Full Press Release Details
Rigel Reports First Quarter 2024 Financial
Results and Provides Business Update
SOUTH SAN FRANCISCO,
Calif., May 7, 2024 /PRNewswire/ -- Rigel
Pharmaceuticals, Inc. (Nasdaq: RIGL) today reported financial results for the first quarter
ended March 31, 2024, 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.
for the first quarter of 2024 continued to demonstrate
strong commercial demand with the highest number of TAVALISSE and REZLIDHIA bottles sold in a quarter since launch.
We are also excited about the recent acquisition of GAVRETO and are on track to include
this product in our commercial portfolio in July of this year," said Raul Rodriguez, Rigel's president and CEO. "At
the same time, we are progressing the development
of olutasidenib with our strategic collaborators, MD Anderson and CONNECT, and driving forward our other pipeline programs."
For the first quarter of 2024, total revenues
were $29.5 million, consisting of $21.1 million in TAVALISSE net product sales, $4.9 million in REZLIDHIA net product sales, and $3.5
million in contract revenue from collaborations. Although TAVALISSE bottles shipped to patients and clinics reached the highest quarterly
number of bottles since launch, net product sales were $21.1 million compared to $22.3 million in the same period of 2023, primarily
due to a decrease in the number of bottles remaining in distribution channels. REZLIDHIA net product sales were $4.9 million compared
to $1.5 million in the same period of 2023. Contract revenue from collaborations consisted of $2.3 million from Kissei Pharmaceutical
Co., Ltd. related to delivery of drug supplies, $1.1 million from Grifols S.A. related to earned royalties, and $0.1 million from
Medison Pharma Trading AG related to delivery of drug supplies and earned royalties.
For the first quarter of 2024, total
costs and expenses were $36.5 million compared to $38.8 million for the same period of 2023. The decrease in costs and expenses was
partly due to decreased research and development costs due to the timing of clinical trial activities related to the IRAK 1/4
inhibitor program, as well as the timing of trial completion activities related to two Phase 3 clinical trials of fostamatinib in
patients with COVID-19 and wAIHA. In addition, the decrease was due to lower consulting and third-party services as well as lower
facility-related costs. These decreases were partially offset by higher stock-based compensation expenses, mainly from
performance-based awards.
For the first quarter of 2024, Rigel reported
a net loss of $8.2 million, or $0.05 per basic and diluted share, compared to a net loss of $13.5 million, or $0.08 per basic and diluted
share, for the same period of 2023.
As of March 31, 2024, Rigel had cash,
cash equivalents and short-term investments of $49.6 million, compared to $56.9 million as of December 31, 2023. In April 2024,
Rigel entered into an amendment to the Credit Agreement with MidCap Financial Trust. As part of the amendment, Rigel extended the maturity
date and interest only period by one year.
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
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 there will be about 20,800 new cases in the United States, most in adults,
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.
It is estimated that over 230,000 adults in the U.S. will be diagnosed with lung cancer in 2024. Lung cancer is
the leading cause of cancer death in the U.S, with NSCLC being the most common type accounting for 80-85% of all lung cancer diagnoses.5 RET
fusions are implicated in approximately 1-2% of patients with NSCLC.6
(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
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 is a registered
trademark 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
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
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.
can cause 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 transaminitis.
women not to breastfeed during treatment with REZLIDHIA and for 2 weeks after the last dose.