On November 7, 2022 Cassava Sciences, Inc. (Nasdaq: SAVA), a clinical-stage biotechnology company focused on Alzheimer’s disease, reported financial results for the third quarter ended September 30, 2022 and provided a clinical update on its Phase 3 clinical program of simufilam in Alzheimer’s disease (Press release, Pain Therapeutics, NOV 7, 2022, View Source [SID1234623269]). Simufilam is Cassava Sciences’ lead drug candidate for the proposed treatment of Alzheimer’s disease.

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"The clinical development of oral simufilam for Alzheimer’s disease continues to make headway," said Remi Barbier, President & CEO. "We now have over 650 patients enrolled in our on-going Phase 3 studies of simufilam in Alzheimer’s disease, up from 150 patients approximately six months ago. We also look forward to presenting new clinical data for simufilam from two other ongoing studies in Alzheimer’s disease."

Net loss for third quarter 2022 was $20.3 million, or $0.51 per share, compared to a net loss of $9.6 million, or $0.24 per share, for the same period in 2021. Net cash used in operations was $56.2 million during the first nine months of 2022. Net cash use for operations for full-year 2022 is expected to be approximately $80 to $90 million, consistent with previous guidance. Cash and cash equivalents were $174.7 million as of September 30, 2022, with no debt.

Financial Results for Third Quarter 2022

At September 30, 2022, cash and cash equivalents were $174.7 million, with no debt.
Net loss was $20.3 million, or $0.51 per share. This compares to a net loss of $9.6 million, or $0.24 per share, for the same period in 2021. Net loss increased compared to the prior period due primarily to a significant increase in our R&D activities for a Phase 3 program of simufilam in Alzheimer’s disease.
Net cash used in operations was $56.2 million during the first nine months of 2022.
Net cash use in operations for full year 2022 is expected to be approximately $80 to $90 million, consistent with previous guidance.
Research and development (R&D) expenses were $18.5 million. This compared to $8.0 million for the same period in 2021. R&D expenses increased compared to the prior period due primarily to increased activities and expenses related to clinical and pre-clinical studies and support functions.
General and administrative (G&A) expenses were $2.8 million. This compared to $1.7 million for the same period in 2021. G&A expenses increased compared to the prior period due primarily to increased activities and expenses related to legal services as well as depreciation and amortization.
Overview of On-going Phase 3 Clinical Program
Cassava Sciences’ Phase 3 program consists of two randomized controlled trials of oral simufilam in patients with mild-to-moderate Alzheimer’s disease. The two studies are named RETHINK-ALZ and REFOCUS-ALZ. In 2021, both studies received Special Protocol Assessments (SPA) from the U.S. Food and Drug Administration.

Over 650 patients are now enrolled in our Phase 3 studies. Studies are being conducted in over 100 clinical trial sites across the U.S., Canada, Puerto Rico, South Korea and Australia.

Cassava Sciences’ RETHINK-ALZ Phase 3 study is designed to evaluate the safety and efficacy of oral simufilam 100 mg in enhancing cognition and slowing functional decline over 52 weeks. This randomized, double-blind, placebo-controlled study plans to enroll approximately 750 patients with mild-to-moderate Alzheimer’s disease. Patients are randomized (1:1) to simufilam 100 mg or matching placebo twice daily.

Cassava Sciences’ REFOCUS-ALZ Phase 3 study is designed to evaluate the safety and efficacy of oral simufilam 100 mg and 50 mg over 76 weeks. This randomized, double-blind, placebo-controlled study plans to enroll approximately 1,000 patients with mild-to-moderate Alzheimer’s disease. Patients are randomized (1:1:1) to simufilam 100 mg, 50 mg, or matching placebo twice daily.

Both of Cassava Sciences’ Phase 3 studies have the same co-primary efficacy endpoints: ADAS-Cog12 (a cognitive scale) and ADCS-ADL (a functional scale). A secondary efficacy endpoint is iADRS, a clinical tool that combines cognitive and functional scores from ADAS-Cog & ADCS-ADL.

Open-label Study – closed enrollment
In March 2020, we initiated a long-term, open-label study to evaluate simufilam, our lead drug candidate, in patients with mild-to-moderate Alzheimer’s disease. The study is intended to monitor the long-term safety and tolerability of simufilam 100 mg twice daily for 12 or more months. The open-label study has reached its final target enrollment of approximately 200 patients with Alzheimer’s disease. We expect to announce open-label study results approximately yearend 2022, consistent with our prior guidance.

Cognition Maintenance Study (CMS) – on-going
In May 2021, we initiated a Cognition Maintenance Study (CMS). This is a randomized, double-blind, placebo-controlled study of oral simufilam in patients with mild-to-moderate Alzheimer’s disease. Patients are randomized (1:1) to simufilam 100 mg or matching placebo twice daily for six months. To enroll in the CMS, patients must have previously completed 12 months or more of open-label treatment with simufilam. The CMS is designed to evaluate simufilam’s effects on in Alzheimer’s patients who continue with drug treatment versus patients who discontinue drug treatment. Over 100 patients are now enrolled in the CMS and over 65 patients have completed this study. We expect to announce CMS study results approximately Q3 2023, consistent with our prior guidance.

SavaDx – on-going
This earlier-stage program refers to the detection of Alzheimer’s disease with a simple blood test. SavaDx was initially designed as an antibody-based detection system for altered filamin A (FLNA). We are currently evaluating a new approach—based on mass spectrometry—to detect FLNA in plasma without the use of antibodies. Mass spectrometry is an analytical tool that measures the mass-to-charge ratio (m/z) of a molecule present in a sample.

About Simufilam
Simufilam (sim-uh-FILL-am) is Cassava Sciences’ proprietary, small molecule (oral) drug 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.