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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 OR 15(d) of
The Securities Exchange Act of 1934
Date of Report (Date of
earliest event reported): May 7, 2024
RIGEL PHARMACEUTICALS, INC.
(Exact name of registrant as specified in
its charter)
Delaware
(State or other jurisdiction of incorporation)
0-29889 |
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94-3248524 |
(Commission File No.) |
|
(IRS Employer Identification No.) |
|
|
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611 Gateway Boulevard |
|
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Suite 900 |
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South San Francisco, CA |
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94080 |
(Address of principal executive offices) |
|
(Zip Code) |
Registrant’s telephone number, including
area code: (650) 624-1100
Not Applicable
(Former name or former address, if changed
since last report)
Check the appropriate box below if the Form 8-K filing
is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General
Instruction A.2. below):
¨ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
¨ Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
¨ Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
¨ Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Title of Each Class |
|
Trading Symbol(s) |
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Name of Each Exchange on
Which Registered |
Common Stock, par value $0.001 per share |
|
RIGL |
|
The Nasdaq Stock Market LLC |
Indicate by check mark whether the registrant is an emerging
growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of
the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ¨
If an emerging
growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with
any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ¨
Item 2.02. |
Results of Operations and Financial Condition. |
On May 7, 2024, Rigel Pharmaceuticals,
Inc. (“Rigel”) announced certain financial results for its first quarter ended March 31, 2024. A copy of Rigel’s
press release, titled “Rigel Reports First Quarter 2024 Financial Results and Provides Business Update,” is furnished pursuant
to Item 2.02 as Exhibit 99.1 hereto.
The information in this
report, including the exhibit hereto, shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange
Act of 1934, as amended, or otherwise subject to the liabilities of that section or Sections 11 and 12(a)(2) of the Securities Act of
1933, as amended. The information contained herein and in the accompanying exhibit shall not be incorporated by reference into any filing
with the U.S. Securities and Exchange Commission made by Rigel, whether made before or after the date hereof, regardless of any general
incorporation language in such filing.
Item 9.01. |
Financial Statements and Exhibits. |
|
|
(d) |
Exhibits. |
SIGNATURES
Pursuant to the requirements
of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto
duly authorized.
Dated: May 7, 2024 |
RIGEL PHARMACEUTICALS, INC. |
|
|
|
By: |
/s/ Ray Furey, J.D. |
|
|
Ray Furey, J.D. |
|
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Executive Vice President, General Counsel and Corporate Secretary |
Exhibit 99.1
Rigel Reports First Quarter 2024 Financial
Results and Provides Business Update
| · | First
quarter 2024 total revenue of $29.5 million, which includes TAVALISSE® net
product sales of $21.1 million and REZLIDHIA® net product sales of $4.9
million |
| · | Expanded
Rigel's portfolio with acquisition of GAVRETO®, a U.S. marketed product for
RET fusion-positive metastatic non-small cell lung cancer and advanced or metastatic thyroid
cancer |
| · | Appointed
Lisa Rojkjaer, M.D. as Chief Medical Officer |
| · | Conference
call and webcast scheduled today at 4:30 p.m. Eastern Time |
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.
“Results
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.”
Business
Update
| · | In
the first quarter of 2024, a total of 2,193 TAVALISSE bottles were sold in the U.S. driven
by 2,483 bottles shipped to patients and clinics, the highest number in a quarter since launch.
Bottles remaining in distribution channels decreased by 290 bottles during the quarter. |
| · | In
the first quarter of 2024,
a total of 390 REZLIDHIA bottles were sold in the U.S.,
significantly accelerating sales growth over last year. This growth was driven by increased
demand, with 326 bottles shipped to patients
and clinics. |
| · | In
April 2024, Rigel announced a peer-reviewed publication in Leukemia &
Lymphoma on data from an analysis of the Phase 2 study evaluating REZLIDHIA in patients
with mIDH1 AML who were R/R to prior venetoclax-based regimens. The findings from these analyses
suggest that REZLIDHIA may provide an effective treatment for patients with recurrent AML
following venetoclax combination therapy. REZLIDHIA induced durable remissions consistent
with those observed in the pivotal trial and had a favorable tolerability profile. |
| · | In
March 2024, Rigel appointed Lisa Rojkjaer, M.D. as Executive Vice President and Chief
Medical Officer. Dr. Rojkjaer is an industry veteran with over 20 years of clinical
development, regulatory, and medical affairs experience with a focus on hematology and oncology.
She is a board-certified hematologist with an international clinical practice background. |
| · | In
February 2024, Rigel announced the acquisition of the U.S. rights to GAVRETO® (pralsetinib).
GAVRETO is a once daily, small molecule, oral, kinase inhibitor of wild-type RET (rearranged
during transfection) and oncogenic RET fusions. GAVRETO is approved by the U.S. Food and
Drug Administration (FDA) for the treatment of adult patients with metastatic RET fusion-positive
non-small cell lung cancer (NSCLC) and advanced or
metastatic thyroid cancer. The acquisition of this
product further expands Rigel's portfolio and leverages Rigel's existing infrastructure in
both the institutional and community settings. Rigel expects to complete the transition of
the asset and start recognizing product sales in July 2024. |
| · | In
January 2024, Rigel and CONNECT announced a strategic development collaboration
to evaluate REZLIDHIA (olutasidenib) in combination with temozolomide in patients with high-grade
glioma (HGG) harboring an IDH1 mutation. Under the collaboration, CONNECT will include olutasidenib
in CONNECT's TarGeT-D, a molecularly guided Phase 2 umbrella clinical trial for HGG. In the
Rigel-sponsored arm, adolescents and young adult patients (≤39 years old) with newly diagnosed
IDH1-mutation positive HGG will receive maintenance therapy with olutasidenib in combination
with temozolomide for the first year after radiotherapy, followed by olutasidenib monotherapy
for the second year. Rigel will provide CONNECT funding up to $3 million and study material
over the four-year collaboration. |
| · | Rigel
continues to advance its Phase 1b clinical trial evaluating the safety, tolerability, pharmacokinetics,
and preliminary efficacy of R2891, a novel and selective IRAK1/4 inhibitor, in
patients with relapsed/refractory lower-risk myelodysplastic syndrome (LR-MDS). Enrollment
in the third cohort of the trial has been completed and the company is planning to include
two additional cohorts with twice daily dosing regimens. Preliminary data are expected by
the end of 2024. |
Financial
Update
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.
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 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
AML
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,
in 2024.2
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.
About
NSCLC
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
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 is a registered
trademark of Rigel Pharmaceuticals, Inc.
About
REZLIDHIA®
INDICATION
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
REZLIDHIA
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.
ADVERSE
REACTIONS
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.
DRUG INTERACTIONS
| · | Avoid
concomitant use of REZLIDHIA with strong or moderate CYP3A inducers. |
| · | Avoid
concomitant use of REZLIDHIA with sensitive CYP3A substrates unless otherwise instructed
in the substrates prescribing information. If concomitant use is unavoidable, monitor patients
for loss of therapeutic effect of these drugs. |
LACTATION
Advise
women not to breastfeed during treatment with REZLIDHIA and for 2 weeks after the last dose.
GERIATRIC
USE
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.
HEPATIC
IMPAIRMENT
In patients with mild or moderate hepatic impairment, closely monitor for increased probability of differentiation
syndrome.
Click
here for Full Prescribing Information, including Boxed WARNING.
To report side
effects of prescription drugs to the FDA, visit www.fda.gov/medwatch or call 1-800-FDA-1088 (800-332-1088).
REZLIDHIA is a registered
trademark of Rigel Pharmaceuticals, Inc.
About
GAVRETO® (pralsetinib)
INDICATIONS
GAVRETO (pralsetinib) is indicated for the treatment of:
| · | Adult
patients with metastatic rearranged during transfection (RET) fusion-positive non-small cell
lung cancer (NSCLC) as detected by an FDA-approved test |
| · | Adult
and pediatric patients 12 years of age and older with advanced or metastatic RET fusion-positive
thyroid cancer who require systemic therapy and who are radioactive iodine-refractory (if
radioactive iodine is appropriate)* |
*This indication is approved
under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent
upon verification and description of clinical benefit in confirmatory trial(s).
IMPORTANT SAFETY INFORMATION
| · | Interstitial
Lung Disease (ILD)/Pneumonitis: Severe, life-threatening, and fatal ILD/pneumonitis
can occur in patients treated with GAVRETO. Pneumonitis occurred in 12% of patients who received
GAVRETO, including 3.3% with Grade 3-4, and 0.2% with fatal reactions. Monitor for pulmonary
symptoms indicative of ILD/pneumonitis. Withhold GAVRETO and promptly investigate for ILD
in any patient who presents with acute or worsening of respiratory symptoms (e.g., dyspnea,
cough, and fever). Withhold, reduce dose or permanently discontinue GAVRETO based on severity
of confirmed ILD. |
| · | Hypertension: Occurred
in 35% of patients, including Grade 3 hypertension in 18% of patients. Overall, 8% had their
dose interrupted and 4.8% had their dose reduced for hypertension. Treatment-emergent hypertension
was most commonly managed with anti-hypertension medications. Do not initiate GAVRETO in
patients with uncontrolled hypertension. Optimize blood pressure prior to initiating GAVRETO.
Monitor blood pressure after 1 week, at least monthly thereafter and as clinically indicated.
Initiate or adjust anti-hypertensive therapy as appropriate. Withhold, reduce dose, or permanently
discontinue GAVRETO based on the severity. |
| · | Hepatotoxicity: Serious
hepatic adverse reactions occurred in 1.5% of patients treated with GAVRETO. Increased aspartate
aminotransferase (AST) occurred in 49% of patients, including Grade 3 or 4 in 7% and increased
alanine aminotransferase (ALT) occurred in 37% of patients, including Grade 3 or 4 in 4.8%.
The median time to first onset for increased AST was 15 days (range: 5 days to 2.5 years)
and increased ALT was 24 days (range: 7 days to 3.7 years). Monitor AST and ALT prior to
initiating GAVRETO, every 2 weeks during the first 3 months, then monthly thereafter and
as clinically indicated. Withhold, reduce dose or permanently discontinue GAVRETO based on
severity. |
| · | Hemorrhagic
Events: Serious, including fatal, hemorrhagic events can occur with GAVRETO. Grade
≥3 events occurred in 4.1% of patients treated with GAVRETO including one patient with
a fatal hemorrhagic event. Permanently discontinue GAVRETO in patients with severe or life-threatening
hemorrhage. |
| · | Tumor
Lysis Syndrome (TLS): Cases of TLS have been reported in patients with medullary
thyroid carcinoma receiving GAVRETO. Patients may be at risk of TLS if they have rapidly
growing tumors, a high tumor burden, renal dysfunction, or dehydration. Closely monitor patients
at risk, consider appropriate prophylaxis including hydration, and treat as clinically indicated. |
| · | Risk
of Impaired Wound Healing: Impaired wound healing can occur in patients who receive
drugs that inhibit the vascular endothelial growth factor (VEGF) signaling pathway. Therefore,
GAVRETO has the potential to adversely affect wound healing. Withhold GAVRETO for at least
5 days prior to elective surgery. Do not administer for at least 2 weeks following major
surgery and until adequate wound healing. The safety of resumption of GAVRETO after resolution
of wound healing complications has not been established. |
| · | Embryo-Fetal
Toxicity: Based on findings from animal studies and its mechanism of action, GAVRETO
can cause fetal harm when administered to a pregnant woman. Advise pregnant women of the
potential risk to a fetus. Advise females of reproductive potential to use effective non-hormonal
contraception during treatment with GAVRETO and for 2 weeks after the last dose. Advise males
with female partners of reproductive potential to use effective contraception during treatment
with GAVRETO and for 1 week after the last dose. |
| · | Common
adverse reactions (≥25%) were musculoskeletal pain, constipation, hypertension,
diarrhea, fatigue, edema, pyrexia, and cough. Common Grade 3/4 laboratory abnormalities
(≥2%) were decreased lymphocytes, decreased neutrophils, decreased hemoglobin,
decreased phosphate, decreased leukocytes, decreased sodium, increased aspartate aminotransferase
(AST), increased alanine aminotransferase (ALT), decreased calcium (corrected), decreased
platelets, increased alkaline phosphatase, increased potassium, decreased potassium, and
increased bilirubin. |
| · | Avoid
coadministration of GAVRETO with strong or moderate CYP3A inhibitors, P-gp inhibitors,
or combined P-gp and strong or moderate CYP3A inhibitors. If coadministration cannot
be avoided, reduce the GAVRETO dose. Avoid coadministration of GAVRETO with strong
or moderate CYP3A inducers. If coadministration cannot be avoided, increase the GAVRETO
dose. |
| · | Lactation: Advise
women not to breastfeed during treatment with GAVRETO and for 1 week after the last dose. |
| · | Pediatric
Use: Monitor open growth plates in adolescent patients. Consider interrupting or
discontinuing GAVRETO if abnormalities occur. |
You may report
side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. You may also report side effects to
Genentech at 1-888-835-2555.
Please click here to
see the full Prescribing Information and Patient Information for GAVRETO.
About
Rigel
Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL) is a biotechnology company dedicated to discovering, developing and
providing novel therapies that significantly improve the lives of patients with hematologic disorders and cancer. Founded in 1996, Rigel
is based in South San Francisco, California. For more information on Rigel, the Company's marketed products and pipeline of potential
products, visit www.rigel.com.
| 1. | R289 is an investigational compound not approved by the FDA. |
| 2. | The
American Cancer Society. Key Statistics for Acute Myeloid Leukemia (AML). Revised January 17,
2024. Accessed Feb. 19, 2024: https://www.cancer.org/cancer/acute-myeloid-leukemia/about/key-statistics.html |
| 3. | Leukaemia
Care. Relapse in Acute Myeloid Leukaemia (AML). Version 3. Reviewed October 2021. Accessed
Feb 19, 2024: https://media.leukaemiacare.org.uk/wp-content/uploads/Relapse-in-Acute-Myeloid-Leukaemia-AML-Web-Version.pdf |
| 4. | Thol
F, Schlenk RF, Heuser M, Ganser A. How I treat refractory and early relapsed acute
myeloid leukemia. Blood (2015) 126 (3): 319-27. doi: https://doi.org/10.1182/blood-2014-10-551911 |
| 5. | The
American Cancer Society. Key Statistics for Lung Cancer. Revised November 20, 2023.
Accessed February 7, 2024: https://www.cancer.org/cancer/types/lung-cancer/about/key-statistics.html |
| 6. | Kato, S. et al. RET aberrations in diverse cancers: next-generation
sequencing of 4,871 patients. Clin Cancer Res. 2017;23(8):1988-1997 doi: 10.1158/1078-0432.CCR-16-1679 |
Forward
Looking Statements
This press release contains forward-looking statements relating to, among other things, expected
commercial and financial results, expectations related to the potential and market opportunity of olutasidenib as therapeutics for
R/R AML and other conditions, the commercialization of fostamatinib or olutasidenib in the U.S. and international markets, the transition
and commercialization of pralsetinib for the treatment of non-small cell lung cancer and advanced thyroid cancer and Rigel's
ability to further develop its clinical stage product candidates and Rigel's partnering and collaboration efforts, including the progress
of Phase 1b clinical trial of R289 for the treatment of lower-risk myeloid dysplastic syndrome, olutasidenib's evaluation in acute
myeloid leukemia (AML) and other hematologic cancers, and in newly diagnosed pediatric and young adult patients with high-grade glioma
(HGG) harboring an isocitrate dehydrogenase-1 (IDH1) mutation. Any statements contained in this press release that are not statements
of historical fact may be deemed to be forward-looking statements. Forward-looking statements can be identified by words such as "plan",
"potential", "may", "expects", "will" and similar expressions in reference to future periods.
Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based on Rigel's current
beliefs, expectations, and assumptions and hence they inherently involve significant risks, uncertainties and changes in circumstances
that are difficult to predict and many of which are outside of our control. Therefore, you should not rely on any of these forward-looking
statements. 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 fostamatinib, olutasidenib or pralsetinib ; risks that the FDA, European Medicines Agency, PMDA or other regulatory
authorities may make adverse decisions regarding fostamatinib, pralsetinib or olutasidenib; risks that clinical trials may not be
predictive of real-world results or of results in subsequent clinical trials; risks that fostamatinib, pralsetinib or olutasidenib
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, 2023 and subsequent filings. Any forward-looking
statement made by us in this press release is based only on information currently available to us and speaks only as of the date
on which it is made. Rigel does not undertake any obligation to update forward-looking statements, whether written or oral, that may
be made from time to time, whether as a result of new information, future developments or otherwise, 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:
Investors:
Rigel Pharmaceuticals, Inc.
650.624.1232
ir@rigel.com
Media:
David Rosen
Argot Partners
212.600.1902
david.rosen@argotpartners.com
RIGEL
PHARMACEUTICALS, INC.
STATEMENTS
OF OPERATIONS
(in
thousands, except per share amounts)
| |
Three
Months Ended March 31, | |
| |
2024 | | |
2023 | |
| |
| | |
| |
| |
(unaudited) | |
Revenues: | |
| | |
| |
Product sales, net | |
$ | 26,003 | | |
$ | 23,745 | |
Contract revenues from collaborations | |
| 3,531 | | |
| 2,325 | |
Total revenues | |
| 29,534 | | |
| 26,070 | |
Costs and expenses: | |
| | | |
| | |
Cost of product sales | |
| 2,025 | | |
| 977 | |
Research and development (see Note A) | |
| 6,026 | | |
| 10,089 | |
Selling, general
and administrative (see Note A) | |
| 28,449 | | |
| 27,729 | |
Total costs and
expenses | |
| 36,500 | | |
| 38,795 | |
Loss from operations | |
| (6,966 | ) | |
| (12,725 | ) |
Interest income | |
| 593 | | |
| 393 | |
Interest expense | |
| (1,874 | ) | |
| (1,204 | ) |
Net loss | |
$ | (8,247 | ) | |
$ | (13,536 | ) |
| |
| | | |
| | |
Net loss per share, basic and diluted | |
$ | (0.05 | ) | |
$ | (0.08 | ) |
Weighted average shares used in computing
net loss per share, basic and diluted | |
| 175,203 | | |
| 173,568 | |
| |
| | | |
| | |
Note A | |
| | | |
| | |
Stock-based compensation expense included in: | |
| | | |
| | |
Selling, general and administrative | |
$ | 4,484 | | |
$ | 1,735 | |
Research and development | |
| 650 | | |
| 1,024 | |
| |
$ | 5,134 | | |
$ | 2,759 | |
SUMMARY BALANCE SHEET
DATA
(in thousands)
| |
As of March 31, | | |
As of December 31, | |
| |
2024 | | |
2023(1) | |
| |
| (unaudited)
| | |
| | |
Cash, cash equivalents and short-term investments | |
$ | 49,550 | | |
$ | 56,933 | |
Total assets | |
| 126,519 | | |
| 117,225 | |
Stockholders' deficit | |
| (31,671 | ) | |
| (28,644 | ) |
(1) Derived from audited financial statements
v3.24.1.u1
Cover
|
May 07, 2024 |
Cover [Abstract] |
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|
Entity Registrant Name |
RIGEL PHARMACEUTICALS, INC.
|
Entity Central Index Key |
0001034842
|
Entity Tax Identification Number |
94-3248524
|
Entity Incorporation, State or Country Code |
DE
|
Entity Address, Address Line One |
611 Gateway Boulevard
|
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Suite 900
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South San Francisco
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CA
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