No Evidence of Data Manipulation in Science Publication on Simufilam

AUSTIN, Texas, Aug. 18, 2022 (GLOBE NEWSWIRE) -- Cassava Sciences, Inc. (Nasdaq: SAVA), a clinical-stage biotechnology company focused on Alzheimer’s disease, was recently informed by the Journal of Prevention of Alzheimer's Disease (JPAD) that there is no convincing evidence to support allegations of data manipulation in a 2020 paper on simufilam co-authored by the Company’s personnel and its science collaborators.

JPAD communicated the following statement to the Company on Monday, August 15^th after the close of market, which is reprinted in full below:

“We have completed our review of your article “PTI-125 Reduces Biomarkers of Alzheimer’s Disease in Patients” (JPAD 2020;7(4):256-264). We do not find convincing evidence of manipulation of data or intent to mislead, and therefore take no action regarding the published paper.”

“From the onset, I have said that allegations of research misconduct are false, and for good reason – I see no supporting evidence for the allegations,” said Remi Barbier, President & CEO. “I’m hopeful that written pronouncements from neutral and independent science experts will help close the chapter of baseless attacks against our science. At some point it becomes irrational for our detractors to repeat over and over again the same old tired mantra of data manipulation.”

• In May 2022, Neurobiology of Aging investigated and found no evidence of data manipulation in a paper on simufilam published in that journal in 2017. The journal’s Editor-in-Chief stated: “A reader has made the editors aware of concerns regarding the above-referenced report published at Neurobiology of Aging [i.e., “PTI-125 binds and reverses an altered conformation of filamin A to reduce Alzheimer's disease pathogenesis.” Neurobiol. Aging, 55:99-114]. These issues were conveyed to the authors, who provided a detailed response, including images of relevant uncropped western blots and photomicrographs, as the editor requested. The material was evaluated by an independent expert with relevant methodological expertise, the manuscript was scanned by AI-based figure proofing software (i.e., Proofig), and all available input was considered by the handling editor and Editor-in-Chief. Overall, the editors did not find compelling evidence of data manipulation intended to misrepresent the results.” The journal’s full notice is available on-line:
  https://www.sciencedirect.com/science/article/pii/S0197458022000562?via%3Dihub

• In December 2021, Cassava Sciences announced that Neuroscience investigated and found no evidence of data manipulation in a paper published in that journal in 2005. The Editor-in-Chief stated: “After careful examination of these original material, Neuroscience found no evidence of manipulation of the western blot data or other figures of this publication.” The journal’s full editorial note is available on-line:
  https://www.sciencedirect.com/science/article/pii/S0306452221005789?via%3Dihub
  

• In November 2021, Cassava Sciences announced that The Journal of Neuroscience investigated and found no evidence of data manipulation in a paper on simufilam published in that journal in July 2012. The Editor-in-Chief previously authorized Cassava Sciences to share a statement on this matter, including: “No evidence of data manipulation was found for Western blot data.” The full statement provided to the Company and the journal’s full notice are both available on-line:
  https://www.cassavasciences.com/news-releases/news-release-details/review-journal-neuroscience-shows-no-evidence-data-manipulation
  https://www.jneurosci.org/content/42/3/529

A related investigation by academic authorities at The City University of New York (CUNY) is ongoing. Pending a public response from CUNY, both Neurobiology of Aging and Journal of Neuroscience previously issued an outstanding “expression of concern”, which is a non-standardized type of editorial notice used by academic publishers to raise awareness to a possible problem, according to the Council of Science Editors (2012).

About Simufilam
Simufilam 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.

About Cassava Sciences, Inc.
Cassava Sciences, Inc. 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. For more information, please visit: https://www.CassavaSciences.com.

For More Information Contact:
Eric Schoen, Chief Financial Officer, (512) 501-2450, or 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, relating to: our expectations regarding CUNY’s on-going investigative activities; our viewpoints regarding lack of supporting evidence for allegations of research misconduct; our expectations regarding the role of written pronouncements from science experts; the potential cessation of attacks against the Company; comments made by our employees regarding allegations of data manipulation; the treatment of Alzheimer’s disease; and potential benefits, if any, of our product candidates. These statements may be identified by words such as “may,” “anticipate,” “believe,” “could,” “expect,” “would”, “forecast,” “intend,” “plan,” “possible,” “potential,” and other words and terms of similar meaning. 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. Our clinical results from earlier-stage clinical trials may not be indicative of full results or results from later-stage 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, 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, 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. 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.