Cassava Sciences Reports Third Quarter 2021 Financial Results
10 Novembro 2021 - 11:00AM
Cassava Sciences, Inc. (Nasdaq: SAVA), a clinical-stage
biotechnology company focused on Alzheimer’s disease, today
announced financial results for the third quarter ended September
30, 2021. Net loss for the third quarter ended September 30, 2021,
was $9.6 million, or $0.24 per share, compared to a net loss of
$1.4 million, or $0.06 per share, for the same period in 2020. Net
cash used in operations was $22.2 million during the first nine
months of 2021. Net cash use for operations for full-year 2021 is
expected to be approximately $25 to $30 million, up from previous
guidance of $20 to $25 million due to a significant prepayment made
to a contract research organization for our Phase 3 clinical
program with simufilam. An additional $22.0 million was used during
the third quarter of 2021 for an all-cash purchase of an office
complex in Austin, Texas, which will serve as the Company’s future
corporate headquarters. Cash and cash equivalents were $241.5
million as of September 30, 2021, with no debt.
Financial Highlights for Third Quarter
2021
- At September 30, 2021, cash and
cash equivalents were $241.5 million, compared to $93.5 million at
December 31, 2020, with no debt.
- Net cash used in operations during
the nine months ended September 30, 2021 was $22.2 million, net of
reimbursements received from the National Institutes of Health
(NIH) grant awards. An additional $22.0 million was used during the
third quarter of 2021 for the purchase of an office complex in
Austin, Texas, which will serve as the Company’s future corporate
headquarters.
- Net cash use for operations for
full year 2021 is expected to be approximately $25 to $30 million,
up from previous guidance of $20 to $25 million due to a prepayment
made to a contract research organization for Phase 3 clinical
program with simufilam. Net cash use in 2021 is expected to be
driven by prepayments made for clinical trial management services
for Phase 3 studies, higher headcount and personnel expenses,
manufacturing costs around large-scale drug supply, and
professional services expenses related to clinical programs.
- R&D expenses were $8.0 million
compared to $0.4 million for the same period in 2020. This increase
was due primarily to costs related to manufacture of clinical trial
supplies for and the initiation of a Phase 3 clinical program with
simufilam, costs of an on-going open-label study in simufilam, as
well as increased personnel expenses. These increases were
partially offset by an increase in grant funding received from NIH
and recorded as a reduction in research and development
expenses.
- Research grant funding
reimbursements of $2.0 million were received from NIH and recorded
as a reduction in research and development (R&D) expenses. This
compared to $1.0 million of NIH grant receipts received for the
same quarter in 2020.
- General and administrative
(G&A) expenses were $1.7 million compared to $1.0 million for
the same period in 2020. This increase was due primarily to higher
legal fees and insurance costs as well as depreciation and
amortization for an office complex in Austin, Texas, purchased in
third quarter 2021 as compared to the prior year.
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. We are testing simufilam, our
lead drug candidate for people with Alzheimer’s disease, in a Phase
3 clinical program, an open-label study and a cognition maintenance
extension study. 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;
the timing, enrollment, duration and other details of a Phase 3
clinical program with simufilam; 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
CONSOLIDATED STATEMENTS OF OPERATIONS |
|
(unaudited, in
thousands, except per share amounts) |
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended
September 30, |
|
Nine months ended
September 30, |
|
|
2021 |
|
|
2020 |
|
|
2021 |
|
|
2020 |
|
|
Operating
expenses |
|
|
|
|
|
|
|
|
|
|
|
|
Research and development, net of grant reimbursement |
$ |
8,041 |
|
|
$ |
399 |
|
|
$ |
14,471 |
|
|
$ |
1,534 |
|
|
General and administrative |
|
1,712 |
|
|
|
1,038 |
|
|
|
3,953 |
|
|
|
2,634 |
|
|
Gain on sale of property and equipment |
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(346 |
) |
|
Total operating expenses |
|
9,753 |
|
|
|
1,437 |
|
|
|
18,424 |
|
|
|
3,822 |
|
|
Operating
loss |
|
(9,753 |
) |
|
|
(1,437 |
) |
|
|
(18,424 |
) |
|
|
(3,822 |
) |
|
Interest
income |
|
15 |
|
|
|
7 |
|
|
|
35 |
|
|
|
106 |
|
|
Other
income, net |
|
176 |
|
|
|
— |
|
|
|
176 |
|
|
|
— |
|
|
Net
loss |
$ |
(9,562 |
) |
|
$ |
(1,430 |
) |
|
$ |
(18,213 |
) |
|
$ |
(3,716 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per
share, basic and diluted |
$ |
(0.24 |
) |
|
$ |
(0.06 |
) |
|
$ |
(0.46 |
) |
|
$ |
(0.15 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted-average shares used in computing net loss per share, basic
and diluted |
|
39,957 |
|
|
|
24,972 |
|
|
|
39,218 |
|
|
|
24,745 |
|
|
|
|
|
|
|
|
|
|
|
|
CONDENSED
CONSOLIDATED BALANCE SHEETS |
|
(unaudited, in
thousands) |
|
|
|
|
|
|
|
|
September 30, 2021 |
|
December 31, 2020 |
|
Assets |
|
|
|
|
|
|
|
|
|
|
|
|
Current
assets |
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
|
|
|
|
|
$ |
241,524 |
|
|
$ |
93,506 |
|
|
Prepaid expenses and other current assets |
|
|
|
|
|
|
|
10,391 |
|
|
|
488 |
|
|
Total current assets |
|
|
|
|
|
|
|
251,915 |
|
|
|
93,994 |
|
|
Operating
lease right-of-use assets |
|
|
|
|
|
|
|
231 |
|
|
|
295 |
|
|
Property and
equipment, net |
|
|
|
|
|
|
|
20,695 |
|
|
|
11 |
|
|
Intangible
assets, net |
|
|
|
|
|
|
|
1,209 |
|
|
|
— |
|
|
Other
assets |
|
|
|
|
|
|
|
199 |
|
|
|
— |
|
|
Total assets |
|
|
|
|
|
|
$ |
274,249 |
|
|
$ |
94,300 |
|
|
Liabilities and stockholders' equity |
|
|
|
|
|
|
|
|
|
|
|
|
Current
liabilities |
|
|
|
|
|
|
|
|
|
|
|
|
Accounts payable |
|
|
|
|
|
|
$ |
2,345 |
|
|
$ |
911 |
|
|
Accrued development expense |
|
|
|
|
|
|
|
3,251 |
|
|
|
719 |
|
|
Accrued compensation and benefits |
|
|
|
|
|
|
|
126 |
|
|
|
83 |
|
|
Operating lease liabilities, current |
|
|
|
|
|
|
|
95 |
|
|
|
58 |
|
|
Other accrued liabilities |
|
|
|
|
|
|
|
509 |
|
|
|
94 |
|
|
Total current liabilities |
|
|
|
|
|
|
|
6,326 |
|
|
|
1,865 |
|
|
Operating lease liabilities, non-current |
|
|
|
|
|
|
|
164 |
|
|
|
235 |
|
|
Other non- current liabilities |
|
|
|
|
|
|
|
194 |
|
|
|
— |
|
|
Total liabilities |
|
|
|
|
|
|
|
6,684 |
|
|
|
2,100 |
|
|
Stockholders' equity |
|
|
|
|
|
|
|
|
|
|
|
|
Common Stock and additional paid-in-capital |
|
|
|
|
|
|
|
460,699 |
|
|
|
267,121 |
|
|
Accumulated deficit |
|
|
|
|
|
|
|
(193,134 |
) |
|
|
(174,921 |
) |
|
Total stockholders' equity |
|
|
|
|
|
|
|
267,565 |
|
|
|
92,200 |
|
|
Total liabilities and stockholders' equity |
|
|
|
|
|
|
$ |
274,249 |
|
|
$ |
94,300 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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