Full Press Release Details
Karyopharm Announces Preliminary Unaudited Fourth Quarter and Full Year 2021 Net Product Revenues and
Outlines 2022 Objectives
Unaudited Net Product Revenues of Approximately $29.7 Million for Fourth Quarter 2021 and
Approximately $98.3 Million for the Full Year 2021
Company on Track to Announce
Top-Line Phase 3 Data from SIENDO Study Evaluating XPOVIO (selinexor) in Patients with Endometrial Cancer in First Quarter 2022
NEWTON, Mass. January 10, 2022 Karyopharm Therapeutics Inc. (Nasdaq: KPTI), a commercial-stage pharmaceutical company
pioneering novel cancer therapies, today announced preliminary unaudited fourth quarter and full year 2021 net product revenue estimates for XPOVIO, the Company s first-in-class, oral XPO1 inhibitor, and outlined its 2021 achievements and 2022
Based on preliminary unaudited financial information, Karyopharm expects net product revenues of XPOVIO to be approximately
$29.7 million for the fourth quarter and approximately $98.3 million for the full year 2021.
For 2022, we are focused on making
significant advances across our pipeline, beginning with top-line results from the Phase 3 SIENDO study evaluating selinexor as a maintenance therapy following front-line chemotherapy in patients with advanced
or metastatic endometrial cancer, which remain on track to be reported this quarter, said Richard Paulson, President and Chief Executive Officer of Karyopharm. Building on the strong revenue growth in the second half of 2021, we will
continue to prioritize driving sales and the adoption of XPOVIO in multiple myeloma. I am extremely pleased with the continued progress of our pipeline in key additional indications of multiple myeloma, myelodysplastic syndromes and myelofibrosis
and our ability to further expand our impact on patients globally with our recent partnership with Menarini.
Key Program Achievements in 2021
Selinexor in Multiple Myeloma
Selinexor in Endometrial
Eltanexor in Myelodysplastic Syndromes (MDS)
Selinexor in Myelofibrosis (MF)
Corporate and Financial Highlights
Anticipated 2022 Catalysts and Operational Objectives
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 40th Annual J.P. Morgan Healthcare Conference to be held on Tuesday,
January 11, 2022, at 3:45 p.m. ET, followed by a question-and-answer breakout session at 4:05 p.m. ET. 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.
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 a growing
number of ex-U.S. territories and countries, including Europe, the United Kingdom, China, South Korea and Israel, and is marketed in those areas by
Karyopharm s global partners. 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,
myelodysplastic syndromes and myelofibrosis.
For more information about Karyopharm s products or clinical trials, please contact the Medical
Information department at:
Tel: +1 (888) 209-9326
XPOVIO (selinexor) is a prescription medicine approved:
SELECT IMPORTANT SAFETY INFORMATION
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 the 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 a growing number of ex-U.S. territories and countries, including Europe (as
NEXPOVIO ), the United Kingdom and China. Karyopharm has a focused pipeline targeting multiple high unmet need cancer indications, including in endometrial cancer, myelodysplastic syndromes
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 fourth quarter and full year 2021;
the ability of selinexor or eltanexor to treat patients with
multiple myeloma, diffuse large B-cell lymphoma, solid tumors and other diseases and expectations related to future clinical development and potential
regulatory submissions of selinexor or 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; that regulators will grant confirmatory approval in the European Union based on the BOSTON study in adult
patients with multiple myeloma; 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, 2021, which was filed with the Securities
and Exchange Commission (SEC) on November 3, 2021, 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.
212.600.1902|karyopharm@argotpartners.com