Akari Therapeutics Plc · NASDAQ:AKTX
Akari Therapeutics — Investor Presentation (July 2017)
33 slides from Akari Therapeutics's investor presentation, Jul 12, 2017
Slide 1: July 2017 Akari Therapeutics
July 2017 NASDAQ: AKTX Copyright Akari Therapeutics, Plc 2017
Slide 2: Cautionary Note Regarding Forward-Looking Statements
1 Cautionary Note Regarding Forward - Looking Statements Certain statements in this presentation constitute "forward - looking statements" within the meaning of Section 27 A of the Securities Act and Section 21 E of the Securities Exchange Act and are usually identified by the use of words such as "
Slide 3: Akari Mission Statement
2 Developing the next generation of rare & orphan anti - inflammatory therapies Akari Mission Statement Ticks have undergone 300 million years of natural selection to produce inhibitors that bind to key inflammatory mediators and are well tolerated in humans . Our unique molecules are derived from t
Slide 4: Exploiting Evolutionary Benefits of Tick-Derived Proteins
3 Exploiting Evolutionary Benefits of Tick - Derived Proteins Tick salivary proteins work by inhibiting host immune responses, enabling tick to repeatedly feed without damage from host inflammatory response EFFICIENT TARGETED Target early inflammatory mediators Specific binding avoids off - target e
Slide 5: Akari Highlights
4 Akari Highlights * PNH: Paroxysmal nocturnal hemoglobinuria; aHUS: Atypical hemolytic - uremic syndrome; AKC: Atopic keratoconjunctivitis; BP: Bullous Pemphigoid Developing tick - derived proteins to inhibit early inflammation Three separate development programs, each focused on distinct inflammat
Slide 6: Strategic Positioning
5 Strategic Positioning Active PNH & upcoming aHUS trials Growing list of other targets Potential for 20 - 30% market share Potential to achieve dominant market share as sole provider Complement inhibition Expected to be ~$5 billion peak market Sub Q delivery differentiated against current IV standa
Slide 7: Akari Portfolio Builds On Complement Experience
6 Phase III Akari Portfolio Builds On Complement Experience Tissue Targeted (NMJ) Complement System (C5) Coversin™ Coversin LA™ LTB4 Bioamine System LTB4 (L - Coversin™) LTB4 LA Histamine binding Serotonin binding Phase II Phase I Coversin - LTB4 + C5 Preclinical Discovery
Slide 8: Complement Program
7 COMPLEMENT PROGRAM
Slide 9: Akari - Complement Pathway Positioning
8 Akari - Complement Pathway Positioning • Two ongoing Phase II PNH programs – CONSENT and COBALT; and a long - term safety study - CONSERVE • Resistant PNH trial (CONSENT) – 1 patient ‒ Currently recruiting ‒ Patient has been on Coversin since February 2016 • Naïve PNH trial (COBALT) - 5 patients ‒
Slide 10: Positive Response For 15 Months In Eculizumab-Resistant PNH Patient
9 0 200 400 600 800 1,000 1,200 1,400 Positive Response For 15 Months* In Eculizumab - Resistant PNH Patient Treated With Coversin CH50 <8.0 U Eq /mL (below level of detection) No hemolytic episodes; no dose changes; symptom free; twice daily self injection Patient treated pursuant to an approved cl
Slide 11: PNH Trials Update
10 Phase 2 PNH Trials Update All five continuing patients (in CONSENT and COBALT) on ongoing treatment have experienced: • Daily (COBALT) or twice daily (CONSENT) subQ self - administration • No neutralizing antibodies • No SAEs related to Coversin • AEs (including mild/moderate injection site react
Slide 12: Declines in Blood Markers of Hemolysis in COBALT Patients
11 LDH plotted as a multiple of ULN 4 patients who remained in COBALT 0 1 2 3 4 5 6 7 8 0 14 28 42 56 70 84 L D H x U L N Day since first dose Mean Patient A Patient B Patient C Patient D 0 20 40 60 80 100 120 140 0 14 28 42 56 70 84 A S T ( U / L ) Day since first dose Mean Patient A Patient B Pati
Slide 13: Packed Red Blood Cells Transfused Prior to and During COBALT
P acked Red Blood Cells (PRBC) Transfused Prior to and During 90 Day COBALT Trial Months prior to start of Trial 12 Patients A and E had no transfusions in the 12 months preceding the COBALT trial or while in the trial. Patient E was withdrawn from the trial at Day 43 0 2 4 6 8 10 12 12-9 9-6 6-3 3-
Slide 14: Treatment Duration, Safety, and Tolerability of Coversin
Treatment Duration, Safety, and Tolerability Of Patients Treated with Coversin 13 17 months Eculizumab - resistant PNH patient (CONSENT) Continuing Phase 2 PNH patients (COBALT)* Patient who did not complete Phase 2 study (COBALT) • Drug well tolerated by patients • No SAEs related to Coversin • CON
Slide 15: Planned PNH Phase III Trials CAPSTONE and ASSET
14 Planned PNH Phase III Trials CAPSTONE and ASSET • Two PNH Phase III clinical trials: ‒ Naïve patients (CAPSTONE) ‒ Switch (ASSET) • CAPSTONE: Naïve patients randomized to Coversin plus standard of care vs. standard of care • ASSET: Eculizumab - treated patients randomized to remain on eculizumab
Slide 16: Coversin Targeting Atypical Hemolytic Uremic Syndrome (aHUS)
15 Coversin Targeting Atypical Hemolytic Uremic Syndrome (aHUS) • Chronic and life - threatening genetic disease characterized by microangio - pathic hemolytic anemia, thrombocytopenia, and kidney injury • Efficacy of C5 inhibition in aHUS demonstrated by the approval of eculizumab for this indicati
Slide 17: Dual C5 and Leukotriene B4 (LTB4) Program
16 DUAL C5 AND LEUKOTRIENE B4 (LTB4) PROGRAM
Slide 18: Dual Leukotriene and Complement Inhibition Has Potential In Wide Range of Diseases
17 Dual Leukotriene and Complement Inhibition by Coversin Has Potential In Wide Range of Diseases with Unmet Need Complement Only Leukotrine & Complement Asthma Rheumatoid Arthritis PAH Trauma Sjögren’s Bronchiolitis obliterans COPD AATD Bullous Pemphigoid Goodpasture’s AKC Dry Eye PNH aHUS Mucous M
Slide 19: Two Phase II Leukotriene/Complement Trials Projected to Start in 1Q 2018
18 Two Phase II Leukotriene/Complement Trials Projected to Start in 1Q 2018 • Phase II programs ‒ AKC (atopic keratoconjunctivitis) - eye (topical drops) ‒ BP (bullous pemphigoid) – skin (sub Q) • Several severe lung conditions are impacted by complement and leukotriene pathways with zileuton and mo
Slide 20: Coversin & L-Coversin Potentially Superior Strategy to Target LTB4
Coversin & L - Coversin Potentially Superior Strategy to Target LTB4 Previous strategies to target LTB4 suffered from a lack of selectivity; benefits of reducing LTB4 were offset by off - target effects Coversin and L - Coversin capture LTB4 within an internal binding site • Directly and specificall
Slide 21: LTB4 Intervention Strategies
LTB4 Intervention Strategies Arachidonic acid LTA 4 Lipoxins LTB 4 LTC 4 LTD 4 LTE 4 5 - LO FLAP LTA 4 H LTC 4 S Lipoxygenases Pro - inflammatory Anti - inflammatory Spasmogenic Zileuton GSK2190915 DG - 031 MK - 0633 TA - 270 5 - LO / FLAP inhibitors Reduces anti - inflammatory lipoxins BLT1/BLT2 an
Slide 22: Dual Action Eye (AKC) and Skin (BP) Program
21 DUAL ACTION EYE (AKC) AND SKIN (BP) PROGRAM
Slide 23: Collaboration with Moorfields Hospital
Collaboration with Moorfields Hospital (Institute of Ophthalmology) EIC pre - clinical model of severe eye surface inflammation Demonstrated Benefit in Mouse Model Late - Phase Ocular Inflammation • C57/Bl6 mice sensitized to OVA for 14 days • OVA eye surface challenge for 6 days post sensitization
Slide 24: Atopic Keratoconjunctivitis (AKC)
Atopic Keratoconjunctivitis (AKC) • Severe eye surface inflammation causing infiltration of immune cells such as neutrophils and T cells. A cause of blindness worldwide • Topical drugs, such as steroids or cyclosporin , often not effective or cannot be given chronically • In AKC disease, despite bes
Slide 25: Coversin Demonstrated Benefit in Bullous Pemphigoid Model
Coversin Demonstrated Benefit in Bullous Pemphigoid Model Preclinical passive mouse model from Dr. Sadik in Lubeck, Germany Leading Bullous Pemphigoid center P=0.0023 between vehicle and 250 µg/kg • ~60% reduction in affected area on Coversin (Sub Q) compared to vehicle or steroid in mouse model • C
Slide 26: Bullous Pemphigoid (BP) Significant Unmet Need
25 Bullous Pemphigoid (BP) Significant Unmet Need • Immune complex deposition initiates complement cascade and inflammatory process • LTB4 recruits neutrophils to dermis - epidermis junction and amplifies inflammation • Phase II open label trial against standard of care projected to start in 1Q 2018
Slide 27: Scientific Development Program
26 SCIENTIFIC DEVELOPMENT PROGRAM
Slide 28: Akari Discovery Platform
27 Akari Discovery Platform Coversin engineered molecules targeted to complement pathway Other Akari tick - derived molecules • Eicosanoid pathway (LTB4 only) L - Coversin (lung) • Bioamine pathway • Extended half life (LA) ‒ Ligand capture preventing action on multiple GPCRs ‒ Similar biophysical p
Slide 29: Coversin LA: Once Weekly Formulation
28 Coversin LA: Once Weekly Formulation 0 20 40 60 80 100 120 0.01 0.1 1 % Total Lysis Coversin Eculizumab PAS Coversin Coversin &Eculizumab Drug concentration (µM) Inhibition of complement alternative pathway rabbit red blood cell lysis PAS Coversin Coversin 5% Human PK simulation of free C5 follow
Slide 30: Financial Summary March 31, 2017
29 Financial Summary March 31, 2017 • ADS* outstanding 11,776,934 • ADS Fully Diluted 12,583,641 • Cash and Cash Equivalents** $35.1m (no debt) * Each ADS represents 100 ordinary shares ** Includes short - term investments
Slide 31: Akari Clinical Program Highlights
30 Akari Clinical Program Highlights Complement program • PNH - projected Phase III start – 4Q 2017 - additional Phase II patients – 4Q 2017 • aHUS - projected Phase II start – 4Q 2017 • Coversin LA - projected Phase I start – 4Q 2018 Dual C5 & leukotriene B4 (LTB4) program • AKC & BP - projected Ph
Slide 32: COBALT Phase II Dosing and Response Summary
• Three of the four continuing patients were updosed – Patient A and B were updosed from 30 mg to 45 mg once daily at Days 40 and 54, respectively – Patient C was updosed to 22.5 mg twice daily at Day 24 and moved to 45 mg once daily at Day 67 – Patient B, the last in to date, did not see a decline
Slide 33: Akari Therapeutics
A AKARI THERAPEUTICS NASDAQ; AKTX July 2017
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