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Item 1. Business

2026-03-25 compared with 2025-03-21 · 467 added, 226 removed, 726 unchanged (49% of the section changed)

We are a clinical-stage biotechnology company having completed three Phase 2 trials focused on the development of high-purity, pathogen-specific bacteriophage therapeutics for the treatment of antibiotic-resistant and difficult-to-treat bacterial infections using our proprietary bacteriophage-based technology.

We are a late clinical-stage biotechnology company focused on the development of high-purity and potency, pathogen-specific bacteriophage therapeutics for the treatment of antibiotic-resistant and difficult-to-treat bacterial infections using our proprietary bacteriophage-based technology.

We have completed three Phase 2 clinical trials to date.

We see bacteriophages as a potentially safer and effective alternative to antibiotics and an essential response to the growing bacterial resistance to current classes of antibiotics.

Bacteriophages or “phages” have a powerful and highly differentiated mechanism of action that enables binding to and killing of specific targeted bacteria while uniquely preserving the normal human microbiome or “healthy bacteria”.

This is in direct contrast to traditional broad-spectrum antibiotics which can alter the human microbiome increasing susceptibility to opportunistic pathogens, such as Clostridium difficile (“ C.

difficile”) .

This is in direct contrast to traditional broad-spectrum antibiotics which can alter the human microbiome increasing susceptibility to opportunistic pathogens, such as Clostridium difficile .

We believe that phages represent a promising means to effectively treat bacterial infections as an alternative to broad-spectrum antibiotics, especially for patients with bacterial infections resistant to current standard of care therapies, including the multidrug-resistant or “superbug” strains of bacteria.

We are a leading developer of clinical-stage phage therapeutics of high purity, and believe we are uniquely positioned to address the growing worldwide threat of antibiotic-resistant bacterial infections.

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 we are on a critical pathway towards pivotal Phase 3 clinical studies.

We are combining our proprietary approach and expertise in identifying, characterizing and developing both naturally occurring and engineered (synthetic) bacteriophages with our proprietary phage-specific host-engineered current good manufacturing practice (“cGMP”) manufacturing capabilities to advance a target pipeline of high-quality bacteriophage product candidates for late-stage clinical development.

We have improved our manufacturing processes by significantly increasing phage titers and improving production efficiency with the goal of ensuring commercial viability.

We believe that we are uniquely advancing two lead candidates, referred to as AP-PA02 and AP-SA02, to address both chronic and acute bacterial infections.

Our first lead phage candidate, inhaled AP-PA02, is focused primarily on the treatment of chronic pulmonary infections due to Pseudomonas aeruginosa ( “ P.

We are a leading developer of clinical-stage phage therapeutics of high purity and potency, and believe we are uniquely positioned to address the growing worldwide threat of antibiotic-resistant bacterial infections.

We are combining our proprietary approach and expertise in identifying, characterizing and developing both naturally occurring and engineered bacteriophages with our proprietary phage-specific host-engineered cGMP manufacturing capabilities to advance a clinical pipeline of high-quality bacteriophage product candidates.

We believe that we are uniquely advancing two distinct clinical candidates, referred to as AP-PA02 and AP-SA02, targeting two different bacterial pathogens with the potential to treat chronic pulmonary disease complicated by bacterial infection as well as acute systemic bacterial infection.

To date, we have completed three critical Phase 2 randomized, double-blind, placebo controlled clinical trials.

We have combined our clinical data with rigorous and innovative in vitro science to extend our knowledge of phage biology enabling continued enhancement of in vivo phage function.

Importantly, we have improved our manufacturing processes, which significantly increases phage titers and purity, and improves production efficiency.

Aligned with these improvements, we have been able to reproducibly produce high titer and high purity phages with lot-to-lot consistency, configuring our phage platform for full commercialization with the goal of ensuring commercial viability of our current and future phage product candidates across a variety of potential use cases.

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.

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.

On October 14, 2020, we received the approval to proceed from the

Food and Drug Administration (the “FDA”) for our Investigational New Drug (“IND”) application for AP-PA02.

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Data indicate that AP-PA02 was well-tolerated with a treatment emergent adverse event profile similar to placebo.

Pharmacokinetcs (“PK”) 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.

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.

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In addition, a correlation was seen between increasing phage dose (higher AP-PA02 exposures) and reduction in the bacterial load, supporting the biologic plausibility of a bacterial specific mechanism of action and creating the opportunity for phage as a therapeutic alternative to inhaled antibiotics.

This study was supported by the Cystic Fibrosis Foundation (“CFF”) , which granted us a Therapeutics Development Award of $5.0 million.

We received the full award’s amount, including the final payment of $0.3 million, in January 2024.

This study was supported by the CFF, which granted us a Therapeutics Development Award of $5.0 million.

We received the full award’s amount in 2024.

Following the promising Phase 1b/2a results of favorable safety and tolerability profile and plausible mechanism of action, an additional confirmatory Phase 2 trial was initiated in non-cystic fibrosis bronchiectasis (“NCFB”) patients with similar chronic pulmonary disease with infections due to P.

Clinical Development of AP-PA02 in Non-Cystic Fibrosis Bronchiectasis:

Completed Phase 2 Study

On February 22, 2022, Armata announced that it had received from the FDA the approval to proceed for our IND application for AP-PA02, in a second indication, NCFB.

On December 19, 2024, Armata announced encouraging results from the completed “Tail wind ” study – a Phase 2 multicenter, double-blind, randomized, placebo-controlled study to

evaluate the safety, phage kinetics, and efficacy of inhaled AP-PA02 in subjects with NCFB and chronic pulmonary P.

On December 19, 2024, Armata announced encouraging results from the completed “Tail wind ” study – a Phase 2 multicenter, double-blind, randomized, placebo-controlled study to evaluate the safety, phage kinetics, and efficacy of inhaled AP-PA02 in subjects with NCFB and chronic pulmonary P.

aeruginosa infection.

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trial that completed in 2023.

We believe the learnings on dose-schedule regimens gained from the two completed Phase 2 studies position us to define a safe and promising biologic correlation for a Phase 3 definitive trial which will aim to evaluate inhaled AP-PA02 as an alternative to antibiotics in chronic pulmonary P.

We believe the learnings on dose-schedule regimens gained from the two completed Phase 2 studies position us to define a safe and promising biologic correlation for a Phase 3 definitive trial to evaluate inhaled AP-PA02 as an alternative to antibiotics in chronic pulmonary P.

aeruginosa infection.

In parallel to developing novel phage therapeutics that target chronic bacterial infections, we have an acute bacterial infection clinical development plan focused on Staphylococcus aureus (“ S.

Contingent upon securing sufficient additional funding, we may at the appropriate time in the future resume clinical development of AP-PA02 for NCFB, which may include the execution of a definitive Phase 3 clinical trial.

We are also actively exploring potential strategic partnerships as a means to further advance this important program.

Pseudomonas aeruginosa Phage Product Candidate, AP-PA03:

Platform Expansion

Based on clinical findings with our intravenously administered S.

aureus phage product candidate AP-SA02 (described below), and the approach that the Company’s P.

aeruginosa phage cocktails are formulated with the same high potency and purity standards, we are exploring preclinical development of an intravenously administered P.

aeruginosa phage cocktail for the treatment of acute ventilator-associated pneumonia (“VAP”) and other severe and difficult-to-treat infections caused by antibiotic-resistant and multidrug-resistant P.

Recognizing the distinct physiology of acute hospitalized pneumonia compared to chronic respiratory infections such as CF and NCFB, we are developing a novel phage cocktail specifically for acute bacterial pneumonia and have leveraged our extensive P.

aeruginosa clinical isolate collection and phage library to identify AP-PA03 as a potential clinical candidate for this indication.

Contingent upon securing sufficient funding, we may at the appropriate time in the future file an IND application in order to initiate clinical development of AP-PA03 for the treatment of VAP.

Staphylococcus aureus Phage Product Candidate, AP-SA02

Clinical Development of AP-SA02 in Bacteremia:

Completed Phase 1b/2a Study

In parallel to developing novel phage therapeutics that target chronic bacterial infections, we have an acute bacterial infection clinical development program focused on S.

aureus bacteremia, a difficult-to-treat and often life-threatening human infection that can result in high morbidity and mortality and for which bacterial resistance to antibiotics is growing.

A key advantage of our phage manufacturing expertise is the purity profiles of our phage products, including AP-SA02, our phage product candidate for S.

We believe a key advantage of our phage manufacturing expertise is the purity profiles and the lot-to-lot consistency of our phage products, including AP-SA02, our phage product candidate for S.

this has enabled us to pursue treatment of complicated S.

aureus bacteremia, where repetitive intravenous dosing is required.

On June 15, 2020, we entered into an agreement (the “MTEC Agreement”) with the Medical Technology Enterprise Consortium (“MTEC”), pursuant to which we received a $15.0 million award and entered into a multi-year program administered by the U.S Department of Defense through 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.

On September 29, 2022, the MTEC Agreement was modified to increase the total award by $1.3 million to $16.3 million and extend the term into the second half of 2024.

In July 2024, the MTEC Agreement was modified to increase the total award by $5.3 million to $21.6 million and extend the term into the third quarter of 2025.

We are using the award to partially fund a Phase 1b/2a, multicenter, randomized, double-blind, placebo-controlled dose escalation study that will assess the safety, tolerability and efficacy of our phage-based candidate, AP-SA02, for the treatment of adults with S.

aureus (the “diSArm study”) .

aureus bacteremia, where repetitive intravenous (“IV”) dosing is required.

On November 17, 2021, we announced that we had received approval from the FDA to proceed with our IND application for AP-SA02.

On November 12, 2024, we announced completion of enrollment of the Phase 1b/2a diSArm study of intravenous AP-SA02 as a potential treatment for S.

On May 19, 2025, we announced positive topline data from the Phase 1b/2a diSArm study of intravenously administered AP-SA02 in complicated S.

aureus bacteremia.

The last patient final follow-up visit

was completed on January 14, 2025.

During the Phase 2a portion of diSArm, Armata focused on evaluating clinical safety of higher intravenous doses of AP-SA02 and accelerating enrollment to arrive at topline data expeditiously.

The manufacture of highly purified phages using Armata’s proprietary methods enabled dose escalation 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 providing early evidence of in vivo phage amplification and resultant release of phage progeny.

The Company anticipates topline data from the diSArm study in the first half of 2025 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 a larger definitive efficacy study.

Data from this Phase 1b/2a study will be invaluable for a follow-on trial that is being designed to demonstrate efficacy of AP-SA02 in treating S.

The diSArm study (NCT05184764) was a Phase 1b/2a, multicenter, randomized, double-blind, placebo-controlled, multiple ascending dose escalation study of the safety, tolerability, and efficacy of intravenous AP-SA02 in addition to best available antibiotic therapy (“BAT”) compared to BAT alone (placebo) for the treatment of adults with complicated SAB.

All doses of AP-SA02 were dosed intravenously every six hours for five days.

The primary clinical efficacy endpoint for the Phase 2a portion of the diSArm study was clinical outcome (responder rate) in subjects with complicated bacteremia, measured at (i) Test of Cure (“TOC”) for AP-SA02, defined as one week following the end of IV treatment with AP-SA02 (day 12), (ii) TOC for BAT, defined as one week following the end of IV BAT, and (iii) end of study (“EOS”), defined as four weeks following the end of IV BAT.

Clinical outcome was evaluated by both the blinded site investigators and a blinded Clinical Efficacy Adjudication Committee (the “CEAC”) in the intent-to-treat (“ITT”) population.

Safety and efficacy were assessed in the ITT population, which included all subjects (n=50) who received at least one dose of AP-SA02 or placebo.

The Phase 2a study enrolled and dosed 42 patients, with 29 randomized to AP-SA02 in addition to BAT and 13 to placebo (BAT alone).

Methicillin-resistant S.

aureus (“MRSA”) was the causative pathogen in ~38% of both the AP-SA02 and placebo groups.

AP-SA02 was well-tolerated with no serious adverse events related to the study drug.

Two subjects had adverse events that were possibly related to the study drug:

one with transient liver enzyme elevation and one with hypersensitivity that resolved with discontinuation of vancomycin.

A statistically significant increase in clinical response rate was observed at TOC for AP-SA02 (day 12) in AP-SA02 treated subjects (88%;

21/24) versus placebo (58%;

7/12) (p = 0.047) as assessed by blinded site investigators, and 83% (20/24) in the AP-SA02 group versus 58% (7/12) in the placebo group as assessed by the blinded CEAC.

At TOC for BAT and at EOS, 100% of the AP-SA02 treated subjects had clinically responded (p = 0.017) versus 25% of placebo subjects considered non-responsive due to either relapse or treatment failure, consistent with the non-responder rate reported in the literature for recent Phase 3 trials.

Of note, the clinical response with AP-SA02 occurred regardless of whether subjects were infected with methicillin-sensitive S.

aureus (“MSSA”) or MRSA.

All subjects infected with MRSA and treated with AP-SA02 and BAT cleared their infection by TOC for BAT with no evidence of relapse through EOS, as compared to the relapse rate of BAT alone as noted above.

Supporting the investigator assessment, clinical outcome was assessed by the CEAC, who agreed that subjects who received placebo had a 22% and 25% non-responder rate at TOC with BAT and at EOS, respectively, while 100% of the subjects who received AP-SA02 clinically responded (p = 0.025:

Additionally, and consistent with the clinical response rate, patients treated with AP-SA02 showed trends toward rapid normalization of key predictors of mortality and complications in SAB including C-reactive protein and interleukin-10, shorter time to negative blood culture, quicker time to resolution of signs and symptoms at the infection site, shorter intensive care unit and hospital utilization.

Clinical efficacy was observed independent of the BAT utilized, in that all patients responded despite receiving different classes of antibiotics.

The active and placebo arms were well-matched for antibiotics utilized.

The clinical response rate also occurred independent of the site of infection, which were well-matched between the active and placebo arms, and were diverse ranging from endocarditis, to osteomyelitis, to septic joints, to deep wounds, and pneumonia.

Moreover, phages in AP-SA02 administered systemically by IV push, were able to hone to the site of infection, bind to, penetrate and kill the target bacteria, enabling phage progeny to exit the burst bacteria and reenter the intravascular space including further target any remaining local bacteria.

Phage are not able to continue to exist and replicate once all target bacteria have been killed.

Defined and reproducible laboratory derived stable genomic variants present in the AP-SA02 drug product may provide an immediate advantage, enabling rapid, strain-specific response to each patient’s S.

aureus isolate.

These characterized variants can expand from as little as 2% to dominance when infecting certain patient isolates in vitro , highlighting that these variants are favored for their enhanced ability to infect those clinical strains and the importance of integrating this diversity into Armata’s phage cocktail from the outset.

This inherent flexibility may be central to achieving optimal therapeutic efficacy in the clinic.

● AP-SA02, combined with BAT, had a higher and earlier cure rate compared to placebo in patients with complicated SAB at day 12 as assessed by both blinded site investigators and independent adjudicators.

● No patients who received AP-SA02 demonstrated non-response or relapse at one week post-BAT or at EOS, as assessed by both blinded site investigators and the independent adjudication committee, compared with approximately 25% non-response or relapse in the placebo group.

● AP-SA02 appears safe with clinical efficacy against both MRSA and MSSA and trends toward earlier resolution and shorter hospitalization, with no evidence of relapse four weeks post-therapy.

● We previously demonstrated the persistence of AP-SA02 in the IV space on multiple days one hour post IV push.

These trial results support AP-SA02 homing to different sites of infection, presumably penetrating biofilms, and infecting and lysing the target S.

aureus bacteria, independent of both antibiotic resistance patterns and site of infection.

● Defined phage variants in AP-SA02 drug product ensure an intrinsic adaptive mechanism — a flexibility that may be key to achieving effective phage therapy from patient to patient.

On October 22, 2025, we highlighted the positive results from our Phase 2a diSArm clinical study of AP-SA02 in an oral presentation at IDWeek 2025 TM .

The abstract, titled, “A Phase 2a Randomized, Double-Blind, Controlled Trial of the Efficacy and Safety of an Intravenous (IV) Bacteriophage Cocktail (AP-SA02) vs.

Placebo in Combination with Best Available Antibiotic Therapy (BAT) in Patients with Complicated Staphylococcus aureus Bacteremia,” was accepted as a late-breaking oral presentation, and was presented by Dr.

Miller, M.D., M.P.H., Professor of Medicine, David Geffen School of Medicine at UCLA, Chief, Division of Infectious Diseases at Harbor-UCLA Medical Center and the Lundquist Institute.

The results from our Phase 1b/2a diSArm study are an important step forward in our effort to confirm the potent antimicrobial activity of phage therapy and the completion of the study represents a significant milestone in the development of AP-SA02, moving us one step closer to introducing an effective new treatment option to patients suffering from complicated SAB.

This is the first clear evidence in a randomized controlled trial of the efficacy of phage against a serious systemic pathogen that is responsible for significant morbidity and mortality in the United States.

Findings from the Phase 1b/2a study, including the favorable safety and tolerability profile of AP-SA02, inform the design of a larger definitive efficacy study to demonstrate superiority of AP-SA02 in treating complicated SAB.

In January 2026, the Company announced the conclusion of an End-of-Phase 2 (“EOP2”) meeting written response from the FDA.

The FDA’s Center for Biologics Evaluation and Research (“CBER”) division, upon reviewing our detailed EOP2 meeting package, confirmed that the safety and efficacy data from our Phase 2a diSArm study support advancement to Phase 3.

The FDA provided critical guidance on key elements of the Phase 3 clinical study design, which will assess the superiority of AP-SA02 over the current standard of care for the treatment of complicated S.

aureus bacteremia.

We anticipate findings from the Phase 1b/2a study will provide the basis for constructing a robust trial strategy for registration which can be the basis for an End-of-Phase-2 meeting with the FDA that enables us to obtain agreement on a path to approval.

We are committed to developing a definitive efficacy trial focused on phage as an alternative to broad-spectrum antibiotics and/or antibiotic sparing to decrease the utilization of broad-spectrum antibiotics and their detrimental impact on the normal human microbiome.

On August 1, 2022, we announced FDA approval to proceed with our IND application for AP-SA02 in a second indication, prosthetic joint infections (“PJI”) with S.

The FDA provided comments on Chemistry, Manufacturing, and Controls (“CMC”) which we are aligning with our existing Phase 3 manufacturing and quality strategy.

The FDA also included recommendations for the future Biologics License Application (“BLA”).

As of the date of this filing, we are already addressing many of the clinical and CMC comments from the FDA.

On February 20, 2026, under Section 505E of the Federal Food, Drug, and Cosmetic Act, the FDA designated AP-SA02 for intravenous use as a Qualified Infectious Disease Product Designation (“QIDP”) for adjunct treatment of complicated bacteremia caused by methicillin-sensitive or methicillin-resistant S.

To achieve QIDP designation, a drug candidate must be intended to treat serious or life-threatening infections, particularly those caused by bacteria and fungi that are resistant to treatment, or that treat qualifying resistant pathogens identified by the FDA.

The QIDP designation makes AP-SA02 eligible to benefit from certain incentives for the development of new antibacterials provided under the Generating Antibiotic Incentives Now (“GAIN”) Act, including an additional five-year extension of Hatch-Waxman market exclusivity.

Further, the QIDP designation makes AP-SA02 eligible for Fast Track status, which provides an opportunity for more frequent meetings and communication with the FDA, priority and rolling review, leading to potential accelerated approval of its BLA.

As of the date of this filing, the Company has submitted to the FDA a request for Fast Track Designation for AP-SA02.

Department of Defense (the “DoD”) through MTEC and managed by the Naval Medical Research Command – Naval Advanced Medical Development with funding from the Defense Health Agency and Joint Warfighter Medical Research Program.

On September 29, 2022, the MTEC Agreement was modified to increase the total award by $1.3 million to $16.3 million and extend the term into the second half of 2024.

On July 29, 2024, the MTEC Agreement was modified to increase the total award by $5.3 million to $21.6 million and extend the term into the third quarter of 2025.

On April 29, 2025, we received $4.65 million of additional non-dilutive award funding through MTEC, thereby increasing the total MTEC award to $26.2 million, and the MTEC Agreement was modified to extend the term to September 30, 2025.

On July 2, 2025, the MTEC Agreement was modified to extend the term to March 31, 2026.

This award has been used to partially fund the Phase 1b/2a, multicenter, randomized, double-blind, placebo-controlled dose escalation study to assess the safety, tolerability and efficacy of AP-SA02 for the treatment of adults with complicated S.

aureus bacteremia (the “diSArm” study), and to support activities related to the EOP2 meeting with the FDA.

Clinical Development of AP-SA02 in Bacteremia:

Phase 3 Superiority Study

The current proposed Phase 3 clinical study design, which incorporates feedback from the Company’s EOP2 meeting with the FDA, is intended to assess the superiority of AP-SA02 administered as an adjunct to 4–6 weeks of BAT for the treatment of adults with complicated S.

aureus bacteremia.

The proposed trial design, which incorporates feedback from the Company’s EOP2 meeting with the FDA, will evaluate clinical response at 7 days post BAT and/or 28 days post BAT as the primary study endpoint, and defined as resolution of all baseline signs and symptoms of bacteremia and negative blood cultures.

Secondary endpoints include clinical response at day 14 (TOC), time to hospital discharge, microbiologic eradication evidenced by two consecutive negative blood cultures, and S.

aureus -specific and all-cause mortality at day 14, 7 days post BAT and/or 28 days post BAT.

The study is expected to enroll approximately 450 patients in a 2:1 randomization, powered to detect a 15% absolute improvement with 90% power at a 0.05 alpha level, and is designed to provide safety data from approximately 300 AP-SA02-treated subjects (receiving the full 7-day dose) to support a potential BLA.

Safety and healthcare resource impact analyses will be included.

The Phase 3 study is anticipated to initiate in the second half of 2026.

aureus Bacteremia Clinical Strategy:

Moving AP-SA02 to Frontline Therapy, Expanding Patient Populations and Indications

The Company believes that, if clinical superiority of AP-SA02 is demonstrated in the Phase 3 study for registration in adults with complicated S.

aureus bacteremia, it is plausible the Phase 3 safety and efficacy data may potentially drive changes to infectious disease clinical treatment guidelines, requiring the use of AP-SA02 with antibiotics as new standard of care.

With demonstration of superiority and following a potential initial approval of AP-SA02 in adults with complicated S.

aureus bacteremia, the Company believes there may be additional development opportunities for AP-SA02, including use as adjunct therapy with shorter antibiotic treatment durations, and evaluation of AP-SA02 as a potential front-line therapy.

Moreover, a potential future bridging study may support label expansion, including expanding into adults with uncomplicated S.

aureus bacteremia, and a potential opportunity to expand into the pediatric population given the high titer formulation of AP-SA02 enables administration at small volume doses.

Additional Clinical Indications for AP-SA02

Improved patient outcomes are needed for other Staphylococcal infections, in settings such as prosthetic joint infections (“PJI”) and wound infections, for which antimicrobial resistance is a growing concern.

We believe AP-SA02 could also have a meaningful impact in these indications, particularly infections caused by MRSA.

On August 1, 2022, we announced FDA approval to proceed with our IND application for AP-SA02 in a second indication, PJI with S.

We had planned to initiate a Phase 1b/2a trial;

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Driven by data from the bacteremia study, and with sufficient funding, we may in the future initiate a Phase 1b/2a trial to assess the safety and tolerability of intravenous and intra-articular AP-SA02 as an adjunct to standard of care antibiotics in adults undergoing treatment of periprosthetic joint infections and/or wound infections caused by S.

We remain committed to our mission to evaluate phage-based therapeutics in randomized controlled clinical trials that evaluate safety and efficiacy 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.

In parallel to the critical pathway Phase 2 trials, Armata has also focused on the validation of the lot release assays to ensure consistency and potency as well as improvement in cGMP manufacturing efficiencies and extension of phage shelf life using specific excipients.

Recent Financing

2025 Credit Agreement

On March 12, 2025, the Company entered into a credit and security agreement (the “2025 Credit Agreement”) for a loan in an aggregate amount of $10.0 million (the “2025 Loan”) with Innoviva Strategic Opportunities LLC, a wholly owned subsidiary of Innoviva, Inc.

INVA), our principal stockholder and a related party (collectively, “Innoviva”) .

The 2025 Loan bears interest at an annual rate of 14.0% and matures on March 12, 2026.

Credit Agreements and Warrants Extensions

On January 23, 2026, we entered into amendments to the March 2025 Credit Agreement, the 2024 Credit Agreement, the credit and security agreement, dated July 10, 2023 (the “2023 Credit Agreement”), and the Convertible Credit Agreement with Innoviva Strategic Opportunities LLC (“Innoviva Sub”), a wholly owned subsidiary of Innoviva, Inc.

(“Innoviva”), our principal stockholder and a related party, extending the maturity dates to June 1, 2027.

In addition, we amended certain outstanding Innoviva Sub warrants to extend their expiration dates to January 26, 2031, and amended the related voting agreement to align with the revised warrant expiration date or FDA approval, as applicable.

December 2025 Sales Agreement

On December 1, 2025, we entered into a Capital on Demand™ Sales Agreement (the “Sales Agreement”) with JonesTrading Institutional Services LLC (“Jones”), relating to the offer and sale of shares of our common stock.

In accordance with the terms of the Sales Agreement, we may offer and sell shares of our common stock having an aggregate offering price of up to $100,000,000 from time to time subject to certain conditions, through or to Jones, acting as agent or principal.

August 2025 Credit Agreement

On August 11, 2025, we entered into a credit and security agreement (the “August 2025 Credit Agreement”) for a loan in the aggregate amount of $15.0 million (the “August 2025 Loan”) with Innoviva Sub.

The August 2025 Loan bears interest at an annual rate of 14.0% and matures on January 11, 2029.

Principal and accrued interest are payable at maturity.

Repayment of the 2025 Loan is guaranteed by the Company’s domestic subsidiaries, and the loan is secured by substantially all of the assets of the Company and the subsidiary guarantors.

Concurrently with the execution of the 2025 Credit Agreement, the Company entered into amendments to (i) its existing convertible loan (the “Convertible Loan”) and secured credit and security agreement, dated January 10, 2023, with Innoviva (the “Convertible Credit Agreement”), (ii) its existing secured term loan facility (the “2023 Loan”) and credit and security agreement, dated July 10, 2023, with Innoviva (the “2023 Credit Agreement”) and (iii) its existing secured term loan facility (the “2024 Loan”) and credit and security agreement, dated March 4, 2024, with Innoviva (the “2024 Credit Agreement”), which, among other things, extended the maturity date of each loan to March 12, 2026.

2024 Credit Agreement

On March 4, 2024, the Company entered into the 2024 Credit Agreement for the 2024 Loan in an aggregate amount of $35.0 million with Innoviva.

The 2024 Loan bears interest at an annual rate of 14.0% and was scheduled to mature on June 4, 2025.

Repayment of the August 2025 Loan is guaranteed by our domestic subsidiaries, and the loan is secured by substantially all of our assets and the subsidiary guarantors.

March 2025 Credit Agreement

On March 12, 2025, we entered into a credit and security agreement (the “March 2025 Credit Agreement”) for a loan in an aggregate amount of $10.0 million (the “March 2025 Loan”) with Innoviva Sub.

The March 2025 Loan bears interest at an annual rate of 14.0% and matures on June 1, 2027.

Principal and accrued interest are payable at maturity.

Repayment of the 2024 Loan is guaranteed by the Company’s domestic subsidiaries, and the loan is secured by substantially all of the assets of the Company and the subsidiary guarantors.

Concurrently with the execution of the 2024 Credit Agreement, the Company amended certain provisions of the Convertible Loan and Convertible Credit Agreement and the 2023 Loan and 2023 Credit Agreement, to, among other things, conform certain terms relating to permitted indebtedness and permitted liens.

On March 12, 2025, the Company executed an amendment to the 2024 Credit Agreement which, among other things, extended the 2024 Loan maturity date to March 12, 2026.

Repayment of the March 2025 Loan is guaranteed by our domestic subsidiaries, and the loan is secured by substantially all of our assets and the subsidiary guarantors.

2024 Credit Agreement

On July 10, 2023, the Company entered into the 2023 Credit Agreement.

The 2023 Credit Agreement provides for the 2023 Loan, a secured term loan facility in an aggregate amount of $25.0 million at an interest rate of 14.0% per annum, and was scheduled to mature on January 10, 2025.

On March 4, 2024, we entered into the credit and security agreement, dated March 4, 2024 (the “2024 Credit Agreement”), for the secured term loan facility in an aggregate amount of $35.0 million (the “2024 Loan”) with Innoviva Sub.

The 2024 Loan bears interest at an annual rate of 14.0% and is scheduled to mature on June 1, 2027.

Principal and accrued interest are payable at maturity.

Repayment of the 2023 Loan is guaranteed by the Company’s domestic subsidiaries, and the 2023 Loan is secured by substantially all of the assets of the Company and the subsidiary guarantors.

On November 12, 2024, the Company executed an amendment to the 2023 Credit Agreement, which, among other things, extended the 2023 Loan maturity date to January 10, 2026.

On March 12, 2025, the Company executed a subsequent amendment to the 2023 Credit Agreement which, among other things, extended the 2023 Loan maturity date to March 12, 2026.

Repayment of the 2024 Loan is guaranteed by the Company’s domestic subsidiaries, and the loan is secured by substantially all of our assets and the subsidiary guarantors.

Concurrently with the execution of the 2024 Credit Agreement, we amended certain provisions of the Convertible Loan and Convertible Credit Agreement and the secured term loan facility in the aggregate amount of $25.0 million (the “2023 Loan”) and 2023 Credit Agreement with Innoviva Sub, to, among other things, conform certain terms relating to permitted indebtedness and permitted liens.

Convertible Credit Agreement

On January 10, 2023, the Company received the Convertible Loan in the aggregate amount of $30.0 million from Innoviva pursuant to the Convertible Credit Agreement.

The Convertible Loan bears interest at a rate of 8.0% per annum and was scheduled to mature on January 10, 2024.

The Convertible Credit Agreement was amended on July 10, 2023, in connection with the Company’s entry into the 2023 Credit Agreement, to, among other changes, extend the maturity of the Convertible Loan to January 10, 2025.

Subsequently, on November 12, 2024, the Company executed another amendment to the Convertible Credit Agreement, which, among other things, extended the Convertible Credit Agreement maturity date to January 10, 2026.

Then, on March 12, 2025, the Company executed a subsequent amendment to the Convertible Credit Agreement which, among other things, extended the Convertible Loan maturity date to March 12, 2026.

On January 10, 2023, we received the convertible loan (the “Convertible Loan”) in the aggregate amount of $30.0 million from Innoviva Sub pursuant to the secured convertible credit and security agreement, dated January 10, 2023, with Innoviva Sub (the “Convertible Credit Agreement”) .

The Convertible Loan bears interest at a rate of 8.0% per annum and is scheduled to mature on June 1, 2027.

The Convertible Loan principal and accrued interest are payable at maturity.

Repayment of the Convertible Loan is guaranteed by the Company’s domestic subsidiaries and foreign material subsidiaries, and the Convertible Loan is secured by substantially all of the assets of the Company and the subsidiary guarantors.

The Convertible Credit Agreement provides that if there is a financing from new investors of at least $30.0 million (a “Qualified Financing”), the outstanding principal amount of and all accrued and unpaid interest on the Convertible Loan shall be converted into shares of the Company’s common stock (the “Common Stock”), at a price per share equal to a 15.0% discount to the lowest price per share for Common Stock paid by investors in such Qualified Financing.

The Convertible Credit Agreement also required the Company to file a registration statement for the resale of all securities issued to the lender in connection with any conversion under the Convertible Credit Agreement, which the Company originally filed on February 13, 2023 and which was declared effective by the SEC on April 6, 2023.

The Convertible Credit Agreement also confers upon the lender the option to convert any outstanding Convertible Loan amount, including all accrued and unpaid interest thereon, at the lender’s option, into shares of Common Stock at a price per share equal to the greater of book value or market value per share of Common Stock on the date immediately preceding the effective date of the Convertible Credit Agreement, which was $1.52 (as may be appropriately adjusted for any stock split, combination or similar act).

Repayment of the Convertible Loan is guaranteed by our domestic subsidiaries and foreign material subsidiaries, and the Convertible Loan is secured by substantially all of our assets and the subsidiary guarantors.

The Convertible Credit Agreement provides that if there is a financing from new investors of at least $30.0 million (a “Qualified Financing”), the outstanding principal amount of and all accrued and unpaid interest on the Convertible Loan shall be converted into shares of our common stock (the “Common Stock”), at a price per share equal to a 15.0% discount to the lowest price per share for Common Stock paid by investors in such Qualified Financing.

The Convertible Credit Agreement also required us to file a registration statement for the resale of all securities issued to the lender in connection with any conversion under the Convertible Credit Agreement, which we originally filed on February 13, 2023 and which was declared effective by the SEC on April 6, 2023.

The Convertible Credit Agreement also confers

upon the lender the option to convert any outstanding Convertible Loan amount, including all accrued and unpaid interest thereon, at the lender’s option, into shares of Common Stock at a price per share equal to the greater of book value or market value per share of Common Stock on the date immediately preceding the effective date of the Convertible Credit Agreement, which was $1.52 (as may be appropriately adjusted for any stock split, combination or similar act).

The following chart summarizes the status of our phage product candidate development programs and partners.

Our strategy is to demonstrate the safety, tolerability and definitive efficacy of multiple phage products in randomized controlled clinical trials required for FDA approval and to support commercialization in both acute and chronic indications of high unmet medical need, including bacterial infections caused by multidrug-resistant and difficult-to-treat pathogens.

Our fully integrated product development capabilities from bench to clinic enable the discovery of optimal phage product candidates, and include the effective adaptation of phages to uniquely engineered host cells, essential for efficient process development and resulting in improved purity, stability, and manufacturability, to power rigorous clinical trials.

Our microbiological surveillance and synthetic biology capabilities drive long-term product life cycle management.

Our fully integrated product development capabilities from bench to clinic enable the discovery of optimal phage product candidates, and include the effective adaptation of phages to uniquely engineered host cells, essential for efficient process development and resulting in improved purity, potency, stability, and manufacturability, to power rigorous human clinical trials.

Our microbiological surveillance and synthetic biology capabilities drive long-term product life cycle management and expansion of the phage platform and potential clinical indications.

We intend to:

● Advance clinical trials of AP-PA02 in patients with CF and NCFB, both chronic pulmonary P.

aeruginosa infections, as an alternative to inhaled antibiotics.

● Advance clinical trials of AP-SA02 in patients with bacteremia due to acute infection with S.

● Advance late-stage clinical trials of AP-SA02 in patients with bacteremia due to acute infection with S.

aureus , including methicillin-resistant S.

aureus (“MRSA”), as an alternative to antibiotics or to significantly limit duration of antibiotic use.

aureus (“MRSA”), as an alternative to antibiotics and/or to significantly limit duration of antibiotic use.

● Develop AP-SA02 for the treatment of other antibiotic-resistant and difficult-to-treat S.

aureus infections such as PJI and wound infections.

● Develop other bacteriophage therapeutics, potentially including AP-PA03, for the treatment of other antibiotic-resistant and difficult-to-treat P.

aeruginosa infections such as acute bacterial pneumonia.

● Advance clinical trials of AP-PA02 in patients with CF and NCFB, both chronic pulmonary P.

aeruginosa infections, as an alternative to inhaled antibiotics.

● Develop other bacteriophage therapeutics, potentially including AP-PA03, for the treatment of antibiotic-resistant and difficult-to-treat P.

aeruginosa acute respiratory infections, including ventilator-associated pneumonia (“VAP”) and other severe acute infections caused by multidrug-resistant P.

The Need for New Anti-Infective Therapies

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The first case of the “superbug”, MRSA, in the United States occurred in 1968.

A void in the discovery of new classes of antibiotics lasting approximately 30 years drove the emergence and spread of antibiotic-resistant bacteria, including vancomycin-resistant enterococci

(“VRE”), and pandrug-resistant strains of Acinetobacter baumannii , P.

A void in the discovery of new classes of antibiotics lasting approximately 30 years drove the emergence and spread of antibiotic-resistant bacteria, including vancomycin-resistant enterococci (“VRE”), and pandrug-resistant strains of Acinetobacter baumannii , P.

aeruginosa , Escherichia coli and Klebsiella pneumoniae .

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antimicrobial resistance

The dramatic and continuous emergence of antibiotic-resistant bacteria, and the lack of novel next generation antibiotics in the pipeline, has prompted calls to action from many of the world’s major health bodies such as the U.S.

Centers for Disease Control and Prevention (the “CDC”), and the World Health Organization (the “WHO”), who warn of an “antibiotic cliff” and a “post-antibiotic era.” A growing list of infections – such as pneumonia, tuberculosis, bacteremia/septicemia, gonorrhea, and foodborne diseases – are becoming harder, and sometimes impossible, to treat as antibiotics become less effective.

In 2009, the European Antimicrobial Resistance Surveillance System concluded that “the loss of effective antimicrobial therapy increasingly threatens the delivery of crucial health services in hospitals and in the community.” This conclusion was reinforced by The Antimicrobial Availability Task Force of the Infectious Diseases Society of America (the “IDSA”), and the European Centre for Disease Prevention and Control in conjunction with the European Medicines Agency (the “EMA”).

The IDSA and the WHO regard antimicrobial resistance as one of the greatest threats to human health worldwide.

The Review on Antimicrobial Resistance, a global project commissioned by the British government and the Wellcome Trust, reports that at least 700,000 people die each year of drug resistance in illnesses that include bacterial infections.

The report predicts that, by 2050, 10 million lives a year worldwide (more people than currently die from cancer) and a cumulative $100 trillion of economic output are at risk due to the rise of drug-resistant infections.

The rapid and continuous emergence of antibiotic-resistant bacteria, coupled with a lack of novel next generation antibiotics in the pipeline, has prompted urgent calls to action from global health authorities including the U.S.

Centers for Disease Control and Prevention (the “CDC”) and the World Health Organization (the “WHO”).

Both agencies warn of a looming “post-antibiotic era”, in which common infections and routine medical procedures could once again become life-threatening.

Antimicrobial resistance (“AMR”) is considered a top 10 global public health threat by the WHO.

The Infectious Diseases Society of America (“IDSA”) highlights the crisis as a major threat to human health, driving up mortality and costs by reducing the effectiveness of treatments for bacterial and other infections.

The threat of broadening antibiotic resistance as well as the impact of broad-spectrum antibiotics on the human microbiome, has been identified as an important new expanded area of research by the National Institutes of Health (“NIH”)/National Institute of Allergy and Infectious Diseases (“NIAID”).

The CDC estimates that at least 2.5 million people in the United States develop infections due to resistant bacteria resulting in more than 35,000 deaths each year;

A 2018 study from the Washington University School of Medicine indicated that the number of deaths would be between 153,113 and 162,044, which suggests that the CDC estimates may be dramatic underestimations.

It is estimated that 50% of hospital-acquired infections are resistant to first-line anti-infective therapies.

The cumulative annual healthcare costs for treating drug-resistant bacterial infections in the United States alone is calculated at $21 billion to $34 billion, with over 8 million additional hospital days.

It is for these reasons that we believe there is a critical and pressing need to develop new and novel antibacterial therapies to combat the rise in antibiotic-resistance bacteria.

Increased public funding as well as foundation funding will be essential to bring new approaches forward through full cycle development.

Definitive controlled clinical trials to test promising novel therapeutics as alternatives to traditional antibiotics must be funded in order to combat the growing issue of drug-resistant bacterial infections across the globe.

the true mortality burden may be far greater according to a report from the Washington University School of Medicine.

A growing list of bacterial infections, including bacteremia/septicemia, pneumonia, tuberculosis, gonorrhea, and foodborne diseases, are increasingly difficult to treat as existing antibiotics lose effectiveness due to resistance.

The European Antimicrobial Resistance Surveillance System cautioned that “the loss of effective antimicrobial therapy increasingly threatens the delivery of crucial health services in hospitals and in the community.” This conclusion was reinforced by the Antimicrobial Availability Task Force of the IDSA, and the European Centre for Disease Prevention and Control in conjunction with the European Medicines Agency (the “EMA”).

The Global Burden of Disease (“GBD”) Antimicrobial Resistance Collaborators, a worldwide consortium of researchers, led by the Institute for Health Metrics and Evaluation, estimated that in 2019, bacterial antimicrobial resistance was associated with approximately 4.95 million deaths worldwide, including 1.27 million deaths directly attributable to resistant infections.

Their 2021 update projects 39 million deaths between 2025 and 2050 without stronger intervention.

The GBD Antimicrobial Resistance Collaborators' work highlights that AMR is a leading cause of death globally, urging for better surveillance, antibiotic stewardship, and new treatment developments.

The NIH/NIAID, U.S.

Department of Health and Human Services (“HHS”), and FDA each affirm that antimicrobial resistance represents one of the most urgent public health challenges of our time.

HHS’s National Action Plan for

Combating Antibiotic-Resistant Bacteria outlines a coordinated “One Health” strategy to address this escalating crisis, while FDA emphasizes its commitment to advancing innovative antibacterial therapies to restore treatment effectiveness.

Global analyses underscore the scale of the antimicrobial resistance crisis, and collectively, these global authorities emphasize that antimicrobial resistance (“AMR”), including resistance among priority pathogens such as S.

aureus and P.

aeruginosa, remains an urgent and growing threat requiring sustained therapeutic innovation.

Increased public funding as well as foundation funding remain essential to bring new and novel antibacterial therapies forward through full cycle development to combat the rise in antibiotic-resistance bacteria.

Definitive randomized controlled clinical trials to test promising novel therapeutics as alternatives to traditional antibiotics must be funded in order to combat the growing issue of drug-resistant bacterial infections in the United States and across the globe.

Anti-Infective Therapeutics Market

The market opportunity for antibiotics is large, with the market estimated to exceed $58 billion in annual sales globally by 2027.

Almost one in every five deaths worldwide occurs as a result of infection and, according to the WHO,

many bacterial infections will become difficult or impossible to cure as the efficacy of current standard-of-care antibiotics wanes.

Despite the advances in antimicrobial and vaccine development, infectious diseases still remain the third-leading cause of death in the United States and the second-leading cause of death worldwide.

The market opportunity for antibiotics is large, with recent industry forecasts estimating the global antibiotics market will exceed $58 billion in annual sales globally in 2027 and grow to more than $83 billion by 2032.

Other recent forecasts put the current market at roughly $50 billion with projected growth to exceed $70 billion by the early 2030s.

According to the WHO, increasing antimicrobial resistance is reducing the effectiveness of current standard-of-care antibiotics, making many bacterial infections harder to treat and in some cases potentially untreatable as resistance continues to rise, and WHO data show that a substantial proportion of bacterial infections are now resistant to antibiotic treatments.

Despite the advances in antimicrobial and vaccine development, infectious diseases still remain among the leading causes of death globally and continue to impose a substantial clinical and economic burden in both developed and developing markets worldwide.

The number of new antibiotics approved by the FDA and other global regulatory authorities has declined consistently over the last two decades.

A recent review from WHO on the number of new antibiotics currently in the pipeline shows that just 12 new antibiotics have entered the market in the five years from 2017-21, and there are fewer than 30 under development in clinical trials against pathogens considered critical by WHO such as P.

This is compared with more than 2,000 new product candidates in the drug pipeline for cancer.

Historically, the success rate from Phase 1 to marketing approval is only one in five for infectious disease products.

We, therefore, believe there is a need for new approaches to treat serious and life-threatening bacterial infections.

Hospital-acquired (nosocomial) infections are a major healthcare problem throughout the world, affecting developed countries as well as resource-poor countries.

The WHO reports that hospital-acquired infections are among the major causes of death and increased morbidity among hospitalized patients.

In the United States alone, the CDC estimates that hospital-acquired infections account for ~1.7 million infections and 99,000 associated deaths each year.

According to recent analyses by the WHO, while approximately 90 antibacterial agents are currently in clinical development worldwide, only a limited subset are considered innovative or target priority drug-resistant pathogens.

WHO has consistently reported that the clinical pipeline remains insufficient to adequately address the increasing prevalence of multidrug-resistant organisms, including priority pathogens such as P.

In contrast, other therapeutic areas, such as oncology, continue to benefit from substantially larger development pipelines.

The relative scarcity of innovative antibacterial agents underscores the unmet medical need and the potential market opportunity for differentiated therapies targeting serious and drug-resistant infections.

Published industry analyses estimate that the overall probability of success for anti-infective therapeutics from Phase 1 through regulatory approval is in the mid-teens, approximately 15–17%, reflecting the significant attrition risk inherent in infectious disease drug development.

We therefore believe there remains a substantial need for new and differentiated approaches to treat serious and life-threatening bacterial infections.

Healthcare-associated infections (“HAIs”) are a major healthcare problem throughout the world, affecting developed countries as well as resource-poor countries.

The WHO has reported that HAIs represent a significant global public health challenge and are associated with increased morbidity and mortality among hospitalized patients.

According to the CDC, HAIs remain a significant patient safety concern in the United States.

CDC surveillance data indicate that on any given day approximately one in 31 hospitalized patients has at least one HAI, and more than one million HAIs occur annually in U.S.

acute care hospitals.

Common infection types include central line-associated bloodstream infections, catheter-associated urinary tract infections, surgical site infections, C.

difficile infections, and MRSA bloodstream infections.

Compounding the above situations is the alarming and continuing rise in the prevalence of multidrug-resistant bacterial infections.

This, coupled with the lack of new antibiotics in current discovery and development pipelines, has generated a significant clinical management problem worldwide, leading to increases in morbidity and mortality due to these antibiotic-resistant bacteria as well as increases in healthcare costs.

This, coupled with the lack of new antibiotics in current discovery and development pipelines, has generated a significant clinical management problem worldwide, with antibiotic-resistant infections contributing to substantial morbidity, mortality and increased healthcare costs.

Bacteriophage therapy has the potential to be an alternative to antibiotics in treating bacterial infections.

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Phage genomes can be modified to confer benefits that address limitations, if any, that are observed during clinical development.

Traits such as host range, burst size and biofilm disruption can be improved.

Traits such as host

range, burst size and biofilm disruption can be improved.

These potential improvements help to assure phage therapeutics efficacy in difficult settings and over time as new isolates emerge.

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Phages have met the criteria to be considered as “generally recognized as safe”, or “GRAS”, in the food and food contact surface categories.

With the growing problem of antimicrobial resistance, we believe it is essential that phage safety and efficacy be demonstrated by conducting rigorous well-powered clinical trials required for FDA approval, in order to move toward commercialization of phage therapy as an alternative to traditional antibiotics and to bring a potential solution to all patients suffering from drug-resistant bacterial infections.

Armata has been focused on enhancing the overall quality of its manufactured phages through engineering and adaptation to maximize production titers while ensuring high level of purity.

With the growing problem of antimicrobial resistance, we believe it is essential that phage safety and efficacy be demonstrated by conducting rigorous well-powered randomized controlled clinical trials required for FDA approval, in order to move toward commercialization of phage therapy as an alternative to traditional antibiotics and to bring a potential solution to all patients suffering from drug-resistant bacterial infections.

Armata combines its proprietary approach and expertise in identifying, characterizing and developing both naturally occurring and engineered bacteriophages with its proprietary phage-specific host-engineered cGMP manufacturing capabilities to advance a clinical pipeline of high-quality bacteriophage product candidates.

Importantly, we have improved our manufacturing processes, which significantly increases phage titers and purity, and improves production efficiency, with the goal of ensuring commercial viability of our phage product candidates.

to traditional antibiotics, providing a potential method of treating patients suffering from antibiotic-resistant and difficult-to-treat bacterial infections.

We believe that we are uniquely advancing multiple phage product candidates to address both chronic and acute bacterial infections with significant unmet medical needs.

Target Markets and Medical Need

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CF affects over 40,000 people in the United States (105,000 people worldwide) with approximately 1,000 new diagnoses per year.

Dysfunction of the CFTR gene leads to dysfunction in multiple organs, but particularly the lungs, where a

failure of hydration of airway secretions results in thick mucus, chronic inflammation, airway remodeling, and recurrent infections.

Dysfunction of the CFTR gene leads to dysfunction in multiple organs, but particularly the lungs, where a failure of hydration of airway secretions results in thick mucus, chronic inflammation, airway remodeling, and recurrent infections.

Lung function continues to decline over time, punctuated by pulmonary exacerbations with increased cough, shortness of breath, and infections that result in rapid declines in lung function.

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Hospitalized Pneumonia

Hospital-acquired pneumonia and ventilated-associated pneumonia is one of the most common causes of death among all hospital‐acquired infections, with approximately 300,000 hospitalizations each year in the United States due to Pseudomonas .

Infection with Pseudomonas results in mortality rates ranging as high as 35‐50%, drives considerable healthcare costs (in excess of $40,000 per patient), and accounts for around 50% of all intensive care unit antibiotics.

Hospital-acquired pneumonia (“HAP”), including VAP, remains a serious healthcare-associated infection in the United States.

VAP caused by P.

aeruginosa represents a significant unmet medical need in critically ill patients.

Published studies have reported mortality rates ranging from approximately 30% to 50% in high-risk ICU populations, particularly in cases involving multidrug-resistant strains.

VAP is associated with prolonged intensive care unit and hospital stays, increased healthcare costs, and substantial antibiotic utilization in the ICU setting.

The clinical severity of P.

aeruginosa VAP, combined with rising antimicrobial resistance and limited availability of novel anti-pseudomonal therapies, underscores the potential market opportunity for differentiated therapeutic approaches targeting this serious and life-threatening infection.

Staphylococcus aureus Infections

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aureus is the most commonly identified pathogen in both hospital- and community-acquired bloodstream infections.

Annually in the United States there are approximately 200,000 hospitalizations for S.

aureus bacteremia (“SAB”).

The annual U.S.

incidence of S.

aureus bacteremia (“SAB”) in a hospitalized setting is estimated at approximately 110,000 to 187,000 cases, with rates expected to remain high through at least 2040.

Complicated SAB represents one of the most severe manifestations of infection with S.

Approximately 40% of SAB cases are classified as complicated, defined by persistent bacteremia, sustained fever beyond 72 hours despite therapy, infective endocarditis, infected prosthetic devices, or metastatic infection, such as deep tissue abscess, vertebral osteomyelitis, or central nervous system involvement.

Complicated SAB is associated with substantial morbidity and high mortality, estimated at 10–30% within 30 days.

Patients with complicated SAB frequently experience prolonged hospitalization, high relapse rates, persistent bacteremia, and significant healthcare utilization.

Despite conventional antibiotics, mortality in SAB results in the death of up to 40% of all cases and 57% of patients over the age of 85.

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Age-adjusted mortality assessments show that SAB mortality is higher than that of AIDS, tuberculosis, or viral hepatitis, and comparable to mortality rates for breast or prostate cancer.

Outcomes are even poorer for SAB due to MRSA, classified as a serious threat to global health by the CDC and a high priority threat by the WHO, with higher rates of complications and increased mortality as compared to methicillin-susceptible S.

aureus (“MSSA”).

Average hospital costs to patients with nosocomial SAB ranges between $40,000 (MSSA) and $114,000 (MRSA).

The average cost per hospitalization is estimated at approximately $31,000, and total annual U.S.

expenditures attributable to complicated SAB exceed $828 million.

Compared with other hospitalized patients, individuals with SAB experience approximately double the length of stay, cost, and mortality risk.

The presence of infective endocarditis further increases morbidity and mortality risk, often necessitating prolonged intravenous therapy, surgical intervention, and extended hospitalization.

Treatment failures are common in SAB, with highest rates due to MRSA.

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While biofilms can render traditional antibiotics ineffective, phages may have the ability to penetrate the biofilm allowing rapid and efficient infection of the host and amplification at the site of infection.

Despite decades of antibiotic development, therapeutic options for complicated SAB remain limited and suboptimal, and management often depends on a small number of cornerstone intravenous agents.

Existing standard-of-care therapies are limited by toxicity, resistance, and anatomical constraints, reinforcing the seriousness of the condition and the vulnerability of the affected hospitalized population.

Vancomycin remains a standard-of-care therapy for MRSA infections but is associated with nephrotoxicity.

Daptomycin, another key agent used in SAB and endocarditis, is associated with adverse effects including myopathy, rhabdomyolysis, eosinophilic pneumonia, and hypersensitivity reactions.

Daptomycin therapy has also been associated with eosinophilic pneumonia and C.

difficile –associated diarrhea.

Because complicated SAB frequently requires prolonged intravenous therapy of 4–6 weeks, the cumulative risk of toxicity, the need for laboratory monitoring, and the potential for treatment discontinuation or escalation are clinically significant.

In patients who are intolerant of, allergic to, or experience toxicity from first-line agents, therapeutic options may become constrained, further complicating management of an already life-threatening infection.

Until 2024, daptomycin (approved in 2006;

based on clinical cure rates of less than 50%) and vancomycin were the only two FDA-approved antibiotics with label indications in the United States for the treatment of SAB, and the emergence of drug-resistant S.

aureus isolates, including to these two standard of care drugs, represents a major threat in terms of increasing morbidity, mortality and health care utilization.

In April 2024, the FDA approved Zevtera (ceftobiprole medocaril sodium for injection) for the treatment of adults with SAB.

based on non-inferiority and clinical cure rates of less than 50%) and vancomycin were the only two FDA-approved antibiotics with label indications in the United States for the treatment of SAB, and the emergence of drug-resistant S.

aureus isolates, including to these two standard of care drugs, represents a major threat in terms of increasing morbidity, mortality and

health care utilization.

In April 2024, the FDA approved Zevtera (ceftobiprole medocaril sodium for injection) based on non-inferiority for the treatment of adults with SAB.

Prosthetic Joint Infection and Wound Infection

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Platform Technologies

Proprietary Phage Platform Offers Opportunities to Efficiently Expand into Different Indications

Our proprietary bacteriophage platform is designed to enable efficient development and lifecycle expansion of targeted phage therapies across multiple serious bacterial infections.

We are initially focusing on two important target pathogens, S.

aureus and P.

aeruginosa , with lead indications including complicated S.

aureus bacteremia, S.

aureus prosthetic joint infections, chronic P.

aeruginosa respiratory infections in people with CF and NCFB, and a preclinical stage program targeting acute Pseudomonas pneumonia.

Multiple potential follow-on opportunities exist including uncomplicated S.

aureus bacteremia, VAP, wound infections, prosthetic joint infections, and additional bloodstream infections.

The phage product development platform is structured to support multiple routes of administration, including inhaled (nebulized), systemic (intravenous), and topical delivery, and is intended to allow efficient modification of existing off-the-shelf phage cocktails to expand into adjacent indications and additional high-priority pathogens.

We maintain robust phage and bacterial libraries to facilitate target expansion and believes our differentiated, modular development approach may enable cost-effective advancement across multiple organisms and clinical indications.

Moreover, multi-phage cocktail redundancy is intended to mitigate resistance development by incorporating multiple phages from different phage families targeting the same organism.

Importantly, we have developed proprietary processes over more than a decade to optimize purity, potency, and drive manufacturing efficiency of our phages, including the use of engineered manufacturing hosts.

Our phage product development capabilities span from earliest discovery through clinical trials, and we have the skills and capabilities for the segments in between that are essential for us to bring forth high quality phage products that are well-selected, well-characterized and well-made whose behavior offer potential clinical benefit;

these represent computational discovery pipelines, preclinical development, process development and analytical sciences, and in-house chemistry, manufacturing and controls (“CMC”) designed to support all stages of clinical development and full commercialization.

Synthetic Phage Platform

Phages, natural predators of bacteria, have been in an uninterrupted battle for millions of years – evolving to kill or evade.

These powerful natural well-adapted phages can be purposely engineered to be more efficient killers.

The use of synthetic biology tools enables us to precisely engineer natural phages in ways that further improve their pharmacological properties and antimicrobial activity.

Attributes of engineered phages can include expanded host range, improved potency which is a fundamental drug property that can translate into improved clinical efficacy, and importantly, biofilm disruption, which is a critical aspect of serious infections that needs to be addressed.

These powerful natural well-adapted phages can sometimes be purposely engineered to be more efficient killers.

Our team of microbiologists and synthetic biologists hunt for natural phages and evaluate the suitability of these natural

phages for engineering and adaptation using our proprietary phage engineering platform, which can serve to enhance the clinical and commercial prospects of phage therapy.

The use of synthetic biology tools enables us to precisely engineer some natural phages in ways that further improve their pharmacological properties and antimicrobial activity.

Attributes of engineered phages can include expanded host range, improved potency which is a fundamental drug property that can translate into improved clinical efficacy, and biofilm disruption, which is a critical aspect of serious infections that needs to be addressed.

Phage Discovery and Phenotyping:

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Engineered phages are evaluated both in vitro and in vivo to determine pharmacological and toxicological parameters to confirm their potential in the clinic.

Engineering the host is critical to decreasing drug product contaminents.

Engineering the host is critical to decreasing drug product contaminants.

Formulation Development and Chemistry, Manufacturing, and Controls:

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aeruginosa and S.

aureus are causative agents for difficult-to-treat infections:

aureus are causative agents for difficult-to-treat

aeruginosa , with its mucoid and multidrug-resistant strains, is a dominant culprit in chronic respiratory infections in CF and NCFB patients as well as acute pneumonia in hospitalized patients;

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Feedback from the FDA in September 2018 included:

agreement on product specifications, manufacturing and analytical plan, and

a stability program.

agreement on product specifications, manufacturing and analytical plan, and a stability program.

Furthermore, the FDA noted that preclinical toxicology studies are not required for AP-PA01 to enter clinical development.

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AP-PA02 is comprised of a cocktail of adapted natural P.

aeruginosa phages originating from distinct families and subfamilies, targeting multiple receptor classes, functioning with compatibility (i.e., the phages do not interfere with one another) and cooperativity (i.e., the phages work together for a better outcome), and further characterized by being highly potent and having a broad host range and overlap.

highly potent and having a broad host range and overlap.

Prior to initiating the SWARM- P.a.

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The improvements in AP-PA02 reflect our core strategy of utilizing clinical isolate surveillance data to drive enhancement of product composition.

aeruginosa isolates from people

diagnosed with NCFB revealed that the five-phage AP-PA02 cocktail offers broad coverage and robust potency in this indication as well.

aeruginosa isolates from people diagnosed with NCFB revealed that the five-phage AP-PA02 cocktail offers broad coverage and robust potency in this indication as well.

Preclinical highlights of AP-PA02 include:

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Through the end of 2024, clinical trial material of AP-PA02 was manufactured under cGMP at our production facility in Marina del Rey, California.

As of 2025, clinicial trial material of AP-PA02 is being manufactured under cGMP at our production facility in Los Angeles, California to support the required regulatory filing(s) for clinical entry both inside and outside the United States.

As of 2025, clinical trial material of AP-PA02 is being manufactured under cGMP at our production facility in Los Angeles, California to support the required regulatory filing(s) for clinical entry both inside and outside the United States.

Clinical Development of AP-PA02 in Cystic Fibrosis :

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aeruginosa colony-forming units.

We looked at clinical parameters

as a part of exploratory endpoints for the SAD and MAD cohorts.

We looked at clinical parameters as a part of exploratory endpoints for the SAD and MAD cohorts.

The SWARM- P.a.

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Data indicate that AP-PA02 was well-tolerated with a treatment emergent adverse event profile similar to placebo.

Pharmacokinetcs (PK) 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 and exposure achievement relatively consistent across patient subjects.

Pharmacokinetics (PK) 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 and exposure achievement relatively consistent across patient subjects.

Additionally, bacterial levels of P.

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The primary efficacy endpoint was the reduction in P.

aeruginosa colony forming units ("CFUs") in lung sputum at one week following completion of dosing (day 17) compared to baseline.

aeruginosa colony forming units (“CFU”) in lung sputum at one week following completion of dosing (day 17) compared to baseline.

Per the statistical analysis plan, efficacy analysis of each independent cohort showed no significant difference between subjects treated with AP-PA02 and placebo due to small numbers of subjects in each cohort.

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Results from the Phase 2 Tail wind study demonstrate the potential of Armata’s high-purity phage cocktail, AP-PA02, as a new monotherapy treatment alternative for chronic pulmonary disease caused by P.

aeruginosa infection,

including drug-resistant bacteria, and indicate the potential for phage therapy to reduce reliance on chronic antibiotic use.

aeruginosa infection, including drug-resistant bacteria, and indicate the potential for phage therapy to reduce reliance on chronic antibiotic use.

The Phase 2 Tail wind study represents the second successful clinical trial for AP-PA02, Armata’s lead pulmonary candidate, which was first evaluated in people with cystic fibrosis in the Phase 1b/2a SWARM- P.a.

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aeruginosa infection.

AP-PA03 for Antibiotic-Resistant and Difficult-to-Treat Acute Bacterial Pneumonia

Conversely and representing the different physiology of acute pneumonia lung infections as compared to chronic CF and NCFB respiratory infections, a novel cocktail is in development for the clinical indication of acute hospitalized pneumonia.

We have deployed our extensive P.

aeruginosa clinical isolate collection and phage library to identify a candidate phage cocktail, AP-PA03.

Pseudomonas aeruginosa Phage Product Candidate, AP-PA03:

Platform Expansion

Based on clinical findings with our intravenously administered S.

aureus phage product candidate AP-SA02 (described below), and the approach that the Company’s P.

aeruginosa phage cocktails are formulated with the same high potency and purity standards, we are exploring preclinical development of an intravenously administered P.

aeruginosa clinical isolate collection and phage library to identify AP-PA03 as a potential clinical candidate for this indication.

Contingent upon securing sufficient funding, we may at the appropriate time in the future file an IND application in order to initiate clinical development of AP-PA03 for the treatment of VAP.

Staphylococcus aureus Phage Product Candidate, AP-SA02

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We have developed AP-SA02 as a sterile solution, suitable for delivery by intravenous administration.

Through the end of 2024, clinical trial material of AP-SA02 was manufactured under cGMP at our production facility in Marina del Rey, California.

As of 2025, clinicial trial material of AP-SA02 is being manufactured under cGMP at our production facility in Los Angeles, California to support the required regulatory filing(s) for clinical entry both inside and outside the United States.

Clinical trial material of AP-SA02 is being manufactured under cGMP at our production facility in Los Angeles, California to support the required regulatory filing(s) for clinical entry both inside and outside the United States.

We combine our proprietary approach and expertise in identifying, characterizing and developing both naturally occurring and engineered bacteriophages with our proprietary phage-specific host-engineered cGMP manufacturing capabilities to advance high-quality bacteriophage product candidates for late-stage clinical development.

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aureus bacteremia, where repetitive intravenous dosing is required.

Throughout the past 12 months, improvements in our proprietary upstream manufacturing processes have resulted in a ten-fold increase in phage titer.

Improvements in our proprietary upstream manufacturing processes have resulted in multi-fold increases in phage titer.

Additionally, significant improvements in recovery throughout our processes has resulted in five-fold more doses from a single production run.

We have improved our overall production efficiency with the goal of ensuring commercial viability.

The Los Angeles site’s approximately 10,000 square foot cGMP facility enables us to bring more efficient manufacturing processes on line and allows for full commercialization from the current facility, streamlining the timeline from potential successful pivotal trial to a Biologics License Application (“BLA”).

The Los Angeles site’s approximately 10,000 square foot cGMP facility enables us to operate efficient manufacturing processes to support all stages of clinical development, including Phase 3, and importantly, allows for full commercialization from the current facility, streamlining the timeline from potential successful pivotal trial to a BLA.

Clinical Development of AP-SA02 in Bacteremia:

Completed Phase 1b/2a Study

On November 17, 2021, Armata received approval for the study to proceed from the FDA for its IND to initiate the “diSArm” study – 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 bacteremia due to Staphylococcus aureus .

The objectives of this study are to:

On November 17, 2021, Armata received approval for the study to proceed from the FDA for its IND application for AP-SA02 to initiate the “diSArm” study (NCT05184764), a Phase 1b/2a, multicenter, randomized, double-blind, placebo-controlled, multiple ascending dose escalation study of the safety, tolerability, and efficacy of intravenous AP-SA02 in addition to BAT compared to BAT alone (placebo) for the treatment of adults with complicated SAB.

The objectives of this study were to:

(i) demonstrate safety and tolerability of multiple different dose levels of AP-SA02;

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and (iii) explore efficacy through evaluation of key meaningful endpoints.

The study is being conducted at sites in the United States and also at sites abroad in Australia.

The Phase 1b/2a study is partially funded by a $15.0 million award administered by the U.S Department of Defense through 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.

On September 29, 2022, the MTEC Agreement was modified to increase the total award by $1.3 million to $16.3 million and extend the term into the second half of 2024.

In July 2024, the MTEC Agreement was modified to increase the total award by $5.3 million to $21.6 million and extend the term into the third quarter of 2025.

On November 12, 2024, we announced completion of enrollment of the Phase 1b/2a diSArm study of intravenous AP-SA02 as a potential treatment for S.

The study was conducted at sites in the United States and also at sites abroad in Australia.

On May 19, 2025, we announced positive topline data from the Phase 1b/2a diSArm study of AP-SA02 in complicated S.

aureus bacteremia.

The last patient final follow-up visit was completed on January 14, 2025.

During the Phase 2a portion of diSArm, Armata focused on evaluating clinical safety of higher intravenous doses of AP-SA02 and accelerating enrollment to arrive at topline data expeditiously.

The manufacture of highly purified phages using Armata's proprietary methods enabled dose escalation 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 providing early

evidence of in vivo phage amplification and resultant release of phage progeny.

The Company anticipates topline data from the diSArm study in the first half of 2025 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 a larger definitive efficacy study.

Data from this Phase 1b/2a study will be invaluable for a follow-on trial that is being designed to demonstrate efficacy of AP-SA02 in treating S.

All doses of AP-SA02 were dosed intravenously every six hours for five days.

The primary clinical efficacy endpoint for the Phase 2a portion of the diSArm study was clinical outcome (responder rate) in

subjects with complicated bacteremia, measured at (i) TOC for AP-SA02, defined as one week following the end of IV treatment with AP-SA02 (day 12), (ii) TOC for BAT, defined as one week following the end of IV BAT, and (iii) end of study (“EOS”), defined as four weeks following the end of IV BAT.

Clinical outcome was evaluated by both the blinded site investigators and a blinded Clinical Efficacy Adjudication Committee (the “CEAC”) in the intent-to-treat (“ITT”) population.

Safety and efficacy were assessed in the ITT population, which included all subjects (n=50) who received at least one dose of AP-SA02 or placebo.

The Phase 2a study enrolled and dosed 42 patients, with 29 randomized to AP-SA02 in addition to BAT and 13 to placebo (BAT alone).

MRSA was the causative pathogen in ~38% of both the AP-SA02 and placebo groups.

AP-SA02 was well-tolerated with no serious adverse events related to the study drug.

Two subjects had adverse events that were possibly related to the study drug:

one with transient liver enzyme elevation and one with hypersensitivity that resolved with discontinuation of vancomycin.

A statistically significant increase in clinical response rate was observed at TOC for AP-SA02 (day 12) in AP-SA02 treated subjects (88%;

21/24) versus placebo (58%;

7/12) (p = 0.047) as assessed by blinded site investigators, and 83% (20/24) in the AP-SA02 group versus 58% (7/12) in the placebo group as assessed by the blinded CEAC.

Of note, the clinical response with AP-SA02 occurred regardless of whether subjects were infected with MSSA or MRSA.