Full Press Release Details
Rigel Reports First Quarter 2022 Financial Results
and Provides Business Update
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
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."
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.
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.
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
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 (Fc R)
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
For more information on Rigel's comprehensive
clinical program in COVID-19, go to: https://www.rigel.com/pipeline/proprietary-programs/covid-19
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
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.
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
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
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
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