Armata Pharmaceuticals, Inc. · AMEX:ARMP
Armata Pharmaceuticals — AmpliPhi Biosciences — IPO Roadshow (May 2017)
28 slides from Armata Pharmaceuticals's IPO roadshow presentation, May 2, 2017
Slide 1: Leading the Phage Therapy Renaissance
Leading the Phage Therapy Renaissance Announcing Personalized Precision Phage (P 3 ) Therapies for Antibiotic - Resistant Infections May 1, 2017 NYSE MKT: APHB This free writing prospectus should be read together with the issuer’s registration statement on Form S - 1 (File No. 333 - 217169) (includi
Slide 2: Forward-looking statements
2 This presentation contains “forward - looking” statements that involve risks, uncertainties and assumptions. If the risks or uncer tainties materialize or the assumptions prove incorrect, our results may differ materially from those expressed or implied by such forward - looking statements. All st
Slide 3: Executive Summary
3 Antibiotic - resistance is a major global health threat Bacteriophage technology is uniquely positioned to address this threat • Precisely targeted, differentiated mechanism of action, synergistic with antibiotics AmpliPhi is pioneering bacteriophage technology to treat multidrug - resistant (MDR)
Slide 4: Year 2050 Looming Era of Drug-Resistant Superbugs
Year 2050 Looming Era of Drug - Resistant Superbugs 4 Est. $100 trillion worldwide cumulative cost Imagine the world without effective antibiotics - if we fail to act, this could become our reality Est. 10,000,000 annual deaths worldwide Source: 2016 O’Neill Report to UK Government
Slide 5: The World Awaits a Response
The World Awaits a Response 5
Slide 6: The Power of Bacteriophages as Targeted Antibacterials
The Power of Bacteriophages as Targeted Antibacterials Harnessing ancient predator - prey relationship to kill bacteria • Naturally - occurring viruses • infect and kill only bacteria • prey on specific bacterial strains • penetrate biofilms Phages are the most abundant and diverse organisms on Eart
Slide 7: The Time for Phage Therapies Is Now
Society is losing the race against pathogenic bacteria 7 The Time for Phage Therapies Is Now Characterization, sequencing, purification, endotoxin removal, synthetic biology • Selecting and optimizing therapeutic phages • proprietary combinations designed to maximize efficacy and minimize resistance
Slide 8: How Phage Destroy Bacteria
How Phage Destroy Bacteria Bacteriophage encounters target bacterial cell Bacteriophage binds to target bacteria and injects DNA Bacteriophage converts cell into bacteriophage “factory” Bacteria is lysed, releasing new generation bacteriophages Process repeats as new bacteriophages encounter target
Slide 9: AmpliPhi's Phage Library Targets Bacteria on WHO Priority Pathogens List
9 AmpliPhi’s Phage Library Targets Bacteria on WHO Priority Pathogens List Source: World Health Organization, 2017 Priority Pathogens List published Feb. 25, 2017 Priority 1: CRITICAL Acinetobacter baumannii , carbapenem - resistant Pseudomonas aeruginosa , carbapenem - resistant Enterbacteriaceae ,
Slide 10: Phage Therapy Has the Potential to Reinvigorate Antibiotic Efficacy
10 Patent protection ▪ Protection for sequential administration of phage and antibiotics ▪ Prosecuting both biofilm - dependent and independent induced sensitivity ▪ Broad species coverage in EU, Australia, Japan, Canada; U.S. protection for Pseudomonas Phages can exert selection pressure on MDR bac
Slide 11: Company Overview
Bacteriophage - based technology • Mechanism of action radically different from traditional antibiotics • Targeted, flexible and diverse R&D expertise • Staphylococcus aureus: 3 - phage cocktail completed two Phase 1 trials • Pseudomonas aeruginosa: 4 - phage cocktail in development • Inventory of p
Slide 12: Management and Board of Directors
Management M. Scott Salka Chief Executive Officer Igor Bilinsky , Ph.D. Chief Operating Officer Steve Martin Chief Financial Officer Alex Gaidamaka, Ph.D., D.V.M. VP CMC Sandra Morales, Ph.D. VP Research Carrie Langlais Furr , Ph.D. VP Regulatory & Project Management 12 Board of Directors Jeremy Cur
Slide 13: Historical Focus on Phage 1.0
13 Historical Focus on Phage 1.0 Phage 1.0 Phage 2.0 Phage 3.0 AB - SA01, AB - PA01 Wild - type Bacterial infections with high unmet need Pipeline programs: CRS, CF, otitis, etc. Personalized Wild - type Antibiotic - resistant serious or life - threatening bacterial infections Precision medicine for
Slide 14: Development Pipeline
Development Pipeline Indication Collaborator Discovery Preclinical Phase 1 Phase 2 AB - SA01 (3 - Phage cocktail targeting Staphylococcus aureus ) Chronic Rhinosinusitis (CRS) Seek partner for Phase 2 Topical indications / wound care AB - PA01 (4 - Phage cocktail targeting Pseudomonas aeruginosa ) C
Slide 15: Completed Phase 1 Trial in Chronic Rhinosinusitis
15 University of Adelaide Patient 1 2 3 4 5 6 7 8 9 10 11 12 13 14 Days Completed Phase 1 Trial in Chronic Rhinosinusitis Low Dose BID (10 8 PFU/mL) High Dose BID (10 9 PFU/mL) Primary Endpoints ▪ Well tolerated, no drug - related SAEs Secondary Observations ▪ Reduction in S. aureus bacterial load a
Slide 16: Completed Intact Skin Phase 1 Trial
16 U.S. Army under CRADA Primary Endpoints (all subjects) • AB - SA01 well tolerated throughout the trial ▪ No treatment - emergent AEs considered definitely or probably related to AB - SA01 ▪ No severe or high - grade treatment - emergent AEs, SAEs or discontinuation of treatment due to treatment -
Slide 17: In-House cGMP Certified Manufacturing Facility
Ljubljana, Slovenia: • ~6,000 square feet - Clean rooms - QC & process development - GMP storage Conducting: • Fermentation (40 - liter scale) • Purification • Aseptic fill • Product QC and release • Stability APHB cGMP Bioreactor 17 In - House cGMP Certified Manufacturing Facility
Slide 18: Planned Near-term Emphasis: Advancing P3 Therapies
18 Planned Near - term Emphasis: Advancing Personalized Precision Phage (P 3 ) Therapies Phage 1.0 Phage 2.0 Phage 3.0 AB - SA01, AB - PA01 Wild - type Bacterial infections with high unmet need Pipeline programs: CRS, CF, otitis, etc. Personalized Wild - type Antibiotic - resistant serious or life -
Slide 19: Resistant Bacterial Infections Responsible for >20,000 Deaths per Year in the U.S.
19 Resistant Bacterial Infections Responsible for >20,000 Deaths per Year in the U.S. Source: Pharmacy & Therapeutics 2015; CDC 2014 (*) Community associated U.S. incidence of resistant hospital associated infections Annual deaths attributed to resistant infections Invasive methicillin - resistant S
Slide 20: Positive FDA Feedback at Type B Meeting in February 2017
Positive FDA Feedback at Type B Meeting in February 2017 FDA expressed support for precision phage therapy for patients with serious or life - threatening infections • “CBER acknowledged that phage therapy is an exciting approach to treatment of multidrug - resistant organisms and expressed a commit
Slide 21: Compassionate-use Case: Refractory P. aeruginosa Bladder Infection
Compassionate - use Case: Patient Suffering from Refractory P. aeruginosa Bladder Infection • 67 - year - old female underwent intra - abdominal resections and radiation for adenocarcinoma • Contracted symptomatic P. aeruginosa bladder infection • Multiple courses of antibiotics over 2 - year period
Slide 22: Compassionate-use Case: Critically Ill Patient with MDR A. baumannii Infection
Compassionate - use Case: Critically Ill Patient Suffering from MDR A. baumannii Infection • 69 - year - old male suffering from MDR Acinetobacter baumannii abdominal infection • Multiple courses of antibiotics over 4 months: vancomycin, meropenem, colistin, tigecycline, azithromycin, and rifampin •
Slide 23: Vision: Conquering MDR Infections
• Establish center to provide P 3 Therapies for patients with antibiotic - resistant infections under compassionate use • Serve patients who have few or no other therapeutic options • Demonstrate real - world clinical evidence • Optimize treatment regimens and expand therapeutic phage libraries • Su
Slide 24: Australia Is an Attractive Location for Initial P3 Therapy Clinical Trials
• We believe there is a strong interest in phage therapy for antibiotic - resistant infections from leading hospitals and infectious disease physicians in Australia • Favorable regulatory environment for treating patients under compassionate - use: physician has ability to administer treatment witho
Slide 25: Planned P3 Therapies Operating Model
25 Planned P 3 Therapies Operating Model Nationwide network • Identify patients • Provide treatment Collect data Optimize regimen AmpliPhi Estimates • < 7 day turnaround for common pathogens • < 14 days for first encounter with new pathogen • On - going pathogen surveillance National Advisory Counci
Slide 26: Planned Regulatory Strategy
26 P 3 T Planned Regulatory Strategy: Leverage Compassionate - use Clinical Data to Inform Path to Approval Demonstrate clinical utility of P 3 T Define path to approval in consultation with FDA Obtain registration - enabling data and commercialize • Compassionate - use for patients with serious and
Slide 27: Funding and Capitalization
27 • Partnerships have helped support development • $9.0M gross raised in 2016 through issuance of common stock • Received $0.9M in tax rebates from Australian Government in 2016 • Filed for $1.8M in tax rebates from Australian Government; expect receipt in mid - 2017 subject to Australian tax autho
Slide 28: In Summary
28 Antibiotic - resistance is a major global health threat We believe bacteriophage technology is uniquely positioned to address this threat • Precisely targeted, differentiated mechanism of action, synergistic with antibiotics AmpliPhi is pioneering bacteriophage technology to treat MDR infections