Cassava Sciences, Inc. (Nasdaq: SAVA), a clinical-stage
biotechnology company focused on Alzheimer’s disease, today
announced financial results for the first quarter ended March 31,
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.
Net loss was $17.5 million, or $0.44 per share,
compared to a net loss of $3.5 million, or $0.09 per share, for the
same period in 2021. Net cash used in operations was $23.5 million
during the first quarter of 2022, including over $10 million of
contractual pre-payments. Pre-payments are amounts paid for in
advance of future research and development (R&D) services.
“We’re seeing an uptick in the rate of patient
enrollment,” said Remi Barbier, President & CEO. “In part, the
pandemic challenged some clinical sites, from staffing shortages to
operational gaps. We hope these challenges are in the rearview
mirror as we continue to move forward with our Phase 3 studies of
simufilam in Alzheimer’s disease, while keeping an eye on the
balance sheet.”
Financial Results for First Quarter
2022
- At March 31, 2022, cash and cash
equivalents were $209.7 million, with no debt.
- Net loss was $17.5 million, or
$0.44 per share. This compares to a net loss of $3.5 million, or
$0.09 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 and G&A expenses.
- Net cash used in operations was
$23.5 million during the first quarter of 2022.
- Net cash use in operations for the
first half 2022 is now expected to be approximately $35 to $40
million, including significant (over $10 million) contractual
pre-payments made to R&D vendors for future services, such as
our contract research organization for the Phase 3 clinical program
of simufilam in Alzheimer’s disease.
- Research and development (R&D)
expenses were $14.9 million. This compared to $2.5 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 studies, clinical trial supplies and support
functions and personnel expenses.
- General and administrative
(G&A) expenses were $2.9 million. This compared to $1.0 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 and depreciation and amortization.
Overview of On-going Phase 3 Clinical
Program Our 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.
A total of over 120 subjects have now been
enrolled in our Phase 3 studies. Studies are being conducted in
over 115 clinical trial sites across the U.S., Canada and Puerto
Rico.
Overview of Each On-going Phase 3 Study
- RETHINK-ALZ and REFOCUS-ALZOur Phase 3 study called
“RETHINK-ALZ” 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.
Details of the RETHINK-ALZ Phase 3 study include:
- Subjects are randomized (1:1) to
simufilam 100 mg or placebo twice daily.
- The co-primary efficacy endpoints
are 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.
Our Phase 3 study called “REFOCUS-ALZ” 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.
Details of the REFOCUS-ALZ Phase 3 study,
include:
- Subjects are randomized (1:1:1) to
simufilam 100 mg, 50 mg, or placebo twice daily.
- The co-primary efficacy endpoints
are 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 enrollment
In 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 subjects with Alzheimer’s disease.
We expect to announce full study results second half 2022.
Cognition Maintenance Study (CMS) –
on-goingIn 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. 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
cognition and health outcomes in Alzheimer’s patients who continue
with drug treatment versus patients who discontinue drug treatment.
The target enrollment for the CMS is approximately 100 subjects.
Over 75 subjects have been enrolled in the CMS and 35 have
completed the study.
SavaDx – on-goingSavaDx, is an
early-stage program focused on detecting the presence of
Alzheimer’s disease from a small sample of blood. For business,
technical and personnel reasons, we continue to prioritize the
development of simufilam, our lead drug candidate, over SavaDx.
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 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, including expected cash use for
operations in the first half of 2022; 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 full results of our open-label clinical study and the
timing thereof; the development path for SavaDx and the use of
alternative methods 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 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
March 31, |
|
2022 |
|
|
2021 |
|
Operating
expenses |
|
|
|
|
|
Research and development, net of grant reimbursement |
$ |
14,906 |
|
|
$ |
2,529 |
|
General and administrative |
|
2,915 |
|
|
|
1,004 |
|
Total operating expenses |
|
17,821 |
|
|
|
3,533 |
|
Operating
loss |
|
(17,821 |
) |
|
|
(3,533 |
) |
Interest
income |
|
31 |
|
|
|
7 |
|
Other
income, net |
|
263 |
|
|
|
— |
|
Net
loss |
$ |
(17,527 |
) |
|
$ |
(3,526 |
) |
|
|
|
|
|
|
Net loss per
share, basic and diluted |
$ |
(0.44 |
) |
|
$ |
(0.09 |
) |
|
|
|
|
|
|
Weighted-average shares used in computing net loss per share, basic
and diluted |
|
39,962 |
|
|
|
37,721 |
|
|
|
|
|
|
|
CONDENSED
CONSOLIDATED BALANCE SHEETS |
(unaudited, in
thousands) |
|
March 31, 2022 |
|
December 31, 2021 |
Assets |
|
|
|
|
|
Current
assets |
|
|
|
|
|
Cash and cash equivalents |
$ |
209,693 |
|
|
$ |
233,437 |
|
Prepaid expenses and other current assets |
|
12,507 |
|
|
|
11,045 |
|
Total current assets |
|
222,200 |
|
|
|
244,482 |
|
Property and
equipment, net |
|
20,863 |
|
|
|
20,616 |
|
Operating
lease right-of-use assets |
|
188 |
|
|
|
210 |
|
Intangible
assets, net |
|
940 |
|
|
|
1,075 |
|
Other
assets |
|
— |
|
|
|
399 |
|
Total assets |
$ |
244,191 |
|
|
$ |
266,782 |
|
Liabilities and stockholders' equity |
|
|
|
|
|
Current
liabilities |
|
|
|
|
|
Accounts payable |
$ |
3,332 |
|
|
$ |
7,126 |
|
Accrued development expense |
|
2,925 |
|
|
|
2,803 |
|
Accrued compensation and benefits |
|
172 |
|
|
|
1,877 |
|
Operating lease liabilities, current |
|
99 |
|
|
|
97 |
|
Other accrued liabilities |
|
261 |
|
|
|
631 |
|
Total current liabilities |
|
6,789 |
|
|
|
12,534 |
|
Operating lease liabilities, non-current |
|
114 |
|
|
|
139 |
|
Other non- current liabilities |
|
194 |
|
|
|
194 |
|
Total liabilities |
|
7,097 |
|
|
|
12,867 |
|
Stockholders' equity |
|
|
|
|
|
Common Stock and additional paid-in-capital |
|
461,927 |
|
|
|
461,221 |
|
Accumulated deficit |
|
(224,833 |
) |
|
|
(207,306 |
) |
Total stockholders' equity |
|
237,094 |
|
|
|
253,915 |
|
Total liabilities and stockholders' equity |
$ |
244,191 |
|
|
$ |
266,782 |
|
|
|
|
|
|
|
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