Cassava Sciences’ topline Phase 3 data did not meet co-primary endpoints

The following table provides a general summary of patient demographics and safety data. Simufilam continued to demonstrate an overall favorable safety profile.

Cassava will continue to review all data and evaluate next steps. We plan to announce the detailed results at a future medical meeting.

Eric Schoen, CFO at Cassava commented: “We remain focused on the interests of Cassava shareholders and are committed to increasing shareholder value.” Cassava is well capitalized with approximately $149.0 million in cash and cash equivalents as of the end of the third quarter of 2024 .”

A webcast of the live call will be available on the investor relations section of the Cassava website. Access to the webcast recording will be available on the Company’s website approximately two hours after the conclusion of the call for approximately 90 days.

About Re-THINK-ALZ

ReThink ALZ (NCT04994483) is a Phase 3 study evaluating the safety and efficacy of simufilam compared to placebo in a multicenter, double-blind, placebo-controlled, randomized, parallel-group study with over 75 clinical trial sites in the United States and Canada and Australia. The study randomized 804 people with confirmed mild or moderate AD, defined by several well-validated parameters, including a Mini-Mental State Examination (MMSE). >16 and <27, layered as light or moderate. Subjects were randomized 1:1 to receive simufilam 100 mg (n=403) or matching placebo (n=401) orally twice daily (BID) for 52 weeks.

The co-primary endpoints were change in cognition and function from baseline to the end of the double-blind treatment period at week 52, assessed using the ADAS-COG12 and ADCS-ADL scales, comparing simufilam to placebo. Secondary endpoints also included several well-validated measures of neuropsychiatric symptoms and caregiver burden. Safety was assessed by multiple measures including monitoring of adverse events. The study also included a pharmacokinetics and plasma biomarker substudy with approximately 100 subjects, which was evaluated at three time points. ReThink-ALZ was conducted as part of a Special Protocol Assessment (SPA) with the US Food and Drug Administration (FDA).

About Simufilam

Simufilam is a proprietary oral small molecule in development that targets the filamin A protein.

About Cassava Sciences, Inc.

Cassava Sciences is a clinical-stage biotechnology company based in Austin, Texas. Our mission is to detect and treat neurodegenerative diseases such as Alzheimer’s disease.

Simufilam, an investigational oral small molecule drug candidate targeting the filamin A protein, is currently being evaluated for the potential treatment of Alzheimer’s disease. Cassava Sciences owns exclusive, worldwide rights to its investigational product candidates and related technologies, with no royalty obligations to third parties.

Further information can be found at: https://www.CassavaSciences.com

For further information contact:

investors
Sandya von der Weid
[email protected]

media
[email protected]

Pursue
Eric Schoen, CFO
(512) 501-2450
[email protected]
[email protected]

Cautionary Note Regarding Forward-Looking Statements:
This press release contains forward-looking statements, including, without limitation, statements regarding the completion and future results of our Phase 3 clinical trials of simufilam in patients with Alzheimer’s disease; the planned discontinuation of the ReFocus-ALZ and open-label extension studies; our intention to share detailed study results at a future medical meeting; the timing of expected milestones; and the potential for approval of simufilam for the treatment of Alzheimer’s disease. These statements can be identified by words such as “expect”, “anticipate”, “believe”, “could”, “expect”, “project”, “intend”, “could”, “pending”, “plan”. “possible,” “potential,” “preparing,” “will,” and other words and terms with similar meaning.

Such statements are based on our current expectations and projections about future events. Such statements 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 associated with the ability to conduct or complete clinical trials within expected timelines; the ability to demonstrate the specificity, safety, effectiveness or potential health benefits of simufilam; our current expectations regarding the timing of clinical data for our Phase 3 trials; and other risks associated with or specific to Cassava Sciences, Inc.’s drug discovery and development as described in the “Risk Factors” section in our Annual Report on Form 10-K for the fiscal year ended December 31, 2023 and Quarterly Report on Form 10-Q for the period ended September 30, 2024 and future reports to be filed with the SEC. The foregoing sets forth many, but not all, factors that could cause actual results to differ from those anticipated in any forward-looking statements. Given these risks, uncertainties and assumptions, the forward-looking statements and events discussed in this press release are inherently uncertain and may not occur. Actual results may differ materially and adversely from those anticipated or implied by the forward-looking statements. Accordingly, you should not rely on forward-looking statements as predictions of future events. Except as required by law, we disclaim any intention or responsibility to update or revise any forward-looking statements. For more information about these and other risks associated with our business, investors should consult our filings with the SEC, which are available on the SEC’s website at www.sec.gov.

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