SEATTLE, Nov. 9, 2017 /PRNewswire/ -- PhaseRx, Inc.
(NASDAQ: PZRX), a biopharmaceutical company developing mRNA
treatments for life-threatening inherited liver diseases in
children, today reported financial results for the third quarter
ended September 30, 2017 and provided
an update on its corporate activities.
"The orphan drug designation of PRX-ASL was an important
milestone for our company this quarter and validates the potential
of our Hybrid mRNA Technology," said Robert
W. Overell, Ph.D., president and chief executive officer of
PhaseRx. "As we move forward with our new corporate strategy, we
continue to believe in our intracellular enzyme replacement therapy
and the benefit it can bring to children suffering from devastating
inherited liver diseases."
Third Quarter Highlights
- On October 13, 2017, PhaseRx
announced that its board of directors made a determination to
conduct a restructuring of operations to reduce short term
operating costs and delay the development of its lead product
candidate PRX-OTC. This reorganization, aimed at preserving the
company's cash resources, included a reduction in PhaseRx's
workforce by 10 employees, including some executive officers. The
board of directors has also begun a review of strategic
alternatives, including but not limited to a potential merger
transaction. The company has not set a timetable for this
process.
- On September 19, 2017, PhaseRx
received orphan drug designation from the U.S. Food and Drug
Administration (FDA) for its second drug development candidate,
PRX-ASL, for the treatment of argininosuccinate lyase deficiency
(ASLD).
- On October 26, 2017, PhaseRx
received a delisting notice from Nasdaq, informing the company,
that unless an appeal was filed, trading in their common stock
would be suspended from Nasdaq. PhaseRx is appealing the decision
to a Nasdaq Hearings Panel, which stays the suspension of their
securities, pending the panel's decision subsequent to the
hearing.
Financial Results for the Three and Nine Months Ended
September 30, 2017
Total operating expenses for the third quarter of 2017 were
$2.5 million, compared to
$3.1 million of operating expenses in
the third quarter of 2016. Total operating expenses for the nine
months ended September 30, 2017 were
$9.8 million compared to $15.1 million for the same period in 2016. The
decrease in operating expenses in the third quarter of 2017 was
primarily due to a decrease in general and administrative
costs. The decrease in costs is related to payroll, investor
and public relation costs and consulting costs.
The net loss for the quarter ended September 30, 2017 was $2.8 million, or $0.23 per share, compared to a net loss of
$3.3 million, or $0.29 per share, for the quarter ended
September 30, 2016. The net loss for
the nine months ended September 30,
2017 was $10.4 million, or
$0.89 per share, compared to
$16.7 million, or $2.72 per share for the nine months ended
September 30, 2016.
As of September 30, 2017, the
company had cash and cash equivalents of $5.3 million.
About PhaseRx
PhaseRx is a biopharmaceutical company dedicated to developing
mRNA products for the treatment of children with inherited enzyme
deficiencies in the liver using intracellular enzyme replacement
therapy (i-ERT). PhaseRx's initial product development focus is on
urea cycle disorders, a group of rare genetic diseases that
generally present before the age of twelve and are characterized by
the body's inability to remove ammonia from the blood with
potentially devastating consequences for patients. The company's
i-ERT approach is enabled by its proprietary Hybrid mRNA
Technologyâ„¢ platform. PhaseRx is headquartered in Seattle. For more information, please visit
www.phaserx.com.
Safe Harbor Statement
This press release contains "forward-looking statements." Such
statements may be preceded by the words "intends," "may," "will,"
"plans," "expects," "anticipates," "projects," "predicts,"
"estimates," "aims," "believes," "hopes," "potential" or similar
words. Forward-looking statements are not guarantees of future
performance, are based on certain assumptions and are subject to
various known and unknown risks and uncertainties, many of which
are beyond the company's control, and cannot be predicted or
quantified and consequently, actual results may differ materially
from those expressed or implied by such forward-looking statements.
Such risks and uncertainties include, without limitation, risks and
uncertainties associated with (i) the fact that the company has
incurred significant losses since its inception and anticipates
that it will continue to incur significant losses for the
foreseeable future, (ii) the company being dependent on
technologies it has licensed and that it may need to license in the
future, (iii) the fact that the company will need to raise
substantial additional funding to develop its planned products,
(iv) the fact that the company's Hybrid mRNA Technology has not
previously been tested beyond company preclinical studies, and that
mRNA-based drug development is unproven, (v) the fact that all of
the company's programs are in preclinical studies or early stage
research and it is uncertain that any company product candidates
will receive regulatory approval or be commercialized, (vi) the
fact that development of the company's product candidates will be
expensive, time-consuming and subject to regulatory approval, (vii)
the company expecting to continue to incur significant research and
development expenses, (viii) the company becoming dependent on
collaborative arrangements for the development and
commercialization of its products, (ix) the company's ability to
adequately protect its proprietary technology from legal
challenges, infringement or alternative technologies and (x) the
biotechnology and pharmaceutical industries being intensely
competitive. More detailed information about the company and the
risk factors that may affect the realization of forward looking
statements is set forth in the company's filings with the
Securities and Exchange Commission (SEC), including the most recent
annual report on Form 10-K and its quarterly reports on Form 10-Q.
Investors and security holders are urged to read these documents
free of charge on the SEC's web site at http://www.sec.gov. The
company assumes no obligation to publicly update or revise its
forward-looking statements as a result of new information, future
events or otherwise.
Contacts:
Corporate Communications Contact:
Jason Spark
Canale Communications
Senior Vice President
jason@canalecomm.com
619.849.6005
Investor Contact:
Robert H. Uhl
Westwicke Partners, LLC
Managing Director
robert.uhl@westwicke.com
858.356.5932
PhaseRx,
Inc.
|
Statements of
Operations and Balance Sheet Data
|
(in thousands, except
per share amounts)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
September 30,
|
|
Nine Months Ended
September 30,
|
Statements of
Operations
|
|
2017
|
|
2016
|
|
2017
|
|
2016
|
|
|
|
(Unaudited)
|
Operating
expenses
|
|
|
|
|
|
|
|
|
Research and
development
|
|
$
1,729
|
|
$
1,787
|
|
$
6,310
|
|
$
4,637
|
General and
administrative
|
|
806
|
|
1,351
|
|
3,460
|
|
2,910
|
Noncash financial
advising fees
|
|
-
|
|
-
|
|
-
|
|
7,515
|
|
Total operating
expenses
|
|
2,535
|
|
3,138
|
|
9,770
|
|
15,062
|
Loss from
operations
|
|
(2,535)
|
|
(3,138)
|
|
(9,770)
|
|
(15,062)
|
Other income
(expense)
|
|
|
|
|
|
|
|
|
Interest
income
|
|
16
|
|
28
|
|
63
|
|
34
|
Interest
expense
|
|
(231)
|
|
(233)
|
|
(707)
|
|
(1,822)
|
Other income,
net
|
|
-
|
|
-
|
|
-
|
|
190
|
|
Total other income
(expense)
|
|
(215)
|
|
(205)
|
|
(644)
|
|
(1,598)
|
|
Net loss
|
|
$
(2,750)
|
|
$
(3,343)
|
|
$
(10,414)
|
|
$
(16,660)
|
|
Basic and diluted net
loss per share
|
$
(0.23)
|
|
$
(0.29)
|
|
$
(0.89)
|
|
$
(2.72)
|
|
Shares used in
computation of basic and diluted net loss per share
|
11,690
|
|
11,690
|
|
11,690
|
|
6,120
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
September
30,
|
|
December
31,
|
Balance Sheet
Data:
|
|
|
|
|
|
2017
|
|
2016
|
|
|
|
|
|
|
|
(unaudited)
|
|
|
Cash and cash
equivalents
|
|
|
|
|
|
$
5,257
|
|
$
9,983
|
Marketable
securities
|
|
|
|
|
|
-
|
|
5,496
|
Total
assets
|
|
|
|
|
|
6,038
|
|
16,448
|
Current portion of
term loan payable
|
|
|
|
|
|
1,830
|
|
576
|
Term loan payable,
net of debt discount and current portion
|
|
|
|
|
3,611
|
|
5,127
|
Total stockholders'
equity (deficit)
|
|
|
|
|
|
(301)
|
|
9,297
|
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SOURCE PhaseRx, Inc.