SOUTH SAN FRANCISCO, Calif.,
Aug. 1, 2017 /PRNewswire/ -- Rigel
Pharmaceuticals, Inc. (Nasdaq:RIGL) today reported financial
results for the second quarter and six months ended June 30, 2017.
Recent Achievements
- On June 19, 2017, Rigel announced
the U.S Food & Drug Administration (FDA) had accepted for
filing its New Drug Application (NDA) for the use of TAVALISSE™
(fostamatinib disodium) in patients with chronic or persistent
immune thrombocytopenia (ITP).
- The FDA has set the date of April 17,
2018 to complete its review of fostamatinib in ITP under the
Prescription Drug User Fee Act (PDUFA).
- Strengthened leadership team with three key hires to support
its commercial and regulatory efforts.
"The FDA acceptance of our NDA for our lead product candidate,
TAVALISSE™, in ITP is a significant milestone for us," said
Raul Rodriguez, Rigel's president
and chief executive officer. "Over the next nine months, we will
work collaboratively with the FDA as they review our
application. In addition, we will continue to prepare for the
commercial launch of fostamatinib as well as explore its potential
across other indications."
For the second quarter of 2017, Rigel reported a net loss of
$19.1 million, or $0.16 per basic and diluted share, compared to a
net loss of $13.5 million, or
$0.15 per basic and diluted share, in
the same period of 2016.
There were no contract revenues from collaborations in the
second quarter of 2017. 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, which was fully amortized in
September 2016, and $95,000 in FTE fees earned pursuant to Rigel's
collaboration and license agreement with Bristol-Myers Squibb, as
well as payments of $3.7 million that
Rigel received pursuant to its license agreement with BerGenBio
AS.
Rigel reported total costs and expenses of $19.3 million in the second quarter of 2017,
compared to $22.2 million for the
same period in 2016. The decrease in costs and expenses was
primarily due to the decreases in personnel costs and
research-related costs as a result of the reduction in workforce in
September 2016, partially offset by
the increase in costs related to the preparation for the potential
commercial launch of fostamatinib in ITP.
For the six months ended June 30,
2017, Rigel reported a net loss of $34.5 million, or $0.29 per basic and diluted share, compared to a
net loss of $31.0 million, or
$0.34 per basic and diluted share,
for the same period of 2016.
As of June 30, 2017, Rigel had
cash, cash equivalents and short-term investments of $82.3 million, compared to $74.8 million as of December 31, 2016. Rigel expects that its cash,
cash equivalents and short-term investments as of June 30, 2017 will be sufficient to support its
current and projected funding requirements, including the
preparation for the potential U.S. commercial launch, through at
least the next 12 months. Rigel continues to evaluate ex-U.S.
partnerships for fostamatinib and other partnering opportunities
across its pipeline.
Corporate Update
In support of its regulatory process
and commercial launch efforts, Rigel recently made three key hires.
Dana Pizzuti, who was Vice President
of Regulatory Affairs at Gilead Sciences since 2007 and facilitated
the approval of 14 new medicines during her tenure there, joins as
Senior Vice President of Regulatory Affairs and Clinical Quality
Assurance; Giovanna Matthews joins
as Executive Director, Market Access, bringing with her many years
of great experience in Market Access and reimbursement; and, later
this month Sandra Tong, M.D., most
recently Vice President of Clinical Research at Plexxikon Inc. will
join Rigel as Vice President, Clinical Science & Drug
Safety.
Portfolio Update
TAVALISSE™ (fostamatinib
disodium) in ITP
On June 19,
2017, Rigel announced that the FDA had accepted for filing
its NDA for fostamatinib for the treatment of patients with chronic
and persistent ITP. The NDA is supported by data from the Phase 3
clinical program, which was comprised of three studies, two
randomized placebo-controlled studies (Studies 047 and 048) and an
open-label extension study (Study 049). Together with an
initial proof of concept study, the NDA included 163 ITP patients.
Across all indications, fostamatinib has been evaluated in over
4,600 patients. Data from all studies, including preclinical
evaluation and drug manufacturing data, were included in the NDA
submission.
Fostamatinib in autoimmune hemolytic anemia
(AIHA)
Enrollment remains on track for Stage 1 (n=17) of
Rigel's Phase 2, open-label, multi-center, two-stage study of
fostamatinib for the treatment of warm antibody autoimmune
hemolytic anemia (AIHA). Also known as the SOAR study, it will
evaluate the safety and efficacy of fostamatinib (150mg BID, twice
a day for 12 weeks) in patients with warm AIHA who have previously
received at least one treatment for this disease, but have not
benefited from it and are still anemic. Rigel expects to
report preliminary results for Stage 1 of the study, which is over
70% enrolled, by the end of 2017. Rigel will evaluate the
results from Stage 1 before proceeding to Stage 2 of the study,
which would enroll another 20 patients using the same protocol.
Fostamatinib in IgA nephropathy
(IgAN)
Enrollment continues in Rigel's second cohort in its
Phase 2 study of fostamatinib (150mg BID) in IgAN. Similar to the
first cohort, which reported results in January 2017, the study will evaluate the
efficacy, safety, and tolerability of fostamatinib as measured by
change in proteinuria, renal function, and histology (comparing the
pre- and post-study renal biopsies). However, the second cohort
evaluates a higher dose of fostamatinib, 150mg BID, whereas the
first cohort evaluated 100mg BID. The primary efficacy endpoint is
the mean change of proteinuria from baseline at 24 weeks. Rigel
expects the second cohort will finish enrollment in 2017 with
results in 2018.
Additional Product Development
During the second
quarter, Rigel selected a molecule from its IRAK program for
preclinical development. The molecule is differentiated in that it
inhibits both the IRAK 1 and IRAK 4 signaling pathways, with
potential to treat autoimmune and inflammatory diseases such as
lupus, gout, psoriatic arthritis and multiple sclerosis. Rigel
expects to initiate clinical trials in the first half of
2018.
About ITP
In patients with ITP, the immune system
attacks and destroys the body's own blood platelets, which play an
active role in blood clotting and healing. Common symptoms of
ITP are excessive bruising and bleeding. People suffering
with chronic ITP may live with increased risk of severe bleeding
events that can result in serious medical complication, or even
death. Current therapies for ITP include steroids, blood
platelet production boosters (TPOs) and splenectomy. However, not
all patients are adequately treated with existing therapies. As a
result, there remains a significant medical need for additional
treatment options for patients with ITP.
About 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. AIHA affects
approximately 40,000 adult patients in the US and can be a severe,
debilitating anemia. To date, there are no FDA approved
disease-targeted therapies for AIHA, despite the tremendous medical
need that exists for these patients as disease relapse is common.
Instead, physicians generally treat acute and chronic cases of the
disorder with corticosteroids, IV immunoglobulin infusion, other
immuno-suppressants, or splenectomy (the surgical removal of the
spleen).
About IgAN
IgAN (also known as Berger's disease) is a
chronic autoimmune disease associated with inflammation in the
kidneys that diminishes their ability to filter blood. It is the
most common primary glomerular disease affecting an estimated
82,500 to 165,000 cases in the US, with a higher prevalence
in Asia. For as many as 25 percent of those living with IgAN,
the disease results in end-stage renal failure requiring dialysis
or kidney transplantation. Other than angiotensin blockade
(primarily for blood-pressure control), there are no
disease-targeted therapies for IgAN.
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 55352069. 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 biotechnology company dedicated to
discovering, developing and providing novel small molecule drugs
that significantly improve the lives of patients with immune and
hematological disorders, cancer and rare diseases. Rigel's
pioneering research focuses on signaling pathways that are critical
to disease mechanisms. The company's current clinical programs
include clinical trials of fostamatinib, an oral spleen tyrosine
kinase (SYK) inhibitor, in a number of indications. Rigel has
submitted and the FDA has accepted for review, an NDA for
fostamatinib in patients with chronic or persistent immune
thrombocytopenia (ITP). In addition, Rigel has product candidates
in development with partners BerGenBio AS, Daiichi Sankyo and
Aclaris Therapeutics.
Forward Looking Statements
This release contains
forward-looking statements relating to, among other things, the
timing of enrollment and results of on-going clinical trials; the
results of the FDA's review of Rigel's NDA for fostamatinib in
patients with chronic and persistent ITP; the sufficiency of
Rigel's cash, cash equivalents and short-term investments to
support its funding requirements through at least the next 12
months; and Rigel's evaluation of ex-US partnerships for
fostamatinib and other partnering opportunities. 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 FDA may interpret Rigel's findings
differently, which could result in
the FDA not approving the
NDA; 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; market
competition; risks related to changes in estimated cash position
based on the completion of financial closing procedures and the
audit of Rigel's financial statements; 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 period ended March 31, 2017. 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: Jessica Daitch
Phone: 917.816.6712
Email: jessica.daitch@inventivhealth.com
RIGEL
PHARMACEUTICALS, INC.
|
STATEMENTS OF
OPERATIONS
|
(in thousands,
except per share amounts)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
June 30,
|
|
Six Months Ended
June 30,
|
|
|
2017
|
2016
|
|
2017
|
2016
|
|
|
(unaudited)
|
Revenues:
|
|
|
|
|
|
|
Contract revenues
from collaborations
|
$
-
|
$
8,594
|
|
$
3,584
|
$
13,623
|
|
|
|
|
|
|
|
Costs and
expenses:
|
|
|
|
|
|
|
Research and
development (see Note A)
|
11,524
|
17,468
|
|
23,900
|
35,641
|
|
General and
administrative (see Note A)
|
7,820
|
4,774
|
|
15,230
|
9,197
|
|
Total costs and
expenses
|
19,344
|
22,242
|
|
39,130
|
44,838
|
|
|
|
|
|
|
|
Loss from
operations
|
(19,344)
|
(13,648)
|
|
(35,546)
|
(31,215)
|
Gain on disposal of
assets
|
—
|
—
|
|
732
|
—
|
Interest
income
|
197
|
115
|
|
353
|
218
|
|
|
|
|
|
|
|
Net loss
|
$
(19,147)
|
$
(13,533)
|
|
$ (34,461)
|
$ (30,997)
|
|
|
|
|
|
|
|
Net loss per share,
basic and diluted
|
$
(0.16)
|
$
(0.15)
|
|
$
(0.29)
|
$
(0.34)
|
|
|
|
|
|
|
|
Weighted-average
shares used in computing net loss
per share, basic and diluted
|
122,500
|
92,495
|
|
118,074
|
91,525
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Note
A
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock-based
compensation expense included in:
|
|
|
|
|
|
|
General and
administrative
|
$
764
|
$
604
|
|
$
1,359
|
$
1,349
|
|
Research and
development
|
336
|
1,410
|
|
696
|
2,103
|
|
|
$
1,100
|
$
2,014
|
|
$
2,055
|
$
3,452
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
SUMMARY BALANCE
SHEET DATA
|
|
|
|
|
|
(in
thousands)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
June
30,
|
December
31,
|
|
|
|
|
|
2017
|
2016
(1)
|
|
|
|
|
|
(unaudited)
|
|
|
|
|
|
Cash, cash
equivalents and short-term investments
|
$
82,302
|
$
74,766
|
|
|
|
|
Total
assets
|
85,478
|
78,134
|
|
|
|
|
Stockholders'
equity
|
69,605
|
55,027
|
|
|
|
|
|
|
|
|
|
|
(1)
|
Derived from audited
financial statements
|
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SOURCE Rigel Pharmaceuticals, Inc.