ANAVEX. NY TRÅD ÅRSRAPPORT 2021!!!!
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Anavex. Udskrift Webcast
Anavex Life Sciences Corp. (AVXL) CEO Christopher Missling on Q4 2021 Results - Earnings Call Transcript
Nov. 24, 2021 9:35 PMAnavex Life Sciences Corp. (AVXL)
SummaryAnavex Life Sciences Corp. (NASDAQ:AVXL) Q4 2021 Earnings Conference Call November 24, 2021 4:30 PM ET
Company Participants
Clint Tomlinson - IR
Christopher Missling - President & CEO
Sandra Boenisch - Principal Financial Officer & Treasurer
Conference Call Participants
Raghuram Selvaraju - H.C. Wainwright
Soumit Roy - Jones Trading
Operator
Welcome to the Anavex Life Sciences Fiscal 2021 Fourth Quarter Conference Call. My name is Vage [ph] and I'll your operator for today's call.
At this time, all participants are in a listen-only mode. [Operator instructions] Please note this conference call is being recorded.
I'll now turn the call over to your host Clint Tomlinson. Sir, you may begin.
Clint Tomlinson
Thank you and good afternoon, everyone. We appreciate you joining us today for Anavex Life Sciences fourth quarter conference call to review financial results and discuss the company's business updates. The tape replay of this call will be available after the call. 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.
Following management's remarks, there will be a question and answer session. Before we begin, please note that during this conference call the company will make some projections and forward looking statements. These statements are only predictions based on current information and expectations and involve a number of risks and uncertainties. We encourage you to review the company's filings with the SEC. This includes without limitation the company's Form-10K 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 an 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, Clint. We really appreciate everyone joining us on today's conference call to review our most recent reported financial results and to provide obvious business update.
We concluded an exceptional fiscal year 2021 while continuing our momentum highlighted by the efficient execution [indiscernible] Phase 2/3 AVATAR clinical trials Rett Syndrome, the ANAVEX 2-73 clinical Phase 2/3 AVATAR Rett Syndrome as well as [indiscernible] ANAVEX 3-71. Starting with our lead drug candidate 2-73, we expect top line results from the second placebo controlled study for the treatment of outpatients with Rett Syndrome, which are expected to be announced [ph] around calendar year end 2021.
This study took place in Australia and the United Kingdom using a higher dose than the US based phase two study and enrolled 33 patients over seven week treatment period, including ANAVEX 2-73 specific precision medicine biomarkers. Top line results from the placebo controlled excellence phase two slash three study for the treatment of patriotic patients with Rett syndrome are expected in the first half of 2022.
This Phase 2/3 study in patriotic patients with Rett Syndrome, with five to 18 will evaluate the safety and efficacy of 2-73 in approximately 84 patients over a 12 week treatment period, including 2-73 specific precision medicine biomarkers. Regarding our Alzheimer disease program top line results from the placebo controlled phase 2b/3 Alzheimer [ph] study for the treatment of Alzheimer disease are confirmed and are expected in the second half of 2022.
The double blind placebo controlled 509 patient late stage Phase 2b/3 study in patients with Alzheimer disease exceeded enrollment of the targeted the number of 52 south across North America, Europe and Australia using others [ph] and ADCS ABL for activities of daily living and function is primary endpoints. This multicenter, double blind clinical trial is measuring efficacy, tolerability and safety of two different ones daily all on ANAVEX 2-73 doses or placebo.
[indiscernible] last month, the independent data safety monitoring board for the company's face 2B free study completed its most recent pre pretend review of the preliminary Phase 2B/3 study data in asthma patients. As specified in a protocol, the [indiscernible] reviewed the interim safety data for the 2-73 Phase 2B/3 disease clinical study and its open label extension attention study. Upon review of the interim safety data, the BS recommended to continue the study to modification.
We're very excited also to report that the top line data from another time compound of ANAVEX 3-71 is received often drug designation by the FDA for Frontotemporal dementia,, a placebo control Phase 1 study in ANAVEX 3-71 evaluating 371 in humans are expected around calendar 2021. During 2022, we were also moving closer to further expanding the pipeline for 273 using gene biomarkers of respond, applying precision medicine for another neurological disorder with unmet medical lead, including a plant initiation [ph] of 273 imaging focus, heart disease clinical study. A plant initiat initiation also of a Phase 2 cell three clinical trials for the treatment of a new rare disease indication and lastly, a planned initiation of a pivotal Phase 2 specialty of a new [indiscernible] the most genetic cause of [indiscernible].
In Federal [ph], most frequent announced August of this year data [indiscernible]. I would like to direct the call to Sandra Boenisch, Principal Financial Officer for a brief financial summary of the recently reported year end.
Sandra Boenisch
Thank you, Christopher and good afternoon to everybody. We continue to maintain a strong balance sheet and fiscal responsibility. Our cash position on September 30, 2021 was $152.1 million, which we believe is sufficient cash runway to fund operations and clinical programs beyond 2025. During fiscal 2021 cash utilization and operations was $30.4 million. We reported a net loss of $37.9 million for the full fiscal year, which is $0.54 per share as compared to $26.3 million or $0.45 per share in the comparable year 2020.
Research and development expenses for the year were $33 million compared to $25.2 million for the comparable fiscal year. The increase is primarily attributable to the continued advancement of our ongoing clinical trials. Most notably the full enrollment of our international Phase 2B/3 Alzheimer's disease trial and the related open label extension and the continued enrollment and advancement of the Rett Syndrome studies and expansion of these trials internationally. General and administrative expenses were $9 million for the year as compared to $5.9 million in the prior year. The increase is mostly significantly associated with an increase in personnel and associated non-cash stock option compensation charges.
Thank you. And now I'll return the call back over to you, Christopher.
Christopher Missling
Thank you, Samra. And as we look to the remainder of 2021 and into 2022, I'm very excited about the company's potential as we continue to advance and expand our position medicine to programs. As we look ahead, we will continue to focus on driving meaningful growth across our broad CMA one platform, portfolio to deliver transformational treatments for patients with both degenerative and developmental neurological disorders around the world.
So we look forward to providing further updates of advanced and continue and at this point, I like to also wish everyone a happy Thanksgiving. I would like now to open the call for questions. Operator, please go ahead.
Question-and-Answer Session
Operator
[Operator instructions] And our first question comes from Charles Duncan from Cantor Fitzgerald. Your line is open.
UnidentifiedAnalyst
This is Pete [ph] for Charles. Good afternoon Christopher and team and congratulations on the progress and appreciate all the updates. I have a couple of questions regarding Rett Syndrome. When you think about the efficacy measures that were made in the efficacy scene in the US adult study, how do you feel about the samples size or the planned effect size out of AVATAR and also the excellence study. And we saw that you upsized the sample size for excellence from 69 to 84 subjects which role that decision, if you can give us some color on that.
Christopher Missling
Appreciate it and thank you. So the efficacy effect size was really significant in the first US study, which was using a low dose, as you remember, and the effect size was in the range 1.3 to 1.1 -- 0.3, which is considered very large. And since we expect those response based on higher doses, we basically inclined to believe that the second study, the other AVATAR study might show a similar if not higher effect size, given that we are using a higher dose in the AVATAR study compared to the US study.
The extension of patient number in the excellent study from originally 69 to 84 was based on a request a regulatory request to also have an additional sub analysis of the number of patient in different age groups for example, from five to 18 to also have an additional analysis of patients from five to 12, and then from 12 or 13 to 18 in order to make sure we have enough power for this additional calculation, we thought it was prudent to just add additional number of patients with ended up to the total number of 84 as we communicated.
UnidentifiedAnalyst
Thank you. Very helpful. We also saw that you made a few changes to the primary and second very endpoint in the excellent study. Can you give us a help us understand on what drove those decisions, was a result of advice or interactions with the FDA or any other regulatory agency,
Christopher Missling
Right. So we have noticed that the RSQ is really the most rigorous, more rigorous endpoint. It is really going through 45, very dedicated questions and detailed question, which can be answered very precisely. There's also the ability which we have seen, and we have demonstrated that in our presentation of doing sub-analysis of the sub scores of the entire score of the RSPQ, however, when we look at that we noticed that there was a weaker ability to make this because it's a really a global assessment and it also has a very known and it's published weak I would say reliability, but we basically include that still, but we didn't want to overemphasize that score. So that was the background for the focus on the RSPQ.
UnidentifiedAnalyst
All right. Thank you. And my last question regards to the Parkinson's disease dementia program, can you provide any updates on that program, have you met with the agency to discuss it and or do you plan to anytime in the near future?
Christopher Missling
Yeah, we plan, Right. Thank you very much. Yes. We plan to do that. We actually are in the process of now discussing the data with the foundations and we are expecting to get a valuable feedback for input on the design of pivotal studies for Parkinson and also pivotal study for Parkinson dementia. And with that, in our package, if you like, we then feel more robustly educated and fully informed to go to do the discussion with the agency about a proper pivotal study in the respective communications.
UnidentifiedAnalyst
Do you think, by some chance you're going to wait for the imaging study results or it'll the meeting will occur beforehand.
Christopher Missling
This will be before the imaging study, but definitely we are still including which we have not yet reported the total gene analysis of the PD study. So that means we've not only looked at the Sigma one gene expression changes of the mRNA, but also the gene expression of all participants that is in the active arm, as well as in the placebo arm and believe that additional intelligence can be drawn out that to make an informed design of a study, which increases further the chances of a pivotal study down the road.
UnidentifiedAnalyst
All right. Thank you. Thank you very much for taking my questions and congratulations again on the progress and happy Thanksgiving,
Christopher Missling
Thank you.
Operator
Next question comes from Raghuram Selvaraju from H.C. Wainwright. Your line is open.
Raghuram Selvaraju
Congrats for the progress and thanks for taking our questions. So firstly, how early in 2022, do you envisage filing an NDA for [indiscernible] in Rett Syndrome, providing you positive readouts from the three trials?
Christopher Missling
It's really, I would let the data first come out and then we can talk about that, but obviously pending data as soon as possible.
Raghuram Selvaraju
Excellent and then with regards to 2-73 what learnings are you transitioning into your Fragile X syndrome development? For example, are you planning on cross analyzing data from the Rett Syndrome and the fragile X syndrome trials, given that the two syndromes sort of share over overlapping symptoms as well as underlying cellular mechanisms?
Christopher Missling
That exactly right. So two pockets here to look at one is the preclinical pocket, and we see a very strong in the animal model of a Fragile X and leading to even reversal of the pathology. And then we look also at the clinical study of the Rett Syndrome, and we see that the phenotypes are overlapping between these two indications. And there are some end points, which are included in the Rett Syndrome study for example, atoms [ph] is one of them and that had been responding very well with the drug and we believe this could be also used as a key measure for the Rett Syndrome for the Fragile X study, since that has been also even used prior in Fragile X study as our primary endpoint. The decision is not yet made exactly about how to use that endpoint, but this could be one potential venue.
Raghuram Selvaraju
Okay. Very helpful. And we read with interest your recent published paper in expert opinion on therapeutic targets where you described 273 and 371 as hand in hand targets for Alzheimer's disease. We were wondering if you've number one, benchmark these drugs together pre-clinically, and number two, test a company nation if not, do you plan to do so.
Christopher Missling
So the two compounds came from different angles and different labs but they are now moving more into what we call, we try to learn as we go. But so far we could not find parable assay other than a very early preclinical assay of target engagement. And there are differences in the affinities of the Sigma 1 receptor and also difference to the muscarinic receptor, which we believe is also important.
And ultimately we will be only able to see really the difference of the two if we run really both indication world drug and the same indication in the same trial. So we think that each drug has its own merits and it could very well be that 371 is really good at focusing more in Frontotemporal, and could also be very good at [indiscernible] but right now we have 273 more advance, so we will eventually find out,
Raghuram Selvaraju
Appreciate the color. And then just finally you've talked about 273 using in a prophylactic manner. We saw a recent science advances article, which describes a unique kind of brain protein signature in younger cohorts, mean age of 39. Are you currently working on or planning a genetic or protein test in a younger cohort to kind of help your 273 administration in the future?
Christopher Missling
Yeah, we look into that and it's a very good point because while the disease is showing up correlating with age, it's clear that early intervention is really most likely the most efficient way to incubate this disease. And our preclinical data indicates that potential, which was done very successfully in animals that who got the drug before they got injected with a toxic, a better load. And they never developed the symptoms of Alzheimer disease. So there's really high likelihood that we should or encouragement to also proceed. And we sat and we committed to eventually do that with the appropriate in the appropriate time, down the road. So we are committed to look into that what you described early on.
Raghuram Selvaraju
Okay. Excellent. That's it from us? Congrats again, and happy Thanksgiving to you and everyone on the call. Thanks.
Operator
Next question comes from Soumit Roy from Jones Trading. Your line is open.
Soumit Roy
Hello everyone. And thank you for taking the question. Could you give us a little color around the upcoming Rett study? So as I understand, there will be different dose cohorts. So is, could you give us an idea of the size and is there going to be intra cohort dose escalation? What should we expect?
Christopher Missling
Yeah. So let me explain that there is not a different dose. It's just a target dose is higher than the US study. So there's only one dose and one placebo arm, and that one dose will be a target dose. So that is just higher than the US study. So there will be not multiple doses, technically it's just one higher dose.
Soumit Roy
Okay. Got it. So, and you are not disclosing if it's going to be 10, 20 or 30,
Christopher Missling
Right. We will find out when we disclose the data and then we'll be able to learn about that.
Soumit Roy
Got it. And any color on the Alzheimer's trial, what are you planning as patients are coming out of the 48 week? Is, are they going to go into maintenance trial or what is the plan there?
Christopher Missling
Right. So we have an extension study called Attention ID, 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 AB 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.
Soumit Roy
Great. It's really good to hear. And one last question on the back to the Rec program, where are you on the conversation turning whether these going to be the data [ph]
Christopher Missling
It's really a question now of the data and the data has to speak for itself. And we also said it's a potential pill study. So the word really weighs in, and the data really will determine this how this will be looked at. We have to point out that for adults, there is no treatment available. And the patient population is also harder to bring into the trial because they're more at large. They also are because of the disease early passing on, they're not many patient available to find in a trial. So the focus is really on the study for that reason, but still there's an unmet need for patients of all ages for X syndrome.
So we could expect, you could even start a rolling submission with the adult trial, if need be that could be approved first before the pediatric really gets filed. I would say it cannot be excluded and, but I cannot promise it either. So that's why I said we would have with ANAVEX [ph] study and the US two independent placebo control study in disease, which usually is beyond the request from for rare diseases usually. So this will be successful, a very powerful package.
Soumit Roy
Got it. Congratulate again for on all the progress and happy Thanksgiving.
Christopher Missling
Happy Thanksgiving. Thank you,
Operator
Next question comes from [ph] from BTIG. Your line is open.
Unidentified Analyst
Hi. Thanks very much for taking the question. So the first one is on Rett Syndrome and so the definition of a responder, is that on each efficacy endpoint, is that going to be the same in pediatric patient as two, an adult patient, and also the definition of a responder is that consistent with how clinicians are viewing as clinic meaningful improvement?
Christopher Missling
That's correct. It's consistent first study and then consistent with the assessment. That's correct.
Unidentified Analyst
Okay. Then I think I didn't see an update on the 371 program in 2020 sorry, 2022 in terms of upcoming milestone. So I just wanted to check if frontal temporal dementia is still going to be the first indication for that program. And when do you expect a study potentially to start.
Christopher Missling
Right. So we have mentioned that we would move ahead with prototype dementia, but we like to have really the solid phase one data in hand before we say we commit to this. And but we definitely will move forward with FTD or any other related dementia indication.
Unidentified Analyst
Okay. And then on the pipeline, I think well, it's very encouraged to be able to target multiple indications, but just wonder which indications do you think you would like to prioritize going for? Of course, the Rett Syndrome and is going to be the lead indication, but which indication do you think might be suited for partnerships?
Christopher Missling
So we believe that we have with the red disease franchise, which is Rett Syndrome FX and others the ability, and it's not been the first time that a company has built this into a commercial entity with the disease targeting rare diseases. So that seems to be very doable. It comes to the indication like Alzheimer disease and Parkinson disease, which requires also the involvement of a detailing practitioners, physicians of general physicians. Then it might be more powerful to penetrate the market with the support of a large pharma partner and at the right time to make sure that we retain most upside for Anavex and for our holders, this will be done at the right time and not to prematurely to give up to much of the upside, but it is no doubt that these large indications require additional support.
Unidentified Analyst
Okay, great. Thank you very much. And happy Thanksgiving.
Operator
And your next question comes from [indiscernible]. Your line is likewise. And that concludes the question and answer portion. And it also concludes the conference call. Thank you for participating. You may now disconnect.
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Anavex præsenterer på ALS konference 29-30 november.
Interessant nok er det Nell Rebowe som gør det, som jeg har checket lidt på.
Hun er meget smuk og er også foto model.
Hvis nu hun havde præsenteret tidligere i stedet for den tørre Missling ville kursen nok værre over 100 allerede, ha-ha.
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MayoMobiles bemærkninger til Conference Call https://investorshub.advfn.com/boards/read_msg.aspx?message_id=166914257
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Hvis ikke man kigger på Ihub så følger dette svar fra MayoMobile på spørgsmål om Cohens Effect size
Anavex Life Sciences Corp (AVXL): Check out these links, but basically eff...
MayoMobile: Check out these links, but basically effect size amplifies and in many ways supersedes the importance of statistical significance. With a good P-value...
InvestorsHub (investorshub.advfn.com)
Interessant at der er supergode Cohens effect size i rett og alzheimers i sigma1 varianten wildtype.
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Anavex Live Webcast torsdag den 2. december
https://newsfilter.io/a/12a6afff289272725b9d50855e3bbb2d
Annual Evercore ISI HealthCONx Conference on December 2, 2021 at 12:10 p.m. ET. - 18.10 DK-tid.
Nell Rebowe er jo også på i morgen tirsdag med ALS.
Der kan komme nyheder hver dag nu - spørgsmålet er om "around end of year" allerede er denne uge?
Bemærk at webcastet den 2. dec. er i åbningstiden - så der vil blive kontant markedsafregning ved gode/dårlige nyheder. -
Anavex Evercore ISI HealthCONx Conference
Dette er en såkaldt "Firesite" konference, hvor man udover muligheden for at afholder et webcast, som Anavex, også kan mødes med andre biotekselskaber - alle de store BP er der også som regel.
Så måske Missling skal sidde lidt i en læderstol ved pejsen, med en god cognac i hånden og sludre lidt med potentiel kommende partner - efter han lige har præsenteret lidt gode data?Hvem ved, men det er i hvert fald det konceptet går ud på!
Fik lige købt for 50.000 kr. til kurs 19.99 $ ved åbning - måske sidste gang aktiekursen var under 20 $??
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Anavex Anavex og ALS
Nell Rebowe er på i dag med potentialet for 2-73 i ALS.
Helt tilbage i 2014 er der udgivet en Peer Review, som beskriver potentialitet for 2-73 i ALS:
Anavex Encouraged By Scientific Data Confirming Sigma-1 Receptor Agonist Extends Survival in ALS (Lou Gehrig's Disease)
Anavex Encouraged By Scientific Data Confirming Sigma-1 Receptor Agonist Extends Survival in ALS (Lou Gehrig's Disease)
Company to Initiate Pre-Clinical Studies of ANAVEX 2-73 in ALS Models...
GlobeNewswire News Room (www.globenewswire.com)
I 2019 fandt forsker fra Mainz ud af, at 2-73 stimulerer den vigtige autophagy process - udrensning af celleindholdet, som menes at spille en afgørende faktor i behandling af bl.a. AD, PD og ALS!
Siden har Anavex hidtil "kun" gået videre med Alzheimer og Parkinson i kliniske forsøg. Et valg man nok har gjort på baggrund af en den gang begrænset økonomi og afvejning af potentialet i markedet for de enkelte indikationer.
Nu da Anavex er relativ stærk kørende økonomisk og man har fået bekræftet effekten i både AD og PD, så er tiden måske nu moden til at starte kliniske forsøg op i ALS!New preclinical data establishes ANAVEX
2-73 as a modulator of autophagy through Sigma-1 receptor activation, possibly needed for the prevention and treatment of neurodegenerative conditions including Alzheimer's disease, Parkinson's disease and ALSAnavex casen vil udvikle sig hurtigere nu, når både videnskaben og økonomien er mere solid.
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Anavex Soumit Roy Jones Trading kursmål 50 $!!
Soumit Roy fra Jones Trading er en 5-stjernet analytiker, der var med da Anavex afgav årsrapporten den 24. november.
Han havde flere gode spørgsmål til Missling.
Efter hans mening skal Anavex stadig op i 50 $, så han har åbenbart stadig tillid til casen.Ellers en relativ stor omsætning i går den 30. nov., over hele linjen - nogle mener, at dette var sidste dag i US, hvor negativ afkast skal realiseres, hvis det skal kunne modregnes i 2021.
Måske andre kan bekræfte dette?Husk webcast i morgen kl. 18.10!
Der må komme en ny december præsentation lidt før, med lidt held også en pr. kl. 13.00 - men det vil jeg nu ikke satse på, da jeg som regel har taget fejl på dette.Annual Evercore ISI HealthCONx Conference on December 2, 2021 at 12:10 p.m. ET. - 18.10 DK-tid.
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Anavex. Ser ud til at Anavex ansætter den 3. tidligere FDA ansat!
Fra IHUB:
Adebayo "Bayo" Laniyonu
Senior Vice President (Nonclinical Development)
Company NameAnavex Life Sciences Corp. Full-time
Dates Employed2021 - Present
Employment Durationless than a year
• Nonclinical Development Program
• Regulatory Writing
• Regulatory PolicyBlarcasamine--Great find--thanks for posting--things happening at Anavex Corp.----Dr. Adebayo (Bayo) Laniyonu, Senior Vice President for Nonclinical Development at Anavex Life Sciences Corp, has over 24 years' experience with the US Food and Drug Administration (FDA).
Prior to joining Anavex, Dr. Laniyonu served as Supervisory Pharmacologist/Toxicologist at the FDA Center for Drug Evaluation and Research (CDER). He has reviewed hundreds of NDAs, BLAs (including first in class), sNDAs, ANDAs and INDs and provided high impact regulatory and strategic recommendations to the sponsors of these products. He organized, chaired and presented at FDA workshops and at scientific sessions of professional societies, where he presented on FDA current thinking on regulatory issues. Additionally, Dr. Laniyonu has presented at FDA Advisory Committee meetings. His review and supervisory experience span several therapeutics areas, including Rare Diseases and Medical Genetics, Hematology, Medical Imaging, Radiation Medicine and Medical Counter Measures products. Dr. Laniyonu played pivotal roles in the development of several FDA regulatory guidance documents.
Tror ikke at der mange mindre biotek selskaber, der har så mange tidligere FDA ansatte.
Mon ikke dr. Bayo har fået lidt intern viden om udviklingen på de forskellige områder, inden han sagde ja til jobbet?Man skulle næsten tro, at han tror på, at skidtet virker? - eller hopper han bare med på vognen for ussel mammon?
Uanset kunne Anavex godt have smidt en lille PR på dette!
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Av av det var ikke så rart at vågne op til:
AVXL: -7.68%
SAVA: =8.79%
ANVS: -10.22%I det mindste er det hele sektoren der for klø og Anavex klarer den lidt bedre end konkurrenterne.
Godt nok at de har hyret endnu en kapacitet indenfor FDA domænet det er et godt tegn, helt sikkert.
Kursmaal på 50$ fra en top analyst er helt fint på kort sigt.
Der er intet andet at gøre som vi har gjort hele tiden: Vi venter spændt på data!
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Anavex Tidligere FDA ansat kom allerede i maj 2021.
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Anavex .. Ingen tvivl om, at Anavex har fat i rigtigt mange kompetente personer enten som rådgivere eller direkte ansatte.
Det er supervigtigt med viden på højt niveau samt en god tilgang til fda. Sidstnævnte kan virkelig spænde ben, hvis firmaet ikke kan levere det der ønskes fra fda's side.
Jeg har flere gange beklaget mig over hastigheden i firmaet og er stadig af den opfattelse.
Udskydelserne af Avartar og Excellence er der nok en forklaring på. Sidstnævnte forsøg efter fda guidance. Man kan diskutere hvorvidt de selv skulle have sørget for en afbalancering af forsøgsdeltagerne aldersmæssigt....
At man først efter ca et år med et færdigt PDD forsøg sidder med hele datasættet fra dette forsøg er mig ubegribeligt. Der må være gået noget galt i den proces. Normalt taler vi måneder før data foreligger endeligt. Jeg køber ikke at det tager tid. Kun et spørgsmål om at tildele ressourcer så kommer data hurtigere frem.
Nu har vi så datapakken. Anavex starter med at diskutere denne med en "faundation" - sandsynligvis MJ Fox.
Hvis ikke de selv kan finde ud af dem så skulle de hellere finde et BigPharma at samarbejde med omkring det videre forløb. Med den hastighed Anavex arbejder med kommer de forsøg jo ikke i gang før langt inde i 2022. Rekruttering vil tage rigtig lang tid i Anavex regi, mens et stort pharma vil relativt hurtigt få indrulleret pts i både PD og PDD.Patienter og investorer skriger på, at det potentielt livsforbedrende stof kommer ud kommercielt.
Hastigheden er vigtig i forhold til patentudløb i sidste ende. Evt Rett approval sætter slutdatoen herfor. Så at forsinke data på PD og PDD og approval er med risiko for at miste 2-3 år i sidste ende af blarcamesines lifecycle. Det kan blive dyrt !
Så mit håb er, at man partner snarest muligt for at komme tættere på mål i de voldsomt mange indikationer der ligger åbne.
Det er muligt, at et positivt udkomme af Avartar kan bringe dem i en god forhandlingssitutation, idet de så står med første markedsføringstilladelse inden udgangen af 2022.
Men at vente meget længere med at tage nogle flere muskler ind er i min optik en fejl.
Investorerne mangler også at blive præsenteret for datapakken på PDD studiet, som lovet.
Missling virker overbevist, men han mangler at vise os hvorfor !
Lad os høre, om der er lidt optimisme i dagen CC vi kan klamre os til.
Aktiekursen er ligegyldig - data afgør fremtiden ikke dagens kurs !
Jeg sælger ikke en aktie, men så gerne lidt turbo tilsat
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Anavex ... Ikke mindre en to partnership nyt i dag af interesse.
Novartis og GSK:
GSKs partner Alector har nogle meget interessante tidlige data i frontotemporal dementia. En direkte konkurrent tl 3-71 vi afventer data fra.
Håbede lidt på Novartis som partner til Anavex....
Så gerne lidt fart på Anavex
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Anavex ... Dagens webcast/fireside chat fra Evercore var igen en opmuntrene oplevelse. Helt forskellig fra kursudviklingen
Missling er inde i sagerne og udspørgeren var ligeså. Evercores mand var synligt imponeret over de historiske data og spurgte ind til hvordan de enkelte igangværende forsøg var powered - for at forsikre sig, at der er nok pts til at sikre signifikante resultater. Missling kunne redegøre tilfredstillende for de enkelte forsøg, hvor historiske data udgjorde beslutningsgrundlaget herfor.
Doseringsstørrelsen blev der spurgt til. Missling redegjorde for, at der næppe er problemer med overdosering og at der er tolerence for stoffet pænt over den dosering der er anvendt. For høj dosering ses kun at hæmme virkningen en anelse.
Følgende blev endnu engang bekræftet:
- Pivotale PD og PDD forsøg er ved at blive planlagt
- Readout for Avatar og 3-71 bekræftet igen til omkring nytårsskiftet
- Readout Excellence H122 og AD ph2/3 H222
- AD ph2/3 er et registreringsforsøg/pivotal, hvis data er stærke - her nævnte Missling Aduhelm som "bencmark" (mon det kan kaldes benchmark)
Nogle spændende uger forude selvom kursen kører sit eget løb indtil data kommer.
Bemærk at der i ovennævnte tråd er lidt benchmark til 3-71 forsøget i frontotemporal dementia, hvis effekt måles.
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Anavex Solsen - fint resume!
Det var i hovedtræk en bekræftelse af, hvad Missling tidligere har meldt ud.
Ser ud til de har helt styr på den aktiv mængde 2-73 og samtidig har et pænt vindue op til en unødvendig overdossering i alle indikationer.FDA synes iflg. Missling begejstret for især RETT - og understregede, at hvis Avatar var overbevisende, så havde man meget sandsynligt nok til en godkendelse her, fordi det er en sjælden og alvorlig indikation.
Missling bekræftede også, at de med den 152 mill. $ på bogen kan financierer alt det de har og agter at sætte i gang de næste 3-5 år - UDEN at skulle hente nye penge.
(Tror dog, at Anavex som hidtil løbende sælger et mindre antal aktier, for at bevare vinduet på de ca. 4 år)For os der kender casen, var der som sagt ikke meget nyt - men for nye potentielle investorer må de beskrevne resultater og fremtidsudsigterne da virke ret tiltalende.
Tror også at flere nu har en anledning til at sætte sig lidt ind i, hvad Anavex egentlig har gang i.Husk Missling er på en RETT konference den 14. december!
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Anavex. December præsentation.
https://www.anavex.com/_files/ugd/850d88_ff99cd3c1332457b8a010590bb0adec2.pdf
Top-line data AVATAR: Potentially pivotal Phase 2/3 adult RTT clinical trial - expected YE 2021
Top-line data Phase 1 ANAVEX
3-71 clinical trial - expected YE 2021Ikke meget nyt ,men en bekræftelse af, at vi kan forvente data i december - spørgsmålet er så, hvor længe før en offentliggørelse/præsentation har Anavex kendskab til resultaterne?
Anavex udgør 0,92 % af XBI indekset, hvilket samlet faldt 4,4 % i dag - Anavex - 5,6 %.
Positive Avatar resultaterne vil forhåbentlig adskille os fra resten af div. indekser. -
Anavex ... En givende debat over weekenden på Ihub og med et indlæg fra bl.a. MayoMobile med en opsummering/analyse af Anavex:
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=167009236
Grønne bjælker i hver slide med interessante kommentarer fra forfatteren.
Lidt surrealistisk at læse om kurs 6.000
Ikke jeg tror på de 6.000. Men mindre kan jo også gøre det.
Første alvorlige test nærmer sig med Avatar data !
NB Stadig GAP ned til 15,5
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Jo så godt the flotte opsummering fra super dygtige MayoMobile og er enig i at kurs 6000 er nok i overkanten. Hvis den når derop vil mange mennesker blive helt vildt rige: 167 aktier = 1mill$.
Jeg vil værre ovenud lykkelig hvis vi passer kurs 100 en dag som er mugligt hvis RETT data er gode og medfører godkendelse da flere indikatorer vil følge efter.
Ser ud til at vi åbner i minus i dag, håber på nyheder i morgen men jeg giver det 30-40% chance, nok større næste uge før RETT konference den 14.
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øh hvorfor ikke kurs 6000, når Tesla er 10 gange mere vær end Toyota og Toyota laver 10-20 gange flere biler, så kan alt lade sig gøre, men jeg vil være glad for kurs 250 på et tidpunkt
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