Cassava Sciences, Inc. (Nasdaq: SAVA), a biotechnology company
focused on Alzheimer’s disease, today reported financial and
operating results for the third quarter ended September 30, 2023.
“In the third quarter, Cassava Sciences made
important progress with simufilam, our lead drug candidate,” said
Remi Barbier, President & CEO. “This progress exemplifies our
unwavering commitment to develop a new treatment option for people
with Alzheimer’s.”
Simufilam is Cassava Sciences’ proprietary oral
drug candidate. This investigational drug binds to altered filamin
A protein in the brain and restores its normal shape and function.
By targeting altered filamin A, simufilam may help patients with
Alzheimer’s achieve better health outcomes.
Cassava Sciences recently announced the
completion of enrollment in a pair of on-going Phase 3 trials to
evaluate the safety and efficacy of oral simufilam versus placebo
in Alzheimer's disease dementia. A total of 1,929 patients were
randomized in these two Phase 3 trials.
The first Phase 3 trial (NCT04994483) has a
52-week treatment period; 804 Alzheimer’s patients were randomized
into this study. Top-line results for the 52-week Phase 3 study are
currently expected approximately year-end 2024.
The second Phase 3 trial (NCT05026177) has a
76-week treatment period; 1,125 Alzheimer’s patients were
randomized into this study. Top-line results for the 76-week Phase
3 study are currently expected approximately mid-year 2025.
Cassava Sciences recently presented interim
safety MRI data that suggests simufilam is not associated with
treatment-emergent ARIA, which are imaging abnormalities. In
addition, in September 2023, a Data and Safety Monitoring Board
(DSMB), recommended that the Phase 3 studies continue as planned,
without modification. Finally, in September 2023, a fourth academic
institution showed non-clinical data in support of the biological
activity of simufilam.
Financial Results for Third Quarter
2023
- At September
30, 2023, cash and cash equivalents were $142.4 million, with no
debt.
- Net loss was
$25.7 million, or $0.61 per share. This compares to a net loss of
$20.3 million, or $0.51 per share, for the same period in 2022. Net
loss increased due primarily to increases in patient enrollment and
associated costs to conduct the Phase 3 clinical program, as well
as other studies with simufilam.
- Net cash used
in operations was $59.7 million during the first nine months of
2023.
- Net cash use in
operations for second half 2023 is expected to be $40 to $50
million, consistent with previous guidance and driven primarily by
expenses for our clinical program in Alzheimer’s disease.
- Research and
development (R&D) expenses were $23.6 million. This compared to
$18.5 million for the same period in 2022. R&D expenses
increased due primarily to increasing patient enrollment and costs
to conduct the Phase 3 clinical program, as well as other studies
with simufilam.
- General and administrative (G&A) expenses were $4.3
million. This compared to $2.8 million for the same period in 2022.
G&A expenses increased due to activities and expenses related
to legal services as well as increases in stock-based
compensation.
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 novel
science is based on stabilizing—but not removing—a critical protein
in the brain. Our product candidates have not been approved by any
regulatory authority, and their safety, efficacy or other desirable
attributes have not been established.
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, that may include but are not limited to: the
design, scope, conduct, continuation, completion, intended purpose,
or future results of our on-going Phase 3 program of simufilam in
patients with Alzheimer's disease; the suitability of clinical data
from our Phase 3 program to support the filing of an NDA; any
findings or recommendations by the DSMB relating to the interim
safety of simufilam in our on-going Phase 3 clinical trials;
interim MRI safety data for the Phase 3 program, including ARIA;
the risk of current or future findings of treatment-emergent ARIA
in our clinical program of simufilam; any expected clinical results
of Phase 3 studies; the treatment of people with Alzheimer’s
disease dementia; the safety or efficacy of simufilam in people
with Alzheimer’s disease dementia; expected cash use in future
periods; comments made by our employees regarding simufilam, drug
effect, and 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,” “forecast,” “intend,” “plan,” “possible,”
“potential,” and other words and terms of similar meaning.
Simufilam is our investigational product
candidate. It is not approved by any regulatory authority in any
jurisdiction and its safety, efficacy or other desirable attributes
have not been established in patients.
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.
Clinical results and analyses of our previous studies should not be
relied upon as predictive of Phase 3 studies or any other study.
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, 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.
– 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, |
|
|
2023 |
|
|
2022 |
|
|
2023 |
|
|
2022 |
|
Operating expenses |
|
|
|
|
|
|
|
|
|
|
|
|
Research and development, net of grant reimbursement |
$ |
23,603 |
|
|
$ |
18,526 |
|
|
$ |
70,692 |
|
|
$ |
50,380 |
|
General and administrative |
|
4,276 |
|
|
|
2,819 |
|
|
|
12,476 |
|
|
|
8,703 |
|
Total operating expenses |
|
27,879 |
|
|
|
21,345 |
|
|
|
83,168 |
|
|
|
59,083 |
|
Operating loss |
|
(27,879 |
) |
|
|
(21,345 |
) |
|
|
(83,168 |
) |
|
|
(59,083 |
) |
Interest income |
|
2,005 |
|
|
|
878 |
|
|
|
6,254 |
|
|
|
1,223 |
|
Other income, net |
|
223 |
|
|
|
210 |
|
|
|
616 |
|
|
|
748 |
|
Net loss |
$ |
(25,651 |
) |
|
$ |
(20,257 |
) |
|
$ |
(76,298 |
) |
|
$ |
(57,112 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per share, basic and diluted |
$ |
(0.61 |
) |
|
$ |
(0.51 |
) |
|
$ |
(1.82 |
) |
|
$ |
(1.43 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted-average shares used in computing net loss per share, basic
and diluted |
|
42,002 |
|
|
|
40,050 |
|
|
|
41,845 |
|
|
|
40,009 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CONDENSED CONSOLIDATED BALANCE SHEETS |
|
|
|
|
(unaudited, in thousands) |
|
|
|
|
|
|
|
|
|
|
|
September 30, 2023 |
|
December 31, 2022 |
|
Assets |
|
|
|
|
|
|
|
|
|
|
|
|
Current assets |
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
|
|
|
|
|
$ |
142,350 |
|
|
$ |
201,015 |
|
Prepaid expenses and other current assets |
|
|
|
|
|
|
|
7,834 |
|
|
|
10,211 |
|
Total current assets |
|
|
|
|
|
|
|
150,184 |
|
|
|
211,226 |
|
Property and equipment, net |
|
|
|
|
|
|
|
22,077 |
|
|
|
22,864 |
|
Operating lease right-of-use assets |
|
|
|
|
|
|
|
— |
|
|
|
122 |
|
Intangible assets, net |
|
|
|
|
|
|
|
268 |
|
|
|
622 |
|
Total assets |
|
|
|
|
|
|
$ |
172,529 |
|
|
$ |
234,834 |
|
Liabilities and stockholders' equity |
|
|
|
|
|
|
|
|
|
|
|
|
Current liabilities |
|
|
|
|
|
|
|
|
|
|
|
|
Accounts payable |
|
|
|
|
|
|
$ |
9,492 |
|
|
$ |
4,017 |
|
Accrued development expense |
|
|
|
|
|
|
|
7,344 |
|
|
|
2,280 |
|
Accrued compensation and benefits |
|
|
|
|
|
|
|
187 |
|
|
|
170 |
|
Operating lease liabilities, current |
|
|
|
|
|
|
|
— |
|
|
|
104 |
|
Other accrued liabilities |
|
|
|
|
|
|
|
391 |
|
|
|
492 |
|
Total current liabilities |
|
|
|
|
|
|
|
17,414 |
|
|
|
7,063 |
|
Operating lease liabilities, non-current |
|
|
|
|
|
|
|
— |
|
|
|
35 |
|
Other non- current liabilities |
|
|
|
|
|
|
|
— |
|
|
|
197 |
|
Total liabilities |
|
|
|
|
|
|
|
17,414 |
|
|
|
7,295 |
|
Stockholders' equity |
|
|
|
|
|
|
|
|
|
|
|
|
Common Stock and additional paid-in-capital |
|
|
|
|
|
|
|
514,965 |
|
|
|
511,091 |
|
Accumulated deficit |
|
|
|
|
|
|
|
(359,850 |
) |
|
|
(283,552 |
) |
Total stockholders' equity |
|
|
|
|
|
|
|
155,115 |
|
|
|
227,539 |
|
Total liabilities and stockholders' equity |
|
|
|
|
|
|
$ |
172,529 |
|
|
$ |
234,834 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cassava Sciences (NASDAQ:SAVA)
과거 데이터 주식 차트
부터 4월(4) 2024 으로 5월(5) 2024
Cassava Sciences (NASDAQ:SAVA)
과거 데이터 주식 차트
부터 5월(5) 2023 으로 5월(5) 2024