Futility analysis and trial enrollment in myelofibrosis, revenue guidance and cash runway, myelofibrosis trial enrollment and timeline, multiple myeloma market strategy and pivotal event, cash runway extension strategies are the key contradictions discussed in
Therapeutics' latest 2025Q1 earnings call.
Myelofibrosis Trial Progress:
-
reported that its Phase 3 SENTRY trial in patients with JAKi-naïve myelofibrosis successfully passed its prespecified futility analysis and continues as planned without modifications.
- The trial has enrolled approximately
80% of the
350 patients targeted, with expectations to complete enrollment in the June-July timeframe.
- The progress is driven by a focus on rapid enrollment and completing key milestones in the trial timeline.
New Clinical Data in Myelofibrosis:
- The company shared new clinical data from its XPORT-MF-035 trial, demonstrating significant spleen volume reduction and symptom improvement in heavily pretreated, hard-to-treat patients.
- The data supports the potential for selinexor plus ruxolitinib to improve patient outcomes and redefine the standard of care in myelofibrosis.
- The data consistency across multiple trials strengthens the belief in selinexor's potential in combination therapies.
Commercial Performance and Market Positioning:
- Karyopharm Therapeutics delivered
5% demand growth in Q1 2025 for
, although net product revenue was negatively impacted by
$5 million in atypical returns of expired products.
- Growth in demand was driven by both academic and community settings, with the company positioned as a flexible therapy following treatment with anti-CD38 therapies.
- The academic setting saw increased use of XPOVIO immediately before and after T-cell therapies.
Financial Impact and Cash Runway:
- U.S. XPOVIO net product revenue for Q1 2025 was
$21.1 million, impacted by a
$5 million increase in the product return reserve.
- The company adjusted its revenue guidance to the lower end of the range due to the impacts of atypical returns and cash burn highest in the first quarter.
- Exploration of various opportunities to extend the cash runway is ongoing to support the advancement of Phase 3 clinical trials and commercial performance.
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