Armata Pharmaceuticals, Inc. · AMEX:ARMP
Armata Pharmaceuticals — AmpliPhi Biosciences — Biotech Showcase Conference 2018
25 slides from Armata Pharmaceuticals's conference presentation, Jan 8, 2018
Slide 1: Advancing bacteriophage therapeutics for patients with antibiotic-resistant infections
Advancing bacteriophage therapeutics for patients with antibiotic - resistant infections Biotech Showcase Conference January 8, 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 therapeutic modality for patients with serious, resistant bacterial infections • Pathogen - targeted mechanism of action that is differentia
Slide 4: WHO warning on 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: 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
10 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 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 twice, most recently in 2017
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's Expanded Access Strategy
15 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 16: Expanded Access treatment of seven patients in 2017
16 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 17: Expanded Access Interim Update: Treatment Schedule
Expanded Access Interim Update: Treatment Schedule 17 Eligibility Treatment Follow - up AB - SA01 IV 3 × 10 9 PFU q12h AB - PA01 IV 4 × 10 9 PFU q12h or q6h AB - PA01 inhaled 4 × 10 9 PFU q12h Signs and symptoms Not responding to best available therapy Susceptibility to AB - SA01 or AB - PA01 Life -
Slide 18: Expanded Access Interim Update: Patient Characteristics
18 Expanded Access Interim Update: Patient Characteristics Patient Characteristic (ITT Population) Value (N=7) Age, years, mean (range) 52 (26 - 77) Male / female 57% / 43% Indications Bacteremia Endocarditis (native valve) Endocarditis (prosthetic valve) Lung infection (cystic fibrosis) Lung infect
Slide 19: Expanded Access Interim Update: Safety and Tolerability
19 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 20: Expanded Access Interim Update: Clinical Outcomes
20 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 wa
Slide 21: Expanded Access Interim Update: All-Cause Mortality
21 Expanded Access Interim Update: All - Cause Mortality Mortality (ITT Population) Value (N=7) 28 - day all - cause mortality 1 (14%)* 90 - day all - cause mortality No mortality between Days 28 and 90 to - date, follow - up ongoing Mortality predicted by APACHE II scores, mean** 46% 3 patients wit
Slide 22: Next Steps for 2018
22 Next Steps for 2018 Potential Milestone Date Expanded Access Program: Treat up to additional ~20 patients in 1H18. Announce additional topline data 1H 2018 Present detailed results at medical conferences 2018 Present data to FDA and define studies required for registration Mid - 2018 Initiate Pha
Slide 23: Experienced Management Team
23 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 24: Funding and Capitalization
24 • Completed an underwritten offering of common stock and warrants for $9.4M of net proceeds in May 2017 • Received $2.0M in cash in September 2017 from the Australian Government as a tax rebate based on R&D activities performed in Australia in 2016 • Cash resources expected to be sufficient to fu
Slide 25: Novel therapies urgently needed to combat antimicrobial resistance
25 Novel therapies urgently needed to combat antimicrobial resistance AmpliPhi is leading development of bacteriophage therapeutics as novel, precisely targeted therapeutic modality for patients with serious, resistant bacterial infections • Pathogen - targeted mechanism of action that is differenti
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