What changed in this filing

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Item 1. Business

2025-03-21 compared with 2024-03-21 · 299 added, 355 removed, 653 unchanged (50% of the section changed)

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

We see bacteriophages as an alternative to antibiotics and an essential response to 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 targeted bacteria while preserving the human microbiome.

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

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 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”) .

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 phage therapeutics and are uniquely positioned to address the growing worldwide threat of antibiotic-resistant bacterial infections.

We are completing two critical Phase 2 trials to ensure a pathway towards pivotal Phase 3 trials.

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 advanced development.

We are advancing two lead candidates to address both chronic and acute bacterial infections.

Our first lead candidate focused primarily on chronic bacterial infections is the clinical phage candidate for Pseudomonas aeruginosa ( “P.

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.

aeruginosa ” ).

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

In the first quarter of 2023, Armata announced positive topline results from the completed “SWARM- P.a.

” study – a Phase 1b/2a, multicenter, double-blind, randomized, placebo-controlled, single ascending dose (“SAD”) and multiple ascending dose (“MAD”) clinical trial to evaluate the safety and tolerability of inhaled AP-PA02 in subjects with cystic fibrosis (“CF”) and chronic pulmonary P.

In the first quarter of 2023, we announced positive topline results from the completed “SWARM- P.a.

” study – a Phase 1b/2a, multicenter, double-blind, randomized, placebo-controlled, single ascending dose and multiple ascending dose clinical trial to evaluate the safety and tolerability of inhaled AP-PA02 in subjects with cystic fibrosis (“CF”) and chronic pulmonary P.

aeruginosa infection.

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

Pharmacokinetcs (PK) findings confirm 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.

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.

AP-PA02 exposures were generally consistent across subjects.

Additionally, bacterial levels of P.

aeruginosa in the sputum measured at several timepoints suggest improvement in bacterial load reduction for subjects treated with AP-PA02 at the end of treatment as compared to placebo after ten days of dosing.

In addition, a correlation was seen between increasing phage dose 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 Armata a Therapeutics Development Award of $5.0 million.

Following these 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 patients with similar chronic pulmonary infections due to Pseudomonas aeruginosa .

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, non-cystic fibrosis bronchiectasis (“NCFB”).

We initiated a Phase 2 trial (“Tailwind”) in NCFB in 2022 and reported first patient dosing in the first quarter of 2023.

The “Tailwind” study is a Phase 2, multicenter, double-blind, randomized, placebo-controlled study to evaluate the safety, phage kinetics, and efficacy of inhaled AP-PA02 phage therapeutic in subjects with NCFB and chronic pulmonary Pseudomonas aeruginosa infection.

We are actively accelerating enrollment and increasing phage dosing with the goal of defining a safe and promising biologic correlation for a Phase 3 definitive trial in 2025 which will evaluate phage as an alternative to antibiotics in chronic pulmonary infections.

In parallel, we have an acute bacterial infection clinical development plan focused on Staphylococcus aureus bacteremia, a difficult-to-treat and often life-threatening infection that can result in high morbidity and mortality and for which bacterial resistance to antibiotics is growing.

We are advancing a phage product candidate for Staphylococcus aureus ( “S.

aureus” ) for the treatment of complicated S.

aureus bacteremia, AP-SA02.

On June 15, 2020, we entered into an agreement (the “MTEC Agreement”) with the Medical Technology Enterprise Consortium (“MTEC”), pursuant to which we expect to receive a $15.0 million grant and entered into a three-year program administered by the U.S Department of Defense (the “DoD”) through MTEC with funding from the Defense Health Agency and Joint Warfighter Medical Research Program.

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.

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.

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.

aeruginosa infection.

Data indicated that inhaled AP-PA02 provides a durable reduction of P.

aeruginosa in the lung, with a favorable safety and tolerability profile.

The Tail wind study was conducted in two cohorts running in parallel:

subjects in one cohort (cohort A) received inhaled AP-PA02 as monotherapy, while subjects in another cohort (cohort B) received inhaled AP-PA02 in combination with inhaled anti-pseudomonal antibiotic treatment.

Subjects in both cohorts were dosed at home by nebulization with study drug administered every 12 hours for 10 days and were followed for approximately four weeks after receiving their last dose of study drug.

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.

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.

Notably, a post-hoc intent-to-treat analysis (n=33 active and n=15 placebo;

all subjects from both cohorts) demonstrated a statistically significant reduction of P.

aeruginosa CFUs in the lung at day 17 (AP-PA02 vs.

The reduction in P.

aeruginosa CFUs persisted two weeks following completion of dosing with AP-PA02 when compared with placebo at day 24 (AP-PA02 vs.

Additionally, paired analysis of P.

aeruginosa CFU density at baseline compared to day 10 (P=0.03), day 11 (P=0.01), day 17 (P=0.003) and day 24 (P=0.018) was significant in the AP-PA02-treated cohort.

We believe the data suggest that AP-PA02 alone is as effective as the combination therapy of phage and antibiotics in reducing P.

aeruginosa CFUs in the lung.

Additionally, approximately one-third of subjects treated with phage monotherapy exhibited at least a 2-log CFU reduction in P.

aeruginosa compared to no reduction in placebo treated subjects.

Safety data indicate that inhaled AP-PA02 was well-tolerated with treatment-emergent adverse events mild and self-limiting.

There was one possibly related serious adverse event that was linked to an acute pulmonary event requiring hospitalization that was responsive to antibiotics.

We believe the safety and tolerability of AP-PA02 offers a promising profile for treating chronically infected NCFB patients.

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.

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.

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.

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.

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.

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.

The grant is being used to partially fund a Phase 1/2, multi-center, 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.

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”) .

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.

aureus bacteremia.

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

We are focused on accelerating enrollment of the Phase 2a segment of the “diSArm” study, evaluating safety with higher intravenous doses, which is possible due to the high purity of Armata’s phage product candidates.

We are committed to developing a definitive efficacy trial in 2025 focused on phage as an alternative to broad-spectrum antibiotics and/or antibiotic sparing to decrease the utilize of broad-spectrum antibiotics and their detrimental impact on the normal human microbiome.

On August 1, 2022, Armata announced that it had received from the FDA the approval to proceed for our IND application for AP-SA02, in a second indication, prosthetic joint infections (“PJI”).

We had planned to initiate a Phase 1b/2a trial in 2023, however in light of the growing concerns of both PJI and wound infections, we are revising the protocol to include both indications.

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.

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.

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

however, in light of the growing concerns of both PJI and wound infections, we are considering revising the protocol to include both indications.

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 conducting randomized controlled clinical trials required for FDA approval in order to move toward the commercialization of its phage products as alternatives to traditional antibiotics, providing a potential method of treating patients suffering from drug-resistant and difficult-to-treat bacterial infections.

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 4, 2024, we entered into a credit and security agreement (the “2024 Credit Agreement”) for a loan in an aggregate amount of $35.0 million with Innoviva Strategic Opportunities LLC (“Innoviva SO”), a wholly owned subsidiary of Innoviva, Inc.

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

The 2024 loan bears interest at an annual rate of 14% and matures on June 4, 2025.

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.

Principal and accrued interest are payable at maturity.

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

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

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 July 10, 2023, we entered into a credit and security agreement (the “2023 Credit Agreement”) for a loan in an aggregate amount of $25.0 million with Innoviva.

This loan bears interest at an annual rate of 14% and matures on January 10, 2025.

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.

Principal and accrued interest are payable at maturity.

Repayment of the loan is guaranteed by our domestic subsidiaries, and the loan is secured by substantially all of our assets.

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.

2023 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.

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.

Convertible Credit Agreement

On January 10, 2023, we entered into a secured convertible credit and security agreement (the “Convertible Credit Agreement”) with Innoviva, which was amended in July 2023.

The Convertible Credit Agreement provides for a secured term loan facility in an aggregate amount of $30.0 million, which bears interest at a rate of 8.0% per annum, and matures on January 10, 2025.

Repayment of this 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 for various conversion and repayment options, including the conversion of principal and accrued interest into the shares of common stock upon a Qualified Financing (as defined below) and we have an option to repay the loan prior to maturity.

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 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 Securities and Exchange Commission (the “SEC”) on April 6, 2023.

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.

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).

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aeruginosa infections, as an alternative to inhaled antibiotics.

● Develop bacteriophage therapeutics, 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-SA02 in patients with bacteremia due to acute infection with S.

aureus , including MRSA, as an alternative to antibiotics or to significantly limit duration of antibiotic use.

aureus , including methicillin-resistant S.

aureus (“MRSA”), as an alternative to antibiotics 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.

The Need for New Anti-Infective Therapies

The introduction of penicillin in the early 1940s marked the start of the antibiotic discovery era, during which more than 20 new classes of antibiotic were marketed over a period of three decades.

The first case of the “superbug”, Methicillin-resistant S.

aureus (“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.

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.

aeruginosa , Escherichia coli and Klebsiella pneumoniae .

methicillin-resistant Staphylococcus aureus ;

vancomycin resistant enterococci;

pandrug-resistant;

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.

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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 CDC estimates

that at least 2 million people in the United States develop infections due to resistant bacteria resulting in more than 23,000 deaths each year.

The CDC estimates that at least 2 million people in the United States develop infections due to resistant bacteria resulting in more than 23,000 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.

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

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

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.

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.

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

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.

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

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

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.

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

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Phages offer several differentiating attributes compared to classic antibiotics:

● Highly specific/selective bactericidal agents, sparing the microbiome.

● Highly specific/selective bactericidal agents, sparing the normal human microbiome .

Since each strain of phage specifically binds and kills only a particular bacterial host, phages may be a precision tool to reduce or eliminate specific strains of harmful bacteria without exposing patients to risks of eliminating the beneficial bacteria of our microbiomes through the use of current standard of care antibiotics.

Such risks could include serious opportunistic infections such as Clostridium difficile infection and VRE infection.

Such risks could include serious opportunistic infections such as C.

difficile infection and VRE infection.

● No known toxicities associated with chemical structures.

Antibiotic use is often associated with toxicities (e.g.

kidneys, bone marrow, hearing).

Antibiotic use is often associated with toxicities (e.g., kidneys, bone marrow, hearing).

Phages are highly unlikely to carry structural features or be metabolized by the body to produce structural elements that confer chemical toxicities associated with small molecules.

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However, the safety and effectiveness of these therapies have not been conclusively established due to the lack of randomized controlled clinical studies.

Recently, Western medicine has seen a rise in the clinical evaluation of phages.

More recently, Western medicine has seen a rise in the clinical evaluation of phages.

In the United Kingdom, two early-stage clinical trials of P.

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Non-Cystic Fibrosis Bronchiectasis:

NCFB is a chronic respiratory disease affecting more than 100,000 people in the United States and 200,000 people in Europe, characterized by recurrent respiratory infections that lead to a vicious cycle of impaired mucociliary clearance, chronic infection, bronchial inflammation, and progressive lung function loss.

No approved therapy for NCFB P.

NCFB is a chronic progressive pulmonary disease with 422,000 prevalent cases and 90,000 incident cases in the United States, expanding at a compound annual growth rate of 3.5%.

NCFB is a condition characterized by recurrent respiratory infections that lead to a vicious cycle of impaired mucociliary clearance, chronic infection, bronchial inflammation, structural damage, and progressive lung function loss.

aeruginosa is the most prevalent pathogen responsible for these recurrent infections.

It is found in approximately 30% of cases and is associated with enhanced disease progression, including poorer lung function and lower quality of life, more frequent exacerbations, 7-fold increase in hospitalizations, and 3-fold increase in death.

Approximately 30% of NCFB patients are colonized with P.

aeruginosa , resulting in enhanced disease progression and poorer outcomes, including decreased lung function and lower quality of life, more frequent acute exacerbations, 7-fold increase in hospitalizations, and 3-fold increase in death.

The average annual healthcare costs for an NCFB patient colonized with P.

aeruginosa exceeds $200,000, 175% higher compared to non-colonized patients.

NCFB patients frequently become chronically colonized with multidrug-resistant strains of P.

aeruginosa because of the need for repeated courses of antibiotic treatment.

There are currently no approved inhaled antibiotics for the treatment of NCFB patients with chronic P.

aeruginosa respiratory infections.

There are currently no FDA-approved medications for the treatment of NCFB patients with chronic P.

aeruginosa respiratory infection, including inhaled antibiotics or therapeutics that address antibiotic resistance and reduce exacerbations.

Advantages of bacteriophages include exquisite specificity for the target bacterial pathogen (e.g., P.

aeruginosa ), minimal risks of dysbiosis compared to broad-spectrum antibiotics (e.g., to lung and gut microbiomes), mitigation of antimicrobial resistance, and lower risk of off-target effects.

Hospitalized Pneumonia

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Bacteremia is a bacterial infection of the bloodstream.

A common diagnosis, the CDC estimates that up to 1.7 million people in the U.S.

develop bacteremia each year.

A common diagnosis, the CDC estimates that up to 1.7 million people in the United States develop bacteremia each year.

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

Annually in the U.S.

there are approximately 200,000 hospitalizations for S.

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

aureus bacteremia (“SAB”).

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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 methicillin-resistant S.

aureus (“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.

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”).

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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.

Daptomycin (approved in 2005;

based on clinical cure rates of less than 50%) and vancomycin are the

only two antibiotics with label indications in the U.S.

for the treatment of SAB, and the emergence of drug-resistant S.

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.

Prosthetic Joint Infection and Wound Infection

The total number of prosthetic joint infection (“PJI”)-related revision surgeries is expected to more than double from 70,000 in 2020 to 144,000 in 2040 in the United States and European Union Five (France, Germany, Italy, Spain, and the United Kingdom), at an annual growth rate of 5.6% due to a growing elderly population.

The total number of PJI-related revision surgeries is expected to more than double from 70,000 in 2020 to 144,000 in 2040 in the United States and European Union Five (France, Germany, Italy, Spain, and the United Kingdom), at an annual growth rate of 5.6% due to a growing elderly population.

The United States is the largest market for PJI, accounting for 61% of PJI-related revision surgery in 2020 (estimated to be 71% by 2040), each estimated to cost $150,000.

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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.

Formulation Development and Chemistry, Manufacturing, and Controls:

We have developed and acquired highly skilled process development and phage manufacturing expertise to manage our proprietary platforms with proven capabilities from the bench to clinic.

Our research and development facilities are equipped with cGMP compliant manufacturing suites enabling the production,

purification, testing and release of reproducible batches of phage clinical trial material exhibiting high purity and high titer designed to be tolerated for both intravenous and inhaled administration.

Our research and development facilities are equipped with cGMP compliant manufacturing suites enabling the production, purification, testing and release of reproducible batches of phage clinical trial material exhibiting high purity and high titer designed to be tolerated for both intravenous and inhaled administration.

Preclinical and Clinical Development Programs

We are committed to developing novel phage therapies, with drug development expertise and product development capabilities that span bench to clinic, including in-house phage-specific cGMP manufacturing.

Our phage discovery platform in which we screen panels of clinically-relevant isolates against our extensive phage library utilizing proprietary methods that identify phage combinations with superior attributes, together with our phage-specific cGMP compliant manufacturing facilities, uniquely enables us to efficiently identify optimal product candidates.

We believe our phage discovery platform in which we screen panels of clinically-relevant isolates against our extensive phage library utilizing proprietary methods that identify phage combinations with superior attributes, together with our phage-specific cGMP compliant manufacturing facilities, uniquely enables us to efficiently identify optimal product candidates.

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

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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 don’t 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.

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.

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.

Preclinical highlights of AP-PA02 include:

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● Components maintain activity in the presence of other CF therapies.

We developed AP-PA02 as a sterile liquid formulation, suitable for delivery by inhalation.

Clinical trial material of AP-PA02 is currently manufactured under cGMP at our production facility in Marina del Rey, California.

We have developed AP-PA02 as a sterile liquid formulation, suitable for delivery by inhalation.

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.

Clinical Development of AP-PA02 in Cystic Fibrosis :

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On October 14, 2020, Armata received approval for the study to proceed from the FDA for its IND to initiate the “SWARM- P.a.

” study – a Phase 1b/2a, multicenter, double-blind, randomized, placebo-controlled, single ascending dose (“SAD”) and multiple ascending dose (“MAD”) clinical trial to evaluate the safety, tolerability and phage recovery profile of AP-PA02 administered by inhalation in subjects with cystic fibrosis and chronic pulmonary Pseudomonas aeruginosa infection.

” study – a Phase 1b/2a, multicenter, double-blind, randomized, placebo-controlled, single ascending dose (“SAD”) and multiple ascending dose (“MAD”) clinical trial to evaluate the safety, tolerability and phage recovery profile of AP-PA02 administered by inhalation in subjects with cystic fibrosis and chronic pulmonary P.

aeruginosa infection.

Primary Endpoints (SAD and MAD) included incidence and severity of treatment-emergent, adverse events.

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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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Additive Clinical Indication for Our AP-PA02 P.

aeruginosa Phage Product Candidate:

Ensuring Patient Population for Definitive Phase 3 Trial

With positive outcomes from the first clinical study, SWARM- P.a.

, we initiated a follow-on Phase 2 study investigating the efficacy of AP-PA02 in NCFB patients chronically infected with P.

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.

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.

The Company initiated a Phase 2 trial (“Tailwind”) in NCFB in late 2022 and reported first patient dosing in the first quarter of 2023.

Throughout 2023, the Company worked closely with clinical sites to rapidly expand enrollment to position the Phase 2 trial for completion in 2024 and have data available to support a pivotal trial in 2025.

Enrollment of the Phase 2 trial is ongoing, with AP-PA02 continuing to demonstrate a favorable safety and tolerability profile, and insights from blinded data of the relationship between phage dose and microbiological impact on P.

Moreover, correlation was seen between increasing phage dose 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.

With positive outcomes from this first clinical study, SWARM- P.a.

, we initiated a follow-on Phase 2 study investigating AP-PA02 in NCFB patients chronically infected with P.

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

Completed Phase 2 Study

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.

Data indicated that inhaled AP-PA02 provides a durable reduction of P.

aeruginosa in the lung, with a favorable safety and tolerability profile.

The Tail wind study was conducted in two cohorts running in parallel:

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.

Notably, a post-hoc intent-to-treat analysis (n=33 active and n=15 placebo;

all subjects from both cohorts) demonstrated a statistically significant reduction of P.

aeruginosa CFUs in the lung at day 17 (AP-PA02 vs.

The reduction in P.

aeruginosa CFUs persisted two weeks following completion of dosing with AP-PA02 when compared with placebo at day 24 (AP-PA02 vs.

Additionally, paired analysis of P.

aeruginosa CFU density at baseline compared to day 10 (P=0.03), day 11 (P=0.01), day 17 (P=0.003) and day 24 (P=0.018) was significant in the AP-PA02-treated cohort.

We believe the data suggest that AP-PA02 alone is as effective as the combination therapy of phage and antibiotics in reducing P.

aeruginosa CFUs in the lung.

Additionally, approximately one-third of subjects treated with phage monotherapy exhibited at least a 2-log CFU reduction in P.

aeruginosa compared to no reduction in placebo treated subjects.

The relationship between phage dose and microbiological impact on P.

aeruginosa confirms the findings in the cystic fibrosis SWARM- P.a.

Phase 2a trial.

We are carefully evaluating the impact of AP-PA02 on P.

aeruginosa in patients not taking antibiotics in order to confirm the independent impact of phage treatment.

Safety data from the Tail wind study indicate that inhaled AP-PA02 was well-tolerated with treatment-emergent adverse events mild and self-limiting.

There was one possibly related serious adverse event that was linked to an acute pulmonary event requiring hospitalization that was responsive to antibiotics.

We believe the safety and tolerability of AP-PA02 offers a promising profile for treating chronically infected NCFB patients.

aeruginosa infection,

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

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 study which will aim to evaluate inhaled AP-PA02 as an alternative to antibiotics in chronic pulmonary P.

aeruginosa infection.

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

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

Clinical trial material of AP-SA02 is currently manufactured under cGMP at our production facility in Marina del Rey, California to support the required regulatory filing(s) for clinical entry in the United States and ex-U.S.

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.

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.

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

this has enabled us to pursue treatment of complicated S.

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.

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”).

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 .

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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 from the DoD through MTEC with funding from the Defense Health Agency and Joint Warfighter Medical Research Program.

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.

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.

aureus bacteremia.

Additional Clinical Indications for AP-SA02

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On August 1, 2022, we announced that we had received from the FDA the approval to proceed for our IND application for AP-SA02, in a second indication, PJI.

We had planned to initiate a Phase 1b/2a trial in 2023;

however, in light of the growing concerns of both PJI and wound infection, we are revising the protocol to include both indications, which will assess the safety and tolerability of intravenous and intra-articular AP-SA02 as an adjunct to standard of care antibiotics in adults undergoing debridement, antibiotics, and implant retention for the treatment of periprosthetic joint infections and/or wound infections caused by S.

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

however, in light of the growing concerns of both PJI and wound infection, we are considering revising the protocol to include both indications.

Discovery Research

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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.

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.

Manufacturing

We currently produce clinical quantities of each of our bacteriophage product candidates at our cGMP-compliant manufacturing facility in Marina del Rey, California.

This facility has approximately 35,500 square feet of laboratory and office space, including 3,000 square feet of cGMP laboratory space, designed to produce clinical quantities of each of our product candidates and to perform in-house Quality Control (“QC”) testing.

We operate in-house process development activities through to the production, purification, formulation, and release of our therapeutic phage cocktails for use in human clinical trials.

Our facility is licensed by the California Department of Public Health for drug manufacturing and is subject to periodic, unannounced inspections for compliance with cGMP and other state and federal laws and regulations.

The facility is subject to periodic inspections by the City of Los Angeles and Los Angeles County for fire hazard and waste management and is in compliance with all applicable regulations.

Our facility is staffed with an independent Quality Unit and Manufacturing and Facilities personnel trained under cGMPs.

Through the end of 2024, we produced, tested and released clinical quantities of each of our bacteriophage product candidates at our cGMP-compliant manufacturing facility in Marina del Rey, California.

This facility has approximately 35,500 square feet of laboratory and office space, including 3,000 square feet of cGMP laboratory space and is licensed by the California Department of Public Health for drug manufacturing.

In the fourth quarter of 2024, manufacturing was fully relocated to our new research and development and manufacturing facility, and corporate headquarters, located in Los Angeles, California.

Our Los Angeles facility consists of approximately 56,500 square feet of office, research and development and manufacturing space.

Office space and research laboratories have been occupied since the third quarter of 2023, and construction of the cGMP manufacturing space (~10,000 square feet) was completed in the third quarter of 2024.

Our Los Angeles facility is licensed by the California Department of Public Health for drug manufacturing and is subject to periodic, unannounced inspections for compliance with cGMP and other state and federal laws and regulations.

The facility is subject to periodic inspections by the City of Los Angeles and Los Angeles County for fire hazard and waste

management and is in compliance with all applicable regulations.

Our facility is staffed with an independent Quality Unit (Quality Assurance and Quality Control) and manufacturing and facilities personnel trained under cGMPs.

We operate in-house process development activities through the production, purification, formulation, and release of our therapeutic phage cocktails for use in human clinical trials.

Our current formulations for our P.

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aureus phage product candidates are intended for inhaled and intravenous delivery, both requiring our drug products to be sterile.

Our Marina del Rey facility is capable of manufacturing sterile drug products, utilizing ISO-certified cleanrooms and ISO 5-certified biological safety cabinets.

Our manufacturing facility is capable of producing sterile drug products, utilizing ISO-certified cleanrooms.

The facility also houses an ISO 5-certified closed system isolator.

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Although our facility is capable of manufacturing our phage product candidates, we rely on, and may continue to rely on, third-party contract manufacturers for the manufacture of certain raw materials, components, or packaging of the product candidates that may be developed for clinical testing, as well as for commercialization.

We are constructing the new manufacturing facility in Los Angeles, California and plan to move manufacturing processes to this new facility in the second half of 2024.

Intellectual Property

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We also depend upon the skills, knowledge, experience and know-how of our management and research and development personnel, as well as that of our advisors, consultants and other contractors.

protection and contractual obligations with third parties to protect our interests and to develop and maintain our competitive position.

To help protect our proprietary processes and know-how, which is not patentable, and for inventions for which patents may be difficult to enforce, we currently and will in the future rely on trade secret protection and contractual obligations with third parties to protect our interests and to develop and maintain our competitive position.

To this end, we require all of our employees, consultants, advisors and other contractors to enter into agreements with contractual obligations that prohibit the disclosure of confidential information and, where applicable, require disclosure and assignment to us of the ideas, developments, discoveries and inventions important to our business.

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There are a handful of small biotechnology companies developing bacteriophage products to treat human diseases.

To our knowledge, several biotechnology companies in the United States and Europe, including Adaptive Phage Therapeutics, BiomX Inc., Intralytix, Inc., Locus Biosciences, Inc., TechnoPhage, SA, Felix Biotechnology, as well as academic institutions, have discovery stage or clinical programs utilizing naturally occurring phages or synthetic biology approaches to genetically modify bacteriophages to remove or input genes to improve therapeutic properties such as increases to the bacterial host range to infect a larger number of bacterial strains and decrease the need for using multiple phages in a product.

To our knowledge, several biotechnology companies in the United States and Europe, including BiomX, Inc.

(merged with Adaptive Phage Therapeutics in 1Q

2024), Intralytix, Inc., Locus Biosciences, Inc., TechnoPhage, SA, as well as academic institutions, have discovery stage or clinical programs utilizing naturally occurring phages or synthetic biology approaches to genetically modify bacteriophages to remove or input genes to improve therapeutic properties such as increases to the bacterial host range to infect a larger number of bacterial strains and decrease the need for using multiple phages in a product.

Our bacteriophage programs may compete with or be synergistic with currently approved antibiotics, and experimental approaches such as novel antibiotics, antimicrobial peptides, antimicrobial vaccines, metals, antisense, monoclonal antibodies and possibly microbiome manipulation.

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Strategic Alliances and Research Agreements

Department of Defense through MTEC managed by the Naval Medical Research Command with funding from the Defense Health Agency and Joint Warfighter Medical Research Program.

On June 15, 2020, we entered into a Research Project Award 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.

The MTEC funds are used to partially fund a Phase 1b/2a, randomized, double-blind, placebo-controlled, dose escalation clinical study of the Company's therapeutic phage-based candidate, AP-SA02, for the treatment of complicated Staphylococcus aureus bacteremia infections.

The MTEC Agreement specifies that the grant is paid to the Company over the term of the award through a cost reimbursable model, based on agreed-upon cost share percentages, and the grant money received is not refundable to MTEC.

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.

aureus (“diSArm” study) .

The MTEC Agreement specifies that the award is paid to the Company over the term of the award through a cost reimbursable model, based on agreed-upon cost share percentages, and the money received is not refundable to MTEC.

Upon license or commercialization of intellectual property developed with the funding from the MTEC Agreement, additional fees will be due to MTEC.

The Company will elect whether to (a) pay a fixed royalty amount, which is subject to a cap based upon total funding received, or (b) pay an additional assessment fee, which would also be subject to a cap based upon a percentage of total funding received.

The MTEC Agreement is effective through October 30, 2024.

The MTEC Agreement is effective through August 15, 2025.

The MTEC Agreement may be terminated in whole or in part, 30 calendar days following written notice from the Company to MTEC.

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The Company’s payment obligations survive the termination of the Award Agreement.

License Agreements

Amended and Restated Research Collaboration and Option to License Agreement with Merck

Pursuant to the terms of the Amended and Restated Research and Option to License Agreement (the “Research and Option Agreement”), entered into by and between us and Merck Sharp & Dohme Corp.

(“Merck”), we were engaged in generating broad host range synthetic bacteriophage candidate(s) targeting an undisclosed infectious disease agent(s), pursuant to the criteria set forth in the research plan.

We granted to Merck an exclusive, worldwide license in our patent rights, and our interest in any joint patent rights, with the right to grant and authorize sublicenses, for any and all uses of any product candidates, or products, developed through the research plans set forth in the Research and Option Agreement in a specific field of use.

Further, in exchange for milestone payments associated with product development and regulatory achievements and royalty payments based on net sales of products developed, we granted to Merck an exclusive, worldwide license, with the right to grant and authorize sublicenses, in our background intellectual property and know-how, solely to make, have made, use, import, offer to sell and sell (but not genetically modify) the product candidates, or products, developed through the research plans set forth in the Research and Option Agreement in the specific field of use.

On December 14, 2022, Armata received a notice of termination, which became effective on March 14, 2023, in accordance with Section 8.2.1 of the Research and Option Agreement.

License Agreement with United Kingdom Secretary of State for the Department of Health

In January 2011, upon completion of our acquisition of Biocontrol Ltd., we assumed a license agreement entered into in March 2007 between Biocontrol Ltd.

and the Health Protection Agency, Centre for Emergency Preparedness and Response, to use certain intellectual property rights to develop treatments for bacterial biofilm infections.

The agreement was subsequently assigned to the United Kingdom Secretary of State for the Department of Health (“DoH”).

Under the license agreement, we have obtained exclusive rights to a patent portfolio related to the use of bacteriophages combined with biofilm-disrupting agents in treating biofilm infections.

In consideration for the exclusive license, we may be required to pay to the DoH certain milestone payments in the aggregate of up to £10,000 per product, as well as single digit percentage royalty on net sales of products incorporating licensed intellectual property.

The license agreement will remain in effect until the expiration of the last patent exclusively licensed under the license agreement.

If we default on any milestone or royalty payments, or upon breach by us of certain other terms of the license agreement, the DoH may either terminate the license agreement immediately upon written notice or modify the license to be non-exclusive upon 30 days’ written notice.

Our corporate headquarters are located in Los Angeles, California, with an address of 5005 McConnell Avenue, Los Angeles, CA 90066.

On October 28, 2021, we entered into a lease for 56,300 square feet of office, research and development and manufacturing space under a non-cancellable lease (the “2021 Lease”).

Our corporate headquarters are located in Los Angeles, California, with an address of 5005 McConnell Avenue, Los Angeles, CA 90066 (the “McConnell Facility”).

On October 28, 2021, we entered into a lease for approximately 56,300 square feet of office, research and development and manufacturing space under a non-cancellable lease (the “2021 Lease”).

The 2021 Lease payment start date was May 1, 2022, and the total lease term is for 16 years and runs through 2038.

Office space and research laboratories have been fully occupied since the third quarter of 2023, with cGMP manufacturing space (~10,000 sq.

ft.) expected to be fully constructed in the second half of 2024.

We have a facility located in Marina del Rey, California, with an address of 4503 Glencoe Avenue, Marina del Rey, CA 90292, where we currently lease 35,500 square feet of office, research and development and manufacturing space.

The lease expires on December 31, 2031.

The facility includes approximately 3,000 square feet of cGMP laboratory space, which currently serves to produce clinical quantities of our phage product candidates for ongoing human trials and to perform in-house QC testing.

As we move our manufacturing into the McConnell facility by mid-2024, we are actively seeking a sub-tenant at the Glencoe location to take over the remaining term of the 4503 Glencoe Avenue lease.

Office space and research laboratories have been occupied since the third quarter of 2023, with cGMP manufacturing space (~10,000 square feet) fully constructed and occupied in the second half of 2024.

We also have a facility located in Marina del Rey, California, with an address of 4503 Glencoe Avenue, Marina del Rey, CA 90292, where we currently lease approximately 35,500 square feet of office, research and development and manufacturing space (the “Marina del Rey Lease”).

The Marina del Rey Lease expires on December 31, 2031.

The facility includes 19,500 square feet of BSL2 laboratory space and approximately 3,000 square feet of cGMP laboratory space.

We are actively seeking a sub-tenant to take over the remaining term of the Marina del Rey Lease.

In addition, we lease a 5,000 square foot facility located in Sydney, Australia, which includes 4,000 square feet of laboratory space providing capabilities to support phage product development and manufacturing process development.

We believe that our facilities are adequate for our current and long-term needs.

Additionally, we believe the newly constructed McConnell facility, offering expanded manufacturing capacity, will allow us to pursue contract manufacturing opportunities for phage and other advanced biologics.

Legal Proceedings

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Clinical trials must be conducted in accordance with GCP requirements.

Further, each clinical trial must be

reviewed and approved by an independent institutional review board (“IRB”) or ethics committee if conducted outside of the United States, at or servicing each institution at which the clinical trial will be conducted.

Further, each clinical trial must be reviewed and approved by an independent institutional review board (“IRB”) or ethics committee if conducted outside of the United States, at or servicing each institution at which the clinical trial will be conducted.

An IRB or ethics committee is charged with protecting the welfare and rights of trial participants and considers such items as whether the risks to individuals participating in the clinical trials are minimized and are reasonable in relation to anticipated benefits.

The IRB or ethics committee also approves the informed consent form that must be provided to each clinical trial subject or his or her legal representative and must monitor the clinical trial until completed.

We intend to use third-party CROs to administer and conduct our planned clinical trials and will rely upon such CROs, as well as medical institutions, clinical investigators and consultants, to conduct our trials in accordance with our clinical protocols.

We intend to use third-party CROs

to administer and conduct our planned clinical trials and will rely upon such CROs, as well as medical institutions, clinical investigators and consultants, to conduct our trials in accordance with our clinical protocols.

The failure by any of such third parties to meet expected timelines, adhere to our protocols or meet regulatory standards could adversely impact the subject product development program and we remain legally responsible for compliance with applicable laws and regulations governing the conduct of these clinical trials.

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The application includes all data available from nonclinical studies and clinical trials, including negative or ambiguous results as well as positive findings, together with detailed information relating to the product’s manufacture and composition, and proposed labeling, among other things.

The testing and approval processes require substantial time and effort and there can be no assurance that the FDA will accept the BLA for filing and, even if filed, that any approval will be granted on a timely basis, if at all.

The testing and approval processes

require substantial time and effort and there can be no assurance that the FDA will accept the BLA for filing and, even if filed, that any approval will be granted on a timely basis, if at all.

Under the Prescription Drug User Fee Act, as amended (“PDUFA”), each BLA must be accompanied by a significant user fee.

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Additionally, the sponsor can benefit from certain financial incentives, including opportunities for grant funding towards clinical trial costs, research and development tax credits, and user fee waivers.

If the same drug has already been approved, the proposed drug needs to demonstrate clinical superiority to obtain orphan exclusivity for the same indication, such as by means of greater effectiveness, greater safety or providing a major contribution to patient care, or in instances of drug supply issues.

If the same drug has already been approved, the proposed drug needs to demonstrate clinical superiority to obtain orphan exclusivity for the

same indication, such as by means of greater effectiveness, greater safety or providing a major contribution to patient care, or in instances of drug supply issues.

Competitors, however, may receive approval of either a different product for the same indication or the same product for a different indication but that could be used off-label in the orphan indication.

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The sponsor of a new drug or biological may request the FDA to designate the drug or biologic as a Fast Track product at any time during the clinical development of the product.

Unique to a Fast Track product, the FDA may consider for review sections of the marketing application on a rolling basis before the complete application is submitted,

if the sponsor provides a schedule for the submission of the sections of the application, the FDA agrees to accept sections of the application and determines that the schedule is acceptable, and the sponsor pays any required user fees upon submission of the first section of the application.

Any product submitted to the FDA for marketing, including under a Fast Track program, may be eligible for other types of FDA programs intended to expedite development and review, such as priority review, accelerated approval, and, as of 2018, for antibacterial and antifungal therapies, approval under the Limited Population Pathway.

Unique to a Fast Track product, the FDA may consider for review sections of the marketing application on a rolling basis before the complete application is submitted, if the sponsor provides a schedule for the submission of the sections of the application, the FDA agrees to accept sections of the application and determines that the schedule is acceptable, and the sponsor pays any required user fees upon submission of the first section of the application.

for antibacterial and antifungal therapies, approval under the Limited Population Pathway.

Any product is eligible for priority review if it has the potential to provide safe and effective therapy where no satisfactory alternative therapy exists or if there is a significant improvement in the treatment, diagnosis or prevention of a disease compared to marketed products.

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Rigorous and extensive FDA regulation of new products continues after approval, particularly with respect to cGMP.

We may rely on third parties for the production of commercial quantities of any products that we may commercialize.

We may rely on third parties for the production of

commercial quantities of any products that we may commercialize.

We and third-party manufacturers of our products are required to comply with applicable requirements in the cGMPs, including quality control and quality assurance and maintenance of records and documentation.

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The term of individual patents depends upon the legal term of the patents in the countries in which they are obtained.

In most countries in which we file, including the United States (“U.S.”), the base term is 20 years from the filing date of the earliest-filed non-provisional patent application from which the patent claims priority.

In most countries in which we file, including the United States, the base term is 20 years from the filing date of the earliest-filed non-provisional patent application from which the patent claims priority.

The term of a U.S.

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Depending upon the timing, duration and specifics of FDA approval of our drugs, some of our U.S.

patents may be eligible for limited patent term extension under the Drug Price Competition and Patent Term

Restoration Act of 1984, referred to as the Hatch-Waxman Amendments.

patents may be eligible for limited patent term extension under the Drug Price Competition and Patent Term Restoration Act of 1984, referred to as the Hatch-Waxman Amendments.

The Hatch-Waxman Amendments permit a patent restoration term of up to five years as compensation for patent term lost during product development and the FDA regulatory review process.

However, patent term restoration cannot extend the remaining term of a patent beyond a total of 14 years from the product’s approval date.

The patent term restoration period is generally one half the time between the effective date of an IND, and the submission date of an NDA or BLA, plus the time between the submission date of an NDA or BLA and the approval of that application.

approval of that application.

Only one patent applicable to an approved drug is eligible for the extension, and the extension must be applied for prior to expiration of the patent.

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or monitor response to treatment with a particular therapeutic product for the purpose of adjusting treatment to achieve improved safety or effectiveness.

Companion diagnostics are regulated as

medical devices by the FDA and, as such, require either clearance or approval prior to commercialization.

Companion diagnostics are regulated as medical devices by the FDA and, as such, require either clearance or approval prior to commercialization.

The level of risk combined with available controls to mitigate risk determines whether a companion diagnostic device requires Premarket Approval Application approval or is cleared through the 510(k) premarket notification process.

For a novel therapeutic product for which a companion diagnostic device is essential for the safe and effective use of the product, the companion diagnostic device should be developed and approved or 510(k)-cleared contemporaneously with the therapeutic.

For a novel therapeutic product for which a companion diagnostic device is essential for the safe and effective use of the product, the

companion diagnostic device should be developed and approved or 510(k)-cleared contemporaneously with the therapeutic.

The use of the companion diagnostic device will be stipulated in the labeling of the therapeutic product.

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● the anti-inducement law, which prohibits, among other things, the offering or giving of remuneration, which includes, without limitation, any transfer of items or services for free or for less than fair market value (with limited exceptions), to a Medicare or Medicaid beneficiary that the person knows or should know is likely to influence the beneficiary’s selection of a particular supplier of items or services reimbursable by a federal or state governmental program;

● The Health Insurance Portability and Accountability Act of 1996 (“HIPAA”), as amended by the Health Information Technology for Economic and Clinical Health Act of 2009 (“HITECH”), which created new federal criminal statutes that prohibit knowingly and willfully executing, or attempting to execute, a scheme to defraud any healthcare benefit program or obtain, by means of false or fraudulent pretenses, representations, or promises, any of the money or property owned by, or under the custody or control of, any healthcare benefit program, regardless of the payor (e.g., public or private) and knowingly and willfully falsifying, concealing or covering up by any trick or device a material fact or making any materially false statements in connection with the delivery of, or payment for, healthcare benefits, items or services relating to healthcare matters; similar to the federal Anti-Kickback Statute, a person or entity does not need to have actual knowledge of the statute or specific intent to violate it in order to have committed a violation;

● HIPAA, as amended by HITECH, and their respective implementing regulations, which impose requirements on certain covered healthcare providers, health plans, and healthcare clearinghouses as well as their respective

business associates that perform services for them that involve the use, or disclosure of, individually identifiable health information, relating to the privacy, security and transmission of individually identifiable health information;

● The Health Insurance Portability and Accountability Act of 1996 (“HIPAA”), which created new federal criminal statutes that prohibit knowingly and willfully executing, or attempting to execute, a scheme to defraud any healthcare benefit program or obtain, by means of false or fraudulent pretenses, representations, or promises, any of the money or property owned by, or under the custody or control of, any healthcare benefit program, regardless of the payor (e.g., public or private) and knowingly and willfully falsifying, concealing or covering up by any trick or device a material fact or making any materially false statements in connection with the delivery of, or payment for, healthcare benefits, items or services relating to healthcare matters; similar to the federal Anti-Kickback Statute, a person or entity does not need to have actual knowledge of the statute or specific intent to violate it in order to have committed a violation;

● HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009 (“HITECH”), and their respective implementing regulations, which impose requirements on certain covered healthcare providers, health plans, and healthcare clearinghouses as well as their respective business associates and covered subcontractors that perform services for them that involve the use, or disclosure of, individually identifiable health information, relating to the privacy, security and transmission of individually identifiable health information;

● the federal transparency requirements under the Affordable Care Act (the “ACA”), including the provision commonly referred to as the Physician Payments Sunshine Act, which requires manufacturers of drugs, devices, biologics and medical supplies for which payment is available under Medicare, Medicaid or the Children’s Health Insurance Program to report annually to the U.S.

Department of Health and Human Services information related to payments or other transfers of value made to physicians (defined to include doctors, dentists, optometrists, podiatrists and chiropractors) and teaching hospitals, as well as ownership and investment interests held by the physicians described above and their immediate family members;

Department of Health and Human Services information related to payments or other transfers of value made to physicians (defined to include doctors, dentists, optometrists, podiatrists and chiropractors), other healthcare professionals (such as physician assistants and nurse practitioners), and teaching hospitals, as well as ownership and investment interests held by the physicians described above and their immediate family members;

● federal government price reporting laws, which require us to calculate and report complex pricing metrics in an accurate and timely manner to government programs; and

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Efforts to ensure that our current and future business arrangements with third parties, and our business generally, will comply with applicable healthcare laws and regulations will involve substantial costs.

It is possible that governmental authorities will conclude that our business practices, including our arrangements with physicians and other healthcare providers, some of whom receive stock options as compensation for services provided, may not comply with current or future statutes, regulations, agency guidance or case law involving applicable fraud and abuse or other healthcare laws and regulations.

It is possible that governmental authorities will conclude that our business practices may not comply with current or future statutes, regulations, agency guidance or case law involving applicable fraud and abuse or other healthcare laws and regulations.

If any such actions are instituted against us, and we are not successful in defending ourselves or asserting our rights, those actions could have a significant impact on our business, including the imposition of civil, criminal and administrative penalties, damages, disgorgement, monetary fines, imprisonment, possible exclusion from participation in Medicare, Medicaid and other federal healthcare programs, contractual damages, reputational harm, diminished profits and future earnings, and curtailment of our operations, any of which could adversely affect our ability to operate our business and our results of operations.

addition, the approval and commercialization of any of our product candidates outside the United States will also likely subject us to foreign equivalents of the healthcare laws mentioned above, among other foreign laws.

In addition, the approval and commercialization of any of our product candidates outside the United States will also likely subject us to foreign equivalents of the healthcare laws mentioned above, among other foreign laws.

If any of the physicians or other healthcare providers or entities with whom we expect to do business are found to be not in compliance with applicable laws, they may be subject to criminal, civil or administrative sanctions, including exclusions from government funded healthcare programs, which may also adversely affect our business.

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Government authorities and other third-party payors have attempted to control costs by limiting coverage and the amount of reimbursement for particular medical products.

For example, in March 2010, the ACA was enacted, which, among other things, increased the minimum Medicaid rebates owed by most manufacturers under the Medicaid Drug Rebate Program;

introduced a new methodology by which rebates owed by manufacturers under the Medicaid Drug Rebate Program are calculated for drugs that are inhaled, infused, instilled, implanted or injected;

extended the Medicaid Drug Rebate Program to utilization of prescriptions of individuals enrolled in Medicaid managed care plans;

imposed mandatory discounts for certain Medicare Part D beneficiaries as a condition for manufacturers’ outpatient drugs coverage under Medicare Part D;

subjected drug manufacturers to new annual fees based on pharmaceutical companies’ share of sales to federal healthcare programs;

imposed a new federal excise tax on the sale of certain medical devices;

created a new Patient Centered Outcomes Research Institute to oversee, identify priorities in and conduct comparative clinical effectiveness research, along with funding for such research;

and established the Center for Medicare Innovation at the Centers for Medicare and Medicaid to test innovative payment and service delivery models to lower Medicare and Medicaid spending.

Since its enactment, there have been a number of significant changes to the ACA.

On October 13, 2017, President Trump signed an Executive Order terminating the cost-sharing subsidies that reimburse insurers under the Affordable Care Act.

Several state Attorneys General filed suit to stop the administration from terminating the subsidies, but their request for a restraining order was denied by a federal judge in California on October 25, 2017.

In addition, CMS has recently proposed regulations that would give states greater flexibility in setting benchmarks for insurers in the individual and small group marketplaces, which may have the effect of relaxing the essential health benefits required under the ACA for plans sold through such marketplaces.

In January 2017, President Trump signed an Executive Order directing federal agencies with authorities and responsibilities under the Affordable Care Act to waive, defer, grant exemptions from, or delay the implementation of any provision of the Affordable Care Act that would impose a fiscal or regulatory burden on states, individuals, healthcare providers, health insurers, or manufacturers of pharmaceuticals or medical devices.

The Tax Cuts and Jobs Act of 2017 includes a provision repealing, effective January 1, 2019, the tax-based shared responsibility payment imposed by the ACA on certain individuals who fail to maintain qualifying health coverage for all or part of a year that is commonly referred to as the “individual mandate.” Additionally, on January 22, 2018, President Trump signed a continuing resolution on appropriations for fiscal year 2018 that delayed the implementation of certain ACA-mandated fees, including the so-called “Cadillac” tax on certain high cost employer sponsored insurance plan, the annual fee imposed on certain health insurance providers based on market share, and the medical device exercise tax on non-exempt medical devices.

Further, the Bipartisan Budget Act of 2018, among other things, amends the ACA, effective January 1, 2019, to reduce the coverage gap in most Medicare drug plans, commonly referred to as the “donut hole.” Congress will likely consider other legislation to replace or modify elements of the Affordable Care Act.

We continue to evaluate the effect that the Affordable Care Act and its possible repeal, replacement or further modification could have on our business.

It is uncertain the extent to which any such changes may impact our business or financial condition.

For example, in March 2010, the ACA was enacted, which has substantially changed healthcare financing and delivery by both governmental and private insurers.

Since its enactment, there have been a number of amendments and legal and political challenges to certain aspects of the ACA.

For example, on August 16, 2022, the Inflation Reduction Act of 2022 (IRA) was signed into law, which among other things, extends enhanced subsidies for individuals purchasing health insurance coverage in ACA marketplaces through plan year 2025.

The IRA also eliminates the "donut hole" under the Medicare Part D program beginning in 2025 by significantly lowering the beneficiary maximum out-of-pocket cost and creating a new manufacturer discount program.

It is possible that the ACA will be subject to judicial or Congressional challenges in the future.

It is unclear how such challenges and any additional healthcare reform measures will impact the ACA.

In addition, the Budget Control Act of 2011 and the Bipartisan Budget Act of 2015 led to aggregate reductions of Medicare payments to providers of up to 2% per fiscal year that will remain in effect through 2032 unless additional Congressional action is taken.

Further, on January 2, 2013, the American Taxpayer Relief Act was signed into law, which, among other things, reduced Medicare payments to several types of providers, including hospitals, imaging centers and cancer treatment centers, and increased the statute of limitations period for the government to recover overpayments to providers from three to five years.

More recently, there has been heightened governmental scrutiny over the manner in which manufacturers set prices for their marketed products, which have resulted in several recent Congressional inquiries and proposed bills designed to, among other things, bring more transparency to product pricing, review the relationship between pricing and manufacturer patient programs, and reform government program reimbursement methodologies for pharmaceutical products.

The current administration is pursuing policies to reduce regulations and expenditures across government including at HHS, the FDA, the Centers for Medicare & Medicaid Services (“CMS”) and related agencies.

These actions may propose policy changes that may create additional uncertainty for our business.

Individual states in the United States have also become increasingly active in passing legislation and implementing regulations designed to control pharmaceutical product pricing, including price or patient reimbursement constraints, discounts, restrictions on certain product access and marketing cost disclosure and transparency measures, and, in some cases, designed to encourage importation from other countries and bulk purchasing.

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If we fail to comply with applicable foreign regulatory requirements, we may be subject to, among other things, fines, suspension or withdrawal of regulatory approvals, product recalls, seizure of products, operating restrictions and criminal prosecution.

Clinical Trials

Certain countries outside of the United States have a regulatory process similar to the U.S.

process that requires the submission of a clinical trial application (“CTA”) much like the IND prior to the commencement of human clinical trials.

In the European Union, for example, CTA must be submitted for each clinical trial to the national health authority and an independent ethics committee in each country in which the trial is to be conducted, much like the FDA and an IRB, respectively.

Clinical trial application must be accompanied by an investigational medicinal product dossier with supporting information prescribed by the Clinical Trials Directive (and corresponding national laws of the member states) and further detailed in applicable guidance documents.

Once the CTA is approved in accordance with a country’s requirements, the clinical trial may proceed.

A similar process to the one described for the European Union is required in

Israel for initiation of clinical trials.

The requirements and process governing the conduct of clinical trials vary from country to country.

In all cases, the clinical trials must be conducted in accordance with GCP and the applicable regulatory requirements and the ethical principles that have their origin in the Declaration of Helsinki.

Approval Process

In order to market our products, we must obtain a marketing approval for each product and comply with numerous and varying regulatory requirements.

The approval procedure varies among countries and can involve additional testing in comparison to the testing carried out for the U.S.

The time required to obtain approval in foreign countries may differ substantially from that required to obtain FDA approval.

Clinical trials conducted in one country may not be accepted by regulatory authorities in other countries.

The regulatory approval process outside the United States generally is subject to all of the same risks associated with obtaining FDA approval.

In addition, in many countries outside the United States, it is required that the product be approved for reimbursement before the product can be approved for sale in that country.

To obtain marketing approval of a medicinal product under the European Union regulatory system, an applicant must submit a marketing authorization application (“MAA”), under either a centralized or a decentralized procedure.

The decentralized procedure is based on a collaboration among the member states selected by the applicant.

In essence, the applicant chooses a ‘lead’ member state that will carry out the scientific assessment of the MAA and review the product information.

The other member states must recognize the outcome of such assessment and review except in case of a “serious potential risk to public health.” The decentralized procedure results in the grant of a national marketing authorization in each selected country.

That procedure is available for all medicinal products unless they fall into the mandatory scope of the centralized procedure.

In practice, it is used for over-the-counter, not highly innovative products, generic products and, increasingly, for biosimilars.

The centralized procedure provides for the grant of a single marketing authorization by the European Commission that is valid for all European Union member states.

The centralized procedure is compulsory for certain medicinal products, including for medicinal products produced by certain biotechnological processes, products designated as orphan medicinal products, advanced therapy medicinal products (“ATMPs”) and products with a new active substance and indicated for the treatment of certain diseases.

For products with a new active substance and indicated for the treatment of other diseases, products that are highly innovative or for which a centralized process is in the interest of patients, the centralized procedure is optional.

Under the centralized procedure, the Committee for Medicinal Products for Human Use (“CHMP”), the main scientific committee established at the EMA, is responsible for conducting the scientific assessment of the future medicinal product.

The CHMP is also responsible for several post-authorization and maintenance activities, such as the assessment of modifications or extensions to an existing marketing authorization.

The maximum timeframe for the evaluation of an MAA is 210 days, excluding clock stops.

The European Commission grants or refuses the marketing authorization, following a procedure that involves representatives of the member states.

The European Commission’s decision is in accordance with the CHMP scientific assessment except in very rare cases.

Pursuant to Regulation (EC) 1394/2007, specific rules apply to ATMPs, a category that is comprised of gene therapy medical products, somatic cell therapy medicinal products, and tissue-engineered medicinal products.

Those rules have triggered the adoption of guidelines on manufacturing, clinical trials and pharmacovigilance that adapt the general regulatory requirements to the specific characteristics of ATMPs.

Regulation (EC) 1394/2007 introduced a “hospital exemption.” which authorizes hospitals to develop ATMP for their internal use without having obtained a marketing authorization and to complying with European Union pharmaceutical law.

The hospital exemption, which is in essence a compounded ATMP, has been transposed in all Member States, sometimes in such a way that the ATMPs under the hospital exemption are competitive alternatives to ATMPs with marketing authorization.

The broad use of the hospital exemption by national hospitals led the European Commission to discuss with the Member States a more reasonable application of the hospital exemption that would not undermine the common legal regime for ATMP.

Marketing authorization is valid for five years in principle and the marketing authorization may be renewed after five years on the basis of a re-evaluation of the risk-benefit balance by the EMA or the competent authority of the

authorizing member state.

To this end, the marketing authorization holder must provide the EMA or the competent authority with a consolidated version of the file in respect of quality, safety and efficacy, including all variations introduced since the marketing authorization was granted, at least six months before the marketing authorization ceases to be valid.

Once renewed, the marketing authorization is valid for an unlimited period, unless the European Commission or the national competent authority decides, on justified grounds relating to pharmacovigilance, to proceed with one additional renewal.

Any authorization which is not followed by the actual placing of the medicinal product on the European Union market (in case of centralized procedure) or on the market of the authorizing member state within three years after authorization ceases to be valid (the so-called sunset clause).

Orphan Designation

Countries other than the United States have adopted a specific legal regime to support the development and marketing of drugs and biologics for rare diseases.

For example, in the European Union, Regulation 141/2000 organizes the grant of orphan drug designations to promote the development of products that are intended for the diagnosis, prevention or treatment of life threatening or chronically debilitating conditions affecting not more than five in 10,000 persons in the European Economic Area (the European Union, plus Iceland, Liechtenstein and Norway) (or where it is unlikely that the development of the medicine would generate sufficient return to justify the investment) and for which no satisfactory method of diagnosis, prevention or treatment has been authorized or, if a method exists, the product would be of significant benefit to those affected.

The EMA’s Committee for Orphan Medicinal Products (“COMP”) examines if the orphan criteria are met and gives opinions thereon, and the orphan status is granted by the European Commission.

The meeting of the criteria for orphan designation is examined again by the COMP at the time of approval of the medicinal product, which typically occurs several years after the grant of the orphan designation.

If the criteria for orphan designation are no longer met at that time, the European Commission withdraws the orphan status.

In the European Union, orphan drug designation entitles the sponsor to financial incentives such as reduction of fees or fee waivers and to ten years of market exclusivity granted following medicinal product approval.

Market exclusivity precludes the EMA or a national regulatory authority from validating another MAA, and the European Commission or a national regulatory authority from granting another marketing authorization, for the same or similar medicinal product and the same therapeutic indication, for that time period.

This 10-year period may be reduced to six years if the orphan drug designation criteria are no longer met, including where it is shown that the product is sufficiently profitable not to justify maintenance of market exclusivity.

The orphan exclusivity may be lost vis-à-vis another medicinal product in cases the manufacturer is unable to assure sufficient quantity of the medicinal product to meet patient needs or if that other product is proved to be clinically superior to the approved orphan product.

A drug is clinically superior if it is safer, more effective or makes a major contribution to patient care.

Orphan drug designation must be requested before submitting a MAA.

Orphan drug designation does not convey any advantage in, or shorten the duration of, the regulatory review and approval process, and it does not afford any regulatory exclusivity until a marketing authorization is granted.

Expedited Development and Approval

Mechanisms are in place in many jurisdictions that allow an earlier approval of the drug so that it reaches patients with unmet medical needs earlier.

The European Union, for example, has instituted several expedited approval mechanisms including two mechanisms that are specific to the centralized procedure:

● the accelerated approval:

the EMA may reduce the maximum timeframe for the evaluation of an MAA from 210 days to 150 days when the future medicinal product is of major interest from the point of view of public health, in particular from the viewpoint of therapeutic innovation;

● the conditional marketing authorization:

as part of its marketing authorization process, the European Commission may grant marketing authorizations on the basis of less complete data than is normally required.

A conditional marketing authorization may be granted when the CHMP finds that, although comprehensive clinical data referring to the safety and efficacy of the medicinal product have not been supplied, all the following requirements are met:

● the risk/benefit balance of the medicinal product is positive;

● it is likely that the applicant will be in a position to provide the comprehensive clinical data;

● unmet medical needs will be addressed; and

● the benefit to public health of the immediate availability on the market of the medicinal product concerned outweighs the risk inherent in the fact that additional data is still required.

The granting of a conditional marketing authorization is typically restricted to situations in which only the clinical part of the application is not yet fully complete.

Incomplete preclinical or quality data may however be accepted if duly justified and only in the case of a product intended to be used in emergency situations in response to public health threats.

Conditional marketing authorizations are valid for one year, on a renewable basis.

The conditions to which approval is subject will typically require the holder to complete ongoing trials or to conduct new trials with a view to confirming that the risk/benefit balance is positive and to collect pharmacovigilance data.

Once the conditions to which the marketing authorization is subject are fulfilled, the conditional marketing authorization is transformed into a regular marketing authorization.

If, however, the conditions are not fulfilled within the timeframe set by the EMA, the conditional marketing authorization ceases to be renewed.

The EMA has also implemented the so-called “PRIME” (PRIority MEdicines) status in order support the development and accelerate the approval of complex innovative medicinal products addressing an unmet medical need.

PRIME status enables early dialogue with the relevant EMA scientific committees and, possibly, some payors and thus reinforces the EMA’s scientific and regulatory support.

It also opens accelerated assessment of the MAA as PRIME status, is normally reserved for medicinal products that may benefit from accelerated assessment, i.e., medicines of major interest from a public health perspective, in particular from a therapeutic innovation perspective.

Finally, all medicinal products (i.e., decentralized and centralized procedures) may benefit from an MAA “under exceptional circumstances.” This marketing authorization is close to the conditional marketing authorization as it is reserved to medicinal products to be approved for severe diseases or unmet medical needs and the applicant does not hold the complete data set legally required for the grant of a marketing authorization.

However, unlike the conditional marketing authorization, the applicant does not have to provide the missing data and will never have to.

The risk/benefit of the medicinal product is reviewed annually.

As a result, although the MAA “under exceptional circumstances” is granted definitively, the risk/benefit balance of the medicinal product is reviewed annually and the marketing authorization is withdrawn in case the risk/benefit ratio is no longer favorable.

Mandatory testing in the pediatric population is required in more and more jurisdictions.

The European Union has enacted a complex and very stringent system that has inspired other jurisdictions, including the United States and Switzerland.

Any application for approval of (i) a medicinal product containing a new active substance or (ii) a new therapeutic indication, pharmaceutical form or route of administration of an already authorized medicinal product that contains an active substance still protected by a supplementary protection certificate (“SPC”) or a patent that qualifies for an SPC, must include pediatric data.

Otherwise, the application is not validated by the competent regulatory authority.

The submission of pediatric data is mandatory in those cases, even if the application concerns adult use.

Submission of pediatric data is not required or fully required if the EMA granted, respectively, a full or partial waiver to pediatric development.

Moreover, that submission can be postponed if the EMA grants a deferral in order not to delay the submission of the MAA for the adult population.

The pediatric data are generated through the implementation of a pediatric investigation plan (“PIP”) that is proposed by the company after completion of the PK studies in adults and agreed upon by the EMA, typically after some modifications.

The PIP lists all the studies to conduct and measures to take in order to prove the safety and efficacy of the future medicinal product when used in children.

The EMA may agree to modify the PIP at the company’s request.

The scope of the PIP is the adult therapeutic indication or the condition of which the adult application is part or even the mechanism of action of the active substance, at the EMA’s quasi-discretion.

This very broad discretion enables the EMA to require companies to develop children indications that are different from the adult indications.

Completion of a PIP renders the company eligible for a pediatric reward, which can be six-month extension of the term of the SPC or, in the cases of orphan medicinal products, two additional years of market exclusivity.

The reward is subject, among other conditions, to the PIP being fully completed, to the pediatric medicinal product being approved in all the member states, and to the results of the pediatric studies being mentioned, in one way or another (for example, the approval of a pediatric indication), in the summary of product characteristics of the product.

Post-Marketing Requirements

Many countries impose post-marketing requirements similar to those imposed in the United States, in particular safety monitoring or pharmacovigilance.

In the European Union, pharmacovigilance data are the basis for the competent regulatory authorities imposing the conduct of post-approval safety or efficacy study, including on off-label use.

Non-compliance with those requirements can result in significant financial penalties as well as the suspension or withdrawal of the marketing authorization.

Supplementary Protection Certificate and Regulatory Exclusivities

In some countries other than the United States, some of our patents may be eligible for limited patent term extension, depending upon the timing, duration and specifics of the regulatory approval of our product candidates and any future product candidates.

Furthermore, authorized drugs and biologics may benefit from regulatory exclusivities (in additional to patent protection resulting from patents).

In the European Union, Regulation (EC) 469/2009 institutes a SPC.

An SPC is an extension of the term of a patent that compensates for the patent protection lost because of the legal requirements to conduct safety and efficacy tests and to obtain a marketing authorization before placing a medicinal product on the market.

An SPC may be applied for any active substance that is protected by a “basic patent” (a patent chosen by the patent holder, which can be a product, process or application patent) and has not been placed on the market as a medicinal product before having obtained a marketing authorization in accordance with European Union pharmaceutical law.

The term of the SPC is maximum five years, and the combined patent and SPC protection may not exceed fifteen years from the date of the first marketing authorization in the European Economic Area (“EEA”).

SPC rights are restricted by both the basic patent and the marketing authorization, i.e., the SPC grants the same rights as those conferred by the basic patent but limited to the active substance covered by the marketing authorization (and any use as medicinal product approved afterwards).

While SPC are regulated at the European level, they are granted by the national patent offices.

The grant of an SPC requires a basic patent granted by the national patent office and a marketing authorization, which is the first marketing authorization for the active substance as a medicinal product in the country.

Furthermore, no SPC must have already been granted to the active substance, and the application for the SPC must be filed with the national patent office within six months of the first marketing authorization in the EEA or the grant of the basic patent, whichever is the latest.

In the future, we may apply for an SPC for one or more of our currently owned or licensed European patents to add patent life beyond their current expiration date, depending on the expected length of the clinical trials and other factors involved in the filing of the relevant MAA.

Furthermore, in the European Union, medicinal products may benefit from the following regulatory exclusivities:

data exclusivity, market protection, market exclusivity, and pediatric reward.

A medicinal product that contains a new active substance (reference medicinal product) is granted eight years of data exclusivity followed by two years of market protection.

Data exclusivity prevents other companies from referring to the non-clinical and clinical data in marketing authorization dossier of the reference medicinal product for submission of generic MAA purposes, and market protection prevents other companies from placing generics on the market.

Pursuant to the concept of global marketing authorization, any further development of that medicinal product (e.g., new indication, new form, change to the active substance) by the marketing authorization holder does not trigger any new or additional protection.

The authorization of any new development is considered as “falling” into the initial marketing authorization with regard to regulatory protection;

hence, the new development only benefits from the regulatory protection that remains when it is authorized.

The only exception is a new therapeutic indication that is considered as bringing a significant clinical benefit in comparison to the existing therapies.

Such new indication will add one-year of market protection to the global marketing authorization, provided that it is authorized within the first eight years of authorization (i.e., during the data exclusivity period).

Moreover, a new therapeutic indication of a “well-established substance” benefits from one-year data exclusivity but limited to the non-clinical and clinical data supporting the new indication.

Any active substance approved for at least ten years in the EEA qualifies as well-established substance.

Biosimilars may be approved through an abbreviated approval pathway after the expiration of the eight-year data exclusivity period and may be marketed after the 10- or 11-year market protection period.

The approval of biosimilars requires the applicant to demonstrate similarity between the biosimilar and the biological medicinal product and to submit the non-clinical and clinical data defined by the EMA.

The biosimilar legal regime has been mainly developed through EMA’s scientific guidelines applicable to categories of biological active substances.

Unlike in the United States, interchangeability is regulated by each member state.

Market exclusivity is a regulatory protection exclusively afforded to medicinal products with an orphan status.

Market exclusivity precludes the EMA or a national regulatory authority from validating another MAA, and the European Commission or a national regulatory authority from granting another marketing authorization, for a same or similar medicinal product and a same therapeutic indication, for a period of ten years from approval (see above).

Pediatric reward is another regulatory exclusivity.

In case a PIP is completed on a voluntary basis, i.e., for an approved medicinal product that is not or no longer protected by an SPC or a basic patent, the pediatric reward takes the form of a “pediatric use marketing authorization”.

That special authorization does not fall into the global marketing authorization and thus benefits from eight years of data exclusivity followed by two or three years of market protection.

Other Healthcare Laws and Compliance Requirements Outside of the United States

Much like the Anti-Kickback Statute prohibition in the United States, the provision of benefits or advantages to physicians to induce or encourage the prescription, recommendation, endorsement, purchase, supply, order or use of medicinal products is also prohibited in the European Union.

The provision of benefits or advantages to physicians is mainly governed by the national anti-bribery laws of the member states, such as the UK Bribery Act 2010, or national anti-kickback provisions (France, Belgium, etc.).

Infringement of these laws could result in substantial fines and imprisonment.

In certain member states, payments made to physicians must be publicly disclosed.

Moreover, agreements with physicians often must be the subject of prior notification and approval by the physician’s employer, his or her competent professional organization and/or the regulatory authorities of the individual member states.

These requirements are provided in the national laws, industry codes or professional codes of conduct, applicable in the member states.

Failure to comply with these requirements could result in reputational risk, public reprimands, administrative penalties, fines or imprisonment.

Much like the U.S.

Foreign Corrupt Practices Act, to which we are subject, that prohibits corporations and individuals from engaging in certain activities to obtain or retain business or to influence a person working in an official capacity, similar rules apply to many other countries worldwide such as France (Loi Sapin) or the United Kingdom (UK Bribery Act).

It is illegal to pay, offer to pay or authorize the payment of anything of value to any foreign government official, government staff member, political party or political candidate in an attempt to obtain or retain business or to otherwise influence a person working in an official capacity.

Pricing and Reimbursement

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Reimbursement may not be available or sufficient to allow us to sell our products on a competitive and profitable basis.

Further, coverage policies and third-party reimbursement rates may change at any time.

Even if favorable coverage and reimbursement status is attained for one or more products for which we seek regulatory approval, less favorable coverage policies and reimbursement rates may be implemented in the future.

Additionally, we may develop companion diagnostic tests for use with our current and future product candidates.

We will be required to obtain coverage and reimbursement for these tests separately and apart from the coverage and reimbursement we may seek for our current and future potential product candidates.

We expect that there will continue to be a number of federal and state proposals to implement governmental pricing controls and limit the growth of healthcare costs, including the cost of prescription drugs.

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Employees and Human Capital

As of March 1, 2024, we had 66 full-time employees.

Of the 66 full-time employees, 54 were engaged in research and development activities and 12 employees were engaged in finance, legal, human resources, facilities and general management.

As of February 28, 2025, we had 60 full-time employees.

Of the 60 full-time employees, 52 were engaged in research and development activities and 8 employees were engaged in finance, legal, human resources, facilities and

general management.

We have no collective bargaining agreements with our employees, we have not experienced any work stoppages and we believe our relations with our employees are good.

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We value the health, safety, and wellbeing of our employees and their families.

Diversity and Inclusion

We are committed to our continued efforts to increase diversity and foster an inclusive work environment.

We recruit the best qualified employees regardless of gender, ethnicity, or other protected traits and it is our policy to fully comply with all laws (domestic and foreign) applicable to discrimination in the workplace.

Our diversity, equity and inclusion principles are also reflected in our employee training and policies.

We continue to enhance our diversity, equity and inclusion policies that are guided by our executive leadership team.

Health, Safety and Well-Being

Protecting the health, safety and well-being of colleagues and, all of whom are essential to delivering our business objectives, is an integral part of how we operate.

In response to the COVID-19 pandemic in 2020, we instituted a remote work protocol to help ensure the safety of our employees, our community, and to adhere to federal, state, and local requirements and the CDC recommendations of social distancing and limited public exposure in connection with the COVID-19 pandemic.

We did not implement any furlough, layoff, or salary reductions during this time.

These precautions have been instrumental in protecting our workforce and helping ensure continued development of our pipeline.

We continue to evaluate our pandemic preparedness and response procedures and the advisability of continuing operations based on federal, state and local guidance, evolving data concerning the pandemic and the best interests of our employees, third parties with whom we collaborate, and our stockholders.

Compensation and Benefits

Our commitment to pay equity for all colleagues is rooted in our core values and our intention is to continue to build a diverse and inclusive workforce.

We are committed to equitable pay practices for employees based on role, education, experience, performance, and location and Armata conducts pay equity reviews on an annual basis.

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We also have a defined contribution plan in the United States, enabling eligible employees to contribute a portion of their salaries and bonuses to the plans, and we match, in cash, a portion of the employee contributions.

Corporate History and Reorganization

Our company was created as a result of a business combination of Armata (formerly known as AmpliPhi) with C3J that became effective on May 9, 2019.

Immediately prior to the closing of the Merger, AmpliPhi changed its name to Armata Pharmaceuticals, Inc.

C3J’s predecessor, C3 Jian, Inc., was incorporated under the laws of the State of California on November 4, 2005.

On February 26, 2016, as part of a reorganization transaction, C3 Jian, Inc.

merged with a wholly-owned subsidiary of C3J, and as part of this process, C3 Jian, Inc.

was converted to a limited liability company organized under the laws of the State of California named C3 Jian, LLC.

Prior to the Merger, C3J was privately held and was financed principally through a series of equity financings.

AmpliPhi was incorporated under the laws of the State of Washington in March 1989 as a wholly-owned subsidiary of Immunex Corporation and began operations as an independent company in 1992 as Targeted Genetics Corporation.

In January 2011, AmpliPhi completed the acquisition of Biocontrol Ltd, an antimicrobial biotechnology company based in the United Kingdom, with the goal of developing their phage therapy programs using funding from the sale of our legacy gene therapy assets.

In November 2012, AmpliPhi completed the acquisition of Special Phage Holdings Pty Ltd, a company based in Australia, with the goal of continuing research addressing the rapidly escalating problem of antibiotic resistance through the development of a series of bacteriophage-based treatments.

Available Information

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We maintain a website at https://www.armatapharma.com, to which we regularly post copies of our press releases as well as additional information about us.

The information on our website is not incorporated by reference into this Annual Report

on Form 10-K or in any other report or document we submit to the SEC, and any references to our website are intended to be inactive textual references only.

The information on our website is not incorporated by reference into this Annual Report on Form 10-K or in any other report or document we submit to the SEC, and any references to our website are intended to be inactive textual references only.

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 1. Business