Karyopharm Announces Q3 2024 Financial Results and Recent Progress

Karyopharm Therapeutics Inc., a pharmaceutical company focusing on innovative cancer therapies, announced its financial results for the third quarter of 2024 ending September 30. The company reported a total revenue of $38.8 million for the quarter, an increase from $36.0 million in the same period last year. The net product revenue for XPOVIO®, used in treating multiple myeloma, was $29.5 million, reflecting a growth from $28.0 million in the second quarter of 2024 but a slight decline from $30.2 million in the third quarter of 2023.

The company's revenue was bolstered by a robust demand growth, especially in community settings which account for around 60% of the overall net product revenues. Despite competitive pressures, the use of XPOVIO in academic settings also saw an increase. Internationally, patient access to selinexor expanded with favorable reimbursement decisions in France and Italy and new regulatory approvals in Turkey, South Korea, Thailand, and Malaysia.

Karyopharm's CEO, Richard Paulson, emphasized the company's continued growth in a competitive market and expressed optimism about the recent changes in the clinical trial endpoints for their Phase 3 SENTRY myelofibrosis trial. Following discussions with the FDA, the absolute change in total symptom score (Abs-TSS) at Week 24 will now be a co-primary endpoint along with spleen volume reduction (SVR35). This change is expected to enhance the evaluation of combination therapy in myelofibrosis and reflects the FDA's openness to more sensitive evaluation methods.

The company is also increasing the total sample size for the SENTRY trial to approximately 350 patients to enhance statistical power. This trial continues to make significant progress, and the top-line data is expected by the second half of 2025. Additionally, the SENTRY-2 Phase 2 trial of selinexor monotherapy in JAKi naïve patients with moderate thrombocytopenia is ongoing, with preliminary data expected in late 2024 or early 2025.

In the field of endometrial cancer, long-term follow-up data from the SIENDO study was presented, showing a significant benefit for selinexor in patients with advanced or recurrent TP53 wild-type endometrial cancer. The Phase 3 XPORT-EC-042 trial is actively enrolling patients with an expected top-line data readout in early 2026.

For multiple myeloma, the XPORT-MM-031 (EMN29) Phase 3 trial is evaluating a combination of selinexor, pomalidomide, and dexamethasone (SPd). The trial is targeting 120 patients, leveraging promising data observed with the SPd 40 mg dose. The company will provide further guidance on the data readout timeline following regulatory feedback.

Karyopharm has narrowed its financial guidance for 2024, projecting total revenues between $145.0 million and $155.0 million and U.S. XPOVIO net product revenue between $110.0 million and $115.0 million. Research and development (R&D) and selling, general and administrative (SG&A) expenses are expected to range from $255.0 million to $265.0 million. The company anticipates its current cash, along with revenue from product sales and strategic agreements, will suffice to fund operations into the first quarter of 2026.

The financial results highlighted several key figures. The cost of sales for the third quarter was $1.3 million, up from $0.9 million the previous year. R&D expenses were $36.1 million, slightly higher than $35.6 million in the same period last year, mainly due to increased clinical trial activities. SG&A expenses decreased to $27.6 million from $30.8 million, reflecting cost reduction initiatives. The net loss for the third quarter was $32.1 million, or $0.26 per share, compared to $34.5 million, or $0.30 per share, in the third quarter of 2023.

Karyopharm's cash, cash equivalents, restricted cash, and investments totaled $133.9 million as of September 30, 2024, down from $192.4 million as of December 31, 2023. The company remains confident that its financial strategy and clinical progress will drive future growth and innovation in cancer treatment.