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Item 7.01 | Regulation FD Disclosure. |
On March 6, 2023, Armata Pharmaceuticals, Inc. (the “Company”) issued a press release pertaining to topline data from a clinical trial and the dosing of the first subject in the Company’s Tailwind study. The full text of the press release issued in connection with this announcement is furnished as Exhibit 99.1 to this Current Report on Form 8-K (this “Form 8-K”).
Furnished as Exhibit 99.2 to this Form 8-K is an updated investor presentation that the Company plans to present to certain prospective investors that the Company will also post on its website.
The information in this Item 7.01 and Exhibits 99.1 and 99.2 attached to this Form 8-K are being furnished and shall not be deemed “filed” for the purposes of Section 18 of the Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, regardless of any general incorporation language in such filing.
Item 9.01 | Financial Statements and Exhibits. |
(d) | Exhibits. |
Exhibit |
Description | ||
99.1 | Press Release, dated March 6, 2023. | ||
99.2 | Updated Investor Presentation. | ||
104 | Cover Page Interactive Data File (embedded within Inline XBRL document). |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
Date: March 6, 2023 | Armata Pharmaceuticals, Inc. | |
By: | /s/ Erin Butler | |
Name: | Erin Butler | |
Title: | Vice President, Finance & Administration |
Exhibit 99.1
Armata Pharmaceuticals Announces Positive Topline Data from Phase 1b/2a SWARM-P.a. Clinical Trial of Inhaled AP-PA02 in Patients with Cystic Fibrosis
AP-PA02 is well-tolerated and data supports progression to Phase 2b
Also announces first subject dosed in Phase 2 ‘Tailwind’ clinical trial of inhaled AP-PA02 in patients with Non-Cystic Fibrosis Bronchiectasis (NCFB)
NCFB represents Armata’s third active clinical program
MARINA DEL REY, Calif., March 6, 2023 -- Armata Pharmaceuticals, Inc. (NYSE American: ARMP) (“Armata” or the “Company”), a biotechnology company focused on pathogen-specific bacteriophage therapeutics for antibiotic-resistant and difficult-to-treat bacterial infections, today announced positive topline results from the completed Phase 1b/2a SWARM-P.a. trial evaluating AP-PA02, a novel, inhaled multi-phage therapeutic for the treatment of chronic pulmonary Pseudomonas aeruginosa infections in cystic fibrosis patients.
“We are pleased to present topline data for our lead multi-phage candidate, AP-PA02, which was evaluated in cystic fibrosis patients in the SWARM-P.a. clinical trial, and to announce the dosing of the first subject in our Tailwind study of AP-PA02 in NCFB,” stated Mina Pastagia, MD, MS, Chief Medical Officer at Armata. “The data from our SWARM-P.a. study gives us confidence that the pharmacokinetics of inhaled phage are predictable and suggest that optimized exposures will correlate with bacterial load reduction. CF and NCFB are chronic pulmonary disorders in which the bronchi become permanently dilated due to a cycle of mucus production, inflammation, and lung tissue damage. The airways often then become colonized by Pseudomonas aeruginosa, with the same bacterial lineage persisting in the lungs of patients for decades despite the use of life-long inhaled antibiotics.”
The SWARM-P.a. trial was a multi-center, randomized, double-blind, placebo-controlled, single- and multiple-ascending dose study that evaluated the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of AP-PA02.
Data indicate that AP-PA02 was well-tolerated with a treatment emergent adverse event (TEAE) profile similar to placebo. Only mild, self-limited adverse events possibly related to study drug were reported in a few subjects.
PK findings confirm that AP-PA02 can be effectively delivered to the lungs through nebulization with minimal systemic exposure. Single ascending doses (SAD) and multiple ascending doses (MAD) resulted in a proportional increase in exposure as measured in induced sputum. Additionally, achieved exposures were relatively consistent from subject to subject.
Bacterial levels of P. aeruginosa in the sputum were measured at several timepoints and compared to baseline levels prior to study drug administration. Trends suggest improvement in bacterial load reduction for subjects treated with AP-PA02 at end of treatment as compared to placebo after ten days of dosing. Importantly, for subjects with the highest average exposure of susceptible phage, there was durability of approximately two-log reduction from end of treatment to end of study (day 28 post dose). PK/PD analysis indicates significant microbiological impacts in the subjects with highest exposures.
Armata also announced today that it has dosed the first subject in its Tailwind study of nebulized AP-PA02 in patients with non-cystic fibrosis bronchiectasis (NCFB). The Tailwind study (NCT05616221) is a double blind, randomized, placebo-controlled trial that will evaluate the safety, tolerability, and efficacy of inhaled AP-PA02 as monotherapy, as well as in combination with inhaled antibiotics. Pharmacokinetic data from SWARM-P.a. were used to design an optimized AP-PA02 dosing regimen for the Tailwind study. Insights from Tailwind will be important for the concurrent design of the Phase 2b cystic fibrosis study, which will be powered to evaluate the efficacy and durability of phage response over time.
“Data from Tailwind, together with our recently completed SWARM-P.a. trial, are intended to provide further evidence of the clinical value of phage therapy as a novel approach for the treatment of chronic, biofilm-related respiratory infections, and will hopefully move Armata one step closer to establishing phage as a new and powerful class of anti-infectives,” stated Dr. Pastagia.
“The initiation of patient dosing in the Tailwind study represents our third active clinical program, highlighting our commitment to bring much needed innovation to clinical indications where antibiotic therapy is failing,” stated Dr. Brian Varnum, Chief Executive Officer of Armata. “In addition to our recently completed SWARM-P.a. study, we have line-of-sight to two additional data readouts that can potentially provide new hope to patients suffering from serious and difficult to treat bacterial infections.”
About Armata Pharmaceuticals, Inc.
Armata is 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 its proprietary bacteriophage-based technology. Armata is developing and advancing a broad pipeline of natural and synthetic phage candidates, including clinical candidates for Pseudomonas aeruginosa, Staphylococcus aureus, and other pathogens. Armata is committed to advancing phage with drug development expertise that spans bench to clinic including in-house phage specific GMP manufacturing.
Forward Looking Statements
This communication contains "forward-looking" statements, including, without limitation, statements related to Armata's bacteriophage development programs, Armata’s ability to set up or operate R&D and manufacturing facilities, Armata's ability to meet expected milestones, Armata's ability to be a leader in the development of phage-based therapeutics, and statements related to the timing and results of clinical trials, including the anticipated results of clinical trials of AP-PA02 and AP-SA02, and Armata's ability to develop new products based on bacteriophages and synthetic phages. Any statements contained in this communication that are not statements of historical fact may be deemed to be forward-looking statements. These forward-looking statements are based upon Armata's current expectations. Forward-looking statements involve risks and uncertainties. Armata's actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, risks related to the ability of Armata's lead clinical candidates, AP-PA02 and AP-SA02, to be more effective than previous candidates; that the top line results are indicative of the final data, Armata's ability to expedite development of AP-PA02; Armata's ability to advance its preclinical and clinical programs and the uncertain and time-consuming regulatory approval process; Armata's ability to develop products based on bacteriophages and synthetic phages to kill bacterial pathogens; the Company's expected market opportunity for its products; Armata's ability to sufficiently fund its operations as expected, including obtaining additional funding as needed; and any delays or adverse events within, or outside of, Armata's control, caused by the ongoing COVID-19 pandemic. Additional risks and uncertainties relating to Armata and its business can be found under the caption "Risk Factors" and elsewhere in Armata's filings and reports with the SEC, including in Armata's Annual Report on Form 10-K, filed with the SEC on March 17, 2022, and in its subsequent filings with the SEC.
Armata expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in Armata's expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based.
Media Contacts:
At Armata:
Pierre Kyme
Armata Pharmaceuticals, Inc.
ir@armatapharma.com
310-665-2928 x234
Investor Relations:
Joyce Allaire
LifeSci Advisors, LLC
jallaire@lifesciadvisors.com
212-915-2569
Exhibit 99.2
February 22, 2023 NYSE American: ARMP CONFIDENTIAL
2 Forward Looking Statements This presentation contains “forward - looking” statements that involve risks, uncertainties and assumptions . If the risks or uncertainties materialize or the assumptions prove incorrect, our results may differ materially from those expressed or implied by such forward - looking statements . All statements other than statements of historical fact could be deemed forward - looking, including, but not limited to : our estimates regarding anticipated operating losses, capital requirements and needs for additional funds ; our ability to raise additional capital when needed and to continue as a going concern ; our ability to manufacture, or otherwise secure the manufacture of, sufficient amounts of our product candidates for our preclinical studies and clinical trials ; our clinical development plans, including planned clinical trials ; our research and development plans, including our clinical development plans ; our ability to select combinations of phages to formulate our product candidates ; our development of bacteriophage - based therapies ; the potential use of bacteriophages to treat bacterial infections ; the potential future of antibiotic resistance ; our ability for bacteriophage therapies to disrupt and destroy biofilms and restore sensitivity to antibiotics ; our planned development strategy, presenting data to regulatory agencies and defining planned clinical studies ; the expected timing of additional clinical trials, including Phase 1 b/Phase 2 or registrational clinical trials ; our ability to manufacture and secure sufficient quantities of our product candidates for clinical trials ; the drug product candidates to be supplied by us for clinical trials ; the potential for bacteriophage technology being uniquely positioned to address the global threat of antibiotic resistance ; the safety and efficacy of our product candidates ; our anticipated regulatory pathways for our product candidates ; the activities to be performed by specific parties in connection with clinical trials ; our ability to successfully complete preclinical and clinical development of, and obtain regulatory approval of our product candidates and commercialize any approved products on our expected timeframes or at all ; our pursuit of additional indications ; the content and timing of submissions to and decisions made by the U . S . Food and Drug Administration (the “FDA”) and other regulatory agencies ; our ability to leverage the experience of our management team and to attract and retain management and keep management and other key personnel ; the capacities and performance of our suppliers, manufacturers, contract research organizations (“CROs”) and other third parties over whom we have limited control ; our ability to staff and maintain our Marina del Rey production facility under fully compliant current Good Manufacturing Practices ; the actions of our competitors and success of competing drugs or other therapies that are or may become available ; our expectations with respect to future growth and investments in our infrastructure, and our ability to effectively manage any such growth ; the size and potential growth of the markets for any of our product candidates, and our ability to capture share in or impact the size of those markets ; the benefits of our product candidates ; potential market growth and market and industry trends ; maintaining collaborations with third parties including our partnership with the Cystic Fibrosis Foundation and the U . S . Department of Defense (the “DoD”) ; potential future collaborations with third parties and the potential markets and market opportunities for product candidates ; our ability to achieve our vision, including improvements through engineering and success of clinical trials ; our ability to meet anticipated milestones for 2023 ; our ability to be a leader in the development of phage - based therapeutics ; the expected use of proceeds from the $ 16 . 3 million DoD grant ; the effects of government regulation and regulatory developments, and our ability and the ability of the third parties with whom we engage to comply with applicable regulatory requirements ; the accuracy of our estimates regarding future expenses, revenues, capital requirements and need for additional financing ; our expectations regarding future planned expenditures ; our ability to achieve and maintain effective internal control over financial reporting in accordance with Section 404 of the Sarbanes - Oxley Act ; our ability to obtain, maintain and successfully enforce adequate patent and other intellectual property protection of any of our products and product candidates ; our ability to protect our intellectual property, including pending and issued patents ; our ability to operate our business without infringing the intellectual property rights of others ; our ability to advance our clinical development programs, which could be impacted by the COVID - 19 pandemic ; the expected impact of the COVID - 19 pandemic on our operations and any statements of assumptions underlying any of the items mentioned ; and statements of belief and any statement of assumptions underlying any of the items mentioned . These statements are based on estimates and information available to us at the time of this presentation and are not guarantees of future performance . Actual results could differ materially from our current expectations as a result of these risks and uncertainties, which include, without limitation, risks related to the ability of our lead clinical candidates, AP - PA 02 and AP - SA 02 (including any modifications thereto) to be more effective than previous candidates ; our ability to enhance AP - PA 02 to treat both CF and NCFB patients ; our ability to develop products as expected ; our expected market opportunity for our products ; our ability to sufficiently fund our operations as expected, including obtaining additional funding as needed ; and any delays or adverse events within, or outside of, our control, caused by the COVID - 19 pandemic . You should not rely upon forward - looking statements as predictions of future events . Although we believe that the expectations reflected in the forward - looking statements are reasonable, we cannot guarantee that the future results, levels of activity, performance or events and circumstances reflected in the forward - looking statements will be achieved or occur . Moreover, we undertake no obligation to update publicly any forward - looking statements for any reason to conform these statements to actual results or to changes in our expectations except as required by law . We refer you to the documents that we file from time to time with the Securities and Exchange Commission, including our most recently filed Annual Report on Form 10 - K, Quarterly Reports on Form 10 - Q and Current Reports on Form 8 - K . These documents, including the sections therein entitled “Risk Factors,” identify important factors that could cause the actual results to differ materially from those contained in forward - looking statements . Any securities of Armata to be offered in any transactions contemplated hereby have not been and will not be registered under the Securities Act of 1933 , as amended (the “Securities Act”), or any applicable state or foreign securities laws . Any securities to be offered in any transactions contemplated hereby (i) have not been approved or disapproved by the Securities and Exchange Commission, any state securities commission or other United States or foreign regulatory authority, nor have any of these authorities passed upon the merits of this offering or determined that this presentation is accurate or complete, and (ii) will be offered and sold solely in reliance on one or more exemptions from the registration requirements of the Securities Act and the rules and regulations promulgated thereunder (including Regulation D or Regulation S) under the Securities Act . This document does not constitute an offer to sell or the solicitation of an offer to buy in any state or other jurisdiction to any person to whom it is unlawful to make such offer or solicitation in such state or jurisdiction .
3 Armata Highlights Phage cocktails addressing unmet need in infectious disease ▪ P. aeruginosa product candidates for respiratory infections • Cystic fibrosis: First multi - center, double - blind, placebo - controlled randomized trial • Non - cystic fibrosis bronchiectasis • Hospitalized pneumonia ▪ S. aureus phage product candidate • Complicated bacteremia • Prosthetic joint infection Phage - specific GMP drug manufacturing facilities ▪ In - house manufacturing and quality systems Strong partnerships ▪ Cystic Fibrosis Foundation ($5M award; $3M equity investment), US DoD ($16.3M award) Strong board and executive leadership team ▪ Seasoned drug development team ▪ Successful track record in capital raises, M&A, and exits CONFIDENTIAL
4 Unmet Need in Antibiotic Resistant Infections Phages May Provide a Powerful Solution to an Urgent Public Health Threat Aug 2019 Xenleta (lefamulin) CONFIDENTIAL
5 Phage: Novel Biologic, MOA Distinct from Antibiotics Key Phage Attributes ▪ Species specific; front line therapy eliminates microbiome disruption that occurs with antibiotics ▪ Live biologic; produces progeny at site of infection ▪ Potential to improve SOC treatment through synergy with antibiotics • Not reserved for salvage or last line therapy ▪ Activity independent of antibiotic resistance, including MDR infections ▪ Potential for product modifications as clinical isolate landscape evolves • During development and after launch How Phages Kill Bacteria CONFIDENTIAL
6 Armata’s Capabilities and Operational Overview Purposely Built for Phage Product Development, Bench to Clinic Discovery • Phage libraries • Pathogen libraries • Synthetic biologists with phage engineering expertise • Computational biology team Preclinical Development • Well - equipped BSL2 labs • Highly trained microbiologists • Experienced translational biologists • Formulation capabilities PD & Analytical Sciences • Fully equipped for all method development • Strong team of biophysical scientists (chemists, structural biologists, etc.) • Aligned with manufacturing for efficient method transfer CMC • Licensed cGMP facility operating 2 clean rooms • In - house Quality Control and Quality Systems • ~100 years combined manufacturing experience from Phase 1 to commercialization Clinical Development • Successful filing of INDs and conducting of FIH studies • Execution of mid - stage studies • Conducting registrational studies and achieving approval (BLAs and INDs) • Operational expertise inside and outside of the US • Support of product launch CONFIDENTIAL
7 New facility; expected to be operational in 2023 ▪ Phage products require efficient manufacturing operations ▪ Products are cocktails of multiple phage ▪ Armata’s 2 lead products require manufacture of 7 drug substances ▪ Purpose - built facility creates essential infrastructure for phage products ▪ 3 independent lines of production ▪ Semi - automated aseptic filling capabilities ▪ Higher scale to meet demands of global late - stage trials ▪ Opportunity from core strength in manufacturing ▪ Phage strategic partnerships or contract manufacturing cGMP Manufacturing: A Core Strength of Armata Essential Component of Novel Phage Pipeline CONFIDENTIAL
8 Clinical Pipeline Multiple Shots on Goal: Evaluation of Local/Systemic Administration for Acute and Chronic Infections Program Discovery Preclinical IND - Enabling Phase 1b/2 Partner Pseudomonas aeruginosa Respiratory Infections Staphylococcus aureus CF Bacteremia US DoD US Department of Defense (Naval Medical Research Center, US Army Medical Research Acquisition Activity, Defense Health Agency ) CF: cystic fibrosis; NCFB: non - CF bronchiectasis; PJI: prosthetic joint infection NCFB Pneumonia PJI AP - PA02 AP - PA03 AP - SA02 Engineered phage ▪ Pseudomonas : AP - PA02 delivering biofilm - disrupting payload Expand indications and pursue additional pathogens Unpartnered Unpartnered Unpartnered CONFIDENTIAL
Cystic Fibrosis Non - CF Bronchiectasis Pneumonia Pseudomonas aeruginosa Program CONFIDENTIAL
10 Robust Discovery Engine Yields Optimal Cocktails Phage Products Tailored for Pseudomonas respiratory Infections Clinical Isolate Collection Phage Screening Genomic Analysis O - antigen Indication Host Sensitivity Phage AP - PA02 AP - PA03 Genus Receptor 3 - phage 5 - phage Phage 1 CF CF, NCFB 1 LPS Phage 2 CF CF, NCFB Pna 1 LPS Phage 3 CF CF, NCFB Pna 2 Pilus Phage 4 CF, NCFB 3 LPS Phage 5 CF, NCFB 4 O - Antigen Phage 6 Pna 4 O - Antigen Phage 7 Pna 5 Pilus and LPS Phage 8 Pna 3 LPS CF: cystic fibrosis; NCFB: non - CF bronchiectasis ; Pna : pneumonia CONFIDENTIAL
11 ▪ Coverage of at least 90% of CF clinical isolates ▪ Improved potency in vitro and in vivo ▪ FDA permission to evaluate optimized AP - PA02 in SWARM - P.a. ▪ Two new phage genera added to AP - PA02 & evaluated in MAD cohorts ▪ Optimized AP - PA02 advanced into Phase 2 trial in NCFB Optimized AP - PA02 for CF and NCFB Improved Cocktail Developed in Parallel to Executing SWARM - P.a. Study In Vivo Activity in Mice 0 50 100 0 50 100 Time (Hours) P e r c e n t S u r v i v a l Untreated 3E8 PFU/phage 1E9 PFU/phage 3E9 PFU/phage 1E10 PFU/phage AP-PA02 (5-phage cocktail) 3 - phage cocktail 5 - phage cocktail In Vitro Potency and Synergy CONFIDENTIAL
12 Pseudomonas aeruginosa Respiratory Infections AP - PA02: Clinical Programs Projected Trials in 2024 Patient population: Medically stable chronically - infected CF patients Route of administration: Nebulized Endpoints: Safety and tolerability, dose exploration Patient population: Chronically - infected NCFB patients Route of administration: Nebulized Endpoints: Safety and tolerability, efficacy (microbial) at dose/schedule based on clinical data from SWARM - P.a. study Phase 2b/3 in CF Phase 2b/3 in NCFB Phase 1b/2a Phase 2 CONFIDENTIAL
* Data is preliminary and remains subject to further review and quality control CF Phase 1b/2a Trial Top Line Data* CONFIDENTIAL
14 Ph1b/2a SWARM - P.a. Study Design and Objectives Outpatient Study in CF Adults with Chronic Pulmonary Pseudomonas aeruginosa Infections Study Objectives • ≥10⁴ CFU of Pa per gram of induced sputum at Screening • Pa isolates susceptible to AP - PA02, based on Screening sputum morphotypes • For SAD: FEV1 ≥ 60% of predicted normal • For MAD: FEV1 ≥ 40% of predicted normal • Stable lung function: FEV1 at the Baseline Visit has not decreased by more than 5% compared to the FEV1 at Screening • For MAD subjects on chronic inhaled antibiotics: • Subjects on a single continu ous inhaled antibiotic must remain on the same regimen from Screening to EOS • Subjects on intermittent inhaled antibiotics (1 month “on” 1 month “off”) must be at least 6 days and not more than 17 days into the on - or off - month on Day 1 Key Inclusion Criteria Study Design (~25 US sites) CONFIDENTIAL
15 Initial study design ▪ 3 SAD cohorts, 3 MAD cohorts (TID, 3 - day duration) ▪ 3 phage cocktail Enrollment progress - SAD cohort 1 & 2 enrolled - SAD cohort 3 and MAD cohort 1 partially enrolled Learnings - Well tolerated - No apparent impact on CFU Revised study design ▪ Extend duration of dosing in MAD cohorts ▪ MAD Cohort 3: 5 days; n= 3 active, 1 placebo ▪ MAD Cohort 4: 10 days; n=15 active, 5 placebo ▪ 5 phage cocktail ▪ BID dosing 6 h apart under supervision during clinic hours ▪ Resulting in 18 h gap between pm dose and next am dose Interim assessment - Well tolerated - Blinded PK analysis: low 18 h phage exposure at trough levels - Low exposure l imits ability to interpret exploratory clinical endpoints such as FEV1, CF - PROs - Achieving Q12H dosing in SWARM - P.a. study challenging due to clinic hours SWARM - P.a. Study Evolution Adapting to Emerging Data Final study execution ▪ MAD cohort 3 enrolled ▪ MAD cohort 4 concluded early: n=10 active, 3 placebo Rationale for early study conclusion - Q12H dosing advancing in NCFB Phase 2 study - At - home dosing permitted by FDA Q12H CONFIDENTIAL
16 N represents the number of subjects in the Safety Population. Treatment emergent adverse event (TEAE) is any untoward medical event occurring after study drug administration until 28 days af ter the last dose of study drug, regardless of causality. Clinical Safety for SAD/MAD Cohorts AP - PA02 Well Tolerated with Few TEAEs Related to Study Drug SAD Cohort 1 (1E10 PFU) N=3 SAD Cohort 2 (3E10 PFU) N=3 MAD Cohort 3 (5.75E10 PFU/dose BID x 5 Days) N=3 MAD Cohort 4 (1.5E11 PFU/dose BID x 10 Days N=10 Placebo (Pooled) N=8 TEAE 1 1 0 3 5 TEAE leading to study drug interruption 0 0 0 0 0 TEAE leading to study drug withdrawal 0 0 0 0 0 TEAE related to study drug 0 0 0 3 2 Grade 1 (Mild) n/a n/a n/a 3 1 Grade 2 (Moderate) n/a n/a n/a 0 1 Grade 3 (Severe) n/a n/a n/a 0 0 Serious TEAE 0 0 0 1 0 Total Deaths 0 0 0 0 0 Overall, AP - PA02 well tolerated up to 10 days of dosing • No Serious TEAEs were determined to be related to AP - PA02 • Few mild, self - limited TEAEs possibly related to study drug (per PI designation) • No clinically significant vital sign, laboratory, spirometry or ECG findings CONFIDENTIAL Data is preliminary and remains subject to further review and quality control
17 Phase 1b: Single Ascending Dose Exposure Assessment Reliable Delivery of Nebulized Phage to the Lung ▪ Active phage levels in the lung assessed in induced sputum samples ▪ Induced sputum collection does not allow frequent sampling (schedule of sampling allows peak and trough only) ▪ Expectorated sputum samples are inconsistent in timing and sample quality ▪ Comparable delivery from subject to subject ▪ Higher exposure in Cohort 2 vs. Cohort 1 ▪ No notable difference in exposure levels due to isolate sensitivity ▪ No phage recovered from blood or urine 0 20 40 60 10 3 10 4 10 5 10 6 10 7 10 8 ARPA0003 Induced Time (Hours) P F U / m L Cohort 1 Cohort 2 0 20 40 60 10 3 10 4 10 5 10 6 10 7 10 8 ARPA0022 Induced Time (Hours) P F U / m L Cohort 1 Cohort 2 ARPA0003 ARPA0034 ARPA0022 CONFIDENTIAL Data is preliminary and remains subject to further review and quality control
18 Phase 2a: Multiple Ascending Dose Exposure Assessment Reliable Delivery of Nebulized Phage to the Lung For Up To 10 Days 0 5 10 10 2 10 3 10 4 10 5 10 6 10 7 10 8 10 9 10 10 101520 ARPA0002 Time (Days) P F U / m L Cohort 3 Cohort 4 10 15 20 0 5 10 10 2 10 3 10 4 10 5 10 6 10 7 10 8 10 9 10 10 101520 ARPA0003 Time (Days) P F U / m L Cohort 3 Cohort 4 10 15 20 0 5 10 10 2 10 3 10 4 10 5 10 6 10 7 10 8 10 9 10 10 101520 ARPA0022 Time (Days) P F U / m L Cohort 3 Cohort 4 10 15 20 0 5 10 10 2 10 3 10 4 10 5 10 6 10 7 10 8 10 9 10 10 101520 ARPA0028 Time (Days) P F U / m L Cohort 3 Cohort 4 10 15 20 1.15E10 PFU/phage (cohort 3) 3E10 PFU/phage (cohort 4) ▪ Phage levels assessed at peak and trough in induced sputum samples ▪ Cohort 3: d1 and d5 peak; d2 - 4 troughs ▪ Cohort 4: d1 and d10 peaks; d2 - 9 troughs ▪ Comparable delivery from subject to subject ▪ Higher exposure in Cohort 4 vs. Cohort 3 ▪ No notable difference in exposure levels due to isolate sensitivity ▪ Trace levels in blood recovered from 2 subjects in Cohort 4; no phage recovered from urine CONFIDENTIAL Data is preliminary and remains subject to further review and quality control
19 ▪ No statistically significant difference between peaks (d1 vs. d10) or troughs (d2 vs. d11) after 10 days of dosing* ▪ End of dosing peaks and troughs provide no evidence of dose accumulation ▪ Phage levels at 18 h troughs: ▪ Are on average 80 - 95% lower than at peak ▪ Have dropped more than 90% for the majority of subjects ▪ 18 h gap in cohort 4 dosing (due to in - clinic dosing 6 hours apart) not standard for typical BID antibiotic dosing regimens Evaluation of Exposure After Repeat Dosing Cohort 4 BID, In - Clinic Dosing 6 Hours Apart * Statistics performed using Kruskal - Wallis ANOVA D a y 1 ( p e a k ) D a y 2 ( t r o u g h ) D a y 1 0 ( p e a k ) D a y 1 1 ( t r o u g h ) 10 2 10 3 10 4 10 5 10 6 10 7 10 8 10 9 10 10 ARPA0002 P F U / m L D a y 1 ( p e a k ) D a y 2 ( t r o u g h ) D a y 1 0 ( p e a k ) D a y 1 1 ( t r o u g h ) 10 2 10 3 10 4 10 5 10 6 10 7 10 8 10 9 10 10 ARPA0003 P F U / m L D a y 1 ( p e a k ) D a y 2 ( t r o u g h ) D a y 1 0 ( p e a k ) D a y 1 1 ( t r o u g h ) 10 2 10 3 10 4 10 5 10 6 10 7 10 8 10 9 10 10 ARPA0022 P F U / m L D a y 1 ( p e a k ) D a y 2 ( t r o u g h ) D a y 1 0 ( p e a k ) D a y 1 1 ( t r o u g h ) 10 2 10 3 10 4 10 5 10 6 10 7 10 8 10 9 10 10 ARPA0028 P F U / m L CONFIDENTIAL Data is preliminary and remains subject to further review and quality control
20 ▪ CFU reduction appears related to exposure ▪ 3 subjects with >1E7 average trough levels have >1 log CFU reduction at EOT ▪ 2 subjects have durable response at prespecified secondary endpoint, d24 (through 14 days post last dose), and at EOS (d38) ▪ 1 subject with >2 log reduction; 1 subject with >1 log reduction ▪ Preliminary PK modeling supports BID dosing at 12 - hour dosing results in trough levels associated with microbiology ▪ Limited sample size does not power statistics for active versus placebo ▪ N=9 active, 2 placebo; 1 active and 1 placebo missing baseline values and are therefore not included in this analysis Cohort 4 CFU Reduction Through Day 24 (Secondary Endpoint) Compared to Placebo, Relationship to Exposure (Trough) EOT EOT d24 Placebo AP - PA02 d24 Active vs. Placebo Relationship of CFU Reduction to Average Trough Levels of Active Phage Day 24 Subjects with average trough levels >1E7 EOT CONFIDENTIAL Data is preliminary and remains subject to further review and quality control D a y 1 0 D a y 2 4 P l a c e b o - 1 0 P - D a y 2 4 -3 -2 -1 0 1 2 Δ l o g ( C F U / m L ) 10 4 10 5 10 6 10 7 10 8 -3 -2 -1 0 1 2 d24 vs sum trough Average Trough Levels During Dosing d 2 4 Δ l o g ( C F U / m L ) 10 4 10 5 10 6 10 7 10 8 -3 -2 -1 0 1 2 Average Trough Levels During Dosing E O T Δ l o g ( C F U / m L )
21 Cohort 4 CFU Reduction Through Day 24 (Secondary Endpoint) Relationship to Phage Susceptibility 3 No. of Susceptible Phage # susceptible phage 1 - 2 EOT EOT d24 d24 Subjects with average trough levels >1E7 ▪ The 2 subjects with the highest level of CFU reduction at Day 24 are susceptible to 3 phage ▪ Susceptibility to multiple phage of the cocktail either: ▪ Contributes to achieving tough levels >1E7 (higher effective dose); and/or ▪ Improves potency through phage synergy as demonstrated in vitro CONFIDENTIAL Data is preliminary and remains subject to further review and quality control D a y 1 0 D a y 2 4 D a y 1 0 D a y 2 4 -3 -2 -1 0 1 2 Δ l o g ( C F U / m L )
22 Pharmacodynamic Assessment Comparing Microbial Impact and Phage Exposures in MAD Cohorts 3 & 4 ▪ Induced sputum samples with trough levels higher than 1E7 had greater reductions in P.a. sputum density ▪ Average CFU reduction of 1.72 log in samples with troughs above E7 (red shading) ▪ Average CFU reduction of 0.06 log in samples with troughs below E7 (gray shading) ▪ Early data points to value of expressing exposure as the sum of each susceptible component of the phage cocktail PK/PD Relationship On Dosing Days* * Cohort 3: troughs on days 2, 3, 4; Cohort 4: troughs on days 2, 3, 4, 8, 9. Each subject has multiple data points. Trough levels = Sum of phage to which the isolate is susceptible. 10 4 10 5 10 6 10 7 10 8 10 9 10 10 -4 -2 0 2 4 SUM Trough Levels Δ l o g ( C F U / m L ) Trough levels of active phage 10 5 10 6 10 7 10 8 10 9 10 10 -4 -2 0 2 4 Sum Trough Levels Δ l o g ( C F U / m L ) Cohort 4 Cohort 3 Data is preliminary and remains subject to further review and quality control CONFIDENTIAL
23 SWARM - P.a. Learnings Safety and Tolerability ▪ No dose - limiting toxicity ▪ No AEs >Grade 1 attributed to study drug: Grade 1 AEs appear to be intermittent with quick recovery Distribution and Clearance ▪ Very low to undetectable systemic exposure after inhalation ▪ Initial assessment of clearance supports Q12H dosing Pharmacodynamics (Target Engagement) ▪ Single dose insufficient for CFU reduction ▪ CFU reduction noted in cohort 4 subjects with higher trough levels and susceptibility to multiple phage Next Steps ▪ Assess change from baseline of isolates’ sensitivity to AP - PA02 and anti - pseudomonal antibiotics ▪ Pre - and post - isolate clonal relatedness will be determined through sequencing ▪ Complete AP - PA02 anti - drug antibody assessment ▪ CSR target date mid - 2023 Learnings and Next Steps for SWARM - P.a. Data AP - PA02 Was Well - Tolerated with Consistent Exposures by Dose CONFIDENTIAL
24 NCFB Phase 2 Trial: Underway ▪ At home dosing permitted by FDA: BID 10 - 12 hours apart ▪ Protocol flexibility to increase dose/dosing duration ▪ Evaluate CFU, spirometry during/after dosing for micro/clinical durability CF Phase 2b/3 Trial ▪ Design study with dose/dosing frequency/duration based on NCFB data ▪ Assess if early NCFB PK/PD data translates to CF population in CF Ph2b trial ▪ Evaluate CFU, FEV1, etc. during/after dosing regimen completed (off - phage cocktail for several months) to determine micro/clinical durability ▪ If positive trends seen in Ph2b, begin enrollment of Ph3 registrational study Next Steps for AP - PA02 SWARM - P.a. PK Data Informs NCFB Ph2 Study Which will Drive CF Phase 2b/3 Design NCFB Ph2 Study Design CONFIDENTIAL
25 AP - PA02 x CF Ph1b/2a top line data x NCFB Ph2 first patient dosed ▪ NCFB Ph2 interim analysis (2H23) ▪ NCFB Ph2 top line data (2H24) Anticipated Milestones CONFIDENTIAL AP - SA02 ▪ PJI first patient dosed (1H23) ▪ SAB progression to Ph2a (2H23) ▪ PJI progression to Ph2a (1H24) Positions AP - PA02 for Phase 2b/3 pivotal studies ▪ Chronic, Pseudomonas aeruginosa respiratory infections ▪ Inhaled route of administration Significant AP - SA02 clinical learnings in two indications ▪ Acute and chronic Staphylococcus aureus infections ▪ Intravenous and intra - articular routes of administration ▪ Positions AP - SA02 for: • SAB Ph1b/2a top line data (1H25) • PJI Ph1b/2a top line data (2H25) CF: cystic fibrosis; NCFB: non - CF bronchiectasis; PJI: prosthetic joint infection; SAB: S. aureus bacteremia
Corporate Summary CONFIDENTIAL
27 Leadership and Board of Directors Diverse Public Company Drug Development Expertise Robin Kramer Todd Peterson, PhD Brian Varnum, PhD Mina Pastagia, MD CMO Bryan Kadotani VP, Program Management & Operations Management Board of Directors Brian Varnum, PhD CEO Jules Haimovitz , Chair Odysseas Kostas, MD Erin Butler VP, Finance & Admin Joseph Patti, PhD Sarah Schlesinger, MD CONFIDENTIAL
28 Funding and Cash Position ▪ $14.9 million at December 31, 2022* ▪ January 2023: $30M convertible credit and security agreement with a subsidiary of Innoviva, Inc. ▪ Mandatory conversion into Armata common stock upon completion of qualified financing ▪ Innoviva (NASDAQ: INVA) is a holding company receiving royalties from GSK; ~$900M mkt cap ▪ March 2022: $45M private placement of common stock and warrants with a subsidiary of Innoviva, Inc. ▪ October 2021: $7M private placement of common stock with two investors - Cystic Fibrosis Foundation and a subsidiary of Innoviva, Inc. Capitalization ▪ 36.1 million common shares outstanding at December 31, 2022* ▪ Trades on NYSE American exchange: ARMP Funding and Capitalization *Preliminary and unaudited and subject to change CONFIDENTIAL
29 Convertible Credit Agreement Conversion Terms Mandatory Conversion into Common Stock upon Qualified Financing ▪ Qualified Financing Terms: ▪ $30M New Investor proceeds ▪ Price per share limited to 15% discount of prior day closing share price ▪ Warrant coverage limited to 50% of shares of common stock sold to New Investors ▪ Mandatory Conversion Terms: ▪ Conversion shall be equal to lowest price per share paid by new investors x 85% ▪ Issuance of shares is subject to the same terms and conditions applicable to shares sold in the qualified financing Pro forma Capitalization under Optional Conversion Terms 36,144,706 (1 ) December 31, 2022 Common Stock Outstanding 21,315,790 Convertible Debt Shares at Optional Conversion Price ($1.52) 57,460,496 December 31, 2022 Pro forma Shares Outstanding 80.7% Innoviva Ownership Percentage (1) Shares outstanding at December 31, 2022 is unaudited and subject to change CONFIDENTIAL
30 Strong Global IP Position Through Pending and Issued Patents 13 Patent Families, Long - Life Patents, Patents Granted in all Major Jurisdictions Expiration dates through 2041 Armata’s patents and applications cover: ▪ Therapeutic phage cocktails ( Staphylococcus and Pseudomonas ) and uses thereof ▪ Synthetic phage and methods of manufacture thereof ▪ Beneficial effects of phage treatment ▪ Phage combinations for treating biofilm infections ▪ Sequential use of phages in combination with antibiotics ▪ Methods to reduce antibiotic resistance ▪ Methods to design therapeutic combination panels of phage ▪ Disinfection methods using bacteriophages ▪ Phage mutants having increased bacterial host spectra Jurisdiction Issued Pending U.S. 12 10 R.O.W. 69 54 CONFIDENTIAL
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