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Re: ckent post# 302480

Wednesday, 03/10/2021 1:49:26 AM

Wednesday, March 10, 2021 1:49:26 AM

Post# of 517634
Notes on the Missling presentation.

HC Wainwright Anavex Presentation March 9, 2021

https://journey.ct.events/myschedule/7fafe09d-6023-4e24-b7be-8dbff9f06c9b



Many thanks to ckent for posting the link to the presentation which was very well presented by Missling.

I like hearing that there are now several Phase-3 'pivotal' studies now running, at the 2:00 mark.

Patent protection to 2030 and 2039 without any extension, as well as world wide rights on all the products, at the 3:07 mark.

Mentions we now have a non opioid compound for pain Anavex 1066 which a patient was issued last week, at the 3:20 mark

He also mentioned that the 48 week Phase 2b/3 Alzheimer trial has nearly completed enrollment and that was very good to hear, at the 15:00 mark.

Three years cash which is enough to reach the milestones listed, at the 4:33 mark.

Will be addressing Fragile-X and PDD in further trails, at the 4:47 mark.

Shows a list of catalysts, briefly talks about 10 individual catalysts, initiation of new studies, talks about several top line data's to be released, mentions a starting a new indication which will be a pivotal study, at the 4:56 mark.

Talks about the MOA across several indications, at the 6:20 mark.

Proof of concept Sigmar1 RNA Expression responds to the drug, the affects of multiple down stream activation and disease intervention, at the 7:57 mark.

The multiple pathways through the SIGMAR1 activation, at the 8:27 mark.

Covers Rett Syndrome and the patient improvement successes in the trials, RSBQ and CGI-I p values, received the FDA Fast Track designation, plus the FDA Orphan designation, and the pediatric voucher for priority review (my note: potentially worth between 80-100 Million USD), starting at the 9:08 mark.

Alzheimer's Disease, population size and cost, the impressive chart showing MMSE and ADCS-ADL scores with very little to no decline after the end of the 148 week Phase-2 trial, starting at the 13:18 mark.

Alzheimer's Disease Phase-2b/3 pivotal trial design with 450 patients, includes bio markers, and ..."the good news is we are almost fully enrolled and will complete the study in 48 weeks", starting at the 14:34 mark.

Parkinson's Dementia Disease, "we are privileged to have had a very successful study in this very difficult indication recently" a very complex disease, 80% of Parkinson's patients eventually develops the dementia, covers the design of the study with N=44, all 5 key cognitive domains improved. Besides the PDD the study included the Parkinson with actigraphy, sleep, and movement impairment, starting at the 15:14 mark.

In summary, starts at 18:30










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