Full Press Release Details
Karyopharm Announces Preliminary Unaudited 2023 Revenue and 2024 Objectives
Accelerating Innovation and Growth Strategy with Top-Line Data Readouts Expected in 2H 2024
and 2025 from Three Pivotal Phase 3 Studies Evaluating Selinexor in Multiple Myeloma, Endometrial Cancer and Myelofibrosis
Preliminary Unaudited Full Year 2023 Total Revenue and U.S. XPOVIO
(selinexor) Net Product Revenue Expected to be Approximately $146 Million and $112 Million, Respectively, Meeting Company s Guidance
Potential for Selinexor to be a Novel Maintenance Treatment for Patients with TP53 Wild-Type Endometrial Cancer Further Strengthened
with Long-Term Exploratory Subgroup Analyses from SIENDO Study; Recruitment Ongoing in the Company s Pivotal Phase 3 Study; Further Updates Planned to be Presented in 2024
Opportunity to Define a New Myelofibrosis Treatment Paradigm Based on the Encouraging Data Presented from the Phase 1 Study of
Selinexor in Combination with Ruxolitinib in Patients with Treatment-Na ve Myelofibrosis; Recruitment Ongoing in the Company s Pivotal Phase 3 Study; Further Updates Planned to be Presented in 2024
Expect Cash Runway into Late 2025 Supporting Company Through Multiple Potentially Value Generating Milestones
NEWTON, Mass. January 8, 2024 Karyopharm Therapeutics Inc. (Nasdaq: KPTI), a commercial-stage pharmaceutical company pioneering
novel cancer therapies, today announced preliminary unaudited fourth quarter and full year 2023 total revenue and U.S. XPOVIO net product revenue estimates and outlined its 2023 achievements and 2024 objectives.
2023 was a year focused on accelerating our prioritized late-stage pipeline with updated data readouts from our studies in endometrial cancer and
myelofibrosis, strengthening our potential to significantly improve outcomes for patients. We focused our resources and delivered on our revenue guidance as we continued to expand use of selinexor amidst a highly competitive multiple myeloma
landscape. In 2024, we will continue to concentrate our investments to rapidly advance our pipeline and strengthen our foundation in multiple myeloma and deliver value for patients and our shareholders with multiple value driving catalysts expected
throughout 2024, said Richard Paulson, President and Chief Executive Officer of Karyopharm.
Key Program Highlights in 2023
Selinexor in Multiple Myeloma (MM)
Selinexor in Endometrial Cancer (EC)
Selinexor in Myelofibrosis (MF)
Myelodysplastic Neoplasms (MDS)
Intellectual Property
Optimization of Corporate Organization
Corporate and Financial Highlights for 2023
The financial information presented in this press
release may be adjusted as a result of the completion of customary annual review and audit procedures.
Near-Term Catalysts and Operational Objectives
Listen to the Webcast
These achievements and updates will be discussed during a webcast presentation at the 42nd Annual J.P. Morgan Healthcare Conference to be held on
January 10, 2024, at 5:15 p.m. Eastern Time/2:15 p.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 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 and myelofibrosis.
For more information about Karyopharm s products or clinical trials, please contact the Medical Information
Tel: +1 (888) 209-9326; Email: medicalinformation@karyopharm.com
XPOVIO (selinexor) is a prescription medicine approved:
SELECT IMPORTANT SAFETY INFORMATION
Use In Specific Populations
Lactation: Advise not to
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
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 2023; guidance on its expected cash runway; expectations with respect to commercialization efforts; the ability of selinexor
or eltanexor to treat patients with multiple myeloma, endometrial cancer, myelofibrosis, diffuse large B-cell lymphoma, myelodysplastic neoplasms and other diseases; 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 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; the direct or indirect impact of the COVID-19 pandemic or any future pandemic on Karyopharm s business, results of
operations and financial condition; 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, 2023, which was filed with the Securities and Exchange Commission (SEC) on November 2,
2023, 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.
Senior Vice President, Investor Relations
617.658.0600 | elhan.webb@karyopharm.com
Head of Corporate Communications
617.658.0540 |stacy.nobles@karyopharm.com