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Karyopharm Announces Strategic Financing Transactions to Support Growth; Extends Cash Runway Into Second Quarter of 2026, Beyond Expected Top-Line Readout of Phase 3 SENTRY Trial in Myelofibrosis
Prnewswire· 2025-10-08 11:00
Core Insights - Karyopharm Therapeutics has secured $100 million in financing to enhance financial flexibility and extend its cash runway into Q2 2026, supporting ongoing clinical trials and operations [1][5][10] - Preliminary total revenue for Q3 2025 is expected to be between $42 million and $44 million, with U.S. XPOVIO net product revenue projected at approximately $32 million [6][7] - The company is on track to report top-line data from the Phase 3 SENTRY trial in myelofibrosis by March 2026 [1][9] Financing Transactions - The financing includes a private placement of 1,487,917 shares of common stock and warrants to purchase 1,317,771 shares at an exercise price of $6.64, expected to generate approximately $8.75 million in gross proceeds [2][3] - The company will issue a total of 7,223,982 new shares and various warrants, with a reduction in the exercise price of existing warrants from $16.50 to $6.64 [3][5] - The financing aims to comply with Nasdaq rules and is structured to strengthen the balance sheet and equitize near-term debt maturities [1][3] Clinical Trials and Programs - The Phase 3 SENTRY trial is evaluating selinexor in combination with ruxolitinib for myelofibrosis, with co-primary endpoints focused on spleen volume reduction and symptom score improvement [13] - Enrollment is ongoing in the Phase 3 XPORT-EC-042 trial for endometrial cancer, with top-line data expected in mid-2026 [9][17] - Karyopharm's lead compound, selinexor, is positioned as a potential first combination therapy for myelofibrosis, aiming to redefine treatment standards [1][15] Financial Position - Prior to the financing, Karyopharm reported approximately $46 million in cash and equivalents as of September 30, 2025 [7][8] - The financing transactions are expected to provide significant financial flexibility, including $67.5 million in new capital and deferrals of interest and royalty payments [5][10]
PMV Pharmaceuticals Reports Full Year 2024 Financial Results and Corporate Highlights
Newsfilter· 2025-03-03 13:00
Core Viewpoint - PMV Pharmaceuticals, Inc. reported strong progress in its clinical trials and financial results for the year ended December 31, 2024, highlighting the advancement of its lead drug candidate, rezatapopt, in treating cancers with TP53 mutations [1][4]. Clinical Development - The pivotal Phase 2 portion of the PYNNACLE trial is advancing well, with enrollment on track and more than 90% of sites activated across multiple regions [3][5]. - An interim analysis of the Phase 2 monotherapy data is expected in mid-2025, with a New Drug Application submission anticipated by the end of 2026 [3][5]. - Enrollment has begun in a Phase 1b study at MD Anderson Cancer Center, evaluating rezatapopt in patients with relapsed/refractory acute myeloid leukemia or myelodysplastic syndrome with a TP53 Y220C mutation [2][6]. Financial Performance - As of December 31, 2024, the company reported cash, cash equivalents, and marketable securities totaling $183.3 million, providing a cash runway expected to last until the end of 2026 [5][12]. - The net loss for the year ended December 31, 2024, was $58.7 million, a decrease from a net loss of $69.0 million in 2023 [12][17]. - Research and development expenses increased to $58.5 million in 2024 from $55.9 million in 2023, primarily due to clinical expenses related to rezatapopt [12][17]. Research Highlights - The Phase 1 data of rezatapopt in advanced ovarian cancer showed a confirmed partial response in 7 out of 15 patients, with a median duration of response of seven months [6]. - In advanced breast cancer, 3 out of 8 patients achieved a confirmed partial response, indicating a favorable safety profile [6]. - A paper detailing the discovery of rezatapopt was published, emphasizing its role as a first-in-class small-molecule reactivator of the p53 Y220C mutant [6][9].