ANAVEX MEETS ENDPOINTS PHASE2 RETT, page-67

AVXL closed @ $8.85 last Thursday, prior to announcing its Robust, Statistically Significant and Clinically Meaningful Absolute Improvement in Cognitive Function results of blarcamesine in early Alzheimer’s disease. The company held a conference on Monday to put to rest any doubts about the quality of the results. Subsequently, the closing price yesterday was $8.38.

Cantor Fitzgerald has received payment as a “sales agent” for Anavex since a number of years, so they’ve been a big supporter of the company. Following Anavex’s conference on Monday, Cantor Fitzgerald downgraded its price target for Anavex from $16 to $11. It should be noted that Cantor Fitzgerald had already downgraded its price target from $27 to $16 in February, following the release of Phase 3 results of blarcamesine in adults with Rett syndrome - a trial which Anavex hailed as a major success.

In explanation of the most recent price downgrade, the Cantor Fitzgerald analyst referred to the latest blarcamesine results as “provocative but not yet compelling, including choice of statistical analyses and other trial design/conduct ‘complexities’. “ Interestingly, he also mentioned “safety signals” which he said could have implications for the broader blarcamesine development program. No specifics were provided.

Anavex is due to complete enrolment soon in a Ph 2/3 trial of blarcamesine in paediatric Rett patients. The clinical trial website shows that the original primary outcomes were the same as those used for the trofinetide Phase 3 trial - change from baseline in both the RSBQ and CGI-I. Anavex has since removed the (physician assessed) CGI-I as a primary outcome and replaced it with “Incidents of Adverse Events”.