Anavex Life Sciences Corporation (AVXL) Options

Don't worry, there are plenty of posters here who won't hear of the possibility of a non-Gaussian distribution. Been there, done that.

Blarcamesine: An Investigational Oral Drug for Alzheimer Disease

Timo Grimmer, MD, Associate Professor of Psychiatry and Psychotherapy and Head of the Centre for Cognitive Disorders at the Technical University of Munich, Germany, discusses the experimental oral small molecule drug blarcamesine, which is under investigation as a potential treatment for Alzheimer disease.

https://theneurologyhub.com/podcasts/expert-voices-in-dementia/blarcamesine-an-investigational-oral-drug-for-alzheimer-disease-1

Good luck and GOD bless,

For a minute there it looked like we might be a $9 stock again.

PHASE IIB/III ATTENTION-AD STUDY: OVER THREE YEARS OF CONTINUOUS TREATMENT WITH ORAL BLARCAMESINE CONTINUES TO SIGNIFICANTLY BENEFIT EARLY ALZHEIMER’S DISEASE PATIENTS (ID 3170)

Session Name
7590 - ADVANCES IN AD DRUG DEVELOPMENT 03 (ID 579)
Session Type
Symposium
Date
Sat, 05.04.2025
Session Time
17:45 - 19:00
Room
Hall A
Presenter
Timo Grimmer (Germany)
Author
Marwan N. Sabbagh (United States of America) William R. Chezem (United States of America) Kun Jin (United States of America) Juan Carlos Lopez-Talavera (United States of America) Christopher U. Missling (United States of America) Timo Grimmer (Germany)
Lecture Time
18:30 - 18:45
Abstract
Aims

There are no approved oral small molecule therapies for treatment of early Alzheimer’s disease (AD). Blarcamesine is an orally bioavailable small molecule that acts as an agonist of the sigma-1 receptor (SIGMAR1) that enhances autophagy through SIGMAR1 activation and restoration of cellular homeostasis in early AD.

The ATTENTION-AD study was an up to 144-week open-label extension study of the Phase IIb/III double-blind placebo-controlled study ANAVEX2-73-AD-004, to evaluate the safety and efficacy of oral once daily blarcamesine in participants with early AD.

Methods

The delayed-start analysis was performed using Mixed effect Model Repeated Measures (MMRM) to evaluate effects of early treatment of blarcamesine. Comparisons were made between ‘Continued blarcamesine’ (early start) and ‘Placebo to blarcamesine’ (late start) for ADAS-Cog13 and ADCS-ADL.

Results

The delayed-start analysis for ADAS-Cog13 showed a significant difference between early and late start treatment groups at week 144 (LS mean difference -2.70, P = 0.0348), favoring the early start group and increasing up to week 192 (LS mean difference -3.83, P = 0.0165). The delayed-start analysis for ADCS-ADL showed a similar trend between early and late start groups at week 144 (LS mean difference +2.32 P = 0.125), increasing up to week 192 and reaching statistical significance (LS mean difference +4.30, P = 0.0206).

Conclusions

Blarcamesine-treated patients continue to accrue benefit through up to 4 years, as measured by co-primary endpoints ADAS-Cog13 and ADCS-ADL. Delayed start group does not catch up to early start group, reflecting importance of early treatment initiation. The results provide further support for the efficacy results in the pivotal phase IIb/III study. No new safety findings have been observed with continued blarcamesine treatment over three years with good comparative safety profile and no associated neuroimaging adverse events.

https://cslide.ctimeetingtech.com/adpd25/attendee/confcal/presentation/list?q=BLARCAMESINE

Good luck and GOD bless,

The approved MABs had CDR-SB as their sole primary end point.
Our CDR-SB score was better than theirs at 48 weeks compared to 72 weeks for theirs. Extrapolating out 72 weeks ours would likely be even better.
If Anavex had chosen CDR-SB as their sole primary end point and ADL as a secondary end point this trial would be classified as a success comparable to the approved MABs.

New post on Bio_Oko

This is a very interesting out-of-the box assessment addressing the possible inappropriateness of applying normal statistical measurements to a drug like Blarcamesine that has demonstrated a therapeutic ceiling. Current statistical analysis of efficacy in AD trials is based on the assumption that a standard deviation curve is appropriate. This post supports the theory that the actual distribution curves for a drug with a front-end therapeutic ceiling are quite different and therefore the associated statistical analysis leaves much to be desired. That gives support to statistics such as the odds ratio, which can more accurately reflect the true efficacy of the drug, which demonstrates itself early on in the treatment process but hits a ceiling with a lengthy trial as patients reflect disease deterioration with time. Let's hope the European regulators share this line of thinking that would result in approval of Blarcamesine for AD treatment at least in early stage patients.

Has been just over 3 weeks since price gave a good test of the midlines. Price today has tested bottom again and now top of the zone.
So far price shaping up nicely.
All ma's flat now or turning up. Another very positive development. That makes them much easier to close above and create higher support level. Testing the brown 50period is now much more likely.
Step my step. The closing price and location will tell us more.

It is what makes a Market.
I just do not view the activity as 100% positive as an outlook parameter.
I can not trade like them and have NO IDEA about most of the reasons
for their actions. Most egregious assumption is that the float
becomes more stable because it lessens the participation of "fickle" Retail.

In addition to previous caveats about employed hedge strategies,
there is no assurance those holdings remain at the time of the report.

The thing about Tutes....they aren't Retail and rarely act like us.

As an exercise....Increase in short positions vs Increase in "Tute" holdings?

Citrati
I really like the RSI move, close to breaking 50+, it's very nice!

This makes quite a bit of sense: treating those early will yield improved results, treating those later in the disease might not be as effective. This results in an increased variability in the treatment arm compared to placebo. Considering this possibility, the use of odds ratio makes sense as an analytic approach.

Yes but there are options strategies that include holding shares long and yet the strategy is not bullish. That would be my guess on Susq's position. 

Here's hoping we outperform SAVA today. And here's hoping we'll someday be a $9 stock. That would be awesome! But I suspect it will be UP today and DOWN tomorrow. Same as it ever was.

AVXL still consolidating within strongest market structure support/resistance zone (thick blue horizontals). See how the day closes.
Fast moving averages continue to flatten. 4ema again trying to turn up and cross the 8 ema. RSI, MACD and Stoch all trying to maintain positivity.

https://investorshub.advfn.com/uimage/uploads/2025/2/18/kqgetScreen_Shot_2025-02-18_at_7.43.03_AM.png

Sounds like a fair 50/50 proposition.

I'll wager you one dollar that it will happen on time...

That company will have to hope that the August 18 date will not be compromised by FDA staff cuts.

Susquehanna...those guys kick ass.

New post on Bio_Oko. "Therapeutic Threshold in Neurodegenerative Disease: Anavex's Blarcamesine" Patreon: Bio_Oko especially of interest to short sellers.

SUSQUEHANNA INTERNATIONAL GROUP, LLP History 1,134,738 12,187,086 0.00% 0.00% 2416 896,321 375.95% 1.34% Q4 2015 7.76 13F Filing 2024-12-31 2025-02-14
SUSQUEHANNA INTERNATIONAL GROUP, LLP PUT History 277,900 2,984,646 0.00% 0.00% 4484 89,300 47.35% Q4 2015 13F Filing 2024-12-31 2025-02-14
SUSQUEHANNA INTERNATIONAL GROUP, LLP CALL History 213,600 2,294,064 0.00% 0.00% 4995 19,800 10.22% Q3 2020 13F Filing 2024-12-31 2025-02-14

One hellava increase in long position. total 12/31/2024 1,134,738 bought 896,321 during 4thQ.

John k9uwa

Ok...Talk of the FDA slowing down etc...No problem here... https://finance.yahoo.com/news/chimerix-announces-fda-acceptance-priority-120000372.html

"Trump administration cuts reach FDA employees in food safety, medical devices and tobacco products"
WASHINGTON (AP) - The Trump
administration's effort to slash the size of the federal workforce reached the Food and Drug Administration this weekend, as recently hired employees who review the safety of food ingredients, medical devices and other products were fired.
The total number of positions eliminated was not clear Sunday, but the firings appeared to focus on employees in the agency's centers for food, medical devices and tobacco products - which includes oversight of electronic cigarettes. It was not clear whether FDA employees who review drugs were exempted.
On Friday, some officials expected the U.S.
Department of Health and Human Services to fire 5,200 probationary employees across its agencies. HHS oversees NIH, FDA and the Centers for Disease Control and Preven + among

https://apnews.com/article/fda-job-cuts-trump-hhs-kennedy-cdc-nih-76dee97eee8209b2605fadac34427aab


Thanks Redshoulder!

ignatiusrielly

I totally agree with you, they are known to be very sharp in the options arena and most of their long positions are there to employ complex trading in options with various in and out tactics.

When I see them holding shares, I think: What in the hell are they doing now? ha ha

💯

rlclark

I hope the people who stay are motivated to do good.

I'm hoping he wants to improve the process & I honestly don't know his position with regards to his new bosses now in place.

Some think the shake ups are bad, some, like me, think it might be good!

We just have to watch before making judgments!

My position now is hope for improvement

Steady T

Normally filings for Institutional Accounts are listed as either 13D or 13F.....13Ds are discretionary (actively oriented /managed such as some of the hedge funds),,,,the 13Fs are normally funds, indexes, etf's...which are more just following their asset allocation efforts.

Note: the filings by Bill Ackman (Pershing Square) on Fannie Mae and Freddy Mac in going private.

When a new 13G is filed it is always "fresh news" (5%).....when a 13D is filed you know they are actively engaged and when they go over 10% they are then treated as INSIDERS and need to file any changes within 2 days, so many of these guys go to 9.99% to avoid the reporting requirements. I would like to see a new position of 5% or more reported....People like Carl Icahn will even file before reaching 5% just to get noticed.

The main trial didn't fail dude, one primary endpoint failed, which is not the same.

That endpoint is in the process of being removed by the FDA which you likely knew already.

Why are you lying?

could be. in 4th qtr there were some significant events such as EMA submission
nothing super exciting so far in 2025

on the other hand, still some reasonable strength.
accumulation at lower levels

STOP IT: He told everyone that the EMA pulled him in, how is that strategic?

Geez stop it already. I had to agree with you once this week, now you say another true statement.

Missling was flat on his back after Rett failure, and didnt have a backup plan

He got LUCKY!

Lakes, I view it as the professional non-index manager of an Invesco growth oriented fund likely made the decision, which I view as a Tute decision to add AVXL to get alpha. The funding behind the decision matters not.

13F 2022-12-31 Anavex Life Sciences Corp AVXL 30,292 -2,899 0.00 9.26
13F 2023-03-31 Anavex Life Sciences Corp AVXL 31,893 1,601 0.00 8.57
13F 2023-06-30 Anavex Life Sciences Corp AVXL 31,654 -239 0.00 8.13
13F 2023-09-30 Anavex Life Sciences Corp AVXL 51,257 19,603 0.00 6.55
13F 2023-12-31 Anavex Life Sciences Corp AVXL 27,934 -23,323 0.00 0.03 9.31
13F 2024-03-31 Anavex Life Sciences Corp AVXL 28,240 306 0.00 0.03 5.09
13F 2024-06-30 Anavex Life Sciences Corp AVXL 25,284 -2,956 0.00 0.03 4.22
13F 2024-09-30 Anavex Life Sciences Corp AVXL 24,409 -875 0.00 0.03 5.68
13F 2024-12-31 Anavex Life Sciences Corp AVXL 615,048 590,639 0.00 0.73 10.74

The above covers the qtrly totals includes the increases and decreases of investco. I can't see any of the qtrs previous to this as I am not a premium member of WhaleWisdom. Only that they have been invested in AVXL since June 30 2020. Up until the 4th qtr of 2024 they appear to always have had a MUCH SMALLER investment into AVXL.

They are but One Investment company who has to file form 13F forms quarterly. There are also those who have to file 13D and 13G forms. The total is now about 42% of the 85M shares are owned by those institutions. Some of them are very small investor groups. That is about a 10% increase 3rd qtr to 4th qtr.

We now have 1/2 of the 1st qtr of 2025 and no idea how many of them have sucked up how many shares. I like Leo and probably many others think it is a real crock of crap that they get away with the buys and sells now being available to the public within about 5 days after they make the trades.

John k9uwa

Susquehanna is a notorious chop shop. I'd rather see them stay away completely. Likely they have shares as part of some combo short/option strategy. They've had a position in the past, off and on. 

I just associate significant institutional accumulation, like we had last quarter, with a rise in the share price. We haven't seen it this year, so I think it's paused.

IF they bought at $10.74 why would you think they quit... after announced acceptance by EMA
Here is an interesting one... SUSQUEHANNA INTERNATIONAL GROUP, LLP owned total shares 1,134,738 They bought 896,321 of those during 4th qtr They first bought into AVXL Q4 of 2015 Their Average Price Per share is $7.76 pps. See any reason why this last week or so they would buy more or not?
MORGAN STANLEY 904,159 share total bought 4th qtr 185,604 first into AXL Q4 2015 their average PPS $7.35
Somebody is usually buying MOC 80,000 to 160,000 per day. Probably not retail.

John k9uwa

Nice to hear!
One senior leader who has stated his intent to remain at the FDA is Center for Biologics Evaluation and Research (CBER) Director Peter Marks
rlc

To me is doesn't matter all that much because it is an increase in holdings by an insty, for whatever reason.

It's a net positive because it results in diminished fickle retail ownership. The bottom line is that AVXL needs increased institutional support to drive the price further up. Retail's ability to raise the stock price becomes more limited at higher stock prices.

Anavex fell into a bit of luck by going with the EMA first instead of the FDA for blarcamesine approval for Alzheimer treatment.


So where was the "luck"? I think AVXL devised a sound strategy based on the collective facts in hand.

Ok. Where those shares went within Investco is unknown. Fine with me. That fact that they were purchased is also fine with me.

it was strategic to go to EMA first. LOL... He told everyone that the EMA pulled him in, how is that strategic? It took him 2 years to file with the EMA. He waited for the OLE data to submit because he knew the main trial had failed miserably.

We almost agree right down the line EXCEPT

I do not think a FUND Manager soliciting Retail (if that is the case)
is a Tute. AVXL performance NOV/JAN could have sparked a Market beating return
which drew more money to the instrument.
I do not have the energy to break it down (if possible) further.

Bottom Line:
Funds do differ by their makeup and THAT is discretion.
But I still see 500K shares as not "owned" by a small group even
of Invesco's valued clients.
It certainly is not the same as Berkshire taking a stake.

Flakes....
One question only

Is it "retail" participants in the Growth Fund
or
Is the Growth Fund for Invesco principals and Wealth clients?

I'm certain some guppies on this MB would be pleased there is a way to be a Whale.

Not luck... it was strategic to go to EMA first... to avoid the BP-compromised FDA. The agency cleaning will result in improvements down the road.

Once RFK sees the approval of blarcamesine, it will have no problem progressing through the restored FDA.

Gives some cover for others to follow.
The peer reviewed article plus EMA submission creates a good rationale for increased institutional buying.

The FDA comes under fire her for the handling of Biogen mAb approval. But, the FDA ran a process where they emerged with a "do not approve" recommendation. Then, the top dog was almost certainly told by the political head to approve the mAb. So, basically, the FDA ran perfectly until it got to the political level.

It is true that on the food side they are be pretty shoddy. For example, I was working with a company that shall remain nameless that is completely out of control and in violation of a massive number of CFRs but the FDA inspector just comes in for an hour, looks through a window at the plant floor, does zero digging and leaves. I was pretty shocked by this because there is zero incentive for this company to adhere to food quality standards if the FDA isn't even going to pretend that it cares. To be fair, a rabbi and an imam came in and certified the facility as being kosher and halal and pig guts are used extensively (but the ocmpany pays the religious guys money so that makes it OK.)

On the pharma side, there is occasionally a dud but most are sharp and care.

First I consider Investco a "Tute", so that answers that question.

As to the exact nature of how they are holding those shares, your guess is as good as mine. To me is doesn't matter all that much because it is an increase in holdings by an insty, for whatever reason.

I get your concern since if it is a new index fund, it is not a discretionary choice and therefore doesn't represent an opinion on the company's prospects.
However, if it is an ETF it could well be a discretionary choice which would represent an opinion of the company's prospects. It also could be in a managed fund or account which would clearly be a positive opinion of the company's prospects.

The total number of companies holding AVXL shares increased considerably as did the number of shares held. That, to me, is the important take away. It appears to be the start of a trend. My opinion is there is an increasing awareness of AVXL in the medical community and the general market.

Anavex fell into a bit of luck by going with the EMA first instead of the FDA for blarcamesine approval for Alzheimer treatment.

overthinking it, Lakes
Invesco is the Tute or Whale
they are a growth fund manager primarily
The increase this quarter was HUGE 590K shares on a previous amount of 25K = 615K shares.

Do you understand that the article you were commenting on ("biased sources") is not the Aduhelm event, but FDA firings happening in the past few days?

Are you able to answer WHERE the shares are held?

@ roughly 0.10% of most of their holdings, it doesn't take a very large
product (or two) to allocate the increase.
And that does not include deposits to existing Funds requiring purchases.
Then again it is INVESCO to which I refer.
.
I am not interested in auditing all the available holdings reports, but
without KNOWING where the money came from.....

You are spitting into the wind. The basic claim that the increase is
a "Tute" verifying positivity is lets just say FAR from reliable.

First Off....Are you assuming that the increase in Invesco holdings
is by a Whale (company insider or otherwise)?
IMHO that would not be a valid assumption.

It is in Fintel Flakes, but none that I challenge can identify
HOW the shares are held within the numerous offerings of Invesco.
So is it a new ETF?
Is it additions to still active products?
Is it a new position for a Wealth client?

Seems to me THAT should matter.