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Karyopharm faces September liquidity deadline after KPTI earnings call
Management said a $15.8 million loan payment due September 10 could breach a liquidity covenant and risk default if it cannot secure new financing.
Karyopharm Therapeutics said on its second-quarter earnings call that it has built a myelofibrosis combination program aimed at an FDA accelerated approval pathway, but the timing of a near-term cash need is tightening the window for investors to wait.
The company plans to submit selinexor plus ruxolitinib for FDA review this month under the Accelerated Approval Pathway for myelofibrosis. In its Phase III SENTRY study, Karyopharm reported statistically significant spleen volume reductions, with responses appearing as early as week 12 and continuing through week 36 across patient subgroups, and it cited a hazard ratio for overall survival of 0.43 at the time of its topline analysis.
Karyopharm also highlighted that at week 24 the combination nearly doubled the spleen response rate versus ruxolitinib alone. The company said response rates were stronger even when ruxolitinib was dosed below 15 milligrams per day, and it expects that if approved it would be the first combination therapy in frontline myelofibrosis, a disease affecting about 20,000 people in the US, with roughly 4,000 newly treated each year.
On the financial side, the company said it has cash to fund operations only into September, with a $15.8 million loan payment coming due September 10. Management acknowledged that paying it without new financing could trip a liquidity covenant and trigger default, while it reported total revenue of $33.4 million, down from $37.9 million a year earlier, largely tied to the end of Menarini reimbursing development costs.