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Which “Precision Medicine?”
Wall Street Week and Nova, on PBS
Thanks. Perhaps so.
Impact of new AVXL share sales.
Ok, Anavex is announcing that it intends to raise $150,000,000 by selling new, created AVXL shares. This, of course, will reduce the relative value of each existing, earlier Anavex share. More shares against which any sort of value must be divided, whether in eventual dividends, or any other calculation.
Pretty distressing, yes? I’ve got a few thousand AVXLs in my brokerage account. After Anavex collects it’s targeted $150 million dollars, what might that mean for the value of my shares. Let’s see. (Spreadsheets wonderfully allow these calculations.)
The first number to enter, at the top left cell, is the number of existing AVXL shares, in trade. My Schwab account says there are 75,710,000 of them right now. To get it’s $150 million new dollars, Anavex will increase the number of shares in trade. How many will that be?
In a new column I entered potential share prices for the new sales. In the first, top cell I entered $20. Next cell, $25, etc. These were the new share sales prices I punched in:
$20
$25
$30
$40
$50
$75
$100
$125
$150
$175
$200
Then, how many new shares, at each of these prices, would be sold (to yield $150 million)? These:
7,500,000
6,000,000
5,000,000
3,750,000
3,000,000
2,000,000
1,500,000
1,200,000
1,000,000
857,143
750,000
Lastly, what would be the percentage increase of total shares, at each of these sales prices:
9.91%
7.92%
6.60%
4.95%
3.96%
2.64%
1.98%
1.58%
1.32%
1.13%
0.99%
In summary, at the worst case (at a new shares sales price of around $20), there will be an approximate 10% increase in the number of Anavex shares in trade. If they can be sold at $200, the increase will be about 1% of new shares.
For my AVXL position, of little or no impact. I’ve only a few thousand shares. For Anavex CEO Dr. Missling? How many hundreds of thousands of shares does he own? Is he jeopardizing the value of his holdings by this proposed sale of $150 million worth of additional shares? I think he’s got it covered, that overall, both the company and its shareholders will eventually benefit.
Another Anavex Clinical Research Week Has Passed
Of course, no announcements or data from any of the three on-going clinical trials that will ultimately demonstrate blarcamesine's safety and efficacy for a) girls with Rett syndrome (this is not sexist; boys who inherit the disease’s genetic anomalies die before birth), b) people suffering from Parkinson’s disease dementia, and finally, c) a statistically sufficient number of people with Alzheimer’s disease.
No results data yet that we can see. But those data are continuing to accumulate, nonetheless. None of the three clinical trials have been halted; patients continue to be dosed with blarcamesine, and the clinical results of the drug continue to be accurately and precisely assessed. When each of the clinical studies are complete, and their therapeutic result data points are properly crunched (with detailed statistical analyses) the information will be made public; to be seen and considered by one and all.
First, with profound consideration of the clinical results, will be both the blarcamesine patients and their families and care givers; revealing whether or not the drug will continue to be available.
Next will be both medical science and investment news writers. These “smart people” will have to interpret for the general public just what the blarcamesine results might mean; whether or not they hold any promise.
Lastly (but quite importantly) will be us; those of us who have taken and hold AVXL equity positions. What we’ve been expecting for these many years will, finally, start to become reality.
Until then, everyone must just wait. Biochemical processes can’t be hastened by external mental hopes or imaginations. Blarcamesine-activated sigma-1 receptor proteins will function at their own pace.
The putative SAVA/AVXL share price linkage.
Why I don't day-trade.
Ok, around 10am this morning, after seeing a nice AVXL share price rise, considering what I've seen so often before, I made the claim, "Time for the day-traders to start selling off their trading positions. Will have a nice one-day profit."
Sure.
Then, of course, the share price continued right on up, from the 6% gain around 10 am on up to the gain of 9.41% at the close. Had I cashed in a few hundred of what would have been my "trading shares," I would have missed another 3% gain --- and if the share price continues to rise (very likely), I'd never be able use my 6% profit to allow me to take an expanded, new position.
I'm better off having just sat all day, watching the day's momentum move.
This confirms: I'm not, should not try to be, a day-trader. I'll let others play that game. I'll just watch them. My best wishes.
Stock Advisor Recommendations Now At Play
As always, a very informative posting, RedShoulder.
These are just the first investor advisory postings more accurately telling both the sound science of the Anavex drug, and how it will treat large numbers of people. There will be more and more of them.
I, too, use the Charles Schwab brokerage, and was delighted to see this headline on my Schwab screen this morning: --BTIG Starts Anavex Life Sciences at Buy with $35 Price Target.
I notice also that Schwab now posts a B investment grade on Anavex, meaning "Outperform." Formerly, none was posted (the Schwab grade scale: A, B, C, D, F).
The word (of the Anavex science) is finally getting out, being understood and applied to understandings of how it will work for the AVXL share price.
As I've contended before, the first giant, irrevocable thing that will propel the Anavex share price will the article in the New York Times, "New Drug Shows Promise for CNS Diseases." That should be right after the FDA approves blarcamesine for Rett syndrome; based upon all of the existing safety and efficacy data, that will surely happen.
For AVXL shareholders (and CNS disease patients), 2022 is going to be quite a year.
Basis for taking an AVXL position.
Interestingly, there are a number of divergent, otherwise unconnected reasons, I see, that equity buyers have or might decide to take an AVXL position.
1. The Investment Advisor Recommendation. In this case, a recommendation in some investor newsletter, blog, or webpage prompts an AVXL buy. The particular reasons the newsletter or investment advisor states are not as important as the recommendation itself. It comes from “someone who knows,” or has “a good record.” Good enough. “I’ll buy some of those.”
2. The FOMO (fear of missing out) Buy. In whatever way, an equity buyer discovers that, at least for the nonce, the AVXL share price is on a steep ascent. The person wants to catch that rise, so “buys low, to sell higher.” Few or no other data or information come into play.
3. The Day-Trading Play. It is noted that the AVXL share price tends, at times, to sharply ascend, then more slowly drop back to some “base price,” Day traders, expert in spotting and playing these moves, go in an out of AVXL positions, making a few percentage points of gains with each buy/sell trade pair.
4. The Technical Analysis (TA) Play. Those confident in TA see and act on various TA buy or sell signals. Trades are based solely on the AVXL or market TA charts and metrics; nothing else.
5. The Anavex Science and Potential Markets Play. AVXL positions taken with these criteria take into consideration the accuracy, validity, and potential applications of the existing, known ANAVEX science, as revealed in scholarly papers, informed postings, research, and corporate and institutional announcements; while also considering the potential markets for the ANAVEX drugs, once they might gain regulatory approval for sales and therapeutic uses.
Each of these will prompt varying time frames in which AVXL positions might be retained.
In Number 1, Investment Advisor Recommendation, positions may be held for some time, contingent on when the recommendations are to play out. Those are likely months or years.
In Number 2, the FOMO Buys, rather short term, for most. When the price ascent levels, time to take the gain and find another equity moving up rapidly. Of course, for some, the AVXL position is then retained for longer-term gains.
Number 3, Day-Traders, are in and out, often within minutes or hours. Nothing long-term here.
Number 4, TA Analysis plays, are probably a bit longer than day-trading. The charts decide.
Number 5, the Anavex Science and Markets plays, are decidedly long-term. Buy, and hold. Wait. Payoffs somewhere in the future; but particularly rewarding when they eventually happen.
Personally, my few thousand shares of AVXL have been purchased, and are retained, because of Number 5, the science and potential markets of Anavex Life Sciences Corp. I utterly reject all of the others, find nothing useful about them at all. But, I dully respect the many individuals who post messages on each of these. I read, and consider them all (but don’t act on any except the science postings). All good people, here; making this one of the most informative iHub message boards.
Time for profit-taking.
It's 9:59am, I see the AVXL price at $18.70, up 6.01% for the day.
Time for the day-traders to start selling off their trading positions. Will have a nice one-day profit.
Don’t want to “pump.”
Spilled beans not on the investor’s menu.
Keeping track of the zeros.
Detection? Prophylaxis? Or Treatment?
There continue to be, from time to time, reports of new methods or procedures that promise to accurately detect Alzheimer's dementia before gross symptoms conventionally reveal the disease. Well and good; except....
Except for the fact that presently, such a diagnosis can offer no useful consequent therapy. Presently, there is very little that can be done to slow or minimize the onset of Alzheimer's disease. Simply (tragically), an Alzheimer's diagnosis is lethal. No one, ever, successfully stops the disease's lethal progression. Yes, Aricept, one of the very few drugs approved as an Alzheimer's therapy, can, for a time, slow the disease's progression. Nonetheless, at some point (sooner than desired) the disease's dementia progresses severely. A morbid death always ensues.
(I know this personally. My father, an accomplished and successful public accountant, had early-stage Alzheimer's; was admitted as a patient in the clinical trial that eventually allowed the approval of Aricept. Whether he was in the control arm of the study, taking a disguised starch pill, or Aricept itself, was never known. Didn't matter. He declined rapidly; was committed to an Alzheimer's care center, where many month later he died.)
I tell, once again, that probably blarcamesine's greatest therapeutic utility will be not just to treat existing Alzheimer's cases (very successfully) but, in fact, to prevent the disease's onset; used as an Alzheimer's prophylactic.
Interestingly, the recent Anavex patent for blarcamesine (Anavex 2-73) patented a dosing regimen where the drug would be given to potential Alzheimer's patients (meaning anyone and everyone in their forties or fifties), for prophylactic, preventative purposes. But it was noted that this proposed (and now protected) dosing regimen would be intermittent. The drug would be taken for short periods of time, say, for several days; followed by an equal or longer no-doses period. This is a new on/off dosing schedule. Anavex must believe, have evidence, that this will be successful.
It makes sense, because when blarcamesine binds, as a ligand, to the sigma-1 receptor protein, it can then remain attached for some time, modulating and promoting the many propitious things that happen when that protein is properly activated. No apparent need for continuous, uninterrupted dosing. Blarcamesine pills on, say, Mondays and Tuesdays of every week may be fully prophylactic.
Instead of new early Alzheimer's detection protocols or methods, as good as those will be (very much invited), the biggest Alzheimer's story, when it can appear, will be news that intermittent dosing with blarcamesine soundly prevents the onset of the disease.
The other, earlier Alzheimer's news will be the clinical realization that blarcamesine can actually reverse and stop the progression of Alzheimer's.
No other drug, or pharmaceutical company, will be able to exhibit these two profound Alzheimer's therapies: a) effective prophylaxis (prevention) of the disease, for people who don't yet have it, and b) effective treatment for those who do.
A new era in neurological medicine.
Thanks.
I did a quick scan-through of the paper; couldn't find any references to the sigma-1 receptor protein.
How, do you think, this paper involves or might be affected by blarcamesine?
Very definitive. Blarcamesine is safe, and works.
Woke up this morning, turned on my desktop computer to see what appeared this morning. Saw that Anavex has put up a new presentation. Clicked on it, and, wow. Pages of data (didn’t see a single datum from a mouse or rat).
I wanted to check the following:
A) Solid evidence of efficacies against listed, targeted CNS diseases — lots of it.
B) Are the efficacy data points statistically significant (p = <0.05) — p-values all very low; profound statistical significance; results not by chance or placebo effects.
C) What diseases and conditions are being targeted — nothing new there; just a broad range of giant CNS diseases, of expansive, global importance and occurrence.
D) What are the side effects of blarcamesine in any and all of the presented studies — virtually none; unique for a drug acting in the CNS.
Of course, most common retail equity investors couldn’t (or wouldn’t) parse out the confirming data. They are still in the dark about Anavex. They will wait to read of FDA approval in the New York Times. I’m not expecting any stout AVXL share price rise today.
Others? Well, anyone with even a low undergraduate level of biological knowledge should be impressed. The data speak for themselves. Blarcamesine is safe, is administered orally in low doses, and in a variety of CNS diseases facilitates, promotes, and causes very significant therapeutic improvements. The molecule works; like no other.
As always, contrary views of the presentation are warmly invited. Please tell, how does this fail to tell the Anavex story?
The biggest Anavex story: blarcamesine prophylaxis.
Placebo stuff again?
Won’t work; not a med-school professor.
Real price catalyst will be NYT article.
Let watch, by the end of 2023.
Oh, no new CNS drug can work?
Pretty generic hopefulness.
AVXL. Now, or later?
My numbers, too.
The other big Anavex application.
Such great potential, for a severe condition.
The errors were not Missling's.
Info errors. But data very promising.
This was a claim in today’s fragile X announcement:
Indeed. The market will stay ignorant, until....
Well, not yet.
The website's author.
I commended the author of the Anavex against Parkinson's website.
But, just what are his qualifications? Well, he's not a high school biology teacher. A bit more:
I am the Deputy Director of Research at the Cure Parkinson's Trust. Before that I was working as a Parkinson's research scientist at the University of Cambridge where I conducted both clinical- and lab-based research on Parkinson's. I have worked in the Parkinson's research field for over 15 years - both academically and in biotech ventures. In addition, I am the president of my local Parkinson's UK support branch in North Hertfordshire. All of my views/opinions expressed here are solely my own, and may not reflect the views of my employer or associated parties.
Who ya gonna believe?
The science, and it's evidence. superbly presented.
Intermittent Prophylactic Dosings
The laying out of on-off blarcamesine (Anavex 2-73) dosing schedules in the treatment of Alzheimer's disease, in the new Anavex patent application, raises the question of intermittency in prophylactic uses of the drug.
Blarcamesine, by activating the sigma-1 receptor protein, presently successfully treats a number of CNS diseases --- awaiting bureaucratic authentication by the FDA. The question then arises, might the drug actually prevent the onset of Alzheimer's, etc., if given before the disease first appears. Prophylaxis; disease prevention.
Now, if that proves to be the case (I personally believe that will happen), would the drug then be used for that purpose? Now, with the on-off dosing schedules listed in the new patent application, it's possible that blarcamesine will prevent various CNS diseases with varying intermittent dosing schedules. Perhaps it will be discovered that to gain the benefits of the drug, before diseases set in, it would need to be taken, say, just once a week. Take a 50mg tablet of blarcamesine with breakfast each Monday morning, and stay clear of the diseases it prevents. Effective? Let's see. Convenient? Inexpensive? Certainly.
Why the rest periods?
The on-off blarcamesine (Anavex 2-73) dosing schedules in today’s patent application are most interesting. The company wouldn’t be laying this out unless it had data and experiences indicating efficacy.
According to the patent application, the drug will be given at full strength for an initial period, a few days or a week or so; followed by a “rest period.” This on-off dosing schedule then continues for a year or more.
How come? Why not just give a daily dose, without interruption, without “rest periods?” Far more convenient. There could be several reasons. Choose the one you thinks fits best.
1) After the first, initial dosing period, the drug loses efficacy; no longer suppresses or turns off Alzheimer’s symptoms. The cellular structures or processes the drug controls become saturated, so they need a rest period for the drug to clear and be able to resume efficacy when dosing re-starts.
2) For whatever exact mechanistic reason is at play, perhaps unknown, Anavex has discovered that intermittent dosings at the intervals laid out in the patent application actually work best, give the best therapeutic results.
3) As shown in early Phase 1 clinical trials, and in murines (lab rodents), continual, unvarying dosings do work; but symptomatic improvement curves flatten after long periods of continuous dosings. With dose rest periods, the drug maintains continuing high, uninterrupted levels of therapeutic efficacy.
4) For whatever reason(s), intermittent dosing simply works; so, with the rest periods, dosing costs are reduced by about a half, or more.
With many drugs there are at the start “loading doses,” strong doses that load biological systems to where they can be properly modulated by the drug. Then, after the loading period, lower, chronic (time-continuing) dosages are administered. This has not been mentioned for blarcamesine. This phenomenon would be investigated with dosage “titrations” in human clinical trials, where dosages are low at the start, but incrementally increased until therapeutic results appear. Then, that dosage level is continued.
After long durations of such symptomatic relief, some clinicians might then want to titrate down, to see if results continue at lower dosage levels.
Anavex 2-73 safety.
For those unfamiliar with the human clinical data showing profound safety of blarcamesine (Anavex 2-73), here, in the patent application, is a summary of the safety data from Phase 1 human trials:
Some 8th-grade Anavex arithmetic.
There have been any number of posts laying out potential numbers for Anavex revenues, and how those might connect to shares and dividends. On my spreadsheet, I did some elemental arithmetic, to see how various numbers connect to the AVXLs I own.
First, I wanted to figure out how much of a year’s annual sales revenues by Anavex Life Sciences Corp would be valued by each outstanding share. To do this, first calculate a per share value. Divide the annual revenues datum by the number of outstanding shares (presently, at the full authorized number: 75,710,000).
Then, let's imagine that in 2023 Anavex takes in $20 million dollars in sales revenue. For each share, that would be $20,000,000 over (divided by) 75,710,000. That would be $0.246 per share, a bit over 24 cents.
One's personal value, based upon one's AVXL share position, is calculated by multiplying that per-share datum times the number shares owned.
On a spreadsheet or table, one can visualize the numbers at various annual revenues. Simply create a stacked, incremental list of potential annual revs, from, say, $10,000,000 on up to (but not limited by) $100,000,000.
Then, presume some reasonable “drop down” figure, the percent of annual revenues that drop down, get distributed as per share dividends. If the per share drop down is 20%, multiply the per share annual revs datum times 0.2 (which is 20%). In this case, $0.246 x 0.2 = $0.0492, a bit less than a nickle per share.
Of course, in an early year, say, 2023, when the company is still expanding, with revenues of only $10 or $20 million dollars, there is not likely to be any dividend; all after-costs dollars get re-invested. But at some time in the future, revenues will generate dividends. Use these 8th-grade arithmetic protocols to visualize the new numbers. When blarcamesine (or, later, Anavex 3-71) is treating millions with various CNS diseases, the numbers get big.
Later, if either Anavex drug becomes a standard, near universal middle-age geriatric disease prophylactic, with many tens of millions taking the drug each day, every year, the numbers get pretty astounding.
The most astounding figures, however, are when either Anavex drug, more distantly in the future, is discovered to prevent or treat not only geriatric-onset CNS diseases, but when consumed by young adults they prevent all sorts of other pathologies, such as autism, cardiovascular conditions, cancers, etc.
Will any of this happen? For most (understandably, respectfully), all of the above is risky speculation, upon which no AVXL investment decisions should be made; wait until Anavex actually has some annual revenues, which won’t happen until they get authorization to actually sell one of their drugs.
Personally, I don’t make high-risk stock purchases. I do have a moderate AVXL position, at a per-share cost basis of $2.67. My entire AVXL position has been purchased over many years, all with discretionary money in my budget. If Anavex goes bust, I’m not hurt at all. If it succeeds, as I anticipate, based upon low clinical trial p values, very positive symptomatic suppression results, and uniform and universal safety outcomes, I (well, my estate) will be well-rewarded.
All of these projected numbers are guesses, but informed, calculated ones. With your own calculator or spreadsheet, punch in your own numbers. Interesting, at least, if not informative yet.
Of course, these projective calculations are of little value or application for those who are in the AVXL game to make dollars by trading; buy low, sell high, etc. Takes more than 8th-grade arithmetic to make that work. I’ll let the traders tell their stories on that. I’ll just sit back and watch, until at least 2023, the year I predicted (I think accurately) that would be Anavex’s first year of real revs; when the company’s future becomes secure and assured.
Any resulting new AVXL positions?
The Rett trial will end before 2022 (https://www.clinicaltrials.gov/ct2/show/NCT04304482). That CNS disease will then be treated with blarcamesine, showing that blarcamesine fixes otherwise recalcitrant CNS dysfunctions. That will elevate the AVXL share price, many months before the Alzheimer's study is completed and the FDA then approves blarcamesine for that big disease.
Check my posting. I referred to the "Alzheimer’s/CNS play," not just Alzheimer's alone. A single blarcamesine success for any of the three it's being tested on, Rett syndrome, Parkinson's disease dementia, or Alzheimer's, will validate the drug and the company. No stopping either the share price or corporate revenues thereafter.
Yes, another problem.