SOUTH SAN FRANCISCO, Calif.,
Aug. 2, 2016 /PRNewswire/
-- Rigel Pharmaceuticals, Inc. (Nasdaq:RIGL) today
reported financial results for the second quarter and six months
ended June 30, 2016.
"We look forward to announcing the topline results for the first
of two Phase 3 studies of fostamatinib in patients with ITP by the
end of this August, followed by the second study's results a few
months later," said Raul Rodriguez,
president and chief executive officer of Rigel. "Our primary
focus at this time is preparing the NDA submission, subject to
positive results in the program, as well as planning our commercial
capabilities in preparation for a successful U.S. launch of
fostamatinib," he added.
For the second quarter of 2016, Rigel reported a net loss of
$13.5 million, or $0.15 per basic and diluted share, compared to a
net loss of $13.9 million, or
$0.16 per basic and diluted share, in
the same period of 2015.
Contract revenues from collaborations of $8.6 million in the second quarter of 2016 were
comprised of $4.8 million from the
amortization of the $30.0 million
upfront payment and FTE fees earned pursuant to Rigel's
collaboration and license agreement with Bristol-Myers Squibb
(BMS), as well as payments amounting to $3.7
million that Rigel received pursuant to its license
agreement with BerGenBio AS. Contract revenues from collaborations
of $5.2 million in the second
quarter of 2015 were comprised of the amortization of the upfront
payment and FTE fees earned with BMS.
Rigel reported total costs and expenses of $22.2 million in the second quarter of 2016,
compared to $19.2 million for the
same period in 2015. The increase in costs and expenses was
primarily due to the increase in research and development costs
related to Rigel's clinical research programs with fostamatinib in
immune thrombocytopenia, autoimmune hemolytic anemia and IgA
nephropathy.
For the six months ended June 30,
2016, Rigel reported a net loss of $31.0 million, or $0.34 per basic and diluted share, compared to a
net loss of $32.1 million, or
$0.36 per basic and diluted share,
for the same period of 2015.
As of June 30, 2016, Rigel had
cash, cash equivalents and short-term investments of $94.9 million, compared to $126.3 million as of December 31, 2015. Rigel expects this amount to
be sufficient to fund operations into the third quarter of
2017.
Portfolio Update
Fostamatinib in Immune Thrombocytopenia (ITP)
Rigel
believes that Fostamatinib may offer a compelling addition to the
treatment options available for patients suffering from
ITP.
ITP
ITP is a rare, autoimmune bleeding disorder. In
healthy individuals, platelets stick together (clot) to seal small
cuts or breaks on blood vessel walls to stop bleeding. In ITP the
blood doesn't clot as it should because platelets are being
destroyed by the body's own immune system.
People suffering with chronic ITP may live with increased risk
of severe bleeding events that can result in serious medical
complications, or even death. The unpredictable nature of chronic
ITP can affect the quality of life for some patients, who are
unaware of when their platelet counts may drop. Current
therapies for ITP include steroids, blood platelet production
boosters (TPO's) and splenectomy.
The Role of Fostamatinib in ITP
Fostamatinib is an
oral treatment with a unique mechanism of action designed to
inhibit spleen tyrosine kinase (SYK), a key player in the immune
process that leads to platelet destruction in ITP. Unlike other
therapies that modulate the immune system in different ways or
stimulate platelet production, fostamatinib may address the
underlying autoimmune cause of ITP by preventing platelet
destruction.
ITP is a highly heterogeneous disease. There is little
certainty which treatment will work for which patient and whether
any benefit is enduring. In Rigel's Phase 2 study, Fostamatinib was
shown to work in certain patients where other treatments had
previously failed, including patients who had previously failed
steroids, rituximab, TPO's and/or splenectomy.
Based on our Phase 2 study, the patients who benefit from
fostamatinib benefit substantially and typically do so within weeks
of initiating treatment, providing early feedback as to whether
fostamatinib may be a viable option for treating their ITP.
Patients from this study who received a benefit had their platelet
counts increase from a median of 14,000 to over 100,000. Regarding
its enduring benefit, follow-up extension study data for two
patients who have been taking fostamatinib for more than seven
years show that they have maintained attractive platelet levels
over an extended time period.
Fostamatinib offers a convenient oral formulation that does not
require weekly office visits or dietary restrictions. These
are believed to be important distinctions from other products used
to treat this disease.
Fostamatinib's clinical safety profile includes more than 5,000
patient years of data across multiple autoimmune indications and
has a generally mild and manageable safety profile, providing data
that it may be suitable for long-term maintenance therapy in
chronic ITP.
Fostamatinib FIT Phase 3 Program
The FIT program
consists of two identical multi-center, randomized, double-blind,
placebo-controlled studies of approximately 75 patients each. The
patients have been diagnosed with persistent or chronic ITP, and
have blood platelet counts consistently below 30,000 per microliter
of blood. Study subjects remained on treatment for up to 24
weeks. The primary efficacy endpoint of this program is a
stable platelet response with platelet counts at or above 50,000
per microliter of blood for at least four of the final six
qualifying blood draws.
Data from the first of these studies is expected in August.
Pending the outcome of the Phase 3 studies, the company expects to
submit a New Drug Application with the U.S. FDA in the first
quarter of 2017.
Fostamatinib in Autoimmune Hemolytic Anemia (AIHA)
Rigel believes that autoimmune hemolytic anemia program represents
an exciting opportunity to evaluate fostamatinib in an underserved
disease and to build upon the synergies that exist between AIHA and
ITP.
AIHA
AIHA is a rare, serious blood disorder where the
immune system produces antibodies that result in the destruction of
the body's own red blood cells. Symptoms can include fatigue,
shortness of breath, rapid heartbeat, jaundice or enlarged
spleen. While no medical treatments are currently approved
for AIHA, physicians generally treat acute and chronic cases of the
disorder with corticosteroids, other immuno-suppressants, or
splenectomy. Research has shown that inhibiting SYK with
fostamatinib may reduce the destruction of red blood
cells.
The same physician audience that treats AIHA also generally
treats ITP. This may allow Fostamatinib, once approved in each
indication, to be used to treat multiple diseases by these same
physicians.
Fostamatinib AIHA Phase 2 Study
Rigel's AIHA trial is
a Phase 2 open-label, multi-center, two-stage study that will
evaluate the safety and efficacy of fostamatinib in patients with
warm antibody AIHA who have previously received treatment for the
disorder, but have relapsed.
Stage 1 will enroll 17 patients who will receive 150 mg of
fostamatinib orally twice a day for a period of 12 weeks. The
patients will return to the clinic every two weeks for blood draws
and medical assessment. The primary efficacy endpoint of this study
is to achieve increased hemoglobin levels by week 12 of greater
than 10 g/dL, and greater than or equal to 2 g/dL higher than
baseline.
Rigel expects to have results of the Stage 1 segment of the
trial in early 2017. With this data, Rigel will evaluate the
best way forward and potentially an expedited path for pursuing
AIHA.
Fostamatinib in IgA Nephropathy (IgAN)
Rigel believes
that IgA Nephropathy offers a significant opportunity to address a
major kidney disease, which lacks proven effective
treatments. This indication may also offer insight into
other autoimmune kidney diseases, which may further expand the
potential of fostamatinib in other synergistic orphan disease
areas.
IgA Nephropathy
IgA Nephropathy is an autoimmune
disease that severely affects the functioning of the kidneys.
An estimated 12,000 Americans are diagnosed with this type of
glomerulonephritis each year, with 25% of its victims eventually
requiring dialysis and/or kidney transplantation. IgAN is
characterized by the deposition of IgA immune complexes in the
glomeruli of the kidneys leading to an inflammatory response and
subsequent tissue damage that ultimately disrupts the normal
filtering function of the kidneys. By inhibiting SYK in kidney
cells, fostamatinib may block the signaling of IgA immune complex
receptors and, arrest or slow destruction of the glomeruli.
Fostamatinib IgA Nephropathy Phase 2 Study
The Phase 2
study of fostamatinib in IgA nephropathy is a double-blind,
placebo-controlled, global study (U.S., Europe and Asia) consisting of two sequential dose
cohorts (100mg BID followed by 150mg BID). The primary
endpoint of the study is mean change in proteinuria from baseline
to 24 weeks. The first cohort (100mg BID) has fully enrolled
and we expect to report results from this cohort at the end of the
year. After a pre-planned safety review, we have begun
enrolling the 150mg BID dose cohort.
Up next: IRAK and more
Rigel has identified a lead
molecule from its IRAK program and plans to initiate clinical
studies in 2017. The product candidate may provide numerous
opportunities in immunology and possibly oncology
indications. Rigel is focused on immunology and oncology and
is pursuing a number of attractive opportunities in these
areas.
Conference Call and Webcast Today at 5:00PM Eastern Time
Rigel will hold a live
conference call and webcast today at 5:00pm
Eastern Time (2:00pm Pacific
Time).
Participants can access the live conference call by dialing
855-892-1489 (domestic) or 720-634-2939 (international) and using
the Conference ID number 54498109. The conference call will
also be webcast live and can be accessed from Rigel's website at
www.rigel.com. The webcast will be archived and available for
replay after the call via the Rigel website.
About Rigel (www.rigel.com)
Rigel
Pharmaceuticals, Inc. is a clinical-stage biotechnology company
dedicated to the discovery and development of novel, targeted drugs
in the therapeutic areas of immunology, oncology and
immuno-oncology. Rigel's pioneering research focuses on signaling
pathways that are critical to disease mechanisms. The company's
current clinical programs include fostamatinib, an oral spleen
tyrosine kinase (SYK) inhibitor, which is in Phase 3 clinical
trials for immune thrombocytopenia (ITP); a Phase 2 clinical trial
for autoimmune hemolytic anemia (AIHA); and a Phase 2 clinical
trial for IgA nephropathy (IgAN). In addition, Rigel has two
oncology product candidates in Phase 1 development with partners
BerGenBio AS and Daiichi Sankyo.
This press release contains "forward-looking" statements
relating to, among other things, timing of reporting topline data
of Phase 3 clinical studies with fostamatinib in ITP; the timing of
a potential New Drug Application submission to the Food and Drug
Administration for fostamatinib in ITP; the management and
advancement of Rigel's other clinical programs; Rigel's belief that
fostamatinib may be an attractive alternative for patients with
ITP; Rigel's ability to successfully prepare for potential
commercial launch of its product candidates; the timing, amount and
sufficiency of Rigel's cash, cash equivalents, and short-term
investments; Rigel's ability to extend the value of Rigel's
pipeline into fields that are beyond its therapeutic focus; the
evaluation of fostamatinib and Rigel's other product candidates for
new treatment indications; and Rigel's product pipeline and
development programs. 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, 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 three months ended March
31, 2016. 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
June 30,
|
|
Six Months Ended
June 30,
|
|
|
2016
|
2015
|
|
2016
|
2015
|
|
|
(unaudited)
|
Revenues:
|
|
|
|
|
|
|
Contract revenues
from collaborations
|
$
8,594
|
$
5,184
|
|
$
13,623
|
$
7,362
|
|
|
|
|
|
|
|
Costs and
expenses:
|
|
|
|
|
|
|
Research and
development (see Note A)
|
17,468
|
15,059
|
|
35,641
|
30,761
|
|
General and
administrative (see Note A)
|
4,774
|
4,099
|
|
9,197
|
8,816
|
|
Total costs and
expenses
|
22,242
|
19,158
|
|
44,838
|
39,577
|
|
|
|
|
|
|
|
Loss from
operations
|
(13,648)
|
(13,974)
|
|
(31,215)
|
(32,215)
|
Interest income,
net
|
115
|
62
|
|
218
|
110
|
|
|
|
|
|
|
|
Net loss
|
$
(13,533)
|
$
(13,912)
|
|
$ (30,997)
|
$ (32,105)
|
|
|
|
|
|
|
|
Net loss per share,
basic and diluted
|
$
(0.15)
|
$
(0.16)
|
|
$
(0.34)
|
$
(0.36)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted-average shares used in
computing net loss per share, basic and
diluted
|
92,495
|
88,137
|
|
91,525
|
88,090
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Note
A
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock-based
compensation expense included in:
|
|
|
|
|
|
|
Research and
development
|
$
1,410
|
$
1,056
|
|
$
2,103
|
$
2,216
|
|
General and
administrative
|
604
|
853
|
|
1,349
|
1,747
|
|
|
$
2,014
|
$
1,909
|
|
$
3,452
|
$
3,963
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
SUMMARY BALANCE
SHEET DATA
|
|
|
|
|
|
(in
thousands)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
June
30,
|
December
31,
|
|
|
|
|
|
2016
|
2015
(1)
|
|
|
|
|
|
(unaudited)
|
|
|
|
|
|
Cash, cash
equivalents and short-term investments
|
$
94,940
|
$
126,276
|
|
|
|
|
Total
assets
|
99,320
|
131,747
|
|
|
|
|
Stockholders'
equity
|
73,720
|
91,381
|
|
|
|
|
|
|
|
|
|
|
(1)
|
Derived from audited
financial statements
|
|
|
|
|
|
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SOURCE Rigel Pharmaceuticals, Inc.