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.
−Removed: Bacteriophages or “phages” have a powerful and highly differentiated mechanism of action that enables binding to and killing specific bacteria, in contrast to traditional broad-spectrum antibiotics.
−Removed: believe that phages represent a promising means to treat bacterial infections, especially those that have developed resistance to current standard of care therapies, including the so-called multidrug-resistant or “superbug” strains of bacteria.
+Added: We see bacteriophages as an alternative to antibiotics and an essential response to growing bacterial resistance to current classes of antibiotics.
+Added: 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.
+Added: This is in direct contrast to traditional broad-spectrum antibiotics which can alter the human microbiome increasing susceptibility to opportunistic pathogens, such as C.
+Added: 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.
−Removed: 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 current good manufacturing practice regulations compliant (“cGMP”) manufacturing capabilities to advance a broad pipeline of high-quality bacteriophage product candidates.
−Removed: We are developing and advancing our lead clinical phage candidate for Pseudomonas aeruginosa (“P.
+Added: We are completing two critical Phase 2 trials to ensure a pathway towards pivotal Phase 3 trials.
+Added: 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.
+Added: We are advancing two lead candidates to address both chronic and acute bacterial infections.
+Added: Our first lead candidate focused primarily on chronic bacterial infections is the clinical phage candidate for Pseudomonas aeruginosa ( “P.
aeruginosa” ).
4 unchanged sentences
aeruginosa infection.
−Removed: Data indicate that AP-PA02 was well-tolerated with a treatment emergent adverse event profile similar to placebo.
−Removed: Pharmacokinetcs (PK) findings confirm that AP-PA02 can be effectively delivered to the lungs through nebulization with minimal systemic exposure, with single ascending doses and multiple ascending doses resulting in a proportional increase in exposure as measured in induced sputum and exposure achievement relatively consistent across patient subjects.
+Added: Data indicated that AP-PA02 was well-tolerated with a treatment emergent adverse event profile similar to placebo.
+Added: 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.
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.
−Removed: This study is supported by the Cystic Fibrosis Foundation (“CFF”), which granted Armata a Therapeutics Development Award of up to $5.0 million.
−Removed: We are also developing and advancing a phage product candidate for Staphylococcus aureus (“S.
+Added: 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.
+Added: This study was supported by the Cystic Fibrosis Foundation (“CFF”), which granted Armata a Therapeutics Development Award of $5.0 million.
+Added: 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 .
+Added: 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”).
+Added: We initiated a Phase 2 trial (“Tailwind”) in NCFB in 2022 and reported first patient dosing in the first quarter of 2023.
+Added: 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.
+Added: 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.
+Added: 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.
+Added: We are advancing a phage product candidate for Staphylococcus aureus ( “S.
aureus” ) for the treatment of complicated S.
1 unchanged sentence
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.
−Removed: 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 third quarter of 2024.
+Added: 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.
1 unchanged sentence
On November 17, 2021, Armata announced that it had received from the FDA the approval to proceed for our IND application for AP-SA02.
−Removed: We plan to continue to advance the “diSArm” study provided that the impacts of COVID-19 do not impede our ability to enroll subjects in this clinical trial.
−Removed: 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”).
−Removed: The Company initiated a Phase 2 trial (“Tailwind”) in NCFB in 2022 and reported first patient dosing in the first quarter of 2023.
−Removed: 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.
+Added: 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.
+Added: 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”).
−Removed: The Company plans to initiate a Phase 1b/2a trial in 2023, 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 caused by S.
−Removed: We are committed to conducting randomized controlled clinical trials required for FDA approval in order to move toward the commercialization of alternatives to traditional antibiotics and provide a potential method of treating patients suffering from drug-resistant and difficult-to-treat bacterial infections.
−Removed: Recent Developments
+Added: 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.
+Added: 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.
+Added: 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.
+Added: Recent Financing
2024 Credit Agreement
−Removed: On January 10, 2023, we entered into, as borrower, a secured convertible credit and security agreement (the “Credit Agreement”) with Innoviva Strategic Opportunities LLC (“Innoviva SO”), a wholly owned subsidiary of Innoviva, Inc.
−Removed: INVA) (collectively, “Innoviva”), a principal stockholder of us.
−Removed: The Credit Agreement provides for a secured term loan facility in an aggregate amount of $30 million (the “Loan”) at an interest rate of 8.0% per annum, and has a maturity date of January 10, 2024.
−Removed: Repayment of the Loan is required to be guaranteed by our domestic subsidiaries and foreign material subsidiaries, and the Loan is secured by substantially all of our assets and the subsidiary guarantors.
−Removed: The Credit Agreement provides that if a Qualified Financing, as defined in the Credit Agreement, occurs, the outstanding principal amount of, and all accrued and unpaid interest on, the Loan shall be converted into shares of our common stock at a price per share equal to a 15.0% discount to the lowest price per share for our common stock paid by investors in a Qualified Financing (which price paid by investors in a Qualified Financing may not be less than a 15.0% discount to the closing price of our common stock immediately prior to the consummation of a Qualified Financing event).The Credit Agreement also requires us to file a registration statement for the resale of all securities issued to the lender in connection with any conversion under the Credit Agreement.
−Removed: After such registration statement has been declared effective by the U.S.
−Removed: Securities and Exchange Commission (the “SEC”), any outstanding Loan amount, including all accrued and unpaid interest thereon, may be converted at the lender’s option, into shares of our common stock at a price per share equal to the greater of book value or market value per share of our common stock on the date immediately preceding the effective date of the Credit Agreement, which is $1.52 (as may be appropriately adjusted for any stock split, combination or similar act).
−Removed: PJI IND Approval
−Removed: On August 1, 2022, we announced that the FDA has cleared Armata's IND application for AP-SA02, in a second indication, PJI.
−Removed: The Company plans to initiate a Phase 1b/2 trial in PJI in 2023.
−Removed: NCFB IND Approval
−Removed: On February 22, 2022, we announced that the FDA has cleared Armata's IND application to initiate a clinical trial of AP-PA02 in a second indication, NCFB.
−Removed: We initiated a Phase 2 trial in NCFB in 2022 and announced first patient dosing in the first quarter of 2023.
−Removed: February 2022 Private Placement
−Removed: On February 9, 2022, we entered into a securities purchase agreement to sell our common stock and warrants to Innoviva SO, a wholly‐owned subsidiary of Innoviva, Inc.
−Removed: INVA) (collectively, "Innoviva"), a principal stockholder of us.
−Removed: Pursuant and subject to the terms and conditions of the securities purchase agreement and related agreements, Innoviva agreed to purchase 9,000,000 newly issued shares of our common stock, at a price of $5.00 per share, and warrants to purchase up to 4,500,000 additional shares of our common stock, with an exercise price of $5.00 per share.
−Removed: The stock purchases were completed in two tranches.
−Removed: On February 9, 2022, Innoviva purchased 3,614,792 shares of common stock and warrants to purchase 1,807,396 shares of common stock for an aggregate purchase price of approximately $18.1 million.
−Removed: On March 31, 2022, upon our stockholders voting in favor of the transaction, Innoviva purchased approximately 5,385,208 shares of common stock and warrants to purchase approximately 2,692,604 shares of common stock for an aggregate purchase price of $26.9 million.
−Removed: Executive Transition
−Removed: On June 30, 2022, Steve R.
−Removed: Martin retired as our Chief Financial Officer and Senior Vice President (and Principal Financial and Accounting Officer).
−Removed: Martin agreed to continue his employment with us as an advisor to his successor in the Principal Financial and Accounting Officer role from July 1, 2022 through December 31, 2022.
−Removed: On March 25, 2022, the Company’s board of directors (the “Board of Directors”) appointed Erin Butler to serve as (i) Vice President of Finance and Administration of the Company, effective April 1, 2022, and (ii) Principal Financial and Accounting Officer of the Company, effective July 1, 2022.
+Added: 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.
+Added: INVA) (collectively, “Innoviva”), our principal stockholder and a related party.
+Added: The 2024 loan bears interest at an annual rate of 14% and matures on June 4, 2025.
+Added: Principal and accrued interest are payable at maturity.
+Added: Repayment of the Loan is guaranteed by our domestic subsidiaries, and the loan is secured by substantially all of our assets.
+Added: 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.
+Added: 2023 Credit Agreement
+Added: 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.
+Added: This loan bears interest at an annual rate of 14% and matures on January 10, 2025.
+Added: Principal and accrued interest are payable at maturity.
+Added: Repayment of the loan is guaranteed by our domestic subsidiaries, and the loan is secured by substantially all of our assets.
+Added: 2023 Convertible Credit Agreement
+Added: 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.
+Added: 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.
+Added: 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.
+Added: 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.
+Added: 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.
+Added: 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.
+Added: The Convertible Credit Agreement also confers upon the lender the option to convert any outstanding Convertible Loan amount, including all accrued and unpaid interest thereon, at the lender’s option, into shares of common stock at a price per share equal to the greater of book value or market value per share of common stock on the date immediately preceding the effective date of the Convertible Credit Agreement, which was $1.52 (as may be appropriately adjusted for any stock split, combination or similar act).
The following chart summarizes the status of our phage product candidate development programs and partners.
−Removed: Our strategy is to demonstrate the safety, tolerability and efficacy of multiple phage products in randomized controlled clinical trials required for FDA approval and to support commercialization in multiple indications of high unmet medical need, including bacterial infections caused by multidrug-resistant and difficult-to-treat pathogens.
−Removed: Our fully integrated product development capabilities from bench to clinic enable the discovery of optimal product candidates, efficient process development and manufacturing, and rigorous clinical trials.
+Added: Our strategy is to demonstrate the safety, tolerability and definitive efficacy of multiple phage products in randomized controlled clinical trials required for FDA approval and to support commercialization in both acute and chronic indications of high unmet medical need, including bacterial infections caused by multidrug-resistant and difficult-to-treat pathogens.
+Added: Our fully integrated product development capabilities from bench to clinic enable the discovery of optimal phage product candidates, and include the effective adaptation of phages to uniquely engineered host cells, essential for efficient process development and resulting in improved purity, stability, and manufacturability, to power rigorous clinical trials.
Our microbiological surveillance and synthetic biology capabilities drive long-term product life cycle management.
We intend to:
−Removed: ● Advance clinical trials of AP-PA02 in patients with CF and chronic pulmonary P.
−Removed: aeruginosa infections.
−Removed: ● Develop bacteriophage therapeutics, including AP-PA02 and AP-PA03, for the treatment of other antibiotic-resistant and difficult-to-treat P.
−Removed: aeruginosa infections such as NCFB and hospitalized pneumonia.
−Removed: ● Initiate and advance clinical trials of AP-SA02 in patients with S.
−Removed: aureus bacteremia.
+Added: ● Advance clinical trials of AP-PA02 in patients with CF and NCFB, both chronic pulmonary P.
+Added: aeruginosa infections, as an alternative to inhaled antibiotics.
+Added: ● Develop bacteriophage therapeutics, including AP-PA03, for the treatment of other antibiotic-resistant and difficult-to-treat P.
+Added: aeruginosa infections such as acute bacterial pneumonia.
+Added: ● Advance clinical trials of AP-SA02 in patients with bacteremia due to acute infection with S.
+Added: aureus , including 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.
−Removed: aureus infections such as PJI.
+Added: aureus infections such as PJI and wound infections.
The Need for New Anti-Infective Therapies
2 unchanged sentences
aureus (“MRSA”), in the United States occurred in 1968.
−Removed: A void in the discovery of new classes of antibiotics lasting approximately 30 years drove the emergence and spread of antibiotic-resistant bacteria, including
−Removed: vancomycin-resistant enterococci (“VRE”), and pandrug-resistant strains of Acinetobacter baumannii , P.
+Added: 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 .
−Removed: The dramatic and continuous emergence of antibiotic-resistant bacteria, and the lack of new antibiotics in the pipeline, has prompted calls to action from many of the world’s major health bodies such as the U.S.
+Added: The dramatic and continuous emergence of antibiotic-resistant bacteria, and the lack of novel next generation antibiotics in the pipeline, has prompted calls to action from many of the world’s major health bodies such as the U.S.
Centers for Disease Control and Prevention (the “CDC”), and the World Health Organization (the “WHO”), who warn of an “antibiotic cliff” and a “post-antibiotic era.” A growing list of infections – such as pneumonia, tuberculosis, bacteremia/septicemia, gonorrhea, and foodborne diseases – are becoming harder, and sometimes impossible, to treat as antibiotics become less effective.
2 unchanged sentences
The Review on Antimicrobial Resistance, a global project commissioned by the British government and the Wellcome Trust, reports that at least 700,000 people die each year of drug resistance in illnesses that include bacterial infections.
−Removed: The report predicts that, by 2050, 10 million lives a year worldwide (more people than currently die from cancer) and a cumulative US$100 trillion of economic output are at risk due to the rise of drug-resistant infections.
−Removed: 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.
+Added: 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.
+Added: The CDC estimates
+Added: 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.
It is estimated that 50% of hospital-acquired infections are resistant to first-line anti-infective therapies.
−Removed: The cumulative annual healthcare costs for treating drug-resistant bacterial infections in United States alone is calculated at US $21 billion to US $34 billion, with over 8 million additional hospital days.
+Added: The cumulative annual healthcare costs for treating drug-resistant bacterial infections in the United States alone is calculated at $21 billion to $34 billion, with over 8 million additional hospital days.
It is for these reasons that we believe there is a critical and pressing need to develop new and novel antibacterial therapies to combat the rise in antibiotic-resistance bacteria.
+Added: Increased public funding as well as foundation funding will be essential to bring new approaches forward through full cycle development.
+Added: 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.
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.
−Removed: 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
−Removed: antibiotics wanes.
+Added: 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.
−Removed: According to a March 2021 report from PEW Charitable Trusts, only 43 new antibiotics (all small molecules that act systemically) with the potential to treat serious or life-threatening bacterial infections are in global clinical development.
−Removed: This is compared with more than 1,100 new product candidates in the drug pipeline for cancer.
+Added: 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.
Historically, the success rate from Phase 1 to marketing approval is only one in five for infectious disease products.
1 unchanged sentence
Hospital-acquired (nosocomial) infections are a major healthcare problem throughout the world, affecting developed countries as well as resource-poor countries.
−Removed: The WHO reports that hospital-acquired infections are among the major causes of death and increased morbidity among hospitalized patients and estimates that more than 1.4 million people per year worldwide suffer from infectious complications from a hospital stay.
−Removed: In 2016, the CDC reported that in the United States, approximately 4% of all patients admitted to a hospital will be affected by a hospital-acquired infection during their stay, typically requiring extended stays and additional care.
+Added: The WHO reports that hospital-acquired infections are among the major causes of death and increased morbidity among hospitalized patients.
+Added: In the US 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.
This, coupled with the lack of new antibiotics in current discovery and development pipelines, has generated a significant clinical management problem worldwide, leading to increases in morbidity and mortality due to these antibiotic-resistant bacteria as well as increases in healthcare costs.
−Removed: Bacteriophage therapy has the potential to be an alternative method of treating bacterial infection.
+Added: Bacteriophage therapy has the potential to be an alternative to antibiotics in treating bacterial infections.
Bacteriophage Therapy
4 unchanged sentences
When there are no target bacteria left for the phages to infect, the phages are removed through the body’s natural clearance processes.
−Removed: Phages have the potential to provide both an alternative to, and a synergistic approach with, antibiotic therapy.
+Added: In contrast to broad-spectrum antibiotics, phages are highly targeted to specific bacteria, and do not attack the normal human microbiome on the skin, the gut or other areas critical to maintaining our defenses against more opportunistic infections like C.
+Added: Phages have the potential to provide both an alternative to, and/or a synergistic approach with, antibiotic therapy.
Phages offer several differentiating attributes compared to classic antibiotics:
● Highly specific/selective bactericidal agents, sparing the microbiome.
−Removed: Since each strain of phage generally exploits 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 beneficial bacteria through the use of antibiotics.
−Removed: Such risks could include serious opportunistic infections such as Clostridium difficile infection and vancomycin-resistant enterococcal (“VRE”) infection.
+Added: 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.
+Added: Such risks could include serious opportunistic infections such as Clostridium difficile infection and VRE infection.
● No known toxicities associated with chemical structures.
17 unchanged sentences
There are hundreds of cases published in the scientific and medical literature describing the use of phage therapy in human medicine over more than 90 years, mostly in the former Soviet Union and Eastern Europe.
−Removed: Phage therapy is still commonly used today in Russia, Poland and Georgia, with numerous reports of success in treating infectious diseases caused by many pathogenic bacterial species.
+Added: Phage therapy is still commonly used today in Russia, Poland and Georgia, with numerous reports of success in treating serious infectious diseases caused by many pathogenic bacterial species.
However, the safety and effectiveness of these therapies have not been conclusively established due to the lack of randomized controlled clinical studies.
4 unchanged sentences
aeruginosa otitis treated with a cocktail of six natural phages.
−Removed: Since 2016, there have been a number of “compassionate use” cases in which patients suffering from various serious or life-threatening infections have been treated with phage therapy under physician-sponsored Emergency Investigational New Drug (“EIND”) Applications with high rates of success and no adverse effects attributable to the therapy.
+Added: Since 2016, there have been a number of “compassionate use” cases in which patients suffering from various serious or life-threatening infections have been treated with phage therapy under physician-sponsored Emergency Investigational New Drug Applications with high rates of success and no adverse effects attributable to the therapy.
Most notable was the well-documented case in 2016 of Tom Patterson, whose disseminated multidrug-resistant Acinetobacter baumannii infection was successfully treated with phage-based therapeutic cocktails administered intravenously and intraperitoneally.
4 unchanged sentences
That patient’s case represents another milestone for phage therapy – the first person to be treated with genetically modified phages.
−Removed: A consistent takeaway from these early phage therapy uses, and from the more recent clinical trials and compassionate use cases, is that phage therapy is generally well tolerated, with generally no reports of serious adverse events.
−Removed: Phage have previously received approvals for use in cleaning food facilities and as a food additive for human consumption by the FDA and the EMA, and as agricultural bacterial pest treatments by the United States Department of Agriculture (“USDA”).
+Added: A consistent takeaway from these early phage therapy uses, and from the more recent clinical trials and compassionate use cases, is that phage therapy is generally well tolerated, with generally no reports of serious adverse events when administered by inhalation.
+Added: Intravenous use of phage has been more limited due to bacterial cell wall and other contaminants in the final phage product.
+Added: Phages have previously received approvals for use in cleaning food facilities and as a food additive for human consumption by the FDA and the EMA, and as agricultural bacterial pest treatments by the United States Department of Agriculture.
Phages have met the criteria to be considered as “generally recognized as safe”, or “GRAS”, in the food and food contact surface categories.
−Removed: With the growing threat of antimicrobial resistance, we believe it is essential that phage safety and efficacy is demonstrated by conducting rigorous well-powered clinical trials required for FDA approval, in order to move toward commercialization of alternatives to traditional antibiotics and bring a potential solution to all patients suffering from drug-resistant bacterial infections.
+Added: With the growing problem of antimicrobial resistance, we believe it is essential that phage safety and efficacy be demonstrated by conducting rigorous well-powered clinical trials required for FDA approval, in order to move toward commercialization of phage therapy as an alternative to traditional antibiotics and to bring a potential solution to all patients suffering from drug-resistant bacterial infections.
+Added: Armata has been focused on enhancing the overall quality of its manufactured phages through engineering and adaptation to maximize production titers while ensuring high level of purity.
Target Markets and Medical Need
8 unchanged sentences
CF affects over 40,000 people in the United States (105,000 people worldwide) with approximately 1,000 new diagnoses per year.
−Removed: Dysfunction of the CFTR gene leads to dysfunction in multiple organs, but particularly the lungs, where a failure of hydration of airway secretions results in thick mucus, chronic inflammation, airway remodeling, and recurrent infections.
+Added: Dysfunction of the CFTR gene leads to dysfunction in multiple organs, but particularly the lungs, where a
+Added: failure of hydration of airway secretions results in thick mucus, chronic inflammation, airway remodeling, and recurrent infections.
Lung function continues to decline over time, punctuated by pulmonary exacerbations with increased cough, shortness of breath, and infections that result in rapid declines in lung function.
3 unchanged sentences
aeruginosa infections occur in 45% of CF patients by age 40, and are strongly associated with worsening lung function, frequent pulmonary exacerbations, and increased mortality.
−Removed: In 2018, the median survival age was 47 years.
+Added: In 2022, the median predicted survival age was 68 years.
Although many patients with chronic P.
1 unchanged sentence
aeruginosa infection.
−Removed: GlobalData projects that total antibiotic sales in the CF market will exceed $400 million in 2020.
+Added: GlobalData projects that total antibiotic sales in the CF market will exceed $900 million in the United States in 2030.
Non-Cystic Fibrosis Bronchiectasis
3 unchanged sentences
NCFB patients frequently become chronically colonized with multidrug-resistant strains of P.
−Removed: aeruginosa because of the need for repeated courses of
−Removed: antibiotic treatment.
+Added: 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.
1 unchanged sentence
Hospitalized Pneumonia
−Removed: Hospital-acquired pneumonia and ventilated-associated pneumonia is one of the most common causes of death among all hospital‐acquired infections, with approximately 300,000 hospitalization each year in the United States due to Pseudomonas .
+Added: Hospital-acquired pneumonia and ventilated-associated pneumonia is one of the most common causes of death among all hospital‐acquired infections, with approximately 300,000 hospitalizations each year in the United States due to Pseudomonas .
Infection with Pseudomonas results in mortality rates ranging as high as 35‐50%, drives considerable healthcare costs (in excess of $40,000 per patient), and accounts for around 50% of all intensive care unit antibiotics.
18 unchanged sentences
Daptomycin (approved in 2005;
−Removed: based on clinical cure rates of less than 50%) and vancomycin are the only two antibiotics with label indications in the U.S.
+Added: based on clinical cure rates of less than 50%) and vancomycin are the
+Added: only two antibiotics with label indications in the U.S.
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.
−Removed: Prosthetic Joint Infection
−Removed: 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, United Kingdom), at an annual growth rate of 5.6% due to a growing elderly population.
+Added: Prosthetic Joint Infection and Wound Infection
+Added: 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 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.
4 unchanged sentences
Moreover, growing antibiotic resistance complicates treatment strategies and antibiotic choice for the treatment of PJI.
−Removed: Phage therapy has been successful in patients who have failed conventional antibiotic treatment, including two 2020 case studies in which phage were administered by intravenous or intraarticular routes and shown to be generally well tolerated.
+Added: Phage therapy has been successful in patients who have failed conventional antibiotic treatment, including two 2020 case studies in which phages were administered by intravenous or intraarticular routes and shown to be generally well tolerated.
+Added: Similarly, secondary and tertiary wound infections due to S.
+Added: aureus are a growing issue worldwide.
Platform Technologies
1 unchanged sentence
Phages, natural predators of bacteria, have been in an uninterrupted battle for millions of years – evolving to kill or evade.
−Removed: These powerful natural phages can be purposely engineered to be more efficient killers.
−Removed: The use of synthetic
−Removed: biology tools enables us to precisely engineer natural phages in ways that further improve their pharmacological properties and antimicrobial activity.
+Added: These powerful natural well-adapted phages can be purposely engineered to be more efficient killers.
+Added: 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.
4 unchanged sentences
We employ next-generation sequencing, proprietary sequencing databases and software, bioinformatics, and comparative genomics, for the analyses of our phages.
−Removed: Engineering Phage to Confer Desirable Properties:
+Added: Engineering Host and Phage to Confer Desirable Properties:
Depending on the target pathogen, identified natural phages are engineered to enable desirable phenotypes such as wide host range, payload expression, biofilm degradation, resistance prevention, and bioactive peptide display.
Engineered phages are evaluated both in vitro and in vivo to determine pharmacological and toxicological parameters to confirm their potential in the clinic.
−Removed: Formulation Development and Chemistry, Manufacturing, and Controls (“CMC”):
+Added: 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.
−Removed: Our research and development facilities are equipped with cGMP compliant manufacturing suites enabling the production, purification and testing and release of clinical trial material.
+Added: Our research and development facilities are equipped with cGMP compliant manufacturing suites enabling the production,
+Added: 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
10 unchanged sentences
aureus are causative agents for difficult-to-treat infections:
−Removed: aeruginosa , with its mucoid and multidrug-resistant strains, is a dominant culprit in chronic respiratory infections in CF and NCFB patients as well as acute pneumonias in hospitalized patients;
−Removed: aureus , with its heteroresistant and MRSA strains, has been implicated in systemic (e.g., bacteremia) as well as prosthetic-related
+Added: aeruginosa , with its mucoid and multidrug-resistant strains, is a dominant culprit in chronic respiratory infections in CF and NCFB patients as well as acute pneumonia in hospitalized patients;
+Added: aureus , with its heteroresistant and MRSA strains, has been implicated in systemic (e.g., bacteremia) as well as prosthetic-related and wound infections.
By advancing randomized controlled clinical trials using P.
3 unchanged sentences
Historical Background
−Removed: AP-PA02 is being developed as a next-generation replacement for AP-PA01 (previously known as AB-PA01).
+Added: AP-PA02 was developed as a next-generation replacement for AP-PA01 (previously known as AB-PA01).
A total of 10 patients with serious or life-threatening P.
12 unchanged sentences
Furthermore, the FDA noted that preclinical toxicology studies are not required for AP-PA01 to enter clinical development.
−Removed: Human exposure through treatment of single patients with AP-PA01 under the expanded access program has been helpful in demonstrating the promise of phage therapy.
+Added: Human exposure through treatment of single patients with AP-PA01 under the expanded access program has been helpful in demonstrating the promise and safety of phage therapy.
Feedback from the pre-IND meeting has been insightful for the regulatory path required for phage therapeutics in general, and specifically for a phage product candidate intended for respiratory infection.
10 unchanged sentences
Immune stimulation was assessed to assure the lack of inflammatory impact by AP-PA02.
−Removed: Animal studies were conducted to provide insight into safe and efficacious dose levels that would support the expectation of pharmacological activity (i.e.
−Removed: antimicrobial potential of phage) in the lung compartment following an inhaled route of administration.
+Added: Animal studies were conducted to provide insight into safe and efficacious dose levels that would support the expectation of pharmacological activity (i.e., antimicrobial potential of phage) in the lung compartment following an inhaled route of administration.
In parallel, we initiated manufacturing feasibility and process optimization efforts with the goal of achieving high-quality phage product free of endotoxin and host cell proteins whilst maintaining adequate phage titers.
−Removed: AP-PA02 is comprised of a cocktail of natural P.
+Added: 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.
Prior to initiating the SWARM- P.a.
−Removed: trial (described below), our clinical isolate screening and phage collections yielded a three-phage AP-PA02 cocktail with compelling host-range
+Added: trial (described below), our clinical isolate screening and phage collections yielded a three-phage AP-PA02 cocktail with compelling host-range coverage.
We subsequently modified AP-PA02 to include additional phage genera that increase potency and broaden coverage of strains of P.
aeruginosa found in CF patients.
−Removed: The optimized five-phage AP-PA02 cocktail provides coverage against at least 90% of tested CF clinical isolates and has shown superior in vitro potency as well as improved efficacy in an animal model of infection.
+Added: The optimized five-phage AP-PA02 cocktail provided coverage against at least 90% of tested CF clinical isolates and has shown superior in vitro potency as well as improved efficacy in an animal model of infection.
The improvements in AP-PA02 reflect our core strategy of utilizing clinical isolate surveillance data to drive enhancement of product composition.
9 unchanged sentences
● Components maintain activity in the presence of other CF therapies.
−Removed: We have developed AP-PA02 as a sterile liquid formulation, suitable for delivery by inhalation.
+Added: 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.
Clinical Development of AP-PA02 in Cystic Fibrosis :
−Removed: AP-PA02 product candidate is currently in clinical development.
+Added: Completed Phase 1b/2a Study
On October 14, 2020, Armata received approval for the study to proceed from the FDA for its IND to initiate the “SWARM- P.a.
−Removed: ” study – a Phase 1b/2a, 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.
−Removed: Primary Endpoints (SAD and MAD) will include incidence and severity of treatment-emergent, adverse events.
−Removed: Secondary Endpoints (MAD) will include changes in P.
−Removed: aeruginosa colony-forming units (“CFU”).
−Removed: We will look at clinical parameters as a part of exploratory endpoints for the SAD and MAD cohorts.
−Removed: The enhanced five-phage AP-PA02 cocktail (described above) was advanced through manufacturing and regulatory review for introduction into the MAD component of the SWARM- P.a.
+Added: ” 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.
+Added: Primary Endpoints (SAD and MAD) included incidence and severity of treatment-emergent, adverse events.
+Added: Secondary Endpoints (MAD) included changes in P.
+Added: aeruginosa colony-forming units.
+Added: We looked at clinical parameters as a part of exploratory endpoints for the SAD and MAD cohorts.
The SWARM- P.a.
−Removed: study is supported by the CFF, which in March 2020 granted us a Therapeutics Development Award of up to $5.0 million.
+Added: study was supported by a $5 million Therapeutics Development Award from the CFF.
In the first quarter of 2023, Armata announced positive topline results from the completed “SWARM- P.a.
−Removed: ” 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.
−Removed: aeruginosa infection.
Data indicate that AP-PA02 was well-tolerated with a treatment emergent adverse event profile similar to placebo.
2 unchanged sentences
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.
−Removed: With positive outcomes from this first study, SWARM- P.a.
−Removed: , we plan to initiate follow-on studies that will investigate the efficacy of AP-PA02 in chronically-infected patients and potentially other CF patient populations.
−Removed: Our ultimate goal is to bring AP-PA02 to the CF community at large as a new FDA-approved novel therapy to treat airway P.
−Removed: aeruginosa infections and improve the long-term health of people with CF.
−Removed: Exploring Additional Clinical Indications for Our P.
−Removed: aeruginosa Phage Product Candidates
+Added: Additive Clinical Indication for Our AP-PA02 P.
+Added: aeruginosa Phage Product Candidate:
+Added: Ensuring Patient Population for Definitive Phase 3 Trial
+Added: With positive outcomes from the first clinical study, SWARM- P.a.
+Added: , 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.
−Removed: The Company initiated a Phase 2 trial (“Tail wind ”) in NCFB in 2022 and reported first patient dosing in the first quarter of 2023.
−Removed: The "Tail wind ” 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.
+Added: The Company initiated a Phase 2 trial (“Tailwind”) in NCFB in late 2022 and reported first patient dosing in the first quarter of 2023.
+Added: 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.
+Added: 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.
+Added: 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.
+Added: aeruginosa confirms the findings in the cystic fibrosis SWARM- P.a.
+Added: Phase 2a trial.
+Added: We are carefully evaluating the impact of AP-PA02 on P.
+Added: aeruginosa in patients not taking antibiotics in order to confirm the independent impact of phage treatment.
+Added: AP-PA03 for Antibiotic-Resistant and Difficult-to-Treat Acute Bacterial Pneumonia
Conversely and representing the different physiology of acute pneumonia lung infections as compared to chronic CF and NCFB respiratory infections, a novel cocktail is in development for the clinical indication of acute hospitalized pneumonia.
−Removed: We have deployed our extensive clinical isolate collection and phage library to identify a candidate phage cocktail, AP-PA03.
+Added: We have deployed our extensive P.
+Added: aeruginosa clinical isolate collection and phage library to identify a candidate phage cocktail, AP-PA03.
Staphylococcus aureus Phage Product Candidate, AP-SA02
Historical Background
−Removed: AP-SA02 is being developed as a more advanced version of AP-SA01 (previously known as AB-SA01).
+Added: AP-SA02 was developed as a more advanced version of AP-SA01 (previously known as AB-SA01).
The therapeutic potential of AP-SA01 has been demonstrated through:
6 unchanged sentences
aureus -derived chronic rhinosinusitis).
−Removed: ● More recently, AP-SA01 was provided for use under single-patient expanded access programs in the United States (Emergency INDs, per the Food and Drug Administration ) or Australia (Special Access Scheme, per the Australian Therapeutic Goods Administration).
+Added: ● AP-SA01 was provided for use under single-patient expanded access programs in the United States (Emergency INDs, per the Food and Drug Administration ) or Australia (Special Access Scheme, per the Australian Therapeutic Goods Administration).
A total of 18 patients with serious or life-threatening S.
8 unchanged sentences
Development of AP-SA02
−Removed: AP-SA02 is a novel biologic product candidate comprised of a cocktail of natural lytic phages that target the problematic pathogen, S.
+Added: AP-SA02 is a novel biologic product candidate comprised of a cocktail of adapted natural lytic phages that target the problematic pathogen, S.
Preclinical highlights of AP-SA02 include:
4 unchanged sentences
vancomycin-resistant S.
−Removed: ● Unique mechanism of action offers synergistic or additive benefit with standard of care antibiotics;
+Added: ● Unique mechanism of action offers independent or synergistic benefit with standard of care antibiotics;
● Component phages are stable and retain infectivity after exposure to relevant biological fluids;
9 unchanged sentences
and (iii) explore efficacy through evaluation of key meaningful endpoints.
−Removed: The study will be conducted at sites in the United States and also at sites abroad.
−Removed: The Phase 1b/2a study will be 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.
−Removed: 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 third quarter of 2024.
−Removed: Data from this Phase 1b/2a study will be invaluable for a follow-on trial that will be designed to demonstrate of efficacy of AP-SA02 in treating S.
+Added: The study is being conducted at sites in the United States and also at sites abroad in Australia.
+Added: 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.
+Added: 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.
+Added: 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.
−Removed: We anticipate findings from this 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.
+Added: 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 in late 2024, early 2025.
Additional Clinical Indications for AP-SA02
−Removed: Improved patient outcomes are needed for other Staphylococcal infections, in settings such as PJI, for which antimicrobial resistance is a growing concern.
−Removed: We believe AP-SA02 could also have a meaningful impact in this indication, particularly PJIs caused by methicillin-resistant S.
+Added: Improved patient outcomes are needed for other Staphylococcal infections, in settings such as PJI and wound infections, for which antimicrobial resistance is a growing concern.
+Added: We believe AP-SA02 could also have a meaningful impact in these indications, particularly infections caused by methicillin-resistant S.
aureus (“MRSA”).
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.
−Removed: We plan to initiate a Phase 1b/2a trial in 2023, 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 caused by S.
+Added: We had planned to initiate a Phase 1b/2a trial in 2023;
+Added: 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.
Discovery Research
1 unchanged sentence
Klebsiella pneumoniae phage, for example, is a potentially important addition to treatment options for serious lung infections.
−Removed: Furthermore, our team of microbiologists and synthetic biologists hunt for natural phages and evaluate the suitability of these natural phages for engineering using our synthetic phage platform.
−Removed: These powerful natural phages can be purposely engineered to be more efficient killers.
+Added: Furthermore, our team of microbiologists and synthetic biologists hunt for natural phages and evaluate the suitability of these natural phages for engineering and adaptation using our synthetic phage platform.
+Added: These powerful natural well-adapted phages can be purposely engineered to be more efficient killers.
The use of synthetic biology tools enables us to precisely engineer natural phages in ways that further improve their pharmacological properties and antimicrobial activity.
−Removed: 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.
+Added: Attributes of engineered phages can include expanded host range, improved potency which is a
+Added: 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
−Removed: We produce clinical quantities of each of our bacteriophage product candidates at our cGMP-compliant manufacturing facility in Marina del Rey, California.
−Removed: This facility, which serves as our headquarters, 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 testing.
+Added: We currently produce clinical quantities of each of our bacteriophage product candidates at our cGMP-compliant manufacturing facility in Marina del Rey, California.
+Added: 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.
−Removed: Our facility is licensed by the California Department of Public Health (“CDPH”) for drug manufacturing and is subject to periodic, unannounced inspections for compliance with cGMP and other state and federal laws and regulations.
+Added: 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.
11 unchanged sentences
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.
+Added: 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
4 unchanged sentences
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.
−Removed: 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.
+Added: 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
+Added: 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.
4 unchanged sentences
Because patent applications in the United States and certain other jurisdictions are maintained in secrecy for 18 months or potentially even longer, and because publication of discoveries in the scientific or patent literature often lags behind actual discoveries and patent application filings, we cannot be certain of the priority of inventions covered by pending patent applications.
−Removed: Accordingly, we may not have been the first to invent the subject matter disclosed in some of our patent applications or the first to file patent applications covering such subject matter, and we may have to participate in interference proceedings or derivation proceedings declared by the United States Patent and Trademark Office (“U.S.
−Removed: PTO”) to determine priority of invention.
+Added: Accordingly, we may not have been the first to invent the subject matter disclosed in some of our patent applications or the first to file patent applications covering such subject matter, and we may have to participate in interference proceedings or derivation proceedings declared by the United States Patent and Trademark Office (the “USPTO”) to determine priority of invention.
Bacteriophage Patent Portfolio
3 unchanged sentences
Patent term adjustments or patent term extensions could result in later expiration dates.
−Removed: We believe these patents and applications cover our lead phage therapeutic programs and use thereof, synthetic phage and methods of manufacture thereof, beneficial effects of bacteriophage treatment, bacteriophage combinations, the sequential use of bacteriophages in combination with conventional antibiotics, genetic sequence variations, methods to reduce antibiotic resistance, methods to design therapeutic combination panels of bacteriophage, disinfection methods using bacteriophages, and bacteriophage mutants having increased bacterial host spectra.
+Added: We believe these patents and applications cover our lead phage therapeutic programs and use thereof, synthetic phage and methods of manufacture thereof, beneficial effects of bacteriophage treatment - including treatment and prevention of bacteria-associated cancers, bacteriophage combinations, the sequential use of bacteriophages in combination with conventional antibiotics, genetic sequence variations, methods to reduce antibiotic resistance, methods to treat bacterial biofilms, methods to design therapeutic combination panels of bacteriophage, disinfection methods using bacteriophages, and bacteriophage mutants having increased bacterial host spectra.
The development and commercialization of new drugs is highly competitive.
14 unchanged sentences
There are a handful of small biotechnology companies developing bacteriophage products to treat human diseases.
−Removed: To our knowledge, several biotechnology companies in the United States and Europe, including Adaptive Phage Therapeutics, Pherecydes Pharma, 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.
+Added: 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.
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.
6 unchanged sentences
We have not yet established a sales, marketing or product distribution infrastructure because our lead candidates are still in early clinical development.
−Removed: Subject to receiving marketing approvals, or earlier we intend to either partner the commercial rights to our products with existing companies that have the wherewithal and resources to commercialize
−Removed: explore building the necessary marketing and sales infrastructure to market and sell our current product candidates.
+Added: Subject to receiving marketing approvals or earlier, we intend to either partner the commercial rights to our products with existing companies that have the wherewithal and resources to commercialize building the necessary marketing and sales infrastructure to market and sell our current product candidates.
We also intend to explore the use of a variety of distribution agreements and commercial partnerships in those territories where we do not establish a sales force for any of our product candidates that obtain marketing approval.
1 unchanged sentence
Strategic Alliances and Research Agreements
−Removed: On June 15, 2020, we entered into a Research Project Award agreement (the “MTEC Agreement”) with MTEC, pursuant to which we will receive a $15.0 million grant and entered into a three-year program administered by the DoD through MTEC with funding from the Defense Health Agency and Joint Warfighter Medical Research Program.
−Removed: 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 third quarter of 2024.
−Removed: We plan to use the grant to partially fund a Phase 1b/2a, randomized, double-blind, placebo-controlled, dose-escalation clinical study of Armata's therapeutic phage-based candidate, AP-SA02, for the treatment of S.
−Removed: aureus bacteremia infections.
−Removed: The MTEC Agreement specifies that the grant will be paid to us through a cost reimbursable model, based on agreed-upon cost-share percentages, and the grant money received is not refundable to MTEC.
+Added: 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 grant and entered into a three-year program administered by the U.S.
+Added: 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.
+Added: 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.
+Added: 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.
+Added: 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.
Upon license or commercialization of intellectual property developed with the funding from the MTEC Agreement, additional fees will be due to MTEC.
−Removed: We 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.
−Removed: The MTEC Agreement will be effective through October 30, 2024.
−Removed: The MTEC Agreement may be terminated in whole or in part, 30 calendar days following the written notice from either party.
−Removed: In addition, MTEC has the right to terminate the MTEC Agreement upon material breach by Armata.
+Added: 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.
+Added: The MTEC Agreement is effective through October 30, 2024.
+Added: The MTEC Agreement may be terminated in whole or in part, 30 calendar days following written notice from the Company to MTEC.
+Added: In addition, MTEC has the right to terminate the MTEC Agreement upon material breach by the Company.
CFF Therapeutics Development Award
−Removed: On March 13, 2020, we entered into an award agreement (the “Award Agreement”) with the CFF, pursuant to which we received a Therapeutics Development Award of up to $5.0 million (the “Award”).
−Removed: The Award will be used to fund a portion of our Phase 1b/2a clinical trial of the P.
−Removed: aeruginosa phage candidate, AP-PA02, as a treatment for P.
−Removed: aeruginosa airway infections in people with CF.
−Removed: The first payment under the AwardAgreement, in the amount of $1.0 million, became due upon signing the Award Agreement and was received in April 2020.
−Removed: The remainder of the award will be paid to us incrementally in installments upon the achievement of certain milestones related to the development program and progress of the Phase 1b/2a clinical trial of AP-PA02, as set forth in the Award Agreement.
−Removed: If we cease to use commercially reasonable efforts directed to the development of AP-PA02, or any other Product (as defined in the Award Agreement), for a period of 360 days (an “Interruption”) and fail to resume the development of the Product after receiving from CFF notice of an Interruption, then we must either repay the amount of the Award actually received by the Company, plus interest, or grant to CFF (1) an exclusive (even as to Armata), worldwide, perpetual, sublicensable license under technology developed under the Award Agreement that covers the Product for use in treating infections in CF patients (the “CF Field”), and (2) a non-exclusive, worldwide, perpetual, sublicensable license under certain background intellectual property covering the Product, to the extent necessary to commercialize the Product in the CF Field.
−Removed: Upon our commercialization of any Product, we will owe a fixed royalty amount to CFF, which is to be paid in installments determined, in part, based on commercial sales volumes of the Product.
−Removed: We will be obligated to make an additional fixed royalty payment upon achieving specified sales milestones.
−Removed: We may also be obligated to make a
−Removed: payment to CFF if we transfer, sell or license the Product in the CF Field, or if we enter into a change of control transaction.
−Removed: The term of the Award Agreement commenced on March 10, 2020 and expires on the earlier of the date on which we have paid CFF all of the fixed royalty payments set forth therein, the effective date of any license granted to CFF following an Interruption, or upon earlier termination of the Award Agreement.
−Removed: Either CFF or Armata may terminate the Award Agreement for cause, which includes our material failure to achieve certain development milestones.
−Removed: Our payment obligations survive the termination of the Award Agreement.
+Added: On March 13, 2020, the Company entered into an award agreement (the “Award Agreement”) with CFF, pursuant to which the Company received a Therapeutics Development Award of $5.0 million (the “CFF Award”).
+Added: The CFF Award has funded a portion of the Company’s Phase 1b/2a clinical trial of the Pseudomonas aeruginosa (“ P.
+Added: aeruginosa ”) phage candidate, AP-PA02, as a treatment for airway infections in people with cystic fibrosis (“CF”).
+Added: The first payment under the Award Agreement, in the amount of $1.0 million, became due upon signing the Award Agreement and was received in April 2020.
+Added: The remainder of the Award was paid to the Company incrementally in installments upon the achievement of certain milestones related to the development program and progress of the Phase 1b/2a clinical trial of AP-PA02, as set forth in the Award Agreement.
+Added: The final milestone was achieved in the fourth quarter of 2023 and the milestone payment was received in the first quarter of 2024.
+Added: If the Company ceases to use commercially reasonable efforts directed to the development of AP-PA02, or any other product (as defined in the Award Agreement), for a period of 360 days (an “Interruption”) and fails to resume the development of the product after receiving from CFF notice of an Interruption, then the Company must either repay the amount of the CFF Award actually received by the Company, plus interest, or grant to CFF (1) an exclusive (even as to the Company), worldwide, perpetual, sublicensable license under technology developed under the Award Agreement that covers the product for use in treating infections in CF patients (the “CF Field”), and (2) a non-exclusive, worldwide, perpetual, sublicensable license under certain background intellectual property covering the product, to the extent necessary to commercialize the Product in the CF Field.
+Added: Upon commercialization by the Company of any product, the Company will owe a fixed royalty amount to CFF, which is to be paid in installments determined, in part, based on commercial sales volumes of the product.
+Added: The Company will be obligated to make an additional fixed royalty payment upon achieving specified sales milestones.
+Added: The Company may also be obligated to make a payment to CFF if the Company transfers, sells or licenses the product in the CF Field, or if the Company enters into a change of control transaction.
+Added: The term of the Award Agreement commenced on March 10, 2020 and expires on the earlier of the date on which the Company has paid CFF all of the fixed royalty payments set forth therein, the effective date of any license granted to CFF following an Interruption, or upon earlier termination of the Award Agreement.
+Added: Either CFF or the Company may terminate the Award Agreement for cause, which includes the Company’s material failure to achieve certain development milestones.
+Added: The Company’s payment obligations survive the termination of the Award Agreement.
License Agreements
1 unchanged sentence
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.
−Removed: (“Merck”), we are 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.
+Added: (“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.
−Removed: On December 14, 2022, Armata received a notice of termination for the Research and Option Agreement, which will be effective in March 14, 2023, in accordance with Section 8.2.1 of the Research and Option Agreement which calls for termination effective 90 days after receipt of written notice to terminate.
+Added: 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
6 unchanged sentences
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.
−Removed: Our corporate headquarters are located in Marina del Rey, California, where we currently lease 35,500 square feet of laboratory and office space.
−Removed: The lease expires on December 31, 2031.
−Removed: The facility includes 19,500 square feet of BSL2 laboratory space dedicated to phage product development.
−Removed: The facility includes approximately 3,000 square feet of cGMP laboratory space, designed to produce clinical quantities of our phage product candidates for human trials and to perform in-house Quality Control (“QC”) testing.
−Removed: The manufacturing space consists of two ISO-certified cleanrooms capable of production, purification, drug product formulation and aseptic filling of drug product.
−Removed: The QC laboratory contains qualified analytical instruments to support the testing and release of clinical trial material.
−Removed: The facility is licensed by the California Department of Public Health (“CDPH”) for drug manufacturing and is subject to periodic, unannounced inspections for compliance with cGMP and other state and federal laws and regulations.
−Removed: Armata’s 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.
−Removed: On October 28, 2021, we entered into a lease for office and research and development space under a non-cancellable lease in Los Angeles, CA (the “2021 Lease”).
+Added: Our corporate headquarters are located in Los Angeles, California, with an address of 5005 McConnell Avenue, Los Angeles, CA 90066.
+Added: 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”).
The 2021 Lease payment start date was May 1, 2022, and the total lease term is for 16 years and runs through 2038.
−Removed: Monthly rent for 2022 and 2023 will be fully or partially abated while we and the lessor complete planned tenant improvements to the facility, which is planned to be completed in the second half of 2023.
−Removed: Base monthly rent will be approximately $0.25 million in 2024.
−Removed: We are entitled to receive an allowance for tenant improvements of up to $7.3 million.
−Removed: In addition, we lease a 5,000 square foot facility located in Sydney, Australia.
−Removed: The 4,000 square feet of laboratory space provides capabilities to support phage product development and manufacturing process development.
−Removed: The facility is also set up to provide microbiological support of clinical trials.
−Removed: We occupy approximately 1,000 square feet of leased office space pursuant to a month-to-month sublease, located at 3579 Valley Centre Drive, Suite 100, San Diego, California 92130.
−Removed: We believe that our facilities are adequate for our current and near-term needs.
+Added: Office space and research laboratories have been fully occupied since the third quarter of 2023, with cGMP manufacturing space (~10,000 sq.
+Added: ft.) expected to be fully constructed in the second half of 2024.
+Added: 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.
+Added: The lease expires on December 31, 2031.
+Added: 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.
+Added: 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.
+Added: 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.
+Added: We believe that our facilities are adequate for our current and long-term needs.
+Added: 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
−Removed: In addition, from time to time, we are a party to certain litigation that is either judged to be not material or that arises in the ordinary course of business.
+Added: From time to time, we are a party to certain litigation that is either judged to be not material or that arises in the ordinary course of business.
We intend to vigorously defend our interests in these matters.
7 unchanged sentences
The process of obtaining regulatory approvals and the subsequent compliance with appropriate federal, state, local and foreign statutes and regulations require the expenditure of substantial time and financial resources.
−Removed: Failure to comply
−Removed: with the applicable FDA requirements at any time during the product development process or approval process, or after approval, may subject an applicant to administrative or judicial sanctions.
+Added: Failure to comply with the applicable FDA requirements at any time during the product development process or approval process, or after approval, may subject an applicant to administrative or judicial sanctions.
FDA sanctions could include refusal to approve pending applications, withdrawal of an approval, a clinical hold, warning letters, product recalls, product seizures, total or partial suspension of production or distribution injunctions, fines, refusals of government contracts, restitution, disgorgement or civil or criminal penalties.
31 unchanged sentences
Clinical trials must be conducted in accordance with GCP requirements.
−Removed: 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.
+Added: Further, each clinical trial must be
+Added: 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.
36 unchanged sentences
The FDA will not approve the product unless it determines that the manufacturing processes and facilities are in compliance with cGMP requirements and adequate to assure consistent production of the product within required specifications.
−Removed: The FDA also may audit data from clinical
−Removed: trials to ensure compliance with GCP requirements.
+Added: The FDA also may audit data from clinical trials to ensure compliance with GCP requirements.
Additionally, the FDA may refer applications for novel product candidates or those that present difficult questions of safety or efficacy to an advisory committee, typically a panel that includes clinicians and other experts, for review, evaluation and a recommendation as to whether the application should be approved and, if so, under what conditions.
16 unchanged sentences
Pediatric Information
−Removed: Under the Pediatric Research Equity Act (“PREA”), a BLA or supplement to a BLA must contain data to assess the safety and efficacy of the biologic for the claimed indications in all relevant pediatric subpopulations and to support dosing and administration for each pediatric subpopulation for which the product is safe and effective.
+Added: Under the Pediatric Research Equity Act, a BLA or supplement to a BLA must contain data to assess the safety and efficacy of the biologic for the claimed indications in all relevant pediatric subpopulations and to support dosing and administration for each pediatric subpopulation for which the product is safe and effective.
The FDA may grant deferrals for submission of pediatric data or full or partial waivers.
2 unchanged sentences
The FDA and the sponsor must reach an agreement on the PSP.
−Removed: A sponsor can submit amendments to an agreed-upon initial PSP at any time if
−Removed: changes to the pediatric plan need to be considered based on data collected from preclinical studies, early phase clinical trials and/or other clinical development programs.
+Added: A sponsor can submit amendments to an agreed-upon initial PSP at any time if changes to the pediatric plan need to be considered based on data collected from preclinical studies, early phase clinical trials and/or other clinical development programs.
Special FDA Expedited Review and Approval Programs
1 unchanged sentence
The purpose of these programs is to provide important new drugs and biological products to patients earlier than under standard FDA review procedures.
−Removed: To be eligible for a Fast Track designation, the FDA must determine, based on the request of a sponsor, that a product is intended to treat a serious or life-threatening disease or condition and demonstrates the potential to address an unmet medical need, or if the drug or biological product qualifies as a qualified infectious disease product under the Generating Antibiotic Incentives Now Act (the “GAIN Act”).
+Added: To be eligible for a Fast Track designation, the FDA must determine, based on the request of a sponsor, that a product is intended to treat a serious or life-threatening disease or condition and demonstrates the potential to address an unmet medical need, or if the drug or biological product qualifies as a qualified infectious disease product under the Generating Antibiotic Incentives Now Act.
The FDA will determine that a product will fill an unmet medical need if it will provide a therapy where none exists or provide a therapy that may be potentially superior to existing therapies based on efficacy or safety factors.
2 unchanged sentences
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.
−Removed: 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.
+Added: 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,
+Added: 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.
36 unchanged sentences
Biological product manufacturers and other entities involved in the manufacture and distribution of approved products are required to register their facilities with the FDA and certain state agencies and are subject to periodic unannounced inspections by the FDA and certain state agencies for compliance with cGMPs and other laws.
−Removed: changes to the manufacturing process or facility generally require prior FDA approval before being implemented and other types of changes to the approved product, such as adding new indications and additional labeling claims, are also subject to further FDA review and approval.
+Added: In addition, changes to the manufacturing process or facility generally require prior FDA approval before being implemented and other types of changes to the approved product, such as adding new indications and additional labeling claims, are also subject to further FDA review and approval.
Labeling, Marketing and Promotion
7 unchanged sentences
The term of a U.S.
−Removed: patent can be lengthened by patent term adjustment, which compensates the owner of the patent for administrative delays at the U.S.
+Added: patent can be lengthened by patent term adjustment, which compensates the owner of the patent for administrative delays at the USPTO.
Depending upon the timing, duration and specifics of FDA approval of our drugs, some of our U.S.
−Removed: 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.
+Added: patents may be eligible for limited patent term extension under the Drug Price Competition and Patent Term
+Added: 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.
2 unchanged sentences
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.
−Removed: PTO, in consultation with the FDA, reviews and approves the application for any patent term extension or restoration.
+Added: The USPTO, in consultation with the FDA, reviews and approves the application for any patent term extension or restoration.
Some foreign jurisdictions, including Europe and Japan, have analogous patent term extension provisions, which allow for extension of the term of a patent that covers a drug approved by the applicable foreign regulatory agency.
20 unchanged sentences
or monitor response to treatment with a particular therapeutic product for the purpose of adjusting treatment to achieve improved safety or effectiveness.
−Removed: Companion diagnostics are regulated as medical devices by the FDA and, as such, require either clearance or approval prior to commercialization.
−Removed: The level of risk combined with available controls to mitigate risk determines whether a companion diagnostic device requires Premarket Approval Application (“PMA”) approval or is cleared through the 510(k) premarket notification process.
+Added: Companion diagnostics are regulated as
+Added: medical devices by the FDA and, as such, require either clearance or approval prior to commercialization.
+Added: 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.
8 unchanged sentences
● federal civil and criminal false claims laws and civil monetary penalties laws, such as the federal False Claims Act, which impose criminal and civil penalties and authorize civil whistleblower or qui tam actions, against individuals or entities for, among other things:
−Removed: knowingly presenting, or causing to be presented, to the federal government, claims for payment that are false or fraudulent; making, using or causing to be made or used, a false statement or record material to a false or fraudulent claim or obligation to pay or transmit money or
−Removed: property to the federal government; or knowingly concealing or knowingly and improperly avoiding or decreasing an obligation to pay money to the federal government;
+Added: knowingly presenting, or causing to be presented, to the federal government, claims for payment that are false or fraudulent; making, using or causing to be made or used, a false statement or record material to a false or fraudulent claim or obligation to pay or transmit money or property to the federal government; or knowingly concealing or knowingly and improperly avoiding or decreasing an obligation to pay money to the federal government;
● 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;
−Removed: ● 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;
+Added: ● 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
+Added: 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 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.
16 unchanged sentences
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.
−Removed: 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.
+Added: 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.
13 unchanged sentences
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;
−Removed: introduced a new methodology by which rebates owed by manufacturers under the Medicaid Drug Rebate Program are calculated for
−Removed: drugs that are inhaled, infused, instilled, implanted or injected;
+Added: 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;
3 unchanged sentences
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;
−Removed: and established the Center for Medicare Innovation at the Centers for Medicare and Medicaid (“CMM”) to test innovative payment and service delivery models to lower Medicare and Medicaid spending.
+Added: 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.
3 unchanged sentences
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.
−Removed: The Tax Cuts and Jobs Act of 2017 (“TCJA”), 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.
+Added: 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.
17 unchanged sentences
Once the CTA is approved in accordance with a country’s requirements, the clinical trial may proceed.
−Removed: A similar process to the one described for the European Union is required in Israel for initiation of clinical trials.
+Added: A similar process to the one described for the European Union is required in
+Added: Israel for initiation of clinical trials.
The requirements and process governing the conduct of clinical trials vary from country to country.
26 unchanged sentences
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.
−Removed: 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.
+Added: 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
+Added: 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.
10 unchanged sentences
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.
−Removed: The orphan exclusivity may be lost vis-à-vis another medicinal product in
−Removed: 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.
+Added: 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.
22 unchanged sentences
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.
−Removed: 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
−Removed: 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.
+Added: 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.
24 unchanged sentences
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.
−Removed: 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
−Removed: marketing authorization in accordance with European Union pharmaceutical law.
+Added: 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”).
23 unchanged sentences
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 (see above).
−Removed: 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” (“PUMA”).
+Added: 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.
28 unchanged sentences
Employees and Human Capital
−Removed: As of March 1, 2023, we had 72 full-time employees and 3 part-time employees.
−Removed: Of the 72 full-time employees, 64 were engaged in research and development activities and 8 employees were engaged in finance, legal, human resources,
−Removed: facilities and general management.
+Added: As of March 1, 2024, we had 66 full-time employees.
+Added: 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.
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.
+Added: Our human resources objectives include, as applicable, identifying, recruiting, retaining, incentivizing, and integrating our existing and prospective employees.
+Added: The principal purposes of our incentive plans are to attract, retain and motivate selected employees, consultants, advisors and directors through the granting of stock-based compensation awards and cash-based performance awards, as applicable.
+Added: We provide a comprehensive benefits package to help employees manage their health, well-being, finances, and life outside of work, including health insurance, dental and vision insurance, life insurance, accidental death and dismemberment issuance, short-term and long-term disability insurance, paid sick leave, a defined contribution plan, an employee stock purchase plan, a flexible spending account program, and paid vacation time.
+Added: We value the health, safety, and wellbeing of our employees and their families.
Diversity and Inclusion
7 unchanged sentences
We did not implement any furlough, layoff, or salary reductions during this time.
−Removed: In 2022, we continued to carry out our COVID-19 pandemic preparedness and response procedures to help ensure on-site workers at all of our locations remained safe and healthy.
These precautions have been instrumental in protecting our workforce and helping ensure continued development of our pipeline.
5 unchanged sentences
In addition to cash compensation, we provide equity compensation, healthcare and insurance benefits, health savings and flexible spending accounts, paid time off, family leave, and employee assistance programs.
−Removed: 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 beginning in 2023 we will match, in cash, a portion of the employee contributions.
+Added: 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
8 unchanged sentences
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.
−Removed: In November 2012, AmpliPhi completed the acquisition of Special Phage Holdings Pty Ltd, a
−Removed: 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.
−Removed: Our corporate headquarters are located in Marina del Rey, California, with an address of 4503 Glencoe Avenue, Marnia del Rey, CA 90292, and our telephone number is +1 (310) 665-2928.
+Added: 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.
+Added: Available Information
+Added: All periodic and current reports and other filings that we are required to file with the Securities and Exchange Commission (“SEC”), including our annual report on Form 10-K, quarterly reports on Form 10-Q, current reports on Form 8-K, and amendments to those reports filed or furnished pursuant Section 15(d) of the Securities Exchange Act of 1934, as amended, are available free of charge from the SEC’s website (www.sec.gov) or through our Investor Relations website at https://investor.armatapharma.com.
+Added: Our corporate headquarters are located in Los Angeles, California, with an address of 5005 McConnell Avenue, Los Angeles, CA 90066, and our telephone number is +1 (310) 665-2928.
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.
−Removed: We have included our website address in this annual report soley as an inactive textual reference.
+Added: The information on our website is not incorporated by reference into this Annual Report
+Added: 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.