Armata Pharmaceuticals, Inc. · AMEX:ARMP
Armata Pharmaceuticals — AmpliPhi Biosciences — Investor Presentation (January 2017)
24 slides from Armata Pharmaceuticals's investor presentation, Jan 9, 2017
Slide 1: Global Leader in Bacteriophage Development to Combat Infectious Diseases
Global Leader in Bacteriophage Development to Combat Infectious Diseases January 2017 NYSE MKT: APHB www.ampliphibio.com
Slide 2: Safe Harbor Statement
2 Safe Harbor Statement 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 for war d - lo
Slide 3: The Looming Era of Drug-Resistant Superbugs
Year 2050 The Looming Era of Drug - Resistant Superbugs 3 $100 trillion cumulative cost If we fail to act, this could become our reality 10,000,000 annual deaths 3.5% global GDP reduction Source: 2016 O’Neill Report to UK Government
Slide 4: The World Awaits a Response
The World Awaits a Response 4 The superbug crisis kills more patients than breast cancer The Telegraph, December 11, 2016
Slide 5: Company Overview: Novel Approach to Combat Antibiotic-Resistant Bacteria
Bacteriophage - based technology • Radically different from traditional antibiotics • Natural enemy of bacteria • Potential to target any species of bacteria Technology and expertise • Over 10 years of bacteriophage development with $60 million invested since 2011 Product pipeline • Multiple program
Slide 6: Investment Highlights
6 • Addressing emerging global medical crisis • Advancing into first Phase 2 phage therapy trial • Scalable technology platform enables pipeline expansion • Strategy aimed at fastest approval for initial products • Know - how and IP as competitive barriers to entry • Public and private partnerships
Slide 7: The Power of Phage
The Power of Phage Harnessing an Ancient Predator - Prey Relationship … • Most abundant and diverse organisms on Earth • Multiple species of phage for every strain of bacteria • Humans evolved with phage in and on us …We Can Engineer Phage Products to Combat Evolving Bacterial Pathogens • Develop mu
Slide 8: Product Pipeline
Product Pipeline
Slide 9: Product Pipeline
Product Pipeline Indication Partner Discovery Preclinical Phase 1 Phase 2 AB - SA01 (3 - Phage cocktail targeting Staphylococcus aureus ) Chronic Rhinosinusitis (CRS) 2H 2017 Intact Skin Healthy Subjects Pending funding from Army AB - PA01 (4 - Phage cocktail targeting Pseudomonas aeruginosa ) Cysti
Slide 10: U.S. Market Opportunity: S. aureus in CRS
10 U.S. Market Opportunity Epidemiology • ~30 million cases each year • Rising prevalence Quality of Life • Score worse than reported for congestive heart failure and chronic back pain • ~300,000 patients undergo invasive surgery each year Economic Burden • $4.3 billion annual direct treatment costs
Slide 11: Completed CRS Phase 1 Trial
11 University of Adelaide Patient 1 2 3 4 5 6 7 8 9 10 11 12 13 14 Days Completed CRS Phase 1 Trial Low Dose BID (10 8 PFU/mL) High Dose BID (10 9 PFU/mL) Primary Endpoints ▪ Well tolerated ▪ No drug - related SAEs Secondary Observations ▪ Reduced S. aureus bacterial load at end of trial compared to
Slide 12: Completed Intact Skin Phase 1 Trial
12 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 13: U.S. Market Opportunity: Pseudomonas in CF
13 U.S. Market Opportunity Epidemiology • Pseudomonas infects ~80% of CF patients ages 25 - 34 • High overlap with CRS Quality of Life • Repeated antibiotic use drives emergence of resistance • Recurrent infections severely compromise lung function Economic Burden • Mean annual costs following initi
Slide 14: U.S. Market Opportunity: C. difficile Infections
14 U.S. Market Opportunity Epidemiology • Disease often arises after systemic antibiotic therapy; 20 - 40% recurrence • One of the most common hospital - acquired infections Quality of Life • Severe diarrhea and physical pain • Can limit antibiotic treatment for other conditions Economic Burden • $
Slide 15: Corporate Overview
Corporate Overview
Slide 16: Scalable Technology Platform: Strategy for Fast FDA Approval
16 Wild - Type Engineered Armed Scalable Technology Platform Strategy for Fast FDA Approval
Slide 17: Competitive Barriers to Entry
Patents Covering: Methods of Treatment and Cocktail Compositions Manufacturing Know - How QIDP Orphan Designations Drug/device Combinations 17 Competitive Barriers to Entry
Slide 18: Reinvigorate Antibiotic Efficacy: Patent Protection
18 Patent Protection ▪ Protection for the sequential administration of phage and antibiotics ▪ Prosecuting both biofilm - dependent and independent induced sensitivity ▪ Broad coverage in EU, Australia, Japan; U.S. protection for Pseudomonas Promising Approach ▪ Bacteria have limited degrees of free
Slide 19: In-House cGMP Certified Manufacturing Facility
Ljubljana, Slovenia: • ~6,000 square feet - Clean rooms - QC & process d evelopment - GMP storage Conducting: • Fermentation (40 - liter scale) • Purification • Aseptic fill • Product QC and release • Stability APHB cGMP Bioreactor 19 In - House cGMP Certified Manufacturing Facility
Slide 20: The AmpliPhi Team
Management M . Scott Salka Chief Executive Officer Steve Martin Chief Financial Officer Wendy Johnson Interim Chief Operating 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 20 Board of Directors Jeremy Cur
Slide 21: Recent History of Accomplishments
Biocontrol and SPH Acquisitions cGMP in Slovenia Uplisted to NYSE MKT First - in - man Dose of AB - SA01 for CRS 21 2011 2015 2016 $13M Financing Scott Salka Appointed as CEO Opened U.S. IND & Initiated Phase 1 Intact Skin Trial $5M Financing $4M Financing Final Results from Phase 1 Intact Skin Tria
Slide 22: Funding and Capitalization
22 Partnerships support development and funding $9.0M raised in 2016 • Raised $5.0M in June • Raised $ 4.0M in November • Received $0.9M incentive payment from Australian Government • $ 5.7M cash balance as of December 31, 2016 16.5M shares outstanding as of December 31 , 2016 • 25M fully diluted Mo
Slide 23: Upcoming Development Milestones
23 2017 2018 S. aureus CRS • Initiate Phase 2 trial • Complete enrollment P. aeruginosa CF and CRS • Complete manufacture of AB - PA01 clinical trial material • Complete design of CF and CRS phase 1 trials • Complete inhalation toxicology studies • Initiate Phase 1 single ascending dose study in CF
Slide 24: In Summary
24 • Addressing emerging global medical crisis • Advancing into first Phase 2 phage therapy trial • Scalable technology platform enables pipeline expansion • Strategy aimed at fastest approval for initial products • Know - how and IP as competitive barriers to entry • Public and private partnerships
AmpliPhi Biosciences — Investor Presentation (January 2017) on 6ix