Anavex
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Ny Anavex tråd her!
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Anavex Årsrapport og Q4 den 28/12 2020
Webcast:
https://wsw.com/webcast/cc/avxl16/1496358Normalt et none event, men denne gang er det måske lidt anderledes, da Anavex står midt i en transformation mellem som hidtil kun at udvikle til også at sælge medicin.
Husk ZOOM kl. 21. 30 i aften med RETT gennemgang!
https://zoom.us/webinar/register/9516079699540/WN_nc7.. -
Anavex Upcoming FDA Reviews!
Biotech Report; Upcoming FDA Reviews and Promising Pipelines
Måske en overskrift, der kan fange interessen for potentielle investorer!
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Anavex Webinar Ladenburg RETT
Super og oplysende gennemgang af RETT sygdommen og dens karakteristika - samt 2-73 effekt i patienterne.
De to professorer Dr. Jeffrey Neul og Dr. Randi Jenssen Hagerman ved hvad de laver.
Især Dr. Randi Jenssen Hagerman, som har været ansvarlig for en af sitesene, var helt overvældet af det hun havde set. Hun ser 2-73 som banebrydende ny medicin inde for et stort spektre af CNS indikation også som antiældnings medicin - hun ville selv meget gerne tage 2-73 i forbindelse med hendes alder!!!
Hun kunne næste ikke vente med at se, hvad 2-73 kunne udrette i andre indikationer - nævnte i denne forbindelse også de signifikante resultater Anavex har opnået i både Alzheimer og Parkinson!
Hos RETT patienterne, hvis indtag af 2-73 eller placebo var blinded for hende, kunne hun se signifikante forbedringer hos de patienter, der senere viste sig også at have fået 2-73 og tilsvarende ingen forbedringer i placebo patienterne. Men når disse placebo patienter så forsatte i ekstension forsøget, hvor alle får ca. 5 mg 2-73, kunne hun nu også se forbedringer hos disse - alt dette uden bivirkninger!!!Der var meget mere af samme skuffe, men bundlinjen er at 2-73 virker i alt det man har afprøvet det i - uden bivirkninger!
På et eller andet tidspunkt opdager markedet det - og så får Anavex en prissætning, som de fortjener! -
Anavex. Webinar Ladenburg forsat..
Deludskrift fra professoren, der havde ansvaret for en af de sites med voksne RETT US patienter.
Har svært ved at se, at man kan få et stærkere udsagn - ikke kun for 2-73s effekt i en indikation, hvor der hidtil ikke fandtes nogen behandling - men også at 2-73 højst sandsynlig har en effekt i mange andre CNS indikationer, samt endda i ældningsprocessen generelt!Dette udtalt fra en højt anset forsker:
"I am very excited about this medication and also as I age I would definitely like to take Anavex myself.
I'm excited that this is a break through medication and for not just Rett Syndrome but other disorders of aging and also neuro-degeneration.
This is an exciting new treatment."
Udskrift:
"Hi I'm Dr. Randi Hagerman,
I'm a Clinician, I'm a developmental and behavioral Pediatrician and I have a great interest in the use of targeted treatments for a variety of neurodevelopmental disorders. And again by targeted treatments, I mean medications that can modify the neurobiological changes that are made in the brain and individuals with neurodevelopmental disorders. I participated in the Adult Rett Syndrome Study using Anavex2-73.
The results are being released now and these are very exciting results.
I was blinded during the control trial where individuals were randomized either to active drug, about 5mg a day vs. placebos so I didn't know who was on what.
I saw a number of individuals who did very well on this medication and others who didn't but also I have been involved now in the follow up where they go on the active medication so I can see actually the results now in individuals that I know are on medication.
I saw a variety of improvements and again as you heard in the last talk from Jeff, these individuals are very severely impaired.
They can't talk or talk very little, often they're in wheel chairs. They can't use their hands well . They often times can have agitation, other types of problems like constipation and what we saw is that individuals were calmer, less agitated, they seemed to be happier. They were able to concentrate better. They made better eye contact and they seemed to understand questions or directions given to them and were able to follow through in many cases on some of the commands that their parents made.
There was less anxiety, better understanding and in general the parents felt they were calmer and less agitated and often we saw improvements in the gastrointestinal problems.
One patient that stands out that I just recently saw, was able to swallow her food better. She didn't have any problems choking now that she's on the active medication.
She was able then to eat better, happier. She had less bloating, less constipation and having better function GI wise I think can lead to less agitation.
The families were able to mark on the main outcome measures that were improved. The Rett Syndrome Behavior Questionaire that the parents answered and also the Clinical Global Improvements Scale. The CGII that the Clinicians do. There were significant with the Anavex2-73.
So this is very exciting.. So far the patients want to continue on the Open Label Extension on this medication.
This is a relatively unique medication that can actually improve the calcium disregulation, the mitochondrial function, the oxidative stress and the neural connections. These problems can be seen in variety of other neural developmental disorders and also neurodegenerative disorders.
They've carried out studies in Alzheimer's and in Parkinson's Disease looking at cognition in Parkinson's disease. It improved cognition in both Alzheimer's and Parkinson's disease.
I do a lot of research also in Fragile X syndrome and this medication can improve the Fragile X symptoms in the mouse model of Fragile X so I'm very excited about this medication causing improvements not just in Rett Syndrome but in other neurodevelopmental disorders and neurodegenerative disorders.
This medication can be a boon. I think in general for aging and certainly for aging syndromes like Parkinson's Disease and Alzheimer's and I can't wait to start it on other neurodevelopmental disorders like Fragile X Syndrome.
I am very excited about this medication and also as I age I would definitely like to take Anavex myself.
I'm excited that this is a break through medication and for not just Rett Syndrome but other disorders of aging and also neuro-degeneration.
This is an exciting new treatment."
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Det lyder super godt.
Skal i julen prøve at lytte med.
At Anavex ikke er så højt kurssat er der nok mange gode grunde til. Men et firma med 16 ansatte jf Yahoo vil mange nok tvivle lidt på er $Xbn værd.
Men som du også skriver Tasso1, så står de foran en voldsom transformation, som mange før dem har fejlet på. Valg af strategi og partner kan være afgørende for, hvor hurtig og stor succes de får. Dette vil vi gerne høre mere til.
Synes de bærer præg af for få ressourcer med langsom databehandling og forsøg med meget få patienter, hvilket ikke er godt for det videre forløb.
Personligt håber jeg at de hurtigst muligt får en god partner med mindst mulig udvanding til følge.
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Helt enig Solsen, en partner vil værre godt, rigtigt godt. Jeg håber ikke at de bliver købt ud set fra et langsigtet investering synspunkt men håber at tingene begynder at gå hurtigere frem.
Jeg bed mest mærke i udtagelsen fra Dr. Randi Hagerman: I am very excited about this medication and also as I age I would definitely like to take Anavex myself!!!
Det er helt fantastisk, marked for Dementia er nærmest uendeligt, potentiale indtægter i multi milliard klassen (i $).
Kursen burde gå et godt stykke op i dag, hvis den falder bliver jeg nok til at købe flere aktier, casen bliver jo mere og mere overbevisende.
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Lidt usædvanligt valgte jeg at følge webinaret i går.
Enig i at Randi Hagemans udtalelser var utrolig positive; næsten så positive at man kunne tænke : " er hun betalt for det?" . Undskyld at jeg skriver sådan i denne tråd. Der er ikke noget jeg hellere vil ,end at mit lille frimærke i firmaet kunne vokse sig stort:-)
Jeg tænker: Få det dog sat i gang til parkinsonpatienter, for hvem en pæn forbedring vil kunne betyde alt. Det bliver jo så netop også sat i gang i Australien gennem delvis betaling af " Shake it up"Det afgørende for mig i det her lige nu er : hvor anerkendte er de to pågældende professorer?
Forøvrigt fik jeg i november dette svar fra lægekonsulent Tove Henriksen på min henvendelse til Parkinsonforeningen i Danmark om at kigge på Anavex.
"Der er ikke meget at finde på PubMed om anavex. De artikler der er at finde er primært om alzheimers sygdom, og ikke parkinsons sygdom. Jeg kan dog se, at anavex, eller AF710B er en ny selektiv M1 muskarin og sigma-1 receptor agonist, det vil sige det stimulerer disse receptorer. Et rotteforsøg har vist, at kognitive forstyrrelser i en alzheimer rotte model, blev forbedret efter behandling med anavex i 4.5 måneder. Man kunne se en reduktion af amyloid aflejringer i rotternes hjerner. Det er netop disse aflejringer, som karakteriserer alzheimers sygdom."
Jeg havde medsendt artikler fra "Parkinsons News Today" om Anavex's fase 2 forsøg i PDD (parkinson disease dementia).
Og desværre , min indsigt i farmakologien rækker slet ikke til debat med fagkyndige.
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Anavex Kikl møder samme direkte uvidenhed fra de læger og eksperter ja har haft kontakt med.
De aner simpelthen intet om Anavex og deres tilgang.
Mit indtryk er, at mange hænger fast i de gl. metoder de altid har brugt og med den arbejdsbyrde mange læger/forsker har, er f.eks. PubMed et typisk sted man henter "ny" viden.
Er bare bare bange for at penge styrer rigtig meget og det for det meste er de større spillere, der har musklerne til netop at få deres udvikling frem i lyset (PubMed m.m. ) - uanset om dette nødvendigvis behøver at være bedre end det mindre selskaber forsker i.Har 2 store ønsker til årsrapporten den 28. dec. 2020:
- Begyndende indtjening fra SASen i Alzheimer fra Australien.
Da 2-73 kun må sælges/tildeles via SAS ordningen, må Anavex iflg. reglerne ikke reklamerer for denne mulighed om køb af 2-73.
De skal dog nu oplyse i regnskabet, hvis de har en indtjening på et evt. salg!- Annoncering af opstart af RETT forsøg i Japan, som samtidig medfører et partnerskab med et japanske medicinalselskab.
Tror at resultaterne fra RETT US var forudsætningen for en sådan aftale og kan måske også forklarer, hvorfor Anavex havde udskudt sin årsrapport bl.a. for at kunne inddrage dette, når de på mødet løfter sløret om deres planer for fremtiden.
Anavex har længe nævnt Japan som næste skridt på RETT området - og siger man dette er og har der sikkert været konkrete kontakter og evt. forhandlinger om dette - man starter bare ikke lige et nyt program op i Japan med kort varsel!Kan se vi får en typisk markedsreaktion fra Anavex i dag - et fald på gode nyheder.
Det er efterhånden så absurd, at selv shorterne på et tidspunkt kan se det.
Men også den manglende interesse fra nye investorer er højst besynderligt.
Måske skal vi have en overskrift, hvor ordet approval indgår, for at deres super computer med kunstig intelligens fanger Anavex på radaren.Handler selv ikke ud fra markedets "mening" og manipulerende mekanismer, som ofte selvforstærkes af TA algoritmer, men på resultater fra forsøg og vidnesbyrd fra det virkelige liv.
Og som jeg tidligere har sagt, så skal videnskaben og en reel positiv effekt i patienter nok vinde i sidste ene!! -
De skal blot annoncere en anerkendt partner ex Takeda så vil der ske ting og sager.
Kigger man på et firma med 16 ansatte vil mange investorer ikke være interesseret.
Derfor skal de have en partner der er respekt omkring og som kan løfte Anavex op på et andet niveau.
Det vanskeligste i biotech er at have produkterne så hvis vi tror på det kommer kursen også. -
Ak ja penge er vigtigere and menneskeliv, medicin industrien er meget "dirty business" ingen trivl om det.
Jo i har ret, de bliver nødt til at få nogle partnere, Takeda har ca 50.000 ansatte, så sætte 25-50 personer på casen betyder ikke meget for dem.
Dr Randi J. Hagerman er meget anerkendt inden for området og når hun sagde det hun gjorde så er jeg sikker på at nogle store medicin selskaber lytter og de vil nok snart snakke med Missling om fremtiden: partner/buy-out. Den 28/12 bliver meget interessant.
Jeg nævnte i mit sidste indlæg at jeg vil købe flere hvis kursen falder, så jeg nappede lige lidt flere til kurs 6, primært baseret på hendes udtalelser og udmelding fra Anavex, det kan simpelt hen ikke gå galt mere.
Lidt info om Dr Hagerman:
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Anavex. Årsrapport og Update af pipeline!,
Hvor er det vildt - Anavex og 2-73 rykker bare nu!!!
Anavex går fra at have 2 forsøg i fase 2/3 til hele 6!!!
Anavex går til FDA for at få acc. Approval baseret på RETT US!
De har nu 49 mill. $ på bogen, mod normalt 25 - 27. mill. $!
RETT AUS/UK forfremmes fra fase 2 til et fase 2/3!
Fragil X går direkt i fase 2/3!
Anden sjælden indikation ( ubenævnt ) direkte i fase 2/3!
Anden udvidet brug af 2-73 og biomarkører i CNS generelt.
Parkinson fase 2 forsøget nåede alle primære endpoints - ikke kun dem Anavex gennemgik på CTAD!
- og der kommer meget mere!!!
Anavex Life Sciences Reports Fiscal 2020 Year End Financial Results And Clinical Program Updates
Conference Call and Webcast Today at 4:30 p.m. ETNEW YORK, Dec. 28, 2020 (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 financial results for its fiscal year ended September 30, 2020. Christopher U Missling, PhD, President and Chief Executive Officer of Anavex said: “Despite all of the new challenges, 2020 was an extraordinary year for Anavex, with significant progress across our portfolio, including our first positive, placebo-controlled, U.S. ANAVEX®2-73 (blarcamesine) Rett syndrome trial, a positive Parkinson’s disease dementia trial, and further progress in Alzheimer’s disease. I want to thank the patients, doctors, and the Anavex team who made all of this progress possible. We look forward to building on this momentum with key milestones expected from multiple programs, including data on the ongoing late-stage Rett syndrome trials AVATAR and EXCELLENCE, expanding the clinical biomarker-driven ANAVEX®2-73 rare disease program into additional late-stage studies with high unmet medical need, completing the late stage ANAVEX®2-73 Phase 2b/3 Alzheimer’s disease trial, and advancing ANAVEX®2-73 into clinical disease modifying testing in Parkinson’s disease.” Key Clinical Updates: Plan to advance the AVATAR adult Rett syndrome study into a pivotal Phase 2/3 clinical trial.Pipeline expansion for ANAVEX®2-73 using gene biomarkers of response, applying precision medicine for neurological disorders with unmet medical need: Planned initiation of a pivotal Phase 2/3 study in Fragile X Syndrome, the most frequent genetic cause of autism spectrum disorder.Planned initiation of a Phase 2/3 clinical trial for the treatment of a new, rare-disease indication. Phase 2b/3 ANAVEX®2-73 Alzheimer’s disease (AD) study currently over 80% enrolled with complete enrollment expected in early 2021.Planned initiation of ANAVEX®2-73 imaging-focused Parkinson’s disease clinical study. Recent Business Highlights: In December 2020, Anavex announced top-line results from a U.S. Phase 2 controlled trial of ANAVEX®2-73 in adult female patients with Rett syndrome. Primary safety, pharmacokinetics and secondary efficacy endpoints were met, with statistically significant and clinically meaningful consistent improvements in Rett Syndrome Behaviour Questionnaire (RSBQ) and Clinical Global Impression Improvement (CGI-I) scores. Improvements in RSBQ Total scores were correlated with decreases (improvements) in plasma glutamate. Based on the results, Anavex is planning to meet with the FDA to discuss an accelerated approval pathway.In November 2020, Anavex presented data at the 13th Clinical Trials on Alzheimer’s Disease (CTAD) 2020 Conference, reporting top-line results from the proof-of-concept Phase 2 placebo-controlled trial with primary objectives of safety, tolerability, and efficacy in cognition of ANAVEX®2-73 in patients in Parkinson’s disease dementia (PDD) compared to placebo. Both primary objectives of the study were met. The results show clinically meaningful, dose-dependent, and statistically significant improvements in the Cognitive Drug Research (CDR) computerized assessment system analysis. The study confirmed the precision medicine approach of targeting SIGMAR1 as a genetic biomarker in response to ANAVEX®2-73 supporting progression to further development in upcoming Phase 2/3 studies.In November 2020, Anavex received a Notice of Allowance from the United States Patent and Trademark Office (USPTO) for its patent application number 16/717,921 expected to remain in force at least until 2037, expanding coverage of treatment methods using its lead drug candidate, ANAVEX®2-73, as well as drug candidate ANAVEX®1-41 for treating a range neurodevelopmental disorders including Rett syndrome, autism spectrum disorder, Angelman syndrome, cerebral palsy and multiple sclerosis, among other indications. Financial Highlights: Cash and cash equivalents of $47.6 million as of today and $29.2 million at September 30, 2020, compared to $22.2 million at September 30, 2019.Net loss of $26.3 million, or $0.45 per share for the year, compared to net loss of $26.3 million, or $0.54 per share in fiscal 2019.Research and development expenses of $25.2 million for the year, compared to $22.3 million for fiscal 2019.General and administrative expenses of $5.9 million for the year, compared to $6.8 million for fiscal 2019. The financial information for the fiscal year ended September 30, 2020 should be read in conjunction with the Company’s consolidated financial statements, which will appear on EDGAR, www.sec.gov and will be available on the Anavex website at www.anavex.com. Conference Call / Webcast Information The live webcast of the conference call can be accessed online at https://wsw.com/webcast/cc/avxl16/1496358. To join the conference call, live via telephone, interested parties within the U.S. should dial, toll-free, 1 (866) 939-3921 and international callers should dial 1 (678) 302-3550. Please use confirmation number 50061077, followed by the pound sign (#). A replay of the conference call will also be available on www.anavex.com. About Anavex Life Sciences Corp. Anavex Life Sciences Corp. (Nasdaq: AVXL) is a publicly traded biopharmaceutical company dedicated to the development of 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, pain and various types of cancer. Anavex’s lead drug candidate, ANAVEX®2-73 (blarcamesine), recently completed successfully a Phase 2a clinical trials for Alzheimer’s disease and a Phase 2 proof-of-concept study in Parkinson’s disease dementia and a Phase 2 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 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 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. undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof. ANAVEX LIFE SCIENCES CORP.CONSOLIDATED STATEMENTS OF OPERATIONSFor the years ended September 30, 2020 and 2019 Expressed in US Dollars 2020 2019 Operating Expenses General and administrative$5,856,609 $6,846,599 Research and development 25,231,623 22,260,349 Total operating expenses (31,088,232) (29,106,948) Other income (expenses) Grant income 149,888 298,943 Research and development incentive income 4,375,025 2,465,691 Interest income, net 179,973 207,280 Gain on settlement of accounts payable - 115,758 Financing related charges - (151,133)Foreign exchange gain (loss), net 125,540 (42,389)Total other income, net 4,830,426 2,894,150 Net loss before provision for income taxes (26,257,806) (26,212,798)Income tax expense, current (22,664) (82,181)Net loss and comprehensive loss$ (26,280,470)$ (26,294,979) Net loss per share Basic and diluted$(0.45)$(0.54) Weighted average number of shares outstanding Basic and diluted 58,194,894 48,906,470 ANAVEX LIFE SCIENCES CORP.CONSOLIDATED BALANCE SHEETSAs at September 30, 2020 and 2019Expressed in US Dollars 2020 2019 ASSETS Current Cash and cash equivalents$29,249,018 $22,185,630 Incentive and tax receivables 4,849,340 2,642,745 Prepaid expenses and deposits 443,839 500,998 Total Assets$34,542,197 $25,329,373 LIABILITIES AND STOCKHOLDERS' EQUITY Current Liabilities Accounts payable$3,989,054 $3,523,332 Accrued liabilities 3,316,574 1,516,342 Total Liabilities 7,305,628 5,039,674 Capital Stock 62,047 52,652 Additional paid-in capital 186,851,752 153,633,807 Accumulated deficit (159,677,230) (133,396,760)Total Stockholders' Equity 27,236,569 20,289,699 Total Liabilities and Stockholders' Equity$34,542,197 $25,329,373 For Further Information: Anavex Life Sciences Corp.Research & Business DevelopmentToll-free: 1-844-689-3939Email: [email protected] Investors & Media:Clint TomlinsonEmail: [email protected]
Yahoo Finance (finance.yahoo.com)
Anavex Life Sciences | Advancing Therapies for Alzheimer’s and Parkinson's Disease
Anavex Life Sciences (Nasdaq: AVXL) is a biopharmaceutical leader advancing targeted CNS therapies through innovative therapeutic discovery and development.
Anavex Life Sciences (www.anavex.com)
Hvor finder man en biotek aktie med 6 fase 3 forsøg, hvor der ingen mulig behandling er, 49 mill. $ på bogen og ingen gæld til en MC på sølle 350 mill. $???
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Anavex. TDT123 løbende salg af aktier eller måske også indtægt fra salg under SAS - vi får vel svaret i aften!
Fedt hvis de evt. er begyndt at tjene penge på et egentlig salg af 2-73 - transformation!
Uanset synes resultaterne fra RETT US til at være tilstrækkelig til markedsgodkendelse - husk dette udløser en voucher, som kan være 50 - 150 mill. $ værd.
Samtidig har dette også medført et ordentlig skub til andre indikationer!Man må virkeligt have set noget banebrydende effekt med 2-73!
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Jeg kan prøve...
Aktierne må have en størrelse på $0,001 idet der er ca 62 mln aktier. Der er altså udstedt små 10 mln aktier mellen de to perioder.
Bortset fra de ca $10.000 som er aktiernes pålydende så er der indbetalt en overkurs på ca $33 mln i mellem periodeopgørelserne.Kursudvikling knald i låget !
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Tilsyneladende var det Anavex selv der solgte aktier, da kursen blev banket ned den dag de kom med gode rett resultater.
Det var hvad jeg forstod af gårsdagen conference ?
Dermed sikrede de sig to års cash-run.Ellers er der knald på med nye forsøg og første approval ansøgning eller forarbejde til det.
Jeg mangler stadig lidt strategi og beskrivelse af, hvad de gør ved evt. approval mht markedsføring/salg, markedsstørrelse og -potentiale.
Men stadig virker de overbevisende om stoffets virkning.En meget spændende case hvor jeg som investor gerne ville have en større pharma ind over på en eller anden måde.
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De solgte deres aktier til 200% (så double pris) hvad der er meget usædvanligt men måske et partner skab?
Saa hvad jeg kan forstå er at der blevet ca 7 mill flere aktier, meget normalt for et bio selskab uden indtægter (endnu).
2021 bliver et meget spændene år for os AVXL aktionærer.
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