Cassava Sciences Reports First Quarter 2019 Financial Results
April 29 2019 - 8:30AM
Cassava Sciences, Inc. (Nasdaq: SAVA), a biopharmaceutical company,
today reported financial results for the first quarter ended March
31, 2019. Net loss was $1.4 million, or $0.08 per
share. This compared to a net loss of $2.2 million, or $0.33
per share, for the same period in the prior year. Cash and
cash equivalents were $19.1 million as of March 31, 2019. The
Company has no debt. Cassava Sciences utilized $0.7 million
of cash during the first quarter of 2019 and expects cash use to be
$5.0 - $6.0 million for full year 2019.
“As we enter 2019, our financial expectations
reflect a thoughtful balance between maintaining fiscal discipline
and advancing our series of product candidates aimed at Alzheimer’s
disease”, said Remi Barbier, President & CEO. “One thing
that won’t change is our focus on developing potential breakthrough
innovations and an unwavering dedication to improve people’s lives.
This emphasis has characterized our history and remains core to our
strategy for 2019 and beyond.”
Cassava Sciences is conducting a Phase 2
clinical program with its investigational drug, PTI-125, in
patients with Alzheimer’s disease. PTI-125 is designed to
exert anti-neuroinflammatory effects and to restore the function of
three key receptors in the brain. The National Institutes of
Health (NIH) is providing substantial scientific and financial
support for the Company’s clinical program.
Cassava Sciences expects to announce results of
its Phase 2a study in the second half of 2019, after study
participants complete drug treatment and their data are
analyzed.
Financial Highlights for First Quarter
2019
- At March 31, 2019, cash and cash
equivalents were $19.1 million, compared to $19.8 million at
December 31, 2018. The company has no debt. Net cash utilized
during the first quarter 2019 was $0.7 million.
- Net loss was $1.4 million compared
to $2.2 million for the same period in the prior year, representing
a 37% decrease. Net loss per share was $0.08 compared to
$0.33 for the same period in the prior year.
- We received research grant funding
reimbursements of $0.8 million from NIH and recorded this as a
reduction in research and development expenses (“R&D”).
This compared to $0.4 million of NIH grant receipts received for
the same period in the prior year.
- R&D expenses were $0.6
million. This compared to $1.1 million for the same period in
the prior year, representing a 46% decrease. The decrease was
due primarily to the increase in NIH grant funding in 2019 compared
to the prior year combined with a decrease in non-cash stock-based
compensation expense. R&D expenses included non-cash stock
related compensation costs of $0.1 million compared to $0.4 million
for same period in the prior year.
- General and administrative
(“G&A”) expenses were $0.9 million. This compared to $1.1
million for the same period in the prior year, representing a 20%
decrease. G&A expenses included non-cash stock-based
compensation costs of $0.2 million compared to $0.5 million for the
same period in the prior year.
Our Scientific
ApproachThe target of PTI-125 is an altered form
of filamin A (FLNA). FLNA is a scaffolding protein found
throughout the body. The function of a scaffolding protein is
to bring multiple proteins together and to ensure they interact
properly. However, an altered and highly toxic form of FLNA is
found in the Alzheimer’s brain. Altered FLNA disrupts the normal
function of neurons, leading to neurodegeneration and brain
inflammation. Our investigational drug candidate, PTI-125, is
designed to restore the normal shape & function of FLNA in the
brain. This drug effect exerts powerful
anti-neuroinflammatory effects and improves the function of
multiple brain receptors.
In animal models of disease, treatment with
PTI-125 resulted in dramatic improvements in brain health, such as
improved learning and memory; improved insulin receptor signaling;
and significant reductions in levels of inflammatory cytokines in
the brain.
We are also developing a biomarker/diagnostic to
detect Alzheimer’s disease with a simple blood test. This
program, called PTI-125Dx, also receives scientific and financial
support from NIH.
The underlying science for our programs in
neurodegeneration is published in several prestigious peer-reviewed
technical journals, including Journal of Neuroscience, Neurobiology
of Aging, and Journal of Biological Chemistry. As previously
announced, NIH awarded us two research grants in 2018 following an
in-depth, confidential review of our science and technology.
These two NIH grants represent up to $6.7 million of non-dilutive
financing.
About Alzheimer's
DiseaseAlzheimer’s disease is a progressive brain disorder
that destroys memory and thinking skills. Eventually, a person with
Alzheimer’s disease may be unable to carry out even simple
tasks. Currently, there are no drug therapies to halt
Alzheimer’s disease, much less reverse its course.An estimated 5.8
million Americans of all ages are living with Alzheimer's disease
in 2019.
About Cassava Sciences,
Inc.The mission of Cassava Sciences is to detect and treat
neurodegenerative diseases, such as Alzheimer’s disease. Over
the past ten years, we have combined state-of-the-art technology
with new insights in neurobiology to develop novel solutions for
Alzheimer’s disease. We own worldwide development and commercial
rights to our research programs in Alzheimer’s disease, and related
technology, without royalty obligations to any third-party.
For More Information Contact:Eric SchoenChief
Financial OfficerCassava Sciences,
Inc.eschoen@CassavaSciences.com(512) 501-2450
Note Regarding Forward-Looking
Statements: This press release contains forward-looking
statements for purposes of the Private Securities Litigation Reform
Act of 1995 (the "Act"). Cassava Sciences disclaims any
intent or obligation to update these forward-looking statements and
claims the protection of the Safe Harbor for forward-looking
statements contained in the Act. Examples of such statements
include, but are not limited to, statements regarding the timing of
clinical studies and the potential benefits of the Company’s
programs in Alzheimer’s disease, including our ongoing Phase II
program, and expected cash use in future periods. The Company
cautions that forward-looking statements are inherently uncertain.
Such statements are based on management's current expectations, but
actual results may differ materially due to various factors. Such
statements involve risks and uncertainties, including, but not
limited to, those risks and uncertainties relating to development
and testing of our drug candidates; unexpected adverse side effects
or inadequate therapeutic efficacy of our drug candidates; the
uncertainty of patent protection for our intellectual property or
trade secrets; unanticipated additional research and development,
litigation and other costs; the need to raise additional funding
from time-to-time, and the potential for competing products to be
developed by competitors and potential competitors or others.
Existing and prospective investors are cautioned not to place undue
reliance on these forward-looking statements, which speak only as
of the date hereof. Except as required by law, the Company
disclaims any intention or responsibility for updating or revising
any forward-looking statements contained in this press
release. For further information regarding these and other
risks related to our business, investors should consult our filings
with the U.S. Securities and Exchange Commission (SEC), which are
available on the SEC's website at www.sec.gov.
– Financial Tables Follow –
CASSAVA SCIENCES, INC. |
|
CONDENSED STATEMENTS OF OPERATIONS |
|
(unaudited, in thousands, except per share
amounts) |
|
|
|
|
|
|
|
Three months ended March 31, |
|
|
2019 |
|
2018 |
|
Operating
expenses |
|
|
|
|
|
|
Research and development, net of grant
reimbursement |
$ |
574 |
|
|
$ |
1,068 |
|
|
General and administrative |
|
877 |
|
|
|
1,099 |
|
|
Total operating expenses |
|
1,451 |
|
|
|
2,167 |
|
|
Operating
loss |
|
(1,451 |
) |
|
|
(2,167 |
) |
|
Interest
income |
|
92 |
|
|
|
7 |
|
|
Net
loss |
$ |
(1,359 |
) |
|
$ |
(2,160 |
) |
|
|
|
|
|
|
|
|
Net loss
per share, basic and diluted |
$ |
(0.08 |
) |
|
$ |
(0.33 |
) |
|
|
|
|
|
|
|
|
Weighted-average shares
used in computing net loss per share, basic and diluted |
|
17,162 |
|
|
|
6,638 |
|
|
|
|
|
|
|
|
|
CONDENSED BALANCE SHEETS |
|
(unaudited, in thousands) |
|
|
March 31, 2019 |
|
December 31,2018 |
|
Assets |
|
|
|
|
|
|
Current
assets |
|
|
|
|
|
|
Cash and cash equivalents |
$ |
19,125 |
|
|
$ |
19,807 |
|
|
Other current assets |
|
140 |
|
|
|
233 |
|
|
Total current assets |
|
19,265 |
|
|
|
20,040 |
|
|
Property and equipment, net |
|
88 |
|
|
|
87 |
|
|
Operating lease right-of-use assets |
|
158 |
|
|
|
— |
|
|
Other assets |
|
12 |
|
|
|
12 |
|
|
Total assets |
$ |
19,523 |
|
|
$ |
20,139 |
|
|
Liabilities and stockholders'
equity |
|
|
|
|
|
|
Current
liabilities |
|
|
|
|
|
|
Accounts payable |
$ |
495 |
|
|
$ |
294 |
|
|
Accrued development expense |
|
243 |
|
|
|
156 |
|
|
Accrued compensation and benefits |
|
62 |
|
|
|
61 |
|
|
Operating lease liabilities, current |
|
90 |
|
|
|
— |
|
|
Other accrued liabilities |
|
12 |
|
|
|
— |
|
|
Total current liabilities |
|
902 |
|
|
|
511 |
|
|
Operating lease liabilities, non-current |
|
68 |
|
|
|
— |
|
|
Total liabilities |
|
970 |
|
|
|
511 |
|
|
Stockholders'
equity |
|
|
|
|
|
|
Common Stock and additional paid-in-capital |
|
183,868 |
|
|
|
183,584 |
|
|
Accumulated deficit |
|
(165,315 |
) |
|
|
(163,956 |
) |
|
Total stockholders' equity |
|
18,553 |
|
|
|
19,628 |
|
|
Total liabilities and stockholders' equity |
$ |
19,523 |
|
|
$ |
20,139 |
|
|
|
|
|
|
|
|
|
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