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,
2020 and provided a mid-year business review.
Financial UpdateFor the second
quarter ended June 30, 2020, net loss was $1.1 million, or $0.05
per share, compared to a net loss of $1.1 million, or $0.06 per
share, for the same period in 2019. Net cash used in operations was
$2.0 million during the first six months of 2020. Net cash use in
full-year 2020 is still expected to be approximately $5.0 million.
The Company’s cash and cash equivalents were $25.3 million as of
June 30, 2020, with no debt.
Update on Market AwarenessIn
June 2020, Cassava Sciences’ stock was added to the Russell 2000®
and Russell 3000® Indexes. These indexes are intended to provide
institutional investors and other market participants with exposure
to the performance of certain segments of the U.S. stock
market.
Update on Phase 2b Study With
PTI-125In Q2 2020, Cassava Sciences completed a
randomized, placebo-controlled, double-blind study of its lead drug
candidate, PTI-125, in patients with mild-to-moderate Alzheimer’s
disease (N=64). This study was substantially funded by a research
grant award from the National Institutes of Health (NIH).
As previously reported, the drug was safe and
well-tolerated. An outside lab (with whom the Company had no
prior work experience) generated an initial bioanalysis in which
the study missed its pre-specified primary outcome, defined as a
drug effect on cerebrospinal fluid (CSF) levels of tau protein and
other biomarker assessments. The data set from that initial
bioanalysis showed unnaturally high variability and other problems,
such as no correlation among changes in levels of biomarkers over
28 days, even in the placebo group, and different biomarkers of
disease moving in opposite directions in the same patient. Overall,
we believe data from the initial bioanalysis can be interpreted as
anomalous and highly improbable.
We are now conducting a comprehensive analysis
of clinical results of our Phase 2b study, including evaluating the
effects of PTI-125 on cognition. Data collected from this analysis
will constitute final clinical results of our Phase 2b study of
PTI-125 in Alzheimer’s disease. We anticipate announcing such
results in September 2020.
“Our Phase 2b study was well-conducted, but we
believe the analysis of results is a re-do,” said Remi Barbier,
President & CEO. “This effort is on-going. I believe the
outcome of our Phase 2b study will be better understood after final
clinical results are announced in September 2020.”
Update on Open-label Study with PTI-125
– Initiated in March, Now Over 50% EnrolledIn March 2020,
Cassava Sciences announced the initiation of an open-label,
multi-center study of PTI-125 at 100 mg twice-daily for 12 months.
Every study participant receives drug treatment in an open-label
design. This on-going study has a target enrollment of
approximately 100 patients with mild-to-moderate Alzheimer’s
disease. The study has exceeded 50% enrollment.
Update on SavaDxOn July 15,
2020, scientists for Cassava Sciences were invited by a scientific
conference to give a keynote presentation on SavaDx, an
investigational diagnostic to detect Alzheimer’s disease with a
simple blood test. In addition to showing that SavaDx could
distinguish and stratify patients with Alzheimer’s disease, this
presentation provided direct evidence for target engagement and for
the treatment effects of PTI-125. Target engagement is a crucial
step in drug research because it shows that our small molecule drug
candidate binds to its intended site of action in cells and
confirms that treatment effects are caused by the drug hitting its
target. The science presentation is available on-line at:
https://www.cassavasciences.com/static-files/7aa9f438-9c73-4380-a804-86a509d5de26
Financial Highlights for Second Quarter
2020
- At June 30, 2020, cash and cash
equivalents were $25.3 million, compared to $23.1 million at
December 31, 2019, with no debt.
- Cash balance included $3.8 million
in proceeds from exercise of warrants in the first six months of
2020. Approximately 1.4 million warrants remain outstanding, each
with an exercise price of $1.25 per share. All warrants expire
February 2021.
- Net cash used in operations during the six months ended June
30, 2020 was $2.0 million, net of reimbursements received from NIH
grant awards.
- Net cash use for full year 2020 is expected to be approximately
$5.0 million, consistent with previous financial guidance.
- Research grant funding
reimbursements of $1.1 million were received from NIH and recorded
as a reduction in research and development (R&D) expenses in
the second quarter of 2020. This compared to $1.4 million of NIH
grant receipts received for the same period in 2019.
- R&D expenses were $0.6 million
compared to $0.3 million for the same period in 2019. The decrease
was due primarily to lower NIH reimbursement compared to the prior
year.
- General and administrative
(G&A) expenses were $0.8 million, consistent with the same
period in 2019.
About Alzheimer's
Disease Alzheimer’s disease is a progressive brain
disorder that destroys memory and thinking skills. Currently, there
are no drug therapies to halt Alzheimer’s disease, much less
reverse its course. In the U.S. alone, approximately 5.8 million
people are currently living with Alzheimer’s disease, and
approximately 487,000 people age 65 or older developed Alzheimer’s
in 2019.1 The number of people living with Alzheimer’s disease is
expected to grow dramatically in the years ahead, resulting in a
growing social and economic burden.2
About PTI-125Cassava Sciences’
lead therapeutic product candidate is for the treatment of
Alzheimer’s disease. PTI-125 is a proprietary, small molecule
(oral) drug that restores the normal shape and function of altered
filamin A (FLNA), a scaffolding protein, in the brain. Altered FLNA
in the brain disrupts the normal function of neurons, leading to
Alzheimer’s pathology, neurodegeneration and neuroinflammation. The
underlying science is published in peer-reviewed scientific
journals, including Journal of Neuroscience, Neurobiology of Aging,
Journal of Biological Chemistry and Journal of Prevention of
Alzheimer’s Disease.
About SavaDxSavaDx is Cassava
Sciences’ investigational diagnostic to detect Alzheimer’s disease.
The goal of SavaDx is to make the detection of Alzheimer’s as
simple as getting a blood test, possibly years before the
appearance of any overt clinical symptoms. This clinical-stage
program is substantially funded by a research grant award from the
National Institutes of Health (NIH).
About Cassava Sciences,
Inc.Cassava Sciences’ mission is to discover and develop
innovations for chronic, neurodegenerative conditions. Over the
past 10 years, Cassava Sciences has combined state-of-the-art
technology with new insights in neurobiology to develop novel
solutions for Alzheimer’s disease. 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.
_______________________________1, 2 Source:
Alzheimer’s Association. 2019 Alzheimer’s Disease Facts and
Figures. Available online at:
https://www.alz.org/media/documents/alzheimers-facts-and-figures-2019-r.pdf
For more information, please visit:
https://www.CassavaSciences.com
For More Information Contact: |
|
For Media Inquiries Contact: |
Eric Schoen, Chief Financial Officer |
|
Kirsten Thomas, SVP |
Cassava Sciences, Inc. |
|
The Ruth Group |
eschoen@CassavaSciences.com |
|
kthomas@TheRuthGroup.com |
(512) 501-2450 |
|
(508) 280-6592 |
The content of this presentation is solely the
responsibility of Cassava Sciences and does not necessarily
represent the official views of the National Institutes of Health
(NIH).
Cautionary 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 claims
the protection of the Safe Harbor for forward-looking statements
contained in the Act. All statements other than statements of
historical fact contained in this press release including, but not
limited to, expected cash use in future periods; statements
regarding the status of clinical studies with PTI-125; the timing
of announcing clinical results of our Phase 2b study, including
biomarker and cognition data; the interpretation of results of our
Phase 2 clinical studies; potential health benefits, if any, of
changes in levels of biomarkers; variability in levels of
biomarkers of disease; expected pace of patient enrollment in our
open-label study of PTI-125; the timing of validation studies with
SavaDx; verbal commentaries made by Cassava Sciences’ employees;
and potential benefits, if any, of the Company’s product candidates
for Alzheimer’s disease are forward-looking statements. Such
statements are based largely on the Company’s current expectations
and projections about future events. Such statements speak only as
of the date of this press 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 Cassava
Sciences’ Annual Report on Form 10-K for the year ended December
31, 2019 and future reports to be filed with the SEC. In light of
these risks, uncertainties and assumptions, the forward-looking
statements and events discussed in this press 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, 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 SEC, which are available on the
SEC's website at www.sec.gov.
– Financial Tables Follow –
CASSAVA SCIENCES, INC. |
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CONDENSED STATEMENTS OF OPERATIONS |
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(unaudited, in thousands, except per share amounts) |
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Three months ended June 30, |
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Six months ended June 30, |
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2020 |
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2019 |
|
2020 |
|
2019 |
Operating expenses |
|
|
|
|
|
|
|
|
|
|
|
Research and development, net of grant
reimbursement |
$ |
591 |
|
|
$ |
308 |
|
|
$ |
1,135 |
|
|
$ |
882 |
|
General and administrative |
|
818 |
|
|
|
845 |
|
|
|
1,596 |
|
|
|
1,722 |
|
Gain on sale of property and equipment |
|
(246 |
) |
|
|
— |
|
|
|
(346 |
) |
|
|
— |
|
Total operating expenses |
|
1,163 |
|
|
|
1,153 |
|
|
|
2,385 |
|
|
|
2,604 |
|
Operating loss |
|
(1,163 |
) |
|
|
(1,153 |
) |
|
|
(2,385 |
) |
|
|
(2,604 |
) |
Interest income |
|
27 |
|
|
|
94 |
|
|
|
99 |
|
|
|
186 |
|
Net loss |
$ |
(1,136 |
) |
|
$ |
(1,059 |
) |
|
$ |
(2,286 |
) |
|
$ |
(2,418 |
) |
|
|
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|
|
|
|
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Net loss per share, basic and
diluted |
$ |
(0.05 |
) |
|
$ |
(0.06 |
) |
|
$ |
(0.09 |
) |
|
$ |
(0.14 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Weighted-average shares used
in computing net loss per share, basic and diluted |
|
24,779 |
|
|
|
17,162 |
|
|
|
24,630 |
|
|
|
17,162 |
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|
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|
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CONDENSED BALANCE SHEETS |
(unaudited, in thousands) |
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June 30, 2020 |
|
December 31,2019 |
Assets |
|
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Current assets |
|
|
|
|
|
|
|
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|
|
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Cash and cash equivalents |
|
|
|
|
|
|
$ |
25,254 |
|
|
$ |
23,081 |
|
Other current assets |
|
|
|
|
|
|
|
186 |
|
|
|
268 |
|
Total current assets |
|
|
|
|
|
|
|
25,440 |
|
|
|
23,349 |
|
Property and equipment,
net |
|
|
|
|
|
|
|
13 |
|
|
|
47 |
|
Operating lease
right-of-use assets |
|
|
|
|
|
|
|
45 |
|
|
|
90 |
|
Total assets |
|
|
|
|
|
|
$ |
25,498 |
|
|
$ |
23,486 |
|
Liabilities and
stockholders' equity |
|
|
|
|
|
|
|
|
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Current liabilities |
|
|
|
|
|
|
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Accounts payable |
|
|
|
|
|
|
$ |
416 |
|
|
$ |
453 |
|
Accrued development expense |
|
|
|
|
|
|
|
755 |
|
|
|
777 |
|
Accrued compensation and benefits |
|
|
|
|
|
|
|
84 |
|
|
|
58 |
|
Operating lease liabilities, current |
|
|
|
|
|
|
|
45 |
|
|
|
90 |
|
Other accrued liabilities |
|
|
|
|
|
|
|
14 |
|
|
|
9 |
|
Total current liabilities |
|
|
|
|
|
|
|
1,314 |
|
|
|
1,387 |
|
Total liabilities |
|
|
|
|
|
|
|
1,314 |
|
|
|
1,387 |
|
Stockholders'
equity |
|
|
|
|
|
|
|
|
|
|
|
Common Stock and additional paid-in-capital |
|
|
|
|
|
|
|
195,057 |
|
|
|
190,686 |
|
Accumulated deficit |
|
|
|
|
|
|
|
(170,873 |
) |
|
|
(168,587 |
) |
Total stockholders' equity |
|
|
|
|
|
|
|
24,184 |
|
|
|
22,099 |
|
Total liabilities and stockholders' equity |
|
|
|
|
|
|
$ |
25,498 |
|
|
$ |
23,486 |
|
|
|
|
|
|
|
|
|
|
|
|
|
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