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If they didn't find a correlation between response and biological function in the patients thus far, I don't think they would bother to present at a late breaking oral session. The fact that they are presenting would be considered "good". Not presenting data would be considered "bad".
Didn't Dr. Missling say in one or more of his presentations that the key to a successful Phase III trial is preparation (including PK/PD I'd assume) to know your markers so that you don't fail?
The fact that they are presenting the PK/PD data in some form and describing it as the way that they have designed the Phase II/III trial indicates that they are preparing for success.
Millstone
That's what I think too. In fact, I see Ariana's use of the term characteristics in their company description as similar to the use of Characterization in the title of the Late Breaking Oral Communication and Poster at CTAD:
"Ariana’s innovative clinical data analysis and diagnostic testing solutions help the healthcare sector better adapt patient treatments to individual biological characteristics."
How is A2-73 a) interacting with the human body, and b) how does it affect the body's systems, based on clinical evidence from the (up to) 32 patients that have participated in the earlier clinical trials? How can we use that information to design a larger Phase II/III, enlisting patients that are more likely to see a positive effect based on all of the discernible biological characteristics (using Ariana's patient stratification technology) of the previous patients?
Basically, the CTAD presentations look to be describing how they were able to formulate a Phase II/III strategy of patient recruitment based on the signals and markers that they discovered by analyzing the current data in thousands or millions of ways using heavy duty data sets and computing power to find similarities in response in the patients so far.
Characterization.
Characterization
A curated list of the use of "characterization" or "characterized" in Anavex's press releases:
CTAD - Late Breaking Oral communications: Saturday, November 4
LB18 - Clinical Pharmacokinetics and Pharmacodynamics Characterization of ANAVEX™2-73 for Designing a Phase 2/3 Study in Mild-to-Moderate Alzheimer’s Disease
Mohammad Afshar, MD, PhD1, Frédéric Parmentier, PhD1, Ene I Ette, PhD2, Emmanuel O Fadiran, PhD3, Christopher U Missling, PhD3;
(1)Ariana Pharma, Paris, France, (2)Anoixis Corp., Natick, MA, (3)Anavex Life Sciences Corp., New York, NY
Anavex Reports Fiscal Third Quarter 2017 Financial Results
NEW YORK – August 7, 2017 ...
“We are entering the second half of 2017 with our strongest balance sheet to date, which allows the Company to execute the Phase 2 clinical trial in Rett syndrome, for which ANAVEX™ 2-73 has been granted Orphan Drug Designation by the FDA, as well as the Phase 2/3 clinical trial in Alzheimer’s disease and the Phase 2 clinical trial in Parkinson’s disease,” said Christopher U. Missling, PhD, President and Chief Executive Officer of Anavex Life Sciences. “We look forward to initiating these placebo-controlled clinical trials. The respective trial designs are based on broad genomic and biomarker characterization, pharmacokinetic and pharmacodynamic modeling including data from patients in previous ANAVEX™ 2-73 trials, as well as preclinical translational science. To our knowledge, this is the first use of this approach in the design of clinical trials for Alzheimer’s disease, Parkinson’s disease and Rett syndrome, and marks a shift towards advancing implementation of precision medicine for these and other neurodegenerative and neurodevelopmental diseases.”
Anavex Announces Positive Primary and Secondary Endpoints were Achieved in a Phase 2a Clinical Trial of ANAVEX 2-73 in Alzheimer’s Disease? - Positive Safety Data, Statistically Significant Improvements on Exploratory Clinical Endpoints
NEW YORK, NY, November 9, 2015
“While we remain focused on Alzheimer’s, the remarkably fast onset of clinical effect of ANAVEX 2-73 increases our options to potentially pursue additional indications for diseases characterized by working memory impairment and may enable clinical trials to be completed within shorter time frames.”
Anavex Announces Expansion of Scientific Advisory Board
New York, NY — November 20, 2013 — Anavex Life Sciences Corp. (“Anavex” or the “Company”) (OTCQB: AVXL) announced today the appointment of Dr. Ottavio Arancio, MD, PhD to the Company’s Scientific Advisory Board. Dr. Arancio is a cellular neurobiologist who has pioneered the field of mechanisms of synaptic dysfunction in Alzheimer’s disease..."
“We are very excited to have Dr. Arancio on the Scientific Advisory Board to support the advancement of our drug candidates and the Company’s next phase of growth,” said Christopher U. Missling, PhD, Anavex’s President and Chief Executive Officer. “Dr. Arancio’s research has contributed to the characterization of the mechanisms behind learning, both in normal conditions and during neurodegenerative diseases. His work is relevant to elucidate Anavex’s potential of upstream acting mixed muscarinic and sigma-1 selective drugs both in Alzheimer’s and other neurodegenerative diseases.”
Press release regarding bringing on Ariana:
About Ariana Pharma
Ariana Pharma is a leading digital health Company focused on developing advanced therapeutic decision support systems. Ariana’s innovative clinical data analysis and diagnostic testing solutions help the healthcare sector better adapt patient treatments to individual biological characteristics.
I recently increased my holdings with the certainty that Rett trials will soon begin. Meaning a readout in a double blind placebo controlled trial will soon be at hand. AVXL is not trading big volume currently. A sale of a big block into low volume would be a mistake for the seller and a boon for the buyer. If people are gonna be selling tomorrow if there is no barnburner press release, I might have to buy more. But I cannot believe a savvy sort would broadcast such intentions in a low volume environment and actually do so. However anybody decides to play it, I won't criticize. I've become much more of a stoic when it comes to biotech, allowing the full story to play out. Buy low for sure. But don't expect the rewards for over a year or two.
Millstone
Kitov's website is currently in "maintenance mode" - interesting. Wonder if they are going to be adding some new information?
Another one:
Page 13 -
Together with a strategic partner, we have initiated biomechanical testing of our solid silicon nitride femoral heads. The results of this test will be released in 2017.
Let's crowdsource digging in to this 10-k. Here's one important piece:
Page 12 of 2016 10-K -
"The company previously submitted to the FDA a 510(k) premarket application to commercialize a composite silicon nitride implant. The device was not cleared for commercialization by the FDA, even though the device is marketed in Europe with successful outcomes. We have since re-filed a 510(k) premarket application with the FDA, for a modified CsC-based cervical implant that is comparable to our own commercially-available Valeo®C cervical implants."
I thought they were paying more than necessary but I stand corrected
I think we would expect a heads up on the submission but since AMDA has been oddly quiet I don't know if they will say anything.
Yes, I agree. Just pointing out that AMDA is moving behind the scenes on all fronts and there was reference to an event coming in October 2017 in their June press release.
It bears repeating that a company "on the ropes" wouldn't have paid down $25 million in debt in 2 years or so. It is irresponsible to leave oneself with little cash by paying off debt at an accelerated pace. Unless...
I don't disagree about counterparty strategies frequently being unknowable and complex. Sometimes also rather than needing to unwind a far out of the money call one just lets it expire. But in general I'm in total agreement on options expirations creating volatility in the market for the common.
Everybody needs to re-read this press release from Amedica in JUNE of THIS YEAR and decide whether this is a company that is going out of business or a company that is about to realize the true potential of Silicon Nitride. Give it a read and let us know:
http://www.amedica.com/news-media/press-releases/detail/100/correction---amedica-releases-2016-preliminary-unaudited
A selected quote: "In December 2016, Amedica re-filed an application with the FDA with a modified porous (cancellous structured ceramic) cervical implant. After a 510(k) pre-submission meeting, the company is using FDA feedback to prepare a 510k submission to be filed in October 2017."
1,179 September $5 Calls represents 117,900 shares, not 1,179,000 shares! And the value is practically zero, since expiration is upon us.
Or they are not really trying. Has anybody at all received a call or email about voting from Amedica or their proxies?
*pats self on back*
"I guess I'll be a contrarian, AGAIN, since it has worked out for me all of my investing life:
The stock is 2.10 now. It doesn't go much lower. In fact, 2.10 will be an amazing buy.
I'm in at an average of 1.50, so I'm holding.
Shorts are taking the opportunity to head for the exits and cover. There is not enough in it for them to stick around.
The SEC thing will blow over, as will the suits. That is the way it goes.
Millstone"
And what does a majority common shares for Economou and affiliates mean for the other common shareholders?
1. Other common shareholders are on the same side as Economou. He wants the stock to rise. We want the stock to rise.
2. Economou could boost the dividend. Great for him. Great for us. Great for the share price.
3. Economou is done with the reverse splits since it would harm his holdings.
The loss per share was based on less than 1 million shares outstanding, not the current number. All in there if one cares to read a balance sheet.
Right, but this will be a looooong investigation, as they are, and in the end Dry Ships is a foreign domiciled, foreign company and the rules are MUCH less restrictive.
I guess I'll be a contrarian, AGAIN, since it has worked out for me all of my investing life:
The stock is 2.10 now. It doesn't go much lower. In fact, 2.10 will be an amazing buy.
I'm in at an average of 1.50, so I'm holding.
Shorts are taking the opportunity to head for the exits and cover. There is not enough in it for them to stick around.
The SEC thing will blow over, as will the suits. That is the way it goes.
Millstone
Seems like somebody is a little upset. If you are going to respond to my posts, please interpret them correctly.
My point, to dumb it down a wee bit, is that we are in a situation where Economou, being out for himself, is now in a position to be aligned with the common shareholders. If he benefits, the common shareholders benefit.
To reiterate something I have learned from 25+ years in the market - the market has a very short memory! If a stock is going up, all is forgiven.
Millstone
You said:
dream on
i have seen this movie before
g e is out for himself not you or anyone else.
go back and find out all you can
you will see you are off base
good luck
Plenty of ways for Economou to extract money from DRYS, WHILE ALSO wanting the common stock price to rise.
This is what will happen, since you just have to ask "cui bono?" or who benefits?
Economou will own between 30% to 65% approx. of common shares. There will be no more preferred shares or other classes of shares.
He currently is paid through TMS to manage all the ships in the DRYS dock. George benefits regardless.
I think he will likely boost the dividend so that his common stock ownership will equate to a huge benefit. Currently the dividend is $10 million per year. If he owns 65% of common shares he would get $6.5 million per year.
A dividend boost, over time, will attract investors who chase dividends. The stock will rise with a dividend boost, and George will benefit most, though he will still be aligned with common shareholders.
If he boosts the dividend by $20 million, he will rake in $18 million per year in divi income alone (at 60% common ownership).
See, it ain't hard to be aligned with shareholders AND rake in the cash. DRYS will be a cash flow machine, considering the Baltic Dry rates, the elimination of a big chunk of debt, low interest rates and the amazing leverage of their unencumbered assets.
There is a lot to this story pointing to greater upside. We have cleared out a lot of penny flippers and things are going to get more interesting for those that are semi-patient (by that I mean one month).
Millstone
Volume going to slow measurably, trapping shorts. Most volume is algorithmic trading. Will reduce once it sinks in that toxic dilution is over.
I'm waiting for at least $5 before thinking about selling a little.
Some great in depth research here by the way!
Millstone
I have been away from AMDA for a while, but decided to check up on things. Interesting tales of corporate intrigue! I had long ago pondered that the paying off of corporate debt and reduction of headcount portended cleaning up the company for a buyout.
One thing I'm having trouble understanding:
Why do a reverse split? If AMDA is booted off of the NASDAQ, they will still trade. Why would being NASDAQ listed assist or enable a merger? The transaction would either be a cash purchase or a share for share exchange in whatever ratio. The price or listing status of AMDA would not matter in any material way - the ratio would adjust based on the overall purchase price.
So, what is the best theory?
1. Going through the motions?
2. Just in case?
3. To comply with the Hercules loan terms while the loan still exists?
Thanks in advance.
Millstone
Some more research on Heidmar Holdings LLC:
Heidmar Holdings LLC is the holding company of Heidmar, Inc. - so they are one and the same:
Article from 2012:
The Board of Directors of Heidmar Holdings LLC, the holding company for Heidmar Inc, announced today that they had selected its new Executive team to lead the company. Marc La Monte has been appointed President and Chief Executive Officer of Heidmar Inc. and Per Heilmann has been appointed Executive Vice President and Chief Risk Officer.
http://gcaptain.com/c-level-executives-appointed-heidmar/
1. They are not issued yet, only contemplated under a Term Sheet;
2. When issued, they will be restricted from sale for a long time;
3. The offering to existing shareholders is not yet issued either, only contemplated under a Term Sheet.
About 40 Million shares are currently outstanding - That is all. For this kind of volume, that is a very small float.
Powerful up moves to come. It will surprise many. A few will expect it. ;)
Thanks for the compliments ash, which are humbly accepted coming from you. Like you, I like to do forensic analysis and find hidden value. Frequently this involves what look like "hairy" situations.
I guess for me that's where the fun is. And, sometimes, the big paydays!
Millstone
Lots of people about to get schooled here...
DRYS is going up. Fundamentals are now being considered. The game has changed and Economou is interested in running this up.
Multi-day rise is in the works.
MACD crossover in sight.
Aroon crossover in sight.
SMA 10 about to cross above 20.
Chaikin money flow about to go positive.
Oh, and the book value of DRYS right now (prior to the placements etc.) is about $8-10 per share!
Thar she blows.
We are going to trend up to fair value.
The market has a very short memory when money is to be made. People will soon forget about bad Economou and think about "clever" Economou.
Millstone
I have heard securities lawyers argue that if an insider purchases shares in advance of positive events, even with inside knowledge about positive events, but does not sell those shares within a period of at least 6 months, then it is not considered insider trading.
You make a couple good points. I expect a 6-K out as early as Monday pre-market, maybe post-market, with details on Kalani's final transactions. If Kalani indeed did not sell as many as 12,500,000 shares then the remaining ones go back into the kitty and DRYS book value improves. You are correct that Heidmar is an operator and not an owner as far as we can tell. So, Heidmar would not be added to the value of vessels. As a strong enterprise, I imagine they could be a good contributor to cash flow. Cash flow is not yet known, but if the transaction is completed, we'll know soon enough.
Guess who owns the other half of Heidmar....
MORGAN STANLEY. Seems that we've heard that name recently....
Shipping Pool Investors to buy 49% stake in Heidmar
Shipping Pool Investors Inc (SPII) has entered into a definitive agreement to purchase a 49% stake in Heidmar.
In a related transaction, senior members of Heidmar's management will purchase a 2% equity stake in the company, and Morgan Stanley will retain 49% ownership of the company.
Subject to the receipt of necessary regulatory approvals, both purchase transactions are expected to close within thirty days.
SPII affiliated with the Cardiff Group, which has extensive interests in the dry and wet freight shipping industry. Ten of Cardiff's vessels currently participate in two of the Heidmar shipping pools.
Heidmar has offices in the US, UK and Singapore, and operates a fleet of more than 90 tankers.
Heidmar is the general agent and commercial manager of five pools:
Star Tankers (panamax/LR1 tankers between 55,000 and 75,000 DWT)
Sigma Tankers (aframax/LR2 tankers between 90,000 and 120,000 DWT)
Dorado Tankers Pool (mid-range product tankers between 37,000 and 55,000 DWT)
Marida Tankers (short-range product tankers between 10,000 and 18,000 DWT)
Blue Fin Tankers (suezmax tankers between 140,000 and 180,000 DWT)
eyefortransport.com
Here's my breakdown of what I believe current value of vessels, cash on hand, debt, and shares outstanding after the private placement with Economou and shareholder placement will be:
Current shares outstanding PLUS Economou pp + shareholder raise:
31,547,436 (as of 8/4)
12,500,000 (estimate of shares "purchased" by Kalani from 8/5-8/11 period)
36,000,000 (shares to Economou in exchange for consideration of $100,000,000)
36,000,000 (shares to existing shareholders for $100 Million at $2.75/share)
_____________
Approx. 116 Million shares O/S
Value of vessels as of 7/21: $652.6 Million
+ Value of Heidmar 49% stake transferred to DRYS: $70 Million (guess based on consideration amount of $100 Million total from Economou).
Current Value of Vessels: $722,600,000
Cash on Hand: $58 Million (as of 7/21)
+ $25 million from Kalani between 8/4 and 8/11
+ $100 million from existing shareholders offering
Current cash on hand (after exchange/offering) = $183 Million
Debt of $237 Million (as of 7/21)
- 27 Million (Economou exchange)
Current debt (after exchange/offering) = $210 Million
Current book value after contemplated exchange/offerings:
$905,600,000 (vessels/companies/equipment plus cash)
- $210,000,000 (debt)
= $695,600,000
= $6.00 PER SHARE IN BOOK VALUE ALONE
Thoughts/comments welcome
Millstone
Research on the $100 million in consideration from Economou entities per this mornings press release:
So, in exchange for the $100 million in consideration from Economou entities, DRYS is getting -
1. 49% interest in Heidmar (www.heidmar.com/about/) which according to Heidmar itself is one of the world's leading tanker operators. Entities with tankers pool them under the Heidmar banner, and Heidmar operates and manages them, getting fees in exchange.
2. Economou (through Sifnos) gives up his Series D
preferred shares (which carry 100,000 votes per sha
re) - No more iron grip control / no more reverse splits without shareholder approval.
3. Repayment of $27 million under the Company’s unsecured credit facility, bringing down DRYS debt by $27 million.
DRYS is going legit in a big way.
Millstone
Thanks. If I am correct, we might see an 8-k come out showing my supposition to be the case.
I maintain that Kalani is just finishing off selling the shares that it purchased from DRYS in advance of the cancellation of the deal (probably bought at 1.50-2.75). Instead of the short-buy to cover routine, Kalani switched it up for the last tranche to buy low-sell higher.
Almost done and ready to climb big.
Millstone
Excited to see where we'll be next week! Certainly higher than $2.93
The stock price is a very good deal for any buyer right now at 2.93. I bought a bunch more.
Do we know the current status of Economou's voting control?