Akari Therapeutics Plc · NASDAQ:AKTX
Akari Therapeutics — Investor Presentation (February 2023)
24 slides from Akari Therapeutics's investor presentation, February 2023
Slide 1: Akari Therapeutics
Akari Therapeutics February 2023
Slide 2: Forward-Looking Statements
Forward-Looking Statements Certain statements in this presentation constitute “forward-looking” statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. These forward-looking statements reflect our current views about our plan
Slide 3: Akari Overview
Akari Overview 1 Novel bispecific recombinant protein targeting both complement C5 and leukotriene B4 (LTB4) Broad therapeutic potential due to bispecific mechanism of action and multiple routes of administration 2 (subcutaneous, topical, intravitreal, intravenous) 3 Advanced late-stage program with
Slide 4: Two Modes of Action
Nomacopan Is a Novel Bispecific Recombinant Protein High resolution structure of nomacopan (cyan) bound to the CUB, C5d, and C345C domains of C5 1 Two Modes of Action Ticks modulate host responses to their own benefit • Inhibits complement C5 activation similarly to eculizumab, but binds a different
Slide 5: Nomacopan Inhibits Cell Activation, Lysis and Inflammation
Nomacopan Inhibits Cell Activation, Lysis and Inflammation Preserving Opsonization and Clearance of Immune Complexes Complement Leukotriene • Specifically prevents activation of C5 and binds LTB4, preventing proinflammatory and potentially tissue- Anaphylatoxins damaging effects mediated by C5a, the
Slide 6: LTB4 & C5 Are Separate Pathways But In Vivo Data Point to Signalling Interplay
LTB4 & C5 Are Separate Pathways But In Vivo Data Point to Signalling Interplay That Leads to Damaging Inflammation In vivo study of autoantibody-induced In vivo study of immune complex- inflammatory arthritis1, 2 induced acute lung injury (IC-ALI)3 • Neutrophils infiltrate joints by way of multiple
Slide 7: Near-Term Potential, Promising Pre-Clinical Program
Near-Term Potential, Promising Pre-Clinical Program Candidate/ Phase 3 Indication Designations Pre-Clinical Phase 1 Phase 2 Formulation Parts A & B FDA Orphan Pediatric hematopoietic Advancing to pivotal Drug, Fast stem cell transplant– Nomacopan/ Track and FDA Orphan, Part B in >2 years age related
Slide 8: Previous Areas of Clinical Development Support Current Development Pathways
Previous Areas of Clinical Development, Including PNH and BP, Support Current Development Pathways • In addition to current areas of focus, Akari has conducted clinical research in several other areas, including Phase 2/3 clinical trials of subcutaneous nomacopan for treatment of bullous pemphigoid
Slide 9: Leadership Team
Leadership Team Rachelle Jacques John Neylan, MD Melissa Bradford-Klug Miles Nunn, DPhil Torsten Hombeck, PhD President & CEO Chief Medical Officer Chief Operating Officer Chief Scientific Officer Chief Financial Officer Discovered nomacopan Volution 9
Slide 10: Thrombotic Microangiopathies (TMAs)
THROMBOTIC MICROANGIOPATHIES (TMAs) 10
Slide 11: Nomacopan May Be the First Treatment for Pediatric HSCT-TMA
Nomacopan May Be the First Treatment for Pediatric HSCT-TMA, a Condition with Mortality Up to 80% 1. Efficacy Efficacy of complement C5 inhibition by eculizumab is established in HSCT-TMA2 and atypical hemolytic uremic syndrome (aHUS) 3,4, another TMA (eculizumab); efficacy of nomacopan C5 inhibitio
Slide 12: Nomacopan in HSCT-TMA Progress Update
Nomacopan in HSCT-TMA Progress Update Acceleration into pivotal, Addition of new pipeline Phase 3 Part A to remain open 1 registrational Phase 3 Part B 2 program in adult HSCT-TMA 3 for youngest pediatric patients Akari is initiating a new Based on FDA Type C Since enrollment for the pipeline progra
Slide 13: Program Acceleration in Pediatric HSCT-TMA
Program Acceleration in Pediatric HSCT-TMA MIDD Predictive Rich Participation PK/PD Data Set Model Akari was selected Akari’s robust, predictive Akari clinical data from 38 subjects (in previous to participate in the PK/PD model simulated clinical studies and healthy volunteers) support FDA Model- 1
Slide 14: Pediatric HSCT-TMA Phase 3 Advancing Into Pivotal Stage
Pediatric HSCT-TMA Phase 3 Advancing Into Pivotal Stage; Adult Phase 2 Supportive of Pediatric Program Phase 3 Part A Phase 3 Part B NDA • Dose confirmation/safety Data from • Pivotal registrational study • Potential • Sites in US, UK, Poland Part A to support NDA for potential Safety pediatric HSCT
Slide 15: Pediatric & Adult HSCT-TMA U.S. Market Opportunity
Pediatric & Adult HSCT-TMA U.S. Market Opportunity HSCT-TMA U.S. Population (incidence in adults and children in the U.S. 2022) ~22,000 HSCTs occur annually in the U.S. 10,000 Children: ~200-300 ~8,400 (38%) lead to TMAs Moderate to severe 7,500 complement PATIENT POPULATION IN mediated ~3,400 TMAs
Slide 16: Geographic Atrophy (GA)
GEOGRAPHIC ATROPHY (GA) 16
Slide 17: PAS-Nomacopan May Provide Key Benefits in GA
PAS-Nomacopan May Provide 3 Key Benefits: Complement Inhibition, Fewer Doses and LTB4 Inhibition to Address CNV Risk • Long-acting PAS-nomacopan is being developed with a profile that has the potential to deliver efficacy benefits of complement inhibition with a fraction of 1. Efficacy the number of
Slide 18: PAS-Nomacopan in GA Progress Update
PAS-Nomacopan in GA Progress Update PAS-nomacopan New PAS-nomacopan New versions expressing versions fully active; target 1 development on track for IND submission 2 dosing interval extended 3 well and on track toward GMP scale for clinical trials 1H24 beyond 3 months Pre-clinical development on lon
Slide 19: PAS-Nomacopan Could Address Burden of Frequent Intravitreal Injections
PAS-Nomacopan Has Potential to Address the Significant Patient Burden of Frequent Intravitreal Injections for GA/CNV • Between monthly or every Long-Acting PAS-Nomacopan Has Potential to Extend other month (EOM) Intravitreal Dose Interval to 3 to 6 Months4 treatment for GA and CNV, patients could fa
Slide 20: LTB4 Inhibition May Prevent Choroidal Neovascularization
LTB4 Inhibition May Prevent Choroidal Neovascularization retina (macular) LTB4 activation can lead 1 CNV starts with inflammation in the choroid and retinal pigment photoreceptor cells 2 to over expression of epithelium (RPE) retinal pigment epithelium VEGF-A choroid • In a pre-clinical model of las
Slide 21: PAS-Nomacopan Decreased VEGF Levels As Effectively As Anti-VEGF
PAS-Nomacopan Decreased VEGF Levels As Effectively As An On-Market Anti-VEGF In a Pre-Clinical CNV Model Effect of PAS-nomacopan on VEGF levels in a • PAS-nomacopan is a bispecific inhibitor of LTB4 and standard complement (C5) pre-clinical model of severe uveitis o Complement inhibition has shown e
Slide 22: Financial Update
FINANCIAL UPDATE 22
Slide 23: Financial Update
Financial Update • Ticker: AKTX (NASDAQ) • 74.4M ADS outstanding • Cash of $16M as of September 30, 2022 • Estimated cash runway into Q3 2023 23
Slide 24: Thank You
THANK YOU 24
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