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, 2022 and provided a clinical update on its Phase 3 clinical
program of simufilam in Alzheimer’s disease. Simufilam is Cassava
Sciences’ lead drug candidate for the proposed treatment of
Alzheimer’s disease.
“The clinical development of oral simufilam for
Alzheimer’s disease continues to make headway,” said Remi Barbier,
President & CEO. “We now have over 650 patients enrolled in our
on-going Phase 3 studies of simufilam in Alzheimer's disease, up
from 150 patients approximately six months ago. We also look
forward to presenting new clinical data for simufilam from two
other ongoing studies in Alzheimer’s disease.”
Net loss for third quarter 2022 was $20.3
million, or $0.51 per share, compared to a net loss of $9.6
million, or $0.24 per share, for the same period in 2021. Net cash
used in operations was $56.2 million during the first nine months
of 2022. Net cash use for operations for full-year 2022 is expected
to be approximately $80 to $90 million, consistent with previous
guidance. Cash and cash equivalents were $174.7 million as of
September 30, 2022, with no debt.
Financial Results for Third Quarter
2022
- At September
30, 2022, cash and cash equivalents were $174.7 million, with no
debt.
- Net loss was
$20.3 million, or $0.51 per share. This compares to a net loss of
$9.6 million, or $0.24 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 $56.2 million during the first nine months of
2022.
- Net cash use in
operations for full year 2022 is expected to be approximately $80
to $90 million, consistent with previous guidance.
- Research and
development (R&D) expenses were $18.5 million. This compared to
$8.0 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.
- General and
administrative (G&A) expenses were $2.8 million. This compared
to $1.7 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.
Overview of On-going Phase 3 Clinical
Program Cassava Sciences’ Phase 3 program consists of two
randomized controlled trials of oral simufilam in patients with
mild-to-moderate Alzheimer’s disease. The two studies are named
RETHINK-ALZ and REFOCUS-ALZ. In 2021, both studies received Special
Protocol Assessments (SPA) from the U.S. Food and Drug
Administration.
Over 650 patients are now enrolled in our Phase
3 studies. Studies are being conducted in over 100 clinical trial
sites across the U.S., Canada, Puerto Rico, South Korea and
Australia.
Cassava Sciences’ RETHINK-ALZ Phase 3 study is
designed to evaluate the safety and efficacy of oral simufilam 100
mg in enhancing cognition and slowing functional decline over 52
weeks. This randomized, double-blind, placebo-controlled study
plans to enroll approximately 750 patients with mild-to-moderate
Alzheimer’s disease. Patients are randomized (1:1) to simufilam 100
mg or matching placebo twice daily.
Cassava Sciences’ REFOCUS-ALZ Phase 3 study is
designed to evaluate the safety and efficacy of oral simufilam 100
mg and 50 mg over 76 weeks. This randomized, double-blind,
placebo-controlled study plans to enroll approximately 1,000
patients with mild-to-moderate Alzheimer’s disease. Patients are
randomized (1:1:1) to simufilam 100 mg, 50 mg, or matching placebo
twice daily.
Both of Cassava Sciences’ Phase 3 studies have
the same co-primary efficacy endpoints: ADAS-Cog12 (a cognitive
scale) and ADCS-ADL (a functional scale). A secondary efficacy
endpoint is iADRS, a clinical tool that combines cognitive and
functional scores from ADAS-Cog & ADCS-ADL.
Open-label Study – closed
enrollmentIn March 2020, we initiated a long-term,
open-label study to evaluate simufilam, our lead drug
candidate, 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 for 12
or more months. The open-label study has reached its final target
enrollment of approximately 200 patients with Alzheimer’s disease.
We expect to announce open-label study results approximately
yearend 2022, consistent with our prior guidance.
Cognition Maintenance Study (CMS) –
on-goingIn May 2021, we initiated a Cognition Maintenance
Study (CMS). This is a randomized, double-blind, placebo-controlled
study of oral simufilam in patients with mild-to-moderate
Alzheimer’s disease. Patients are randomized (1:1) to simufilam 100
mg or matching placebo twice daily for six months. To enroll in the
CMS, patients must have previously completed 12 months or more of
open-label treatment with simufilam. The CMS is designed to
evaluate simufilam’s effects on in Alzheimer’s patients who
continue with drug treatment versus patients who discontinue drug
treatment. Over 100 patients are now enrolled in the CMS and over
65 patients have completed this study. We expect to announce CMS
study results approximately Q3 2023, consistent with our prior
guidance.
SavaDx – on-goingThis
earlier-stage program refers to the detection of Alzheimer’s
disease with a simple blood test. SavaDx was initially designed as
an antibody-based detection system for altered filamin A (FLNA). We
are currently evaluating a new approach—based on mass
spectrometry—to detect FLNA in plasma without the use of
antibodies. Mass spectrometry is an analytical tool that measures
the mass-to-charge ratio (m/z) of a molecule present in a
sample.
About SimufilamSimufilam
(sim-uh-FILL-am) is Cassava Sciences’ 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. The Company’s 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,
oreschoen@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 mass spec
as 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 any of our studies. 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
September 30, |
|
Nine months ended
September 30, |
|
|
2022 |
|
|
2021 |
|
|
2022 |
|
|
2021 |
|
|
Operating
expenses |
|
|
|
|
|
|
|
|
|
|
|
|
Research and development, net of grant reimbursement |
$ |
18,526 |
|
|
$ |
8,041 |
|
|
$ |
50,380 |
|
|
$ |
14,471 |
|
|
General and administrative |
|
2,819 |
|
|
|
1,712 |
|
|
|
8,703 |
|
|
|
3,953 |
|
|
Total operating expenses |
|
21,345 |
|
|
|
9,753 |
|
|
|
59,083 |
|
|
|
18,424 |
|
|
Operating
loss |
|
(21,345 |
) |
|
|
(9,753 |
) |
|
|
(59,083 |
) |
|
|
(18,424 |
) |
|
Interest
income |
|
878 |
|
|
|
15 |
|
|
|
1,223 |
|
|
|
35 |
|
|
Other
income, net |
|
210 |
|
|
|
176 |
|
|
|
748 |
|
|
|
176 |
|
|
Net
loss |
$ |
(20,257 |
) |
|
$ |
(9,562 |
) |
|
$ |
(57,112 |
) |
|
$ |
(18,213 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per
share, basic and diluted |
$ |
(0.51 |
) |
|
$ |
(0.24 |
) |
|
$ |
(1.43 |
) |
|
$ |
(0.46 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted-average shares used in computing net loss per share, basic
and diluted |
|
40,050 |
|
|
|
39,957 |
|
|
|
40,009 |
|
|
|
39,218 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CONDENSED
CONSOLIDATED BALANCE SHEETS |
|
(unaudited, in
thousands) |
|
|
|
|
|
|
|
|
September 30, 2022 |
|
December 31, 2021 |
|
Assets |
|
|
|
|
|
|
|
|
|
|
|
|
Current
assets |
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
|
|
|
|
|
$ |
174,662 |
|
|
$ |
233,437 |
|
|
Prepaid expenses and other current assets |
|
|
|
|
|
|
|
8,610 |
|
|
|
11,045 |
|
|
Total current assets |
|
|
|
|
|
|
|
183,272 |
|
|
|
244,482 |
|
|
Property and
equipment, net |
|
|
|
|
|
|
|
23,130 |
|
|
|
20,616 |
|
|
Operating
lease right-of-use assets |
|
|
|
|
|
|
|
144 |
|
|
|
210 |
|
|
Intangible
assets, net |
|
|
|
|
|
|
|
740 |
|
|
|
1,075 |
|
|
Other
assets |
|
|
|
|
|
|
|
— |
|
|
|
399 |
|
|
Total assets |
|
|
|
|
|
|
$ |
207,286 |
|
|
$ |
266,782 |
|
|
Liabilities and stockholders' equity |
|
|
|
|
|
|
|
|
|
|
|
|
Current
liabilities |
|
|
|
|
|
|
|
|
|
|
|
|
Accounts payable |
|
|
|
|
|
|
$ |
3,534 |
|
|
$ |
7,126 |
|
|
Accrued development expense |
|
|
|
|
|
|
|
4,096 |
|
|
|
2,803 |
|
|
Accrued compensation and benefits |
|
|
|
|
|
|
|
160 |
|
|
|
1,877 |
|
|
Operating lease liabilities, current |
|
|
|
|
|
|
|
102 |
|
|
|
97 |
|
|
Other accrued liabilities |
|
|
|
|
|
|
|
416 |
|
|
|
631 |
|
|
Total current liabilities |
|
|
|
|
|
|
|
8,308 |
|
|
|
12,534 |
|
|
Operating lease liabilities, non-current |
|
|
|
|
|
|
|
62 |
|
|
|
139 |
|
|
Other non- current liabilities |
|
|
|
|
|
|
|
197 |
|
|
|
194 |
|
|
Total liabilities |
|
|
|
|
|
|
|
8,567 |
|
|
|
12,867 |
|
|
Stockholders' equity |
|
|
|
|
|
|
|
|
|
|
|
|
Common Stock and additional paid-in-capital |
|
|
|
|
|
|
|
463,137 |
|
|
|
461,221 |
|
|
Accumulated deficit |
|
|
|
|
|
|
|
(264,418 |
) |
|
|
(207,306 |
) |
|
Total stockholders' equity |
|
|
|
|
|
|
|
198,719 |
|
|
|
253,915 |
|
|
Total liabilities and stockholders' equity |
|
|
|
|
|
|
$ |
207,286 |
|
|
$ |
266,782 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cassava Sciences (NASDAQ:SAVA)
Historical Stock Chart
From Apr 2024 to May 2024
Cassava Sciences (NASDAQ:SAVA)
Historical Stock Chart
From May 2023 to May 2024