Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Well Missling again reiterated 21m cash as of Dec 2016, no debt and a run rate of about 1m per month - inviting the audience to check his almost 3 years before running out of money calculation.
It would be a bit rich saying that on top of declaring 2 or 3 trials starting this year with possible readout in late 2017 or early 2018 without an in the know funding plan.
The 10m 'poison pill' share issue is not for general corporate purposes.
Missling also pointed out the cost effective Anavex way of conducting ethical proper confirmatory pivotal trials leading to success rather than 'unexpected' failure.
My own expectation is that the funding plan includes utilising the already well known LPC facility with due care.
I am beginning to see you are right Plato. The best way out of this confusion is for me to just sell the lot to the lowest bidder tomorrow. Just one less thing to burden my unsophisticated life. Tanks again for your kind and dedicated advice.
Missling was also keen to point out to investors the prophylactic application of A2-73.
Also got the general impression that he was working hard to dispel some the myths and misinterpretations of the data published so far.
The way I heard Missling, we may get the all important PK/PD data before further longitudinal data updates.
Statistically based on the history of Alzheimer's trials, not hard to predict the outcome about 99% of the time.
But eventually AF will be wrong and it looks like it could be soon.
and only covers mild AD patients.
If this was a problem with the A2-73 trial, it would be a problem any other AD trial too.
Not shaking out any of my shares.
I am aware of one peer reviewed article concerning A2-73.
Mitochondrial protection by the mixed muscarinic/s1 ligand ANAVEX2-73, a tetrahydrofuran derivative, in Aß25–35 peptide-injected mice, a nontransgenic Alzheimer’s disease model
Published by Frontiers: Frontiers reviews are standardized, rigorous, fair, constructive, efficient and transparent
Here is a short article on Placebo and Historical Control Arm comparison to drug effect in Alzheimer's studies: Understanding Placebo Responses in Alzheimer’s Disease (AD) Clinical Trials from the Literature Meta-Data and CAMD Database
Some quotes of note relating to the discussions on the Board:
Baseline cognitive function is an important covariate of disease progression, therefore, it is important to evaluate the baseline severity and predict the disease progression accordingly when comparing trial results. Furthermore, study duration, sample size and study design may affect the placebo response, all of which have the potential to confound understanding of study results.
Across studies, the placebo effect is evident to at least week 12. Interestingly, the short Phase II studies (Studies 1000 and 1009, 12 week Phase II studies) had larger placebo effects, perhaps due to expectations from investigators and/or patients. Also, these studies had a relatively small sample size (N=102 and 164, respectively), which might have effects on interpreting trial results. These differences could potentially cause misinterpretation of study results, especially when trying to estimate the disease progression rate across trials of different study durations.
particular interpretive caution should be taken if a treatment effect is observed in one population, but not another, without a plausible (a priori) biological mechanism as to why this may occur
The model prediction and placebo comparison against historical placebo data provide a way to double- check the reliability of trial results before making important drug development decisions (e.g. terminating a compound or initiating an expensive lengthy new trial in AD patients)
Indeed I suspect not. Although if there is it will need to be PR'ed in about an hour.
I note that the slide presentation is dated February 2017.
The Corporate presentation is still from 2016 and the latest presentation available on anavex.com is from CTAD 2016.
Is there anything new in that Asia Bio presentation...?
Quiet place this board and hope you are right. With financing and a potential pivot-able trial about to start we may get some of the desired action - at long last!
Yes I think Missling is playing an admirable, but risky game if Rett does not work out well. Guess he must be quite confident, if indeed going it alone using the shelf with minimum dilution is his game plan.
Based upon slides 18 and onwards: ANAVEX 2-73 as a Potential Treatment for Rett Syndrome and Other Pediatric or Infantile Disorders with Seizure Pathology, it seems A2-73 has pathological benefits rather than being decease modifying.
An impressive read the way the Anavex accomplishments and events are laid out in that report!
http://eithealth.eu/partners/biom-biotech-cluster-development-gmbh/
This is the c/o address org. Maybe a cost effective way for Anavex to build out their R&D capability.
LOL, excellent analogy and how true to real world it is
I read it opposite that A2-73 is further along than A3-71 in Parkinson's. Phase 2 seems to be denoted by green arrows. So a longer smudge of green for A2-73 Parkinson's, I read as closer to entering Phase 2. But then again not sure how much can be read into the length of the green bit of the arrows...
A guess could be that a MOC order won't have the possibility of starting a run and sort of put a lid on subsequent rapid price increases.
Why did Biotech in general gap up yesterday. I don't know..
Prospectus, LPC agreement and proxy vote - how I understand it, so please do comment and correct.
This is the latest SEC filing regarding the LPC agreement.
$100,000,000 of Shares of Common Stock and Warrants
I had forgotten that the prospectus is for a $100M facility, but still based on maximum 6,754,609 Shares of Common Stock.
The prospectus talks about a primary and secondary offering, where the existing LPC agreement constitutes a secondary offering of up to $50M.
So the other up to $50M of the primary offering can yet become effective and not necessarily involving LPC, ie. could be sold to anyone offering better terms and the prospectus potentially being amended from time to time.
About 4M shares have been sold to LPC, so far as we can tell, and raised some $15M.
That means roughly 2.5M shares that can still be sold per the prospectus.
The shares being offered for resale by the Selling Security Holder represents approximately 18.9% of the outstanding Common Stock of the Company.
Effect of Stockholder Approval
If the stockholders approve Proposal 5, we expect to sell shares to Lincoln Park as and when needed, unless more attractive sources of capital are identified and secured. Based on the current market price of $5.26 as of the record date, the additional issuance may result in dilution to our stockholders.
Risks Relating to the Purchase Agreement with the Selling Security Holder
The sale or issuance of our Common Stock to the Selling Security Holder may cause dilution and the sale of the shares of Common Stock acquired by the Selling Security Holder, or the perception that such sales may occur, could cause the price of our Common Stock to fall.
We may not be able to access sufficient funds under the Purchase Agreement with Lincoln Park when needed.
Our ability to sell shares to Lincoln Park and obtain funds under the Purchase Agreement is limited by the terms and conditions in the Purchase Agreement, including restrictions on when we may sell shares to Lincoln Park, restrictions on the amounts we may sell to Lincoln Park at any one time, and a limitation on our ability to sell shares to Lincoln Park to the extent that it would cause Lincoln Park to beneficially own more than 9.99% of our outstanding Common Stock. Therefore, we might not have access to the full amount available to us under the Purchase Agreement. In addition, any amounts we sell under the Purchase Agreement may not satisfy all of our funding needs, even if we are able and choose to sell all $50,000,000 of our Common Stock under the Purchase Agreement.
In addition to Regular Purchases described above, we may also direct Lincoln Park, on any business day on which we have properly submitted a Regular Purchase notice, to purchase an additional amount of our Common Stock, which we refer to as an Accelerated Purchase, not to exceed the lesser of:
• 30% of the aggregate shares of our Common Stock traded during normal trading hours on the purchase date; and
• 200% of the number of purchase shares purchased pursuant to the corresponding Regular Purchase.
The purchase price per share for each such Accelerated Purchase will be equal to the lower of:
• 96% of the volume weighted average price during (i) the entire trading day on the purchase date, if the volume of shares of our Common Stock traded on the purchase date has not exceeded a volume maximum calculated in accordance with the Purchase Agreement, or (ii) the portion of the trading day of the purchase date (calculated starting at the beginning of normal trading hours) until such time at which the volume of shares of our Common Stock traded has exceeded such volume maximum; or
• the closing sale price of our Common Stock on the purchase date.
In the case of both Regular Purchases and Accelerated Purchases, the purchase price per share will be equitably adjusted for any reorganization, recapitalization, non-cash dividend, stock split, reverse stock split or other similar transaction occurring during the business days used to compute the purchase price.
The Purchase Agreement limits our sales of shares of Common Stock to Lincoln Park to the maximum number of shares of our Common Stock that we may issue without breaching our obligations under applicable rules of the NASDAQ Stock Market (approximately 6,754,609 shares, or 19.99% of our total outstanding Common Stock upon entering into the Purchase Agreement) or obtaining stockholder approval under such rules.
Other than as set forth above, there are no trading volume requirements or restrictions under the Purchase Agreement, and we will control the timing and amount of any sales of our Common Stock to Lincoln Park.
Thank you for your reminder. Keep forgetting how unsophisticated I am. Keep up the good work.
No, same old 2015 LPC agreement and $50,000,000, of which about 1/3 has already been taken. Though I am not quite sure why it has to be ratified again by share holders.
Probably a timely find of a mistake.
Oh and change the "Is the study currently looking for suitable participants?" field to All, instead of Recruiting.
Use the Advanced Search tab, then only type Anavex in the Keyword field. Brings up our phase 2 part A and B trials.
Interesting, on my screen the trading session ended with:
22:00:00 5,67 19131 1799 NDRG NDRG 6
19131 is volume of that last trade.
I am in Europe, hence time stamp.
I am keeping an eye here, but so far no new registration: Australian Clinical Trials
Btw. Enough cash to include the LPC facility, which despite all the previous criticism seems be cheap funding.
I was thinking about this interview with Missling (from SEC filing):
TWST: I know you are knee-deep in some very important work, but if, let us say all goes well, where do you see the company going in the future? Do you want to stay in the neurology area? Do you see increased partnerships in the future? Can you elaborate on any kind of longer-term vision?
Dr. Missling: Yes, we are focusing on the central nervous system. And I mentioned specifically indications like Alzheimer’s and Parkinson’s disease, and then also for the neurodevelopmental orphan designations or rare diseases like Rett syndrome, infantile spasm and Fragile X, which is a special form of autism. Then, we also work on improving pain management. So we have a balanced pipeline, but the main focus is indeed on the central nervous system.
TWST: Did you want to say anything further on partnerships?
Dr. Missling: For larger markets like Alzheimer’s disease, partnerships for commercialization are very common. This is something that no small company can market by itself and, for that reason, at some point in time, there will be certainly discussions in that direction.
TWST: When might that be happening? Perhaps pre-Phase 3 or afterwards?
Dr. Missling: Our goal is always to create the highest possible value for shareholders. When you enter into such a collaboration or partnership for a larger indication, we will always try to aim for improving the outcome for the shareholders.
Yep, and from everything we've heard from Missling it will not be until the marketing/commercialisation stage that we will see partnership with BP.
To my mind; "Complement current pipeline through in-licensing - ongoing", means Anavex extending their own pipeline by licensing in?
Agree, the most logical outcome is buy-out or solid licensing partnership. I am hopeful and believe that Missling genuinely aim to optimise share holder value.
Can't help being cynical - Still hanging on to the amyloid hypothesis, only sell more of it to a younger population for much longer. Money talks.
Wouldn't it be great to see Anavex fight on through all the headwinds to beat the odds and change this old game for the good.
Sadly, I think you are completely correct.
We see that same attitude in regards to research and long standing empirical knowledge that the food we eat and our life-style in general have profound effects on health. But there is no corporate profits in educating people in healthy living, much more profitable to prescribe medication for symptom management for as longs as possible to as many as possible.
It would be good if Trump could clear that swamp, but will he and could he...
Of course despite life-style changes there will still be deceases for Biotech/Pharma sector to tackle, some of which Anavex may have a good chance of addressing.
Yes I would think Anavex could extend the protection into Alzheimer's and other indications based on showing utility.
The A2-73 composition of matter is protected in this case for cancer. Since Anavex have disclosed other indications, such as Alzheimer's based on the exact same molecule, I would think that preclude others from patenting this particular molecule in any disclosed indication.
It may be possible to improve on A2-73 in novel and non-obvious ways, but it seems to me that the A2-73 patent in the cancer indication offers decent protection for Anavex.
While only the claims, if granted, will provide patent protection, the rest i believe would classify as public disclosure. That would have the effect that no one can later claim same.
everyday..it's not announced..brings the announcement a day closer..
Do you have a link for that story, please?