– Preliminary Unaudited Full Year 2022 Total
Revenue and U.S. XPOVIO® (selinexor)
Net Product Revenue Expected to be Approximately
$157.7 Million and $120.4 Million, Respectively, Meeting Company's
Guidance –
– Initiated Pivotal Phase 3 Study
Evaluating Selinexor as a Maintenance Therapy in Women with
Advanced or Recurrent TP53 Wild-Type Endometrial Cancer;
Encouraging Updated Exploratory Subgroup Analysis in Patients with
TP53 Wild-Type Endometrial Cancer Continues to Support Study
Rationale; Partnership with Foundation Medicine to Develop TP53
Companion Diagnostic –
– Planning to Initiate Pivotal Phase 3 Study
in Front-Line Myelofibrosis in 1H 2023; Report Updated Results from
the Phase 1 study of Selinexor in Combination with Ruxolitinib in
Patients with Treatment-Naïve MF in 1H 2023 –
– Anticipate Multiple Data Catalysts and
Progress Across Multiple Myeloma, Myelofibrosis, Endometrial Cancer
and Myelodysplastic Neoplasms in 2023 –
– Extended Cash Runway to Late 2025 –
NEWTON,
Mass., Jan. 9, 2023 /PRNewswire/ -- Karyopharm
Therapeutics Inc. (Nasdaq: KPTI), a commercial-stage pharmaceutical
company pioneering novel cancer therapies, today announced
preliminary unaudited fourth quarter and full year 2022 total
revenue and U.S. XPOVIO net product revenue estimates and outlined
its 2022 achievements and 2023 objectives.
Based on preliminary unaudited financial information, Karyopharm
expects total revenue, which includes license and royalty revenue
from partners, to be approximately $34.2
million for the fourth quarter 2022 and approximately
$157.7 million for the full year
2022, and net product revenue for XPOVIO in the U.S. to be
approximately $31.1 million for the
fourth quarter 2022 and approximately $120.4
million for the full year 2022, representing growth of 22%
over 2021.
"In 2022, we delivered solid revenue growth with XPOVIO and made
meaningful progress with our pipeline, achieving several clinical
and regulatory milestones. Importantly, we solidified our financial
runway to late 2025, enabling us to be well positioned to deliver
the next stages of the company's growth. Moving forward in 2023, we
look to continue growing our foundation in multiple myeloma,
progressing our focused clinical pipeline through several important
milestones, and leveraging both our commercialization and mid to
late-stage clinical development expertise to deliver value for our
shareholders and patients," said Richard
Paulson, President and Chief Executive Officer of
Karyopharm.
Key Program Highlights in 2022
Selinexor in Multiple Myeloma (MM)
- Over 20% U.S. revenue growth driven by continued progress in
shifting selinexor use into earlier lines of therapy and strong
growth in the community setting, accounting for approximately 70%
of selinexor revenues, offsetting increased pressure in the
academic setting due to intensifying late-line competition and
ongoing trials.
- Selinexor is now approved in 40 countries globally, following
full marketing authorization from the European Commission for
NEXPOVIO® (selinexor) in combination with bortezomib (Velcade®) and
dexamethasone (SVd) for the treatment of adult patients with
multiple myeloma who have received at least one prior therapy,
expanding the indication to 2L+.
- First patient dosed in pivotal Phase 3 study, in collaboration
with and sponsored by the European Myeloma Network (EMN),
evaluating an all-oral regimen of selinexor in combination with
pomalidomide and dexamethasone post anti-CD38 therapy in
relapsed/refractory MM.
Selinexor in Endometrial Cancer (EC)
- Initiated pivotal Phase 3 study of selinexor as a maintenance
therapy following systemic therapy in patients with TP53
wild-type advanced or recurrent endometrial cancer (EC-042;
NCT03555422).
- Entered into a global collaboration with Foundation Medicine,
Inc., a pioneer in molecular profiling for cancer, to develop
FoundationOne®CDx as a companion diagnostic for selinexor and to
identify and enroll patients whose tumors are TP53 wild-type
in the EC-042 Phase 3 study.
Eltanexor in Myelodysplastic Neoplasms (MDS)
- Completed recruitment for the interim analysis of the Phase 2
study evaluating eltanexor in relapsed/refractory MDS.
- Received orphan drug designations by the U.S. Food and Drug
Administration (FDA) and the European Commission for eltanexor for
the treatment of MDS. The FDA also granted Fast Track Designation
for eltanexor in MDS.
Selinexor in Myelofibrosis (MF)
- Presented encouraging preliminary data results from the Phase 1
study (XPORT-MF-034) evaluating selinexor in combination with
ruxolitinib in patients with treatment-naïve MF at the American
Society of Hematology (ASH) Annual Meeting. Initial data from this
study were also presented at the European Hematology Association
(EHA) 2022 Hybrid Congress and ASCO.
- Received orphan drug designations from the FDA and the European
Commission for selinexor for the treatment of MF.
Corporate and Financial Highlights for 2022
- Based on preliminary unaudited financial information, expect
total revenue to be approximately $157.7
million, including estimated U.S. XPOVIO net product revenue
of approximately $120.4 million, an
increase of 22% from 2021.
- Cash, cash equivalents, restricted cash and investments as of
December 31, 2022 was approximately
$279.0 million, following the
completion of a $165 million private
placement in December 2022, extending
cash runway to late 2025.
- Strengthened leadership team with several key appointments,
including Reshma Rangwala, MD, PhD
as Chief Medical Officer and Stuart
Poulton as Chief Development Officer.
Anticipated Near-Term Catalysts and Operational Objectives in
2023
- Continue to grow our commercial foundation in the competitive
multiple myeloma marketplace, driving increased XPOVIO sales.
- Additional global launches of selinexor by partners in ex-U.S.
territories.
- Present data supporting optimization of selinexor dose in
multiple myeloma and other key programs.
- Continue to generate data demonstrating selinexor's efficacy,
combinability and tolerability in patients with multiple
myeloma.
- Report interim data from the Phase 2 study evaluating eltanexor
in relapsed/refractory MDS in 1Q.
- Report updated results from the Phase 1 study of selinexor in
combination with ruxolitinib in patients with treatment-naïve MF in
1H. Initiate pivotal Phase 3 study in front-line myelofibrosis in
1H 2023, subject to regulatory feedback.
- Present updated subgroup analysis results in patients with TP53
wild-type endometrial cancer from the SIENDO study at a medical
conference in 2023 further supporting rationale for EC-042 pivotal
Phase 3 study.
- Further exploration of biomarker subsets to identify patient
populations who best respond to SINE compounds.
The financial information presented in this press release may be
adjusted as a result of the completion of customary quarterly and
annual review and audit procedures.
Listen to the Webcast
These achievements and updates will be discussed during a
webcast presentation at the 41st Annual J.P. Morgan Healthcare
Conference to be held on January 11,
2023, at 1:30 p.m. Eastern
Time/10:30 a.m. Pacific Time.
A live webcast of the presentation and breakout session, along with
accompanying slides, can be accessed under "Events &
Presentations" in the Investor section of the Company's website,
http://investors.karyopharm.com/events-presentations. An archived
replay will be available for 30 days following the event. The
presentation slides will also be available on the Company's website
following the event.
About XPOVIO® (selinexor)
XPOVIO is a first-in-class, oral exportin 1 (XPO1) inhibitor and
the first of Karyopharm's Selective Inhibitor of Nuclear Export
(SINE) compounds to be approved for the treatment of cancer. XPOVIO
functions by selectively binding to and inhibiting the nuclear
export protein XPO1. XPOVIO is approved in the U.S. and marketed by
Karyopharm in multiple oncology indications, including: (i) in
combination with Velcade® (bortezomib) and dexamethasone (XVd) in
patients with multiple myeloma after at least one prior therapy;
(ii) in combination with dexamethasone in patients with heavily
pre-treated multiple myeloma; and (iii) in patients with diffuse
large B-cell lymphoma (DLBCL), including DLBCL arising from
follicular lymphoma, after at least two lines of systemic therapy.
XPOVIO (also known as NEXPOVIO® in certain countries) has received
regulatory approvals in various indications in a growing number of
ex-U.S. territories and countries, including but not limited to the
European Union, the United
Kingdom, China,
South Korea, Canada, Israel and Taiwan. XPOVIO and NEXPOVIO is marketed by
Karyopharm's partners, Antengene, Menarini, Neopharm and FORUS, in
China, South Korea, Singapore, Australia, Hong
Kong, Germany, Austria, Israel and Canada.
Please refer to the local Prescribing Information for full
details.
Selinexor is also being investigated in several other mid- and
late-stage clinical trials across multiple high unmet need cancer
indications, including in endometrial cancer and myelofibrosis.
For more information about Karyopharm's products or clinical
trials, please contact the Medical Information department at:
Tel: +1 (888) 209-9326
Email: medicalinformation@karyopharm.com
SELECT IMPORTANT SAFETY INFORMATION
Warnings and Precautions
- Thrombocytopenia: Monitor platelet counts throughout treatment.
Manage with dose interruption and/or reduction and supportive
care.
- Neutropenia: Monitor neutrophil counts throughout treatment.
Manage with dose interruption and/or reduction and granulocyte
colony–stimulating factors.
- Gastrointestinal Toxicity: Nausea, vomiting, diarrhea,
anorexia, and weight loss may occur. Provide antiemetic
prophylaxis. Manage with dose interruption and/or reduction,
antiemetics, and supportive care.
- Hyponatremia: Monitor serum sodium levels throughout treatment.
Correct for concurrent hyperglycemia and high serum paraprotein
levels. Manage with dose interruption, reduction, or
discontinuation, and supportive care.
- Serious Infection: Monitor for infection and treat
promptly.
- Neurological Toxicity: Advise patients to refrain from driving
and engaging in hazardous occupations or activities until
neurological toxicity resolves. Optimize hydration status and
concomitant medications to avoid dizziness or mental status
changes.
- Embryo–Fetal Toxicity: Can cause fetal harm. Advise females of
reproductive potential and males with a female partner of
reproductive potential, of the potential risk to a fetus and use of
effective contraception.
- Cataract: Cataracts may develop or progress. Treatment of
cataracts usually requires surgical removal of the cataract.
Adverse Reactions
- The most common adverse reactions (≥20%) in patients with
multiple myeloma who receive XVd are fatigue, nausea, decreased
appetite, diarrhea, peripheral neuropathy, upper respiratory tract
infection, decreased weight, cataract and vomiting. Grade 3–4
laboratory abnormalities (≥10%) are thrombocytopenia, lymphopenia,
hypophosphatemia, anemia, hyponatremia and neutropenia. In the
BOSTON trial, fatal adverse
reactions occurred in 6% of patients within 30 days of last
treatment. Serious adverse reactions occurred in 52% of patients.
Treatment discontinuation rate due to adverse reactions was
19%.
- The most common adverse reactions (≥20%) in patients with
multiple myeloma who receive Xd are thrombocytopenia, fatigue,
nausea, anemia, decreased appetite, decreased weight, diarrhea,
vomiting, hyponatremia, neutropenia, leukopenia, constipation,
dyspnea and upper respiratory tract infection. In the STORM trial,
fatal adverse reactions occurred in 9% of patients. Serious adverse
reactions occurred in 58% of patients. Treatment discontinuation
rate due to adverse reactions was 27%.
- The most common adverse reactions (incidence ≥20%) in patients
with DLBCL, excluding laboratory abnormalities, are fatigue,
nausea, diarrhea, appetite decrease, weight decrease, constipation,
vomiting, and pyrexia. Grade 3–4 laboratory abnormalities (≥15%)
are thrombocytopenia, lymphopenia, neutropenia, anemia, and
hyponatremia. In the SADAL trial, fatal adverse reactions occurred
in 3.7% of patients within 30 days, and 5% of patients within 60
days of last treatment; the most frequent fatal adverse reactions
was infection (4.5% of patients). Serious adverse reactions
occurred in 46% of patients; the most frequent serious adverse
reaction was infection (21% of patients). Discontinuation due to
adverse reactions occurred in 17% of patients.
Use In Specific Populations
Lactation: Advise not to
breastfeed.
For additional product information, including full prescribing
information,
please visit www.XPOVIO.com.
To report SUSPECTED ADVERSE REACTIONS, contact Karyopharm
Therapeutics Inc. at 1–888–209–9326 or FDA at 1–800–FDA–1088 or
www.fda.gov/medwatch.
About Karyopharm Therapeutics
Karyopharm Therapeutics Inc. (Nasdaq: KPTI) is a
commercial-stage pharmaceutical company pioneering novel cancer
therapies. Since its founding, Karyopharm has been an industry
leader in oral Selective Inhibitor of Nuclear Export (SINE)
compound technology, which was developed to address a fundamental
mechanism of oncogenesis: nuclear export dysregulation.
Karyopharm's lead SINE compound and first-in-class, oral exportin 1
(XPO1) inhibitor, XPOVIO® (selinexor), is approved in the U.S. and
marketed by the Company in three oncology indications and has
received regulatory approvals in various indications in a growing
number of ex-U.S. territories and countries, including Europe and the United Kingdom (as NEXPOVIO®) and China. Karyopharm has a focused pipeline
targeting multiple high unmet need cancer indications, including in
multiple myeloma, endometrial cancer, myelodysplastic neoplasms and
myelofibrosis. For more information about our people, science and
pipeline, please visit www.karyopharm.com, and follow us on Twitter
at @Karyopharm and LinkedIn.
Forward-Looking Statements
This press release contains forward-looking statements within
the meaning of The Private Securities Litigation Reform Act of
1995. Such forward-looking statements include those regarding
Karyopharm's preliminary financial information for the fourth
quarter and full year 2022; guidance on its expected cash runway;
the ability of selinexor to treat patients with multiple myeloma,
endometrial cancer, myelofibrosis, diffuse large B-cell lymphoma,
solid tumors and other diseases; expectations with respect to
commercialization efforts; and expectations with respect to
the clinical development plans and potential regulatory submissions
of selinexor and eltanexor. Such statements are subject to numerous
important factors, risks and uncertainties, many of which are
beyond Karyopharm's control, that may cause actual events or
results to differ materially from Karyopharm's current
expectations. For example, there can be no guarantee that
Karyopharm will successfully commercialize XPOVIO or that any of
Karyopharm's drug candidates, including selinexor and eltanexor,
will successfully complete necessary clinical development phases or
that development of any of Karyopharm's drug candidates will
continue. Further, there can be no guarantee that any positive
developments in the development or commercialization of
Karyopharm's drug candidate portfolio will result in stock price
appreciation. Management's expectations and, therefore, any
forward-looking statements in this press release could also be
affected by risks and uncertainties relating to a number of other
factors, including the following: the risk that the COVID-19
pandemic could disrupt Karyopharm's business more severely than it
currently anticipates, including by negatively impacting sales of
XPOVIO, interrupting or delaying research and development efforts,
impacting the ability to procure sufficient supply for the
development and commercialization of selinexor or other product
candidates, delaying ongoing or planned clinical trials, impeding
the execution of business plans, planned regulatory milestones and
timelines, or inconveniencing patients; the adoption of XPOVIO in
the commercial marketplace, the timing and costs involved in
commercializing XPOVIO or any of Karyopharm's drug candidates that
receive regulatory approval; the ability to obtain and retain
regulatory approval of XPOVIO or any of Karyopharm's drug
candidates that receive regulatory approval; Karyopharm's results
of clinical trials and preclinical studies, including subsequent
analysis of existing data and new data received from ongoing and
future studies; the content and timing of decisions made by the
U.S. Food and Drug Administration and other regulatory authorities,
investigational review boards at clinical trial sites and
publication review bodies, including with respect to the need for
additional clinical studies; the ability of Karyopharm or its third
party collaborators or successors in interest to fully perform
their respective obligations under the applicable agreement and the
potential future financial implications of such agreement;
Karyopharm's ability to enroll patients in its clinical trials;
unplanned cash requirements and expenditures; development or
regulatory approval of drug candidates by Karyopharm's competitors
for products or product candidates in which Karyopharm is currently
commercializing or developing; and Karyopharm's ability to obtain,
maintain and enforce patent and other intellectual property
protection for any of its products or product candidates. These and
other risks are described under the caption "Risk Factors" in
Karyopharm's Quarterly Report on Form 10-Q for the quarter ended
September 30, 2022, which was filed
with the Securities and Exchange Commission (SEC) on November 3, 2022, and in other filings that
Karyopharm may make with the SEC in the future. Any forward-looking
statements contained in this press release speak only as of the
date hereof, and, except as required by law, Karyopharm expressly
disclaims any obligation to update any forward-looking statements,
whether as a result of new information, future events or
otherwise.
XPOVIO® and NEXPOVIO® are registered trademarks of Karyopharm
Therapeutics Inc. Any other trademarks referred to in this release
are the property of their respective owners.
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