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FWIW - Increase In AVXL Outstanding Share Count From Sept. 30, 2020 Thru June 30, 2023:
Sept. 30, 2020 - 62,045,198 ($4.55 closing price)
Mar. 31, 2021 - 70,030,620 ($4.55 - $14.95 price range w/spike up to $28+)
7,985,422 increase (1,330,904 per month avg.)
June 30, 2021 - 75,149,833 ($14.95 - $22.86 price range w/about 1 week in high $20's up to $31+ )
5,119,213 increase (1,706,404 per month avg.)
Sept. 30, 2021 - 75,918,465 ($22.86 - $17.95 price range)
768,632 increase (256,211 per month avg.)
Sept. 30, 2022 - 77,942,815 ($17.95 - $7.30 price range)
2,024,350 increase (168,696 per month avg.)
Feb. 7, 2023 - 78,032,135 ($10.32 - $7.65 price range)
89,320 increase (21,016 per month avg.)
June 30, 2023 - 81,390,916 ($11.75 - $7.60 price range w/majority of time in the $7.00's & $8.00's)
3,358,781 increase (707,112 per month avg.)
I never said that the CRO "screwed up."
Also hoping there isn't one CRO that is lagging behind and holding everything up (as was the case with the AD data last December)...
"Want see something potentially revenue driving..."
Understood. Safe to assume the release of stellar Rett EXCELLENCE top line data followed up by AVXL's submission of a Rett NDA to the FDA (maybe in or around Feb'ish...hehe) would get you excited?
FWIW - Here is the latest update from MayoMobile:
IMHO should AVXL be fortunate enough to gain FDA approval for AD, I can envision a BP buyout offer being submitted at that time, but I do not see it happening prior to that event...
Hoping for the day to come where we see you say "those $50 additions are looking rather good..."
Obviously, Roche could offer up their stock (instead of cash) for AVXL, but you have to admit that the chances of Georgejjl's theory that Roche will be buying AVXL coming to fruition just got much smaller now that they have decided to spend 85% of their cash on another deal. Agree?
By the way, whatever happened to that picture of your "dog"? hehe
Certainly appears to put a big dent in Georgejjl's theory that Roche will be buying AVXL...
Assuming the upcoming Rett EXCELLENCE top line data is a hit, hopefully we will see the NDA filed sometime in or just prior to "Feb'ish"...
Maybe that was LTB's business buddy in Korea!
Excitement and irrational exuberance to the point of us seeing a repeat of the AVXL price action that took place back in early February and June 2021 surely would be more than welcomed here!
How about the possibility that AVXL is seeking to enter into a partnership with a BP so that this potential AD prophylactic trial could be accomplished much faster?
After countless red days, AVXL is soaring today by 7.6%! Thank the sweet L_ _ D! (spaces inserted in place of letters since this word can be deemed to be "religious"...hehe)
I (along with many, many others here) am sure as heck looking forward to seeing it. Here's to hoping that it will be stellar and followed up by the filing of an NDA (maybe sometime in Feb'ish - hehe), as that would most certainly get us out of this annoying single-digit land and establish a new share price floor somewhere in the teens...
It sure is nice to see AVXL on the Top % Gainers list once again. Hopefully, it can stay there come the end of the day. We shall see...
If that happens sometime after AVXL first attains a share price of $50+...with maybe the initial offer being around $90 and the bidding war taking it up to around $140 or so...I'd be just fine with that
nidan - You are certainly not short on optimism!
While I hope to one day feel the same way as you have expressed below, today is not quite yet that day for me...
Anavex Life Sciences Reports New Publication in Scientific Journal Demonstrating the Potential of ANAVEX®3-71 to Prevent Cognitive Decline in Alzheimer’s Disease
GLOBENEWSWIRE 8:00 AM ET 10/25/2023
ANAVEX®3-71 treatment prevents cognitive impairment, reduces amyloid, and neuroinflammation even after a long drug washout
ANAVEX®3-71 halts neurodegeneration and prevents cognitive decline in a transgenic Alzheimer’s disease model
Confirmation of Anavex’s upstream SIGMAR1 oral small molecule drug platform in Alzheimer’s disease
NEW YORK, Oct. 25, 2023 (GLOBE NEWSWIRE) -- Anavex Life Sciences Corp.(AVXL) (“Anavex” or the “Company”) , 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 a new peer-reviewed publication in the journal Neurobiology of Aging, titled “Early treatment with an M1 and sigma-1 receptor agonist prevents cognitive decline in a transgenic rat model displaying Alzheimer-like amyloid pathology”, featuring the orally available small molecule ANAVEX®3-71 (AF710B).1
This study ascertains potential disease-modifying properties of ANAVEX®3-71 (AF710B) on Alzheimer’s disease (AD) pathology and could be a drug candidate for a once daily oral preventive strategy.
ANAVEX®3-71 activates the sigma-1 receptor (SIGMAR1) and the M1 muscarinic receptor (M1R). Data suggests that activation of SIGMAR1 results in the restoration of homeostatic function within the body and is pivotal to restoring neural cell balance and promoting neuroplasticity.2 Previous studies of ANAVEX®3-71 have demonstrated its potential to treat Alzheimer’s disease (AD)-like pathology at advanced stages of disease in animal models.3,4
ANAVEX®3-71, an orally available small molecule, has already successfully completed a Phase 1 human clinical trial demonstrating good safety and tolerability signals at all doses studied.5
In this publication, transgenic rats that develop AD-like symptoms as they age were treated with ANAVEX®3-71 for 7-months before they developed amyloid plaques, followed by a 4-week washout period. Preventative treatment with ANAVEX®3-71 reduced levels of insoluble and soluble amyloid-beta as well as plaque deposition in the aging cortex and hippocampus, areas heavily impacted by AD. Notably, the reduction in amyloid pathology was accompanied by a reduction in inflammatory glial activity which is connected to the disease cascade in AD and other dementias. ANAVEX®3-71 treatment downregulated the proinflammatory IL-1ß and IL-6 cytokines, which are known to be associated with AD. Additionally, ANAVEX®3-71 treatment boosted brain derived neurotrophic factor (BDNF) which reinforces the evidence that ANAVEX®3-71 protects neurons.
Importantly, these beneficial effects were sustained after a month-long drug washout. This differentiates ANAVEX®3-71 from other therapeutic approaches and suggests long-lasting, disease-modifying effects on AD pathology. This long-lasting effect was also observed in previous animal studies of ANAVEX®3-71 at advanced stages of the disease.
The publication is consistent with previous scientific findings, including with the more advanced drug candidate ANAVEX®2-73 (blarcamesine), which successfully completed a Phase 2b/3 study in early Alzheimer’s disease, that SIGMAR1 activation acts upstream of multiple contributors to AD and other dementias including but not limited to mitochondrial dysfunction6, oxidative stress7, impaired autophagy8 and that amyloid pathology can be reduced by M1R stimulation9.
The authors of the paper (Neurobiology of Aging 132 (2023) 220–232) from the Laboratory of Professor Cuello, MD at McGill University concluded: “This involved study could be considered as proof of principle for preventive therapies in Alzheimer’s disease and illustrates that this category of compounds, or similar effective agents, could be considered as candidates for preventive strategies to slow down the early amyloid pathology in Alzheimer’s disease, a condition that is increasingly diagnosed at preclinical stages.”
“This publication is a confirmation of the scientific depth of Anavex’s upstream SIGMAR1 platform, which gives hope to the Alzheimer’s disease community, especially for the patients, families and caregivers who fight everyday against this devastating disease for a potential disease-modifying drug candidate with a once daily oral preventive strategy. We also look forward to presenting in an upcoming major publication the complete dataset of the Phase 2b/3 Alzheimer’s disease trial of ANAVEX®2-73 (blarcamesine), a potential next-generation precision medicine convenient once daily oral Alzheimer’s disease treatment,” said Christopher U Missling, PhD, President and Chief Executive Officer of Anavex. "We are also on track within our neurodevelopmental precision medicine Rett syndrome program to release top-line data of ANAVEX®2-73-RS-003 Phase 2/3 EXCELLENCE pediatric clinical trial in the current quarter of 2023.”
About Anavex Life Sciences Corp.(AVXL)
Anavex Life Sciences Corp. (AVXL) is a publicly traded biopharmaceutical company dedicated to the development of novel 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, pain, and various types of cancer. Anavex's lead drug candidate, ANAVEX®2-73 (blarcamesine), has successfully completed a Phase 2a and a Phase 2b/3 clinical trial for Alzheimer's disease, a Phase 2 proof-of-concept study in Parkinson's disease dementia, and both a Phase 2 and a Phase 3 study in adult patients with Rett syndrome. ANAVEX®2-73 is an orally available drug candidate that restores cellular homeostasis by targeting sigma-1 and muscarinic receptors. Preclinical studies demonstrated its potential to halt and/or reverse the course of Alzheimer's disease. ANAVEX®2-73 also exhibited anticonvulsant, anti-amnesic, neuroprotective, and anti-depressant properties in animal models, indicating its potential to treat additional CNS disorders, including epilepsy. The Michael J. Fox Foundation for Parkinson's Research previously awarded Anavex a research grant, which fully funded a preclinical study to develop ANAVEX®2-73 for the treatment of Parkinson's disease. ANAVEX®3-71, which targets sigma-1 and M1 muscarinic receptors, is a promising clinical stage drug candidate demonstrating disease-modifying activity against the major hallmarks of Alzheimer's disease in transgenic (3xTg-AD) mice, including cognitive deficits, amyloid, and tau pathologies. In preclinical trials, ANAVEX®3-71 has shown beneficial effects on mitochondrial dysfunction and neuroinflammation. Further information is available at www.anavex.com. You can also connect with the Company on Twitter, Facebook, Instagram, and LinkedIn.
Forward-Looking Statements
Statements in this press release that are not strictly historical in nature are forward-looking statements. These statements are only predictions based on current information and expectations and involve a number of risks and uncertainties. Actual events or results may differ materially from those projected in any of such statements due to various factors, including the risks set forth in the Company’s most recent Annual Report on Form 10-K filed with the SEC. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement and Anavex Life Sciences Corp.(AVXL) undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof.
For Further Information:
Anavex Life Sciences Corp. (AVXL)
Research & Business Development
Toll-free: 1-844-689-3939
Email: info@anavex.com
Investors:
Andrew J. Barwicki
Investor Relations
Tel: 516-662-9461
Email: andrew@barwicki.com
1 Orciani C, Do Carmo S, Foret MK, et al. Early treatment with an M1 and sigma-1 receptor agonist prevents cognitive decline in a transgenic rat model displaying Alzheimer-like amyloid pathology [published online ahead of print, 2023 Sep 26]. Neurobiol Aging. 2023;132:220-232. doi:10.1016/j.neurobiolaging.2023.09.010
2 Advances in Experimental Medicine and Biology Volume 964 (2017) Sigma Receptors: Their Role in Disease and as Therapeutic Targets.
3 Fisher A, Bezprozvanny I, Wu L, et al. AF710B, a Novel M1/s1 Agonist with Therapeutic Efficacy in Animal Models of Alzheimer’s Disease. Neurodegener Dis. 2016;16(1-2):95-110. doi:10.1159/000440864
4 Hall H, Iulita MF, Gubert P, et al. AF710B, an M1/sigma-1 receptor agonist with long-lasting disease-modifying properties in a transgenic rat model of Alzheimer's disease. Alzheimers Dement. 2018;14(6):811-823. doi:10.1016/j.jalz.2017.11.009
5 Fadiran EO, Hammond E, Tran J, et al. Concentration-QTc Relationship from a Single Ascending Dose Study of ANAVEX3-71, a Novel Sigma-1 Receptor and Allosteric M1 Muscarinic Receptor Agonist in Development for the Treatment of Frontotemporal Dementia, Schizophrenia, and Alzheimer's Disease. Clin Pharmacol Drug Dev. 2023;12(9):888-901. doi:10.1002/cpdd.1303
6 Lahmy, V., Long, R., Morin, D., Villard, V., Maurice, T., 2014. Mitochondrial protection by the mixed muscarinic/sigma1 ligand ANAVEX2-73, a tetrahydrofuran derivative, in Aß25-35 peptide-injected mice, a nontransgenic Alzheimer’s disease model. Front. Cell. Neurosci. 8, 463. https://doi.org/10.3389/fncel.2014.00463
7 Arimon, M., Takeda, S., Post, K.L., Svirsky, S., Hyman, B.T., Berezovska, O., 2015. Oxidative stress and lipid peroxidation are upstream of amyloid pathology. Neurobiol. Dis. 84, 109–119. https://doi.org/10.1016/j.nbd.2015.06.013
8 Christ MG, Clement AM, Behl C. The Sigma-1 Receptor at the Crossroad of Proteostasis, Neurodegeneration, and Autophagy. Trends Neurosci. 2020;43(2):79-81. doi:10.1016/j.tins.2019.12.002
9 Zhao LX, Chen MW, Qian Y, Yang QH, Ge YH, Chen HZ, Qiu Y. M1 Muscarinic Receptor Activation Rescues ß-Amyloid-Induced Cognitive Impairment through AMPA Receptor GluA1 Subunit. Neuroscience. 2019 Jun 1;408:239-247. doi: 10.1016/j.neuroscience.2019.04.007. Epub 2019 Apr 11. PMID: 30981860
Image: https://www.globenewswire.com/newsroom/ti?nf=ODk2NTI2NyM1ODg5Nzk4IzIwMTk1Mzk=
Image: https://ml.globenewswire.com/media/MTUxNTEzOTQtZGFjNy00OTJlLWExNjQtMWE4YTZmOTZhOWE4LTEwMzExNzY=/tiny/Anavex-Life-Sciences-Corp-.png
Image: Primary Logo
Source: Anavex Life Sciences Corp.(AVXL)
WHAT?!? That would be 4x - 8x the amount of shares that were traded on February 4, 2021! I think seeing an eventual share price of $1249 has more of a chance than seeing a day where between 450M - 900M shares trade in a single day...but hey, I sure as heck would love to see it happen!
frrol recently posted here that he spoke with Andrew Barwicki (AVXL IR) and was told by him that AVXL has all they need now with regards to AD data to present to the FDA. Assuming whatever AVXL presents to the FDA is for the purpose of obtaining AA for AD, what percentage odds do you give that the FDA will accept the current ongoing OLE as the confirmatory trial?
Best of luck with your newest 20K shares. Here's to hoping they see $10+ by Thanksgiving!
I really never thought that you (or anyone else for that matter) would have gotten the chance to buy shares for $10 less than what I paid for my last batch 🤮
By the way, do you have a "mental stop loss" in mind or are you committing to holding onto the 20K through Turkey Day?
Hey Georgejjl - Are you still absolutely positive that Roche is interested in buying or partnering with AVXL, even after the announcement earlier this morning of their $7.1B deal to buy Telavant Holdings?
https://www.cnbc.com/2023/10/23/roche-agrees-7point1-billion-deal-to-buy-telavant-holdings.html?&qsearchterm=roche%20buy%20telavant
And how about your buddies? Are they buying with both fists yet? We AVXL longs here appreciate all your support!
Well, AVXL is sub $5.40 now. Time to pull that 100k share trigger!
Well, since LTB stated yesterday that he will be buying 100k @ $5.40, you might not get a chance to get anymore for yourself below that level...
Just to be accurate, the reported p-value with respect to brain volume loss was actually "p=0.0005"
Why the need for 500 words?!?
Heck, a large part of the reason why can be explained using just 1 single word - CITADEL
Let's hope the day arrives when we see you post the following:
"Additionally, one of my favorite indicators, the 30 day RSI, is screaming buy while you can at $56.00 range." hehe
FWIW - Difference between waiting for $0.675 to buy $10k worth of NWBO rather than just buying right now at the current $0.695 ask is 426 shares. Hey, who knows...those extra 426 shares could be worth $1,000's this time next year!
You got that 100k buy order locked and loaded?
Sure would love to look back a year from now and be able to say, "Dang, that bas2020 was right on the mark with his AD AA call!"
Let's just hope you will never get the opportunity to say the following:
"This stock could double and still be in single digits."
Since I consider myself fully loaded with AVXL shares, I won't be adding any more shares...
After all this time, I am hoping to have the opportunity to begin selling some shares upon FDA approval of AVXL's NDA.
Sometime prior to Christmas 2024 sure would be nice! hehe
4) Would not sell any of my shares
Well, let's hope your $16.xx's (along with my $15.xx's...ugh!) can get back in the black in the not-too-distant future!
Yep, whaddya gonna do LOL
By the way, here's to hoping we'll be looking back at your recent sub $5.90 purchase as marking the damn bottom!
AND valuation too...
For what reason? Do you really think it is going to look any different than watching grass grow or watching paint dry?