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Today is the first time I have ever received an unsolicited PR emailed from Anavex regarding their appearance at B. Riley Securities. I wonder if there's any reason for this extra email promotion of the conference on Wednesday. Something they don't want us to miss? What's brewing?
- Final launch window determination
- Activate flight recorders
- Final "go/no-go" launch polls conducted by Anavex management team and directors
- Start automatic ground launch sequencer with peer review from Harald Hampel
- Retract orbiter access arm and ready GABA Glutamate regulation(T-7 minutes, 30 seconds)
- Start auxiliary SIGMAR1 power units (T-5 minutes, 0 seconds)
- Arm solid rocket booster range safety safe and no side effects (T-5 minutes, 0 seconds)
- Start orbiter aerosurface homeostasis profile test, followed by main engine gimbal profile test and autophagy (T-3 minutes, 55 seconds)
- Retract gaseous oxygen vent arm, or "beanie cap" (T-2 minutes, 55 seconds)
- Crew members close and lock their visors and prepare to meet all primary and secondary endpoints (T-2 minutes, 0 seconds)
- Orbiter transfers from ground to internal power increased MMSE scores (T-50 seconds)
- Ground launch sequencer is go for auto sequence chromatin start (T-31 seconds)
- Activate launch pad dementia suppression reversal system (T-16 seconds)
- Activate main engine hydrogen burnoff system and share price appreciation system (T-10 seconds)
- Main engine start (T-6.6 seconds)
- Solid rocket booster ignition...
Yes, what you say regarding authorized shares is true but worse case scenario, we're diluted 125% and we lose about 62% of our equity in the company. I'm not willing to vote for this worse case scenario. If in the future, Missling asks for additional shares stating they were for a forward split, that would be a different story; however, it is unclear what the additional shares are for so I'm going to err on the side of caution.
I will be voting NO as well. I have not been a member of this board for long but I have been invested since 2015 and have accumulated a substantial amount of shares over that time. Many here have supported this company longer than I have. We believed in this science and continued to support this company for so many years when everyone else has been against us and now they want to dilute our shares by 125%?!!! If we vote for that, our stake in the company would be about 38% less of what it is now. No way! I'm going to keep my stake in this company. Even if they give us the best news possible, I'm still going to vote to keep the amount of ownership I have. If the science is real, this company will be unstoppable whether we approve the additional shares or not, and I'm sure we all would prefer to hang on to the percentage of this company that we own now rather than give away 62% of what we have. Missling already asked us to trust him and approve the preferred shares. We've already done that and I'm not giving anymore. It's time for Missling to stop coming back to the well asking for more, stop missing his deadlines, and finally, deliver on his promises.
Jack Hanna diagnosed with dementia.
https://apnews.com/article/jack-hanna-dementia-f289177a395963391963c2a4e6b00ba7
- Final launch window determination
- Activate flight recorders
- Final "go/no-go" launch polls conducted by Anavex management team and directors
- Start automatic ground launch sequencer with peer review from Harald Hampel
- Retract orbiter access arm and ready GABA Glutamate regulation(T-7 minutes, 30 seconds)
- Start auxiliary SIGMAR1 power units (T-5 minutes, 0 seconds)
- Arm solid rocket booster range safety safe and no side effects (T-5 minutes, 0 seconds)
- Start orbiter aerosurface homeostasis profile test, followed by main engine gimbal profile test and autophagy (T-3 minutes, 55 seconds)
- Retract gaseous oxygen vent arm, or "beanie cap" (T-2 minutes, 55 seconds)
- Crew members close and lock their visors and prepare to meet all primary and secondary endpoints (T-2 minutes, 0 seconds)
- Orbiter transfers from ground to internal power increased MMSE scores (T-50 seconds)
- Ground launch sequencer is go for auto sequence chromatin start (T-31 seconds)
- Activate launch pad dementia suppression reversal system (T-16 seconds)
- Activate main engine hydrogen burnoff system and share price appreciation system (T-10 seconds)
- Main engine start (T-6.6 seconds)
- Solid rocket booster ignition...
"... if Adu will get approved, we believe it will be synergistic to ANAVEX 2-73 because it is a different pathway. But also we have seen that ANAVEX 2-73 has been shown preclinically to prevent the disease." https://www.fool.com/earnings/call-transcripts/2021/02/11/anavex-life-sciences-avxl-q1-2021-earnings-call-tr/
Full quote from transcript:
"I would rather think that a synergy could be with other compounds targeting other pathways, like if Adu will get approved, we believe it will be synergistic to ANAVEX 2-73 because it is a different pathway. But also we have seen that ANAVEX 2-73 has been shown preclinically to prevent the disease. So it's not only the treatment which is the goal and that's what we're now finding out with our ongoing Phase 3 study in Alzheimer's disease.
But also thinking ahead strategically that one day of ANAVEX 2-73 could be used as a daily mini-aspirin potentially to avoid being -- coming in near to be in a situation where you get affected by or afflicted by such a horrible disease like Alzheimer's disease."
"... ANAVEX 2-73 has been shown preclinically to prevent the disease." It’s in the transcript you posted. https://www.fool.com/earnings/call-transcripts/2021/02/11/anavex-life-sciences-avxl-q1-2021-earnings-call-tr/
Full quote from transcript:
"I would rather think that a synergy could be with other compounds targeting other pathways, like if Adu will get approved, we believe it will be synergistic to ANAVEX 2-73 because it is a different pathway. But also we have seen that ANAVEX 2-73 has been shown preclinically to prevent the disease. So it's not only the treatment which is the goal and that's what we're now finding out with our ongoing Phase 3 study in Alzheimer's disease.
But also thinking ahead strategically that one day of ANAVEX 2-73 could be used as a daily mini-aspirin potentially to avoid being -- coming in near to be in a situation where you get affected by or afflicted by such a horrible disease like Alzheimer's disease."
You're correct; I forgot the ellipses. Here is the corrected quote "one day ANAVEX 2-73 could be used as a daily mini-aspirin potentially to avoid... such a horrible disease like Alzheimer's disease." - Christopher Missling
Just posting some highlights from over the years. The best is yet to come!
Recent third party peer review in Neuropharmacology confirms the efficacy of blarcamesine on neurodegenerative diseases.
https://www.anavex.com/anavex-life-sciences-reports-anavex2-73-blarcamesine-featured-as-a-disease-modifying-small-molecule-in-phase-3-clinical-trials-in-a-new-publication-in-medical-journal-titled-future-av/
The Neuropharmacology publication noted that in the clinical study, 57 weeks of oral once daily ANAVEX®2-73 treatment showed patients improved cognition scores by +2.0 points on MMSE, a 9% mean improvement from baseline to 57 weeks, corresponding to a calculated ADAS-Cog score change of -3.4 (improvement). In these same patients ANAVEX®2-73 also improved ADCS-ADL, by +4.9 points, a 7% mean improvement from baseline to 57 weeks.
An extension of the published study (ANAVEX2-73-003) demonstrated that for the same patients at week 70 MMSE scores improved by +3.0, a 14% improvement from baseline, corresponding to a calculated ADAS-Cog score change of -5.1 (improvement). In these same patients, ANAVEX®2-73 also improved ADCS-ADL, by +6.0 points, an 8% mean improvement from baseline to 70 weeks. The mean MMSE and ADCS-ADL baseline scores for these patients in this study were 22.3 and 71.1, respectively.[4],[5]
This data seems to be consistent with the effect of ANAVEX®2-73 on cognition assessed in the recently completed placebo-controlled Phase 2 study of 132 patients with Parkinson’s disease dementia (ANAVEX2-73-PDD-001) with once-daily administration of oral 30 mg ANAVEX®2-73, 50 mg ANAVEX®2-73 and placebo for 14 weeks. The observed statistically significant improvement of CDR system Episodic Memory of +42.22 between 50 mg ANAVEX®2-73 and placebo was also dose-dependent (p = 0.003).[6] CDR system Episodic Memory has been shown to be highly correlated (70%) with the ADAS-Cog score (r = 0.7).[7]
The calculated corresponding ADAS-Cog mean change from baseline score is -1.9 (improvement) for patients in the 50 mg dose group, an 8% mean improvement from baseline to 14 weeks. The difference between the ANAVEX®2-73 group and the placebo group in the change from baseline at 14 weeks was a 4.0-point improvement of calculated corresponding ADAS-Cog score (p = 0.015).
The Mini-Mental State Exam (MMSE) and the ADAS-Cog (Alzheimer’s Disease Assessment Scale–Cognitive Subscale) are standard tests for assessing changes in cognition in Alzheimer’s disease trials and known to correlate to a high degree.[8] The ADCS-ADL (Alzheimer’s Disease Cooperative Study–Activities of Daily Living), assesses the competence of patients with Alzheimer’s disease in basic and instrumental function or activities of daily living.
Alzheimer’s is a progressive disease and over time, a patient’s cognition will always worsen. “Experience based on longitudinal studies of ambulatory patients with mild to moderate Alzheimer’s disease suggest that scores on the ADAS-cog worsen by 6-12 points per year” with the annualized rate of decline might be smaller depending on the disease stage, according to FDA’s Prescription Information sheet for ARICEPT® (donepezil), a drug approved for the treatment of dementia of the Alzheimer’s type.[9]
While the placebo-controlled 450-patient Phase 2b/3 ANAVEX®2-73 clinical study in Alzheimer’s disease is currently ongoing, prior clinical research in Alzheimer’s disease conducted by other sponsors can serve as a contextual reference for estimates of an expected rate of decline in cognition (MMSE and ADAS-Cog) and function (ADCS-ADL) in placebo patients:
In 2019, a randomized controlled trial of aducanumab (Biogen) was conducted in >1,000 patients with early Alzheimer’s disease.[10] In this Phase 3 study (EMERGE), patients on placebo showed from baseline to week 50 a mean decline in cognition of approximately -2.2 points on MMSE, an 8.3% decline, and from baseline to week 78 approximately -3.3 points on MMSE, a 12.5% decline, respectively. Mean baseline MMSE score was 26.4.
Large placebo arm data from 20 randomized controlled clinical trials including over 4500 mild-to-moderate Alzheimer’s disease patients treated with standard of care, containing ARICEPT® (donepezil, Eisai) and memantine was analyzed.[11] In this analysis, patients on placebo showed from baseline to week 52 a mean decline in cognition of approximately -2.05 points on MMSE, a 10% decline and from baseline to week 78 approximately -3.4 points on MMSE, a 16% decline, respectively, with a calculated mean baseline MMSE score of 21.0. The respective ADAS-Cog decline was 3.9 points from baseline to week 52 and a decline of 6.6 points from baseline to week 78, respectively.
A randomized controlled study including of ARICEPT® (donepezil, Eisai) and memantine was conducted in >500 patients in the placebo arm with mild-to-moderate Alzheimer’s disease.[12] In this Phase 3 study, patients on placebo showed from baseline to week 76 an estimated mean decline in cognition of approximately -3.4 points on MMSE, a 16% decline from baseline. Mean baseline MMSE score was 20.9. The mean ADAS-Cog decline was 6.4 points from baseline to week 76. The mean ADCS-ADL decline was -9.0 points from baseline to week 76.
ANAVEX®2-73 is currently in a late-stage Phase 2b/3 Alzheimer’s disease clinical trial utilizing same dosing regimen as in the above-described completed Parkinson’s disease dementia (ANAVEX2-73-PDD-001) study with differentiated patient selection criteria.[13]
“This paper highlights the relevance of the analyses of gene expression data in precision medicine to drug development that may predict increased chances of success of Alzheimer’s disease treatments, which is especially relevant in late-stage clinical studies like the ongoing ANAVEX®2-73 Phase 2b/3 clinical Alzheimer’s disease study,” 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.[14]
Anavex Life Sciences’ product portfolio includes small molecule drug lead candidate ANAVEX®2-73 for the treatment of Alzheimer’s disease, Parkinson’s disease and Rett syndrome.
These valuations make no sense. Anavex is at least two years ahead of SAVA with their phase 3 Alzheimer’s trial close to full enrollment and has many other phase 3 trials in other indications. How is SAVA's market cap 3 times AVXL? Be careful of Wall Street games. There can be a revaluation very quickly once everyone realizes.
http://www.anavex.com/wp-content/uploads/2021/02/Anavex-Presentation-February-2021.pdf
Just some added safety. Even astronauts buckle up when they get ready for launch.
Buckle Up!
HC Wainwright Anavex Presentation March 9, 2021
https://journey.ct.events/myschedule/7fafe09d-6023-4e24-b7be-8dbff9f06c9b
HHS setting up Monoclonal Antibody Infusion Centers nationwide. They are recommending receiving the infusions within two to five days of developing symptoms. They also state that Regeneron's antibodies are more effective than Lilly's against the new variants from South Africa and Brazil. It would be great if Cytodyn can eventually be included as an option at these infusion centers. Expecting an exciting next few weeks for us CYDY shareholders. Good luck to all!
https://news.yahoo.com/covid-19-treatments-monoclonal-antibodies-143133454.html
NBC's TODAY did a good segment on monoclonal antibodies for Covid-19. At least they are getting the word out. Hopefully Leronlimab can be made available soon.
https://news.yahoo.com/covid-19-treatments-monoclonal-antibodies-143133454.html