New Research Shows Simufilam Suppresses Overactive mTOR

• Overactive mTOR Plays a Key Role in Aging and Alzheimer’s Disease.

• Simufilam Suppresses Overactive mTOR, Suggesting a Beneficial Drug Effect.
  
• Research is Published in Frontiers in Aging, a Peer-reviewed Journal.

AUSTIN, Texas, June 27, 2023 (GLOBE NEWSWIRE) — Cassava Sciences, Inc. (Nasdaq: SAVA), a clinical-stage biotechnology company, today announced the publication of a new paper in Frontiers in Aging, a peer-reviewed journal focused on age-related scientific research. The new paper examined the effects of simufilam on mTOR. Simufilam is Cassava Sciences’ novel, oral drug candidate currently in Phase 3 clinical testing in patients with mild-to-moderate Alzheimer’s disease dementia.

“Today’s publication suggests a meaningful impact of simufilam on overactive mTOR signaling,” said Lindsay Burns, PhD, SVP Neuroscience at Cassava Sciences, and co-author of the paper. “The data add to our understanding of simufilam’s mechanism of action in Alzheimer’s disease.”

The scientific literature shows overactive mTOR plays a key role in aging, Alzheimer’s disease and other conditions. When functioning normally, mTOR monitors cellular needs and is activated by insulin. The research published today shows mTOR is overactive in lymphocytes isolated from blood collected from Alzheimer’s patients versus healthy controls. After oral administration of simufilam 100 mg twice daily to Alzheimer’s patients for 28 days, lymphocytes showed normalized mTOR activity and restored mTOR sensitivity to insulin.

“Normalizing mTOR may have tantalizing potential in Alzheimer’s disease and beyond,” said Remi Barbier, President & CEO. “There is a wide body of research on this topic.”

An abstract of the research paper appeared on-line June 23, 2023, ahead of print and is titled “Simufilam Suppresses Overactive mTOR and Restores Its Sensitivity to Insulin in Alzheimer’s Disease Patient Lymphocytes”. This paper is open-access (free) under the terms of the Creative Commons Attribution License. The full-text paper is expected to be available on-line shortly.

About Simufilam
Simufilam is Cassava Sciences’ novel, oral drug candidate currently in Phase 3 clinical trials in patients with mild-to-moderate Alzheimer’s disease dementia. Simufilam binds tightly to and reverses an altered conformation of the filamin A protein (FLNA) in Alzheimer’s patients. Altered FLNA is critical to the toxicity of amyloid beta (1-42). Simufilam is wholly owned by Cassava Sciences, without royalty or payment obligation to any third party.

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. Our novel science is based on stabilizing—but not removing—a critical protein in the brain. Our product candidates have not been approved by any regulatory authority, and their safety, efficacy or other desirable attributes have not been established. For more information, please visit our website: https://www.CassavaSciences.com

For More Information Contact:
Eric Schoen, Chief Financial Officer
(512) 501-2450
ESchoen@CassavaSciences.com

Cautionary Note Regarding Forward-Looking Statements:
This news release contains forward-looking statements, including statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, that may include but are not limited to: published research regarding simufilam and the mTOR protein; the potential benefit, impact or significance of simufilam on mTOR in humans; potential benefits to normalizing mTOR in humans; the design, scope, conduct or intended purpose of our Phase 3 program of simufilam in patients with Alzheimer’s disease; the safety or expected effects of mTOR or simufilam in Alzheimer’s disease, if any; any expected clinical results of Phase 3 studies; the treatment of people with Alzheimer’s disease dementia; the safety or efficacy of simufilam in people with Alzheimer’s disease dementia; verbal commentaries made by our employees; and potential benefits, if any, of the our product candidates. These statements may be identified by words such as “may,” “anticipate,” “believe,” “could,” “expect,” “forecast,” “intend,” “plan,” “possible,” “potential,” and other words and terms of similar meaning.

Simufilam is our investigational product candidate. It is not approved by any regulatory authority in any jurisdiction and its safety, efficacy or other desirable attributes have not been established in patients.

Drug development and commercialization involve a high degree of risk, and only a small number of research and development programs result in commercialization of a product. Clinical results from our prior studies may not be indicative of results of future or larger scale clinical trials and do not ensure regulatory approval. You should not place undue reliance on these statements or any scientific data we present or publish.

Such statements are based largely on our current expectations and projections about future events. Such statements speak only as of the date of this news release and are subject to a number of risks, uncertainties and assumptions, including, but not limited to, those risks relating to the ability to conduct or complete clinical studies on expected timelines, to demonstrate the specificity, safety, efficacy or potential health benefits of our product candidates, any unanticipated impacts of inflation on our business operations, and including those described in the section entitled “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2022, and future reports to be filed with the SEC. The foregoing sets forth many, but not all, of the factors that could cause actual results to differ from expectations in any forward-looking statement. In light of these risks, uncertainties and assumptions, the forward-looking statements and events discussed in this news release are inherently uncertain and may not occur, and actual results could differ materially and adversely from those anticipated or implied in the forward-looking statements. Accordingly, you should not rely upon forward-looking statements as predictions of future events. Except as required by law, we disclaim any intention or responsibility for updating or revising any forward-looking statements contained in this news release. For further information regarding these and other risks related to our business, investors should consult our filings with the SEC, which are available on the SEC’s website at www.sec.gov.