Anavex Life Sciences Corporation (AVXL) Options

vg_future, Nice find. - This would apply to Rett Syndrome, Fragile X, Infantile spasms, Angelman Syndrome, Frontotemporal Dementia, Schizophrenia. Would also make sense to bring in Alzheimer's Disease, Dementia and as you stated. imo GLTU

Some Arab whales in Abu Dhabi UAE may be looking to diverse some of that excessive oil money for growth; and not affected by tariffs.

Sunday April 20 8:30 am Dr.Sabbagh

Khalifa University, Abu Dhabi, UAE ..."Oral Blarcamesine Novel Mechanism for Alzheimer Disease: Autophagy Restoration through Upstream SIGMAR1 Activation Clinical Efficacy Phase IIb/III Trial"

boi568, yes, understood. He is talking about super rare diseases in this context, but I am thinking about the flexibilities/provisions that they might offer for other diseases provided there is enough proof of efficacy and more importantly a BIG and unmet need.

-vg_future

If you listen carefully, he's suggesting skipping a trial and approving on only a "plausible" MOA when a clinical trial isn't "feasible," e.g., it is a super rare serious disease. I don't think that applies here.

My concern is the restructuring of a science based organization is being done by someone with no legitimate scientific background while at the same time removing highly qualified leaders with no apparent justification based on performance.
Will the FDA remain the world recognized leader for drug approval when it has clearly become a political toy?

I recall the analyst at the Leerink conference asked Missling why he ran two adult Rett trials over years using different dosages instead of one and he never got a clear answer. It never made sense to me. The bow out of Cantor subsequent to the PD trial was concerning as well. it could have been tthe backing away from financing. Wall street is ruthless and is in bed with big pharma and will play hard ball if they have an axe to grind. The back door financing is all they need to put the screws to AVXL. They would never get a fair shake in the US.
You have been right about the timing of a partnership. What are your current thoughts?

I have lived through restructuring in large organizations multiple times. No matter how well it was planned, initially productivity suffered.
People are moving into new responsibilities, new reporting structures are in place which people have to get used to, new work flow processes are being developed and optimized.

The end result can be an increase in productivity over time or not depending on how well the new organization functions.
Initially, productivity goes down.

We won't know the final impact of the FDA restructuring for a while.

He has been talking about a PD trial for several years, sometimes even giving dates -- on May 9 2024 he stated "Regarding Parkinson’s disease, initiation of an ANAVEX2-73 Phase 2b/3 six-month trial is expected in the second half of 2024." Why should his more recent statement be any different. He has had every opportunity to dicuss with the FDA x several years.

I asked Grok to review the last 3 years of quarterly CC transcripts in regards to a PD trial

Please review anavex quarterly confernece call transcripts including quations/answers over last 3 years. Summarize by quarter, what they have said in reference to running a parkinson disease clinical trial


Below is a summary of Anavex Life Sciences’ quarterly conference call transcripts from the past three years (2022–2025) regarding their plans and updates for Parkinson’s disease (PD) clinical trials, specifically focusing on ANAVEX®2-73 (blarcamesine). The summaries are organized by fiscal quarter and year, based on available transcripts from sources such as Anavex’s website, Seeking Alpha, Yahoo Finance, Insider Monkey, and Investing.com. Each summary includes key statements, including relevant quotes from the calls, particularly from Dr. Christopher Missling, President and CEO, and addresses the status of PD clinical trials. Note that not all quarters explicitly mention PD trials, but I’ve included all relevant references found. If a quarter lacks specific PD trial discussion, it’s noted for completeness.
Fiscal 2022 (October 2021 – September 2022)
Q1 2022 (Ended December 31, 2021; Call on February 1, 2022)
No specific mention of PD clinical trials: The transcript does not explicitly discuss PD trials. The focus is on Alzheimer’s disease (AD) and Rett syndrome programs for ANAVEX®2-73. Anavex mentions general pipeline expansion using precision medicine but does not detail PD-specific plans.

Q2 2022 (Ended March 31, 2022; Call on May 10, 2022)
No specific mention of PD clinical trials: The transcript emphasizes AD and Rett syndrome trials, with no direct reference to PD trial plans. Anavex notes the completion of the Phase 2 PD dementia (PDD) study (ANAVEX®2-73-PDD-001) and ongoing open-label extension (OLE) but does not discuss new PD trials.

Q3 2022 (Ended June 30, 2022; Call on August 9, 2022)
PD Trial Updates: Anavex reports the last patient visit in the 48-week OLE of the Phase 2 PDD study (ANAVEX®2-73-PDD-001) occurred this quarter, with data expected by year-end 2022. They plan to meet with the FDA to discuss the ANAVEX®2-73 PD program, including a pivotal Phase 3 study, and initiate an imaging-focused PD study sponsored by The Michael J. Fox Foundation (MJFF).
Quote (Christopher Missling): “So we believe that we have enough evidence of moving forward in a study in Parkinson’s disease, in a pivotal study, because of the data from our Parkinson’s Disease Dementia Phase 2 study in 132 patients’ placebo-controlled study.”

Context: The MJFF-funded study will use PET imaging to measure sigma-1 receptor engagement in PD patients, supporting ANAVEX®2-73’s mechanism of action. The planned pivotal Phase 3 study indicates confidence in advancing ANAVEX®2-73 for PD based on Phase 2 PDD results.

Q4 2022 (Ended September 30, 2022; Call on November 28, 2022)
PD Trial Plans: Anavex reiterates plans to meet with the FDA to discuss the ANAVEX®2-73 PD program, aiming for a pivotal Phase 3 study. They confirm the MJFF-sponsored imaging-focused PD trial and note preliminary PDD OLE data showing clinical improvements.
Quote (Christopher Missling): “So there is a possibility that the next study that you conduct in Parkinson’s disease will be a pivotal study based on your discussion with the FDA? … We are aiming for that. We have very strong evidence from the PDD study that the effect on MDS-UPDRS, which is the main primary endpoint of this indication has been very favorable with ANAVEX 2-73. So the plan would be to make sure we are able to move forward as quickly as possible. That would mean to aim for a Phase 3.”

Context: The MDS-UPDRS (Movement Disorder Society-Unified Parkinson’s Disease Rating Scale) improvement in the PDD study supports the rationale for a Phase 3 trial. The imaging study will further validate ANAVEX®2-73’s target engagement.

Fiscal 2023 (October 2022 – September 2023)
Q1 2023 (Ended December 31, 2022; Call on February 7, 2023)
PD Trial Updates: Anavex plans to announce data from the 48-week OLE of the Phase 2 PDD study. They confirm the MJFF-sponsored imaging-focused PD study and express intent to initiate a pivotal Phase 3 trial pending FDA discussions.
Quote (Christopher Missling): “In Parkinson’s disease Dementia, we are planning to announce the data from the 48-week open-label extension of the previously successfully completed Phase 2 study. … Further, pipeline expansion of the Anavex platform using gene biomarkers of response applying precision medicine of neurological disorders is expected, including planned initiation of an ANAVEX 2-73 imaging-focused Parkinson disease clinical study sponsored by the Michael J. Fox Foundation.”

Context: The OLE data is expected to reinforce Phase 2 findings, and the MJFF study will use PET imaging to assess ANAVEX®2-73’s brain penetration in PD patients.

Q2 2023 (Ended March 31, 2023; Call on May 9, 2023)
PD Trial Updates: Anavex reports preliminary 48-week OLE data from the Phase 2 PDD study, noting improved clinical symptoms under ANAVEX®2-73 treatment, contrasting with symptom worsening during the off-drug period. A new PD trial in Australia is mentioned for later in 2023.
Quote (Christopher Missling): “It is encouraging that the patients’ clinical symptoms consistently improved longitudinally over time during the extension phase under active ANAVEX®2-73 treatment. … This data suggests ANAVEX®2-73’s potential capability to slow and potentially reverse the life altering symptoms of Parkinson’s disease, an urgent unmet global need.”

Context: The OLE data strengthens the case for ANAVEX®2-73’s disease-modifying potential. The Australian trial (not detailed in the transcript) is likely the MJFF-funded imaging study or a precursor to a larger trial.

Q3 2023 (Ended June 30, 2023; Call on August 8, 2023)
No specific mention of PD clinical trials: The transcript focuses on AD, Rett syndrome, and Fragile X syndrome. While ANAVEX®2-73’s PD program is part of the pipeline, no new trial updates or FDA discussions are mentioned.

Q4 2023 (Ended September 30, 2023; Call on November 27, 2023)
No specific mention of PD clinical trials: The transcript emphasizes AD trial results and Rett syndrome. PD is referenced in the context of ANAVEX®2-73’s broad CNS applications, but no specific trial plans or updates are provided.

Fiscal 2024 (October 2023 – September 2024)
Q1 2024 (Ended December 31, 2023; Call on February 6, 2024)
No specific mention of PD clinical trials: The focus is on AD, schizophrenia (ANAVEX®3-71), and Rett syndrome. PD is not explicitly discussed, though ANAVEX®2-73’s prior PDD data is part of the company’s broader narrative.

Q2 2024 (Ended March 31, 2024; Call on May 9, 2024)
PD Trial Plans: Anavex announces plans to initiate a Phase 2b/3 six-month trial for ANAVEX®2-73 in PD in the second half of 2024.
Quote (Christopher Missling): “Regarding Parkinson’s disease, initiation of an ANAVEX2-73 Phase 2b/3 six-month trial is expected in the second half of 2024.”

Context: This is a significant update, indicating a new, larger trial beyond the PDD focus, likely building on Phase 2 PDD data and MJFF-funded studies. The trial’s scope (e.g., PD vs. PDD) is not detailed.

Q3 2024 (Ended June 30, 2024; Call on August 6, 2024)
No specific mention of PD clinical trials: The transcript highlights AD, Rett syndrome, and schizophrenia. The planned PD Phase 2b/3 trial from Q2 is not reiterated, possibly due to focus on other programs or delays in initiation.

Q4 2024 (Ended September 30, 2024; Call on December 23, 2024)
No specific mention of PD clinical trials: The transcript focuses on AD (EMA filing for blarcamesine), schizophrenia, and upcoming presentations. PD is referenced in the context of ANAVEX®2-73’s patent protection for neurodegenerative disorders, including PD, but no trial updates are provided.
Quote (Christopher Missling): “This new patent claims crystalline forms of the dihydrogen phosphate salt of Anavex two seventy three free base … for neuroprotection and treatment of neurodegenerative disorders, including Alzheimer disease, Parkinson disease, and other disorders.”

Context: The lack of PD trial discussion suggests the Phase 2b/3 trial planned for H2 2024 may not have started or is not a priority in this call.

Fiscal 2025 (October 2024 – September 2025)
Q1 2025 (Ended December 31, 2024; Call on February 12, 2025)
PD Trial Updates: Anavex expects updates on the PD program, including the planned Phase 2b/3 trial, and anticipates presenting detailed data at the AD/PD 2025 conference.
Quote (Christopher Missling): “Then further we will provide updates on the pipeline. We expect updates on the Parkinson’s disease program and other subsequent programs as well.”

Context: The mention of PD program updates suggests progress on the Phase 2b/3 trial or related studies (e.g., MJFF imaging study). The AD/PD conference presentation may include PDD OLE data or new trial plans.

Likely.

New FDA direction...looks positive for AVXL..experts?....I apologize if already posted

Found this on another bio message board.
🧬 Did the FDA just make gene editing investable overnight?

New commissioner just dropped a bomb:
Conditional approval based on a plausible mechanism. No RCTs. No Phase 3. Just strong biology + real-time monitoring.

What happens when CRISPR no longer needs a 5-year trial to… pic.twitter.com/UE3r2lRyGg— BowTiedBiotech 🧪🔬🧬 (@BowTiedBiotech) April 20, 2025

-vg_future

They can play a bigger role in late-stage trial design. But I suspect they have not been there holdup here. MJF is a possible factor in some way.

It's been a problem at the company. The PD readout (and Rett) was pre-Kun, who is providing more potential credibility with our subsequent readouts.

Not involved with the FDA.

Nobody could deliver if FDA staff were rendered completely and unexpectedly unavailable.

Future trials might best be served by future partners or licensees due to money, resources, available staffing and existing collaborative location services.

Much will be decided upon with the first to get some agreements with Anavex. From there the dominoes might line up in some order.

I'm guessing there's a lot of chatter backstage about many things.

Have you ever been sat in on guidance meetings with the FDA, boi?

Could well be. Still, PD pump followed the exact same pattern: claim a very short term material development and then fail to deliver. No one is falling for the puffery any longer - and this puffery is part of the reason, IMO, that no major IB covers Anavex.

There is certainly one possibility to believe that the FDA have not given any feedback on any PD trial design from Anavex, which is that the company hasn't put one to the FDA to comment on.

The only explanation I have for your Rett report is that Missling was very soon after overruled on that decision -- which was a reasonable thing for the Board to do. I can make no other sense of a statement that was immediately proven wrong, since even a lie would have to serve a purpose.

There's no reason to believe that the FDA has given its final feedback on the PD trial design.

We have no way of knowing what is real and what is puffery. We can only see regulatory actions, legal actions and agreements, and published data and analysis. What we know right now is 2-73 and 3-71 data and analysis as well as the fact that an MAA was submitted and accepted. Everything else is unknown. And, don't forget, CM uses the safe harbor statement as cover for lots of exciting stories that never happen. After he used it to tell us about the imminent Rett trial launch -describing the trial design in detail, and then abandoned the program literally within the next 2 days - I totally discounted anything he said at JPM Conference about PD trial news coming within 2 weeks of the conference (and obviously was right to assume nothing would happen.)

I think we have to invest based ONLY on what we absolutely know - and not at all based on what CM says. What we know is really good right now.

I don't think turmoil at the FDA would slow down a trial start. It would slow down approvals for sure.

The circumstances here indicate that Missling wants the PD trial initiated.

Make Anavex Great Again seems more fitting and appropriate over so far imaginary explanations.

What is stopping the PD trial from being initiated in Australia, Europe and all sort of other non FDA countries?

Have you got a great explanation for the how many years old mystery rare disease trial naming and initiation?

All business decisions are fluid, until executed. Make plans, but understand they change more often than not.

He doesn't go silent when he has been specific and short term -- except for this time. And why is that? Because the FDA is now a black hole for new trials.

Make Clinical Trials Great Again.

Notice how Missling has since gone dead silent on the PD trial, after it was supposed to be imminent.

What I noticed in the several years I have owned AVXL is that NOTHING Missling says in the way of guidance to shareholders is imminent. You act like that is a new discovery you have just made. I could easily list ten things that Missling has gone silent on.

LOL

Notice how Missling has since gone dead silent on the PD trial, after it was supposed to be imminent. At this point he doesn't have a clue when it might start.

Thanks, DOGE.

the obvious explanation has been the chaos at the FDA, which is consistent with the WSJ report.

There is nothing "obvious" that comes from only a couple of anecdotal stories put together by the Wall Street Journal. What is obvious is that the U.S. must cut its spending across all areas to avoid bankruptcy. The FDA, like all the three letter agencies, is a bloated organization needing reform and dramatic downsizing as is made evident each and every day by the DOGE initiative. There is not even a hint of "chaos" at the FDA. Lefty talking points are cheap so they are abundant. The focus on this board is on Blarcamesine approval in Europe for AD. All the other "concerns" that people like you like to focus on are nothing but daily routine propaganda.

Well if that's you only comment....

I can't help but to take this opportunity to recall how wrong you were about the Rett EXCELLENCE outcome.

But your comment has no relevance since those two trials involve two distinct indications among many other differences. That's like saying Al Copeland couldn't some up with a commercially successful fried chicken recipe because he failed in his early attempts. But then emerged Popeyes!

Missling has been pretty reliable when he announces a very near term deadline in relatively specific terms. This is not surprising, since something planned for the very near future is unlikely to be disrupted. However, his near term deadline for initiating the PD trial has been blown, and the obvious explanation has been the chaos at the FDA, which is consistent with the WSJ report.

I refer you on this follow-on non sequitur post to my reply earlier today to your previous post.

it is likely that Anavex's PD trial has been delayed by the cuts to the FDA's staff.

Most likely wrong. AVXL has been delaying another PD trial for many years. It has nothing to do with the current administration. Missling must get Blarcamesine approved in Europe before starting additional trials as its cash position must be closely guarded.

Thank you on the lecture on placebo controlled trials -- which of course I am familiar with and was not at all the point.

The debate here has been, also before you joined the MB, whether DPZ hinders the full effect of A2-73 given that both molecules have affinity to S1R with DPZ in fact having the highest affinity of the two:

Aspect | Donepezil | Anavex2-73
s1R affinity | High (14.6 nM) | Moderate (860 nM)
ROS suppression under Aß1–42 | Moderate | Minimal
Evidence of interference | ❌ None reported | ❌ None reported
Potential receptor competition | ⚠️ Possible | ⚠️ Possible
There is no evidence of interference between the two molecules both binding at some site to S1R. The word reported is important because none reported is not the same as none existing.

I referenced and quoted the Nino Goguadze et. al. paper because it dives deep into Sigma-1 Receptor agonists incl. DPZ and A2-73 and their relative effect on various biological / biochemical effects modulate by the compounds.

The backdrop to that I also posted, since Anavex have a patent on AnavexPlus combining A2-73 with DPZ claiming "The combined therapeutic, called ANAVEX PLUS, produced up to 80% greater reversal of memory loss in Alzheimer’s disease models versus when the drugs were used individually." - quite an enormous different to the molecules administered separately - I think you would agree?

Since then Anavex starting with their P2a results have shown that concomitant administration of A2-73 with DPZ makes no significant difference. PW seem to think differently, probably looking just at the graphics below ignoring the text, that specifically says why this data is not deemed significant.



My contention is simply that neither outcomes have been established yet or at least not communicated with the required subgroup analysis results. I have also said that in a Bayesian logic sense the most likely is no significant difference to A2-73 response whether with or without concomitant DPZ - we just don't know for sure. It is however clear to me that CHMP would want this substantiated and perhaps it has been with the data package summitted by Anavex as part of the MAA filing.

I agree with you and also expect that Anavex with Ariana must have spent significant efforts to KEM analyse multi-factor one and two-way correlations to things like DPZ and for example COL24A1 subgroups. This analysis must take into account how the 70%/30% SOC vs. no SOC is distributed between the A2-73 and placebo arms along with the subgroup complexities of multiple other factors. The n=21 of P2a peer review clearly could not and did not ultimately conclude how this would look in a larger RTC such as the one we sort of have (no dose / effect comparison arm) with the P2b/3 RCT data.

I had personally hoped to see all this analysis from the P2a paper in the P2b/3 paper, but alas none of that was present. To me that would been far more valuable than the 58 names of scientists listed that many here seem in awe of.

These questions are not eliminated simply by a placebo controlled trial design.

I do own $AVXL shares, which happens to be why I am interested in things like this and share it - you know like a biotech investor might be for some higher chance of managing a succesful portfolio of pre-revenue spec. biotech stock.

But its ok if you want to treat my post as FUD - Sorry I can't help but to take this opportunity to recall how wrong you were about the Rett EXCELLENCE outcome. You won't find me joining the cheering WGT type choir on any of my biotech investments until the bear is shot and dead with the money for the skin in my broker account.

As I have suggested, and this Wall Street Journal article supports, it is likely that Anavex's PD trial has been delayed by the cuts to the FDA's staff.

Make Clinical Trials Great Again.

Applying to the EMA first is looking better every day.
If it passes I will be able to afford to go to Europe to get a prescription.

Just reposting so it can continue ascending…

New research continues to shift focus away from the amyloid hypothesis, highlighting mitochondrial dysfunction, DNA damage, and impaired autophagy as key drivers of Alzheimer’s pathogenesis. This week, new data published in the International Journal of Molecular Sciences and insightful commentary in Nature further support this evolving perspective.

https://www.linkedin.com/posts/jesse-silveira-1a366927b_alzheimer-mitochondrial-lysosomal-activity-7319485407912419328-Y48z?utm_source=social_share_send&utm_medium=member_desktop_web&rcm=ACoAAERDW8sBlyrV0QeJz43ptIXjxOLSEnCDyqA

Drug Development Is Slowing Down After Cuts at the FDA.
https://www.wsj.com/health/healthcare/drug-development-is-slowing-down-after-cuts-at-the-fda-f22369cf?st=KdT1Ef&reflink=desktopwebshare_permalink

Happy 420!

Happy 420!

One more thought about the sigma1 receptor impact of DZP: many, many molecules can impact any given receptor or set of receptors. For example, anti-TNF mabs all target TNF...and the three most popular ones each have a different molecular structure and have drastically different efficacy and safety profiles. There are 5-10 million possible configurations that companies could have chosen from, had they been able to identify them. Humira, Remicade, and Enbrel are all approved drugs that a purpose-built for TNF - and Humira is by far the safest and most efficacious (by ~10x.)

So, DZP is a GPCR that is meant to target AChE receptors - and it has an impact on S1r, too. It is not designed for that - not optimized for S1r - but it has an effect. But so minimal relative to 2-73 and 3-71 - which were selected primarily because of their specificity for S1r - that it doesn't really move the needle. DZP having a small impact on S1r is interesting but non-material.

Happy Easter!!!

Good luck and GOD bless,

glad that we can celebrate Easter on the same day this year....normally my Greek friends always have a different date!

Happy Easter

Steady T
Happy Easter !

If the price drops after you are put the stock, then you carry a loss...the difference between the strike price minus the premium received for the option establishes your cost basis, so from there you are up or down. If the price goes UP you are good.

Really!

With falsified data, everyone can make it look good until discovery!

But in the end of the day; a pig is still a pig no matter how much lipstick you put on it, even I could see that and stayed far away from it.

We got 3-4 self-proclaimed experts on here that likes to sow a bit of doubt into people, I am not sure what their movies are?

Wrong!!! He did not answer my question because he liked SAVA and dislikes AVXL

GOD bless and have a wonderful Easter

He didn't answer your question because it is a troll question.

With the caveat, that if the share price drops below the put price you wind up buying the shares at higher than the market price.

I have been on the wrong end of that with AVXL on one occasion.

Christos anesti! Alithos anesti!
Easter blessings to all!