Anavex HISTORISKE OG BANEBRYDENDE RESULTATER I ALZHEIMER!!!
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Anavex Ikke meget nyt - alt kører efter planen.
Anavex har fuld fokus på Alzheimer med 2-73 og tror ikke vi får uddybende resultater før Peer Reviewet - nok flere mdr.
Data fra OLE PDD burde være næste udmelding - måske kun uger.
Data RETT Excellence om min. 5-6 mdr.Opstart af øvrige forsøg inden for de næste mdr.
Vedr. 3-71, så ser det ud til, at Anavex i første omgang satser på Skizofreni - venter med Alzheimer. (at overlade AD til 2-73 giver god mening, hvis data her er gode - hvorfor skabe en konkurrent til 2-73)
Evt. partneraftaler kan udmærket komme på baggrund af de data vi allerede har fået.
Positivt at Anavex ikke har nogen væsentlig udvanding og agerer generelt økonomisk fornuftig - dette område er ofte en stor hæmsko/udfordring for opstartsbiotek.
Håber på at kunne starte en ny tråd med en større milepæl i nær fremtid - trækker det ud skal jeg nok starte en ny tråd uanset - håber dette er ok?
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Anavex Udskrift fra Q1 rapport
Anavex Life Sciences Corp. (AVXL) Q1 2023 Earnings Call Transcript
Feb. 07, 2023 10:55 AM ETAnavex Life Sciences Corp. (AVXL)
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Anavex Life Sciences Corp. (NASDAQ:AVXL) Q1 2023 Earnings Conference Call February 7, 2023 8:30 AM ETCompany Participants
Clint Tomlinson - IR
Christopher Missling - President and CEO
Sandra Boenisch - Principal Financial Officer
Conference Call Participants
Soumit Roy - Jones Trading
Yun Zhong - BTIG
Clint Tomlinson
Good morning, everyone. And welcome to the Anavex Life Sciences' Fiscal 2023 First Quarter Conference Call. My name is Clint Tomlinson, and I'll be your host for today's call. At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session. [Operator Instructions] Please note that this conference is being recorded. 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.
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 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, Clint. We appreciate everyone joining us on today's conference call to review our most recently reported financial results and to provide our business update.
We are excited with the continued advancement of our lead product candidate ANAVEX 2-73 in Alzheimer disease and Rett syndrome as we maintain our attention on execution across each of our clinical programs, and overall business operations. We were very pleased to present top line data of the randomized double-blind placebo controlled Phase 2b/3 study for the treatment of early Alzheimer disease at the CTAD Congress 2022 on December 1.
The trial met both co-primary and secondary endpoints showing statistically significant reduction of clinical decline as measured by those endpoints. We are excited about the data and plan to submit the data for publication and peer reviewed medical journal in the near term. As a reminder, Alzheimer disease represents a growing burden to healthcare systems and societies worldwide. This disease is often multifactorial, and complex in nature.
We believe that our precision medicine platform and novel central nervous system mechanism improve the chance of clinical success. We are pleased by the results of the placebo-controlled Phase 2b/3 Alzheimer disease trial, which data suggests that ANAVEX 2-73 blarcamesine, an orally available small molecule activator of the upstream sigma-1 receptor is pivotal to restoring neural cell homeostasis and promoting neuroplasticity and might be at the forefront of biomarker guided pathway based targeted precision medicine drug development.
We look forward to presenting the complete data set of the study as well as the other long-term study data of the other programs, including Parkinson disease, Dementia and Rett syndrome. With a deep portfolio of promising therapies, we believe that Anavex remains well positioned to address the urgent needs of patients affected by neurodegenerative in rare neurodevelopmental diseases.
Going back to the Rett syndrome program, we announced recently on February 2 last week, the completion of enrollment of the randomized placebo-controlled EXCELLENCE Phase 2/3 study for the treatment of pediatric patients with Rett syndrome. We expect to announce top-line results from this study in the second half of this year.
In Parkinson's disease Dementia, we are planning to announce the data from the 48-week open-label extension of the previously successfully completed Phase 2 study. In other indications, recent communication with the FDA confirms our strategy to advance ANAVEX 2-73 for the treatment of Fragile X syndrome. We plan to initiate this trial soon, and we'll share more details about this clinical program in the near term as it becomes available.
Further, pipeline expansion of the Anavex platform using gene biomarkers of response applying precision medicine of neurological disorders is expected, including planned initiation of an ANAVEX 2-73 imaging-focused Parkinson disease clinical study sponsored by the Michael J. Fox Foundation, a planned initiation of our Phase 2/3 three clinical trial for the treatment of a new rare disease indication and the planned initiation of ANAVEX 3-71 Phase 2 clinical trial for schizophrenia. And last but not least, we expect several clinical publications involving ANAVEX 2-73 and ANAVEX 3-71 and a Rett syndrome burden of illness study.
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 morning to everyone. We continue to demonstrate operating fiscally responsibly. During our first fiscal quarter, general and administrative expenses were $3.3 million, compared to $3.1 million for the comparable quarter of fiscal 2022. Our research and development expenses for the quarter were $12.1 million as compared to $8.7 million for the comparable quarter of fiscal 2022. Overall, we reported a net loss of $13 million or $0.17 per share, inclusive of $5.3 million in non-cash compensation items.
Our cash position at December 31, 2022, was $143.6 million. During the quarter, we utilized cash and cash equivalents of $5.8 million to fund our operations. At our current cash utilization rate, we believe we have sufficient cash runway to fund operations and clinical programs beyond the next four years, consistent with guidance in previous quarters.
The increase in research and development expenses over the comparable period is primarily related to the expansion of our team and an associated increase in compensation and non-cash charges period-over-period as well as costs associated with our Phase 2b/3 study, ANAVEX 2-73-AD-004, and the manufacture of additional clinical trial supply for upcoming pipeline programs.
Thank you. And now back to you, Christopher.
Christopher Missling
Thank you, Sandra. This is an exciting time for the company, and we remain on track for completion and readout of ongoing clinical trials and initiation of additional biomarker-driven precision medicine clinical trials as planned.
I would like now to turn the call back to Clint for Q&A.
Question-and-Answer Session
A - Clint Tomlinson
Thank you, Christopher. We will now begin the Q&A session [Operator Instructions] The first question is going to come from Soumit Roy at Jones Research. You can go ahead, Soumit.
Soumit Roy
Hi, everyone. Congratulations on the progress. Could you give us a little color on what kind of details on the Alzheimer data we are going to expect? Are we going to see some MRI data? Or time course of how the reduction in the cognitive decline has occurred or something like that?
Christopher Missling
Yes. So several items will be in the paper, in the publication. Of course, we made sure that the study has a lot of biomarkers in additional measures of end points. So among them is MRI, which is a very important marker of pathology, which is the most accurate picture of the brain, and it's very well described that brain atrophy moves in this pathology aggressively.
So that will be part of the analysis as well as additional biomarkers of pathology like a better intel as well as the biomarker, which are specific to Anavex, which is the sigma-1 variant analysis, which was clearly prespecified which you remember, we noted that patients with a wild type sigma-1 receptor did much better compared to those who had a variant. But because the variant carriers were in the minority, often that signal overall was not affecting the significance of all patients, but it was notable that there was a better outcome in patients with wild type sigma-1 carrier status in previous studies. So we are looking forward to seeing how this plays out in this study as well.
But then also, we will see the response to the endpoints of the study depending on doses as well as over the period of time because we measure every three months the time points of the -- within the study. And then you will see additional endpoints, which have been included in the study, like quality of life, sleep quality and other behavioral measures, which are related to the Alzheimer pathology.
Soumit Roy
Thank you for the detail. That was really helpful. Should we expect the data to come out first half of this year? Or are you -- it'd be more like second half would be our expectation?
Christopher Missling
We actually try to do this as soon as possible because we want to share that also with the agencies in the FDA in Europe. So we are really keen to do that as soon as possible. But at this point in time, it's too premature to give guidance on the timing, but you can be assured we do that as soon as possible.
Soumit Roy
Great. Thank you so much for taking the questions. And congrats on all the progress.
Christopher Missling
Thank you.
Clint Tomlinson
The next call comes from Yun Zhong at BTIG. You can go ahead, Yun.
Yun Zhong
Hi, good morning. Thank you very much for taking my question. So Christopher, can you talk about your plan for the regulatory discussion with the FDA on the Alzheimer's indication? Have you started any [technical difficulty] talk to the FDA?
Christopher Missling
A bit of cut off. So do mind --
Clint Tomlinson
Sorry, you asked that again. We had a glitch.
Yun Zhong
Okay. No problem. So yeah, I was wondering your plan for the discussion with the FDA. Have you started anything? Or do you have to wait for additional data to be available before you can start that conversation with the FDA?
Christopher Missling
That's correct. The FDA engages when you have data, and that's exactly where we are. So the data means a complete data set as far as possible, and that's what we want to -- that's why we're also keen to complete that, as I just mentioned, because that's how you can engage with the FDA as well as with the European EMA, agency.
Yun Zhong
Okay. And then switching to the Rett syndrome study. I believe though press release announcing over enrollment had the language that with the FDA's input, you are using the primary endpoint. So I wanted to confirm that the primary endpoint is RSBQ and you see similar to -- or the same to the one used in the EBITDAR study? And so has the FDA agreed that the AUC, the modified RSBQ scale can be an appropriate endpoint for Rett syndrome study?
Christopher Missling
Yeah. We have it described in clinicaltrial.gov, and it was also never change in clinicaltrial.gov for the EXCELLENCE study. It is the RSBQ primary endpoint, and the CGI is key secondary endpoint over the course of the trial.
Yun Zhong
Is that the same endpoint that was used in the AVATAR study?
Christopher Missling
Slightly different. So it's actually the measurement over time from beginning to end of trial. AUC.
Yun Zhong
Not AUC?
Christopher Missling
Not AUC.
Yun Zhong
Not AUC?
Christopher Missling
Exactly, yes. Because the study is large enough that it can carry the signal by itself without AUC.
Yun Zhong
Okay. Great. So the last question, I believe that the original plan is to initiate all those studies that you talked about by year-end last year. And I understand that the focus was on the Alzheimer's disease program. But are there any specific reason for the delay? Or -- also, are you able to provide any specific in terms of timing? When do you expect to initiate those studies?
Christopher Missling
Yeah. So we were very ambitious last year when we made those plans. And the attention to detail required really to finance and work on the specific protocol because it's easy to start any trial. It's more difficult to finish a trial successfully, and that's what we're aiming for. So I think we should appreciate that initiating a trial is not difficult, it's about making the trial successful and meaningful for when it's growing.
And so when you look at each trial, there's always things to consider and you learn to improve it as you go before you really start it. And we didn't want to rush it. So that's why we want to say -- we want to do this with the right timing. But obviously, we will catch up very nicely now with all these trials, which we plan to do. And they are still on track to be executed.
Yun Zhong
Okay, great. Thank you very much.
Christopher Missling
You're welcome.
Clint Tomlinson
I don't see any further questions at this time. Christopher?
Christopher Missling
Good. Thank you. Again, we are very much looking forward and we're very excited about the company's potential as we build on biomarker-driven precision medicine studies with significant unmet medical need and economic burden. And we're looking forward to upcoming data readouts in the Parkinson's dementia and Alzheimer's disease with complete data set as well as Parkinson's dementia open-label extension and the pancreatic Rett syndrome study. Thank you very much.
Clint Tomlinson
All right. Thank you, ladies and gentlemen. This concludes today's conference. We appreciate you participating. And you may now disconnect.
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Anavex Endnu en positiv artikel fra Motley Fool!
Why Anavex Life Sciences Stock Bolted Higher in January | The Motley Fool
The biotech's shares have been steadily leaking higher following positive late-stage Alzheimer's disease trial results.
The Motley Fool (www.fool.com)
Selv Motley Fool undre sig over manglende anerkendelse og prissætning!
"Is Anavex stock worth buying right now? It all depends on your take on blarcamesine's prospects. If this oral Alzheimer's treatment does make it to market, Anavex's shares might be one of the biggest bargains in biotech in a very long time"
Why Anavex Life Sciences Stock Bolted Higher in January
By George Budwell - Feb 8, 2023 at 10:16AM
KEY POINTS
Anavex's stock has been charging higher in recent weeks following a positive late-stage readout in Alzheimer's disease.
Even so, the biotech's share price doesn't reflect the multi-billion dollar commercial potential of this underserved indication.
10 stocks we like better than Anavex Life Sciences
NASDAQ: AVXL
Anavex Life Sciences
Market Cap
$916M
Today's Change
(-1.28%) -$0.15
Current Price
$11.60
Price as of February 8, 2023, 12:04 p.m. ET
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The biotech's shares have been steadily leaking higher following positive late-stage Alzheimer's disease trial results.
What happened
Shares of the clinical-stage biopharma Anavex Life Sciences (AVXL -1.28%) rose by a stately 17.4% over the course of January, according to data provided by S&P Global Market Intelligence. The biopharma's shares have been charging higher of late thanks to positive late-stage results for its Alzheimer's disease candidate, Anavex 2-73 (blarcamesine).On Dec. 1, 2022, Anavex announced that blarcamesine hit both its co-primary and a key secondary endpoint in a placebo-controlled 509 patient phase 2b/3 study. The company said it intends to discuss these results with regulators in the U.S. and elsewhere soon.
So what
The big deal is that blarcamesine is an orally administered drug, which may confer certain competitive advantages over Eisai and Biogen's twice-monthly intravenous Alzheimer's therapy Leqembi. That said, Anavex's double-digit upturn on this positive clinical update was still rather subdued relative to the enormous commercial opportunity inherent in this underserved indication.The long and short of it is that Wall Street clearly has doubts about blarcamesine's clinical profile. An Alzheimer's disease drug with a fairly clean safety profile and a disease-modifying capability, after all, could easily generate over $5 billion a year in annual sales. However, Anavex's market cap following this clinical update currently sits at a meager $916 million. This massive valuation gap speaks volumes about the doubt surrounding this experimental Alzheimer's drug.
Now what
Is Anavex stock worth buying right now? It all depends on your take on blarcamesine's prospects. If this oral Alzheimer's treatment does make it to market, Anavex's shares might be one of the biggest bargains in biotech in a very long time.Speaking to this point, H.C. Wainwright & Co. reiterated its $50 price target on the stock in the wake of these positive late-stage results. That price target implies an upside potential of 325% from current levels.
Perhaps most curiously, though, Wall Street doesn't appear to be assigning much, if any, value to Anavex's other clinical activities. The biotech has ongoing clinical trials in multiple high-value indications such as Rett syndrome and Parkinson's disease.
Based on the wide spectrum of price targets on this stock at the moment, it doesn't appear that many analysts have factored these additional indications into their valuation models. That fact is a testament to Wall Street's considerable doubt about Anavex's platform.
And short-sellers have clearly taken this doubt to heart. At last count, Anavex was one of the most heavily shorted biotech stocks in the market.
All that being said, this biotech stock does have a handful of uber-bullish supporters on Wall Street. Time will tell who is right about this battleground stock.
8-K meddelelse den 7. februar 2023
Siden 1. maj 2020 har Anavex haft en på generalforsamling godtkendt aftale med Cantor om at kunne sælge aktier efter behov på et samlet beløb på 150 mill. $.
Indtil nu har Anavex solgt for ca. 87 mill. $ på denne ordning.
Ordningen er nu blevet overdraget til Lincoln for de resterende ca. 63 mill. $ med en provision på 3 %.
Deres årlig cashburn har ligget på ca. 23-25 mill. $, så resten af de 87 mill. $ er gået til at polstre deres pengetank til nuværende 143 mill. $
Det er vigtig, at Anavex hurtig kan frigøre ekstra kapital til evt. nye forsøg eller for at kunne opbygge eksempelvis en salgsorganisation.
Anavex sender også et signal til evt. kommende partner, at de ikke er i pengenød og selv kan financierer udviklingen af casen om nødvendig.
Anavex kan også frit sælge aktier på evt. gunstige tidspunkter - f.eks da de solgte 2 mill. aktier ved kurshoppet til 30 $ for et par år siden.Alt i alt en relativ billig og fleksibel finansiering, som Anavex hidtil har udnyttet meget klogt!
De er ikke i lommen på nogen!Flash Alert
Real-time alerts about equities, ETFs, cryptocurrencies and more sent to any device
(flashalert.me)
Fra IHUB:
"finally, it is based on the previous agreement with Cantor, at 3% commission, so it is safe, and its max 150 m$, not so bad:
The Sales Agents will be entitled to compensation at a commission rate equal to 3.0% of the aggregate gross proceeds from the sale of our common stock
We previously sold 7,395,005 shares of common stock under the Sales Agreement for $86,607,450 in gross proceeds.
So this one runs since May 1, 2020, and only half of it is still available... They only switched it from Cantor to Lincoln. I am suprised Lincoln accepts only 3% commission, but, up to now, its the deal." -
Denne Short-squeeze-kandidat kunne faktisk slå ud i det lange løb.
For det andet, og måske vigtigst af alt, mener Wall Street-analytikere - i hvert fald dem med et bullish syn på virksomheden - at Anavex-aktien er massivt undervurderet lige nu.
Læs selv på Yahoo Finance...
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Anavex Ja - Motley Fool er godt nok kommet på banen til fordel for Anavex i den senere tid!
This Short-Squeeze Candidate Could Actually Pan Out in the Long Run | The Motley Fool
Short-sellers have piled into this clinical-stage biopharma stock.
The Motley Fool (www.fool.com)
Også på Seeking Alpha ser man gode muligheder for en godkendelse!
Will ANAVEX 2-73 be approved?
Well, Leqembi received accelerated approval centered on its amyloid-clearing ability, despite some significant safety after 3 deaths have been reported that may be associated with the drug. Meanwhile, ANAVEX 2-73 throttled cognitive decline by 45% with an ADAS-Cog score of 28.75, vs Leqembi's score of 24.45. In addition, ANAVEX 2-73 had superior efficacy at 48 weeks in patients who were in more advanced stages of the disease. Indeed, we don't know for certain if ANAVEX 2-73 will be approved, but the current data suggests it is very likely. -
Det kunne da være fantastisk. Det er enhver investors våde drøm at befinde sig på den rigtige side af en short squeeze. Det er bare ikke så tit det sker....
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Det lidt som et hamsterhjul, det køre rundt og rundt, men man kommer ikke nogen vegne....
Nu vi gået i gang med 2023, hvor vi igen afventer resultater/data præcis som vi gjorde i 2022....
Håber ikke jeg skriver det samme i 2024
................Groundhog Day Med Bill Murray.................
Fed film i øvrigtVi ramte så ikke helt 12$ var ellers så tæt på målet (11,93$) at mit lille swing fra 8$ kunne indløses........
Nå op på hesten igen, pludselig så rammer vi pletskud
Om ikke andet, så kommer der en squeeze på et tidspunkt.Mvh
Jeg helt sikkert med
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Mother of all squeezes:
Hedge funds lose $30 billion on VW infinity squeeze - MOX Reports
Related article. How Martin Shkreli caused a 10,000% squeeze on KBIO Volkswagen Infinity Squeeze. The October 2008 short squeeze on shares of
MOX Reports (moxreports.com)
En vild historie og meget dyrt for nogle.
Fatter heller ikke, at man tør ligge short i en aktie som AVXL, hvor shortandelen er over 20%.
Ledelsen siger igen og igen, at fase 2b/3 nåede endpints.
Derfor er der en betydelig risiko for at partner bliver meddelt eller et take over kommer. FDA eller anden myndighed kan komme med positive tilkendegivelser etc.
Vi ser tillige indberetninger, der viser, at de store aktionærer øger - senest State Street med 2 mio flere aktier end for et år siden (+50%) og nu 7-8% af alle aktier.
For mig at se arbejder short folkene forgæves. De banker typisk kursen ned i begyndelsen af dagen for at købe ind senere.
Med de rette nyheder får vi en squeeze
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Det sikkert at der kommer en squeeze, det er kun hvornår, og meget gerne på data alene..
State Street, VG, black Rock...
Er ikke børsmarkedets svar på renlighed og englebasser
De forvalter enorme summer, og tænker mere i profit end menneskeheden, mere i fosille brændstoffer end grønne alternativer, at de er stor aktionær i anavex er ikke nødvendigvis et plus.Men håber da jeg tager fejl, og deres hensigt er reelle.
Mvh
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Nu var min oplysning omkring de større investorer blot at de ikke flygter, men snarere mindsker det frie flow af aktier. Det gør det sværere at få lukket shortpositionen.
Husk at der i vedtægterne er en poison pill, som sikrer imod fjendtlig overtagelse. Så hvor meget skade kan de bringe. Vi er vel smadret kursmæssigt lige nu.
Den omtalte poison pill skulle helst ikke bringes i anvendelse. Derfor tror jeg også at Missling ikke siger for meget lige nu.
En partneraftale vil være optimalt at se meget snart.
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Motley Fool ser også en mulig squeeze
This Short-Squeeze Candidate Could Actually Pan Out in the Long Run | The Motley Fool
Short-sellers have piled into this clinical-stage biopharma stock.
The Motley Fool (www.fool.com)
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ok Sherlock og hvis man ikke er i markedet, så oplever man aldrig et short squeeze
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Anavex Håb for Alzheimer patienter - meget positiv omtale!
Anavex Life Sciences Offers Hope for People Living With Alzheimer's
Anavex Life Sciences Corporation recently announced promising results for its new drug, ANAVEX
2-73 (Blarcamesine). This oral medication for mild cognitive impairment (MCI) due to Alzheimer's disease is a readily absorbed small molecule that acts as a sigma-1 receptor (SIGMAR1) activator, believed to stabilize neurons and restore the plasticity of the brain. Researchers believe that activating the SIGMAR1 receptor activates a process called autophagy, in which cells break down and recycle defective proteins.Blarcamesine achieved significant, visible improvements in patients in the beginning stages of Alzheimer's disease. The medication had its greatest effect in patients with the mildest cognitive impairment, measured by the 30-question MMSE. Volunteers who received the drug for 48 weeks showed increased capability for performing tasks of daily living, as well as improved memory and decision-making ability. Better yet, there were very few side effects reported.
The future is beginning to look more bright for people suffering from Alzheimers. Although further research is underway, it's possible that in the near future, treatments such as ANAVEX2-73 may allow people living with Alzheimer's to live independently for even longer.
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