Armata Pharmaceuticals, Inc. · AMEX:ARMP
Armata Pharmaceuticals — AmpliPhi Biosciences — Investor Presentation (September 2018)
21 slides from Armata Pharmaceuticals's investor presentation, Sep 5, 2018
Slide 1: Advancing bacteriophage therapeutics for patients with antibiotic-resistant infections
Advancing bacteriophage therapeutics for patients with antibiotic - resistant infections Company Overview September 5, 2018 NYSE American: APHB
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 for war d - looking statements. All
Slide 3: AmpliPhi Biosciences Overview
3 Novel therapies are urgently needed to combat antimicrobial resistance AmpliPhi is leading development of bacteriophage therapeutics as a novel therapeutic modality for patients with serious, resistant bacterial infections • Targeted therapies with a mechanism of action that is different from anti
Slide 4: The world is headed for a post-antibiotic era
4 “ The world is headed for a post - antibiotic era, in which common infections and minor injuries which have been treatable for decades can once again kill .” Dr. Keiji Fukuda, WHO’s Assistant Director - General for Health Security
Slide 5: Bacteriophage therapeutics vs. superbugs
5 Bacteriophage therapeutics: novel, precisely targeted investigational therapy for patients with serious, resistant bacterial infections Pathogen - targeted mechanism of action that is differentiated from antibiotics • Kill bacteria by cell lysis • Disrupt and destroy biofilm • Restore sensitivity
Slide 6: Bacteriophages: Novel Precisely Targeted Antibacterials
6 Naturally - occurring viruses • Evolved to infect and kill only bacteria • Target specific bacterial strains Most abundant and diverse organisms on Earth • Humans co - exist with phages • An abundant variety of phage types exist, capable of infecting and killing most, if not all, bacterial strains
Slide 7: Today's Advances in Bacteriophage Therapeutics Enabled by Modern Biotechnology
7 Today’s Advances in Bacteriophage Therapeutics Enabled by Modern Biotechnology • Biologics manufacturing • Purification (e.g., endotoxin removal) • Sequencing Advances in phage development Enabling technologies • Select and optimize proprietary phage combinations • Maximize efficacy and host cover
Slide 8: Bacteriophages As Precisely Targeted Therapeutics: Preclinical Data
8 Bacteriophages As Precisely Targeted Therapeutics: Preclinical Data 6h 8h 24h Untreated Phage Tx Ciprofloxacin (200 mg/kg SC) Biofilm thickness Targeted and selective 1 Directly kill bacteria by cell lysis 2 Destroy biofilm 3 Restore sensitivity to antibiotics 4
Slide 9: Experienced Management Team
9 Experienced Management Team Management Paul Grint, M.D. 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 Bo
Slide 10: AmpliPhi's In-House cGMP Manufacturing Facility
10 AmpliPhi’s In - House Facility Pioneering cGMP Manufacturing of Bacteriophage Therapeutics In - house CMC capabilities: • Process development • Bioanalytical • Fermentation • Purification • Aseptic fill • QC and QA Facility certified and inspected by local EU regulatory authorities, most recently
Slide 11: AmpliPhi Development Pipeline
AmpliPhi Development Pipeline Program Delivery Preclinical Phase 1/ Expanded Access Phase 2 Phase 3 AB - SA01 ( S. aureus) Intravenous Intrasinal Topical AB - PA01 ( P. aeruginosa) Intravenous Inhaled Topical Other ESKAPE pathogens 11 CF, cystic fibrosis; CRS, chronic rhinosinusitis; LVAD, left vent
Slide 12: Lead Product Candidates AB-SA01 and AB-PA01
12 Lead Product Candidates AB - SA01 and AB - PA01 AB - SA01 ( S. aureus ) • 3 lytic phages • 3 ¨ 10 9 PFU per dose • Coverage: ~95% of S. aureus strains, including MDR AB - PA01 ( P. aeruginosa ) • 4 lytic phages • 4 ¨ 10 9 PFU per dose • Coverage: ~80% of P. aeruginosa strains, including MDR PFU,
Slide 13: Significant Market Opportunity
13 Significant Market Opportunity 500,000+ U.S. Annual Incidence of Infections Targeted by AB - SA01 & AB - PA01 Indication S. aureus incidence P. aeruginosa incidence Bacteremia 150,000 50,000 Cardiac implant infections (LVAD and pacemaker) 1,000 200 CF lung infections 10,000 20,000 Complicated int
Slide 14: Positive Feedback from FDA in 2017 Type B Meeting and FDA/NIH Workshop
Positive Feedback from FDA in 2017 Type B Meeting and FDA/NIH Bacteriophage Therapy Workshop Minutes from Type B Meeting with FDA: • FDA expressed support for phage therapy for patients with serious or life - threatening infections • “CBER acknowledged that phage therapy is an exciting approach to t
Slide 15: AmpliPhi's Expanded Access Strategy
15 Expanded Access allows critically ill patients to receive experimental therapies in attempt to save lives • Patients who are not responding to standard - of - care antibiotics • Emergency IND (US FDA) or Special Access Scheme (Australian TGA) AmpliPhi initiated Expanded Access Program for two lea
Slide 16: Expanded Access Summary: August 2018 Update
16 Encouraging results from treatment of 21 patients at 7 hospitals, with serious or life - threatening infections not responding to antibiotic therapy, under Expanded Access Program (EAP) • 15 patients - AB - SA01. 6 patients - AB - PA01 • Serious or life - threatening infections: bacteremia, endoc
Slide 17: Expanded Access Results Presented at Conferences in 2018
17 Expanded Access Results Presented at Conferences in 2018 Conference Date Presentation Biotech Showcase Jan 8 Topline results from patients treated in 2017 International Society for Heart and Lung Transplantation Apr 13 “ Bacteriophage Treatment in a Lung Transplant Patient ” (UCSD) – designated a
Slide 18: Meetings with FDA in Aug. and Sept. 2018: Define Clinical Trial Design and Path to Registration
18 AB - SA01: Type B (pre - IND) Meeting with FDA conducted in August 2018 • Shared clinical and microbiological results for patients treated with AB - SA01 under single - patient expanded access program in 2017 and 2018 • Discussed proposed design of randomized controlled clinical trials in two ind
Slide 19: Next Steps
Next Steps AB - SA01 ( S. aureus ): based on FDA feedback, plan to initiate one or more randomized controlled clinical trials in early 2019 to evaluate the safety and efficacy of AB - SA01 • Expect official FDA meeting minutes in September 2018 AB - PA01 ( P. aeruginosa ): Type B (pre - IND) Meeting
Slide 20: Funding and Capitalization
20 • Completed two common stock only fund - raises under the existing S - 3 shelf in January and March of 2018. Raised approximately $7M of gross proceeds • Cash resources expected to be sufficient to fund operations into the fourth quarter of 2018 • 16.5M common shares outstanding and 25.9M fully d
Slide 21: AmpliPhi Biosciences Overview
21 Novel therapies are urgently needed to combat antimicrobial resistance AmpliPhi is leading development of bacteriophage therapeutics as a novel therapeutic modality for patients with serious, resistant bacterial infections • Targeted therapies with a mechanism of action that is different from ant
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