Akari Therapeutics Plc · NASDAQ:AKTX
Akari Therapeutics — Investor Presentation (July 2016)
21 slides from Akari Therapeutics's investor presentation, Jul 12, 2016
Slide 1: Akari Therapeutics, July 2016
A AKARI THERAPEUTICS NASDAQ: AKTX July 2016
Slide 2: Cautionary Note Regarding Forward-Looking Statements
Cautionary Note Regarding Forward - Looking Statements Copyright 2016 Akari Therapeutics Plc 1 Certain statements in this presentation constitute "forward - looking statements" within the meaning of Section 27A of the Securit ies Act and Section 21E of the Securities Exchange Act and are usually ide
Slide 3: Coversin: An Evolution in Complement Treatment
Coversin: An Evolution in Complement Treatment Definitive Proof of Concept Copyright 2016 2 Competitive Advantages Expanding Opportunities Driving Value • Phase 2 PNH patient in successful ongoing treatment – 5 months + • Significant reduction in LDH and full complement inhibition • Proven predicate
Slide 4: Clinical Timeline
Topline data Phase 1 Phase 3 3 2018 2016 2017 Phase 2 Phase 3 Ongoing treatment/potential regulatory pathway Phase 3 Copyright 2016 Preclinical Phase 2 Phase 2 Clinical Timeline 2019 Eculizumab Resistance PNH aHUS GBS Coversin LA Phase 2
Slide 5: Coversin: Nature's Complement Inhibitor
• Coversin discovered by Miles Nunn (CSO) in saliva of Ornithodoros moubata tick • Dampened host immune response allows tick to repeatedly feed without damage from inflammatory substances (300 million years of natural development) • Clinical & scientific data emphasizes natural origins ‒ Tight indep
Slide 6: Coversin Binding Sites and Activity in Range of Diseases
C5a, LTB4 and MAC act jointly on granulocytes, leukocytes and many other immune and tissue cell types - potentially causing inflammation and damage. Activity demonstrated in a range of diseases in animal models C345C C5a C3b Bb Eculizumab epitope Position of Coversin binding Binding Sites Coversin A
Slide 7: Single Dose Phase Ia Trial Demonstrated Full C5 Inhibition
Single Dose Phase Ia Clinical Trial Demonstrated Full C5 Inhibition • Full complement ablation within 12 hours at 0.57 mg/kg • Inhibition maintained for 24 hours after single dose • Good safety profile: no SAEs or injection site reactions Copyright 2016 Co nfidential 6 Elisa CH50 • 24 normal volunte
Slide 8: Phase 1b: Full C5 Inhibition and Once-Daily Maintenance Dosing
Copyright 2016 7 Phase 1b: Full C5 Inhibition in 24 Hours and Once - Daily Maintenance Dosing 0 20 40 60 80 100 120 140 0 24 48 72 96 120 144 168 192 CH50 U Eq/ml Placebo Coversin 0 20 40 60 80 100 120 140 0 24 48 72 96 120 144 168 192 Lytic CH50 Coversin Placebo Time from first dose (h) • First coh
Slide 9: Positive Ongoing Results in Phase 2 Trial in PNH Patient
Positive Ongoing Results In Phase 2 Trial in PNH Patient Copyright 2016 8 • Eculizumab - resistant PNH patient treated since Feb 2016 ‒ Continues to self - inject • Patient has demonstrated: ‒ Full complement inhibition (CH50) ‒ LDH reduction <1.5X upper limit of normal (ULN) • “Coversin has proven
Slide 10: No Neutralizing Antibodies to Date
Successful Phase 2 Trial in PNH Patient No Neutralizing Antibodies to Date • Purified IgG from Dutch patient (over 4 months) • No effect on Coversin C5 inhibition • Antibody response peak approximately 9 weeks after initial dosing and declines % inhibition of lysis 0 20 40 60 80 100 120 PNS IgG anti
Slide 11: Patient Groups Prefer Subcutaneous Over IV Delivery
Patient Groups Indicate Clear Preference For Subcutaneous Over IV Delivery • Feedback from PNH/aHUS patient groups and KOLs consistently highlights preference for self - administration • Coversin - small injection volume (< 0.5ml), no ISR • Auto injector pen planned for commercialisation Pivot X. et
Slide 12: PNH Phase 2 Data Expected By YE 2016
PNH Phase 2 Data Expected By YE 2016 • Trial initiation expected summer 2017 • Working with broad network of leading PNH centres • Undergoing scientific advice with EMA & FDA Copyright 2016 11 2016 Phase 2 2017 Phase 3 • Leading PNH treatment centers in EU: Leeds & London, UK and Nijmegen, NL • Open
Slide 13: Developing Once-Weekly Formulation Coversin LA
Developing Once - Weekly Formulation Coversin LA • Increases MW from 17 to 47kda – Effective MW of ~500kda • Remains fully active; increased C5 binding • Highly soluble and fully bioavailable • Expected timing – 3Q 2016 - PK and toxicity studies – 2H 2017 - Phase 1 POC clinical study Plasma half - l
Slide 14: aHUS Phase 2 Trial Expected Q4 2016
aHUS Phase 2 Trial Expected Q4 2016 • Open label clinical trial planned for Q4 2016 in EU • Clinical centers identified 13 Copyright 2016 2016 Phase 2 Complement - mediated hemolytic uremic syndrome (aHUS) Chronic and life - threatening genetic disease characterized by microangio - pathic hemolytic
Slide 15: GBS Phase 2 Trial Expected 1Q 2017
GBS Phase 2 Trial Expected 1Q 2017 • Attractive clinical trial duration: 28 days + 6 month follow up • Primary endpoint: improvement in GBS Disability Rating Scale • 1 point = difference between wheelchair - bound or ambulatory • Sites and lead investigator identified 14 Copyright 2016 2017 Phase 2
Slide 16: Coversin: C5 + LTB4 Combination Targeting
Coversin: C5 + LTB4 Combination Targeting Emerging Differentiation • Existing LTB4 long term treatment inhibition with Zileuton * (small molecule approved in EU) • LTB4 acts as signal relay molecule • Coversin LTB4 binding may reduce non - complement - mediated recruitment & activation of granulocyt
Slide 17: Dual C5/LTB4 Activity May Lead To Enhanced Market Opportunities
Dual C5/LTB4 Activity * May Lead To Enhanced Market Opportunities Complement & LTB4 Primarily Complement Systemic Local Good - pastures Rare & orphan Copyright 2016 *Coversin activity demonstrated in over 10 animal models 16 Larger prevalence RA Bronchiolitis obliterans PAH aHUS MG PNH GBS NMO Psori
Slide 18: Financial Summary
Financial Summary • $75m PIPE September 2015 • ADS outstanding 11,776,934 • ADS Fully Diluted 12,667,441 • Cash as of March 31 $56m (no debt) • Funding through Early 2018 Copyright 2016 17
Slide 19: Proven Management Team
Executive Chairman • Lead investor (RPC); entrepreneur; founder Volution/Akari and TDL Chief Executive Officer • Celsus; Venrock; Piper Jaffray; Internist Chief Operating Officer • LEK Consulting; Head of Research - Investec; RPC Medical Director • European Medical Director, BMS; 25 years developmen
Slide 20: Milestones Historic and Anticipated
Milestones Historic and Anticipated Copyright 2016 19 2H 2015 - 1H 2016 2H 2017 2H 2016 1H 2017 • Merger / $75MM PIPE • 3 - month NHP toxicity study • Phase 1b • Phase 2 (resistant) trials - PNH patient treated (>5 months) • Development of Coversin LA - initiated • Phase 2 PNH and aHUS trial - initi
Slide 21: Akari Therapeutics
A AKARI THERAPEUTICS NASDAQ: AKTX July 2016
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