Akari Therapeutics Plc · NASDAQ:AKTX
Akari Therapeutics — Investor Presentation (July 2023)
33 slides from Akari Therapeutics's investor presentation, July 2023
Slide 1: Akari Therapeutics
Akari Therapeutics July 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 the current views of Akari Thera
Slide 3: Akari Overview
Akari Overview 1. Novel C5+LTB4 inhibitor 4. HSCT-TMA Phase 3 2 IN Nomacopan is a unique asset inhibiting 2 Phase 3 clinical trial in pediatric 1 co-dependent, proinflammatory targets: complement C5 and leukotriene B4 (LTB4) hematopoietic stem cell transplant- related thrombotic microangiopathy (HSC
Slide 4: Leadership Team
Leadership Team Rachelle Jacques Miles Nunn, DPhil John Neylan, M.D. Melissa Bradford-Klug Wendy DiCicco President & CEO Chief Scientific Officer Chief Medical Officer Chief Operating Officer Chief Financial Officer (Interim) Discovered nomacopan Board member Volution Board member Board member 4
Slide 5: Complement Technologies Continue to Garner Significant Investment
Complement Technologies Continue to Garner Significant Investment 8 acquisitions 2017-2022 14 collaborations 2017-2022 Company* Company Value Product(s) Status/Phase Type Indications Astra Zeneca / Alexion $39 billion completed acquisition Soliris®/Ultomiris® On market C5 PNH, aHUS, gMG, NMOSD,/PHN,
Slide 6: 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 7: 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 8: C5 and LTB4 Contribute Equally to Inflammation in an In Vivo Model
C5 and LTB4 Contribute Equally to Inflammation in an In Vivo Model of Immune Complex-Induced Acute Lung Injury In vivo study of immune complex-induced acute lung injury (IC-ALI) • C5 and LTB4 contribute equally to this model of IC-ALI • C5a receptor signaling regulates Inflammation at the alveolar s
Slide 9: In Vivo Data Point to Signalling Interplay Between C5 and LTB4
In Vivo Data Point to Signalling Interplay Between C5 and LTB4 That Leads to Damaging Inflammation In vivo study of autoantibody-induced inflammatory arthritis1, 2 • Neutrophils infiltrate joints by way of multiple chemoattractant receptors, including LTB4 (BLT1) and chemokine receptors • In the joi
Slide 10: The Akari Pipeline Includes Near-Term Potential, Promising Pre-Clinical Program
The Akari Pipeline Includes Near-Term Potential, Promising Pre-Clinical Program 10
Slide 11: 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 12: Thrombotic Microangiopathies (TMAs)
THROMBOTIC MICROANGIOPATHIES (TMAs) 12
Slide 13: Nomacopan May Be the First Treatment for HSCT-TMA
Nomacopan May Be the First Treatment for HSCT-TMA, a Condition with Mortality Up to 80% • HSCT-TMA is a rare but Nomacopan in HSCT-TMA serious complication of HSCT involving 1. Complement C5 inhibition efficacy complement activation, inflammation, tissue Nomacopan C5 inhibition supported by clinical
Slide 14: Diagnostic Criteria International Consensus Guidelines Informed Akari Phase 3 Design
Diagnostic Criteria International Consensus Guidelines Informed Akari Phase 3 Clinical Trials Design “ There is consensus that prospective ~7,920 (36%) lead toscreening TA-TMAand early diagnosis of TMA following transplantation 2 • Transplant-associated TMAs are associated with significant mortality
Slide 15: Estimated HSCT-TMA Incidence By Region
Estimated HSCT-TMA Incidence By Region 29,300 HSCT-TMAs across regions; 13,600 high risk Adult incidence is about 10X pediatric in most regions 15
Slide 16: Nomacopan in HSCT-TMA Development Programs
Nomacopan in HSCT-TMA Development Programs Pediatric Adult • Registrational Phase 3 study of nomacopan in pediatric HSCT-TMA “ It’s important there is harmonization between adult and pediatric studies with the study design, such as inclusion criteria, because comparability • Akari is moving forward
Slide 17: 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 18: Clinical Trial Patient Case Study Presented at Two Meetings
Clinical Trial Patient Case Study Presented at Two Transplantation and Cellular Therapy 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 nomacopan • 6-year-old
Slide 19: Nomacopan May Have Potential for Other TMA Indications
Nomacopan May Have Potential As a Treatment for Other TMA Indications in the Future Immune & autoimmune Transplant Cell & gene • A hallmark of atypical hemolytic uremic • Other types of transplant- • TMAs are safety risks syndrome (aHUS) is TMA related TMA, such as solid associated with certain orga
Slide 20: Geographic Atrophy (GA)
GEOGRAPHIC ATROPHY (GA) 20
Slide 21: 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 22: KOL Insights on GA Treatment Landscape and Unmet Needs
KOL Insights on GA Treatment Landscape and Unmet Needs The recent key opinion leader event hosted by Akari discussed GA diagnosis, treatment, and significant unmet needs “ Despite FDA approval of the first treatment for GA, there are still significant unmet needs. It’s important that we reduce the f
Slide 23: Complement-Only Inhibitors Have Demonstrated Promising Efficacy in GA, Yet Burdens Exist
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 24: PAS-Nomacopan May Provide Key Benefits in GA
PAS-Nomacopan May Provide 3 Key Benefits: Complement Inhibition, Fewer Doses & LTB4 Inhibition to Address CNV Risk PAS-nomacopan in GA 1. Complement C5 inhibition to slow GA progression Efficacy of complement C3 and C5 inhibition slowing progression of GA lesions is well understood1,2 2. Fewer needl
Slide 25: 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 26: LTB4 Inhibition May Prevent CNV Associated with Complement-Only Inhibitors
LTB4 Inhibition May Prevent CNV Associated with Approved & Late-Stage Complement-Only Inhibitors 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
Slide 27: PAS-Nomacopan Decreased VEGF Levels As Effectively As 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 28: PAS-Nomacopan in GA Development Program
PAS-Nomacopan in GA Development Program Candidate selection Start of clinical trials Manufacturing • Selected the PAS-nomacopan candidate that • On track for an IND • Selected Wacker will move forward into clinical trials for submission in the first half of Biotech GmbH as treatment of geographic at
Slide 29: Next Steps
NEXT STEPS 29
Slide 30: 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 31: Finances
FINANCES 31
Slide 32: 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 32
Slide 33: Thank You
THANK YOU 33
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