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
