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Why in the world do they have to wait for the data to be published? How about just going to the regulatory agencies with the data and say we have the best data ever in the world with no real side effects. Waiting for months upon months without getting to the fda is crazy.
I’m still not convinced that having Ma’s in the role is going to be doing much for us unless she is responsible for negotiating the acquisition. From a day-to-day perspective, I do not believe that Missling is giving up any control, and that things will proceed business as usual for the foreseeable future. Remember, Missling has always stated that they will become big Pharma and partner Alzheimer’s, and Parkinson’s and keep the rare disease business for themselves. so I don’t believe Ma’s is in position for anything to happen in the short term maybe five years from now yes.
Yes, but there is an in between. We shouldn’t be at 7 1/2 certainly but maybe closer to 15 to 20 in this bad market environment. So yes, I think some of it has to be blamed on Dr. Missling since shareholder value is one of his most important roles.
Now, as far as Jiung Ma goes, I remember looking at her résumé when she first came on board, and I thought , what an impressive person that is , and I still believe that. But let’s not think that this is an independent chairman of the board.
She was brought in by Missling a few years ago, which tells me she is loyal to him. I’m sure he has known her in the past and brought her in for her qualifications, and maybe a friendship they had. Nothing wrong with that, but where do her allegiances lie and that is to him. I think he will continue to get as many options as he wants within reason and she will sign off on them. The only way Dr. Missling leaves this company is by an acquisition.
Or maybe they bump Missling up to chairman and bring on a big hitter as ceo
Could it be that they have a partnership ready to announce and part of the deal there is a requirement for a truly independent chairman. Maybe an announcement at the shareholders meetings where everyone can meet the new chairman and announce the partnership.
This is bizarre. Any thoughts as to why this would be taking place now.
Anavex Life Sciences Corp.
HISTORY TOOLS
CIK: 1314052 Ticker: AVXL
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, DC
Date of Report (Date of earliest event reported): April 11, 2023
ANAVEX LIFE SCIENCES CORP.
(Exact name of registrant as specified in its charter)
Nevada 001-37606 98-0608404
(State or other jurisdiction (Commission (IRS Employer
of incorporation) File Number) Identification No.)
630 5th Avenue
20th Floor
New York, NY 10111
Emerging growth company ?
Item 5.03 Amendments to Articles of Incorporation or Bylaws; Change in Fiscal Year.
On April 11, 2023, the Board of Directors (the “Board”) of Anavex Life Sciences Corp., a Nevada corporation (the “Company”), determined that it was in the best interests of the Company and its stockholders to amend and restate the Company’s Bylaws, and approved and adopted the Amended and Restated Bylaws of the Company (the “Amended and Restated Bylaws”). The Board amended the Company’s Bylaws to require that the position of Chairman of the Board of Directors must be filled by an independent director and cannot be held by the Chief Executive Officer of the Company. The Amended and Restated Bylaws became effective immediately upon their adoption.
The foregoing summary of the Amended and Restated Bylaws does not purport to be a complete statement of the terms of such document and is qualified in its entirety by reference to the full text the Amended and Restated Bylaws, a copy of which is filed herewith as Exhibit 3.1 to this Current Report on Form 8-K.
Item 9.01. Financial Statements and Exhibits.
Exhibit No.
Description
Exhibit 3.1 Amended and Restated Bylaws
Exhibit 104 Cover Page Interactive Data File
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
ANAVEX LIFE SCIENCES CORP.
By:
/s/ Christopher Missling
Name: Christopher Missling, PhD
Title: Chief Executive Officer
Any more great news like this and we will be right back to $5.
Question for the board. Does the company necessarily have to announce that they started a trial. For example the "undisclosed" trial. Could that be going on for the last 6 months and we don't know it?? Maybe for competitive reasons.
Nidan, your last email has what looks like something that you copied and pasted from somewhere. Just wondering where that came from. Do you have a link? The link that you posted just came from the MJFF announcement about the presentation. Below is the part I am looking for a link on. Not sure where that info is coming from. Thanks.
The MJFF has strong leadership skills and a positive following WW. They impress as an organization that is focused , using multiple mechanisms to be a visible and effective focal point for solution, not just "LOOK AT ME", but serious management program continuity.
Other such rare disease effort can be seen and heard including RETT- RSD, Autism and a long list serious CNS RARE diseases WW. With continued support from AVXL Australia team and other selected WW RARE CNS DISEASE then not only can a lot of visibility and focus be raised By Dr.M. and the Australian team CNS Rare disease organizations WW might be able to help focus the CNS RARE Diseases in an AVXL-Australian coordinated and effective manner.
If all CNS RARE diseases efforts WW had a collective -effective- focused science effort to collaborate the science work around the universal CNS AVXL S1R collaborative effort (including required ancillary research-trials ) effort then a massive WIN_WIN CAN BE a CNS diseases WW vision based on AVXL core science can be seen. IMO, Australia is dispositioned with AVXL and A WW network to make it happen.
We recognize that the TERM..."RARE CNS DISEASE"' can often be read as ...get in line and good luck.
BUT, if The PD research program is seen as a model ...(how to do...CNS RARE DISEASE pathway ) , then anything is possible. BTW, this may have been Dr.'M's plan all along which can now be seen to take shape using PDD as the core example.
So, an expanded AVXL CNS RARE Diseases program may now have hope and resources to move forward WW. WOW.
Is this us.
https://www.michaeljfox.org/webinar/major-breakthrough-parkinsons-research-mjff
I hope so by the title.
Lots of large blocks going off at these low levels with increased volume as well. I hope it some big funds are doing some buying this morning. I see three blocks one at 35,000 one at 25,000 aand one at 20,000 shares.
You are so full of it. Lane said no such thing. He ended his article stating that Anavex is still a good opportunity.
So do you think the hiring of all these higher level people are part of the scheme to pull one over the retail shareholders eyes? And also the 37% of institutional shareholders that are out there as well? Yes, they have been unbelievably quiet for the last four months and yes, they’ve missed many many deadlines, but there’s still seems to be improvement over the current standard of care for Alzheimer’s, Parkinson’s, and Rett syndrome that our drug is doing better than anything else there.
Now how in the world is that possible??? The Top Line Headline was " ANAVEX®2–73 (Blarcamesine) Phase 2B/3 Study Met Primary and Key Secondary Endpoints, Showing Statistically Significant Reduction of Clinical Decline in Global Clinical Study of Patients With Early Alzheimer’s Disease "
How could they not have met the COMBINED ENDPOINTS. If the low 30mg dose did not meet the goal then the 50mg must have blown it away the primary endpoints. If they both did not meet the end points then they could not say that they met the endpoints And it would not make any sense if the 30mg did better than the 50mg. So tell me how they get to announce that they hit the endpoints and you come here saying that they didn't.
The Primary endpoints are as follows:
ADAS-Cog (Alzheimer Disease Assessment Scale-Cognition) [ Time Frame: 48 weeks ]
Reduction in cognitive decline assessed from baseline over 48 weeks with ANAVEX2-73 compared to placebo using the Alzheimer Disease Assessment Scale-Cognition (ADAS-Cog)
ADCS-ADL (Activities of Daily Living) [ Time Frame: 48 weeks ]
Reduction in decline of the ability to perform daily activities assessed from baseline over 48 weeks with ANAVEX2-73 compared to placebo using the Activities of Daily Living Scale (ADCS-ADL).
Now maybe they didn't hit all the Secondary like they stated. But some of them they hit.
Secondary Endpoints:
CDR-SB (Clinical Dementia Rating Scale Sum of Boxes) [ Time Frame: 48 weeks ]
Reduction in cognitive decline assessed from baseline over 48 weeks with ANAVEX2-73 compared with placebo using the Clinical Dementia Rating Scale Sum of Boxes (CDR-SB)
Number of participants with treatment-related adverse events as assessed by CTCAE v4.03 [ Time Frame: 48 weeks ]
Assess the safety and tolerability of ANAVEX2-73 compared to placebo
Also remember, Alz approval is a low bar. Biogen was horrible for patients. At least we see some improvement with our drug.
Strategy to ponder. I have 25K shares at avg. $15pps in one of my accounts. That is an investment of $375K. What if I sell all shares at say $8 freeing up $225K and taking a loss of $175K for tax purposes. Then I go out and buy 300 of the Jan. 2025 $10 Strike for $4 effectively setting a pps of $14 for these potential shares and it will cost me $120K to make this trade. It also lowers my avg. cost to $14. It gives me 653 days for AVXL to either go to $50 -$100 or a bust. I would like to think that within a year we will know if we have a $100 stock or a POS. It also frees up $80K of cash.
Anyone have any thoughts on this strategy ??
Another new position being recruited. Looks like a big one coming on board soon. Head of Research And Development
https://www.linkedin.com/jobs/view/3551138569/?trackingId=X5ZoovVlRkhdsNFkiFj01w%3D%3D&refId=b578ab51-3bdd-4a92-b053-bd71d5b7c7d8&midToken=AQFez-sDqmAQMg&midSig=3SYwyFBq1OrqI1&trk=eml-email_job_alert_digest_01-job_card-0-jobcard_body&trkEmail=eml-email_job_alert_digest_01-job_card-0-jobcard_body-null-be6bl~lg3xdenx~59-null-null&eid=be6bl-lg3xdenx-59
If you go to clinical trials web site https://clinicaltrials.gov/ct2/results?cond=&term=anavex&cntry=&state=&city=&dist= it will show you that we currently have just the one Rett pediatrice trial running except the Alz OLE trial. No PDD, no Parkinson's, no Fragile X, no imaging focused Parkinson's trial, no undisclosed disease, no P3 or P4 Alz trial.
Most of this was supposed to start by the end of the year per Missling.
Did we set ourselves up for a buyout with the data that we have to date or will we get some movement on the start of all of this soon.
Well I've been telling everyone for the last several weeks that we won't stop going down until they get their fill of cheap shares and todays FORM 4's prove that out. Dr. Missling now owns 7,579M shares or 8.8%. Not sure if that includes any of the 500K that they laid out for his in the for of a bonus for getting the Alz and Rett trials completed.
Everyone got their shares at $8.57. Not bad. Little piggy's at the trough. Can we go up now please or are forced with more pain from their lack of transparency?
BTW, Cummings was not about to say a word that would make the stock go up until they announced the share price.
Anyone want to make a bet that the next shoe to drop is that Missling will be selling some shares to really screw retail instead of buying some on the open market? Only joking but I would not be surprised. Either we have a partnership coming and they are just in quiet mode or more probably word is getting out that a new Alz P3 will be done and the market is not liking it.
Well if you think about it the $140M we have in the bank is not enough which is why they have the $150M as backup. They will need $40M to $60M for Alz, $20M - $30M for PD, $10M to commercialize Rett, $10M ish for Autism, $10M for the undisclosed trial. To run the company for the next 2 years along with adding employees maybe another $20M - $40M. That pretty much eats up the $140M. Might be on the low side a bit.
The ideal path forward at this point in time would be to partner, go grab $250M - $500M up front for someone to get control of the P3 or P4 Alz trial and the PD trial and we handle the rest. The stock price would go wild and give us some validation. I am not longer in the camp that we get a billion for a partnership. We have not shown enough to warrant that level of commitment.
For those who say they will have rev for Rett to help offset , that is true but that will take over a year to ramp up assuming they get approval by the end of the first quarter of next year and they will have to spend a lot of money prior to they actual selling of the product.
Hey George. This is all fine and dandy but there are no current trials started yet or planned. So I guess what I’m saying is save the pump for something that actually has a plan attached to it. And by the way, the company hasn’t been able to get anything over the goal line yet let alone provide good clean irrefutable data. Maybe whoever buys us can get these other things going. Also why would any of the trial participants have Covid??? Don’t we fix that?? :)
I would think that if they were going to have to do a P3 or P4 trial that they would have their partner compete it which would make everyone happy. Fingers crossed that our path leads to this.
Well the counter to that and if you really want a higher stock price to counter the AF cabal you can either do a stock deal with one of the big players on Wall Street or a partnership on something or do a small share buy back or have the execs buy some shares on the open market or have a few biotech institutional investors buy some shares or hire a big name executive or all the above instead of burying your head in the sand and not fighting back.
I don’t think they really care about a higher share price today. They know what they have and they have plenty of cash to get them through the next year and get Rett on the market. They will also get their next round of stock options at cheaper prices. So why do anything??? They are not motivated for higher prices like we are. We make buying decisions based based on what the company tells us. Like having all these milestones completed by EOY. So we buy stock based on what the company tells us hoping the results are great like they say. Then they are off the mark by 6-12 months and your investment falls apart because the ceo has no control on timing. So now your great investment falls apart because you added more shares based on ceo guidance. I’m pissed off because I have dead money for the last year thanks to the company not hitting its own guidance, ever. This is my bad for continuing to believe. Now I’m an angry shareholder when I used to be an 8 year happy and patient shareholder. It is much easier to be patient when the stock was sitting between 15-20.
People are pissed off because he keeps everything secret and shares very little. Why not tell everyone that the ole is having trouble enrolling or staying enrolled due to Covid. Every business was having issues. This was just an ole, why hide for over a year. Make what you can out of the data and move on. Keeping the mystery alive about the ole data then coming out to tell us that there were only 20 people in it and Covid was the reason is just wrong. If you remember correctly they downplayed the Covid impact and they told us that the ole trials were over 90% enrolled. What they did was not right. I remain a very large shareholder because of the technology. I was a very big supporter of Dr Missling up until a few months ago. I am encouraged by the new hires but remain cautious because of his constantly promising a lot but delivering less approach to the role of ceo. Promise a lot and deliver even more is the way. How does he get this so wrong?? To me when you constantly promise to have six milestones completed by end of year and you accomplish only one and three months later only a second one you are doing something wrong. They should have been completed in November or early December. Remember promise a lot….These are self inflicted wounds, all controllable. Get your act together Dr. Missling.
Well if that’s true that Missling a ceo, needs Jin to make sure that he is truthful with the FDA is worrisome. It makes you wonder what kind of bs he has been telling them and based on his lack of candor with his shareholders he might be guilty. Guilty of skewing his data, not giving all the facts etc. He needs better people around him and the last few hires are a great start. These people need to be strong and have a big voice. We need new people to present their material. People that are huge names in the industry. If we have the potential to be selling tens of billions of dollars per year we deserve to have the best and the brightest on board. Are they? If not why not? Do we have the best ceo? If not are we hiring people to surround him with the skills that he does not currently possess? Ie. a great Sr. VP of Sales and Marketing? Take Jin for example. A great hire with skills Missling lacks. If we truly are on the verge of greatness we should see more hires of greatness.
So I don't know if it was ever mentioned during any discussions on the PDD OLE but from what I can remember Missling has always stated that greater than 90% of trial participants has moved onto the OLE with Alz and Rett. Anyone remember if he said the same for PDD? I hope not.
Great work as always mayo. I appreciate it the candor and I wish the company would be as transparent as you are. Thanks again.
Hi so?? I was just pointing out that he cannot possibly have the experience with the FDA and drug development in general to make his opinion something to base an investment decision on. Does he possess a skill set to understand and decipher the data that is being presented? Yes. But I would much rather take advice from the scientific community like a peer review or the medical community like a Harold Hample. In between these types of events I love his work.
I love mayo. Make no mistake about it. I like his analysis and his approach to logic. But mayo is 29 years old. He is not be all end all in biotech and I am sure he would agree. He is trying to interpret what the company is saying. We need to rely on the press release to get our information and to form our own decisions.
With this said why does the company always, and I mean always leave us wanting more?? We never get full data readouts. We always have questions that we cannot get answered? They always hide. Is this normal in biotech or is Anavex special? Are they special because they have a major home run in multiple huge indications? Or are they special because they are incompetent on the public facing side of the company?? Or both? Time will tell. Go to the shareholders meeting please.
Sorrry Red but I am not buying a partnership at this point in time. No one will partner without the P2/3 Alz trial full data set so any day for partnership I don't buy. Lets say it takes anotherr 60 days for the data to come out then it will take another 6 months to get a partnership completed. EOY at best for partnership. Also, as good as Mayo is he is not in the know on who Anavex is speaking with or when it might happen. We are also waiting for Alz OLE data for P2. If the PDD OLE data is any indication, we might have a ways to go for any more OLE data. The P2/3 Alz full data set is something we need badly. If they release piecemeal data with this as well we are in trouble. At some point in time we need transparency and complete data.
The bigger questions are, why are we constantly getting hammered when we release any news. I don't think the company is being open with regards to overall strategy, data, financing strategy, etc . Mixed signals at best but I do like the more recent hires they have made which doesn't jive with the all the other screw ups like the Rett and Alz releases last year.
He was also clear that we will have PDD ole results in December along with Alzheimer’s ole and new trial started.
So what you were saying is that Dr. Missling was lying when he said we would have the PDD OLE data and the Alzheimer’s OLE data, and the new trial starts all before the end of the year. If you’re saying that everything hinges on rett. Why have all of that in the milestones chart for the end of last year to complete?
Not sure what you’re talking about. Stock options are priced the day that they are handed out, not some preset price. He could be waiting for all of the latest options he will receive from completing Rett trial, completing the Alzheimer’s trial and I believe the third was starting the new Rare Disease.
So what you are saying is that we need the full data set from the company for the Alzheimer’s p2/3 trial for us to reach fair value? If that is what you are suggesting then our ability to not reach fair value is truly based on the realization that the street does not trust Dr Missling when he says that we met all primary and secondary endpoints. If Biogen published the same press release that we did in early December they would have gone up tremendously. But since Wall Street has no history with Missling the company takes a hit for having a rookie ceo. Also lets not use the market down turn as a defense. If we had the right data the market would not care. We would be up. Maybe not to a $7B market cap but certainly $3-$5B.
OK bass I am with you 100%. We all know that we have the goods and that Anavex will deliver a drug that works much than Biogen and any other drug out there on the market. If we all know that then why doesn’t the stock price show it? Are you telling me that Adam Fierstein, and the whole short and distort crowd are more powerful than, the rest of Wall Street who should be able to take this thing to $100 price per share but they’re being held down because of Adam Fierstein and the short crowd. If we were Biogen we would be at $100 price per share. but we are being held down because of Adam Fierstein and the short crowd. !!! That doesn’t make sense.
I contend that even though we on this board believe it wall st doesn’t. Not yet. What will it take for them to jump on board and move the price to a fair value? Wait until they have their fair share of the available shares? Maybe up to 70% of outstanding shares. That would leave 13% for management and 17% for retail. Wait for the confirming data that we have been waiting to see for what seems like forever. Wait for approval? Partnership? Have Missling go on a world TV tour touting this historic moment?
So tell us bas, what will it take to reach fair value??
Looks like we have a new employee. https://www.linkedin.com/in/emma-smith-99a23226b/recent-activity/
Emma will be the new Human Resources Manager at Anavex Life Sciences.
This is how a baby biotech stock behaves when they have not had P3 data readouts. If you put our data in the hands of BIIB or AXSM they would have a market cap of $7-10B. Because the market respects them. In our hands the data and we the company are dog sxxx. We are at the price we are at because of Dr. Missling not doing the things that make wall st happy. Like doing deals with them. Like doing an ipo with them. He obviously knows what he has and maybe he doesn't need wall st to sell the company for $10B. But the stock price will languish until a partnership or buyout and personally I think that is a horrible way to run the company. For retail shareholders anyway.
Answer me this How come we did not go for approval with the adult Rett data? Why were we forced into the pediatric trial before we can go to any of the regulatory agencies for approval for the adult population? Maybe if we push back harder on the FDA and all the other regulatory agencies around the world we would have an approved product right now. Do we really know why the company took this path as a strategy? I don’t and I’ve been here for eight years. Do we know why we switched from Alzheimer’s being the all important indication, then moved to Rett and then back to Alzheimer’s, and now to something else Maybe a basket trial as some of speculated. We are putting our faith and Dr. Missling who has not brought a product to market before so he does not have the credibility with the FDA or Wall Street. He has not made Wall Street any money in the past. Why would Wall Street trust them when so many things seem to be a bit confusing to us. The confusing parts being the overall strategy, and of course the Alzheimer’s data and Rett data debacle that has taken place when he released data on both of these indications. That was not just a short attack that was confusion, and he tried to clear up that confusion, in subsequent meetings, which also didn’t go over very well. Yes, he is sticking to his guns and has not come out and retracted any data but certainly Wall Street does not believe him and if they did, the stock price would be above 30 right now. His failure to adequately communicate to Wall Street and the scientific community is why we are where we are. And what that does is it makes Wall Street wait for more data and we have no idea when that date is coming. We have been waiting eight years for the big release that’s going to drive this company forward. Who thought that was going to be last December with the Alzheimer’s data. I certainly did how many others? Who thought when we had spectacular news on adult Rett data we would’ve been to the promised land as well? I did I’m sure many others have also. Who thought when we came out with the phase 2 Parkinson’s dementia data we would’ve had a Parkinson’s dementia phase 3 trial completed by now. Who thought that we would’ve had the undisclosed indication trial that has been out there for over 12 months would’ve been started by now? At some point in time Dr. Missling needs to be held accountable and I think the more people that rise up and voice their concern that the company is not going in the right direction as far as properly communicating to the investment community the better off we will be. Why are we giving Dr. Missling a free pass? Why aren’t we acting as activists like some of the big guys you see on CNBC do. We are the ones that held this company together during the first six years of existence. It was not the institutions. It was all of us buying shares whenever we could because we believe. How come we don’t get a little respect back and get some of the information we’ve all been clamoring for. How come some of our biotech peers like AXSM are doing well in spite of the market. I know why? Wall St backing. Why didn't Dr. Missling do a deal with one of the big investment banks to get his $150M done instead of Lincoln Park? Imagine if he did a deal with Goldman Sachs or JP Morgan? They would be jump starting our stock price. Why does he hate Wall St. as much as they hate him? My advice is rise up and become an activist professionally. Go on the offensive and tell the company how you feel and what you expect. Maybe they’ll give us a tidbit of information if we all stick together. I have done this already myself, and would love to see more people jump on the bandwagon. I know several others have done so as well. It has been brought to my attention that maybe Dr. Missling will be filling the executive staff coffers with cheap shares soon. Will anyone be surprised to see this happen in the coming weeks? Sorry for the rant, and I am very very pro Anavex. I just want some action, NOW!! I don't want to see some produced video telling everyone how good our data is. I want to see us on CNBC, CNN, FOX, MSNBC telling the world what we did.
Here is what the real problem is. As you state we sit here and speculate on what the doctor is doing. We have been speculating what the doctor has been doing for eight years. We really don’t have a clue as to the overall strategy for this company. We all just sit around and speculate. Me personally I wish we had a bit more data as to the game plan. What is the doctor doing behind the scenes to help push this through. Have we had contact with the FTA? If so, what was their direction. Are they trying to get approval in Australia first? Was that the reason for his trip down there. Is he trying to push the data through the FDA first? We have been promised 0LE data for both alz and Parkinson’s disease Dementia for ever now. my biggest question and concern is why can’t shareholders understand more about the strategy. I don’t see how that is going to interfere with any overall strategy to keep our competitors at bay. Everything is too far down the path that even if the competition knew our strategy, they could not react to it. Why can’t we know that he wants the PDD, Alzheimer’s data, and Rett data all together to go to the FDA. Why not just say you’re waiting for that and we will have all that prepared in X amount of time. Then we will present that data to all regulatory agencies at the same time or will go to Australia first. Just give us something that helps us understand what they’re doing. I am pretty tired of hearing the statement When you find out why we did and why we did it. You will understand. I’m sure blackrock or state street does not have to sit here and worry about all these questions. I’m sure they have access to Missling and he gives them much more information.