ANAVEX NY TRÅD 2022 - positive resultater for 3-71!!!
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Anavex Super Seeking Alpha artikel!!
Ikke meget nyt, men den kan måske få nye investorer til at interesserer sig lidt for casen.
Når man endnu en gang kigger på Anavex`s pipeline, som alt er baseret på ekstrem grundig forarbejde og kun udelukkende positive resultater, ingen gæld og 150 mill.$ på bogen - så kan man godt undre sig, at MC ikke er højere pt. - fratrækkes likvider, er Anavex og hele dets pipeline sat til en værdi på sølle 900 mill.$!!2022 bliver showdown året!
Anavex: 2022 Has Major, Pivotal Catalysts.
Bottomline
AVXL has proven itself, over and over again, as a stock that rallies on news, however slight. 2022 is a year full of major catalysts for the stock, so the stock looks attractive from that point of view. However, these catalysts, and especially the AD trial, are major binary events. If the company succeeds with that trial, it will be worth billions and billions of dollars. If it fails, well, they do have two other indications with topline data this year, but a failure in AD will impact the stock very badly. No wonder everyone, including even analysts at earnings calls, are walking softly around the Alzheimer's question. It appears to me that the Street does not want to take anything but a fluid position, for fear of being wrong.Kopi til dem, der ikke abonnerer.
Anavex: 2022 Has Major, Pivotal Catalysts
Jan. 17, 2022 10:12 AM ETAnavex Life Sciences Corp. (AVXL)5 Comments5 Likes
Summary
Anavex's long story is coming to a climax this year.
The company will announce topline data from the Alzheimer's trial by 2H 2022.
This will be the most important event in the lifecycle of this company.
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Hot air balloons flying over the Botan Canyon in TURKEY
guvendemir/E+ via Getty ImagesSince my April coverage of Anavex (AVXL), a midstage drug developer for Alzheimer's and other CNS diseases, the stock nearly doubled, then subsided right back to where it was in April. Some of the spike may have been caused by the surprise approval of Biogen's (BIIB) Aduhelm, which occurred in early June. However, AVXL stock has stayed at a decent price on its own merit, not just as a sympathy play.
Anavex's lead candidate is ANAVEX 2-73, or blarcamesine, an agonist of the intracellular sigma-1 chaperone protein. This company has a broad pipeline targeting various CNS indications.
Anavex pipeline
Anavex pipelineAnavex website
ANAVEX 2-73 is targeting Rett syndrome and Parkinson's disease and Parkinson's dementia, as well as Fragile X syndrome. However, the lead indication is Alzheimer's, where the asset is running late-stage trials.
In my previous coverage, I discussed the company's long and arduous path towards success in this indication, a variety of early-stage data, and that the DSMB has approved that a larger phase 2/3 trial continue as planned. In mid-2021, this study exceeded its target enrollment of 450 patients:
The study exceeded enrollment beyond 450 patients at 52 sites across North America, Europe and Australia using ADAS-Cog (cognition) and ADCS-ADL (activities of daily living and function) as primary endpoints.
In October, the DSMB approved - a second time (?) - that the trial, now with 509 patients, should continue as planned.
Topline data is expected in mid-to-late 2022; this will be the most important catalyst in the lifetime of Anavex.
A research report published in the journal of Expert Opinion on Therapeutic Targets, and available here describes how ANAVEX2-73 may address Alzheimer's Disease or AD through the activation of autophagy. Autophagy is a physiological process that works like a scavenger of damaged cellular components, including those components that have long been held to be responsible for AD. ANAVEX2-73 targets and activates the sigma-1 receptor, which is thought to chaperone a number of these housekeeping processes. AVXL owns and is developing a number of such Sigma-1 receptor agonists like AF710B, T-817 MA, and ANAVEX2-73. The key statement of the report is:
...the activation of σ-1R and autophagy could alter amyloid precursor protein processing to inhibit amyloid-β production by reconstituting cholesterol and gangliosides in the lipid raft to offer neuroprotection against AD.
Other key highlights of the article:
The σ-1R's expression increases with age; however, in Alzheimer's disease (AD) pathology, it decreases.
The decrease in σ-1R expression during AD coincides with an age-related decrease in autophagy.
The σ-1R may compensate for loss of receptors and autophagic machinery during healthy aging.
Activation of the σ-1R can induce cytoprotective autophagic pathways.
Promising σ-1R ligands used as AD drugs have been shown to induce autophagy.
Autophagy plays a key role in the progression of AD pathology.
Like I said, the AD trial is AVXL's biggest catalyst ahead. This trial now has an extension phase due to patient requests, said company management in their earnings call:
So we have an extension study called ATTENTION-AD, which is a two-year study of following up as an open label after the 48-week, which has started, after the first patient finished the 48 weeks. And because these patients have actually, some of them finished this phase two Open Label Extension, they had requested to continue to stay on the study drug.
And so what we did, we initiated and we're successful in expanding now this ATTENTION-AD study Open Label Extension from two years to three years. So patients who are finish the study, the placebo control study, enter into the EXTENSION study finish the two years will now continue to go into the third year. And that is because of request by the patient, the caretakers and the physician. It also, I like to add that the -- I like to add also that the conversion from the placebo-controlled part of the study to the open label is very high it's above 94% currently, which is a good sign.
Earlier in 2021, the company also announced positive data from its Parkinson's disease study. The molecule was able to improve motor and cognitive functions in patients, while, at the same time, improving SIGMAR1 concentration. This correlation between efficacy and biomarker is important, says FierceBiotech, because it scores one over Biogen's aduhelm, which was approved on the basis of only biomarker improvement.
About the pipeline progress, Christopher U. Missling, PhD, President and Chief Executive Officer of Anavex, said during November earnings:
Anavex concluded an exceptional fiscal year 2021 while continuing its momentum, highlighted by the efficient execution and full enrollment of three Precision Medicine clinical trials, including the Phase 2b/3 ANAVEX
2-73 clinical trial in Alzheimer's disease, the Phase 2/3 ANAVEX2-73 clinical trial in Rett syndrome as well as the Phase 1 of ANAVEX3-71.Financials
AVXL has a market cap of $1.04bn and a cash reserve of $152.1mn as of September. This is a considerably better number than what we saw in my April article. This may have been assisted by two fundraisings. In June, AVXL announced a $50mn direct offering. In September, the company filed for what appears to be a $150mn secondary offering. R&D costs for the company were $33mn in 2021, and $9mn was G&A expenses. At that rate, the company has cash for a number of years.The company is very heavily publicly owned, with just about 30% of the company in the hands of funds and institutions. Key holders are BlackRock, State Street and Vanguard. There are very few insider transactions at Anavex; however, the few that are, are buys:
AVXL stock insider transactions
Anavex insider dataOpeninsider
The company is covered by the following analysts:
Anavex <span class='ticker-hover-wrapper'>(NASDAQ:<a href='https://seekingalpha.com/symbol/AVXL' title='Anavex Life Sciences Corp.'>AVXL</a>)</span> stock analyst coverage
AVXL Analyst CoverageAnavex website
Here's a look at the company management and advisory board:
Anavex management
AVXL managementAnavex website
Bottomline
AVXL has proven itself, over and over again, as a stock that rallies on news, however slight. 2022 is a year full of major catalysts for the stock, so the stock looks attractive from that point of view. However, these catalysts, and especially the AD trial, are major binary events. If the company succeeds with that trial, it will be worth billions and billions of dollars. If it fails, well, they do have two other indications with topline data this year, but a failure in AD will impact the stock very badly. No wonder everyone, including even analysts at earnings calls, are walking softly around the Alzheimer's question. It appears to me that the Street does not want to take anything but a fluid position, for fear of being wrong.About the TPT service
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Disclosure: I/we have no stock, option or similar derivative position in any of the companies mentioned, and no plans to initiate any such positions within the next 72 hours. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article. -
Anavex Værdisætning af Alzheimer behandling.
https://www.ipwatchdog.com/2021/10/26/assessing-much-alzheimers-drug-worth/id=139154/
Denne artikel beskriver værdiansættelsen af en Alzheimer behandling, både som endelig godkendt, men også når det "kun" er i et fase 3 forsøg.
Illustrerer hvor skævt/lavt værdien af 2-73 i fase 3 forsøget i Alzheimer er sat - ifht. hvis selskabet hed Biogen eller Eli Lilly og ikke bare lille Anavex.
Iflg. dette burde Anavex`s MC alene baseret på det fremskredende Alzheimer fase 3 forsøg, ligge på ca. 20 milliarder $ - uden RETT, Parkinson, 3-71 og resten af pipelinen - eller ca. 20 X nuværende værdi!!!
Sidste patient i Alzheimer forsøget ventes færdigbehandlet omkring 1. maj 2022 - altså meget snart!
Topline data får vi måske i slutningen af 2022 - selv med Missling tidsregning.
De første patienter har nu både været igennem de 48 uger for selve forsøget + 2 års OLE/ekstension + påbegyndt endnu et ekstension år.
Leverer Anavex, så skal vi nok få en mere fair MC."Based on the event studies on Biogen's Aducanumab and Lilly's Donanemab, the value of a drug candidate at or ready for Phase 3 trial would be worth $20.2 billion to $20.7 billion, and a Breakthrough Therapy Designation has a value of $13.4 billion. An Alzheimer's drug approved by the FDA carries a market value of $43.4 billion."
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@Tasso, måske man skulle opfordre nogen med "debatør tyngde" til at skrive noget om Anavex inkl. tickercode i "join the discussion" på ovenstående indlæg. Fx. MayoMobile fra iHub eller måske dig? En har allerede skrevet om Casava og Annovis.... og det giver jo et hit når man søger bredt ...
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Klemmensen,
MayoMobile har allerede skrevet et indlæg til Seeking Alpha men det blev afvist fordi han var for videnskabelig og ikke skrev noget om økonomien i Anavex.
Med andre ord, de fattede ikke noget som helst af det han skrev, så de fik kolde fødder.Han overvejer hvad han vil gøre nu, tror jeg.
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Anavex ... Kun gode data kan ændre billedet.
Mht Alzheimers fase 2/3 så kan man jo sige, at ingen tidligere har haft succes med et stof der rigtigt virkede. Så hvis man tager højde for den sandsynlighed i en økonomisk model så er værdien 0 kr.
Tålmodighed så skal vi nok blive belønnet er min vurdering.
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I have been here since 2020 haha.
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Anavex. BTIG fastholder kursmål på 35 $.
Gennemsnitlig kursmål på 39,8 $
MayoMobile - please continue your amazing work of analyzing the science behind Anavex!
Nice to see you here at Proinvestor. -
Anavex ... Alle PDD pts blev indrulleret i efterfølgende OLE studie - alle incl placebo.
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=167556276Det er et godt tegn.
Også dejligt med lidt kursstigninger
Måske vi kunne få den danske MayoMobile til at give en kommentar ?
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Thank you Tasso1! Sun, there were two things of interest in the regulatory site updates. First, the PDD OLE trial is now set to finish within 1 month of the AD 2b/3 trial (primary complete) with both the OLE and the AD 2b/3 expected to finish (study complete) in June 2022. This lines up extremely nicely as it gives Ariana time to either focus on one trial data set or run the analysis on both simultaneously. I personally think Missling will combine the PDD OLE and the AD data together for investors.
Even if he doesn't do this publicly, I guarantee he will be combing the data for regulators (FDA, EMA, TGA).
The other tidbit is of course the 'OLE enrolled patients' now matching the placebo group. This of course indicates that 100% of patients opted into the extension which is fantastically optimistic.
Sorry if you guys have to translate this.
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Anavex. Min. 70 % sammenfald mellem AD og PDD.
Som MayoMobile skiver, så afsluttes både AD fase 2/3 og PDD OLE næsten samtidig her til sommer 2022.
Dvs. 2/3 gange 509 + 132 = ca. 470 pt, der har fået min. 30 - 50 mg 2-73 i min. 48 uger.
Da vi fra tidligere har fået oplyst, at der er min. 70 % sammenfald i de parameter AD og PDD undersøges i, så må Anavex kunne sammensætte et meget stærkt samlet billede på effekten i demens, over en længere periode, hvor bivirkningsprofilen også bliver belyst.Samtidig ved vi, at flere pts. fra AD fase 2/3 udover hovedforsøget også har gennemført 2 år OLE og nu er forsat på deres 4. år. - dvs. man nu også kan begynde at indhente data for en relativ langtidseffekt af 2-73.
Jeg tror også på, at Anavex vil udnytte muligheden og formidle et samlet billede til myndighederne.
Det er påfaldende, at Anavex netop nu har opdateret status på deres forsøg - det sker ellers kun ganske få gange om året og ofte noget forsinket ifht. den reelle status.
Min første tanke var - at det var noget Anavex lige skulle have på plads før udmelding af resultater.Det ville jo virke upassende, at komme med resultater på et forsøg, som officielt ikke er afsluttet?
Så måske Avatar i denne uge?
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Lugter sgu lidt af nogle negative resultater der er sivet ud.. ved godt XBI er nede osv. men det er jo voldsomt. Skulle de komme så ville $5 da nok være et sted at starte. Skulle de være positive så måske oppe 100% på dagen for at falde tilbage til 20%
Kald mig pessimist
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Altid en udfordring for nerverne at "tabe" penge.
I biotech bør man inden offentliggørelse af afgørende data have taget stilling til om man vil ligge med aktien ind over dette tidspunkt.
Mange grunde til at investorerne smider i nervøsitet nu.
Og der skulle udløbe større portioner af optioner i morgen, hvilket kan få pengemændene til at presse kursen.
Jeg holder fast og tror, at de stærke US rett data kan gentages. Ganske gode Cohen D effect size i dette forsøg prøver jeg at finde ro i
Anavex Life Sciences Corp (AVXL): Cohen’s D Effect Size & Anavex Would...
MayoMobile: Cohen’s D Effect Size & Anavex Would strongly recommend reading this: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2791668/ Especially the porti...
InvestorsHub (investorshub.advfn.com)
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It has been brought to my attention that there were some patients that dropped out of the PDD study (I forgot about this).
Taken directly from the CTAD presentation: "Subjects with at least one TEAE leading to study discontinuation in the maintenance phase were
4.9% in the active cohort versus 4.7% receiving placebo"This indicates one of three most likely possibilities.
1: During the titration phase (maintenance?) ~9.6% of total patients dropped out of the study... those patients were then back filled and the trial overall still completed with 132 patients - all of whom opted into the OLE. This is supported by the fact that on the episodic memory chart, Anavex is stating an N of 132. How could there be an N of 132 if 9.6% of the patients were never measured?
2: Anavex made a clerical error and all eligible patients opted into the OLE (less than 132).
3: 9.6% of patients did drop put of the main trial and the OLE replenished the original 132 with a few fresh patients (this is done in other OLE but seems unlikely given enrollment prerequisites). -
Anavex. Missling på den 22-24. feb. 2022
https://mitochondria-targets.com/
9:30 am Using Precision Medicine in Clinical Trials to Advancing Therapeutics for both Degenerative & Rare Mitochondrial Diseases
Christopher Missling
President & Chief Executive Officer, Anavex Life Sciences Corp
SynopsisAssessing clinical data with biomarker-correlated outcomes of ANAVEX2-73 (blarcamesine) in Alzheimer's, Parkinson's, and Rett Syndrome
Reviewing mechanistic analysis of involvement of mitochondrial functionDet ville nok være lidt op ad bakke for Missling, at skulle virke overbevisende, hvis han ankom med friske dårlige Avatar resultater?
En anden udmærket artikel fra ellers tidligere negative The Motley Fool, fra den 21. okt. 2021, som dengang synes at have en positiv effekt på kursen - intet har ændret sig siden og casen er kun blevet styrket af en løbende positiv udvikling.
2 Biotech Stocks Set to Go Supernova Soon | The Motley Fool
Anavex Life Sciences and Affimed both sport unique drug development platforms that could be worth billions.
The Motley Fool (www.fool.com)
At aktiemarkedet generelt er presset af overordnede økonomiske og geopolitiske årsager, afgør jo ikke om skidtet fra Anavex virker eller ikke virker!
Vi skal bare have tålmodighed - holder også fast og stoler på de udelukkende positive fakta vi fået præsenteret gennem årene! -
Anavex ... Som supplement til ovenstående tråd omkring Cohens D effect size har vi også fået oplyst af Missling, at doseringen i Avatar er "slightly higher" end US forsøget.
Se side 18 i investorpræsentationen fra Anavex https://www.anavex.com/_files/ugd/79bcf7_3dc7aeae98c145f8b80acfa95798dad1.pdf
Kurven viser dækningen af SIGMAR1 receptoren med Blarcamesine. Det ses, at der er en klar forbedret dækning fra 5mg til ca 10 mg. I hvilket interval vi må forvente Avatars dosering ligger.
Forudsættes en lineær sammenhæng til effekt kunne der måske forventes op til 30% bedre effekt af 10 mg i stedet for 5 mg - teoretisk. Så her er endnu et element der beroliger os.
Dosering er tolereret op til 50-80 mg i AD pts så en øget dosering burde ikke give negativt udslag på SAE.
Effekt beregnes jf præsentationsmaterialet kun på SIGMAR1 WT (wild type) varianten i Avatar. Det samme med US-trial data - kun 14 af 25 pts i US-trial var med denne variant. Uheldigt ikke flere WT var repræsenteret i US-trial (56%) når forekomsten ellers er 80-90%
Cohens D effect size på 1,1-1,3 samt den højere dosering samt udelukkelse af flere SIGMAR1 varianter fra effektberegning gør, at vi bør have rimelig chance for gode data.
Jeg undrer mig dog stadig over det relativt lille forsøg (Avatar) med kun 33 pts hvoraf 11 er placebo. Havde personligt været mere tryg med et forsøg med 2-3 gange flere pts.
Måske MayoMobile har nogle bemærkninger til urolige investorer samt om vi kan forvente at se hans artikel indenfor overskuelig fremtid
Tak på forhånd.
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Vi har brug for trøst i dette super sure market, tror vi går ned igen i dag.
Nogle tror måske at gab på 7$ skal fyldes men jeg håber virkelig ikke vi skal helt derned igen. Hvis det gør må jeg lige ha fundet lidt mønt og købe lidt mereSaa i det mindste har Tip Ranks en stærk købs rating på Anavex med 5 analytikere med pris taget imellem 35 og 50$.
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A trial with 2-3x more patients would have been relatively massive for a rare orphan disease. I was reading an article yesterday which demonstrated most failed orphan trials are caused by inability to recruit and sustain enrollment.
I have decided that if my article and material is not published by Feb 15 I will release it myself. Feb 15 is Angelman day. My niece has Angelman Syndrome and there is a special honorary mention of her in my analysis.
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Anavex Ser frem til din dybdegående analyse MayoMobile.
For et par år siden meldte FDA ud, at man udmærket var klar over udfordringen ved at få et større antal patienter indlemmet i især de mindre og sjældne indikationer.
Man opfordrede derfor biotek selskaberne til at opsætte selv mindre og tidlige forsøg (som fase 2 forsøg), som større fase 3 forsøg med placebogrupper mm.
FDA ville være mere imødekommende og tage hensyn, når resultaterne skulle evalueres.
Alt dette har Anavex efterlevet - og de udtalte også ved forrige CC, at med samlede data fra RETT US og AVATAR ville opfylde det krævede datagrundlag til en evt. ansøgning hos FDA.MayMobile - håber for din niece, at Angelman er den omtalte indikation!
"Around year end" er vel ikke henne i februar, selv efter Missling tidsregning - så måske Avatar data i næste uge?
God weekend
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