Cassava Sciences, Inc. (Nasdaq: SAVA), a clinical-stage
biotechnology company focused on Alzheimer’s disease, today
announced financial results for the first quarter ended March 31,
2021 and guidance regarding the release of new clinical data with
simufilam. Simufilam is the Company’s lead drug candidate to treat
Alzheimer’s disease.
“Alzheimer’s is a progressive disease, so a
patient’s cognition is expected to worsen over time,” said Remi
Barbier, President & CEO. “Patients’ cognition scores actually
improved following 6 months of open-label treatment with simufilam.
Showing similar drug effects following 9 months of open-label
treatment would be remarkable, yet consistent with simufilam’s
mechanism of action. Eventually, we’d like this drug candidate to
benefit cognition for a year or longer.”
In July 2021, Cassava Sciences plans to announce
results of a pre-specified interim analysis that summarizes safety
and cognition data on approximately the first 50 subjects to
complete at least 9 months of open-label drug treatment. The
Company will present these data July 26 - 29th at the 2021
Alzheimer’s Association International Conference (AAIC). AAIC’s
scientific committee has invited the Company’s scientists to
present the dataset as an oral presentation.
About the Open-label Study with
SimufilamIn March 2020, Cassava Sciences initiated a
long-term, open-label study to evaluate simufilam in patients with
Alzheimer’s disease. This study is funded by a research grant award
from the National Institutes of Health (NIH). The open-label
study is intended to monitor the long-term safety and
tolerability of simufilam 100 mg twice-daily for 12 months or
longer in patients with Alzheimer’s disease. Another study
objective is to measure changes in cognition on ADAS-Cog, a
standard test of cognition in Alzheimer’s disease. The study’s
clinical protocol has pre-specified cognition measurements at 6, 9
and 12 months.
The study’s target enrollment is approximately
150 subjects with mild-to-moderate Alzheimer’s disease
(recently increased by 50 subjects). One-hundred subjects have
enrolled in this study across multiple clinical sites in the U.S.
and Canada.
On February 2, 2021, Cassava Sciences
announced positive results of a first interim analysis that
summarizes clinical data on the first 50 subjects to complete 6
months of open-label treatment. Patients’ cognition scores improved
from baseline following 6 months of simufilam treatment, with no
safety issues. Six months of simufilam treatment improved cognition
scores by 1.6 points on ADAS-Cog11, a 10% mean improvement from
baseline to month 6.
In September 2021, Cassava Sciences plans to
announce results of an interim analysis that summarizes safety and
cognition data on approximately the first 50 subjects to complete
at least 12 months of open-label drug treatment.
About the Cognition Maintenance Study
(CMS)In June 2021, Cassava Sciences plans to initiate a
double-blind, randomized, placebo-controlled study in patients with
Alzheimer’s disease. Patients who have completed at least one year
of open-label treatment with simufilam qualify to enroll in the
Cognition Maintenance Study (CMS). Study subjects in the CMS will
be randomized (1:1) to simufilam or placebo for six months. The CMS
is designed to compare simufilam’s effects on cognition in
Alzheimer’s patients who continue with drug treatment versus
patients who discontinue drug treatment.
About the Phase 3 Clinical
ProgramCassava Sciences plans to initiate a Phase 3
program of simufilam in Alzheimer’s disease in the second half of
2021. The Phase 3 program consists of two large, double-blind,
randomized, placebo-controlled studies in patients with
mild-to-moderate Alzheimer’s disease dementia.
Cassava Sciences’ first Phase 3 study is
designed to evaluate disease-modifying effects of simufilam in
Alzheimer’s disease. The goal is to demonstrate a slower rate of
decline in cognition and health function in subjects treated with
simufilam compared to placebo. Approximately 1,000 subjects to be
enrolled, randomized (1:1:1) to simufilam 100 mg, 50 mg or placebo
BID, and treated for 18 months. The co-primary efficacy endpoints
are ADAS-Cog, a cognitive scale, and ADCS-ADL, a functional scale,
both widely used clinical tools in trials of Alzheimer’s
disease.
Cassava Sciences’ second Phase 3 study is
designed to evaluate symptomatic improvement in Alzheimer’s
disease. The goal is to demonstrate improved cognition and health
function in subjects treated with simufilam compared to placebo.
Approximately 600 subjects to be enrolled, randomized (1:1) to
simufilam 100 mg or placebo BID, and treated for 12 months. The
co-primary efficacy endpoints are ADAS-Cog, a cognitive scale, and
ADCS-ADL, a functional scale.
Slide DeckCassava Sciences’
latest corporate presentation is available on its website under the
Investors/Presentations page: https://www.CassavaSciences.com
Financial Results for First Quarter
2021Net loss was $3.5 million, or $0.09 per share,
compared to a net loss of $1.2 million, or $0.05 per share, for the
same period in 2020. Net cash used in operations was $2.3 million
during the first quarter of 2021.
Net cash use for operations for full-year 2021
is expected to be approximately $20 to $25 million. Cash and cash
equivalents were $282.2 million as of March 31, 2021, with no
debt.
Financial Highlights for First Quarter
2021
- At March 31, 2021, cash and cash
equivalents were $282.2 million, compared to $93.5 million at
December 31, 2020, with no debt. Cash balance included net proceeds
of approximately $189.8 million from the sale of 4.1 million shares
of common stock completed February 2021. Cash balance also included
$0.7 million from exercise of common stock warrants in the quarter.
There were no remaining common stock warrants outstanding as of
March 31, 2021.
- Net cash used in operations during
the quarter ended March 31, 2021 was $2.3 million, net of
reimbursements received from NIH grant awards.
- Research grant funding
reimbursements of $0.6 million were received from NIH and recorded
as a reduction in research and development (R&D) expenses. This
compared to $1.3 million of NIH grant receipts received for the
same period in 2020.
- Net cash use for operations for
full year 2021 is expected to be approximately $20 to $25 million,
consistent with previous financial guidance. Net cash use in 2021
is expected to be driven by higher headcount and personnel
expenses, manufacturing costs around large-scale drug supply,
professional services expenses related to clinical programs, and
operating costs such as insurance, office space and IT related
expenses.
- R&D expenses were $2.5 million.
This compared to $0.5 million for the same period in 2020,
representing a 365% increase. This increase was due primarily to
costs related to manufacture of clinical trial supplies in
anticipation of launching a Phase 3 clinical program in simufilam,
increased personnel expenses, as well as a decrease in grant
funding received from NIH compared to the prior year.
- General and administrative
(G&A) expenses were $1.0 million. This compared to $0.8 million
for the same period in 2020, representing a 29% increase. This
increase was due primarily to higher insurance costs and
professional fees compared to the prior year.
About SimufilamSimufilam 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. Cassava Sciences is also
developing an investigational diagnostic, called SavaDx, to detect
Alzheimer’s disease with a simple blood test.
Simufilam and SavaDx were both developed
in-house. Both product candidates are substantially funded by
peer-review research grant awards from the National Institutes of
Health (NIH). 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 Alzheimer’s
Disease Alzheimer’s disease is a progressive brain
disorder that destroys memory and thinking skills. Currently, there
are no drug therapies to halt Alzheimer’s disease, much less
reverse its course. 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 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. 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: our strategy and plans; expected
cash use in future periods; the treatment of Alzheimer’s disease;
the status of current and future clinical studies with simufilam,
including the interpretation of an interim analysis of an
open-label study; plans to conduct additional interim analyses of
an open-label study and the timing thereof; planned enrollment
targets to said open-label program; our intention to initiate a
Phase 3 clinical program with simufilam and the timing, enrollment,
duration and other details thereof; verbal commentaries made by our
employees; 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, 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.
The content of this press release is solely our
responsibility and does not necessarily represent the official
views of the National Institutes of Health (NIH).
– Financial Tables Follow –
CASSAVA SCIENCES,
INC. |
CONDENSED STATEMENTS
OF OPERATIONS |
(unaudited, in
thousands, except per share amounts) |
|
|
|
|
|
|
|
Three months ended
March 31, |
|
2021 |
|
|
2020 |
|
Operating
expenses |
|
|
|
|
|
Research and development, net of grant reimbursement |
$ |
2,529 |
|
|
$ |
544 |
|
General and administrative |
|
1,004 |
|
|
|
778 |
|
Gain on sale of property and equipment |
|
— |
|
|
|
(100 |
) |
Total operating expenses |
|
3,533 |
|
|
|
1,222 |
|
Operating
loss |
|
(3,533 |
) |
|
|
(1,222 |
) |
Interest
income |
|
7 |
|
|
|
72 |
|
Net
loss |
$ |
(3,526 |
) |
|
$ |
(1,150 |
) |
|
|
|
|
|
|
Net loss per
share, basic and diluted |
$ |
(0.09 |
) |
|
$ |
(0.05 |
) |
|
|
|
|
|
|
Weighted-average shares used in computing net loss per share, basic
and diluted |
|
37,721 |
|
|
|
24,481 |
|
|
|
|
|
|
|
CONDENSED BALANCE
SHEETS |
(unaudited, in
thousands) |
|
March 31, 2021 |
|
December 31, 2020 |
Assets |
|
|
|
|
|
Current
assets |
|
|
|
|
|
Cash and cash equivalents |
$ |
282,192 |
|
|
$ |
93,506 |
|
Other current assets |
|
1,574 |
|
|
|
488 |
|
Total current assets |
|
283,766 |
|
|
|
93,994 |
|
Property and
equipment, net |
|
10 |
|
|
|
11 |
|
Operating
lease right-of-use assets |
|
274 |
|
|
|
295 |
|
Total assets |
$ |
284,050 |
|
|
$ |
94,300 |
|
Liabilities and stockholders' equity |
|
|
|
|
|
Current
liabilities |
|
|
|
|
|
Accounts payable |
$ |
864 |
|
|
$ |
911 |
|
Accrued development expense |
|
1,553 |
|
|
|
719 |
|
Accrued compensation and benefits |
|
99 |
|
|
|
83 |
|
Operating lease liabilities, current |
|
84 |
|
|
|
58 |
|
Other accrued liabilities |
|
50 |
|
|
|
94 |
|
Total current liabilities |
|
2,650 |
|
|
|
1,865 |
|
Operating lease liabilities, non-current |
|
213 |
|
|
|
235 |
|
Total liabilities |
|
2,863 |
|
|
|
2,100 |
|
Stockholders' equity |
|
|
|
|
|
Common Stock and additional paid-in-capital |
|
459,634 |
|
|
|
267,121 |
|
Accumulated deficit |
|
(178,447 |
) |
|
|
(174,921 |
) |
Total stockholders' equity |
|
281,187 |
|
|
|
92,200 |
|
Total liabilities and stockholders' equity |
$ |
284,050 |
|
|
$ |
94,300 |
|
|
|
|
|
|
|
1 Alzheimer's Disease International, Dementia Statistics,
available on-line and accessed April 20, 2021:
https://www.alzint.org/about/dementia-facts-figures/dementia-statistics/
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