Anavex
-
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. $???
-
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!
-
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 !
-
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.
-
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.
-
Anavex. Solgte ca. 7 mill. aktier i sidste kvartal.
Ja det var nok det der primært var med til at holde kursen nede, selvom resultaterne har været gode hele vejen.
Når de nu ikke har en partner, som putter penge i casen, men som så også skal have deres del af kagen, når 2-73 kommer på markedet og når Anavex heller ikke ønsker at stifte dyr gæld og være i lommen på pengemænd - så er salg af aktier eneste måde at financiere driften og fremtidig udvikling - det har de aldrig lagt skjul på.
En egentlig emission, som for flere nok har ligget som en skygge over casen, synes heller ikke at blive aktuel med den forøgede polstring.
De har nu hele 48 mill. $ på bogen og har nu nok til at financierer deres kraftig ekspanderende pipeline fra 2 til nu kommende hele 6 fase 2/3 forsøg i de næste 2 år. Iflg. Anavex vil de derfor heller ikke have behov for at sælge yderligere betydelige mængder aktier fremover ( iflg. CEOen ).
Dvs. at man må forvente noget mindre devaluering af kursen på denne baggrund den næste tid.Selv med en partner ( bortset fra SIUF i PD der betaler 200 % i overpris for aktier til et nyt PD forsøg ), så har jeg svært ved at se, hvordan udviklingen kan gå meget hurtigere. Resultaterne fra Parkinson og RETT US skal nu diskuteres med FDA og for RETT US endda om en acc. Approval - dette går nok ikke hurtigere end den tid myndighederne behøver.
Det var overraskende, at man kan gå/går direkte i fase 2/3 med Fragil-X og at man også går direkte i fase 2/3 med en anden ubenævnt sjælden indikation.
Det virkede på CEOen, at man næsten kunne vælge og vrage, hvilken ny indikation man valgte at gå ind i, men at det endelig valg var "on top" af de andre sjældne sygdomme - dvs. større patientgruppe og derfor større markedsværdi.Anavex er nået over i en ny fase, hvor de ovre det at skulle bevise MOA og at skidtet virker. Det det drejer sig om nu, er først og fremmest at få 2-73, via RETT, hurtigst muligt på markedet og samtidig få ekspanderer deres pipeline, så de i fremtiden spænder over en stor bredde af indikationer.
Især inden for de sjældne indikationer, ser vi nu, at Anavex hurtig og relativt billigt kan udvide markedet, netop fordi de nu har lavet et grundigt og langvarigt forarbejde.Anavex fremhævede især det sidste tildelte patent for 2-73 her i starten af dec. - hvor man nu er dækket ind over et stort antal sjældne indikationer og andre f.eks. Multi Skelrose mm. til og med 2037.
Tror mange BP ville være lykkelig for at få muligheden for at overtage Anavexs pipeline, men hvorfor sælge ud eller afgive guldet nu så tæt på målstregen.
Anavex casen har minimeret mange usikkerheder i forbindelse effekten og bivirkningsprofilen - og samtidig polstret sig økonomiske, så de kan gennemfører alt det de har sat sig for, uden at udvande aktien væsentlig den kommende tid.
Burde være en relativ sikker investering fremadrettet - sandsynligvis ser vi dette også afspejle sig i en større andel af større institution og fonde. -
First Cobalt Corp. (FCC.V)
0,32+0,02 (+ 6,6667%)
mens vi vi venter på anavex i 2021-2022-2023
er jeg sikker på at fcc.v bliver vinder i 2021 og i 2022
så det bliver dejligt at have 2 vinder i de 5-6 år
-
Ja det hørte jeg godt og fint med det.
Anavex har tilsyneladende to aftaler kørende om løbende salg af nye aktier.
De er ikke specielt transparante omkring deres aktieudvidelser. I DK skulle det løbende meddeles.
De oplyser i deres årsregnskab, at de pt har godt 69 mln aktier udestående. Jeg regner med at det er disse og de oplyste 62 mln pr 30/9 Tasso får til 7 mln.
Provenuet herfra og de tidligere omtalte 200% i overpris ser jeg ingen steder eller er jeg blind ?
-
Enig Tasso i hvad alt hvad du skriver.
Der er meget der tyder på at 2-73 virker i næsten alle CNS sygdomme hvad er helt fantastisk.
Der er næsten ingen trivl om a big Bio tec vil prøve at bremse Anavex (nu når de ikke vil sælge), nok en af grundene til at Missling kører forsøg i mange lande, så er det meget svære at bremse, gudskelov.Her er lidt, ikke så god omtale om FDA:
Det værre sagt, tror på at videnskaben vinder i den sidste ende og jeg er meget meget tungt lastet i AVXL i min forholdsvis beskedne portfoelge. Hvis vi kommer over kurs 100 vil jeg nok kraftigt overveje at gå tidligt på pension. Lad os se hvor vi er om 1-2 års tid.
-
Ingen betvivler at biotek skal bruge penge, slet ikke mig. De udstedte aktier må være godkendt på en generalforsamling på et tidspunkt, men det gider jeg simpelthen ikke at undersøge. Jeg kan se at Misling nu har over 6 mill aktier, eller tilsvarende ( f.eks 500.000 warrants i 1,31). Håber han er pengene værd. Der er en masse information i dette"aktive" link", blandt andet at der nu er 66 mill+ aktier udstedt. Gud ved om de stadig har de 10 mill i pengeskabet til forebyggelse mod fjendligt take over? For så er der jo 76 mill. Hvad vi også ved nu er at det ikke var shortere der holdt kursen nede, det var "os selv". Det kunne han jo bare have sagt ikke.....Altså selvfølgelig bagefter: Vi har i perioden solgt så og så mange aktier til en gennemsnitskurs på x antal dollar. Jeg er med i mange bioteks, og det er der en hel del af dem der godt kan finde ud af, altså simpel IR virksomhed. I dette tilfælde ville det være god stil, både overfor nuværende og evet. nye aktionærer.
Trods den lysere fremtid (penge i kassen og tentativ hurtigere vej til markedet) håber jeg nu på et buyout, eller at de finder en partner. En partner med de nødvendige ressourcer til at styre biksen, f. eks IR og at følge op på lovede opdateringer (PDD), samt selvfølgelig salgskanaler (markedsføring/sælgere) når vi forhåbentlig får noget at sælge.
Her link: https://www.sec.gov/ix?doc=/Archives/edgar/data/1314052/000173112220001338/e2298_10k.htm#item12
Pøj pøj til os
-
Anavex. Transcript
De 200 % fra SIUF fremgår i deres K10 - side 39:
In August 2020, we announced a financial commitment by Shake It Up Australia Foundation (SIUAF) for Parkinson's Research to fund up to 50% of the costs of an Australian clinical study to develop ANAVEX
2-73 for the disease modifying treatment of Parkinson's disease. The financial commitment would be made through private placement purchases of our common stock at 200% of the fair market value on the purchase date and will be contingent upon the completion of certain clinical trial milestones relating to the proposed clinical trial. There was no impact on our consolidated financial statements for the year ended September 30, 2020 as a result of the commitment from SIUAF. -
Mette F, Lars L, Inger s osv osv kunne have sagt det her TDT. Will not need to use it anymore OG We always want to make sure we have enough cash and ressources. Ja, så kan han da selv vælge hvis han bliver holdt op på det senere hen....
Jeg fornemmer i øvrigt at du ikke længere kun er inde med dine swings
MM
Hello! It looks like you're interested in this conversation, but you don't have an account yet.
Getting fed up of having to scroll through the same posts each visit? When you register for an account, you'll always come back to exactly where you were before, and choose to be notified of new replies (either via email, or push notification). You'll also be able to save bookmarks and upvote posts to show your appreciation to other community members.
With your input, this post could be even better 💗
Tilmeld Log ind