SOUTH SAN FRANCISCO, Calif.,
March 7, 2017 /PRNewswire/
-- Rigel Pharmaceuticals, Inc. (Nasdaq:RIGL) today
reported financial results for the fourth quarter and year ended
December 31, 2016.
Recent Achievements
- In August and October 2016, Rigel
reported results from the three FIT Phase 3 clinical studies of
fostamatinib in immune thrombocytopenia (ITP), which showed a
consistent fostamatinib response rate.
- In January 2017, Rigel announced
its post hoc calculations of the overall response rate for two FIT
Phase 3 clinical studies (Study 047 and Study 048) by combining
stable and intermediate responders. The overall response rate
to fostamatinib of stable and intermediate responders is 29%
(29/101) compared to 2% (1/49) for placebo (p=<0.0001).
- In January 2017, Rigel also
announced additional data for the FIT Phase 3, open-label,
extension study, which further validates fostamatinib as a
potential new treatment option for some patients with ITP. Rigel
believes that the data from the FIT Phase 3 clinical program
support its intention to submit a New Drug Application (NDA) to the
Food and Drug Administration (FDA) this month.
- 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 estimated offering
expenses.
- In preparation for the potential launch of fostamatinib, Rigel
has hired key executives, whose contributions will be instrumental
in transitioning the organization into a profitable,
commercial-stage biotechnology company.
"We believe that the favorable safety profile and demonstrated
efficacy of fostamatinib may make it an excellent treatment option
for patients with chronic ITP," said Raul
Rodriguez, Rigel's president and chief executive officer.
"The company expects to submit a New Drug Application (NDA) for
fostamatinib in ITP in the first quarter of 2017."
For the fourth quarter of 2016, Rigel reported a net loss of
$15.6 million, or $0.16 per basic and diluted share, compared to a
net loss of $12.7 million, or
$0.14 per basic and diluted share, in
the fourth quarter of 2015.
Contract revenues from collaborations of $3.0 million in the fourth quarter of 2016 were
related to the payment received from Bristol-Myers Squibb Company
(BMS) pursuant to Rigel's collaboration and license agreement with
BMS for the discovery, development and commercialization of
potential immuno-oncology therapeutics. Contract revenues from
collaborations of $8.5 million
in the fourth quarter of 2015 were primarily comprised of the
amortization of the $30.0 million
upfront payment from BMS, as well as a license fee from a third
party.
Rigel reported total costs and expenses of $18.8 million in the fourth quarter of 2016,
compared to $21.3 million in the
fourth quarter of 2015. The decrease in costs and expenses was
primarily due to the reduction in workforce in September 2016, partially offset by the increase
in stock-based compensation expense, mainly related to certain
performance-based stock options.
For the year ended December 31,
2016, Rigel reported contract revenues from collaborations
of $20.4 million and a net loss of
$69.2 million, or $0.73 per basic and diluted share, compared to
contract revenues from collaborations of $28.9 million and a net loss of $51.5 million, or $0.58 per basic and diluted share, in 2015.
Contract revenues from collaborations in 2016 were mainly comprised
of the $13.4 million
amortization of the upfront payment, $3.0 million contingent payment received and
$290,000 in FTE fees we earned from
BMS, as well as the $3.7 million
contingent payment received from BerGenBio AS. Contract revenues
from collaborations in 2015 were mainly comprised of $16.6 million amortization of the upfront payment
from BMS and upfront payments received from other
collaborators.
As of December 31, 2016, Rigel had
cash, cash equivalents and short-term investments of $74.8 million, compared to $126.3 million as of December 31, 2015. In February 2017, Rigel completed an underwritten
public offering in which it received net proceeds of approximately
$43.0 million after deducting
underwriting discounts and commissions and estimated offering
expenses.
Rigel expects that its cash, cash equivalents and short-term
investments will be sufficient to support its current and projected
funding requirements, including the preparation for the potential
commercial launch of fostamatinib in ITP in the U.S., through at
least the next 12 months. Rigel continues to evaluate ex-U.S.
partnerships for fostamatinib and other partnering opportunities
across its pipeline.
Portfolio Update
Fostamatinib in Immune Thrombocytopenia (ITP)
During
the fourth quarter of 2016, Rigel continued to report topline
results for its FIT Phase 3 clinical studies of fostamatinib in
ITP. Results from the FIT Phase 3 clinical studies demonstrated
that patients who responded to fostamatinib have a timely, robust,
and sustained response to treatment. Seventeen patients who
achieved a stable response to fostamatinib in the parent studies
(047, 048) enrolled in the open-label, long-term extension study
(049). As of September 2016, these
responders had been on fostamatinib treatment for a median of 16
months and maintained a median platelet count over
100,000/μL.
Rigel also recently announced its calculations of an overall
response rate for Study 047 and Study 048 by combining stable and
intermediate responders. The overall response rate to
fostamatinib of stable and intermediate responders is 29% (29/101)
compared to 2% (1/49) for placebo (p=<0.0001). In this
post-study analysis performed by Rigel, an intermediate response
was defined to include patients achieving at least 2 consecutive
median platelet counts over 50,000/μL during study without rescue,
but who did not otherwise meet the stable response criteria. Also
notable:
- Data from the FIT Phase 3 clinical program (comprised of Study
047, 048 and 049) demonstrate that fostamatinib works effectively
for certain ITP patients and that the benefit was consistent across
all sub-groups analyzed including TPO (blood platelet production
booster) experienced patients who have limited treatment options
remaining.
- Adverse events (AEs) in the fostamatinib group in Study 047 and
048 were generally mild or moderate, with gastrointestinal-related
AEs reported most frequently, and were reversible over time.
- In Study 049, 41 former placebo patients newly exposed to
fostamatinib for a minimum of 12 weeks achieved a prospectively
defined stable platelet response of 22% (9/41, p=0.0078). Rigel
believes this further validates fostamatinib as a potential new
treatment option for some patients with this serious disease.
Fostamatinib in 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 a low 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 that the second cohort, evaluating a higher
dose of fostamatinib (150mg BID) for IgAN, will finish enrollment
in 2017 with results in 2018.
Additional Product Development
- Rigel expects to complete enrollment and have results from its
proof-of-concept study of fostamatinib in patients with autoimmune
hemolytic anemia (AIHA) in 2017.
- Pursuant to Rigel's license agreement with BerGenBio AS, Rigel
received a milestone payment of $3.3
million in the first quarter of 2017. This is the
result of BerGenBio AS advancing BGB324, its selective, potent and
orally available small molecule AXL kinase inhibitor, to a Phase 2
clinical study. BGB324 is the most advanced, selective AXL kinase
inhibitor and was discovered by Rigel and licensed to BerGenBio
AS.
- Rigel plans on selecting a molecule from its IRAK program for
preclinical development in 2017. It is expected that the program
will include clinical evaluation in immunology areas, such as for
lupus, gout and/or psoriasis.
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 75337580. The conference call and
accompanying slide presentation 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 studies of fostamatinib,
an oral spleen tyrosine kinase (SYK) inhibitor in a number of
indications. The company completed and reported results from the
FIT Phase 3 clinical program of fostamatinib in chronic immune
thrombocytopenia (ITP). Rigel is also conducting a Phase 2 clinical
study with fostamatinib in autoimmune hemolytic anemia (AIHA) and a
Phase 2 clinical study for IgA nephropathy (IgAN). In addition,
Rigel has two oncology product candidates in development with
partners BerGenBio AS (Phase 2) and Daiichi Sankyo (Phase 1).
This press release contains "forward-looking" statements
relating to, among other things, 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
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 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 FDA may
interpret our findings differently, which could result in the FDA
not approving any submitted NDA, the availability of resources to
develop Rigel's product candidates, the uncertain timing of
completion of and the success of clinical studies, Rigel's need for
additional capital in the future to sufficiently fund Rigel's
operations and research, 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 period ended September
30, 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,
Inventiv Health PR Group
Phone: 917-816-6712
Email: jessica.daitch@inventivhealth.com
RIGEL
PHARMACEUTICALS, INC
|
STATEMENTS OF
OPERATIONS
|
(in thousands,
except per share amounts)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
December 31,
|
|
Year Ended
December 31,
|
|
|
2016
|
2015
|
|
2016
|
2015
|
|
|
(unaudited)
|
|
|
|
|
|
|
|
|
|
|
Revenues:
|
|
|
|
|
|
|
Contract revenues
from collaborations
|
$
3,000
|
$
8,537
|
|
$
20,383
|
$
28,895
|
|
|
|
|
|
|
|
Costs and
expenses:
|
|
|
|
|
|
|
Research and
development (see Note A)
|
11,634
|
16,563
|
|
63,446
|
62,825
|
|
General and
administrative (see Note A)
|
7,153
|
4,721
|
|
20,908
|
17,813
|
|
Restructuring charges
(see Note A)
|
-
|
-
|
|
5,770
|
-
|
|
Total costs and
expenses
|
18,787
|
21,284
|
|
90,124
|
80,638
|
|
|
|
|
|
|
|
Loss from
operations
|
(15,787)
|
(12,747)
|
|
(69,741)
|
(51,743)
|
Interest
income
|
109
|
60
|
|
437
|
222
|
Gain on disposal of
assets
|
88
|
-
|
|
88
|
57
|
|
|
|
|
|
|
|
Net loss
|
$
(15,590)
|
$
(12,687)
|
|
$
(69,216)
|
$
(51,464)
|
|
|
|
|
|
|
|
Net loss per share,
basic and diluted
|
$
(0.16)
|
$
(0.14)
|
|
$
(0.73)
|
$
(0.58)
|
|
|
|
|
|
|
|
Weighted-average
shares used in computing
|
|
|
|
|
|
net loss per share, basic and diluted
|
98,981
|
89,038
|
|
94,387
|
88,434
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Note
A
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock-based
compensation expense included in:
|
|
|
|
|
|
|
General and
administrative
|
$
2,309
|
$
707
|
|
$
4,230
|
$
3,303
|
|
Research and
development
|
357
|
918
|
|
3,103
|
4,100
|
|
Restructuring
charges
|
-
|
-
|
|
499
|
-
|
|
|
$
2,666
|
$
1,625
|
|
$
7,832
|
$
7,403
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
SUMMARY BALANCE
SHEET DATA
|
|
|
|
|
(in
thousands)
|
|
|
|
|
|
|
|
|
|
|
|
|
December
31,
|
|
|
|
|
|
2016
|
2015
|
|
|
|
|
|
|
|
|
|
|
|
Cash, cash
equivalents and short-term investments
|
$
74,766
|
$
126,276
|
|
|
|
|
Total
assets
|
78,134
|
131,747
|
|
|
|
|
Stockholders'
equity
|
55,027
|
91,381
|
|
|
|
To view the original version on PR Newswire,
visit:http://www.prnewswire.com/news-releases/rigel-announces-fourth-quarter-2016-and-year-end-2016-financial-results-and-provides-company-update-300419641.html
SOURCE Rigel Pharmaceuticals, Inc.