SOUTH SAN FRANCISCO, Calif.,
Nov. 4, 2014 /PRNewswire/
-- Rigel Pharmaceuticals, Inc. (Nasdaq:RIGL) today
reported financial results for the third quarter and nine months
ended September 30, 2014.
For the third quarter of 2014, Rigel reported a net loss of
$20.9 million, or $0.24 per share, compared to a net loss of
$23.8 million, or $0.27 per share, for the same period of 2013.
Weighted average shares outstanding for the third quarters of 2014
and 2013 were 87.8 million and 87.4 million, respectively.
Rigel reported total operating expenses of $21.0 million for the third quarter of 2014,
compared to $23.9 million for the
same period in 2013. The decrease in operating expenses was
primarily due to the completion of two Phase 2 studies in 2013 and
a workforce reduction implemented in September 2013, partially
offset by an increase in research and development costs in the
third quarter of 2014 related to Rigel's FIT program, a Phase 3
clinical program with fostamatinib in patients with immune
thrombocytopenic purpura (ITP).
For the nine months ended September 30,
2014, Rigel reported a net loss of $68.6 million, or $0.78 per basic and diluted share, compared to a
net loss of $72.2 million, or
$0.83 per basic and diluted share,
for the same period of 2013.
As of September 30, 2014, Rigel
had cash, cash equivalents and available for sale securities of
$157.7 million, compared to
$212.0 million as of December 31, 2013. Rigel expects to end
2014 with cash and investments in excess of $135.0 million,
which is expected to be sufficient to fund operations into the
third quarter of 2016.
FIT Program Update
The FIT Phase 3 clinical program was initiated in July 2014 and consists of two identical
multi-center, double-blind, placebo-controlled studies to evaluate
the potential of fostamatinib to increase the blood platelet counts
of patients with chronic ITP. One trial will enroll patients
from predominantly US and UK-based sites while the other is more
internationally focused. Rigel expects that the top line
results of these two studies will be reported separately; with the
US/UK-based study results expected by the end of 2015 and the other
study results expected in the first quarter of 2016.
Recent Events
In October 2014, Rigel earned a
milestone payment of $2.5 million
from partner AstraZeneca for moving forward R256 toward clinical
studies for the potential treatment of moderate to severe chronic
asthma.
"We continue to focus on fostamatinib with our ongoing Phase 3
studies in ITP and the Phase 2 study in IgA nephropathy which is
expected to begin shortly," said James M.
Gower, chairman and chief executive officer of Rigel.
"Additionally, we are also pleased with AstraZeneca's decision to
move R256 forward in their development pipeline."
About Rigel (www.rigel.com)
Rigel Pharmaceuticals, Inc. is a clinical-stage drug development
company that discovers and develops novel, small-molecule drugs for
the treatment of inflammatory and autoimmune diseases, as well as
muscle disorders. Rigel's pioneering research focuses on
intracellular signaling pathways and related targets that are
critical to disease mechanisms. Rigel currently has the following
product candidates in development: fostamatinib, an oral SYK
inhibitor, which is in Phase 3 clinical trials for ITP and is
expected to enter a Phase 2 clinical trial for IgAN in the second
half of 2014; R348, a topical JAK/SYK inhibitor, in a Phase 2
clinical trial for dry eye in GvHD; and two oncology product
candidates in Phase 1 development with partners BerGenBio AS and
Daiichi Sankyo.
This press release contains "forward-looking" statements,
including, without limitation, statements related to Rigel's
clinical development plans, including the enrollment and timing of
planned clinical trials and the timing and reporting of results
from our current and planned clinical trials, as well as our
expected cash balances and sufficiency of our cash. Any
statements contained in this press release that are not statements
of historical fact may be deemed to be forward-looking statements.
Words such as "planned," "will," "may," "expect," and similar
expressions are intended to identify these forward-looking
statements. These forward-looking statements are based on Rigel's
current expectations and inherently involve significant risks and
uncertainties. Actual results and the timing of events could differ
materially from those anticipated in such forward looking
statements as a result of these risks and uncertainties, which
include, without limitation, the availability of resources to
develop Rigel's product candidates, Rigel's need for additional
capital in the future to sufficiently fund Rigel's operations and
research, the uncertain timing of completion of and the success of
clinical trials, market competition, risks associated with and
Rigel's dependence on Rigel's corporate partnerships, as well as
other risks detailed from time to time in Rigel's reports filed
with the Securities and Exchange Commission, including its
Quarterly Report on Form 10-Q for the quarter ended June 30,
2014. Rigel does not undertake any obligation to update
forward-looking statements and expressly disclaims any obligation
or undertaking to release publicly any updates or revisions to any
forward-looking statements contained herein.
Contact: Ryan D. Maynard
Phone: 650.624.1284
Email: invrel@rigel.com
Media Contact: Susan C. Rogers,
Rivily, Inc.
Phone: 650.430.3777
Email: susan@rivily.com
RIGEL
PHARMACEUTICALS, INC
|
STATEMENTS OF
OPERATIONS
|
(in thousands,
except per share amounts)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
September 30,
|
|
Nine Months Ended
September 30,
|
|
|
2014
|
2013
|
|
2014
|
2013
|
|
|
(unaudited)
|
Revenues:
|
|
|
|
|
|
|
Contract
revenues
|
$
-
|
$
-
|
|
$
-
|
$ 1,400
|
|
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
|
|
Research and
development (see Note A)
|
16,151
|
17,574
|
|
53,083
|
57,282
|
|
General and
administrative (see Note A)
|
4,889
|
4,677
|
|
15,798
|
14,964
|
|
Restructuring charges
(see Note A)
|
-
|
1,679
|
|
-
|
1,679
|
|
Total operating
expenses
|
21,040
|
23,930
|
|
68,881
|
73,925
|
|
|
|
|
|
|
|
Loss from
operations
|
(21,040)
|
(23,930)
|
|
(68,881)
|
(72,525)
|
Interest income,
net
|
98
|
106
|
|
245
|
359
|
|
|
|
|
|
|
|
Net loss
|
$
(20,942)
|
$
(23,824)
|
|
$ (68,636)
|
$ (72,166)
|
|
|
|
|
|
|
|
Net loss per share,
basic and diluted
|
$
(0.24)
|
$
(0.27)
|
|
$ (0.78)
|
$ (0.83)
|
|
|
|
|
|
|
|
Weighted-average
shares used in computing net
loss per share, basic and diluted
|
|
|
|
|
|
87,793
|
87,430
|
|
87,618
|
87,240
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Note
A
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock-based
compensation expense included in:
|
|
|
|
|
|
Research and
development
|
$
1,151
|
$
1,035
|
|
$ 3,654
|
$ 3,060
|
|
General and
administrative
|
929
|
789
|
|
2,922
|
2,304
|
|
Restructuring
charges
|
-
|
239
|
|
-
|
239
|
|
|
$
2,080
|
$
2,063
|
|
$ 6,576
|
$ 5,603
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
SUMMARY BALANCE
SHEET DATA
|
|
|
|
|
|
(in
thousands)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
September
30,
|
December
31,
|
|
|
|
|
|
2014
|
2013 (1)
|
|
|
|
|
|
(unaudited)
|
|
|
|
|
|
Cash, cash
equivalents and available for sale
securities
|
|
|
|
|
|
|
$
157,672
|
$
211,975
|
|
|
|
|
Total
assets
|
163,219
|
226,058
|
|
|
|
|
Stockholders'
equity
|
146,850
|
208,251
|
|
|
|
|
|
|
|
|
|
|
(1)
|
Derived from audited
financial statements
|
|
|
|
|
SOURCE Rigel Pharmaceuticals, Inc.