First time poster (and technically, bag holder of 300 shares at a cost basis of $49.40). Cassava Sciences Inc is a clinical-stage biotechnology company engaged in developing a scientific approach for the treatment and detection of Alzheimer’s disease.
Family history of Alzheimer’s and after seeing my father pass away from it, I greatly fear coming down with it myself.
I think Cassava’s Alzheimer’s drug (simufilam) will be world changing and it looks like insiders also have conviction in the company. Yesterday (Aug 16), one of their independent directors purchased 100k shares at $20.69/share and the CFO purchased 2,500 shares AND it is up almost 20% in premarket today.
Over the last year, there’s been a lot of controversy regarding a citizen’s petition by short holders, investigation by CUNY about ink blots, etc. HOWEVER, they are currently in two Phase 3 trials with over 400 subjects, have an open label study in progress with over 200 subjects with an expectation of announcing top line results at year end for that one, and are targeting over 100 subjects for a randomized, placebo controlled cognition maintenance study with results expected in 2023Q3.
I don’t have a price target on this long term but could see this easily going to into the hundreds with good results from the studies/trials.
I don’t expect them to be profitable for a while. I agree on your thoughts about the chart, and their big news was the hiring of a new general counsel (which is a new position, they didn’t have one before.)
Still patiently waiting for an update on the trials. (Did you see what I did there - feeling very punny.)
The open-label study completed, it was for ~200 people over 12 months, with 2 doses administered daily. Due to all the chicanery that went down with this stock over the last 2 years, the firm is hiring outside biostatisticians with specific expertise in Alzheimer’s disease to analyze the dataset. It is expected the results will be available around year end.
The CEO said “We are thrilled with the progress made to date in the clinical development of simufilam, our oral drug candidate for people with Alzheimer’s disease” which makes me feel the results are positive.
Lastly, the company has over 750 (out of a total 1700) patients enrolled in phase 3, which is randomized, double-blind, placebo-controlled study.
Most recent update from the company:
Their CMO passed away.
Over 800 patients are now enrolled in Phase 3 studies of simufilam in Alzheimer’s disease dementia. (This is up from 750 last month).
Open label study of ~200 patients; Data release expected 2nd half January 2023, pending completion of an independent statistical analysis on the clinical dataset.
As of August 3, 2023:
Over 1,587 patients with mild-to-moderate Alzheimer’s disease are now enrolled in a Phase 3 program of simufilam, an increase of over 340 patients in the last three months. The target enrollment is approximately 1,750 patients. Cassava Sciences expects to complete patient enrollment for its Phase 3 program in Q4 2023.
On-going Phase 3 Studies with Simufilam
Cassava Sciences is currently evaluating oral simufilam for Alzheimer’s disease dementia in two Phase 3 clinical studies. These are large, randomized, double-blind, placebo-controlled trials. The Phase 3 program is recruiting a total of approximately 1,750 patients with mild-to-moderate Alzheimer’s disease who also meet other study eligibility criteria. Both Phase 3 studies have received a Special Protocol Assessment (SPA) from the U.S. Food and Drug Administration. Our Phase 3 studies recruit Alzheimer’s patients in clinical sites in the United States, Canada, Puerto Rico, South Korea and Australia.
SAVA announced a significant safety finding based on interim magnetic resonance imaging (MRI) brain data from Alzheimer’s patients who are enrolled in a Phase 3 clinical trial of simufilam. The MRI data suggest simufilam is not associated with treatment-emergent amyloid-related imaging abnormalities, or ARIA. MRIs were all analyzed for ARIA by board-certified neuroradiologists. Shares closed up 21% at $2.83.
