KPTI 最新10-Q变化

相对上期新增的文字 · 来源:10-Q · 2026-08-13

• Our primary focus is on marketing XPOVIO in its currently approved indications in multiple myeloma as well as developing and seeking regulatory approval of selinexor in myelofibrosis. Subject to obtaining additional funding, we plan to explore opportunities to develop our leading next-generation XPO…

• The commercialization of XPOVIO and NEXPOVIO®(selinexor) (the brand name for selinexor in Europe and the United Kingdom) outside of the U.S. is managed by our partners in their respective territories. XPOVIO/NEXPOVIO has received regulatory

• approvals in various indications in more than 50 territories and countries outside the U.S. and is commercially available in a growing number of countries as our partners continue to secure reimbursement approvals.

• On July 30, 2026, we announced topline results from our Phase 3 randomized, double-blind trial evaluating selinexor as a maintenance-only therapy compared to placebo in adult patients with TP53 wild-type advanced or recurrent endometrial cancer in which patients were randomized 1:1 to receive either…

• The safety and tolerability profile of selinexor was consistent with its established safety profile, with no new safety signals observed. We intend to complete a full evaluation of the data from the XPORT-EC-042 Trial and plan to present the data at a future medical meeting. The results of the XPORT…

相对上期删除的文字 · 来源:10-Q · 2026-05-14

• Our primary focus is on marketing XPOVIO in its currently approved indications as well as developing and seeking regulatory approval of selinexor as an oral agent targeting multiple high unmet need cancer indications, including our lead clinical programs in myelofibrosis and endometrial cancer and o…

• The commercialization of XPOVIO and NEXPOVIO®(selinexor) (the brand name for selinexor in Europe and the United Kingdom) outside of the U.S. is managed by our partners in their respective territories. XPOVIO/NEXPOVIO has received regulatory approvals in various indications in more than 50 territorie…

• On March 24, 2026, we announced topline data results from our Phase 3 clinical trial to evaluate the efficacy and safety of once-weekly selinexor in combination with ruxolitinib versus placebo plus ruxolitinib in JAK2 inhibitor (“JAKi”)-naive myelofibrosis patients (the “SENTRY Trial”) in which pati…

• We have completed enrollment of our global, Phase 3, randomized, double-blind trial evaluating selinexor as a maintenance-only therapy following systemic therapy in patients with TP53 wild-type advanced or recurrent endometrial cancer (the “XPORT-EC-042 Trial”). Approximately 220 patients enrolled i…

• Patients enrolled in a randomized global Phase 3 trial sponsored by the European Myeloma Network evaluating an all-oral combination of selinexor 40 mg in combination with pomalidomide and dexamethasone versus elotuzumab, pomalidomide, and dexamethasone in patients with previously treated multiple my…

相对上期新增的文字 · 来源:10-Q · 2026-08-13

• We expect that our existing liquidity, including cash, cash equivalents and investments, as well as cash flow from net product revenue and license and other revenue, will enable us to fund our current operating plans into September 2026. On September 10, 2026, a $15.8 million principal payment is du…

• We will require additional capital to fund our operations and clinical development of selinexor and to pursue regulatory approval of selinexor in myelofibrosis. As a result, our continued operations are dependent on our ability to raise additional funding and/or enter into strategic alternatives, as…

• With the assistance of our advisors, including our financial advisor Centerview Partners and other advisors, we are actively evaluating a range of financing opportunities and strategic alternatives with the objective of extending our cash runway, preserving strategic flexibility and maximizing long-…

• of their investment. If there remains substantial doubt about our ability to continue as a going concern, investors or other financing sources may be unwilling to provide funding to us on commercially reasonable terms, if at all.

• Our ability to become and remain profitable depends significantly on our success in many areas, including:

相对上期删除的文字 · 来源:10-Q · 2026-05-14

• We believe that our existing liquidity, including cash and cash equivalents, as well as cash flow from net product revenue and license and other revenue, will enable us to fund our current operating plans to late in the third quarter of 2026. We will require additional capital to fund the ongoing cl…

• We plan to address the conditions that raise substantial doubt regarding our ability to continue as a going concern by, among other things, obtaining additional funding through equity offerings, debt financings and refinancings, collaborations, strategic alliances and/or licensing arrangements. In a…

• If we utilize our capital resources more quickly than anticipated or are unable to obtain additional funding or engage in strategic alternatives, we may have to significantly curtail, delay, reduce or eliminate one or more of our research and development programs or any current or future commerciali…

• initiating and successfully completing clinical trials required to file for, obtain and maintain marketing approval for our product candidates, including reporting a positive benefit-risk profile from our ongoing Phase 3 clinical trial in endometrial cancer, with topline data anticipated in mid-2026…

• We will need additional funding or to enter into strategic alternatives to achieve our business objectives. If we are unable to raise sufficient capital or to enter into strategic alternatives on acceptable terms to meet our needs, we may be forced to delay, reduce or eliminate our research and deve…