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Item 2. Management’s Discussion and Analysis

2025-11-03 compared with 2025-08-11 · 124 added, 92 removed, 148 unchanged (59% of the section changed)

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and is commercially available in a growing number of countries as our partners continue to secure reimbursement approvals.

We completed enrollment in our ongoing Phase 3 SENTRY trial evaluating selinexor in combination with once or twice-daily ruxolitinib versus placebo plus ruxolitinib in JAKi-naive myelofibrosis patients in September 2025.

We expect to report top-line data from the SENTRY trial in March 2026.

We continue to enroll JAKi-naïve myelofibrosis patients with platelet counts above 50,000 in the selinexor 60 mg cohort of the Phase 2 SENTRY-2 trial.

A recently amended protocol includes patients with platelet counts above 100,000.

We expect to report top-line data from all patients in the 60 mg cohort with at least 24 weeks of follow-up in 2026.

We are continuing to enroll patients in the Phase 3 XPORT-EC-042 trial evaluating selinexor as a maintenance-only therapy following systemic therapy versus placebo in patients with TP53 wild-type advanced or recurrent endometrial cancer.

We expect to report top-line data from this event-driven trial in mid-2026.

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 our other late-stage clinical programs in endometrial cancer and multiple myeloma.

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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.

As of June 30, 2025, we had an accumulated deficit of $1.6 billion.

We had net losses of $60.7 million and $13.6 million for the six months ended June 30, 2025 and 2024, respectively.

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 our 3.00% convertible senior notes maturing on October 15, 2025 (the “2025 Notes”) with an aggregate principal amount of $24.5 million and a requirement of our Credit Agreement, as defined below, and the indenture governing our 6.00% convertible senior notes due 2029 (the “2029 Notes”) to maintain cash, cash equivalents and investments of at least $25.0 million at all times, 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.

As of September 30, 2025, we had an accumulated deficit of $1.7 billion.

We had net losses of $93.8 million and $45.6 million for the nine months ended September 30, 2025 and 2024, respectively.

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 and the 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 and Capital Resources ” below for a further discussion of our liquidity and the conditions that raise substantial doubt regarding our ability to continue as a going concern.

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”), which was subsequently assigned by HCRx to KKR & Co.

(“KKR”) in connection with its acquisition of a majority ownership stake in HCRx in July 2025, under a new, senior secured term loan facility and used a portion of the proceeds of that 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 2025 Notes for (i) $111.0 million aggregate principal amount of our 2029 Notes and (ii) warrants to purchase up to 3.1 million shares of our common stock.

In addition, HCRx purchased $5.0 million aggregate principal amount of our 2029 Notes through satisfaction of $5.0 million of our existing obligations to KKR (as successor in interest to HCRx).

Please refer to Note 10 “ Long-Term Obligations ”, to the condensed consolidated financial statements contained within Part I, Item 1 of this Quarterly Report on Form 10-Q for additional details of the Refinancing Transactions.

On July 11, 2025, we announced that our Board is evaluating potential financing transactions, along with 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;

among other potential alternatives.

We, with the assistance of our advisors, are exploring potential financing and strategic alternatives to enhance liquidity and maximize value.

However, there is no assurance that such additional funding, financing transactions, or strategic alternatives will be available on terms acceptable to us, or at all.

In August 2025, we announced that we expect to close new patient screening in our Phase 3 myelofibrosis trial in August 2025 and expect to report top-line data from this trial in March 2026.

October 2025 Financing Transactions

On October 7, 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.

Following consummation of the Financing Transactions, we had $112.5 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.

Following consummation of the Financing Transactions, holders of pre-funded warrants to purchase common stock exercised pre-funded warrants to purchase an aggregate of 1,123,895 shares of common stock in cashless exercises, pursuant to which we issued an aggregate of 1,123,874 shares of common stock.

Please refer to Note 12 “ Subsequent Event ”, to the condensed consolidated financial statements contained within Part I, Item 1 of this Quarterly Report on Form 10-Q for additional details of the Financing Transactions.

CRITICAL ACCOUNTING ESTIMATES

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The following table summarizes our results of operations (in thousands, except for percentages):

For the Three Months Ended June 30,

For the Six Months Ended June 30,

For the Three Months Ended September 30,

For the Nine Months Ended September 30,

Product revenue, net

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Loss from operations

Other income (expense), net

(Loss) income before income taxes

Other (expense) income, net

Loss before income taxes

Income tax provision

Net (loss) income

Product Revenue, net (in thousands, except for percentages)

For the Three Months Ended June 30,

For the Six Months Ended June 30,

For the Three Months Ended September 30,

For the Nine Months Ended September 30,

Product revenue, net

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sales of XPOVIO.

Net product revenue for the three months ended June 30, 2025 increased by $1.6 million as compared to the three months ended June 30, 2024, due to gross-to-net favorability mainly driven by lower 340B discounts, which are discounts provided under the federal 340B Drug Pricing Program for eligible safety-net providers, in the second quarter of 2025.

Net product revenue for the six months ended June 30, 2025 decreased by $3.3 million as compared to the six months ended June 30, 2024, primarily due to an increase in the gross-to-net provision largely due to the increase in the product return reserve, partially offset by gross-to-net favorability driven by lower 340B discounts in the six months ended June 30, 2025.

Net product revenue for the three months ended September 30, 2025 increased by $2.5 million as compared to the three months ended September 30, 2024.

The increase was primarily driven by gross-to-net favorability, reflecting lower 340B discounts, partially offset by higher Medicare discount program charges and increased deductions associated with group purchasing organization arrangements.

Net product revenue for the nine months ended September 30, 2025 decreased by $0.8 million as compared to the nine months ended September 30, 2024, due to an increase in the gross-to-net provision largely due to the increase in the product return reserve and Medicare rebates, partially offset by gross-to-net favorability driven by lower 340B discounts in the nine months ended September 30, 2025.

The product return reserve increased as a result of atypical returns in the first quarter of 2025, primarily driven by expired units returned from clinics and hospitals that had purchased these units following the 2020 approval of XPOVIO ®.

We expect net product revenue to increase in the second half of 2025 as compared to the first half of 2025 due to gross-to-net favorability, driven by lower product returns and lower 340B discounts than the first half of the year, coupled with increased demand.

We expect net product revenue in the fourth quarter of 2025 to be consistent with the third quarter of 2025 due to both consistent gross-to-net adjustments and demand.

License and Other Revenue (in thousands, except for percentages)

For the Three Months Ended June 30,

For the Six Months Ended June 30,

For the Three Months Ended September 30,

For the Nine Months Ended September 30,

Menarini Group ("Menarini")

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Total license and other revenue

License and other revenue for the three and six months ended June 30, 2025 decreased as compared to the three and six months ended June 30, 2024 by $6.5 million and $4.7 million, respectively, primarily due to $6.0 million of non-recurring license-related revenue recognized during the three months ended June 30, 2024.

We expect license and other revenue to decrease in the second half of 2025 as compared to the first half of 2025 primarily because the reimbursement of development-related expenses from Menarini is limited to $1.5 million for the second half of 2025.

License and other revenue for the three months ended September 30, 2025 increased by $2.7 million as compared to the three months ended September 30, 2024, primarily due to increased milestone-related revenue.

License and other revenue for the nine months ended September 30, 2025 decreased by $1.9 million as compared to the nine months ended September 30, 2024, primarily due to decreased milestone-related revenue.

We expect license and other revenue to decrease in the fourth quarter of 2025 as compared to the third quarter of 2025, reflecting lower expected milestone revenue and the fact that the maximum reimbursement revenue from Menarini was fully recognized in the third quarter.

Operating Expenses (in thousands, except for percentages)

For the Three Months Ended June 30,

For the Six Months Ended June 30,

For the Three Months Ended September 30,

For the Nine Months Ended September 30,

Cost of sales

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Cost of Sales

Cost of sales for the three and six months ended June 30, 2025 and 2024 were relatively consistent.

We expect cost of sales to remain relatively consistent in the second half of 2025 as compared to the first half of 2025.

Cost of sales for the three months ended September 30, 2025 increased by $0.8 million as compared to the three months ended September 30, 2024, primarily due to an increase in charges to write-off inventory in excess of demand.

Cost of sales for the nine months ended September 30, 2025 and 2024 were relatively consistent.

We expect cost of sales to remain relatively consistent in the fourth quarter of 2025 as compared to the third quarter of 2025.

Research and Development Expenses (in thousands, except for percentages)

For the Three Months Ended June 30,

For the Six Months Ended June 30,

For the Three Months Ended September 30,

For the Nine Months Ended September 30,

Clinical trial and related costs:

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Our major programs include our lead clinical programs in myelofibrosis and our other late-stage clinical programs 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.

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 months ended June 30, 2025 decreased by $5.6 million as compared to the three months ended June 30, 2024, primarily due to the $1.7 million decrease in clinical trial and related costs for selinexor in multiple myeloma, which was primarily due to the reduced scope of our Phase 3 multiple myeloma trial, and the $2.1 million decrease in personnel and stock-based compensation costs, which was primarily due to a reduction in headcount and contractors for the three months ended June 30, 2025 as compared to the three months ended June 30, 2024 due to the realization of previously implemented cost reduction initiatives.

Research and development expenses for the six months ended June 30, 2025 decreased by $6.4 million as compared to the six months ended June 30, 2024.

The $3.8 million decrease in clinical trial and related costs for selinexor in multiple myeloma was primarily due to the reduced scope of our Phase 3 multiple myeloma trial.

The $3.9 million decrease in personnel and stock-based compensation costs was primarily due to a reduction in headcount and contractors for the six months ended June 30, 2025 as compared to the six months ended June 30, 2024 due to the realization of previously implemented cost reduction initiatives.

The $4.1 million increase in clinical trial and related costs for selinexor in myelofibrosis was primarily due to increased purchases of comparator drugs during the six months ended June 30, 2025 as compared to the six months ended June 30, 2024.

We expect our research and development expenses to be relatively consistent in the second half of 2025 as compared to the first half of 2025 as we continue to invest in our myelofibrosis and endometrial cancer Phase 3 clinical trials.

Research and development expenses for the three months ended September 30, 2025 decreased by $5.6 million as compared to the three months ended September 30, 2024.

The decrease was primarily driven by a $4.9 million reduction in clinical trial and related costs for selinexor in multiple myeloma, reflecting the reduced scope of our Phase 3 multiple myeloma trial, and a $2.6 million reduction in personnel and stock-based compensation costs resulting from lower headcount and contractor utilization following previously implemented cost reduction initiatives.

The decreases were partially offset by a $2.2 million increase in clinical trial and related costs for selinexor in myelofibrosis, which was driven by $2.6 million in costs associated with the purchase of comparator drug for use in the trial, partially offset by lower costs related to enrollment activities.

Research and development expenses for the nine months ended September 30, 2025 decreased by $12.0 million as compared to the nine months ended September 30, 2024.

The decrease was primarily attributable to an $8.7 million reduction in clinical trial and related costs for selinexor in multiple myeloma, reflecting the reduced scope of our Phase 3 trial, and a $6.6 million reduction in personnel and stock-based compensation costs resulting from lower headcount and contractor utilization following the previously implemented cost reduction initiatives.

These decreases were partially offset by a $6.4 million increase in clinical trial and related costs for selinexor in myelofibrosis, primarily due to increased trial activity and higher patient enrollment, as well as an increase of $2.3 million in costs associated with the purchase of comparator drug for use in the trial.

We expect research and development expenses to remain relatively consistent in the fourth quarter of 2025 compared to the third quarter of 2025, as we continue to invest in our ongoing Phase 3 clinical trials in myelofibrosis and endometrial cancer.

Selling, General and Administrative Expenses (in thousands, except for percentages)

For the Three Months Ended June 30,

For the Six Months Ended June 30,

For the Three Months Ended September 30,

For the Nine Months Ended September 30,

Personnel costs

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Total selling, general and administrative expenses

Selling, general and administrative expenses for the three and six months ended June 30, 2025 decreased as compared to the three and six months ended June 30, 2024 by $2.6 million and $4.8 million, respectively, primarily due to a reduction in headcount and contractors resulting from previously implemented cost reduction initiatives.

Consulting, professional and other costs decreased $0.4 million for the three and six months ended June 30, 2025 as compared to three and six months ended June 30, 2024 due to a decrease in spend from cost reduction initiatives that was partially offset by an increase in legal expenses incurred in the three and six months ended June 30, 2025 in connection our recent evaluation of potential financings and other strategic transactions.

We expect our selling, general and administrative expenses to remain relatively consistent in the second half of 2025 as compared to the first half of 2025 due to our ongoing cost reduction initiatives, offset by fees to be incurred in connection with pursuit of strategic alternatives, such as efforts to extend our cash runway.

Selling, general and administrative expenses for the three and nine months ended September 30, 2025 decreased by $1.0 million and $5.8 million, respectively, compared to the corresponding periods in 2024.

The decreases were primarily due to lower headcount and contractor utilization resulting from previously implemented cost reduction initiatives that were largely offset by an increase in professional fees incurred in connection with the Financing Transactions and other strategic initiatives of $2.7 million and $4.3 million, for the three and nine months ended September 30, 2025, respectively.

We expect our selling, general and administrative expenses to remain relatively consistent in the fourth quarter of 2025 as compared to the third quarter of 2025, reflecting the continued impact of our cost reduction initiatives, partially offset by fees incurred in connection with the Financing Transactions.

Other Income (Expense), net (in thousands, except for percentages)

For the Three Months Ended June 30,

For the Six Months Ended June 30,

For the Three Months Ended September 30,

For the Nine Months Ended September 30,

Interest expense

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Other (expense) income

Total other income (expense), net

Other income (expense), net for the three and six months ended June 30, 2025 decreased as compared to the three and six months ended June 30, 2024 by $64.8 million and $51.4 million, respectively, primarily due to a $44.7 million gain on extinguishment of debt from the Refinancing Transactions and a $14.3 million gain from the remeasurement of embedded derivatives and liability classified common stock warrants recognized during the three months ended June 30, 2024, both of which are non-cash items.

There was also an increase in interest expense related to the senior secured term loan facility and 2029 Notes, both of which were issued in May 2024 and a decrease in interest income resulting from lower investment balances during the three and six months ended June 30, 2025 as compared to the three and six months ended June 30, 2024.

We expect other income (expense), net to remain relatively consistent in the second half of 2025 as compared to the first half of 2025, however the future impact from remeasurements of the embedded derivatives and liability classified common stock warrants will depend on a variety of factors, including movements in our stock price.

Total other (expense) income, net

Total other (expense) income, net for the three and nine months ended September 30, 2025 increased as compared to the three and nine months ended September 30, 2024 by $12.1 million and $63.6 million, respectively, compared to the corresponding periods in 2024.

The increases were primarily due to the remeasurement of embedded derivatives and liability-classified common stock warrants, both of which are non-cash items.

In addition, the nine months ended September 30, 2024 included a $44.7 million non-cash gain on extinguishment of debt.

The increases were further impacted by higher interest expense associated with the senior secured term loan facility and 2029 Notes, both issued in May 2024, and decreased interest income resulting from reduced investment balances during the 2025 periods compared to 2024.

We expect total other (expense) income, net to remain relatively consistent in the fourth quarter of 2025 compared to the third quarter of 2025, excluding the impact of the Financing Transactions.

However, future period results may continue to be affected by non-cash gains or losses from the remeasurement of embedded derivatives and liability-classified common stock warrants, which will vary depending on movements in our stock price and other market factors.

LIQUIDITY AND CAPITAL RESOURCES

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 June 30, 2025, our principal source of liquidity was $51.7 million of cash, cash equivalents and investments.

We have had recurring losses since inception and incurred a loss of $60.7 million for the six months ended June 30, 2025.

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 September 30, 2025, our principal source of liquidity was $45.9 million of cash, cash equivalents and investments.

Our cash balance as of September 30, 2025 reflects the benefit of $7.4 million of interest and royalties that were paid in kind in connection with the Financing Transactions announced on October 8, 2025.

We have had recurring losses since inception and incurred a loss of $93.8 million for the nine months ended September 30, 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, given the uncertainty regarding the availability of additional funding or other strategic alternatives and considering our debt service obligations, including the October 15, 2025 maturity date of our 2025 Notes, with an aggregate principal amount of $24.5 million and a requirement of our Credit Agreement, as defined below, and the indenture governing our 6.00% convertible senior notes due 2029 (the “2029 Notes”) to maintain cash, cash equivalents and investments of at least $25.0 million at all times, 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 currently expect that cash, cash equivalents and investments as of June 30, 2025 as well as cash flow from net product revenue and license and other revenue, will fund our current operating plans and debt obligation requirements into October 2025 given the $24.5 million aggregate principal amount of the 2025 Notes and $25.0 million minimum liquidity covenant.

Excluding repayment of the 2025 Notes and minimum liquidity covenant, we expect that our cash runway would be sufficient to fund planned operations into January 2026.

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 and the 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 currently expect that our existing cash, cash equivalents and investments as well as cash flows from net product revenue and license and other revenue, will enable us to fund our current operating plans into the second quarter of 2026.

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 I 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.

The following table provides information regarding our cash flows (in thousands):

For the Six Months Ended June 30,

For the Nine Months Ended September 30,

Net cash used in operating activities

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Operating activities.

The $24.5 million decrease in net cash used in operating activities for the six months ended June 30, 2025 compared to the six months ended June 30, 2024 was primarily driven by changes in working capital resulting primarily from decreased spend year-over-year as a result of the realization of previously implemented cost reduction initiatives.

The $38.1 million decrease in net cash used in operating activities for the nine months ended September 30, 2025 compared to the nine months ended September 30, 2024 was primarily driven by changes in working capital resulting primarily from decreased spend year-over-year as a result of the realization of previously implemented cost reduction initiatives.

Investing activities.

The $39.6 million decrease in net cash provided by investing activities for the six months ended June 30, 2025 compared to the six months ended June 30, 2024 was driven by a $76.3 million decrease in proceeds from the maturities of investments, partially offset by a $36.5 million decrease in purchases of investments.

The $42.3 million decrease in net cash provided by investing activities for the nine months ended September 30, 2025 compared to the nine months ended September 30, 2024 was driven by a $99.8 million decrease in proceeds from the maturities of investments, partially offset by a $57.3 million decrease in purchases of investments.

Financing activities .

The $40.6 million decrease in net cash provided by financing activities for the six months ended June 30, 2025 compared to the six months ended June 30, 2024 was driven primarily by the Refinancing Transactions which occurred during the six months ended June 30, 2024 and consisted of $83.3 million of proceeds from the term loan, partially offset by a $40.5 million payment of our deferred royalty obligation and a $2.6 million payment of debt issuance costs.

The $40.6 million decrease in net cash provided by financing activities for the nine months ended September 30, 2025 compared to the nine months ended September 30, 2024 was driven primarily by activity during the nine months

ended September 30, 2024 and consisted of $83.3 million of proceeds from the term loan, partially offset by a $40.5 million payment of our deferred royalty obligation and a $2.6 million payment of debt issuance costs.

Sources of Liquidity

On September 14, 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 and May 8, 2024, and which was subsequently assigned by HCRx to KKR in connection with its acquisition of a majority ownership stake in HCRx in July 2025 (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.

For additional information on the Amended Revenue Interest Agreement, see Note 10, “ Long-Term Obligations ”, to the condensed consolidated financial statements included under Part I, Item I of this Quarterly Report on Form 10-Q.

On May 8, 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.

On October 7, 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.

On October 7, 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.

On September 14, 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 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.

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 I of this Quarterly Report on Form 10-Q.

On October 7, 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 condensed consolidated financial statements included under Part I, Item I of this Quarterly Report on Form 10-Q.

On 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 Sales Agreement during the three and six months ended June 30, 2025 and 2024.

As of June 30, 2025, $100.0 million of Shares was available for issuance and sale under the 2023 Open Market Sale Agreement.

Under the license agreement we entered into with Menarini in December 2021 (the “Menarini Agreement”), Menarini is required to reimburse us for 25% of all documented expenses we incur for the global development of selinexor from 2022 through 2025, provided that such reimbursements shall not exceed $15.0 million per calendar year.

We received $7.0 million of reimbursements under the Menarini Agreement during the six months ended June 30, 2025.

We did not sell any Shares under the 2023 Open Market Sales Agreement during the three and nine months ended September 30, 2025 and 2024.

As of September 30, 2025, $100.0 million of Shares was available for issuance and sale under the 2023 Open Market Sale Agreement.

During the nine months ended September 30, 2025, we received $8.2 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.

In addition, under the license agreement we entered into with Menarini in December 2021 (the “Menarini Agreement”), Menarini is required to reimburse us for 25% of all documented expenses we incur for the global development of selinexor from 2022 through 2025, provided that such reimbursements shall not exceed $15.0 million per calendar year.

We received $13.5 million of reimbursements under the Menarini Agreement during the nine months ended September 30, 2025.

Commitments, Contingencies and Contractual Obligations

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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 98,502 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.

As of June 30, 2025, we expect to incur total lease costs of $10.8 million from June 30, 2025 to September 30, 2030.

Contractual Obligations

We have contractual obligations under our (i) 2025 Notes;

(ii) Credit Agreement, (iii) 2029 Notes, and (iv) Amended Revenue Interest Agreement as disclosed in 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.

We currently have contractual obligations under our (i) Amended Credit Agreement;

(ii) 2028 Notes;

(iii) 2029 Notes;

and (iv) Amended Revenue Interest Agreement as disclosed in Note 10, “ Long-Term Obligations ” and Note 12, “ Subsequent Event ”, to the condensed consolidated financial statements included under Part I, Item 1 of this Quarterly Report on Form 10-Q.

See below under “ Funding Requirements ” for the amounts due under each of these contractual obligations.

Funding Requirements

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Our ability to become and remain profitable depends on our ability to generate revenue.

and may never achieve or maintain profitability ,” under the heading “ Risk Factors ” in this Quarterly Report on Form 10-Q.

There can be no assurance as to the amount or timing of any such revenue, and we may not achieve profitability for several years, 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.

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If we are unable to raise capital or enter into strategic alternatives sufficient to meet our needs 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, given the uncertainty regarding the availability of additional funding or other strategic alternatives and considering our debt service obligations, including the October 15, 2025 maturity date of the 2025 Notes with an aggregate principal amount of $24.5 million and a requirement under our Credit Agreement and the indenture governing the 2029 Notes to maintain cash, cash equivalents and investments of at least $25.0 million at all times, 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.

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 and the 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 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 I 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.

Excluding repayment of the 2025 Notes and minimum liquidity covenant, we expect that our cash runway would be sufficient to fund planned operations into January 2026.

We currently expect that our existing 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.

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 though the issuance and sale of shares of our common stock under our 2023 Open Market Sale Agreement with Jefferies 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 Term Loan, the 2029 Notes, the 2025 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 delay, reduce or eliminate our research and development programs and/or commercialization efforts ,” 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 June 30, 2025 also include the following:

In addition to the expenses required to fund our operations described above, our current funding requirements, following the Financing Transactions that occurred in October 2025, also include the following:

• Lease costs of our headquarters in Newton, Massachusetts of $9.7 million through September 30, 2030;

• Future obligations related to the Amended Credit Agreement of $152.4 million through May 2028 in addition to the financial covenant to maintain minimum liquidity;

• Future obligations related to the 2028 Notes of $19.7 million through October 15, 2028;

• Future obligations related to the 2029 Notes of $136.1 million through May 13, 2029;

• Future obligations related to the Credit Agreement of $135.0 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;

• Future royalty obligations to KKR under the Amended Revenue Interest Agreement of $116.2 million by October 1, 2035.

On July 11, 2025, we announced that our Board is considering potential financing transactions along with strategic alternatives to maximize near and long-term stockholder value, including, but 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 execute on a strategic alternative is dependent on a number of factors and we may not be able to execute upon a transaction or other strategic alternative having favorable terms within an advantageous time frame and/or recognize significant value for our assets, if at all.

Additionally, the negotiation and consummation of a financing transaction or strategic alternative may be costly and time-consuming.

If we are not able to successfully consummate a successful financing transaction or strategic alternative, our Board may decide to pursue a dissolution and liquidation of our company.

In such an event, we would be required under Delaware corporate law to pay our outstanding obligations, as well as to make reasonable provision for contingent and unknown obligations, prior to making any distributions in liquidation to our stockholders.

As a result of this requirement, a portion of our assets may need to be reserved pending the resolution of such obligations.

In addition, we may be subject to litigation or other claims related to a dissolution and liquidation of our company.

If our Board determined to pursue a dissolution and liquidation, our Board, in consultation with its advisors, would need to evaluate these matters and make a determination about a reasonable amount to reserve.

Depending on these factors, the amount available for distribution to our common stockholders in such an event could be as low as zero and result in a total loss of investment to our stockholders.

Quantitative and Qualitati ve Disclosures About Market Risk.

We are exposed to market risk related to changes in interest rates.

We had cash, cash equivalents and investments of $51.7 million as of June 30, 2025.

We had cash, cash equivalents and investments of $45.9 million as of September 30, 2025.

Our primary exposure to market risk is interest rate sensitivity, which is affected by changes in the general level of U.S.

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What changed 10-Q

Item 2. Management’s Discussion and Analysis