Karyopharm Therapeutics Inc.

11/03/2025 | Press release | Distributed by Public on 11/03/2025 06:15

Quarterly Report for Quarter Ending September 30, 2025 (Form 10-Q)

Management's Discussion and Analysis of Financial Condition and Results of Operations.

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 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

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

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

OVERVIEW

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 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. 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 in July 2019, and is currently approved and marketed in the U.S. for the following indications:

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 (Bortezomib, Selinexor and Dexamethasone) 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. Approval in this indication was based on the results from the STORM (Selinexor Treatment of Refractory Myeloma) trial; and
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 two lines of systemic therapy. This indication was approved under accelerated approval based on response rate and was based on the results from the SADAL (Selinexor Against Diffuse Aggressive Lymphoma) trial. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

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 50 countries outside of the U.S. 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 TP53wild-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. 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. 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 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.

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

We believe that several accounting policies are important to understanding our historical and future performance. We refer to these policies as "critical" because these specific areas generally require us to make judgments and estimates about matters that are uncertain at the time we make the estimate, and different estimates - which also would have been reasonable - could have been used, which would have resulted in different financial results. 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.

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,

2025

2024

$ Change

% Change

2025

2024

$ Change

% Change

Product revenue, net

$

32,032

$

29,516

$

2,516

9

%

$

82,767

$

83,554

$

(787

)

(1

)%

License and other revenue

12,012

9,267

2,745

30

%

29,221

31,141

(1,920

)

(6

)%

Total revenue

44,044

38,783

5,261

14

%

111,988

114,695

(2,707

)

(2

)%

Operating expenses:

Cost of sales

2,113

1,300

813

63

%

4,465

4,676

(211

)

(5

)%

Research and development

30,544

36,134

(5,590

)

(15

)%

97,950

109,930

(11,980

)

(11

)%

Selling, general and administrative

26,607

27,632

(1,025

)

(4

)%

82,436

88,251

(5,815

)

(7

)%

Loss from operations

(15,220

)

(26,283

)

11,063

(42

)%

(72,863

)

(88,162

)

15,299

(17

)%

Other (expense) income, net

(17,873

)

(5,761

)

(12,112

)

>100%

(20,868

)

42,686

(63,554

)

(>100)%

Loss before income taxes

(33,093

)

(32,044

)

(1,049

)

3

%

(93,731

)

(45,476

)

(48,255

)

>100%

Income tax provision

(34

)

(28

)

(6

)

21

%

(110

)

(166

)

56

(34

)%

Net loss

$

(33,127

)

$

(32,072

)

$

(1,055

)

3

%

$

(93,841

)

$

(45,642

)

$

(48,199

)

>100%

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

For the Three Months Ended September 30,

For the Nine Months Ended September 30,

2025

2024

$ Change

% Change

2025

2024

$ Change

% Change

Product revenue, net

$

32,032

$

29,516

$

2,516

9

%

$

82,767

$

83,554

$

(787

)

(1

)%

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 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 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 September 30,

For the Nine Months Ended September 30,

2025

2024

$ Change

% Change

2025

2024

$ Change

% Change

Menarini Group ("Menarini")

$

11,142

$

8,753

$

2,389

27

%

$

26,960

$

27,232

$

(272

)

(1

)%

Antengene Therapeutics Limited ("Antengene")

670

273

397

>100%

1,811

1,272

539

42

%

Other

200

241

(41

)

(17

)%

450

2,637

(2,187

)

(83

)%

Total license and other revenue

$

12,012

$

9,267

$

2,745

30

%

$

29,221

$

31,141

$

(1,920

)

(6

)%

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 September 30,

For the Nine Months Ended September 30,

2025

2024

$ Change

% Change

2025

2024

$ Change

% Change

Cost of sales

$

2,113

$

1,300

$

813

63

%

$

4,465

$

4,676

$

(211

)

(5

)%

Research and development

30,544

36,134

(5,590

)

(15

)%

97,950

109,930

(11,980

)

(11

)%

Selling, general and administrative

26,607

27,632

(1,025

)

(4

)%

82,436

88,251

(5,815

)

(7

)%

Total operating expenses

$

59,264

$

65,066

$

(5,802

)

(9

)%

$

184,851

$

202,857

$

(18,006

)

(9

)%

Cost of Sales

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 September 30,

For the Nine Months Ended September 30,

2025

2024

$ Change

% Change

2025

2024

$ Change

% Change

Clinical trial and related costs:

Selinexor in myelofibrosis

$

8,990

$

6,757

$

2,233

33

%

$

28,576

$

22,225

$

6,351

29

%

Selinexor in endometrial cancer

4,513

3,344

1,169

35

%

12,844

11,511

1,333

12

%

Selinexor in multiple myeloma

1,460

6,357

(4,897

)

(77

)%

6,625

15,354

(8,729

)

(57

)%

Other programs

511

1,135

(624

)

(55

)%

1,567

2,403

(836

)

(35

)%

Non-program specific clinical trial and related costs

1,729

1,819

(90

)

(5

)%

4,670

5,701

(1,031

)

(18

)%

Total clinical trial and related costs

17,203

19,412

(2,209

)

(11

)%

54,282

57,194

(2,912

)

(5

)%

Unallocated costs:

Personnel

8,490

11,039

(2,549

)

(23

)%

28,615

34,492

(5,877

)

(17

)%

Consulting, professional and other

3,884

4,621

(737

)

(16

)%

11,989

14,469

(2,480

)

(17

)%

Stock-based compensation

967

1,062

(95

)

(9

)%

3,064

3,775

(711

)

(19

)%

Total unallocated costs

13,341

16,722

(3,381

)

(20

)%

43,668

52,736

(9,068

)

(17

)%

Total research and development expenses

$

30,544

$

36,134

$

(5,590

)

(15

)%

$

97,950

$

109,930

$

(11,980

)

(11

)%

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 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 expenses incurred across multiple programs or to support our general research and development operations.

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 September 30,

For the Nine Months Ended September 30,

2025

2024

$ Change

% Change

2025

2024

$ Change

% Change

Personnel costs

$

12,697

$

14,121

$

(1,424

)

(10

)%

$

41,163

$

44,619

$

(3,456

)

(8

)%

Consulting, professional and other costs

12,105

10,452

1,653

16

%

34,303

33,022

1,281

4

%

Stock-based compensation

1,805

3,059

(1,254

)

(41

)%

6,970

10,610

(3,640

)

(34

)%

Total selling, general and administrative expenses

$

26,607

$

27,632

$

(1,025

)

(4

)%

$

82,436

$

88,251

$

(5,815

)

(7

)%

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 September 30,

For the Nine Months Ended September 30,

2025

2024

$ Change

% Change

2025

2024

$ Change

% Change

Interest expense

$

(11,008

)

$

(11,385

)

$

377

(3

)%

$

(33,230

)

$

(26,218

)

$

(7,012

)

27

%

Interest income

553

1,832

(1,279

)

(70

)%

2,166

5,918

(3,752

)

(63

)%

Gain on extinguishment of debt

-

-

-

-

-

44,702

(44,702

)

(100

)%

Other (expense) income

(7,418

)

3,792

(11,210

)

(>100)%

10,196

18,284

(8,088

)

(44

)%

Total other (expense) income, net

$

(17,873

)

$

(5,761

)

$

(12,112

)

>100%

$

(20,868

)

$

42,686

$

(63,554

)

(>100)%

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 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 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.

Cash Flows

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

For the Nine Months Ended September 30,

2025

2024

$ Change

% Change

Net cash used in operating activities

$

(63,541

)

$

(101,676

)

$

38,135

(38

)%

Net cash provided by investing activities

38,378

80,676

(42,298

)

(52

)%

Net cash provided by financing activities

356

40,966

(40,610

)

(99

)%

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

15

9

6

67

%

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

$

(24,792

)

$

19,975

$

(44,767

)

(>100)%

Operating activities.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 $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 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 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 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 (the "Term Loan"). 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 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

Operating Leases

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.

Contractual Obligations

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

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. 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 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. 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 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 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.

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 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; and
Future royalty obligations to KKR under the Amended Revenue Interest Agreement of $116.2 million by October 1, 2035.
Karyopharm Therapeutics Inc. published this content on November 03, 2025, and is solely responsible for the information contained herein. Distributed via Edgar on November 03, 2025 at 12:15 UTC. If you believe the information included in the content is inaccurate or outdated and requires editing or removal, please contact us at [email protected]