Benzinga | Mar 23, 2021 08:39AM EDT

Cassava Sciences Says Plans To Initiate A Randomized, Placebo-Controlled Cognition Maintenance Study In Alzheimer's Disease

Cassava Sciences, Inc. (NASDAQ:SAVA), a clinical-stage biotechnology company focused on Alzheimer's disease, today announced financial results for the year ended December 31, 2020 and provided business updates. Unaudited cash and cash equivalents were approximately $280 million as of February 2021.



"In Q1 2021 we announced that our lead drug candidate, simufilam, improved cognition scores in 50 patients with Alzheimer's disease who completed at least 6 months of open-label treatment," said Remi Barbier, President & CEO. "In mid-2021, we look forward to announcing cognition scores in patients who'll have completed at least 12 months of open-label treatment with simufilam. To our knowledge, no drug has stabilized, much less improved, cognition scores over 12 months in patients with Alzheimer's disease. For this reason, I feel there is a sense of anticipation around the upcoming release of 12-month clinical data from our open-label study, as well as our plans to conduct a pivotal Phase 3 program with simufilam in the second half of 2021. With solid science, the right people in place, cash in the bank and a clinical roadmap that makes sense, I think Cassava Sciences is positioned to becoming a premier organization to serve patients with Alzheimer's disease."

"We have approximately $280 million in cash on our balance sheet, against expected cash use of approximately $20 to $25 million in 2021," said Eric Schoen, Chief Financial Officer. "We believe our cash levels support a pivotal Phase 3 clinical program of simufilam in Alzheimer's disease."

Cassava Sciences remains on-track to initiate two pivotal Phase 3 studies in second half of 2021. In mid-year 2021, the Company also plans to initiate a randomized, placebo-controlled cognition maintenance study in patients with mild-to-moderate Alzheimer's disease. Expected milestones for 2021 appear below.

Summary of Expected Milestones for 2021

Milestone Anticipated Timing * End-of-phase 2 (EOP2) meeting with FDA to gain general agreement around a Phase 3 clinical development program Completed Q1 2021 in Alzheimer's disease dementia.

* Announce cognition scores from a pre-planned interim analysis (6-month data) of an ongoing, open-label study Completed Q1 2021 of simufilam in Alzheimer's disease.

* Announce results of EOP2 meeting with FDA. Completed Q1 2021

* Announce long-term, large-scale drug supply agreement for simufilam with contract manufacturer (Evonik). Completed Q1 2021

Announce cognition scores of a pre-planned interim analysis(12-month data) of an ongoing, open-label study of simufilam Mid-2021in Alzheimer's disease.Initiation of a Cognition Maintenance Study (CMS) withsimufilam ? randomized, placebo-controlled design in Mid-2021Alzheimer's patients.Manufacture large-scale Phase 3 clinical trial supplies. Ongoing, rolling basisInitiation of a first Phase 3 study of simufilam -- 18-month, Q3 2021approx. 1,000+ patients with Alzheimer's disease.Initiation of a second Phase 3 study of simufilam -- Q4 202112-month, approx. 600+ patients with Alzheimer's disease.Complete patient enrollment of an on-going, open-label study Ongoing, rollingof simufilam in Alzheimer's patients. basisPublication of Phase 2b results in peer-reviewed journal. 2021Initiate validation study with SavaDx ? blood-based 2021diagnostic to detect Alzheimer's disease.

Net cash use in 2021 is expected to be driven by higher headcount and personnel expenses, manufacturing costs around large-scale drug supply, professional services expenses related to clinical programs, and operating costs such as insurance, office space and IT related expenses.

Full Year 2020 Financial Results: Net loss in full-year 2020 was $6.3 million, or $0.24 per share, compared to a net loss in 2019 of $4.6 million, or $0.27 per share. Net cash used in operations in full-year 2020 was $5.4 million. Cash and cash equivalents were $93.5 million as of December 31, 2020. Unaudited cash and cash equivalents were approximately $280 million as of February 2021, including net proceeds of approximately $189.7 million from the sale of 4.1 million shares of common stock completed February 12, 2021.