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Mayo indicated on ST he plans to weigh in on todays PR this evening. Should be interesting to get his take.
Fair enough... Take my advice and don't do a five to six page deep dive into Lincoln Park Capital background, history or business practices.
I did and my takeaway was why in the world would Anavex become entangled with LPC vs a host of big name reputable Wall Street firms that would immediately lend gravitas as their primary financier?
Fingers crossed I'm wrong. I often am.
Just an observation... The stock has been steadily descending since the Lincoln Park financing deal was announced in February which raised eyebrows in the more knowledgable segments of the market who can differentiate between reputable and toxic financiers.
Fair or not, Lincoln Park does not have a good business reputation and carry's the stench of a vulture capital firm who has taken advantage of other client companies. It's a further mystery why Anavex would chose this point in time to do another deal with Lincoln, with $140M cash on hand, nor has the company felt the need to inform investor owners about the drivers requiring access to $150M in additional capital. Was Lincoln Park the only option, and if so, why with Anavex' promising portfolio?
Just one of many valid questions for an upcoming Shareholder meeting, once a meeting is held.
Dr Missling... Your shareholders are concerned they haven't heard from you. Long periods of silence, following results, provide time to conjure up financial fears and investment demons. Assuming you can talk, but just don't want to, here's a suggestion.
Pull up your Schwab Brokerage account. Clink on the trade screen. Enter symbol AVXL. Click on the buy symbol. Enter 25,000 - 50,000 indicating the number of shares you want to purchase. Indicate market price. Yes, we're all aware you already have millions of cheap options, but this action is about sending an important message to your shareholders, without talking.
Next send an email to your leadership team, and the sycophants on your Board, advising them it would be a great symbolic gesture for them to exhibit loads of confidence in Anavex and buy shares in the company paying them a big salary or board stipend.
Follow these simple steps, that don't require you to say a word to your investors, and the likelihood militant shareholders show up at the next annual meeting with torches and pitchforks, will be greatly diminished.
Just trying to help... Your pal, G.B.
When you've lost BigBioBoom on StockTwits...
"The Rett Syndrome Research Trust seems to have a much more honest, patient-focused assessment of trofinetide than the Alzheimer's Association has of lecanemab and Aduhelm."
Agreed.
In addition, the FDA must have followed twisted logic that with no current Rett treatment options available, trofinetide, with a terrible medical profile, is better than nothing.
Really disappointing choice for Rett patient parents and caregivers.
From Rett Syndrome Research Trust - Posted on ST by monregi
DAYBUE (TROFINETIDE): KEY FACTS FOR PARENTS
https://reverserett.org/news/articles/daybue-trofinetide-key-facts-for-parents/
KEY SUMMARY FACTS OF LAVENDERTM AND LILAC-1 TRIALS
61% of patients taking DAYBUE did not improve
13% of patients were rated as “much improved”
No data are provided regarding which specific symptoms improve
85% of patients treated with DAYBUE had diarrhea and 29% had vomiting
In the study where everyone received DAYBUE, 46% of patients withdrew before completing the study
The article includes a number of additional data points and trial observations.
If I'm reading the option exercise price correctly, it appears nearly all of Dr. Missling's options are in the money. Not overwhelmingly, but in the money nonetheless, including the $1.60 upcoming July 5, 2023 options. He's sitting on a boatload of options. I'm happy for him if he delivers a successful outcome for shareholders.
The details are in the Anavex proxy. Sorry, it didn't copy well.
Christopher Missling Options schedule
500,000 1.60 July 5, 2023
73,380 — — 1.32 May 8, 2024
500,000 — — 0.92 April 2, 2025
187,500 — — 5.04 Sept 18, 2025
379,625 — — 6.26 July 5, 2026
861,429 — — 7.06 July 18, 2026
500,000 — — 3.28 Sept 22, 2026
450,000 — — 5.92 May 12, 2027
400,000 — — 3.30 Dec 13, 2027
450,000 — — 2.30 May 15, 2028
409,500 — — 2.58 Oct. 1, 2028
500,000 250,000 — 3.15 May 3, 2029
— 550,000 — 2.96 January 6, 2030
— 550,000 — 5.49 December 30, 2030
— 500,000 — 18.11 August 2, 2031
So... They've had the AD data in hand since early December. We'll round it up to four months. I can only assume they've had it tied up in a basement in Hoboken with car batteries, jumper cables, gallon jugs of water and towels. They have their shiny new head of statistics, cattle prod in hand, extracting the truth out of every data point. By golly, the right narrative will be attained, one way or another.
It took less time to put the squeeze on El Chapo.
Luke Brown, recently hired IR dude at Anavex entering Dr. M's sprawling office suite...
Luke: Sorry to interrupt your full body massage sir, but I thought you'd want to know, based on the tone of the phone calls and emails I'm receiving, the natives are getting very restless for news.
Dr M (slightly irritated tone): Natives? What natives? What are natives?
Luke: Natives, in this case, is a metaphor for shareholders sir.
Dr. M: Shareholders?
The FDA has adopted the "Let's give it a shot and see if it does more good than harm" strategy.
ST post - From Endpoints Journal - FDA indicates willingness to approve Biogen ALS drug despite failed PhIII study.
Max Gelman
Senior Editor
Full article behind a paywall.
Ahead of Wednesday’s advisory committee hearing to discuss Biogen’s ALS drug tofersen, the FDA appeared open to approving the drug, newly released briefing documents show.
Citing the need for flexibility in a devastating disease like ALS, regulators signaled a willingness to consider greenlighting tofersen based on its effect on a certain protein associated with ALS despite a failed pivotal trial.
Bodes well for our medical projects?
Thanks for the info Sage4...
I would enjoy having Mayo weigh in and offer his thoughts and opinions on what's occurring behind the scenes at Anavex.
I'll try to give you the short version. A number of us on this board have a shared painful experience. Common investors, were we, in a small biotech that appeared to have science that was destined be a game changer. Multiple trials with favorable trends and lots of promise. $200M to work with. Partnerships, including one with Amgen. Hiring left and right. A exuberant CEO, being paid millions, who was dripping with WGT. It all appeared great, until suddenly, it wasn't.
Several rounds of toxic financing, massive share issues and reverse splits later, a symbolic toxic crater is generally all that's left.
So yeah... The fact that delay after delay after delay is a recurring theme and dead solid irrefutable proof of WGT always seems to be just barely beyond our grasp... It's logically a bit more concerning to some of us than others and, while clinging to optimism, we pray history isn't repeating.
I realize most all biotech investors have a similar sad story to share.
We can all take comfort in knowing they will be forced by regulatory statue to break radio silence and communicate an Annual Shareholder meeting soon.
Good luck.
500 shares at $8.60 seemed like a gift on the surface.
Let's all hope Anavex doesn't have chicken wire installed around the stage at the annual meeting in April.
What I assumed was a silly lowball bid of $8.60 for 500 shares three hours ago just filled. Thanks to the seller... I guess.
As some may have reported earlier, Lilly threw in the towel today on solanezumab. A second Lilly drug, donanemab, which also focuses on Amyloid plaque removal is still under development. LLY stock closed up 1.38% or $4.31.
"Eli Lilly LLY announced that the phase III A4 study evaluating its candidate, solanezumab, in people with preclinical Alzheimer's disease (AD)failed to achieve its primary and secondary endpoints. Preclinical AD refers to those patients who have not shown any AD symptoms but have an amyloid plaque.
Data from the A4 study, which evaluated solanezumab in preclinical AD patients, showed that treatment with the drug did not slow cognitive decline or reduce the risk of progression to symptomatic AD. The treatment, designed to target soluble amyloid beta proteins, did not result in the clearance of amyloid plaque. Amyloid is a key driver of cognitive decline in AD indication.With the A4 study failing to meet the primary and secondary endpoints, Lilly has stopped the clinical development of solanezumab for Alzheimer’s prevention."
"I've wondered how hard it is for labs to develop alternative small molecules that wouldn't be covered by Anavex's patents but would have similar (or maybe even superior) efficacy."
Fair question. Pure speculation is Pharmas with the intellectual research depth to develop alternative Sigma-1 receptors have simply ignored or dismissed the science out of hand. They're locked on to other medical theories involving a massive amount of sunk research investment.
Summary of Anavex Peer Review article from last year. Work was submitted April 1st and published mid-June. The actual peer review content is behind the, Expert Opinion on Therapeutic Targets, pay wall.
Jun 14, 2021
Anavex Life Sciences Reports New Publication in Medical Journal Elucidating the Mechanism of ANAVEX®2-73 (blarcamesine) and ANAVEX®3-71 (AF710B) related to the Treatment of Alzheimer's Disease
NEW YORK, June 14, 2021 (GLOBE NEWSWIRE) -- Anavex Life Sciences Corp. (“Anavex” or the “Company”) (Nasdaq: AVXL), a clinical-stage biopharmaceutical company developing differentiated therapeutics for the treatment of neurodegenerative and neurodevelopmental disorders including Alzheimer’s disease, Parkinson’s disease, Rett syndrome and other central nervous system (CNS) diseases, today reported that ANAVEX®2-73 (blarcamesine) and ANAVEX®3-71 (AF710B) are featured in a new peer-reviewed publication in the journal of Expert Opinion on Therapeutic Targets, titled “The emerging role of the sigma-1 receptor in autophagy: Hand-in-hand targets for the treatment of Alzheimer's”.1
Scientific Paper Highlights:
Sigma-1 receptor (SIGMAR1)’s expression increases with age, however in Alzheimer’s disease (AD) it decreases
The decrease in SIGMAR1 expression during AD coincides with an age-related decrease in autophagy
The SIGMAR1 may compensate for loss of receptors and autophagic machinery during healthy aging
SIGMAR1 is activated by ANAVEX-compounds
ANAVEX®2-73 has been shown to induce autophagy
Activation of the SIGMAR1 can induce cytoprotective autophagic pathways
The authors of the paper point out that studies using positron emission tomography (PET) have shown that in healthy aging, there is no loss of the SIGMAR1; in fact, there is a possible increase in SIGMAR1 expression2 that coincides with the age-related loss of the M1/M4 muscarinic receptors3, D1/D2 dopamine receptors4, and serotonin (5HT2A) receptors5. The increase in SIGMAR1 expression may be a compensatory mechanism for the loss of the other receptors6.
However, PET scans of patients with a recent AD diagnosis show a reduction of SIGMAR1 expression7. SIGMAR1 also promotes autophagy and results in the degradation of amyloid-beta precursor protein (APP) thereby inhibiting Aß production8.
The publication explains that AD is a multifactorial disease, where several pathways interlink with each other and cause cognitive impairments. The available drugs only tend to target a single pathway and mitigate the symptoms of AD without slowing the disease progression. Combinatorial therapy has been suggested as a treatment strategy; however, the existence of drug-drug interaction is a concern. Hence, there is a need for the development of drug molecules that can target multiple pathways to halt disease progression and improve the memory function.
SIGMAR1 has emerged as one of the prominent targets in treating neurodegeneration. It is involved in the modulation of glutamate levels, maintaining endoplasmic reticulum (ER) function, and calcium regulation, promoting neurogenesis, reducing reactive oxygen species (ROS) formation, suppressing neuroinflammation and ameliorating Aß toxicity9. Recent studies with ANAVEX®2-73 show that SIGMAR1 activation is also involved in autophagy, an intricate phenomenon that clears damaged cellular organelles and misfolded proteins10. SIGMAR1 agonists, including ANAVEX®2-73 and ANAVEX®3-71 have been reported to block toxic Aß, tau and neuroinflammation11.
Autophagy and the cellular machinery involved are essential to homeostasis and cell survival. Autophagy has been shown to be important for axonal health and homeostasis as autophagy inhibition leads to axonal wasting12.
During the early stages of AD, it has been noted that there is an accumulation of Aß and tau protein in the dystrophic or swollen neurites of AD patients’ brains. Furthermore, it is well known that autophagy plays a key role in the management of Aß and tau protein levels, and that some of the key proteins involved in the autophagy mechanism disappear with age, resulting in decreased autophagy in older brains13. At the same time the SIGMAR1 is upregulated, possibly compensating for the reduction in autophagy, and reduction in other receptors, such as muscarinic receptors14, dopamine receptors15, and serotonin receptors16, in an attempt to protect the neuron cells.
Since it has been observed that a number of SIGMAR1 agonists, including ANAVEX®2-73, is able to upregulate SIGMAR1 expression in the brain, it is possible that these drugs could help the cells to compensate for the loss of other receptors and autophagy machinery.
The authors conclude, that in the future it may be the case that SIGMAR1 ligands (or drug combinations) targeting the activation of autophagy, and other SIGMAR1 related neuroprotective pathways, are prescribed prophylactically, in much the same way as with statins for the prevention of heart disease today in an effort to prevent the loss of the SIGMAR1 receptor seen during AD.
“This independent paper highlights the understanding of the relevance of utilizing sigma-1 receptor activation as compensatory mechanism to chronic CNS diseases, currently tested in late-stage placebo-controlled ANAVEX®2-73 Phase 2b/3 clinical Alzheimer's disease study, which recently completed enrollment, as well as in Parkinson’s disease dementia (ANAVEX2-73-PDD-001) and ongoing Rett syndrome program (ANAVEX2-73-RS-001/002/003)”, said Christopher U Missling, PhD, President and Chief Executive Officer of Anavex.
ANAVEX®2-73 activates the sigma-1 receptor (SIGMAR1). Data suggests that activation of SIGMAR1 results in the restoration of complete housekeeping function within the body and is pivotal to restoring neural cell homeostasis and promoting neuroplasticity.17
Anavex Life Sciences’ product portfolio platform includes small molecule drug lead candidate ANAVEX®2-73 for the treatment of Alzheimer’s disease, Parkinson’s disease and Rett syndrome and ANAVEX®3-71 for frontotemporal dementia.
We don't know who will publish a peer review of the 2b/3 AD trial of 2-73, but if it is Nature, they have their Peer Review outline published online. As might be expected it's a rigorous process. There are numerous examples of Peer Reviews on the Nature site to provide a sense of the effort involved.
https://www.nature.com/nature/editorial-policies/peer-review
Save us all from giant egos and the dogma of settled science.
https://thefederalist.com/2022/07/28/inside-the-corrupt-world-of-alzheimers-science-and-what-its-failure-means-for-all-settled-science/
"Sure would smell bad if Dunn joined Anavex!"
Yes it would. Hopefully AVXL is all stocked up on FDA expats.
"Sure would smell bad if Dunn joined Biogen"
Odds are good Biogen is on his short list of suitors. Of course they may get outbid by a paragon of virtue, like Pfizer.
Others on the board will have a better sense for the Excellence trial timeline. It is clear we have another medical opportunity where current treatment options are essentially non-existent for either adult or pediatric Rett patients.
Avatar results were very good. No reason to think Excellence results won't be equally solid. Not sure "no brainer" and the FDA should ever be referenced in the same sentence but...
The voucher is substantial and definitely worth pursuing.
This is also good news and a very telling statement about the Alzheimer's Association.
"The Alzheimer's Association, in a statement Wednesday, said it was "appalled" by CMS' decision.
The hurdle for a safe effective AD treatment is still on the ground.
"We're now one year (2/1/2022) post the Avatar successful phase 3 trial announcement. Wording in that announcement indicated near term Anavex plans to meet with the FDA to seek an accelerated approval pathway for 2-73 treatment of adult Rett patients."
I'm not sure I understand the dogged linkage between seeking approval for adult Rett patients a year ago and holding up until the pediatric Rett trial is completed.
If the Excellence pediatric trial isn't a success, is Anavex going to abandon the Adult Rett population after the successful Avatar trial? It's important to note again there are no existing treatments for Rett Syndrome for adults or children. Not seeking approval following the successful Avatar trial last year has had real world consequences for adult patients.
Assuming strong Avatar results in February 2022 were worthy of 2-73 accelerated approval, having subsequent months of safe and effective treatment experience would seem to help clear the path to quick pediatric approval if Excellence trial results are similarly successful.
Perhaps someone at Anavex can provide a bit of transparency and explain their rationale for waiting and the assumed linkage between the trials, if it's only to confirm they wanted to move more quickly after Avatar, but the FDA said no.
We're now one year post the Avatar successful phase 3 trial announcement. Wording in that announcement indicated near term plans to meet with the FDA to seek an approval pathway for 2-73 treatment of adult Rett patients.
https://finance.yahoo.com/news/anavex-2-73-blarcamesine-avatar-120000337.html
February 1, 2022
"ANAVEX®2-73 (Blarcamesine) AVATAR Phase 3 Trial met Primary and Secondary Efficacy Endpoints for the Treatment of Adult Patients with Rett Syndrome
Efficacy endpoints demonstrated statistically significant and clinically meaningful reductions in Rett syndrome symptoms with related changes in potential biomarkers (GABA and L-AAA) of disease pathology
"Key milestone met to advance regulatory approval pathway for adult patients with Rett syndrome."
"Based on the results in this Phase 3 study (ANAVEX®2-73-RS-002)3 and the prior successful U.S. Phase 2 (ANAVEX®2-73-RS-001)4 study in adult patients with Rett syndrome, Anavex is planning to meet with FDA to discuss the approval pathway. There are no FDA-approved drugs for Rett syndrome. ANAVEX®2-73 has Fast Track designation, Rare Pediatric Disease designation and Orphan Drug designation from the FDA for the treatment of Rett syndrome and may be considered for accelerated approval."
The placebo-controlled EXCELLENCE Phase 2/3 pediatric Rett syndrome study (ANAVEX®2-73-RS-003)5 is currently ongoing and is evaluating ANAVEX®2-73 for Rett syndrome patients ages 5 to 17."
An update from Anavex on where things stand would be great.
Posted on ST by DakotaSentMe.. Full Measure is reporter Sharyl Attkisson news site. Video aired today in New England per the poster.
https://fullmeasure.news/news/shows/rx-repeat
Thanks ST... I was just attempting to point out it will take an outsized experienced pharma with J&J resources to execute a partnership or acquisition with Anavex based on the value and upside potential of the Anavex pipeline.
J&J has executed $104B in acquisitions. A couple of examples being Actelion $30B or $280 a share and Abiomed $16.6B or $380 a share. Both companies had approved drugs J&J coveted. Anavex will also be highly coveted when one or more 2-73 applications are approved. We could do much worse than J&J as a partner or acquirer.
The board is quickly devolving into daily pitched battles due to the negative elements who have invaded and react to even the most benign posts. Really unfortunate.
"Johnson & Johnson poaches Sanofi R&D head."
"French drugmaker Sanofi (SNY) (OTCPK:SNYNF) has lost its Global Head of R&D, Dr. John Reed, to Johnson & Johnson (NYSE:JNJ), where he will assume duties as the Executive Vice President of pharma R&D from Apr. 03."
J&J, the worlds largest pharma, market cap $424B. Cash on hand $34B. 43 acquisitions, 7 in the last five years.
Surprising Dr Reed wouldn't have a non-compete agreement with Sanofi preventing him from working for a direct competitor for a year or even two. He leaves with possession of the keys to Sanofi's kingdom with insider knowledge of every transaction they have in flight. Tough loss for Sanofi.
Great stuff as always...
May have a typo in the intro line...
"Lecanemab Features Dramatically Improved CDR-SB Scores Over Lecanemab When Taking Into Account Disease Stage"
Since Anavex shareholders apparently have zero opportunities to engage with company leadership it would be extremely beneficial if analyst on the earnings calls would express some intellectual curiosity and ask hard questions instead of a couple of powderpuff queries from two analyst and then fall silent. At a bare minimum they should have been prepared to press hard for answers on all the missed deliverables in 2022.
I've been on a lot of earnings calls. Company leaders generally knew going in they had to know their stuff because they were going to be grilled, at some length, by aggressive analyst. Often it's "congratulations on a good quarter, now when did you stop beating your wife?" and then it goes down hill from there. If ever a company deserved to be pressed hard for some program schedule and deliverable answers...
Analyst do their companies and investors a disservice by being unprepared and sleep walking through a call, like Tuesday, as if they don't give a crap. They have the high ground to press for information. Not sure why the Anavex analyst are so damn reluctant to use it.
ConfirmationBiasSuxs posted this on ST around 2:00pm today.
"Some shorts got out! report says on 1-31-23... 16,719,384 shares were short.... 22.11% Still some ammo for a squeeze... but the sexiness is dropping... Good for us either way... the remaining shorts are gonna start second guessing themselves."
Some could reattach based on how they skew the new financing deal but the run up prior to the earnings call was definitely shaking some of them loose.
boi - If long investors don't have special access to data or the schedule of upcoming company actions, you can be damn sure the shorts don't either. Everything they're spewing is conjured up to support a negative self-serving agenda a.k.a. they're lying.
My ignore list is long and keeps growing.
Posted on ST... posted earlier on IH by xodcode.
https://www.conferencecalltranscripts.org/summary/?id=11773683
Active link for Edgar filings.
nidan7500... In spite of my misgivings the market has responded really well to the call.
Will be interesting to see the influence the new IR resource has on managing or expanding the boundaries of interactions with analyst and the public on future calls. A really good IR resource makes sure questions the company wants to cover are planted ahead of the call. I believe there were a number of positive directional indications TGD could have provided without crossing the line, but his extreme conservative heritage/nature makes him super cautious. He should go into every interaction with the thought here's the one or two things I want to have people talking about afterwards.
I appreciate the skill people on various boards have in drawing out positives from todays extremely short call, but it honestly seemed like opportunities were missed to say something positive without breaking SEC rules. As it stands, and I realize it was an earnings call, the call was short on information, dry as dirt and provided no anticipation for when another update might be expected.
As referenced, the new IR professionals arrival provides hope for improvement.
Feuerstein, who bills himself as "The Night King of Biotech" (a juvenile Game of Thrones reference) and uses an "often wrong, but never in doubt" bullhorn to trash startup developmental biotechs for a living.
But when it comes to unethical behavior from billion dollar Pharma companies like Pfizer, who have been fined millions and millions for unscrupulous actions, often harmful to the public, he's stricken mute. Puzzling, but apparently it's much safer from a career standpoint to kick the little guys around.
I'm totally speculating here, but suspect A. He's fearful of the army of lawyers at big Pharma disposal and/or B. He's absolutely crazy about the smell of big Pharma money in the morning.
In either event, I'm not a member of his fan club and have the opinion he does far more harm than good. But... He does have that Night King of Biotech thing going for him. I wonder if he wears his black cape in public?