Cassava Sciences, Inc. (Nasdaq: SAVA), a biotechnology company
focused on Alzheimer’s disease, today announced it will present two
new clinical datasets for its product candidates at the 2021
Alzheimer’s Association International Conference (AAIC), which is
being held in Denver, Co and virtually on July 26th through July
30th. Cassava Sciences’ investigational product candidates include
simufilam, a drug treatment for Alzheimer’s disease, and SavaDx, a
biomarker/diagnostic to detect Alzheimer’s disease with a simple
blood test.
On Monday, July 26th, at approximately 10 am ET,
scientists for Cassava Sciences will show a poster presentation at
AAIC, titled “SavaDx, a Novel Plasma Biomarker to Detect
Alzheimer’s Disease, Confirms Mechanism of Action of
Simufilam”.
On Thursday, July 29th, at approximately 11 am
ET, simufilam will be featured in a live podium presentation at
AAIC, including a brief Q&A session. This oral presentation
will announce results of an interim analysis on safety and
cognition for the first 50 patients with Alzheimer’s disease to
complete 9 months of open-label treatment. Scientists for Cassava
Sciences will also present biomarker data analyzed from
cerebrospinal fluid (CSF) collected from 25 study subjects at
baseline and again after completing 6 months of open-label drug
treatment, including:
- Biomarkers of Alzheimer’s disease:
amyloid beta42, total tau, P-tau181
- Biomarkers of neurodegeneration:
neurogranin, neurofilament light chain (NfL)
- Biomarkers of neuroinflammation:
YKL-40, sTREM2 and HMGB1
“Cassava Sciences’ contributions to AAIC
showcase our efforts to develop innovative product candidates for
people living with Alzheimer’s disease,” said Remi Barbier,
President and CEO. “We are honored AAIC’s scientific committee has
invited us to present the latest clinical dataset for simufilam in
an oral presentation on Thursday, July 29th.”
AAIC policy requires that all materials
submitted to AAIC remain embargoed for public broadcast until their
officially scheduled date and time of presentation at AAIC.
Cassava Sciences expects to publicly release all
AAIC materials contemporaneously with their scheduled date and time
of presentation at AAIC. At those times, materials will be posted
on the ‘Investors’ page of the Company’s website:
https://www.CassavaSciences.com
About SavaDxSavaDx is Cassava
Sciences’ investigational diagnostic to detect Alzheimer’s disease.
The goal of SavaDx is to make the detection of Alzheimer’s as
simple as getting a blood test, possibly years before the
appearance of any overt clinical symptoms. SavaDx was substantially
funded by a peer-reviewed research grant award from the National
Institutes of Health (NIH).
About SimufilamSimufilam
(sim-uh-FILL-am) is a proprietary, small molecule (oral) drug that
restores the normal shape and function of altered filamin A (FLNA),
a scaffolding 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. Simufilam is
substantially supported by peer-reviewed research grant awards from
the National Institutes of Health (NIH).
About Alzheimer’s Disease
Alzheimer’s disease is a progressive brain disorder that destroys
memory and thinking skills. As of 2020, there were approximately 50
million people worldwide living with dementia, a figure expected to
increase to 150 million by 2050.1 The annual global cost of
dementia is now above $1 trillion, according to
Alzheimer’s Disease International, a charitable organization.
About AAIC2The Alzheimer’s
Association International Conference (AAIC) is the largest and most
influential international meeting dedicated to advancing dementia
science. Each year, AAIC convenes the world’s leading basic science
and clinical researchers, next-generation investigators, clinicians
and the care research community to share research discoveries that
will lead to methods of prevention and treatment and improvements
in the diagnosis of Alzheimer’s disease.
About Cassava Sciences,
Inc.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.
Simufilam and SavaDx were both developed
in-house. 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.
For more information, please visit
https://www.CassavaSciences.com
For More Information Contact:
Eric Schoen, Chief Financial
Officereschoen@CassavaSciences.com (512) 501-2450
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 Company’s anticipated data
presentations at AAIC; expectations regarding the clinical benefits
of SavaDx or simufilam; and the Company’s execution on its strategy
to initiate a Phase 3 clinical program in Alzheimer’s disease in
2021. 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.
Biopharmaceutical product development involves a
high degree of risk, and historically only a small number of
research and development programs result in commercialization of a
product. Clinical results from our 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, 2020 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.
____________________________
1 Alzheimer's Disease International, Dementia Statistics,
available on-line and accessed July 20, 2021.2 Source:
https://www.alz.org/aaic/about/overview.asp, accessed July 19,
2021.
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