Akari Therapeutics Plc · NASDAQ:AKTX
Akari Therapeutics — Investor Presentation (May 2023)
27 slides from Akari Therapeutics's investor presentation, May 2023
Slide 1: Akari Therapeutics
Akari Therapeutics IN May 2023 AKARI THERAPEUTICS
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 the current views of Akari Thera
Slide 3: Akari Overview
Akari Overview 1. Novel C5+LTB4 inhibitor 2. Broad potential 2 IN Nomacopan is a unique asset Potential for use in several 1 inhibiting 2 co-dependent, diseases; commercial flexibility proinflammatory targets: due to multiple routes of complement C5 and administration (subcutaneous, leukotriene B4 (
Slide 4: 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 Board member Board member 4
Slide 5: Nomacopan Is a Dual Action Recombinant Protein Discovered In Ticks
Nomacopan Is a Dual Action Recombinant Protein Discovered In Ticks High resolution structure of nomacopan High resolution structure of (blue) bound to human complement C51 nomacopan capture of LTB4 (yellow))2 Novel, bispecific nomacopan is a recombinant protein derived from nature via discovery in t
Slide 6: Nomacopan Inhibits Two Pathways That Can Cause Damaging Inflammation
Nomacopan Inhibits Two Pathways That Can Cause Damaging Inflammation, While Preserving Important Immune Functions C5a, LTB4 and MAC act jointly on neutrophils, Complement Leukotriene macrophages and other cell types that can cause inflammation and damage Anaphylatoxins • Bispecific mechanism prevent
Slide 7: 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-induced inflammatory arthritis1, 2 acute lung injury (IC-ALI)3 • Neutrophils infiltrate joints by way of multiple c
Slide 8: 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 Part B in Drug, Fast stem cell transplant– Nomacopan/ Track and FDA Orphan, >2 years age cohorts
Slide 9: Previous Areas of Clinical Development, Including PNH and BP
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 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 supported in HSCT-TMA2 and atypical hemolytic uremic syndrome (aHUS) 3,4, another TMA; efficacy of nomacopan C5 inhibition supported by
Slide 12: Pediatric & Adult HSCT-TMA U.S. Market Opportunity
Pediatric & Adult HSCT-TMA U.S. Market Opportunity HSCT-TMA U.S. Population ~22,000 HSCTs occur annually in the U.S. 10,000 (incidence in adults and children in the U.S. 2022) ~8,400 (38%) lead to TMAs Moderate to severe ~3,400 TMAs are moderate to severe PATIENT POPULATION IN THOUSANDS 7,500 comple
Slide 13: Nomacopan in HSCT-TMA Recent Progress
Nomacopan in HSCT-TMA Recent Progress 1 Acceleration into pivotal, registrational Phase 3 Part B 2 Addition of new pipeline program in adult HSCT-TMA 3 Phase 3 Part A to remain open for youngest pediatric patients Initiating new program Enrollment for youngest Based on FDA guidance, for indication i
Slide 14: Program Acceleration in Pediatric HSCT-TMA
Program Acceleration in Pediatric HSCT-TMA MIDD Predictive Rich Participation PK/PD Model Data Set Akari was selected Akari’s robust, predictive Akari clinical data from 38 subjects (in previous to participate in PK/PD model simulated clinical studies and healthy volunteers) support the FDA Model- 1
Slide 15: Clinical Trial Patient Case Study Presented As Late-Breaker
Clinical Trial Patient Case Study Presented As Late-Breaker at Transplantation and Cellular Therapy Tandem Meetings A patient with severe pediatric HSCT-TMA, which typically involves multi-organ failure and other acute consequences, was discharged home from the hospital following treatment with noma
Slide 16: Geographic Atrophy (GA)
GEOGRAPHIC ATROPHY (GA) 16
Slide 17: Geographic Atrophy (GA)
Geographic Atrophy (GA) • Geographic atrophy (GA) manifests as a chronic progressive degeneration of the macula, which occurs during late-stage dry age-related macular degeneration (dAMD) and can lead to irreversible vision loss 1,2 • Approximately 5 million people worldwide are affected, 3 with nea
Slide 18: Complement-Only Inhibitors Have Demonstrated Promising Efficacy in GA
Complement-Only Inhibitors Have Demonstrated Promising Efficacy in GA, Yet Significant Treatment Burdens Exist Drug MOA Stage Dose Reduction GA growth Incidence Injections/year Injections/year interval (mm2) vs sham1, 2 of CNV2,3 with no CNV with CNV pegcetacoplan anti-C3 FDA 25 to 60 EM: 17% EM: 12
Slide 19: 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 1. Efficacy Efficacy of complement C3 and C5 inhibition slowing progression of GA lesions is well understood1,2 2. Frequency of Intravitreal Injections New PAS-nomacopan construct Fre
Slide 20: Long-Acting PAS-Nomacopan Has Potential for Fewer Injections Per Year
Long-Acting PAS-Nomacopan Has Potential for 4 or Fewer Injections Into the Eye Per Year • PK/PD data show PAS-nomacopan has extended half-life in the eye after intravitreal injection (7.4 to 8.4 days), suggesting the dose interval may be 3 months or longer1 Long-Acting PAS-Nomacopan Has Potential to
Slide 21: LTB4 Inhibition May Prevent Choroidal Neovascularization
LTB4 Inhibition May Prevent Choroidal Neovascularization 2 LTB4 activation can lead to retina (macular) CNV starts with inflammation in the choroid 1 and retinal pigment epithelium (RPE) photoreceptor cells over expression of VEGF-A retinal pigment epithelium choroid • In a pre-clinical model of las
Slide 22: PAS-Nomacopan Decreased VEGF Levels As Effectively As An Anti-VEGF Antibody
PAS-Nomacopan Decreased VEGF Levels As Effectively As An Anti-VEGF Antibody In a Pre-Clinical Model Effect of PAS-nomacopan on VEGF levels in a standard pre- clinical model of severe uveitis In a pre-clinical model of severe uveitis, long-acting PAS-nomacopan (single IVI) p = 0 .0 4 8 decreased VEGF
Slide 23: Next Steps
NEXT STEPS 23
Slide 24: Next Steps
Next Steps • Enrollment expected • Initiation of to begin in Phase 3 clinical trial Part B clinical trial in in adult pediatric HSCT-TMA HSCT-TMA Nomacopan in HSCT-TMA 2023 2024 PAS-Nomacopan in GA • IND-enabling • Initiate • IND filing • First-in-human/ studies clinical expected initiation of under
Slide 25: Financial Update
FINANCIAL UPDATE 25
Slide 26: Financial Update
Financial Update • Ticker: AKTX (NASDAQ) • 101.1M ADS outstanding • Cash of $13.2M as of December 31, 2022 • Additional gross proceeds of $4M raised in a registered direct offering in March 2023 • Estimated cash runway into Q4 2023 26
Slide 27: Thank You
THANK YOU 27
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