Cassava Sciences Inc (SAVA)

[FooBarAndGrill]

Almost any clinical will yield some super-responders. Even existing treatments like Aricept have great results with a few people. It just doesn't mean much to the big picture.
That said, I occasionally see some 2nd-hand stories on different platforms such as Twitter and Reddit.

[ranchhand71]

With more than 1000 families having a loved one in trials why are we not hearing anecdotal evidence or comments about progress?

[FooBarAndGrill]

Another update on clinicaltrials.gov yesterday.
The Phase III OLE trial (NCT05575076) is enrolling by invitation. The number of sites participating in this OLE increased from 57 to 83. This is good.

[runncoach]

Thx

[FooBarAndGrill]

Appointed Three New Members Board of Directors
Claude Nicaise, MD ... Pierre Gravier, MS ... Robert Anderson, Jr
https://www.cassavasciences.com/news-releases/news-release-details/cassava-sciences-appoints-three-new-members-its-board-directors

[FooBarAndGrill]

Yeah, so ... The same could be said for other companies we hold.
Anyway, I enjoy the up days and this is one of them. Positive news.

[runncoach]

Any news of why it's up almost 20% today?

[georgejjl]

Unfortunately Remi Barbier is still the Company’s founder, has served as President, Chief Executive Officer and Chairman of the Board of Directors.

[runncoach]

I'm always hopeful in all these alternative plays as the SOC plaque attack drugs aren't worth the money

[grich1]

Thanks, they are really hopeful since
Buntanetap is the only drug to attack multiple neurotoxic proteins.

Best wishes to you.

[runncoach]

I had researched them in the past. In theory I liked their story about synaptic health and how the drug potentially worked. Preclinical it had a secondary impact on PKCe and Hgf and as you know, this is something I have researched. When I looked at details of how they were running their clinical trials I had concerns about the memantine free period before dosing so have never bought in. I still think they have a shot but maybe longer than I first thought. Of course at current prices it may be a better gamble than in the past.

I still follow the sector but I'm just not seeing a revolutionary treatment at this time. Doesn't mean none of these will have limited success, or potential approvals in some groups, or nice sales, or even make shareholders good money. I've been hoping for a true game changer and I don't currently see one. JMHO

[grich1]

Have you looked at Annovis bio?

[runncoach]

Quite a swing

[FooBarAndGrill]

It's a good day to cover.

[FooBarAndGrill]

November Corporate Presentation.
Cassava Nov update
I'm pleased the company is using this as a living document.

[FooBarAndGrill]

I have no idea. With approval comes reality.
The stock changes from a speculative play to a revenue generator.
Earnings, expenses, partnerships and buyouts are all on the table.

[Lvogel]

I am hearing that SAVA could have the best drug for the Alzheimers in the near term, 1 more year if approved. What would be an estimated PPS on the day FDA approves Simufilam if this were to happen at the end of next year? Thanks

[FooBarAndGrill]

Q3 10-Q
Cash burn $7.5M/Month. Cash $142M.

[runncoach]

Yeah it's hard to wait them out. Looks like 12-15 months

[HANUMAN]

Thanks. I got burned on SNPX, so gonna wait this one out.

[FooBarAndGrill]

Two P3 studies. The 76-week just filled enrollment. The 52-week has been full for a few weeks.
The 52-week October 2024.
The 76-week May 2025

[runncoach]

Nice

[HANUMAN]

How long is this study?

[FooBarAndGrill]

Full Enrollment. 1,929 patients randomized.
Cassava Sciences Completes Enrollment for Pivotal Phase 3 Program of Simufilam in Alzheimer’s Disease

[FooBarAndGrill]

Welcome sir. IMO, the 6-mo randomized withdrawal results are as expected.

[Doc328]

Thanks for posting the CTAD slide link
There is also a youtube video of the presentation. Since the stats were standard (not requiring a statistician to explain), a presentation by a clinician may have been better. Platform sessions are always difficult as one usually has 10-12 minutes to present followed by 3 minutes of Q/A. Therefore a lot gets glossed over.

Data out to 18 months is very useful but until the large P3s come out we have more questions than answers. I'll add a few thoughts/comments (I will probably end up annoying both the longs and the shorts)

The study presented has an unusual protocol. All 216 patients received simufilam x 12 months. The 157 patients remaining were then split to receive simufilam OR placebo for the next 6 months. 133 of these patients were available for 18 month analysis. Patients were evaluated as the entire population (2 groups - 12 month simu/6 mo placebo vs 18 month simuilam) or further split into mild and moderate to 4 smaller groups (mild 12/6, mild 18, mod 12/6 and mod 18). All remaining patients are eligible for 6 more months simufilam. The thought is that if simufilam is a symptomatic drug, the M12-M18 placebo patients will lose ground to the patients on drug the whole 18 months. If simufilam is disease modifying they won't lose ground.

To me, the data that is most favorable is that the MILD patients were stable the whole 18 months - about 1/2 would have improved the ADAS-Cog score. Obvious caveats include open label, small n, were patients going downhill withdrawing more than the stable patients, etc. Additionally, the entry criteria did not require proof of amyloid --- meaning about 20-25% of patients may not have had AD. AF jumped on this fact. Highlighting the issue (slide 17) is that the mild patients included patients with normal MMSE (27-30) and normal ADAS-Cog (0-10).

Moderate patients did not fare as well. They may have done a little better than historical but by the time you throw in open label (matters less in mod than mild), small n, entry criteria, etc no conclusion about efficacy in this population is possible. That's ok - the new anti-amyloid mAbs are approved only for amyloid proven MCI and Mild AD. What troubles me is that the moderate population is included in the 2 Phase 3's and potentially could dilute efficacy data. My hope would be that the SAP has been changed to put mild amyloid positive patients at the top of the statistical hierarchy and total population further down. If indeed this change has been made, they need to be clear now to avoid claims of cherry picking after the P3s are analyzed.

I think the n is too small and entry criteria too liberal to determine whether a disease modifying effect has actually occurred - In reality this is very difficult to prove.

As far as AF, I think pointing out the issues with the entry criteria is valid. However, his calls to stop the P3 studies due to this issue and Dr. Wang are silly and hurts his credibility. If anything the results presented offer just enough hint of efficacy to add more excitement to the P3 results to be presented at the end of 2024. Also note that the P3s have an SPA with the FDA, have standard proof of amyloid entry criteria, standard endpoints, have large n and reasonable duration (one is 12 months and one is 18 months). I would have preferred ADAS-13 over -12 as slightly better in the mild AD population.

Educational note about ADAS-Cog: This test has gone through multiple revisions with most recent ones trying to improve sensitivity to measure change over time in MCI/mild patients. All revisions are downward compatible (you can derive ADAS-Cog 11 from -13 as the difference is 2 additional tests). Adas-Cog-11 has a range of 0-70, ADAS-Cog 12 a range 0-80 and ADAS-Cog 13 a range 0-85a and ADASCog 14 is range 0-90. The additional 'points' are more sensitive to MCI and Mild AD change over time. This is one reason why entry ADAS-Cog differs from study to study (i.e in the simufilam P2 mild average aDAS-Cog11 was 11 and in the AVXL study entry average was 29 on Adas-Cog13 and lecanemab was 24 on the Adas-Cog 14)

[BoilerRoom]

$SAVA $$$$$$$$

[tredenwater2]

Is the powers to be readying his stock for another secondary offering or are they prepping the price for a buyout incase the unblinded TLR data comes in successful?

Whoever it is doing the “tankdown” they are very patient and coordinated as they have dropped the whole sector.

[FooBarAndGrill]

Currently reading this Research Report.
Alzheimer's Disease State of Play with Focus On Similarities Between Mechanisms of Action of NE3107, XPRO, SIMUFILAM AND COYA 301/302

[FooBarAndGrill]

It's hard out here for a short.
https://www.iborrowdesk.com/report/SAVA

[FooBarAndGrill]

Oct corp presentation plus all CTAD slides and posters.
https://www.cassavasciences.com/company-presentations

[Hoskuld]

Yes I saw that - excellent presentation. The numbers seem pretty terrible though.

[FooBarAndGrill]

Here is the slide deck.
https://www.cassavasciences.com/static-files/2275022c-b8db-4f1a-8c34-ebe389e1f239

[Hoskuld]

The separations between placebo and drug groups for mild (especially) and for moderate were very small. Let’s hope the P3 trials with their much higher N’s and longer duration will show both separation and stat sig. The presentation was largely marketing but the numbers themselves were not great.

[FooBarAndGrill]

Suzanne Hendrix presenting at CTAD today. I expect straight talk no BS.

[runncoach]

Of course it is and most DON'T know it. It's also beneficial when recruiting for these trials as well. Evidently the market thought it was important as well, even if most of those on this board knew it already.

[FooBarAndGrill]

re. "One would expect that aria would only be an issue for mAbs."
For a patient or a caregiver, this is good to know, don't you think?

[Hoskuld]

It doesn't really. You could claim carrots don't cause safety issues...but they are not proven to help slow dementia, either. The ARIA issue was a silly one to highlight. But, it wasn't bad news at any rate.

[runncoach]

It certainly differentiates it in the safety department from any approved drug. Not everyone understands the MOAs of each of the drugs but knowing its safe is important to most. Nice 50% bump of the bottom! Probably not going to be greedy here

[Hoskuld]

One would expect that aria would only be an issue for mAbs. This is kind of like having a house painted white and pointing out that it isn’t red.

[FooBarAndGrill]

MRI Safety Poster looks good too.
https://acrobat.adobe.com/link/track?uri=urn%3Aaaid%3Ascds%3AUS%3A954d0240-d919-4022-8174-fa3026f6a2c9

[PiperC.MD]

10/27/23 will be a great day. Suzanne Hendrix is respected in the ALZ community and will be presenting MRI data for CMS study. You cannot refute this type of data hang tight.

[crescentmotor]

SAVA legal filing with demands on CUNY.

This is a blistering response to the leaked committee document setting forth SAVA's demands. CUNY can no longer hide in corner and sweep this matter under a rug.

[McMagyar]

Kids this looks quite promising..

[elmasry]

I think it will go down below 10 soon

[Monksdream]

SAVA New 52 week low

[joyceschoice]

SAVA Company response

https://www.globenewswire.com/news-release/2023/10/13/2759741/8339/en/Statement-by-Cassava-Sciences-Regarding-an-Internal-CUNY-Report-Leaked-to-the-Press.html

[TRADER99]

I was told to buy this one yesterday in a WhatsApp stock group lol. Of course I didn't but looks like it was a mini pump and dump

[joyceschoice]

Interesting. Not much discussion here about the events of this evening. I'm curious to see what happens tomorrow.

[runncoach]

Thats why I almost bought back in for a quick trade before the bounce back above 12. You have to figure more insider purchases on the way but price has to be lower than 12 for me. Jmho