Anavex Life Sciences Corp (AVXL)

[Biostockclub]

Time for a view of the field?

Observations relevant to the AD/CNS/PM arena and post CTAD score update and strategy available - all in favor say “Aye” - jimmy!!!!

I believe we met our goal, brilliantly. First, we eliminated the “Mabs”. Today, we took care of the pesky BACE inhibitors. The goal is to clear the table and bring everyone to deal...they know what we have...and they folded. Won’t be long now.

Some recent relevant plots for the CNS drug development chart. These are October moves on the chess board (some not yet mentioned). Consider them and view them as a whole.

I’ll start with the CTAD cause it’s the lead then add things which preceded it in October for our company - and a few thoughts on where we go from here.

A lot happened at the CTAD.
All sources are tweets. Most will find these stark but amusing in the way that tragedy becomes comedy when coupled with reality and time.

As to companies not getting up and announcing their mistakes: check out these failures. But they did what was best for shareholders and patients and I respect that very much. There is no shame in failing only in not admitting it and not learning from it.

BACE inhibitor candidates for AD by Lilly, Merck, Janssen all failed, worsened and halted. (See tweets)

https://twitter.com/ilyachorny/status/1055115033678659584?s=21
MERCK BACE failure: questioning AB theory big time.


https://twitter.com/adamjbutler/status/1055112840397406208?s=21
Merck worsening, failure.

https://twitter.com/adamjbutler/status/1055132436265353217?s=21
More bad BACE - guess it’s not all about the BACE...?

https://twitter.com/mariempowers/status/1055128286874005504?s=21
JanssenUS halted

https://twitter.com/alz_gal/status/1055131526357307392?s=21
Lilly tweet

https://twitter.com/mariempowers/status/1055124097347280896?s=21
Bad day for BACE

Amyloid Theory beginning to crumble...

https://twitter.com/andybiotech/status/1055139994577321986?s=21
Amyloid hypothesis dying

https://twitter.com/alz_gal/status/1055409875667337216?s=21
Amyloid picture unfolding

Learning from failure:
https://twitter.com/lonschneidermd/status/1055138472544092160?s=21
Baseball analogy and learning

https://twitter.com/jeangeorgesae/status/1055139822128513026?s=21
About learning from failure

Good comment (nothing against either team - meant in general.) - hope it rings true for our approach replacing older theories we have learned from.

Now, What kind of day did Biogen have??
Just think, what would Missling be called if he had pulled a stunt like Biogen before AAIC and fleeced folks at prices greater than 360$/share??? They knew exactly what they had done and if not, that’s incompetence all you incompetence police on the board. That’s deceit and scam/sham business - but it’s ok because they are not Missling and hairstyle and a lousy website etc.
Read what folks are tweeting about Biogen’s wonder drug today:
https://twitter.com/lonschneidermd/status/1055450022026842112?s=21
Biogen spins...great caption!

https://twitter.com/andybiotech/status/1055613361222762506?s=21
Biogen’s hypocrisy (incompetence?) note: they trade over 100 x the price of AVXL (but they have revenue from other streams which also cause harmful effects, were poorly tested - spent a lot in research, and price gouged to recoup for poor designs. Okay.)

https://twitter.com/stevedoc22/status/1055442550713208832?s=21
Biogen takes it on the chin apoe and response

Also, the apoe genetic part. That’s where Biogen failed and we passed. The slide was there so we must have known that the attack on Biogen’s data was coming. See what Cummings said. Tweet. Lot of talk in this industry.
https://twitter.com/megtirrell/status/1055441759742894086?s=21
Cummings

https://twitter.com/byjongardner/status/1055429747809939457?s=21
Biogen ARIA-E

https://twitter.com/byjongardner/status/1055442410703065088?s=21
Biogen exposed - compare this to AVXL...they should be putting 2-73 in the drinking water. Safer than fluoride...

https://twitter.com/byjongardner/status/1055451553388208129?s=21
He gets it!

More On BAN2401, Unfortunately $BIIB
https://seekingalpha.com/article/4214775

All of the above is why THIS will never NOT be funny:

https://twitter.com/byjongardner/status/1055445211919323137?s=21
Never not funny!



Sleep was a big subject...
https://twitter.com/lead_coalition/status/1055100599690235904?s=21

https://twitter.com/brainbodydevel1/status/1055864887983788032?s=21

Just posted 2 samples but many many... search Alzheimer’s sleep.



From earnings call last week, Biogen does not answer if they will seek ph 3 for BAN2401 - the wonder drug just 3 mos ago at AAIC. SMH! The games people play.
Also:
Meanwhile, CEO of BIIB, MV, reiterates they would really like to get something (deal, license, buy) in the later stages...
Biogen Inc. (BIIB) CEO Michel Vounatsos on Q3 2018 Results - Earnings Call Transcript $BIIB
https://seekingalpha.com/article/4213588

Bernstein downgrades BIIB citing no catalysts after CTAD. Also, new competition for Spinraza and MS and price regulating. Set target for 314$ now below 300$.
- Bernstein softens view on Biogen, fully valued due lack of catalysts; shares down 2%
https://seekingalpha.com/news/3398910

Biogen and Eisai’s 3rd compound elenbecestat is a BACE inhibitor...uh oh!
(They have the notorious BAN2401, looking bad, and adcanumab (a plaque attack, been there, done this) they have no viable candidates imo.)


But, now the plot thickens. Every BP is turning in their keys and will be looking for a piece of the golden pie. Imo, this will go into extra innings - lots of at bats! Personally, I don’t think Biogen has the money to afford us, and if other interested parties are involved who have much greater sense of integrity (no games - admit your drug doesn’t work) Biogen surely will not take the prize. Biogen now looks to be twisting in the wind. And therefore, THIS will never NOT be funny!
https://twitter.com/byjongardner/status/1055445211919323137?s=21
Still funny!


Loved the tweet with the crazy pills gif!!! Still funny! That’s a keeper / describes the whole industry. Anavex has had no coverage so far on Twitter...hmmm, the industry is desperate and all approaches dropping like flies...everyone saying they wish something could prove effective...it’s interesting to see this. Not sure if this is “crazy pills” ignorance or a set up for something...
I’m thinking the Missling is hiding our light under a bushel because as others noted - no mention of the strong responders in the update, no press coverage of our results, although a couple of analysts from different firms initiated coverage (which you would expect when the sector was red and only a couple were big gainers early on - they don’t know science but they know something happened.)

When someone says after it is over you will know why we did what we did - that is a sign that you will most likely not understand it at the time - unconventional path. If it were 3 straight trials - Hell, that’s standard operating procedure and there were be no need to say later you will understand why we did what we did...because it’s the normal typical way things are done? So, right off, you know there will be moves we won’t see until they are much clearer.
The fact that he did them was for the best (his duty) or he wouldn’t have done them. The fact that he doesn’t reveal the moves for what role they are playing in the big scheme must also be for the best or he would be announcing the moves and what they mean. The fact that he told Jj this, means, that he knows that we do not know why he’s doing things but he is confident to make that statement...like a “you’ll thank me later” - usually someone who says that has something of a “lock” guaranteed to surprise and help you later.


Much better than this:
https://twitter.com/byjongardner/status/1055445211919323137?s=21
Watch it 100 times - you will still laugh.
Repost crazy pills tweet. Still funny!

What’s NOT funny is that some press takes them seriously and they continue on with this sham...maybe (could be ready to reconsider and call it quits). The CEO just can not learn. They have no catalysts, no pipeline, we would be crucified! It’s a good thing they price gouged all those years or they would be Bankrupt.

Missling kept one small pack of matches (our AD small safety trial) and lit a torch (biomarkers and extension and more approvals and extensions). Now we can light many more sticks off this (all our approvals). The single match did not give off enough heat or light so he did the wisest thing leveraging the heck out of it (Xena, start the metaphor meter...)
Confidentially, not feeling very analogous today / but I never metaphor I didn’t like!

Why did our presentation include the slide mentioning what our 3 year results would have been without the 20% biomarker cohort? Because...he wanted a biomarker to be acknowledged, and a trial to be conducted at the same time. The extensions will count for approval.
Biogen is trying the same thing with its adcanumab ext. It’s too bad 25% are having ARIA-E. That’s a tough extension to put your family member through...agh!
See tweet above about ARIA-E


This was a forum for failure - and one success at the end which got no press. I think it was a plan to clear the table and for companies to lay down their cards to get down to business with S1r acquisition. Would not be surprised to see Missling get all Regulatory paths cleared for approvals and then let out the press coverage (always keep one in the chamber!) right before entertaining the big offers - justify!! Our day will come and we will “know why he did what he did...”
Stay strong - we got this (cause it’s sure as hell no one else does!)


October saw Anavex announce the FDA approval of the 7 week 15 sample safety trial to be conducted pre-larger RCT (maybe 80ish sample). The 7 week component has an extension, which I feel is significant for the piggy back approval, while others feel it is significant so that we could fill it without losing spots in the longer trial to folks who don’t want to miss out on longer dosing. I think both are plausible and sensible for the company. There is a third possibility which can never really be excluded when administering test drugs to women of childbearing age: the thalidomide effect. If Rett girls see significant improvement in their lives (which I hope) many will lead very typical lives and, no longer limited by a debilitating disease, go on to experience normal activities - including living independent lives and wanting marriages and families of their own. Question: will a drug which a mother has to take to maintain a normal life cross the placenta and cause birth defects? And, if so, how can these women go off the medicine for 9 months without it affecting their ability to function normally? Some epilepsy meds have been associated with birth defects - I defer to Dado.
But, if a CNS drug is going to cause either infertility, miscarriages, or birth defects, it would come from aberrations to the eggs, which can be harvested now and tested for changes prior to fertilization with regard to drugs in the testing phase (comparing them to eggs in girls with Rett who are not taking any medications to determine if any predisposition to non-pregnancy and birth defects already exist as a result of the mother’s genetic state which produces the disease.)
In short, we can tease out the thalidomide effect and know beforehand, although all medications taken by women who might become pregnant come with the strongest warnings as they should. (FASD - fetal alcohol syndrome defects are sadly common and unmonitored. Imagine what more potent drugs which aren’t sold over the counter can do. Nuff said.)


My Bryostatin research will have to be in a separate post - I researched it awhile back and have to dig out my analysis of why it is a mirage mechanism of action. Stay tuned, thanks.

I still believe that we have one helluva pipeline going simultaneously. (More indications to come, and more compounds but only one pack of matches ($$$$) we will get there.) Those who see this see that the potential as was mentioned at the end of our presentation today is great for our compound to therapeutically target many CNS diseases and patients. It just won’t be conventional or Missling would not have said it wouldn’t be apparent until the end.

- Bio out (for the post. Not the stock! Never more optimistic!)
Watching that crazy pills tweet all night! wink*
https://twitter.com/byjongardner/status/1055445211919323137?s=21
Still funny!