KPTI on Nasdaq

Karyopharm Therapeutics Inc.

In its 2026 annual report the company says: “We are a commercial-stage pharmaceutical company pioneering novel cancer therapies and dedicated to the discovery, development and commercialization of first-in-class drugs directed against nuclear export for the treatment of cancer. Our scientific expertise is based upon an understanding of the regulation of intracellular communication between the nucleus and the cytoplasm. We have discovered and are developing and commercializing novel, small molecule XPO1 inhibitor compounds that inhibit the nuclear export protein exportin 1.”5 It is headquartered in Wilmington, United States.2 Its shares trade on Nasdaq under the symbol KPTI.2

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Last updated Oct 21, 2026.

Overview

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  • TickerKPTI on Nasdaq2
  • IndustryPharmaceutical Preparations2
  • HeadquartersWilmington, United States2
  • Incorporated inDE3
  • Business address85 Wells Avenue, Second Floor, Newton, Ma 024593
  • Filer categoryNon-accelerated filer, Smaller reporting company3
  • Legal formCorporation2
  • LEI549300J1VANRCNTYST872
  • StatusActive2
  • LEI statusLapsed (not renewed)2
  • Registered addressC/O The Corporation Trust Company, 19801 Wilmington, United States2
  • Registered withDivision of Corporations, Department of State, 46371372

We are a commercial-stage pharmaceutical company pioneering novel cancer therapies and dedicated to the discovery, development and commercialization of first-in-class drugs directed against nuclear export for the treatment of cancer. Our scientific expertise is based upon an understanding of the regulation of intracellular communication between the nucleus and the cytoplasm. We have discovered and are developing and commercializing novel, small molecule XPO1 inhibitor compounds that inhibit the nuclear export protein exportin 1 (“XPO1”). These compounds represent a new class of drug candidates with a novel mechanism of action that have the potential to treat a variety of diseases with high unmet medical need. Our lead asset, XPOVIO ® (selinexor), was the first oral XPO1 inhibitor to receive marketing approval, receiving its initial U.S. approval from the U.S. Food and Drug Administration…5 From its latest annual report

Financials

From the company’s reports to the SEC. Every number links to the filing it came from.

Key numbers, fiscal 2025

-62.1%Operating margin6
-134.2%Net margin6
0.6%Revenue growth, 20256
-$75.4MFree cash flow6

What sells

Revenue by product, business segment and region, as the company reports it to the SEC.

Products and services

Product brought in 79% of the revenue Karyopharm Therapeutics Inc. broke down this way in fiscal 2025.

  1. Product$114.9M679%up 2% from 2024
  2. License And Other$31.2M621%down 4% from 2024
Products and services by year
Products and services202320242025
Product$112.0M$112.8M$114.9M
License And Other$34.0M$32.4M$31.2M

Where the money goes

Where each dollar of revenue went, fiscal 2025

  • Research and development54¢$125.6M
  • Selling, general and admin46¢$105.2M
  • Income tax0¢$43.0K

Out of $146.1M in revenue.6 The company lost money this year.

Financial statements

Revenue789106$146.1M in 2025+257% since 2019
0$100.0M$200.0M$300.0M2019: $40.9M$40.9M20192020: $108.1M$108.1M2020+164%2021: $209.8M$209.8M2021+94%2022: $157.1M$157.1M2022−25%2023: $146.0M$146.0M2023−7%2024: $145.2M$145.2M2024−1%2025: $146.1M$146.1M2025+1%
Operating income789106-$90.7M in 2025−52% since 2019
-$200.0M-$150.0M-$100.0M-$50.0M02019: -$189.3M-$189.3M20192020: -$171.8M-$171.8M2020−9%2021: -$98.3M-$98.3M2021−43%2022: -$142.2M-$142.2M2022+45%2023: -$129.5M-$129.5M2023−9%2024: -$119.4M-$119.4M2024−8%2025: -$90.7M-$90.7M2025−24%
Net income789106-$196.0M in 2025−2% since 2019
-$200.0M-$150.0M-$100.0M-$50.0M02019: -$199.6M-$199.6M20192020: -$196.3M-$196.3M2020−2%2021: -$124.1M-$124.1M2021−37%2022: -$165.3M-$165.3M2022+33%2023: -$143.1M-$143.1M2023−13%2024: -$76.4M-$76.4M2024−47%2025: -$196.0M-$196.0M2025+157%

Every line of the income statement as filed: the last 3 fiscal years, latest first.6

Period ending2025-12-312024-12-312023-12-31
Revenue from contract with customer, license and other revenue$146.1M$145.2M$146.0M
Research and development$125.6M$143.2M$138.8M
Selling, general and administrative$105.2M$115.4M$131.9M
Total operating expenses$236.8M$264.7M$275.6M
Loss from operations-$90.7M-$119.4M-$129.5M
Interest income$2.8M$7.4M$10.9M
Interest expense-$45.8M-$37.4M-$23.8M
(Loss) gain on extinguishment of debt-$62.4M$44.7M$0
Other income (expense), net$152.0K$28.4M-$356.0K
Total other (expense) income, net-$105.3M$43.1M-$13.2M
Loss before income taxes-$196.0M-$76.4M-$142.8M
Income tax provision-$43.0K-$57.0K-$323.0K
Net loss-$196.0M-$76.4M-$143.1M
Basic net loss per share-$17.93-$9.41-$18.79
Diluted net loss per share (Note 2)-$17.93-$14.00-$18.79
Weighted-average number of common shares outstanding used to compute basic net loss per share10.9K shares8.1K shares7.6K shares
Weighted-average number of common shares outstanding used to compute diluted net loss per share10.9K shares8.5K shares7.6K shares

Compare Karyopharm Therapeutics Inc. with another company

Corporate structure

Karyopharm Therapeutics Inc. sits at the top of its group. 3 entities, 3 countries on record. Switch between the flow chart and the network, and select any entity to see its details.

Major holders of Karyopharm Therapeutics Inc.

  • ACORN BIOVENTURES, L.P. Filed SCHEDULE 13G/A on Karyopharm Therapeutics Inc., latest Oct 8, 2026 (4 filings since May 15, 2026)
  • INTEGRATED CORE STRATEGIES (US) LLC Filed SCHEDULE 13G on Karyopharm Therapeutics Inc., latest Sep 4, 2026 (3 filings since Feb 10, 2026)
  • Commodore Capital LP Filed SCHEDULE 13G/A on Karyopharm Therapeutics Inc., latest Aug 14, 2026 (4 filings since May 9, 2022)
  • RA CAPITAL MANAGEMENT, L.P. Filed SCHEDULE 13G/A on Karyopharm Therapeutics Inc., latest Aug 14, 2026 (2 filings since Apr 2, 2026)
  • Adage Capital Management, L.P. Filed SCHEDULE 13G/A on Karyopharm Therapeutics Inc., latest Aug 12, 2026 (4 filings since Feb 12, 2025)
  • Goldman Sachs Filed SCHEDULE 13G/A on Karyopharm Therapeutics Inc., latest Aug 11, 2026 (2 filings since May 12, 2026)
  • BlackRock Filed SCHEDULE 13G on Karyopharm Therapeutics Inc., latest Jul 28, 2026 (7 filings since Jan 26, 2022)
  • T. Rowe Price Investment Management, Inc. Filed SCHEDULE 13G/A on Karyopharm Therapeutics Inc., latest Jun 5, 2026 (4 filings since Aug 14, 2025)
  • Ikarian Capital, LLC Filed SCHEDULE 13G on Karyopharm Therapeutics Inc., latest May 15, 2026
  • Affinity Asset Advisors, LLC Filed SCHEDULE 13G/A on Karyopharm Therapeutics Inc., latest May 14, 2026 (3 filings since Apr 10, 2025)
  • Opaleye Management Inc. Filed SCHEDULE 13G/A on Karyopharm Therapeutics Inc., latest May 11, 2026 (2 filings since Oct 17, 2025)
  • HIGHBRIDGE CAPITAL MANAGEMENT LLC Filed SCHEDULE 13G/A on Karyopharm Therapeutics Inc., latest Nov 14, 2025 (2 filings since Oct 25, 2024)
  • Karyopharm Therapeutics Inc. Wilmington, Delaware, United States
    • Karyopharm Europe GmbH Subsidiary · Germany
    • Karyopharm Israel Ltd. Subsidiary · Israel

Built from parent and subsidiary links from GLEIF, the Global Legal Entity Identifier Foundation (CC0); subsidiaries listed in Exhibit 21 of annual reports filed with the SEC; major holders from Schedules 13D and 13G. Each entity in the chart links to its source.

What it owns

What Karyopharm Therapeutics Inc. reports owning in its annual reports to the SEC: buildings, land and equipment, real estate and locations, investments, intangible assets and inventory, at the end of its latest fiscal year and a year before.

Property and equipment

ItemLatestA year beforeChange
Property and equipment, before depreciation$5.6M6 Dec 31, 2025$7.1M6 Dec 31, 2024−20.8%
Accumulated depreciation$5.5M6 Dec 31, 2025$6.7M6 Dec 31, 2024−17.7%
Property and equipment, net$104.0K6 Dec 31, 2025$400.0K6 Dec 31, 2024−74.0%
Operating-lease assets (leased space)$4.5M6 Dec 31, 2025$5.9M6 Dec 31, 2024−22.7%

Investments

ItemLatestA year beforeChange
Cash and cash equivalents$60.5M6 Dec 31, 2025$62.5M6 Dec 31, 2024−3.1%
Marketable securities, current$3.2M6 Dec 31, 2025$46.2M6 Dec 31, 2024−93.1%
Debt securities available for sale$46.2M6 Dec 31, 2024$139.2M10 Dec 31, 2023−66.8%

Inventory

ItemLatestA year beforeChange
Inventory, total$4.0M6 Dec 31, 2025$4.7M6 Dec 31, 2024−14.8%
Work in process$3.0M6 Dec 31, 2025$3.5M6 Dec 31, 2024−15.9%
Finished goods$430.0K6 Dec 31, 2025$477.0K6 Dec 31, 2024−9.9%

Properties, in its own words

Our headquarters are located in Newton, Massachusetts, where we currently lease a total of 52,224 square feet of office space through September 30, 2030.

We also lease approximately 3,681 square feet of office space in Munich, Germany.

Item 2 of the 10-K filed Feb 13, 2026.5

Leadership

Who has led Karyopharm Therapeutics Inc., and when. Pick a name to see everywhere that person has worked.

Board members and other officers (29)

Named in SEC Form D filings

People the company listed in its private-offering notices.

  • Executive OfficerMichael Mason named Dec 8, 202249

Subsidiaries and ownership

Subsidiaries (Exhibit 21)

  • Karyopharm Europe GmbH Germany4
  • Karyopharm Israel Ltd. Israel4

The subsidiaries the company lists in Exhibit 21 of its annual report, as filed.

Timeline

  1. Oct 14, 20268-K Other events50
  2. Sep 18, 20268-K Change to shareholders' rights; Bylaws or fiscal year changed51
  3. Sep 11, 20268-K Entered a material agreement; Debt or obligation accelerated; Unregistered sale of shares52
  4. Aug 31, 20268-K Other events53
  5. Aug 13, 20268-K Results of operations54
  6. Jul 31, 20268-K Other events55
  7. Jul 17, 20268-K Executive or director change56
  8. May 28, 20268-K Executive or director change; Shareholder vote57
  9. May 14, 20268-K Results of operations58
  10. Mar 27, 20268-K Other events59
  11. Mar 24, 20268-K Entered a material agreement; Unregistered sale of shares; Regulation FD disclosure60
  12. Mar 3, 20268-K Entered a material agreement; Other events61
  13. May 4, 2021New chief executive Richard A. Paulson becomes CEO14
  14. Nov 13, 2013New chief executive Michael Kauffman becomes CEO15
  15. Dec 22, 2008Founded Karyopharm Therapeutics Inc. is founded2

Calendar

Coming up

  1. Nov 2, 2026Reports results for the quarter ending Sep/2026 A year earlier it reported ($3.82) a share, on Nov 3, 2025.62

When it reported results

  1. Aug 13, 2026Reported quarterly or annual results54
  2. May 14, 2026Reported quarterly or annual results58
  3. Feb 12, 2026Reported quarterly or annual results63
  4. Jan 12, 2026Reported quarterly or annual results64
  5. Nov 3, 2025Reported quarterly or annual results65
  6. Oct 8, 2025Reported quarterly or annual results66
  7. Aug 11, 2025Reported quarterly or annual results67
  8. May 12, 2025Reported quarterly or annual results68

Upcoming dates from Nasdaq's calendar; past results from the company's 8-K filings (Item 2.02). The full markets calendar

Filings

424 filings to the SEC since October 2021: 5 annual reports, 15 quarterly reports, 72 major events, 209 insider forms, 63 large holders, 1 private raises, 59 other. The latest 20:

  1. Oct 14, 20268-K EDGAR
  2. Oct 8, 2026SCHEDULE 13G/A EDGAR
  3. Oct 2, 20264 EDGAR
  4. Sep 25, 2026SCHEDULE 13G/A EDGAR
  5. Sep 25, 2026SCHEDULE 13G/A EDGAR
  6. Sep 18, 20268-K EDGAR
  7. Sep 11, 20268-K EDGAR
  8. Sep 4, 2026SCHEDULE 13G EDGAR
  9. Sep 2, 20264 EDGAR
  10. Aug 31, 20268-K EDGAR
  11. Aug 14, 2026SCHEDULE 13G/A EDGAR
  12. Aug 14, 2026SCHEDULE 13G/A EDGAR
  13. Aug 13, 202610-Q EDGAR
  14. Aug 13, 20268-K EDGAR
  15. Aug 12, 2026SCHEDULE 13G/A EDGAR
  16. Aug 11, 2026SCHEDULE 13G/A EDGAR
  17. Jul 31, 20268-K EDGAR
  18. Jul 30, 20264 EDGAR
  19. Jul 28, 2026SCHEDULE 13G EDGAR
  20. Jul 17, 20268-K EDGAR

The 424 filings since October 2021 can be filtered by form type and year here when JavaScript is on.

Every filing from the last five years, summarized. The full record is on SEC EDGAR.

Insider trades

135 open-market trades by officers, directors and large owners since October 2021: 1 buys and 134 sales. Grants, option exercises and gifts are left out.

DateWhoTradeSharesPriceValueFiling
Sep 1, 2026Abate KristinChief Accounting OfficerSale19$2.02$38Form 4
Jul 28, 2026Poulton StuartEVP, Chief Development OfficerSale189$7.10$1.3KForm 4
May 14, 2026Poulton StuartEVP, Chief Development OfficerSale403$9.50$3.8KForm 4
May 14, 2026Rangwala ReshmaEVP & Chief Medical OfficerSale408$9.50$3.9KForm 4
May 14, 2026Cheng Sohanya RoshanEVP & Chief Commercial OfficerSale324$9.50$3.1KForm 4
May 14, 2026Abate KristinChief Accounting OfficerSale53$9.50$504Form 4
May 14, 2026Paulson Richard A.President and CEOSale2,203$9.50$20.9KForm 4
May 14, 2026Mano MichaelEVP, CLO&SecretarySale266$9.50$2.5KForm 4
Apr 21, 2026Rangwala ReshmaEVP & Chief Medical OfficerSale449$8.94$4.0KForm 4
Mar 2, 2026Abate KristinChief Accounting OfficerSale559$9.41$5.3KForm 4
Mar 2, 2026Poulton StuartEVP, Chief Development OfficerSale5,101$9.41$48.0KForm 4
Mar 2, 2026Cheng Sohanya RoshanEVP & Chief Commercial OfficerSale4,604$9.41$43.3KForm 4
Mar 2, 2026Mano MichaelEVP, CLO&SecretarySale3,526$9.41$33.2KForm 4
Mar 2, 2026Rangwala ReshmaEVP & Chief Medical OfficerSale5,066$9.41$47.7KForm 4
Mar 2, 2026Paulson Richard A.President and CEOSale12,361$9.41$116.3KForm 4
Feb 17, 2026Poulton StuartEVP, Chief Development OfficerSale378$8.63$3.3KForm 4
Feb 3, 2026Macomber LoriEVP, CFO & TreasurerSale1,626$6.30$10.2KForm 4
Jan 28, 2026Abate KristinChief Accounting OfficerSale50$7.03$352Form 4
Jan 21, 2026Abate KristinChief Accounting OfficerSale265$5.96$1.6KForm 4
Oct 1, 2025Abate KristinChief Accounting OfficerSale362$6.30$2.3KForm 4

All 135 trades can be filtered by person here when JavaScript is on.

From Forms 4 filed with the SEC.

Major holders

Investors who own more than 5% of the shares must tell the SEC: a 13D if they may seek to influence the company, a 13G if they hold passively.

Executive pay

What the company paid its top executives, from the summary compensation table in its proxy statement. Total pay includes salary, bonus, stock and option awards and other pay, as the company valued them.

YearExecutiveAgeSalaryTotal pay
2025Richard Paulson58$770.0K$2.3M90
2025Reshma Rangwala$567.7K$2.0M90
2025Stuart Poulton$500.1K$1.4M90
2024President and Chief Executive Officer$769.6K$2.1M90
2024Chief Medical Officer and Head of Research$567.7K$1.1M90

Money raised

Private offerings the company reported to the SEC on Form D.

  1. Dec 7, 2022Raised $165 million in a private offering of equity Form D: 33 investors so far Form D

Held by these funds

The largest holders among investment managers' 13F reports for the quarter ending Jun 30, 2026, the top 25 of 96. Change is in shares since the quarter before.

FundSharesValueShare of the fundChange
Ra Capital Management, L.P.1,917,354$18.7M0.2%No change
Adage Capital Partners Gp, L.l.c.1,521,322$14.9M0.0%−285,000
Acorn Capital Advisors, LLC1,518,113$14.8M4.0%+1,230,287
Goldman Sachs Group Inc1,424,658$13.9M0.0%+477,079
BlackRock, Inc.1,418,799$13.9M0.0%+1,173,900
Kalehua Capital Management LLC1,371,288$13.4M4.3%New
Vanguard Capital Management LLC958,979$9.4M0.0%+219,234
Catalio Capital Management, LP940,855$9.2M1.7%+43,146
Avidity Partners Management LP924,487$9.0M1.4%−2,995
Two Sigma Investments, LP695,264$6.8M0.0%+544,032
NEA Management Company, LLC576,780$5.6M0.4%New
Geode Capital Management, LLC531,231$5.2M0.0%+325,098
Ghisallo Capital Management LLC500,000$4.9M0.1%New
Soleus Capital Management, L.P.440,000$4.3M0.1%No change
UBS Group AG353,545$3.5M0.0%+159,528
State Street Corp325,991$3.2M0.0%+245,249
Affinity Asset Advisors, LLC312,500$3.1M0.2%−187,500
Brevan Howard Capital Management LP309,817$3.0M0.0%+97,450
Millennium Management LLC305,676$3.0M0.0%−114,895
Boxer Capital Management, LLC302,536$3.0M0.2%No change
Davidson Kempner Capital Management LP300,000$2.9M0.1%No change
Silverarc Capital Management, LLC297,460$2.9M0.3%New
Eversept Partners, LP276,174$2.7M0.1%No change
Jpmorgan Chase & Co207,609$2.1M0.0%+207,138
Morgan Stanley202,506$2.0M0.0%+183,936

13F reports cover disclosed long positions in U.S. stocks only.

SEC filer profile

How Karyopharm Therapeutics Inc. is registered with the Securities and Exchange Commission, from its EDGAR record and the cover page of its latest annual report.

  • Name on EDGARKaryopharm Therapeutics Inc.1
  • CIK0001503802
  • Employer ID (EIN)26-39317045
  • Filer statusNon-accelerated filer not an emerging growth company; a smaller reporting company; not a shell company5
  • Incorporated inDelaware5
  • Fiscal year endsDecember 311
  • Industry code (SIC)2834 Pharmaceutical Preparations1
  • SEC reviewing officeOffice of Life Sciences, Division of Corporation Finance1
  • Business address85 Wells Avenue, Second Floor, Newton, MA 024591
  • Phone617-658-06001
  • Shares outstanding22,681,460 as of Aug 6, 202612
  • Public float$37.0M as of Jun 30, 20255
  • AuditorErnst & Young LLP, Boston, Massachusetts PCAOB ID 42; it also attests to the company’s internal control over financial reporting5
  • On EDGAR sinceNov 5, 20101
  • Filings1,146 in all: 4 (559), 8-K (192), SC 13G/A (74), 10-Q (39), 3 (36), SC 13G (28), S-8 (21), SCHEDULE 13G/A (19)1
    All 44 form types

    424B5 (15), CORRESP (15), DEF 14A (15), DEFA14A (14), SCHEDULE 13G (14), 10-K (13), EFFECT (11), UPLOAD (11), S-3 (9), CT ORDER (7), ARS (5), PRE 14A (5), 5 (4), D (4), S-3ASR (4), POS AM (3), S-1 (3), 10-Q/A (2), 424B3 (2), 424B4 (2), POSASR (2), S-1/A (2), S-1MEF (2), SC 13D/A (2), 144 (1), 4/A (1), 8-A12B (1), CERTNAS (1), DRS (1), DRSLTR (1), RW (1), S-3/A (1), SC 13D (1), SC TO-C (1), SC TO-I (1), SC TO-I/A (1)

  • Latest filingsAnnual report (10-K) Feb 13, 2026
    Quarterly report (10-Q) Aug 13, 2026
    Proxy statement (DEF 14A) Apr 13, 2026
    Latest 8-K (8-K) Oct 14, 2026

Securities registered for trading

ClassSymbolExchange
Common StockKPTINasdaq Global Select Market

From the cover page of the 10-K filed Feb 13, 2026 (Section 12(b) of the Exchange Act).5

Risk factors and legal proceedings

The risks Karyopharm Therapeutics Inc. names in Item 1A of its 10-K filed Feb 13, 2026: 68 risks under these headings, as written.5

  • 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.
  • Risks Related to Our Financial Position and Capital Requirements
  • Our financial condition raises substantial doubt as to our ability to continue as a going concern.
  • We have incurred significant losses since inception, expect to continue to incur significant losses, and may never achieve or maintain profitability.
  • We will need additional funding or to enter into strategic alternatives to achieve our business objectives. If we are unable to raise sufficient capital or to enter into strategic alternatives on acceptable terms to meet our needs, we may be forced to delay, reduce or eliminate our research and development programs and/or commercialization efforts.
  • We are continuing to evaluate strategic alternatives, which may include a potential merger or sale of the Company; in or out of court restructurings; repurchases, redemptions, exchanges or other refinancings of the Company’s existing debt; and financing transactions; among other potential alternatives. The potential impact and success of our exploration of any strategic alternatives, if available at all, are uncertain and may not be successful.
  • Our Amended Revenue Interest Agreement with KKR contains various covenants and other provisions, which, if violated, could, subject to the Amended and Restated Intercreditor Agreement, result in the acceleration of payments due under such agreement or the foreclosure on the pledged collateral, including all of our present and future assets relating to selinexor.
  • Our Credit Agreement and the indentures governing the Convertible Notes contain various covenants and other provisions, which will limit the manner in which we may operate, and, if violated, could, subject to the Amended and Restated Intercreditor Agreement, result in the acceleration of payments due under such agreements or the foreclosure on the pledged collateral, including all of our present and future assets.
  • Our indebtedness could limit cash flow available for our operations, expose us to risks that could adversely affect our business, financial condition and results of operations and impair our ability to satisfy our obligations under the Amended Term Loan, the Convertible Notes or the Amended Revenue Interest Agreement.
  • We may not have the ability to raise the funds necessary to settle any conversions of or other obligations in respect of the Convertible Notes required to be settled in cash, to repay the Convertible Notes at maturity, to repurchase the Convertible Notes for cash upon a fundamental change, to pay the redemption price for any Convertible Notes we redeem or to refinance the Convertible Notes, and any future debt we incur may contain limitations on our ability to pay cash upon conversion or repurchase of the Convertible Notes.
  • The accounting method for convertible debt securities such as the Convertible Notes could have a material effect on our reported financial results.
  • Raising additional capital and other equity issuances by us may cause dilution to our stockholders, restrict our operations or require us to relinquish rights to our product candidates.
The other 57 risks
  • Unstable market and economic conditions may have serious adverse consequences on our business, financial condition and stock price.
  • Risks Related to Commercialization and Product Development
  • Our business is substantially dependent on the commercial success of XPOVIO. If we, either alone or with our collaborators, are unable to successfully commercialize current and future indications of XPOVIO or other products or product candidates on a timely basis, including achieving widespread market acceptance by physicians, patients, third-party payors and others in the medical community, our business, financial condition and future profitability will be materially harmed.
  • We face substantial competition for XPOVIO in multiple myeloma and will face competition for XPOVIO in any additional indications for which it may be approved.
  • Clinical development is a lengthy and expensive process, with uncertain timelines and outcomes. We or our collaborators may be unable to successfully enroll patients in our ongoing and planned clinical trials in a reasonable timeframe, or at all. In addition, if clinical trials of our product candidates fail to demonstrate safety and effectiveness to the satisfaction of regulatory authorities or do not otherwise produce positive results, we or our collaborators may incur additional costs, fail to secure regulatory approvals, or be unable to commercialize such product candidates.
  • Serious adverse or unacceptable side effects related to XPOVIO, our product candidates or future products may delay or prevent their regulatory approval, cause us or our collaborators to suspend or discontinue clinical trials, limit the commercial value of approved indications or result in significant negative financial consequences following any marketing approval.
  • 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 based on the complete analyses of data and, therefore, may not be predictive of the final results of a trial.
  • 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.
  • If we are unable to maintain or expand our sales, marketing and distribution capabilities, we may not be successful in commercializing XPOVIO or any of our products or product candidates, if approved, that we may acquire or develop.
  • Even if we, or our collaborators, are able to effectively commercialize XPOVIO or any approved products that we may develop or acquire, the products may not receive coverage or may become subject to unfavorable pricing regulations, third-party reimbursement practices or healthcare reform initiatives, all of which would harm our business.
  • Product liability lawsuits against us could divert our resources, cause us to incur substantial liabilities and limit commercialization of XPOVIO or any other products that we may develop or acquire.
  • The business that we or our collaborators conduct outside of the U.S. may be adversely affected by international risks and uncertainties.
  • Risks Related to Regulatory Matters
  • Even if we, or our collaborators, complete the necessary preclinical studies and clinical trials for our product candidates, the regulatory approval process is expensive, time-consuming and uncertain and we or they may not receive approvals for the commercialization of some or all of our or their product candidates in a timely manner, or at all.
  • XPOVIO and any of our product candidates for which we, or our collaborators, obtain marketing approval in the future are subject to post-marketing regulatory requirements, including following accelerated or conditional approvals of our product candidates, and could be subject to post-marketing restrictions or withdrawal from the market, and we, and our collaborators, may be subject to substantial penalties if we, or they, fail to comply with regulatory requirements or if we, or they, experience unanticipated problems with our products following approval.
  • If we, or our collaborators, are required by the FDA, EMA or comparable regulatory authority to obtain clearance or approval of one or more companion diagnostic tests in connection with approval of any of our product candidates or a group of therapeutic products, and we or they do not obtain or there are delays in obtaining clearance or approval of a diagnostic test, we may not be able to commercialize the product candidate and our ability to generate revenue may be materially impaired.
  • We or our collaborators may seek certain designations for our product candidates in or outside of the U.S., including Breakthrough Therapy, Fast Track and Priority Review designations, and PRIME Designation in the EU, but we, or they, might not receive such designations, and even if we, or they, do, such designations may not lead to a faster development or regulatory review or approval process.
  • We, or our collaborators, may not be able to obtain orphan drug exclusivity for any product candidates we, or they, may develop, and even if we do, that exclusivity may not prevent the FDA or the EMA from approving other competing products.
  • Current and future legislation may increase the difficulty and cost for us, or any collaborators, to obtain marketing approval and commercialize our or their product candidates, if approved, and affect the prices we, or they, may obtain.
  • The prices of prescription pharmaceuticals in the U.S. and foreign jurisdictions are subject to considerable legislative and executive actions and could impact the prices we obtain for our products, if and when licensed.
  • Our relationships with healthcare providers, physicians and third-party payers will be subject to applicable anti-kickback, fraud and abuse, and other healthcare laws and regulations, which could expose us to criminal sanctions, civil penalties, contractual damages, reputational harm and diminished profits and future earnings.
  • Our reporting and payment obligations under the Medicaid Drug Rebate Program and other governmental drug pricing programs are complex and may involve subjective decisions. Any failure to comply with those obligations could subject us to penalties and sanctions.
  • We are subject to stringent privacy laws, information security laws, regulations, policies and contractual obligations related to data privacy and security and changes in such laws, regulations, policies and contractual obligations, and failure to comply with such requirements could subject us to significant fines and penalties and other consequences, which may have a material adverse effect on our business, financial condition or results of operations.
  • Our employees, independent contractors, consultants, collaborators and vendors may engage in misconduct or other improper activities, including non-compliance with regulatory standards and/or requirements and insider trading, which could cause significant liability for us and harm our reputation.
  • If we fail to comply with environmental, health and safety laws and regulations, we could become subject to fines or penalties or incur costs that could have a material adverse effect on our business.
  • Laws and regulations governing international operations we may have in the future may preclude us from developing, manufacturing and selling certain products outside of the U.S. and require us to develop and implement costly compliance programs.
  • With the passage of the CREATES Act, we are exposed to possible litigation and damages by competitors who may claim that we are not providing sufficient quantities of our approved products on commercially reasonable, market-based terms for testing in support of their ANDAs and 505(b)(2) applications.
  • We are subject to governmental export and import controls that could impair our or our collaborators’ ability to compete in international markets due to licensing requirements and subject us or them to liability if we or they are not in compliance with applicable laws.
  • Changes in and uncertainty surrounding U.S. trade policy could have a material adverse impact on our business, financial condition and results of operations.
  • Changes in U.S. and international trade policies, particularly with respect to China, may adversely impact our business and operating results.
  • The biopharmaceutical industry is subject to extensive regulatory obligations and policies that may be subject to change, including due to judicial challenges, election cycles, and resulting regulatory updates and changes in policy priorities.
  • Risks Related to Our Dependence on Third Parties
  • We depend on collaborations with third parties for certain aspects of the development, marketing and/or commercialization of XPOVIO and/or our product candidates. If those collaborations are not successful, or if we are not able to maintain our existing collaborations or establish additional collaborations, we may have to alter our development and commercialization plans and may not be able to capitalize on the market potential of XPOVIO or our product candidates, if approved.
  • If we are unable to establish and maintain our agreements with third parties to distribute XPOVIO to patients, our results of operations and business could be adversely affected.
  • We rely on third parties as we conduct our clinical trials and some aspects of our research and preclinical studies, and those third parties may not perform satisfactorily, including not meeting local regulatory submission requirements or failing to meet deadlines for the completion of such trials, research or testing.
  • We rely on third parties to conduct investigator-sponsored clinical trials of selinexor and our other product candidates. Any failure by a third party to meet its obligations with respect to the clinical development of our product candidates may delay or impair our ability to obtain regulatory approval for selinexor and our other product candidates.
  • We are completely dependent on third parties for the manufacture of our products and product candidates and any difficulties, disruptions, delays or unexpected costs, or the need to find alternative sources, could adversely affect our results of operations, profitability and future business prospects.
  • Risks Related to Our Intellectual Property
  • If we are unable to obtain and maintain patent protection for our products or product candidates and other discoveries, or if the scope of the patent protection obtained is not sufficiently broad, our competitors could develop and commercialize drugs and other discoveries similar or identical to ours, and our ability to successfully commercialize our products or product candidates and other discoveries may be adversely affected.
  • Third parties may initiate legal proceedings alleging that we are infringing their intellectual property rights, the outcome of which would be uncertain and could have a material adverse effect on the success of our business.
  • We may be subject to claims that our employees have wrongfully used or disclosed alleged trade secrets of their former employers.
  • Intellectual property litigation could cause us to spend substantial resources and distract our personnel from their normal responsibilities.
  • Obtaining and maintaining our patent protection depends on compliance with various procedural, documentary, fee payment and other requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements.
  • If our product candidates or any of our future product candidates obtain regulatory approval, additional competitors could enter the market with generic versions of such products, which may result in a material decline in sales of our competing products.
  • If we do not successfully extend the term of patents covering our product candidates under the Hatch-Waxman Amendments and similar foreign legislation, our business may be materially harmed.
  • If we are unable to protect the confidentiality of our trade secrets, our business and competitive position would be harmed.
  • Not all of our trademarks are registered. Failure to secure those registrations could adversely affect our business.
  • We use artificial intelligence in our business processes, which could adversely impact our business and operations, including by posing security and other risks to our confidential or proprietary information, including personal information, and, as a result, we may be exposed to reputational harm and liability.
  • Risks Related to Our Operations and Employee Matters
  • Our future success depends on our ability to retain key members of our management team and to attract, retain and motivate qualified personnel.
  • Our business and operations may be materially adversely affected in the event of information technology system failures or security breaches, and the costs and consequences of implementing data protection measures could be significant.
  • Risks Related to Our Common Stock
  • If we fail to maintain compliance with the continued listing requirements of Nasdaq, our common stock could be delisted from trading, which would adversely affect the liquidity of our common stock and our ability to raise additional capital.
  • We have a substantial number of warrants to purchase common stock outstanding and may in the future issue additional warrants. The exercise of our outstanding warrants will dilute existing stockholders and could adversely affect the trading price of our common stock.
  • Provisions in our corporate charter documents and under Delaware law could make an acquisition of us, which may be beneficial to our stockholders, more difficult and may prevent attempts by our stockholders to replace or remove our current management.
  • The price of our common stock has been and may continue to be volatile and your investment in our stock could decline in value or fluctuate significantly, including as a result of analysts’ activities.
  • Securities or other litigation could result in substantial costs and may divert management’s time and attention from our business.
  • We have broad discretion in the use of our cash, cash equivalents and investments and may not use them effectively.
  • We are a “smaller reporting company”, and the reduced disclosure requirements applicable to smaller reporting companies may make our common stock less attractive to investors.
  • If we identify a material weakness in our internal control over financial reporting, it could have an adverse effect on our business and financial results and our ability to meet our reporting obligations could be negatively affected, each of which could negatively affect the trading price of our common stock.
  • If the estimates we make, or the assumptions on which we rely, in preparing our consolidated financial statements, our projected guidance and/or our projected market opportunities prove inaccurate, our actual results may vary from those reflected in our projections and accruals.
  • Our ability to use our net operating loss carryforwards and tax credit carryforwards to offset future taxable income may be subject to certain limitations.
  • Changes in tax laws or in their implementation or interpretation may adversely affect our business and financial condition.

Legal proceedings

The information required by this Item is provided under “Litigation” in Note 13, “Commitments and Contingencies”, of the consolidated financial statements included in Part II, Item 8 of this Annual Report on Form 10-K.

The opening of Item 3, Legal Proceedings.5

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