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.
No, mine is the correct evaluation.
Missling in SA: "So the expected date is provided in ClinicalTrials.gov and I think that’s what you’re referring to."
https://clinicaltrials.gov/ct2/show/NCT03790709?spons=Anavex&rank=2
The estimated study completion date posted on the FDA clinical trials website above is March 31, 2021.
10 weeks to scrub/evaluate data puts AVXL release of data at June 7, 2021.
That looks like almost 1 year and 11 months before AVXL reports data on Alzheimer's.
Missling in SA: "But the question is, so we will provide an update on the timing when we have more granularity on the overall continuous enrollment"
Until they get more granularity, the hard finish date of March 31, 2021 stands.
So, regardless of synergy or MOA or whatever, until Anavex reports placebo-controlled data in AD, which looks like ~2 years from now, AVXL has zero relevance to the outcome of NTRP's results within the next 6 weeks.
"That presumed respect is not worth much when the 2nd and only Neurotrope P2 trial again fails. Just as the presumptive disrespect of investors doesn’t matter when Anavex succeeds with Rett and PDD."
There are many nuances to "success".
Success to NTRP could mean outright success in the top-line data. It also could mean success in a highly significant subgroup. Realizing that there are no new ideas in the industry in moderate or severe AD, success in a highly significant subgroup could mean a very lucrative partnership with a big pharma in AD, followed by further development in other diseases (MS, Fragile-X, etc). Of course, outright success should be looking at a 10-bagger from here within a few months.
AVXL isn't a potential competitor of NTRP in AD for 2 years (when they expect their AD readout), so good luck to them in their other ventures. That Rett readout has a significant competitor going into phase 3, so that should be kept in mind.
"...if only the market would look at $NTRP data, but maybe they actually did?"
You mean like the way the market looked at AXSM's data before they released phase 2 data in January?
That's no guarantee that we will be successful, but AXSM is a good example of the market being VERY wrong before a data readout.
Market cap of AXSM about 10X where it was in January BTW.
Let's take total compensation to Missling for the last 3 years in AVXL, including 2018, which SHOULD enter your investment thesis:
My calculations show total compensation to Missling for 2016-2018 of ~$16.3M.
That's an average of > $5M/year. Far greater than any development-stage biotech I've ever seen.
Ouch.
Would be great if both succeed, but at least NTRP has reasonable total compensation at this stage, when cash is so precious to these non-revenue development biotechs.
One biotech (NTRP) seems to treat investors with respect, rather than seeking obscene compensation for one executive (AVXL).
Maybe the market doesn't know this about $AVXL :
$11M total compensation for an employee (Missling) of a development-stage company (AVXL) in recent history (2016) is OBSCENE no matter how you look at it.
That's quite a haircut. Ouch.
$11M total compensation for an employee (Missling) of a development-stage company (AVXL) in recent history (2016) is OBSCENE no matter how you look at it.
I've never seen such an obscene compensation package for 1 year for 1 individual in any development-stage (non-revenue) biotech. Can you give a link to a similar payout in another biotech company?
That's $11M out of the pockets of (AVXL) shareholders. For one year. To one employee (Missling).
Futher, (if I'm reading the report correctly), $2.3M of that 2016 compensation was to pay his TAXES on those options grants!!!
That's a cash grant (not options).
Nice gig if you can get it.
As an addendum on AVXL CEO Missling's compensation:
The deeper you look, the uglier it gets for AVXL in terms of "Executive Compensation":
If I'm reading the 12/14/2016 10-K correctly:
The total compensation to CEO Missling in 2016: $11M+
As follows:
Salary: $ 305,000
Option Awards: $ 8,495,900
Other Annual Compensation: $ 2,290,340
Total: $11,091,240
Holy mackerel!
But year after year of multi-million dollar options grants to AVXL CEO hasn't worked out that well for the company. So I guess it does make sense to second-guess the BOD and founder of the company, no?
A long way to go for AVXL to where those companies are. A LONG way.
I would think a one-time large options grant to attract a key employee, followed by smaller options grants each year would be much more appropriate.
But year after year after year of $2M options grant just doesn't make sense for any development-stage biotech.
There's already significant dilution for AVXL in cash raises to continue development.
Not fair to shareholders for AVXL CEO to pile on to this dilution year after year after year, as well.
"Options to compensate a successful CEO, especially at a reasonable rate, are different because they are deferred compensation that puts the CEO on the side of the shareholder."
I don't know how $2M in option compensation year after year after painful year can be viewed as a "reasonable rate". If this was a biotech company with CURRENT annual revenues totaling several 100M's, then by all means that would be a reasonable rate. But a development biotech with no near-term revenues for the next several years? Not reasonable to me by any means.
"The problem with warrants is they hold the stock back. People won't like spending $10 a share knowing that insiders get their shares for a fraction of the price."
Won't matter if NTRP is successful. They'll get cashed in for a profit by holders, NTRP raises cash, and institutions buy them for their accounts. Everyone wins if successful.
Those option awards to Missling aren't a one-time thing. It's year after year after year of option awards to Missling. Shareholders don't get that same privilege.
"Actually it's not about the salaries with NTRP IMO, it's about stringing things out so those warrants can be cashed in cheap and sold for a profit."
The last cash raise for NTRP (with warrants) was unfortunate. But it was necessary, and it was done in the middle of a deep downturn in the stock market/biotechs in Q4 2018.
If Ryan turns NTRP into a CNS drug company worth billions, those warrants won't matter to me.
"A rose by any other name would smell as sweet"
AVXL's dilution by any other name still stinks.
Yeah, me too.
AVXL CEO Missling total 2018 compensation (w/option awards): $2.5M
NTRP CEO Ryan total 2018 compensation (w/option awards): $.7M
"drive out some hope for diluting and paying salaries a bit longer"
Remind me again, who's abusing shareholders by, in your words, "drive out some hope for diluting and paying salaries a bit longer"
Because it isn't NTRP/Ryan.
http://secfilings.nasdaq.com/filingFrameset.asp?FilingID=13171399&RcvdDate=1/25/2019&CoName=ANAVEX%20LIFE%20SCIENCES%20CORP.&FormType=10-K/A&View=html
http://secfilings.nasdaq.com/filingFrameset.asp?FilingID=13288138&RcvdDate=3/8/2019&CoName=NEUROTROPE%2C%20INC.&FormType=10-K&View=html
"...some hope for diluting and paying salaries a bit longer..."
And since you brought up salaries...
Care to make a comparison of AVXL's CEO Missling's total 2018 compensation vs NTRP's CEO Ryan's total 2018 compensation?
I'll give you a hint: There's one big piggy among those 2 and there's one reasonably-compensated executive.
I'll give you a further hint: the big piggy ain't Ryan, lol!
"posthoc [sic] subgroup data mining"
Not true. It wasn't post hoc subgroup data mining.
The look at the data in the last trial was a pre-specified subgroup analysis.
And one more time for me .. simple freekin common sense:
Placebo effect is VERY real. Could be over 35% of patients in a trial on placebo that experience placebo effect, whether improvement in sleep or SIB or whatever.
It sounds like someone isn't taking that fact into consideration in this AVXL conspiracy theory.
I'd be very worried if I was an AVXL stockholder, and someone was counting on some rogue healthcare worker not understanding placebo, and inadvertantly unblinding the data.
Could set AVXL back 2 years in AD trials. And that healthcare worker would face criminal charges.
The blind absolutely has to be broken.
How do you know who's on drug and who isn't?
Can't just assume because some random percentage improves that everyone who improved was on drug.
Patients on placebo can improve, as well.
Placebo effect is very real and can affect up to 1/3 or more of patients in any clinical trial.
And no health care worker is going to unblind the data to determine who is on drug, facing potential criminal charges.
An interim look isn't pre-specified for AVXL, and no Australian healthcare worker is going to go out of their way to do an ad hoc interim look by actively evaluating a primary or secondary outcome of an ongoing clinical trial.
Zero chance of this AVXL conspiracy theory playing out as portrayed.
Breaking the blind in ANY way (whether primary or secondary outcome) means starting a whole new trial.
And if AVXL has to start a whole new trial, AVXL is likely looking at an Alzheimer's readout in 2023.
My information is correct. No AVXL readout for Alzheimer's for 2 years.
RE: sleep/provisional approval for 2-73. Are you kidding me? 2-73 trial has no pre-specified interim readouts and nobody in Australia is going to break the blind on the AD trial and face criminal charges. So unless you are aware of some healthcare worker in Australia who will illegally break the blind, your conspiracy theory has zero chance of playing out as you state.
Rett and PDD readout? Meaningless for NTRP Alzheimer's readout, so who cares??
We'll be happy to make direct Alzheimer's comparisons with AVXL...see you in 2 years!
Your calendar is wrong. Re-read my post. No readout for AVXL Alzheimer's until 2021 at the earliest. So no DIRECT comparison of Alzheimer's readouts between AVXL and NTRP for 2 years.
AVXL's PDD and Rett readouts look like next year at the earliest, but there will be no direct comparison to NTRP Alzheimer's readout, so who cares when they read out as it pertains to NTRP? It will be more meaningful for AVXL to try comparing their PDD and Rett readouts to AVXL's competitors in those diseases.
Re-reading the Benzinga article, there seems to be a transcription error. The final sentences read:
"...Then, we would check to see what would happen if we divided up the patients that got NMDA and the ones that didn't. When we looked at the results, it was remarkable: the patients that got NMDA had no benefit. However, patients that did not receive NMDA had a unique advantage."
I think they should read:
"...Then, we would check to see what would happen if we divided up the patients that got namenda and the ones that didn't. When we looked at the results, it was remarkable: the patients that got namenda had no benefit. However, patients that did not receive namenda had a unique advantage.
I'd love to see AVXL prove something in the clinic in Alzheimer's, but that won't be until...(checks calendar)...their 2021 readout.
There's really not much to compare between the two, until there's something to compare.
We'll have something in Alzheimer's in under 6 weeks, and hopefully AVXL will have something to show in 2 years. Until then, direct comparisons are just hypotheticals.
Yes. That would be significant news IMO.
Battle Ready:
I certainly agree on most points, and like the way you think.
If results are convincingly successful, would it make sense for NTRP to hire an investment banker, to set up a competitive bid for either the most lucrative partnership agreement or the highest outright bidder for buyout of the company?
I just think it will take time to work through all the non-disclosure agreements, analysis of the data by the scientists, review of the IP protection layers, and preparation of any partnership/buyout offers that may result.
All of this is, of course, a good problem to have if we're successful.
I honestly haven't kept track of it lately, but I know it's north of 10M warrants and > $50M if all are exercised. If successful, most of the warrants would likely be in the money.
But, I don't think it would be wise to wait for those to be exercised. I think having a definitive plan, including a moderate share raise (without warrants) to advance other programs immediately, seems optimal to me.
I'm not sure a partnership can be done quickly enough, so I think the cash raise and announcement of other programs will continue the momentum in the share price, thus putting the company in the best position for a partnership or whatever maximizes shareholder value.
Battle Ready:
If outright success, I agree it will get to > $1B at some point, but I just think it will take time. I'll be very happy to be wrong.
I think a solid partnership would propel NTRP to > $1B MC quicker than going alone, but either way it will get there, with the actions of management dictating the speed (share raise price/size, advancement of other programs, etc).
If results highly successful, all of these are certainly things to take into consideration, with AXSM as a good model, as you've pointed out many times:
- $29 resistance
- many warrants outstanding
- institutional demand vs warrants will be the battle, with a strong uptrend
- Likely a cash raise to jump start other programs and continue Alzheimer's program ($40M-$60M seems reasonable)
- I would hope NTRP mgt would feed into the strong uptrend, with some announcements like starting new trials
Good strategy going into results.
Right, but IF NTRP can succeed, market cap of NTRP should increase substantially, similar to AXSM's meteoric rise.
11X NTRP's share price sounds good to me!
I haven't seen anyone say AXSM's successful phase 2 data predicts that NTRP will succeed in it's phase 2 data.
Please give a link if you've seen someone say that AXSM's success means NTRP will suceeed.
As far as i know, the only reference is to what will happen to NTRP's share price IF NTRP is successful in it's phase 2 data.
You said: "Given AXSM has nothing to do with whether NTRP will succeed or fail, I'm not sure how it is relevant though?"
It's very relevant. It's been written here many times before.
AXSM produced a successful phase 2 in a CNS disease that doesn't have treatments. And the stock is about 10X where it was before results. (market cap about $800M)
If NTRP can produce a successful phase 2 in a CNS disease (AD) that doesn't have treatments to reverse the disease, why wouldn't it's share price increase by about 12X (market cap currently $64M according to you)?
Yup, that's likely what the AXSM shorts said before their results, as well.
This is so ridiculous to get concerned about Dr. Alkon's reply.
There doesn't need to be any permanent record of Dr. Alkon's reply (an explanation of the science) to the SA author's misguided misinformation.
I read it. There was no material nonpublic information that was selectively disclosed in his reply.
His reply was no different from a company exec giving a presentation or talk or symposium at a conference, followed by questions on the science. Many times, that presentation/talk/symposium and follow-up discussion is not webcast to shareholders, so most shareholders are unaware of the content. If inadvertently the exec discloses something, then the company lawyers will review it and decide if it needs to be disclosed.
If anyone can find something in his reply that was material nonpublic information, then by all means contacted the company!
Here is Reg FD, from an SEC website:
Regulation FD addresses the selective disclosure of information by publicly traded and other issuers. Regulation FD provides that when an issuer discloses material nonpublic information to certain individuals or entities—generally, securities market professionals, such as stock analysts, or holders of the issuer's securities who may well trade on the basis of the information—the issuer must make public disclosure of that information. In this way, Regulation FD aims to promote the full and fair disclosure.
Yes, a well-executed hit piece with misinformation and little understanding of bryostatin and PKC-e. Is it all about profit? Or should those with a platform act with integrity?
Which is it investor2014?
Babaji: thanks for downloading and posting both links.
Almost a perfect post by Dr. Alkon.
Would have been perfect if at the end he had asked the author if she was going to hold her short thru results!
Thanks for that, Whatsupp.
Hard to imagine why they wouldn’t publish their results on an FDA clinical trials site.
Why does AVXL force shareholders to search around for the results?
Doesn’t make any sense
You’re arguing a false equivalence
Because some unnamed drug had problems after approval, therefore bryostatin will have problems after it’s approved
That’s ridiculous.
Neurotrope is playing by the rules that the FDA has set for all drugs. If we get approval with a 6-month phase 3, so be it.
There are no safety signals from long-term high dosage usage.
Can you give a link to a peer-reviewed article that says long-term use of bryostatin is not safe? Minor AE’s don’t count.
What does this even mean?
The FDA approved many cancer trials for long periods of time and higher doses. DSMB’s have never halted these long trials for safety. After long-term trials, the FDA subsequently approved more long-term trials.
The FDA has been on-board with safety from previous trials, and certainly their opinion is far more meaningful than any dissenting opinions on this board