Company: ARMP
Filing Date: 2025-12-01
Form Type: 424B5
Source: 0001104659-25-117382
Chunk: 35

Company: Armata Pharmaceuticals, Inc.
Filing Date: 2025-12-01
Form: 424B5
Chunk 35
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 Practices (“cGMP”)
manufacturing capabilities to advance a target pipeline of high-quality bacteriophage product candidates for late-stage clinical development.
Our optimized manufacturing processes significantly increase phage titers and improve production efficiency with the goal of ensuring
commercial viability.

We
remain committed to our mission to evaluate phage-based therapeutics in randomized controlled clinical trials that evaluate safety and
efficacy required to support potential regulatory approval and commercialization of our phage products as alternatives to traditional
antibiotics, providing a potential method of treating patients suffering from drug-resistant and difficult-to-treat bacterial infections.
To date, we have completed three critical Phase 2 trials, utilizing two distinct phage cocktails against two different bacterial pathogens
with the potential to treat chronic pulmonary disease complicated by bacterial infection, as well as acute systemic bacterial infection.
We believe that we are uniquely advancing our two lead candidates, referred to as AP-PA02 and AP-SA02, to address both chronic and acute
bacterial infections.

Pseudomonas aeruginosa Phage Product Candidate, AP-PA02

Clinical Development of AP-PA02 in Cystic Fibrosis: Completed Phase 1b/2a Study

Our
first phage candidate, inhaled AP-PA02, is focused primarily on the treatment of chronic pulmonary infections due to Pseudomonas aeruginosa (“P. aeruginosa”). On October 14, 2020, we received 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