SOUTH SAN FRANCISCO, Calif.,
March 6, 2018 /PRNewswire/ -- Rigel
Pharmaceuticals, Inc. (Nasdaq:RIGL) today reported financial
results for the fourth quarter and year end 2017.
Recent Achievements
- The U.S. Food and Drug Administration (FDA) is continuing its review of Rigel's
New Drug Application (NDA) for fostamatinib for the treatment of
adult patients with chronic immune thrombocytopenia (ITP). The
Prescription Drug User Fee Act (PDUFA) action date for the FDA to
complete its review of the NDA is April 17,
2018.
- The FDA awarded Orphan Drug Designation to fostamatinib for the
treatment of warm antibody autoimmune hemolytic anemia (AIHA) on
January 31, 2018.
- Updated results from Stage 1 of Rigel's fostamatinib Phase 2
AIHA trial showed an increased clinical response rate after an
additional patient met the primary endpoint. This brings the Stage
1 response rate to 53% (9/17) of evaluable patients receiving
fostamatinib.
"The milestones achieved by our team in 2017 have set Rigel up
to realize our goal of building a commercial-stage company prepared
to launch our first medicine," said Raul
Rodriguez, president and CEO of Rigel. "We are excited about
the potential of fostamatinib as a treatment option for patients
with chronic ITP as well as the encouraging preliminary
fostamatinib data in patients living with autoimmune hemolytic
anemia, a rare disease for which there are no approved
therapies."
For the fourth quarter of 2017, Rigel reported a net loss of
$25.9 million, or $0.18 per basic and diluted share, compared to a
net loss of $15.6 million, or
$0.16 per basic and diluted share, in
the same period of 2016.
There were no contract revenues from collaborations in the
fourth quarter of 2017. Contract revenues from collaborations of
$3.0 million in the fourth quarter of
2016 were related to the payment received pursuant to Rigel's
collaboration and license agreement with Bristol-Myers Squibb
Company (BMS) for the discovery, development and commercialization
of potential immuno-oncology therapeutics.
Rigel reported total costs and expenses of $26.2 million in the fourth quarter of 2017,
compared to $18.8 million in the
fourth quarter of 2016. The increase in costs and expenses was
primarily due to the commercial launch preparation costs incurred
for fostamatinib in ITP as well as costs for managing the NDA
submission.
For the year ended December 31,
2017, Rigel reported contract revenues from collaborations
of $4.5 million and a net loss
of $78.0 million, or $0.62 per basic and diluted share, compared to
contract revenues from collaborations of $20.4 million and a net loss of $69.2 million, or $0.73 per basic and diluted share, in 2016.
Weighted average shares outstanding for the years ended
December 31, 2017 and 2016 were
126.3 million and 94.4 million, respectively. Contract
revenues from collaborations in 2017 are comprised of the
$3.3 million payment Rigel received
from BerGenBio AS pursuant to advancing a licensed AXL kinase
inhibitor to a Phase 2 clinical study and a $1.2 million payment Rigel earned pursuant to a
license agreement with a third party. 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
research service fees earned from BMS, as well as the $3.7 million contingent payment received
from BerGenBio AS.
As of December 31, 2017, Rigel had
cash, cash equivalents and short-term investments of $115.8 million, compared to $74.8 million as of December 31, 2016. Rigel expects that its cash,
cash equivalents and short-term investments will be sufficient to
support its current and projected funding requirements, including
the launch of fostamatinib for chronic ITP in the U.S., through the
next 12 months.
Corporate Update
Contingent on FDA approval of the NDA
for fostamatinib for the treatment of chronic ITP, Rigel is
preparing for a product launch in the second quarter of 2018.
Rigel continues to execute on its commercial readiness plan to
support this potential launch, including establishing distribution
channels with external partners, developing the systems needed to
provide medication access, and hiring all key personnel. The last
recruiting milestone will be the addition of the sales force
pending product approval.
Portfolio Update
TAVALISSE™ (fostamatinib disodium)
in Chronic ITP
Rigel is working with the FDA as it conducts its review of
Rigel's NDA for fostamatinib, an oral spleen tyrosine kinase
(SYK) inhibitor, for the treatment of adult patients with chronic
ITP.
Fostamatinib in Autoimmune Hemolytic Anemia
(AIHA)
Rigel is evaluating the safety and efficacy of
fostamatinib in patients with warm antibody AIHA. The Phase
2, open-label, multi-center, Simon two-stage study completed
enrollment of Stage 1 in 2017. A clinical response in this trial
was defined as achieving a hemoglobin level of greater than 10 g/dl
and at least a 2 g/dl increase from baseline.
In February 2018, an additional
patient in the Stage 1 extension study met the response
criteria. As of February 2018,
53% (9 of 17) of evaluable patients achieved a response to
fostamatinib treatment. Six patients achieved a response during the
12-week evaluation period, and an additional three patients met the
response criteria in the extension study after 12 weeks of dosing.
The safety profile was consistent with the existing fostamatinib
safety database. Data from this study will be presented at the
Thrombosis and Hemostasis Societies of North America meeting in San Diego, CA on March
8, 2018.
Stage 2 enrollment commenced in late 2017. Stage 2 follows the
same protocol as Stage 1 and will include 20 patients. Rigel
plans to meet with the FDA in the first half of 2018 to
determine the regulatory development pathway of fostamatinib in
AIHA.
On January 31, 2018, the FDA
granted Orphan Drug designation to fostamatinib for the treatment
of patients with AIHA.
Additional Product Development
- Rigel completed enrollment of the second cohort in its blinded
Phase 2 study of fostamatinib in IgA Nephropathy (IgAN). The study
is evaluating the efficacy, safety, and tolerability of
fostamatinib as measured by changes
in proteinuria, renal function, and histology (comparing the pre-
and post-study renal biopsies). The second cohort receives a higher
dose of fostamatinib, 150mg BID, while the first cohort received
100mg BID. The primary efficacy endpoint is the mean change in
proteinuria from baseline at 24 weeks. Rigel expects to have study
results by April 2018.
- During 2017, Rigel selected a molecule from its Interleukin-1
receptor-associated kinase (IRAK) program for preclinical
development. The molecule was selected for development based on its
ability to inhibit both the IRAK 1 and IRAK 4 signaling pathways in
preclinical studies, potentially providing a profound clinical
benefit in autoimmune and inflammatory diseases such as psoriasis,
lupus, gout, psoriatic arthritis and multiple sclerosis. The
Company expects to initiate clinical trials in mid-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 an 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, 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
Autoimmune hemolytic anemia (AIHA) is a
rare, serious blood disorder in which 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 disease-targeted therapies approved for AIHA, despite the
tremendous medical need that exists for these patients.
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 7289803. 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
hematologic disorders, cancer and rare diseases. Rigel's
pioneering research focuses on signaling pathways that are critical
to disease mechanisms. The company's current programs include
clinical studies of fostamatinib, an oral spleen tyrosine kinase
(SYK) inhibitor, in a number of indications. Rigel has an NDA under
review with the FDA for fostamatinib in patients with chronic
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 initiation, enrollment and results of
clinical trials; the results of the FDA's review of
Rigel's NDA for fostamatinib in patients with chronic or persistent
ITP; Rigel's ability to transition to an organization prepared to
launch its first commercial product; Rigel's belief that
fostamatinib may be an important alternative for patients with ITP
or AIHA; Rigel's evaluation of ex-US partnerships for fostamatinib
and other partnering opportunities across its pipeline; the timing
and outcome of Rigel's interactions with the FDA and other
regulatory agencies; the sufficiency of Rigel's cash, cash
equivalents, and short-term investments; the management and
advancement of Rigel's clinical programs; and the timing and
results of Rigel's clinical trials. 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," "should," "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; market
competition; 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, 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: Raul Rodriguez
Phone: 650.624.1302
Email: invrel@rigel.com
Media Contact: Jessica L. Daitch,
Syneos Health
Phone: 917.816.6712
Email: jessica.daitch@syneoshealth.com
RIGEL
PHARMACEUTICALS, INC.
|
STATEMENTS OF
OPERATIONS
|
(in thousands,
except per share amounts)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
December 31,
|
|
Year Ended
December 31,
|
|
|
|
2017
|
2016
|
|
2017
|
2016
|
|
|
|
(unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenues:
|
|
|
|
|
|
|
|
Contract revenues
from collaborations
|
$
-
|
$
3,000
|
|
$
4,484
|
$
20,383
|
|
|
|
|
|
|
|
|
|
Costs and
expenses:
|
|
|
|
|
|
|
|
Research and
development (see Note A)
|
11,561
|
11,634
|
|
46,269
|
63,446
|
|
|
General and
administrative (see Note A)
|
14,654
|
7,153
|
|
37,831
|
20,908
|
|
|
Restructuring charges
(see Note A)
|
-
|
-
|
|
-
|
5,770
|
|
|
Total costs and
expenses
|
26,215
|
18,787
|
|
84,100
|
90,124
|
|
|
|
|
|
|
|
|
|
Loss from
operations
|
(26,215)
|
(15,787)
|
|
(79,616)
|
(69,741)
|
|
Interest
income
|
344
|
109
|
|
892
|
437
|
|
Gain on disposal of
assets
|
-
|
88
|
|
732
|
88
|
|
|
|
|
|
|
|
|
|
Net loss
|
$ (25,871)
|
$ (15,590)
|
|
$ (77,992)
|
$ (69,216)
|
|
|
|
|
|
|
|
|
|
Net loss per share,
basic and diluted
|
$
(0.18)
|
$
(0.16)
|
|
$
(0.62)
|
$
(0.73)
|
|
|
|
|
|
|
|
|
|
Weighted-average
shares used in computing net
loss per share, basic and diluted
|
144,252
|
98,981
|
|
126,324
|
94,387
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Note
A
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock-based
compensation expense included in:
|
|
|
|
|
|
|
|
General and
administrative
|
$
2,540
|
$
2,309
|
|
$
4,490
|
$
4,230
|
|
|
Research and
development
|
519
|
357
|
|
1,497
|
3,103
|
|
|
Restructuring
charges
|
-
|
-
|
|
-
|
499
|
|
|
|
$
3,059
|
$
2,666
|
|
$
5,987
|
$
7,832
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
SUMMARY BALANCE
SHEET DATA
|
|
|
|
|
|
(in
thousands)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December
31,
|
|
|
|
|
|
|
2017
|
2016
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash, cash
equivalents and short-term investments
|
$ 115,751
|
$
74,766
|
|
|
|
|
|
Total
assets
|
119,111
|
78,134
|
|
|
|
|
|
Stockholders'
equity
|
100,646
|
55,027
|
|
|
|
|
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SOURCE Rigel Pharmaceuticals, Inc.