UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form 6-K
Report of Foreign Private Issuer
Pursuant to Rule 13a-16 or 15d-16
under the Securities Exchange Act of 1934
July 12, 2016
Commission file number: 001-36288
Akari Therapeutics, Plc
(Translation of registrant's name into English)
24 West 40th Street, 8th Floor
New York, NY 10018
(Address of principal executive offices)
Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.
Form 20-F x Form 40-F ¨
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulations S-T Rule 101(b)(1):_____
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulations S-T Rule 101(b)(7):_____
CONTENTS
Akari Therapeutics, Plc has posted an updated investor presentation to its website. A copy of the presentation is furnished with this Report of Foreign Private Issuer on Form 6-K as Exhibit 99.1 and is incorporated herein by reference.
Cautionary Note Regarding Forward-Looking Statements
The presentation attached hereto as Exhibit 99.1 may contain forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995 and other Federal securities laws. These forward-looking statements reflect our current views about our plans, intentions, expectations, strategies and prospects, which are based on the information currently available to us and on assumptions we have made. Although we believe that our plans, intentions, expectations, strategies and prospects as reflected in or suggested by those forward-looking statements are reasonable, we can give no assurance that the plans, intentions, expectations or strategies will be attained or achieved. Furthermore, actual results may differ materially from those described in the forward-looking statements and will be affected by a variety of risks and factors that are beyond our control. Such risks and uncertainties for our company include, but are not limited to: an inability or delay in obtaining required regulatory approvals for Coversin and any other product candidates, which may result in unexpected cost expenditures; risks inherent in drug development in general; uncertainties in obtaining successful clinical results for Coversin and any other product candidates and unexpected costs that may result therefrom; failure to realize any value of Coversin and any other product candidates developed and being developed in light of inherent risks and difficulties involved in successfully bringing product candidates to market; inability to develop new product candidates and support existing product candidates; the approval by the FDA and EMA and any other similar foreign regulatory authorities of other competing or superior products brought to market; risks resulting from unforeseen side effects; risk that the market for Coversin may not be as large as expected; inability to obtain, maintain and enforce patents and other intellectual property rights or the unexpected costs associated with such enforcement or litigation; inability to obtain and maintain commercial manufacturing arrangements with third party manufacturers or establish commercial scale manufacturing capabilities; the inability to timely source adequate supply of our active pharmaceutical ingredients from third party manufacturers on whom the company depends; our inability to obtain additional capital on acceptable terms, or at all; unexpected cost increases and pricing pressures; uncertainties of cash flows and inability to meet working capital needs; and risks and other risk factors detailed in our public filings with the U.S. Securities and Exchange Commission, including our Annual Report on Form 10-K filed on March 23, 2016. Except as otherwise noted, these forward-looking statements speak only as of the date of the presentation and we undertake no obligation to update or revise any of these statements to reflect events or circumstances occurring after this presentation. We caution investors not to place considerable reliance on the forward-looking statements contained in this presentation.
Exhibit No.
| 99.1 | Investor Presentation dated July 2016 of Akari Therapeutics, Plc. |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
| Akari Therapeutics, Plc | |||
| (Registrant) | |||
| By: | /s/ Gur Roshwalb | ||
| Name: | Gur Roshwalb | ||
| Chief Executive Officer | |||
Date: July 12, 2016
Exhibit 99.1
July 2016 NASDAQ: AKTX
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 identified by the use of words such as "anticipates," "believes," "es timates," "expects," "intends," "may," "plans," "projects," "seeks," "should," "will," and variations of such words or similar expressions. We int end these forward - looking statements to be covered by the safe harbor provisions for forward - looking statements contained in Section 27A of the Se curities Act and Section 21E of the Securities Exchange Act and are making this statement for purposes of complying with those safe harbor pro vis ions. These forward - looking statements reflect our current views about our plans, intentions, expectations, strategies and prospects, which are based on the information currently available to us and on assumptions we have made. Although we believe that our plans, intentions, expect ati ons, strategies and prospects as reflected in or suggested by those forward - looking statements are reasonable, we can give no assurance that the plans, intentions, expectations or strategies will be attained or achieved. Furthermore, actual results may differ materially from t hos e described in the forward - looking statements and will be affected by a variety of risks and factors that are beyond our control. Risks and uncert ainties for our company include, but are not limited to: an inability or delay in obtaining required regulatory approvals for Coversin and an y o ther product candidates, which may result in unexpected cost expenditures; risks inherent in drug development in general; uncertainties in ob taining successful clinical results for Coversin and any other product candidates and unexpected costs that may result therefrom; failure to rea liz e any value of Coversin and any other product candidates developed and being developed in light of inherent risks and difficulties involved in successfully bringing product candidates to market; inability to develop new product candidates and support existing products; the approva l b y the FDA and EMA and any other similar foreign regulatory authorities of other competing or superior products brought to market; risks res ult ing from unforeseen side effects; risk that the market for Coversin or other product candidates may not be as large as expected; inabi lit y to obtain, maintain and enforce patents and other intellectual property rights or the unexpected costs associated with such enforcement or litigation; inability to obtain and maintain commercial manufacturing arrangements with third party manufacturers or establish commercial sc ale manufacturing capabilities; unexpected cost increases and pricing pressures; and uncertainty of our ability to raise capital and our inability to meet working capital needs. Many of these factors that will determine actual results are beyond our ability to control or pre dic t. For a discussion of the factors that may cause our actual results, performance or achievements to differ materially from any future results, p erf ormance or achievements expressed or implied in such forward - looking statements, see the “Risk Factors” section of our most recently filed 10K. Existing and prospective investors are cautioned not to place undue reliance on these forward - looking statements, which speak only as of the date hereof. The statements made in this press release speak only as of the date stated herein, and subsequent events and developments may cau se our expectations and beliefs to change. Unless otherwise required by applicable securities laws, we do not intend, nor do we unde rta ke any obligation, to update or revise any forward - looking statements contained in this news release to reflect subsequent information, events, results or circumstances or otherwise. While we may elect to update these forward - looking statements publicly at some point in the future, we specifically disclaim any obligation to do so, whether as a result of new information, future events or otherwise, except as required by l aw.
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 biology • No placebo effect • Prioritizing PNH and aHUS - $2.6 billion in 2015 sales • Unique C5/LTB4 targeting – new market opportunities supported by pre - clinical data • PNH: Phase 2 top line data expected YE 2016, Phase 3 mid - 2017 • aHUS: Phase 2 initiation 4Q 2016 • GBS: Phase 2 initiation 1Q 2017 • Once daily, self - administered, subcutaneous injection - no ISRs • Once - weekly version in development • LTB4 - independent inhibition may reduce thrombotic risk • Smaller – increased tissue penetration and organ specific therapy
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
• 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 independent binding to C5 & LTB4 ‒ No toxicity signals to date ‒ No neutralizing antibodies seen to date Copyright 2016 Coversin Nature’s Complement Inhibitor Natural Origins and Development Modern Production 4 • Coversin successfully produced in E. coli • Clinical manufacturing at a leading CMO • Scale up in 4Q 2016
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 Active in Range of Diseases Inhibits C5 – Proven Complement Target Additional LTB4 Anti - inflammatory Activity MAC PLA2 Arachidonic acid C3 C3b Classical Mannose binding lectin Alternative Activation pathways C3 convertase Opsonisation Amplification loop Liver, Macrophages, etc. C5 convertase C3a C5b C6 C7 C9 C8 C5 Inflammation autoimmunity C3b Anaphylatoxins Lysis and cell death C5a LTB4 Lipoxygenases Ig binding to Fc gamma receptors Cytokines e.g. TNF and IL8 LTA4 Toll - like receptors Coversin 5 Copyright 2016 Coversin 0 25 50 75 100 * * LTB4 % after treatment* Albumin E. coli Eculizumab * In vivo E coli model, Barrett - Due et al 2011
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 volunteer subjects (16 active, 8 placebo) • Only highest dosing cohort (n=6) had CH50 testing done through full 96 hour period • Single subcutaneous dose at time 0 0 24 48 72 96 0 20 40 60 80 100 120 140 0.57mg/kg Change from baseline (mean) Hrs % a c t i v i t y ACTIVE n=4 PLACEBO n=2 At 3 - 72 hrs p<0.001
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 cohort (30mg) • Alignment of Elisa and Lytic results • Full C5 Inhibition • No ISRs • No SAEs Last Coversin dose
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 safe and effective in the first PNH patient treated”* Weeks Coversin started 0 200 400 600 800 1,000 1,200 1,400 LDH (IU/ml) 1.5 ULN Initial dose finding for first treated patient 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 0 17 18 * 2016 EH, Saskia Langemeijier, University of Radboud, Nijmegen 19 20
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-Cov Rb IgG Day 0 IgG Day 28 IgG Day 63 IgG Day 100 IgG Day 126 IgG Immunoblot : anti - Cov Rb serum 1:4000; Dutch patient serum 1:200 Copyright 2016 9 No Neutralizing Antibodies After 4 Months
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 al. Ann Oncol 2014;25:1979 - 1987 Study of IV vs SQ Trastuzumab Strong preference for SubQ “All things considered, which method of administration did you prefer?” Coversin – PNH/ aHUS Subcutanous Preference Copyright 2016 10
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 label trial in patients with PNH • Primary efficacy endpoint: LDH at 28 days • Secondary efficacy endpoints: Hgb, transfusions, hemoglobinuria and QOL
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 - life extended >50X (mouse model) Coversin LA fully active (mouse model) Unbound OmCI in serum [nM] Time post - injection PK of Coversin and Coversin LA in blood of BALB/c mice post intravenous injection Copyright 2016 12
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 anemia, thrombocytopenia, and kidney injury 2017 Phase 3 • Currently projected clinical protocol allows direct progression into Phase 3 trial • Expected continuation by mid - 2017 • Approximately 30 total patients
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 Guillain Barré syndrome (GBS) Immune - mediated polyneuropathy leading to destruction of myelin sheath GBS patients: 2 – 12% die; 10 – 35% have permanent impairment Growing worldwide annual incidence (15K in US/EU) + Zika - driven increases
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 granulocytes and platelets to sites of inflammation and thrombosis • LTB4 plays a role is neutrophil attraction in thrombosis * Removed from US due to off target effects Roversi P et al. J Biol Chem 288: 18789; 2013 Complex - mediated acute lung injury model Significant decline in inflammation markers Complement and LTB4 - equal & additive roles LTB4 Binding Adds to Coversin Copyright 2016 15
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 Psoriasis Asthma COPD Ocular Sjögren's GVHD Dry Eye VKC
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
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 development exp. Chief Scientific Officer • Coversin inventor; expert on parasite:host interactions Chief Financial Officer • Lev Pharmaceuticals; EpiCept; Synvista; Tetragenix General Counsel • KV Pharmaceuticals; Savient Pharmaceuticals; Pliva Inc. Corporate Development • Aprecia Pharmaceuticals; McKinsey Consulting; Sandoz GmbH Proven Management Team Copyright 2016 18 Ray Prudo MD Gur Roshwalb MD, MBA Clive Richardson Dov Elefant Robert Shaw JD Wynne Weston - Davies, MD Miles Nunn PhD Michael King MBA
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 - initiations • US IND Submission • CMC scale up 4Q 2016 • Phase 2 PNH topline data YE 2016 • Phase 2 GBS trial data • Phase 2 aHUS trial data • Phase 3 PNH trial – initiation • Phase 3 aHUS trial – initiation • Phase 1 Coversin LA trial - initiation
July 2016 NASDAQ: AKTX