Armata Pharmaceuticals, Inc.（ARMP）资讯与事件ARMPArmata Pharmaceuticals, Inc.

Armata Appoints David House as CFO

Armata announced the promotion of David House to CFO. House has served as the Company's Senior Vice President, Finance and Principal Financial Officer since August 2024. The appointment ensures Armata has the right financial leadership in place to execute on its strategy and advance its clinical programs through late-stage development.

Armata Pharmaceuticals Advances AP-SA02 Clinical Study

Armata Pharmaceuticals announced significant clinical, regulatory, manufacturing and operational progress supporting advancement of AP-SA02, the Company's intravenously administered Staphylococcus aureus multi-phage product candidate, toward a planned Phase 3 superiority study for adjunct treatment of complicated bacteremia caused by methicillin-sensitive S. aureus or methicillin-resistant S. aureus. Recent milestones include submission of the complete Phase 3 protocol and comprehensive responses to all comments received from the FDA following the Company's End-of-Phase 2, or EOP2, meeting, and completion of key manufacturing activities supporting Phase 3 readiness. Collectively, these milestones support the Company's planned initiation of its pivotal Phase 3 superiority study in the second half of 2026, designed to support a future Biologics License Application for AP-SA02. The $2.5M announced on June 23 is a continuation of the previously announced award from the U.S. Department of Defense bringing total funding received to date under this award to $28.7M. These additional $2.5M funds are intended to support activities related to Armata's continued preparation and readiness for its planned Phase 3 clinical study. The Company is in close communication with its partners at the DoD regarding potential new support, including for the execution of the planned Phase 3 clinical study. Separate from the existing or any new DoD award, the Company continues to pursue and evaluate other funding pathways to support the execution of the planned Phase 3 clinical study.

Armata Receives FDA Approval for Pediatric Study Plan

Armata Pharmaceuticals announced that it has received agreement from the U.S. FDA on an Agreed Initial Pediatric Study Plan, which establishes the agreed regulatory framework for the future evaluation of AP-SA02 for the adjunct treatment of complicated Staphylococcus aureus bacteremia 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. 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 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.