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Wonder how much Ern would want to do a 10 minute youtube interview update :).
$AVXL
NFXF webinar:Fragile X Premutation
1 of our favorite doctors, Dr. Randi Hagerman speech on Fragile X. TONs of info about the disease and what’s available.
*****Skip to 1:13:40. AFTER going over current and upcoming treatments Dr Hagerman says, “So the most exciting treatment we wanted to start yesterday”****
When this was originally found, I believe there was mention about presenting results. I think they originally agreed to this conference thinking they would have results by then.
Will they have results by then, not sure. I wouldn't complain if we had other announcements before a positive Avatar readout the first week of 2022. I don't know if much credit is being given to the ACAD drug. A few organizations celebrating its success but not a ton. They previously fumbled an FDA submission so I would expect them to fall and us to rise once our results are made public.
Are they the individuals who are claiming that stopping the sigma 1 from working would stop AD? I might have it mixed up.
Was Tanzi testing out their theory in humans or petri dishes?
Pretty sure Anavex is past the petri dish phase by now. Best of luck to Tanzi and them not killing anyone if they test their theory in actual humans.
Have a great weekend! GL!
What gives us more bang for our buck?
Partnering before P3 results are reported or partnering after you hit all clinical endpoints?
I tend to lean toward the latter...unless your trial doesn't pass :), Not sure partnership matters either way at that point though.
Anyone have hypothetical possibilities to share?
You have to give it a month :). That's what worked for the other company.
I like your list Bourbon!
The only one I slightly disagree with is Rett top line for Avatar. If that is positive we will see $30 at some point soon after. Now lol... will it hold, I wish I knew!
I still believe it comes back to waiting until they had every bit of complete data and were confident in a path forward for Rett. That data wouldn't have been completed till the summer. After that, a request for guidance from the FDA would have been another time consuming process. I'm pretty sure they can't simply pick up the phone, call the FDA hotline, and say hey I'm at 69 people whatcha think, we good?
That's my take on the delay.
Thank you for the explanation Doc. Appreciate it!
Thanks for sharing Raja, this was a fascinating read.
https://www.dbsandme.com/en/understanding-dbs/dbs-procedure.html
I was not aware a procedure like this existed. The original article is interesting, they said the new way provides 4 time longer results. But your looking at 1 seconds going to 4 second duration.
This method is claiming a 70% reduction in tremors, 63% improvement in motor function (after 1 year), and so far treatment results that last for 5 years.
Is DBS a standard of care we will be up against for PD (its 10K for the implant and 8K every few years to replace batteries)? I would rather a pill then an implant. But I wouldn't be opposed to a combination of the 2 either. 70 and 65% are nice numbers for a procedure that doesn't have a ton of risk (just cost).
Thanks for the message George! And for the clarification on dyp's 7% comment. Was curious who he was referencing because I didn't know any AD players who had a good Friday.
Have a great weekend!
Apologies as it was more of a smart remark to our resident know it alls...not intended to raddle any longs feathers :).
I agree that at the end of the day, the only thing that will matter for approval is data. I was disagreeing with anyone being skeptical regarding the little girl being part of the trial.
Maybe we should move on to the painter... naaa forget it, enough handouts are here today right ;). Always appreciate your positive and informed post George! Very good points you make and happy to see others looking beyond what's placed in front of them.
lol George got it :). You are getting closer. I'm having a boring day or I'd just tell you.
Amen to this. Prayers for all the families. A friend of theirs went through the same spinal correction and unfortunately did not come out OK. Another person was on trofinetide and passed away.
This disease is absolutely devastating :(.
No idea what this means but it does not relate to what I was hinting at, I can guarantee that much ;)
https://rettaustralia.org.au/
Start here, take a look around. If you spot what I'm talking "about"... lets just say "Ah ok! well that makes things interesting"
The question I posted (probably 8 months ago by now)... is a very large hint to validating this. How many parents would post this on a public forum if the drug was a dud?
After you answer that question...ask yourself if you would still make that posting knowing an entire Country of parents and children are following along.
Someone will piece this together eventually... GL!
Maybe I'll post the link later if no one figures it out :)
There is more to this story than you know it seems ;)
I'm 100% sure its not here online either. GL!... and this is not nonsense.
to be very specific its 253 members haha! I'm sure plenty of others not in their discord pile on but that little group spends all day refreshing twitter waiting till they can tag their company and then post it on stock twits.
Seeking Alpha is a sad display of their bag holders doing anything possible to recover.
I firmly believe Anavex has more of an older (hopefully wiser :)) investor base. The portion of kids looking to becoming millionaires overnight is far greater in SAVA vs AVXL and the younger crowd goes to town on all social media outlets. That's my reasoning for the lack of chatter we have around the web.
I looked up some of the comp set
AVXL - GS
SAVA - CM
CRTX - GS
INNMB - CM
BIIB - GS
*Interesting, hasn't SAVA been around for a very long time? They were called Pain Therapeutics at one time. For as much credibility people like to give them, they don't have this mark of confidence by the market.
With overall enrollment being previously being exceeded... I'm starting to wonder about the info I received from the Malborne Hospital. I was told the 2nd week of August was the end of recruitment. That would put the time for competition around the End of September. I've always said a December 21 to Feb 22 for the readout (leaning more towards by the end of Feb myself).
I didn't previously think of this, but enrolment for Rettt in Australia was very slow and they are going through extreme lockdowns (families literally not leaving their homes for over a month). There could be a very high probability that we did not have any new patients join in August. If that was the case and the company is clearly motivated to get to the next step.... we could very well have a readout earlier in Q4 2021. GL!
Correct! I'm pretty sure we follow the same people but 1 of our OLE Rett family members shared how bad the lockdown is. Families are not even leaving their homes too often.
I commented around the date that flyer was released, I contacted a rep from one of 2 hospitals still recruiting (which the flyer was for) and they were finishing up enrolment the first 2 weeks of August. Of course things can always change last minute, but with only 14 days left of recruitment and over enrollment already announced. I anticipate they stayed true to this and the final participants will finish the 7 week trial by the end of September. GL!
Agree with you guys, a merger with SAVA would be career suicide for Missling. Anavex would get no benefit from this what so ever (what 1/2 of that new empty 21million dollar office building SAVA bought?...no thanks)
The blood test, SAVA is not the only player trying this. Difference is, SAVA relies on Filamin A identification I believe... which might well be useless if they don't prove out in P3....they have very little if any peer reviewed scientific data linking Filamin A to AD.
Anavex will definitely benefit from an AD drug test. Our timeline for p3 AD results IMO should show results before any blood test comes on the market. At that point SAVA will be useless as well as their blood test. In the future, we'll be using the blood test which produces the most accurate results overall. My money is betting it won't be SAVA's test.
Thanks for the follow up info Steady! I always appreciate your feedback.
haha this is pretty good. They named it after a street in Texas where I'm guessing Remi lives near or has some association with him. I mean common...the man went balls to the wall on multiple FDA failures on a drug he named after himself, Remoxy.
What confuses me is, I could have sworn I heard Missling describe in a presentation how a new drug gets named...and I don't recall the CEO having a say over it. I thought it gets assigned by the United States Adopted Names Council (USANC).
The #2 point in the statement of grounds, that was made regarding filamin A, I found interesting and gave me a new appreciation for the peer-reviews $AVXL submits.
We might go down as well... I've already made plans to cash in other investments which have hit their potential for the year and move more to AVXL.
Looks like the SAVA longs are finally realizing their CEO is a con artist.
Plenty of cheap buying opportunities to get into #AVXL $AVXL right now. I see no benefit in holding SAVA at this point... the chances of SAVA doubling their MC at the current price is slim to none IMO. AVXL on the other hand is 1 Rett PR away from doubling its MC.
SAVA PR's will continue to be nothing but fluff until the rug is pulled out from them for good.
He might have been thinking of the Excellence trail where the N=84 and its a 12 week trial vs 7 week trial. Both have a 48 week OLE afterward.
The Feb 2022 could very well end up being correct. Discounted priced below current levels...I don't see. $15.50 is the absolute bottom I'd see before Rett readout. And that is if 0 meaningful PR's are released the rest of the year. Any BTD PR's, FDA talks PR's... and in my opinion we can forget about seeing anything under $20 again... maybe even say goodbye to $20's depending on how powerful the PR is.
At some point in the next 10 or less months, the market is going to pay attention to us in a big way with AD completing. Its happened to all other competitors on anticipation of data. If we continue to show positive results leading up to this (no matter the difference in indication) the previous positive workings with agencies should speak volumes in confidence for Anavex. When all of that is realized, we'll see a drastic rise.
I didn't think of it based on being able to complete it faster now that they know what they are looking for. Good point guys :)!
I spoke with someone at the Alfred Hospital in Melbourne on Aug 3rd and they were in the final stages of recruiting still. Knowing that, I'm going to assume this week or next is it. Then Avatar is a 7 week study correct? That brings us to a completion around October 9th.
Add 13.5 weeks and we are looking at the 1st or 2nd week on Jan 2022 imo.
If they release just topline and don't wait for the full analysis (since this could be a very pivotal trial) for the adult rett program... then I see 2H 21 as a possibility. IMO it looks like they are aiming for a release in the same time frame as the first trial last year.
If they are pulling more data together then the 1st trial before they make any announcement, I think it will be Jan 2022 they release news. If that is the case, I would except them to come out hot and heavy with PR's in 2022.
haha! I'd like to see that party after 5 years. I have a feeling we'll be the only company that still has patients at that point to talk about ;)
Transcript - 8.12.21, Seeking Alpha
https://seekingalpha.com/article/4448993-anavex-life-sciences-corp-avxl-ceo-christopher-missling-on-q3-2021-results-earnings-call?utm_source=conferencecalltranscripts.org?part=single
Anavex Life Sciences Corp. (NASDAQ:AVXL) Q3 2021 Earnings Conference Call August 12, 2021 4:30 PM ET
Company Participants
Clint Tomlinson - Investor Relations
Christopher Missling - President & Chief Executive Officer
Sandra Boenisch - Principal Financial Officer & Treasurer
Conference Call Participants
Tom Bishop - BI Research
Operator
Good afternoon. My name is Adrian and I'll be your conference call operator today. Welcome to the Anavex Life Sciences Fiscal 2021 Third Quarter Conference Call. As a reminder, this conference call is being recorded.
And I'd like to call over 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 third 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. And we appreciate everyone joining us on today's conference call to review our financial results and describe the company's whole strategy. Let me start by stating that we can proceed into the remainder of 2021 with a background of a strong balance sheet of over $157 million in cash and no debt. Starting with our lead candidate ANAVEX 2-73, we expect to announce top line results from the confirmatory double blind placebo controlled late stage Phase 2b/3 in Alzheimer's disease in second half 2022. The double blind placebo controlled 509 patient late stage Phase 2b/3 ANAVEX 2-73 trial in patients with Alzheimer disease exceeded enrollment beyond 450 patients at 52 sites across North America, Europe and Australia using others [indiscernible] and ADCS ABL 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.
ANAVEX 2-73 is only available small molecule activator of the Sigma 1 receptor. Data suggests that activation of sigma 1 results in the restoration of complete housekeeping function within the body and is pivotal to restoring neural cell homeostasis, and promote neuroplasticity. The study includes a pre-specified precision medicine biomarker, sigma 1 gene expression, which demonstrated correlation with direct measures of clinical benefit, cognition and activities of daily living and [indiscernible] previous stage 2 Alzheimer's disease. Parent data previous confirmed those dependent target engagement of sigma 2 with ANAVEX 2-73. As a reminder of our clinical strategy is clearly differentiated from other biopharma companies in clinical studies in CNS ANAVEX is continuing to pioneer the approach of big data in clinical trials to leverage the relevance of phenotypic and genotypic precision medicine analysis of whole exome sequencing and gene expression data in drug development. And in particular, the potential to identify patients and the variants and gene expression changes that may predict increased chances of success of Alzheimer's disease, Parkinson's disease and Rett Syndrome treatments.
Additionally, we can announce that we exceeded the enrollment targets for the precision medicine ANAVEX 2-73 Phase 2/3 AVATAR clinical trials in patients with Rett Syndrome. And currently topline results from this study are expected in the second half of 2021. Further clinical milestones are provided in Anavex Life Sciences latest corporate presentation, available at www.anavex.com.
And now, I would like to direct the call to Sandra Boenisch, Principal Financial Officer of Anavex for brief financial summary of the recently reported quarter.
Sandra Boenisch
Thank you, Christopher and good afternoon to everyone. We can report a significant increase in cash runway. Our cash position on June 30 2021 was $157.6 million, which we believe is sufficient cash runway to fund operations and clinical programs beyond 2025. [Technical Difficulty]
Question-and-Answer Session
A - Christopher Missling
Animals usually they get sick, they lose ignition. And you see that in the measures water maze behavior and so forth. And we noticed in the arm which had been given this seven day pretreatment prevention that these adults never developed after the injection [ph] with a better any symptoms of cognitive impairment. They behaved in cognitively stood as their wild type path, but those who were given a better and without the pretreatment, they developed the cognitive impairment as you expected from the animal model. So this is the observation which led to the potential that the one activation with ANAVEX 2-73, which as we know by now is extremely upstream and possibly able to prevent the cellular stress which is caused by via better interjection rejection. And so in the entire challenges of the pathology, which is not limited to a data that this could be used as a prevention. Also, in the future, if it has to be awfully confirmed.
The intelligence we have the Alzheimer's [ph] study seems to be also giving credibility in that direction, since we noticed a gradual ability to improve completion, earlier stage status of productive capacities. So when I mentioned before the cognitive impairment, lower than 20 MMSE and the lower score means more cognition or more cognitive impairment that those were better off the earlier you treat them. So we might be able to continue the trajectory of into the ability to prevent the cognitive impairment to even take place. When we give the drug to patients, which are either as you point out mildly cognitive impaired, or before even any symptoms of cognitive impairment is present, just to be able to always prevent this cellular stress by this activation. And we compare in a way to many aspirin, which some people take for avoiding cardiovascular problems. And they do that every morning for breakfast. So I'm not saying that this is confirmed in human. But eventually we will be able one day to tackle that. And that is the plan in a study.
Unidentified Analyst
Great thanks. And also I wanted to ask about your thoughts regarding lessons takeaways from the rest syndrome experience with [indiscernible] and their applicability to your potential clinical development initiative with the compound in Fragile X syndrome. And if you could also give us a sense of when you anticipate the Fragile X syndrome program to initiate patient enrollment. Thank you.
Christopher Missling
We have included in our Red syndrome clinical trial, a measure which is called Adams [ph], and that score is interesting enough a secondary score in the Red syndrome study, but it is often used as a primary endpoint in Fragile X studies in that Adam score was extremely positive with behavior improvement of general mood of anxiety, and compulsive behavior improvement, which were very significant and very broad and global. So we believe that in a data readout of the preclinical data of Fragile X with ANAVEX 2-73, which we submitted to a peer reviewed paper of a nature paper, which we expect to come out as forthcoming, that this could be a very good basis for the rationalizing, progressing Fragile X into an indication of choice also for ANAVEX 2-73 and the ideas of this to move this forward, as soon as possible given the unmet need of Fragile X which is the largest population of autism spectrum disorder.
And that syndrome is also part of the family of the autism spectrum disorder. So these are correlated diseases, although they are originated in different places in the causation, causality, but they have similar symptoms in overlapping symptoms with each other. So we expect the trial to be initiated, once we are able to showcase the data in a peer reviewed paper.
Unidentified Analyst
Thank you very much.
Operator
And our next question comes from Tom Bishop from BI Research.
Tom Bishop
Hi, Christopher, you said that you were expected to include a phase 3 prevention study, or to initiate one of you know, for the prevention indication, and I was wondering what the status of that was, and how soon we could expect that?
Christopher Missling
So this is something which we like, discuss with the agency, because it's an awfully a very important study. And we want to get that right. So we will let that happen first, before providing more details on that. But I'd like to just point out the potential for that to be the case. And that gives us also a great hope that given the broad upstream effect of the sigma 1 activation, which is I want to remind everybody, it's not something we came up with, but it's really the endogenous the body's own defense mechanism to avoid and to prevent cellular stress, which causes diseases like Alzheimer, but also Parkinson and other cognitive impairment, indications, and probably also the degenerative and as well as the new developmental vacations, which is the reason why we see this strong effect, beneficial effect with a drug in this broad therapeutic, different indications. So this is something we like to discuss with the agency first, before making providing more details. But this is the long shot. And as of probably the big prize, that one day, this could be used as a prevention treatment for all degenerative diseases, and not only for treatment.
Tom Bishop
That's a very exciting possibility. What is the status of the meeting to proceed on to phase three and Parkinson's? Sometimes it seems like we lose a lot of time between trials. I know you've presented the final data. And I'm just wondering what the timeline is here. Have you scheduled the meeting with FDA or add one or?
Christopher Missling
There's a very good question. Your key background is to know that the trial itself has finished but the analysis is not limited to the endpoints which we reported. There are more work or work up ongoing right now. And this is also unique for ANAVEX and differentiates other companies that we have included in our trials, including the PDD trial, the Parkinson disease dementia trial, the whole genomics exome analysis, both DNA but also RNA. And you know that we reported the RNA changes of the Sigma 1 gene, what we have not yet done is they have the intelligence on the RNA of all the other genes, which the whole genome. So, there will be so much more intelligence from this PDD study, which we are right now putting together and once we have that, then we will have the ability to put this all forward because this will determine a much more robust phase three design of a pivotal study in Parkinson's dementia, as well as in Parkinson, but that requires also the dialogue with the agency first but before that, we have to have the entire data at hand.
Tom Bishop
Well, okay, and the status of the Michael J. Fox million dollar imaging study. Is Michael J. Fox doing that independently of you. I mean, you're supplying the drug, but they're doing the imaging. I mean, how's that going?
Christopher Missling
Nope, it's basically a grant that allows us to do this study. And we are in the process of starting this year. It's a study which will capture the imaging, and the profile of the ANAVEX [ph] three of the drug in the brain in the humans with the same pet like and which we have done already in animals. So this will be a confirmatory, of that effect in human brains. And that is the study which was fully funded by Michael Fox Foundation, which we are executing and they basically funded that study with a grant.
Tom Bishop
Oh, I see. Okay. And you indicated a mystery indication earlier this year. And also, there's a 371 trial, is there not a phase 1 ongoing? Could you comment on those two, where they same? I don't know.
Christopher Missling
Right, it's not a mystery indication, we have only said, we have not disclosed yet, the indication, we have several animal models were ANAVEX 2-73 has been positive, very well, achieving a confirmatory effect on a disease which is rare in nature, ultra rare nature. And we want to make sure, before we move forward with the clinical trial, that we pick the right one to do, because we have the choice of several indications, and we are doing this right now. So once we have that completed that assessment, we will disclose that indication and start that trial also right away. And regarding ANAVEX 3-71 is basically another molecule has its own IP, and that is now in a phase 1. And we expect data without in the second half of this year, is progressing well. And we are excited, because it confirms, the validates the mechanism of action of our platform portfolio to focus on sigma 1 modulation, and also it has received an orphan drug designation for Frontotemporal dementia, which is also an unmet need. So we are now preparing after the phase one, the next stage of that which will be studied in an indication of cognitive impairment, it could very well the Frontotemporal dementia for another indication with an unmet need with cognitive impairment.
Tom Bishop
But the phase one study is, are you saying it's done?
Christopher Missling
It is about to wrap up. And we will be able to report this data in the second half of this year. That's correct.
Tom Bishop
Will it include any efficacy data or just the safety trial literally?
Christopher Missling
It's predominantly a safety trial. But I will allow us to basically share the data once we have it. And that gives us better visibility on what is included in that in that outcome measures beyond phase one data on safety data.
Tom Bishop
Okay, well, you know, I've been very encouraged by the breadth of the positive readouts, you're getting on a variety of indications. And I think that helps support the idea that 2-73 really does something in the brain, which I think you have a little doubt of, and I do too, but it's just good to see so many different positive readouts coming. Thank you.
Christopher Missling
If I might add, it is really important to notice. And to highlight the fact that in all clinical trials we have performed so far, not only was ANAVEX 2-73 efficacious at the right doses, but it was also demonstrated a dose response curve, which is always a very clear indication of our effect. And thirdly, we have noticed that all the data, all the trials so far performed, had a very strong biomarker of response or predictive biomarker response, which was borne by the by the level of mRNA expression of the target of our drug itself. So there's really no better way of showing efficacy and confirming efficacy of a drug with these strong biomarker outcomes, which correlated with all the primary and secondary endpoints of the drugs we have performed.
Tom Bishop
Like I said, it's very encouraging. Alright, thank you.
Operator
Thank you, ladies and gentlemen, this concludes today's conference call. You may now disconnect.
I also felt this was a very important note. To compare, CRTX who will readout in November had a 90% turnover to OLE and that was said to be amazing. I was very happy with the turnover and even happier to see they want to continue after OLE like our previous AD participants.
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