Karyopharm Announces Preliminary Unaudited 2024 Revenue and 2025 Objectives

Core Insights - Karyopharm Therapeutics is focused on redefining the treatment paradigm for myelofibrosis with the Phase 3 SENTRY trial evaluating selinexor in combination with ruxolitinib, with top-line data expected in the second half of 2025 [1][2] - The company has made key leadership changes, appointing Lori Macomber as CFO and Brendan Strong as SVP of Investor Relations and Corporate Communications [1][20] - Preliminary unaudited total revenue for 2024 is estimated at approximately $145 million, with U.S. XPOVIO net product revenue expected to be around$113 million [1][12] Company Objectives and Strategy - The primary strategic goal for 2025 is to deliver transformative results from the SENTRY trial, aiming to establish selinexor as the first all-oral combination therapy for myelofibrosis [2][15] - The company is committed to high-quality clinical trial execution and is on track to complete enrollment in the SENTRY trial by the first half of 2025 [2][21] Financial Performance - Demand for XPOVIO remained consistent in 2024 compared to 2023, with growth in the second half of the year offsetting earlier declines due to increased competition [5] - The company expects total revenue of approximately $30 million for Q4 2024 and$145 million for the full year, with U.S. XPOVIO net product revenue projected at $29 million for Q4 and$113 million for the full year [12][20] Clinical Development Highlights - The SENTRY trial has updated its co-primary endpoint to absolute mean change in total symptom score (Abs-TSS) and increased the sample size to approximately 350 patients to enhance statistical power [4][19] - Updated clinical data from the Phase 2 trials of selinexor in combination with pomalidomide and dexamethasone showed a median progression-free survival of 18.4 months [5][11] Regulatory and Market Expansion - Karyopharm has expanded global patient access for selinexor with favorable reimbursement decisions in multiple countries, increasing approvals to over 45 countries [5][12] - The company is engaged with the FDA regarding the evolving treatment landscape in endometrial cancer and plans to provide updates on its Phase 3 XPORT-EC-042 trial in early 2025 [8][17] Pipeline and Future Catalysts - The company is preparing for a rapid launch of selinexor following the SENTRY trial results and aims to maintain its commercial foundation in the competitive multiple myeloma market [2][21] - Key upcoming milestones include reporting topline results from the SENTRY trial and updates on the XPORT-MM-031 trial [21][22]