Akari Therapeutics Plc · NASDAQ:AKTX
Akari Therapeutics — Investor Presentation (January 2017)
26 slides from Akari Therapeutics's investor presentation, Jan 9, 2017
Slide 1: Akari Therapeutics
iN AKARI THERAPEUTICS NASDAQ: AKTX January 2017
Slide 2: Cautionary Note Regarding Forward-Looking Statements
Cautionary Note Regarding Forward - Looking Statements 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 identified by the use of words such as "ant
Slide 3: Portfolio of Anti-Inflammatory Compounds for Orphan Conditions
Portfolio of Anti - Inflammatory Compounds for Orphan Conditions Advancing Clinical Program Coversin Competitive Advantages • PNH resistant patient successfully on therapy for >11 months • PNH - expect Ph2 data 1Q 2017 & Ph3 initiated mid - 2017 • aHUS pivotal trial expected 2017 • Complete ablation
Slide 4: Pipeline of Diverse Molecules Targeting Multiple Pathways
Pipeline of Diverse Molecules Targeting Multiple Pathways Tissue Targeted (NMJ) Complement System Coversin™ Coversin LA™ Oral Eicosanoid System Bioamine System LTB4 LTB4 LA Histamine binding Serotonin binding Thromboxane binding Lipoxin binding Phase 2 Phase 1 Preclinical Discovery LTB4 + C5 Copyrig
Slide 5: Current Coversin Clinical Timeline
Phase 1 Phase 3 2018 2017 Phase 2/3 Phase 3 Ongoing treatment/potential regulatory pathway Phase 3 Preclinical Phase 2 Phase 2 Current Coversin Clinical Timeline Eculizumab Resistance PNH aHUS GBS Coversin LA Phase 2 Copyright Akari Therapeutics, Plc 2017 4 Filing 2019
Slide 6: Coversin Differentiated by Dual C5 and LTB4 Action
C5a, LTB4 and MAC act jointly on granulocytes, leukocytes and many other immune and tissue cell types - potentially causing inflammation and damage Coversin Differentiated by Dual C5 and LTB4 Action MAC PLA2 Arachidonic acid C3 C3b Classical Mannose binding lectin Alternative Activation pathways C3
Slide 7: Phase Ib Trial: Once Daily Dosing Provides Full Ablation
Phase Ib Trial: Once Daily Dosing Provides Full Ablation • Subjects received 4 ablating injections Q12 for 2 days, then QD for 5 days • Dose effect demonstrates once - daily dosing • Advanced 30 mg dose into Ph2 trial • Alignment of Elisa and Lytic CH50 results 0 20 40 60 80 100 120 140 1 7 13 19 25
Slide 8: >11 Months Successful Treatment of Eculizumab-Resistant PNH Patient
>11 Months Successful Treatment* of Eculizumab - Resistant PNH Patient • Since day 18: ‒ No dose changes ‒ No haemolytic episodes; no SAEs ‒ CH50 <8.0 U Eq /mL (lower limit of quantification) * Pursuant to an approved clinical protocol in the Netherlands 2016 EH, Saskia Langemeijier, University of R
Slide 9: Eculizumab-Resistant PNH Patient: No Neutralizing Antibodies to Date
Eculizumab - Resistant PNH Patient: No Neutralizing Antibodies to Date Coversin 0 20 40 60 80 100 120 PNS Anti-Cov Rb Day 0 Day 16 Day 34 Day 58 Day 83 Day 125 Day 153 Day 181 Day 205 Day 237 Anti-Cov Rb % inhibition of lysis + ve * CTR 14 17 21 9 kDa Days since first dose + ve * CTR Coversin * Posi
Slide 10: PNH Clinical Program Phase Planned for Mid-2017
PNH Clinical Program Phase 3 Planned for Mid - 2017 • Trial initiation planned mid - 2017 • Network of leading PNH centers • Scientific advice received from EMA & FDA • Infrastructure in place to roll over from Phase 2 - 3 Phase 2 Ongoing Phase 3 2017 • Data release expected March 2017 • Leading PNH
Slide 11: aHUS and GBS Clinical Programs
aHUS and GBS Clinical Programs • Open label Phase 2 first patient expected 2Q 2017 • Leading treatment centers in EU • Planned to progress directly into Ph 3 trial in late 2017 aHUS • Immune - mediated polyneuropathy with severe clinical outcomes (2 – 12% die; 10 – 35% permanent impairment) • Phase
Slide 12: Exploiting the Power of Nature: Akari Discovery Platform
Pipeline of tick - derived molecules selected to suppress mediators of chronic inflammation in wide range of orphan disorders Exploiting the Power of Nature: Akari Discovery Platform Coversin engineered molecules targeted to complement pathway New Akari tick - derived anti - inflammatory molecules •
Slide 13: Once-Weekly Formulation Coversin LA
Once - Weekly Formulation Coversin LA • Addition of 600 Pro - Ala - Ser amino acids (PASylation ™ ) • Increases MW from 17 to 68 kDa – Apparent ~600 kDa MW • Terminal half life est. at 4 days • Phase 1 clinical study - expected timing 4Q 2017 • Clean initial toxicology comparable to unmodified Cover
Slide 14: Tissue-Targeting Coversin Program to Access New Indications
Tissue - Targeting Coversin Program to Access New Indications • Coversin targeted to specific tissues by fusing peptides to N - terminal • First condition is Myasthenia Gravis (MG) – Neuromuscular junction (NMJ) using targeted aptamer – Dose expected to be <20% of that for other C5 indications – Pot
Slide 15: Coversin Dual C5/LTB4 Activity May Lead to New Market Opportunities
Coversin - Dual C5/LTB4 Activity May Lead to New Market Opportunities • Synergistic with C5 inhibition • Co - occurrence at inflammatory site • Feedback loops between C5 and LTB4 • Can also be activated independently • Lung - Obliterative Bronchiolitis • Juvenile Rheumatoid Arthritis • Ophthalmic –
Slide 16: LTB4 Inhibitors: Increasingly Important Clinical Target
LTB4 Inhibitors: Increasingly Important Clinical Target • Differentiated MOA • Captures ligand • No effect on cysLT or lipoxines , resolvins • Does not cause shunt to prostanoids • Leaves LTA4H hydrolytic activity against PGP intact • Lung: ‒ Treatment resistant Asthma ‒ Alpha - 1 - Antitrypsin ‒ CO
Slide 17: L-Coversin Competitive Advantage: Unique Mode of Action
L - Coversin Competitive Advantage: Unique Mode of Action Ig binding to Fc gamma receptors Cytokines e.g. TNF and IL8 Toll - like receptors Arachidonic acid LTB4 Lipoxygenases (5 - LOX) LTA4 Coversin PGP inactivated PGP Anaphylatoxin C5a PLA2 Collagen Matrix Metalloproteases BLT1 BLT2R Ono/JJ zileut
Slide 18: Portfolio of Distinct Bioamine Inhibitors
Portfolio of Distinct Bioamine Inhibitors • Different molecules targeting different or multiple ligands • Prevents interaction with all four GPCRs (H1, H2, H3, H4) • Mast cell stabilizer • Skin - severe eczema • CNS - neuropathic pain • Ophthalmic - retinopathies Copyright Akari Therapeutics, Plc 20
Slide 19: Financial Summary
Financial Summary • $75 million PIPE September 2015 • ADS outstanding 11,776,934 • ADS Fully Diluted 12,667,441 • Cash as of Sept 30 $51m (no debt) • Funding through Early 2018 Copyright Akari Therapeutics, Plc 2017 18
Slide 20: Proven Management Team
Executive Chairman • Lead investor (RPC); founder Akari; medical entrepreneur 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 development experie
Slide 21: Milestones Historic and Anticipated
Milestones Historic and Anticipated 2016 2H 2017 1H 2017 • Phase 1b • PNH resistant patient treated (>11 months) • Phase 2 PNH trial initiated • US IND and US/EU orphan designations allowed • CMC scale up 4Q 2016 • Phase 2 PNH data – 1Q 2017 • Phase 2 GBS trial – initiation • Phase 2 aHUS trial – in
Slide 22: Appendix
Appendix Copyright Akari Therapeutics, Plc 2017 21
Slide 23: Dual C5/LTB4 Activity May Lead To New Market Opportunities
Dual C5/LTB4 Activity May Lead To New Market Opportunities Roversi P et al. J Biol Chem 288: 18789; 2013 Immune - Complex Mediated Acute Lung Injury Mouse Model * Proteins only ** LTB 4 (0:1, outer) or ethanol (0:0, central) only 4 : 1 2 : 1 1 : 1 4 : 0 * 0.5 : 1 + ve and – ve controls** Molar ratio
Slide 24: Coversin Tissue Targeting: NMJ
• Coversin linked to peptide which binds laminin γ1 ‒ Differentially concentrates at basal lamina of NMJ • Immunohistochemical analysis in mice shows that Coversin - laminin construct – unlike Coversin alone - concentrates to NMJ of diaphragm and tibialis muscles Coversin Tissue Targeting: NMJ • No
Slide 25: LPS Mouse Lung Challenge Model
n=5 n=5 n=10 n=10 n=10 • Neutrophilic response (mean and SEM) in bronchoalveolar lavage fluid of mice 8 hr following 50µg LPS i.t. • Treatments (i.t.): 100 µg Coversin, 100 µg LTB4 saturated Coversin, 50 mg/Kg Zileuton or vehicle • Statistical comparisons to vehicle and between Coversin and Zileuton
Slide 26: Akari Therapeutics
iN AKARI THERAPEUTICS NASDAQ: AKTX January 2017
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