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https://seekingalpha.com/article/4437842-anavex-catalyst-rich-year
Anavex: A Catalyst-Rich yeear
Jul. 05, 2021 3:36 AM
Summary
Anavex Life Sciences Corporation conducts clinical trials for its small Anavex 2-73 (blarcamesine) and Anavex 3-71 (AF710B) molecules.The biotech has a rich development pipeline aimed at neurodegenerative and neuro-developmental disorders, such as Parkinson's, Alzheimer's and Rett diseases.It has been a catalyst-rich year with a lot of news pertaining to the biotech's own clinical trials, as well as peer Biogen's aducanumab obtaining FDA approval.A comparison with another peer shows that the company has a more disciplined cash generation and use strategy and is still undervalued despite the recent stock upside.Looking forward, there are catalysts to propel the share price to the $28 level, all amid a volatile path.
skynesher/E+ via Getty Images
After recording a 52-week high on the back of promising mid-stage data for its Parkinson's disease candidate, Anavex Life Sciences (NASDAQ:AVXL) dropped sharply on June 29, posting its highest one-day loss since early November.
Data by YCharts
This drop was not due to bad news though.
The previous day, the stock had jumped by 17% after announcing results from a proof-of-concept Phase 2 trial randomizing 132 patients with Parkinson's disease dementia (PDD).
Now, with vaccination in progress and normal care, including clinical trials having resumed in most geographies, it makes sense to dig into the biotech's research pipeline in order to explain the stock's phenomenal 400% rise during the last one-year period.
The pipeline
Anavex conducts clinical trials for its small molecules Anavex 2-73 (blarcamesine) and Anavex 3-71 (AF710B), for slowing the progression of Alzheimer's disease. In addition, the therapies being developed are intended to treat other neurodegenerative and neuro-developmental disorders, such as Rett syndrome and Parkinson's disease as well as other central nervous system diseases.
Lesser known, Rett syndrome is a serious and rare neurological disorder that primarily affects women. It was once considered to be a form of autism. It has since been singled out as a genetic disorder, with a mutation occurring on the X chromosome. The exact location of this mutation is unknown, but researchers know that it is usually a sporadic one with symptoms of the disease usually appearing between the first 12 and 18 months of life. The effects include slow brain growth, a small head and problems with muscle coordination.
Anavex has two active studies for Rett, including a Phase 2, designed to test for safety, tolerability and efficacy with "completed" status in October 2020 involving 31 participants as part of an interventional clinical trial.
Source: clinicaltrials.gov
Coming back to June 28, Anavex reported that 2-73 improved endpoints in a Phase 2 Parkinson's disease study. Going into details, the predictive biomarker of response established with SIGMAR1 mRNA expression correlates significantly with responses in primary and secondary clinical efficacy endpoints from the proof-of-concept randomized, double-blind, placebo-controlled Phase 2 trial.
In simpler English, the treatment resulted in significant increase of SIGMAR1, or activation of the sigma-1 receptor whose production typically increases with age, but is reduced in people with neuro-degenerative diseases.
As a result, a series of neuro-protective effects was triggered, including the clearance of unnecessary or damaged cellular components. This study (highlighted in yellow), which assessed safety, tolerability, and efficacy of 2-73 for cognitive impairment in patients with PDD also demonstrates for the first time that a drug-specific biomarker correlates with clinical efficacy end points.
Now, for Anavex, the data also strengthens the regulatory pathway for Parkinson as a new therapy, in the same way as for Alzheimer's disease, where phase IIb/phase III trials are already under way using 2-73 in the same dosing regimen as for the completed PDD study, but with differentiated patient selection criteria. The study completed enrollment in the first week of June.
Exploring further, Parkinson's disease is a chronic central nervous system disease and the second largest age-related disorder after Alzheimer's. It is a fairly common neurological disorder in older adults, estimated to affect nearly 2% of those older than 65. Furthermore, the Parkinson's Foundation estimates that 1 million Americans have Parkinson's disease. It is also estimated that up to 80% of those with the disease eventually experience PDD.
I now assess the finances.
The finances
The biotech had cash and equivalents of approximately $75.9 million as at March 31, 2021, sufficient to last for up to three years, according to its CEO. Now, Anavex does not generate revenues and has to resort to equity offerings to finance operations.
Pursuing further, operational costs consist mainly of R&D, which were at $6.7 million for the first quarter, compared to $6.1 million in Q1-2020, while General and Administrative expenses increased by $0.5 million. These are likely to increase further given the progression to advanced phases of trials which typically imply more expenses.
Now, in this era of cheap money, getting funding through public offerings is a common financing option, but thinking aloud, this remains a loan from investors. Also, their timings can get jittery at times, and this was the case on June 23, when Anavex's shares were down pre-market by 10.7% after entering into a purchase agreement with Deep Track Capital for the issuance and sale of an aggregate of 2,380,953 common shares, at $21.00 each in a registered direct offering. Around $50 million of gross proceeds were expected.
Adopting a cautionary posture, I make a comparison with Cassava Sciences (SAVA) as to the cash used versus issuance of common stock.
Source: Table compiled using data from Seeking Alpha
Exploring further, Cassava also has three clinical trials at Phase 2 for Alzheimer's compared to more for Anavex, which is additionally involved for Phase 2/Phase 3.
Source: clinicaltrials.gov
Consequently, it is logical that Anavex is using more cash for operations as it is involved in more late stage trials, but its equity issuance seems more disciplined, rising gradually, with the total still below Cassava.
For investors, this comparison is strictly limited to cash use and generation over a historical period, and does not pertain to efficacy of drug candidates nor constitute an elaborate assessment of the way the corporate finances are managed. As a matter of fact, Cassava has also progressed and selected Premier Research International to help conduct the phase 3 trial for Alzheimer's disease, which is planned to begin in the second half of 2021. It is also involved in a number of dietary supplements trials and one for type 2 diabetes.
Valuations and key takeaways
Therefore, it has been a rich second quarter with data readouts for its lead drug candidate, Anavex 2-73, both in Parkinson and Alzheimer's diseases. These have resulted in moving the stock higher. With enrollment for Alzheimer's having been completed, the remainder of 2021 looks to be a catalyst-rich year for Anavex.
Now, another reason for shares witnessing over a five-fold rise in the year is also partly due to its prospects in Alzheimer's after the FDA granted Biogen's (NASDAQ: BIIB) accelerated approval for ADUHELM (aducanumab) as the first and only Alzheimer's disease treatment to address a defining pathology of the disease by reducing amyloid beta plaques in the brain.
Now, Alzheimer's disease is one of our biggest challenges for healthcare today as it is a progressive, and the most common cause of primary neurodegenerative dementias. Its global incidence is 47 million, with the U.S. having approximately 5 million of people afflicted. Despite availability of aducanumab, there are still no commercially available therapies to address the cause of the progressive cognitive decline. For this purpose, the FDA provided only an accelerated approval for Biogen, and the company will be required to produce a phase 4 confirmatory trial.
Thus, developing new drugs remains a huge unmet medical need and, with Biogen's drug possibly costing over $56,000 per year for treatment, biotech companies stand to benefit from a $2,600 trillion market (47,000,000 x 56,000). Now, looking at the trailing Price to Book multiples, those like Anavex with a richer developmental pipeline consisting of Alzheimer's, Parkinson and Rett diseases deserve a better valuation, at least two times Cassava's.
Source: Seeking Alpha
Hence, I obtain a target price of $28 taking into consideration the current $25 share price.
Target price for Anavex = (12.81 x 2)/22.71 x 25 = $28.2.
Now, some will have realized that this remains a cautious target for Anavex, considering the 3000% one-year stock price appreciation of its peer and the biotech being near to developing a treatment for Alzheimer's after the completed Parkinson's study also using 2-73.
Finally, as shown by the one and three months price performances, biotechs' stock move along a very volatile path, highly susceptible to news pertaining to clinical trials and equity offerings. In this fluctuating environment, Anavex's display of more disciplined fiscal management is a big positive.
Short seller restriccions for today? like 16th June and big bounce?
I hope so.
https://www.fool.com/investing/2021/06/26/3-top-biotech-stocks-to-buy-right-now/
Anavex has a potential blockbuster in blarcamesine
Anavex's stock is up more than 376% this year, and it continued to climb on positive reports of the company's phase 2 trial of ANAVEX2-73 (blarcamesine) in adult female patients.
The small-molecule therapy targets Rett syndrome, a central nervous system disease caused by the mutation of the MECP2 gene. The trial found that ANAVEX 2-73 activated the sigma-1 receptor, helping to restore neural cell homeostasis (a stable, relatively constant internal environment) and promoting neuroplasticity, the ability of nerve networks to adapt through growth and reorganization. Rett syndrome affects the development of the brain, and according to the National Organization for Rare Disorders, Rett syndrome occurs almost exclusively in girls, affecting one in 10,000 by age 12. ANAVEX 2-73 has the potential to be the first therapy approved for Rett syndrome by the FDA. The drug has already been given Fast Track designation, Rare Pediatric Disease designation, and Orphan Drug designation from the FDA for the treatment of Rett syndrome, so it could be considered for accelerated approval, the company said, meaning that it could come to the market later this year.
It is the company's leading drug, and it's also in late-stage studies as a therapy for Alzheimer's disease and Parkinson's disease dementia.
Anavex lost $8.2 million in the second quarter, but the company has $75.9 million in cash, enough, it said, to fund operations for three years.
March 31, 92 %.
Anavex, Cyclo Therapeutics, And Green Valley: Stalling The Progression Of Alzheimer's Disease https://seekingalpha.com/article/4421858-anavex-cyclo-therapeutics-and-green-valley-stalling-the-progression-of-alzheimers-disease
The email is the PR about the conference.
At 1:09 .
9 min after the announcement.
I also received the email.
First time as well.
It was listed in last presentation, not now .
Strange, In the presentation C.M said that a large trial is coming but he didn't say phase 3.
Maybe MayoMobile could be right ..P4 ..?
They didn't announce an increase in the Rett US trial until it was exceeded by 50%.
Anavex Life Sciences (AVXL) PT Raised to $20 at Ladenburg Thalmann
https://www.streetinsider.com/dr/news.php?id=17921464
Long time without writing. Happy new year to all the longs and congratulations! A 273 works.
Amazing how this board has changed ,too many trolls with the same repetitive posts, and the worst of all , people that say that they are long in Avxl...and they write negative comments about the company, pathetic!!
Now the main point of discussion is about dilution.
I don´t see as a problem the dilution if A273 works only for Rett obviously not good for shareholders a big amount of shares , but if it works for AD,..90,100, 120 m shares ?? I don't see any difference , Anavex will be a multi billion MK company, and even more considering Rett and a few more indications.
Anavex is talking about approval for Rett after the phase 2 trial in Us, why?...it sounds pretty optimistic!
Dr Hagerman on the webinar´s Rett said about Us Rett trial " I saw a number of individuals who did very well on this medication and others who didn't.."
Dr Missling, last CC: " We expect the hight dose to even stronger effect size"
I think that the answer is pretty obvious...what are they seeing in the Avatar study??? ummmm...big response.. or maybe huge response in a few individuals ?
Going back to the dilution, they doubled the funds, right ,they are going to start more trials, but did they need now such amount of money?? or just in anticipation like when they bought a big amount of pills 2 years ago..?? anticipation of what ??? maybe ready for the first Anavex approval in the coming months..??
Anavex is not question of if , is question of when.
1 week , 1 month , or 6 months...but sooner than later Anavex will sky rocket.
Now is screaming buy, the safest moment to buy the stock.
Saludos!!
I was right but not in the date of the end of the trial, that finished one month later ( good find investor)
Again , We have to wait at least another month for PDD results.
Trial finished on 11th June ,plus the time needed to built the results, (it could take about 2 months if not longer )..so results during August..
I have the impression that Anavex likes Mondays for the most important news: Preliminary Rett results, FDA Rett F.T designation, 100 % enrollment PDD trial..
So if there is good results I think that it will be announced one Monday, if results are bad it will be announced one Friday ( based on financing news before 4th July last 2 years).
We have to wait at least another month for PDD results.
I don´t understand why people are saying that results could be announced any day during last days.
I think that C.M was very clear in last C.C on 7th May:
"So the upcoming quarter will be the announcement of top-line data after Phase 2 Parkinson’s disease dementia study. That is really something we can put on everybody's calendar because the trial has been enrolled the last patient and we now have to wait for the 14 days – 14 weeks, which is the duration of this study plus the times needed to for the independent research zero to build the results.
And then we will update the data as a – in a public announcement the top-line data, which will be mid of 2020. And we will update the other studies, the Rett syndrome studies. We will update the enrollment completion. And then it's also relatively easy then to predict the expected top-line data period of time given that we know how long the trial duration is plus sometime needed for the calculation."
So results from July. On 7th May the trial was not finished, I think that the trial finished by mid May, plus the time needed to build the results.......it could take two months if not longer.. for example on Sava took about 2 months and 3 weeks.
So I really think that we won't have PDD results before mid July , just a bit more of patience.
Do we have a Kamikaze CEO?
LOL ! If first trials fail, there will be no excuse, low dosage? extensions? Nothing matters.
S.P will tank to 0,5 $ ? ?
They will need a lot of millions of $ to finish the AD trial, the Avatar study, and they are planning to start soon, the Excellence study , plus a new trial with 3-71.
How are the going to get the money for the trials with such low S.P? R/ S and to sink the S.P again?
They know that if trials fail they "kill" the company.
Don't forget that the real experts about Anavex , are the people that work for the company., every word that we can write in a board is only speculation, positive or negative depending of your situation, long or short ....
How are they going to go against the company in the trials???
Do we have a Kamikaze CEO? LOL
ElsaSara, have you heard any rumors and/or additional
No sorry. Thanks for your words!
We are living a terrible situation here in Spain ,the actual 118 k cases, it is a complete joke, we have too many more. We are confined at home 3 weeks in a row , and another 4 weeks more for sure. Fortunately I have a dog so I can go for a small walk every day.
I live in the South , in the region with less Covid- 19 cases , all my family ,friends are virus free.
Considering the actual situation we had great news last Tuesday, I mean ,no delay in PDD results..
Now the virus is spreading around USA, so..be careful..
Saludos!
Just bought a few thousand more shares.
Yes I live in Spain.
Are you from Peru , arent you?
I just wanted to buy the 7 k at 2.60$
When I saw the big order A.H at 2.56 $ ..I couldnt resist .
I bought another 7 k at 2,60
I also bought at 2,56 A.H . 12650 shares
Cantor Fitzgerald initiated Anavex Life Sciences (AVXL) coverage with Overweight and target $11
Issuance Date: 2020-02-26
StreetInsider.com
Rank : positive
Clay was here during all the week writing 2 ,3 posts every day and Avxl soared 40%.
If Avxl goes down today or next sessions will be for technical reasons , RSI, gap .
The trend for next months until results it is very clear..up up up
would it be a stretch to say the 10 & 20 mg doses in the main trial were not proving efficacious?
I don't think so..
1- The trial is blinded.
2- If they realized that with the 10/20 mg the drug didn't work, why are they going to start with the extension.?The trial will fail and that it means that A273 won't be approved. The extension means to expend millions of $ and 0 chances of approval. They should do another trial with higher doses and placebo. and for now this is not the case.
There is an email contact for the CRO listed on the trial registration
is there any chance that they can confirm that 10 / 20 mg were the dosed used? or like is a info that has been not provided for the company, it is not possible.
8/14 cities included in the clinical trial do not have a hospital in the OLE.
Distance to the closest city with hospital in the OLE : From- to:
Baracaldo- Oviedo: 278 km
Burgos- Madrid: 249
Cádiz - Sevilla: 121
Coslada- Madrid: 16
Ferrol: Oviedo 262
Girona- Barcelona: 104
Móstoles- Madrid: 22
Santiago de Compostela - Oviedo: 323
Something similar would be Acad with PDP.
If A2-73 works for Pdd, we can expect a MK 3-4 b $..only for this indication.
Great post!! In reference to my yesterday´s post.
I´m not going to argue with anyone..
Yesterday was talking about old people.
Free of charge is to visit the doctor/ hospital.. A few months ago I broke a muscle of my leg doing sport, I went to the hospital ,I just waited a few minutes.. and a few days later I had rehabilitation untill I recovered, and I paid 0 € .
I have to pay for drugs but some some people hasn't to pay for drugs, the majority of the old people has to pay a little amount 10% . maximun 8 €.
We pay with our taxes the health care system.
I read yesterday a post about socialism in Spain but it was deleted .. Spanish are terrible in many , many things , it is the sad reality, and now yes with a terrible socialist goverment + communist Spain is divided in two parts.
We don't learn ..we had a terrible crisis due to a pathetic socialist government a few years ago..and now again the same goverment.
Saludos from Spain!
Go Anavex!!
Come on man!....lol lol and lol
Hope I never get old in Spain
FYI.
In a ranking of the best healthcare systems in the world the Spanish is ranked in 7th position.
Spain is the 3rd country in the world with higher life expectancy. Is expected to be the 1st in the coming years.
To get older for Spanish means to have the possibility of living more years and to have access to a very good healthcare system FREE OF CHARGE.
The last patient enrolled for screning on the 13th or earlier, so the screening ended on Friday 27th or earlier.
After delays, delays, and more delays... no news about Rett, do you think that they are not whising to announce the completion???
If we dont have news tomorrow or on Tuesday ...bad , very bad..
Yes."PDD study is expected to be completed by the end of December 2019". On 16th dec he stated it because they had the last patient in the pre screening period , and it takes two weeks unless they had a dropout.( 20% posiblity.).
News tomorrow..??
It seems that the 6 month delay in the clinical trial of PDD is absolutely normal.
https://www.esparkinson.es/entre-el-40-y-el-70-de-los-ensayos-clinicos-se-retrasan-o-cancelan-por-la-falta-de-participantes/
"Según la Michael J. Fox Foundation, entre el 40% y el 70% de los ensayos clínicos se retrasan o cancelan por falta de participantes. Desde la FEP hemos detectado una serie de deficiencias en torno a la comunicación de estos procesos, lo que se traduce en un desafío al que dar respuesta a través del Observatorio Párkinson”
'According to the Michael J. Fox Foundation, between 40% and 70% of clinical trials are delayed or canceled due to lack of participants. From the FEP we have detected a series of deficiencies regarding the communication of these processes, which translates into a challenge to respond to through the Parkinson Observatory ”
Last Monday they had the last patient in the pre screening period and it takes two weeks for this reason he said that 100% enrollment before eoy.
https://quotes.freerealtime.com/quotes/AVXL/Time&Sales
In this web you can see all the trades.
Buying again. I bought 21000 shares at 2.39$.
I will buy more in the coming days...
I was sure that Avxl was going to drop.
Yes I believe in the science for this reason I'm going to buy again, the same amount of $ , but a few thousand more shares.
Predictable stock.
A believe in the science.
I really think that A 273 will work..at least for Rett..
But last movement was very predictable. Pump & dump,for this reason i sold out. First time in 18 months that I've sold all my shares.
40% of my shares around 2.70$ , 60% at 3.09 - 3.29 $.
We will see what happens on Monday , but i think that in a couple of weeks Avxl will be much lower.
Soon I will buy again , but no doubt that Avxl at 2.37$ is a gift.
Probably.
For me no doubt that S.P = 2.78 $ because they can't finish the enrollments.
Once they announce 100% enrollment , S.P will rise..
My guess is that those two sites are recruiting a number of patients in addition to the 120 originally planned and therefore total full enrolment takes a little longer than originally anticipated.
I agree. It has been always my thinking, but n in Rett Usa at the beginning was 15, later they updated to 21, I think that since last presentation we know that n in Avatar study is 33 , not 30.
If n was different than 120 they could have updated this number in last presentation as well.
Some here contend that the trials are already fully enrolled. Company may or may not announce.
I really hope that you are right but dr M. has always stated that they will announce full enrollment, in fact he did again during last C.C.
Maybe we can understand that is difficult to recruit patients for Rett trial, but patients for Pdd trial??
There are around 450 k people living between Spain and Australia with PD , 80% of this people will develop during their lives PDD, and they can´t enroll 36 patients since 8th May..!!!!
I thought that n would be higher than 120 , but based on last presentation , it looks like that is the same n= 120.
So I´m still thinking that they stopped the trial in Spain during May / June.. but anyway they have had enough time to enroll only 20-36 patients in Au, so what is happening with PDD trial??
Elsa, are you trying to say "casualty" or "causality"
Sorry.
Too much chance = demasiada casualidad.