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Karyopharm Therapeutics Inc

For the period ended Dec 31, 2023. Filed Feb 29, 2024.

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About this filing

A company's yearly report to the SEC, with audited financial statements. It is the fullest account a company gives of its business, its finances and the risks it sees.

FY2023 · Filed Feb 29, 2024

KPTI$0.04-27.1%Stored close · as of Nov 9, 2026

Extracted filing text, with the paragraph anchors used by the comparison.

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Contents

Table of Contents

Page No.
PART I5
Item 1.Business5
Item 1A.Risk Factors49
Item 1B.Unresolved Staff Comments94
Item 1C.Cybersecurity94
Item 2.Properties96
Item 3.Legal Proceedings96
Item 4.Mine Safety Disclosures96
PART II97
Item 5.Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities97
Item 6.[Reserved]98
Item 7.Management’s Discussion and Analysis of Financial Condition and Results of Operations99
Item 7A.Quantitative and Qualitative Disclosures about Market Risk106
Item 8.Financial Statements and Supplementary Data106
Item 9A.Controls and Procedures106
Item 9B.Other Information109
Item 9C.Disclosure Regarding Foreign Jurisdictions that Prevent Inspections109
PART III110
Item 10.Directors, Executive Officers and Corporate Governance110
Item 11.Executive Compensation110
Item 12.Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters110
Item 13.Certain Relationships and Related Transactions, and Director Independence110
Item 14.Principal Accountant Fees and Services110
PART IV111
Item 15.Exhibits and Financial Statement Schedules111
SIGNATURES149

Forward-Looking Information

This Annual Report on Form 10-K contains forward-looking statements regarding the expectations of Karyopharm Therapeutics Inc., herein referred to as “Karyopharm,” the “Company,” “we,” or “our,” with respect to the possible achievement of discovery and development milestones, our future discovery and development efforts, including regulatory submissions and approvals, our commercialization efforts, our partnerships and collaborations with third parties, our future operating results and financial position, our business strategy, and other objectives for future operations. We often use words such as “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “target,” “potential,” “will,” “would,” “could,” “should,” “continue,” and other words and terms of similar meaning to help identify forward-looking statements, although not all forward-looking statements contain these identifying words. You also can identify these forward-looking statements by the fact that they do not relate strictly to historical or current facts. There are a number of important risks and uncertainties that could cause actual results or events to differ materially from those indicated by forward-looking statements. These risks and uncertainties include, but are not limited to, those described in “Part I—Item 1A. Risk Factors” of this Annual Report on Form 10-K and under the heading “Summary of Risk Factors” below. As a result of these and other factors, we may not actually achieve the plans, intentions, expectations or results disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. Our forward-looking statements do not reflect the potential impact of any future acquisitions, mergers, dispositions, joint ventures or investments we may make. We do not assume any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

References to XPOVIO® (selinexor) also refer to NEXPOVIO® (selinexor) when discussing its approval and commercialization in certain countries or territories outside of the U.S.

Summary of Risk Factors

Below is a summary of the principal factors that make an investment in our common stock speculative or risky. This summary does not address all of the risks that we face. Additional discussion of the risks summarized in this risk factor summary, and other risks that we face, can be found below under the heading “Risk Factors” and should be carefully considered, together with other information in this Annual Report on Form 10-K and our other filings with the SEC, before making an investment decision regarding our common stock.

If we or our collaborators are unable to successfully commercialize current and future indications of XPOVIO or other products or product candidates, our business, financial condition and future profitability will be materially harmed.

XPOVIO faces substantial competition.

If our clinical trials fail to demonstrate safety and effectiveness to the satisfaction of regulatory authorities or do not otherwise produce positive results, we may incur additional costs, experience delays or be unable to complete the development of such product candidates.

We may be unable to successfully enroll patients in our ongoing and planned clinical trials in a reasonable timeframe, or at all.

Serious adverse or unacceptable side effects related to XPOVIO, our product candidates or future products may delay or prevent their regulatory approval, cause us to suspend or discontinue clinical trials, or limit the commercial value of our approved indications.

The results of previous clinical trials may not be predictive of future trial results and interim or top-line data may be subject to change or qualification.

We may not be successful in our efforts to identify or discover additional potential product candidates, or our decisions to prioritize the development of certain product candidates over others may later prove wrong.

We may not be able to maintain or expand our sales, marketing and distribution capabilities in order to successfully commercialize XPOVIO or any of our products or product candidates, if approved.

Any business that we or our collaborators conduct outside of the U.S. may be adversely affected by international risks and uncertainties.

We or our collaborators may not receive regulatory approvals for the commercialization of some or all of our or their product candidates, including necessary companion diagnostic devices, in a timely manner, or at all.

We or our collaborators may not be able to utilize accelerated development pathways to obtain regulatory approval, orphan drug exclusivity or certain other designations for our or their product candidates, which may result in delays receiving necessary marketing approvals.

Our or our collaborators’ ability to commercialize our or their products may be limited by the terms of their respective regulatory approvals and ongoing regulation of our products.

Our failure to comply with post-approval development and regulatory requirements, reporting and payment obligations under governmental drug pricing programs, applicable healthcare, privacy and data security laws and environmental, health and safety laws and regulations may have a material adverse effect on our business, financial condition or results of operations.

We may never achieve or maintain profitability and will need additional funding to achieve our business objectives.

We may not be able to satisfy our indebtedness, on a timely basis or at all.

Our business, financial condition and stock price may be impacted by unstable market and economic conditions.

Our dependence on third parties for certain aspects of our business, such as clinical development, manufacturing, marketing, distribution and/or commercialization of XPOVIO and/or our product candidates, could negatively impact our development and commercialization plans.

If we are unable to obtain and maintain patent protection for our products and product candidates and other discoveries, or the scope of the patent protection obtained is not sufficiently broad, our ability to successfully commercialize our products or product candidates may be adversely affected.

We may become involved in lawsuits to protect or enforce our intellectual property rights, or third parties may initiate legal proceedings against us alleging our infringement of their intellectual property rights.

If we are unable to protect the confidentiality of our trade secrets, our business and competitive position would be harmed.

Information technology system failures or security breaches may materially adversely affect our business and operations.

The price of our common stock has been and may continue to be volatile.

Securities or other litigation could result in substantial costs and may divert management’s time and attention from our business.

ContentsView on SEC.gov

The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.