Armata Pharmaceuticals Receives $4.65 Million of Additional Non-Dilutive Award Funding from the U.S. Department of Defense to Support Ongoing diSArm Clinical Trial of AP-SA02

Rhea-AI Summary

Armata Pharmaceuticals (NYSE: ARMP) has received an additional $4.65 million in non-dilutive funding from the Department of Defense, bringing the total award to $26.2 million. The funding supports the development of AP-SA02, a phage-based treatment for complicated Staphylococcus aureus bacteremia (SAB). The Phase 1b/2a diSArm trial, which completed enrollment of 50 subjects in November 2024, evaluated AP-SA02 as an adjunct to best available antibiotic therapy. The study successfully achieved dose escalation to 5e10 PFU every six hours without significant adverse events. Notably, approximately half of the treated group showed evidence of phage persistence in blood, suggesting successful targeting of SAB reservoirs. Topline data is expected in Q2 2025, which will inform the optimal dosing for future pivotal trials.

Positive

• Secured additional $4.65M non-dilutive funding from DoD, bringing total to $26.2M
• Successfully completed Phase 1b/2a trial enrollment with 50 subjects
• Achieved dose escalation without clinically significant adverse events
• Evidence of phage persistence in blood for ~50% of treated group, suggesting therapeutic effectiveness
• In-house U.S.-based manufacturing capacity for both clinical and future commercial production

Negative

• Company's 2024 annual report includes going concern explanatory paragraph, indicating financial stability risks

Insights

Biotechnology Analyst

DoD awards Armata $4.65M for promising phage therapy against S. aureus bloodstream infections; preliminary signs positive amid financial concerns.

Armata's additional $4.65 million non-dilutive funding from the Department of Defense represents a significant vote of confidence in their phage therapy program. This brings the total DoD funding to $26.2 million for AP-SA02, which targets Staphylococcus aureus bacteremia (SAB) - a potentially fatal bloodstream infection with high mortality rates, especially when antibiotic-resistant.

The completed Phase 1b/2a diSArm trial provides several encouraging signals. First, investigators were able to dose-escalate to 5e10 PFU every six hours without clinically significant adverse events, establishing a preliminary safety profile. Second, and more intriguingly, they observed two distinct subject subsets, with approximately 50% showing evidence of phage persistence in the bloodstream consistent with in vivo amplification.

This persistence pattern is particularly noteworthy as it suggests AP-SA02 phages are finding, infecting, and destroying bacterial reservoirs that survived more than five days of best available antibiotic therapy. This potential for targeting persistent infection sites represents the core value proposition of phage therapy in the era of antibiotic resistance.

Armata's in-house U.S.-based manufacturing capabilities also represent a strategic advantage, providing both clinical trial support and readiness for potential commercialization. However, the going concern notation in their recent annual report signals significant financial challenges despite this additional funding. The imminent topline data will be crucial for determining whether AP-SA02 advances to pivotal trials and attracts additional investment or partnerships.

Financial Analyst

DoD funding provides short-term runway but going concern warning reveals deeper financial challenges despite promising clinical signals.

The $4.65 million in additional non-dilutive funding from the DoD serves as a critical lifeline for Armata, extending their operational runway without shareholder dilution. This incremental capital will finance the closeout of their Phase 2a study and preparations for their FDA end-of-phase 2 meeting - both essential steps before initiating potentially more expensive pivotal trials.

However, the going concern explanatory paragraph in Armata's 2024 annual report represents a significant red flag that cannot be overlooked. This standard accounting disclosure indicates substantial doubt about the company's ability to continue operations for the next 12 months without additional financing or material changes to their business plan. The timing of this disclosure alongside the funding announcement suggests that even with this $4.65 million, the company faces considerable financial uncertainty.

The imminent topline data from the diSArm trial represents a binary inflection point for Armata's valuation. Positive efficacy signals could potentially attract partnership interest or enable additional financing on favorable terms. Conversely, disappointing results would likely exacerbate their funding challenges.

Armata's strategic focus on U.S.-based manufacturing capability demonstrates foresight regarding production control and potential commercial readiness, but also represents ongoing operational costs that must be balanced against their limited capital resources. The company appears to be executing a rational development strategy with their lead asset, but investors should closely monitor both the upcoming clinical results and the company's success in addressing the underlying financial concerns signaled by the going concern notation.

Phase 1b/2a diSArm trial evaluated AP-SA02 as a potential treatment for complicated Staphylococcus aureus bacteremia

Topline data anticipated in Q2 2025 to support potential future pivotal bacteremia efficacy trial

LOS ANGELES, May 1, 2025 /PRNewswire/ -- Armata Pharmaceuticals, Inc. (NYSE American: ARMP) ("Armata" or the "Company"), a 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 an additional $4.65 million of non-dilutive funding pursuant to a previously announced Department of Defense (DoD) award, received through the Medical Technology Enterprise Consortium (MTEC) and managed by the Naval Medical Research Command (NMRC) – Naval Advanced Medical Development (NAMD) with funding from the Defense Health Agency and Joint Warfighter Medical Research Program. The award, currently totaling $26.2 million, was awarded to Armata to support clinical development of its optimized phage candidate, AP-SA02, as a potential treatment for complicated Staphylococcus aureus bacteremia (SAB). The additional $4.65 million will be used to support Phase 2a study close out activities as well as for the preparation and execution of an end-of-phase 2 meeting with the U.S. Food and Drug Administration.

"The DoD has been an essential partner throughout the development of AP-SA02, and we are very grateful for their continued support of this important program," stated Dr. Deborah Birx, Chief Executive Officer of Armata. "We remain committed to efficiently advance AP-SA02 through full clinical development and introduce this novel phage-based anti-infective for the benefit of military personnel and civilians alike."

"At Armata, we remain laser focused on demonstrating, in rigorously designed placebo-controlled clinical trials, the potential of phage therapy to successfully combat evolving deadly bacteria, including systemic Staphylococcus aureus infections. In parallel, we have developed our proprietary manufacturing process with complete in-house U.S.-based capacity to support clinical development as well as full future commercial production. This not only allows us to be efficient but is also expected to ensure immediate access to patients in need if AP-SA02 is found to be effective," Dr. Birx concluded.   

The diSArm study is a Phase 1b/2a, randomized, double-blind, placebo-controlled, multiple ascending dose escalation study of the safety, tolerability, and efficacy of intravenous AP-SA02 as an adjunct to best available antibiotic therapy compared to best available antibiotic therapy alone for the treatment of adults with SAB.

This study was conducted in two phases: Phase 1b evaluated the safety and tolerability of multiple ascending intravenous doses of AP-SA02 or placebo as an adjunct to best available therapy (BAT) compared to BAT alone in subjects with SAB. Phase 2a evaluated the efficacy, safety, and tolerability of multiple doses of AP-SA02 or placebo as an adjunct to BAT compared to BAT alone in subjects with complicated SAB. The study achieved full enrollment of 50 subjects in November 2024, with the last patient visit having taken place in January 2025. During the execution of the trial, Armata was able to dose escalate to 5e10 PFU every six hours (2E11 PFU every 24 hours) for five days without clinically significant adverse events. In parallel with dose escalation, the evolution of two distinct blinded subsets of subjects receiving phage has been observed. One subset, comprising approximately half of the treated group, has evidence of persistence of detectable phage in the blood consistent with in vivo phage amplification. This suggests that, despite the best available antibiotic treatment for greater than five days, reservoirs of active SAB remained that Armata's phages targeted, infected and killed before recirculating in the intravascular space.

As of now, the Company anticipates receipt of topline data in the next few weeks, where it can explore the two aforementioned subsets in an unblinded manner. Topline results are also expected to inform the optimal dose of AP-SA02 to be evaluated in the larger definitive efficacy study.

For more information on the diSArm study, see NCT05184764.

In addition, Armata filed its Annual Report for the year ended December 31, 2024 on Form 10-K with the Securities and Exchange Commission (the "SEC") on March 21, 2025. The audit opinion included in the Company's Form 10-K for the year ended December 31, 2024 contains a going concern explanatory paragraph. This announcement is made pursuant to the disclosure requirements of NYSE American Company Guide Sections 401(h) and 610(b) and does not represent any change or amendment to the Company's financial statements or to its Annual Report on Form 10-K for the year ended December 31, 2024.

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 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 current Good Manufacturing Practices; 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 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
Armata Pharmaceuticals, Inc.
ir@armatapharma.com
310-665-2928 x234

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

View original content:https://www.prnewswire.com/news-releases/armata-pharmaceuticals-receives-4-65-million-of-additional-non-dilutive-award-funding-from-the-us-department-of-defense-to-support-ongoing-disarm-clinical-trial-of-ap-sa02--302443865.html

SOURCE Armata Pharmaceuticals, Inc.

FAQ

What is the purpose of Armata's AP-SA02 clinical trial?

The diSArm trial evaluates AP-SA02 as a potential treatment for complicated Staphylococcus aureus bacteremia (SAB), testing it as an adjunct to best available antibiotic therapy.

How much funding did ARMP receive from the Department of Defense?

Armata received an additional $4.65 million, bringing the total DoD funding to $26.2 million for the AP-SA02 development program.

What were the key findings from ARMP's Phase 1b/2a trial?

The trial achieved dose escalation to 5e10 PFU every six hours without significant adverse events, and approximately half of treated patients showed evidence of phage persistence in blood, suggesting therapeutic effectiveness.

When will Armata Pharmaceuticals release topline data for the AP-SA02 trial?

Armata expects to release topline data for the AP-SA02 trial in Q2 2025.

What is the current manufacturing capability of Armata Pharmaceuticals?

Armata has developed proprietary manufacturing processes with complete in-house U.S.-based capacity to support both clinical development and future commercial production.