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Cassava Sciences Launches Clinical Website to Support Phase 3 Studies of Oral Simufilam in Alzheimer’s Disease

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  • New website (www.Rethink-ALZ.com) is intended to increase visibility and information for potential study participants.

  • Rethink-ALZ.com connects patients with nearest participating clinical site.

  • Phase 3 efficacy studies now in over 25 clinical sites across the country.

AUSTIN, Texas, Dec. 23, 2021 (GLOBE NEWSWIRE) -- Cassava Sciences, Inc., (NASDAQ: SAVA) a biotechnology company, today announced the launch of a new clinical website, called www.Rethink-ALZ.com. Rethink-ALZ.com is intended to provide access, visibility and information on Cassava Sciences’ Phase 3 safety and efficacy studies of oral simufilam in people with Alzheimer’s disease. Simufilam is a new oral drug candidate for the proposed treatment of mild-to-moderate Alzheimer’s disease.

“I think clinical sites around the country are quite excited by the potential of oral simufilam to impact Alzheimer’s disease,” said James Kupiec, MD, Chief Clinical Development Officer at Cassava Sciences. “Rethink-ALZ.com is dedicated to enhance patient experience and enrollment for both of our on-going Phase 3 studies of oral simufilam in Alzheimer’s disease.”

Rethink-ALZ.com includes a patient-friendly, care-giver friendly pre-qualification questionnaire for individuals with Alzheimer’s disease to see if study participation is right for them. If an individual decides to register interest, s/he is given the option to select their nearest clinical investigational site. This establishes connection with the site and the individual can then choose to contact the site or ask to be contacted for pre-screening.

Over 25 clinical sites across the country are now participating in the Phase 3 efficacy studies of simufilam in Alzheimer’s disease.

About The First Phase 3 Study (RETHINK-ALZ)
The first Phase 3 study, called RETHINK-ALZ, is designed to evaluate the safety and efficacy of oral simufilam 100 mg in enhancing cognition and slowing cognitive and functional decline over 52 weeks. Secondary objectives include the assessment of simufilam's effect on neuropsychiatric symptoms and caregiver burden. This randomized, double-blind, placebo-controlled study plans to enroll approximately 750 patients with mild-to-moderate Alzheimer’s disease in the U.S. and Canada and, eventually, overseas.

About The Second Phase 3 Study (REFOCUS-ALZ)
The second Phase 3 study, called REFOCUS-ALZ, 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 in the U.S. and Canada and, eventually, overseas.

About Simufilam
Simufilam (sim-uh-FILL-am) is a proprietary, small molecule (oral) drug candidate that restores the normal shape and function of altered filamin A (FLNA) protein in the brain. Altered FLNA in the brain disrupts the normal function of neurons, leading to Alzheimer’s pathology, neurodegeneration and neuroinflammation. The underlying science for simufilam is published in peer-reviewed journals, including Journal of Neuroscience, Neurobiology of Aging, Journal of Biological Chemistry, Neuroimmunology and Neuroinflammation and Journal of Prevention of Alzheimer’s Disease. 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.

About Cassava Sciences
Cassava Sciences’ mission is to discover and develop innovations for chronic, neurodegenerative conditions. Over the past 10 years, Cassava Sciences has combined state-of-the-art technology with new insights in neurobiology to develop novel solutions for Alzheimer’s disease. We are currently testing simufilam, our lead drug candidate for the proposed treatment of Alzheimer’s disease, in Phase 3 clinical studies under Special Protocol Assessments from the FDA. Simufilam is also being tested in an open-label study and a randomized, double-blind, placebo-controlled Cognition Maintenance Study in patients with Alzheimer’s disease. For more information, please visit: https://www.CassavaSciences.com

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

Cautionary Note Regarding Forward-Looking Statements: This press release includes forward looking statements including but not limited to those regarding the size, scope and locations of our Phase 3 program with simufilam in Alzheimer’s disease, the expected treatment benefits of simufilam for people with Alzheimer’s disease and oral or written comments made by our employees regarding simufilam and its clinical development.

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 conduct or completion of our clinical studies on expected timelines, to demonstrate the specificity, safety, efficacy or potential health benefits of our product candidates, the severity and duration of health care precautions given the COVID-19 pandemic, any unanticipated impacts of the pandemic 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, 2020, as supplemented by the section entitled “Risk Factors” in our Quarterly Report on SEC Form 10-Q for the quarter ended September 30, 2021, 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. Drug development involves a high degree of risk, and historically only a small number of research and development programs result in commercialization of a product.

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.