SOUTH SAN FRANCISCO, Calif.,
Aug. 3, 2021 /PRNewswire/ -- Rigel
Pharmaceuticals, Inc. (Nasdaq: RIGL) today reported financial
results for the second quarter ended June
30, 2021, 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.
"As we begin the second half of 2021, Rigel is well-positioned
to execute on several key milestones that have the potential to be
important inflection points for the company," said Raul Rodriguez, Rigel's president and CEO.
"TAVALISSE sales are growing as we are able to access more
clinicians in-person, and we are expanding our commercial team to
allow us to have a greater impact as physicians and patients
continue to return to the clinic. Our pipeline programs continue to
advance as we wait for a decision on our EUA, with our own Phase 3
clinical trial of fostamatinib in hospitalized COVID-19 patients
rapidly enrolling and our Phase 3 clinical trial of fostamatinib in
wAIHA nearing its enrollment goal," continued Mr. Rodriguez.
Business Update
In July, Rigel initiated expansion of
its sales force from 39 to 55 territories. Recruiting is underway
and it is expected that the team will be fully trained and in the
field by the end of September.
In June, Rigel announced that fostamatinib had been selected as
part of the National Institutes of Health (NIH) sponsored ACTIV-4
Host Tissue trial. Recruiting is underway and the first patient has
been enrolled in the multi-site, randomized, placebo-controlled
trial of therapies, including fostamatinib, targeting the host
response to COVID-19 in hospitalized patients.
In late-May, Rigel submitted a request to the U.S. Food and Drug
Administration (FDA) for an emergency use authorization (EUA) for
fostamatinib in hospitalized patients diagnosed with COVID-19. The
request included data from a NHLBI/NIH-sponsored Phase 2 study,
which reported positive topline results in April.
Rigel's Phase 3 clinical trial evaluating fostamatinib in
high-risk patients hospitalized with COVID-19 has enrolled ~150 of
the targeted 308 patients, and expects to complete enrollment by
year-end 2021.
Rigel's FORWARD study, a Phase 3 pivotal trial of TAVALISSE in
patients with warm autoimmune hemolytic anemia (wAIHA), has
enrolled 80 of the targeted 90 patients. If approved, TAVALISSE has
the potential to be the first to market therapy for patients with
wAIHA.
During the quarter, Rigel received feedback from the FDA
supporting its proposed clinical program to evaluate R289, a
pro-drug formulation of R835, in low-risk myelodysplastic syndromes
(MDS). Planning is now underway on the Phase 1/2 clinical
trial.
In June, Rigel entered into a research collaboration with MD
Anderson Cancer Center to evaluate Rigel's novel IRAK1/4 inhibitors
in a series of preclinical studies of MDS and chronic
myelomonocytic leukemia (CMML). The translational research
generated from these studies will add to the body of data generated
to date on R835 and R289 and further elucidate the therapeutic
potential of targeting deregulated innate immune signaling in MDS
and CMML.
Financial Update
For the second quarter of 2021, Rigel
reported net loss of $13.8 million,
or $0.08 per basic and diluted share,
compared to a net loss of $17.6
million, or $0.10 per basic
and diluted share, for the same period of 2020.
In the second quarter of 2021, total revenues were $26.3 million, consisting of $17.1 million in TAVALISSE net product sales,
$3.7 million in contract revenues
from collaborations, and $5.5 million
in government contract revenue. TAVALISSE net product sales of
$17.1 million in the second quarter
of 2021 increased by 14% from $15.0
million for the same period of 2020.
Contract revenues from collaborations of $3.7 million for the second quarter of 2021
consisted of $3.3 million in revenue
related to Rigel's license agreement with Lilly, and $0.4 million in revenue related to the
performance of certain research and development services pursuant
to its collaboration agreement with Grifols. Government contract
revenue was related to the income recognized pursuant to the
agreement Rigel entered in January
2021 with the U.S. Department of Defense (DOD) to support
Rigel's ongoing Phase 3 clinical trial of fostamatinib in
hospitalized patients with COVID-19.
Rigel reported total costs and expenses of $39.3 million in the second quarter of 2021,
compared to $33.4 million for the
same period in 2020. The increase in costs and expenses was
primarily due to increases in personnel-related costs, stock-based
compensation expense, and research and development costs related to
Rigel's various on-going clinical studies.
For the six months ended June 30,
2021, Rigel reported net income of $25.7 million, or $0.15 per basic and diluted share, compared to a
net income of $3.7 million, or
$0.02 per basic and diluted share,
for the same period of 2020.
Rigel reported total revenues of $107.3
million for the six months ended June
30, 2021, consisting of $29.4
million in TAVALISSE net product sales, $69.4 million in contract revenues from
collaborations, and $8.5 million in
government contract revenues. TAVALISSE net product sales of
$29.4 million increased by 6% from
$27.7 million for the same period of
2020. Contract revenues from collaborations of $69.4 million for the six months ended
June 30, 2021, consisted of
$63.9 million in revenue related to
Rigel's license agreement with Lilly, $4.0
million in revenue related to the grant of a non-exclusive
license of a certain patent to an unrelated third-party company,
and $1.4 million in revenue for the
delivery of drug supply, as well as performance of certain research
and development services pursuant to its collaboration agreement
with Grifols. Government contract revenue of $8.5 million for the six months ended
June 30, 2021, was related to the
income recognized pursuant to the agreement Rigel entered in
January 2021 with the DOD to support
Rigel's ongoing Phase 3 clinical trial of fostamatinib in
hospitalized patients with COVID-19.
Total costs and expenses for the six months ended June 30, 2021, were $78.6
million, compared to $68.1
million for the same period in 2020. The increase in costs
and expenses was primarily due to increases in personnel-related
costs, stock-based compensation expense, and research and
development costs related to Rigel's various on-going clinical
studies.
As of June 30, 2021, Rigel had
cash, cash equivalents, and short-term investments of $153.4 million, compared to $57.3 million as of December 31, 2020.
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
(877) 407-3088 (domestic) or (201) 389-0927 (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 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 (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 destroy 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. To date, there are no
disease-targeted therapies approved for AIHA, despite the unmet
medical need that exists for these patients. Warm antibody 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.
About COVID-19 & SYK Inhibition
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
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 pro-inflammatory cytokine release by monocytes
and macrophages, production of neutrophil extracellular traps
(NETs) by neutrophils, and platelet aggregation.3,4,5,6
Furthermore, SYK inhibition in neutrophils and platelets may lead
to decreased thrombo-inflammation, alleviating organ dysfunction in
critically ill patients with COVID-19.
For more information on Rigel's comprehensive clinical program
in COVID-19, go to:
https://www.rigel.com/pipeline/proprietary-programs/covid-19
About RIP1 Inhibitor, R552
Investigational
candidate, R552, is an orally available, potent and selective
inhibitor of receptor-interacting serine/threonine-protein kinase 1
(RIP1). RIP1 is believed to play a critical role in necroptosis.
Necroptosis is a form of regulated cell death where the rupturing
of cells leads to the dispersion of their inner contents, which
induces immune responses and enhances inflammation. In preclinical
studies, R552 prevented joint and skin inflammation in a
RIP1-mediated murine model of inflammation and tissue damage. The
safety and efficacy of R552 has not been established by the FDA or
any healthcare authority.
About IRAK1/4 Inhibitor R835/R289
Investigational
candidates, R835 and its pro-drug, R289 are orally available,
potent and selective inhibitors of both IRAK1 and IRAK4. In
clinical and preclinical studies, R835 has been shown to block
inflammatory cytokine production in response to toll-like receptor
(TLR) and the interleukin-1 receptor (IL-1R) family signaling. TLRs
and IL-1Rs play a critical role in the innate immune response and
dysregulation of these pathways can lead to a variety of
inflammatory conditions. R835 treatment demonstrates amelioration
of clinical symptoms in multiple rodent models of inflammatory
disease including psoriasis, arthritis, lupus, multiple sclerosis
and gout. The safety and efficacy of R835 or its pro-drug, R289,
have not been established by the FDA or any healthcare
authority.
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.TAVALISSEUSPI.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 hematologic disorders, cancer
and rare immune 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 is also commercially available in Europe (TAVLESSE) and Canada (TAVALISSE) for the treatment of
chronic immune thrombocytopenia in adult patients.
Fostamatinib is currently being studied in a Phase 3 clinical
trial (NCT03764618) for the treatment of warm autoimmune
hemolytic anemia (wAIHA)7; a Phase 3 clinical
trial (NCT04629703) for the treatment of
hospitalized high-risk patients
with COVID-197; an NIH/NHLBI-sponsored Phase 3
clinical trial (ACTIV-4 Host Tissue Trial) for the treatment of
COVID-19 in hospitalized patients, and a Phase 2 clinical trial for
the treatment of COVID-19 being conducted by Imperial College
London. An NIH/NHLBI-sponsored Phase 2 clinical trial for the
treatment of hospitalized patients with COVID-19, in collaboration
with Inova Health System, was recently completed.
Rigel's other clinical programs include its interleukin
receptor-associated kinase (IRAK) inhibitor program, and a
receptor-interacting serine/threonine-protein kinase (RIP1)
inhibitor program in clinical development with partner Eli Lilly
and Company. In addition, Rigel has product candidates in
development with partners AstraZeneca, BerGenBio ASA, and
Daiichi Sankyo.
For further information, visit www.rigel.com or follow
us on Twitter or LinkedIn.
1. Berlin DA, Gulick RM, and Martinez FJ. Severe
Covid-19. N Engl J Med 2020.
DOI: https://doi.org/10.1056/NEJMcp2009575
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. High titers and
low fucosylation of early human anti–SARS-CoV-2 IgG
promote inflammation by alveolar macrophages. Science
Translational Medicine 02 Jun 2021.
DOI: https://www.doi.org/10.1126/scitranslmed.abf8654
4. Sung P-S and Hsieh S-L. CLEC2 and CLEC5A: Pathogenic
Host Factors in Acute Viral Infections. Frontiers in Immunology
December 6, 2019.
DOI: https://doi.org/10.3389/fimmu.2019.02867
5. Strich J et al. Fostamatinib Inhibits Neutrophils
Extracellular Traps Induced by COVID-19 Patient Plasma: A Potential
Therapeutic. Journal of Infectious Disease March 15, 2021.
DOI: https://doi.org/10.1093/infdis/jiaa789
6. Bye AP et al. Aberrant glycosylation of anti-SARS-CoV-2
IgG is a pro-thrombotic stimulus for
platelets. BioRxiv March 26, 2021.
DOI: https://doi.org/10.1101/2021.03.26.437014
7. 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. and TAVLESSE in
Europe, including its ability to
expand its sales force; expectations related to the potential and
market opportunity for fostamatinib as a COVID-19 therapeutic;
Rigel's ability to further develop its clinical stage and
early-stage product candidates and programs; 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
Quarterly Report on Form 10-Q for the quarter ended March 31, 2021. 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 for Investors & Media:
Jodi Sievers - Rigel
Pharmaceuticals
Phone: 650.624.1232
Email: ir@rigel.com
|
RIGEL
PHARMACEUTICALS, INC.
|
STATEMENTS OF
OPERATIONS
|
(in thousands,
except per share amounts)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
June 30,
|
|
Six Months Ended
June 30,
|
|
|
2021
|
|
2020
|
|
2021
|
|
2020
|
|
|
(unaudited)
|
Revenues:
|
|
|
|
|
|
|
|
|
Product sales,
net
|
$
17,053
|
|
$
14,974
|
|
$
29,429
|
|
$
27,654
|
|
Contract revenues
from collaborations
|
3,713
|
|
1,047
|
|
69,355
|
|
44,128
|
|
Government
contract
|
5,500
|
|
-
|
|
8,500
|
|
-
|
|
Total
revenues
|
26,266
|
|
16,021
|
|
107,284
|
|
71,782
|
Costs and
expenses:
|
|
|
|
|
|
|
|
|
Cost of product
sales
|
129
|
|
279
|
|
445
|
|
434
|
|
Research and
development (see Note A)
|
16,807
|
|
14,214
|
|
33,633
|
|
30,363
|
|
Selling, general and
administrative (see Note A)
|
22,378
|
|
18,920
|
|
44,499
|
|
37,350
|
|
Total costs and
expenses
|
39,314
|
|
33,413
|
|
78,577
|
|
68,147
|
Income from
operations
|
(13,048)
|
|
(17,392)
|
|
28,707
|
|
3,635
|
|
Interest
income
|
16
|
|
169
|
|
17
|
|
527
|
|
Interest
expense
|
(1,759)
|
|
(353)
|
|
(2,244)
|
|
(495)
|
Income before income
taxes
|
(14,791)
|
|
(17,576)
|
|
26,480
|
|
3,667
|
Provision for
(Benefit from) income taxes
|
(970)
|
|
-
|
|
801
|
|
-
|
Net income
|
$
(13,821)
|
|
$
(17,576)
|
|
$
25,679
|
|
$
3,667
|
|
|
|
|
|
|
|
|
|
Net loss per share,
basic and diluted
|
|
|
|
|
|
|
|
|
Basic
|
$
(0.08)
|
|
$
(0.10)
|
|
$
0.15
|
|
$
0.02
|
|
Diluted
|
$
(0.08)
|
|
$
(0.10)
|
|
$
0.15
|
|
$
0.02
|
|
|
|
|
|
|
|
|
|
Weighted average
shares used in computing net loss per share, basic and
diluted
|
|
|
|
|
|
|
|
Basic
|
170,192
|
|
168,570
|
|
169,997
|
|
168,519
|
|
Diluted
|
170,192
|
|
168,570
|
|
175,912
|
|
168,525
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Note
A
|
|
|
|
|
|
|
|
Stock-based
compensation expense included in:
|
|
|
|
|
|
|
|
|
Selling, general and
administrative
|
$
1,772
|
|
$
1,299
|
|
$
3,825
|
|
$
2,629
|
|
Research and
development
|
534
|
|
458
|
|
1,120
|
|
1,152
|
|
|
$
2,306
|
|
$
1,757
|
|
$
4,945
|
|
$
3,781
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
SUMMARY BALANCE
SHEET DATA
|
|
|
|
|
|
(in
thousands)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
June
30,
|
|
December
31,
|
|
|
|
|
|
|
2021
|
|
2020
(1)
|
|
|
|
|
|
|
(unaudited)
|
|
|
|
|
|
|
Cash, cash
equivalents and short-term investments
|
$
153,387
|
|
$
57,327
|
|
|
|
|
Total
assets
|
201,598
|
|
110,378
|
|
|
|
|
Stockholders'
equity
|
68,110
|
|
34,026
|
|
|
|
|
(1)
|
Derived from audited
financial statements
|
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SOURCE Rigel Pharmaceuticals, Inc.