SOUTH SAN FRANCISCO, Calif.,
May 2, 2017 /PRNewswire/ -- Rigel
Pharmaceuticals, Inc. (Nasdaq:RIGL) today reported financial
results for the first quarter ended March
31, 2017.
Recent Achievements
- On April 27, 2017, Rigel
announced the conditional acceptance by the U.S Food & Drug
Administration (FDA) of the proprietary name TavalisseTM
for fostamatinib disodium, its lead investigational product
candidate.
- On April 17, 2017, Rigel
announced it submitted a New Drug Application (NDA) to the FDA for
Tavalisse for the treatment of chronic and persistent immune
thrombocytopenia (ITP). The FDA previously granted Orphan Drug
designation to Tavalisse for the treatment of patients with
ITP.
- In February 2017, Rigel completed
an underwritten public offering of 23,000,000 shares of common
stock, which resulted in net proceeds to Rigel of approximately
$43.0 million, after deducting
underwriting discounts and commissions and offering expenses paid
by Rigel.
"The first quarter was an exciting time at Rigel as we achieved
significant milestones related to our lead product candidate,
Tavalisse, in ITP," said Raul
Rodriguez, Rigel's president and chief executive officer.
"Looking ahead, we hope to report on FDA acceptance of our
submitted NDA for review by the end of the second quarter. In
addition, we will continue to advance fostamatinib across other
indications."
For the first quarter of 2017, Rigel reported a net loss of
$15.3 million, or $0.13 per share, compared to a net loss of
$17.5 million, or $0.19 per share, in the first quarter of
2016.
Contract revenues from collaborations of $3.6 million in the first quarter of 2017 is
comprised primarily of the $3.3
million payment from BerGenBio AS as a result of advancing
BGB324, its selective, potent and orally available small molecule
AXL kinase inhibitor, to a Phase 2 clinical study. Contract
revenues from collaborations of $5.0 million during the first quarter of
2016 were comprised of the $4.8
million amortization of the $30.0
million upfront payment, which was fully amortized in
September 2016, and $195,000 in FTE fees earned pursuant to Rigel's
collaboration and license agreement with Bristol-Myers Squibb, for
the discovery, development and commercialization of potential
immuno-oncology therapeutics.
Rigel reported total costs and expenses of $19.8 million in the first quarter of 2017,
compared to $22.6 million in the
first quarter of 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 increases in costs related to NDA preparation, as well as
preparation for the potential commercial launch of Tavalisse
(fostamatinib disodium) in ITP.
As of March 31, 2017, Rigel had
cash, cash equivalents and short-term investments of $98.1 million, compared to $74.8 million as of December 31, 2016. Rigel expects this amount will
be sufficient to support its current and projected funding
requirements, including the preparation for the potential
commercial launch of Tavalisse in ITP in the U.S., through at least
the next 12 months. Rigel continues to evaluate ex-U.S.
partnerships for Tavalisse and other partnering opportunities
across its pipeline.
Portfolio Update
Tavalisse (fostamatinib disodium) in ITP
On
April 17, 2017, Rigel submitted an
NDA to the FDA for Tavalisse 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).
Fostamatinib in autoimmune hemolytic anemia
(AIHA)
Enrollment remains on track for stage 1 of Rigel's
Phase 2, open-label, multi-center, two-stage study of fostamatinib
for the treatment of warm antibody autoimmune hemolytic anemia
(AIHA). The SOAR study will evaluate the safety and efficacy of
fostamatinib at 150 mg (oral, twice daily for 12 weeks) in
approximately 17 patients with AIHA who have previously received
treatment for the disorder, but have relapsed. Rigel expects to
have results of the Stage 1 segment of the trial in 2017.
Fostamatinibin IgA nephropathy
(IgAN)
In January 2017, Rigel reported results from the
first cohort in the Phase 2 clinical study of fostamatinib in IgAN,
which evaluated the efficacy, safety, and tolerability of the lower
dose of fostamatinib (100mg BID, n=26; placebo n=12) as measured by
change in proteinuria, renal function, and histology (comparing the
pre- and post-study renal biopsies). The primary efficacy endpoint
was the mean change of proteinuria from baseline at 24 weeks. The
study found that at 24 weeks, fostamatinib was well tolerated with
a good safety profile and data suggest a trend towards a greater
reduction in proteinuria in fostamatinib treated patients relative
to placebo. Rigel expects the second cohort, evaluating a higher
dose of fostamatinib (150mg BID) will finish enrollment in 2017
with results in 2018.
Additional Product Development
Rigel is selecting a
molecule from its IRAK program for preclinical development. It is
expected that the program will include clinical evaluation in
immunology areas, such as for lupus, gout and/or psoriasis.
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 complications, or even
death. Current therapies for ITP include steroids, blood
platelet production boosters (TPOs) and splenectomy. However, a
portion of patients do not derive a benefit from 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 11028280. 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 clinical trials of fostamatinib,
an oral spleen tyrosine kinase (SYK) inhibitor in a number of
indications. The company submitted a NDA to the FDA for
fostamatinib in patients with chronic and persistent immune
thrombocytopenia (ITP) in April 2017.
Rigel is also conducting Phase 2 clinical studies with fostamatinib
in IgA nephropathy (IgAN) and autoimmune hemolytic anemia (AIHA).
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 a response from the FDA to our NDA submission and Rigel's
belief that fostamatinib may be an attractive alternative for
patients with ITP. 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," "conditional" 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 not accept our NDA submission; the
FDA may interpret Rigel's findings differently, which could result
in the FDA not approving any
submitted 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; the
uncertain timing of enrollment and completion of and the results of
clinical studies; market competition, risks associated with and
Rigel's dependence on Rigel's corporate partnerships; 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 Annual Report on Form 10-K for the year
ended December 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: 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
March 31,
|
|
|
2017
|
2016
|
|
|
(unaudited)
|
|
|
|
|
Revenues:
|
|
|
|
Contract revenues
from collaborations
|
$
3,584
|
$
5,029
|
|
|
|
|
Costs and
expenses:
|
|
|
|
Research and
development (see Note A)
|
12,376
|
18,173
|
|
General and
administrative (see Note A)
|
7,410
|
4,423
|
|
Total costs and
expenses
|
19,786
|
22,596
|
Loss from
operations
|
(16,202)
|
(17,567)
|
Gain on disposal of
assets
|
732
|
—
|
Interest
income
|
156
|
103
|
Net loss
|
$
(15,314)
|
$
(17,464)
|
|
|
|
|
Net loss per share,
basic and diluted
|
$
(0.13)
|
$
(0.19)
|
|
|
|
|
Weighted-average
shares used in computing
|
|
|
net loss per share, basic and diluted
|
113,598
|
90,555
|
|
|
|
|
|
|
|
|
Note
A
|
|
|
|
|
|
|
Stock-based
compensation expense included in:
|
|
|
|
General and
administrative
|
$
595
|
$
745
|
|
Research and
development
|
360
|
693
|
|
|
$
955
|
$
1,438
|
|
|
|
|
SUMMARY BALANCE
SHEET DATA
|
(in
thousands)
|
|
|
|
|
|
|
March
31,
|
December
31,
|
|
|
2017
|
2016
(1)
|
|
|
(unaudited)
|
|
|
Cash, cash
equivalents and short-term investments
|
$
98,141
|
$
74,766
|
|
Total
assets
|
101,326
|
78,134
|
|
Stockholders'
equity
|
84,081
|
55,027
|
|
(1)
|
Derived from audited
financial statements
|
|
|
To view the original version on PR Newswire,
visit:http://www.prnewswire.com/news-releases/rigel-announces-first-quarter-2017-financial-results-and-provides-company-update-300449943.html
SOURCE Rigel Pharmaceuticals, Inc.