Karyopharm Therapeutics(KPTI) - 2025 Q4 - Annual Results

Financial Projections - Preliminary unaudited total revenue for full year 2025 is expected to be approximately $145 million, with U.S. XPOVIO net product revenue estimated at $115 million[1][4][8]. - Cash and cash equivalents as of December 31, 2025, were approximately $64 million, expected to fund operations into Q2 2026[8]. - The company is currently evaluating its preliminary financial information for Q4 and full year 2025, including expected cash runway and liquidity[28]. Clinical Trials and Research - The Phase 3 SENTRY trial in myelofibrosis completed enrollment with 353 patients, evaluating selinexor in combination with ruxolitinib[3][13]. - Top-line data from the Phase 3 SENTRY trial is expected in March 2026, which could redefine the standard-of-care in myelofibrosis[2][14]. - The Phase 3 XPORT-EC-042 trial in endometrial cancer is on track to report top-line data in mid-2026, focusing on a targeted patient population[2][10]. - The company modified the design of the Phase 3 XPORT-EC-042 trial to focus on patients with proficient and deficient mismatch repair status, increasing the sample size to approximately 276 patients[8][18]. Product and Market Development - Demand for XPOVIO remained consistent in 2025 compared to 2024, with approximately 60% of overall net product revenue driven by the community setting[4]. - Global patient access for selinexor expanded in 2025, with approvals in over 50 countries, including favorable reimbursement decisions in Spain and China[4]. - Karyopharm Therapeutics' lead compound, XPOVIO® (selinexor), is approved in the U.S. and marketed in three oncology indications, with regulatory approvals in over 50 territories including the EU and China[27]. Safety and Adverse Reactions - In the BOSTON trial, 6% of patients experienced fatal adverse reactions within 30 days of the last treatment, while serious adverse reactions occurred in 52% of patients[26]. - The treatment discontinuation rate due to adverse reactions in the BOSTON trial was 19%[26]. - In the STORM trial, 9% of patients experienced fatal adverse reactions, with serious adverse reactions occurring in 58% of patients[26]. - The discontinuation rate due to adverse reactions in the STORM trial was 27%[26]. - In the SADAL trial, fatal adverse reactions occurred in 3.7% of patients within 30 days and 5% within 60 days, with serious adverse reactions occurring in 46% of patients[26]. Strategic Outlook - Karyopharm anticipates 2026 to be a catalyst-rich year with significant opportunities for long-term value creation[2]. - The company completed strategic financing transactions to extend cash runway beyond the expected top-line readout of the Phase 3 SENTRY trial[8]. - Management emphasizes the importance of regulatory approvals and successful commercialization of XPOVIO and other drug candidates[29]. - Karyopharm is focused on developing therapies for multiple high unmet need cancers, including multiple myeloma and diffuse large B-cell lymphoma (DLBCL)[27]. Risks and Uncertainties - Karyopharm's forward-looking statements are subject to numerous risks and uncertainties that may cause actual results to differ materially from current expectations[28].