Anavex Life Sciences Corp. · NASDAQ:AVXL

Anavex Life Sciences — Investor Presentation (May 2015)

34 slides from Anavex Life Sciences's investor presentation, May 2015

  1. Slide 1: Corporate Presentation Spring 2015

    OTCQX: AVXL Corporate Presentation Christopher U. Missling, PhD President & CEO Spring 2015

  2. Slide 2: Safe Harbor

    Safe Harbor 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,'' ``intends,

  3. Slide 3: Anavex Overview

    Anavex Overview  Lead drug ANAVEX 2-73 and ANAVEX PLUS are currently in a Phase 2a clinical trial for Alzheimer‘s disease (AD) • ANAVEX PLUS is a combination of our proprietary compound, ANAVEX 2-73 and the current standard of care, donepezil (Aricept®) • ANAVEX 2-73 is an orally available small mo

  4. Slide 4: Broad Pipeline In Alzheimer's, Oncology and Pain

    Broad Pipeline In Alzheimer’s, Oncology and Pain PRECLINICAL PHASE 1 PHASE 2 PHASE 3 ANAVEX PLUS ALZHEIMER’S ANAVEX 2-73 ALZHEIMER’S EPILEPSY RARE DISEASES ANAVEX 3-71 (AF710B) ALZHEIMER’S PARKINSON’S ANAVEX 1-41 DEPRESSION STROKE PARKINSON’S ALZHEIMER’S ANAVEX 1079 CANCER (MELANOMA) ACUTE & NEUROPA

  5. Slide 5: Recent 3rd Party Publications on Sigma-1R Pathway: Additional Indications

    Recent 3rd Party Publications on Sigma-1R Pathway: Additional Indications  Calcium target over-expression IP3 may be involved in causing Alzheimer’s disease, same target regulated through Sigma-1 receptor − K. Foskett, K. et al., The Journal of Neuroscience, 14 May 2014, 34(20):6910-6923  Sigma-1

  6. Slide 6: Sigma-1 Receptor is a Multi-Targeted Key Cellular Modulator

    Sigma-1 Receptor is a Multi-Targeted Key Cellular Modulator ANAVEX  Blocking NOS  Enabling neuroprotection  Reducing protein misfolding  Modulating Ca2+  Reducing oxidative stress  Reducing mitochondrial dysfunction  Reducing inflammation Cauli et al., Neuroscience, Volume 190, 2011, Pages 27

  7. Slide 7: Sigma-1 Receptor Demonstrates Broad Range of Modulatory Effects

    Sigma-1 Receptor Demonstrates Broad Range of Modulatory Effects Sig-1R Sig-1R Increases Decreases Sigma-1 R potentially beneficial for Neurodegenerative Diseases? 7 Francardo,V. Neural Regen Res. 2014 Nov 1; 9(21): 1882–1883.doi: 10.4103/1673-5374.145351

  8. Slide 8: ANAVEX 2-73 Potential as Platform Drug: Strong Pre-Clinical Epilepsy Data

    ANAVEX 2-73 Potential as Platform Drug for other CNS Indication’s: Strong Pre-Clinical Epilepsy Data Significant Anti-Convulsive Action of ANAVEX2-73 Long-Lasting Effect Shown in PTZ- Against both MES and PTZ-Induced Convulsions Induced Convulsions *** *** *** *** 100 *** *** 100 90 90 80 MES-induce

  9. Slide 9: Alzheimer's is the Largest and Fastest Growing Therapeutic Area

    Alzheimer’s is the Largest and Fastest Growing Therapeutic Area  More effective and potentially disease-modifying treatments will create a multibillion dollar product market opportunity* $80bn $67.1bn $70bn $60bn Market Assuming $20,000 per year Potential $40bn treatment cost $30bn Assuming $100,00

  10. Slide 10: Alzheimer's: Complicated Cause with Tragic Outcome

    Alzheimer‘s: Complicated Cause with Tragic Outcome ... Stages of Increased Alzheimer’s burden Loss of speech; locomotion, Terminal consciousness; death Very Severe Full-time care needed; institutionalized Can no longer care for self; incontinent, depressed Severe Can no longer manage personal affair

  11. Slide 11: Alzheimer's Disease is Complicated

    Alzheimer‘s Disease is Complicated ...  Removing amyloid beta (A-beta) plaques in the brain might be too simplistic to be effective - Recent disappointments of bapineuzumab (Pfizer), solanezumab (Eli Lilly), crenezumab (Roche) and gantenerumab (Roche)  More likely: Free-floating particles of A-bet

  12. Slide 12: Chronic Stress of Aging: Misfolding of Proteins

    Chronic Stress of Aging: Misfolding of Proteins …  Age is strongest correlation to develop AD - People are living longer  Chronic stress of aging in brain cells causes gradual accumulation of damaged proteins causing misfolding of proteins - Protein Misfolding creates a “Domino Effect”  ANAVEX 2-

  13. Slide 13: ANAVEX 2-73 Reverses Cycle of Protein Misfolding

    ANAVEX 2-73 Reverses Cycle of Protein Misfolding Our therapeutic’s Potential Mode of Action - mixed muscarinic / Sig-1R agonist Ca2+ modulation, reducing inflammation, mitochondrial dysfunction, and oxidative stress, while also reducing both A-beta and Tau ANAVEX 2-73 ANAVEX 2-73 ANAVEX 2-73 Exposin

  14. Slide 14: ANAVEX 2-73 Targets all Hallmarks of AD

    ANAVEX 2-73 Targets all Hallmarks of AD  Primary effect of A-beta toxicity: after staying in neurons for too long continued induction ANAVEX 2-73 of cell stress  Endogenous Sig-1R expressed to reduce chronic cell stress level not sufficient  Chronic cell stress possibly causing Alzheimer’s diseas

  15. Slide 15: ANAVEX 3-71 Significantly Decreases Hallmark Pathologies in 3xTg-AD Model

    ANAVEX 3-71 Significantly Decreases Hallmark Pathologies in 3xTg-Alzheimer’s Disease Model  10 month-old 3xTg-AD and WT mice  administered p.o. (oral) with tap water or ANAVEX 3-71 (10 mcg/kg/day) for 2 months Presented at AAIC 2014 15

  16. Slide 16: ANAVEX 2-73 Significantly Improves Memory in Transgenic AD Model

    ANAVEX 2-73 Significantly Improves Memory in Transgenic Alzheimer's Disease Model (Tg2576) P<0.01  10 month-old Tg2576 and WT male mice administered p.o. (oral) with tap water or ANAVEX 2-73 (3 mg/kg/day); After 2 months, tested for place learning in the water-maze; N = 6-12 per group 16 Presented

  17. Slide 17: ANAVEX PLUS: Synergistic Memory Enhancing Effect with Donepezil

    ANAVEX PLUS: Synergistic Memory Enhancing Effect of ANAVEX 2-73 with Donepezil (Aricept®) Improved memory  Short-term (YMT) and long-term (PAT) memory test. Only the data with lowest doses are shown (mg/kg ip). 100% protection level represents control group (Sc.Ab/V) and 0% represents toxic group (

  18. Slide 18: ANAVEX PLUS: Potential Symptomatic and Disease-Modifying Agent

    ANAVEX PLUS: Potential Symptomatic and Disease- Modifying Agent  ANAVEX PLUS Δ=2.8 Δ=2.5 - Combination of ANAVEX 2-73 “plus” donepezil (Aricept®) - Potential novel combination drug for Alzheimer’s  ANAVEX 2-73 is potentially disease modifying - Able to reverse memory and learning deficits and prot

  19. Slide 19: ANAVEX PLUS Anticipated Cognition Response is >2x Higher than Donepezil Alone

    ANAVEX PLUS Anticipated Cognition Response is >2x Higher than Donepezil (Aricept®) Alone  Lower clinical trial risk since one compound (donepezil) already on the market  General efficacy of donepezil (Aricept®) 2-3 points on the ADAS-Cog scale  Early AD progression proceeds at a rate of 5.5 point

  20. Slide 20: ANAVEX 2-73 / ANAVEX PLUS Efficient Clinical Trial Execution Plan

    ANAVEX 2-73 / ANAVEX PLUS Efficient Clinical Trial Execution Plan ANAVEX2-73-001 Study: • Phase 1 (oral) • Single Ascending Dose (SAD) Completed • Healthy subjects ANAVEX2-73-002 Study: • Phase 2a (oral) • Mild-to-moderate AD patients • Adaptive trial with Population PK Underway – Preliminary • Bioa

  21. Slide 21: EEG (Electroencephalogram)

    EEG (Electroencephalogram) EEG /ERP Study correlating quantitatively EEG /ERP P300 directly with ADAS-Cog at Baseline, 15 days, 1 month, 2 months, 3 months and 6 months: Clinical Neuropharmacology Vol. 25, No. 4, pp. 207–215 (2002)

  22. Slide 22: EEG/ERP Are Fast Onset Signals

    EEG /ERP Are Fast Onset Signals  Demonstrates sensitivity to Alzheimer’s disease  Real-time physiological measure of cognitive processes  More proximal to disease pathology and pharmacological intervention than psychometric measures Coyne, J. et al. Foundations of Augmented Cognition. Neuroergono

  23. Slide 23: Sigma-1 R Agonists Show Fast Onset of Action

    Sigma-1 R Agonists Show Fast Onset of Action  Sigma-1 agonists are able to potentiate the firing of serotonergic neurons, as early as after 2 days of treatment; whereas SSRI and MAOI induced changes take several weeks to emerge  Sigma-1 agonists have a more rapid onset of antidepressant efficacy o

  24. Slide 24: P300 Change Correlates with ADAS-Cog

    P300 Change Correlates with ADAS-Cog P300 Change 40% 30% Change in % 20% 10% 0% -10% -20% -30% Baselin 15 1 2 3 6 e Days Month Months Months Months Donepezil 0% 4% 10% 16% 22% 34% Control 0% -1% -7% -12% -13% -18% ADAS-Cog Change 15% 10% Change in % 5% 0% -5% -10% Baselin 15 1 2 3 6 e Days Month Mon

  25. Slide 25: FDA Guidelines for Adaptive Trial and Population PK Design

    FDA Guidelines for Adaptive Trial and Population PK Design  Fewer patients needed  Shorter duration required  More likely to demonstrate an effect of the drug (if one exists)  More informative on the treatment’s effects  Broader and better dose-response information and subgroup effects Leads to

  26. Slide 26: Integrated Phase 2a with Adaptive Trial Design

    ANAVEX 2-73/ ANAVEX PLUS: Integrated Phase 2a with Adaptive Trial Design PHASE 2a STUDY ANAVEX 2-73 Dose A-E Mild-to-moderate ANAVEX 2-73 Dose A-E + Donepezil AD patients Donepezil* No. of Patients:  32 mild-to-moderate AD patients No. of Sites:  Up to 7 sites Allocation:  Randomized Duration: 

  27. Slide 27: ANAVEX 2-73 Completed Phase 1

    ANAVEX 2-73 Completed Phase 1  Randomized, placebo-controlled single ascending dose study  22 healthy male volunteers  Strong safety profile -No serious adverse event was reported, no study discontinuation -Only at highest doses, observed adverse events included moderate and reversible dizziness

  28. Slide 28: Comparable Companies

    Comparable Companies Market Capitalization ($) Development Phase Rationale Avanir Acquired for 3,200M Marketed Sigma 1 Receptor (AVNR) Heptares M1 agonist, Acquired for 400M Phase 1b (Private) Alzheimer’s Prothena 1,000M Phase 1/2 Protein misfolding (PRTA) Prana 60M Phase 2 Alzheimer's Disease (PRAN

  29. Slide 29: Financial Summary

    Financial Summary Symbol: AVXL Shares Outstanding: 77.2 million 52-Week Stock Price Range: $0.15-$0.60 Cash @ 3/31/2015: $6.3 million Cash Burn: ~$300K/month 29

  30. Slide 30: Strong Relevant Team Track Record

    Strong Relevant Team Track Record Management and Directors Christopher U. Missling, PhD, MBA Tasos Zografidis, PhD Bernd Metzner, PhD Elliot Favus, MD Tom Skarpelos Scientific Advisory Board Abraham Fisher, PhD Jeffrey Cummings, MD Paul Aisen, MD Norman Relkin, MD, PhD Michael Gold, MD Jacqueline Fr

  31. Slide 31: 2015 Progress and Upcoming Milestones

    2015 Progress and Upcoming Milestones  Secure cGMP manufacturing for drug candidate trial supplies – 3Q 2014  Start Phase 2a study in 2014 Safety and exploratory efficacy  Phase 1 full data in Q4 2014 ☐ File IND for non-disclosed rare disease indication by 2H 2015 ☐ Phase 2a – Report preliminary

  32. Slide 32: Anavex Summary

    Anavex Summary  Lead drug ANAVEX 2-73 and ANAVEX PLUS are currently in a Phase 2a clinical trial for Alzheimer‘s disease (AD) • ANAVEX PLUS is a combination of our proprietary compound, ANAVEX 2-73 and the current standard of care, donepezil (Aricept®) • ANAVEX 2-73 is an orally available small mol

  33. Slide 33: Every 67 seconds someone develops Alzheimer's

    “… Today every 67 seconds someone develops Alzheimer’s” ̶ The Alzheimer’s Association Anavex is working on a potential solution. 33

  34. Slide 34: Contact Us

    Contact Us Corporate Office: Anavex Life Sciences Corp. 51 West 52nd Street, 7th floor New York, NY 10019 (212) 332 4449 Shareholder & Media Relations: Toll-free: 1-866-505-2895 Outside North America: + 1 (416) 489-0092 Email: [email protected] www.anavex.com OTCQX: AVXL 34

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