Cassava Sciences Announces Recent Clinical Highlights and Third Quarter 2019 Financial Results
October 29 2019 - 8:15AM
Cassava Sciences, Inc. (Nasdaq: SAVA), a clinical-stage
biopharmaceutical company focused on Alzheimer’s disease, today
announced recent clinical highlights and reported financial results
for the third quarter ended September 30, 2019.
Net loss for the third quarter 2019 was $0.7
million, or $0.04 per share, as compared to a net loss of $1.3
million, or $0.11 per share, for the same period in 2018. Net cash
used was $0.7 million during the third quarter of 2019. Cassava
Sciences ended the third quarter 2019 with $17.8
million of cash and equivalents, and no debt.
“Cassava Sciences had a productive quarter with
our clinical research program in Alzheimer’s,” said Remi Barbier,
President & CEO. “We are encouraged by the robust biomarker
data from a Phase 2a study in Alzheimer’s with lead drug candidate,
PTI-125. PTI-125 is a twice-daily oral drug that targets both the
neurodegeneration and the inflammatory components of Alzheimer’s.
We’re seeing the research community shift from an amyloid-centric
view, with all its noise and confusion, to one that targets
neurodegeneration and neuroinflammation. PTI-125’s mechanism of
action supports this evolution in Alzheimer’s drug
development. That gets us excited.”
Clinical Highlights
- In September, Cassava Sciences reported positive clinical
results in Alzheimer’s disease with its lead drug candidate,
PTI-125. In a first-in-patient, Phase 2a study funded by the
National Institutes of Health (NIH), treatment with PTI-125 for 28
days significantly reduced biomarkers of disease pathology,
neuroinflammation and neurodegeneration, consistent with years of
basic research and pre-clinical data.
- Key results of the Phase 2a study include: total tau (T-tau)
decreased 20% (p<0.001); phosphorylated tau (P-tau) decreased
34% (p<0.0001); neurofilament light chain (NfL), a marker for
neurodegeneration, decreased 22% (p<0.0001); neurogranin, a
marker for cognitive decline, decreased 32% (p<0.0001); and
neuroinflammatory marker YKL-40, an indicator of microglial
activation, decreased 9% (p<0.0001). We believe these and
other data provide evidence of target engagement in patients with
Alzheimer’s disease.
- All evaluable patients showed a biomarker response to PTI-125.
The drug was well tolerated, with no observable drug-related
adverse events.
- As a result of positive clinical results from its Phase 2a
study of PTI-125, Cassava Sciences recently initiated a Phase 2b
study. This Phase 2b is designed to evaluate safety, tolerability
and drug effects of PTI-125 in Alzheimer’s disease. This blinded,
randomized, placebo-controlled, oral dose study will enroll
approximately 60 patients with mild-to-moderate Alzheimer’s
disease. Patients will be dosed with PTI-125 100 mg, 50 mg or
matching placebo, twice daily for 28 continuous days. The primary
endpoint is improvement in biomarkers of neurodegeneration and
neuroinflammation from baseline to Day 28. The study is
supported by a clinical research grant award from NIH.
- In October, Cassava Sciences announced that results of its
Phase 2a study of PTI-125 were selected for a late-breaking oral
presentation by the 12th International Conference on Clinical
Trials on Alzheimer’s Disease (CTAD), which takes place December
4-7th, 2019.
Financial Highlights
- At September 30, 2019, cash and
cash equivalents were $17.8 million, compared to $19.8 million at
December 31, 2018, with no debt.
- Cash used was $0.7 million during the third quarter of 2019,
net of reimbursements received from NIH.
- Net cash use for full year 2019 is expected to be $3.0 - $5.0
million, consistent with previous financial guidance.
- Net loss for the third quarter 2019 was $0.7 million, or $0.04
per share, as compared to a net loss of $1.3 million, or $0.11 per
share, for the same period in 2018.
- Research grant funding
reimbursements of $1.5 million from NIH were recorded as a
reduction in research and development expenses (R&D).
This compared to $1.1 million of NIH grant receipts received for
the same period in the prior year.
- R&D expenses, after deducting
the grant reimbursement, were negative $0.1 million. This
compared to $0.4 million for the same period in the prior year,
representing a 112% decrease. The decrease was due primarily
to an increase in NIH grant funding in 2019 compared to the prior
year, combined with a decrease in non-cash stock-based compensation
expense.
- General and administrative expenses
were $0.8 million, consistent with the same period in 2018.
About PTI-125 and Cassava Sciences’
Scientific ApproachThe target of PTI-125 is an altered
form of filamin A (FLNA), a scaffolding protein. Published studies
have shown that altered FLNA in the brain disrupts the normal
function of neurons, leading to Alzheimer’s pathology,
neurodegeneration and neuroinflammation. Cassava Sciences’ lead
drug candidate, PTI-125, is a small molecule that restores the
normal shape and function of FLNA in the brain. This action
improves the function of certain receptors in the brain and exerts
powerful anti-neuroinflammatory effects.
Cassava Sciences is also developing an
investigational diagnostic to detect Alzheimer’s disease with a
simple blood test. This program, called PTI-125Dx, also receives
significant scientific and financial support from NIH.
The underlying science for Cassava Sciences’
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 has awarded Cassava
Sciences two research grants following an in-depth, confidential
review of its science and technology. These two grant awards
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. 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 will develop Alzheimer’s in
2019.1 The number of people living with Alzheimer’s disease
is expected to grow dramatically in the years ahead, which may also
result in a growing social and economic burden.2
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
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, 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 technology, without royalty obligations to any
third-party.
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 |
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. Examples of
such statements include, but are not limited to, expected cash use
in future periods; statements regarding the status of Phase 2
clinical studies; the interpretation of clinical results, including
potential health benefits, if any, of changes in levels of
biomarkers; comments and commentaries made by its Chief Executive
Officer; and other potential benefits, if any, of the Company’s
product candidates for Alzheimer’s disease. The Company cautions
that forward-looking statements are inherently uncertain. Such
statements are based on 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 the ability to
demonstrate the specificity, safety, efficacy or potential health
benefits of our product candidates 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, 2018. 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. The
content of this press release is solely the responsibility of the
Company and does not necessarily represent the official views of
the National Institutes of Health. 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 STATEMENTS
OF OPERATIONS |
(unaudited, in
thousands, except per share amounts) |
|
|
Three months ended
September 30, |
|
Nine months ended
September 30, |
|
2019 |
|
|
|
2018 |
|
|
2019 |
|
|
2018 |
|
Operating
expenses |
|
|
|
|
|
|
|
|
|
|
|
Research and development, net of grant reimbursement |
$ |
(52 |
) |
|
$ |
436 |
|
|
$ |
830 |
|
|
$ |
2,967 |
|
General and administrative |
|
831 |
|
|
|
848 |
|
|
|
2,553 |
|
|
|
2,945 |
|
Total operating expenses |
|
779 |
|
|
|
1,284 |
|
|
|
3,383 |
|
|
|
5,912 |
|
Operating
loss |
|
(779 |
) |
|
|
(1,284 |
) |
|
|
(3,383 |
) |
|
|
(5,912 |
) |
Interest
income |
|
82 |
|
|
$ |
17 |
|
|
|
268 |
|
|
|
32 |
|
Net
loss |
$ |
(697 |
) |
|
$ |
(1,267 |
) |
|
$ |
(3,115 |
) |
|
$ |
(5,880 |
) |
Net loss per
share, basic and diluted |
$ |
(0.04 |
) |
|
$ |
(0.11 |
) |
|
$ |
(0.18 |
) |
|
$ |
(0.69 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Weighted-average shares used in computing net loss per share, basic
and diluted |
|
17,162 |
|
|
|
11,959 |
|
|
|
17,162 |
|
|
|
8,498 |
|
CONDENSED BALANCE
SHEETS |
(unaudited, in
thousands) |
|
September 30, 2019 |
|
December 31, 2018 |
Assets |
|
|
|
|
|
Current
assets |
|
|
|
|
|
Cash and cash equivalents |
$ |
17,804 |
|
|
$ |
19,807 |
|
Other current assets |
|
385 |
|
|
|
233 |
|
Total current assets |
|
18,189 |
|
|
|
20,040 |
|
Property and
equipment, net |
|
61 |
|
|
|
87 |
|
Operating
lease right-of-use assets |
|
113 |
|
|
|
— |
|
Other
assets |
|
12 |
|
|
|
12 |
|
Total assets |
$ |
18,375 |
|
|
$ |
20,139 |
|
Liabilities and stockholders' equity |
|
|
|
|
|
Current
liabilities |
|
|
|
|
|
Accounts payable |
$ |
340 |
|
|
$ |
294 |
|
Accrued development expense |
|
415 |
|
|
|
156 |
|
Accrued compensation and benefits |
|
55 |
|
|
|
61 |
|
Operating lease liabilities, current |
|
90 |
|
|
|
— |
|
Other accrued liabilities |
|
7 |
|
|
|
— |
|
Total current liabilities |
|
907 |
|
|
|
511 |
|
Operating
lease liabilities, non-current |
|
23 |
|
|
|
— |
|
Total liabilities |
|
930 |
|
|
|
511 |
|
Stockholders' equity |
|
|
|
|
|
Common Stock and additional paid-in-capital |
|
184,516 |
|
|
|
183,584 |
|
Accumulated deficit |
|
(167,071 |
) |
|
|
(163,956 |
) |
Total stockholders' equity |
|
17,445 |
|
|
|
19,628 |
|
Total liabilities and stockholders' equity |
$ |
18,375 |
|
|
$ |
20,139 |
|
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