- 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.
- R289 is an investigational compound not approved by the
FDA.
- 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
- 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
- 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
- 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
- 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
|
|
|
|
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SOURCE Rigel Pharmaceuticals, Inc.