1 unchanged sentence
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: We 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.
−Removed: We are a leading developer of phage therapeutics which 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 regulation (“cGMP”) manufacturing capabilities to advance a broad pipeline of high-quality bacteriophage product candidates.
−Removed: We believe that synthetic phage, engineered using advances in sequencing and synthetic biology techniques, represent a promising means to advance phage therapy, including improving upon the ability of natural phage to treat bacterial infections, especially those that have developed resistance to current antibiotic therapies, including the multidrug-resistant or “superbug” bacterial pathogens.
−Removed: We are developing and advancing our lead clinical phage candidate for Pseudomonas aeruginosa .
−Removed: On October 14, 2020, Armata received the approval to proceed from the U.S.
−Removed: Food and Drug Administration (“FDA”) for its Investigational New Drug application for AP-PA02.
−Removed: We plan to continue to advance the “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 CF and chronic pulmonary P.
−Removed: aeruginosa infection, provided that the impacts of COVID-19 do not further impede our ability to enroll subjects in this clinical trial.
−Removed: This study is supported by the CFF, which granted us a Therapeutics Development Award of up to $5.0 million.
−Removed: As discussed in more detail below, in October 2021, we issued and sold 909,091 shares of newly issued commons stock to CFF at a per share price of $3.30 pursuant to a private placement transaction.
−Removed: We are also developing a phage product candidate for Staphylococcus aureus for the treatment of S.
−Removed: aureus bacteremia.
−Removed: 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 (“DoD”) through MTEC with funding from the Defense Health Agency and Joint Warfighter Medical Research Program.
−Removed: We expect to use the grant to partially fund a Phase 1b/2a, multi-center, randomized, double-blind, placebo-controlled dose escalation study (“diSArm” study), that will assess the safety, tolerability, and efficacy of AP-SA02, a phage-based candidate for the treatment of adults with S.
+Added: 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 are a leading developer of phage therapeutics and are uniquely positioned to address the growing worldwide threat of antibiotic-resistant bacterial infections.
+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 current good manufacturing practice regulations compliant (“cGMP”) manufacturing capabilities to advance a broad pipeline of high-quality bacteriophage product candidates.
+Added: We are developing and advancing our lead clinical phage candidate for Pseudomonas aeruginosa (“P.
+Added: aeruginosa”) .
+Added: On October 14, 2020, we received the approval to proceed from the U.S.
+Added: Food and Drug Administration (the “FDA”) for our Investigational New Drug (“IND”) application for AP-PA02.
+Added: In the first quarter of 2023, Armata announced positive topline results from the completed “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 and tolerability of inhaled AP-PA02 in subjects with cystic fibrosis (“CF”) and chronic pulmonary P.
+Added: aeruginosa infection.
+Added: Data indicate that AP-PA02 was well-tolerated with a treatment emergent adverse event profile similar to placebo.
+Added: 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: Additionally, bacterial levels of P.
+Added: 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.
+Added: This study is supported by the Cystic Fibrosis Foundation (“CFF”), which granted Armata a Therapeutics Development Award of up to $5.0 million.
+Added: We are also developing and advancing a phage product candidate for Staphylococcus aureus (“S.
+Added: aureus”) for the treatment of complicated S.
+Added: aureus bacteremia, AP-SA02.
+Added: 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.
+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 third quarter of 2024.
+Added: 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.
aureus bacteremia.
−Removed: On November 17, 2021, Armata announced that it had received the approval to proceed from the FDA for its Investigational New Drug application for AP-SA02.
−Removed: We plan to initiate the “diSArm” study provided that the impacts of COVID-19 do not impede our ability to enroll subjects in this clinical trial.
−Removed: In addition to our more advanced pipeline programs, we have phage development efforts underway to target other indications including non-cystic fibrosis bronchiectasis (“NCFB”), prosthetic joint infections (“PJI”) and hospitalized pneumonia.
−Removed: Our proprietary phage engineering platform serves to enhance the clinical and commercial prospects of phage therapy.
−Removed: We are committed to conducting randomized controlled clinical trials required for FDA approval in order to move toward 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: Corporate History and Reorganization
−Removed: Armata was created as a result of a business combination of AmpliPhi Biosciences Corporation, a bacteriophage development stage company (“AmpliPhi”) with C3J Therapeutics, Inc.
−Removed: (“C3J”), where Ceres Merger Sub, Inc., a wholly-owned subsidiary of AmpliPhi, merged with and into C3J (the “Merger”).
−Removed: On May 9, 2019, immediately prior to the closing of the Merger, AmpliPhi changed its name to Armata Pharmaceuticals, Inc.
−Removed: C3J’s predecessor, C3 Jian, Inc., was incorporated under the laws of the State of California on November 4, 2005.
−Removed: On February 26, 2016, as part of a reorganization transaction, C3 Jian, Inc.
−Removed: merged with a wholly-owned subsidiary of C3J, and as part of this process, C3 Jian, Inc.
−Removed: was converted to a limited liability company organized under the laws of the State of California named C3 Jian, LLC.
−Removed: Prior to the Merger, C3J was privately held and was financed principally through a series of equity financings.
−Removed: AmpliPhi was incorporated under the laws of the State of Washington in March 1989 as a wholly-owned subsidiary of Immunex Corporation and began operations as an independent company in 1992 as Targeted Genetics Corporation.
−Removed: 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 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: Business Update Regarding COVID-19
−Removed: In March 2020, the World Health Organization (“WHO”) declared COVID-19 a global pandemic and the United States declared a national emergency with respect to COVID-19.
−Removed: The COVID-19 pandemic has directly and indirectly impacted our business, results of operations and financial condition and is expected to continue to impact our business.
−Removed: For example, the COVID-19 pandemic has resulted in delays in our clinical trials due to the implementation of COVID-19 protocols at investigator sites, which resulted in longer than anticipated site identification and initiation activities.
−Removed: In addition, while we currently do not anticipate any interruptions in our supply chain, it is possible that the COVID-19 pandemic and the continuing response efforts may have a future impact on our third-party suppliers and partners.
−Removed: It is possible that due to the continued development and manufacturing of vaccines for COVID-19, certain basic supply chain materials such as resins, vessels, vials and stoppers may be in high demand by the pharmaceutical companies developing and manufacturing vaccines and our ability to obtain these materials for our development activities could be negatively impacted.
−Removed: Although we have experienced some delays of this nature during 2021, such delays have not had a material adverse impact on our business, results of operations or financial condition .
−Removed: The full extent of the COVID-19 pandemic impact continues to depend on future developments that remain highly uncertain and cannot be accurately predicted, including new information that may emerge concerning COVID-19, the actions taken to contain it or treat its impact, the identification and spread of COVID-19 variants such as the Delta and the Omicron variants, the distribution of vaccines, the acceptance of vaccines and the implementation of vaccine mandates, and the economic impact on local, regional, national and international markets.
−Removed: Management continues to actively monitor the developments regarding the pandemic and the impact that the pandemic could have on our financial condition, liquidity, ability to enroll patients in our contemplated clinical trials, manufacturing and research and development operations, suppliers to our operations and suppliers to our outside clinical trial organizations, biotech industry overall, and importantly the health and safety of our workforce.
−Removed: Given the continued volatility of the COVID-19 pandemic and the global responses to curb its spread, we are not able to estimate the effects of the COVID-19 pandemic on our results of operations, financial condition, or liquidity for 2022.
−Removed: Any recovery from negative impacts to our business and related economic impact due to the COVID-19 pandemic may also be slowed or reversed by a number of factors, including the current widespread resurgence in COVID-19 infections attributable to the Omicron variant, combined with the seasonal flu.
+Added: On November 17, 2021, Armata announced that it had received from the FDA the approval to proceed for our IND application for AP-SA02.
+Added: 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.
+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: The Company 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: 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”).
+Added: 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.
+Added: 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.
Recent Developments
−Removed: NCFB Investigational New Drug (“IND”) Approval
−Removed: On February 22, 2022, we announced that the U.S.
−Removed: FDA has cleared Armata's IND application to initiate a clinical trial of its optimized lead therapeutic candidate, AP-PA02, in a second indication, NCFB.
−Removed: The company plans to initiate a Phase 2 trial in 2022.
+Added: 2023 Credit Agreement
+Added: 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.
+Added: INVA) (collectively, “Innoviva”), a principal stockholder of us.
+Added: 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.
+Added: 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.
+Added: 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.
+Added: After such registration statement has been declared effective by the U.S.
+Added: 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).
+Added: PJI IND Approval
+Added: On August 1, 2022, we announced that the FDA has cleared Armata's IND application for AP-SA02, in a second indication, PJI.
+Added: The Company plans to initiate a Phase 1b/2 trial in PJI in 2023.
+Added: NCFB IND Approval
+Added: 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.
+Added: We initiated a Phase 2 trial in NCFB in 2022 and announced first patient dosing in the first quarter of 2023.
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 Strategic Opportunities LLC, a wholly ‐ owned subsidiary of Innoviva, Inc.
−Removed: INVA) (collectively, "Innoviva"), our largest shareholder.
−Removed: The gross proceeds from the transaction are expected to be $45 million, before deducting estimated offering expenses.
−Removed: Pursuant and subject to the terms and conditions of the securities purchase agreement and related agreements, Innoviva will 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 are expected to occur in two tranches.
−Removed: Upon execution, 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 $18.1 million.
−Removed: At the closing of the second tranche, upon our stockholders voting in favor of the transaction, Innoviva will purchase 5,385,208 shares of common stock and warrants to purchase 2,692,604 shares of common stock for an aggregate purchase price of $26.9 million.
−Removed: Subject to the satisfaction of certain closing conditions, including the approval of our stockholders, the second closing contemplated by the securities purchase agreement is expected to occur near the end of the first quarter of 2022.
−Removed: October 2021 Private Placements
−Removed: On October 28, 2021, we entered into a securities purchase agreement (the “October 2021 Securities Purchase Agreement”) with the Cystic Fibrosis Foundation, a Delaware corporation (“CFF”), our partner for the lead Phase 1b/2a clinical development program, and Innoviva for the private placement of newly issued shares of our common stock, par value $0.01 per share (“Common Stock”).
−Removed: Pursuant to the October 2021 Securities Purchase Agreement, we issued and sold 909,091 shares to CFF and 1,212,122 shares to Innoviva, each at a per share price of $3.30 (the “October 2021 Private Placements”).
−Removed: We received aggregate gross proceeds from the October 2021 Private Placements of approximately $7.0 million, before deducting transaction expenses.
−Removed: 2021 Lease Agreement
−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”).
−Removed: The leased space comprises approximately 56,000 square feet.
−Removed: The 2021 Lease payment start date is 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.
−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.
+Added: 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.
+Added: INVA) (collectively, "Innoviva"), a principal stockholder of us.
+Added: 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.
+Added: The stock purchases were completed in two tranches.
+Added: 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.
+Added: 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.
+Added: Executive Transition
+Added: On June 30, 2022, Steve R.
+Added: Martin retired as our Chief Financial Officer and Senior Vice President (and Principal Financial and Accounting Officer).
+Added: 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.
+Added: 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.
The following chart summarizes the status of our phage product candidate development programs and partners.
6 unchanged sentences
● 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 non-cystic fibrosis bronchiectasis (“NCFB”) and hospitalized pneumonia.
+Added: aeruginosa infections such as NCFB and hospitalized pneumonia.
● Initiate and advance clinical trials of AP-SA02 in patients with S.
1 unchanged sentence
● Develop AP-SA02 for the treatment of other antibiotic-resistant and difficult-to-treat S.
−Removed: aureus infections such as periprosthetic joint infections (“PJI”).
+Added: aureus infections such as PJI.
The Need for New Anti-Infective Therapies
145 unchanged sentences
Platform Technologies
−Removed: Proprietary Synthetic Phage Platform
+Added: Synthetic Phage Platform
Phages, natural predators of bacteria, have been in an uninterrupted battle for millions of years – evolving to kill or evade.
1 unchanged sentence
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, with the potential to create supercharged synthetic phages that, once marketing authorization is obtained, can be deployed in the clinic as highly effective weapons in the fight against multidrug-resistant bacterial infections.
−Removed: Engineering natural phages may broaden their host range, minimize resistance and improve efficacy through the expression of beneficial moieties such as biofilm-degrading enzymes and antimicrobial peptides.
+Added: biology tools enables us to precisely engineer natural phages in ways that further improve their pharmacological properties and antimicrobial activity.
+Added: 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.
Phage Discovery and Phenotyping:
2 unchanged sentences
Bioinformatics Powers Engineering:
−Removed: In partnership with Synthetic Genomics, we employ next-generation sequencing and a proprietary sequencing database and software for the analyses of our phages.
+Added: We employ next-generation sequencing, proprietary sequencing databases and software, bioinformatics, and comparative genomics, for the analyses of our phages.
Engineering Phage to Confer Desirable Properties:
21 unchanged sentences
aureus natural phage cocktails, Armata will gain experience treating site-specific as well as systemic infections.
−Removed: We believe our cGMP-facility has the capacity to produce our proprietary bacteriophage therapeutics for our clinical trials through a potential biologics license application filing and potential approval.
Pseudomonas aeruginosa Phage Product Candidate, AP-PA02
32 unchanged sentences
AP-PA02 is comprised of a cocktail of natural P.
−Removed: aeruginosa phages originating from distinct families and subfamilies, targeting multiple receptor classes, functioning with compatibility (i.e., the phages don’t interfere with one
−Removed: 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.
+Added: 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 coverage.
+Added: trial (described below), our clinical isolate screening and phage collections yielded a three-phage AP-PA02 cocktail with compelling host-range
We subsequently modified AP-PA02 to include additional phage genera that increase potency and broaden coverage of strains of P.
16 unchanged sentences
AP-PA02 product candidate is currently in clinical development.
−Removed: On October 14, 2020, Armata received approval for the study to proceed from the FDA for its Investigational New Drug (“IND”) to initiate the “SWARM- P.a.
+Added: On October 14, 2020, Armata received approval for the study to proceed from the FDA for its IND to initiate the “SWARM- P.a.
” study – a Phase 1b/2a, 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.
3 unchanged sentences
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
−Removed: above) was advanced through manufacturing and regulatory review for introduction into the MAD component of the SWARM- P.a.
−Removed: The SWARM- P.a.
−Removed: study is designed to include a total of approximately 32 subjects in multiple U.S.-based sites.
−Removed: We anticipate generating topline data from the SWARM- P.a.
−Removed: study in 2022.
+Added: 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.
The SWARM- P.a.
study is supported by the CFF, which in March 2020 granted us a Therapeutics Development Award of up to $5.0 million.
+Added: In the first quarter of 2023, Armata announced positive topline results from the completed “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 and tolerability of inhaled AP-PA02 in subjects with cystic fibrosis (“CF”) and chronic pulmonary P.
+Added: aeruginosa infection.
+Added: Data indicate that AP-PA02 was well-tolerated with a treatment emergent adverse event profile similar to placebo.
+Added: 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: Additionally, bacterial levels of P.
+Added: 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.
With positive outcomes from this first study, SWARM- P.a.
4 unchanged sentences
aeruginosa Phage Product Candidates
−Removed: In addition to pursuing lung infections in CF patients, we have begun charting the appropriate clinical and regulatory paths for other respiratory infections with high unmet clinical need, such as in NCFB patients as well as acute cases of pneumonia in hospitalized patients.
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.
−Removed: In 2022, we received regulatory approval to a initiate Phase 2 clinical trial for NCFB using AP-PA02.
−Removed: The Company plans to initiate a Phase 2 trial during 2022.
+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, NCFB.
+Added: The Company initiated a Phase 2 trial (“Tail wind ”) in NCFB in 2022 and reported first patient dosing in the first quarter of 2023.
+Added: 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.
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, that is entering manufacturing with a regulatory filing expected in 2022 or 2023.
+Added: We have deployed our extensive clinical isolate collection and phage library to identify a candidate phage cocktail, AP-PA03.
Staphylococcus aureus Phage Product Candidate, AP-SA02
15 unchanged sentences
We no longer offer AP-SA01 through any expanded access program.
−Removed: Human exposure through treatment of single patients with AP-SA01 under the expanded access program has been helpful in demonstrating the promise of phage therapy and warrants further study to support safety and efficacy through
−Removed: randomized controlled trials required to support registration.
+Added: Human exposure through treatment of single patients with AP-SA01 under the expanded access program has been helpful in demonstrating the promise of phage therapy and warrants further study to support safety and efficacy through randomized controlled trials required to support registration.
Feedback from a Type B pre-IND meeting with the FDA in August 2018 has been insightful for the regulatory path required for phage therapeutics in general, and specifically for a phage product candidate intended for systemic delivery.
16 unchanged sentences
Clinical Development of AP-SA02 in Bacteremia
−Removed: On November 17, 2021, Armata received approval for the study to proceed from the FDA for its Investigational New Drug (“IND”) to initiate the “diSArm” study – a Phase 1b/2a, randomized, double‐blind, placebo‐controlled, multiple ascending dose escalation study of the safety, tolerability, and efficacy of intravenous AP‐SA02 as an adjunct to best available antibiotic therapy compared to best available antibiotic therapy alone for the treatment of adults with bacteremia due to Staphylococcus aureus .
+Added: On November 17, 2021, Armata received approval for the study to proceed from the FDA for its IND to initiate the “diSArm” study – a Phase 1b/2a, randomized, double‐blind, placebo‐controlled, multiple ascending dose escalation study of the safety, tolerability, and efficacy of intravenous AP‐SA02 as an adjunct to best available antibiotic therapy compared to best available antibiotic therapy alone for the treatment of adults with bacteremia due to Staphylococcus aureus .
The objectives of this study are to:
3 unchanged sentences
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 the Medical Technology Enterprise Consortium (“MTEC”) with funding from the Defense Health Agency and Joint Warfighter Medical Research Program.
+Added: 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.
+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 third quarter of 2024.
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.
2 unchanged sentences
Additional Clinical Indications for AP-SA02
−Removed: Improved patient outcomes are needed for other Staphylococcal infections, in settings such as prosthetic joint infection (“PJI”), for which antimicrobial resistance is a growing concern.
+Added: Improved patient outcomes are needed for other Staphylococcal infections, in settings such as PJI, for which antimicrobial resistance is a growing concern.
We believe AP-SA02 could also have a meaningful impact in this indication, particularly PJIs caused by methicillin-resistant S.
−Removed: aureus (“MRSA").
−Removed: A regulatory filing for AP-SA02 in this indication is expected in 2022.
+Added: aureus (“MRSA”).
+Added: 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.
+Added: 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.
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 proprietary synthetic phage platform.
+Added: 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.
These powerful natural phages can be purposely engineered to be more efficient killers.
−Removed: The use of synthetic biology tools enables us to precisely engineer natural phages in ways that further improve their pharmacological properties and antimicrobial activity, with the potential to create supercharged synthetic phages that can be deployed in the clinic as highly effective weapons in the fight against multidrug-resistant bacterial infections.
+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.
−Removed: On our own, and in partnership, we are developing proprietary synthetic phage candidates designed to target pathogens such as Pseudomonas aeruginosa , as well as undisclosed infectious disease agents.
Manufacturing
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Strategic Alliances and Research Agreements
−Removed: 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 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.
+Added: 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.
+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 third quarter of 2024.
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.
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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 January 25, 2024.
+Added: The MTEC Agreement will be effective through October 30, 2024.
The MTEC Agreement may be terminated in whole or in part, 30 calendar days following the written notice from either party.
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CFF Therapeutics Development Award
−Removed: On March 13, 2020, we entered into an award agreement (the “Agreement”) with the CFF, pursuant to which we received a Therapeutics Development Award of up to $5.0 million (the “Award”).
+Added: 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”).
The Award will be used to fund a portion of our Phase 1b/2a clinical trial of the P.
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aeruginosa airway infections in people with CF.
−Removed: The first payment under the Agreement, in the amount of $1.0 million, became due upon signing the 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 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 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 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 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: 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.
+Added: 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.
+Added: 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.
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.
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 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 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 Agreement.
−Removed: Either CFF or Armata may terminate the agreement for cause, which includes our material failure to achieve certain development milestones.
−Removed: Our payment obligations survive the termination of the Agreement.
+Added: We may also be obligated to make a
+Added: 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.
+Added: 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.
+Added: Either CFF or Armata may terminate the Award Agreement for cause, which includes our material failure to achieve certain development milestones.
+Added: Our payment obligations survive the termination of the Award Agreement.
License Agreements
Amended and Restated Research Collaboration and Option to License Agreement with Merck
−Removed: Pursuant to the terms of the Research and Option Agreement, 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: 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.
+Added: (“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.
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.
−Removed: Further, 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: We will be entitled to milestone payments tied to the achievement of product development and regulatory milestones, and royalty payments based on net sales of products developed pursuant to the Research and Option Agreement.
−Removed: Each party to the Research and Option Agreement is responsible for its costs and expenses in connection with the research program.
−Removed: Unless the Research and Option Agreement is terminated by Merck, it will continue in full force and effect until one or more products developed thereunder has received marketing authorization and, thereafter, until expiration of all royalty obligations thereunder.
−Removed: Upon termination of the Research and Option Agreement, Merck’s licenses pursuant to the Research and Option Agreement will become fully paid-up, perpetual licenses.
+Added: 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.
+Added: 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.
License Agreement with United Kingdom Secretary of State for the Department of Health
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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”).
−Removed: The 2021 Lease payment start date is May 1, 2022, and the total lease term is for 16 years and runs through 2038.
+Added: The 2021 Lease payment start date was May 1, 2022, and the total lease term is for 16 years and runs through 2038.
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.
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patent can be lengthened by patent term adjustment, which compensates the owner of the patent for administrative delays at the U.S.
−Removed: Patent and Trademark Office (“PTO”).
Depending upon the timing, duration and specifics of FDA approval of our drugs, some of our U.S.
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and (3) one or more clinical trials to demonstrate safety, purity and potency in one or more appropriate conditions of use for which the reference product is approved.
−Removed: In addition, the applicant must show that the biosimilar and reference products
−Removed: have the same mechanism of action for the conditions of use on the label, route of administration, dosage and strength, and the production facility must meet standards designed to assure product safety, purity and potency.
+Added: In addition, the applicant must show that the biosimilar and reference products have the same mechanism of action for the conditions of use on the label, route of administration, dosage and strength, and the production facility must meet standards designed to assure product safety, purity and potency.
An application for a biosimilar product may not be submitted until four years after the date on which the reference product was first approved.
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● 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
−Removed: 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;
+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
+Added: 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;
−Removed: ● The Health Insurance Portability and Accountability (“HIPAA”), which created new federal criminal statutes that prohibit knowingly and willfully executing, or attempting to execute, a scheme to defraud any healthcare benefit program or obtain, by means of false or fraudulent pretenses, representations, or promises, any of the money or property owned by, or under the custody or control of, any healthcare benefit program, regardless of the payor (e.g., public or private) and knowingly and willfully falsifying, concealing or covering up by any trick or device a material fact or making any materially false statements in connection with the delivery of, or payment for, healthcare benefits, items or services relating to healthcare matters; similar to the federal Anti-Kickback Statute, a person or entity does not need to have actual knowledge of the statute or specific intent to violate it in order to have committed a violation;
−Removed: ● HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009, 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;
−Removed: ● the federal transparency requirements under the Affordable Care Act, 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.
+Added: ● 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;
+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 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: ● the federal transparency requirements under the Affordable Care Act (the “ACA”), including the provision commonly referred to as the Physician Payments Sunshine Act, which requires manufacturers of drugs, devices, biologics and medical supplies for which payment is available under Medicare, Medicaid or the Children’s Health Insurance Program to report annually to the U.S.
Department of Health and Human Services information related to payments or other transfers of value made to physicians (defined to include doctors, dentists, optometrists, podiatrists and chiropractors) and teaching hospitals, as well as ownership and investment interests held by the physicians described above and their immediate family members;
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There are ambiguities as to what is required to comply with these state requirements, and if we fail to comply with an applicable state law requirement, we could be subject to penalties.
−Removed: Finally, there are state and foreign laws governing the privacy and security of health
−Removed: information, many of which differ from each other in significant ways and often are not preempted by HIPAA, thus complicating compliance efforts.
+Added: Finally, there are state and foreign laws governing the privacy and security of health information, many of which differ from each other in significant ways and often are not preempted by HIPAA, thus complicating compliance efforts.
Because of the breadth of these laws and the narrowness of the statutory exceptions and safe harbors available, it is possible that some of our business activities could be subject to challenge under one or more of such laws.
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healthcare industry and elsewhere is cost containment.
−Removed: Government authorities and other third-party payors have attempted to control costs by limiting coverage and the amount of reimbursement for
−Removed: particular medical products.
−Removed: For example, in March 2010, the Affordable Care Act (“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 drugs that are inhaled, infused, instilled, implanted or injected;
+Added: Government authorities and other third-party payors have attempted to control costs by limiting coverage and the amount of reimbursement for particular medical products.
+Added: 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;
+Added: introduced a new methodology by which rebates owed by manufacturers under the Medicaid Drug Rebate Program are calculated for
+Added: 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;
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The centralized procedure provides for the grant of a single marketing authorization by the European Commission that is valid for all European Union member states.
−Removed: The centralized procedure is compulsory for certain medicinal products, including for medicinal products produced by certain biotechnological processes, products designated as
−Removed: orphan medicinal products, advanced therapy medicinal products (“ATMPs”) and products with a new active substance and indicated for the treatment of certain diseases.
+Added: The centralized procedure is compulsory for certain medicinal products, including for medicinal products produced by certain biotechnological processes, products designated as orphan medicinal products, advanced therapy medicinal products (“ATMPs”) and products with a new active substance and indicated for the treatment of certain diseases.
For products with a new active substance and indicated for the treatment of other diseases, products that are highly innovative or for which a centralized process is in the interest of patients, the centralized procedure is optional.
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In the European Union, orphan drug designation entitles the sponsor to financial incentives such as reduction of fees or fee waivers and to ten years of market exclusivity granted following medicinal product approval.
−Removed: Market exclusivity
−Removed: precludes the EMA or a national regulatory authority from validating another MAA, and the European Commission or a national regulatory authority from granting another marketing authorization, for the same or similar medicinal product and the same therapeutic indication, for that time period.
+Added: Market exclusivity precludes the EMA or a national regulatory authority from validating another MAA, and the European Commission or a national regulatory authority from granting another marketing authorization, for the same or similar medicinal product and the same therapeutic indication, for that time period.
This 10-year period may be reduced to six years if the orphan drug designation criteria are no longer met, including where it is shown that the product is sufficiently profitable not to justify maintenance of market exclusivity.
−Removed: 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.
+Added: The orphan exclusivity may be lost vis-à-vis another medicinal product in
+Added: 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.
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PRIME status enables early dialogue with the relevant EMA scientific committees and, possibly, some payors and thus reinforces the EMA’s scientific and regulatory support.
−Removed: It also opens accelerated assessment of the MAA as PRIME
−Removed: 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 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: 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.
+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
+Added: 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.
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Furthermore, authorized drugs and biologics may benefit from regulatory exclusivities (in additional to patent protection resulting from patents).
−Removed: In the European Union, Regulation (EC) 469/2009 institutes a supplementary protection certificate (“SPC”).
+Added: In the European Union, Regulation (EC) 469/2009 institutes a SPC.
An SPC is an extension of the term of a patent that compensates for the patent protection lost because of the legal requirements to conduct safety and efficacy tests and to obtain a marketing authorization before placing a medicinal product on the market.
−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 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
+Added: 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”).
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Pediatric reward is another regulatory exclusivity.
−Removed: 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
−Removed: additional years of market exclusivity (see above).
+Added: 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).
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”).
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Employees and Human Capital
−Removed: As of March 1, 2022, we had 69 full-time employees and two part-time employees.
−Removed: Of the 69 full-time employees, 62 were engaged in research and development activities and seven employees were engaged in finance, legal, human resources, facilities and general management.
+Added: As of March 1, 2023, we had 72 full-time employees and 3 part-time employees.
+Added: Of the 72 full-time employees, 64 were engaged in research and development activities and 8 employees were engaged in finance, legal, human resources,
+Added: facilities and general management.
We have no collective bargaining agreements with our employees, we have not experienced any work stoppages and we believe our relations with our employees are good.
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We continue to enhance our diversity, equity and inclusion policies that are guided by our executive leadership team.
−Removed: Workforce Health and Safety
+Added: Health, Safety and Well-Being
+Added: Protecting the health, safety and well-being of colleagues and , all of whom are essential to delivering our business objectives, is an integral part of how we operate.
In response to the COVID-19 pandemic in 2020, we instituted a remote work protocol to help ensure the safety of our employees, our community, and to adhere to federal, state, and local requirements and the CDC recommendations of social distancing and limited public exposure in connection with the COVID-19 pandemic.
We did not implement any furlough, layoff, or salary reductions during this time.
−Removed: We continue to evaluate our ability to operate in light of recent resurgences of COVID-19 and the advisability of continuing operations based on federal, state and local guidance, evolving data concerning the pandemic and the best interests of our employees, third parties with whom we collaborate, and our stockholders.
+Added: 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.
+Added: These precautions have been instrumental in protecting our workforce and helping ensure continued development of our pipeline.
+Added: We continue to evaluate our pandemic preparedness and response procedures and the advisability of continuing operations based on federal, state and local guidance, evolving data concerning the pandemic and the best interests of our employees, third parties with whom we collaborate, and our stockholders.
Compensation and Benefits
+Added: Our commitment to pay equity for all colleagues is rooted in our core values and our intention is to continue to build a diverse and inclusive workforce.
+Added: We are committed to equitable pay practices for employees based on role, education, experience, performance, and location and Armata conducts pay equity reviews on an annual basis.
We believe that we must offer and maintain market competitive compensation and benefit programs for our employees in order to attract and retain qualified personnel.
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.
+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 beginning in 2023 we will match, in cash, a portion of the employee contributions.
Corporate History and Reorganization
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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 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: In November 2012, AmpliPhi completed the acquisition of Special Phage Holdings Pty Ltd, a
+Added: 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: 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: 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.
+Added: We have included our website address in this annual report soley as an inactive textual reference.
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.