Anavex og CNS
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Velkommen til elssan.
Forsøger at holde mig så faktuelt som muligt, men da det jo er biotek skal enhver gøre op med sig selv at dette er et high risk segment.
For mit vedkommende håber jeg ellers at kunne holde min lille investorgruppe informeret og bruge super PI til at passe på evt. links m.m.
Super hvis øvrige også kan få lidt ud af det.
Anden synsvinkel er også velkommen, så man ikke lader sig for blænde uden at man kritisk vurderer sin investering. -
Hvis nogle leger med bio, evt leder efter en kandidat...
Så kan man her se hvor langt fremme de forskellige cases er med deres forsøg. https://www.biopharmcatalyst.com/calendars/fda-calendar
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Anavex og Fast Track Designation i RETT!
I forvejen fik Anavex også for RETT en RPD -Rare Pediatric Disease den 14. november med mulighed for tildeling af en voucher for priority review af et andet stof ved endelig gedkendelse af RETT. ( Salgsværdi på 50-350 mill. $ )
FDA har for alvor fået øjnene op for Anavex, ikke så sært FDA havde Anavex på dagsorden både i november og december 2019 - måske også ved deres møde her den 28.-31. januar, med tildeling af Fast Track!
A drug that receives Fast Track designation is eligible for some or all of the following:
More frequent meetings with FDA to discuss the drug's development plan and ensure collection of appropriate data needed to support drug approval
More frequent written communication from FDA about such things as the design of the proposed clinical trials and use of biomarkers
Eligibility for Accelerated Approval and Priority Review, if relevant criteria are met
Rolling Review, which means that a drug company can submit completed sections of its Biologic License Application (BLA) or New Drug Application (NDA) for review by FDA, rather than waiting until every section of the NDA is completed before the entire application can be reviewed. BLA or NDA review usually does not begin until the drug company has submitted the entire application to the FDA.FDA er nu løbene i dialog med Anavex og løbene kører en proces for endelig markedesansøgning NDA.
Ja og skulle/når RETT så godkendes, kan Anavex aktiverer RPDen og putte lidt lommepenge i kassen.Tror snart vi vil se mere nyt fra FDA omkring Alzheimer og opstart af de varskoede nye sites i Nordamerika.
FDA kender nu 2-73s virkemåde og kan se at det både er effektiv og uden bivirkninger over en længere periode og i både ældre og yngre mennesker - FDA har indsigt og informationer om ting vi andre aktionærer først ser om 4-6 mdr.En spændende tid de næste mdr. med bl.a. CC på torsdag 22.30 DK tid og så flere forskellige præsentationer med nyt på forskellige områder.
Er ramt af skiferie i denne uge, så følger lidt op, når det er muligt.
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Anavex Fast Track og godkendelse.
Mellem 1998 og 2015 tildelte FDA 270 FTD, heraf blev 147 eller 54 % endelig markedsgodkendt.
Desuden har Anavex jo også fået en RPD.
Anavex har også den fordel, at de har en tidligere FDA ansat til netop at køre processen med FDA!
FTD gælder godt nok kun for RETT ( indtil videre ), men mon ikke der bliver kigget/diskuteret resultater og bivirkningsprofil fra Alzheimer og Parkinson også!
Så mon ikke vi har langt mere end 54 % sandsynlighed for endelig godkendelse.
På trods af ovenstående tror jeg dog stadig på, at Australien rykker først!!Når 2-73 så skulle blive godkendt, er der ikke langt til at udskrive 2-73 off label for netop Alzheimer og Parkinson m.m.
Det kan komme til at gå rigtig stærkt meget hurtigt!
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Hej tasso. Endnu engang skal der herfra lyde en stor tak for dit flotte arbejde med at holde os andre interesserede opdateret. Hvis vi alle gjorde som du og udvalgte en aktie, som vi fulgte tæt, og delte resultatet af vores arbejde, ville man som Proinvestor bruger have adgang til en fantastisk database, der kunne danne grundlag for at sammensætte ens portefolio. Thumps up
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Anavex CC og paneldeltager den 10. februar.
Først webcast kl. 17.15 dk tid med opdatering om nyt fra Anavex.
Her er der mulighed for nyt med formodentlig mere kød på end ved deres Q1 den 6. feb.Efterfølgende kl. 21.00 - 21.55 deltager CEOen i et panel med titlen:
Neuroscience at the Crossroads: Late Stage Brain Disorder Pipelines and Unmet Needs!
Her har Anavex om nogen noget at byde ind med.
Ville være de helt rigtige rammer, hvis Anavex lige forinden var kommet med evt. resultater, der kunne betyde et vigtig skifte - Crossroads - i tilgangen indenfor CNS.Efterfølgende kan man så anmode at møde Anavex under fire øjne, hvis man vil have uddybet videnskaben eller måske ligefrem har interesse om et fremtidig samarbejde m.m.
Tidspunktet med den sidste tids medie omtale fra Australien, FDA udmelding og stadet i de forskellige forsøg synes at nærme sig en kulmination!!
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Anavex i RETT Syndrome News.
Alene afbalanceringen af Glutamat og GABA, der hhv. skærmer mod støj og fremme forbindelser, så signaler mellem hjernecellerne bliver mere klare/rene, vil ved eftervisning i de følgende RETT forsøg være tilstrækkelig for godkendelse af 2-73 - efter min mening, hvis det kan eftervises i forsøgene og samtidig ser en almen forbedring i patienterne.
Disse biomarkører/værdier er også relative nemme at måle.
Om ca. 3 mdr. får vi resultater fra RETT US med 21 patienter, men FDA har i mellemtiden også adgang til open label resultater fra de første patienter, der er overgået til extension forsøget med titreret dosis 2-73.
Der er i dag ingen behandling mod RETT, så barren er sat meget lav.
Men igen - tror simpelthen ikke at Australien vil lade US løbe med hele æren efter alt det de selv har sat i gang/medfinansieret med Anavex og over 500 patienter fordelt i RETT, PD og AD - en lille konkurrence mellem FDA og TGA skader ikke.
Ser en stor sandsynlighed for PA Provisional Approval i Australien i 2020.Treatment also lowered the levels of the neurotransmitter glutamate and raised the levels of another neurotransmitter called gamma-aminobutyric acid (GABA) in the blood.
Nå - endnu en dag på pisterne her i Norge - lidt hårdt, men nogen skal jo gøre det
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Det er yderst sjældent vi ikke lukker GAPs .. men lad os bare høre til sjældenhederne, hvis Avxl når i mål, så springer vi rammen for GAPs og kan som minimum smide mindst et ciffer mere på kursen. Det eneste der er lidt risky er kassebeholdningen/ hvad har de tilbage ? Resten af 2020/ og mon ikke der kommer et bud eller en partner inden kassen er empty. Håber ikke der kommer et bud, og der sker det samme som med Velo.... den havde jeg set i kurs 10 kr.
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Håber du også må få en super ferie i Østen - pas nu på ikke at få en virus med hjem tdt.
Skal nok passe på lille Anavex imens - ellers kan du vel følge lidt med fra standsengen mellem svømmeturen.Tak for de pæne ord Thorkild - håber ikke jeg har fået lokket jer ud i noget snavs, min tiltro til casen har dog aldrig været stærkere - og det siger ikke så lidt!
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$AVXL Cash went up 5.3 million. They have a years worth of cash on hand at least. Great news, not likely to raise till after the next catalyst. Safe to buy without dilution. Very likely BO or partner candidate with positive data. Bullish
Lånt fra 2 forum/ har ikke selv kiggede tallene igennem... -
Anavex Q1 - hvad kan man ønske sig mere!
Øget deres kassebeholdning til godt 27 mill. $
Relativt lille cashburn.
INGEN GÆLDUdvider sites i Alzheimer fra de nuværende 15 i AUS. til yderligere 30 sites i Nordamerika og EU i 2020.
Hvordan mon de har kunnet overbevise 30 nye sites til at køre forsøg med 2-73? Anavex har haft travlt og været overbevisende - tror bl.a medieomtalen har været en del af strategien.
Disse nye sites ved nu, hvilke resultater man kan opnå i Alzheimer patienter - hvem vil ikke være en del af dette nye historiske gennembrud indenfor et så stort indtil nu ubehandlet område!
Samtidig vil fordelen af et stort internationalt fase 3 forsøg lette vejen for en samtidig godkendelse i den vestlige verden!Nu får de så også det måske mere potente 3-71 i klinisk forsøg i 2020.
Her har Anavex i forvej fået tildelt en orphan status fra FDA i en sjælden CNS indikation.
At de nu også har fået en IND til at køre forsøg i mennesker er nyt. Andre biotek selskaber havde nok stolt udsendt en pr. på dette, men ikke Anavex! De bruger ikke tiden på sådanne nogle småting - de har langt større milepæle i sigte!Resultater fra Parkinson bekræftes til midt 2020.
Spændende om der kommer nogle ekstra guldkorn påi CCen i aften kl. 22.30!
Utroligt hvad et lille biotek selskab med 13 ansatte formår.
Ved ikke hvad man som aktionær kan forlange mere - på volumen og kursen, ser det også ud til at anerkendelsen fra de store penge er godt på vej.
Shorterne kommer til at kæmpe voldsomt for ikke at få brændt fingerene - ja hele kroppen!
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Anavex - udskrift CC Q1!
Læs især spørgsmål og svar til sidst!
Den bedste CC hidtil - CEOen kan nok ikke sige det mere tydligt. - 2-73 virker og man vil ved at gå fra 15 til hele 45 sites internationalt have det kørt igennem hurtigst muligt.
Bekræftede også, at FDA er med ind over Alzheimer også!Husk Biogen mistede + 10 milliarder $ bare fordi de stoppede et fase 3 forsøg i AD - nu får vi sandsynligvis en godkendelse på 2-73 til AD i løbet af 2021!
Hvor mange milliarder er det værd? - og det er bare for AD! Hertil kommet PD, RETT m.m. + nu også 3-71i 2020!!!Finansieringen er også på på plads - der kan sælges aktier løbene - men formodentlig til en noget højere kurs fremadrette, så udhulningen bliver minimal.
Det kan snart ikke blive mere vildt!!!!
Udskrift:
Anavex Life Sciences' (AVXL) CEO Christopher Missling on Q1 2020 Results - Earnings Call Transcript
Feb. 6, 2020 7:16 PM ET'2 comments ' About: Anavex Life Sciences Corp. (AVXL)
FQ1: 02-06-20 Earnings Summary
Press Release 10-Q
EPS of $-0.12 Revenue of $0M (-% Y/Y)
Subscribers Only
Earning Call AudioAnavex Life Sciences Corp. (NASDAQ:AVXL) Q1 2020 Earnings Conference Call February 6, 2020 4:30 PM ET
Company Participants
Clint Tomlinson - Investor Relations
Christopher Missling - President and Chief Executive Officer
Sandra Boenisch - Principal Financial Officer
Conference Call Participants
Edward Marks - H. C. Wainwright
Yun Zhong - Janney
Tom Bishop - BI Research
Operator
Good afternoon. My name is Anna, and I will be your conference operator today. Welcome to the Anavex Life Sciences to announce Fiscal 2020 First Quarter Financial Results Conference Call. As a reminder, this conference call is being recorded.
I would now like to introduce your host for today's conference, Clint Tomlinson. Please go ahead.
Clint Tomlinson
Thank you, and good afternoon, everyone. We appreciate you joining us today for Anavex Life Sciences conference call and webcast. Our agenda is to is to review the company's financial results for its first quarter of fiscal 2020 and provide clinical study update. A taped replay of this call will be available approximately two hours after the call's conclusion and will remain available for one month. The call will also be available for replay on Anavex's website at www.anavex.com.
With us today is Dr. Christopher Missling, President and Chief Executive Officer; and Sandra Boenisch, Principal Financial Officer. Dr. Missling and Ms. Boenisch will make prepared remarks, and then we will take questions from equity analysts. Before we begin, please note that during this conference call, the company will make some projections and forward-looking statements regarding future events.
We encourage you to review the company's filings with the SEC. This includes, without limitation, the company's Forms 10-K and 10-Q, which identify the specific factors that may cause actual results or events to differ materially from those described in these forward-looking statements. These factors may include, without limitation, risks inherent in the development and/or commercialization of potential products, uncertainty in the results of clinical trials or regulatory approvals, need and ability to obtain future capital and maintenance of intellectual property rights.
And with that, I'd like to turn the call over to Dr. Missling.
Christopher Missling
Thank you. I'd like to thank everyone for joining us on today's conference call to review our first quarter financial results and share with you some clinical updates for ANAVEX 2-73 or blarcamesine. We were pleased to announce earlier this week that the U.S. Food and Drug Administration, FDA, has granted Fast Track designation for the ANAVEX 2-73 clinical development program for the treatment of Rett syndrome.
FDA Fast Track is a program designed to facilitate and expedite the development and review of a new drug to address unmet medical need in the treatment of a serious and life-threatening condition for which it demonstrates the potential to address unmet medical needs for such a disease or condition. The purpose of the program is to get important new therapies to the patients earlier in order to address the unmet medical need in the treatment of serious and life-threatening diseases. Our clinical Rett Syndrome Program, RS-001 and RS-002, AVATAR, are on track with continued enrollment.
We continue to strengthen our patent position as well. During the quarter, we were granted another U.S. patent to support Anavex's leading drug candidate, ANAVEX 2-73 for the treatment of neurodevelopmental disorders, including Rett syndrome and multiple sclerosis. This patent is expected to remain enforced at least until 2037, not including any patent term extensions. It covers methods of treatment for neurodevelopmental disorders, including Rett syndrome, autism spectrum disorder, Angelman syndrome and cerebral palsy, among others, and also treatment for multiple sclerosis using ANAVEX 2-73.
Regarding the ANAVEX 2-73 Parkinson's disease dementia study, we were pleased to report that we met our enrollment target for the study. The study enrollment over 100 patients at 20 sites across Spain and three sites in Australia. We expect to announce top line results from this study by mid-2020. Enrollment for the Phase 2b/3 ANAVEX 2-73 Alzheimer's disease study is 50% complete.
Recruitment is expected to accelerate given the anticipated international expansion of the study, which will increase the total number of sites from 15 to approximately 45 in 2020. We are reporting advancement of another pipeline compound. We have successfully completed IND-enabling toxicology studies and drug product manufacturing for ANAVEX 3-71. ANAVEX 3-71 previously received Orphan Drug Designation from the U.S. FDA for frontotemporal dementia, FTD, and initiation of the first Phase 1 clinical trial of ANAVEX 3-71 is expected in 2020.
And now I would like to direct the call to Sandra Boenisch, Principal Financial Officer of Anavex, for a brief financial summary of the recently reported quarter.
Sandra Boenisch
Thank you, Christopher, and good afternoon, everyone. We reported a net loss of $6.6 million or $0.12 per share during the quarter compared to a net loss of $6.9 million or $0.15 per share in the comparable first quarter of fiscal 2019. The decrease in reported net loss is due to increased research and development incentive income.
Research and development expenses were $6.3 million for the first quarter of 2020, as compared to $5.7 million for the comparable period in 2019. This increase was driven by increased clinical development activities related to the advancement of our pipeline.
General and administrative expenses were $1.4 million for the first quarter of 2020, as compared to $1.8 million for the comparable period in 2019. This decrease was primarily due to lower noncash stock-based compensation charges. During the quarter, our cash position grew to $27.5 million at December 31, 2019, from $22.2 million at our year-end September 30, 2019.
Thank you. And now I will turn the call back over to Christopher. Christopher, please go ahead.
Christopher Missling
In summary - thank you, Sandra. In summary, we continue to make steady progress towards reaching several important milestones, and we are poised to an exciting 2020 with multiple data readouts. We look forward to providing further updates as advancements continue.
I would now like to open the call for questions. Operator, please go ahead.
Question-and-Answer Session
Operator
Thank you. At this time, we will be conducting a question-and-answer session for equity analysts. [Operator Instructions] Our first question is from Raghuram Selvaraju from H. C. Wainwright. Please go ahead.
Edward Marks
This is Edward Marks on for Ram. I appreciate you guys taking the questions. Quickly, on the clinical side, I'm just wondering what the gating items are before you're able to initiate the pediatric Rett syndrome trial?
Christopher Missling
Thank you for the question. There are no gating items. We did announce that we were able to get approval for starting the study. It is really the customary requirements of site initiation visits and preparing the drug to the sites, and then we can start. So I expect this to be over shortly, and we will make that announcement public.
Edward Marks
Okay. Good to hear. And you mentioned the recent patent announcement, and I noticed that multiple sclerosis was mentioned multiple times in there. I'm just wondering if you intend to or if other companies have shown interest in rapidly developing blarcamesine for multiple sclerosis. And I noticed that you also mentioned autism and cerebral palsy in there that are covered by the patent. So are these also planning to be pursued in the future?
Christopher Missling
So we did actually had encouraging data for MS from an in vitro study from several investigators, which was also presented at ACTRIMS last year or the year - and the year before. And we have to be aware that - or mindful that this is a very exciting indication and - but however, still requires more preclinical work, like an animal study or other forms of validation. But I think the best way to look at this is once we get clarity on the data of Rett syndrome, we would immediately accelerate that program thereafter, and the same applies for the supranuclear palsy indication as well.
Edward Marks
Got it. And then my final question, I was just wondering if there's any more detail available regarding the microbial biomarker analysis for Alzheimer's and Parkinson's. And when do you anticipate releasing some of this data?
Christopher Missling
So we did get - received an initial positive signal from the Phase 2a study in Alzheimer's disease that there was a correlation of the gut microbiota changes with drug exposure, and we added this measure into our Parkinson's disease dementia study extension. So we will be able to report this with the Parkinson's dementia study extension outcome, where we will be able to see the level of changes in measures of gut microbiota before drug exposure and after as well as for patients on placebo and then on drug - active drug.
So we will have a very good ability to see if we will be able to confirm the correlation of drug effect with increase of variety of gut microbiota, which is the beneficial effect since healthy volunteers have a higher variety of gut microbiome than diseased patients.
Edward Marks
All right. Thank you for all the details.
Christopher Missling
You're welcome.
Operator
Our next question is from Yun Zhong from Janney. Please go ahead.
Yun Zhong
Hi. Thanks for taking the questions. So the first question is on the status of the two ongoing Rett syndrome studies. I believe I heard you said that the two studies are still enrolling patients. And I'm wondering, did you run into any challenges in recruiting patient in addition to the fact that just being is an orphan indication with the small prevalence?
Christopher Missling
Sorry. What was the last part of the question?
Yun Zhong
I understand that this is an orphan indication with a small prevalence. But did you run into any additional challenges in recruiting patients into those two studies?
Christopher Missling
No, we did not. We just want to make sure that the patients are recruited in a fashion that the right patients are in the study because that study now becomes relevant given that we received a Fast Track designation. And so our goal is not to rush the enrollment and make sure we get the right patients into the study. But we did not find any challenges during this - at this point.
Yun Zhong
Okay. Then about the Parkinson's disease dementia study, so I believe that primary efficacy endpoint is the continuity of ATTENTION. So I assume that you're reporting where you see positive data by mid-2020. Are you going to approach the FDA to discuss about the next step? And do you think the same primary endpoint will likely be used in the next study?
Christopher Missling
Yes. So the second question regarding [indiscernible] is a little bit a dialogue with the agency to see if this would be able to be confirmed. But the good news is that the measure you mentioned has been shown to be correlated with a drug, which was approved for Parkinson dementia many years ago. So that is the reason why we picked that measure. And indeed, it's correct to make that assumption. After the data is available, we would sit down with the agency and discuss next steps.
Yun Zhong
Okay. So then the last question about the new compound 3-71. What do you expect will be the indication that you pursue with this compound? And how do you plan to position the new compound as compared to the 2-73 - sorry, 2-73, yes?
Christopher Missling
So we do have the advantage that ANAVEX 3-71 has already received from the FDA Orphan Drug Designation for frontotemporal dementia, FTD. And we would most likely then advance the Phase 1 into a Phase 2 with that indication. That would be our current strategy.
Yun Zhong
Okay. But in terms of mechanism of action, the two compounds are the same or quite similar. Is that correct?
Christopher Missling
So there are differences. The molecules are completely different, but there is a similarity that they both activate the sigma-1 receptor, which is the core of our hypothesis. That ANAVEX 373 has also an activation mechanism of the M1 sigma muscarinic receptor, which is very strong, and that is slightly different to ANAVEX 2-73. So there are differences in that regard. And we still believe, though, that for that reason, that's intriguing to move forward with 3-71 because we have the ability to demonstrate that the drug has shown very solid reduction in tau, in inflammation and a better aggregation in a triple transgenic animal model. And that basically is the reason why we're very excited about 3-71 as well.
Yun Zhong
Okay. Thank you very much.
Christopher Missling
You're welcome.
Operator
[Operator Instructions] And we have a question from Tom Bishop from BI Research. Please go ahead.
Tom Bishop
Hi. If I'm recalling correctly, has the FDA given A 2-73 for Rett Orphan Drug Designation and rare pediatric disease status and now Fast Track designation? Is my memory correct? Or am I in need of some A 2-73?
Christopher Missling
This is absolutely correct. All three designations have been awarded to ANAVEX 2-73 for Rett syndrome.
Tom Bishop
That's pretty impressive. It sounds like the FDA is really doing its best to speed this along. It is clear that the FDA is in the loop for Rett, but is the FDA as much in the loop here on the Alzheimer's trials, so that the company is working closely with the FDA to assure that the Alzheimer's trial results will be to their liking as well as in Australia?
Christopher Missling
We did - and we announced it. It was by now several years ago that we had interaction with the FDA in a pre-IND meeting and that was shared the design of the study among them. So the assumption is correct. We do have the interaction with the FDA on the Alzheimer's program as well.
Tom Bishop
On that Alzheimer's trial, how do you define - it's for early Alzheimer's, as I understand it. And I was just wondering how the company defines that in terms of MMSE or activities of daily living scores.
Christopher Missling
So the designation of early Alzheimer's is a - is developed by the consortium, the Alzheimer's consortium, and it basically discriminates to more advanced Alzheimer's. And it's basically the area of dysfunction, which is subsequent mild cognitive impairment. And the next level is early Alzheimer's. And the next level is then mild to moderate Alzheimer's and then followed by severe Alzheimer's. So it's basically sandwiched between mild cognitive impairment and moderate to - mild to moderate Alzheimer's disease.
Tom Bishop
But I'm just wondering if there's some cutoff for the MMSE or ADL scores.
Christopher Missling
Yes. That's, in fact, the requirement - or the scores cutoff is 20 MMSE and higher, so 20 to 28. To remind again, 30 MMSE score is the perfect cognition. And the score decreases with advancing of cognitive impairment. So the inclusion of the trial for early Alzheimer's is in the range of 20 MMSE to 28 MMSE score.
Tom Bishop
Okay. And just also, I wanted to ask about this acceleration in the number of sites for the Alzheimer's trial, moving it, I guess, offshore - or opening sites offshore. And to increase the number of sites, like, 200% kind of surprised me a little bit. Seems kind of expensive, but is there some reason for the - behind the acceleration? And...
Christopher Missling
So the - it's not going to be actually much more expensive. It's just that we are going to more places to buy, so to speak, something. So we still need 450 patients. We now have 50% enrolled. So it would just accelerate enrollment. It's not more expensive. It just accelerates it. So the - what remains the - what cost the money is the number of patients, and that's already in the budget, which is 450 patients. So it's independent from which sites this would be coming.
Tom Bishop
But is there some reason for the acceleration? I must admit to having had some exciting anecdotal news of patient improvements coming out of Australia. And that we're just...
Christopher Missling
So we are excited about this program. And we already had said previously that the Phase 2a Alzheimer's study gave us the confidence to move forward into this Phase 2b/3 study, and that is the basis of now accelerating this because we are realizing that we want to now make sure that the study is finishing sooner than later. And so we were confident so far with the first 50%. And now we are moving to this level of acceleration by increasing the number of sites.
Tom Bishop
Okay, good. And finally, does the company have any thoughts on additional Rett data, when that might be coming out because there's two ongoing studies? I don't know how close they are.
Christopher Missling
Yes. So these studies are ongoing, as I mentioned, and we will report when each of the enrollment is completed. And then we will also be able to exactly precisely say when are the top line data of these respective two study will be presented.
Tom Bishop
Okay, great. Thank you.
Christopher Missling
Thank you.
Operator
And we have no further questions at this time. I will now turn the call over to Dr. Missling for closing remarks.
Christopher Missling
Thank you all for participating in today's conference call. I hope that based on the described developments today, you're looking forward to 2020 as much as we are. Should you need any additional information or have any questions, please visit our website at www.anavex.com or call or e-mail us as well. This concludes our remarks for today, operator.
Operator
Ladies and gentlemen, this concludes our call for today. You may now disconnect.
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Anavex. Ja det er god læsning en tidlig morgen. Tasso1, ved du om de stadig har 10 millioner aktier liggende til beskyttelse mod overtagelse? Hvis ikke du ved det spørger jeg ir.
VH
MM -
Anavex - Black Rock 13 G filing 5,3 %!
En af de største kapitalfonde ejer nu 5,3 % af Anavex!
De store penge er vågnet - mon ikke flere følger.MM - ja er helt overbevist om, de 10 mill. særlige aktier ligger trykt og godt i Anavexs pengeskab.
Dette er ikke alm. aktier - som jeg har forstået, kan de i princippet konverteres til f.eks. 100 mill. stemmeberettigede aktier.
Anavex vil til hver en tid kunne bevare et stemmeflertal.
Derudover fik de jo også sidste år aktionærernes velsignelse til at kunne sælge op til en samlet mængde aktier på 100 mill. stk.
Der er nu ca. 58 mill ude nu, så de kan stadig løbene sælge op til 42 mill. aktier, til at financiere udviklingen/casen.
Men der er jo ikke behov at sælge så mange, hvis kursen f.eks. er 10 eller 15 $.
Anavex har fuldstændig styr på, at ingen løber med guldet - man kan højst få lov til at hoppe med på vognen og få en bid af kagen.
Når kagen bare er stor nok, kan det også være særdeles lukrativt.
Anavex har i princippet ikke behov for en partner.
Fordel ved at indgå en partneraftale med en eller flere BP kunne være, at man meget hurtigt kan få gang i et salg af 2-73 i en stor del af verden.
Anavex har jo tidligere udtalt, at man selv kan håndterer salg i RETT, men man måske ville finde en egnet partner til salg i Alzheimer og Parkinson.Anavex sidder her med den lange ende i sådan en aftale - tror flere BP vil stå i kø får at få lov til at være med!
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Anavex CC 17.15 Webcast!
Anavex Life Sciences
Anavex utilizes precision genetic medicine to treat severe and devastating neurological disorders and is focusing on rare diseases with no available therapy (Rett syndrome) as well as neurodegenerative diseases that are on the rise due to aging population
(www.veracast.com)
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Anavex CC - kort, men super godt!
Meget koncentreret ( kun 18 min. ) - men budskabet om at 2-73 virker var meget klart.
Også at virkemåden af 2-73 er bred og godt underbygget af bl.a. 3. part.
CEOen understregede, at Anavex var det eneste selskab, der via. precision tilgang, gik efter/kunne behandle så bredt et spektre af CNS indikationer.Et guldkorn vedr. det internationale RETT forsøg med 69 børn/unge 5-18 år ( 14 ugers varighed ), som starter meget snart - er blevet godkendt som et fase 3 forsøg.
Dvs. at de respektive myndigheder internationalt har vurderet at de vil have nok til at kunne bedømme effekten af 2-73 i RETT til en evt. markedsgodkendelse.
Ikke så sært det tager lidt tid af sætte forsøg op, når man både skal have TGA, EMA og FDA til at være enige.
Men som altid, ved alle indikationer, er Anavex meget grundigt og sætter omhyggelige strukturerede forsøg op, så man sandsynligvis ikke behøver at kører ekstra forsøg og derved i sidste ende når i mål på kortere tid og til færre omkostninger.Næste umiddelbare milepæle:
( Se slides )100 % indrulning i de første 2 RETT fase 2 forsøg.( må være meget tæt på - dage/få uger )
Opstart af det internationale RETT - nu fase 3 forsøg. Her bliver det spændende at se geografien af sites. ( få uger )
Annoncering af de nye hele 30 sites i Alzheimer fase 2/3 forsøget - og især geografien af dem.
( få uger/1-2 mdr. )- og følger de respektive myndigheder op med evt. Fast Track eller lignende, ved opstart!
Men som vi eksempelvis fik at vide den 6. feb. på Q1, snakker Anavex også med FDA om Alzheimer og sikkert også om Parkinson.
Samme snak har Anavex nok også med EMA.
Så der kan komme lidt af hvert inden vi får resultater af RETT og Parkinson maj/juni 2020.Derudover deltager Anavex løbende på div. konferencer, hvor vi hele tiden får ny viden om robustheden af casen
Slides:
https://www.anavex.com/wp-content/uploads/2020/02/Anavex-Presentation-February-2020.pdfWebcast:
Anavex Life Sciences
Anavex utilizes precision genetic medicine to treat severe and devastating neurological disorders and is focusing on rare diseases with no available therapy (Rett syndrome) as well as neurodegenerative diseases that are on the rise due to aging population
(www.veracast.com)
2-73 (blarcamesine) Clinical Development Program for the Treatment of Rett Syndrome
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