Cassava Sciences, Inc. (Nasdaq: SAVA), a clinical-stage
biotechnology company focused on Alzheimer’s disease, today
announced recent business highlights and financial results for the
first quarter ended March 31, 2020. Net loss was $1.2 million, or
$0.05 per share, compared to a net loss of $1.4 million, or $0.08
per share, for the same period in 2019. Net cash used in operations
was $1.2 million during the first quarter of 2020. Net cash use in
full-year 2020 is expected to be approximately $5 million. Cash and
cash equivalents were $25.6 million as of March 31, 2020, with no
debt.
“Cassava Sciences had a productive quarter with
its research programs in Alzheimer’s disease,” said Remi Barbier,
President & CEO. “As a result, we anticipate having top-line
results for our Phase 2b study of PTI-125, our lead drug candidate
for Alzheimer’s, earlier than mid-2020.”
Phase 2b Study – Early data readout on
effects of PTI-125 on tau protein anticipatedIn March
2020, Cassava Sciences announced the completion of a double-blind,
randomized, placebo-controlled study of PTI-125 in 64 patients with
mild-to-moderate Alzheimer’s disease, 50-85 years of age, with 16 ≤
MMSE ≤ 26. Study participants received PTI-125 100 mg, 50 mg or
matching placebo, twice-daily, for 28 continuous days. The
primary efficacy endpoint is the effect of PTI-125 vs placebo on
CSF levels of tau protein, and other biomarker assessments.
Open-label Study – Initiated in March,
approximately 20% 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 is
approximately 20% enrolled.
Finance Update – $2.9 million of new NIH
research grant awards announced in 2020Cassava Sciences’
scientific programs continue to be supported by research grant
awards from the National Institutes of Health (NIH), the nation’s
foremost medical research agency. In April 2020, the Company
announced it had been awarded a new $2,500,000 research grant from
NIH. In March 2020, NIH awarded the Company supplemental research
funding in the amount of $374,000. The NIH's National Institute on
Aging awarded the Company these research grant award following an
in-depth, peer review of PTI-125. Peer review, one of the gold
standards of science, is a process where independent, outside
scientists evaluate the merits of new research.
Operations Update – No major disruptions
to dateIn these times of pandemic, Cassava Sciences’ top
priorities are to protect the health, well-being, and safety of its
employees and partners, while still focusing on the key drivers of
its business. The company believes it remains on-track to achieve
its major strategic objectives for 2020. The Company has not
experienced major disruptions across its drug manufacturing
operations or supply of materials. Its broad spectrum of technical
consultants, scientific advisors and service providers continue to
provide timely services. The Company has adapted flexible business
practices, such as remote work arrangements and temporary travel
restrictions, to insure it continues to operate safety and
cautiously while meeting its public health responsibilities.
Cassava Sciences recognizes the on-going
pandemic has created an unstable and uncertain situation in the
national economy. The Company continues to closely monitor the
latest information to make timely, informed business decisions and
public disclosures regarding the potential impact of pandemic on
its operations. However, the scope of this pandemic is
unprecedented and its long-term impact on the Company’s operations
and financial condition cannot be reasonably estimated at this
time.
Financial Highlights for First Quarter
2020
- At March 31, 2020, cash and cash
equivalents were $25.6 million, compared to $23.1 million at
December 31, 2019, with no debt.
- Cash balance included $3.6 million
in proceeds from exercise of warrants in the first quarter of 2020.
Approximately 1.6 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 quarter ended March 31,
2020 was $1.2 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 $1.3 million were received from NIH and recorded
as a reduction in research and development (R&D) expenses. This
compared to $0.8 million of NIH grant receipts received for the
same period in 2019.
- R&D expenses were $0.5 million.
This compared to $0.6 million for the same period in 2019,
representing a 5% decrease. While Phase 2 clinical program expenses
were higher in Q1 2020, overall expense was reduced by greater NIH
reimbursement.
- General and administrative
(G&A) expenses were $0.8 million. This compared to $0.9 million
for the same period in 2019, representing a 11% decrease. The
decrease was due primarily to lower stock-based compensation
expense compared to 2019.
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. The Company is also developing an
investigational diagnostic, called SavaDx, to detect Alzheimer’s
disease with a simple blood test.
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 Cassava Sciences,
Inc.The mission of Cassava Sciences, Inc. is to detect and
treat neurodegenerative diseases, such as Alzheimer’s disease. 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.
For more information, please visit:
https://www.CassavaSciences.com
____________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 Contact:
Eric Schoen, Chief Financial Officer
Cassava Sciences, Inc.
eschoen@CassavaSciences.com (512) 501-2450
|
For Media Inquiries Contact:Kirsten Thomas, SVP
The Ruth Groupkthomas@TheRuthGroup.com (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. 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;
the interpretation of results of clinical studies, potential health
benefits, if any, of changes in levels of biomarkers; verbal
commentaries made by Cassava Sciences’ employees; and potential
benefits, if any, of the Company’s product candidates for
Alzheimer’s disease are all 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. |
CONDENSED STATEMENTS OF OPERATIONS |
(unaudited, in thousands, except per share amounts) |
|
|
|
|
|
|
|
Three months ended March 31, |
|
2020 |
|
|
2019 |
|
Operating expenses |
|
|
|
|
|
Research and development, net of grant reimbursement |
$ |
544 |
|
|
$ |
574 |
|
General and administrative |
|
778 |
|
|
|
877 |
|
Gain on sale of property and equipment |
|
(100 |
) |
|
|
— |
|
Total operating expenses |
|
1,222 |
|
|
|
1,451 |
|
Operating loss |
|
(1,222 |
) |
|
|
(1,451 |
) |
Interest income |
|
72 |
|
|
|
92 |
|
Net loss |
$ |
(1,150 |
) |
|
$ |
(1,359 |
) |
|
|
|
|
|
|
Net loss per share, basic and diluted |
$ |
(0.05 |
) |
|
$ |
(0.08 |
) |
|
|
|
|
|
|
Weighted-average shares used in computing net loss per share, basic
and diluted |
|
24,481 |
|
|
|
17,162 |
|
|
|
|
|
|
|
CONDENSED BALANCE SHEETS |
(unaudited, in thousands) |
|
March 31, 2020 |
|
December 31, 2019 |
Assets |
|
|
|
|
|
Current assets |
|
|
|
|
|
Cash and cash equivalents |
$ |
25,600 |
|
|
$ |
23,081 |
|
Other current assets |
|
277 |
|
|
|
268 |
|
Total current assets |
|
25,877 |
|
|
|
23,349 |
|
Property and equipment, net |
|
33 |
|
|
|
47 |
|
Operating lease right-of-use assets |
|
67 |
|
|
|
90 |
|
Total assets |
$ |
25,977 |
|
|
$ |
23,486 |
|
Liabilities and stockholders' equity |
|
|
|
|
|
Current liabilities |
|
|
|
|
|
Accounts payable |
$ |
608 |
|
|
$ |
453 |
|
Accrued development expense |
|
387 |
|
|
|
777 |
|
Accrued compensation and benefits |
|
72 |
|
|
|
58 |
|
Operating lease liabilities, current |
|
67 |
|
|
|
90 |
|
Other accrued liabilities |
|
11 |
|
|
|
9 |
|
Total current liabilities |
|
1,145 |
|
|
|
1,387 |
|
Total liabilities |
|
1,145 |
|
|
|
1,387 |
|
Stockholders' equity |
|
|
|
|
|
Common Stock and additional paid-in-capital |
|
194,569 |
|
|
|
190,686 |
|
Accumulated deficit |
|
(169,737 |
) |
|
|
(168,587 |
) |
Total stockholders' equity |
|
24,832 |
|
|
|
22,099 |
|
Total liabilities and stockholders' equity |
$ |
25,977 |
|
|
$ |
23,486 |
|
|
|
|
|
|
|
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