– Phase 3 SENTRY Results Selected for Late-Breaking Oral Presentation at ASCO on June 2,
– Total Revenue was $35.1 Million and U.S. XPOVIO® (selinexor) Net Product Revenue was $29.2 Million for the First Quarter of 2026,
– Company Reaffirms Full-Year 2026 Total Revenue Guidance of $130 Million to $150 Million Including U.S. XPOVIO Net Product Revenue Guidance of $115 Million to $130 Million,
– Conference Call Scheduled for Today at 8:00 a.m. ET,
NEWTON, Mass., May 14, 2026 /PRNewswire/ -- Karyopharm Therapeutics Inc. (NASDAQ:KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, today reported financial results for the first quarter of 2026 and highlighted progress on key clinical development programs. These milestones reflect meaningful progress towards Karyopharm's goal of advancing selinexor in late-stage indications and expanding the value of the franchise.
"As we move through 2026, Karyopharm is in a pivotal period with meaningful clinical and regulatory milestones ahead," said Richard Paulson, President and Chief Executive Officer of Karyopharm. "Through the second and third quarters of 2026, we expect several important developments that have the potential to create significant value for the Company, while improving outcomes for patients. In endometrial cancer, we have completed enrollment in our Phase 3 XPORT-EC-042 trial and remain on track to report topline data in mid-2026. In myelofibrosis, the Phase 3 SENTRY results reinforced the potential of selinexor to meaningfully improve patient outcomes, including a statistically significant SVR35 benefit and a promising overall survival signal. With the endometrial cancer readout ahead and the myelofibrosis regulatory and guideline path coming into focus, we believe these programs could meaningfully expand the impact and long-term opportunity of the selinexor franchise."
First Quarter 2026 and Recent Company Highlights
XPOVIO Commercial Performance
U.S. net product revenue was $29.2 million for the quarter ended March 31, 2026 compared to $21.1 million for the quarter ended March 31, 2025.
Demand for XPOVIO was lower in the first quarter of 2026 compared to the first quarter of 2025, due to new competitive entrants. The community setting continued to represent approximately 60% of net product revenue.
Expanded global patient access for selinexor is translating into growth in royalty revenue from Menarini, Antengene and other international partners. Royalty revenue increased to $1.9 million in the first quarter of 2026 compared to $1.7 million in the first quarter of 2025, with selinexor now approved in more than 50 ex-U.S. countries and territories.
Research and Development (R&D) Highlights
Myelofibrosis
Results from the Phase 3 SENTRY trial in myelofibrosis were accepted for a late-breaking oral presentation at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting.
Reported topline results from the Phase 3 SENTRY trial, a randomized, double-blind trial evaluating 60 mg selinexor in combination with ruxolitinib in frontline myelofibrosis compared to ruxolitinib alone (n=353). The trial met the first co-primary endpoint of spleen volume reduction of 35% or more (SVR35) at week 24 and also demonstrated rapid, deep and sustained improvement in this endpoint over time. The trial did not meet its second co-primary endpoint of mean change in absolute total symptom score (Abs-TSS) at week 24 relative to baseline. Similar symptom improvement from baseline was observed in patients who received the combination of selinexor plus ruxolitinib compared to ruxolitinib alone. Importantly, a promising overall survival signal was also observed, which further reinforces the relevance of XPO1 inhibition in combination with ruxolitinib in frontline myelofibrosis. The combination of selinexor and ruxolitinib demonstrated a manageable safety and tolerability profile consistent with the known profile of each agent individually with no new safety signals observed.
Completed enrollment of the 60 mg cohort (n=29) of the Phase 2 SENTRY-2 trial (NCT05980806) and began enrolling patients into the 40 mg cohort.
Endometrial Cancer
Completed enrollment of the Phase 3 XPORT-EC-042 trial (NCT05611931), which is evaluating selinexor as a maintenance-only therapy following systemic therapy versus placebo in patients with TP53 wild-type advanced or recurrent endometrial cancer. Approximately 220 patients enrolled in the modified intent-to-treat (mITT) population and 257 enrolled in the intent-to-treat (ITT) population. Enrollment in the mITT population was focused on patients with either proficient mismatch repair status (pMMR) tumors or patients with deficient mismatch repair status (dMMR) tumors who are medically ineligible for checkpoint inhibitors.
Multiple Myeloma
Patients enrolled in the Phase 3 XPORT-MM-031 trial (EMN29; NCT05028348) continued to be followed for progression-free survival events contributing towards the primary endpoint. The trial is being conducted in collaboration with the European Myeloma Network and is evaluating the all-oral combination of selinexor 40 mg, pomalidomide and dexamethasone (SPd40) in patients with previously treated multiple myeloma who received an anti-CD38 as their immediate prior line of therapy.
Anticipated Catalysts and Operational Objectives
Myelofibrosis
Present results from the Phase 3 SENTRY trial in myelofibrosis at ASCO as a late-breaking oral presentation on June 2 at 9:45 a.m. Central Time during the "Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant" oral abstract session. The Company expects that its abstract titled "Selinexor plus ruxolitinib in JAK inhibitor–naïve myelofibrosis: Phase 3 SENTRY trial" (abstract number LBA6500) will be available on ASCO's website on June 2 at approximately 8:00 a.m. Eastern Time / 7:00 a.m. Central Time. A copy of the SENTRY presentation will be available following its presentation at ASCO under "Publications and Presentations" in the Investors & Media section of the Company's website.
Engage with the U.S. Food and Drug Administration (FDA) on the data from the SENTRY trial and the Company's supplemental new drug application (sNDA) filing plan; engage with other global regulatory agencies in collaboration with the Company's partners.
The Company believes the potential inclusion of the combination in relevant compendia could occur in the second half of 2026.
Announce topline data from all patients in the 60 mg cohort of the Phase 2 SENTRY-2 trial with at least 24 weeks of follow-up, expected in the second half of 2026.
Endometrial Cancer
Announce topline data from the event-driven, Phase 3 XPORT-EC-042 trial, expected in mid-2026.
Multiple Myeloma
Maintain the Company's commercial foundation in the increasingly competitive multiple myeloma marketplace and drive increased XPOVIO revenues.
Support global launches by our partners following regulatory and reimbursement approvals for selinexor in ex-U.S. countries and territories.
Announce topline data from the event-driven, Phase 3 XPORT-MM-031 (EMN29) trial, expected in the second half of 2026.
2026 Financial Outlook
Based on its current operating plans, Karyopharm expects the following for full year 2026:
Total revenue to be in the range of $130 million to $150 million. Total revenue consists of U.S. XPOVIO net product revenue and license, royalty and milestone revenue earned from partners.
U.S. XPOVIO net product revenue to be in the range of $115 million to $130 million.
R&D and selling, general and administrative (SG&A) expenses to be in the range of $230 million to $245 million.
The Company expects its existing liquidity, including cash and cash equivalents, as well as cash flow from net product revenue and license and other revenue, will enable it to fund its current operating plans into late in the third quarter of 2026.
First Quarter 2026 Financial Results
Total revenue: Total revenue for the first quarter of 2026 was $35.1 million, compared to $30.0 million for the first quarter of 2025.
Net product revenue: Net product revenue was $29.2 million for the first quarter of 2026, compared to $21.1 million for the first quarter of 2025. The increase was primarily driven by lower gross-to-net adjustments, which were 21.8% in the first quarter of 2026 versus 45.0% in the prior-year period. The gross-to-net adjustments were impacted by an atypical product return adjustment in the first quarter of 2025 and lower realized discounts and returns in the first quarter of 2026.
License and other revenue: License and other revenue was $5.9 million for the first quarter of 2026, compared to $9.0 million for the first quarter of 2025. License and other revenue for the first quarter of 2026 primarily consisted of $3.5 million in milestone revenue and $1.9 million in royalties. For the first quarter of 2025, license and other revenue primarily consisted of $7.0 million related to the reimbursement of development-related expenses and $1.7 million in royalties.
Cost of sales: Cost of sales was $1.3 million for both the first quarter of 2026 and 2025.
R&D expenses: R&D expenses were $33.8 million for the first quarter of 2026, compared to $34.6 million for the first quarter of 2025.
SG&A expenses: SG&A expenses were $26.7 million for the first quarter of 2026, compared to $27.4 million for the first quarter of 2025.
Loss from operations: Loss from operations was $26.8 million for the first quarter of 2026, compared to $33.3 million for the first quarter of 2025, representing a 20% improvement. The decrease reflects improved operating efficiency and disciplined cost management.
Interest income: Interest income was $0.5 million for the first quarter of 2026, compared to $1.0 million for the first quarter of 2025. The decrease reflects lower investment balances during 2026 compared to 2025.
Interest expense: Interest expense was $12.6 million for the first quarter of 2026, compared to $11.0 million for the first quarter of 2025. The increase reflects higher outstanding debt and higher interest rates following the Company's financing transactions executed in October 2025.
Other income, net: Other income, net was $16.4 million in the first quarter of 2026, compared to $19.8 million in the first quarter of 2025. The amounts primarily reflect non-cash fair value remeasurements of embedded derivatives and liability-classified common stock warrants related to the refinancing transactions completed in the second quarter of 2024 and the fourth quarter of 2025.
Net loss: Net loss was $22.4 million, or $1.02 per basic share and $1.24 per diluted share, for the first quarter of 2026, compared to $23.5 million, or $2.77 per basic and diluted share, for the first quarter of 2025. Net loss included non-cash stock-based compensation expense of $3.0 million in the first quarter of 2026 compared to $3.6 million in the first quarter of 2025.
Cash position: Cash, cash equivalents, and restricted cash as of March 31, 2026 totaled $91.2 million, including approximately $50 million of gross proceeds raised from a private placement of common stock and warrants and sales of common stock under the Company's Open Market Sale Agreement during the first quarter of 2026, compared to $64.1 million as of December 31, 2025.
Conference Call Information
Karyopharm will host a conference call today, May 14, 2026, at 8:00 a.m. Eastern Time, to discuss the first quarter 2026 financial results, the financial outlook for 2026 and to provide other business updates. To access the conference call, please dial (800) 836-8184 (local) or (646) 357-8785 (international) at least 10 minutes prior to the start time and ask to be joined into the Karyopharm Therapeutics call. A live audio webcast of the call, along with accompanying slides, will be available under "Events & Presentations" in the Investor section of the Company's website. An archived webcast will be available on the Company's website approximately two hours after the event.
About the Phase 3 SENTRY Trial
SENTRY (XPORT-MF-034; NCT04562389) is a Phase 3 clinical trial evaluating a once-weekly dose of 60 mg of selinexor in combination with ruxolitinib compared to placebo plus ruxolitinib in JAKi-naïve myelofibrosis patients with platelet counts >100 x 109/L (N=353). Patients were randomized 2-to-1 to the selinexor arm. The co-primary endpoints for this trial are spleen volume reduction ≥ 35% (SVR35) at week 24 and the average change in absolute total symptom score (Abs-TSS) over 24 weeks relative to baseline.
About Myelofibrosis
Myelofibrosis is a rare blood cancer that affects approximately 20,000 patients in the United States and 17,000 patients in the European Union1. The disease causes bone marrow fibrosis (scarring in the bone marrow), which makes it difficult for the bone marrow to make healthy blood cells, splenomegaly (enlarged spleen), progressive anemia which often leads to ...
