Cassava Sciences, Inc. (Nasdaq: SAVA), a clinical-stage
biotechnology company focused on Alzheimer’s disease, today issued
the following statement regarding an internal report purportedly
prepared by City University of New York (CUNY). This report was
leaked to the press. The leak of the CUNY report was preceded by a
40% increase in short selling activity in the stock of Cassava
Sciences.
Beginning August 2021, short sellers executed a
brutal, widely publicized “short-and-distort” campaign against
Cassava Sciences. The short-sellers alleged that Cassava Sciences
and its academic researcher at CUNY had engaged in data
manipulation and other forms of research misconduct. In response to
these allegations, CUNY initiated an internal investigation in Fall
2021. In 2022, Cassava Sciences filed a lawsuit against certain
individuals who participated in the short-and-distort campaign,
identifying over 1,000 false and defamatory statements.
On October 12, 2023, Science reported that it
had obtained a copy of CUNY’s report from “a person who requested
anonymity because they are not authorized to share it.” The Science
article quotes a person paid by a lawyer for certain short-sellers,
but does not indicate what role, if any, short-sellers had in the
leak. According to Science, CUNY completed its investigation in May
2023. The short interest in Cassava Sciences’ stock jumped 40%, to
over 14 million shares, between June 30, 2023, and September 29,
2023, according to NASDAQ.
CUNY’s report makes no findings of data
manipulation. Rather, the “egregious misconduct” cited in the
report relates exclusively to internal record-keeping failures at
CUNY. The report also finds that internal record-keeping failures
“prevented us [CUNY] from making an objective assessment” of the
allegations of research misconduct.
“We remain confident in the underlying science
for simufilam, our lead drug candidate,” said Remi Barbier,
President & CEO. “We intend to continue to translate our
passion for science into a novel drug for people living with
Alzheimer’s disease. Our Phase 3 clinical program continues.”
Cassava Sciences played no role in CUNY’s
investigation. The university turned down all requests for
information and offers of assistance from Cassava. Because CUNY did
not interview any employee of Cassava Sciences, the university has
no legitimate basis on which to make accusations against the
Company or its employees.
CUNY has not responded to an inquiry Cassava
Sciences made yesterday regarding the authenticity of the leaked
report.
Importantly, Cassava Sciences does not rely
exclusively on research at CUNY. The science underlying simufilam,
Cassava Sciences’ lead drug candidate, is supported by the work of
scientists at academic institutions that have no connection to
CUNY, including:
- In September
2023, Cassava Sciences announced the publication of new research
that confirms the biological activity of simufilam. Researchers at
the Cochin Institute (Paris, France) used a highly precise
cell-based assay to show that simufilam interrupts amyloid binding
to the α7 nicotinic acetylcholine receptor. Cassava Sciences
believes this protein interaction underlies simufilam’s mechanism
of action in Alzheimer’s disease. The research appears in a special
issue of International Journal of Molecular Sciences, a
peer-reviewed scientific publication, and is currently available
on-line at: https://www.mdpi.com/1422-0067/24/18/13927
- In May 2023,
Cassava Sciences announced the publication of new data that
highlights the biological activity of simufilam on Filamin A.
Researchers at the University of Milan (Italy) showed a functional
interaction between simufilam, filamin A (FLNA) and somatostatin
receptors. Specifically, the researchers showed that simufilam
treatment significantly reduced levels of phosphorylation at a site
on FLNA in human pituitary tumor cells. The research was presented
at the 25th European Congress of Endocrinology and is currently
available on-line at:
https://www.endocrine-abstracts.org/ea/0090/ea0090oc7.5
- In February
2020, Cassava Sciences announced that filamin A inhibition by
simufilam reduced seizure activity in a mouse model of epilepsy.
The data was generated by researchers at Yale University, was
published in Science Translational Medicine and is currently
available on-line at:
https://pubmed.ncbi.nlm.nih.gov/32075941/
Other independent researchers have shown a role
for filamin A in neurodegeneration.
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
product candidates have not been approved by any regulatory
authority, and their safety, efficacy or other desirable attributes
have not been established in humans.
For more information, please visit:
https://www.CassavaSciences.com
For More Information Contact: Eric Schoen,
Chief Financial Officer(512)
501-2450ESchoen@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: the continuation of our Phase 3
clinical program; results of research relating to simufilam and to
the mechanism of action underlying simufilam; the treatment of
patients with Alzheimer’s disease dementia; comments made by our
employees regarding the purported CUNY report, our science or
simufilam and the treatment of Alzheimer’s disease; the continued
development of simufilam; and potential benefits, if any, of our
product candidates. These statements may be identified by words
such as “may,” “anticipate,” “believe,” “could,” “expect,” “look
forward,” “would”, “forecast,” “intend,” “plan,” “possible,”
“potential,” and other words, phrases, and terms of similar
meaning.
Simufilam is our investigational product
candidate. Its safety, efficacy or science has not reviewed or
approved by any regulatory authority in any jurisdiction and its
desirable clinical attributes, if any, have not been established in
patients.
Drug development involves a high degree of risk,
and only a small number of research and development programs result
in regulatory approval and 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.
Cassava Sciences (NASDAQ:SAVA)
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