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Re: abew4me post# 345173

Monday, 01/17/2022 11:00:41 AM

Monday, January 17, 2022 11:00:41 AM

Post# of 470241
Here are some key points covered by the Seeking Alpha article:

“Topline data is expected in mid-to-late 2022; this will be the most important catalyst in the lifetime of Anavex.
A research report published in the journal of Expert Opinion on Therapeutic Targets, and available here describes how ANAVEX2-73 may address Alzheimer's Disease or AD through the activation of autophagy. Autophagy is a physiological process that works like a scavenger of damaged cellular components, including those components that have long been held to be responsible for AD. ANAVEX2-73 targets and activates the sigma-1 receptor, which is thought to chaperone a number of these housekeeping processes. AVXL owns and is developing a number of such Sigma-1 receptor agonists like AF710B, T-817 MA, and ANAVEX2-73. The key statement of the report is:
…the activation of s-1R and autophagy could alter amyloid precursor protein processing to inhibit amyloid-ß production by reconstituting cholesterol and gangliosides in the lipid raft to offer neuroprotection against AD.
Other key highlights of the article:
The s-1R's expression increases with age; however, in Alzheimer's disease (AD) pathology, it decreases.
The decrease in s-1R expression during AD coincides with an age-related decrease in autophagy.
The s-1R may compensate for loss of receptors and autophagic machinery during healthy aging.
Activation of the s-1R can induce cytoprotective autophagic pathways.
Promising s-1R ligands used as AD drugs have been shown to induce autophagy.
Autophagy plays a key role in the progression of AD pathology.
Like I said, the AD trial is AVXL's biggest catalyst ahead. This trial now has an extension phase due to patient requests, said company management in their earnings call:…..”

(Quoting from Missling from the earring call) …So patients who are finish the study, the placebo control study, enter into the EXTENSION study finish the two years will now continue to go into the third year. And that is because of request by the patient, the caretakers and the physician. It also, I like to add that the -- I like to add also that the conversion from the placebo-controlled part of the study to the open label is very high it's above 94% currently, which is a good sign.

Continuing from article …

“Earlier in 2021, the company also announced positive data from its Parkinson's disease study. The molecule was able to improve motor and cognitive functions in patients, while, at the same time, improving SIGMAR1 concentration. This correlation between efficacy and biomarker is important, says FierceBiotech, because it scores one over Biogen's aduhelm, which was approved on the basis of only biomarker improvement.”

Mentions plenty of cash, management, and advisory board and concludes as follows:

Bottomline
AVXL has proven itself, over and over again, as a stock that rallies on news, however slight. 2022 is a year full of major catalysts for the stock, so the stock looks attractive from that point of view. However, these catalysts, and especially the AD trial, are major binary events. If the company succeeds with that trial, it will be worth billions and billions of dollars. If it fails, well, they do have two other indications with topline data this year, but a failure in AD will impact the stock very badly. No wonder everyone, including even analysts at earnings calls, are walking softly around the Alzheimer's question. It appears to me that the Street does not want to take anything but a fluid position, for fear of being wrong.

Note: You can also read the expert opinion cited in the Seeking Alpha article here: https://www.tandfonline.com/doi/abs/10.1080/14728222.2021.1939681?journalCode=iett20
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