Armata Pharmaceuticals Announces Formal Commissioning of State-of-the-Art cGMP Phage Manufacturing Facility in Los Angeles, California

Rhea-AI Summary

Armata Pharmaceuticals (NYSE American: ARMP) announced formal commissioning of its new cGMP phage manufacturing facility in Los Angeles on November 10, 2025. The 56,000 sq ft site includes 10,000 sq ft of cGMP clean rooms, an automated fill-and-finish suite, quality control and R&D labs, and administrative space. The company notified the FDA that production has commenced and completed full production runs with no issues. The facility is positioned to supply high-purity multi-phage cocktails for clinical programs and to support a potential Phase 3 AP-SA02 trial planned for 2026, subject to FDA review, plus future commercial and contract manufacturing opportunities.

Positive

• Production commenced with full runs completed and no issues
• Facility spans 56,000 sq ft with 10,000 sq ft of cGMP clean rooms
• Automated fill-and-finish and internal QC labs for clinical material release
• Supports potential Phase 3 AP-SA02 trial planned for 2026, subject to FDA review
• Enables onshore manufacturing to align with federal supply-chain goals

Negative

• Initiation of AP-SA02 Phase 3 remains subject to FDA review
• Commissioning does not itself guarantee regulatory approval or commercial sales

Insights

Manufacturing Expert

Commissioning of a 56,000 sq ft cGMP phage facility with successful full production runs is a material operational milestone.

The commissioning and completion of full production runs with no issues, plus notification to the FDA on Nov. 10, 2025, establishes internal control over supply and release testing. The facility’s scale—56,000 square feet with 10,000 square feet of cGMP clean rooms, an automated fill-and-finish suite, and quality control labs—supports both clinical supply and future commercial manufacturing.

Key dependencies include sustained process reproducibility, regulatory acceptance of the facility and batch records, and scale-up of multi-phage cocktail production. Watch for formal FDA feedback on the facility and any released batch release data; near-term milestones to monitor include regulatory communications and continued successful production runs in the next 6–12 months.

Clinical Development Expert

Onshoring manufacturing materially reduces a practical barrier to initiating pivotal studies and supports the stated plan for a Phase 3 program.

Having on-site cGMP manufacture and internal QC labs removes a common bottleneck for late-stage trials by aligning clinical supply control with study timelines. The announcement links facility readiness directly to advancing AP-SA02 into a potential pivotal Phase 3 trial planned for 2026, subject to FDA review and feedback.

Risks that could delay clinical start include outstanding regulatory comments and the need to demonstrate consistent product quality across batches. Concrete near-term items to watch are FDA feedback on the Phase 3 plan and confirmation of clinical supply release; expect visibility on these items within the next 3–9 months if timelines hold.

LOS ANGELES, Nov. 10, 2025 /PRNewswire/ -- Armata Pharmaceuticals, Inc. (NYSE American: ARMP) ("Armata" or the "Company"), a 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 its state-of-the-art current Good Manufacturing Practice ("cGMP") manufacturing facility in Los Angeles, California, has been formally commissioned. As part of the commissioning process, the U.S. Food and Drug Administration (the "FDA") has been notified that production has commenced, and full production runs have been completed with no issues or concerns.

"The full commissioning of our state-of-the-art manufacturing facility in Los Angeles represents a key milestone for Armata, ensuring that we are operationally ready to initiate pivotal studies of our phage-based therapeutics," stated Dr. Deborah Birx, Chief Executive Officer of Armata. "Importantly, this facility reflects our commitment to onshore manufacturing, from procurement of active pharmaceutical ingredients through fill and finish activities, to ensure that we can achieve the quality, quantity, and consistency of high-purity phage that our clinical programs require, while aligning with the federal government's efforts to further secure the essential medicine supply chain through domestic manufacturing. With this production facility now online, I believe we have taken another meaningful step forward in our quest to ensure that our phage-based therapeutics are available to treat patients in need in the not-too-distant future and reduce reliance on antibiotics that continues to contribute to the antimicrobial resistance crisis."

The facility, which spans 56,000 square feet, includes 10,000 square feet of cGMP clean rooms, an automated fill and finish suite, quality control laboratories for internal testing and release of clinical trial material, research and development laboratories, and administrative space. The facility allows Armata to manufacture its proprietary high-purity, multi-phage cocktails in support of the Company's future clinical trials, including advancement of AP-SA02 into a potential pivotal Phase 3 trial that Armata plans to initiate in 2026, subject to review and feedback from the FDA, as well as to support future commercial production and potential partnering and contract manufacturing opportunities. 

About Armata Pharmaceuticals, Inc.
Armata is a 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 using its proprietary bacteriophage-based technology. Armata is developing and advancing a broad pipeline of natural and synthetic phage candidates, including clinical candidates for Pseudomonas aeruginosa, Staphylococcus aureus, and other important pathogens. Armata is committed to advancing phage therapy with drug development expertise that spans bench to clinic including in-house phage-specific cGMP manufacturing to support full commercialization.

Forward Looking Statements
This communication contains "forward-looking" statements as defined by the Private Securities Litigation Reform Act of 1995. These statements relate to future events, results or to Armata's future financial performance and involve known and unknown risks, uncertainties and other factors which may cause Armata's actual results, performance or events to be materially different from any future results, performance or events expressed or implied by the forward-looking statements. In some cases, you can identify these statements by terms such as "anticipate," "believe," "could," "estimate," "expect," "intend," "may," "plan," "potential," "predict," "project," "should," "will," "would" or the negative of those terms, and similar expressions. These forward-looking statements reflect management's beliefs and views with respect to future events and are based on estimates and assumptions as of the date of this communication and are subject to risks and uncertainties including risks related to Armata's development of bacteriophage-based therapies; ability to staff and maintain its production facilities under fully compliant cGMP; ability to meet anticipated milestones in the development and testing of the relevant product; ability to be a leader in the development of phage-based therapeutics; ability to achieve its vision, including improvements through engineering and success of clinical trials; ability to successfully complete preclinical and clinical development of, and obtain regulatory approval of its product candidates and commercialize any approved products on its expected timeframes or at all; and Armata's estimates regarding anticipated operating losses, capital requirements and needs for additional funds. Additional risks and uncertainties relating to Armata and its business can be found under the caption "Risk Factors" and elsewhere in Armata's filings and reports with the U.S. Securities and Exchange Commission (the "SEC"), including in Armata's Annual Report on Form 10-K, filed with the SEC on March 21, 2025, and in its subsequent filings with the SEC.

Armata expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in Armata's expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based. 

Media Contacts:

At Armata:

Pierre Kyme
ir@armatapharma.com
310-665-2928

Investor Relations:

Joyce Allaire
LifeSci Advisors, LLC
jallaire@lifesciadvisors.com
212-915-2569

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SOURCE Armata Pharmaceuticals, Inc.

FAQ

What did Armata announce about its Los Angeles manufacturing facility on November 10, 2025 (ARMP)?

Armata announced formal commissioning of a 56,000 sq ft cGMP phage manufacturing facility and notified the FDA that production has commenced.

How large are the cGMP clean rooms at Armata's new facility (ARMP)?

The facility includes 10,000 sq ft of cGMP clean rooms plus an automated fill-and-finish suite.

Will Armata's facility support a Phase 3 trial for AP-SA02 and when (ARMP)?

The facility supports advancement of AP-SA02 into a potential Phase 3 trial planned for 2026, but initiation is subject to FDA review.

Did Armata report any production issues at the new facility (ARMP)?

No; Armata reported that full production runs have been completed with no issues or concerns.

Can the new Armata facility support commercial manufacturing and partnerships (ARMP)?

Yes; the company said the facility can support future commercial production and potential partnering and contract manufacturing opportunities.

How does onshore manufacturing at Armata's facility relate to supply-chain policy (ARMP)?

Armata said the onshore facility aligns with federal efforts to further secure the essential medicine supply chain through domestic manufacturing.