologic 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.

<div align='center'>2</div>

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