- First quarter TAVALISSE® net product sales of $16.2 million and total revenues of $16.7 million
- Topline data from FORWARD study, a pivotal, Phase 3
clinical trial of fostamatinib in warm autoimmune hemolytic anemia
(wAIHA), on track for mid-2022
- Management to host a conference call and webcast
today at 4:30 p.m. Eastern Time and
will be joined by Key Opinion Leader and FORWARD trial
investigator, Caroline Piatek,
M.D.
SOUTH
SAN FRANCISCO, Calif., May 3, 2022
/PRNewswire/ -- Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL) today
reported financial results for the first quarter ended March 31, 2022, 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.
"Rigel delivered on a solid quarter of TAVALISSE sales in ITP,
and we believe we are well positioned for increasing sales in
upcoming quarters," said Raul
Rodriguez, Rigel's president and CEO. "wAIHA is a highly
synergistic indication to ITP and we are very excited to be
reporting Phase 3 fostamatinib results from our wAIHA trial in
mid-2022. If approved, the addition of fostamatinib as a
first-to-market therapy in wAIHA is a key next step in building a
world-class hem-onc franchise."
Business Update
- In the first quarter of 2022, 1,836 bottles of TAVALISSE were
shipped directly to patients and clinics, representing the highest
number of bottles shipped to patients and clinics in a quarter
since launch and an increase of 15% compared to the first quarter
of 2021. Rigel believes these achievements are the result of
several factors, including Rigel's salesforce expansion completed
in September 2021 and a substantial
increase in in-person physician interactions in the quarter, and an
expansion of market access for TAVALISSE to now include broad
commercial coverage, with preferred status on three key national
formularies.
- Rigel is on track to report topline data from its FORWARD
trial, a pivotal Phase 3 clinical trial of fostamatinib, an oral
SYK inhibitor, in patients with wAIHA in mid-2022. If the data is
positive, Rigel expects to proceed with regulatory filings and if
approved, fostamatinib has the potential to be the first-to-market
therapy for patients with wAIHA in 2023.
- In the first quarter of 2022, Rigel announced the publication
of data in the American Journal of Hematology from the open
label, multicenter, Phase 2 clinical study of fostamatinib in
adults with wAIHA who had failed at least one prior treatment.
- Rigel's pivotal Phase 3 clinical trial evaluating fostamatinib
in high-risk patients hospitalized with COVID-19 has enrolled 268
of the targeted 308 patients as of May 2,
2022. Due to the recent decline in COVID-19
hospitalizations, Rigel is reviewing strategies to complete
enrollment and report topline results before the end of the year,
including potentially completing the trial with fewer patients than
the initial targeted enrollment of 308 patients.
- New data on fostamatinib in hospitalized patients with COVID-19
will be presented by collaborators from the National Institutes of
Health and Inova Fairfax Hospital at the American Thoracic Society
2022 Annual Meeting being held in San
Francisco, May 13 – 18,
2022.
- Startup activities are ongoing in Rigel's open-label, Phase
1b clinical trial of R289, a potent
and selective IRAK1/4 inhibitor, in patients with lower-risk
myeloid dysplastic syndrome (LR-MDS) who are refractory/resistant
to prior therapies. The primary endpoint for this trial is safety
with key secondary endpoints including preliminary efficacy and
evaluation of pharmacokinetic properties. Rigel will also collect
key biomarker data to further characterize R289's mechanism of
action in LR-MDS.
- Partner Eli Lilly continues to advance R552, a potent and
selective RIPK1 inhibitor, with the initial Phase 2 study in an
immunologic disease indication now anticipated to begin in the
first quarter of 2023. RIPK1 is implicated in a broad range of key
inflammatory cellular processes and plays a key role in tumor
necrosis factor (TNF) signaling, especially in the induction of
pro-inflammatory necroptosis.
- On April 27, 2022, Rigel's
partner Kissei Pharmaceutical Co., Ltd. (Kissei) announced that a
new drug application (NDA) was submitted to Japan's Pharmaceuticals and Medical Devices
Agency (PMDA) for fostamatinib in chronic ITP. Rigel has an
exclusive license and supply agreement with Kissei to develop and
commercialize fostamatinib in all current and potential indications
in Japan, China, Taiwan
and the Republic of Korea.
Financial Update
For the first quarter of 2022, Rigel reported a net loss of
$27.4 million, or $0.16 per basic and diluted share, compared to a
net income of $39.5 million, or
$0.23 per basic share and
$0.22 per diluted share for the same
period of 2021.
In the first quarter of 2022, total revenues were $16.7 million, consisting of $16.2 million in TAVALISSE net product sales and
$0.5 million in contract revenues
from collaborations. TAVALISSE net product sales of $16.2 million increased by 31% from $12.4 million in the first quarter of 2021.
Rigel reported total costs and expenses of $43.0 million in the first quarter of 2022,
compared to $39.3 million for the
same period in 2021. The increase in costs and expenses was
primarily due to increased commercial activities related to the
sales force expansion in late 2021, increased research and
development costs related to the development of Rigel's IRAK 1/4
inhibitor program, and increased personnel related costs and
stock-based compensation expense, partially offset by decreased
research and development costs related to the Phase 3 clinical
trial of fostamatinib for wAIHA and the ongoing Phase 3 clinical
trial of fostamatinib in hospitalized patients with COVID-19.
As of March 31, 2022, Rigel had
cash, cash equivalents and short-term investments of $107.5 million, compared to $125.0 million as of December 31, 2021.
Conference Call and Webcast Today
at 4:30pm Eastern Time, with KOL and
FORWARD Trial Investigator, Caroline
Piatek, M.D.
Rigel will hold a live conference call and webcast today at
4:30pm Eastern Time (1:30pm Pacific Time) to discuss financial results
and provide an update on the business. The conference call will
also feature a presentation by Caroline
Piatek, M.D., Associate Professor of Clinical Medicine, Jane
Anne Nohl Division of Hematology at the Keck School of Medicine of
the University of Southern California,
Key Opinion Leader, and FORWARD trial investigator. Dr. Piatek will
discuss the current treatment landscape, unmet medical need,
patient journey and how she may incorporate fostamatinib, if
approved, into clinical practice in wAIHA.
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 lead
to the destruction of the body's own red blood cells. Warm antibody
AIHA (wAIHA), which is the most common form of AIHA, is
characterized by the presence of antibodies that react with the red
blood cell surface at body temperature. wAIHA affects approximately
36,000 adult patients in the U.S.1 and can be a severe,
debilitating disease. To date, there are no disease-targeted
therapies approved for wAIHA, despite the unmet medical need that
exists for these patients.
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.2 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.3
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. 4,5,6,7
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 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
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, the United Kingdom (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)8; a Phase 3 clinical
trial (NCT04629703) for the treatment of
hospitalized high-risk patients
with COVID-198; and an NIH/NHLBI-sponsored Phase 3
clinical trial (ACTIV-4 Host Tissue Trial, NCT04924660) for the
treatment of COVID-19 in hospitalized patients.
Rigel's other clinical programs include its interleukin
receptor-associated kinase (IRAK) inhibitor program, and a
receptor-interacting serine/threonine-protein kinase (RIPK)
inhibitor program in clinical development with partner Eli Lilly
and Company. In addition, Rigel has product candidates in
development with partners BerGenBio ASA and Daiichi
Sankyo.
For further information, visit www.rigel.com or follow
us on Twitter or LinkedIn.
1. Prevalence: A. Zanella, et al, haematologica
2014; 99(10); % Warm AIHA: T. Kalfa; Hematology Am Soc Hematol Educ
Program. 2016 Dec 2; 2016(1):
690–697
2. Berlin DA, Gulick RM, and Martinez FJ. Severe
Covid-19. N Engl J Med 2020.
DOI: https://doi.org/10.1056/NEJMcp2009575
3. 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
4. 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
5. 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
6. 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
7. 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
8. 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 timing of reporting topline data from the
FORWARD trial in patients with wAIHA; enrollment and reporting of
data from the Company's Phase 3 clinical trial of fostamatinib in
hospitalized COVID-19 patients; the commercial success of TAVALISSE
in the U.S. and TAVLESSE in Europe, including expectations related to the
potential and market opportunity for fostamatinib as therapeutic
for, among other things, wAIHA and COVID-19, the commercialization
of fostamatinib in international markets, Rigel's ability to
further develop its clinical stage and early-stage product
candidates and programs including its IRAK1/4 inhibitor program,
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, 2021 and subsequent filings. 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, except as required by law.
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
March 31,
|
|
|
2022
|
|
2021
|
|
|
(unaudited)
|
Revenues:
|
|
|
|
|
Product sales,
net
|
$
16,197
|
|
$
12,376
|
|
Contract revenues from
collaborations
|
538
|
|
65,642
|
|
Government
contract
|
-
|
|
3,000
|
|
Total
revenues
|
16,735
|
|
81,018
|
Costs and
expenses:
|
|
|
|
|
Cost of product
sales
|
121
|
|
316
|
|
Research and
development (see Note A)
|
15,474
|
|
16,826
|
|
Selling, general and
administrative (see Note A)
|
27,401
|
|
22,121
|
|
Total costs and
expenses
|
42,996
|
|
39,263
|
Income (loss) from
operations
|
(26,261)
|
|
41,755
|
|
Interest
income
|
21
|
|
1
|
|
Interest
expense
|
(1,205)
|
|
(485)
|
Income (loss) before
income taxes
|
(27,445)
|
|
41,271
|
Provision for income
taxes
|
-
|
|
1,771
|
Net income
(loss)
|
$
(27,445)
|
|
$
39,500
|
|
|
|
|
|
Net income (loss) per
share, basic and diluted
|
|
|
|
|
Basic
|
$
(0.16)
|
|
$
0.23
|
|
Diluted
|
$
(0.16)
|
|
$
0.22
|
|
|
|
|
|
Weighted average shares
used in computing net income (loss) per share, basic and
diluted
|
|
|
|
Basic
|
171,774
|
|
169,800
|
|
Diluted
|
171,774
|
|
176,069
|
|
|
|
|
|
|
|
|
|
|
Note
A
|
|
|
|
Stock-based
compensation expense included in:
|
|
|
|
|
Selling, general and
administrative
|
$
2,739
|
|
$
2,053
|
|
Research and
development
|
468
|
|
586
|
|
|
$
3,207
|
|
$
2,639
|
|
|
|
|
|
|
|
|
|
|
SUMMARY BALANCE
SHEET DATA
|
(in
thousands)
|
|
|
|
|
|
|
|
March
31,
|
|
December
31,
|
|
|
2022
|
|
2021
(1)
|
|
|
(unaudited)
|
|
|
Cash, cash equivalents
and short-term investments
|
$
107,519
|
|
$
124,967
|
Total
assets
|
149,074
|
|
167,328
|
Stockholders'
equity
|
6,798
|
|
30,374
|
(1)
|
Derived from audited
financial statements
|
|
|
|
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SOURCE Rigel Pharmaceuticals, Inc.