Anavex Life Sciences Corp (AVXL)

[XenaLives]

Compiled Due Diligence 09/29/19


________________________________________________________________________________
Comments to put the shelf offering in perspective:
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=149743089
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=149743702
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=149748255
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=149780479
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=149784662
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=149788415
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=149801350
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=150059795

General analysis of S-3 filings -
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=149784281

Link to Annual Report:
https://www.sec.gov/Archives/edgar/data/1314052/000161577418014328/0001615774-18-014328-index.htm
https://www.sec.gov/Archives/edgar/data/1314052/000161577418014328/s114606_10k.htm
Link to all SEC filings:
https://www.sec.gov/cgi-bin/browse-edgar?CIK=0001314052&action=getcompany
Link to Pipeline graphic: https://www.sec.gov/Archives/edgar/data/1314052/000161577418014328/img001_v1.jpg
Mouse PET images: https://www.sec.gov/Archives/edgar/data/1314052/000161577418014328/img002_v1.jpg

PIPELINE


Evolution of the pipeline:
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=147064606

Results of 4/5/19 shareholder vote:
https://www.sec.gov/Archives/edgar/data/1314052/000161577419005452/s117292_8k.htm

Shareholder rights plan:
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=145724043

Company website - upcoming and past events:
https://www.anavex.com/investor-material/events/

Company Website - presentations on line:
https://www.anavex.com/investor-material/

Transcript of 12/12/18 Conference call:
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=145435190

Access to 12/18 Conference call:
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=145347046

** note that current and past conference calls and transcripts should be added here

Quick link to SEC filings:
https://fintel.io/filings/us/avxl

Link to SEC filings on EDGAR:
https://www.sec.gov/cgi-bin/browse-edgar?CIK=avxl&owner=exclude&action=getcompany
____________________________________________________________________________________
SHAREHOLDER'S MEETING NOTES:

Discussion of shareholder's meeting 04/05/19 begins here:
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=148045215

Thanks to our MB, on the scene reporters...
brichnyc, bourbon, and Jonjones325

From bourbon_on_my_cornflakes:
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=148047383
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=148050828
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=148058557

From Jonjones325:
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=148057082
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=148057307

From brichnyc:
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=148084098
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=148086244

2018 Shareholder meeting report:
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=140128467
__________________________________________________________________________________________________
UPCOMING PRESENTATIONS, OTHER POSSIBLE EVENTS:


Oct 11 : Australasian Consortium Of Centres For Clinical Cognitive Research (AC4R) Annual Scientific Meeting - Sydney, AU
“The sigma 1 receptor– blocking protein misfolding” - Dr. Missling
https://www.ac4r.com.au/wp-content/uploads/2019/08/AC4R-ASM-Conference-Agenda-2019-1.pdf

Also speaking at this one-day event will be A/Prof Michael Woodward of Austin Health, Prof Simon Lewis of the University of Sydney, and Prof Phillip Morris of the Gold Coast Memory Disorders Clinic — there's no reason to believe their appearances are related, but each of them run AD clinical trial sites for 2-73 at their respective institutions.(copy snitched from TTTav66)
Coomment on this from traderherpete:
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=150868995

see Also:
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=151080828
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=150867161

Dec 5 : 3rd Microbiome Movement – Gut-Brain Axis Summit - Boston, MA
"Sharing Clinical Data that Identifies Gut Microbiota Biomarkers Associated with Improved Clinical Response in Alzheimer’s Disease Patients Treated with ANAVEX®2-73" - Dr. Missling
https://microbiome-gba.com/seminar/sharing-clinical-data-that-identifies-gut-microbiota-biomarkers-associated-with-improved-clinical-response-in-alzheimers-disease-patients-treated-with-anavex2-73/


16th international conference on Dementia and Alzheimer Disease
February 10-11, 2020 Sydney, Australia (from georgejjl)
https://dementia.annualcongress.com/events-list/parkinson-s-disease

Possible Catalysts
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=145908635
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=148107153
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=149157245

We are still awaiting Dr Kaufmann's presentation on gut microbiome data. (from kevli33)
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=148871706
_________________________________________________________________________________
RECENT HAMPEL COMMENTS AND PAPERS:

Hampel: “What Electrophysiology Tells Us About Alzheimer’s Disease: A Window into the Synchronization and Connectivity of Brain Neurons - ScienceDirect”(from Investor2014)
https://www.sciencedirect.com/science/article/abs/pii/S019745801930329

Hampel: Revolution of Alzheimer Precision Neurology,Passageway of Systems Biology and Neurophysiology(from kevli33 )
https://content.iospress.com/download/journal-of-alzheimers-disease/jad179932?id=journal-of-alzheimers-disease%2Fjad179932


HH Tweet on AI:
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=150177121

Hampel on our "small" P2a:
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=149548350

Time for the systems-level integration of aging:
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=150247109

See also Anavex Partnerships under Precision Medicine Initiative

_________________________________________________________________________________
PAST PRESENTATIONS:

Anavex presentations -
https://www.anavex.com/presentations/
Including these for 2019

6th Annual European Rett Syndrome Conference September 2019 (Finland)
https://www.anavex.com/wp-content/uploads/2019/09/ANAVEX2-73-RS-001-Finland-Conference-Sept-2019-Final.pdf

Janney presentation September 2019 (audio)
https://www.anavex.com/wp-content/uploads/2019/09/Janney-Audio-Presentation-Sept-2019.mp3

Corporate presentation March 2019
https://www.anavex.com/wp-content/uploads/2019/03/Anavex-Presentation-March-2019-1.pdf

ASENT 21th Annual Meeting Conference March 2019
https://www.anavex.com/wp-content/uploads/2019/03/Anavex-ASENT-March-2019.pdf

upcoming medical journal
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=150808695

Presentation links from georgejjl:

https://www.anavex.com/wp-content/uploads/2019/03/Anavex-AAIC-2018-DT-Presentation.pdf

https://www.anavex.com/wp-content/uploads/2018/05/Anavex-Presentation-May-2018-1.pdf

https://www.anavex.com/wp-content/uploads/2019/03/Anavex-ASENT-March-2019.pdf

https://www.anavex.com/wp-content/uploads/2019/03/Anavex-Presentation-March-2019-1.pdf

https://www.anavex.com/wp-content/uploads/2019/07/Anavex-Microbiota-Presentation-AAIC-July-2019-1.pdf

Feb. 11-12 : BIO CEO & Investor Conference
Presentation
https://www.veracast.com/webcasts/bio/ceoinvestor2019/78204240532.cfm?0.22201266802
Slides only
https://www.anavex.com/wp-content/uploads/2019/02/Anavex-BIO-CEO-Feb-2019-1.pdf

Cantor Fitzgerald Presentation from Cantor Fitzgerald Global Healthcare Conference October 3, 2018 2:50 p.m.
http://wsw.com/webcast/cantor7/avxl/

Comment on the above from dia76ca "At Cantor Dr. Missing said that the Rett trial would "clear VERY SOON"(At the 27:30 minute mark). We would do well to remember some of the other things he said.(e.g. Cash on hand for 2 years...21:21 minute mark ; Anavex 3-71 in clinic in 2019...29:34 minute mark ; Parkinson read-out in 2019...30:40 minute mark."
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=144349470

Additional audio presentations on the company web site see links at top of post.
_________________________________________________________________________________________________
VIDEO PRESENTATIONS

Anavex SAB member Dr Paul Aisen speaks about PET Scans:
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=143921781

History of rettsyndrome.org featuring Christopher Missling:

Missling interview:

Walter E. Kaufmann
Until recently, he was the Director of the Center for Translational Research at the Greenwood Genetic Center, where he also held the Ravenel Boykin Curry Chair in Genetic Therapeutics. Now he is the Anavex CMO. (originally posted by kevli33)

Dr. Tangui Maurice on the Sigma 1 - 2015 video:(from kevli33)
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=143980208

SAB member Jacquelin French, videos discussing Seizures and Epilepsy: (from kevli33)

Videos from UC and Rob Knight (not Anavex specific, but cutting edge science.)
Microbiomes and aging:

Microbiome mind and brain interaction:
https://www.youtube.com/watch?v=2iKHMyWzclM&t=134s
All of Rob Knight's videos are interesting:
https://www.youtube.com/results?search_query=rob+knight

Dementia risk and blood pressure from kevli33:

Macfarlane on medication in dementia:

Additional video presentations on the company web site see links at top of post.


_________________________________________________________________________________________________
SLIDE SHOWS AND POSTERS:

AAIC Gut Brain slide show
https://www.anavex.com/wp-content/uploads/2019/07/Anavex-Microbiota-Presentation-AAIC-July-2019-1.pdf
See the GUT BRAIN link at the bottom of this post for comments and discussion.

October Corporate Presentation used at the Cantor Fitzgerald Conference
https://www.anavex.com/wp-content/uploads/2018/10/Anavex-Presentation-Oct-2018.pdf

Dr Robert Lisak’s MS poster presented at the 2018 ECTRIMS conference:
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=144223191&txt2find=ectrims

Anavex 2-73 as a potential treatment for autism spectrum disorders 2016
https://anavex.com/wp-content/uploads/2016-06-06_Poster_AV2-73_Autism_FXS_Conference_June_2016.pdf

Kaufmann presentation 3/27/19
American Society for Experimental Neurotherapeutics - ASENT 2019 Annual Meeting
https://www.anavex.com/wp-content/uploads/2019/03/Anavex-ASENT-March-2019.pdf

https://www.anavex.com/wp-content/uploads/2019/03/Anavex-Presentation-March-2019-1.pdf

Titration could increase the response and efficacy of Anavex 2-73.
A plasma concentration of greater than 4 ng/ml would increase postive responses and efficacy to Anavex 2-73 (from georgejjl)

Slide 10
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=147511076

From Slide 27:

Value-Creating Catalysts – Clinical updates from Phase 2 Parkinson’s disease dementia study, Phase 2b/3 Alzheimer’s disease and Phase 2 Rett syndrome studies anticipated in 2019. Clinical datapublications and additional indications to be announced in 2019.

What is Actigraphy Monitoring? Mentioned in 3/19 Missling presentation. (from nidan7500)
https://www.verywellhealth.com/what-is-actigraphy-3015130
https://www.actigraphcorp.com/

CTAD 2018 slides - see the following archive
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=146087872

____________________________________________________________________________________________
POSSIBLE SIGNS OF MOVE TOWARD COMMERCIALIZATION:

Does 2-73 have a name?
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=146539861
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=146540287
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=146540557
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=146545746

Info on why Anavex needed to spend $1 million on product development in 2018. (from ohsaycanyousee82)
http://www.pharmtech.com/api-sourcing
Discussion of above follows this post:
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=146733092

September 25-27 AAIC down under
https://www.ac4r.com.au/
https://alz.org/sydney/downloads/AAIC%20Satellite%20Symposium%20Sydney%20Agenda_8.7_final.pdf
Xena opinion: part of Aussie systemic preparation for P4 trials.
Supporting post
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=150854241&txt2find=rowe

__________________________________________________________________________________________________
GENERAL TRIAL DISCUSSION AND COMMENTS ON TRIAL PROCEDURE:


These discussions are moved to the "OTHER COUNTRIES - General Coments" post, see the links at the end. For more on Cognition, Neuronetrix, and the Consortium see the Anavex Parnters link at the end.
__________________________________________________________________________________________________
MISCELLANEOUS DISCUSSION:

Anavex extended trials defining a new sort of success:
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=150370866
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=150373170
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=150380618

The industry of aging
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=150881079
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=150881395

Systems theory and systems biology paradigms bio
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=149449161

Derek Lowe's commentary on drug discovery and the pharma industry.
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=151382722

Neurodevelopment in children:
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=143439222
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=151301338

Protein degradation disease treatments:
https://www.investors.com/news/technology/protein-degradation-eyed-pharmaceutical-companies-drug-development/

AI estimates brain age:
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=147255249

Orphan Disease Designation in Rett and Infantile Spasm
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=146540508

The U.S. has a "national mental health epidemic. The damage is on the scale of the global financial crisis." (from Lima4918)
https://www.bloomberg.com/news/articles/2019-06-20/latest-suicide-data-show-the-depth-of-u-s-mental-health-crisis?srnd=premium

Rising to the Challenge: Developing New Medicines for Rare Disease (from kevli33)
https://checkrare.com/rising-to-the-challenge-developing-new-medicines-for-rare-disease/

Expansion of rare disease diagnostic codes (from nidan7500)
https://dravetsyndromenews.com/2019/02/04/icd-10-codes-really-important-to-rare-disease-patients-soon-up-for-fresh-consideration/

Missling has a strategy - comments from posters on that strategy:
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=144051610
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=144350599
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=145164402

Personal comments from falconer66a on the failure of traditional western medicine:
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=144979916

How the U.S. is failing its people in healthcare:
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=145076878

Brain cells from stem cells at Lund University:
https://www.lunduniversity.lu.se/article/new-method-grows-brain-cells-from-stem-cells-quickly-and-efficiently

Sokol with a 2016 perspective on potential Alzheimer's treatments:
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=144809093

Falconer taking the temperature of the medical research community:
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=148589256

2015 mention of ERP results at five weeks:
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=148130307

Anavex 2-73 might show better results with younger patients than older patients.
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=148058285

Comment on industry trends (link from PennyDouble)
https://www2.deloitte.com/us/en/pages/life-sciences-and-health-care/articles/us-and-global-life-sciences-industry-trends-outlook.html
2015 new discovery about the brain and the immune system:
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=148062119

“Enabling precision medicine with integrated genomic and clinical data” posted by Harald Hampel and kevli33
https://twitter.com/harald_hampel/status/1114590967531753472?s=21
https://azure.microsoft.com/en-us/blog/enabling-precision-medicine-with-integrated-genomic-and-clinical-data/

Old brains and neurogenesis (from powerwalker).
https://www.statnews.com/2019/03/25/old-brains-make-new-neurons-possibly-protecting-against-alzheimers/

Top 20 CNS drug companies:
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=147869585

Anavex is not just a drug company - opinion from Lima4918
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=147759921

A new urgency for Expanded Access:
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=147906853

An excellent summary of why we are here from poster sokol:
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=143320176

Sokol on Anavex's international strategies:
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=144504285

Link to PeterKarol's blog:
https://piotrpeterblog.com/

Scientists rise up against statistical significance (from Biostockclub)
https://www.nature.com/articles/d41586-019-00857-9

Life expectancy in the US still continues to go down, 2018 graphic:
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=147424525

Short term milestone summary:
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=144330988


_________________________________________________________________________________________________
GENERAL CNS Diagnostics and Biomarkers:

Biomarkers and decision making
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=150383196

The neuroinflammatory biomarker YKL-40 for neurodegenerative diseases: advances in development.
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=149674738

On Biomarkers and Surrogate Endpoints. A read forward into the discussion is suggested for additional information on sleep and Alzheimer's:
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=145241236
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=145245388
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=145245674
(several posts follow the last link)

Cognision and ERP/EEG tracking in trials - is this why trials are adding sites slowly?
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=148909354

Possible approval based on sleep, with ERP/EEG taken as suporting biomarker evidence
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=148919365

More biomarker info under individual diseases- see link at the end of this post




______________________________________________________________________________________________
TRIAL PROCEDURE:

Reasons why it's good to be running trials in Australia...
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=140883830
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=147033379

Data from another trial can be used to support an approval:
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=148906992

Japan:
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=148770129
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=148770231

Multi-regional clinical trials and global drug development - 2016 changes in trial technique:
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=149099281
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=149099929
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=149100322

Procedure and implications of post trial access to drugs:
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=149179546
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=149180303


U.S. FDA: 09/29/19
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=151418809

AUSTRALIA'S TGA: 09/29/19
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=151418733

OTHER COUNTRIES-General Comments: 08/08/19
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=150393295
_____________________________________________________________________________________________
LINKS TO OTHER SECTIONS:

SPECIFIC INDICATIONS09/29/19
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=151418934

MOA and MEDICAL SCIENCE DISCUSSION 09/29/19
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=151418911

IP Protection:09/29/19
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=151418888

GUT and BRAIN - barrier and permeability 09/29/19
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=151418789

PRESS AND THIRD PARTY 09/29/19
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=151418761

BIG PHARMA and Potential Partners 9/26/19
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=151368809

AVXL -The Stock and the Market 9/26/19
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=151368338

3-71 Discussion 09/29/19
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=151418818

SLEEP 08/08/19
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=150393238

Anavex Partners 08/08/19
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=150393213

Elder Care Crisis:07/12/19
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=149887464

The People of Anavex 07/12/19
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=149887343

Genetic issues- sex and more 07/12/19
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=149887394