Armata Pharmaceuticals, Inc. · AMEX:ARMP
Armata Pharmaceuticals — Investor Presentation (March 2023)
31 slides from Armata Pharmaceuticals's investor presentation, Mar 6, 2023
Slide 1: February 22, 2023
February 22, 2023 NYSE American: ARMP CONFIDENTIAL
Slide 2: Forward Looking Statements
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 -
Slide 3: Armata Highlights
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
Slide 4: Unmet Need in Antibiotic Resistant Infections
4 Unmet Need in Antibiotic Resistant Infections Phages May Provide a Powerful Solution to an Urgent Public Health Threat Aug 2019 Xenleta (lefamulin) CONFIDENTIAL
Slide 5: Phage: Novel Biologic, MOA Distinct from Antibiotics
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 antibiotic
Slide 6: Armata's Capabilities and Operational Overview
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 •
Slide 7: cGMP Manufacturing: A Core Strength of Armata
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
Slide 8: Clinical Pipeline
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 (
Slide 9: Pseudomonas aeruginosa Program
Cystic Fibrosis Non - CF Bronchiectasis Pneumonia Pseudomonas aeruginosa Program CONFIDENTIAL
Slide 10: Robust Discovery Engine Yields Optimal Cocktails
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 L
Slide 11: Optimized AP-PA02 for CF and NCFB
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 -
Slide 12: AP-PA02: Clinical Programs
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 - inf
Slide 13: CF Phase 1b/2a Trial Top Line Data
* Data is preliminary and remains subject to further review and quality control CF Phase 1b/2a Trial Top Line Data* CONFIDENTIAL
Slide 14: Ph1b/2a SWARM-P.a. Study Design and Objectives
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
Slide 15: SWARM-P.a. Study Evolution
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
Slide 16: Clinical Safety for SAD/MAD Cohorts
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 We
Slide 17: Phase 1b: Single Ascending Dose Exposure Assessment
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
Slide 18: Phase 2a: Multiple Ascending Dose Exposure Assessment
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 10 101
Slide 19: Evaluation of Exposure After Repeat Dosing
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
Slide 20: Cohort 4 CFU Reduction Through Day 24
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
Slide 21: CFU Reduction Relationship to Phage Susceptibility
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 pha
Slide 22: Pharmacodynamic Assessment in MAD Cohorts 3 & 4
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
Slide 23: Learnings and Next Steps for SWARM-P.a.
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 clear
Slide 24: Next Steps for AP-PA02
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
Slide 25: Anticipated Milestones
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 - PA
Slide 26: Corporate Summary
Corporate Summary CONFIDENTIAL
Slide 27: Leadership and Board of Directors
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 Kosta
Slide 28: Funding and Capitalization
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
Slide 29: Convertible Credit Agreement Conversion Terms
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
Slide 30: Strong Global IP Position Through Pending and Issued Patents
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
Slide 31: Armata Pharmaceuticals
PHARMACEUTICALS
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