Anavex Life Sciences Corp (AVXL)

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AVXL AD DOSAGE CONCENTRATION P VALUES BIOMARKERS RESPONSE SUMMARY FROM SLIDE PRESENTATIONS:

1.ANAVEX DOSAGE OVER TIME:

ANAVEX®2-73 Phase 2a Study in Alzheimer’s Disease
Efficacy (MMSE & ADCS-ADL) has been evaluated long-term

Part A (5 weeks)
Period 1 Period 2
IV (3mg or 5mg)
&
Oral (30mg or 50mg)

Part B (52 weeks)
Daily Oral Dose:
10mg, 20mg, 30mg, or 50mg

Part A and B – 57 weeks total

Extension (208 weeks) (57 & 208 weeks extension – 265 weeks)
Daily Oral Dose:
10mg, 20mg, 30mg, or 50mg

Note: This is from slide 5 of this slide presentation: https://www.anavex.com/wp-content/uploads/2019/03/Anavex-ASENT-March-2019.pdf

See also slide 7: Concentration is key as Investor says. This slide also states:
• High Concentration of ANAVEX®2-73 => High Delta ADCS-ADL (improved response)
• # Plasma concentration of ANAVEX®2-73 is correlated with the administered dose

2.AVXL 2-73 - GENOMIC BIOMARKERS - CONCENTRATION - P VALUES – AT 148 WEEKS:

• Systematic analysis using KEM® identifies actionable parameters enabling a precision medicine approach to include best responders in follow-up Phase 2b/3 study
• Patients with a wild-type SIGMAR1 gene were found to have an improved benefit from ANAVEX®2-73. Patients with a variant of the SIGMAR1 gene (rs1800866) were found to have a limited benefit from ANAVEX®2-73. Same for COMT variant (rs113895332/rs61143203)
• Including patients with milder disease stage (baseline MMSE ≥20) and the exclusion of AD patients carrying SIGMAR1 variants results in a score improvement of +1.7 MMSE and +3.9 ADCS-ADL, respectively at week 57. The additional exclusion of the COMT variant results in a score improvement of +2 MMSE and +4.9 ADCS-ADL, respectively for the same period. Both effects would be clinically meaningful
• The minority of the population (about 20%) has the variant SIGMAR1 gene, hence the majority of patients (about 80%) is expected to benefit from ANAVEX®2-73
• Gut microbiota has been collected and will be incorporated in future analysis

https://www.anavex.com/wp-content/uploads/2019/03/AAIC_Anavex_Gene_poster_2018_Final.pdf


High Concentration cohort shows 88 % difference to low concentration cohort

In addition to Concentration, the significant covariates identified in MMRM-LME model are: SIGMAR1 (p<0.0080),COMT (p<0.0014) andAPOE e4 status (p<0.0001)
SLIDE 16

Patients treated with higher ANAVEX®2-73 Concentration show higher cognitive MMSE1 Performance over 148 Weeks, compared to the lower Concentration (p-value < 0.0008) SLIDE 17

http://www.arianapharma.com/wp-content/uploads/2019/03/ANAVEX2-73_CTAD_2018_Presentation_v2.pdf