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I forgot to mention that if they don't meet the market value requirements for Nasdaq they can choose to do another reverse split in order to get approved through the equity standard requirements.
Hopefully those one year warrants get exercised or else we're probably having another offering before results next year.
We might not know the cause yet, but this trial could have the answer to how we reverse the damage, and that alone could save millions of lives and trillions in healthcare costs.
Alzheimer's was the 2nd leading cause of death in high income countries during 2019, and I'm afraid it will become #1 soon if we don't find a way to stop it.
I must've misunderstood it then.
It does seem a bit strange though that there hasn't been a word about approval since they received their breakthrough designation in 2019.
Thanks for the summary. If the closing price can stay above $2 I'd say the Nasdaq listing will happen in March around the same time the 10K is filed.
Diagnostic test doesn't seem to need FDA approval since it's not a medical device:
https://www.ndx-discern.com/discern/
"Disclaimer: This test was developed and its performance characteristics were determined by the Rockefeller Neuroscience Institute and SYNAPS Dx. It has not been cleared or approved by the US Food and Drug Administration. The FDA does not require this test to go through premarket FDA review. It should not be regarded as investigational or for research. This test should be interpreted in context with other clinical findings. The SYNAPS Dx’s laboratory is certified under the Clinical Laboratory Improvement Amendments (CLIA) as qualified to perform high complexity clinical laboratory testing. Although these tests are highly accurate, rare diagnostic errors may occur. Possible diagnostic errors include sample mix-up, erroneous specimen identification, technical errors and clerical errors. The report from SYNAPS Dx does not represent medical advice. Any questions, suggestions, or concerns regarding interpretation of results should be forwarded to a physician skilled in interpretation of the relevant medical literature."
Just updated the ibox with more recent market information.
There are 14,032,516 outstanding shares and at a price of $2.80 the market cap is currently at $39,291,045.
Nasdaq Capital Market only requires a $2 closing price if certain requirements are met.
I very much doubt they would have filed an application if they were below the required price for listing.
I know that feeling of missed trades all too well. Throw in a bid and they'll start trading shares one cent above you. What I do now is instead of aiming for a specific price I'll set a price range for myself that I can buy/sell within.
Sometimes you need to move a couple percent in order to lock in a trade. Other times it's a standoff where they pull away hoping that you'll chase after them.
Wouldn't the S-1 becoming effective add downward pressure to the stock price?
If I had participated in the latest offering I would:
1. Sell shares to drop cost basis to $0.
2. Exercise one year warrants to give company more liquidity at no cost and prevent another offering before results that would dilute my five year warrants.
3. Hold five year warrants through results.
If the one year warrants are all exercised we could ride into results with about 40 million shares fully diluted.
I think it's interesting how $20 billion is the number that keeps getting priced into these BP AD trials:
https://www.bloomberg.com/opinion/articles/2021-01-11/lilly-s-alzheimer-s-drug-isn-t-worth-20-billion-yet
Very consistent market cap moves across different companies after they release results.
Sounds about right. We'll know for sure once the 10-K is filed in about a month.
Biggest question for me will be what their new cash burn looks like. If those one year warrants are not exercised they might just do another offering before results are out, in which case we're looking at an additional 10-20 million shares and warrants depending on the price.
At this point I mostly see bryolog development as experimental research rather than something that will be approved for clinical use any time soon.
I think I read somewhere that the average time for approving a new drug for the market is 15 years from start to finish, and Neurotrope only started working on bryo 1 in the early 2010s, which means bryologs will probably not be available for another decade or two.
My guess is they'll go with bryo because there's already huge amounts of safety data and infrastructure in place to synthesize it on a larger scale.
Any bryolog candidates will have to finish preclinical and safety testing first before being used in human clinical trials.
I also doubt that any of them will be tailored to specific diseases. They're all being tested as PKC activators, so you really only need the most potent and safe one for all indications IMO.
Good stuff. Thanks for sharing.
I think most drugs work like that. With IV you get it injected directly into your blood while oral versions need to make it past stomach acid and several other barriers.
Dr. Wender has been quite the miracle for this company.
Not only did his team invent the synthesis of Bryo 1, but they're also developing more potent bryologs that are easier to manufacture.
I imagine in a decade or so they'll be able to mass produce a bryolog pill that can be given to patients suffering from various neurological conditions.
Who knows how many trillions this could save in healthcare costs if the trial proves it works.
I wouldn't buy more shares now while several biotechs are being pumped for no legitimate reason. The trial won't finish until late 2022 so there's plenty of time to buy later.
I also think the new warrants aren't valid until the company puts out a registration statement, so my guess is that this will not lead to many warrants being exercised.
Feels strange to see all these random biotech stock prices pop with no explanation.
Got any ideas about what's going on?
Maybe you're right, but at least this way you have more time to load up on cheap shares while the results are guaranteed to deliver a bigger and more definitive bang to the stock price than if they had pursued a smaller trial, which could possibly also have been too short to prove beyond a doubt that it beats placebo.
The latest paper from Dr. Alkon's team certainly makes a point about how important longer trials can be for a drug like this that takes time to properly work in humans.
Could be, but the thing that makes AD worth pursuing first is that the potential market is ridiculously huge to the point where a single failed Alzheimer's trial can cause a 20 billion dollar drop in valuation if you're a big pharma company. AD and other forms of dementia are currently ranked as the 7th leading cause of death worldwide and 3rd leading cause in the developed world.
And that's just AD. A drug that works for several of these indications is something I don't think any of us can properly value at this point.
I think what a lot of people seem to miss is that the MOA of Bryostatin 1 inherently means that they only need one good trial to prove that this drug can work for multiple indications.
AD, Fragile X, MS, PD, TBI, autism and depression all have the same symptom, not the same cause but the same symptom, which is dysfunctional/destroyed synapses in the brain. There is a good reason for why they are pursuing all these indications with the same drug. There is a good reason for why they have shown improvements in mice suffering from all these different disorders by using the same drug.
AD is just one of many neurological disorders that involve brain damage and this is a drug that is meant to work by repairing brain damage, no matter how that damage is caused.
I firmly believe that one good trial is all it takes to prove that the MOA works and can be used effectively across indications.
In the latest paper by Dr. Wender he once again proves that PKC activation is what drives the positive changes in mouse brains, and Synaptogenix currently owns the biggest patent portfolio and drug pipeline for PKC activators that I know of.
It's not just an Alzheimer's drug. It's an entire platform of PKC activators meant to reverse brain damage by activating the growth of new brain cells, and the company never seems quite able to get that message across to the market which thinks that this company is only worth the cash it has.
The poison pill doesn't apply to acquirers that are approved by the board. Because these pre-funded warrants were sold by the company, I assume exercising them is something they're okay with.
The only reason I can think of to buy pre-funded warrants instead of regular shares is to avoid having to make your holdings public because of SEC requirements.
The current price is basically the market saying this company is worthless beyond the cash it has, which is just nuts considering the valuations of similar companies.
Something I also noticed is that they sold pre-funded warrants in the last offering, which means that someone has acquired a big chunk of the company and wants to avoid SEC reporting requirements.
The mean baseline MMSE scores of those patients was 22.1, which is mild dementia. There is also no placebo to compare it to.
If results like that are worth a billion, who knows what double blind placebo controlled improvement in moderately severe patients is worth.
Trial completion should occur about 10 months after they post the PR about completing enrollment, so my guess is patient enrollment won't be completed until late December this year.
The current trial is almost 10 months long either way. Dosing period is 28 weeks but the final follow-up visit is at week 42, meaning that patients will be monitored almost 3 times longer this time.
Remember, a positive phase 2 trial doesn't necessarily have to completely restore patients. It just has to prove that it can outperform placebo and put patients on a path to full recovery.
Testing for full recovery is something that would be better suited for a more expensive multi-year phase 3 trial.
Here's the part I think was most interesting:
"The most significant findings of our study are not only that bryostatin-1 can rescue both the phenotypes of autistic and cognitive abnormalities in the Fmr1 KO2 mice, but also that such a rescue can be achieved only through an appropriate (i.e. chronic) dosing and therapeutic period. A shorter duration of treatment (5-weeks) with the same dose of bryostatin-1 evoked only minimal, partial, and inconsistent effects in the Fmr1 KO2 mice, while a 13-week treatment with bryostatin-1 rescued all the impaired behaviors evaluated in the Fmr1 KO2 mice. These include hyperactivity, ADL nesting and marble burying, fear learning and memory, and habituation to a novel environment. It should also be mentioned here that, at this effective dose, chronic bryostatin-1 has been found to produce an anti-depressive effect in rodents, a behavioral abnormality highly associated with autism, though not directly tested in this study. It is possible the mechanism of the delayed therapeutic effect could be similar to anti-depressants that act pharmacologically in days but only therapeutically after 4–6 weeks."
"In summary, 13 week treatment with bryostatin 1 demonstrated significant therapeutic effects compared to a 5 week treatment regime. This effect was comparable to other treatment strategies being investigated for FXS. It is possible that longer-term treatment would result in further improvement in fragile X phenotypes. This effect is clearly different from other treatment strategies tested to date, in that the drug shows little acute effect, but strong long-term effects. It also shows no evidence of tolerance, which has been a problem with other drug classes (mGluR5 antagonists, GABA-A and -B agonists). Five weeks of treatment in a mouse is comparable to many months of human treatment, and 13 weeks of treatment in a mouse is comparable to years of treatment in humans and when planning future clinical trials this factor should be considered."
"New Study Demonstrates Bryostatin Normalizes Autistic Spectrum Behaviors in Mice"
https://www.prnewswire.com/news-releases/new-study-demonstrates-bryostatin-normalizes-autistic-spectrum-behaviors-in-mice-301215137.html
If history is anything to go by, the stock price will stay below the exercise price until they expire worthless, at least the 1 year ones. 5 year ones could be worth a lot if this trial prints good numbers.
Synaptogenix Announces $14.0 Million Private Placement
https://www.prnewswire.com/news-releases/synaptogenix-announces-14-0-million-private-placement-301212583.html
Called it lol
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=160913828
Maybe the pump was to get additional funding in at a higher price.
A 32% slowing of decline in mild/moderate patients using yet another amyloid drug.
I thought the industry had learned from its mistakes by now, but apparently they're still clinging to the amyloid theory that keeps getting debunked.
Very frustrating to watch. Who knows how many more lives will be lost because of their fragile egos.
Maybe the price action is a result of both the uplisting and Eli Lilly posting results for their phase 2 AD trial:
https://www.nytimes.com/2021/01/11/health/alzheimers-amyloid-lilly.html
Just noticed they're an OTCQX member now. No more pink sheets.
Even if it's just a short term pump, it still gives the company an opportunity to raise new funds at a higher price and reduce dilution.
"Future development activities beyond 12 months from this Form 10-Q filing date will require additional equity or debt financing or additional collaboration or licensing agreements. Such equity financing may not be on favorable terms and would likely be dilutive or in the case of debt financing may involve restrictive covenants. Collaboration or licensing arrangements may require the Company to relinquish rights to some of its technologies or product candidates on terms that may not favorable to the Company. The Company’s ability to access capital when needed is not assured and, if not achieved on a timely basis, could materially harm its business, financial condition and results of operations."
https://www.sec.gov/Archives/edgar/data/1571934/000110465920139193/tm2039002d1_10q.htm
Seems to me like they'll raise more funds this year.
Supplements can be helpful if done right. I think covid has been proven to have a more severe effect on vitamin D deficient people, which there are a lot of. The problem is actually finding something good among all the placebos that are being sold everywhere.
That's why doing research before buying is so important.
Regular exercise, intermittent fasting and a good diet will do wonders for your health. Take some multivitamins and nootropics to give your mind and body the nutrients that are missing from your diet.
You can learn a lot just by reading research papers that include the symptoms and diseases you're trying to avoid. There's always some new paper being published that sheds more light on what you're looking for.
I set up a board for PTPI here:
https://investorshub.advfn.com/Petros-Pharmaceuticals-Inc-PTPI-38694/
Doesn't really make sense to discuss it here considering it's basically a new version of Metuchen that has nothing to do with the former Neurotrope business.
Expiry date for all spinoff warrants was extended until December 2025 through the merger agreement. The warrants will definitely dilute shareholders if new results are good and send the stock price soaring over their strike prices.
Maybe they're not relevant now, but that can quickly change 2 years from now.
I hope you're right about the NIH grants being enough, but I have my doubts.