Anavex Life Sciences Corp. · NASDAQ:AVXL
Anavex Life Sciences — Investor Presentation (May 2016)
33 slides from Anavex Life Sciences's investor presentation, May 6, 2016
Slide 1: Corporate Presentation
Ww anevex. LIFE SCIENCES Corp.™ NASDAQ: AVXL Corporate Presentation Christopher U. Missling, PhD President & CEO 2016
Slide 2: Safe Harbor
Safe Harbor This presentation contains forward-looking statements made within the meaning of the Private brareebg Litigation Reform Act of 1995 by Anavex™ Life Sciences Corp. and its These statements can be identi \ductory words such as » plans," “intends,” “believes,” “will, “estimates, “forecasts,
Slide 3: Anavex Mission
Anavex™ Mission és Developing Differentiated Therapeutics for the Treatment of Neurodevelopmental and Neurodegenerative Diseases 3 WNonayex.
Slide 4: Convergence of Pathological and Genetic Lesions in All Neurodegenerative Diseases
Convergence of Pathological and Genetic Lesions in All ‘ive Di: ER-Mitochondria Axis Disruption ey Tends inNeurecionces Press There's Something Wrong with my MAM; the ER-Mitochondria ont ation acelin Oo Axis and Neurodegenerative mand Diseases ‘sabasson Patusson'® Rady Sica"? A La “Tanya Miter" and
Slide 5: Common in All Neurodegenerative Diseases: ER-Mitochondria Axis Disruption
Common in All Neurodegenerative Diseases: ER-Mitochondria Axis Disruption ... Sigma-1R Restores Association ... Disease situation Normal situation eR x — an > a Mitochondrion \drion Endoplasmic reticulum (ER)-Mitochondria associations are disrupted in neurodegenerative diseases ...* .. Sigma-1R rest
Slide 6: ANAVEX 2-73: Confirmed Targeted Indications
ANAVEX™ 2-73: Confirmed Targeted Indications: From Rare Disease Indication to Largest CNS Indication ... 1s Alzheimer’s Disease (AD) Rett Syndrome (RTT) Rare neurodevelopmental disease Preclinical validation, RettSyndrome.org Planning blinded controlled Phase 2 Oo ~ Depression Ca Preclinical validat
Slide 7: Neurodegenerative Disease Pipeline
Neurodegenerative Disease Pipeline sv PRECLINICAL, PHASE 1 PHASE 2 PHASE 3 ANAVEX™ 2.73 ALZHEIMER'S COGNITION NEUROPSYCHIATRIC : PARKINSONS MPEGS) Tai) RARE DISEASE, RETT SYNDROME ANAVEX™ 3.71 (AFT108) DEMENTIA FTO) MER’ O00 Twas ANAVEX™ 141 —_—— DEPRESSION ——- a —<<<—> “ANAVEX™ 107 ‘CANCER (MELANOM
Slide 8: Positive Preclinical Data of ANAVEX 2-73 in Rare Disease: Rett Syndrome
Positive Preclinical Data of ANAVEX™ 2-73 in Rare Disease: Rett Syndrome What is Rett Syndrome? Rare non-inherited genetic postnatal progressive neurodevelopmental disorder Caused by mutation of MECP2 gene Occurs almost exclusively in girls and leads to severe impairments One in 10,000 to 15,000 gir
Slide 9: Assessment of ANAVEX 2-73 in a MECP2 Rett Syndrome Model
Assessment of ANAVEX 2-73 in a MECP2 Rett Syndrome Model 1s = Administration of ANAVEX 2-73 results in both significant and dose related improvements in an array of behavioral paradigms in the MECP2 HET Rett syndrome disease model = Taken together, these behavioral paradigms measure different aspect
Slide 10: Clasping as a Behavioral Paradigm
Clasping as a Behavioral Paradigm 1s - Clasping at 8 weeks 90 p<0.001 Normal Impaired == < zy ae E 2 0.05 2 so p< go * $20 ° 20 10 o By. wise tier ra om uc a DOM oon Clasping at 12 weeks ° 0.01 _% 2 2 6 ” sad p<0.05 “0 20 oo Mice treated with AV2-73 (30 mg/kg) clasped less than 7 vehicle-treated mut
Slide 11: Multiple Behavioral Rett Syndrome Paradigms Demonstrate Significant Improvement
Multiple Behavioral Rett Syndrome Paradigms Demonstrate Significant Improvement x Startle: Wild type (WT) mice have a higher startle response compared to impaired mice: AV2-73 treated mice showed a significant increase in startle response compared to vehicle- treated mutant mice Rotarod: Motor Coord
Slide 12: Anti-Depressant and Anti-Anxiety Effect of ANAVEX 2-73
Anti-Depressant and Anti-Anxiety Effect of ANAVEX™ 2-73 in Porsolt Swim Test (PST) and in Open Field Test x b No observed “sedative” effect of ANAVEX 2-73 | Em . Zw é btw 2 © : a 0 v 2 to AMAvExET (mgikgp.0) " Effect of ANAVEX2-73 on immobility time on PST. P<0.01, *p<0.05 and **p<0.01 for 50 and 10
Slide 13: ANAVEX 2-73 Pre-Clinical Epilepsy Data
‘% of Seizure reduction ANAVEX™ 2-73 Pre-Clinical Epilepsy Data 7s jignificant Seizure Reduction with ANAVEX2-73 in both MES and PTZ-Induced Seizure Models | Long-Lasting Effect Shown in PTZ- Induced Seizures ee ee cE ee 100 5 2 | * p<0.001 80 + = MES-induced zo 4 convulsions® 60 | so 40 + @ PTZ-ind
Slide 14: ANAVEX 2-73 Potential Protective Role in Treatment of Patients with MS
ANAVEX™ 2-73 Potential Protective Role in Treatment of Patients with MS (Multiple Sclerosis) ES ANAVEX 2-73 reduces both oligodendrocytes (OL) and OL precursor cell death induced by 4 different toxic molecules by over 50% Conclusion: ANAVEX 2-73 protects oligodendrocytes (OL) from cytotoxic mechanis
Slide 15: Alzheimer's Market Overview
Alzheimer’s Market Overview x Changes in Number of Deaths {All Ages) Between 2000 and 2010 Forecast of Alzheimer's Disease Prevalence in the 45 Million 86 Million 16.0 Million =$307 billion spent caring for AD patients - expected to reach $1.5 trillion by 2050 =FDA has approved 4 drugs for AD that o
Slide 16: Alzheimer's Disease is Complicated
Alzheimer‘s Disease is Complicated ... x = Removing amyloid beta (A-beta) plaques in the brain might be not sufficient to be completely effective - Recent disappointments of large Phase 3 studies: bapineuzumab (Pfizer), (Eli Lilly), (Roche) and gi (Roche) = More likely: Free-floating particles of A-
Slide 17: Sigma-1R Reduces Chronic Stress and Protein Misfolding
Sigma-1R Reduces Chronic Stress and Protein Misfolding és ) . Distressed Cell a | r Misfolded Proteins : Sigma-1R (Aut ~~ wa 2 5 Helping / Stimulating = : Ca2. Pas ® Om AB i> Gycfunction 2% | Own Body to > ® AB plays ; Regain important role Boot a, i lity — Hic = Functionality memory r Mitochondrial
Slide 18: ANAVEX 3-71 Significantly Decreases Hallmark Pathologies in 3xTg-Alzheimer's Disease Model
ANAVEX™ 3-71 Significantly Decreases Hallmark Pathologies in 3xTg-Alzheimer’s Disease Model Hl Vehicle I anavex3-71 (AF710B) Pg/mg protein palma protein = 10 month-old 3xTg-AD and WT mice = administered i.p. with tap water or ANAVEX 3-71 (10 mcg/ke/day) for 2 months Time target quadrant (s) V_AF OV
Slide 19: FDA Guidelines for Adaptive Trial and Population PK Design
FDA Guidelines for Adaptive Trial and Population PK Design 1s v Fewer patients needed Y Shorter duration required Y More likely to demonstrate an effect of the drug (if one exists) Y More informative on the treatment’s effects v Broader and better dose-response information and subgroup effects q Lea
Slide 20: ANAVEX 2-73 Efficient Clinical Trial Execution Plan
ANAVEX™ 2-73 Efficient Clinical Trial Execution Plan + Healthy subjects Phase 2a (oral) ANAVEX™2-73-002 Study: Mild-to-moderate AD patients Adaptive trial with Population PK. x ANAVEX™2-73-001 Study: + Phase 1 (oral) * Single Ascending Dose (SAD) Completed reliminary Data CTAD 2015 jose-Response Bio
Slide 21: ANAVEX 2-73: Phase 2a with Adaptive Trial Design
ANAVEX 2-73: Phase 2a with Adaptive Trial Design oS ANAVEX 2-73 starting dose 30mg/SOmg (oral) or 77 3m, 5g (WV) ANAVEX 2-73 starting dose 30mg/SOmg (oral) or —— 23mg, 5mg (IV) + Donepezil ~*~ Healthy control, Donepezil/ AchEI* No. of Pts: = 32 mild-moderate AD patients (MMSE 16-28), M/F = 19/13 Sit
Slide 22: Positive Phase 2a Results
Positive Phase 2a Results as Phase 2a (PART A) results demonstrate a favorable safety, bioavailability, dose-response curve and tolerability/risk profile Despite the relative small sample size of this proof-of-concept randomized open-label study, dose-response analysis seem to indicate a cognitive b
Slide 23: PART A: Bioavailability Adaptive Cross-Over Design
PART A: Bioavailability Adaptive Cross-Over Design PART B: 52 Wk Open-Label Extension and New 104 Week Study es ORAL ORAL 52 week 104 week | [time] Part B PK Study - completed Extension - ongoing PART A is 5 week with on-off-on dosing of ANAVEX 2-73 starting dose of 30mg/SOmg (oral) and 3mg, 5mg (IV
Slide 24: ANAVEX 2-73 Safety from Phase 2a
ANAVEX™ 2-73 Safety from Phase 2a x = Safety profile The most common AE was dizziness followed by headache = Events were mild or moderate and reversible with 80% being grade 1 = There were no drug related AEs Grade 3, 4 and5 = Most (94.4%) observed within first 8 days AE profile similar to that of h
Slide 25: Efficacy Data Measurements Cognition and Function
Efficacy Data Measurements Cognition and Function 1s = Exploratory cognitive measures (Cogstate battery); (MMSE) = Functional measures (ADCS-ADL) Supportive Biomarker Measurements a «\\ = ERP (P300): fundamental measures of synaptic network performance and target engagement = ERP target detection ta
Slide 26: Comparable Baseline of SoC (AIBL-AD) and ANAVEX 2-73 Trial
Comparable Baseline of SoC (AIBL-AD) and ANAVEX 2-73 Trial és SoC (Standard of Care) data from Australian Imaging Biomarkers and Lifestyle (AIBL-AD*) study testing Cogstate battery in Alzheimer’s disease patients Baseline data: SoC (AIBL-AD) AV 2-73 Participants (n) 43 32 ‘Age (mean) 79.6 7 MMSE (me
Slide 27: ANAVEX 2-73 Improves Components of Cogstate Tasks at Week 5
ANAVEX 2-73 Improves Components of Cogstate Tasks at x Week 5 Cognitive Decline Cognitive bein — effectsizes “mn — po onthe — baseline Visual Learning = ‘er ' “p<0.05, “*p<0.001 t"-ely = : Magnitude of change rom baseline) pata beteton Fereenne es relative to enfeatont eee os change in. ayes toe AD
Slide 28: ANAVEX 2-73 Positive Trend in Interim ADCS-ADL Data
ANAVEX 2-73 Positive Trend in Interim ADCS-ADL Data ey At week 12 70.00 ” —] A= 43.21 points 62.00 60.00 58.00 ADCS-ADL (Baseline PART B) ADCS-ADL (Week 12) ANAVEX 2-73 improved ADCS-ADL signal in 11 out of 14 (78.6%) patients at week 12 ‘Macfarlane etal, presented at CTAD 2015
Slide 29: EEG/P300/ERP Highlights Target Engagement of ANAVEX 2-73
EEG/P300/ERP Highlights Target Engagement of ANAVEX 2-73 and Potential Correlation with Cognitive Effect on a Cellular Level x al Baseline = F300 Week 5 “H Healthy Control* “T| cas at ot simmers A events ADM 2058 One SETS Task Accuracy (%) | False Al ) _ | Reaction Time (ms) Baseline 5,990.58 9384.3
Slide 30: Financial Summary
Financial Summary x Symbol: AVXL Shares Outstanding: 34.6 million 52-Week Stock Price Range: $3.16 - $14.84 Average Daily Volume: 1,261,330 Cash @ 12/31/2015: $13.8 million Cash Burn (est.): ~$600K/month = Well-capitalized to achieve key clinical readouts = No debt 30 WNonayex.
Slide 31: Experienced Management Team with Strong Track Record in the CNS Space
Experienced Management Team with Strong Track Record in the CNS Space Management and Directors Christopher U. Missling, PhD, MBA Tasos Zografidis, PhD Uli Elben, PhD Kristina Capiak Bernd Metzner, PhD Elliot Favus, MD Steffen Thomas, PhD Tom Skarpelos Scientific Advisory Board ‘Abraham Fisher, PhD J
Slide 32: Key Achievements to Date and Expected Catalysts in 2016
Key Achievements to Date and Expected Catalysts in 2016 x New 104 week extension study of Phase 2a after PART B Preparation for Phase 2 study in Rett syndrome Preparation for Phase 2/3 study in Alzheimer’s disease Double-blinded, randomized, placebo-controlled, Potential for first registration study
Slide 33: Contact Us
Contact Us Wanevex LIFE SCIENCES Corp.™ 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: ir@anavex.com www.anavex.com NASDAQ: AVXL A
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