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Karyopharm Reports Second Quarter 2025 Financial Results and Highlights Recent Company Progress
Prnewswire· 2025-08-11 11:30
Core Insights - Karyopharm Therapeutics is nearing the completion of patient enrollment for its Phase 3 SENTRY trial in myelofibrosis, with top-line results expected in March 2026 [2][9] - The company reported total revenue of $37.9 million for the second quarter of 2025, with U.S. XPOVIO (selinexor) net product revenue at $29.7 million, reflecting a 6% increase compared to the same quarter in 2024 [1][15] - Karyopharm has reaffirmed its full-year 2025 total revenue guidance of $140 million to $155 million and updated its U.S. XPOVIO net product revenue guidance to $110 million to $120 million [1][13] Financial Performance - Total revenue for Q2 2025 was $37.9 million, down from $42.8 million in Q2 2024 [15] - U.S. net product revenue for Q2 2025 was $29.7 million, compared to $28.0 million in Q2 2024 [5][15] - License and other revenue decreased to $8.2 million in Q2 2025 from $14.8 million in Q2 2024, primarily due to non-recurring license-related revenue recognized in the previous year [16] - R&D expenses for Q2 2025 were $32.8 million, down from $38.4 million in Q2 2024, attributed to reduced personnel and clinical trial costs [18] - SG&A expenses decreased to $28.5 million in Q2 2025 from $31.1 million in Q2 2024, reflecting cost reduction initiatives [19] - The company reported a net loss of $37.3 million for Q2 2025, compared to a net income of $23.8 million in Q2 2024 [22] Clinical Development - The Phase 3 SENTRY trial is targeting 350 patients and is evaluating the efficacy of 60 mg once-weekly selinexor in combination with ruxolitinib [5][9] - Preliminary safety data from the first 61 patients in the SENTRY trial suggest potential improvements in treatment-emergent adverse events compared to previous studies [5] - Karyopharm is also enrolling patients in the Phase 3 XPORT-EC-042 trial for endometrial cancer and has completed enrollment in the Phase 3 XPORT-MM-031 trial for multiple myeloma [7][8][11] Strategic Initiatives - The company is exploring financing transactions and strategic alternatives to extend its cash runway and enhance liquidity [1][14] - Karyopharm's cash position as of June 30, 2025, was $52.0 million, down from $109.1 million at the end of 2024 [23]
Karyopharm Announces Poster Presentation on Selinexor in Myelofibrosis at the 2025 European Hematology Association Annual Meeting
Prnewswire· 2025-05-14 13:31
Core Insights - Karyopharm Therapeutics Inc. announced that its abstract on selinexor monotherapy for myelofibrosis has been selected for presentation at the 2025 European Hematology Association Annual Meeting [1][2] - The data from the Phase 2 XPORT-MF-035 trial indicates that selinexor shows clinical activity in heavily pretreated myelofibrosis patients, demonstrating spleen volume reduction, hemoglobin stabilization, and symptom improvement [2][4] Summary by Sections Company Overview - Karyopharm Therapeutics is a commercial-stage pharmaceutical company focused on developing novel cancer therapies, particularly through its lead compound, XPOVIO (selinexor), which is a first-in-class oral exportin 1 (XPO1) inhibitor [4][11] - The company has received regulatory approvals for XPOVIO in multiple oncology indications in the U.S. and various international markets, including Europe and China [5][11] Clinical Trial Insights - The XPORT-MF-035 trial involved 24 patients, randomized 1:1 to receive either selinexor monotherapy or physician's choice treatment, with selinexor administered at 80 mg weekly for the first two cycles, then reduced to 60 mg [4] - Key findings from the trial include: - 67% of selinexor-treated patients achieved a spleen volume reduction of 25% or more compared to 38% in the physician's choice group [4] - 33% of selinexor patients achieved a spleen volume reduction of 35% or more versus 13% in the physician's choice group [4] - Patients on selinexor had higher mean hemoglobin levels and lower rates of red blood cell transfusions compared to those on physician's choice [4] Safety and Adverse Events - The most common treatment-emergent adverse events (TEAEs) in the selinexor arm included decreased weight (50%), asthenia (42%), and nausea (33%) [4] - Serious adverse reactions were reported in 52% of patients in the BOSTON trial, with a treatment discontinuation rate of 19% due to adverse reactions [9]
Karyopharm to Report First Quarter 2025 Financial Results on May 12, 2025
Prnewswire· 2025-05-08 20:05
Core Viewpoint - Karyopharm Therapeutics Inc. is set to report its first quarter 2025 financial results on May 12, 2025, and will host a conference call to discuss these results and other updates [1]. Company Overview - Karyopharm Therapeutics Inc. is a commercial-stage pharmaceutical company focused on pioneering novel cancer therapies, particularly through oral compounds that address nuclear export dysregulation, a key mechanism in cancer development [3]. - The company's lead product, XPOVIO® (selinexor), is an oral exportin 1 (XPO1) inhibitor that has received approval in the U.S. for three oncology indications and has also been approved in various international markets, including Europe and China [3]. - Karyopharm has a focused pipeline targeting multiple high unmet need cancers, including multiple myeloma, endometrial cancer, myelofibrosis, and diffuse large B-cell lymphoma (DLBCL) [3].