Cassava Sciences Inc (SAVA) Options

Annual meeting notes.
All measures passed.
Decision to close the warrant distributions after conversions dried up. May or may not do another at some point.
735 P3 completers. 20% dropout rate with reasons all over the board (lost their ride, etc.) 90% conversions from P3-blinded to OLE
OLE is very expensive but they're happy to continue it.
Total focus on AD at this point. Research in other areas (cancer, Parkinson's) is on-going but AD is THE THING.

Today 10:00 AM Central
https://apps.computershare.com/MeetingsShareholderWeb/Home?Code=MXKUQLX&Invitation=&Locale=en

WOW! $125M Cash! P3 trials are covered.
Cassava Sciences Announces Over $125 Million Raised from Warrant Distribution

125 million....that's real money. Brilliant strategy from company management it would seem to me. 6ish months to go!

$22 cap removed.

Reports 5/8

Proxy
https://www.cassavasciences.com/static-files/3efd35a5-e3ba-41ea-be8b-a99d20c9c835

Thursday, May 9 10:00 AM Central
https://apps.computershare.com/MeetingsShareholderWeb/Home?Code=MXKUQLX&Invitation=&Locale=en

These PK trial results will be used to complete a section of the NDA.

SAVA will run another Pharmacokinetics (PK) trial for patients with impaired liver function.
A Pharmacokinetic Study of Simufilam in Subjects With Impaired Hepatic Function
Pharmacokinetics (PK) is the study of how the body interacts with administered medications for the entire duration of exposure.

These guys are closer than anyone else in the alternative AD space. They aren't pretending like some thanks to the SPA. let's pray that it's an improvement over current SOC

The cash burn for the two P3 Clinical Trials Is represented by a Bell Curve. The peak of the Bell Curve was reached upon full enrollment in the trials. We are now on the down slope of that P3 cash burn. Patients are completing the P3 trials and transferring to the P3 OLE..

Cassava updated Corporate Presentation.
https://www.cassavasciences.com/static-files/2e5fa90d-4e73-4b96-8d19-57edabe08130

SAVA Clinical Trial Completed April 29. Pharmacokinetics ...
Pharmacokinetics (PK) is the study of how the body interacts with administered medications for the entire duration of exposure. This is closely related to but distinctly different from pharmacodynamics, which examines the drug's effect on the body more closely.
Open-label Study of the Absorption, Metabolism, and Excretion of [14C]-Simufilam Following a Single Oral Dose in Healthy Male Subjects

April Insiders Warrant Transactions.
Richard Barry Director spent $3,873,870 of his own cash to add 176,085 shares to holdings.

Sanford Robertson Director spent $1,518,000 of his own cash to add 69,000 shares to holdings.

James Kupiec CMO spent $33,000 of his own cash to add 1500 shares to holdings.

Eric Schoen CFO spent $33,000 of his own cash to add 1500 shares to holdings.

My thoughts on warrants.
(1) Capped share price at $22
(2) Exercise was not a click away, so they just sat there.
(3) I have no idea how many were actually exercised.

Warrant announcement Apr 15.
https://www.cassavasciences.com/news-releases/news-release-details/redemption-date-announced-warrants

Bonus warrant status page.
https://www.cassavasciences.com/static-files/5b796146-4e6a-41e6-9909-5e084bcacfec

Rumors might be true

If Carl Icahn took stake. This should moon shot.

This thread has some thoughts:
I wonder why $sava is moving the last couple days. High volume move up despite a market that is not up. Shorts always seem to be in the know. It doesn’t seem like a bull trap as those on $sava tend to be a couple hours of action.

I’m wondering if the shorts got a heads up…— Matt Nachtrab (@MattNachtrab) April 9, 2024

>

Why? I don't see any news.

SAVA over $25
And, right now, I'm contemplating the implications of T+1 settlement.

SAVA over $20
Next day settlement begins 5/27 per SEC mandate

Simu safety is well established.
$SAVA has now completed two 6-month-interval safety reviews.
(1) https://www.cassavasciences.com/node/16556/pdf
(2) https://www.cassavasciences.com/node/16851/pdf

Yeah I saw that recently. Going to be close overall top line. Folks will need to understand what to look for with readout. Only 10 months to go!

MILD 71%

https://www.cassavasciences.com/static-files/12519635-9edf-4ac9-93f9-55fbb32d5dc0

Moderate AD will become a thing of the past.

In a 6 page research report today Jones Resrach sets $75 target .
Partial comments include:
2-Year Data Continue to Show Robust Benefits, Primarily
in Mild Alzheimer's Patients
Summary: Cassava announced that mild Alzheimer’s disease patients
who received simufilam continuously for 24 months showed no decline in
cognition scores (ADAS-Cog11) in a two-year open-label safety study (n=47;
press release). As expected and seen in prior data update, the more progressed
moderate patients showed larger decline in cognition scores. Mild AD patients
represented approx. 60% of the enrolled patients in the open label trial, and our
prior conversations with the management indicated similar proportion of mild
AD patients in the two ongoing Phase 3 trials. To put it in context, the large
pharma trials for the approved AD drugs were in even earlier patients, i.e. early
stage AD patients or MCI, with even less disease progression. Management
has previously indicated to us that the Phase 3 trials are powered adequately
to show stat sig if data were to be stratified by mild and moderate AD patient
subgroups.
The open label study enrolled over 200 patients with mild-to-moderate
Alzheimer’s disease, AD (MMSE 16-26) that received 100 mg BID simufilam.
Taking into account that this study is open label and non-randomized for most
parts, we view this data as supportive for the ongoing Phase 3 trials. The safety
profile especially is a major advantage as potential long term treatment with
no drug-related serious adverse events after 24 months of treatment. With low
sales uptake of Leqembi in recent quarter (approx. $7.5mn), we see a clear
market for an effective oral drug with a clean safety profile.
We expect topline results from the Phase3 trials in the next 12-18 months—(1)
YE24: results from the 52-week RETHINK-ALZ trial, and (2) mid-2025: results
from the 76-week REFOCUS-ALZ trial. We note that Cassava previously
announced that 60-70% of study participants entered a Phase 3 study with
mild Alzheimer’s (MMSE 21-27) and the rest entered with moderate Alzheimer’s
(MMSE 16-20) . Both Phase 3 studies received a Special Protocol Assessment
(SPA) from the FDA and the Data and Safety Monitoring Board (DSMB)
recommended that both studies continue as planned, without modification.
Key points from the two-year open-label safety study:
¦ In 47 patients with mild AD who received simufilam continuously for two
years, the average ADAS-Cog showed a change of 0.07 points (± 1.51 SE)
from baseline to month 24. Mean ADAS-Cog scores at baseline was 15.2.
¦ In 40 patients with mild AD who received simufilam non-continuously, the
average ADAS-Cog score declined 1.04 point (± 1.65 SE) from baseline
to month 24. These patients received one year of simufilam, six months
on placebo and six months back on simufilam. Mean ADAS-Cog scores at
baseline was 14.6.
¦ In 32 patients with moderate AD who received simufilam continuously for
two years, the average ADAS-Cog score declined 11.05 points (± 1.91 SE)
Company and Market Data
Symbol SAVA
Price (Feb 6, 2024) $23.66
Market Cap (MM) $998
Enterprise Value $855 MM
Shares/Units Outstanding
(MM) 42.174
Free Float (MM) 38.2
Free Float % 90.6%
52-Week Range $12.32—$32.10
3-Month Avg. Daily Vol. 1,075,492

You're right. I believe the FDA will see the value for mild.

Setting aside it was an open label study with folks promoting the drug on social media in a way that is likely not beneficial, the real problem is the trial design has potentially set the final top line results up for failure. Today's results continued to enforce this thesis. The current trials include patients with MMSE between 16-26. The bottom half of those scores are the moderate ones who scored even worse than what was to be expected (-11) on today's data. We don't know how many will be in each group but it would seem unlikely that even if the mild patient group stabilizes as we saw today, it would overcome the moderate patients in a stat significant way. There is no doubt in my mind that the two groups scores will be broken out in a pre-specified but post hoc fashion that will satisfy many but could be piled on by naysayers and could take awhile for the FDA to sort things out, especially considering it will take the 2nd trial an additional 6 months to complete.

I am hopeful that the mild group is highly stat significant and that the FDA will allow SAVA to go down this path since there are nearly 2000 patients total in the 2 trials, making the mild group significant in numbers. Will be interesting to see how it plays out. JMHO

Ha, I think you're right.

Doesn't almost everyone that gets AD start out as "mild"?

IMO, mild AD patients will now have a way out of this disease. So yeah.

That seems like great news, correct?

Saw this. It still makes me question the recruitment of the current trial. Hopeful that there are enough patients on the milder scale to get the job done.

In case you're wondering?
No Decline in Cognition Scores in Patients with Mild Alzheimer's Disease Who Received Simufilam Continuously For 24 Months
https://www.sec.gov/Archives/edgar/data/1069530/000117184324000648/exh_991.htm

I'm still holding. Volume went high (1-4M) for the first few days. Much less now..

Has anyone paid for the warrants or maybe sold some? I personally have converted the warrants to shares. I only had 48 which turned to 72 shares. I bought 30 shares the day it dropped but it was the day before the warrants cutoff date, so I didn't get any warrants for those shares. O well, my bag. Anyway, just wondering if anyone else has done this. Alot of people on Yahoo board are claiming they are still holding and waiting or turned their warrants into shares. Many are claiming to wait and see what the board members are doing with their warrants. GLTA

Risky;over priced and infusions are time consuming ,create lots of plastic waste going into landfills. SAVA has a much better alternative

Biogen is pulling the plug on its Aduhelm (Aducanumab) Alzheimer’s disease drug.
https://www.google.com/search?q=Aduhelm

Thank you.i have seen that but hard to know if true and why aren’t there a lot more???

Yeah I don't like to see stuff like this at all but I sure pray the the drug is beneficial!

This is a YT compilation of some anecdotal testimonials.

I'm a skeptic regarding this type of data but here it is.

Bonus Warrant Status Page:
https://www.cassavasciences.com/static-files/5b796146-4e6a-41e6-9909-5e084bcacfec

SHORTS have to purchase 5,554,850 warrants on the open market.

As of Jan 1, 2024 $SAVA short count was 13,887,126 shares*
OWNERS of 10 $SAVA shares have rights to 4 warrants. **
(13,887,126 x 0.4) = 5,554,850

It's hard out here for the SHORTS.

* https://www.nasdaq.com/market-activity/stocks/sava/short-interest
** https://www.sec.gov/Archives/edgar/data/1069530/000149315224000298/form424b2.htm

SAVAW on reg sho list. Can you say SQUEEEEEEZE?
https://www.nasdaqtrader.com/trader.aspx?id=RegSHOThreshold

Next week will be $10+. GL

Nice

Warrants did well today.
SAVAW $7.30 +3.30 (82.5%)