On February 28, 2023 Cassava Sciences, Inc. (Nasdaq: SAVA), a clinical-stage biotechnology company focused on Alzheimer’s disease, reported financial results for the year ended December 31, 2022, and provided operating updates. Simufilam is Cassava Sciences’ oral drug candidate for the proposed treatment of Alzheimer’s disease dementia (Press release, Pain Therapeutics, FEB 28, 2023, View Source [SID1234627871]).
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"Setting aside headwinds, 2022 was highlighted by positive developments with patient enrollment in our Phase 3 clinical studies of simufilam in Alzheimer’s disease", said Remi Barbier, President & CEO. "Over 1,000 patients with Alzheimer’s are now enrolled in these two studies. By year-end 2023, we expect to reach our enrollment target of approximately 1,750 patients for the Phase 3 studies. Recently, we announced top-line results for an open-label study. In this study, over 200 mild-to-moderate Alzheimer’s patients were treated with simufilam for a year. Simufilam was well-tolerated, 47% of patients improved on ADAS-Cog scores over 12 months and an additional 23% of patients declined less than 5 points on ADAS-Cog. I believe these are noteworthy trial results, even as I am keenly aware that the gold standard in Alzheimer’s research requires results from randomized, controlled studies."
Alzheimer’s disease is a major public health issue. It imposes an immense burden on patients, their families and caregivers. Anti-amyloid antibody drugs that have received FDA approval are a step in the right direction. But by themselves, anti-amyloid drugs may not be enough for patients. Anti-amyloid drugs can slow cognitive decline modestly, but they can also cause brain bleeds in elderly patients, they require monthly trips to the local infusion center and periodical monitoring with MRI, they’re expensive and they lack Medicare coverage because they bypassed the full FDA approval process. Patients have waited many years for anti-amyloid drugs to be FDA-approved. Now that the wait is over, Cassava Sciences sees an even greater need to develop the next generation of innovative treatments, even if some of these potential treatments challenge scientific orthodoxy.
"It’s the spirit of innovation and our intense desire to help patients and their families that fuels our drive to develop simufilam as an oral drug candidate for people with Alzheimer’s disease," said Remi Barbier.
Cassava Sciences’ Scientific Goals for 2023
In Q2 2023, we expect to complete patient dosing for our on-going Cognition Maintenance Study, in which over 100 patients with mild-to-moderate Alzheimer’s disease are randomized (1:1) to simufilam or placebo for six months.
In Q3 2023, we expect to announce top-line results of the Cognition Maintenance Study.
In Q4 2023, we expect to complete patient enrollment for both of our Phase 3 studies.
Mid-year 2023, we expect an independent, third party to present evidential data for the biological activity of simufilam outside the field of neurodegeneration.
Mid-year 2023, we expect an independent, third party to generate new data for SavaDx using mass spectrometry.
Financial Highlights
At December 31, 2022, cash and cash equivalents were $201 million, compared to $233.4 million at December 31, 2021, with no debt. Year-end cash balance included net proceeds of $47.3 million from the sale of 1.7 million shares of common stock completed in November 2022.
Net cash used in operations full-year 2022 was $77.5 million, net of reimbursements received from National Institutes of Health (NIH) grant awards.
Net cash use for operations for the first half of 2023 is expected to be approximately $45 to $50 million, driven primarily by expenses for our clinical program in Alzheimer’s disease.
Research and development (R&D) expenses for the year ended December 31, 2022 were $68.0 million compared to $24.8 million for the same period in 2021. This increase was due primarily to costs to conduct the ongoing Phase 3 clinical program in simufilam, costs of an ongoing cognition maintenance study and open-label study in simufilam, and costs related to manufacture of clinical trial supplies, as well as increased pre-clinical study and personnel expenses compared to the prior year. These expenses are net of grant funding received from NIH, which is recorded as a reduction in R&D expenses.
Research grant funding reimbursements of $0.9 million were received from NIH and recorded as a reduction in R&D expenses. This compared to $3.9 million of NIH grant receipts received for 2021.
General and administrative (G&A) expenses for the year ended December 31, 2022 were $12.0 million compared to $8.1 million for 2021. This increase was primarily due to higher legal fees, personnel costs, insurance costs and depreciation and amortization as compared to 2021.
Ongoing Phase 3 Studies with Simufilam
Cassava Sciences is currently evaluating simufilam tablets for Alzheimer’s disease dementia in two Phase 3 clinical studies. These are 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. The Phase 3 studies are actively recruiting Alzheimer’s patients in over 100 clinical sites in the United States, Canada, Puerto Rico, South Korea and Australia.
About Simufilam
Simufilam (sim-uh-FILL-am) is the chemical name for Cassava Sciences’ proprietary, small molecule (oral) drug candidate that restores the normal shape and function of altered filamin A (FLNA) protein in the brain. Cassava Sciences owns worldwide development and commercial rights to its research programs in Alzheimer’s disease, and related technologies, without royalty obligations to any third party.