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Item 2. Management’s Discussion and Analysis

2025-05-12 compared with 2024-11-05 · 71 added, 96 removed, 134 unchanged (55% of the section changed)

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You should read the following discussion and analysis of our financial condition and results of operations together with our financial statements and related notes appearing elsewhere in this quarterly report and the audited financial information and the notes thereto included in our Annual Report on Form 10-K for the year ended December 31, 2024, as filed with the Securities and Exchange Commission (“SEC”) on February 19, 2025 (“Annual Report ” ).

Unless otherwise indicated, in this Quarterly Report on Form 10-Q, all share amounts and per share amounts have been adjusted to reflect a 1-for-15 reverse split of our common stock (the “Reverse Stock Split”).

FORWARD-LOOKING STATEMENTS

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

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 and other diseases.

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 S elective I nhibitor of N uclear E xport (“SINE”) compounds that inhibit the nuclear export protein exportin 1 (“XPO1”).

We have discovered and are developing and commercializing novel, small molecule Selective Inhibitor of Nuclear Export (“SINE”) 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.

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• In combination with bortezomib and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior therapy.

Approval in this indication was based on the results from the BOSTON ( B o rtezomib, S elinexor and Dexame t has on e) trial;

Approval in this indication was based on the results from the BOSTON ( Bo rtezomib, S elinexor and Dexame t has on e) trial;

• 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.

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is managed by our partners in their respective territories.

XPOVIO/NEXPOVIO has received regulatory approval in various indications in 45 countries outside the U.S.

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 core programs in endometrial cancer, multiple myeloma, and myelofibrosis.

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.

We plan to continue to conduct clinical trials and to seek 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.

In January 2024, we announced that further clinical development of our eltanexor program is on hold in an effort to focus our resources on our prioritized late-stage programs.

As of September 30, 2024, we had an accumulated deficit of $1.5 billion.

We had net losses of $45.6 million and $101.3 million for the nine months ended September 30, 2024 and 2023, respectively.

Based on our current business plan and current capital resources, combined with the uncertainty regarding the availability of additional funding, we have concluded that there is substantial doubt regarding our ability to continue as a going concern within one year after the date the condensed consolidated financial statements are issued.

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 March 31, 2025, we had an accumulated deficit of $1.6 billion.

We had net losses of $23.5 million and $37.4 million for the three months ended March 31, 2025 and 2024, respectively.

Based on our current business plan and current capital resources, combined with the uncertainty regarding the availability of additional funding, and considering our debt obligations, including the October 15, 2025 maturity date of our 3.00% convertible senior notes due 2025 (the “2025 Notes”) and a requirement of our other indebtedness 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.

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.

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Pursuant to these transactions, we borrowed $100.0 million from existing lenders and certain entities managed by HealthCare Royalty Management, LLC (“HCRx”) 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 3.00% unsecured convertible senior notes for (i) $111.0 million aggregate principal amount of our new 6.00% secured convertible senior 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 our new 6.00% secured convertible senior notes through satisfaction of $5.0 million of our existing obligations to 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 new 6.00% secured convertible senior notes due 2029 (the “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 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.

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There have been no changes to the critical accounting estimates we identified in Item 7.

Management's Discussion and Analysis of Financial Condition and Results of Operations in our Annual Report except for our estimated value of the gain on extinguishment of debt, the embedded derivatives in the 2029 Notes (as defined below) and the liability classified common stock warrants related to the Refinancing Transactions, which 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.

Management's Discussion and Analysis of Financial Condition and Results of Operations in our Annual Report.

RESULTS OF OPERATIONS

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

For the Three Months Ended September 30,

For the Nine Months Ended September 30,

For the Three Months Ended March 31,

Product revenue, net

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

For the Three Months Ended September 30,

For the Nine Months Ended September 30,

For the Three Months Ended March 31,

Product revenue, net

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sales of XPOVIO.

Net product revenue for the three months ended September 30, 2024 decreased as compared to the three months ended September 30, 2023, primarily due to higher gross-to-net discounts driven by increased Medicare rebates and 340B discounts.

Net product revenue for the nine months ended September 30, 2024 decreased as compared to the nine months ended September 30, 2023, primarily due to decreased demand as a result of increasing competition and higher gross-to-net discounts driven by increased Medicare rebates and 340B discounts.

We expect net product revenue to remain relatively consistent in the fourth quarter of 2024 as compared to the third quarter of 2024.

Net product revenue for the three months ended March 31, 2025 decreased by $5.0 million as compared to the three months ended March 31, 2024, due to an increase in the gross-to-net provision largely due to the increase in the product return reserve.

These atypical returns were primarily driven by expired 80 mg and 100 mg units returned from clinics and hospitals that had purchased these units following the 2020 approval of XPOVIO ® 100 mg in combination with bortezomib and dexamethasone.

The majority of XPOVIO ® that is prescribed today are 40 mg and 60 mg doses.

We expect net product revenue to increase in the second quarter of 2025 as compared to the first quarter of 2025 primarily due to gross-to-net favorability with product returns expected to be more in-line with historical averages in future quarters.

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

For the Three Months Ended September 30,

For the Nine Months Ended September 30,

For the Three Months Ended March 31,

Menarini Group ("Menarini")

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Total license and other revenue

License and other revenue for the three months ended September 30, 2024 increased by $3.5 million as compared to the three months ended September 30, 2023 primarily due to $6.0 million of milestone revenue recognized from Menarini during the three months ended September 30, 2024, partially offset by a $3.3 million decrease in revenue for the reimbursement of development-related expenses from Menarini due to the timing of the reimbursement we receive, up to a limit of $15.0 million per calendar year.

License and other revenue for the nine months ended September 30, 2024 increased by $5.8 million as compared to the nine months ended September 30, 2023 primarily due to $10.0 million of milestone revenue recognized from Menarini during the nine months ended September 30, 2024, partially offset by a decrease of $3.5 million of license-related revenue from Menarini.

We expect license and other revenue to decrease in the fourth quarter of 2024 as compared to the third quarter of 2024 due to the maximum reimbursement revenue from Menarini already having been recognized, coupled with lower milestone revenue expected in the fourth quarter of 2024 compared to the third quarter of 2024.

License and other revenue for the three months ended March 31, 2025 increased by $1.8 million as compared to the three months ended March 31, 2024 primarily due to the timing of $1.2 million of revenue recognized for the reimbursement of development-related expenses from Menarini.

We expect license and other revenue to be relatively consistent in the second quarter of 2025 as compared to the first quarter of 2025 based on the expected timing and amount of revenue recognition for the reimbursement of development-related expenses from Menarini in the second quarter of 2025.

Operating Expenses (in thousands, except for percentages)

For the Three Months Ended September 30,

For the Nine Months Ended September 30,

For the Three Months Ended March 31,

Cost of sales

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Cost of Sales

Cost of sales in aggregate dollars were consistent for the three and nine months ended September 30, 2024 and 2023.

We expect cost of sales to remain relatively consistent in the in the fourth quarter of 2024 as compared to the third quarter of 2024.

Cost of sales for the three months ended March 31, 2025 and 2024 were relatively consistent.

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

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

For the Three Months Ended September 30,

For the Nine Months Ended September 30,

For the Three Months Ended March 31,

Clinical trial and related costs:

Selinexor in myelofibrosis

Selinexor in multiple myeloma

Selinexor in endometrial cancer

Selinexor in multiple myeloma

Other programs

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We track our external clinical trial and related costs on a program-by-program basis.

Our major programs include our three core clinical development programs in myelofibrosis, endometrial cancer and multiple myeloma.

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.

These costs represent costs that are incurred across multiple programs or to support our general research and development operations.

Research and development expenses for the three months ended September 30, 2024 increased by $0.6 million as compared to the three months ended September 30, 2023 primarily due to increased activity in our ongoing pivotal Phase 3 trial in myelofibrosis, partially offset by decreases in clinical trial and related costs in other programs.

Research and development expenses for the nine months ended September 30, 2024 increased by $10.6 million as compared to the nine months ended September 30, 2023.

The $13.9 million increase in clinical trial and related costs was primarily due to increased activity in each of our three ongoing pivotal Phase 3 trials, including increased purchases of comparator drugs.

These increases were partially offset by decreases of clinical trial and related costs in other programs.

The decrease in personnel costs of $4.8 million was primarily due to a reduction in headcount and contractors for the nine months ended September 30, 2024 as compared to the nine months ended September 30, 2023 primarily due to our ongoing cost reduction initiatives.

We expect our research and development expenses to slightly decrease in the fourth quarter of 2024 as compared to the third quarter of 2024 primarily due to the reduced scope of our Phase 3 trial in multiple myeloma, as well as reduced headcount due to our ongoing cost reduction initiatives, partially offset by an expected increase in expenses related to our Phase 3 trial in myelofibrosis.

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 March 31, 2025 decreased by $0.8 million as compared to the three months ended March 31, 2024.

The $2.1 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 $1.9 million decrease in personnel and stock-based compensation costs was primarily due to a reduction in headcount and contractors for the three months ended March 31, 2025 as compared to the three months ended March 31, 2024 due to the realization of previously implemented cost reduction initiatives.

The $5.0 million increase in clinical trial and related costs for selinexor in myelofibrosis was primarily due to increased purchases of comparator drugs during the three months ended March 31, 2025 as compared to the three months ended March 31, 2024.

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

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

For the Three Months Ended September 30,

For the Nine Months Ended September 30,

For the Three Months Ended March 31,

Personnel costs

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Total selling, general and administrative expenses

Selling, general and administrative expenses for the three months ended September 30, 2024 decreased by $3.2 million as compared to the three months ended September 30, 2023.

The decrease in personnel costs of $2.4 million was primarily due to a reduction in headcount and contractors.

Selling, general and administrative expenses for the nine months ended September 30, 2024 decreased by $12.9 million as compared to the nine months ended September 30, 2023.

The decrease in personnel costs of $8.0 million was primarily due to a reduction in headcount and contractors.

The $4.5 million decrease in consulting, professional and other costs was primarily due to our ongoing cost reduction initiatives.

We expect our selling, general and administrative expenses to remain relatively consistent in the fourth quarter of 2024 as compared to the third quarter of 2024.

Selling, general and administrative expenses for the three months ended March 31, 2025 decreased by $2.2 million as compared to the three months ended March 31, 2024.

The decrease in personnel and stock-based compensation costs of $2.2 million was primarily due to a reduction in headcount and contractors for the three months ended March 31, 2025 as compared to the three months ended March 31, 2024 primarily due to the realization of previously implemented cost reduction initiatives.

We expect our selling, general and administrative expenses to remain relatively consistent in the second quarter of 2025 as compared to the first quarter of 2025 as we continue to closely manage our spend.

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

For the Three Months Ended September 30,

For the Nine Months Ended September 30,

For the Three Months Ended March 31,

Interest expense

Interest income

Gain on extinguishment of debt

Other income (expense)

Total other income (expense), net

Other income (expense), net for the three months ended September 30, 2024 decreased by $2.5 million, as compared to the three months ended September 30, 2023, primarily due to a $5.3 million increase in interest expense related to the new term loan and new secured convertible senior notes, partially offset by a gain of $4.0 million recognized during the three months ended September 30, 2024 from the remeasurement of embedded derivatives and liability classified common stock warrants, both of which are non-cash items.

Other income (expense), net for the nine months ended September 30, 2024 increased by $52.0 million as compared to the nine months ended September 30, 2023, primarily due to a $44.7 million gain on extinguishment of debt from the Refinancing Transactions and a $18.3 million gain from the remeasurement of embedded derivatives and liability classified common stock warrants, both of which are non-cash items.

These gains were partially offset by an increase in interest expense related to the new term loan and new secured convertible senior notes.

We expect Other income (expense), net to remain relatively consistent in the fourth quarter of 2024 as compared to the third quarter of 2024, 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.

Other income (expense), net for the three months ended March 31, 2025 increased by $13.4 million as compared to the three months ended March 31, 2024, primarily due to a $20.0 million non-cash gain from the remeasurement of embedded derivatives and liability classified common stock warrants.

These gains were partially offset by an increase in interest expense related to the senior secured term loan facility and 2029 Notes, both of which were issued in May 2024.

There was also a decrease in interest income resulting from lower investment balances during the three months ended March 31, 2025 as compared to the three months ended March 31, 2024.

We expect other income (expense), net to remain relatively consistent in the second quarter of 2025 as compared to the first quarter 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.

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 September 30, 2024, our principal source of liquidity was $133.5 million of cash, cash equivalents and investments.

We have had recurring losses since inception and incurred a loss of $45.6 million for the nine months ended September 30, 2024.

As of March 31, 2025, our principal source of liquidity was $69.9 million of cash, cash equivalents and investments.

We have had recurring losses since inception and incurred a loss of $23.5 million for the three months ended March 31, 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, 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 cash, cash equivalents and investments as of September 30, 2024 will be sufficient to fund our current operating plans and debt obligation requirements into the fourth quarter of 2025.

Based on our current business plan and current capital resources, combined with the uncertainty regarding the availability of additional funding and considering our debt obligations, including the October 15, 2025 maturity date of our 2025 Notes and a requirement of our other indebtedness 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 expect that our cash, cash equivalents and investments as of March 31, 2025 will fund our current operating plans and debt obligation requirements into early fourth quarter of 2025.

See “ Liquidity and Capital Resources – Funding Requirements ” below and Note 1 “ Nature of Business ” 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 Nine Months Ended September 30,

For the Three Months Ended March 31,

Net cash used in operating activities

Net cash provided by (used in) investing activities

Net cash provided by financing activities

Effect of foreign exchange rates

Net increase (decrease) in cash, cash equivalents and restricted cash

Net cash provided by investing activities

Effect of exchange rates on cash, cash equivalents and restricted cash

Net decrease in cash, cash equivalents and restricted cash

Operating activities.

The $27.5 million increase in net cash used in operating activities for the nine months ended September 30, 2024 compared to the nine months ended September 30, 2023 was primarily driven by working capital changes, including the collection of $22.4 million of milestone payments from Antengene in the first quarter of 2023.

The $4.7 million decrease in net cash used in operating activities for the three months ended March 31, 2025 compared to the three months ended March 31, 2024 was primarily driven by changes in the timing of payments made for drug product.

Investing activities.

The $99.6 million increase in net cash provided by investing activities for the nine months ended September 30, 2024 compared to the nine months ended September 30, 2023 was driven by a $85.3 million decrease in purchases of investments and a $14.5 million increase in proceeds from the maturities of investments.

Financing activities.

The $40.1 million increase in net cash provided by financing activities for the nine months ended September 30, 2024 compared to the nine months ended September 30, 2023 was driven by $83.3 million of proceeds from our new 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 related to the Refinancing Transactions.

The $6.7 million decrease in net cash provided by investing activities for the three months ended March 31, 2025 compared to the three months ended March 31, 2024 was driven by a $38.5 million decrease in proceeds from the maturities of investments, partially offset by a $31.6 million decrease in purchases of investments.

Sources of Liquidity

On September 14, 2019, we and certain of our subsidiaries entered into the Revenue Interest Financing Agreement with HealthCare Royalty Partners III, L.P.

and HealthCare Royalty Partners IV, L.P.

(“HCRx”), which was subsequently amended on June 23, 2021, August 1, 2023 and May 8, 2024 (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 September 14, 2019, we and certain of our subsidiaries entered into the Revenue Interest Financing Agreement with certain entities managed by HealthCare Royalty Management, LLC (“HCRx”), which was subsequently amended on June 23, 2021, August 1, 2023 and May 8, 2024 (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 provides for a senior secured term loan facility of $100.0 million.

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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 nine months ended September 30, 2024 and 2023.

As of September 30, 2024, $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, 2024, we received $17.7 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 will 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 $13.0 million of reimbursements under the Menarini Agreement during the nine months ended September 30, 2024.

We did not sell any Shares under the 2023 Open Market Sales Agreement during the three months ended March 31, 2025 and 2024.

As of March 31, 2025, $100.0 million of Shares was available for issuance and sale under the 2023 Open Market Sale Agreement.

Commitments, Contingencies and Contractual Obligations

Operating Leases

We are party to an operating lease of 98,502 square feet of office and research space in Newton, Massachusetts with a term through September 30, 2025 (the “Newton, MA Lease”).

Pursuant to the Newton, MA Lease, we have provided a security deposit in the form of a cash-collateralized letter of credit in the amount of $0.3 million which is classified in long-term restricted cash on our condensed consolidated balance sheets.

As of September 30, 2024, we expect to incur total lease costs of $3.9 million from September 30, 2024 to September 30, 2025.

In addition, we are party to certain short-term leases having a term of twelve months or less at the commencement date.

We recognize short-term lease expense on a straight-line basis and do not record a related right-of-use asset or lease liability for such leases.

These costs were insignificant for both the nine months ended September 30, 2024 and 2023.

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 March 31, 2025, we expect to incur total lease costs of $10.9 million from March 31, 2025 to September 30, 2030.

Contractual Obligations

We have contractual obligations under (i) our 3.00% Convertible Senior Notes due 2025 (the “2025 Notes”);

(ii) our Credit Agreement, (iii) our 6.00% Convertible Senior Notes due 2029 (the “2029 Notes”), and (iv) our 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 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.

Funding Requirements

We expect to continue to incur costs related to our clinical development programs as we rapidly advance three pivotal Phase 3 trials, 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.

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 our other late-stage clinical programs 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.

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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.

See Note 1 “ Nature of Business ” 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.

We currently expect that cash, cash equivalents and investments as of September 30, 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.

We currently expect that cash, cash equivalents and investments as of March 31, 2025 will fund our current operating plans and debt obligation requirements into early fourth quarter of 2025 while we continue to commercialize XPOVIO in the U.S.

and continue the clinical trials of our product candidates.

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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 Quarterly Report on Form 10-Q.

In addition to the expenses required to fund our operations described above, our funding requirements as of September 30, 2024 also include the following:

• Lease costs for our headquarters in Newton, Massachusetts of $3.9 million from September 30, 2024 to September 30, 2025;

• Future obligations related to the 2025 Notes of $25.6 million over the next two years;

• Future obligations related to the 2029 Notes of $148.1 million over the next five years;

• Future obligations related to the Credit Agreement of $154.3 million;

• Future royalty obligations to HCRx under the Amended Revenue Interest Agreement of $122.4 million.

In addition to the expenses required to fund our operations described above, our funding requirements as of March 31, 2025 also include the following:

• Lease costs of our headquarters in Newton, Massachusetts of $10.9 million through September 30, 2030;

• Future obligations related to the 2025 Notes of $25.2 million through October 2025;

• Future obligations related to the 2029 Notes of $144.7 million through May 2029;

• Future obligations related to the Credit Agreement of $141.9 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 HCRx under the Amended Revenue Interest Agreement of $117.8 million by October 1, 2031.

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 $133.5 million as of September 30, 2024.

We had cash, cash equivalents and investments of $69.9 million as of March 31, 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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Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-Q

Item 2. Management’s Discussion and Analysis