Fulfills important regulatory milestone for AP-SA02 on the path toward a future BLA and supports expansion into pediatric patients

LOS ANGELES, July 13, 2026 /PRNewswire/ -- Armata Pharmaceuticals, Inc. (NYSE:ARMP) ("Armata" or the "Company"), a late clinical-stage biotechnology company focused on the development of high-purity, pathogen-specific bacteriophage therapeutics for the treatment of antibiotic-resistant and difficult-to-treat bacterial infections, today announced that it has received agreement from the U.S. Food and Drug Administration (the "FDA") on an Agreed Initial Pediatric Study Plan ("Agreed iPSP"), which establishes the agreed regulatory framework for the future evaluation of AP-SA02 for the adjunct treatment of complicated Staphylococcus aureus bacteremia ("SAB") in pediatric patients. Agreement with the FDA on an iPSP is a regulatory requirement that must be met prior to submitting a Biologics License Application ("BLA").

The Agreed iPSP outlines a proposed pediatric development program targeting patients up to 17 years of age with complicated SAB, the same indication that Armata is pursuing in adults. Consistent with FDA requirements under the Pediatric Research Equity Act (PREA) and with established FDA and European Medicines Agency regulatory frameworks, the FDA agreed that because the disease pathophysiology and treatment response in SAB are consistent across all age groups, pediatric studies should be deferred until safety and efficacy data are generated in adults in the planned Phase 3 program. Following completion of the adult Phase 3 study which is expected to initiate in the second half of 2026, the proposed program will comprise a single, multicenter, open-label, pediatric study to assess safety, tolerability, and clinical response outcomes. This strategy establishes a pathway for potential future expansion of AP-SA02 into the pediatric population while prioritizing patient safety and efficient clinical development.