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Who knows how many more billions will be wasted on anti-amyloid drugs if this one is approved...
Say what you will about Anavex, but at least they're not pursuing a strategy that has failed for over two decades now. Hopefully the FDA decides to do what's right and nips this in the bud instead of falling for lobbyist bribes, marketing campaigns and sob stories.
Just updated the ibox with new post-split market information. Let me know if I got something wrong.
"Synaptogenix Announces Plan to Uplist on the Nasdaq Stock Market"
https://www.prnewswire.com/news-releases/synaptogenix-announces-plan-to-uplist-on-the-nasdaq-stock-market-301294928.html
Thanks. That means the minimum price for uplisting will be around $4.29 (to meet market cap requirements)
The real pressure should be above $1.7 and $2.1 where it becomes profitable for investors to sell their shares and exercise warrants. Seems to me like it will fluctuate between $1 and $3 until the next offering.
Filings say 12 months after effective date, so those warrants will probably expire on April 29 next year
True. I could be wrong but my gut feeling is telling me to stay away until next year. I just don't see many reasons for the price to climb while we're still over a year away from results.
Looks like we're having another offering early next year. At current prices that would mean an additional 31,250,000 shares and warrants if they raise $20 million.
I think it makes sense to split it in a way where the minimum bid price ($4) and minimum market cap ($15 million) align.
1-for-3 would mean that a $4 share price equals a market cap of about $18.7 million, and if they use the closing price requirement it can drop to $3.21 and still be eligible.
1-for-4 would mean that a $4 share price equals a market cap of $14 million, which doesn't meet the requirements.
Why delay it? The current price and volume supports a 1-for-3 split and uplisting imo.
New Bloomberg article about aducanumab that includes comments from board members George Perry & Marwan Sabbagh:
https://www.bloomberg.com/news/articles/2021-05-13/alzheimer-s-drug-biogen-hopes-controversial-aducanumab-gets-fda-approval
"The drug may cost $30,000 a year, bringing in $5 billion a year in annual sales, estimates Jay Olson, an analyst at Oppenheimer & Co. who gives the medicine only a one-in-three chance of approval."
While I can't predict the outcome of our current trial, I do think that a high enough difference between patient groups could be worth several billions, based on all these estimates that are given to Biogen and their mixed results. Should be interesting to see how much Biogen's market cap moves after June 7.
Although I don't expect aducanumab to get approved, I did find this part of the article interesting:
"If considering only the successful trial, ICER figured aducanumab’s annual price tag could rise to between $11,100 to $23,100."
https://www.fiercepharma.com/pharma/despite-biogen-s-close-communication-drug-cost-watchdog-hits-alzheimer-s-hopeful-aducanumab
With a price tag like that, you only need about 100,000 patients to start earning billions.
I can't find anything either. My guess is it's the same material as usual since there isn't much new to discuss.
The way I see it there's 4 things left to watch out for this year:
1. Reverse split
2. Uplisting
3. Enrollment complete PR (so we can more accurately estimate when results are out next year)
4. Cash burn / Warrant exercise (so we can more accurately predict when they'll have their next offering)
Probably because the S1 wasn't declared effective until yesterday.
It looked like the latest offering was exempt from registration requirements, but apparently it wasn't, or maybe it was but they decided to register it anyways. Either way, I'm guessing all shares and warrants can be sold now.
Still waiting for that reverse split & Nasdaq uplisting.
Depends on how the market perceives it. A successful Alzheimer's drug is worth several tens of billions, but if the drug is perceived as a failure we won't see a nickel.
The AD companies you see that are worth a billion don't have an approved drug yet and are still in phase 2/3. Remove that risk and you have something worth at least 10x more.
Q4 2022
Which profits? The warrants that were issued in previous offerings are worthless today because the share price is below strike price. Any shares they received were paid for at above market price.
If anything those accredited investors seem to have only lost money so far.
I think that's the point. Dilution will continue until the drug is approved and starts bringing in revenues, and anyone that invests in this company should be aware of that.
Do you think it's wrong to offer free warrants to accredited investors that are risking their money on a company with no revenues?
Something else I noticed in the 10K is that the recent offering is exempt from registration requirements, so I guess I was wrong to expect an S-1 filing.
Trial design was completed a long time ago. 43 out of 100 patients have started their treatment in the new trial and are being monitored by an independent group for statistical imbalances & safety issues, which should remedy the issues encountered in the last trial.
But yes, new results won't be out until late next year and they will probably have to raise more money before then. The only thing that will change short-term is the potential uplisting to Nasdaq, which should bring in more institutional investors.
Synthetic bryo has already been produced and shipped to the company, although I don't think they have announced anything about actually using it yet. Maybe they're already using it, maybe not.
Oral bryo has been tested successfully in mice but it will be a while before it replaces the standard IV version.
No real news about the Fragile X trial or other indications. I don't expect much to happen here anyways considering the limited amount of cash they have. For now it's all about the current AD trial.
Good to see that they're monitoring the groups for imbalances.
"Synaptogenix Announces Phase 2b Bryostatin-1 Clinical Trial Update"
https://www.prnewswire.com/news-releases/synaptogenix-announces-phase-2b-bryostatin-1-clinical-trial-update-301260630.html
The trial may finish in Q3 2022 but we probably won't see results until Q4.
Lots of time left.
New 10K is out:
https://www.sec.gov/ix?doc=/Archives/edgar/data/0001571934/000110465921043923/tm2110636d1_10k.htm
Some noteworthy things I found:
- "As of March 29, 2021, the Company has enrolled 42 patients and has completed contracts with 17 clinical sites that will participate in the current Phase 2 Study."
- "As of March 19, 2021, we had approximately $15 million of available cash and cash equivalents plus funds not yet received from the NIH of approximately $1.7 million."
- "We incurred losses of $15,130,197 and $15,134,750 for the years ended December 31, 2020 and 2019, respectively."
Reverse splits don't affect the financials of a company, so no.
New shares will be issued based on when they need more money to continue their drug development, so I'd say their balance sheets and income statements are the best places to look for this kind of stuff.
Investors usually fund the exercise of their warrants by selling some of the shares they receive from the company. They could obviously just pay the company with their cash, but as far as I know that's not a common thing to do.
Low volume means it will be harder to sell those shares without creating big dips.
Special stockholder meeting moved to April 7:
https://www.sec.gov/Archives/edgar/data/1571934/000110465921035650/tm219311d1_def14a.htm
No need to rush things. The current AD trial won't finish until later next year, so there's plenty of time to make a decision.
See my sticky for a quick summary. More detailed stuff can be found in the ibox and on the board like runncoach mentioned.
Might just be shorts covering their positions. I don't see a reason for why it should stay above $2 once the latest S1 is effective.
Found some research that shows increased effectiveness when encapsulating bryo-1 with nanoparticles:
https://pubmed.ncbi.nlm.nih.gov/33602091/
Lots of potential here for next-gen PKC activators if the current trial goes well.
Not really. It also has anti-inflammatory and anti-depressant effects, promotes proteasome activity and degrades plaques through Neprilysin. Promoting synaptic growth factors is just one of several effects.
If Q3 2022 is the goal then there should be an enrollment complete PR out by mid-December this year.
Once that PR is out I'm setting a countdown timer for 42 + 8 weeks.
I think 2-for-1 is too risky. If the current price drops below $2 they're not getting listed. With a 3-for-1 the current price can drop to $1.34 and still meet the requirements after the reverse split. With a 4-for-1 it can go to $1 and still meet requirements.
I'm leaning more towards a 3-for-1 because of the daily trading volume, but management might see things a different way.
One of the listing requirements is that any OTC stock needs to have a minimum average daily trading volume of 2000 shares, so my guess is the reverse split will be either a 3-for-1 or a 4-for-1.
Anything higher and they risk failing that requirement because of the low daily trading volume. The low volume may also make it difficult for investors to exercise their warrants without significantly moving the stock price.
Special stockholder meeting on April 2 about approving a reverse split (probably in order to meet Nasdaq bid price requirements) and increasing the number of shares available for the grant of awards:
https://www.sec.gov/Archives/edgar/data/1571934/000110465921030144/tm218203d1_pre14a.htm
Maybe you're right. Personally I'm expecting it to dip below $2 because the stock price has a tendency to stay below warrant exercise prices. Not only does the market not care about this company (yet), but now we also have rising bond yields that will add downward pressure to the whole stock market.
I also don't think launching new trials will have any major effect on the price, even though it's a good thing that they start working on additional indications.
I wouldn't be so sure about that pipeline expansion. If the price stays below $2.2 they'll have to raise more cash within a year just to fund the current trial.
The 10K will only include last year's numbers so I'm waiting for their 10Q in May to see what their current cash burn looks like. By then they'll hopefully have completed another reverse split and uplisted to Nasdaq.
28 weeks being the primary endpoint makes this trial a perfect comparison to the Memantine one, but the 42 week visit should teach us a lot about how long those improvements actually last, and could help a lot with the design of the P3 trial. Long-term safety is certainly also important, but this drug has been tested with much higher doses so many times now that I don't think it's a cause for concern anymore.
This trial and the next one will be all about effectiveness and dosing optimization.
I don't think the FDA needs more safety data. That last patient checkup is probably just to make sure all placebo patients have declined far enough.
I'm sure nobody wants another set of results where the placebo group shows improvements over baseline because the trial was too short.