Cassava Sciences, Inc. (Nasdaq: SAVA), a clinical-stage
biotechnology company focused on Alzheimer’s disease, today
announced financial results for the second quarter ended June 30,
2023. Net loss was $26.4 million, or $0.63 per share, compared to a
net loss of $19.3 million, or $0.48 per share, for the same period
in 2022. Net cash used in operations was $33.2 million during the
first half of 2023. Net cash use in second half 2023 is expected to
be $40 to $50 million, driven primarily by expenses for our
clinical program in Alzheimer’s disease.
“In July 2023, we announced clinical results of
a randomized controlled trial with oral simufilam in over 150
patients with Alzheimer’s disease,” said Remi Barbier, President
& CEO. “In this study simufilam treatment for 6 months slowed
cognitive decline by 38% versus placebo over six-month in patients
with mild-to-moderate Alzheimer’s disease. In addition, oral
simufilam continues to be safe, well-tolerated. We believe these
clinical results are noteworthy.”
Cassava Sciences continues to evaluate its lead
oral drug candidate, simufilam, in Alzheimer’s disease. Over 1,587
patients with mild-to-moderate Alzheimer’s disease are now enrolled
in a Phase 3 program of simufilam, an increase of over 340 patients
in the last three months. The target enrollment is approximately
1,750 patients. Cassava Sciences expects to complete patient
enrollment for its Phase 3 program in Q4 2023.
Financial Results for Second Quarter
2023
- At June 30, 2023, cash and cash equivalents were $168.4
million, with no debt.
- Net loss was $26.4 million, or $0.63 per share. This compares
to a net loss of $19.3 million, or $0.48 per share, for the same
period in 2022. Net loss increased due primarily to increases in
the rate of 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 $33.2 million during the first
six months of 2023.
- Net cash use in operations for second half 2023 is expected to
be $40 to $50 million, driven primarily by expenses for our
clinical program in Alzheimer’s disease.
- Research and development (R&D) expenses were $25.0 million.
This compared to $16.9 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 $3.8
million. This compared to $3.0 million for the same period in 2022.
G&A expenses increased due primarily to increases in
stock-based compensation and activities and expenses related to
legal services.
On-going Phase 3 Studies with
SimufilamCassava Sciences is currently evaluating oral
simufilam for Alzheimer’s disease dementia in two Phase 3 clinical
studies. These are large, randomized, double-blind,
placebo-controlled trials. The Phase 3 program is recruiting a
total of approximately 1,750 patients with mild-to-moderate
Alzheimer’s disease who also meet other study eligibility criteria.
Both Phase 3 studies have received a Special Protocol Assessment
(SPA) from the U.S. Food and Drug Administration. Our Phase 3
studies recruit Alzheimer’s patients in clinical sites in the
United States, Canada, Puerto Rico, South Korea and Australia.
About SimufilamSimufilam is
Cassava Sciences’ proprietary, small molecule (oral) drug candidate
that restores the normal shape and function of altered filamin A
(FLNA) protein in the brain. 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 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 or intended purpose of our randomized
withdrawal study, whose top-line results we announced in July 2023,
or Phase 3 program of simufilam in patients with Alzheimer’s
disease; the ability of simufilam to provide patients with drug
effects; the apparent ability of simufilam to favor patients with
mild Alzheimer’s disease; the safety or tolerance of simufilam in
clinical studies; our current expectations regarding timing of and
the target patient enrollment numbers for our Phase 3 studies; 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 open-label study 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 June 30, |
|
Six months ended June 30, |
|
2023 |
|
2022 |
|
2023 |
|
2022 |
Operating expenses |
|
|
|
|
|
|
|
|
|
|
|
Research and development, net of grant reimbursement |
$ |
24,969 |
|
|
$ |
16,948 |
|
|
$ |
47,089 |
|
|
$ |
31,854 |
|
General and administrative |
|
3,808 |
|
|
|
2,969 |
|
|
|
8,200 |
|
|
|
5,884 |
|
Total operating expenses |
|
28,777 |
|
|
|
19,917 |
|
|
|
55,289 |
|
|
|
37,738 |
|
Operating loss |
|
(28,777 |
) |
|
|
(19,917 |
) |
|
|
(55,289 |
) |
|
|
(37,738 |
) |
Interest income |
|
2,198 |
|
|
|
314 |
|
|
|
4,249 |
|
|
|
345 |
|
Other income, net |
|
203 |
|
|
|
275 |
|
|
|
393 |
|
|
|
538 |
|
Net loss |
$ |
(26,376 |
) |
|
$ |
(19,328 |
) |
|
$ |
(50,647 |
) |
|
$ |
(36,855 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per share, basic and diluted |
$ |
(0.63 |
) |
|
$ |
(0.48 |
) |
|
$ |
(1.21 |
) |
|
$ |
(0.92 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Weighted-average shares used in computing net loss per share, basic
and diluted |
|
41,793 |
|
|
|
40,015 |
|
|
|
41,766 |
|
|
|
39,989 |
|
|
|
CONDENSED CONSOLIDATED BALANCE SHEETS |
(unaudited, in thousands) |
|
June 30,2023 |
|
December 31,2022 |
Assets |
|
|
|
|
|
Current assets |
|
|
|
|
|
Cash and cash equivalents |
$ |
168,438 |
|
|
$ |
201,015 |
|
Prepaid expenses and other current assets |
|
6,095 |
|
|
|
10,211 |
|
Total current assets |
|
174,533 |
|
|
|
211,226 |
|
Property and equipment, net |
|
22,328 |
|
|
|
22,864 |
|
Operating lease right-of-use assets |
|
— |
|
|
|
122 |
|
Intangible assets, net |
|
387 |
|
|
|
622 |
|
Total assets |
$ |
197,248 |
|
|
$ |
234,834 |
|
Liabilities and stockholders’ equity |
|
|
|
|
|
Current liabilities |
|
|
|
|
|
Accounts payable |
$ |
10,338 |
|
|
$ |
4,017 |
|
Accrued development expense |
|
7,044 |
|
|
|
2,280 |
|
Accrued compensation and benefits |
|
220 |
|
|
|
170 |
|
Operating lease liabilities, current |
|
— |
|
|
|
104 |
|
Other accrued liabilities |
|
293 |
|
|
|
492 |
|
Total current liabilities |
|
17,895 |
|
|
|
7,063 |
|
Operating lease liabilities, non-current |
|
— |
|
|
|
35 |
|
Other non- current liabilities |
|
— |
|
|
|
197 |
|
Total liabilities |
|
17,895 |
|
|
|
7,295 |
|
Stockholders’ equity |
|
|
|
|
|
Common Stock and additional paid-in-capital |
|
513,552 |
|
|
|
511,091 |
|
Accumulated deficit |
|
(334,199 |
) |
|
|
(283,552 |
) |
Total stockholders’ equity |
|
179,353 |
|
|
|
227,539 |
|
Total liabilities and stockholders’ equity |
$ |
197,248 |
|
|
$ |
234,834 |
|
|
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