– Announces Significant Refinancing Transactions and Amends Royalty Agreement with HealthCare Royalty Extending Vast Majority of Its Debt Maturities into 2028 and 2029, Well Beyond Expected Data Readouts and Potential Approvals from the Company's Three Phase 3 Trials, Strengthening the Company for its Next Stage of Growth –
– Achieves First Quarter 2024 Total Revenue of $33.1 Million and U.S. XPOVIO® (selinexor) Net Product Revenue of $26.0 Million –
– Reaffirms Full Year 2024 Total Revenue Guidance of $140.0 Million to $160.0 Million, Including U.S. XPOVIO Net Product Revenue Guidance of $100.0 Million to $120.0 Million –
– Invited to Present Updated Data from a Pre-Specified Exploratory Subgroup Analysis of the Phase 3 SIENDO Trial of Selinexor Maintenance Treatment in Patients with TP53 Wild-type Advanced/Recurrent Endometrial Cancer at 2024 ASCO Annual Meeting –
– Conference Call Scheduled for Today at 8:00 a.m. ET –
NEWTON, Mass., May 8, 2024 /PRNewswire/ -- Karyopharm Therapeutics Inc. (Nasdaq: KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, today reported financial results for the quarter ended March 31, 2024, and highlighted select corporate milestones and progress on its key clinical development programs.
"We have taken a significant step that improves our capital structure, strengthening our opportunity to realize the full value of three potential new indications for selinexor. We are strongly positioned for our next stage of growth, driven by our focused and rapidly advancing late-stage pipeline with expected data readouts from our three ongoing Phase 3 trials next year," said Richard Paulson, President and Chief Executive Officer of Karyopharm.
First Quarter 2024 and Recent Highlights
XPOVIO Commercial Performance
- Achieved U.S. net product revenue of $26.0 million for the first quarter of 2024, compared to $25.1 million for the fourth quarter of 2023 and $28.3 million for the first quarter 2023.
- XPOVIO net product revenue was supported by quarter-over-quarter growth in new patient starts amidst increased competition, while being adversely impacted by softness in refills following lower new prescriptions in the fourth quarter of 2023 and higher gross to net driven by increased Medicare rebates and 340B discounts.
- Approximately 60% of XPOVIO net product revenue came from the community setting, with a vast majority of XPOVIO patient mix continuing to be in earlier lines of therapy. In the academic setting, demand for XPOVIO grew quarter-over-quarter despite competitive pressures, driven by the expanding use of XPOVIO immediately preceding and following T-cell therapies in later lines.
- Effective January 1, 2024, XPOVIO was added to Mainland China's National Reimbursement Drug List for the treatment of adult patients with relapsed or refractory multiple myeloma whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent and an anti-CD38 monoclonal antibody.
- In April 2024, the National Institute for Health and Care Excellence (NICE) in the United Kingdom recommended the expanded use of NEXPOVIO in combination with bortezomib and dexamethasone, as a treatment for multiple myeloma patients who have received one or two prior treatments.
R&D Highlights
Endometrial Cancer
- Invited to present updated long-term follow-up data of selinexor in patients with TP53 wild-type advanced or recurrent endometrial cancer – a pre-specified exploratory subgroup analysis from the Phase 3 ENGOT-EN5/GOG-3055/SIENDO Study – during the "ASCO Plenary Series: Rapid Abstract Updates" session in June 2024.
- Long-term follow-up data from a pre-specified exploratory subgroup analysis of patients with advanced or recurrent TP53 wild-type endometrial cancer from the SIENDO study (NCT03555422) was presented as an encore oral presentation at the 25th European Gynaecological Oncology Congress (ESGO) in March 2024.
Myelofibrosis
- Initiated the Phase 2 SENTRY-2 trial (XPORT-MF-044; NCT05980806), evaluating the efficacy and safety of selinexor monotherapy at 60 mg QW or 40 mg QW in subjects (n=58) with JAK inhibitor-naïve myelofibrosis with platelet counts of 50 to less than (