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,
2022, a mid-year corporate update, and interim clinical results of
an open-label study with simufilam. Simufilam is Cassava Sciences’
lead drug candidate for the proposed treatment of Alzheimer’s
disease. SavaDx is Cassava Sciences’ investigational diagnostic
candidate to detect Alzheimer’s disease from a simple blood draw.
“I’m pleased with our operating performance in
the first half of 2022,” said Remi Barbier, President & CEO.
“I’m also humbled by the hard work of our team members and clinical
partners. Persistence and a focus on performance are key when
you’re trying to beat Alzheimer’s disease.”
Update on Patient Enrollment for Phase 3
ProgramA total of over 400 patients are now enrolled in
our on-going Phase 3 program of simufilam in Alzheimer’s disease.
Enrollment is almost evenly split between the two Phase 3
studies.
Overview of Phase 3
Program with Simufilam in Alzheimer's DiseaseOur Phase 3
program consists of two double-blind, randomized,
placebo-controlled studies of simufilam in patients with
mild-to-moderate Alzheimer’s disease. Both Phase 3 studies have
Special Protocol Assessments (SPA) from the U.S. Food and Drug
Administration. Both studies have the same co-primary efficacy
endpoints: ADAS-Cog12 (a cognitive scale) and ADCS-ADL (a
functional scale). A secondary efficacy endpoint for both studies
is iADRS, a clinical tool that combines cognitive and functional
scores from ADAS-Cog & ADCS-ADL. Patients are now being
screened in clinical trial sites in the U.S., Canada, Puerto Rico
and Australia.
RETHINK-ALZ is the trade name of our 52-week
Phase 3 study. This randomized, double-blind, placebo-controlled
study is designed to evaluate the safety & efficacy of oral
simufilam 100 mg or placebo, twice daily, over 52 weeks in
approximately 750 patients with Alzheimer’s disease.
REFOCUS-ALZ is the trade name of our 76-week
Phase 3 study. This randomized, double-blind, placebo-controlled
study is designed to evaluate the safety & efficacy of oral
simufilam 100 mg, 50 mg or placebo, twice daily, over 76 weeks in
approximately 1,000 patients with Alzheimer’s.
Future Open-label Extension Study for
the Phase 3 ProgramIn the second half of 2022, we expect
to initiate an open-label extension study for our Phase 3 program.
This new study is designed to provide no-cost access to simufilam
to patients with Alzheimer’s disease who have successfully
completed a Phase 3 study of simufilam.
On-going Open-label Study
with Simufilam in Alzheimer's DiseaseIn March
2020, we initiated a long-term, open-label study to
evaluate simufilam in patients with mild-to-moderate
Alzheimer’s disease. The study is intended to monitor the
long-term safety and tolerability of simufilam 100 mg
twice daily over 12 months or more. This study has reached its
target enrollment of approximately 200 patients. We expect all
patients for this study will complete drug treatment in Q4 2022. We
expect to announce top-line clinical results for this study
approximately year-end 2022.
On-going Open-label Study - Interim
Analysis on 100 Subjects at 12 Months An interim analysis
was conducted on the first 100 evaluable patients who completed at
least 12 months of open-label treatment with simufilam 100 mg
twice daily. Top-line results of this interim analysis show that
from baseline to month-12:
- Drug appears
safe and well tolerated.
- Overall
ADAS-Cog11 scores improved an average of 1.5 points (S.D. ± 6.6;
P<0.05)
- 63% of the 100
patients showed an improvement in ADAS-Cog11 scores, and this group
of patients improved an average of 5.6 points (S.D. ± 3.8).
- An additional
21% of the 100 patients declined less than 5 points on ADAS-Cog11,
and this group of patients declined an average of 2.7 points (S.D.
± 1.4).
The 11-item Alzheimer’s Disease Assessment
Scale–Cognitive subscale (ADAS-Cog) was originally developed by the
research community to measure cognitive impairment in patients with
Alzheimer’s disease. ADAS-Cog is often used in clinical studies of
patients with Alzheimer’s because it can help determine incremental
improvements or declines in cognition over time.
Standard deviation (“S.D.”) is a measure of how
dispersed the data is in relation to the average. A low standard
deviation generally shows the data are closely clustered around the
average. A high standard deviation generally shows that the data is
widely spread.
All clinical data from our open-label study are
inherently exploratory in nature and, as with all open-label data,
should be interpreted with caution. Data results from our
open-label study does not constitute, and should not be interpreted
as, evidence of therapeutic benefit for simufilam.
Cognition Maintenance Study
(CMS) with Simufilam in Alzheimer's
DiseaseIn May 2021, we initiated a Cognition Maintenance
Study (CMS). This is a double-blind, randomized, placebo-controlled
study of simufilam in patients with mild-to-moderate Alzheimer’s
disease. Study participants are randomized (1:1) to simufilam or
placebo for six months. The CMS is designed to evaluate simufilam’s
effects on cognition and health outcomes in Alzheimer’s patients
who continue with drug treatment versus patients who discontinue
drug treatment. To enroll in the CMS, patients must have previously
completed 12 months or more of open-label treatment with
simufilam.
The target enrollment for the CMS is 100 or more
patients. Over 50 patients have now completed this study. Our goal
is to complete patient enrollment for the CMS in Q4 2022. We expect
to announce clinical results of the CMS approximately third-quarter
2023.
SavaDxOur investigational
product candidate, called SavaDx, is an early-stage program focused
on detecting the presence of Alzheimer’s disease from a simple
blood draw. SavaDx is currently designed as an antibody-based
detection system for altered filamin A (FLNA) protein. Working with
third parties, we continue to evaluate an innovative method to
detect FLNA without the use of antibodies. For business, technical
and personnel reasons, we continue to prioritize the development of
simufilam, our novel drug candidate, over SavaDx.
Financial UpdateNet loss for
the second quarter 2022 was $19.3 million, or $0.48 per share,
compared to a net loss of $5.1 million, or $0.13 per share, for the
same period in 2021. Net cash used in operations was $34.6 million
during the first six months of 2022. Net cash use for operations
for full-year 2022 is expected to be approximately $80 to $90
million. Cash and cash equivalents were $197.2 million as of June
30, 2022, with no debt.
Financial Results for Second Quarter
2022
- At June 30,
2022, cash and cash equivalents were $197.2 million, with no
debt.
- Net loss was
$19.3 million, or $0.48 per share. This compares to a net loss of
$5.1 million, or $0.13 per share, for the same period in 2021. Net
loss increased compared to the prior period due primarily to a
significant increase in our R&D activities for a Phase 3
program of simufilam in Alzheimer’s disease.
- Net cash used in
operations was $34.6 million during the first six months of
2022.
- Net cash use in
operations for full year 2022 is expected to be approximately $80
to $90 million.
- Research and
development (R&D) expenses were $16.9 million. This compared to
$3.9 million for the same period in 2021. R&D expenses
increased compared to the prior period due primarily to increased
activities and expenses related to clinical and pre-clinical
studies and support functions and personnel expenses.
- General and
administrative (G&A) expenses were $3.0 million. This compared
to $1.2 million for the same period in 2021. G&A expenses
increased compared to the prior period due primarily to increased
activities and expenses related to legal services as well as
depreciation and amortization.
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)
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, Inc. 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. For more information,
please visit: https://www.CassavaSciences.com
For More Information Please
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, 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, geography and other details of a
Phase 3 clinical program with simufilam; plans to release clinical
results of our open-label study or CMS study, and the timing
thereof; the development path for SavaDx and the use of an
alternative method of detection; 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 interim data and analysis
should not be relied upon as predictive of full study results for
this study, 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, 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, 2021, 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, |
|
2022 |
|
|
2021 |
|
|
2022 |
|
|
2021 |
|
Operating expenses |
|
|
|
|
|
|
|
|
|
|
|
Research and development, net of grant reimbursement |
$ |
16,948 |
|
|
$ |
3,901 |
|
|
$ |
31,854 |
|
|
$ |
6,430 |
|
General and administrative |
|
2,969 |
|
|
|
1,237 |
|
|
|
5,884 |
|
|
|
2,241 |
|
Total operating expenses |
|
19,917 |
|
|
|
5,138 |
|
|
|
37,738 |
|
|
|
8,671 |
|
Operating loss |
|
(19,917 |
) |
|
|
(5,138 |
) |
|
|
(37,738 |
) |
|
|
(8,671 |
) |
Interest income |
|
314 |
|
|
|
13 |
|
|
|
345 |
|
|
|
20 |
|
Other income, net |
|
275 |
|
|
|
— |
|
|
|
538 |
|
|
|
— |
|
Net loss |
$ |
(19,328 |
) |
|
$ |
(5,125 |
) |
|
$ |
(36,855 |
) |
|
$ |
(8,651 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per share, basic and diluted |
$ |
(0.48 |
) |
|
$ |
(0.13 |
) |
|
$ |
(0.92 |
) |
|
$ |
(0.22 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Weighted-average shares used in computing net loss per share, basic
and diluted |
|
40,015 |
|
|
|
39,953 |
|
|
|
39,989 |
|
|
|
38,843 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CONDENSED CONSOLIDATED BALANCE SHEETS |
(unaudited, in thousands) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
June 30, 2022 |
|
December 31, 2021 |
Assets |
|
|
|
|
|
|
|
|
|
|
|
Current assets |
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
|
|
|
|
|
$ |
197,232 |
|
|
$ |
233,437 |
|
Prepaid expenses and other current assets |
|
|
|
|
|
|
|
6,969 |
|
|
|
11,045 |
|
Total current assets |
|
|
|
|
|
|
|
204,201 |
|
|
|
244,482 |
|
Property and equipment, net |
|
|
|
|
|
|
|
22,155 |
|
|
|
20,616 |
|
Operating lease right-of-use assets |
|
|
|
|
|
|
|
166 |
|
|
|
210 |
|
Intangible assets, net |
|
|
|
|
|
|
|
859 |
|
|
|
1,075 |
|
Other assets |
|
|
|
|
|
|
|
— |
|
|
|
399 |
|
Total assets |
|
|
|
|
|
|
$ |
227,381 |
|
|
$ |
266,782 |
|
Liabilities and stockholders' equity |
|
|
|
|
|
|
|
|
|
|
|
Current liabilities |
|
|
|
|
|
|
|
|
|
|
|
Accounts payable |
|
|
|
|
|
|
$ |
4,758 |
|
|
$ |
7,126 |
|
Accrued development expense |
|
|
|
|
|
|
|
3,318 |
|
|
|
2,803 |
|
Accrued compensation and benefits |
|
|
|
|
|
|
|
176 |
|
|
|
1,877 |
|
Operating lease liabilities, current |
|
|
|
|
|
|
|
100 |
|
|
|
97 |
|
Other accrued liabilities |
|
|
|
|
|
|
|
370 |
|
|
|
631 |
|
Total current liabilities |
|
|
|
|
|
|
|
8,722 |
|
|
|
12,534 |
|
Operating lease liabilities, non-current |
|
|
|
|
|
|
|
88 |
|
|
|
139 |
|
Other non- current liabilities |
|
|
|
|
|
|
|
201 |
|
|
|
194 |
|
Total liabilities |
|
|
|
|
|
|
|
9,011 |
|
|
|
12,867 |
|
Stockholders' equity |
|
|
|
|
|
|
|
|
|
|
|
Common Stock and additional paid-in-capital |
|
|
|
|
|
|
|
462,531 |
|
|
|
461,221 |
|
Accumulated deficit |
|
|
|
|
|
|
|
(244,161 |
) |
|
|
(207,306 |
) |
Total stockholders' equity |
|
|
|
|
|
|
|
218,370 |
|
|
|
253,915 |
|
Total liabilities and stockholders' equity |
|
|
|
|
|
|
$ |
227,381 |
|
|
$ |
266,782 |
|
Cassava Sciences (NASDAQ:SAVA)
Historical Stock Chart
From Aug 2024 to Sep 2024
Cassava Sciences (NASDAQ:SAVA)
Historical Stock Chart
From Sep 2023 to Sep 2024