Anavex Life Sciences Corp. · NASDAQ:AVXL

Anavex Life Sciences — Investor Presentation (June 2020)

27 slides from Anavex Life Sciences's investor presentation, June 2020

  1. Slide 1: Corporate Presentation

    Corporate Presentation Christopher U Missling, PhD | President & CEO Nasdaq: AVXL | June 2020

  2. Slide 2: Forward Looking Statement

    Forward Looking Statement This presentation contains forward-looking statements made within the meaning of the Private Securities Litigation Reform Act of 1995 by Anavex® Life Sciences Corp. and its representatives. These statements can be identified by introductory words such as “expects,” “plans,”

  3. Slide 3: Anavex Expanding Pipeline: Potential for Significant Value Creation Near and Long Term

    Anavex Expanding Pipeline: Potential for Significant Value Creation Near and Long Term CANDIDATE PRECLINICAL PHASE 1 PHASE 2 PHASE 3 ALZHEIMER’S DISEASE AD ANAVEX®2-73-AD-004 ANAVEX®2-73 (Blarcamesine) PARKINSON’S DISEASE DEMENTIA ANAVEX®2-73-PDD-001 *RETT SYNDROME EXCELLENCE ANAVEX®2-73-RS-003 *RET

  4. Slide 4: Addressing Unmet Needs in Significant Populations

    Addressing Unmet Needs in Significant Populations 1) Alzheimer’s Disease Facts and Figures. Alzheimers Dement 2018;14(3):367-429. 2) Marras C et al 2018. npj Parkinson's Disease volume 4, Article number: 21 3) Based on prevalence number on orphanet 4

  5. Slide 5: A Transformative Year for Anavex

    A Transformative Year for Anavex • Rett syndrome program Fast Track Designation and eligible for Pediatric Priority Review Voucher • Pursuing Large Markets With High Unmet Need by Applying Genetic Precision Medicine • Novel CNS Mechanism of Action Upstream of Neurodevelopment and Neurodegeneration •

  6. Slide 6: Catalysts to Drive Value

    Catalysts to Drive Value The company expects to achieve key clinical milestones Full enrollment Phase 2 Parkinson’s disease dementia (PDD) Topline data Phase 2 Parkinson’s disease dementia (PDD) – MID 2020 FDA Fast Track designation for Rett syndrome program (RTT) Initiate EXCELLENCE Phase 2/3 in pe

  7. Slide 7: Clinical Trials – MoA and First Clinical Data

    Clinical Trials – MoA and First Clinical Data: • Rett Syndrome (RTT) • Alzheimer’s Disease (AD)

  8. Slide 8: ANAVEX2-73 MoA: S1R Activation is Upstream from other Therapeutic Targets

    ANAVEX®2-73 MoA: S1R Activation is Upstream from other Therapeutic Targets Neural cells suffer functional loss in neurological disorders which causes cellular stress Pathologies include: ü Aβ, Tau and ApoE fragmentation and dysfunction ü Proteinopathy ü Microglia activation, migration, and dysregula

  9. Slide 9: ANAVEX2-73 Establishes Human Proof-of-Concept and SIGMAR1 Target Occupancy

    ANAVEX®2-73 Establishes Human Proof-of-Concept and SIGMAR1 Target Occupancy 2D [18F]FTC-146-PET imaging of ANAVEX®2-73: Dose- ANAVEX®2-73 positive response in functional dependent ANAVEX®2-73 Target Engagement (ADCS-ADL*) outcome in Alzheimer’s disease patients correlate with SIGMAR1 mRNA levels p-v

  10. Slide 10: SIGMAR1 Activation has been Shown to Modulate Multiple Aspects of Neurodegenerative Processes

    SIGMAR1 Activation has been Shown to Modulate Multiple Aspects of Neurodegenerative Processes Sigma-1 receptor agonists ANAVEX®2-73 enhances Sigma-1 receptor agonists have been shown to restore autophagy and alleviates Tau have a neuroprotective effect neuronal functions in pathology in neurodegener

  11. Slide 11: What is Rett Syndrome?

    What is Rett Syndrome? Devastating neuro-developmental disease in girls with both movement impairment and cognitive impairment Rett Syndrome (RTT) § Non-inherited genetic postnatal disorder caused by mutations in the MECP2 gene Ø Occurs almost exclusively in girls Ø Leads to severe impairments, affe

  12. Slide 12: Phase 2 U.S. Rett Syndrome Trial Part A: Improvement in All Key Domains

    Phase 2 PART A: Improvement in All Key Domains U.S. Rett Syndrome ANAVEX®2-73-RS-001 Trial (NCT03758924) SUMMARY EFFICACY* • Phase 2, safety, tolerability, efficacy for 7 weeks, oral, liquid formulation, • Global severity RSBQ and CGI-I 5 mg daily (relatively low dose) RSBQ = Rett Syndrome Behavior

  13. Slide 13: Precision Medicine

    Precision Medicine Patient Selection with Biomarker Increases Probability of Success 76% 55% 46% 28% Phase II to Phase III Phase III to NDA/BLA Without Biomarkers With Patient Selection Biomarkers Thomas DW et al. Clinical Development Success Rates 2006-2015. BIO Industry Analysis 13

  14. Slide 14: MeCP2 deficiency leads to increased glutamate in RTT

    In patients with RTT, MeCP2 deficiency leads to increased levels of Glutamate, Loss of synaptic in comparison to homeostasis can healthy controls1,2,3, impair nerve cells which results in (neurons) and excitatory-inhibitory their connections imbalance and further synaptic dysfunction Glutamate as po

  15. Slide 15: Part A: Reported Improvements Correlate with Biomarkers

    Phase 2 PART A: Reported Improvements Correlate with Biomarkers U.S. Rett Syndrome ANAVEX®2-73-RS-001 Trial (NCT03758924) Glutamate REPORT on PART A: INTENSIVE PK SUBCOHORT Baseline We ek 7 0 • Plasma levels of the biomarker Glutamate decreased significantly (Week 0 vs. Week 7; 2-tailed Wilcoxon sig

  16. Slide 16: ANAVEX2-73 Phase 2 U.S. Rett Syndrome Study

    ANAVEX®2-73 Phase 2 U.S. Rett Syndrome Study N>21 * 7 RTT patient population ANAVEX®2-73 Primary and Secondary Endpoints Active dose# • PK, Safety and tolerability of ANAVEX®2-73 • Diagnosis of • Behavioral symptoms confirmed RTT • Sleep function • Patients age >18 Randomization • Seizure activity •

  17. Slide 17: ANAVEX2-73 Phase 2 Rett Syndrome AVATAR Study

    ANAVEX®2-73 Phase 2 Rett Syndrome AVATAR Study N=33 * 7 RTT patient population ANAVEX®2-73 Primary and Secondary Endpoints Active dose# • Safety and tolerability of ANAVEX®2-73 • Diagnosis of • Behavioral symptoms confirmed RTT • Sleep function • Patients age >18 Randomization • Seizure activity • E

  18. Slide 18: ANAVEX2-73-RS-003 Rett Syndrome EXCELLENCE Study

    ANAVEX®2-73-RS-003 Rett Syndrome EXCELLENCE Study N>69 12 RTT patient population ANAVEX®2-73 Primary and Secondary Endpoints Active dose# • Safety and tolerability of ANAVEX®2-73 • Diagnosis of • Behavioral symptoms confirmed RTT • Sleep function • Patients age 5-18 Randomization • Seizure activity

  19. Slide 19: Alzheimer's Disease (AD)

    Alzheimer’s Disease (AD) Alzheimer’s disease, progressive, irreversible neurological disease and most common cause of dementia Alzheimer’s Disease (AD) § Alzheimer’s disease incidence highly correlates with age Ø AD prevalence in US:~5,700,000 Ø Estimated 50 million people live with dementia worldwi

  20. Slide 20: ANAVEX2-73 Improved MMSE and ADCS-ADL Scores in Phase 2a AD Study through 148 Weeks

    ANAVEX®2-73 Demonstrated Improved MMSE1 and ADCS-ADL2 Scores in Phase 2a AD Study through 148 Weeks Adjusted change in ADCS-ADL2 (±SE) Adjusted change in MMSE1 (±SE) N=8 N=8 N=13 N=13 p-value < 0.0008 p-value < 0.0001 Source: Hampel et al. A precision medicine framework using artificial intelligence

  21. Slide 21: ANAVEX2-73 Phase 2b/3 Alzheimer's Disease and ATTENTION-AD OLE Study

    ANAVEX®2-73 Phase 2b/3 Alzheimer's Disease and ATTENTION-AD OLE Study N=450 48 … and Open Label Extension (OLE) 96weeks Primary Endpoints Early AD patient population • ADAS-Cog ANAVEX®2-73 • ADCS-ADL High dose# • Confirmed amyloid • Safety and tolerability of pathophysiology ANAVEX®2-73 (CSF/amyloid

  22. Slide 22: Parkinson's Disease Dementia (PDD)

    Parkinson’s Disease Dementia (PDD) Up to 80 percent of those with Parkinson’s disease eventually experience Parkinson’s disease dementia Parkinson’s Disease Dementia (PDD) § Parkinson’s disease is a fairly common neurological disorder in older adults, estimated to affect nearly 2 percent of those ol

  23. Slide 23: ANAVEX2-73 Phase 2 Parkinson's Disease Dementia Study

    ANAVEX®2-73 Phase 2 Parkinson’s Disease Dementia (PDD) Study N=120 14 PDD patient population Primary Endpoints • CDR Continuity of Attention ANAVEX®2-73 • Safety and tolerability of • Diagnosis of High dose# ANAVEX®2-73 probable Parkinson’s disease dementia Key Secondary Endpoints • MDS-UPDRS (PDD)

  24. Slide 24: Primary Endpoint 'CDR Continuity of Attention' of PDD Ph2 Study

    Primary Endpoint ‘CDR Continuity of Attention’ of PDD ANAVEX®2-73 Ph2 Study: Confirmed Beneficial Effect in Previous Ph2a AD Study Identification (IDN) in Cogstate battery assessed in ANAVEX®2-73 Ph2a AD Study comparable to CDR Continuity of Attention (choice reaction time paradigm) CDR battery Cogs

  25. Slide 25: Anavex is the only Company pursuing Large Markets by Applying Precision Medicine

    Anavex is the only Company PRECISION MEDICINE IMPROVES CHANCE OF CLINICAL pursuing Large Markets by SUCCESS Testing for biomarkers demonstrated improved clinical response Applying Precision Medicine to to ANAVEX ®2-73 in Rett syndrome correlated with glutamate and for Alzheimer’s patients carrying w

  26. Slide 26: Anavex Life Sciences Expertise

    Anavex Life Sciences Expertise Management Team Christopher U. Missling PhD - President & CEO Walter E Kaufmann, MD - Chief Medical Officer Stephan Toutain, MS, MBA – Chief Operating Officer Emmanuel O Fadiran, RPh, PhD - SVP of Regulatory Affairs Daniel Klamer, PhD - VP of Business Development & Sci

  27. Slide 27: Contact Us

    Contact Us Corporate Office Anavex®Life Sciences Corp. 51 West 52nd Street, 7th floor New York, NY 10019 1-844-689-3939 Shareholder & Media Relations ir@anavex.com www.anavex.com NASDAQ: AVXL 27

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