Anavex Life Sciences Corp (AVXL)
Eigenlijk net vorige week een positie ingenomen , maar gaat nu gelijk al hard....en dat eigenlijk alleen nog maar door die recente Cassava Sciences Inc (SAVA) -hype geloof ik = mooie Phase 2 Alzheimer results....
Als er hier toevallig ook nog Cassava bezitters rondhangen: allereerst wow, feli!
Maargoed, had die Anavex positie ingenomen op basis van wat eigen due diligence / huiswerk -->morgen wordt de nieuwe earnings- kwartaalrapportage verwacht.
Market cap: nu $500 Miljoen (eergister nog 320M)
Profiel: Alzheimer, Parkinson, Rett, depressie, pijn
Top product : Anavex2-73
Insiders 19,5%, Institutions 29,3%
Short 14% (redelijk laag voor nasdaq begrippen)
Cash Runway: 50M cash = 2 jaar
Persoonlijke trigger: de topline Phase 2 results uit dec-20
Komende milestones: H1 zit vol met verwachte Phase 1/2/3 trial results, waarvan een deel al heel snel schijnt te komen...zie ook de bijlage met de laatste Anavex Presentatie uit Januari 2021 (pagina 6)
Concurrentie: aan de beurskoers te zien had ik voorlopig dus eigenlijk voor de concurrent Cassave kunnen kiezen, maar geen klachten: er zit nog heel wat mooi nieuws aan te komen lijkt het....
Wel toont het wel weer mooi aan hoeveel potentieel Anavex heeft. Want Anavex lijkt al weer een stuk verder te zijn dan Cassave qua Alzheimer:
"Despite the different approaches from SAVA and AVXL, it is interesting to note that both arrive at similar molecules for treating AD. This bodes well for both companies,with AVXL in the lead for about 3 years."
Overig: brede/mooie/goede pipeline, en echt gigantische grote potentiële markten
Anavex gains after favorable data from Cassava Sciences in Alzheimer’s.
Weighing in on the stock, with a bullish thesis on Anavex, Seeking Alpha contributor Lane Simonian comments: ‘Anavex 2-73 likely has the best chance of long-term success of the current group of drugs being studied for Alzheimer’s disease.’
mooie uitleg 2-73:
Anavex’s lead asset ANAVEX®2-73 is currently undergoing a Phase 2b/3 study in Alzheimer’s disease. The enrollment was 80% complete, and full enrollment of 450 patients is expected in early 2021, the company announced in late December.
ANAVEX 2-73 is based on oxidation and nitration causing Alzheimer’s. Other drug companies have instead focused on the cause being amyloid. They have misdiagnosed the cause while we believe Anavex has the correct approach.
Anti-amyloid and anti-tau drugs have proven to only slightly slow down the progression of Alzheimer’s disease. The prevention or removal of either has shown little effect on the progression of the disease.
Inflammation, tau, and amyloid all add to oxidative stress but are themselves the products of this stress. The key then is not only to inhibit oxidative stress (which only moderately slows down the progression of the disease over time), but to remove compounds that are causing oxidation and nitration, and reverse part of the damage that they are doing to the brain.
Oxidation and nitration also likely play a role in Parkinson’s Disease Dementia and Rett syndrome. This is why we believe Anavex 2-73 is the most promising drug being developed today.
Anavex Life Sciences Fiscal 2021 First Quarter Financial Results and Business Outlook on Thursday, February 11, 2021:
Conference Call and Webcast To be Held Thursday, February 11, 2021 4:30 pm Eastern Time
Anavex Life Sciences Reports Fiscal 2021 First Quarter Financial Results And Business Outlook
NEW YORK – February 11, 2021 – 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 financial results for its fiscal quarter ended December 31, 2020.
“We are thrilled to begin the new year with this business outlook, which adds to the breadth of strong clinical data we’ve reported across our precision medicine pipeline using orally once daily ANAVEX®2-73 (blarcamesine) for Rett syndrome, Parkinson’s disease dementia and Alzheimer’s disease,” said Christopher U Missling, PhD, President and Chief Executive Officer of Anavex. “We look forward to providing on a timely basis in 2021 multiple clinical data read-outs from these clinical programs. The converging biomarker-driven clinical data is giving us added confidence in our efforts to meet our goal of potentially bringing new therapeutic interventions to patients.”
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.
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.
Anavex Life Sciences’ 2021 Business and Clinical Outlook:
Underlying cause of Alzheimer’s disease and therapeutic intervention:
Researchers at the University of California San Diego have identified the underlying cause of Alzheimer’s disease in neurons. They discovered that changes in the structure of chromatin are responsible. Sigma-1 Receptor (SIGMAR1), the direct target which gets activated with ANAVEX®2-73 demonstrated to restore chromatin structures.
ANAVEX®2-73 linked to the prevention and treatment of age-associated diseases through induction of the autophagy “cellular recycling” process and enhanced protein clearance in cells.
ANAVEX®2-73 is currently in a Phase 2b/3 Alzheimer’s disease clinical trial utilizing differentiated patient selection criteria and study is presently over 86% recruited.
ANAVEX®2-73 program for Rett syndrome and other pipeline updates:
Potential accelerated approval strategy planning underway as Phase 2 U.S. Rett syndrome trial clinical data showed positive clinical activity and safety data with progress within ongoing Phase 2/3 AVATAR adult Rett syndrome and Phase 2/3 EXCELLENCE pediatric Rett syndrome studies.
U.S. Food and Drug Administration (FDA) approved extension of ANAVEX®2-73 U.S. Rett syndrome Phase 2 open-label extension study from 12 weeks to 36 weeks.
Anavex received compassionate use Special Access Scheme (SAS) approval in Australia for Rett syndrome patients to continue treatment with ANAVEX®2-73 after completing the Phase 2/3 AVATAR adult Rett syndrome clinical extension study.
Anavex has sufficient ANAVEX®2-73 available to support all ongoing and planned clinical trials and first-year commercial launch needs for the Rett syndrome program.
ANAVEX®2-73 drug substance and oral solution exhibit excellent chemical stability based upon 3 years of stability data in both cases.
New clinical pipeline compound ANAVEX®3-71 Phase 1 study is on track: Independent Data Safety Monitoring Board (DSMB) for the Company’s Phase 1 study of its new investigational compound ANAVEX®3-71, also a small molecule activating SIGMAR1, has completed its recent pre-planned review of the preliminary Phase 1 safety data. The DSMB recommendation is to continue the study without modification.
Anavex is pioneering the approach of big data in clinical trials to leverage the relevance of phenotypic and genotypic precision medicine analyses of Whole Exome Sequencing (WES) and gene expression (RNAseq) data in drug development and in particular the potential to identify patients’ genetic variants and gene expression changes that may predict increased chances of success of Alzheimer’s disease, Parkinson’s disease and Rett syndrome treatments.
Further clinical milestones are provided in Anavex Life Sciences’ latest corporate presentation, available on anavex.com.
Recent Business Highlights:
In January 2021, Anavex announced that it has been awarded a research grant of $995,862.51 from the Michael J. Fox Foundation for Parkinson’s Research (MJFF) to develop ANAVEX®2-73 (blarcamesine) for the treatment of Parkinson’s disease. The award will explore utilization of PET imaging biomarkers to enable measurement of target engagement and pathway activation of the sigma-1 receptor (SIGMAR1) with clinically relevant doses in people with Parkinson’s disease.
On February 11, 2021, cash and cash equivalents of approximately $75 million, sufficient cash runway for up to three (3) years.
Cash and cash equivalents of $47.4 million as of December 31, 2020, compared to $29.2 million at September 30, 2020.
Net loss of $7.9 million, or $0.12 per share for the quarter, compared to net loss of $6.6 million, or $0.12 per share in comparative quarter of fiscal 2020.
Research and development expenses of $7.9 million for the quarter, compared to $6.3 million for comparable quarter of fiscal 2020.
The financial information for the fiscal quarter ended December 31, 2020 should be read in conjunction with the Company’s interim condensed consolidated financial statements, which will appear on EDGAR, www.sec.gov and will be available on the Anavex website at www.anavex.com.
iemand misschien al een mening over die laatste update van Anavex?
Ik vind in de laatste conference call transscript toch wel heel wat interessante dingetjes...maar gaan ze waarmaken?
-2-73: 100% of all patients continued in the extension study. And the reason for the extension of the extension by another six months was the interest from the participating patients and families, as well as, the ability to continue to learn and add long-term safety data of -- for Rett syndrome patients with our compound
We believe that now the chances have increased to also be successful in a clinical study in the Fragile X and that's why we're planning, and we already have developed the study design to move into Fragile X as a next study for ANAVEX 2-73.
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.
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.
3-71: What we have noticed that we received for ANAVEX 3-71 orphan drug designation by the FDA for frontotemporal dementia and we might bring 3-71 toward indications first which are not competing with ANAVEX 2-73 directly. But we are very excited that we have another compound with the same valuable target of sigma-1 activation which is -- and turns out to be so important biologically that we can use this also for indications which we have not yet covered 2-73
3-71 Phase 1: the first two panels was a single ascending dose. And that was very impressive that we got this green light to move forward now in the panels of going into female/male effect and their differences, as well as, recurring treatment, as well as, food effect of the drug. So basically, the most important hurdle of a Phase 1 is like dose ascending that was well tolerated to the highest dose, a planned dose was positive. That is the most, I would say, crucial information about the Phase 1 study and now comes just nunances of the Phase 1. We said that we would have the data within the first half of 2021. I think it looks like it will be earlier
RETT: The ability to get voucher is given that we have a faster designation and orphan designation, and we also have the voucher eligibility so that also is a positive answer if the pedriatric study is positive.
this is really a classical case where a company can move into marketing the drug ourselves, like example has shown like Alexion and other comparable, a company which had successfully launched a drug in a rare disease setting in the size we have and at hands with Rett syndrome
ATM Facility: we were obviously very fortunate to take advantage of this recent stock move, but I think the details will be provided in the next Q, which will show up early next week. Because our -- the latest filing will be on Monday because Monday is a US holiday, so it will be next week, Tuesday, most likely, at least dilutive possible, so it will be not by much.
Cassava: I think the trial you're referring to is an open-label study. So that is a different situation you have here. But I just want to point out that we, obviously, are almost completing the randomization of our Phase 3 study, if you so like. What the other company you mentioned still has to start and the other point I tried to make is that we have the program in Rett syndrome, which could generate revenue pretty soon by itself in addition to Parkinson's disease dementia data which also is unique for Anavex. So I think we're in a good position
sinds vorige bericht eigenlijk alleen maar goed nieuws gepubliceerd:
koers staat nu ook weer rond die van Feb-21 ($15)
@admin @mod: verhuizen jullie dit draadje mee naar dat nieuwe anavex-subforum
mercurius-adept schreef op 10 juni 2021 09:48:
@admin @mod: verhuizen jullie dit draadje mee naar dat nieuwe anavex-subforum
Ik ga maar even verder in dit oude draadje, omdat ik het eigenlijk wel mooi vind dat die al loopt sinds 2015...het bedrijf is niet van gister ;)
Er zijn op dit moment nu al 3(!) FDA panelleden opgestapt naar aanleiding van die controversiële toelating van alzheimer medicijn van Biogen:
Dr. Kesselheim: "My rationale for resigning was that the FDA needs to re-evaluate how it solicits and uses the advisory committees ... because I didn’t think that the firm recommendations from the committee in this case ... were appropriately integrated into the decision-making process,"
Dr. Joel Perlmutter: “Approval of a drug that is not effective has serious potential to impair future research into new treatments that may be effective,”
Dr. David Knopman: “I was very disappointed at how the advisory committee input was treated by the FDA,”
En CNBC citeert nog uit ontslagbrief Dr. Kesselheim: "...decision on Biogen “was probably the worst drug approval decision in recent U.S. history,”
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||25 jan 2022 22:00