SOUTH SAN FRANCISCO, Calif.,
Nov. 1, 2016 /PRNewswire/
-- Rigel Pharmaceuticals, Inc. (Nasdaq:RIGL) today
reported financial results for the third quarter and nine months
ended September 30, 2016.
During the third quarter of 2016, Rigel accomplished a number of
noteworthy milestones, most importantly, the announcement of
topline results for its FIT Phase 3 clinical studies of
fostamatinib in ITP. Additionally, the company undertook a
restructuring to focus resources on building a commercial
enterprise, and appointed executive-level members to the management
team that will move Rigel forward toward its goals.
"We believe that the collective data from the FIT Phase 3
clinical program of fostamatinib support a clear treatment effect,
a sustained clinical benefit and a positive benefit-risk profile,"
said Raul Rodriguez, president and
chief executive officer of Rigel. "We look forward to
discussing the top-line FIT program results with the FDA in the
very near future, and obtaining their feed-back on our plan to
submit an NDA. Assuming a successful discussion, we expect to
submit the NDA in the first quarter of 2017."
For the third quarter of 2016, Rigel reported a net loss of
$22.6 million, or $0.24 per basic and diluted share, compared to a
net loss of $6.7 million, or
$0.08 per basic and diluted share, in
the same period of 2015.
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 pursuant to Rigel's
collaboration and license agreement with Bristol-Myers Squibb
(BMS). Contract revenues from collaborations of $13.0 million in the third quarter of 2015 were
primarily comprised of an $8.0
million upfront payment from Aclaris Therapeutics
International Limited pursuant to the license agreement executed in
August 2015 for the development and
commercialization of certain Rigel JAK inhibitors, as well as
$4.8 million from the
amortization of the upfront payment with BMS.
In September 2016, Rigel announced
that it had reduced its workforce by 46 positions, mostly in the
research area. Rigel recorded restructuring charges during the
third quarter of 2016 of approximately $5.8
million, which included $5.0 million of severance costs paid or to
be paid in cash, $319,000 impairment
of certain property and equipment, and $499,000 of non-cash stock-based compensation
expense as a result of the modification of Rigel's former
executive's stock options.
Rigel reported total costs and expenses of $26.5 million in the third quarter of 2016,
compared to $19.8 million for the
same period in 2015. The increase in costs and expenses was
primarily due to restructuring charges incurred in the third
quarter of 2016.
For the nine months ended September 30,
2016, Rigel reported a net loss of $53.6 million, or $0.58 per basic and diluted share, compared to a
net loss of $38.8 million, or
$0.44 per basic and diluted share,
for the same period of 2015.
As of September 30, 2016, Rigel
had cash, cash equivalents and short-term investments of
$85.3 million, compared to
$126.3 million as of December 31, 2015. Rigel expects this amount to
be sufficient to fund its operations through the end of 2017.
In this forecast, Rigel has allocated substantial funds to continue
efforts in preparation of the potential commercial launch of
fostamatinib in ITP in the U.S. Rigel also continues to evaluate
ex-U.S. partnerships for fostamatinib and other partnering
opportunities across its pipeline.
Company and Portfolio Update
Fostamatinib FIT
Phase 3 Program
In August and October
2016, respectively, Rigel announced results of two identical
Phase 3 clinical studies, FIT 1 (Study 047) and FIT 2 (Study 048),
of fostamatinib in adult chronic/persistent immune thrombocytopenia
(ITP). Study 047 met the primary endpoint in a statistically
significant manner, with 18% of the patients in the fostamatinib
arm achieving stable platelet response of greater than 50,000
platelets per μL of blood on at least four of the last scheduled
visits between weeks 14 and 24 of treatment and no patients on
placebo meeting the stable platelet response criteria
(p=0.0261). Study 048, which also had an 18% responder rate
for the fostamatinib subjects, did not achieve a statistically
significant distinction between the treatment and placebo cohorts
(p=0.15) because a single placebo patient met the stable platelet
response criteria. When the data from the two studies are
combined (n=150), the difference between the fostamatinib and
placebo groups would be statistically significant
(p=0.007).
Rigel also announced in October
2016 that as of June 2016, the
open-label long-term extension study (Study 049), was tracking the
experience of 118 patients who opted to receive treatment with
fostamatinib after completing either Study 047 or Study 048.
Patients who responded to fostamatinib in the parent studies had
achieved a median platelet count of 96,000/μL in Study 049.
In addition, there were 36 patients out of 43 who were placebo
non-responders in the parent studies who had a minimum of 12 weeks
of follow-up in the extension study. Of those, 6 patients (17%)
have achieved a prospectively defined stable platelet response,
which is statistically significant and similar to the response rate
fostamatinib achieved in the parent studies.
Rigel believes that the data from the FIT Phase 3 clinical
program (comprised of Study 047, 048 and 049) demonstrate that
fostamatinib works effectively for some ITP patients, providing a
substantial and enduring clinical benefit in a disease that has
proven difficult to manage for many physicians and patients. This
benefit was consistent across all sub-groups analyzed including TPO
(blood platelet production booster) experienced patients who have
limited treatment options remaining.
Rigel is continuing its work on compiling the NDA, which it
plans to file in the first quarter of 2017, pending positive
feedback from discussions of the data with the FDA.
Restructuring to Focus on Commercialization
Following
the release of the results for Study 047, Rigel announced a
restructuring and plans to build a commercial organization to
support the potential launch of fostamatinib. The
restructuring reduced the size of the research department while
maintaining Rigel's most advanced and promising projects. The
savings from the restructuring will be devoted to support the
commercialization of the company's first potential drug product as
well as extending the company's financial runway.
As part of the restructuring announcement in September, the
first of Rigel's new management team members was introduced;
Eldon Mayer joined the company as
its first chief commercial officer. Mr. Mayer will be
responsible for establishing and managing a commercial organization
that will lead the launch of fostamatinib. He brings
pharmaceutical marketing and sales management experience to Rigel,
having most recently led Questcor Pharmaceuticals' commercial
strategy and operations.
This quarter Rigel made additional key senior management
appointments to drive the organization forward. Esteban Masuda, Ph.D. was appointed senior vice
president research and will lead Rigel's refocused research
efforts. Joe Lasaga was appointed vice president
business development and alliance management and will lead Rigel's
effort to partner certain assets including ex-U.S. partnerships for
fostamatinib.
Clinical Portfolio Update
Fostamatinib Phase 2
Study in IgA Nephropathy (IgAN)
Rigel is conducting a global
Phase 2, double blind, placebo-controlled study of fostamatinib in
IgAN consisting of two sequential dose cohorts (100mg BID, followed
by 150 mg BID). Enrollment for the first cohort has been completed
and the company expects to report those results by the end of
2016. The second cohort is currently enrolling
patients.
Fostamatinib Phase 2 Study in Autoimmune Hemolytic
Anemia (AIHA)
Rigel is conducting a Phase 2, open-label,
multi-center, two-stage study that will evaluate the safety and
efficacy of fostamatinib in patients with warm antibody AIHA who
have previously received treatment for the disorder, but have
relapsed. Results of the Stage 1 segment of the trial are
expected in 2017.
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 5733500. 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 trials of fostamatinib,
an oral spleen tyrosine kinase (SYK) inhibitor, in a number of
indications. The company completed and reported results from two
Phase 3 clinical studies of fostamatinib in chronic immune
thrombocytopenia (ITP) in August and October
2016. Rigel is also conducting a Phase 2 clinical trial with
fostamatinib in autoimmune hemolytic anemia (AIHA) and a Phase 2
clinical trial for IgA nephropathy (IgAN). In addition, Rigel has
two oncology product candidates in Phase 1 development with
partners BerGenBio AS and Daiichi Sankyo.
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 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 completion of and
the success of clinical trials, 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 June 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: Susan C. Rogers,
Rivily, Inc.
Phone: 650.430.3777
Email: susan@rivily.com
RIGEL
PHARMACEUTICALS, INC.
|
STATEMENTS OF
OPERATIONS
|
(in thousands,
except per share amounts)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
September 30,
|
|
Nine Months Ended
September 30,
|
|
|
2016
|
2015
|
|
2016
|
2015
|
|
|
(unaudited)
|
Revenues:
|
|
|
|
|
|
|
Contract revenues
from collaborations
|
$
3,760
|
$
12,996
|
|
$
17,383
|
$
20,358
|
|
|
|
|
|
|
|
Costs and
expenses:
|
|
|
|
|
|
|
Research and
development (see Note A)
|
16,171
|
15,501
|
|
51,812
|
46,262
|
|
General and
administrative (see Note A)
|
4,558
|
4,276
|
|
13,755
|
13,092
|
|
Restructuring charges
(see Note A)
|
5,770
|
-
|
|
5,770
|
-
|
|
Total costs and
expenses
|
26,499
|
19,777
|
|
71,337
|
59,354
|
|
|
|
|
|
|
|
Loss from
operations
|
(22,739)
|
(6,781)
|
|
(53,954)
|
(38,996)
|
Interest income,
net
|
110
|
54
|
|
328
|
162
|
Gain on disposal of
assets
|
-
|
55
|
|
-
|
57
|
|
|
|
|
|
|
|
Net loss
|
$
(22,629)
|
$
(6,672)
|
|
$ (53,626)
|
$ (38,777)
|
|
|
|
|
|
|
|
Net loss per share,
basic and diluted
|
$
(0.24)
|
$
(0.08)
|
|
$
(0.58)
|
$
(0.44)
|
|
|
|
|
|
|
|
Weighted-average
shares used in computing
|
|
|
|
|
|
net loss per share, basic and diluted
|
95,454
|
88,506
|
|
92,844
|
88,231
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Note
A
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock-based
compensation expense included in:
|
|
|
|
|
|
|
Research and
development
|
$
643
|
$
966
|
|
$
2,746
|
$
3,182
|
|
General and
administrative
|
572
|
849
|
|
1,921
|
2,596
|
|
Restructuring
charges
|
499
|
-
|
|
499
|
-
|
|
|
$
1,714
|
$
1,815
|
|
$
5,166
|
$
5,778
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
SUMMARY BALANCE
SHEET DATA
|
|
|
|
|
|
(in
thousands)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
September
30,
|
December
31,
|
|
|
|
|
|
2016
|
2015
(1)
|
|
|
|
|
|
(unaudited)
|
|
|
|
|
|
Cash, cash
equivalents and short-term investments
|
$
85,255
|
$
126,276
|
|
|
|
|
Total
assets
|
88,641
|
131,747
|
|
|
|
|
Stockholders'
equity
|
65,943
|
91,381
|
|
|
|
|
|
|
|
|
|
|
(1)
|
Derived from audited
financial statements
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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SOURCE Rigel Pharmaceuticals, Inc.