Armata Pharmaceuticals, Inc. · AMEX:ARMP
Armata Pharmaceuticals — AmpliPhi Biosciences — Investor Presentation (May 2018)
27 slides from Armata Pharmaceuticals's investor presentation, May 15, 2018
Slide 1: Company Overview
Advancing bacteriophage therapeutics for patients with antibiotic - resistant infections Company Overview May 15, 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 urgently needed to combat antimicrobial resistance AmpliPhi is leading development of bacteriophage therapeutics as novel, precisely targeted treatment modality for patients with serious, resistant bacterial infections • Pathogen - targeted mechanism of action that is differentiate
Slide 4: Post-antibiotic era quote from WHO
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: Bacteriophages Provide Hope Against Superbugs
5 Bacteriophages Provide Hope Against Superbugs
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: Clinical Case Study - Mr. P (2016)
Clinical Case Study - Mr. P* (2016) Critically Ill Patient Suffering from MDR A. baumannii Infection • 68 - year - old male suffering from MDR Acinetobacter baumannii abdominal infection • Multiple courses of antibiotics over 4 months: vancomycin, meropenem, colistin , tigecycline, azithromycin, and
Slide 10: AmpliPhi's Phage Library Targets WHO Priority Pathogens List
10 AmpliPhi’s Phage Library Targets Bacteria on WHO Priority Pathogens List Source: World Health Organization, 2017 Priority Pathogens List published in 2017 Priority 1: CRITICAL Acinetobacter baumannii , carbapenem - resistant Pseudomonas aeruginosa , carbapenem - resistant Enterbacteriaceae , carb
Slide 11: AmpliPhi Development Pipeline
AmpliPhi Development Pipeline Program Preclinical Phase 1/ Expanded Access Phase 2 Phase 3 AB - SA01 ( S. aureus) Intravenous: endocarditis, bacteremia, PJI Intrasinal : chronic rhinosinusitis Topical: various AB - PA01 ( P. aeruginosa) Intravenous: lung infections, cUTI , cIAI Inhaled: lung infecti
Slide 12: In-House Facility Pioneering cGMP Manufacturing of Bacteriophage Therapeutics
12 In - House Facility Pioneering cGMP Manufacturing of Bacteriophage Therapeutics In - house CMC capabilities: • Process development • Bioanalytical • Fermentation • Purification • Aseptic fill • QC and QA Inspected by European regulatory authorities, most recently in 2018
Slide 13: Lead Product Candidates AB-SA01 and AB-PA01
13 Lead Product Candidates AB - SA01 and AB - PA01 AB - SA01 ( S. aureus ) • 3 lytic phages • 3 ¨ 10 9 PFU per dose • Coverage: ~96% 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 14: Positive Feedback from FDA in 2017
Positive Feedback from FDA in 2017 • FDA expressed support for phage therapy for patients with serious or life - threatening infections • Data from Expanded Access cases could inform approval pathway 14 “CBER acknowledged that phage therapy is an exciting approach to treatment of multidrug - resista
Slide 15: AmpliPhi Presented at FDA/NIH Bacteriophage Therapy Workshop in 2017
AmpliPhi Presented at FDA/NIH Bacteriophage Therapy Workshop in 2017 15 “…Though it was discovered… over a century ago, before the modern antibiotic era, bacteriophage may turn out to be important therapeutics in combatting antibiotic - resistant infections.” “… phage therapy appears to be non - tox
Slide 16: AmpliPhi's Expanded Access Strategy
16 Expanded Access allows critically ill patients to receive experimental, unapproved 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
Slide 17: Expanded Access Program: Seven Patients Treated in 2017
17 Seven patients with serious or life - threatening infections, not responding to antibiotic therapy, treated with AB - SA01 or AB - PA01 in 2017 • Four patients with S. aureus infections treated with AB - SA01 • Three patients with P. aeruginosa infections treated with AB - PA01 • Emergency IND (U
Slide 18: Expanded Access Interim Update: Safety and Tolerability
18 Expanded Access Interim Update: Safety and Tolerability ITT Population AB - SA01 (N=4) AB - PA01 (N=3) Total IV doses 90 402* Total inhaled doses - 92** Safety and tolerability Well tolerated in all patients No treatment - related SAEs Well tolerated in all patients No treatment - related SAEs *
Slide 19: Expanded Access Interim Update: Clinical Outcomes
19 Expanded Access Interim Update: Clinical Outcomes Clinical Outcome (Physician’s Assessment) (ITT Population) Value (N=7) Treatment Success 6 (86%) Improvement – Failure 1 ( 14%)* * The patient presented with septic shock, APACHE II score of 47 at baseline (predicted mortality risk 97%). Patient w
Slide 20: ISHLT 2018: Bacteriophage Treatment in a Lung Transplant Patient (AB-PA01)
20 ISHLT 2018: Bacteriophage Treatment in a Lung Transplant Patient (AB - PA01)
Slide 21: Next Steps for 2018
21 Next Steps for 2018 Potential Milestone Date Continue Expanded Access Program for AB - SA01 and AB - PA01 2018 Present detailed results at medical conferences 2018 Present data to FDA and define studies required for registration Mid - 2018 Initiate Phase 2 or registrational studies of AB - SA01 a
Slide 22: Significant Market Opportunity
22 Significant Market Opportunity 500,000+ U.S. Annual Incidence of Infections Targeted by AB - SA01 & AB - PA01 Indication S. aureus P. aeruginosa Bacteremia 150,000 50,000 Cardiac implant infections (LVAD and pacemaker) 1,000 200 CF lung infections 10,000 20,000 Complicated intra - abdominal infec
Slide 23: Bacteriophages as Targeted Therapy: Infectious Diseases, Microbiome, Oncology, and Beyond
23 Bacteriophages as Targeted Therapy: Infectious Diseases, Microbiome, Oncology, and Beyond Selectively remove bacterial populations Targeted therapy Precisely modulate microbiome Preserve commensal bacterial species
Slide 24: Experienced Management Team
24 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 B
Slide 25: Advisors
25 Advisors Robert T. Schooley, MD Professor of Medicine, Division of Infectious Diseases UCSD Editor - in - Chief, Clinical Infectious Diseases Timothy K. Lu, MD, PhD Associate Professor of Biological Engineering and Electrical Engineering and Computer Science MIT
Slide 26: Funding and Capitalization
26 • 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 27: Novel therapies urgently needed to combat antimicrobial resistance
27 Novel therapies urgently needed to combat antimicrobial resistance AmpliPhi is leading development of bacteriophage therapeutics as novel, precisely targeted treatment modality for patients with serious, resistant bacterial infections • Pathogen - targeted mechanism of action that is differentiat
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