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Great post ThesT! I am really impressed by the way Missling is running the Company.
The remarkable initial positive cognitive data was achieved with a not-yet-optimized dosing regimen -
http://www.anavex.com/?news=anavex-presents-positive-initial-phase-2a-study-data-with-anavex-2-73-showing-early-evidence-of-improving-cognition-in-patients-with-alzheimers-disease-at-aaic-2015
I am very confident that we'll see great data on 11/7.
LOL!!!
Thanks TD!
Huge future for Anavex!!!
I made my first sells yesterday, 5,000 at 14.74 and 2,500 at 14.35.
I have a post split cost basis of 1.60 and have wanted to lighten up a little for awhile.
These were Roth shares and if we see a pullback I will buy back. If not, it's ok, I still have 115,000 shares.
Missling didn't choose to set the bar at 83%. He reported the data.
The share price is up 616% since the shorts started attacking.
Whoa, we should be really scared and run. At this rate the shorts may hold us down to a 10 bagger from here over the next couple of years.
I do know AF. I know that his network likes to push retail around. I know that his network saw the 4,000,000 shares traded yesterday and that they know that wasn't retail.
I can't fathom shorts holding into data, so the best they could hope for is a flash crash and cover. I doubt they would try that with the demand there is for AVXL.
AF's followers know that he has been wrong about AVXL since $0.50 on 7/22. Anytime anyone is so wrong on a stock for so long they lose their influence to move that stock.
You've been heaping negativity on the board lately. At what price did you sell?
The RSI(14) on the daily chart is 74.70
Price $12.05
The new data to be released on 11/7 follows this remarkable data released on 7/22 -
NEW YORK, NY, July 22, 2015 – Anavex Life Sciences Corp. (“Anavex” or the “Company”) (OTCQX: AVXL) today announced initial positive cognitive data for ANAVEX 2-73, the Company’s lead investigational oral treatment for Alzheimer’s targeting sigma-1 and muscarinic receptors, which is believed to reduce protein misfolding including reduction of beta amyloid, tau and inflammation. Cognitive EEG/ERP P300 data, a real-time physiological measure of cognitive processes with demonstrated sensitivity to Alzheimer’s disease, is being presented today for the first 12 of 32 mild-to-moderate Alzheimer’s patients in the ongoing ANAVEX 2-73 Phase 2a clinical trial at AAIC 2015 in Washington, DC.
ANAVEX 2-73 showed in 83 percent (10/12) of patients positive cognitive effects during PART A of the study, which consists of a 36-day on-off-on not-yet-optimized dosing regimen to assess bioavailability. At day 36, the amplitude of the cognitive EEG/ERP biomarker P300 increased 38 percent from baseline. Published data suggests that a 38 percent increase is approximately 4 times higher than donepezil (Aricept®), the current standard of care, in the same timeframe.
Preliminary measured Mini Mental State Examination (MMSE) and Cogstate scale changes are consistent with the observed trend of the cognitive EEG/ERP effect. The safety profile of ANAVEX 2-73 during Phase 2a appears consistent with the Phase 1 data; additional clinical data of the trial will be presented at future medical meetings.
“This is the first time the investigational drug ANAVEX 2-73 has been administered to Alzheimer’s patients. In addition to the positive EEG/ERP P300 biomarker signal, the feedback we’ve had so far is that patients and care providers have noticed both cognitive and functional improvement, increased alertness, improvement in activities of daily living, greater organization and a requirement for less prompting,” said study’s principal investigator Dr. Stephen Macfarlane, FRANZCP, Associate Professor and Director of Aged Psychiatry at The Alfred Hospital. “Subsequent to the positive initial feedback, we are applying to expand the extension period from 26 weeks to 52 weeks at the request of the participants.”
“We are cautiously optimistic given the encouraging feedback and the preliminary cognitive data. We look forward to the full ANAVEX 2-73 Phase 2a trial results,” said Christopher U. Missling, PhD, President and Chief Executive Officer of Anavex. “As of today, we have enrolled two-thirds of the patients. We expect the trial to be fully enrolled and to have PART A completed by the end of the year.”
The poster entitled “New Exploratory Alzheimer’s Drug ANAVEX 2-73 Changes in Electrophysiological Markers in Alzheimer’s Disease – First Patient Data from an ongoing Phase 2a Study in mild-to-moderate Alzheimer’s Patients” was co-authored by Steve Macfarlane, Marco Cecchi, Dennis Moore, Anastasios Zografidis and Christopher Missling and is available on the publications page of the Anavex website.
About the ANAVEX 2-73 Phase 2a Study
The ongoing, multicenter Phase 2a adaptive trial of ANAVEX 2-73 in both male and female mild-to-moderate Alzheimer’s patients seeks to enroll 32 patients. It started in January 2015 and the first 12 patients, most who are also taking donepezil, have completed PART A of the two-part trial. Lasting up to 36 days for each patient, PART A is a simple randomized, open-label, two-period trial with an on-off-on not-yet-optimized dosing regimen to assess bioavailability, and cross-over between oral (30mg/50mg) and IV (3mg/5mg) administration. Event-related potentials (EEG/ERP) are used to assess cognitive effects and optimize dosing of ANAVEX 2-73. PART B is an open-label extension for an additional 26 weeks, with daily oral dosing so as to establish a longer drug effect.
The primary endpoint of the Phase 2a trial is evaluation of the maximum tolerated dose of ANAVEX 2-73, which had shown potential in preclinical studies to prevent, halt and/or reverse the course of the disease. Secondary endpoints are dose response, bioavailability, exploratory cognitive effects using electroencephalographic (EEG) activity, including event-related potentials (EEG/ERP), Mini Mental State Examination (MMSE), Cogstate and evaluation of ADSC-ADL and add-on therapy to donepezil, the current standard of care, which represents ANAVEX PLUS, the combination of ANAVEX 2-73 and donepezil (Aricept®).
Additional information regarding the trial is available from the U.S. National Institutes of Health (NIH) clinical trials database at www.clinicaltrials.gov.
NEW YORK, NY – October 7, 2015 – Anavex Life Sciences Corp. (“Anavex” or the “Company”) (OTCQX: AVXL), a clinical-stage biopharmaceutical company developing drug candidates to treat Alzheimer’s disease, other central nervous system (CNS) diseases, pain, and various types of cancer, today announced the presentation of full PART A data and preliminary PART B data from the ongoing Phase 2a clinical trial of ANAVEX 2-73 at the upcoming Clinical Trials on Alzheimer’s Disease (CTAD) conference in Barcelona, Spain from November 5-7, 2015. The late-breaking oral session will be presented by the trial’s Principal Investigator, Stephen Macfarlane, FRANZCP, Director and Associate Professor, Aged Psychiatry at Caulfield Hospital in Melbourne, Australia.
Presentation Details
Title: New Exploratory Alzheimer’s Drug ANAVEX 2-73: Assessment of Safety and Cognitive Performance in a Phase 2a Study in mild-to-moderate Alzheimer’s Patients
Date/Time: Saturday, November 7, 2015
9:45 a.m. Central European Time (3:45 a.m. Eastern Time)
Location: Gran Hotel Princesa Sofia, Barcelona, Spain
The multicenter Phase 2a clinical trial of ANAVEX 2-73 consists of two parts and a total of 32 mild-to-moderate Alzheimer’s patients. PART A is a simple randomized, open-label, two-period, cross-over, adaptive trial lasting up to 36 days for each patient. PART B is an open-label extension for an additional 52 weeks.
The primary objective of the trial is to evaluate the maximum tolerated dose of ANAVEX 2-73. Secondary trial objectives include exploratory cognitive efficacy using mini-mental state examination score (MMSE), dose response, bioavailability, Cogstate and electroencephalographic (EEG) activity, including event-related potentials (EEG/ERP), as well as the relationship of ANAVEX 2-73 as an add-on therapy to donepezil (Aricept®).
Additional information regarding the ongoing Phase 2a clinical trial is available from the U.S. National Institutes of Health (NIH) clinical trials database at www.clinicaltrials.gov.
About ANAVEX 2-73
ANAVEX 2-73 is the investigational drug in the Phase 2a trial and is the Company’s lead investigational oral treatment for Alzheimer’s. It targets sigma-1 and muscarinic receptors, which is believed through upstream action to reduce protein misfolding, beta amyloid, tau and inflammation. Preclinical data indicates that ANAVEX 2-73 has the potential to prevent, halt and/or reverse the course of Alzheimer’s disease.
About Anavex Life Sciences Corp.
Anavex Life Sciences Corp. (OTCQX: AVXL) is a publicly traded biopharmaceutical company dedicated to the development of novel drug candidates to treat Alzheimer’s disease, other central nervous system (CNS) diseases, pain, and various types of cancer. Anavex’s lead drug candidate, ANAVEX 2-73, is currently in a Phase 2a clinical trial for Alzheimer’s disease. Initial positive data was presented at AAIC 2015. Full PART A data and preliminary PART B data is expected by year end. ANAVEX 2-73 is an orally available drug candidate that targets sigma-1 and muscarinic receptors and successfully completed Phase 1 with a clean data profile. Preclinical studies demonstrated its potential to halt and/or reverse the course of Alzheimer’s disease. It has also exhibited anticonvulsant, anti-amnesic, neuroprotective and anti-depressant properties indicating its potential to treat additional CNS disorders. Further information is available at www.anavex.com.
Regarding the Lincoln Park Shelf Offering and funding an emerging biotech in general -
I would love to see a live debate between Adam F., SA author, and CEO Missling.
This is what Missling brings to the table -
Christopher U. Missling, MS, PhD, MBA
Dr. Missling, President and CEO of Anavex™, has over 20 years of healthcare industry experience within large pharmaceutical companies, the biotech industry and investment banking. Prior to joining Anavex, he served as the Chief Financial Officer of Curis and ImmunoGen. In addition, at Aventis (now Sanofi), Dr. Missling worked as head of financial planning on all aspects of financial strategy and M&A. His career experience also includes working as an investment banker in the healthcare practice at Deutsche Bank, serving pharmaceutical, biotech, and diagnostic companies, as well as serving as the head of healthcare investment banking at Brimberg & Co. in New York. Dr. Missling has an MS and PhD from the University of Munich in Chemistry and an MBA from Northwestern University Kellogg School of Management.
The debate would be even more satisfying if the posters that came on here and challenged CEO Missling's LP decision joined the short's mouthpieces mentioned above.
Adam F. has a mound of egg on his face. Best not to listen to him as he tries to regain some credibility.
This was his first bash on 7/22 at $0.50 pre-split, $2.00 post-split. Closed at $10.58 yesterday -
Adam Feuerstein ?@adamfeuerstein
Not sure many folks care, but the $AVXL Alzheimer’s PR is sorta ridiculous. To call this “data” stretches definition to breaking point.
The suckers are the ones that followed him!
Sheff missed the big move on AVXL twice now -
He bought at 0.40 and sold at 0.54
Rebought at 7.70 and sold on 10/23. The day AVXL dipped to 6.51 inter day. I can't find his sell post. He may have deleted it.
At any rate, be careful following Sheff's actions. He front loads shares and then announces his buys.
CEO Missling needed to up list AVXL and have access to large funding in order to attract institutional investors. He has done both. After the institutional investors drive the share price up, he can do an offering if that's his plan.
The Lincoln Park deal is excellent. AVXL decides when LP has to buy and there are no warrants. Should CEO Missling decide to sell $50,000,000 worth of shares to LP, at say $20 per share, he'll only be selling 2.5 million shares.
CEO Missling has set the table perfectly for the institutions -
Nasdaq up list
Access to $50,000,000 worth of funding
Now all we need is confirmation on 11/7 that A2-73 is on track to become the new Standard of Care for AD.
I believe that this confirmation is coming and that there will be months of accumulation by institutions post 11/7!
There is absolutely no way that IR would make up and provide that false information.
Congratulations!
This was his first bash at $0.50 pre-split, $2.00 post-split -
renv Wednesday, 07/22/15 09:10:59 AM
Re: None
Post # of 27248
Adam Feuerstein ?@adamfeuerstein
Not sure many folks care, but the $AVXL Alzheimer’s PR is sorta ridiculous. To call this “data” stretches definition to breaking point.
AF started bashing AVXL on 7/22, the day of the first data release.
Share price that day around $0.50 pre-split or $2.00 today.
Hi BooDog, good to see you here!
Everything is great and I'm looking forward to AVXL knocking it out of the park on 11/7!
If AVXL decides to sell shares to LP, and the sales price is higher than AVXL's share price on the day of the LP deal, then the funding is more than 100% efficient. Correct?
I think the beauty of the deal is that shares can be sold to LP all the way up to $40.00 a share.
A couple interesting posts from another board -
Ask Adam F how his F'en bash piece went down on ACAD when the stock went from $1 to $5 the very next month. By the way. ACAD broke $40 less than a year later.
Right and the situation was pretty much the same as AVXL's -- back in Nov 2012 ACAD set up ATM financing similar to what AVXL has done with Lincoln less than a month before it was to release important trial data. Feuerstein wrote a big hit piece about it, but ACAD's data was great and the stock immediately soared and has never looked back since.
Thanks for posting that. Unlike the Street Sweeper and Dan Ward SA articles, which were posted on this board, there were actually quite a few facts about the Company in the sales pitch.
I'm glad the late breaking entry into CTAD was mentioned.
LOL - negative 10 cents is damn good for an investor. It's usually only the traders that buy that cheap.
NEW YORK, NY – October 26, 2015 – Anavex Life Sciences Corp. (“Anavex” or the “Company”) (AVXL), a clinical-stage biopharmaceutical company developing drug candidates to treat Alzheimer’s disease, other central nervous system (CNS) diseases, pain and various types of cancer, today announced the Company has received approval to begin trading its common stock on the NASDAQ Capital Market. Anavex’s common stock will begin to trade on NASDAQ under the symbol “AVXL” at the opening of market hours on October 28, 2015.
“This is a significant milestone for Anavex. As we become a NASDAQ-listed company, our team is now able to communicate our progress with a broader audience, raise the visibility of Anavex’s capabilities, as well as generate more value for our shareholders,” said Christopher U. Missling, PhD, President and Chief Executive Officer of Anavex. “The NASDAQ uplisting also comes at an important time in our growth as full PART A and preliminary PART B Phase 2a clinical trial data will be presented at the CTAD conference on November 7, 2015.”
Before trading on NASDAQ commences on October 28, 2015, Anavex’s common stock will continue to trade on the OTCQX under the symbol “AVXLD.”
Yes, fortunately AVXL is not dealing with them as a possible source of future funding.
You might be interested in what death spiral financing is. Also, how about sending the link to the author of the tweet so he learns what it is -
https://en.wikipedia.org/wiki/Death_spiral_financing
Death spiral financing is a process where convertible financing used to fund primarily small cap companies can be used against it in the marketplace to cause the company’s stock to fall dramatically and can lead to the company’s ultimate downfall.
Many small companies rely on selling convertible debt to large private investors (see Private investment in public equity) to fund their operations and growth. This convertible debt, often convertible preferred stock or convertible debentures, can be converted to the common stock of the issuing company often at steep discounts to the market value of the common stock. Under the typical “death spiral” scenario the holder of the convertible debt initially shorts the issuer’s common stock which often causes the stock price to decline at which time the debt holder converts some of the convertible debt to common shares with which he then covers his short position. The debt holder continues to sell short and cover with converted stock which along with selling by other shareholders alarmed by the falling price continually weakens the share price making the shares unattractive to new investors and can severely limit the company’s ability to obtain new financing if the need arises.
An important characteristic of this kind of convertible debt is that it often carries conditions like a quarterly or semi-annual reset of the conversion price to keep the conversion price more or less close to the actual stock price. But a lower conversion price also increases the number of shares that a bond holder gets in exchange for one bond, increasing the dilution of existing shareholders. A lower price reset can also force investors that have set up a long CB/short stock position to sell more stock ("adjust the delta"), creating a vicious circle, hence the nickname death spiral.
The companies that are willing to agree to financing on these terms are often desperate and could not obtain funding through any other means. The terms, though viewed by some as onerous, give the lender a potential way to recover their debt regardless of what happens to the shares of the company. The lender would have a potentially greater gain if the shares were to increase in value but if they do decrease in value, there is some protection. If this were not the case they would probably not be willing to lend the money given the poor risk profiles of the companies interested in this type of financing.
These are consumer comments. Anybody can post BS to that site. Here's one comment -
I did a deal with Lincoln Park and they illegal shorted my stock hurting the stock price so they could purchase the stock at a lower price. Big mistake in doing a financing with them.
Oh, really? No mention of the Company affected?
Nonsense to post something like this!
SEC Charges Six Firms for Short Selling Violations in Advance of Stock Offerings
In 2014, enforcement actions were brought against 19 firms.
In 2013, enforcement actions were brought against 23 firms.
Lincoln Park, although bashed heavily yesterday by uninformed traders, is not one of those charged.
http://www.sec.gov/news/pressrelease/2015-239.html
Nothing new. VNDM has been here everyday on the bid and ask. Right now they're bidding 8.17 and asking 8.45.
Should we listen to a message board poster's bashing or trust Dr. Missling to do the right thing -
Christopher U. Missling, MS, PhD, MBA
Dr. Missling, President and CEO of Anavex™, has over 20 years of healthcare industry experience within large pharmaceutical companies, the biotech industry and investment banking. Prior to joining Anavex, he served as the Chief Financial Officer of Curis and ImmunoGen. In addition, at Aventis (now Sanofi), Dr. Missling worked as head of financial planning on all aspects of financial strategy and M&A. His career experience also includes working as an investment banker in the healthcare practice at Deutsche Bank, serving pharmaceutical, biotech, and diagnostic companies, as well as serving as the head of healthcare investment banking at Brimberg & Co. in New York. Dr. Missling has an MS and PhD from the University of Munich in Chemistry and an MBA from Northwestern University Kellogg School of Management.
Enough said!!!
AVXL has locked down future funding. They do not have to sell to LP if a reputable tute comes along with a better offer after 11/7.
Dr. Missling and the board are smart people.
LP is an excellent deal. Far better than a public offering that no doubt would have come with warrants.
The buyers of these offerings sell the shares too, as soon as the holding period expires and hold on to the free warrants.
Fantastic financing announced today by AVXL!
No Warrants = Sweet
It would be a scream if the 269,397 shares Lincoln Park is allowed to sell actually became worth $50,000,000. Those shares would then be worth $185 a piece.
In addition, Lincoln Park may, from time to time, offer and sell up to an aggregate of $50,000,000 of shares of our Common Stock in one or more transactions, or an additional 269,397 shares of Common Stock.
This is a "shelf" registration. Under the shelf registration AVXL may sell securities. Lincoln Park may sell 269,397 shares, right?
This prospectus of Anavex Life Sciences Corp., a Nevada corporation (collectively with all of its subsidiaries, the “Company”, “Anavex”, or “we”, “us”, or “our”) is a part of a registration statement that we filed with the Securities and Exchange Commission (“SEC”) utilizing a “shelf” registration process. Under this shelf registration process, we may, from time to time, sell the securities described in this prospectus in one or more offerings. In addition, Lincoln Park may, from time to time, offer and sell up to an aggregate of $50,000,000 of shares of our Common Stock in one or more transactions, or an additional 269,397 shares of Common Stock.
Other than the up listing being a positive for the Company, I don't see any change. The shorted shares will move to the Nasdaq the same as long shares will.
The shorts are still in AVXLD in a big way. The estimated annual interest rate for shorts is 35.25% this morning.
This should be a very interesting week as shorts try to keep the price down while covering. If longs are done selling, the shorts will have to keep adding to their short position to keep the price down.
I think the shorts are in trouble.
Yup, that's quite a mouthful -
WW, from 8-K filed on 6/15/15 -
http://www.sec.gov/Archives/edgar/data/1314052/000106299315003421/form8k.htm
Item 5.02 Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.
Effective June 15, 2015 (the “Effective Date” ), the board of directors (the “Board” ) of Anavex Life Sciences Corp., a Nevada corporation (the “Company” ), appointed Steffen Thomas, PhD, to serve as a member of the Board until his successor is duly elected, qualified and seated or until his earlier resignation or removal.
In addition to being a member of the Board, it is anticipated that Dr. Thomas will serve on the Audit Committee, effective as of the Effective Date. As compensation for his services, the Company granted Dr. Thomas options to purchase two hundred thousand (200,000) shares of common stock in the Company, said options to vest annually over a three year period commencing on the first anniversary of the Effective Date.
The Company has not entered into any transactions with Dr. Thomas that would require disclosure pursuant to Item 404(a) of Regulation S-K under the Exchange Act of 1934, as amended.
Anavex on their clinical trial risk (underline by Anavex) -
ANAVEX™ PLUS is a promising, potentially novel combination drug for Alzheimer’s disease. It combines ANAVEX™ 2-73 PLUS donepezil (Aricept®), the best-selling Alzheimer’s drug with annual global sales of $4 billion.
ANAVEX PLUS shows a highly encouraging synergistic effect in Alzheimer’s disease models, producing up to 80% greater reversal of memory loss and neuroprotection when used in combination, versus when the drugs were administered individually.
The drug combination candidate might have a lower clinical trial risk because donepezil (Aricept®) is already FDA approved and on the market.
ANAVEX PLUS also represents a compelling commercial opportunity because donepezil (Aricept®) is now generic. A patent application filed for the combination would, if granted, provide protection until 2033.
Additional Study Data
Results from a computer simulation model of Alzheimer’s presented at the CNS Summit 2013 (November 2013) confirmed the significant synergy previously seen between ANAVEX 2-73 and donepezil (Aricept®) in a pre-clinical model.
The findings in a humanized calibrated realistic cortical network computer model of Alzheimer’s disease predict that combining ANAVEX 2-73 with low dose (5mg) donepezil (Aricept®) will show up to 7 points improvement in Alzheimer’s Disease Assessment Scale–Cognitive (“ADAS-Cog”) at 12 weeks and up to 5.5 points at 26 weeks in mild-to-moderate Alzheimer’s patients, respectively.
These improvements might suggest the effects will likely be clinically detectable and meaningful.
34% interest charged on shorted shares is the highest I've seen.