Exhibit 99.1
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1180 Veterans Blvd.
South San Francisco, CA 94080
Main Phone: 650.624.1100
FAX: 650.624.1101
http://www.rigel.com
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Rigel Announces Third Quarter 2008 Financial Results
and Clinical Update
Company to Host Update Conference Call Today at 8:30 a.m. EST
South
San Francisco, Calif. – November 3, 2008 — Rigel Pharmaceuticals, Inc.
(Nasdaq:RIGL) today reported financial results for the three and nine months
ended September 30, 2008.
For
the third quarter of 2008, Rigel reported a net loss of $37.7 million, or $1.03
per share, compared to a net loss of $18.9 million, or $0.61 per share, in the
third quarter of 2007. Weighted average shares outstanding for the third
quarters of 2008 and 2007 were 36.6 million and 31.0 million, respectively.
There
were no contract revenues from collaborations reported in the third quarters of
2008 and 2007.
Rigel
reported operating expenses of $38.7 million in the third quarter of 2008,
compared to $20.4 million in the third quarter of 2007. The increase in operating
expenses was primarily due to increases in clinical development expenses and,
to a lesser extent, stock-based compensation expense. The increase in clinical
development expenses was mainly due to the costs associated with the ongoing
Phase 2b clinical trials of R788 in rheumatoid arthritis (TASKi2 and TASKi3).
Stock-based compensation expense increased from $2.8 million in the third
quarter of 2007 to $6.0 million in the third quarter of 2008, primarily due to
the higher valuation of options granted in the first quarter of 2008.
For
the nine months ended September 30, 2008, Rigel reported a net loss of
$99.0 million, or $2.76 per share, compared to a net loss of $55.3 million, or
$1.96 per share, for the same period last year. Rigel recorded no contract
revenue from collaborations for the first nine months of 2008, compared with
$4.6 million for the same period in 2007.
As
of September 30, 2008, Rigel had cash, cash equivalents and available for
sale securities of $160.4 million, compared to $185.0 million as of June 30,
2008 and $108.3 million as of December 31, 2007. In February 2008,
Rigel completed a public offering raising aggregate net proceeds of
approximately $127.5 million.
“Data
from our Phase 2a clinical trial of R788 in rheumatoid arthritis was recently
presented by the principal investigator at the plenary session of the American
College of Rheumatology,” said James M. Gower, chairman and chief executive
officer of Rigel. “We continue to be
very pleased with the safety profile of R788 and expect to release data on the
Phase 2b clinical trials in the second half of 2009,” he added.
Clinical
Update
R788
Rigel
expects that R788 for rheumatoid arthritis will continue to be the primary
clinical focus for Rigel. Two Phase 2b
clinical trials are ongoing in rheumatoid arthritis, TASKi2 and TASKi3. Rigel
expects Taski2 to complete enrollment by the first quarter of 2009 and to have
initial results by late summer 2009.
Rigel also anticipates that initial results on Taski3 will be available
by late summer 2009.
Rigel
expects to initiate a Phase 2 clinical trial for T-cell lymphoma within the
next several months. The ongoing Phase 2
lymphoma clinical trial is continuing and is focused on diffuse large B-cell,
follicular and other B-cell lymphomas, including Chronic Lymphocytic Leukaemia
and Small Lymphocytic Lymphoma (CLL/SLL).
Rigel plans to present further results from this ongoing clinical trial
at the American Society of Hematology (ASH) meeting in December 2008.
The
exploratory Phase 2a clinical trial in Immune Thrombocytopenic Purpura (ITP) is
ongoing and we expect the results to be published in the next couple of
months. Rigel has deferred initiating
any further trials in ITP until a collaboration partner for R788 is in place.
Likewise,
Rigel has deferred initiating a clinical trial in Lupus with R788 until a
collaboration partner for R788 is in place.
Rigel plans to work with any future collaboration partner for R788 to
jointly evaluate this indication and decide how to proceed.
R348
Moving
forward, Rigel plans to focus on psoriasis and possible topical applications
with its Jak3 inhibitor, R348, and to do so with a collaboration partner. Rigel
will move forward with another selective Jak3 inhibitor compound for transplant
rejection. Rigel expects to select this
new Jak3 inhibitor compound by the end of 2008. Rigel will proceed on its own
with this compound in transplant rejection.
Rigel does not plan to start a second rheumatoid arthritis program at
this time so as not to compete with the more advanced R788 program in the
clinic.
Given
the large Phase 3 requirements of the rheumatoid arthritis indication for R788,
and that Rigel will share in part of this effort with a corporate partner, the
above clinical decisions allow Rigel to focus its clinical resources primarily
on R788 in rheumatoid arthritis while maintaining momentum on the product
pipeline. Initiation of investment in new large clinical programs will be
deferred until corporate partnering is completed.
Conference
Call and Webcast Information
Rigel
will host a conference call with simultaneous webcast today at 5:30 a.m.
PST/8:30 a.m. EST to provide a company update. To access the live call,
please dial 800-265-0241 (domestic) or 617-847-8704 (international) 10 minutes prior
to the start time and use the passcode 39911675. A replay of the call will be
available, in podcast format, at approximately 9:30 a.m. EST on November 3,
2008 until November 10, 2008. To access the replay, please dial
888-286-8010 (domestic) or 617-801-6888 (international) and use the passcode
37653591. The conference call will also be webcast live and can be accessed
from Rigel’s website at http://www.rigel.com. Please connect to Rigel’s website
several minutes prior to the start of the live webcast to ensure adequate time
for any software downloads that may be necessary.
About Rigel (www.rigel.com)
Rigel
is a clinical-stage drug development company that discovers and develops novel,
small-molecule drugs for the treatment of inflammatory/autoimmune diseases and
cancer, as well as viral and metabolic diseases. Our pioneering research
focuses on intracellular signaling pathways and related targets that are
critical to disease mechanisms. Rigel’s productivity has resulted in strategic
collaborations with large pharmaceutical partners to develop and market our
product candidates. Rigel has product development programs in
inflammatory/autoimmune diseases such as rheumatoid arthritis thrombocytopenia
and asthma, as well as in cancer.
This
press release contains “forward-looking” statements, including statements
related to relating to the potential efficacy of R788, as well as Rigel’s plans
to pursue clinical development of R788 and other product candidates, and the
timing thereof, the market opportunity for its product candidates, expansion of
and changes in its product portfolio and its plans to pursue collaboration
partnerships for product candidates. 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 “plans,” “potential,” “intends,” “indicates,”
“promising,” “expects,” “anticipates” and similar expressions are intended to
identify these forward-looking statements. There are a number of important
factors that could cause Rigel’s results to differ materially from those
indicated by these forward-looking statements, including risks associated with
the timing and success of clinical trials and the commercialization of product
candidates, potential problems that may arise in the clinical testing and
approval process and Rigel’s need for additional capital, as well as other
risks detailed from time to time in Rigel’s SEC reports, including its Form 10-Q
for the quarter ended June 30, 2008. Rigel does not undertake any
obligation to update forward-looking statements.
###
Contact:
Ryan D. Maynard
Phone:
650.624.1284
Email:
invrel@rigel.com
Media
Contact: Susan C. Rogers, Alchemy Consulting, Inc.
Phone:
650.430.3777
Email:
susan@alchemyemail.com
SOURCE:
Rigel Pharmaceuticals, Inc.
STATEMENTS OF OPERATIONS
(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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2008
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2007
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2008
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2007
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(unaudited)
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(unaudited)
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Revenues:
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Contract revenues
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$
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—
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$
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—
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$
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—
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$
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4,600
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Operating
expenses:
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Research and
development (see Note A)
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31,232
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15,372
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81,268
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48,404
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General and
administrative (see Note A)
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7,450
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5,054
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21,436
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15,466
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Total operating
expenses
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38,682
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20,426
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102,704
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63,870
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Loss from
operations
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(38,682
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(20,426
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(102,704
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(59,270
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Interest income,
net
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991
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1,482
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3,722
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4,000
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Net loss
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$
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(37,691
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$
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(18,944
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$
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(98,982
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$
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(55,270
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Net loss per
share, basic and diluted
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$
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(1.03
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$
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(0.61
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$
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(2.76
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$
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(1.96
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Weighted average
shares used in computing net loss per share, basic and diluted
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36,581
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31,030
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35,837
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28,211
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Note A
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Stock-based
compensation expense included in:
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Research and
development
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$
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3,035
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$
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1,294
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$
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9,229
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$
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4212
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General and
adminstrative
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3,001
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1,500
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8,572
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4,909
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$
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6,036
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$
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2,794
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$
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17,801
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$
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9,121
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SUMMARY
BALANCE SHEET DATA
(in
thousands)
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September 30,
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December 31,
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2008
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2007(1)
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(unaudited)
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Cash, cash
equivalents and available for sale securities
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$
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160,358
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$
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108,296
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Total assets
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168,577
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115,789
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Stockholder’s
equity
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130,740
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82,182
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(1) Derived from audited financial statements