SEATTLE, Nov. 7, 2016 /PRNewswire/ -- PhaseRx, Inc. (NASDAQ:
PZRX), a biopharmaceutical company developing treatments for life-threatening inherited liver diseases in children, today
reported financial results for the quarter and nine months ended September 30, 2016, and provided
an update on its corporate activities.
"During the third quarter, we were very proud to add Peggy Phillips to our board of directors
and Gordon Brandt, M.D., as our chief medical officer," said Robert W.
Overell, Ph.D., president and chief executive officer. "They both bring years of experience in clinical development and
drug approvals, and will expand our capabilities as our company continues to progress into clinical and ultimately commercial
development."
Corporate Update
- On July 11, 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 July 20, the company announced the appointment of Gordon
Brandt, M.D., as chief medical officer.
- On August 22, PhaseRx announced the appointment of Peggy
Phillips to the company's board of directors.
Financial Results for the Three and Nine Months Ended September 30, 2016
Total operating expenses for the third quarter of 2016 were $3.1 million, compared to
$1.5 million of operating expenses in the third quarter of 2015. Total operating expenses for the
nine months ended September 30, 2016 were $15.1 million compared to $4.5 million for the same period in 2015. The increase in operating expenses in the third 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 net loss for the quarter ended September 30, 2016 was $3.3 million, or $0.29 per share, compared to a net loss of $1.9 million, or $3.67 per share, for the quarter ended September 30, 2015. The net loss for the nine months ended
September 30, 2016 was $16.7 million, or $2.72 per share,
compared to $5.1 million, or $9.95 per share for the nine months
ended September 30, 2015. As of September 30, 2016, the Company had cash, cash
equivalents, and marketable securities of $18.6 million.
About PhaseRx
PhaseRx is a leading biopharmaceutical company dedicated to developing 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 TechnologyTM 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 to develop its products, (iii) the fact that the company will need to raise substantial additional
funding to bring its planned products through clinical trials, regulatory approval, manufacturing and marketing and to become
profitable, (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 and may never lead to marketable products, (v) the fact that all of the
company's programs are in preclinical studies or early stage research, so the company cannot predict how these results will
translate into results in humans, nor can it be certain 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 and time-consuming, and
if the development of company product candidates does not produce favorable results or is delayed, the company may be unable to
commercialize these products, (vii) the company expecting to continue to incur significant research and development expenses,
which may make it difficult to attain profitability, (viii) the company becoming dependent on collaborative arrangements with
third parties for a substantial portion of its revenue, and its development and commercialization activities being delayed or
reduced if it fails to initiate, negotiate or maintain successful collaborative arrangements, (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, with competition from existing drugs, new treatment
methods and new technologies that may prove to be more effective or marketable than the company's products. 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 company's prospectus filed pursuant to
Rule 424(b) under the Securities Act of 1933, as amended, with the SEC on May 23, 2016. 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
Media 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.
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Statements of Operations and Balance Sheet Data
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(in thousands, except per share amounts)
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Three Months Ended September 30,
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Nine Months Ended September 30,
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Statements of Operations
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2016
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2015
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2016
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2015
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|
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(Unaudited)
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|
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Revenue
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$
-
|
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$
-
|
|
$
-
|
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$ 375
|
|
|
|
|
|
|
|
|
|
Operating expenses
|
|
|
|
|
|
|
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Research and development
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1,787
|
|
1,173
|
|
4,637
|
|
3,615
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General and administrative
|
1,351
|
|
320
|
|
2,910
|
|
887
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Noncash financial advising fees
|
-
|
|
-
|
|
7,515
|
|
-
|
|
Total operating expenses
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3,138
|
|
1,493
|
|
15,062
|
|
4,502
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Loss from operations
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(3,138)
|
|
(1,493)
|
|
(15,062)
|
|
(4,127)
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Interest income
|
28
|
|
-
|
|
34
|
|
-
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Interest expense
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(233)
|
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(480)
|
|
(1,822)
|
|
(1,050)
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Other income, net
|
-
|
|
24
|
|
190
|
|
61
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Total other income (expense)
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(205)
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(456)
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(1,598)
|
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(989)
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Net loss
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$ (3,343)
|
|
$ (1,949)
|
|
$ (16,660)
|
|
$ (5,116)
|
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Basic and diluted net loss per share
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$ (0.29)
|
|
$ (3.67)
|
|
$ (2.72)
|
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$ (9.95)
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Shares used in computation of basic and diluted net loss per
share
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11,690
|
|
531
|
|
6,120
|
|
514
|
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|
|
|
|
|
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|
|
|
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|
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September 30,
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December 31,
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Balance Sheet Data:
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2016
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2015
|
|
|
|
|
|
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(unaudited)
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Cash and cash equivalents
|
|
|
|
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$ 8,640
|
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$ 3,290
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Marketable securities
|
|
|
|
|
9,995
|
|
-
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Total assets
|
|
|
|
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19,346
|
|
3,914
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Accrued interest
|
|
|
|
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46
|
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3,199
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Convertible notes, net of debt discount
|
|
|
|
|
-
|
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19,841
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Preferred stock warrant liability
|
|
|
|
|
-
|
|
3,163
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Term loan payable, net of debt discount
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|
|
|
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5,611
|
|
-
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Redeemable convertible preferred stock
|
|
|
|
|
-
|
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25,712
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Total stockholders' equity (deficit)
|
|
|
|
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12,477
|
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(48,889)
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SOURCE PhaseRx, Inc.