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Neurotrope Launches New Long-Term Clinical Trial of Bryostatin with the National Institutes of Health for the Treatment of Patients with Alzheimer's Disease
https://www.prnewswire.com/news-releases/neurotrope-launches-new-long-term-clinical-trial-of-bryostatin-with-the-national-institutes-of-health-for-the-treatment-of-patients-with-alzheimers-disease-301066973.html
I should probably also mention that Neurotrope is worth about $30 million today, which means that the new company needs to be worth at least $150 million for this deal to break even. The new company is expected to have 120 million outstanding shares, which means the stock price needs to be at least $1.25 after the deal has closed or else this will all have been for nothing.
Should be interesting to see if they manage to increase shareholder value for once or end up shooting themselves in the foot again.
Hopefully they can at least get the new trial started before then.
20% of the new entity in addition to 100% of the spin-off that isn't bogged down by about 25 million options and warrants, not to mention dodgy directors and CEOs.
I think it's a great deal actually. Hear me out:
1. The board and management (which are responsible for this mess) go over to Petros while Dr. Alkon stays with the Neurotrope spin-off. Hopefully this means the spin-off gets a new board and management while Dr. Alkon can keep working on synthetic Bryo-1.
2. All Neurotrope warrants and options are converted to Petros warrants and options, which makes the balance sheet for the spin-off much much cleaner.
3. If you're like me and don't feel like investing in a penis pill company, you can just sell the Petros shares (whose worth will include the cash the new company gets) and use it for something else.
The way I see this, it's a neat way to dump the trash at the new company while the spin-off gets a fresh start. The spin-off will probably have to raise cash again next year, but in that case you can just sell everything now and buy in before or after the next results are out.
If investors don't like penis pills they can just sell their shares in the new company and buy a bigger stake in the Neurotrope spin-off.
And if neurodegenerative diseases doesn't interest them either they can sell all their shares and go somewhere else.
Two life forms. They're taking some of the money they raised and putting it in a company earning $25 million a year.
Hopefully this will get rid of all those pesky warrants and give the spin-off a cleaner balance sheet before new results are out.
Neurotrope and Metuchen Pharmaceuticals Announce Merger Agreement to Form Petros Pharmaceuticals, a Men's Health Company
https://www.prnewswire.com/news-releases/neurotrope-and-metuchen-pharmaceuticals-announce-merger-agreement-to-form-petros-pharmaceuticals-a-mens-health-company-301060769.html
Correct.
New results won't be out for another 2 years probably. If people want to keep having the same arguments with the same people for that long then so be it. Personally I prefer to keep my sanity and wait for real news.
First and foremost, this pandemic needs to be dealt with before the new trial can start. Having patients drop dead from a virus in the middle of a trial would be pretty bad. It's especially risky for AD trials considering the advanced age of the patients.
Definitely. Let's hope this mess gets resolved quickly so we can get the next trial started.
Thanks. There were a couple of days where I couldn't take any deep breaths, but it's all gone now. I feel more bad about the people hooked up to ventilators.
From what I've heard, you're not supposed to take Ibuprofen or other NSAIDs since they apparently upregulate the ACE receptors that the virus binds to.
The severity of the disease seems to depend a lot on how much of it you're exposed to, which would explain the many healthcare workers dying from it. Old age and conditions that weaken the immune system seem to also be a risk factor.
Basic stuff like staying in shape, drinking lots of water and having a good diet seems to help the immune system do a better job at fighting it off. Personally I'm also taking multivitamins to make up for what's missing in my diet.
Apparently there's a malaria drug that's supposed to help, but they recently cancelled a trial in France because of the severe side effects it caused, so I'm not so sure about that one.
People are very eager for a cure, but it takes time to run clinical trials and make sure a drug actually does what it's supposed to.
Either way, stay safe. You only need to beat it once and then you're immune for the next couple of months.
Be careful about trying experimental treatments based on word of mouth alone. There's plenty of snake oil salesmen around trying to take advantage of people that are afraid, and you can't really be sure who's right unless you do your own research and read some papers on whatever drug you decide to take.
https://www.ncbi.nlm.nih.gov/pubmed
At least that's what I would do if I wasn't already infected lol. I'm lucky to only have the mild form of it, which is what most people get.
Better to have a delayed trial than an ongoing one where a pandemic ruins the data.
Having enough money in the bank to wait things out is also helpful.
"Coronavirus Takes Its Toll on Alzheimer’s Clinical Studies"
https://www.alzforum.org/news/community-news/coronavirus-takes-its-toll-alzheimers-clinical-studies
At this rate we'll be waiting until 2022 for new results.
My guess is they'll raise more cash in 2H 2021 which will further drive down the share price and at that point we'll be looking at a potential delisting or reverse split.
Can't really argue against the science though considering they've shown improvements in about 50 patients so far. The p-values keep shrinking which means the chance of this being a fluke is shrinking too.
No. This is a company working on neurological disorders and not coronavirus vaccines.
You would know this if you had spent even a minute reading about what this company actually does.
It'll get worse before it gets better. I give it a few more months before people have calmed down and adapted to the situation.
In the meantime I have updated the ibox with the latest numbers. Reading the 10K honestly makes me want to walk away from this company and never look back because of the absurd amount of warrants. Some of them don't even have an expiry date.
There are certainly worse ways to spend government money. Aside from NTRP and AVXL, I don't see any other companies developing a disease-modifying AD drug that doesn't follow the debunked amyloid/tau hypothesis.
Would be quite the coincidence if both companies were to finish their definitive trials next year at the same time.
From the last PR:
"The Company is pleased to announce that it has been awarded $2.7 million from the National Institute of Health ("NIH") to support an additional Phase 2 clinical study focused on the Moderate Stratum for which the Company saw improvement in the 203 study."
My guess is they'll announce a new trial in a few months focused on synthetic bryostatin in patients with moderate AD.
New results would then probably be out 2H 2021.
The first trial showed improvements in a 16 patient group (p=0.0488).
The second trial showed improvements in a 32 patient group (p=0.0076).
Following this trend they'll need 64 improved patients this time around and 128 improved patients for a potential P3 trial.
Doesn't matter what the market does at this point. They have enough cash to ride out whatever happens in the next couple of years.
Mr. Haywood seems optimistic too. The latest filings show he's still holding his 1 million shares.
I doubt it. The money will last them 4 years at most and the only blockbusters here are the scientists, not the executives (I'm still very skeptical about certain board members and their connections to fraudsters).
Those of us who have been here long enough will know how often this thing can move 10% up and down based on nothing at all. Just take a look at the chart for the months leading up to the 2017 results.
Looking at the past also shows that the truly big moves here only occur after trial results are released, and I wouldn't expect something like that to happen until next year.
The industry has seen too many P2/P3 failures to care about a post-hoc analysis, even if the data looks good in moderate patients. What they need is a trial that doesn't miss its primary endpoints again.
The first time it was because of Memantine and non-optimal doses.
The second time it was because of baseline imbalance and severe patients.
Let's see if they can convert the third shot on goal into an actual goal.
That's how startups work. You either buy shares to maintain your share of the pie or you get diluted.
I doubt they'll have anything substantial to offer until next year, which is probably for the best considering the 5 million warrants that will expire worthless by November 2021 as long as the price stays below $6.40.
Have you tried contacting one of the researchers? They usually include their email addresses in these papers where you can send them questions about their research.
Looks like the Chinese are starting to show some interest in the Bryostatins:
https://pdfhost.io/v/BkncGb4U_wu2019pdf.pdf
"
2.4. Bioactivities of Bryostatin 1 in Central Nervous System Diseases
As a PKC activator, bryo 1 effectively enhanced the expression and activation of the brain-derived neurotrophic factor in the hippocampus. Thus bryo 1 can improve learning and memory, and reverse depression. It is also a potential clinical therapeutic drug for neurodegenerative diseases such as Alzheimer's disease (AD), fragile X syndrome (FXS), and stroke. The preclinical research progress in these fields is discussed below.
Studies by Thomas J. Nelson demonstrated that bryo 1 could go through the blood-brain barrier (BBB) and activate PKC in the brain, including signal transduction enzyme PKCe, which is involved in learning and memory functions. Therefore, it could prevent/reverse the synaptic loss and promote synaptic maturation. Meanwhile, bryo 1 was well tolerated in patients in an anti-AD clinical trial, although there was a pharmacokinetic difference among individuals.
In 2014, Rosen analyzed the biological restorative effect of bryo 1 on BBB after single blast exposure by examining the degree of brain damage. It was found that bryo 1 could effectively repair the injury of BBB via up-regulating tight junction proteins (occluding, VE-cadherin and ZO-1) and modulating PKC isozymes.
FXS is a CNS disease resulting in intellectual disability caused by transcriptional silencing of neurons of the FMR1 (the X-linked gene fragile mental retardation 1) gene product. The deficiency in FMRP (fragile X mental retardation protein, a repressor of dendritic mRNA translation) leads to dysregulation of synaptically driven protein synthesis and impairments of intellectual, cognitive and behavioral functions. Many great efforts for finding effective therapy have been performed to treat FXS. In 2014, Alkon et al. reported that after treatment with bryo 1, the synaptic growth and cognitive ability, spatial learning and memory of adult FXS mice were effectively improved. The mechanism of bryo 1 on FXS was shown to be based on the restoration of the normal functioning of the hippocampus. This result opened a new avenue for bryostatin-like agents as new drugs to treat FXS even after the complete development of the postpartum brain.
Combined therapeutic effects of bryo 1 and exercise regime on stroke-induced paralysis were studied by Shimpo’s group. They found that in contrast to treatment with bryo 1 alone, combined therapy promoted the recovery via improvement in synaptic transmission efficiency. Further research on the mechanism of this compound revealed in 2016 that the combination therapy effectively increased serotonin (5-HT) levels and decreased 5-HT turnover, in contrast to exercise or bryo 1 alone. In this study the levels of 5-HT, a contributing factor to brain plasticity and therefore may facilitate paralysis recovery, were monitored in the perilesional cortex, a potential site for intracortical brain-machine interfaces that may restore motor ability after stroke. This conclusion supported the theory that the administration of bryo 1 in combination therapy would be beneficial for motor function recovery in stroke rehabilitation.
Multiple sclerosis (MS) is an inflammation of CNS, mainly driven by self-activated T-helper (Th) 1 and peripheral activation of Th17 lymphocytes, while diffuse activation of myeloid cells is a progression of MS and currently has no satisfactory treatment. In 2018, the researchers at John Hopkins University brought the hope for the treatment of MS, they discovered that bryo 1 could prevent the progress of MS.
"
I have to say, it's pretty amusing to see how much the market hates this company. The shares are now worth less than half the cash they have in the bank.
Other than launching new trials I don't think much else is going to happen this year.
At least it's nice to see they're considering synthetic bryo for the next trial. No need for bioequivalence trials if they drop the natural version and go straight for synthetic version approval. Dropping the severe patients and only focusing on moderate ones should also provide better results for the next trial. Hopefully they'll also find a way to prevent another baseline imbalance.
Cue another year of arguing and debating before they cause another ruckus with new results. Third time's the charm, right?
That's the problem. Dr. Alkon and his research team are doing an incredible job, but I wonder what the other executives are doing other than writing reports and making sweetheart deals with high net worth individuals so they can cash in some cheap warrants while existing shareholders get screwed.
Hopefully the stock price stays low enough for those older 5 million warrants to expire worthless in November 2021.
Let's be honest here. This company is run by a pack of clowns.
There was enough cash to last another 2 years and they decided to raise more for "general corporate purposes" right before a positive PR. There was an excuse for the terrible timing of the last fundraiser but I can't think of any for this one.
Here we go again lol
Time to wait another year until we see if third time's the charm.
This stock is the craziest rollercoaster I´ve ever been on.
What are the chances? I think I need a drink.
"Neurotrope Provides Corporate Update After Completing Bryostatin-1 Data Analysis for Advanced Alzheimer's Disease Trial"
https://www.prnewswire.com/news-releases/neurotrope-provides-corporate-update-after-completing-bryostatin-1-data-analysis-for-advanced-alzheimers-disease-trial-300991105.html
No reason. This stock isn't going anywhere until they give an update on what they'll do next, which I don't expect from them until at least March.
This is of course assuming they don't find anything in their analysis that they can use going forward. It would be a completely different story if it turns out they got the vials mixed up or messed up the dosing.
For now though, I'll keep my expectations low and assume the drug didn't work, even if the placebo group performed suspiciously well compared to other AD trials.
There's a poison pill in effect that prevents just that.
They may have $1.5/share in cash, but they'll obviously burn through that cash eventually.
If the past repeats itself, we're looking at another $20 million fundraising in late 2020.
If the price stays $0.80 then they'll have to issue 25 million new shares and possibly 25 million new warrants too.
Fully diluted shares would then expand to around 75 million in total, and the share price would most likely lose almost half its value.
They obviously had the data before it was announced.
If they got the data late Friday, there would've been plenty of time during the weekend to crank out a cookie cutter poison pill and have the board sign it before the PR on Monday.
You know what's strange?
Both patient groups moved exactly 3.2 points in the opposite direction.
Non-memantine placebo group went from -1.1 in the previous trial to +2.1 in the current trial.
Non-memantine bryo group went from +4.5 in the previous trial to +1.3 in the current trial.
There's also this part:
"If the Rights become exercisable, all holders of Rights, other than the Acquiring Person, will be entitled to acquire shares of the Company’s common stock at a 50% discount or the Company may exchange each Right held by such holders for one share of its common stock."
So you would get:
- the right to buy 1 preferred share for every 1000 rights that you own at a price of $20,000/preferred share
or
- the right to buy common shares at a 50% discount
or
- the right to have your rights exchanged for common shares by the company
No, you would not.
First of all, there are no extra shares being handed out. It's just a right being attached to every share no matter who owns it.
Second of all, the rights are separated and given to those who own shares 10 business days after a public disclosure that someone has hit the 15% limit or intends to do so.
This means that if you want the rights you will have an entire 10 business days after the public disclosure to buy the shares you want your rights for. The preferred shares would then cost you $20,000 each and require you to own 1000 common shares for every preferred share you want to buy.
That's not how the rights work.
"Initially, the Rights will be attached to all Common Share certificates and no separate certificates evidencing the Rights (“Right Certificates”) will be issued. Until the Distribution Date (as defined below), the Rights will be transferred with and only with the Common Shares. As long as the Rights are attached to the Common Shares, the Company will issue one Right with each new Common Share so that all such Common Shares will have Rights attached.
The Rights will separate and begin trading separately from the Common Shares, and Right Certificates will be caused to evidence the Rights, on the earlier to occur of (i) the Close of Business (as such term is defined in the Rights Agreement) on the tenth day following a public announcement, or the public disclosure of facts indicating (or the Board of Directors becoming aware), that a Person (as such term is defined in the Rights Agreement) or group of affiliated or associated Persons has acquired Beneficial Ownership (as defined below) of 15% or more of the outstanding Common Shares (an “Acquiring Person”) (or, in the event the Board of Directors determines to effect an exchange in accordance with Section 24 of the Rights Agreement and the Board of Directors determines that a later date is advisable, then such later date) or (ii) the Close of Business on the tenth Business Day (as such term is defined in the Rights Agreement) (or such later date as may be determined by action of the Board of Directors prior to such time as any Person becomes an Acquiring Person) following the commencement of, or the first public announcement of the intention to commence, a tender offer or exchange offer the consummation of which would result in the Beneficial Ownership by a Person or group of 15% or more of the outstanding Common Shares (the earlier of such dates, the “Distribution Date”). As soon as practicable after the Distribution Date, unless the Rights are recorded in book-entry or other uncertificated form, the Company will prepare and cause the Right Certificates to be sent to each record holder of Common Shares as of the Distribution Date."
https://www.sec.gov/Archives/edgar/data/1513856/000114420419043867/tv529014_8k.htm
If you buy new shares next week, you will still get the rights attached to them.
Only when someone hits the 15% unauthorized ownership trigger do the rights get separated and start to trade independently.
It's basically a poison pill.
Here's one: https://www.alzforum.org/news/conference-coverage/first-phase-3-trial-tau-drug-lmtm-did-not-work-period
Tau hasn't been tested in as many trials as amyloid, but the results so far don't show any reversal of the disease either. The best we have today is a slowing of the decline, and for that we already have Memantine, Aricept etc.
What's more interesting to me is how Bryostatin has managed to regrow human neurons in vitro (confirmed by electron microscopy) while at the same time failing the last trial. It makes me feel like there's a piece of the puzzle still missing.
It's not like the FDA would have given a PKCe biomarker test a breakthrough designation unless it actually showed something groundbreaking.