KPTI 10-K & 10-Q changes, risk factors and insider trading
Karyopharm Therapeutics Inc. · Nasdaq · Pharmaceutical Preparations · CIK 1503802 · All filings on SEC.gov
At a glance
What changed in the latest 10-K
Risk Factors
New heading “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.”
New heading “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.”
New heading “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.”
New heading “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.”
New heading “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.”
New heading “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.”
New heading “The accounting method for convertible debt securities such as the Convertible Notes could have a material effect on our reported financial results.”
New heading “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.”
New heading “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.”
New heading “Changes in and uncertainty surrounding U.S. trade policy could have a material adverse impact on our business, financial condition and results of operations.”
New heading “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.”
New heading “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.”
New heading “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.”
Removed heading “We face substantial competition, which may result in others discovering, developing or commercializing drugs before or more successfully than we do.”
Removed heading “Inadequate funding for the FDA, the SEC and other government agencies, including from government shut downs, or other disruptions to these agencies’ operations, could hinder their ability to hire and retain key leadership and other personnel, prevent new products and services from being developed or commercialized in a timely manner or otherwise prevent those agencies from performing normal business functions on which the operation of our business may rely, which could negatively impact our business.”
Removed heading “We will need additional funding to achieve our business objectives. If we are unable to raise capital when needed or on acceptable terms, we would be forced to delay, reduce or eliminate our research and development programs and/or commercialization efforts.”
Removed heading “Our Amended Revenue Interest Agreement with HCRx contains various covenants and other provisions, which, if violated, could, subject to the 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.”
Removed heading “Our Credit Agreement and indenture governing the 2029 Notes contain various covenants and other provisions, which will limit the manner in which we may operate, and, if violated, could, subject to the 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.”
Removed heading “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 Term Loan, the 2029 Notes, the 2025 Notes or the Amended Revenue Interest Agreement.”
Removed heading “We may not have the ability to raise the funds necessary to settle any conversions of or other obligations in respect of the 2029 Notes or the 2025 Notes required to be settled in cash, to repurchase the 2029 Notes or the 2025 Notes for cash upon a fundamental change, to pay the redemption price for any 2029 Notes or 2025 Notes we redeem or to refinance the 2029 Notes or the 2025 Notes, and any future debt we incur may contain limitations on our ability to pay cash upon conversion or repurchase of the 2029 Notes or the 2025 Notes.”
Removed heading “The conditional conversion feature of the 2025 Notes, if triggered, may adversely affect our financial condition and operating results.”
Removed heading “The accounting method for convertible debt securities such as the 2025 Notes and the 2029 Notes could have a material effect on our reported financial results.”
Removed heading “Raising additional capital may cause dilution to our stockholders, restrict our operations or require us to relinquish rights to our product candidates.”
Largest changes
“Holders may require us to repurchase their 2029 Notes or 2025 Notes following a fundamental change at a cash repurchase price generally equal to the principal amount of the 2029 Notes or the 2025 Notes to be repurchased, plus accrued and unpaid interest. As discussed in more detail below under the risk factor entitled “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. …”see in full comparison
“The October 2025 First Amendment and Waiver to Credit and Guaranty Agreement, with the lenders party thereto and Wilmington Savings Fund Society, FSB, as administrative agent for the lenders and collateral agent (as amended, the “Amended Credit Agreement”) which amended the May 2024 credit and guaranty agreement and the indentures governing the Convertible Notes contain, and any future indebtedness that we incur may contain, various negative covenants that restrict, among other things, our indebtedness, liens, fundamental changes, asset sales, investments and other matters. …”see in full comparison
“The May 2024 credit and guaranty agreement (the “Credit Agreement”) and the indenture governing the 2029 Notes contain, and any future indebtedness that we incur may contain, various negative covenants that restrict, among other things, our indebtedness, liens, fundamental changes, asset sales, investments and other matters. In addition, the Credit Agreement and the indenture governing the 2029 Notes each have a financial covenant requiring us to maintain liquidity of at least $25.0 million at all times. …”see in full comparison
“Global credit and financial markets have experienced extreme disruptions over the past several years. Such disruptions have resulted, and could in the future result, in diminished liquidity and credit availability, declines in consumer confidence, declines in economic growth, increases in unemployment rates and uncertainty about economic stability. …”see in full comparison
“In addition to financial market risks, broader geopolitical and economic volatility could adversely affect our business. Uncertainty associated with governmental policies, shifts in regulatory priorities, and geopolitical tensions, such as conflicts involving multiple regions and nations including Ukraine, Russia, China, the Middle East and other areas of international concern, could negatively influence investor perceptions and economic conditions. …”see in full comparison
Our stock price has been, and may continue to be, volatile and your investment in our stock could decline or fluctuate significantly. Our common stock price has ranged fromsee in full comparison$0.59$3.54 to$1.58$9.85 in the 52-week period ended February14,5,2025.2026. On February14,5,2025,2026, the closing sale price of our common stock on the Nasdaq Global Select Market was$0.62$6.09 per share. The stock market in general and the market for pharmaceutical and biotechnology companies in particular have experienced extreme volatility that has often been unrelated to the operating performance of particular companies, such as the response to world-wide economic disruptions related tothetariffsCOVID-19andpandemic,other trade restrictions, uncertainty associated with governmental policies, shifts in regulatory priorities, and geopolitical tensions, such as conflicts involving multiple regions and nations including Ukraine, Russia, China, theconflictMiddlebetween RussiaEast andUkraine,other areas of international concern, reduced investor confidence in thewarcapitalbetween Israel and Hamas,markets, inflation and sustained high interest rates. The market price for our common stock may be influenced by many factors, including:
Full comparison: every changed paragraph (222)
We will require substantial funds to maintain our research and development programs, including as we continue to develop and seek regulatory approval of selinexor for multiple cancer indications, and to support our continued operations. We have incurred significant operating losses since our inception. As of December 31, 2025, we had approximately $63.7 million in cash, cash equivalents, and investments.
We believe that our existing liquidity, including cash, cash equivalents and investments, as well as cash flow from net product revenue and license and other revenue, will enable us to fund our current operating plans into the second quarter of 2026. We will require additional capital to complete the ongoing clinical development of selinexor, including the Phase 3 SENTRY trial beyond top-line results, the Phase 3 XPORT-EC-042 trial and the Phase 3 XPORT-MM-031/EMN29 trial. We have based this assessment on assumptions that may prove to be wrong, and we could exhaust our capital resources sooner than we expect. We anticipate that we will continue to incur significant operating losses as we continue our research and development programs, including as we continue to develop and seek regulatory approval of selinexor for multiple cancer indications, and to support our continued operations. As a result, our continued operations are dependent on our ability to raise additional funding and/or enter into strategic alternatives, as described in the risk factor entitled “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,” below. Based on our current business plan and current capital resources, given the uncertainty regarding the availability of additional funding or other strategic alternatives and considering our debt service obligations, including requirements under our Amended Credit Agreement, as defined below, and the indentures governing our 9.00% convertible senior notes due 2028 (the “2028 Notes”) and 9.00% convertible senior notes due 2029 (the “New 2029 Notes”, and together with the 2028 Notes, the “Convertible Notes”) to maintain cash, cash equivalents and investments of at least $10.0 million, subject to increase in the event we issue indebtedness for borrowed money or issue capital stock, through October 10, 2026, after which we will be required to maintain liquidity of at least $25.0 million, we have concluded that there is substantial doubt regarding our ability to continue as a going concern within one year after the date the accompanying consolidated financial statements are issued.
We plan to address the conditions that raise substantial doubt regarding our ability to continue as a going concern by, among other things, obtaining additional funding through equity offerings, debt financings and refinancings, collaborations, strategic alliances and/or licensing arrangements. In addition, we expect to evaluate opportunities to raise additional funds from time to time, including through the issuance and sale of shares of our common stock under our Open Market Sale Agreement with Jefferies LLC and in connection with the reporting of data from our ongoing Phase 3 clinical trials. However, there is no assurance that such additional financing or strategic alternatives will be available on terms acceptable to us, or at all.
Additionally, we have issued or reserved a significant portion of our currently authorized shares of common stock, which limits the number of authorized and unreserved shares available to raise capital for our business plans and strategic initiatives. The amount of unreserved shares of common stock may be insufficient, and could impede our ability to, raise sufficient capital through future equity or equity-linked offerings to meet our cash needs to fund our planned operations and to continue operations. Increasing the authorized number of shares of common stock requires the approval of our stockholders. We have scheduled a Special Meeting of Stockholders to be held on February 18, 2026 to seek stockholder approval for an increase in our authorized shares of capital stock and common stock. There is no guarantee that a sufficient number of stockholders will vote to approve the increase and, if the increase is not approved by the requisite vote of our stockholders, it will limit our ability to raise capital through future equity or equity-linked offerings.
If we utilize our capital resources more quickly than anticipated or are unable to obtain additional funding or engage in strategic alternatives, we may have to significantly curtail, delay, reduce or eliminate one or more of our research and development programs or any current or future commercialization efforts for one or more of our products or product candidates, which could materially adversely affect our business, financial condition, and results of operations. We may determine to take additional actions to reduce our spending in the near term. As we announced in July 2025, we reduced our workforce by approximately 20% as part of our ongoing careful management of operating expenses. If we are unable to continue as a going concern, we may have to liquidate assets and may receive less than the value at which those assets are carried on our financial statements. We may also determine to cease operations or file for bankruptcy protection. In any of these circumstances, it is likely that investors will lose all or part of their investment. If there remains substantial doubt about our ability to continue as a going concern, investors or other financing sources may be unwilling to provide funding to us on commercially reasonable terms, if at all.
Since inception, we have incurred significant operating losses. Our loss from operations was $90.7 million for the year ended December 31, 2025. As of December 31, 2025, we had an accumulated deficit of $1.8 billion. As described above in “Our financial condition raises substantial doubt as to our ability to continue as a going concern,” our financial condition raises substantial doubt about our ability to continue as a going concern. Although we received our first FDA-approval for XPOVIO in July 2019, we may never attain profitability or positive cash flows from operations. We have historically financed our operations primarily through a combination of proceeds from (i) product revenue sales; (ii) public and private placements of equity securities; (iii) the issuance of convertible debt; (iv) a term loan; (v) our deferred royalty obligation; (vi) at the market offerings; and (vii) business development activities. Substantially all of our operating losses have resulted from costs incurred in connection with our research and development programs, the pursuit of regulatory approvals within and outside of the U.S., and the commercialization of XPOVIO. We expect to continue to incur significant expenses and operating losses as we continue to commercialize XPOVIO in the U.S. and engage in activities to prepare for the potential approval and commercialization of additional indications for selinexor as well as any other product candidates we develop or acquire. The net losses we incur may fluctuate significantly from quarter to quarter.
While we began to generate revenue from the sales of XPOVIO in July 2019 and have received revenue from our license arrangements, such as the partnership we have with Antengene Therapeutics Limited (“Antengene”) for our programs across most of the Asia-Pacific region, and with Berlin-Chemie AG, an affiliate of the Menarini Group (“Menarini”) for our programs in Europe, Latin America, certain Middle East and Africa regions and other key countries, there can be no assurance as to the amount or timing of future product or license and other revenues, and we may not achieve profitability in the near-term, if at all. Our ability to become and remain profitable depends significantly on our success in many areas, including:
obtaining sufficient pricing, coverage and reimbursement, including government pricing and reimbursement policies or a change in the mix of our business affecting discounts and/or rebates related to 340B Programs, Medicare and Medicaid, for XPOVIO and any of our other approved products from private and government payers and the impact of any pricing changes, any of which can impact our gross-to-net provisions related to product sales;
initiating and successfully completing clinical trials required to file for, obtain and maintain marketing approval for our product candidates, including reporting a positive benefit-risk profile from our ongoing Phase 3 clinical trials in myelofibrosis and endometrial cancer, with top-line data from both trials anticipated in 2026;
placement of selinexor in the treatment recommendations adopted by the National Comprehensive Cancer Network and similar guidelines;
the willingness of patients to pay out-of-pocket in the absence of third-party coverage or as co-pay amounts under third-party coverage; for example, multiple myeloma foundation closures during 2023 resulted in significantly increased use of our Patient Assistance Program, which adversely impacted our 2023 revenues; and navigating the negative impacts to healthcare systems, the ability of our clinical trial sites to conduct current or future trials and the regulatory review process.
We anticipate that our operating expenses will continue to be significant and could increase as we continue to:
invest in our research and development programs, identify additional product candidates and initiate and conduct clinical trials, including clinical trials required by the FDA or other regulatory agencies in addition to those that have been or are currently expected to be conducted;
manufacture XPOVIO and our product candidates; and evaluate strategic opportunities, such as the acquisition or in-license of other products, product candidates, technologies or companies.
Because of the numerous risks and uncertainties associated with pharmaceutical product development and commercialization, we are unable to accurately predict the timing or amount of our revenue and expenses or when, or if, we will be able to achieve profitability. We cannot be certain that our revenue from sales of XPOVIO alone, in the currently approved indications, will be sufficient for us to become profitable in the near-term, if at all. We may never generate revenues that are significant or large enough to achieve profitability. Even if we do achieve profitability, we may not be able to sustain or increase profitability on a quarterly or annual basis. Our failure to become and remain profitable would decrease the value of our company and could impair our ability to raise capital, maintain our research and development and commercialization efforts, expand our business and/or continue our operations. A decline in the value of our company could also cause our stockholders to lose all or part of their investment.
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.
Discovering, developing and commercializing products involve time-consuming, expensive and uncertain processes that take years to complete. We have used substantial funds to develop XPOVIO and expect our operating expenses to continue to increase as we continue to commercialize XPOVIO or any future approved product, conduct further research and development of our product candidates, seek marketing approval and prepare for commercialization of selinexor in additional indications or for our other product candidates, if approved, to the extent that such functions are not the responsibility of a collaborator. Furthermore, we will continue to incur additional costs associated with operating as a public company, hiring or retaining personnel and expanding our geographical reach. Although currently XPOVIO is commercially available in three indications, we do not anticipate that our revenue from product sales of XPOVIO or any funds we may receive from our collaborators will be sufficient for us to become profitable in the near-term, if at all. Accordingly, we will need to continue to rely on additional financing, or strategic alternatives, to achieve our business objectives.
We believe that our existing liquidity, including cash, cash equivalents and investments, as well as cash flow from net product revenue and license and other revenue, will enable us to fund our current operating plans into the second quarter of 2026. The amount and timing of our future capital requirements will depend on many factors, including, but not limited to:
the timing and success of our efforts to enter into strategic alternatives, if available;
our ability to extend our cash runway through additional financing activities;
our ability to establish and maintain collaboration, partnership, licensing, marketing, distribution or other arrangements on favorable terms and the level and timing of success of these arrangements, and our ability to use proceeds of those arrangements in our business as opposed to being required to pay those proceeds to the lenders of our $112.5 million senior secured term loan facility, as amended in October 2025 (the “Amended Term Loan”) and/or holders of the Convertible Notes;
the extent to which we acquire or in-license other products, product candidates, technologies or other companies, and our ability to enter into such acquisitions and in-licenses pursuant to the restrictions under the Amended Term Loan and the Convertible Notes;
In addition, the terms of any financing may adversely affect the holdings or the rights of our stockholders. If we raise additional funds by issuing equity or equity-linked securities, dilution to our existing stockholders will result. In addition, as a condition to providing additional funding to us, future investors may demand, and may be granted, rights superior to those of existing stockholders. Moreover, in addition to the restrictions on our operations under the Amended Term Loan and the Convertible Notes, the restrictions contained in the Amended Revenue Interest Agreement (defined below) and the repayment requirements in respect of obligations from proceeds of the transactions under each of the foregoing agreements, any future debt financing, if available and permitted, may involve further restrictive covenants that could limit our flexibility in conducting future business activities and using transaction proceeds in our business and, in the event of insolvency, the Amended Term Loan, the Convertible Notes, the Amended Revenue Interest Agreement obligations, and any further indebtedness, if available and permitted, would be paid before holders of equity securities received any distribution of corporate assets. Our ability to satisfy and meet our current and any future debt service obligations will depend upon our future performance, which will be subject to financial, business and other factors affecting our operations, many of which are beyond our control.
Even if we believe we have sufficient funds for our current or future operating plans, we may seek additional capital due to favorable market conditions or strategic considerations, and any such efforts could divert management’s attention away from their day-to-day activities. However, adequate additional financing has not been, and may continue to not be, available to us on acceptable terms, or at all. Raising additional capital may be particularly challenging in the current economic environment, as adverse or uncertain financial market conditions, including inflationary pressures, sustained high interest rates, volatility in the capital markets and slower economic growth or recession, could negatively impact investor demand for biotechnology equity or debt offerings. We cannot predict the extent or duration of such conditions or their impact on our ability to access the capital markets on acceptable terms.
In addition, changes in government policies, priorities and administration could create increased uncertainty and volatility that adversely affect our business, our ability to raise capital, and our ability to enter into strategic alternatives. For example, evolving healthcare, pricing and reimbursement policies, including potential drug pricing reforms such as “most-favored-nation” or similar pricing frameworks, as well as shifts in regulatory or enforcement priorities at federal agencies, including the FDA and other governmental bodies, could negatively affect investor sentiment, the perceived commercial viability of our product and our access to financing. Further, instability or disruption in the global or domestic banking system could impair our access to cash deposits or limit the availability of financing from financial institutions. If adequate funds are not available to us on a timely basis or on attractive terms, we may be required to delay, reduce or eliminate our research and development programs or any current or future commercialization efforts for one or more of our products or product candidates, which could have a material adverse effect on our business, operating results and prospects.
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.
In October 2025, we announced that we are continuing to evaluate potential financing transactions along with strategic alternatives to maximize near and long-term stockholder value, which may include, but are not limited to, a merger or sale of the Company, in or out of court restructurings, repurchases, redemptions, exchanges or other refinancings of our existing debt, and financing transactions, among other potential alternatives. Our ability to successfully raise additional funds or execute on a financing transaction or a strategic alternative is dependent on a number of factors. If we are not able to successfully consummate a financing transaction or strategic alternative, our Board may explore a sale of assets or the initiation of bankruptcy proceedings under Chapter 11 of the U.S. Bankruptcy Code. Further, our indebtedness, as discussed under the risk factor titled “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,” may be unattractive to potential sources of funding and strategic partners and may decrease our ability to consummate a financing transaction or enter into a strategic alternative. Additionally, the negotiation and consummation of a financing transaction or strategic alternative may be costly and time-consuming. Even if we are able to consummate a financing transaction or a strategic alternative, it may not maximize or even enhance stockholder value, could result in total costs and expenses that are greater than expected, could make it more difficult to attract and retain qualified personnel and may disrupt our operations, each of which could have a material adverse effect on our business.
The market price of our common stock may reflect a market assumption that a strategic alternative will occur, and a failure to complete a strategic alternative on favorable terms, in an advantageous timeframe, or at all could result in negative investor perceptions and could cause a decline in the market price of our common stock, which could adversely affect our ability to access the equity and financial markets, as well as our ability to explore and enter into future strategic alternatives. In addition, potential strategic alternatives, if available, that require stockholder approval may not be approved by our stockholders.
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.
In September 2019, we entered into the Revenue Interest Financing Agreement with certain entities managed by HealthCare Royalty Management, LLC (“HCRx”), which was amended on June 23, 2021, August 1, 2023, May 8, 2024, August 14, 2025, August 27, 2025 and October 7, 2025 and which was assigned by HCRx to an affiliate of KKR & Co. Inc. (“KKR”) in July 2025 in connection with its acquisition of a majority ownership stake in HCRx (the “Amended Revenue Interest Agreement”). Pursuant to the Amended Revenue Interest Agreement, we are required to comply with various covenants relating to the conduct of our business and the commercialization of XPOVIO, including obligations to use commercially reasonable efforts to commercialize our products. In addition, the Amended Revenue Interest Agreement limits our ability to incur or prepay indebtedness, create or incur liens, pay dividends on or repurchase outstanding shares of our capital stock or dispose of assets. The Amended Revenue Interest Agreement also includes customary events of default upon the occurrence of enumerated events, including non-payment of revenue interests, failure to perform certain covenants and the occurrence of insolvency proceedings, specified judgments, specified cross-defaults and specified revocations, withdrawals, suspensions or cancellations of regulatory approval for XPOVIO. Upon the occurrence of an event of default and in the event of a change of control, KKR may accelerate payments due under the Amended Revenue Interest Agreement up to $128.3 million, less the aggregate amount of all of the payments paid to HCRx and KKR after the date of the May 2024 amendment. Our obligations to KKR are secured by a second-priority security interest in certain assets of ours related to selinexor, which shares such second priority with the Convertible Notes and which is subordinated to the first-priority security interest securing the Amended Term Loan. Subject to an intercreditor agreement with KKR, the Amended Term Loan lenders and the holders of the New 2029 Notes (the “Amended and Restated Intercreditor Agreement”), in the event that an uncured default by us under the Amended Revenue Interest Agreement results in an acceleration of obligations by KKR which we are unable to pay, KKR will have the right to foreclose on the collateral that was pledged to KKR. Any such foreclosure remedy would significantly and adversely affect us and could result in us losing our interest in such assets, which would have a material adverse impact on our business.
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.
The October 2025 First Amendment and Waiver to Credit and Guaranty Agreement, with the lenders party thereto and Wilmington Savings Fund Society, FSB, as administrative agent for the lenders and collateral agent (as amended, the “Amended Credit Agreement”) which amended the May 2024 credit and guaranty agreement and the indentures governing the Convertible Notes contain, and any future indebtedness that we incur may contain, various negative covenants that restrict, among other things, our indebtedness, liens, fundamental changes, asset sales, investments and other matters. In addition, the Amended Credit Agreement and the indentures governing the Convertible Notes each have a financial covenant requiring us to maintain liquidity of at least $10.0 million, subject to increase in the event we issue indebtedness for borrowed money or issue capital stock, through October 10, 2026, after which we will be required to maintain liquidity of at least $25.0 million. As a result, we are limited in the manner in which we conduct our business and we may be unable to engage in favorable business activities. The Amended Credit Agreement and the indentures governing the Convertible Notes also contain certain events of default, after which the Amended Term Loan or the Convertible Notes may be due and payable immediately, including, without limitation, withdrawal of approval for selinexor with respect to its current approved indication for use with bortezomib and dexamethasone, payment defaults, material inaccuracy of representations and warranties, covenant defaults, bankruptcy and insolvency proceedings, cross-defaults to certain other agreements, judgments against us and our subsidiaries, change in control and lien priority. Our obligations under the Amended Credit Agreement and the indentures governing the Convertible Notes are secured by substantially all of our assets. Subject to the Amended and Restated Intercreditor Agreement, in the event that an uncured default by us under the Amended Credit Agreement or the indentures governing the Convertible Notes results in an acceleration of obligations thereunder, the Amended Term Loan lenders and the holders of the Convertible Notes will have the right to foreclose on the collateral that was pledged to each such party. Any such foreclosure remedy would significantly and adversely affect us and could result in us losing our interest in such assets, which would have a material adverse impact on our business.
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.
In October 2025, we entered into a series of transactions with our term loan lenders, holders of our outstanding convertible notes and other investors to provide financial flexibility, additional working capital and equitize maturing notes (collectively, the “Financing Transactions”). Following consummation of the Financing Transactions, we had (i) $112.5 million of aggregate principal amount under the Amended Term Loan; (ii) $15.0 million aggregate principal amount of the 2028 Notes; (iii) $103.5 million aggregate principal amount of the New 2029 Notes; and (iv) $116.2 million of maximum remaining payments payable under our revenue interest financings agreement. We may also incur additional indebtedness to meet future financing needs, to the extent such indebtedness is available and permitted under the agreements governing our existing indebtedness. Our indebtedness could have significant negative consequences for our security holders and our business, results of operations and financial condition by, among other things:
diluting the interests of our existing stockholders as a result of issuing shares of our common stock upon conversion of the Convertible Notes and/or the exercise of outstanding warrants; and placing us at a possible competitive disadvantage with competitors that are less leveraged than we are or have better access to capital.
Our ability to pay the principal of or interest or other obligations on our present and any future indebtedness, including our remaining obligations to KKR and under the Amended Credit Agreement, the Convertible Notes, or to make cash payments in connection with any conversion of the Convertible Notes, depends on our future performance and ability to raise additional funds, which is subject, in part, to economic, financial, competitive and other factors beyond our control. Our business may not generate cash flow from operations in the future sufficient to service the Amended Term Loan, the Amended Revenue Interest Agreement, the Convertible Notes or any other future indebtedness and make necessary capital expenditures.
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.
If we do not have enough available cash at the time we are required to repurchase the Convertible Notes, pay cash amounts due upon conversion or redemption of, at maturity or otherwise required to be paid in respect of the Convertible Notes or refinance the Convertible Notes, we may be required to adopt one or more alternatives, such as selling assets, restructuring indebtedness or obtaining additional debt financing or equity capital on terms that may be onerous or highly dilutive. Our ability to refinance the Convertible Notes or other future indebtedness will depend on the capital markets, our financial condition at such time and our obligations under any other existing indebtedness in effect at such time. We may not be able to engage in any of these activities on desirable terms, or at all, which could result in a default on our debt obligations, including the Convertible Notes. In addition, our ability to repurchase the Convertible Notes, to pay cash upon conversion or redemption or at maturity of the Convertible Notes or to refinance the Convertible Notes may be limited by law, regulatory authority or agreements governing any future indebtedness that we may incur. Our failure to repurchase the Convertible Notes at a time when the repurchase is required by the applicable indenture governing such notes or to pay cash upon conversion or at maturity of or in respect of other obligations under the Convertible Notes as required by the applicable indenture governing such notes would constitute a default under such indenture.
Note holders may require us to repurchase their Convertible Notes following a fundamental change at a cash repurchase price generally equal to the principal amount of the Convertible Notes to be repurchased, plus accrued and unpaid interest.
The 2028 Notes will be convertible by holders of the 2028 Notes into shares of common stock at an initial conversion rate of 150.6024 shares per $1,000 principal amount of 2028 Notes (equivalent to an initial conversion price of $6.64 per share of common stock). The conversion rate will be subject to adjustment upon the occurrence of certain events as provided in the 2028 Notes Indenture. Holders of the 2028 Notes may convert their 2028 Notes at their option at any time prior to the close of business on the scheduled trading day immediately preceding the maturity date of the 2028 Notes.
The 2029 Notes will be convertible by holders of the 2029 Notes into shares of common stock at an initial conversion rate of 44.444 shares per $1,000 principal amount of 2029 Notes (equivalent to an initial conversion price of $22.50 per share of common stock). The conversion rate will be subject to adjustment upon the occurrence of certain events as provided in the 2029 Notes Indenture. Holders of the 2029 Notes may convert their 2029 Notes at their option at any time prior to the close of business on the scheduled trading day immediately preceding the maturity date of the 2029 Notes.
A default under the indentures governing the Convertible Notes or the fundamental change itself could also lead to a default under the Amended Credit Agreement, the Amended Revenue Interest Agreement or agreements governing our future indebtedness, if any. Moreover, the occurrence of a fundamental change under the indentures governing the Convertible Notes could constitute an event of default under any such agreements. If the repayment of the related indebtedness were to be accelerated after any applicable notice or grace periods, we may not have sufficient funds to repay the indebtedness and repurchase the Convertible Notes or to pay cash upon conversion or at maturity 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.
Conversions of the Convertible Notes may only be settled in shares (subject to, and in accordance with, the settlement provisions of the indentures governing the Convertible Notes), plus cash in lieu of any fractional shares. Under the if-converted method, the maximum potential dilutive impact of the conversion of the Convertible Notes is assumed when calculating diluted earnings per share during periods of net income. This could result in a material impact to diluted earnings per share. Diluted earnings per share is not impacted by the Convertible Notes during periods of net loss.
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.
Until such time, if ever, as we can generate substantial revenues from the sale of our products, we expect to finance our cash needs through a combination of equity offerings, debt financings and refinancings, collaborations, strategic alliances and/or licensing arrangements or asset sales. We do not have any committed external source of funds. To the extent that we raise additional capital through the sale of equity or convertible debt securities, the ownership interests of stockholders will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect the rights of common stockholders. In addition, our ability to raise additional capital through the sale of equity or convertible debt securities may be limited by the extent of our then remaining authorized and available shares of common stock. Debt financing, if available and permitted, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends. For example, during the terms of the Amended Revenue Interest Agreement, the Amended Credit Agreement and the indentures governing the Convertible Notes, we cannot make any voluntary or optional cash payment or prepayment on our existing convertible debt and cannot enter into any new debt without the consent of KKR, the required lenders or the required holders, respectively, subject to the exceptions and other provisions under the applicable governing document. Further, any future renegotiation of these agreements will require extensive, multi-party discussions that will require significant time and resources and could result in additional debt, higher rates of interest, the issuance of additional warrants or equity securities, and dilution to our current stockholders.
If we raise additional funds through further collaborations, strategic alliances or licensing arrangements with third parties, we may have to relinquish valuable rights to our future revenue streams, research programs or product candidates or to grant licenses on terms that may not be favorable to us. If we are unable to raise sufficient additional funds through equity or debt financings, we may be required to delay, limit, reduce or terminate our research and drug development or current or future commercialization efforts or grant rights to develop and market product candidates that we would otherwise prefer to develop and market ourselves.
We may also issue additional equity securities in other types of transactions that result in additional significant dilution to our stockholders, for example, in connection with other strategic or financing transactions, in exchange transactions similar to the exchange transactions we completed in October 2025 and May 2024 or in other future exchange transactions with our lenders and convertible noteholders, to satisfy obligations to our lenders and our convertible noteholders or other creditors, as equity compensation, or for other reasons.
Unstable market and economic conditions may have serious adverse consequences on our business, financial condition and stock price. Global credit and financial markets have experienced periods of extreme disruption in recent years, which have contributed to diminished liquidity and credit availability, declines in consumer and investor confidence and slower economic growth. As a result, financial institutions and markets face a range of risks that could adversely affect our operations and access to capital, including the potential for future banking failures, changes in regulatory frameworks, governing banks and deposit insurance, tightened credit conditions that reduce liquidity availability, volatility in interest rates and evolving cyber threats and disruptions to financial systems and payment networks. If the financial institutions with which we do business were to enter receivership, become insolvent or suffer a significant cyber incident or operational disruption, there is no guarantee that we would have access to our existing cash, cash equivalents and investments, or that we would be able to finance or fund our business on acceptable terms or at all, and any of these outcomes could materially and adversely affect our business, financial condition and results of operations.
In addition to financial market risks, broader geopolitical and economic volatility could adversely affect our business. Uncertainty associated with governmental policies, shifts in regulatory priorities, and geopolitical tensions, such as conflicts involving multiple regions and nations including Ukraine, Russia, China, the Middle East and other areas of international concern, could negatively influence investor perceptions and economic conditions. While the direct effects of tariffs and trade restrictions to date have been limited, such measures, along with other macroeconomic pressures such as inflation and slower economic growth or recession, may contribute to instability in global markets. There is also a risk that one or more of our service providers, manufacturers or other third parties with which we conduct business may face financial difficulties, geopolitical disruption or operational challenges, which could hinder our ability to meet developmental and commercial objectives on schedule and on budget. If these risks materialize in a manner that disrupts normal economic activity or financial markets, our business, results of operations and financial condition could be materially and adversely affected.
Our business and our ability to generate product revenue from the sales of drugs that treat cancer depend heavily on our and our collaborators’ ability to successfully commercialize our lead drug, XPOVIO® (selinexor), on a global basis in currently approved and future indications, and the level of market adoption for, and the continued use of, our products and product candidates, if approved. XPOVIO is currently approved and marketed in the U.S. in multiple hematologic malignancy indications, including in combination with bortezomib and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior therapy; in combination with dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, at least two immunomodulatory agents, and an anti-CD38 monoclonal antibody; and under accelerated approval as a monotherapy for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (“DLBCL”), not otherwise specified, including DLBCL arising from follicular lymphoma, after at least 2two lines of systemic therapy. Efforts to drive adoption within the medical community and third-party payors based on the benefits of our products and product candidates require significant resources and may not be successful. The success of XPOVIO and any current or future product candidates, whether alone or in collaboration with third parties, including achieving and maintaining an adequate level of market adoption, depends on several factors, including:
reporting a positive benefit-risk profile from our ongoing Phase 3 clinical trials in myelofibrosis and endometrial cancer, with top-line data from both trials anticipated in 2026;
the willingness of patients to pay out-of-pocket in the absence of third-party coverage or as co-pay amounts under third-party coverage; for example, multiple myeloma foundation closures during 2023 resulted in significantly increased use of our Patient Assistance Program (“PAP”),Program, which adversely impacted our 2023 revenues;
establishing and maintaining commercial manufacturing capabilities or makingentering arrangementsinto, maintaining and managing supply and manufacturing agreements with qualified third-party manufacturers;
the ability for patients to continue on therapies once prescribed, which may be driven by factors such as progression of disease, line of therapy, tolerability and the availability of other competitor therapies;
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.
The discovery, development and commercialization of new drugs is highly competitive, particularly in the cancer field. We and our collaborators face competition with respect to XPOVIO and will face competition with respect to any product candidates that we may seek to discover and develop or commercialize in the future, from major pharmaceutical companies, specialty pharmaceutical companies, biotechnology companies, academic institutions and governmental agencies as well as public and private research institutions worldwide, many of which have significantly greater financial resources and expertise in research and development, manufacturing, preclinical studies, conducting clinical trials, obtaining regulatory approvals and marketing approved products than we do.
We face substantial competition, which may result in others discovering, developing or commercializing drugs before or more successfully than we do.
The discovery, development and commercialization of new drugs is highly competitive, particularly in the cancer field. We and our collaborators face competition with respect to XPOVIO and will face competition with respect to any product candidates that we may seek to discover and develop or commercialize in the future, from major pharmaceutical companies, specialty pharmaceutical companies, biotechnology companies, academic institutions and governmental agencies as well as public and private research institutions worldwide, many of which have significantly greater financial resources and expertise in research and development, manufacturing, preclinical studies, conducting clinical trials, obtaining regulatory approvals and marketing approved products than we do. There are a number of major pharmaceutical, specialty pharmaceutical and biotechnology companies that currently market and sell drugs and/or are pursuing the development of drugs for the treatment of cancer and the other disease indications for which we, and our collaborators, are developing our product candidates. Several new novel therapeutics have recently entered, and are expected to continue to enter, the multiple myeloma treatment landscape. For example, TECVAYLI™ (teclistamab-cqyv), the first bispecific T-Cell engager, was approved by the FDA in October 2022, followed by approvals of two more bispecifics, ELREXFIO™ (elranatamab-bcmm) and TALVEY™ (talquetamab-tgvs) in August 2023. Other T-cell engaging therapies, bispecifics with different targets, and immunomodulators are in clinical development and may be introduced into the multiple myeloma market in 20252026 and beyond. CARVYKTI® (ciltacabtagene autoleucel; cilta-cel) and Abecma® (idecabtagene vicleucel; ide-cel) were approved in April 2024 for the treatment of multiple myeloma in earlier lines. In October 2025, BLENREP (belantamab mafodotin), a BCMA-targeted bispecific antibody, in combination with bortezomib and dexamethasone was approved. In addition, new competitors and label expansions into earlier lines of existing therapies could also be approved in the future (e.g. belantamab mafodotin and linvoseltamab),future, which could negatively impact our product revenues. The approval of these anti-cancer agents, or any others which may receive regulatory approval, have had a significant impact and may continue to have a significant impact on the therapeutic landscape and our product revenues. See Item 1 under the heading Business - Competition in this Annual Report on Form 10-K for more information on competition.
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,we or our collaborators,collaborators may incur additional costs, fail to secure regulatory approvals, or be unable to commercialize such product candidates.
Management's Discussion & Analysis (MD&A)
Largest changes
“We currently expect that our existing liquidity, including cash, cash equivalents and investments as well as cash flow from net product revenue and license and other revenue, will enable us to fund our current operating plans into the second quarter of 2026. We will require additional capital to complete the ongoing clinical development of selinexor, including the Phase 3 SENTRY Trial beyond top-line results and the Phase 3 XPORT-EC-042 Trial and the Phase 3 XPORT-MM-031/EMN29 trial. …”see in full comparison
“In May 2024, we entered into a credit and guaranty agreement (the “Credit Agreement”) with certain existing lenders and HCRx, which was subsequently assigned by HCRx to KKR in connection with its acquisition of a majority ownership stake in HCRx in July 2025, which provides for a senior secured term loan facility of $100.0 million (the “Term Loan”). …”see in full comparison
“In October 2025, we entered into a series of transactions with our term loan lenders, holders of our outstanding convertible notes and other investors to provide financial flexibility, additional working capital and equitize maturing notes (collectively, the “Financing Transactions”). …”see in full comparison
Based on our current business plan and current capital resources, combined with the uncertainty regarding the availability of additional funding or other strategic alternatives and considering our debtsee in full comparisonobligations,serviceincludingobligationsaandrequirementfinancial covenant to maintaincash,minimumcash equivalents and investments of at least $25.0 million at all times,liquidity, we have concluded that there is substantial doubt regarding our ability to continue as a going concern within one year after the date the accompanying consolidated financial statements are issued. See Note 1, “Organization and Operations”, to the consolidated financial statements included under Part II, Item 8 of this Annual Report on Form 10-K for a further discussion of the conditions that raise substantial doubt regarding our ability to continue as a going concern.We currently expect that cash, cash equivalents and investments as of December 31, 2024 will be sufficient to fund our current operating plans and debt obligation requirements into the fourth quarter of 2025 while we continue to commercialize XPOVIO in the U.S. and continue the clinical trials of our product candidates. Our future long-term capital requirements will depend on many factors, as described more fully in the risk factor entitled “We will need additional funding to achieve our business objectives. If we are unable to raise capital when needed or on acceptable terms, we would be forced to delay, reduce or eliminate our research and development programs and/or commercialization efforts,” under the heading “Risk Factors” in this Annual Report on Form 10-K.
As of December 31,see in full comparison2024,2025, we had an accumulated deficit of$1.6$1.8 billion. We had net losses of$76.4$196.0 million,$143.1$76.4 million, and$165.3$143.1 million for the years ended December 31,2024,2025,20232024 and2022,2023, respectively. We recognized total revenue of$145.2$146.1 million in2024,2025, including$112.8$114.9 million of XPOVIO net product revenue and$32.4$31.2 million of license revenue. License revenue included $15.0 million of revenue for the reimbursement of development related expenses from the Menarini Group (“Menarini”). As of December 31,2024,2025, we had$108.7$63.7 million in cash, cash equivalents and investments. Based on our current business plan and current capital resources, combined with the uncertainty regarding the availability of additional funding or other strategic alternatives and considering our debtobligations,serviceincludingobligationsaandrequirementfinancial covenant to maintaincash,minimumcash equivalents and investments of at least $25.0 million at all times,liquidity, we have concluded that there is substantial doubt regarding our ability to continue as a going concern within one year after the date the accompanying consolidated financial statements are issued. See “Liquidity, Capital Resources, and Going Concern” below for a further discussion of our liquidity and the conditions that raise substantial doubt regarding our ability to continue as a going concern.
We anticipate that we will continue to incur significant operating losses in the foreseeable future. Based on our current business plan and current capital resources, combined with the uncertainty regarding the availability of additional funding or other strategic transactions and considering our debtsee in full comparisonobligations,serviceincludingobligationsaandrequirementfinancial covenant to maintaincash,minimumcash equivalents and investments of at least $25.0 million at all times,liquidity, we have concluded that there is substantial doubt regarding our ability to continue as a going concern within one year after the date the accompanying consolidated financial statements are issued. We expect that our existing liquidity, including cash, cash equivalents and investments as of December 31,20242025 as well as cash flow from net product revenue and license and other revenue, willbeenablesufficientus to fund our current operating plansand debt obligation requirementsinto thefourthsecond quarter of2025.2026. See “Liquidity, Capital Resources and Going Concern – Funding Requirements” below and Note 1 “Organization and Operations” to the consolidated financial statements included under Part II, Item 8 of this Annual Report on Form 10-K for a further discussion of our liquidity and the conditions that raise substantial doubt regarding our ability to continue as a going concern.
Full comparison: every changed paragraph (58)
The following discussion and analysis of our financial condition and results of operations is meant to provide material information relevant to an assessment of the financial condition and results of operations of our company, including an evaluation of the amounts and uncertainties of cash flows from operations and from outside resources, so as to allow investors to better view our company from management’s perspective. You should beread readthe following discussion and analysis of our financial condition and results of operations in conjunction with our consolidated financial statements and related notes included elsewhere in this report. Some of the information contained in this discussion and analysis and set forth elsewhere in this report, including information with respect to our plans and strategy for our business, includes forward-looking statements that involve risks and uncertainties. You should review the section entitled “Risk Factors” in Part I - Item 1A of this report for a discussion of important factors that could cause actual results to differ materially from the results described in or implied by the forward-looking statements contained in the following discussion and analysis.
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 SelectiveXPO1 Inhibitor of Nuclear Export (“SINE”)inhibitor compounds that inhibit the nuclear export protein exportin 1 (“XPO1”). These SINE 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 (“FDA”) in July 2019, and is currently approved and marketed in the U.S. for the following indications:
The commercialization of XPOVIO in the U.S. is currently supported by sales representatives, nurse liaisons, and a market access team, as well as KaryForward®, an extensive patient and healthcare provider support program. Our commercial efforts are also supplemented by patient support initiatives coordinated by our dedicated network of participating specialty pharmacy providers. We plan to continue to educate physicians, other healthcare providers and patients about XPOVIO’s clinical profile and unique mechanism of action as we continue to expand XPOVIO use.
The commercialization of XPOVIO and NEXPOVIO® (selinexor) (the brand name for selinexor in Europe and the United Kingdom) outside of the U.S. is managed by our partners in their respective territories. XPOVIO/NEXPOVIO has received regulatory approval in various indications in over 45 countries outside the U.S. and is commercially available in a growing number of countries as our partners continue to secure reimbursement approvals.
Our primary focus is on marketing XPOVIO in its currently approved indications as well as developing and seeking the regulatory approval of selinexor as an oral agent targeting multiple high unmet need cancer indications, including our lead clinical programs in myelofibrosis and endometrial cancer and our other late-stage clinical programsprogram in multiple myeloma. Depending on the data in our Phase 3 myelofibrosis and/or endometrial cancer programs and multiplethe myeloma.availability Weof capital resources, we plan to continueexplore opportunities to conductdevelop clinicalour trialsleading next-generation XPO1 inhibitor, eltanexor, in additional myeloproliferative neoplasms and toTP53 seekwild-type additional approvals for the use of selinexor as a single agent or in combination with other oncology therapies to expand the patient populations that are eligible for treatment with selinexor. As announced in January 2024, further clinical development of our eltanexor program continues to remain on hold in an effort to focus our resources on our prioritized late-stage programs.tumors.
The commercialization of XPOVIO in the U.S. is currently supported by sales representatives, nurse liaisons, and a market access team, as well as KaryForward®, an extensive patient and healthcare provider support program. Our commercial efforts are also supplemented by patient support initiatives coordinated by our dedicated network of participating specialty pharmacy providers.
The commercialization of XPOVIO and NEXPOVIO® (selinexor) (the brand name for selinexor in Europe and the United Kingdom) outside of the U.S. is managed by our partners in their respective territories. XPOVIO/NEXPOVIO has received regulatory approvals in various indications in 50 territories and countries outside the U.S. and is commercially available in a growing number of countries as our partners continue to secure reimbursement approvals.
In September 2025, we completed enrollment in our ongoing Phase 3 clinical trial to evaluate the efficacy and safety of once-weekly selinexor in combination with ruxolitinib versus placebo plus ruxolitinib in JAK2 inhibitor (“JAKi”)-naive myelofibrosis patients (the “SENTRY Trial”). We expect to report top-line data from the SENTRY Trial in March 2026. We continue to enroll JAKi-naïve myelofibrosis patients in the Phase 2 clinical trial to evaluate the safety and efficacy of selinexor as a monotherapy in patients with JAKi-naïve myelofibrosis with moderate thrombocytopenia (the “SENTRY-2 Trial”). The protocol, as amended in 2025, includes patients with platelet counts above 50,000 per microliter. We expect to report top-line data from all patients in the 60 mg cohort with at least 24 weeks of follow-up in the second half of 2026.
We are continuing to enroll patients in a global, Phase 3, randomized, double-blind trial evaluating selinexor as a maintenance-only therapy following systemic therapy in patients with TP53 wild-type advanced or recurrent endometrial cancer (the “XPORT-EC-042 Trial”). We expect to report top-line data from this event-driven trial in mid-2026.
In October 2025, we entered into a series of transactions with our term loan lenders, holders of our outstanding convertible notes and other investors to provide financial flexibility, additional working capital and equitize maturing notes (collectively, the “Financing Transactions”). The Financing Transactions included the following key components: (i) $27.5 million in new term loan borrowings and new convertible debt; (ii) $25.4 million of near-term deferrals of interest and royalty payments; (iii) a temporary reduction of $15.0 million in our minimum liquidity covenant; (iv) an exchange of $15.0 million aggregate principal amount of our convertible notes due 2029 for shares of common stock; (v) an exchange of $24.3 million aggregate principal amount of our convertible notes due October 15, 2025 for shares of our common stock and warrants to purchase shares of our common stock; and (vi) a private placement of shares of our common stock and warrants to purchase shares of our common stock for gross proceeds of approximately $8.8 million. In connection with the Financing Transactions, we issued an aggregate of 7,223,982 shares of common stock, pre-funded warrants to purchase an aggregate of 2,913,136 shares of common stock, and warrants to purchase an aggregate of 5,918,358 shares of common stock with an exercise price of $6.64 per share. In addition, we reduced the exercise price of outstanding warrants to purchase 3,068,417 shares from $16.50 to $6.64 per share.
Following consummation of the Financing Transactions, we had $116.5 million outstanding under our senior secured term loan with a maturity date in May 2028 (the “Amended Term Loan”), $15.0 million aggregate principal amount of 9.00% senior secured convertible notes due October 2028, $103.5 million aggregate principal amount of 9.00% senior secured convertible notes due May 2029, and $116.2 million of maximum remaining payments payable under our revenue interest financing agreement.
In May 2024, we entered into a series of transactions (the “Refinancing Transactions”) to limit our aggregate indebtedness, extend the maturity of certain of our indebtedness and provide us with additional working capital. Pursuant to these transactions, we borrowed $100.0 million from existing lenders and certain entities managed by HealthCare Royalty Management, LLC (“HCRx”) under a $100.0 million senior secured term loan facility (the “Term Loan”) and used a portion of the proceeds of the Term Loan to repay obligations under our existing financing arrangement with HCRx pursuant to an amendment that made other changes to our existing financing arrangement with HCRx. We also exchanged, pursuant to privately negotiated agreements, an aggregate principal amount of $148.0 million of our existing 3.00% unsecured convertible senior notes due 2025 (the “2025 Notes”) for (i) $111.0 million aggregate principal amount of new 6.00% secured convertible senior notes due 2029 (the “2029 Notes”) and (ii) warrants to purchase up to 45.8 million shares of our common stock. In addition, HCRx purchased $5.0 million aggregate principal amount of the 2029 Notes through satisfaction of $5.0 million of our existing obligations to HCRx. Please refer to Note 10 “Long-Term Obligations”, to the consolidated financial statements included under Part II, Item 8 of this Annual Report on Form 10-K for additional details of the Refinancing Transactions.
As of December 31, 2024,2025, we had an accumulated deficit of $1.6$1.8 billion. We had net losses of $76.4$196.0 million, $143.1$76.4 million, and $165.3$143.1 million for the years ended December 31, 2024,2025, 20232024 and 2022,2023, respectively. We recognized total revenue of $145.2$146.1 million in 2024,2025, including $112.8$114.9 million of XPOVIO net product revenue and $32.4$31.2 million of license revenue. License revenue included $15.0 million of revenue for the reimbursement of development related expenses from the Menarini Group (“Menarini”). As of December 31, 2024,2025, we had $108.7$63.7 million in cash, cash equivalents and investments. Based on our current business plan and current capital resources, combined with the uncertainty regarding the availability of additional funding or other strategic alternatives and considering our debt obligations,service includingobligations aand requirementfinancial covenant to maintain cash,minimum cash equivalents and investments of at least $25.0 million at all times,liquidity, we have concluded that there is substantial doubt regarding our ability to continue as a going concern within one year after the date the accompanying consolidated financial statements are issued. See “Liquidity, Capital Resources, and Going Concern” below for a further discussion of our liquidity and the conditions that raise substantial doubt regarding our ability to continue as a going concern.
We recognize product revenue, net of variable consideration related to certain allowances and accruals, when the customer takes control of the product, which is upon delivery to the customer. Revenue from product sales is recorded at the net sales price, which includes estimates of variable consideration for which reserves are reported. These reserves are based on the amounts earned, or to be claimed on the related sales, and are generally classified as reductions of accounts receivable (if the amount is payable to the customer) or a current or long-term liability (if the amount is payable to a party other than a customer). Certain amounts are known at the time of sale based on contractual terms and are recorded pursuant to the most likely amount method, which is the single most likely amount in a range of possible considerations. Other amounts are estimated pursuant to the expected value method, which is the sum of probability-weighted amounts in a range of possible consideration amounts. Relevant factors used in the expected value method include: current contractual and statutory requirements, specific known market events and trends, industry data, and forecasted customer buying and payment patterns. These reserves reflect our best estimates of the variable consideration based on the terms of the respective underlying contracts.
The estimates for our product revenue allowances and accruals are most significantly affected by chargebacks, which are contractual commitments to provide products to qualified healthcare entities at prices lower than the list prices charged to our customers who purchase XPOVIO directly from us, and rebates that represent discount obligations under government programs, including Medicaid, Medicare, Tricare, the Department of Veterans Affairs, the Department of Defense, and others.
We estimate our accrued research and development costs by reviewing quotes and contracts, identifying services that have been performed on our behalf, and estimating the associated cost incurred for services performed when we have not yet been invoiced or otherwise notified of the actual cost. Most of our service providers invoice us monthly in arrears for services performed or when contractual milestones are met. We make estimates of our accrued research and development costs at each balance sheet date in our financial statements based on facts and circumstances known to us at that time. We periodically confirm the accuracy of our estimates with the service providers and make adjustments if necessary. The significant estimates in our accrued research and development costs include fees toincurred be paid towith contract research organizations (“CROs”) and contract manufacturing organizations (“CMOs”) in connection with research and development activities, as well as fees to be paid to investigative sites in connection with clinical studies, for which we have not yet been invoiced.
We base our expenses related to CROs and CMOs on our estimates of the services performed and efforts expended pursuant to quotes and contracts with CROs and CMOs that conduct research and development activities on our behalf. The payment terms of these agreements are subject to negotiation, vary from contract to contract and may result in uneven payment flows. There may be instances in which payments made to our service providers will exceed the level of services performed and result in a prepayment. In accruing service fees, we estimate the time period over which the services will be performed and the level of effort to be expended in each period. If the actual timing of the performance of services or the level of effort varies from our estimates, we adjust the accrual or prepayment accordingly. Although we do not expect our estimates to be materially different from amounts actually incurred, if our estimates of the status and timing of services performed differ from the actual status and timing of services performed, it could result in us reporting amounts that are too high or too low in any particular period. To date, our estimates have not been materially different than amounts actually incurred.
RefinancingFinancing Transactions
Our estimated value of the gain or loss on extinguishment of debt, the embedded derivatives in theour 2029convertible Notes (as defined above)notes and the liability-classified common stock warrants relatedon toour theconsolidated Refinancingbalance Transactions,sheets were valued using methodologies that incorporate certain unobservable inputs including (i) the volatility of our common stock price, (ii) our estimated credit spread and (iii) an estimate of when the warrants will be exercised based on an option pricing model. See Notethe 6, “Fair Value Measurements”, and Note 10, “Long-Term Obligations”,notes to the consolidated financial statements included under Part II, Item 8 of this Annual Report on Form 10-K for additional information.
To date, our only source of product revenue has been from the U.S. sales of XPOVIO. Net product revenue from U.S. commercial sales of XPOVIO for the year ended December 31, 20242025 wasincreased relativelyby consistent$2.1 asmillion compared to the year ended December 31, 2023.2024, XPOVIOprimarily due to higher net productprice revenueyear wasover adverselyyear. impactedGross-to-net year-over-yearadjustments remained relatively consistent year over year and reflected lower 340B chargeback discounts in 2025, which were offset by higher gross-to-netMedicare adjustmentsInflation inRebate 2024, driven primarily by 340B discountscharges and Medicarean rebates.increase Weto expect netthe product revenuereturns to increase in 2025 as compared to 2024 due to demand growth.reserve.
License and other revenue for the year ended December 31, 20242025 decreased by $1.6$1.2 million as compared to the year ended December 31, 20232024 primarily due to a decrease in milestone-related revenue from our other license agreements, offset by an increase in milestone-related and royalty revenue from Menarini.agreements. The license agreements with Menarini and Antengene Therapeutics Limited (“Antengene”) are each defined and described in Note 5, “License Agreements”, to the consolidated financial statements included under Part II, Item 8 of this Annual Report on Form 10-K.
We expect license and other revenue to slightlydecrease decreaseas a result of the expiration of Menarini’s reimbursement of development-related expenses, which had previously provided up to $15.0 million in 2025 as compared to 2024 primarily due to a decrease in milestone-relatedother revenue from our partners.annually.
Cost of sales for the year ended December 31, 20242025 was relatively consistent with the year ended December 31, 2023. We expect cost of sales to remain relatively consistent in 2025 as compared to 2024.
At any one time, we have a number of ongoing clinical development programs that we are conducting independently or in collaboration with third parties. We track our external clinical trial and related costs on a program-by-program basis. Our major programs include our lead clinical programs in myelofibrosis and endometrial cancer and our other late-stage clinical programsprogram in endometrial cancer and multiple myeloma. To the extent that external clinical trial and related costs are not attributable to a major program, they are included in “Other programs” and to the extent external clinical trial and related costs cannot be allocated to a specific program, they are included in “Non-program specific clinical trial and related costs.” We also have unallocated research and development costs, which we do not track on a program-by-program basis. These costs represent expenses incurred across multiple programs or to support our general research and development operations.
Research and development expenses for the year ended December 31, 2025 decreased by $17.6 million as compared to the year ended December 31, 2024, primarily due to lower personnel and stock-based compensation costs and reduced clinical trial spending. Personnel and stock-based compensation costs decreased by $9.7 million as a result of lower headcount and reduced contractor utilization following previously implemented cost reduction initiatives. In addition, clinical trial and related costs for selinexor in multiple myeloma decreased by $8.7 million, reflecting the reduced scope of our Phase 3 trial, including lower comparator drug expenses. These decreases were partially offset by a $5.0 million increase in clinical trial and related costs for selinexor in myelofibrosis, primarily driven by increased trial activity and higher patient enrollment.
We expect our research and development expenses to increase as we continue to support our ongoing Phase 3 trials as they progress from the enrollment phase to the maintenance phase. In the event of positive top-line data in any of our trials, we would expect to incur incremental costs primarily associated with regulatory filings.
Research and development expenses for the year ended December 31, 2024 increased by $4.5 million as compared to the year ended December 31, 2023. The $9.8 million increase in clinical trial and related costs was primarily due to increased activity in each of our ongoing Phase 3 trials, including increased purchases of comparator drugs. These increases were partially offset by a $9.8 million decrease in clinical trial and related costs in other programs. The decrease in personnel costs of $5.7 million was primarily due to a reduction in headcount and contractors for the year ended December 31, 2024 as compared to the year ended December 31, 2023 due to the realization of previously implemented cost reduction initiatives.
We expect our research and development expenses to decrease in 2025 as compared to 2024 due primarily to full enrollment in mid-2024 of our Phase 3 multiple myeloma study and decreased headcount costs, partially offset by an increase in expenses in connection with our ongoing Phase 3 trials in myelofibrosis and endometrial cancer.
Selling, general and administrative expenses for the year ended December 31, 20242025 decreased by $16.4$10.2 million as compared to the year ended December 31, 2023. The decrease in personnel costs of $8.8 million and the decrease in stock-based compensation of $1.5 million were2024, primarily due to a reductionreductions in headcountpersonnel-related costs. Personnel costs decreased by $6.2 million and contractorsstock-based forcompensation thedecreased yearby ended$3.6 Decembermillion, 31,reflecting 2024lower asheadcount comparedresulting to the year ended December 31, 2023 due tofrom our ongoing cost reduction initiatives. The decrease in consulting,Consulting, professional and other costs ofremained $6.2relatively millionconsistent wasyear over year, as increases in professional fees, primarily duelegal tofees, lowerwere commercial-relatedmore activitiesthan offset by cost reduction measures in connectionother withareas, costincluding optimizationmarketing effortsagencies duringand 2024.other commercial spend.
We expect selling, general and administrative expenses to remain relatively consistent. In the event of positive top-line data in any of our trials, we would expect to incur incremental costs related to launch preparation.
We expect our selling, general and administrative expenses to slightly decrease in 2025 as compared to 2024 due to continued realization of previously implemented cost reduction initiatives.
OtherTotal incomeother (expense), income, net for the year ended December 31, 20242025 increased by $56.3$148.4 million as compared to the year ended December 31, 2023,2024. The increase was driven primarily dueby a $107.1 million increase in the loss on extinguishment of debt, reflecting a $62.4 million loss recorded in 2025 related to the Financing Transactions, compared to a $44.7 million gain onrecorded extinguishmentin of debt2024 from the Refinancing Transactions and a $28.7separate millionrefinancing gaintransaction. fromIn theaddition, other income, net decreased by $28.2 million, primarily due to non-cash remeasurement of embedded derivatives and liability-classified common stock warrants,warrants. bothInterest ofexpense which are non-cash items. These gains were partially offsetincreased by an$8.4 increasemillion, primarily due to debt issuances in 2024 and 2025 and higher interest expenserates relatedon toour debt following the TermFinancing LoanTransactions. and the 2029 Notes and a decrease inLastly, interest income resultingdecreased fromby $4.6 million due to lower investment balances in 2024 as2025 compared to 2023.2024.
We expect total other income (expense), income, net to decreasedecrease, in 2025 as compared to 2024primarily due to the $44.7 million gain ondebt extinguishment ofrecorded debtin being2025 ain one-time,connection non-recurringwith item.the Financing Transactions. We also expect increased interest expense into 2025increase as compareda toresult 2024of onhigher debt balances and interest rates in 2026 following the TermFinancing Loan and the 2029 Notes, as both of these instruments were issued in May 2024, and 2025 will include a full year of interest expense on these instruments.Transactions. The future impact fromof remeasurements of the embedded derivatives and liability-classified common stock warrants will depend on a variety of factors, including movements in our stock price, and cannot be forecasted.
We have historically financed our operations primarily through a combination of proceeds from (i) product revenue sales,sales; (ii) public and private placements of equity securities,securities; (iii) the issuance of convertible debt,debt; (iv) a term loan,loan; (v) our deferred royalty obligation,obligation; (vi) at the market offerings; and (vii) business development activities. As of December 31, 2024,2025, our principal source of liquidity was $108.7$63.7 million of cash, cash equivalents and investments. We have had recurring losses since inception and incurred aan operating loss of $76.4$90.7 million for the year ended December 31, 2024.2025.
We anticipate that we will continue to incur significant operating losses in the foreseeable future. Based on our current business plan and current capital resources, combined with the uncertainty regarding the availability of additional funding or other strategic transactions and considering our debt obligations,service includingobligations aand requirementfinancial covenant to maintain cash,minimum cash equivalents and investments of at least $25.0 million at all times,liquidity, we have concluded that there is substantial doubt regarding our ability to continue as a going concern within one year after the date the accompanying consolidated financial statements are issued. We expect that our existing liquidity, including cash, cash equivalents and investments as of December 31, 20242025 as well as cash flow from net product revenue and license and other revenue, will beenable sufficientus to fund our current operating plans and debt obligation requirements into the fourthsecond quarter of 2025.2026. See “Liquidity, Capital Resources and Going Concern – Funding Requirements” below and Note 1 “Organization and Operations” to the consolidated financial statements included under Part II, Item 8 of this Annual Report on Form 10-K for a further discussion of our liquidity and the conditions that raise substantial doubt regarding our ability to continue as a going concern.
The $34.8 million increase in netNet cash used in operating activities decreased by $52.1 million during the year ended December 31, 2024 as2025 compared to the year ended December 31, 20232024. The decrease was primarily driven by workinglower capitalcash changes,disbursements includingresulting from reduced operating expenses and the collectiondeferral of $27.3cash millioninterest ofand milestoneroyalty payments fromassociated Antengenewith inthe 2023.Financing Transactions.
Net cash provided by investing activities increaseddecreased by $87.5$52.1 million during the year ended December 31, 2024 as2025 compared to the year ended December 31,2023.31, 2024. Proceeds from the maturities of investments decreased by $12.7$111.1 millionmillion, in 2024, which was significantlypartially offset by a decrease of $100.3$58.8 million decrease in purchases of investmentsinvestments, in 2024, due toreflecting liquidity needs to fund our operations.
The $40.5 million increase in netNet cash provided by financing activities decreased by $11.6 million during the year ended December 31, 2024 as2025 compared to the year ended December 31, 20232024. The decrease was primarily driven by $83.3lower million ofnet proceeds from thedebt Termand Loan,equity partiallyfinancing offsetin by2025 a $40.5 million payment of our deferred royalty obligationcompared to HCRx and a $2.6 million payment of debt issuance costs related to the Refinancing Transactions.2024.
In October 2025, we entered into a securities purchase agreement with certain institutional investors to which we issued and sold, in a private placement, an aggregate of (i) 1,487,917 shares of common stock at a price per share of $5.88 and (ii) accompanying warrants to purchase 1,317,771 shares of common stock at an exercise price of $6.64 per share. We received aggregate gross proceeds of approximately $8.8 million.
In October 2025, we entered into a note purchase agreement pursuant to which issued and sold, in a private placement, $15.0 million aggregate principal amount of new 9.00% senior secured convertible notes due 2028 (the “2028 Notes”) to certain holders of our existing 6.00% senior secured convertible notes due 2029. The 2028 Notes are senior secured second-lien obligations and bear interest at a rate of 9.00% per year payable quarterly in arrears on March 31, June 30, September 30, and December 31 of each year, beginning on December 31, 2025. Interest will be paid in kind on December 31, 2025 and March 31, 2026 with cash interest payments beginning on June 30, 2026. The 2028 Notes will mature on October 15, 2028, unless earlier converted, redeemed or repurchased in accordance with their terms.
OnIn September 14,September, 2019, we and certain of our subsidiaries entered into the Revenue Interest Financing Agreement with certain entities managed by HCRx, which was subsequently amended on June 23, 2021, August 1, 2023 and2023, May 8, 20242024, August 14, 2025, August 27, 2025 and October 7, 2025 and which was assigned in July 2025 by HCRx to KKR in connection with its acquisition of a majority ownership stake in HCRx (the “Revenue Interest Agreement” and, as amended, the “Amended Revenue Interest Agreement”), pursuant to which, HCRx paid us a total of $135.0 million, less certain transaction expenses. ForIn additionalOctober information2025, we entered into the Sixth Amendment to the Revenue Interest Financing Agreement pursuant to which (i) HCRx waived our obligation to pay royalties on revenue recognized between April 1, 2025 and March 31, 2026 and (ii) we agreed to increase the Applicable Tiered Percentage (as defined in the Amended Revenue Interest Agreement,Agreement ) to 8.00% beginning on April 1, 2026. The total amount payable under the Revenue Interest Financing Agreement will remain capped at $263.3 million. For additional information, see Note 10, “Long-Term Obligations”, to the consolidated financial statements included under Part II, Item 8 of this Annual Report on Form 10-K.
In May 2024, we entered into a credit and guaranty agreement (the “Credit Agreement”) with certain existing lenders and HCRx, which was subsequently assigned by HCRx to KKR in connection with its acquisition of a majority ownership stake in HCRx in July 2025, which provides for a senior secured term loan facility of $100.0 million (the “Term Loan”). In October 2025, we entered into the First Amendment and Waiver to Credit and Guaranty Agreement with the lenders party thereto and Wilmington Savings Fund Society, FSB, as administrative agent for the lenders and collateral agent (the “Amended Credit Agreement”), pursuant to which, among other things, the lenders provided $12.5 million principal amount of additional loans (the “Amended Term Loan”). The amendments to the Credit Agreement include, among other things (i) reducing the financial covenant requiring us to maintain liquidity of at least $10.0 million, subject to increase in the event we issue indebtedness for borrowed money or issue capital stock, through October 10, 2026, after which we will be required to maintain liquidity of at least $25.0 million and (ii) increasing the interest rate on borrowings under the Amended Term Loan to the secured overnight financing rate plus 10.25% for interest payments occurring after June 30, 2025. Interest on borrowings under the Amended Term Loan incurred from July 1, 2025 to October 10, 2025 were paid in kind at closing. Interest on borrowings will be paid in kind on December 31, 2025 and March 31, 2026 and cash interest payments will begin on June 30, 2026. For additional information, see Note 10, “Long-Term Obligations”, to the consolidated financial statements included under Part II, Item 8 of this Annual Report on Form 10-K.
On May 8, 2024, we entered into a credit and guaranty agreement (the “Credit Agreement”) with certain existing lenders and HCRx, which provides for a senior secured term loan facility of $100.0 million. For additional information, see Note 10, “Long-Term Obligations”, to the consolidated financial statements included under Part II, Item 8 of this Annual Report on Form 10-K.
OnIn February 17, 2023, we entered into an Open Market Sale Agreement (the “2023 Open Market Sale Agreement”) with Jefferies LLC, as agent (“Jefferies”). Under the 2023 Open Market Sale Agreement, we may issue and sell shares of our common stock having an aggregate offering price of up to $100.0 million (the “Shares”) from time to time through Jefferies. We did not sell any Shares under the 2023 Open Market SalesSale Agreement during the year ended December 31, 2024.2025. As of December 31, 2024,2025, $100.0 million of Shares was available for issuance and sale under the 2023 Open Market Sale Agreement.
During the year ended December 31, 2024,2025, we received $19.6$8.2 million in milestone and upfront payments under our license and distribution arrangements pursuant to which we are entitled to receive additional milestone payments, if certain development goals and sales milestones are achieved, as well as royalties on future net sales of the licensed and sold products in the territories under such arrangements. In addition, under the Menarini Agreement, Menarini will reimbursereimbursed us $15.0 million per calendar year, or $60 million in total, for 25% of all development related expenses we incurincurred for selinexor from 2022 through 2025, provided that such reimbursements shall not exceed $15.0 million per calendar year. We received $15.0 million of reimbursements for development related expenses under the Menarini Agreement during the year ended December 31, 2024.2025.
We are party to an operating lease of office and research space in Newton, Massachusetts, which was amended in November 2024 and under which we currently lease a total of 98,50252,224 square feet of research and office space through September 30, 2025, which will be reduced to 52,224 square feet of solely office space from October 1, 2025 through September 30, 2030. We expect to incur total lease costs of $10.9 million from January 1, 2025 to September 30, 2030.
We have contractual obligations under our (i) 2025Amended NotesCredit Agreement; (ii) Credit2028 Agreement,Notes; (iii) 9.00% convertible senior notes due 2029 Notes,; and (iv) Amended Revenue Interest Agreement as disclosed in Note 10, “Long-Term Obligations”, to the consolidated financial statements included under Part II, Item 8 of this Annual Report on Form 10-K.
We expect to continue to incur costs related to our clinical development programs as we continue to advance our lead clinical programs in myelofibrosis and endometrial cancer and our other late-stage clinical programsprogram in endometrial cancer and multiple myeloma, as well as commercialization expenses related to sales, marketing, manufacturing and distribution of our approved products, to the extent that these functions are not the responsibility of our collaborators.
Identifying potential product candidates and conducting preclinical studies and clinical trials is a time-consuming, expensive and uncertain process that takes years to complete. In addition, our product candidates for which we receive marketing approval may not achieve commercial success. Our ability to become and remain profitable depends on our ability to generate revenue. There can be no assurance as to the amount or timing of any such revenue, and we may not achieve profitability forin severalthe years,near-term, if at all, as described more fully in the risk factor entitled “We have incurred significant losses since inception, expect to continue to incur significant losses, and may never achieve or maintain profitability,” under the heading “Risk Factors” in this Annual Report on Form 10-K. Accordingly, we will need to continue to rely on additional financing to achieve our business objectives. Adequate additional financing may not be available to us on acceptable terms, or at all. We may seek additional capital due to favorable market conditions or strategic considerations, even if we believe we have sufficient funds for our current or future operating plans. If we are unable to raise capital when needed or on attractive terms, we would be forced to delay, reduce or eliminate our research and development programs or commercialization efforts.
Based on our current business plan and current capital resources, combined with the uncertainty regarding the availability of additional funding or other strategic alternatives and considering our debt obligations,service includingobligations aand requirementfinancial covenant to maintain cash,minimum cash equivalents and investments of at least $25.0 million at all times,liquidity, we have concluded that there is substantial doubt regarding our ability to continue as a going concern within one year after the date the accompanying consolidated financial statements are issued. See Note 1, “Organization and Operations”, to the consolidated financial statements included under Part II, Item 8 of this Annual Report on Form 10-K for a further discussion of the conditions that raise substantial doubt regarding our ability to continue as a going concern. We currently expect that cash, cash equivalents and investments as of December 31, 2024 will be sufficient to fund our current operating plans and debt obligation requirements into the fourth quarter of 2025 while we continue to commercialize XPOVIO in the U.S. and continue the clinical trials of our product candidates. Our future long-term capital requirements will depend on many factors, as described more fully in the risk factor entitled “We will need additional funding to achieve our business objectives. If we are unable to raise capital when needed or on acceptable terms, we would be forced to delay, reduce or eliminate our research and development programs and/or commercialization efforts,” under the heading “Risk Factors” in this Annual Report on Form 10-K.
We currently expect that our existing liquidity, including cash, cash equivalents and investments as well as cash flow from net product revenue and license and other revenue, will enable us to fund our current operating plans into the second quarter of 2026. We will require additional capital to complete the ongoing clinical development of selinexor, including the Phase 3 SENTRY Trial beyond top-line results and the Phase 3 XPORT-EC-042 Trial and the Phase 3 XPORT-MM-031/EMN29 trial. We plan to address the conditions that raise substantial doubt regarding our ability to continue as a going concern by, among other things, obtaining additional funding through equity offerings, debt financings and refinancings, collaborations, strategic alliances and/or licensing arrangements. We expect to evaluate opportunities to raise additional funds from time to time, including through the issuance and sale of shares of our common stock under our Open Market Sale Agreement and in connection with the reporting of data from our ongoing Phase 3 clinical trials. There is no assurance that such additional financing or strategic alternatives will be available on terms acceptable to us, or at all. Our ability to successfully raise additional funds or execute on a strategic alternative is dependent on a number of factors. If we are not able to successfully consummate a financing transaction or strategic alternative, our Board may explore a sale of assets or the initiation of bankruptcy proceedings under Chapter 11 of the U.S. Bankruptcy Code. Further, our indebtedness, as discussed under the risk factor titled “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,” under the heading “Risk Factors” in this Annual Report on Form 10-K, may be unattractive to potential sources of funding and strategic partners and may decrease our ability to consummate a financing transaction or enter into a strategic alternative. Additionally, the negotiation and consummation of a financing transaction or strategic alternative may be costly and time-consuming.
Our future long-term capital requirements will depend on many factors, as described more fully in the risk factor entitled “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,” under the heading “Risk Factors” in this Annual Report on Form 10-K.
Future obligations related to the 2025 Notes of $25.2 million through October 2025;
Future obligations related to the 2029Amended NotesCredit Agreement of $146.4$153.2 million through May 20298, 2028 in addition to the financial covenant to maintain minimum liquidity;
Future obligations related to the 2028 Notes of $19.2 million through October 15, 2028;
Future obligations related to the New 2029 Notes of $138.2 million through May 13, 2029;
Future royalty obligations to KKR under the Amended Revenue Interest Agreement of $116.2 million by September 26, 2035.
Future obligations related to the Credit Agreement of $142.7 million through May 2028 in addition to our requirement to maintain cash, cash equivalents and investments of at least $25.0 million at all times; and Future royalty obligations to HCRx under the Amended Revenue Interest Agreement of $119.9 million by October 1, 2031.
What changed in the latest 10-Q
Risk Factors
New heading “We are evaluating 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 our existing debt; potential 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.”
New heading “In the event we file for bankruptcy, we would be subject to the risks and uncertainties associated with such proceedings.”
New heading “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.”
Removed heading “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.”
Largest changes
see in full comparisonWe believe that our existing liquidity, including cash and cash equivalents, as well as cash flow from net product revenue and license and other revenue, will enable us to fund our current operating plans to late in the third quarter of 2026.We will require additional capital to fundtheourongoingoperations and clinical development of selinexor andother product candidates andto pursuepotential regulatory approvals. We have based this assessment on assumptions that may prove to be wrong, and we could exhaust our capital resources sooner than we expect. We anticipate that we will continue to incur significant operating losses as we continue our research and development programs, including as we continue to develop and seekregulatory approval of selinexorforinmultiple cancer indications, and to support our continued operations.myelofibrosis. As a result, our continued operations are dependent on our ability to raise additional funding and/or enter into strategic alternatives, as described in the risk factor entitled “Wewillneed 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 undertake additional cost reduction measures such as further reducing operating expenses, including through additional workforce reductions, delay, reduce or eliminate our research and development programs and/or commercializationefforts,efforts or at any time we may elect to or may be required to cease operations entirely, liquidate all or a portion of our assets, and/or seek protection under the U.S. Bankruptcy Code, and you may lose all or part of your investment,” below. Based on our current business plan and current capital resources, combined with the uncertainty regarding the availability of additional funding or other strategic alternatives and considering our debt service obligations, including requirements under the Amended Credit Agreement, as defined below, and the indentures governing our 9.00% convertible senior notes due 2028 (the “2028 Notes”) and 9.00% convertible senior notes due 2029 (the “New 2029 Notes”, and together with the 2028 Notes, the “Convertible Notes”) to maintain cash, cash equivalents and investments through October 10, 2026 of at least the lesser of (i) $10.0 million plus 50% of the net cash proceeds received from certain debt and equity issuances and (ii) $25.0 million, and $25.0 million thereafter, we have concluded that there is substantial doubt regarding our ability to continue as a going concern within one year after the date the accompanying consolidated financial statements are issued.
“We expect that our existing liquidity, including cash, cash equivalents and investments, as well as cash flow from net product revenue and license and other revenue, will enable us to fund our current operating plans into September 2026. …”see in full comparison
“We expect that our existing liquidity, including cash, cash equivalents and investments, as well as cash flow from net product revenue and license and other revenue, will enable us to fund our current operating plans into September 2026. …”see in full comparison
“With the assistance of our advisors, including our financial advisor Centerview Partners and other advisors, we are actively evaluating a range of financing opportunities and strategic alternatives with the objective of extending our cash runway, preserving strategic flexibility and maximizing long-term shareholder value as we advance our myelofibrosis program. Our ability to successfully consummate a financing transaction or execute on a strategic alternative is dependent on a number of factors. …”see in full comparison
In addition, changes in government policies, priorities and administration could create increased uncertainty and volatility that adversely affect our business, our ability to raise capital, and our ability to enter into strategic alternatives. For example, evolving healthcare, pricing and reimbursement policies, including potential drug pricing reforms such as “most-favored-nation” or similar pricing frameworks, as well as shifts in regulatory or enforcement priorities at federal agencies, including the FDA and other governmental bodies, could negatively affect investor sentiment, the perceived commercial viability of our product and our access to financing. Further, instability or disruption in the global or domestic banking system could impair our access to cash deposits or limit the availability of financing from financial institutions. If adequate funds are not available to us on a timely basis or on attractive terms, we may be required to take additional actions to address our liquidity needs, including additional cost reduction measures such as further reducing operating expenses, including through additional workforce reductions, or to delay, reduce or eliminate our research and development programs or any current or future commercialization efforts for one or more of our products or product candidates, which could have a material adverse effect on our business, operating results and prospects. We may be required to or elect to cease operations entirely at any time, liquidate all or a portion of our assets, and/or seek protection under the U.S. Bankruptcy Code, and you may lose all or part of your investment. Future sales and issuances of equity securities would result in substantial dilution to our stockholders..see in full comparison
“In the event we file for relief under the U.S. Bankruptcy Code, our operations and our continuation as a going concern will be subject to the risks and uncertainties associated with bankruptcy proceedings. Any delays in our bankruptcy proceedings would increase the risks of our being unable to reorganize our business and emerge from bankruptcy proceedings and may increase our costs associated with the bankruptcy process or result in prolonged operational disruption for us. …”see in full comparison
Full comparison: every changed paragraph (87)
We will require substantial funds to maintain our research and development programs, including as we continue to support our operations and develop and seek regulatory approval of selinexor forin multiplemyelofibrosis canceror indications,any andfuture toproducts supportor ourproduct continued operations.candidates. We have incurred significant operating losses since our inception. As of MarchJune 31,30, 2026, we had approximately $90.9$65.1 million in cash, cash equivalents, and cash equivalents.investments.
We expect that our existing liquidity, including cash, cash equivalents and investments, as well as cash flow from net product revenue and license and other revenue, will enable us to fund our current operating plans into September 2026. On September 10, 2026, a $15.8 million principal payment is due under our senior secured term loan facility; if this payment is made without additional financing or a waiver from our lenders, we expect that (i) our cash, cash equivalents and investments will fall below our $10.0 million minimum liquidity covenant, which would trigger a default on our term loan and (ii) we will not have sufficient resources to fund our operations following such payment. In addition to the $15.8 million principal payment due on September 10, 2026, we have approximately $10.1 million of aggregate interest payments due on September 30, 2026 under our senior secured term loan, 2028 Notes and 2029 Notes.
We believe that our existing liquidity, including cash and cash equivalents, as well as cash flow from net product revenue and license and other revenue, will enable us to fund our current operating plans to late in the third quarter of 2026. We will require additional capital to fund theour ongoingoperations and clinical development of selinexor and other product candidates and to pursue potential regulatory approvals. We have based this assessment on assumptions that may prove to be wrong, and we could exhaust our capital resources sooner than we expect. We anticipate that we will continue to incur significant operating losses as we continue our research and development programs, including as we continue to develop and seek regulatory approval of selinexor forin multiple cancer indications, and to support our continued operations.myelofibrosis. As a result, our continued operations are dependent on our ability to raise additional funding and/or enter into strategic alternatives, as described in the risk factor entitled “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 undertake additional cost reduction measures such as further reducing operating expenses, including through additional workforce reductions, delay, reduce or eliminate our research and development programs and/or commercialization efforts,efforts or at any time we may elect to or may be required to cease operations entirely, liquidate all or a portion of our assets, and/or seek protection under the U.S. Bankruptcy Code, and you may lose all or part of your investment,” below. Based on our current business plan and current capital resources, combined with the uncertainty regarding the availability of additional funding or other strategic alternatives and considering our debt service obligations, including requirements under the Amended Credit Agreement, as defined below, and the indentures governing our 9.00% convertible senior notes due 2028 (the “2028 Notes”) and 9.00% convertible senior notes due 2029 (the “New 2029 Notes”, and together with the 2028 Notes, the “Convertible Notes”) to maintain cash, cash equivalents and investments through October 10, 2026 of at least the lesser of (i) $10.0 million plus 50% of the net cash proceeds received from certain debt and equity issuances and (ii) $25.0 million, and $25.0 million thereafter, we have concluded that there is substantial doubt regarding our ability to continue as a going concern within one year after the date the accompanying consolidated financial statements are issued.
With the assistance of our advisors, including our financial advisor Centerview Partners and other advisors, we are actively evaluating a range of financing opportunities and strategic alternatives with the objective of extending our cash runway, preserving strategic flexibility and maximizing long-term shareholder value as we advance our myelofibrosis program. Our ability to successfully consummate a financing transaction or execute on a strategic alternative is dependent on a number of factors. There is no assurance that these efforts will result in additional funding, executing a strategic alternative transaction, will increase value for stakeholders, or will sufficiently address our ability to continue as a going concern. Absent additional funding or our ability to successfully complete one or more strategic transactions to extend our cash runway beyond September 10, 2026, we will be unable to continue as a going concern and we may have to consider seeking protection under the bankruptcy laws, liquidating our assets or ceasing our operations. If we decide to seek protection under the bankruptcy laws, we expect that we would file for bankruptcy protection at a time that is earlier than when we would otherwise exhaust our cash resources. In any of these circumstances, it is likely that investors will lose all or part of their investment. If there remains substantial doubt about our ability to continue as a going concern, investors or other financing sources may be unwilling to provide funding to us on commercially reasonable terms, if at all.
We plan to address the conditions that raise substantial doubt regarding our ability to continue as a going concern by, among other things, obtaining additional funding through equity offerings, debt financings and refinancings, collaborations, strategic alliances and/or licensing arrangements. In addition, we expect to evaluate opportunities to raise additional funds from time to time, including through the issuance and sale of shares of our common stock under our Open Market Sale Agreement with Jefferies LLC and in connection with the reporting of data from our ongoing Phase 3 clinical trials. However, there is no assurance that additional financing or strategic alternatives will be available on terms acceptable to us, or at all, or that such additional financing or strategic alternatives, if consummated, will be sufficient to address doubt regarding our ability to continue as a going concern.
If we utilize our capital resources more quickly than anticipated or are unable to obtain additional funding or engage in strategic alternatives, we may have to significantly curtail, delay, reduce or eliminate one or more of our research and development programs or any current or future commercialization efforts for one or more of our products or product candidates, which could materially adversely affect our business, financial condition, and results of operations. We have and may in the future determine to take actions to reduce our spending in the near term, including reductions to our workforce. If we are unable to continue as a going concern, we may have to liquidate assets and may receive less than the value at which those assets are carried on our financial statements. We may also determine to cease operations or file for bankruptcy protection. In any of these circumstances, it is likely that investors will lose all or part of their investment. If there remains substantial doubt about our ability to continue as a going concern, investors or other financing sources may be unwilling to provide funding to us on commercially reasonable terms, if at all.
Since inception, we have incurred significant operating losses. Our loss from operations was $26.8$22.5 million for the quarter ended MarchJune 31,30, 2026. As of MarchJune 31,30, 2026, we had an accumulated deficit of $1.8 billion. As described above in “Our financial condition raises substantial doubt as to our ability to continue as a going concern,” our financial condition raises substantial doubt about our ability to continue as a going concern. Although we received our first FDA-approvalU.S. Food and Drug Administration (“FDA”) approval for XPOVIO in July 2019, we may never attain profitability or positive cash flows from operations. We have historically financed our operations primarily through a combination of proceeds from (i) product revenue sales; (ii) public and private placements of equity securities; (iii) the issuance of convertible debt; (iv) a term loan; (v) our deferred royalty obligation; (vi) at the market offerings; and (vii) business development activities. Substantially all of our operating losses have resulted from costs incurred in connection with our research and development programs, the pursuit of regulatory approvals within and outside of the U.S., and the commercialization of XPOVIO. We expect to continue to incur significant expenses and operating losses as we continue to commercialize XPOVIO in the U.S. in multiple myeloma and engage in activities to prepare for the potential approval and commercialization of additional indications for selinexor asin well as any other product candidates we develop or acquire.myelofibrosis. The net losses we incur may fluctuate significantly from quarter to quarter.
While we began to generate revenue from the sales of XPOVIO in July 2019 and have received revenue from our license arrangements, such as the partnership we have with Antengene Therapeutics Limited (“Antengene”) for our programs across most of the Asia-Pacific region, and with Berlin-Chemie AG, an affiliate of the Menarini Group (“Menarini”) for our programs in Europe, Latin America, certain Middle East and Africa regions and other key countries, there can be no assurance as to the amount or timing of future product or license and other revenues, and we may not achieve profitability in the near-term, if at all. Our ability to become and remain profitable depends significantly on our success in many areas, including:
Our ability to become and remain profitable depends significantly on our success in many areas, including:
initiating and successfully completing clinical trials required to file for, obtain and maintain marketing approval for our product candidates, including reporting a positive benefit-risk profile from our ongoing Phase 3 clinical trial in endometrial cancer, with topline data anticipated in mid-2026candidates;
Because of the numerous risks and uncertainties associated with pharmaceutical product development and commercialization, we are unable to accurately predict the timing or amount of our revenue and expenses or when, or if, we will be able to achieve profitability. We cannot be certain that our revenue from sales of XPOVIO alone, in the currently approved indications,indications in multiple myeloma, will be sufficient for us to become profitable in the near-term, if at all. We may never generate revenues that are significant or large enough to achieve profitability. Even if we do achieve profitability, we may not be able to sustain or increase profitability on a quarterly or annual basis. Our failure to become and remain profitable would decrease the value of our company and could impair our ability to raise capital, maintain our research and development and commercialization efforts, expand our business and/or continue our operations. A decline in the value of our company could also cause our stockholders to lose all or part of their investment.
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 undertake additional cost reduction measures such as further reducing operating expenses, including through additional workforce reductions, delay, reduce or eliminate our research and development programs and/or commercialization efforts.efforts or at any time we may elect to or may be required to cease operations entirely, liquidate all or a portion of our assets, and/or seek protection under the U.S. Bankruptcy Code, and you may lose all or part of your investment.
We expect that our existing liquidity, including cash, cash equivalents and investments, as well as cash flow from net product revenue and license and other revenue, will enable us to fund our current operating plans into September 2026. On September 10, 2026, a $15.8 million principal payment is due under our senior secured term loan facility; if this payment is made without additional financing or a waiver from our lenders, we expect that (i) our cash, cash equivalents and investments will fall below our $10.0 million minimum liquidity covenant, which would trigger a default on our term loan and (ii) we will not have sufficient resources to fund our operations following such payment. In addition to the $15.8 million principal payment due on September 10, 2026, we have approximately $10.1 million of aggregate interest payments due on September 30, 2026 under our senior secured term loan, 2028 Notes and 2029 Notes.
The amount and timing of our future capital requirements will depend on many factors, including, but not limited to:
We believe that our existing liquidity, including cash and cash equivalents, as well as cash flow from net product revenue and license and other revenue, will enable us to fund our current operating plans to late in the third quarter of 2026. The amount and timing of our future capital requirements will depend on many factors, including, but not limited to:
our ability to establish and maintain collaboration, partnership, licensing, marketing, distribution or other arrangements on favorable terms and the level and timing of success of these arrangements, and our ability to use proceeds of those arrangements in our business as opposed to being required to pay those proceeds to the lenders of our $112.5 million senior secured term loan facility, as amended in October 2025 (the “Amended Term Loan”) and/or holders of the Convertible Notes;
Even if we believe we have sufficient funds for our current or future operating plans, we may seek additional capital due to favorable market conditions or strategic considerations, and any such efforts could divert management’s attention away from their day-to-day activities. However, adequateAdequate additional financing has not been, and may continue to not be, available to us on acceptable terms, or at all.terms. Raising additional capital may be particularly challenging in the current economic environment, as adverse or uncertain financial market conditions, including inflationary pressures, sustained high interest rates, volatility in the capital markets and slower economic growth or recession, could negatively impact investor demand for biotechnology equity or debt offerings. We cannot predict the extent or duration of such conditions or their impact on our ability to access the capital markets on acceptable terms.
In addition, changes in government policies, priorities and administration could create increased uncertainty and volatility that adversely affect our business, our ability to raise capital, and our ability to enter into strategic alternatives. For example, evolving healthcare, pricing and reimbursement policies, including potential drug pricing reforms such as “most-favored-nation” or similar pricing frameworks, as well as shifts in regulatory or enforcement priorities at federal agencies, including the FDA and other governmental bodies, could negatively affect investor sentiment, the perceived commercial viability of our product and our access to financing. Further, instability or disruption in the global or domestic banking system could impair our access to cash deposits or limit the availability of financing from financial institutions. If adequate funds are not available to us on a timely basis or on attractive terms, we may be required to take additional actions to address our liquidity needs, including additional cost reduction measures such as further reducing operating expenses, including through additional workforce reductions, or to delay, reduce or eliminate our research and development programs or any current or future commercialization efforts for one or more of our products or product candidates, which could have a material adverse effect on our business, operating results and prospects. We may be required to or elect to cease operations entirely at any time, liquidate all or a portion of our assets, and/or seek protection under the U.S. Bankruptcy Code, and you may lose all or part of your investment. Future sales and issuances of equity securities would result in substantial dilution to our stockholders..
We are evaluating 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 our existing debt; potential 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.
On July 31, 2026, we announced that we are evaluating potential financing transactions along with strategic alternatives in order to maximize near and long-term stakeholder value. These efforts may include, but are not limited to, a potential merger or sale of the Company, in- or out-of-court restructurings, repurchases, redemptions, exchanges or other refinancings of our existing debt, and potential financing transactions, among other potential alternatives. Our ability to successfully raise additional funds or execute on a financing transaction or a strategic alternative is dependent on a number of factors. If we are not able to successfully consummate a financing transaction or strategic alternative, our Board may explore a sale of assets or the initiation of bankruptcy proceedings under Chapter 11 of the U.S. Bankruptcy Code. Further, our indebtedness, as discussed under the risk factor titled “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,” may be unattractive to potential sources of funding and strategic partners and may decrease our ability to consummate a financing transaction or enter into a strategic alternative. Additionally, the negotiation and consummation of a financing transaction or strategic alternative may be costly and time-consuming. Even if we are able to consummate a financing transaction or a strategic alternative, it may not maximize or even enhance stockholder value, could result in total costs and expenses that are greater than expected, could make it more difficult to attract and retain qualified personnel and may disrupt our operations, each of which could have a material adverse effect on our business.
The market price of our common stock may reflect a market assumption that a strategic alternative will occur, and a failure to complete a strategic alternative on favorable terms, in an advantageous timeframe, or at all could result in negative investor perceptions and could cause a decline in the market price of our common stock, which could adversely affect our ability to access the equity and financial markets, as well as our ability to explore and enter into future strategic alternatives. In addition, potential strategic alternatives, if available, that require stockholder approval may not be approved by our stockholders.
In the event we file for bankruptcy, we would be subject to the risks and uncertainties associated with such proceedings.
In the event we file for relief under the U.S. Bankruptcy Code, our operations and our continuation as a going concern will be subject to the risks and uncertainties associated with bankruptcy proceedings. Any delays in our bankruptcy proceedings would increase the risks of our being unable to reorganize our business and emerge from bankruptcy proceedings and may increase our costs associated with the bankruptcy process or result in prolonged operational disruption for us. Also, we would need the prior approval of the bankruptcy court for transactions outside the ordinary course of business during the course of any bankruptcy, which may limit our ability to respond timely to certain events or take advantage of certain opportunities. Because of the risks and uncertainties associated with any bankruptcy proceedings, we cannot accurately predict or quantify the ultimate impact of events that could occur during any such proceedings. There can be no guarantees that if we file for bankruptcy we will emerge from bankruptcy as a going concern or that holders of our common stock will receive any recovery from any bankruptcy proceedings. In addition, we would need to have the bankruptcy court confirm any plan of reorganization and for such plan to go effective to emerge from bankruptcy.
Our Amended Revenue Interest Agreement with KKRHCRx 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.
In September 2019, we entered into the Revenue Interest Financing Agreement with certain entities managed by HealthCare Royalty Management, LLC (“HCRx”), whichas was amended on June 23, 2021, August 1, 2023, May 8, 2024, August 14, 2025, August 27, 2025 and October 7, 2025amended, and which was assigned by HCRx to an affiliate of KKR & Co. Inc. (“KKR”) in July 2025 in connection with its acquisition of a majority ownership stake in HCRx (the “Amended Revenue Interest Agreement”). Pursuant to the Amended Revenue Interest Agreement, we are required to comply with various covenants relating to the conduct of our business and the commercialization of XPOVIO, including obligations to use commercially reasonable efforts to commercialize our products. In addition, the Amended Revenue Interest Agreement limits our ability to incur or prepay indebtedness, create or incur liens, pay dividends on or repurchase outstanding shares of our capital stock or dispose of assets. The Amended Revenue Interest Agreement also includes customary events of default upon the occurrence of enumerated events, including non-payment of revenue interests, failure to perform certain covenants and the occurrence of insolvency proceedings, specified judgments, specified cross-defaults and specified revocations, withdrawals, suspensions or cancellations of regulatory approval for XPOVIO. Upon the occurrence of an event of default and in the event of a change of control, KKRHCRx may accelerate payments due under the Amended Revenue Interest Agreement up to $128.3 million, less the aggregate amount of all of the payments paid to HCRx and KKR after the date of the May 2024 amendment. Our obligations to KKRHCRx are secured by a second-priority security interest in certain assets of ours related to selinexor, which shares such second priority with the Convertible Notes and which is subordinated to the first-priority security interest securing the Amended Term Loan. Subject to an intercreditor agreement with KKR,HCRx, the Amended Term Loan lenders and the holders of the New 2029 Notes (the “Amended and Restated Intercreditor Agreement”), in the event that an uncured default by us under the Amended Revenue Interest Agreement results in an acceleration of obligations by KKRHCRx which we are unable to pay, KKRHCRx will have the right to foreclose on the collateral that was pledged to KKR.HCRx. Any such foreclosure remedy would significantly and adversely affect us and could result in us losing our interest in such assets, which would have a material adverse impact on our business.
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.
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.
The October 2025 First Amendment and Waiver to Credit and Guaranty Agreement and February 2026 Second Amendment to Credit and Guaranty Agreement, with the lenders party thereto and Wilmington Savings Fund Society, FSB, as administrative agent for the lenders and collateral agent which amended the May 2024 credit and guaranty agreement and the indentures governing the Convertible Notes (as amended, the “Amended Credit Agreement”) contain, and any future indebtedness that we incur may contain, various negative covenants that restrict, among other things, our indebtedness, liens, fundamental changes, asset sales, investments and other matters. In addition, the Amended Credit Agreement and the indentures governing the Convertible Notes each have a financial covenant requiring us to maintain liquidity through October 10, 2026 of at least the lesser of (i) $10.0 million plus 50% of the net cash proceeds received from certain debt and equity issuances and (ii) $25.0 million, after which we will be required to maintain liquidity of at least $25.0 million. See the risk factor captioned “We 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 undertake additional cost reduction measures such as further reducing operating expenses, including through additional workforce reductions, delay, reduce or eliminate our research and development programs and/or commercialization efforts or at any time we may elect to or may be required to cease operations entirely, liquidate all or a portion of our assets, and/or seek protection under the U.S. Bankruptcy Code, and you may lose all or part of your investment” above for a discussion of the risks associated with our need to raise additional capital.
In October 2025, we entered into a series of transactions with our term loan lenders, holders of our outstanding convertible notes and other investors to provide financial flexibility, additional working capital and equitize maturing notes (collectively, the “Financing Transactions”). Following consummationAs of theJune Financing30, Transactions,2026 we had future obligations of: (i) $112.5$153.6 million ofrelated aggregate principal amount underto the Amended Term Loan in addition to the financial covenant to maintain minimum liquidity; (ii) $15.0$19.2 million aggregaterelated principal amount ofto the 2028 Notes; (iii) $103.5$138.3 million aggregaterelated principal amount ofto the New 2029 Notes; and (iv) $116.2 million of maximum remaining payments payable under our revenue interest financingsfinancing agreement. We may also incur additional indebtedness to meet future financing needs, to the extent such indebtedness is available and permitted under the agreements governing our existing indebtedness. Our indebtedness could have significant negative consequences for our security holders and our business, results of operations and financial condition by, among other things:
Our ability to pay the principal of or interest or other obligations on our present and any future indebtedness, including our remaining obligations to KKRHCRx and under the Amended Credit Agreement, the Convertible Notes, or to make cash payments in connection with any conversion of the Convertible Notes, depends on our future performance and ability to raise additional funds, which is subject, in part, to economic, financial, competitive and other factors beyond our control. Our business may not generate cash flow from operations in the future sufficient to service the Amended Term Loan, the Amended Revenue Interest Agreement, the Convertible Notes or any other future indebtedness and make necessary capital expenditures.
Until such time, if ever, as we can generate substantial revenues from the sale of our products, we expect to finance our cash needs through a combination of equity offerings, debt financings and refinancings, collaborations, strategic alliances and/or licensing arrangements or asset sales. We do not have any committed external source of funds. To the extent that we raise additional capital through the sale of equity or convertible debt securities, the ownership interests of stockholders will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect the rights of common stockholders. Debt financing, if available and permitted, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends. For example, during the terms of the Amended Revenue Interest Agreement, the Amended Credit Agreement and the indentures governing the Convertible Notes, we cannot make any voluntary or optional cash payment or prepayment on our existing convertible debt and, other than certain permitted refinancings, cannot enter into any new debt without the consent of KKR,HCRx, the required lenders or the required holders, respectively, subject to the exceptions and other provisions under the applicable governing document. Further, any future renegotiation of these agreements will require extensive, multi-party discussions that will require significant time and resources and could result in additional debt, higher rates of interest, the issuance of additional warrants or equity securities, and dilution to our current stockholders.
Unstable market and economic conditions may have serious adverse consequences on our business, financial condition and stock price. Global credit and financial markets have experienced periods of extreme disruption in recent years, which have contributed to diminished liquidity and credit availability, declines in consumer and investor confidence and slower economic growth. As a result, financial institutions and markets face a range of risks that could adversely affect our operations and access to capital, including the potential for future banking failures, changes in regulatory frameworks, governing banks and deposit insurance, tightened credit conditions that reduce liquidity availability, volatility in interest rates and evolving cyber threats and disruptions to financial systems and payment networks. If the financial institutions with which we do business were to enter receivership, become insolvent or suffer a significant cyber incident or operational disruption, there is no guarantee that we would have access to our existing cash andcash, cash equivalents, and investments, or that we would be able to finance or fund our business on acceptable terms or at all, and any of these outcomes could materially and adversely affect our business, financial condition and results of operations.
our ability to achieve broad adoption of XPOVIO in earlier lines of therapy or to successfully launch and achieve broad adoption of any future XPOVIO indications or any product candidates for which we obtain marketing approval;
the outcome of discussions with the FDA regarding the regulatory pathway for aour potentialanticipated supplemental New Drug Application (“sNDA”) for selinexor in combination with ruxolitinib in myelofibrosis following our announcement that the SENTRY trial met one, but not both, of its two co-primary endpoints,myelofibrosis, including whether the FDA agrees that the data from the SENTRY trial support filing an sNDA and the possibility that the FDA may require additional clinical data, longer follow-up, an additional clinical trial, or impose other requirementsrequirements, inand advance ofwhether an sNDA submissionis ultimately accepted and approved by the FDA;
any conditions, limitations or restrictions imposed in connection with a potential approval of selinexor in combination with ruxolitinib in myelofibrosis based on accelerated approval, including a narrower-than-anticipated indication or patient population, limitations on the approved labeling or the claims and communications we may use to promote XPOVIO, requirements to submit promotional materials to the FDA prior to dissemination, or requests by the FDA that we revise, delay or refrain from using particular promotional materials or communications;
reporting a positive benefit-risk profile from our ongoing Phase 3 clinical trialstrial in endometrialpatients cancer andwith multiple myeloma, with topline data anticipated in mid-2026 and the second half of 2026, respectively2026;
Our long-term success depends in a large part on our ability to continue to successfully develop new indications of selinexor, our product candidates, or any new product candidates we may develop or acquire. Clinical testing is expensive, time consuming, difficult to design, implement and enroll, inherently uncertain as to outcome, and can fail at any stage of testing. For example, in March 2026 we announced that our SENTRY Trial for myelofibrosis met one, but not both, of its two co-primary endpoints. Following recent engagements with the FDA with respect to the regulatory path forward for the combination of selinexor plus ruxolitinib in myelofibrosis under the accelerated approval pathway utilizing spleen volume reduction ≥ 35% (“SVR35”) as a surrogate endpoint that is reasonably likely to predict clinical benefit, we plan to submit an sNDA in August 2026. However, there can be no assurance that we will submit the sNDA by this time or that the sNDA, if submitted, will be accepted for review or approved. In addition, any approval obtained under the accelerated approval pathway would be conditioned on verifying clinical benefit in post-marketing confirmatory trial/data. Although the SENTRY Trial continues to follow patients for long-term outcomes, there can be no assurance that such data or any other confirmatory trial will verify clinical benefit. A failure to verify clinical benefit could result in any accelerated approval being withdrawn.
Furthermore, the failure of any product candidates to demonstrate safety and effectiveness in any clinical trial could negatively impact the perception of selinexor or our other product candidates and/or cause the FDA or other regulatory authorities to require additional testing before any of our product candidates are approved and/or adversely impact the inclusion of current or future indications of selinexor or other products or product candidates on pharmaceutical/drug compendia and/or negatively impact treating physicians’ confidence in the benefit observed in earlier phase clinical trials. For example, in July 2026, we announced topline results from our Phase 3 XPORT-EC-042 trial evaluating selinexor as a maintenance-only therapy compared to placebo in adult patients with TP53 wild-type advanced or recurrent endometrial cancer (the “XPORT-EC-042 Trial”). The trial did not meet the pre-specified threshold for statistical significance for its primary endpoint of progression free survival in the modified intent-to-treat population. Based on these topline results, we do not expect to pursue U.S. regulatory approval for selinexor in endometrial cancer and have determined to reduce our planned investment in our endometrial cancer program. In addition, if the benefit-risk profile from our global Phase 3 trial sponsored by the European Myeloma Network evaluating an all-oral combination of selinexor 40 mg in combination with pomalidomide and dexamethasone versus elotuzumab, pomalidomide, and dexamethasone in patients with previously treated multiple myeloma who received an anti-CD38 in their immediate prior line of therapy is not positive, the commercialization and listed compendia for our currently approved indications of selinexor could be adversely impacted, as well as their perception of the benefit of selinexor in combination with pomalidomide and dexamethasone.
delays or failure to reach agreement with regulatory authorities on a trial design or the receipt of feedback requiring us to modify the design of our clinical trials, perform additional or unanticipated clinical trials to obtain approval or alter our regulatory strategy, as iswas the case in connection with the feedback from the FDA that we announced in December 2024 regarding the appropriateness of our global, Phase 3 trial evaluating selinexor as a maintenance therapy following systemic therapy in patients with TP53 wild-type advanced or recurrent endometrial cancer (the “XPORT-EC-042 Trial”) given the evolving treatment landscape for patients with advanced or recurrent endometrial cancer, further in March 2026 the FDA requested and we agreed to voluntarily withdraw the accelerated approval of the DLBCL indication in light of the infeasibility of completing the confirmatory trial, especially considering the evolving treatment landscape, including the availability of new therapeutic options;
clinical trials of our product candidates may produce negative or inconclusive results or other patient safety concerns, including undesirable side effects or other unexpected characteristics, and we may decide, or regulatory authorities may require us, to conduct additional clinical trials, suspend ongoing clinical trials ortrials, abandon drug development programs or reduced planned investment in such programs, including as a result of a finding that the participants are being exposed to unacceptable health risks or that a trial did not meet its primary endpoint or otherwise did not produce results sufficient to support regulatory approval, as occurred with the XPORT-EC-042 Trial, enrollment in our clinical trials may be slower than we anticipate, including as a result of competition with other ongoing clinical trials or recently approved agents, which could decrease the overall supply of patients, or decreasing interest from selected clinical trial sites, delays in site activation, higher than expected screen failure rates, newly approved competitive products for the same indications as our product candidates or new or amended regulations;
enrollment in our clinical trials may be slower than we anticipate, including as a result of competition with other ongoing clinical trials or recently approved agents, which could decrease the overall supply of patients, or decreasing interest from selected clinical trial sites, delays in site activation, higher than expected screen failure rates, newly approved competitive products for the same indications as our product candidates or new or amended regulations; for example, in August 2024, we announced expected delays in our topline data readout for our XPORT-EC-042 Trial due primarily to higher than expected screen failure rates, which has required us to screen a larger number of patients than originally planned;
changes in the treatment landscape on which a clinical development plan was based, such as the approval of new therapies during the course of a clinical trial, can change the potential approvability of a drug even if the results of a pivotal, Phase 3 clinical trial are considered clinically meaningful and the primary endpoints achieve statistical significance since global regulatory agencies, including the FDA, often consider approvability in light of the current treatment landscape at the time of approval, and not at the time when a clinical trial is first designed; for example, in recent years three new novel agents (dostarlimab-gxly, pembrolizumab and durvalumab) have been approved for treatment in patients with endometrial cancer, which has evolved the treatment landscape;
for any biomarker driven clinical trial, the potential regulatory requirement to develop one or more companion diagnostics; for example, the required development of companion diagnostics for our ongoing clinical trial evaluating selinexor in patients with TP53 wild-type advanced or recurrent endometrial cancer;
any partners or collaborators that help us conduct clinical trials may face any of the above issues, and may conduct clinical trials in ways they view as advantageous to them but that are suboptimal for us; and negative impacts resulting from a pandemic or other public health emergency, including impacts to healthcare systems and our trial sites’ ability to conduct trial.trials.
If we, or our collaborators, are required to conduct additional clinical trials or other testing of our product candidates or a companion diagnostic beyond those that we currently contemplate or are unable to successfully complete clinical trials of our product candidates or other testing, on a timely basis or at all, if changes to the external landscape impact our planned patient population or current clinical trial protocols, and/or if the results of these trials or tests are not positive or are only modestly positive or if there are safety concerns, we, or our collaborators, may:
Although we believe the Phase 3 SENTRY trial generated data supporting the potential use of SVR35 as a surrogate endpoint in myelofibrosis, including data that have been presented at medical meetings and published in a peer-reviewed journal, there can be no assurance that prior, interim, published or presented data from the SENTRY trial or any related clinical or scientific literature will be predictive of regulatory success. As discussed above, following recent engagements with the FDA with respect to the regulatory path forward for the combination of selinexor plus ruxolitinib in myelofibrosis under the accelerated approval pathway utilizing SVR35 as a surrogate endpoint that is reasonably likely to predict clinical benefit, we plan to submit an sNDA in August 2026. There can be no assurance that we will submit the sNDA by this time or that the sNDA, if submitted, will be accepted for review or approved. The Phase 3 SENTRY trial continues to follow patients for long-term outcomes, and such long-term outcomes may not confirm or support earlier observations, including any overall survival signal, evidence of disease modification or other findings from prior analyses. Any failure to verify clinical benefit, including in post-marketing confirmatory trials if accelerated approval is granted, could result in an accelerated approval being withdrawn.
We are currently advancing multiple clinical development studies of selinexor, which may create a strain on our limited human and financial resources. As a result, we may not be able to provide sufficient resources to any single product candidate to permit the successful development and commercialization of such product candidate, which could result in material harm to our business. Further, becauseBecause we have limited financial and managerial resources, we focusmust onmake researchsignificant strategic decisions regarding which product candidates, programs and productindications candidatesto thatprioritize weand identifywhich forto specificdelay, indications.reduce, suspend or discontinue. As a result, we may forego or delay pursuit of opportunities with other product candidates or for other indications that later prove to have greater commercial potential. For example, as announced in January 2024, further clinical development of our eltanexor program continues to remain on hold in an effort to focus our resources on our prioritized late-stage programs. Our resource allocation decisions may cause us to fail to capitalize on viable commercial products or profitable market opportunities. Our spending on current and future research and development programs and product candidates for specific indications may not yield any additional commercially-viable products. If we do not accurately evaluate the commercial potential or target market for a particular product candidate, we may relinquish valuable rights to that product candidate through collaboration, licensing or other royalty arrangements in cases in which it would have been more advantageous for us to retain sole development and commercialization rights to such product candidate.
We have built a commercial infrastructure in the U.S. for XPOVIO, our first commercial product, in hematological malignancies and our company did not previously have any prior experience in the sales, marketing or distribution of pharmaceutical drugs. If XPOVIO or any of our product candidates is approved for additional indications beyond hematological malignancies, such as solid tumors, we may need to evolve our sales, marketing and distribution capabilities and we may not be able to do so successfully or on a timely basis. In the future, we may choose to expand our sales, marketing and distribution infrastructure to market or co-promote one or more of our product candidates, if and when they are approved, or enter into additional collaborations with respect to the sale, marketing and distribution of our product candidates. We are working with existing and potential partners to establish the commercial infrastructure to support the sale of selinexor outside of the U.S. For example, we entered into a license agreement with Menarini in December 2021, and as amended in March 2023, to, among other things, develop and commercialize NEXPOVIO® for all human oncology indications in Europe (including the United Kingdom (“UK”)), Latin America, certain Middle East and Africa regions and other key countries. For additional risks associated with commercializing our products outside of the U.S., please see the risk factor entitled “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 candidatescandidates, if approved” below.
Our, and our collaborators’, ability to successfully commercialize XPOVIO and any other products that we may develop or acquire will depend, in part, on the extent to which reimbursement for these products is available from government health administration authorities, private health insurers and other organizations. Government authorities and third-party payors, such as private health insurers and health maintenance organizations, decide which medications they will pay for and establish reimbursement levels. Obtaining and maintaining adequate reimbursement for XPOVIO and any of our product candidates, if approved, may be difficult. Moreover, the process for determining whether a third-party payor will provide coverage for a product may be separate from the process for setting the price of a product or for establishing the reimbursement rate that such a payor will pay for the product. Further, one payor’s determination to provide coverage for a product does not assure that other payors will also provide coverage and reimbursement for our products. Even with payer coverage, patients may be unwilling or unable to pay the copay required and may choose not to take XPOVIO.
Further, one payor’s determination to provide coverage for a product does not assure that other payors will also provide coverage and reimbursement for our products. Even with payer coverage, patients may be unwilling or unable to pay the copay required and may choose not to take XPOVIO.
The FDA or other regulatory authorities may determine that (i) our product candidates do not have an overall positive benefit-risk profile; (ii) the dose used in a clinical trial has not been optimized and require us to conduct additional dose optimization studies;
The FDA or other regulatory authorities may determine that (i) our product candidates do not have an overall positive benefit-risk profile; (ii) the dose used in a clinical trial has not been optimized and require us to conduct additional dose optimization studies; or (iii) the comparator arm and/or endpoint in a trial is no longer the appropriate comparator or endpoint due to the evolution of the competitive landscape or subsequent data of the comparator product, even if the FDA or other regulatory authority had previously approved the trial design, and we may be required to amend the trial or we may not receive approval of the indication. For example, in December 2024, we announced that we were engaged in discussions with the FDA regarding the evolving treatment landscape in advanced or recurrent endometrial cancer, particularly the approval of checkpoint inhibitors (e.g., pembrolizumab, dostarlimab-gxly and durvalumab). We have submitted to the FDA and other relevant global regulatory authorities an amendment to the EC-042 Trial protocol incorporating modifications, which we believe are responsive to certain of the FDA’s concerns. However, the FDA may not agree that some or all of our proposed modifications to the XPORT-EC-042 Trial adequately address their concerns, which may ultimately impact approvability. In addition, the FDA’s Oncology Center of Excellence has a number of projects to advance the development and regulation of medical products for patients with cancer, such as Project Optimus to reform the dose optimization and dose selection paradigm in oncology drug development to emphasize selection of an optimal dose. These projects exemplify the emphasis the FDA is placing on various elements in the drug development process and therefore may require sponsors to spend additional time and resources either pre- or post-approval, and our ability to complete existing trials or initiate new trials may be delayed.
regulatory authorities may require more information, including additional preclinical or clinical data or trials, to support approval, as in the case of our initiation of the EC-042 Trial for patients with TP53 wild-type advanced or recurrent endometrial cancer following discussions with the FDA in early 2022 on our SIENDO trialapproval;
For example, following recent engagements with the FDA with respect to the regulatory path forward for the combination of selinexor plus ruxolitinib in myelofibrosis under the accelerated approval pathway utilizing SVR35 as a surrogate endpoint that is reasonably likely to predict clinical benefit, we plan to submit an sNDA in August 2026. However, there can be no assurance that the sNDA, if submitted, will be accepted for review or approved. We also continue to be engaged with the FDA on the final details for the sNDA submission, including data to be used to support the sNDA and convert potential accelerated approval to traditional approval. In addition, any approval obtained under the accelerated approval pathway would be conditioned on verifying clinical benefit in post-marketing confirmatory trial/data. Although the SENTRY Trial continues to follow patients for long-term outcomes, there can be no assurance that such data or any other confirmatory trial will verify clinical benefit. A failure to verify clinical benefit could result in any accelerated approval being withdrawn.
There can be no assurance that the FDA or foreign regulatory agencies will agree with our, or our collaborators’, surrogate endpoints or intermediate clinical endpoints in any of our, or their, clinical trials, or our, or our collaborators’, plans to verify clinical benefit, even after we have obtained feedback from the FDA or foreign regulatory agencies on these topics. There can also be no assurance that we, or our collaborators, will decide to pursue or submit any additional NDA for accelerated approval or any other form of expedited development, review or approval. Similarly, there can be no assurance that, after feedback from the FDA or comparable foreign regulatory agencies, we, or our collaborators, will continue to pursue or apply for accelerated approval or any other form of expedited development, review or approval. Furthermore, for any submission of an application for accelerated approval or application under another expedited regulatory designation, there can be no assurance that such submission or application will be accepted for filing or that any expedited development, review or approval will be granted on a timely basis, or at all.
The FDA also imposes requirements for costly post-marketing studies or clinical trials to maintain approval of any products that received accelerated approval. For drugs approved under the FDA’s Accelerated Approval Program, the FDA typically requires post-marketing confirmatory trials to evaluate the anticipated effect on irreversible morbidity or mortality or other clinical benefit. These confirmatory trials must be completed with due diligence. For example, we plan to submit an sNDA seeking accelerated approval of selinexor to treat myelofibrosis using overall survival data from long-term follow-up of the ongoing Phase 3 SENTRY trial as the confirmatory trial to verify clinical benefit. Although the SENTRY Trial continues to follow patients for long-term outcomes, there can be no assurance that such data or any other confirmatory trial will verify clinical benefit. In addition, in June 2020, the FDA approved XPOVIO to treat DLBCL under the FDA’s accelerated approval regulations and as a condition of the accelerated approval for this indication we are required to comply with a number of post-approval requirements, including timely completion of a confirmatory clinical trial. In March 2026 the FDA requested and we agreed to voluntarily withdraw the accelerated approval of the DLBCL indication in light of the infeasibility of completing the confirmatory trial, especially considering the evolving treatment landscape, including the availability of new therapeutic options. Although we do not actively promote XPOVIO in DLBCL and generate insignificant revenue from this indication, withdrawal of the accelerated approval may require certain of our ex-U.S. partners to take action to maintain their current approvals in DLBCL to the extent such approvals reference the U.S. label.
Similar risks to those described above are also applicable to any application that we, or our collaborators, have submitted or may submit in other jurisdictions outside of the U.S., including applications submitted to the EMA to support approval of selinexor to treat patients with multiple myeloma or any other cancer indication. For medicinal products where the benefit of immediate availability outweighs the risk of less comprehensive data than normally required, based on the scope and criteria defined in legislation and guidelines, it is possible to obtain a conditional marketing authorization for a new drug in the EU with a 12-month validity period and annual renewal pursuant to Regulation No 507/2006. These are granted only if the EMA’s Committee for Medicinal Products for Human Use (“CHMP”) finds that all four of the following requirements are met: (i) the benefit-risk balance of the product is positive; (ii) it is likely that the sponsor will be able to provide comprehensive data; (iii) unmet medical needs will be fulfilled; and (iv) the benefit to public health of the medicinal product’s immediate availability on the market outweighs the risks due to the need for further data.
(ii) it is likely that the sponsor will be able to provide comprehensive data; (iii) unmet medical needs will be fulfilled; and (iv) the benefit to public health of the medicinal product’s immediate availability on the market outweighs the risks due to the need for further data.
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.
In connection with our ongoing development of selinexor in patients whose endometrial cancer is TP53 wild-type, we are utilizing a companion diagnostic to identify patients whose tumors are TP53 wild-type. We may be required to develop a second companion diagnostic pending the ultimate patient population included in the potential label for our endometrial indication. To be successful in developing and commercializing product candidates in combination with companion diagnostics, we or our collaborators will need to address a number of scientific, technical, regulatory and logistical challenges. According to FDA guidance, if the FDA determines that a companion diagnostic device is essential to ensuring the safety and effectiveness of a novel therapeutic product or new indication, the FDA generally will not approve the therapeutic product or new therapeutic product indication if the companion diagnostic is not also approved or cleared. In certain circumstances (for example, when a therapeutic product is intended to treat a serious or life-threatening condition for which no satisfactory available therapy exists or when the labelling of an approved product needs to be revised to address a serious safety issue), however, the FDA may approve a therapeutic product without the prior or contemporaneous marketing authorization of a companion diagnostic. In this case, approval of a companion diagnostic may be a post-marketing requirement or commitment.
Management's Discussion & Analysis (MD&A)
New heading “Myelofibrosis Regulatory Update”
New heading “Phase 3 SENTRY Trial Topline Results”
Largest changes
“We expect our existing liquidity, including cash, cash equivalents and investments, as well as cash flow from net product revenue and license and other revenue, will enable us to fund our current operating plans into September 2026. With the assistance of our advisors, including our financial advisor Centerview Partners and other advisors, we are actively evaluating a range of financing opportunities and strategic alternatives with the objective of extending our cash runway, preserving strategic flexibility and maximizing long-term shareholder value as we advance our myelofibrosis program. …”see in full comparison
see in full comparisonWe currently expect that our existing liquidity, including cash and cash equivalents as well as cash flow from net product revenue and license and other revenue, will enable us to fund our current operating plans to late in the third quarter of 2026.We will require additional capital to fundtheourongoingoperations and clinical development of selinexor andother product candidates andto pursuepotentialregulatoryapprovals. We plan to address the conditions that raise substantial doubt regarding our ability to continue as a going concern by, among other things, obtaining additional funding through equity offerings, debt financings and refinancings, collaborations, strategic alliances and/or licensing arrangements. We expect to evaluate opportunities to raise additional funds from time to time, including through the issuance and saleapproval ofshares of our common stock under our Open Market Sale Agreement andselinexor inconnection with the reporting of data from our ongoing Phase 3 XPORT-EC-042 trial. There is no assurance that such additional financing or strategic alternatives will be available on terms acceptable to us, or at all.myelofibrosis. Our ability to successfullyraiseconsummateadditionalafundsfinancing transaction or execute on a strategic alternative is dependent on a number of factors.IfThereweisarenonotassuranceablethat these efforts will result in additional funding, executing a strategic alternative transaction, will increase value for stakeholders, or will sufficiently address our ability to continue as a going concern. Absent additional funding or our ability to successfullyconsummatecomplete one or more strategic transactions to extend our cash runway beyond September 10, 2026, we will be unable to continue as afinancinggoingtransactionconcernorandstrategic alternative, our Boardwe mayexplorehaveatosaleconsiderofseeking protection under the bankruptcy laws, liquidating our assets or ceasing our operations. If we decide to seek protection under theinitiationbankruptcy laws, we expect that we would file for bankruptcy protection at a time that is earlier than when we would otherwise exhaust our cash resources. In any ofbankruptcytheseproceedingscircumstances,underitChapteris11likely that investors will lose all or part ofthetheirU.S.investment.BankruptcyIfCode.there remains substantial doubt about our ability to continue as a going concern, investors or other financing sources may be unwilling to provide funding to us on commercially reasonable terms, if at all. Further, our indebtedness, as discussed under the risk factor titled “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,” may be unattractive to potential sources of funding and strategic partners and may decrease our ability to consummate a financing transaction or enter into a strategic alternative. Additionally, the negotiation and consummation of a financing transaction or strategic alternative may be costly and time-consuming.
“We expect that our existing liquidity, including cash, cash equivalents, and investments as well as cash flow from net product revenue and license and other revenue, will enable us to fund our current operating plans into September 2026. …”see in full comparison
We anticipate that we will continue to incur significant operating losses in the foreseeable future. Based on our current business plan and current capital resources, combined with the uncertainty regarding the availability of additional funding or other strategic transactions and considering our debt service obligations and financial covenant to maintain minimum liquidity, we have concluded that there is substantial doubt regarding our ability to continue as a going concern within one year after the date the accompanying condensed consolidated financial statements are issued. We expect that our existing liquidity, including cash, cash equivalents, andsee in full comparisoncash equivalents as of March 31, 2026investments as well as cash flow from net product revenue and license and other revenue, will enable us to fund our current operating planstointolateSeptemberin2026. With thethird quarterassistance of2026.our advisors, including our financial advisor Centerview Partners and other advisors, we are actively evaluating a range of financing opportunities and strategic alternatives with the objective of extending our cash runway, preserving strategic flexibility and maximizing long-term shareholder value as we advance our myelofibrosis program. On September 10, 2026, a $15.8 million principal payment is due under our senior secured term loan facility; if this payment is made without additional financing or a waiver from our lenders, we expect that (i) our cash, cash equivalents and investments will fall below our $10.0 million minimum liquidity covenant, which would trigger a default on our term loan and (ii) we will not have sufficient resources to fund our operations following such payment. In addition to the $15.8 million principal payment due on September 10, 2026, we have approximately $10.1 million of aggregate interest payments due on September 30, 2026 under our senior secured term loan, 2028 Notes and 2029 Notes. See “Liquidity and Capital Resources – Funding Requirements” below and Note 1 “Nature of Business, Basis of Presentation and Segment Information” to the condensed consolidated financial statements included under Part I, Item 1 of this Quarterly Report on Form 10-Q for a further discussion of our liquidity and the conditions that raise substantial doubt regarding our ability to continue as a going concern.
Our future long-term capital requirements will depend on many factors, as described more fully in the risk factor entitled “Wesee in full comparisonwillneed 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 undertake additional cost reduction measures such as further reducing operating expenses, including through additional workforce reductions, delay, reduce or eliminate our research and development programs and/or commercializationefforts,efforts or at any time we may elect to or may be required to cease operations entirely, liquidate all or a portion of our assets, and/or seek protection under the U.S. Bankruptcy Code, and you may lose all or part of your investment,” under the heading “Risk Factors” in this Quarterly Report on Form 10-Q.
The effectiveness of the Forbearance Agreement was conditioned upon, among other things, the consummation of a sale and issuance of our common stock, in one or more transactions, resulting in proceeds to us of not less than $25.0 million actually received in cash before June 10, 2026 (the “Capital Raise Trigger”). The Capital Raise Trigger was satisfied and the Forbearance Agreement became effective in March 2026 upon receipt of the proceeds from the Private Placement (as defined below). Under the Amendment and the Forbearance Agreement,see in full comparisonwe can defercertain principal and interest payments were deferred until September 2026 and the Consenting Parties agreed not to exercise certain rights and remedies with respect to specified matters, including: (i) payment-related defaults through September 30, 2026 that would result from our non-payment of the interest due on June 30, 2026 for the New 2029 Notes and 2028 Notes and (ii) any defaults that result from a requirement under the indentures of the New 2029 Notes and 2028 Notes for us to have a Minimum Liquidity Covenant Amount greater than the lesser of (i) $10.0 million plus 50% of the net cash proceeds received from certain debt and equity issuances and (ii) $25.0 million through October 10, 2026. After October 10, 2026, the minimum liquidity covenant will require minimum consolidated liquidity of $25.0 million. See “Liquidity, Capital Resources and Going Concern” below for a further discussion of our liquidity and our need to raise additional capital.
Full comparison: every changed paragraph (51)
Our primary focus is on marketing XPOVIO in its currently approved indications in multiple myeloma as well as developing and seeking regulatory approval of selinexor as an oral agent targeting multiple high unmet need cancer indications, including our lead clinical programs in myelofibrosismyelofibrosis. andSubject endometrialto cancerobtaining andadditional our other late-stage clinical program in multiple myeloma. Depending on the data in our Phase 3 myelofibrosis and/or endometrial cancer programs and the availability of capital resources,funding, we plan to explore opportunities to develop our leading next-generation XPO1 inhibitor, eltanexor, in additional myeloproliferative neoplasms and TP53 wild-type tumors.neoplasms.
Phase 3 SENTRY TrialXPORT-EC-042 Topline Data Results
On July 30, 2026, we announced topline results from our Phase 3 randomized, double-blind trial evaluating selinexor as a maintenance-only therapy compared to placebo in adult patients with TP53 wild-type advanced or recurrent endometrial cancer in which patients were randomized 1:1 to receive either a 60 mg, once-weekly, administration of oral selinexor or placebo until disease progression (the “XPORT-EC-042 Trial”). The trial did not meet its primary endpoint of progression free survival (“PFS”). The trial included two patient populations, for which the primary endpoint of PFS was designed to be tested sequentially: (1) a modified intent to treat population (“mITT”) that included patients with either (a) TP53 wild-type tumors with proficient mismatch repair status or (b) TP53 wild-type tumors with deficient mismatch repair status, who are medically ineligible to receive checkpoint inhibitors; and (2) the trial’s original intent to treat population, which included all patients enrolled in the trial whose tumors are TP53 wild-type, regardless of MMR status. A trend favoring the selinexor arm was observed in the mITT population (n=236), with a median PFS of 12.75 months in the selinexor arm compared to 7.43 months in the placebo arm (hazard ratio=0.76 [95% CI: 0.51, 1.12]; one-sided p-value=0.0791).
The safety and tolerability profile of selinexor was consistent with its established safety profile, with no new safety signals observed. We intend to complete a full evaluation of the data from the XPORT-EC-042 Trial and plan to present the data at a future medical meeting. The results of the XPORT-EC-042 Trial do not affect ongoing trials of selinexor in other potential indications.
Myelofibrosis Regulatory Update
On July 30, 2026, we announced that we plan to submit a supplemental New Drug Application (“sNDA”) to the U.S. Food and Drug Administration (“FDA”) in August 2026 seeking accelerated approval of selinexor in combination with ruxolitinib for the treatment of patients with myelofibrosis.
The planned submission follows productive engagements with the FDA, including written feedback that spleen volume reduction ≥ 35% (“SVR35”) appears to qualify as a reasonably likely surrogate endpoint to predict overall survival and can be used to support an sNDA under the accelerated approval pathway. We plan to use overall survival data from long-term follow-up of our ongoing randomized, double-blind Phase 3 clinical trial to evaluate the efficacy and safety of once-weekly selinexor in combination with ruxolitinib versus placebo plus ruxolitinib in JAK2 inhibitor (“JAKi”)-naive myelofibrosis patients (the “SENTRY Trial”) to verify clinical benefit. Overall survival is a pre-specified secondary endpoint of the SENTRY Trial. The trial does not permit patient crossover; patients, investigators and the Karyopharm study team remain blinded to treatment assignment during ongoing follow-up.
The results from our SENTRY Trial will be the basis of the planned sNDA, including the statistically significant improvement in SVR35 at week 24, the rapid, deep and sustained nature of the spleen responses, a promising overall survival signal, reductions in variant allele frequency and the overall safety data package.
We remain on track for a planned August 2026 sNDA submission and have continued to productively engage with the FDA on the final details of the data that will be used to confirm the anticipated clinical benefit, a requirement under the accelerated approval pathway. These confirmatory data will be used to convert potential accelerated approval to traditional approval. We continue to address the FDA’s requests and provide the FDA with additional data and information in advance of the sNDA submission in August 2026.
We intend to request Priority Review at the time of submission of the sNDA, which, if granted, would result in a Prescription Drug User Fee Act target action date of approximately six months following the FDA’s receipt of the application.
Phase 3 SENTRY Trial Topline Results
On March 24, 2026, we announced topline data results from our Phase 3 clinical trial to evaluate the efficacy and safety of once-weekly selinexor in combination with ruxolitinib versus placebo plus ruxolitinib in JAK2 inhibitor (“JAKi”)-naive myelofibrosis patients (the “SENTRY Trial”) in which patients were randomized 2:1 to 60 mg of selinexor once weekly plus ruxolitinib or placebo plus ruxolitinib. The ruxolitinib dose was determined based on the patients’ baseline platelet count per the drug’s prescribing information. The SENTRY Trial met the first co-primary endpoint, demonstrating statistically significant improvement in spleen volume reduction of 35% or moreSVR35 for patients treated with the combination of selinexor plus ruxolitinib, with rapid, deep and sustained spleen volume reduction rates seen in the combination arm, but did not meet its second co-primary endpoint in absolute total symptom score. The mean change in absolute total symptom score at week 24 relative to baseline was comparable across the two arms with similar symptom improvement relative to baseline; the difference across the two arms was not statistically significant. In addition, a promising overall survival signal was observed in the topline data, which further reinforces the relevance of XPO1 inhibition in combination with ruxolitinib in frontline myelofibrosis. Further, a greater proportion of patients on the combination arm compared to ruxolitinib alone experienced reductions in variant allele frequency, which may be indicative of an underlying effect on disease biology, raising the potential for disease modification. The combination demonstrated a manageable safety and tolerability profile consistent with the known profile of selinexor and ruxolitinib individually. No new safety signals were observed. Our key near term objectives in advancing our SENTRY program include: engagement with the U.S. Food and Drug Administration (“FDA”) to discuss the data from the SENTRY Trial and our supplemental new drug application filing plan; disclosure of additional data from the Phase 3 SENTRY Trial at an upcoming medical meeting; and potential inclusion of the combination in relevant compendia, which could occur in the second half of 2026.
We have completed enrollment of our global, Phase 3, randomized, double-blind trial evaluating selinexor as a maintenance-only therapy following systemic therapy in patients with TP53 wild-type advanced or recurrent endometrial cancer (the “XPORT-EC-042 Trial”). Approximately 220 patients enrolled in the modified intent-to-treat (“mITT”) population and 257 enrolled in the intent-to-treat population. Enrollment in the mITT population was focused on patients with either proficient mismatch repair status tumors or patients with deficient mismatch repair status tumors who are medically ineligible for checkpoint inhibitors. We expect to report topline data from this event-driven trial in mid-2026.
Patients enrolled in a randomized global Phase 3 trial sponsored by the European Myeloma Network evaluating an all-oral combination of selinexor 40 mg in combination with pomalidomide and dexamethasone versus elotuzumab, pomalidomide, and dexamethasone in patients with previously treated multiple myeloma who received an anti-CD38 in their immediate prior line of therapy (the “EMN29 Trial”). The patients enrolled in this event-driven trial continued to be followed for progression-free survivalPFS events contributing towards the primary endpoint. We expect to report topline data from thethis EMN29event-driven Trialtrial in the second half of 2026.
In March 2026, we met with the FDA regarding the Accelerated Approval of the Diffuse Large B-Cell Lymphoma (“DLBCL”) indication of XPOVIO, which was granted on June 22, 2020 for the treatment of adult patients with relapsed or refractory DLBCL, not otherwise specified, including DLBCL arising from follicular lymphoma, after at least two lines of systemic therapy. The FDA requested and we agreed to voluntarily withdraw the accelerated approval of the DLBCL indication in light of the infeasibility of completing the confirmatory trial, especially considering the evolving treatment landscape, including the availability of new therapeutic options. As a result, we expectare toin terminatethe process of terminating our ongoing company-sponsored trials in this indication. This withdrawal is not due to safety concerns with the DLBCL indication and does not affect the regulatory approval of any other indications for XPOVIO.
We expect our existing liquidity, including cash, cash equivalents and investments, as well as cash flow from net product revenue and license and other revenue, will enable us to fund our current operating plans into September 2026. With the assistance of our advisors, including our financial advisor Centerview Partners and other advisors, we are actively evaluating a range of financing opportunities and strategic alternatives with the objective of extending our cash runway, preserving strategic flexibility and maximizing long-term shareholder value as we advance our myelofibrosis program. On September 10, 2026, a $15.8 million principal payment is due under our senior secured term loan facility; if this payment is made without additional financing or a waiver from our lenders, we expect that (i) our cash, cash equivalents and investments will fall below our $10.0 million minimum liquidity covenant, which would trigger a default on our term loan and (ii) we will not have sufficient resources to fund our operations following such payment. In addition to the $15.8 million principal payment due on September 10, 2026, we have approximately $10.1 million of aggregate interest payments due on September 30, 2026 under our senior secured term loan, 2028 Notes and 2029 Notes, all as defined below. Our ability to successfully consummate a financing transaction or execute on a strategic alternative is dependent on a number of factors. There is no assurance that these efforts will result in additional funding, executing a strategic alternative transaction, will increase value for stakeholders, or will sufficiently address our ability to continue as a going concern.
The effectiveness of the Forbearance Agreement was conditioned upon, among other things, the consummation of a sale and issuance of our common stock, in one or more transactions, resulting in proceeds to us of not less than $25.0 million actually received in cash before June 10, 2026 (the “Capital Raise Trigger”). The Capital Raise Trigger was satisfied and the Forbearance Agreement became effective in March 2026 upon receipt of the proceeds from the Private Placement (as defined below). Under the Amendment and the Forbearance Agreement, we can defer certain principal and interest payments were deferred until September 2026 and the Consenting Parties agreed not to exercise certain rights and remedies with respect to specified matters, including: (i) payment-related defaults through September 30, 2026 that would result from our non-payment of the interest due on June 30, 2026 for the New 2029 Notes and 2028 Notes and (ii) any defaults that result from a requirement under the indentures of the New 2029 Notes and 2028 Notes for us to have a Minimum Liquidity Covenant Amount greater than the lesser of (i) $10.0 million plus 50% of the net cash proceeds received from certain debt and equity issuances and (ii) $25.0 million through October 10, 2026. After October 10, 2026, the minimum liquidity covenant will require minimum consolidated liquidity of $25.0 million. See “Liquidity, Capital Resources and Going Concern” below for a further discussion of our liquidity and our need to raise additional capital.
On March 24, 2026, we entered into a Securities Purchase Agreement with RA Capital Healthcare Fund, L.P. (“RA Capital Management”) pursuant to which we issued and sold in a private placement (the “Private Placement”): (i) 1,030,354 shares of common stock, (ii) pre-funded warrants to purchase up to 3,391,164 shares of common stock, and (iii) accompanying warrants to purchase 4,421,518 shares of common stock with an exercise price of $10.00 per share (the “2026 Warrants”) for aggregate net proceeds of $26.9 million. The 2026 Warrants are exercisable until 30August days29, following our public announcement of topline data results from our Phase 3 XPORT-EC-042 clinical trial of selinexor in patients with endometrial cancer2026 and the pre-funded warrants do not expire. As of MarchJune 31,30, 2026, none of these warrants have been exercised.
As of MarchJune 31,30, 2026, we had an accumulated deficit of $1.8 billion. We had operating losses of $26.8$49.3 million and $33.3$57.6 million for the threesix months ended MarchJune 31,30, 2026 and 2025, respectively. We recognized total revenue of $35.1$68.5 million and $30.0$67.9 million for the threesix months ended MarchJune 31,30, 2026 and 2025, respectively, including $29.2$59.9 million and $21.1$50.7 million of XPOVIO net product revenue, respectively, and $5.9$8.6 million and $9.0$17.2 million of license revenue, respectively. As of MarchJune 31,30, 2026, we had $90.9$65.1 million in cash, cash equivalents, and cash equivalents.investments. Based on our current business plan and current capital resources, combined with the uncertainty regarding the availability of additional funding or other strategic alternatives and considering our debt service obligations and financial covenant to maintain minimum liquidity, we have concluded that there is substantial doubt regarding our ability to continue as a going concern within one year after the date the accompanying condensed consolidated financial statements are issued. See “Liquidity, Capital Resources, and Going Concern” below for a further discussion of our liquidity and the conditions that raise substantial doubt regarding our ability to continue as a going concern.
To date, our only source of product revenue has been from the U.S. sales of XPOVIO. Net product revenue for the three months ended June 30, 2026 remained relatively consistent as compared to the three months ended June 30, 2025, reflecting relatively consistent demand for XPOVIO in an increasingly competitive multiple myeloma marketplace.
To date, our only source of product revenue has been from the U.S. sales of XPOVIO. Net product revenue for the threesix months ended MarchJune 31,30, 2026 increased by $8.1$9.2 million compared to the samesix periodmonths inended June 30, 2025. This increase was primarily attributable to an unusually high product returnreturns reserve recorded induring the prior-yearsix period,months ended June 30, 2025, which reduced net revenue in thatthe period,prior-year asperiod. wellThe asincrease was also driven by lower gross-to-net discounts,deductions, specificallyprimarily adue decreaseto inlower chargebacks and a reduction in the Medicare rebate reserve induring the firstsix quartermonths ofended June 30, 2026 compared to the firstprior-year quarter of 2025.period.
License and other revenue for the three months ended MarchJune 31,30, 2026 decreased by $3.1$5.6 million as compared to the three months ended MarchJune 31,30, 2025, primarily due to a decrease of $7.0$6.5 million ofdecrease in reimbursement revenue from Menarini for development-related expenses asfollowing theirthe expiration of its reimbursement obligation to reimburse us expired on December 31, 2025. This decrease was partially offset by ana $0.9 million increase in milestone-relatedroyalty revenue from our other partners in the three months ended March 31, 2026, primarily due to a $3.5 million milestone payment under a licensing agreement with a privately-held biotech company related to the research, development and commercialization of verdinexor for the treatment of cancer in certain animals.partners.
License and other revenue for the six months ended June 30, 2026 decreased by $8.7 million as compared to the six months ended June 30, 2025, primarily due to a decrease of $13.5 million of reimbursement revenue from Menarini for development-related expenses following the expiration of its reimbursement obligation on December 31, 2025. This decrease was partially offset by higher milestone and royalty revenue, including a $3.5 million milestone payment under a licensing agreement with a privately held biotechnology company related to the research, development and commercialization of verdinexor for the treatment of cancer in certain animals, as well as a $1.2 million increase in royalty revenue from our partners.
We expect license and other revenue to decrease in the second quarter of 2026 as compared to the first quarter of 2026, as we do not anticipate recognizing any milestone-related revenue.
Cost of sales for the three and six months ended MarchJune 31,30, 2026 and 2025 were relatively consistent.
At any one time, we have a number of ongoing clinical development programs that we are conducting independently or in collaboration with third parties. We track our external clinical trial and related costs on a program-by-program basis. Our major programs reported in the table above include our lead clinical programs in myelofibrosis andmyelofibrosis, endometrial cancer and our other late-stage clinical program in multiple myeloma. To the extent that external clinical trial and related costs are not attributable to a major program, they are included in “Other programs” and to the extent external clinical trial and related costs cannot be allocated to a specific program, they are included in “Non-program specific clinical trial and related costs.” We also have unallocated research and development costs, which we do not track on a program-by-program basis. These costs represent expenses incurred across multiple programs or to support our general research and development operations.
Research and development expenses for the three and six months ended June 30, 2026 decreased by $3.8 million and $4.7 million, respectively, as compared to the three and six months ended June 30, 2025. The decreases were driven by our continued prioritization, focus, and efficient spending while advancing our late-stage programs, with our Phase 3 trials having completed enrollment. Research and development expenses for our multiple myeloma program decreased by $1.8 million and $2.0 million for the three and six month periods, respectively, mainly driven by timing of comparator drug expenses related to the EMN29 trial. The decrease in our myelofibrosis program expenses was primarily driven by the SENTRY Trial transitioning from enrollment to the maintenance phase, resulting in lower trial site and patient-related costs of $1.1 million and $1.5 million for the three and six month periods, respectively.
We expect research and development expenses to remain relatively consistent as we continue to balance the near-term requirements of our ongoing programs with actions intended to materially reduce our cost base and advance our most important near-term value drivers in myelofibrosis.
Research and development expenses for the three months ended March 31, 2026 were relatively consistent as compared to the three months ended March 31, 2025. If the topline data of our trials is positive or we are able to submit a supplemental New Drug Application (“sNDA”), we expect our research and development expenses will increase, primarily due to costs associated with regulatory filings.
Selling, general and administrative expenses for the three and six months ended June 30, 2026 decreased by $2.6 million and $3.2 million, respectively, as compared to the three and six months ended June 30, 2025. The decreases were primarily driven by proactive cost containment while maintaining disciplined alignment of pre-launch investments with clinical and regulatory milestones.
In the near term, we expect selling, general and administrative expenses to increase due to incremental professional advisory fees related to our ongoing liquidity and strategic initiatives, as well as targeted retention costs intended to support organizational continuity and execution during this pivotal period.
Selling, general and administrative expenses for the three months ended March 31, 2026 were relatively consistent as compared to the three months ended March 31, 2025. If the anticipated topline data of our trials in 2026 is positive or we are able to submit a sNDA, we expect that our selling, general administrative expenses will increase, primarily due to launch preparation costs.
Total other income,expense, net for the three and six months ended MarchJune 31,30, 2026 decreasedincreased by $31.7 million and $37.1 million, respectively, as compared to the three and six months ended MarchJune 31,30, 2025 by $5.5 million.. The decreaseincreases waswere primarily due to the fair value remeasurement of embedded derivatives and liability-classified common stock warrants, both of which are non-cash items. There was also an increase in interest expense due to an increase to the interest rate in October 2025 on our senior secured term loan facility and convertible debt.
We have historically financed our operations primarily through a combination of proceeds from (i) product revenue sales; (ii) public and private placements of equity securities; (iii) the issuance of convertible debt; (iv) a term loan; (v) our deferred royalty obligation; (vi) at the market offerings; and (vii) business development activities. As of MarchJune 31,30, 2026, our principal source of liquidity was $90.9$65.1 million of cash, cash equivalents, and cash equivalents.investments. We have had recurring losses since inception and incurred an operating loss of $26.8$49.3 million for the threesix months ended MarchJune 31,30, 2026.
We anticipate that we will continue to incur significant operating losses in the foreseeable future. Based on our current business plan and current capital resources, combined with the uncertainty regarding the availability of additional funding or other strategic transactions and considering our debt service obligations and financial covenant to maintain minimum liquidity, we have concluded that there is substantial doubt regarding our ability to continue as a going concern within one year after the date the accompanying condensed consolidated financial statements are issued. We expect that our existing liquidity, including cash, cash equivalents, and cash equivalents as of March 31, 2026investments as well as cash flow from net product revenue and license and other revenue, will enable us to fund our current operating plans tointo lateSeptember in2026. With the third quarterassistance of 2026.our advisors, including our financial advisor Centerview Partners and other advisors, we are actively evaluating a range of financing opportunities and strategic alternatives with the objective of extending our cash runway, preserving strategic flexibility and maximizing long-term shareholder value as we advance our myelofibrosis program. On September 10, 2026, a $15.8 million principal payment is due under our senior secured term loan facility; if this payment is made without additional financing or a waiver from our lenders, we expect that (i) our cash, cash equivalents and investments will fall below our $10.0 million minimum liquidity covenant, which would trigger a default on our term loan and (ii) we will not have sufficient resources to fund our operations following such payment. In addition to the $15.8 million principal payment due on September 10, 2026, we have approximately $10.1 million of aggregate interest payments due on September 30, 2026 under our senior secured term loan, 2028 Notes and 2029 Notes. See “Liquidity and Capital Resources – Funding Requirements” below and Note 1 “Nature of Business, Basis of Presentation and Segment Information” to the condensed consolidated financial statements included under Part I, Item 1 of this Quarterly Report on Form 10-Q for a further discussion of our liquidity and the conditions that raise substantial doubt regarding our ability to continue as a going concern.
Operating activities. Net cash used in operating activities decreased by $16.3$10.0 million for the threesix months ended MarchJune 31,30, 2026 compared to the threesix months ended MarchJune 31,30, 2025, primarily due to a $7.3 million decrease in interest and royalty payments in 2026 as a result of certain debt modifications which occurred in October 2025.
Investing activities. Net cash provided by investing activities decreased by $12.1$40.4 million for the threesix months ended MarchJune 31,30, 2026 compared to the threesix months ended MarchJune 31,30, 2025, primarily due to lower proceeds from maturities of investments as a result of a lower investment balance inbetween periods as well as increased purchases of investments during the threesix months ended MarchJune 31,30, 2026.2026 due to the cash inflows from the financing activities described below.
Financing activities. Net cash provided by financing activities increased by $49.8$48.5 million for the threesix months ended MarchJune 31,30, 2026 compared to the threesix months ended MarchJune 31,30, 2025, primarily due to the proceeds from the issuance of common stock during the threesix months ended MarchJune 31,30, 2026 under our Private Placement and Open Market Sale Agreement, as described in further detail under the heading “Sources of Liquidity”.
On March 24, 2026, we entered into a Securities Purchase Agreement with RA Capital Management pursuant to which we issued and sold in a private placement: (i) 1,030,354 shares of common stock, (ii) pre-funded warrants to purchase up to 3,391,164 shares of common stock, and (iii) accompanying 2026 Warrants to purchase 4,421,518 shares of common stock with an exercise price of $10.00 per share for aggregate net proceeds of $26.9 million. The 2026 Warrants are exercisable until 30August days29, following our public announcement of topline data results from our Phase 3 XPORT-EC-042 clinical trial of selinexor in patients with endometrial cancer2026 and the pre-funded warrants do not expire. As of MarchJune 31,30, 2026, none of these warrants have been exercised.
In September 2019, we and certain of our subsidiaries entered into the Revenue Interest Financing Agreement with certain entities managed by HCRx, which was subsequently amended on June 23, 2021, August 1, 2023, May 8, 2024, August 14, 2025, August 27, 2025 and October 7, 2025 and which was assigned in July 2025 by HCRx to an affiliate of KKR & Co. Inc. in connection with its acquisition of a majority ownership stake in HCRx (the “Revenue Interest Agreement” and, as amended, the “Amended Revenue Interest Agreement”), pursuant to which, HCRx paid us a total of $135.0 million, less certain transaction expenses. On October 7, 2025, we entered into the Sixth Amendment to the Revenue Interest Financing Agreement pursuant to which (i) HCRx waived our obligation to pay royalties on revenue recognized between April 1, 2025 and March 31, 2026 and (ii) we agreed to increase the Applicable Tiered Percentage (as defined in the Amended Revenue Interest Agreement ) to 8.00% beginning on April 1, 2026. The total amount payable under the Revenue Interest Financing Agreement will remain capped at $263.3 million. For additional information, see Note 10, “Long-Term Obligations”, to the condensed consolidated financial statements included under Part I, Item 1 of this Quarterly Report on Form 10-Q.
In May 2024, we entered into a credit and guaranty agreement (the “Credit Agreement”) with certain existing lenders and HCRx, which was subsequently assigned by HCRx to KKR in connection with its acquisition of a majority ownership stake in HCRx in July 2025, which provides for a senior secured term loan facility of $100.0 million (the “Term Loan”). On October 7, 2025, we entered into the First Amendment and Waiver to Credit and Guaranty Agreement, pursuant to which, among other things, the lenders provided $12.5 million principal amount of additional loans (the “Amended Term Loan”). On February 27, 2026, we entered into the Second Amendment to Credit and Guaranty Agreement (the “Amended Credit Agreement”). The amendments to the Credit Agreement include, among other things (i) reducing the financial covenant requiring us to maintain liquidity of at least the lesser of (i) $10.0 million plus 50% of the net cash proceeds received from certain debt and equity issuances and (ii) $25.0 million, through October 10, 2026, after which we will be required to maintain liquidity of at least $25.0 million and (ii) increasing the interest rate on borrowings under the Amended Term Loan to the secured overnight financing rate plus 10.25% for interest payments occurring after June 30, 2025. Interest on borrowings under the Amended Term Loan incurred from July 1, 2025 to MarchJune 31,30, 2026 were paid in kind.kind Interestand onwe borrowingsare incurred from April 1, 2026obligated to June 30, 2026 will be paid in kind on June 30, 2026 andmake cash interest payments will beginbeginning on September 30, 2026. For additional information, see Note 10, “Long-Term Obligations”, to the condensed consolidated financial statements included under Part I, Item 1 of this Quarterly Report on Form 10-Q.
In February 2023, we entered into an Open Market Sale Agreement (the “Open Market Sale Agreement”) with Jefferies LLC, as agent (“Jefferies”). Under the Open Market Sale Agreement, we may issue and sell shares of our common stock having an aggregate offering price of up to $100.0 million (the “Shares”) from time to time through Jefferies. During the threesix months ended MarchJune 31,30, 2026, we sold an aggregate of 2,994,441 Shares under the Open Market Sale Agreement, resulting in net proceeds of $19.8 million. We did not sell any Shares under the Open Market Sale Agreement during the threesix months ended MarchJune 31,30, 2025. AsPursuant to a prospectus we thereafter filed with the SEC as part of Marcha 31,registration statement on Form S-3 on May 4, 2026, $79.8as of June 30, 2026, $100.0 million of Shares waswere available for issuance and sale under the Open Market Sale Agreement.
During the threesix months ended MarchJune 31,30, 2026, we received $3.5 million in milestone payments under our license and distribution agreements pursuant to which we are entitled to receive additional milestone payments, if certain development goals and sales milestones are achieved as well as royalties on future net sales of the licensed and sold products in the territories under such arrangements.
We expect to continue to incur costs related to our clinical development programs as we continue to advance our lead clinical programs in myelofibrosis and endometrial cancer and our other late-stage clinical program in multiple myeloma, as well as costs associated with continued patient follow-up and other wind-down activities related to our endometrial cancer clinical trial. We also expect to incur commercialization expenses related to sales, marketing, manufacturing and distribution of our approved products, to the extent that these functions are not the responsibility of our collaborators.
Identifying potential product candidates and conducting preclinical studies and clinical trials is a time-consuming, expensive and uncertain process that takes years to complete. In addition, our product candidates for which we receive marketing approval may not achieve commercial success. Our ability to become and remain profitable depends on our ability to generate revenue. There can be no assurance as to the amount or timing of any such revenue, and we may not achieve profitability in the near-term, if at all, as described more fully in the risk factor entitled “We have incurred significant losses since inception, expect to continue to incur significant losses, and may never achieve or maintain profitability,” under the heading “Risk Factors” in this Quarterly Report on Form 10-Q. Accordingly, we will need to continue to rely on additional financing to achieve our business objectives. Adequate additional financing may not be available to us on acceptable terms, or at all. We may seek additional capital due to favorable market conditions or strategic considerations, even if we believe we have sufficient funds for our current or future operating plans. If we are unable to raise capital when needed or on attractive terms, we would be forced to delay, reduce or eliminate our research and development programs or commercialization efforts.
Based on our current business plan and current capital resources, combined with the uncertainty regarding the availability of additional funding or other strategic alternatives and considering our debt service obligations and financial covenant to maintain minimum liquidity, we have concluded that there is substantial doubt regarding our ability to continue as a going concern within one year after the date the accompanying condensed consolidated financial statements are issued. See Note 1 “Nature of Business, Basis of Presentation and Segment Information” to the condensed consolidated financial statements included under Part I, Item 1 of this Quarterly Report on Form 10-Q for a further discussion of the conditions that raise substantial doubt regarding our ability to continue as a going concern.
We expect that our existing liquidity, including cash, cash equivalents, and investments as well as cash flow from net product revenue and license and other revenue, will enable us to fund our current operating plans into September 2026. With the assistance of our advisors, including our financial advisor Centerview Partners and other advisors, we are actively evaluating a range of financing opportunities and strategic alternatives with the objective of extending our cash runway, preserving strategic flexibility and maximizing long-term shareholder value as we advance our myelofibrosis program. On September 10, 2026, a $15.8 million principal payment is due under our senior secured term loan facility; if this payment is made without additional financing or a waiver from our lenders, we expect that (i) our cash, cash equivalents and investments will fall below our $10.0 million minimum liquidity covenant, which would trigger a default on our term loan and (ii) we will not have sufficient resources to fund our operations following such payment. In addition to the $15.8 million principal payment due on September 10, 2026, we have approximately $10.1 million of aggregate interest payments due on September 30, 2026 under our senior secured term loan, 2028 Notes and 2029 Notes. In addition, prior to October 10, 2026, the minimum liquidity covenant will increase by 50% of the net cash proceeds of any issuance of debt or sale of capital stock up to a maximum amount of $25.0 million and will increase to $25.0 million on October 10, 2026.
We currently expect that our existing liquidity, including cash and cash equivalents as well as cash flow from net product revenue and license and other revenue, will enable us to fund our current operating plans to late in the third quarter of 2026. We will require additional capital to fund theour ongoingoperations and clinical development of selinexor and other product candidates and to pursue potential regulatory approvals. We plan to address the conditions that raise substantial doubt regarding our ability to continue as a going concern by, among other things, obtaining additional funding through equity offerings, debt financings and refinancings, collaborations, strategic alliances and/or licensing arrangements. We expect to evaluate opportunities to raise additional funds from time to time, including through the issuance and saleapproval of shares of our common stock under our Open Market Sale Agreement andselinexor in connection with the reporting of data from our ongoing Phase 3 XPORT-EC-042 trial. There is no assurance that such additional financing or strategic alternatives will be available on terms acceptable to us, or at all.myelofibrosis. Our ability to successfully raiseconsummate additionala fundsfinancing transaction or execute on a strategic alternative is dependent on a number of factors. IfThere weis areno notassurance ablethat these efforts will result in additional funding, executing a strategic alternative transaction, will increase value for stakeholders, or will sufficiently address our ability to continue as a going concern. Absent additional funding or our ability to successfully consummatecomplete one or more strategic transactions to extend our cash runway beyond September 10, 2026, we will be unable to continue as a financinggoing transactionconcern orand strategic alternative, our Boardwe may explorehave ato saleconsider ofseeking protection under the bankruptcy laws, liquidating our assets or ceasing our operations. If we decide to seek protection under the initiationbankruptcy laws, we expect that we would file for bankruptcy protection at a time that is earlier than when we would otherwise exhaust our cash resources. In any of bankruptcythese proceedingscircumstances, underit Chapteris 11likely that investors will lose all or part of thetheir U.S.investment. BankruptcyIf Code.there remains substantial doubt about our ability to continue as a going concern, investors or other financing sources may be unwilling to provide funding to us on commercially reasonable terms, if at all. Further, our indebtedness, as discussed under the risk factor titled “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,” may be unattractive to potential sources of funding and strategic partners and may decrease our ability to consummate a financing transaction or enter into a strategic alternative. Additionally, the negotiation and consummation of a financing transaction or strategic alternative may be costly and time-consuming.
Our future long-term capital requirements will depend on many factors, as described more fully in the risk factor entitled “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 undertake additional cost reduction measures such as further reducing operating expenses, including through additional workforce reductions, delay, reduce or eliminate our research and development programs and/or commercialization efforts,efforts or at any time we may elect to or may be required to cease operations entirely, liquidate all or a portion of our assets, and/or seek protection under the U.S. Bankruptcy Code, and you may lose all or part of your investment,” under the heading “Risk Factors” in this Quarterly Report on Form 10-Q.
In addition to the expenses required to fund our operations described above, our funding requirements as of MarchJune 31,30, 2026 also include the following:
Future obligations related to the New 2029 Notes of $138.3 million through May 13, 2029; and Future royalty obligations to KKRHCRx under the Amended Revenue Interest Agreement of $116.2 million by October 1, 2035.
KPTI insider buying and selling (Form 4)
Since 2026-04-11, insiders reported open-market purchases in 0 Form 4 filings and open-market sales in 10 filings (6 insiders, 5 trade dates, 4,692 shares, about $40.6K). Net open-market shares: -4,692 (purchases minus sales); net value about -$40.6K.Totals add up every open-market (code P and S) line in those filings, using the prices reported in the filings. Awards, option exercises, tax withholding and gifts are listed below but not counted.
| Trade date | Insider | Transaction | Shares | Price | Value |
|---|---|---|---|---|---|
| 2026-10-01 | Abate Kristin |
Open-market sale | 378 | $1.19 | $450 |
| 2026-09-01 | Abate Kristin |
Open-market sale | 19 | $2.02 | $38 |
| 2026-07-28 | Poulton Stuart |
Open-market sale | 189 | $7.10 | $1.3K |
| 2026-05-21 | Oliger Christy J. |
Grant/award | 15,508 | — | — |
| 2026-05-21 | Pakianathan Deepika |
Grant/award | 15,508 | — | — |
| 2026-05-21 | Schor Chen |
Grant/award | 15,508 | — | — |
| 2026-05-21 | Su Zhen |
Grant/award | 15,508 | — | — |
| 2026-05-21 | Bohlin Garen G |
Grant/award | 15,508 | — | — |
| 2026-05-21 | Greene Barry E |
Grant/award | 15,508 | — | — |
| 2026-05-14 | Poulton Stuart |
Open-market sale | 403 | $9.50 | $3.8K |
| 2026-05-14 | Rangwala Reshma |
Open-market sale | 408 | $9.50 | $3.9K |
| 2026-05-14 | Cheng Sohanya Roshan |
Open-market sale | 324 | $9.50 | $3.1K |
| 2026-05-14 | Abate Kristin |
Open-market sale | 53 | $9.50 | $504 |
| 2026-05-14 | Paulson Richard A. |
Open-market sale | 2,203 | $9.50 | $20.9K |
| 2026-05-14 | Mano Michael |
Open-market sale | 266 | $9.50 | $2.5K |
| 2026-05-13 | Poulton Stuart |
Grant/award | 896 | — | — |
| 2026-05-13 | Rangwala Reshma |
Grant/award | 947 | — | — |
| 2026-05-13 | Cheng Sohanya Roshan |
Grant/award | 947 | — | — |
| 2026-05-13 | Abate Kristin |
Grant/award | 121 | — | — |
| 2026-05-13 | Paulson Richard A. |
Grant/award | 4,920 | — | — |
| 2026-05-13 | Mano Michael |
Grant/award | 700 | — | — |
| 2026-04-21 | Rangwala Reshma |
Open-market sale | 449 | $8.94 | $4.0K |
Well-known investors holding KPTI (13F)
| Investor | Quarter | Shares | Reported value | % of their 13F | Change vs prior quarter |
|---|---|---|---|---|---|
| Two Sigma Investments | 2026-06-30 | 695,264 | $6.8M | 0.01% | Added 360% |
| Millennium Management (Israel Englander) | 2026-06-30 | 305,676 | $3.0M | 0.0% | Reduced 27% |
| Renaissance Technologies | 2026-06-30 | 108,214 | $1.1M | 0.0% | Added 3% |
| Citadel Advisors (Ken Griffin) | 2026-06-30 | 52,069 | $508.7K | 0.0% | New position |