Full Press Release Details
Rigel Reports First Quarter 2023 Financial Results
and Provides Business Update
SAN FRANCISCO, Calif., May 2, 2023 /PRNewswire/
-- Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL) today reported financial results
for the first quarter ended March 31, 2023, 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 and
sales of REZLIDHIA (olutasidenib) capsules for the treatment of adult
patients with relapsed or refractory (R/R) acute myeloid leukemia (AML) with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation
as detected by an FDA-approved test.
are thrilled with our strong first quarter net product sales performance, a 47% increase from Q1 2022. This reflects our ability to advance
our launch of REZLIDHIA in mIDH1 R/R AML while driving continued growth in TAVALISSE ITP
sales," said Raul Rodriguez, Rigel's president and CEO. "For the remainder of 2023, we have established a strong foundation
for our hematology-oncology business to successfully deliver growth in both TAVALISSE and REZLIDHIA, and to advance our development programs."
the first quarter of 2023, Rigel reported a net loss of $13.5 million, or $0.08 per basic and diluted share, compared to a net loss of
$27.4 million, or $0.16 per basic and diluted share, for the same period of 2022.
the first quarter of 2023, total revenues were $26.1 million, consisting of $22.3 million in TAVALISSE net product sales, $1.5 million
in REZLIDHIA net product sales, and $2.3 million in contract revenues from collaborations. TAVALISSE net product sales of $22.3 million
increased by 38% from $16.2 million for the same period of 2022. Contract revenues from collaborations for the first quarter of 2023
consisted primarily of revenue from Grifols S.A., with $1.6 million related to the delivery of drug supplies and a royalty of $0.7 million.
the first quarter of 2023, total costs and expenses were $38.8 million, compared to $43.0 million for the same period of 2022. The decrease
in costs and expenses was primarily due to decreased research and development costs related to the Phase 3 clinical trial of fostamatinib
for wAIHA, the Phase 3 clinical trial of fostamatinib in high-risk hospitalized patients with COVID-19, and the IRAK 1/4 inhibitor program.
of March 31, 2023, Rigel had cash, cash equivalents and short-term investments of $58.7 million, compared to $58.2 million as of
December 31, 2022. In March 2023, Rigel accessed an additional $20.0 million term loan through its credit facility with MidCap
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).
can access the live conference call by dialing (877) 407-3088 (domestic) or (201) 389-0927 (international). The conference call 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.
Acute myeloid leukemia
(AML) is a rapidly progressing cancer of the blood and bone marrow that affects myeloid cells, which normally develop into various types
of mature blood cells. AML occurs primarily in adults and accounts for about 1 percent of all adult cancers. The American Cancer Society
estimates that in the United States alone, there will be about 20,380 new cases, most in adults, in 2023.2
Relapsed AML affects
about half of all patients who, following treatment and remission, experience a return of leukemia cells in the bone marrow.3 Refractory
AML, which affects between 10 and 40 percent of newly diagnosed patients, occurs when a patient fails to achieve remission even after
intensive treatment.4 Quality of life declines for patients with each successive line of treatment for AML, and well-tolerated
treatments in relapsed or refractory disease remain an unmet need.
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.
Warnings and Precautions
see www.TAVALISSEUSPI.com for full Prescribing Information.
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.
REZLIDHIA is indicated for the treatment of adult
patients with relapsed or refractory acute myeloid leukemia (AML) with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation as detected
by an FDA-approved test.
IMPORTANT SAFETY INFORMATION
WARNING: DIFFERENTIATION SYNDROME
Differentiation syndrome, which can be fatal,
can occur with REZLIDHIA treatment. Symptoms may include dyspnea, pulmonary infiltrates/pleuropericardial effusion, kidney injury, hypotension,
fever, and weight gain. If differentiation syndrome is suspected, withhold REZLIDHIA and initiate treatment with corticosteroids and
hemodynamic monitoring until symptom resolution.
WARNINGS AND PRECAUTIONS
Differentiation Syndrome
REZLIDHIA can cause differentiation syndrome.
In the clinical trial of REZLIDHIA in patients with relapsed or refractory AML, differentiation syndrome occurred in 16% of patients,
with grade 3 or 4 differentiation syndrome occurring in 8% of patients treated, and fatalities in 1% of patients. Differentiation syndrome
is associated with rapid proliferation and differentiation of myeloid cells and may be life-threatening or fatal. Symptoms of differentiation
syndrome in patients treated with REZLIDHIA included leukocytosis, dyspnea, pulmonary infiltrates/pleuropericardial effusion, kidney
injury, fever, edema, pyrexia, and weight gain. Of the 25 patients who experienced differentiation syndrome, 19 (76%) recovered after
treatment or after dose interruption of REZLIDHIA. Differentiation syndrome occurred as early as 1 day and up to 18 months after REZLIDHIA
initiation and has been observed with or without concomitant leukocytosis.
If differentiation syndrome is suspected, temporarily
withhold REZLIDHIA and initiate systemic corticosteroids (e.g., dexamethasone 10 mg IV every 12 hours) for a minimum of 3 days and until
resolution of signs and symptoms. If concomitant leukocytosis is observed, initiate treatment with hydroxyurea, as clinically indicated.
Taper corticosteroids and hydroxyurea after resolution of symptoms. Differentiation syndrome may recur with premature discontinuation
of corticosteroids and/or hydroxyurea treatment. Institute supportive measures and hemodynamic monitoring until improvement; withhold
dose of REZLIDHIA and consider dose reduction based on recurrence.
hepatotoxicity, presenting as increased alanine aminotransferase (ALT), increased aspartate aminotransferase (AST), increased blood alkaline
phosphatase, and/or elevated bilirubin. Of 153 patients with relapsed or refractory AML who received REZLIDHIA, hepatotoxicity occurred
in 23% of patients; 13% experienced grade 3 or 4 hepatotoxicity. One patient treated with REZLIDHIA in combination with azacitidine in
the clinical trial, a combination for which REZLIDHIA is not indicated, died from complications of drug-induced liver injury. The median
time to onset of hepatotoxicity in patients with relapsed or refractory AML treated with REZLIDHIA was 1.2 months (range: 1 day to 17.5
months) after REZLIDHIA initiation, and the median time to resolution was 12 days (range: 1 day to 17 months). The most common hepatotoxicities
were elevations of ALT, AST, blood alkaline phosphatase, and blood bilirubin.
Monitor patients frequently for clinical symptoms
of hepatic dysfunction such as fatigue, anorexia, right upper abdominal discomfort, dark urine, or jaundice. Obtain baseline liver function
tests prior to initiation of REZLIDHIA, at least once weekly for the first two months, once every other week for the third month, once
in the fourth month, and once every other month for the duration of therapy. If hepatic dysfunction occurs, withhold, reduce, or permanently
discontinue REZLIDHIA based on recurrence/severity.
The most common ( 20%) adverse reactions,
including laboratory abnormalities, were aspartate aminotransferase increased, alanine aminotransferase increased, potassium decreased,
sodium decreased, alkaline phosphatase increased, nausea, creatinine increased, fatigue/malaise, arthralgia, constipation, lymphocytes
increased, bilirubin increased, leukocytosis, uric acid increased, dyspnea, pyrexia, rash, lipase increased, mucositis, diarrhea and
Advise women not to breastfeed during treatment
with REZLIDHIA and for 2 weeks after the last dose.
No overall differences in effectiveness were
observed between patients 65 years and older and younger patients. Compared to patients younger than 65 years of age, an increase in
incidence of hepatotoxicity and hypertension was observed in patients 65 years of age.
In patients with mild or moderate hepatic impairment,