Exciting Update from Cassava Sciences

Key data from the REFOCUS-ALZ Phase 3 study of simufilam in patients with mild to moderate Alzheimer’s disease expected by end of first quarter/early second quarter of 2025.

Implementation of cost reduction measures, including a workforce reduction of approximately 33%.

Approximately $128.6 million in cash and cash equivalents as of December 31, 2024 (unaudited).

AUSTIN, Texas, January 7, 2025 (GLOBE NEWSWIRE) — Cassava Sciences, Inc. (NASDAQ: SAVA, “Cassava”, the “Company”), a clinical-stage biopharmaceutical company focused on developing innovative treatments for diseases of the central nervous system, including Alzheimer’s dementia, today provided an update on its activities.

In November 2024, Cassava announced that preliminary results from the Phase 3 RETHINK-ALZ study, evaluating simufilam as a potential treatment for patients with mild to moderate Alzheimer’s disease, did not meet primary endpoints predefined. The Company has expressed its intention to share a detailed analysis of the data at a future medical meeting. It also confirmed its plan to stop the phase 3 REFOCUS-ALZ study as well as the open-label extension study and to analyze all 52-week data from the REFOCUS-ALZ study, in addition of a large part of the data over 76 weeks. The Company plans to complete this work and announces the publication of preliminary results from REFOCUS-ALZ by the end of the first quarter or the beginning of the second quarter of 2025.

Today, the Company announced that it will reduce its workforce by 10 employees, or approximately 33%, during the first quarter of 2025, while continuing its strategic expense management efforts. These cost reductions include discontinuation of biomarker analysis for additional plasma samples from previous Phase 2 studies. The Company estimates that one-time costs of approximately $0.4 million will be incurred in the first quarter of 2025 in link with workforce reduction.

The Company’s cash and cash equivalents balance as of December 31, 2024 was approximately $128.6 million.

“Cassava remains committed to achieving its mission of developing innovative medicines for central nervous system disorders and improving shareholder value. We are in the final stages of winding down the REFOCUS-ALZ study and plan to report preliminary results by the end of Q1/beginning of Q2 2025. We also continue to carefully review data from the RETHINK-ALZ study. ALZ and intend to integrate the results of the REFOCUS-ALZ study into our assessment of next steps for Cassava. In this context, after the announcement that the RETHINK-ALZ study did not achieve its main objectives and that the REFOCUS-ALZ and Open Label Extension studies will be interrupted, we believe that it is wise to implement additional cost-saving measures, including a reduction in headcount,” said Rick Barry, President and CEO. “Cassava is a close-knit organization, and I would like to thank each of our employees affected by this reduction. We recognize and appreciate your dedicated service to Cassava’s mission, our clinical programs, and Alzheimer’s patients.”

About RETHINK-ALZ

RETHINK ALZ (NCT04994483) is a phase 3 trial designed to evaluate the safety and effectiveness of simufilam compared to placebo in a multicenter, double-blind, placebo-controlled study involving more than 75 clinical trial sites in the United States, Canada and Australia. The trial randomized 804 people with confirmed mild or moderate Alzheimer’s disease, defined by several well-validated parameters, including a mental state examination (MMSE) greater than 16 and less than 27, stratified by gravity. Subjects were randomized 1:1 to receive one 100 mg simufilam tablet (n=403) or matching placebo (n=401), dosed orally twice daily (BID) for 52 weeks. On November 25, 2024, the Company reported that the RETHINK-ALZ study did not meet the primary study endpoints. The Company also indicated its intention to fully analyze the results and share the data at a future medical meeting.

The primary endpoints of this trial included cognitive and functional change from the start to the end of the double-blind treatment period at 52 weeks, assessed by the ADAS-COG12 and ADCS-ADL scales, comparing simufilam to placebo. Secondary outcomes included several well-validated measures of neuropsychiatric symptoms and caregiver burden. Safety was assessed through adverse event monitoring, as well as standard laboratory assessments and ECGs. The study also included a pharmacokinetic and plasma biomarker substudy consisting of approximately 100 subjects, evaluated at three different time points. RETHINK-ALZ was conducted under a Special Protocol Assessment (“SPA”) with the Food and Drug Administration (“FDA”).

About REFOCUS-ALZ

REFOCUS-ALZ (NCT05026177) is a phase 3 trial designed as a multicenter, double-blind, placebo-controlled, randomized, parallel-group study to evaluate the safety and efficacy of two doses of simufilam compared to placebo, involving more than 75 clinical trial sites in the United States, Canada, Puerto Rico and South Korea. The clinical trial sites that conducted REFOCUS-ALZ were completely separate from those that conducted RETHINK-ALZ. REFOCUS-ALZ randomized approximately 1,125 people using the same eligibility criteria as RETHINK-ALZ. Subjects were randomized 1:1:1 to receive simufilam, dosed as 50 mg or 100 mg tablets, or matching placebo, dosed orally twice daily (BID) for 76 weeks. The Company announced on November 25, 2024 its intention to discontinue the REFOCUS-ALZ study and plans to release preliminary data from this trial, including all 52-week data and a large portion of the 76-week data. The Company expects to report preliminary data for this study by the end of the first quarter/beginning of the second quarter of 2025.

The primary endpoints of this study included cognitive and functional change from the start to the end of the double-blind treatment period at 76 weeks, assessed by the ADAS-COG12 and ADCS-ADL scales, comparing each dose of simufilam to placebo. . Secondary outcomes included various well-validated measures of neuropsychiatric symptoms and caregiver burden. Safety was assessed by adverse event monitoring, as well as laboratory standards and ECG assessments. The study also included assessment of changes in plasma and cerebrospinal fluid biomarkers from baseline to week 76, including P-tau181, P-tau217, and neurofilament light chain, as well as assessment of various brain volumes at baseline. using MRI and analysis of amyloid and tau deposition by week 76 PET scans. REFOCUS-ALZ was also put implemented under an SPA with the FDA.

About Simufilam

Simufilam is an investigational oral small molecule that targets the filamin A protein.

About Cassava Sciences, Inc.
Cassava Sciences is a clinical-stage biopharmaceutical company focused on developing innovative treatments for central nervous system diseases, including Alzheimer’s dementia. The Company is headquartered in Austin, Texas.

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For more information, contact:

Investors
Sandya von der Weid
[email protected]

Media
[email protected]

Company
Eric Schoen, Financier Director
(512) 501-2450
[email protected]
[email protected]

Cautionary note regarding forward-looking statements:
This press release contains forward-looking statements that include, but are not limited to, statements regarding: the planned interruption of the REFOCUS-ALZ and open-label extension studies and the status of their current termination; our intention to share preliminary data from REFOCUS-ALZ; our intention to share detailed study results from the RETHINK-ALZ and REFOCUS-ALZ studies at a future medical meeting; the schedule of anticipated milestones; the reduction of the Company’s workforce; and anticipated costs associated with downsizing. These statements may be identified by words such as “anticipate”, “before”, “believe”, “could”, “expect”, “plan”, “intend”, “may”, “pending”, “anticipate,” “possible,” “potential,” “prepare for,” “will,” and other words and terms of similar meaning.

These statements are based on our current expectations and projections regarding future events. They speak only as of the date of this press release and are subject to a number of risks, uncertainties and assumptions, including, but not limited to, risks relating to the ability to lead to clinical studies completed on time; clinical results relating to studies of simufilam in Alzheimer’s disease, results of the RETHINK-ALZ study reported on November 25, 2024; our current expectations regarding the timing of clinical data analysis for our Phase 3 studies; the potential for unanticipated costs associated with our workforce reduction announcement; and other risks inherent in drug discovery and development or specific to Cassava Sciences, Inc., as described in the section entitled “Risk Factors” in our Annual Report on Form 10-K for the current year. ending December 31, 2023 and the Quarterly Report on Form 10-Q for the period ending September 30, 2024, as well as in future reports to be filed with the SEC.

All of our pharmaceutical assets in development are investigative product candidates. These have not been approved for use in any medical indication by any regulatory authority in any jurisdiction, and their safety, effectiveness, or other desirable characteristics, if any, have not been established in any patient population. As a result, none of our product candidates are approved or available for sale worldwide.