SOUTH SAN FRANCISCO, Calif.,
Nov. 5, 2020 /PRNewswire/ -- Rigel
Pharmaceuticals, Inc. (Nasdaq: RIGL) today reported financial
results for the third quarter ended September 30, 2020, including sales of
TAVALISSE® (fostamatinib disodium hexahydrate) tablets,
for the treatment of adults with chronic immune thrombocytopenia
(ITP) who have had an insufficient response to a previous
treatment.
"Our team has done an excellent job advancing our key value
drivers while adapting to the widespread changes in the current
global environment," said Raul
Rodriguez, Rigel's president and CEO. "We have continued to
grow our TAVALISSE franchise with third quarter sales increasing
39% year-over-year and our global Phase 3 clinical trial for warm
AIHA having enrolled over 60% of our patient goal. Additionally,
exploration of fostamatinib's potential in COVID-19 is rapidly
expanding with our Phase 3 clinical trial launching this quarter
and enrollment ongoing in the Phase 2 trials sponsored by the
NIH/NHLBI and Imperial College London."
Business Update
Rigel's FORWARD study, a Phase 3
pivotal trial of TAVALISSE in warm autoimmune hemolytic anemia
(AIHA), has enrolled 57 of the 90 patients targeted for
enrollment. The trial currently has over 90 clinical trial
sites established across 22 countries.
Rigel plans to launch a Phase 3 clinical trial to evaluate
the safety and efficacy of fostamatinib in hospitalized COVID-19
patients without respiratory failure that have certain high-risk
prognostic factors. This multi-center, double-blind,
placebo-controlled, adaptive design study is expected to enroll
over 300 evaluable patients that will be randomly assigned to
either fostamatinib plus standard of care (SOC) or matched placebo
plus SOC (1:1). Treatment will be administered orally twice
daily for 14 days. There will be a follow-up period to day 60. The
primary endpoint of this study is the proportion of subjects who
progress to severe/critical disease within 29 days.
The Phase 2 clinical trial sponsored by the NIH/NHLBI, in
collaboration with Inova Health System, to evaluate the safety of
fostamatinib for the treatment of hospitalized COVID-19 patients
has enrolled 9 patients. This multi-center, double-blind,
placebo-controlled study will randomly assign fostamatinib
plus SOC or matched placebo plus SOC (1:1) to approximately 60
evaluable patients. Treatment will be administered orally twice
daily for 14 days. There will be a follow-up period to day 60. The
primary endpoint of this study is cumulative incidence of serious
adverse events (SAE) through day 29. The trial also includes
multiple secondary endpoints designed to assess the early efficacy
and clinically relevant endpoints of disease course.
The Imperial College London-sponsored Phase 2 clinical trial to
evaluate the efficacy of fostamatinib for the treatment of COVID-19
pneumonia has begun enrolling patients. The study is a two-stage,
open label, controlled clinical trial with patients randomized
(1:1:1) to fostamatinib plus SOC, ruxolitinib plus SOC, or SOC.
Treatment will be administered twice daily for 14 days and patients
will receive a follow-up assessment at day 14 and day 28 after the
first dose. The primary endpoint of this study is progression from
mild to severe COVID-19 pneumonia within 14 days in hospitalized
patients.
Rigel recently launched FORTE, an observational study to further
evaluate TAVALISSE as a second-line treatment for adult chronic
ITP. The study goal is to generate additional data on
patient quality of life and financial expenditures relative to the
healthcare of ITP patients. Along with the post-hoc data analysis
of its Phase 3 clinical program, Rigel plans to use this study
to further increase and enhance its database of TAVALISSE in early
line treatment of adult chronic ITP patients.
Financial Update
For the third quarter of 2020, Rigel
reported a net loss of $14.2 million,
or $0.08 per share, compared to a net
loss of $11.5 million, $0.07 per share, in the same period of 2019.
In the third quarter of 2020, total revenues were $18.4 million, consisting of $16.3 million in net product sales and
$2.1 million in contract revenues
from collaborations for the achievement of a milestone in
accordance with the amended license and collaboration agreement
with Daiichi-Sankyo. Net product sales increased by 39% from
$11.7 million in the third quarter of
2019. The decrease in contract revenues from collaborations in the
third quarter of 2020 from $9.1
million in the same period of 2019 was due to developmental
and commercial milestones from its various collaborative partners
in 2019, partially offset by the milestone in the third quarter of
2020 from Daiichi-Sankyo as noted above.
Rigel reported total costs and expenses of $32.2 million in the third quarter of 2020,
compared to $32.9 million in the same
period of 2019. The decrease in total costs and expenses was
primarily due to decreases to the timing of certain
commercial-related activities due to the COVID-19 pandemic,
partially offset by the increases in personnel-related costs and
increased use of consultants.
For the nine months ended September 30,
2020, Rigel reported a net loss of $10.5 million, or $0.06 per share, compared to a net loss of
$49.7 million, or $0.30 per share, in the same period of 2019.
Rigel reported total revenues of $90.2
million for the nine months ended September 30, 2020, compared to $43.9 million in the same period of 2019. Total
revenues for the nine months ended September
30, 2020 consisted of $43.9
million in net product sales and $46.2 million in contract revenues from
collaborations. The increase in contract revenues from
collaborations related to revenue from the upfront fee previously
received in 2019, as well as the milestone payment received from
Grifols in the first quarter of 2020 upon EC approval of the MAA
for fostamatinib in Europe and the
$2.1 million in contract revenues for
achievement of a milestone in accordance with the amended license
and collaboration agreement with Daiichi-Sankyo, partially offset
by the developmental and commercial milestones from its
various collaborative partners in 2019.
Total costs and expenses for the nine months ended September 30, 2020 were $100.3 million, compared to $95.6 million in the same period of 2019. The
increase in total costs and expenses was primarily related to
increases in research and development cost for the on-going Phase 3
trial in warm AIHA, Phase 1 trial in RIP 1 inhibitor program and
Phase 1 trial in IRAK 1/4 inhibitor program, partially offset by
decreases in stock-based compensation expense and various
third-party costs.
As of September 30, 2020, Rigel
had cash, cash equivalents and short-term investments of
$72.8 million, compared to
$98.1 million as of December 31, 2019.
Conference Call and Webcast with Slides Today at 4:30pm Eastern Time
Rigel will hold a live
conference call and webcast today at 4:30pm
Eastern Time (1:30pm Pacific
Time).
Participants can access the live conference call by dialing
1-800-954-0603 (domestic) or 1-415-226-5355 (international). The
conference call and accompanying slides will also be webcast live
and can be accessed from the Investor Relations section of the
company's website at www.rigel.com. The webcast will be archived
and available for replay after the call via the Rigel website.
About ITP
In patients with ITP (immune
thrombocytopenia), 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 include fatigue,
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. In addition
to fostamatinib, current therapies for ITP include steroids, blood
platelet production boosters (TPO-RAs) and splenectomy. However,
not all patients respond to 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 45,000 adult patients in
the U.S. and can be a severe, debilitating disease. Warm AIHA
(wAIHA), the most common form of AIHA, is characterized by the
presence of antibodies that react with the red blood cell surface
at body temperature. To date, there are no disease-targeted
therapies approved for AIHA, despite the unmet medical need that
exists for these patients.
About Coronavirus Disease 2019 (COVID-19) &
SYK-Signaling
COVID-19 is the infectious disease caused by
Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2).
SARS-CoV-2 primarily infects the upper and lower respiratory tract
and can lead to acute respiratory distress syndrome (ARDS).
Additionally, some patients develop other organ dysfunction
including myocardial injury, acute kidney injury, shock resulting
in endothelial dysfunction and subsequently micro and macrovascular
thrombosis.1 Much of the underlying pathology of
SARS-CoV-2 is thought to be secondary to a hyperinflammatory immune
response associated with increased risk of
thrombosis.2
Spleen tyrosine kinase (SYK) is involved in the intracellular
signaling pathways of many different immune cells. Therefore, SYK
inhibition may improve outcomes in patients with COVID-19 via
inhibition of key Fc gamma receptor (FcγR) and c-type lectin
receptor (CLR) mediated drivers of pathology, such as inflammatory
cytokine release by monocytes and macrophages, production of
neutrophil extracellular traps (NETs) by neutrophils, and platelet
aggregation.3,4,5 Furthermore, SYK inhibition in
neutrophils and platelets may lead to decreased
thromboinflammation, alleviating organ dysfunction in critically
ill patients with COVID-19.
About
TAVALISSE
Indication
TAVALISSE®
(fostamatinib disodium hexahydrate) tablets is indicated for the
treatment of thrombocytopenia in adult patients with chronic immune
thrombocytopenia (ITP) who have had an insufficient response to a
previous treatment.
Important Safety Information
Warnings and
Precautions
- Hypertension can occur with TAVALISSE treatment. Patients with
pre-existing hypertension may be more susceptible to the
hypertensive effects. Monitor blood pressure every 2 weeks until
stable, then monthly, and adjust or initiate antihypertensive
therapy for blood pressure control maintenance during therapy. If
increased blood pressure persists, TAVALISSE interruption,
reduction, or discontinuation may be required.
- Elevated liver function tests (LFTs), mainly ALT and AST, can
occur with TAVALISSE. Monitor LFTs monthly during treatment. If ALT
or AST increase to >3 x upper limit of normal, manage
hepatotoxicity using TAVALISSE interruption, reduction, or
discontinuation.
- Diarrhea occurred in 31% of patients and severe diarrhea
occurred in 1% of patients treated with TAVALISSE. Monitor patients
for the development of diarrhea and manage using supportive care
measures early after the onset of symptoms. If diarrhea becomes
severe (≥Grade 3), interrupt, reduce dose or discontinue
TAVALISSE.
- Neutropenia occurred in 6% of patients treated with TAVALISSE;
febrile neutropenia occurred in 1% of patients. Monitor the ANC
monthly and for infection during treatment. Manage toxicity with
TAVALISSE interruption, reduction, or discontinuation.
- TAVALISSE can cause fetal harm when administered to pregnant
women. Advise pregnant women the potential risk to a fetus. Advise
females of reproductive potential to use effective contraception
during treatment and for at least 1 month after the last dose.
Verify pregnancy status prior to initiating TAVALISSE. It is
unknown if TAVALISSE or its metabolite is present in human milk.
Because of the potential for serious adverse reactions in a
breastfed child, advise a lactating woman not to breastfeed during
TAVALISSE treatment and for at least 1 month after the last
dose.
Drug Interactions
- Concomitant use of TAVALISSE with strong CYP3A4 inhibitors
increases exposure to the major active metabolite of TAVALISSE
(R406), which may increase the risk of adverse reactions. Monitor
for toxicities that may require a reduction in TAVALISSE dose.
- It is not recommended to use TAVALISSE with strong CYP3A4
inducers, as concomitant use reduces exposure to R406.
- Concomitant use of TAVALISSE may increase concentrations of
some CYP3A4 substrate drugs and may require a dose reduction of the
CYP3A4 substrate drug.
- Concomitant use of TAVALISSE may increase concentrations of
BCRP substrate drugs (eg, rosuvastatin) and P-Glycoprotein (P-gp)
substrate drugs (eg, digoxin), which may require a dose reduction
of the BCRP and P-gp substrate drug.
Adverse Reactions
- Serious adverse drug reactions in the ITP double-blind studies
were febrile neutropenia, diarrhea, pneumonia, and hypertensive
crisis, which occurred in 1% of TAVALISSE patients. In addition,
severe adverse reactions occurred including dyspnea and
hypertension (both 2%), neutropenia, arthralgia, chest pain,
diarrhea, dizziness, nephrolithiasis, pain in extremity, toothache,
syncope, and hypoxia (all 1%).
- Common adverse reactions (≥5% and more common than placebo)
from FIT-1 and FIT-2 included: diarrhea, hypertension, nausea,
dizziness, ALT and AST increased, respiratory infection, rash,
abdominal pain, fatigue, chest pain, and neutropenia.
Please see www.TAVALISSE.com for full Prescribing
Information.
To report side effects of prescription drugs to the FDA,
visit www.fda.gov/medwatch or call 1-800-FDA-1088
(800-332-1088).
TAVALISSE and TAVLESSE are registered trademarks of Rigel
Pharmaceuticals, Inc.
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 first FDA approved product is
TAVALISSE® (fostamatinib disodium hexahydrate) tablets,
the only oral spleen tyrosine kinase (SYK) inhibitor, for the
treatment of adult patients with chronic immune thrombocytopenia
who have had an insufficient response to a previous treatment. The
product has been approved by the European Commission for the
treatment of chronic immune thrombocytopenia in adult patients who
are refractory to other treatments and is marketed in Europe under the name TAVLESSE®
(fostamatinib).
Fostamatinib6 is currently being studied in a
Phase 3 trial for the treatment of warm autoimmune hemolytic anemia
(AIHA); a NIH/NHLBI-Sponsored Phase 2 trial for the treatment of
hospitalized COVID-19 patients, in collaboration with Inova® Health
System; and a Phase 2 trial for the treatment of COVID-19 pneumonia
being conducted by Imperial College London.
Rigel's other clinical programs include an ongoing Phase 1 study
of R8356, a proprietary molecule from its interleukin
receptor associated kinase (IRAK) inhibitor program, and an ongoing
Phase 1 study of R5526, a proprietary molecule from its
receptor-interacting protein kinase (RIP) inhibitor program. In
addition, Rigel has product candidates in clinical development with
partners AstraZeneca, BerGenBio ASA, and Daiichi Sankyo.
Please see www.TAVALISSE.com for the full Prescribing
Information.
1.
|
Berlin DA, Gulick RM,
Martinez FJ. Severe Covid-19. N Engl J Med 2020
|
2.
|
Becker RC. COVID-19
Update: COVID-19 associated coagulopathy. Journal of Thrombosis and
Thrombolysis May 15, 2020. DOI:
https://doi.org/10.1007/s11239-020-02134-3
|
3.
|
Hoepel W. et al.
Anti-SARS-CoV-2 IgG from severely ill COVID-19 patients promotes
macrophage hyper-inflammatory responses. bioRxiv July 13,
2020. DOI:
https://doi.org/10.1101/2020.07.13.190140
|
4.
|
Sung P-S and Hsieh
S-L (2019) CLEC2 and CLEC5A: Pathogenic Host Factors in Acute Viral
Infections. Front. Immunol. 10:2867. DOI:
https://doi.org/10.3389/fimmu.2019.02867
|
5.
|
Behnen M. Immobilized
Immune Complexes Induce Neutrophil Extracellular Trap Release by
Human Neutrophil Granulocytes via Fcγ RIIIB and Mac-1. The Journal
of Immunology July 2014. DOI:
https://doi.org/10.4049/jimmunol.1400478
|
6.
|
The product for this
use or indication is investigational and has not been proven safe
or effective by any regulatory authority.
|
Forward Looking Statements
This release contains
forward-looking statements relating to, among other things, the
commercial success of TAVALISSE in the U.S.; the sufficiency of
Rigel's supplies of TAVALISSE; the commercialization of TAVLESSE in
Europe and the timing thereof; the
utility of fostamatinib in warm autoimmune hemolytic anemia (AIHA);
the impact of the COVID-19 pandemic on Rigel's results and
operations; Rigel's ability to complete enrollment in its phase 3
clinical trial for AIHA and as a treatment for COVID-19
related conditions and the timing thereof; the trial design, the
potential clinical benefit of fostamatinib for the treatment of
hospitalized COVID-19 patients and the role of SYK inhibition in
potentially improving outcomes of critically ill COVID-19 patients,
including by alleviating organ dysfunction in critically ill
patients with COVID-19; Rigel's ability to further develop
its clinical stage products; the scientific rationale for exploring
use of fostamatinib to treat COVID-19 and related conditions;
Rigel's plans to support Imperial College London's IST; the
potential clinical benefit of fostamatinib in COVID-19
patients and the prevention of ARDS; role of SYK inhibition in
potentially improving outcomes in COVID-19 patients; and Rigel's
partnering efforts. 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 "potential," "may,"
"expects" 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, risks and
uncertainties associated with the commercialization and marketing
of TAVALISSE; risks that the FDA, EMA or other regulatory
authorities may make adverse decisions regarding fostamatinib;
risks that TAVALISSE clinical trials may not be predictive of
real-world results or of results in subsequent clinical trials;
risks that TAVALISSE may have unintended side effects, adverse
reactions or incidents of misuses; 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 Annual
Report on Form 10-K for the year ended December 31, 2019 and Quarterly Report on Form
10-Q for the quarter ended June 30,
2020. In addition, the COVID-19 pandemic may result in
further delays in Rigel's studies, trials and sales, or impact
Rigel's ability to obtain supply of TAVALISSE. 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.
IR Contact: David Burke
Phone: 650.624.1232
Email: dburke@rigel.com
|
|
RIGEL
PHARMACEUTICALS, INC.
|
STATEMENTS OF
OPERATIONS
|
(in thousands,
except per share amounts)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
September 30,
|
|
Nine Months Ended
September 30,
|
|
|
|
2020
|
2019
|
|
2020
|
2019
|
|
|
|
(unaudited)
|
|
(unaudited)
|
|
|
|
|
|
|
|
|
|
Revenues:
|
|
|
|
|
|
|
|
Product sales,
net
|
$
16,289
|
$
11,716
|
|
$
43,943
|
$
29,943
|
|
|
Contract revenues
from collaborations
|
2,100
|
9,141
|
|
46,228
|
13,945
|
|
|
Total
revenues
|
18,389
|
20,857
|
|
90,171
|
43,888
|
|
|
|
|
|
|
|
|
|
Costs and
expenses:
|
|
|
|
|
|
|
|
Cost of product
sales
|
140
|
310
|
|
574
|
728
|
|
|
Research and
development (see Note A)
|
14,600
|
14,463
|
|
44,963
|
38,638
|
|
|
Selling, general and
administrative (see Note A)
|
17,430
|
18,121
|
|
54,780
|
56,276
|
|
|
Total costs and
expenses
|
32,170
|
32,894
|
|
100,317
|
95,642
|
|
Loss from
operations
|
(13,781)
|
(12,037)
|
|
(10,146)
|
(51,754)
|
|
Interest
income
|
36
|
555
|
|
563
|
2,068
|
|
Interest
expense
|
(429)
|
(8)
|
|
(924)
|
(8)
|
|
Net loss
|
$
(14,174)
|
$
(11,490)
|
|
$
(10,507)
|
$
(49,694)
|
|
|
|
|
|
|
|
|
|
Net loss per share,
basic and diluted
|
$
(0.08)
|
$
(0.07)
|
|
$
(0.06)
|
$
(0.30)
|
|
|
|
|
|
|
|
|
|
Weighted average
shares used in computing net loss per share, basic and
diluted
|
168,932
|
167,609
|
|
168,658
|
167,326
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Note
A
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock-based
compensation expense included in:
|
|
|
|
|
|
|
|
Selling, general and
administrative
|
$
1,352
|
$
1,611
|
|
$
3,981
|
$
5,519
|
|
|
Research and
development
|
532
|
487
|
|
1,684
|
2,185
|
|
|
|
$
1,884
|
$
2,098
|
|
$
5,665
|
$
7,704
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
SUMMARY BALANCE
SHEET DATA
|
|
|
|
|
|
(in
thousands)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
September
30,
|
December
31,
|
|
|
|
|
|
|
2020
|
2019
(1)
|
|
|
|
|
|
|
(unaudited)
|
|
|
|
|
|
|
Cash, cash
equivalents and short-term investments
|
$
72,812
|
$
98,078
|
|
|
|
|
|
Total
assets
|
123,058
|
147,569
|
|
|
|
|
|
Stockholders'
equity
|
50,955
|
53,815
|
|
|
|
|
|
|
|
|
|
|
|
|
(1)
|
Derived from audited
financial statements
|
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SOURCE Rigel Pharmaceuticals, Inc.