Karyopharm Reports Second Quarter 2025 Financial Results and Highlights Recent Company Progress

– New Patient Screening for Phase 3 SENTRY Trial in Myelofibrosis Expected to Close This Week; Top-Line Results Anticipated in March 2026 –

– Total Revenue was $37.9 Million; U.S. XPOVIO® (selinexor) Net Product Revenue was $29.7 Million, up 6% in comparison with Second Quarter of 2024 –

– Reaffirms Full-Year 2025 Total Revenue Guidance of $140 Million to $155 Million; Updates U.S. XPOVIO Net Product Revenue Guidance to $110 Million to $120 Million –

– The Company is Exploring Financing Transactions and Strategic Alternatives to Extend its Cash Runway and Maximize Value –

– Conference Call Scheduled for Today at 8:00 a.m. ET –

NEWTON, Mass., Aug. 11, 2025 /PRNewswire/ — Karyopharm Therapeutics Inc. (Nasdaq: KPTI), a commercial-stage pharmaceutical firm pioneering novel most cancers therapies, at this time reported monetary outcomes for the second quarter ended June 30, 2025 and highlighted progress on key medical improvement packages.

“As we continue to seek potential financing and strategic alternatives to extend our cash runway and enhance liquidity, I am excited to announce that we are in our final weeks of enrolling our Phase 3 SENTRY trial and are on track to report top-line data from this pivotal trial in March 2026,” stated Richard Paulson, President and Chief Executive Officer of Karyopharm. “Over the past seven years, we have led the development of a growing body of evidence supporting the role of XPO1 inhibition in myelofibrosis and are optimistic about selinexor’s potential in this disease. Completing enrollment is a very important step in our journey to potentially redefine the standard-of-care in myelofibrosis and provide a transformational opportunity for patients and our organization, pending positive data.”

Second Quarter 2025 Highlights

XPOVIO Commercial Performance

• U.S. internet product income was $29.7 million within the second quarter of 2025 in comparison with $28.0 million within the second quarter of 2024.
• Demand for XPOVIO was constant within the second quarter of 2025 in comparison with the second quarter of 2024, with the neighborhood setting persevering with to drive roughly 60% of total internet product income.
• Expanded world affected person entry for selinexor is translating into development in royalty income from Menarini, Antengene and different worldwide companions. Royalty income elevated 28% to $1.6 million within the second quarter of 2025 in comparison with the second quarter of 2024.

Research and Development (R&D) Highlights

Myelofibrosis

• The Phase 3 SENTRY trial (XPORT-MF-034; NCT04562389) is nearing full enrollment and the Company expects new affected person screening shall be closed this week. SENTRY is focusing on 350 sufferers for enrollment and is evaluating 60 mg once-weekly selinexor together with ruxolitinib in comparison with ruxolitinib plus placebo. The preliminary baseline traits for sufferers enrolled in SENTRY are consultant of the meant affected person inhabitants. In addition, preliminary blinded combination security knowledge from the primary 61 sufferers with a median follow-up of higher than 12 months could counsel enhancements in each hematologic and non-hematologic therapy emergent hostile occasions as in comparison with the Phase 1 knowledge evaluating selinexor 60 mg weekly together with customary of care ruxolitinib in JAKi-naïve myelofibrosis sufferers, in addition to historic ruxolitinib monotherapy knowledge. The Company cautions that the preliminary baseline traits and preliminary blinded combination security knowledge will not be reflective of the particular top-line knowledge.
• Presented knowledge from the XPORT-MF-035 (NCT04562870) Phase 2, randomized, open-label trial of selinexor versus doctor’s-choice in hard-to-treat sufferers with closely pretreated myelofibrosis (N=24) on the European Hematology Association (EHA) 2025 Congress. The knowledge counsel the potential for single-agent medical exercise with selinexor, together with spleen quantity discount, symptom enchancment, hemoglobin stabilization, and proof of illness modification. A replica of the poster that was introduced at EHA, titled “A Study to Evaluate Single-Agent Selinexor Versus Physician’s Choice in Participants With Previously Treated Myelofibrosis” is obtainable below “Publications and Presentations” within the Investor part of the Company’s web site.
• The Company continues to enroll JAKi-naïve myelofibrosis sufferers with reasonable thrombocytopenia (outlined as having platelet counts between 50,000 and 100,000) within the selinexor 60 mg cohort of the Phase 2 SENTRY-2 trial (XPORT-MF-044; NCT05980806). The Company plans to amend the protocol for SENTRY-2 to additionally embrace sufferers with platelet counts above 100,000, which can broaden the variety of sufferers which can be eligible to take part within the trial. Approximately 10% to fifteen% of sufferers with myelofibrosis have platelet counts between 50,000 and 100,000¹. The Company expects to report top-line knowledge from all sufferers within the 60 mg cohort with at the least 24 weeks of follow-up in 2026.

Endometrial Cancer

• Enrollment continues within the Phase 3 XPORT-EC-042 (NCT05611931) trial evaluating selinexor as a maintenance-only remedy following systemic remedy versus placebo in sufferers with TP53 wild-type superior or recurrent endometrial most cancers.

Multiple Myeloma

• Enrollment of roughly 120 sufferers within the Phase 3 XPORT-MM-031 trial (EMN29; NCT05028348) was accomplished within the fourth quarter of 2024. The trial is being performed in collaboration with the European Myeloma Network and is evaluating the all-oral mixture of selinexor 40 mg, pomalidomide and dexamethasone (SPd40) in sufferers with beforehand handled a number of myeloma who obtained an anti-CD38 of their speedy prior line of remedy.

Anticipated Catalysts and Operational Objectives

Myelofibrosis

• The Company expects new affected person screening shall be closed for the Phase 3 SENTRY trial this week with top-line knowledge anticipated in March 2026.

Multiple Myeloma

• Maintain the Company’s business basis within the more and more aggressive a number of myeloma market and drive elevated XPOVIO revenues.
• Continue to assist world launches by our companions following regulatory and reimbursement approvals for selinexor in ex-U.S. territories.
• Continue to comply with sufferers which can be enrolled within the Phase 3 XPORT-MM-031 (EMN29) trial. The Company expects to report top-line knowledge from this event-driven trial within the first half of 2026.

Endometrial Cancer

• Continue to enroll sufferers into the Phase 3 XPORT-EC-042 trial of selinexor as a upkeep monotherapy for sufferers with TP53 wild-type superior or recurrent endometrial most cancers. The Company expects to report top-line knowledge from this event-driven trial in mid-2026.

2025 Financial Outlook

Based on its present working plans, Karyopharm expects the next for full 12 months 2025:

• Total income to be within the vary of $140 million to $155 million. Total income consists of U.S. XPOVIO internet product income and license, royalty and milestone income earned from companions.
• U.S. XPOVIO internet product income to be within the vary of $110 million to $120 million.
• R&D and promoting, common and administrative (SG&A) bills to be within the vary of $240 million to $250 million.
• The Company expects its current liquidity, together with the income it expects to generate from XPOVIO internet product gross sales and its license agreements, shall be ample to fund its deliberate operations to the maturity of its senior convertible notes due October 2025 (Remaining 2025 Notes). Excluding the $24.5 million Remaining 2025 Notes maturity and its $25.0 million minimal liquidity covenant, the Company expects it could have ample liquidity to fund deliberate operations into January 2026. The Company, with the help of its advisors, together with its monetary advisor Centerview Partners, is exploring potential financing and strategic alternate options to reinforce liquidity and maximize worth.

Second Quarter 2025 Financial Results

Total income: Total income for the second quarter of 2025 was $37.9 million, in comparison with $42.8 million for the second quarter of 2024. 

Net product income: Net product income for the second quarter of 2025 was $29.7 million, in comparison with $28.0 million for the second quarter of 2024.

License and different income: License and different income for the second quarter of 2025 was $8.2 million, in comparison with $14.8 million for the second quarter of 2024. The lower was primarily attributable to $6.0 million of non-recurring license-related income acknowledged throughout the second quarter of 2024.

Cost of gross sales: Cost of gross sales for the second quarter of 2025 was $1.1 million, in comparison with $1.5 million for the second quarter of 2024. Cost of gross sales displays the prices of XPOVIO models bought and the prices of merchandise bought to our companions.

R&D bills: R&D bills for the second quarter of 2025 have been $32.8 million, in comparison with $38.4 million for the second quarter of 2024. The lower was attributable to a discount in personnel prices and stock-based compensation prices primarily attributable to a discount in headcount and contractors, coupled with decrease medical trial and associated prices because of the diminished scope of our Phase 3 a number of myeloma trial.

SG&A bills: SG&A bills for the second quarter of 2025 have been $28.5 million, in comparison with $31.1 million for the second quarter of 2024. The lower was primarily because of the realization of beforehand applied value discount initiatives.

Interest revenue: Interest revenue for the second quarter of 2025 was $0.6 million, in comparison with $1.9 million for the second quarter of 2024. The lower was attributable to a decrease money and investments steadiness quarter-over-quarter.

Interest expense: Interest expense for the second quarter of 2025 was $11.2 million, in comparison with $8.9 million for the second quarter of 2024. The improve was associated to a full quarter of curiosity on the time period mortgage and convertible debt that have been issued within the second quarter of 2024.

Gain on Extinguishment of Debt and Other (expense) revenue: Other expense for the second quarter of 2025 was $2.2 million in comparison with $14.3 million of different revenue for the second quarter of 2024. The change is attributable to recurring non-cash honest worth remeasurements associated to the refinancing transactions that have been accomplished within the second quarter of 2024. The refinancing transactions additionally resulted in a $44.7 million achieve on extinguishment of debt throughout the second quarter of 2024.

Net (loss) revenue: Karyopharm reported a internet lack of $37.3 million, or $4.32 internet loss per primary and diluted share, for the second quarter of 2025, in comparison with internet revenue of $23.8 million, or $2.26 internet revenue per primary share and $2.97 internet loss per diluted share, for the second quarter of 2024. Net (loss) revenue included non-cash stock-based compensation expense of $3.8 million and $5.4 million for the second quarters of 2025 and 2024, respectively.

Cash place: Cash, money equivalents, restricted money and investments as of June 30, 2025 totaled $52.0 million, in comparison with $109.1 million as of December 31, 2024.

Conference Call Information

Karyopharm will host a convention name at this time, August 11, 2025, at 8:00 a.m. Eastern Time, to debate the second quarter 2025 monetary outcomes, the monetary outlook for 2025 and to supply different enterprise updates. To entry the convention name, please dial (800) 836-8184 (native) or (646) 357-8785 (worldwide) at the least 10 minutes previous to the beginning time and ask to be joined into the Karyopharm Therapeutics name. A dwell audio webcast of the decision, together with accompanying slides, shall be obtainable below “Events & Presentations” within the Investor part of the Company’s web site. An archived webcast shall be obtainable on the Company’s web site roughly two hours after the occasion.

About XPOVIO® (selinexor)

XPOVIO is a first-in-class, oral exportin 1 (XPO1) inhibitor and the primary of Karyopharm’s Selective Inhibitor of Nuclear Export (SINE) compounds for the therapy of most cancers. XPOVIO capabilities by selectively binding to and inhibiting the nuclear export protein XPO1. XPOVIO is accepted within the U.S. and marketed by Karyopharm in a number of oncology indications, together with: (i) together with VELCADE® (bortezomib) and dexamethasone (XVd) in grownup sufferers with a number of myeloma after at the least one prior remedy; (ii) together with dexamethasone in grownup sufferers with closely pre-treated a number of myeloma; and (iii) below accelerated approval in grownup sufferers with diffuse giant B-cell lymphoma (DLBCL), together with DLBCL arising from follicular lymphoma, after at the least two strains of systemic remedy. XPOVIO® (also called NEXPOVIO® in sure nations) has obtained regulatory approvals in varied indications in a rising variety of ex-U.S. territories and nations, together with however not restricted to the European Union, the United Kingdom, Mainland China, Taiwan, Hong Kong, Australia, South Korea, Singapore, Israel, and Canada. XPOVIO®/NEXPOVIO® is marketed in these respective ex-U.S. territories by Karyopharm’s companions: Antengene, Menarini, Neopharm, and FORUS. Selinexor can also be being investigated in a number of different mid- and late-stage medical trials throughout a number of excessive unmet want most cancers indications, together with in endometrial most cancers and myelofibrosis.

For extra details about Karyopharm’s merchandise or medical trials, please contact the Medical Information division at: Tel: +1 (888) 209-9326; Email: medicalinformation@karyopharm.com

XPOVIO^® (selinexor) is a prescription medication accepted:

• In mixture with bortezomib and dexamethasone for the therapy of grownup sufferers with a number of myeloma who’ve obtained at the least one prior remedy (XVd).
• In mixture with dexamethasone for the therapy of grownup sufferers with relapsed or refractory a number of myeloma who’ve obtained at the least 4 prior therapies and whose illness is refractory to at the least two proteasome inhibitors, at the least two immunomodulatory brokers, and an anti‐CD38 monoclonal antibody (Xd).
• For the therapy of grownup sufferers with relapsed or refractory diffuse giant B‐cell lymphoma (DLBCL), not in any other case specified, together with DLBCL arising from follicular lymphoma, after at the least two strains of systemic remedy. This indication is accepted below accelerated approval based mostly on response fee. Continued approval for this indication could also be contingent upon verification and outline of medical profit in confirmatory trial(s).

SELECT IMPORTANT SAFETY INFORMATION

Warnings and Precautions

• Thrombocytopenia: Monitor platelet counts all through therapy. Manage with dose interruption and/or discount and supportive care.
• Neutropenia: Monitor neutrophil counts all through therapy. Manage with dose interruption and/or discount and granulocyte colony‐stimulating elements.
• Gastrointestinal Toxicity: Nausea, vomiting, diarrhea, anorexia, and weight reduction could happen. Provide antiemetic prophylaxis. Manage with dose interruption and/or discount, antiemetics, and supportive care.
• Hyponatremia: Monitor serum sodium ranges all through therapy. Correct for concurrent hyperglycemia and excessive serum paraprotein ranges. Manage with dose interruption, discount, or discontinuation, and supportive care.
• Serious Infection: Monitor for an infection and deal with promptly.
• Neurological Toxicity: Advise sufferers to chorus from driving and interesting in hazardous occupations or actions till neurological toxicity resolves. Optimize hydration standing and concomitant drugs to keep away from dizziness or psychological standing adjustments.
• Embryo‐Fetal Toxicity: Can trigger fetal hurt. Advise females of reproductive potential and males with a feminine associate of reproductive potential, of the potential threat to a fetus and use of efficient contraception.
• Cataract: Cataracts could develop or progress. Treatment of cataracts normally requires surgical elimination of the cataract.

Adverse Reactions

• The most typical hostile reactions (≥20%) in sufferers with a number of myeloma who obtain XVd are fatigue, nausea, decreased urge for food, diarrhea, peripheral neuropathy, higher respiratory tract an infection, decreased weight, cataract and vomiting. Grade 3‐4 laboratory abnormalities (≥10%) are thrombocytopenia, lymphopenia, hypophosphatemia, anemia, hyponatremia and neutropenia. In the BOSTON trial, deadly hostile reactions occurred in 6% of sufferers inside 30 days of final therapy. Serious hostile reactions occurred in 52% of sufferers. Treatment discontinuation fee attributable to hostile reactions was 19%.
• The most typical hostile reactions (≥20%) in sufferers with a number of myeloma who obtain Xd are thrombocytopenia, fatigue, nausea, anemia, decreased urge for food, decreased weight, diarrhea, vomiting, hyponatremia, neutropenia, leukopenia, constipation, dyspnea and higher respiratory tract an infection. In the STORM trial, deadly hostile reactions occurred in 9% of sufferers. Serious hostile reactions occurred in 58% of sufferers. Treatment discontinuation fee attributable to hostile reactions was 27%.
• The most typical hostile reactions (incidence ≥20%) in sufferers with DLBCL, excluding laboratory abnormalities, are fatigue, nausea, diarrhea, urge for food lower, weight lower, constipation, vomiting, and pyrexia. Grade 3‐4 laboratory abnormalities (≥15%) are thrombocytopenia, lymphopenia, neutropenia, anemia, and hyponatremia. In the SADAL trial, deadly hostile reactions occurred in 3.7% of sufferers inside 30 days, and 5% of sufferers inside 60 days of final therapy; essentially the most frequent deadly hostile reactions was an infection (4.5% of sufferers). Serious hostile reactions occurred in 46% of sufferers; essentially the most frequent critical hostile response was an infection (21% of sufferers). Discontinuation attributable to hostile reactions occurred in 17% of sufferers.

Use In Specific Populations
Lactation: Advise to not breastfeed.

For further product info, together with full prescribing info, please go to www.XPOVIO.com.

To report SUSPECTED ADVERSE REACTIONS, contact Karyopharm Therapeutics Inc. at 1‐888‐209‐9326 or FDA at 1‐800‐FDA‐1088 or www.fda.gov/medwatch. 

About Karyopharm Therapeutics

Karyopharm Therapeutics Inc. (Nasdaq: KPTI) is a commercial-stage pharmaceutical firm whose dedication to pioneering novel most cancers therapies is fueled by a perception within the extraordinary energy and braveness of sufferers with most cancers. Since its founding, Karyopharm has been an trade chief in oral compounds that deal with nuclear export dysregulation, a basic mechanism of oncogenesis. Karyopharm’s lead compound and first-in-class, oral exportin 1 (XPO1) inhibitor, XPOVIO® (selinexor), is accepted within the U.S. and marketed by the Company in three oncology indications. It has additionally obtained regulatory approvals in varied indications in 50 ex-U.S. territories and nations, together with Europe and the United Kingdom (as NEXPOVIO®) and China. Karyopharm has a targeted pipeline focusing on indications in a number of excessive unmet want cancers, together with in a number of myeloma, endometrial most cancers, myelofibrosis, and diffuse giant B-cell lymphoma (DLBCL). For extra details about our folks, science and pipeline, please go to www.karyopharm.com, and comply with us on LinkedIn and on X at @Karyopharm.

Forward-Looking Statements

This press launch comprises forward-looking statements inside the that means of The Private Securities Litigation Reform Act of 1995. Such forward-looking statements embrace these relating to Karyopharm’s steerage on its 2025 whole income, 2025 U.S. internet product income and 2025 R&D and SG&A bills; anticipated money runway and liquidity; Karyopharm’s exploration of strategic alternate options and financing transactions; expectations with respect to commercialization efforts; the power of selinexor to deal with sufferers with a number of myeloma, endometrial most cancers, myelofibrosis, diffuse giant B-cell lymphoma and different ailments; and expectations with respect to the medical improvement plans and potential regulatory submissions of selinexor. Such statements are topic to quite a few essential elements, dangers and uncertainties, a lot of that are past Karyopharm’s management, that will trigger precise occasions or outcomes to vary materially from Karyopharm’s present expectations. For instance, there may be no assure that Karyopharm will efficiently commercialize XPOVIO or that any of Karyopharm’s drug candidates, together with selinexor, will efficiently full crucial medical improvement phases or that improvement of any of Karyopharm’s drug candidates will proceed. Further, there may be no assure that any optimistic developments within the improvement or commercialization of Karyopharm’s drug candidate portfolio will lead to inventory value appreciation. Management’s expectations and, subsequently, any forward-looking statements on this press launch may be affected by dangers and uncertainties referring to plenty of different elements, together with the next: the adoption of XPOVIO within the business market, the timing and prices concerned in commercializing XPOVIO or any of Karyopharm’s drug candidates that obtain regulatory approval; the power to acquire and retain regulatory approval of XPOVIO or any of Karyopharm’s drug candidates that obtain regulatory approval; Karyopharm’s outcomes of medical trials and preclinical trials, together with subsequent evaluation of current knowledge and new knowledge obtained from ongoing and future trials; the content material and timing of selections made by the U.S. Food and Drug Administration and different regulatory authorities, investigational overview boards at medical trial websites and publication overview our bodies, together with with respect to the necessity for added medical trials; the power of Karyopharm or its third get together collaborators or successors in curiosity to completely carry out their respective obligations below the relevant settlement and the potential future monetary implications of such settlement; Karyopharm’s potential to enroll sufferers in its medical trials; unplanned money necessities and expenditures; substantial doubt exists relating to Karyopharm’s potential to proceed as a going concern; improvement or regulatory approval of drug candidates by Karyopharm’s opponents for merchandise or product candidates by which Karyopharm is at the moment commercializing or growing; the direct or oblique influence of the COVID-19 pandemic or any future pandemic on Karyopharm’s enterprise, outcomes of operations and monetary situation; and Karyopharm’s potential to acquire, keep and implement patent and different mental property safety for any of its merchandise or product candidates. These and different dangers are described below the caption “Risk Factors” in Karyopharm’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2025, which was filed with the Securities and Exchange Commission (SEC) on May 12, 2025, and in different filings that Karyopharm could make with the SEC sooner or later. Any forward-looking statements contained on this press launch communicate solely as of the date hereof, and, besides as required by legislation, Karyopharm expressly disclaims any obligation to replace any forward-looking statements, whether or not because of new info, future occasions or in any other case.

XPOVIO^® and NEXPOVIO^® are registered logos of Karyopharm Therapeutics Inc.

 

 

 

SOURCE Karyopharm Therapeutics Inc.