For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- Karyopharm Therapeutics Inc (KPTI, Financial) reported a significant increase in total revenue for the fourth quarter of 2025, up by 11.8% compared to the same period in 2024.
- The company has a strong commercial foundation in multiple myeloma, with Expovio net product revenue reaching $32.1 million in Q4 2025 and $114.9 million for the full year.
- Karyopharm Therapeutics Inc (KPTI) is on track to share top-line data from its phase 3 century trial for myelofibrosis in March 2026, which could establish a new standard of care.
- The company is actively preparing for a potential launch in myelofibrosis, with a commercial strategy targeting a multi-billion dollar market opportunity.
- Karyopharm Therapeutics Inc (KPTI) has managed to reduce research and development expenses by 17% in Q4 2025 compared to Q4 2024, reflecting disciplined financial management.
Negative Points
- Karyopharm Therapeutics Inc (KPTI) reported a net loss of $102.2 million for Q4 2025 and $196 million for the full year, driven by non-cash items such as loss on extinguishment of debt.
- The company's cash position decreased significantly, ending 2025 with $64.1 million compared to $109.1 million at the end of 2024.
- Interest expenses increased to $12.6 million in Q4 2025 and $45.8 million for the full year, reflecting higher outstanding debt and interest rates.
- The company faces competition in the myelofibrosis market, with Novartis potentially moving forward with its own plans, which could impact Karyopharm's market positioning.
- Karyopharm Therapeutics Inc (KPTI) will no longer receive R&D reimbursement from Metarini, which contributed $15 million to 2025 revenue, potentially impacting future financials.
Q & A Highlights
Q: Can you discuss the differences in efficacy and safety between the 40 mg and 60 mg doses of Selenexor in the phase 1 trial?
A: The 60 mg dose showed a clear benefit-risk advantage over the 40 mg dose, with maximized efficacy in terms of spleen volume reduction (SVR) and total symptom score (TSS). Safety differences were not as pronounced, and pharmacokinetic data supported higher exposure with the 60 mg dose. Thus, the 60 mg dose was chosen for the phase 3 trial. - Reshma, Chief Medical Officer.
Q: What are your thoughts on Novartis's recent plans in myelofibrosis and how it affects your strategy?
A: Novartis's plans highlight the importance of enrolling highly symptomatic patients, which aligns with our strategy. Their potential EU filing suggests regulatory flexibility, but our upcoming data readout in March positions us to establish Selenexor as a standard of care in frontline myelofibrosis, especially since Novartis's US trial will take years to complete. - Richard, CEO.
Q: Can you elaborate on the strategy for Etonexor and other myeloproliferative neoplasms (MPNs) if myelofibrosis data is positive?
A: Etonexor, a second-generation XPO1 inhibitor, has potential in other MPNs like polycythemia vera and essential thrombocythemia. It offers lower IC50s and better safety profiles, allowing for lower dosing and more frequent administration. We aim to expand beyond myelofibrosis into these areas. - Reshma, Chief Medical Officer.
Q: What are the key reasons for confidence in hitting the TSS endpoint of the Century study?
A: Confidence stems from strong phase 1 data showing significant TSS improvement and cytokine reduction, which correlates with symptom improvement. The FDA allowed us to change the endpoint to absolute TSS, a more sensitive measure, and we are focusing on TSS without fatigue, which is a challenging domain to evaluate. - Reshma, Chief Medical Officer.
Q: Can you provide insights into the blinded safety data and any changes in discontinuation rates or adverse events?
A: We haven't updated beyond what was previously disclosed. Baseline demographics were consistent with expectations, and the TSS evolution is promising. Blinded safety data suggests potentially lower grade 3+ anemia rates and manageable non-hematologic toxicities. - Reshma, Chief Medical Officer.
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