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MarketScreener Homepage  >  Equities  >  Nasdaq  >  Anavex Life Sciences Corp.    AVXL

ANAVEX LIFE SCIENCES CORP.

(AVXL)
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Anavex Life Sciences : Corporate presentation November 2020

11/20/2020 | 04:07pm EST

Corporate Presentation

Christopher U Missling, PhD | President & CEO

Nasdaq: AVXL | November 2020

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," "intends," "believes," "will," "estimates," "forecasts," "projects," or words of similar meaning, and by the fact that they do not relate strictly to historical or current facts. Forward-looking statements frequently are used in discussing potential product applications, potential collaborations, product development activities, clinical studies, regulatory submissions and approvals, and similar operating matters. Many factors may cause actual results to differ from forward-looking statements, including inaccurate assumptions and a broad variety of risks and uncertainties, some of which are known and others of which are not. Known risks and uncertainties include those identified from time to time in reports filed by Anavex Life Sciences Corp. with the Securities and Exchange Commission, which should be considered together with any forward-looking statement. No forward-looking statement is a guarantee of future results or events, and one should avoid placing undue reliance on such statements. Anavex Life Sciences Corp. undertakes no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise. Anavex Life Sciences Corp. cannot be sure when or if it will be permitted by regulatory agencies to undertake clinical trials or to commence any particular phase of any clinical trials. Because of this, statements regarding the expected timing of clinical trials cannot be regarded as actual predictions of when Anavex Life Sciences Corp. will obtain regulatory approval for any "phase" of clinical trials. We also cannot be sure of the clinical outcome for efficacy or safety of our compounds. Potential investors should refer to the risk factors in our reports filed on Edgar.

2

Broad Pipeline Targeting Neurodegenerative and

Neurodevelopmental Diseases with Significant Unmet Medical Need

CANDIDATE

ANAVEX®2-73 (Blarcamesine)

ANAVEX®3-71

(AF710B)

ANAVEX®1-41

ANAVEX®1066

* = Orphan Drug Designation by FDA

PRECLINICAL

ALZHEIMER'S DISEASE PARKINSON'S DISEASE DEMENTIA *RETT SYNDROME *RETT SYNDROME *RETT SYNDROME *INFANTILE SPASMS

FRAGILE X ANGELMAN'S

*FRONTOTEMPORAL DEMENTIA (FTD) ALZHEIMER'S DISEASE PARKINSON'S DISEASE

DEPRESSION

STROKE

PARKINSON'S DISEASE

ALZHEIMER'S DISEASE

VISCERAL PAIN

ACUTE & NEUROPATHIC PAIN

PHASE 1

PHASE 2

PHASE 3

AD ANAVEX®2-73-AD-004

ANAVEX®2-73-PDD-001

EXCELLENCE ANAVEX®2-73-RS-003

U.S. ANAVEX®2-73-RS-001 Fast Track, Rare Pediatric,

Orphan Drug (U.S./EU)

AVATAR ANAVEX®2-73-RS-002

ANAVEX®3-71-001

  • Differentiated clinical-stage CNS assets targeting significant and growing markets
  • Patent protection to 2030-2039, worldwide rights for all product candidates

3

Targeting Large Market Opportunities with Significant Unmet

Medical Need

All U.S. Patient Numbers

  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

4

3)

Based on prevalence number on orphanet

Transformative Events for Anavex

  • Rett Syndrome Program Received Fast Track Designation and is 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
  • Compelling first Human Patient Data in Parkinson's Disease Dementia, Rett Syndrome and Alzheimer's Disease
  • Sufficient Cash for >24 months To Achieve Key Milestones - Including non-dilutiveCash from Australian

Government for Alzheimer's Trial, and from Rettsyndrome.org for Rett Syndrome Trial

Continued Significant Value-creating Events with Several Clinical Readouts in 2020/2021:

  • Two Phase 2 Adult Rett Syndrome Trials (ClinicalTrials.gov Identifier: NCT03758924, NCT03941444)
  • Phase 2/3 Pediatric Rett Syndrome Trial (ClinicalTrials.gov Identifier: NCT04304482)
  • Phase 2b/3 Alzheimer's Disease Trial (ClinicalTrials.gov Identifier: NCT03790709)
  • Phase 1 of ANAVEX®3-71 with focus on Frontotemporal Dementia (ClinicalTrials.gov Identifier: NCT04442945)

5

Catalysts to Drive Value

The company has multiple near-term clinical milestones

Full enrollment Phase 2 Parkinson's disease dementia (PDD)

Rett syndrome program received FDA Fast Track Designation and is eligible for FDA Pediatric Priority Review Voucher

Initiate EXCELLENCE Phase 2/3 in pediatric Rett syndrome (RTT) Initiate Phase 1 ANAVEX®3-71

Full enrollment U.S. Phase 2 RTT Topline data Phase 2 PDD

Topline data U.S. Phase 2 RTT - Q4 2020 Topline data AVATAR Phase 2 RTT - 1H 2021 Topline data Phase 1 ANAVEX®3-71 - 1H 2021

6

Clinical Trials - MoA and First Clinical Data:

  • Rett Syndrome (RTT)
  • Alzheimer's Disease (AD)
  • Parkinson's Disease Dementia (PDD)

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 dysregulation

ü Apoptosis feedback loops that lead to neuronal degradation

ü Autophagy dysfunction

ü Mitochondrial Dysfunction and Oxidative Stress that leads to further neuronal degradation

ü Neurodegeneration that spreads through a cascade of stress responses

S1R activates neuroprotective signals that help neurons return to homeostasis

S1R = Sigma-1 Receptor

8

ANAVEX®2-73 Establishes Human Proof-of-Concept and SIGMAR1

Target Occupancy

2D [18F]FTC-146-PET imaging of ANAVEX®2-73: Dose-

dependent ANAVEX®2-73 Target Engagement

0 mg /kg

1 mg/kg

10 mg/kg

30 mg/kg

Receptor1-SigmaPercent

Occupancy

100

80

60

40

20

0

0

5

10

15

20

25

30

mg/kg of ANAVEX2-73

ANAVEX®2-73 positive response in functional

(ADCS-ADL*) outcome in Alzheimer's disease patients

correlate with SIGMAR1 mRNA levels

p=0.015

p-value of Mann-Whitney U test

SIGMAR1 RNA expression (TPM)

All n=20 patients in study. Slope of

ADCS-ADL* from baseline to week 57

with available genomic data

Decrease (Negative)

Increase (Positive)

Source: Reyes S et al, AAIC 2018; Hampel H et al. Alzheimer's Dement. 2020;00:1-14; *Alzheimer's Disease Cooperative Study Activities of Daily Living 23-item scale (ADCS-ADL)

9

SIGMAR1 Activation has been Shown to Modulate Multiple Aspects

of Neurodegenerative Processes

Sigma-1 receptor agonists have been shown to restore neuronal functions in neurodegenerative processes

ANAVEX®2-73 enhances autophagy and alleviates Tau pathology in neurodegenerative disease models

Sigma-1 receptor agonists have a neuroprotective effect in neurodegenerative disease models

10

What is Rett Syndrome?

Devastating neuro-developmental disease in girls with both movement impairment and cognitive

impairment

Rett Syndrome (RTT)

  • Non-inheritedgenetic postnatal disorder caused by mutations in the MECP2 gene
    • Occurs almost exclusively in girls
    • Leads to severe impairments, affecting nearly every aspect of the child's life
    • Impairment includes ability to speak, walk, eat and even breathe easily
    • Hallmark of RTT is near constant repetitive hand movements while awake
    • Occurs worldwide in approximately one in every 10,000 to 15,000 live female births

Source: https://www.rettsyndrome.org/about-rett-syndrome

11

Phase 2 PART A: Improvement in All Key Domains

U.S. Rett Syndrome ANAVEX®2-73-RS-001 Trial (NCT03758924)

SUMMARY

  • Phase 2, safety, tolerability, efficacy for 7 weeks, oral, liquid formulation, 5 mg daily (relatively low dose)
  • Part A: Intensive PK, n=6, Completed
  • Part B: Randomized, double-blind,placebo-controlled, n=25, ongoing
  • Females > 18 years, classic RTT w/MECP2 mutation
  • Evaluations at baseline (Week 0), Week 4 & Week 7 (End of Treatment)
  • Good safety and tolerability: No serious adverse events, only three grade 1-2 adverse events

EFFICACY*

  • Global severity RSBQ and CGI-I
    RSBQ = Rett Syndrome Behavior Questionnaire CGI-I = Clinical Global Impressions - Improvements
  • Secondary: Behavior (ADAMS), Sleep (CSHQ), VAS (top caregiver concerns), Seizure diary
  • Response Biomarker*: Glutamate, GABA; Genetic biomarker: DNA & RNA profiles

RSBQ Total

RSBQ Hand Behaviors

0

Baseline

Week 7

0

Baseline

Week 7

10

Behaviors

1

2

Total

20

3

p = 0.027

30

4

RSBQ

RSBQHand

5

40

RSBQ

8

6

50

7

60

p = 0.042

improves by

9

70

over 30%

10

*Preliminary evaluation of efficacy: two-tailed, nonparametric tests (conservative)

RSBQ Breathing Problems

Baseline

Week 7

0

Problems

2

Breathing

4

8

RSBQ

6

10

p = 0.042

12

Sleep - CSHQ-Waking During the Night

0

Baseline

Week 7

During

0.5

1

Waking-CSHQ

Nightthe

1.5

2

2.5

3

-

3.5

p = 0.042

4.5

Sleep

4

5

12

Precision Medicine

Biomarkers Increase 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

In patients with RTT, MeCP2 deficiency leads to increased levels of Glutamate, in comparison to healthy controls1,2,3, which results in excitatory-inhibitory imbalance and further synaptic dysfunction

Loss of synaptic homeostasis can impair nerve cells (neurons) and their connections

Glutamate as potential biomarker of microglia activation and

synaptic dysfunction

  1. Hamberger, A., et al., Elevated CSF glutamate in Rett syndrome. Neuropediatrics, 1992. 23(4): p. 212-3.;2) Lappalainen, R. and R.S. Riikonen, High levels of cerebrospinal fluid glutamate in Rett syndrome. Pediatr Neurol, 1996. 15(3): p. 213-6; 3) J.L. Neul at al., Metabolic signatures differentiate Rett syndrome from unaffected siblings.

Frontiers in Integrative Neuroscience (2020) Vol14, Art 7, doi:10.3389/fnint.2020.00007

14

Phase 2 PART A: Reported Improvements Correlate with Biomarkers

U.S. Rett Syndrome ANAVEX®2-73-RS-001 Trial (NCT03758924)

REPORT on PART A: INTENSIVE PK SUBCOHORT

  • Plasma levels of the biomarker Glutamate decreased significantly (Week 0 vs. Week 7; 2-tailed Wilcoxon signed rank test, p = 0.046)
  • Levels of Glutamate at Week 7 directly correlated with CGI-I scores at Week 7 (2-tailed Spearman's rho = 0.837, p = 0.038)
  • Greater decreases in Glutamate associated with greater improvement in these efficacy scores
  • GABA changes demonstrated an inverse correlation of the magnitude of Glutamate changes (2- tailed Spearman's rho = -0.829, p = 0.042)

Glutamate (mo/L)

0

10

20

30

40

50

60

70

Glutamate

Baseline

Week 7

p = 0.046

Glutamate

decreases by

over 40%

Significant Correlations: RSBQ & CGI-I

7

5

Iat Week

4

3

CGI-

2

p = 0.003

1

0

20

40

RSBQ Total at Week 7

Improvement

Glutamate & CGI-I

5

Week 7

4

3

CGI-I

2

60

p = 0.038

1

10.00

20.00

30.00

40.00

Glutamate mol/L Week 7

RSBQ Hand Behaviors Week 7

Glutamate & Hand Behaviors

Glutamate & Sleep

8

40

7

7

Visit

35

6

5

Total

30

4

CSHQ-

25

3

20

2

p = 0.021

Sleep

p = 0.005

1

15

0

-100

-50

0

50

10

% Change in Glutamate

10.00

20.00

30.00

40.00

Glutamate mol/L Week 7

15

ANAVEX®2-73 Phase 2 U.S. Rett Syndrome Study

N=31*

RTT patient population

ANAVEX®2-73

Active dose#

  • Diagnosis of confirmed RTT

Patients age >18

Randomization

Entire DNA and RNA

3:2

sequencing

ANAVEX®2-73-RS-001 STUDY ()*

Placebo

  • Includes a 6 patient cohort undergoing a 7-week pharmacokinetic (PK) assessment with safety, tolerability, pharmacokinetic and efficacy evaluation of ANAVEX®2-73

7

Primary and Secondary Endpoints

  • PK, safety and tolerability of ANAVEX®2-73
  • Behavioral symptoms
  • Sleep function
  • Seizure activity

Pre-specified Endpoints

  • Genetic variants SIGMAR1 (rs1800866), COMT (rs113895332/rs61143203) with influence on treatment effect

# Oral liquid solution once daily; Dose restricted to maintain complete blinding

16

ANAVEX®2-73 Phase 2 Rett Syndrome AVATAR Study

N=33*

RTT patient population

ANAVEX®2-73

Active dose#

  • Diagnosis of confirmed RTT

Patients age >18

Randomization

Entire DNA and RNA

3:2

sequencing

ANAVEX®2-73-RS-001 STUDY (NCT0

Placebo

  • Includes a 3 patient cohort undergoing a 3-week pharmacokinetic (PK) assessment with safety, tolerability, pharmacokinetic and efficacy evaluation of ANAVEX®2-73

7

Primary and Secondary Endpoints

  • Safety and tolerability of ANAVEX®2-73
  • Behavioral symptoms
  • Sleep function
  • Seizure activity

Pre-specified Endpoints

  • Genetic variants SIGMAR1 (rs1800866), COMT (rs113895332/rs61143203) with influence on treatment effect

# Oral liquid solution once daily; Dose restricted to maintain complete blinding

17

ANAVEX®2-73-RS-003 Rett Syndrome EXCELLENCE Study

N>69

RTT patient population

ANAVEX®2-73

Active dose#

  • Diagnosis of confirmed RTT

Patients age 5-18

Randomization

Entire DNA and RNA

2:1

sequencing

ANAVEX®2-73-RS-001 STUDY (NCT037

Placebo

12

Primary and Secondary Endpoints

  • Safety and tolerability of ANAVEX®2-73
  • Behavioral symptoms
  • Sleep function
  • Seizure activity

Pre-specified Endpoints

  • Genetic variants SIGMAR1 (rs1800866), COMT (rs113895332/rs61143203) with influence on treatment effect

# Oral liquid solution once daily; Dose restricted to maintain complete blinding

18

Alzheimer's Disease (AD)

Alzheimer's disease is a progressive, irreversible neurological disease and the most common cause of

dementia

Alzheimer's Disease (AD)

  • Alzheimer's disease incidence highly correlates with age
    • AD prevalence in US:~5,700,000
    • Estimated 50 million people live with dementia worldwide
    • Today, there are no commercially available therapies to address the underlying cause of Alzheimer's
    • The current annual cost of dementia is estimated at $1 trillion, a figure set to double by 2030

Source: www.alz.org/alzheimers-dementia/what-is-dementia/types-of-dementia/parkinson-s-disease-dementia

19

ANAVEX®2-73 Demonstrated Improved MMSE1 and ADCS-ADL2 Scores in Phase 2a AD

Study through 148 Weeks

Adjusted change in MMSE1 (±SE)

N=8

N=13

p-value < 0.0008

Adjusted change in ADCS-ADL2 (±SE)

N=8

N=13

p-value < 0.0001

Source: Hampel et al. A precision medicine framework using artificial intelligence for the identification and confirmation of genomic biomarkers of response to an Alzheimer's disease therapy: Analysis of the blarcamesine (ANAVEX2-73) Phase 2a clinical study. Alzheimer's Dement. 2020;00:1-14

  • Mini Mental State Examination (MMSE)

2 Alzheimer's Disease Cooperative Study Group - Activities of Daily Living Inventory (ADCS-ADL)

20

ANAVEX®2-73 Phase 2b/3 Alzheimer's Disease and ATTENTION-AD OLE Study

N=450

Early AD patient population

  • Confirmed amyloid pathophysiology (CSF/amyloid PET)
  • Patients aged 60 to 85 years
  • MMSE score 20-28
  • Entire DNA and RNA sequencing

ANAVEX®2-73

High dose#

Randomization

ANAVEX®2-73

1:1:1

Medium dose#

Placebo

48

… and Open Label Extension (OLE) 96weeks

Primary Endpoints

  • ADAS-Cog
  • ADCS-ADL
  • Safety and tolerability of ANAVEX®2-73

Key Secondary Endpoints

  • CDR-SB
  • Structural and functional MRI
  • Biomarkers: Abeta40/Abeta42, T-tau,P-tau, NFL, YKL-40, neurogranin, BACE1

Pre-specified Endpoints

  • Genetic variants SIGMAR1 (rs1800866), COMT (rs113895332/rs61143203) with influence on treatment effect

# Oral capsule once daily; Dose restricted to maintain complete blinding

21

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

  • Parkinson's disease is a fairly common neurological disorder in older adults, estimated to affect nearly 2 percent of those older than age 65
    • PD prevalence in US:~1,000,000
    • The brain changes caused by Parkinson's disease begin in a region that plays a key role in movement
    • Highly heterogeneous multisystem disorder
    • Etiology of cognitive impairment in PD has not yet been fully elucidated
    • As Parkinson's brain changes gradually spread, they often begin to affect mental functions, including memory and the ability to pay attention, make sound judgments and plan the steps needed to complete a task

Source: Aarsland D, Creese B, Politis M, Chaudhuri KR, Ffytche DH, Weintraub D, Ballard C. Cognitive decline in Parkinson disease. Nat Rev

Neurol. 2017 Apr;13(4):217-231. doi: 10.1038/nrneurol.2017.27. Epub 2017 Mar 3. PMID: 28257128; PMCID: PMC5643027;

www.alz.org/alzheimers-dementia/what-is-dementia/types-of-dementia/parkinson-s-disease-dementia

22

ANAVEX®2-73 PoC Phase 2 PDD Study Design

A Phase 2 trial to Assess the Safety, Tolerability and Efficacy of ANAVEX®2-73 (blarcamesine) Oral Capsules in the Treatment of Parkinson's Disease Dementia

1:1:1 randomization

2-week baseline period

3-weekup-titration period

11-week target dose treatment period

Study data collected

at Baseline, Week 8

Screening

Baseline

Week 3

Week 8

Week 14

and 14

N=44

ANAVEX®2-73 High Dose

(10, 20, 30, then 50 mg QD)

2-week baseline

ANAVEX®2-73 Medium Dose

N=132

including

N=44

actigraphy

(10, 20, then 30 mg QD)

N=44

Placebo

(QD)

QD = once per day

  • PDD Patient Population
    • Diagnosis of probable Parkinson's disease dementia
    • Diagnosis of idiopathic Parkinson's disease
    • Patients aged ≥ 50 years
    • MoCA score 13-23
  • Key Primary and Secondary Endpoints
    • Safety and tolerability
    • CDR Cognitive Domain of Attention
    • Sleep function
    • MDS-UPDRS
    • Actigraphy (24-hour monitoring)
    • Entire DNA and RNA sequencing
  • Pre-specifiedEndpoints
    • Genetic variants SIGMAR1 (rs1800866),
    • COMT(rs113895332/rs6114320 3) with influence on treatment effect

ANAVEX®2-73-PDD- 001 is a Proof of Concept (PoC) Phase 2, multicenter, randomized, double- blind, placebo- controlled, parallel- group, 3-arm, 14- week study

23

Addressed in PoC Phase 2 PDD Study

Key Cognitive Domains

Key cognitive features addressed by ANAVEX®2-73 (blarcamesine)

The criteria from the National Institute on Aging and Alzheimer's Association (NIA-AA) workgroup mention the following five cognitive domains when diagnosing MCI-AD:

  1. Episodic memory
  2. Attention
  3. Language
  4. Visuospatial skills
  5. Executive functions

Related CDR

system

domains

Episodic memory

Choice reaction time

Word recognition

Picture recognition

Numeric working memory

Source: Albert MS, DeKosky ST, Dickson D, Dubois B, Feldman HH, Fox NC, Gamst A, Holtzman DM, Jagust WJ, Petersen RC, Snyder PJ, Carrillo MC, Thies B, Phelps CH.

The diagnosis of mild cognitive impairment due to Alzheimer's disease: recommendations from the National Institute on Aging-Alzheimer's Association workgroups

on diagnostic guidelines for Alzheimer's disease. Alzheimers Dement. 2011 May;7(3):270-9. doi: 10.1016/j.jalz.2011.03.008. Epub 2011 Apr 21. PMID: 21514249;

24

PMCID: PMC3312027.

Significant Improvements in Episodic Memory with Increased Dose

ANAVEX®2-73-PDD-001 Study: Dose-dependent, statistically significant

improvement of Quality of Episodic Memory with ANAVEX®2-73 (blarcamesine)

Direction of

Improvement

(counts)

Quality of Episodic Memory (counts)

All participants

Time: 14 weeks change from baseline

• A high score reflects

ability to store, hold

and retrieve

information of an

episodic nature (e.g.,

21.40

an event or name)

-1.20

+42.22

• CDR system Quality

of Episodic Memory

-20.82

highly correlated

(70%) with ADAS-Cog

(r = 0.7)1

1. Wesnes K, Edgar C, Andreasen N, Annas P, Basun H, Lannfelt L, et al. Computerized cognition assessment during acetylcholinesterase inhibitor treatment in Alzheimer's disease. Acta Neurol Scand 2010; 122:270-7

All participants; ANAVEX2-73 = Active 30 mg, Active 50 mg vs Placebo

25

J-T test based on actual maintenance dose: p = 0.003

Summary of Topline Results:

Broad and Significant Effects with ANAVEX®2-73 (blarcamesine) in PDD Patients

  • ANAVEX®2-73 (blarcamesine): a novel, oral, investigational sigma-1 receptor (Sig-1R / SIGMAR1) agonist with multimodal activity
  • Data confirm SIGMAR1 as gene "signature" biomarker of response to ANAVEX®2-73 (blarcamesine) confirming SIGMAR1 activation as mechanism of action
  • Broad and statistically significant improvements in CDR system Cognitive Domain of Attention assessed by Choice Reaction Time (p = 0.039) and Digital Vigilance (p = 0.008) and CDR system Episodic Memory (p = 0.047), representing complex cognitive tasks with impact on quality of life such as making a choice between similar objects and remembering daily personal experiences, which are mostly impaired in both PD and AD1
  • Statistically significant dose-dependent (p = 0.003) improvement of CDR system Episodic Memory, which has been shown to be highly correlated (70%) with the Alzheimer's Disease Assessment Scale-Cognitive score (ADAS-Cog; r = 0.7)2
  • ANAVEX®2-73 (blarcamesine) does not impair sleep and has a positive effect on REM sleep behavior disorder
  • ANAVEX®2-73 (blarcamesine) was generally safe, well tolerated, and improved safety profile compared to dementia drugs associated with typical adverse effects
  • These results support continued development in PDD / PD as well as currently ongoing Phase 2 and Phase 2/3 clinical studies with ANAVEX®2-73 (blarcamesine) in Rett syndrome3 and Alzheimer's disease4
  • Data will be submitted to the U.S. Food and Drug Administration to seek regulatory guidance
  1. Mahurin, R. K., & Pirozzolo, F. J. (1993). Application of Hick's law of response speed in Alzheimer and Parkinson diseases. Perceptual and Motor Skills, 77(1), 107-113
  2. Wesnes K, Edgar C, Andreasen N, Annas P, Basun H, Lannfelt L, et al. Computerized cognition assessment during acetylcholinesterase inhibitor treatment in Alzheimer's disease. Acta Neurol Scand 2010; 122:270-7
  3. ClinicalTrials.gov Identifiers: NCT03758924, NCT03941444, NCT04304482
  4. ClinicalTrials.gov Identifiers: NCT03790709, NCT02756858

26

Anavex is pursuing Large Markets by Applying Precision Medicine to Develop Treatments for both Global Aging CNS diseases (Alzheimer's, Parkinson's), as well as catastrophic Orphan Genetically caused diseases, Rett Syndrome with High Unmet Needs

$ 277B

Economic burden

2018 Alzheimer'sAssociation

OVERARCHINGMESSAGE

A novel approach is needed to address the totality of CNS diseases

PRECISION MEDICINE IMPROVES CHANCE OF CLINICAL SUCCESS

Testing for biomarkers demonstrated improved clinical response to ANAVEX®2-73 in Rett syndrome correlated with glutamate and for Alzheimer's and Parkinson's patients carrying wild-type (WT) SIGMAR1 gene

NOVEL CNS MECHANISM OF ACTION

ANAVEX®2-73, an orally available Sigma-1 receptor agonist, is upstream of neurodevelopment and neurodegeneration and has been shown to restore homeostasis

COMPELLING INITIAL HUMAN DATA

ANAVEX®2-73 Phase 2 Parkinson's disease dementia, ongoing Phase 2 in Rett syndrome and Phase 2a trial in Alzheimer's with favorable safety and initial efficacy results through 148 weeks

WORLDWIDE COMMERCIAL RIGHTS AND STRONG IP FOUNDATION

We retain global commercial rights to all of our product candidates and our lead product candidate, ANAVEX®2-73, including patent protection to 2030-2039

SUFFICIENT CASH TO ACHIEVE KEY MILESTONES Sufficient cash for >24 months to achieve key milestones, including non-dilutive cash from Australian government for Alzheimer 's trial and from Rettsyndrome.org for Rett syndrome trial

27

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 & Scientific Strategy

Scientific Advisory Board Members

Jeffrey Cummings, MD

Paul Aisen, MD

Corinne Lasmezas, PhD

Norman Relkin, MD, PhD

Ottavio Arancio, MD, PhD

Jacqueline French, MD

Andrew Cole, MD

Dag Aarsland, MD, PhD

Daniel Weintraub, MD

Tangui Maurice, PhD

28

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

29

Disclaimer

Anavex Life Sciences Corp. published this content on 10 November 2020 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 20 November 2020 21:06:00 UTC


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Financials (USD)
Sales 2021 - - -
Net income 2021 -33,7 M - -
Net Debt 2021 - - -
P/E ratio 2021 -11,2x
Yield 2021 -
Capitalization 400 M 400 M -
Capi. / Sales 2021 -
Capi. / Sales 2022 -
Nbr of Employees 20
Free-Float 96,4%
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Anavex Life Sciences Corp. Technical Analysis Chart | MarketScreener
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Technical analysis trends ANAVEX LIFE SCIENCES CORP.
Short TermMid-TermLong Term
TrendsNeutralNeutralBullish
Income Statement Evolution
Consensus
Sell
Buy
Mean consensus BUY
Number of Analysts 3
Average target price 13,00 $
Last Close Price 5,82 $
Spread / Highest target 192%
Spread / Average Target 123%
Spread / Lowest Target 71,8%
EPS Revisions
Managers and Directors
NameTitle
Christopher U. Missling Chairman, President, CEO & Secretary
Stephan Toutain Chief Operating Officer
Sandra Boenisch Principal Financial Officer & Treasurer
Walter E. Kaufmann Chief Medical Officer
Athanasios Skarpelos Independent Director
Sector and Competitors
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