SOUTH SAN FRANCISCO, Calif.,
Nov. 7, 2017 /PRNewswire/ -- Rigel
Pharmaceuticals, Inc. (Nasdaq:RIGL) today reported financial
results for the third quarter and nine months ended September 30, 2017.
Recent Achievements
- On October 2, 2017, Rigel
announced that the U.S. Food and Drug Administration (FDA) is not
currently planning on holding an Oncology Drugs Advisory Committee
(ODAC) meeting to discuss the New Drug Application (NDA) for
fostamatinib, an oral spleen tyrosine kinase (SYK) inhibitor, in
adult patients with chronic or persistent immune thrombocytopenia
(ITP).
- Rigel recently completed enrollment of Stage 1 of its Phase 2
study of fostamatinib for the treatment of warm antibody autoimmune
hemolytic anemia (AIHA). On a top-line, preliminary basis, the
Phase 2 study achieved the pre-specified primary efficacy endpoint
for Stage 1. Given this achievement, Rigel is preparing to begin
enrollment of Stage 2 of this study.
- Rigel announced the closing of a public offering of common
stock in October, with proceeds of $69,730,250, before deducting underwriting
discounts and commissions and other estimated offering expenses
payable by Rigel.
"Our NDA review is progressing smoothly," said Raul Rodriguez, president and chief executive
officer of Rigel. "As we prepare for an FDA decision, we are
simultaneously implementing our commercial plan for a potential
launch of fostamatinib in ITP, as well as continuing our clinical
studies of fostamatinib in other disorders."
For the third quarter of 2017, Rigel reported a net loss of
$17.7 million, or $0.14 per basic and diluted share, compared to a
net loss of $22.6 million, or
$0.24 per basic and diluted share, in
the same period of 2016.
Contract revenues from collaborations of $900,000 in the third quarter of 2017 were
related to a payment received from a license agreement with a third
party. Contract revenues from collaborations of $3.8 million in the third quarter of 2016
represent the remaining amortization of the $30.0 million upfront payment which was fully
amortized in September 2016, pursuant
to Rigel's collaboration and license agreement with Bristol-Myers
Squibb.
Rigel reported total costs and expenses of $18.8 million in the third quarter of 2017,
compared to $26.5 million for the
same period in 2016. The decrease in costs and expenses was
primarily due to the decreases in personnel costs as a result of
the reduction in workforce in September
2016 and the completion of the pivotal Phase 3 clinical
trials in ITP in 2016, partially offset by the increase in costs
related to the preparation for the potential commercial launch of
fostamatinib in ITP.
For the nine months ended September 30,
2017, Rigel reported a net loss of $52.1 million, or $0.43 per basic and diluted share, compared to a
net loss of $53.6 million, or
$0.58 per basic and diluted share,
for the same period of 2016.
As of September 30, 2017, Rigel
had cash, cash equivalents and short-term investments of
$68.1 million, compared to
$74.8 million as of December 31, 2016. In October 2017, Rigel completed an underwritten
public offering in which it received proceeds of approximately
$65.3 million, net of
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 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
Rigel continues to execute on its
commercial readiness plan to support the potential commercial
launch of fostamatinib in 2018. This includes the hiring of key
personnel across several functions such as marketing, sales, market
access, business operations and medical affairs.
Portfolio Update
TAVALISSE™ (fostamatinib disodium)
in ITP
During the Mid-Cycle Communication teleconference,
the FDA confirmed that it was not currently planning to hold an
ODAC meeting to discuss the NDA for fostamatinib in
patients with chronic or persistent ITP. The FDA indicated
that the review of fostamatinib is proceeding according to the
standard internal review timeline as described in the Guidance on
Good Review Management Principles and Practices for Prescription
Drug User Fee Act (PDUFA) Products. Under the PDUFA, the
action date for the FDA to complete its review will
be April 17, 2018.
Update on Fostamatinib in Autoimmune Hemolytic Anemia
(AIHA)
The Phase 2, open-label, multi-center, Simon
two-stage study of fostamatinib for the treatment of warm AIHA
recently completed enrollment of Stage 1. The study is evaluating
the safety and efficacy of fostamatinib, at 150mg BID (twice
daily), in patients with warm AIHA who have previously received at
least one treatment for this disease, but did not have a meaningful
benefit and are still anemic.
Stage 1 of the 12-week study enrolled 17 patients. As of
September 30, 2017, four patients
responded during the 12-week evaluation period and an additional
two patients met the response criteria in the extension study after
12 weeks of dosing, for a response rate of 35% (6/17) on
fostamatinib (these data are preliminary and require further
verification). A response was defined as achieving a hemoglobin
level of greater than 10 g/dl and at least a 2 g/dl increase from
baseline. The safety profile was consistent with the existing
fostamatinib safety database.
Fostamatinib in IgA Nephropathy (IgAN)
Rigel has completed enrollment of the second cohort in its Phase 2
study of fostamatinib 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, while the first cohort evaluated 100mg BID. The primary
efficacy endpoint is the mean change of proteinuria from baseline
at 24 weeks.
Additional Product Development
During the second
quarter of 2017, 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. The
company expects to initiate clinical trials in 2018.
About ITP
ITP affects approximately 65,000 adult
primary patients in the US. 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, bleeding and fatigue. 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 and as
a result, there remains a significant medical need for additional
treatment options for patients with chronic 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 (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 4894258. 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; and the sufficiency of
Rigel's cash, cash equivalents and short-term investments to
support its funding requirements through at least the next 12
months. 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 June 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: 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
September 30,
|
|
Nine Months Ended
September 30,
|
|
|
2017
|
2016
|
|
2017
|
2016
|
|
|
(unaudited)
|
Revenues:
|
|
|
|
|
|
|
Contract revenues
from collaborations
|
$
900
|
$
3,760
|
|
$
4,484
|
$
17,383
|
|
|
|
|
|
|
|
Costs and
expenses:
|
|
|
|
|
|
|
Research and
development (see Note A)
|
10,808
|
16,171
|
|
34,708
|
51,812
|
|
General and
administrative (see Note A)
|
7,947
|
4,558
|
|
23,177
|
13,755
|
|
Restructuring charges
(see Note A)
|
—
|
5,770
|
|
—
|
5,770
|
|
Total costs and
expenses
|
18,755
|
26,499
|
|
57,885
|
71,337
|
|
|
|
|
|
|
|
Loss from
operations
|
(17,855)
|
(22,739)
|
|
(53,401)
|
(53,954)
|
Gain on disposal of
assets
|
—
|
—
|
|
732
|
—
|
Interest
income
|
195
|
110
|
|
548
|
328
|
|
|
|
|
|
|
|
Net loss
|
$
(17,660)
|
$
(22,629)
|
|
$ (52,121)
|
$ (53,626)
|
|
|
|
|
|
|
|
Net loss per share,
basic and diluted
|
$
(0.14)
|
$
(0.24)
|
|
$
(0.43)
|
$
(0.58)
|
|
|
|
|
|
|
|
Weighted-average
shares used in computing net loss
per share, basic and diluted
|
124,628
|
95,454
|
|
120,282
|
92,844
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Note
A
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock-based
compensation expense included in:
|
|
|
|
|
|
|
General and
administrative
|
$
591
|
$
572
|
|
$
1,950
|
$
1,921
|
|
Research and
development
|
282
|
643
|
|
978
|
2,746
|
|
Restructuring
charges
|
-
|
499
|
|
-
|
499
|
|
|
$
873
|
$
1,714
|
|
$
2,928
|
$
5,166
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
SUMMARY BALANCE
SHEET DATA
|
|
|
|
|
|
(in
thousands)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
September
30,
|
December
31,
|
|
|
|
|
|
2017
|
2016
(1)
|
|
|
|
|
|
(unaudited)
|
|
|
|
|
|
Cash, cash
equivalents and short-term investments
|
$
68,076
|
$
74,766
|
|
|
|
|
Total
assets
|
71,250
|
78,134
|
|
|
|
|
Stockholders'
equity
|
56,167
|
55,027
|
|
|
|
|
|
|
|
|
|
|
(1)
|
Derived from audited
financial statements
|
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SOURCE Rigel Pharmaceuticals, Inc.