SEATTLE, March 27, 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 fourth quarter
and full year ended December 31, 2016
and provided an update on its corporate activities.
"PhaseRx continued to make progress during the fourth quarter of
2016 through the announcement of positive results from
our non-human primate safety study, and with our lead
development candidate, PRX-OTC, receiving orphan drug designation
by the FDA," said Robert W. Overell,
Ph.D., president and chief executive officer. "In 2017, we
anticipate completing our GLP toxicology and GMP manufacturing
activities and submitting an IND for PRX-OTC in the fourth quarter.
I look forward to updating investors on our progress with PRX-OTC
and other programs as the year unfolds."
Full Year 2016 and Subsequent Highlights
- On February 8, 2017, PhaseRx
announced a poster presentation for its lead product candidate,
PRX-OTC, at the 13th Annual WORLDSymposium™ 2017 that took place
February 13-17, 2017. PRX-OTC is in
development for the treatment of Ornithine Transcarbamylase
Deficiency (OTCD).
- On November 28, 2016, the company
announced that its lead candidate, PRX-OTC, which is being
developed for the treatment of OTCD, received orphan drug
designation by the U.S. Food and Drug Administration (FDA).
- On November 8, 2016, PhaseRx
announced positive results from the company's single escalating
dose response study in non-human primates. The administration of
mRNA delivered using the company's proprietary Hybrid mRNA
TechnologyTM platform in a large animal model was safe
and well tolerated at all dose levels tested.
- On October 25, 2016, the company
presented data evaluating its mRNA Hybrid Technology platform at
the 4th International mRNA Health Conference in Boston. The poster, titled, 'Targeted mRNA
delivery to the liver for Intracellular Enyzme Replacement Therapy
(i-ERT)' was presented by Pierrot Harvie, Ph.D., Associate Director
of Formulations at PhaseRx.
- On July 11, 2016, PhaseRx
announced the presentation of data evaluating its mRNA Hybrid
TechnologyTM platform at the 43rd Annual Meeting &
Exposition of the Controlled Release Society (CRS) that took place
July 17-20, 2016, in Seattle. The presentation was titled "Targeted
mRNA Delivery to the Liver for Intracellular Enzyme Replacement
Therapy (i-ERT)."
- On June 21, 2016, the company
announced product pipeline advancements including the selection of
its lead product candidate, PRX-OTC, for treatment of OTCD, and
positive proof-of-concept data for a second product candidate,
PRX-ASL, for treatment of Argininosuccinate Lyase Deficiency
(ASLD).
- On June 7, 2016, PhaseRx entered
into a loan and security agreement with Hercules Capital, Inc.,
pursuant to which it received $6
million.
- On May 23, 2016, the company
closed its initial public offering of 3,700,000 shares of common
stock at a price of $5.00 per share
for aggregate gross proceeds of $18.5
million.
Financial Results for the Three Months and Year Ended
December 31, 2016
Total operating expenses for the fourth quarter of 2016 were
$3.3 million, compared to
$1.7 million of operating expenses in
2015. Total operating expenses for the year ended December 31, 2016 were $18.3 million compared to $6.2 million for 2015. The increase in operating
expenses in the fourth quarter of 2016 was primarily due to
increased research and development costs to execute PhaseRx's
product development plan of its lead drug candidate PRX-OTC,
increased costs associated with being a publicly-traded company and
an increase in non-cash stock-based compensation expenses. The
operating expenses for the year ended December 31, 2016 included non-recurring,
non-cash financial advising fees of $7.5
million related to the company's IPO.
The net loss for the quarter ended December 31, 2016 was $3.5
million, or $0.30 per share,
compared to a net loss of $2.3
million, or $4.25 per share,
for the quarter ended December 31,
2015. The net loss for the year ended December 31, 2016 was $20.1 million, or $2.68 per share, compared to $7.4 million, or $14.22 per share for 2015.
As of December 31, 2016, the
company had cash, cash equivalents, and marketable securities of
$15.5 million. The company believes
it has sufficient cash to fund its operations for at least the next
12 months.
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
Technology™ 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:
Company Contact:
Erin Cox
PhaseRx, Inc.
Director of Investor Relations
erin@phaserx.com
206.805.6306
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
December 31,
|
|
Year Ended
December 31,
|
Statements of
Operations
|
2016
|
|
2015
|
|
2016
|
|
2015
|
|
|
|
(Unaudited)
|
|
|
|
|
Revenue
|
|
$
-
|
|
$
-
|
|
$
-
|
|
$
375
|
|
|
|
|
|
|
|
|
Operating
expenses
|
|
|
|
|
|
|
|
Research and
development
|
2,025
|
|
1,268
|
|
6,662
|
|
4,883
|
General and
administrative
|
1,243
|
|
412
|
|
4,153
|
|
1,299
|
Noncash financial
advising fees
|
-
|
|
-
|
|
7,515
|
|
-
|
|
Total operating
expenses
|
3,268
|
|
1,680
|
|
18,330
|
|
6,182
|
Loss from
operations
|
(3,268)
|
|
(1,680)
|
|
(18,330)
|
|
(5,807)
|
Interest
income
|
|
27
|
|
-
|
|
61
|
|
-
|
Interest
expense
|
|
(236)
|
|
(599)
|
|
(2,058)
|
|
(1,649)
|
Other income,
net
|
-
|
|
18
|
|
190
|
|
79
|
|
Total other income
(expense)
|
(209)
|
|
(581)
|
|
(1,807)
|
|
(1,570)
|
|
Net loss
|
|
$
(3,477)
|
|
$
(2,261)
|
|
$
(20,137)
|
|
$
(7,377)
|
|
Basic and diluted net
loss per share
|
$
(0.30)
|
|
$
(4.25)
|
|
$
(2.68)
|
|
$
(14.22)
|
|
Shares used in
computation of basic and diluted net loss per share
|
11,690
|
|
532
|
|
7,524
|
|
519
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December
31,
|
|
December
31,
|
Balance Sheet
Data:
|
|
|
|
|
2016
|
|
2015
|
|
|
|
|
|
|
|
|
|
|
Cash and cash
equivalents
|
|
|
|
|
$
9,983
|
|
$
3,290
|
Marketable
securities
|
|
|
|
|
5,496
|
|
-
|
Total
assets
|
|
|
|
|
|
16,448
|
|
3,914
|
Accrued
interest
|
|
|
|
|
|
49
|
|
3,199
|
Current portion of
term loan payable
|
|
|
|
|
576
|
|
-
|
Convertible notes,
net of debt discount
|
|
|
|
|
-
|
|
19,841
|
Preferred stock
warrant liability
|
|
|
|
|
-
|
|
3,163
|
Term loan payable,
net of debt discount and current portion
|
|
|
|
|
5,127
|
|
-
|
Redeemable
convertible preferred stock
|
|
|
|
|
-
|
|
25,712
|
Total stockholders'
equity (deficit)
|
|
|
|
|
9,297
|
|
(48,889)
|
To view the original version on PR Newswire,
visit:http://www.prnewswire.com/news-releases/phaserx-reports-fourth-quarter-and-full-year-2016-financial-results-and-provides-corporate-update-300428835.html
SOURCE PhaseRx, Inc.