NEWTON, Mass., Dec. 3, 2024 /PRNewswire/ -- Karyopharm Therapeutics Inc. (Nasdaq: KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, today announced that it is in discussions and has an upcoming meeting with the U.S. Food and Drug Administration (FDA) regarding the evolving treatment landscape in endometrial cancer and any implications this may have with respect to the Company's Phase 3 XPORT-EC-042 trial. In light of this, Karyopharm does not plan to discuss its endometrial ...

NEWTON, Mass., Nov. 25, 2024 /PRNewswire/ -- Karyopharm Therapeutics Inc. (Nasdaq: KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, today announced that the Company's senior management team will participate at the Piper Sandler 36th Annual Healthcare Conference in a fireside chat on Tuesday, December 3 at 11:30 a.m. ET in New York, NY.A live webcast of the fireside chat can be accessed under "Events & Presentations" in the Investor section of the Company's website, https:/ ...

NEWTON, Mass., Nov. 20, 2024 /PRNewswire/ -- Karyopharm Therapeutics Inc. (Nasdaq: KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, today announced that Kristin Abate, the Company's Vice President, Accounting, Corporate Controller and Assistant Treasurer has been appointed the Company's Vice President, Chief Accounting Officer, and Assistant Treasurer, effective November 20, 2024. Ms. Abate, who has also served as the Company's interim principal financial officer and inter ...

NEWTON, Mass., Nov. 18, 2024 /PRNewswire/ -- Karyopharm Therapeutics Inc. (Nasdaq: KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, today announced abstracts detailing selinexor data have been selected to be presented at the 66th American Society of Hematology (ASH) Annual Meeting and Exposition, being held December 7-10, 2024 in San Diego, CA."We are pleased to share presentations on selinexor at this year's annual meeting," said Reshma Rangwala, MD, PhD, Chief Medical Of ...

Karyopharm Therapeutics Inc. (NASDAQ:KPTI) Q3 2024 Earnings Conference Call November 5, 2024 8:00 AM ET Company Participants Elhan Webb - Senior Vice President, Investor Relations Richard Paulson - President and Chief Executive Officer Reshma Rangwala - Chief Medical Officer Sohanya Cheng - Chief Commercial Officer Michael Mason - Chief Financial Officer Conference Call Participants Brian Abrahams - RBC Capital Markets Ed White - H.C. Wainwright Peter Lawson - Barclays Maury Raycroft - Jefferies Operator Go ...

believers in the extraordinary | --- | --- | --- | |-------|--------------------|-------| | | | | | | | | | | Third Quarter 2024 | | | | | | | | Financial Results | | | | & Business Update | | November 5, 2024 On Today's Call • Welcome Elhan Webb, CFA, Senior Vice President, Investor Relations • Overview Richard Paulson, President and Chief Executive Officer • Pipeline Update Dr. Reshma Rangwala, Chief Medical Officer and Head of Research • Commercial Highlights Sohanya Cheng, Chief Commercial Officer • Fin ...

Karyopharm Therapeutics (KPTI) came out with a quarterly loss of $0.26 per share versus the Zacks Consensus Estimate of a loss of $0.27. This compares to loss of $0.30 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of 3.70%. A quarter ago, it was expected that this pharmaceutical company would post a loss of $0.29 per share when it actually produced a loss of $0.20, delivering a surprise of 31.03%.Over the last four quarters, th ...

Revenue Performance - Net product revenue for Q3 2024 was $29.5 million, a decrease of 2% from $30.2 million in Q3 2023, primarily due to higher gross-to-net discounts driven by increased Medicare rebates and 340B discounts [108]. - For the nine months ended September 30, 2024, net product revenue was $83.6 million, down 4% from $87.0 million in the same period of 2023, attributed to decreased demand and increased competition [109]. - License and other revenue for Q3 2024 was $9.3 million, a 60% increase from $5.8 million in Q3 2023 [107]. - Total revenue for the nine months ended September 30, 2024, was $114.7 million, compared to $112.3 million in the same period of 2023 [107]. - Total license and other revenue for the nine months ended September 30, 2024, increased by $5.8 million to $31.14 billion, a 23% increase year-over-year [111]. Operating Expenses - Operating expenses for Q3 2024 were $38.8 million, an 8% increase from $36.0 million in Q3 2023 [107]. - Research and development expenses for Q3 2024 were $36.1 million, a slight increase of 2% from $35.6 million in Q3 2023 [107]. - Selling, general and administrative expenses for the three months ended September 30, 2024, decreased by $3.2 million to $27.63 billion, a 10% decrease year-over-year [118]. - Personnel costs in selling, general and administrative expenses decreased by $2.4 million to $14.12 billion for the three months ended September 30, 2024, a 15% decrease year-over-year [118]. - The company anticipates a slight decrease in research and development expenses in Q4 2024 due to reduced scope in ongoing trials [117]. Net Loss and Financial Position - The net loss for Q3 2024 was $32.1 million, a decrease of 7% from a net loss of $34.5 million in Q3 2023 [107]. - As of September 30, 2024, the company had an accumulated deficit of $1.5 billion [102]. - The company expects to incur significant operating losses in the foreseeable future, raising substantial doubt regarding its ability to continue as a going concern within one year [137]. - The company anticipates that cash, cash equivalents, and investments will be sufficient to fund current operating plans into the fourth quarter of 2025 [137]. Cash Flow and Investments - Cash, cash equivalents, and investments totaled $133.5 million as of September 30, 2024, with a loss of $45.6 million incurred for the nine months ended September 30, 2024 [123]. - Net cash used in operating activities for the nine months ended September 30, 2024 was $(101,676) thousand, an increase of $27,538 thousand or 37% compared to the same period in 2023 [124]. - Net cash provided by investing activities increased by $99.6 million for the nine months ended September 30, 2024, driven by a decrease in purchases of investments [125]. - The company has not sold any shares under the 2023 Open Market Sale Agreement, with $100.0 million available for issuance as of September 30, 2024 [130]. - As of September 30, 2024, the company had cash, cash equivalents, and investments totaling $133.5 million [139]. Debt and Future Obligations - The company entered into refinancing transactions in May 2024, borrowing $100 million to limit aggregate indebtedness and provide additional working capital [103]. - Future obligations related to the 2025 Convertible Senior Notes amount to $25.6 million over the next two years [138]. - Future obligations related to the 2029 Convertible Senior Notes total $148.1 million over the next five years [138]. Clinical Trials and Research - The company plans to continue clinical trials and seek additional approvals for selinexor in various cancer indications, focusing on late-stage programs [101]. - Clinical trial costs for Selinexor in myelofibrosis increased by over 100% to $6.76 billion for the three months ended September 30, 2024 [114]. - The increase in clinical trial costs was primarily driven by heightened activity in pivotal Phase 3 trials, including increased purchases of comparator drugs [116]. Market Risks - The company is primarily exposed to interest rate sensitivity, with an immediate 100 basis point shift in interest rates expected to have no material effect on the fair market value of its investment portfolio [139]. - The company does not believe its cash, cash equivalents, and investments have significant risk of default or illiquidity, but acknowledges potential future adverse changes [140]. - The company is exposed to market risk related to changes in foreign currency exchange rates due to contracts with organizations in Canada, the UK, and Europe [141]. - The company does not currently hedge its foreign currency exchange rate risk, which may lead to fluctuations in costs associated with foreign-denominated agreements [141].

Revenue Performance - Total revenue for Q3 2024 was $38.8 million, an increase from $36.0 million in Q3 2023[10] - U.S. XPOVIO net product revenue for Q3 2024 was $29.5 million, compared to $30.2 million in Q3 2023[10] - License and other revenue for Q3 2024 was $9.3 million, up from $5.8 million in Q3 2023, primarily due to $6.0 million milestone revenue from Menarini[11] - The company narrowed its full-year 2024 total revenue guidance to $145.0 million to $155.0 million[9] - U.S. XPOVIO net product revenue guidance for 2024 is now $110.0 million to $115.0 million[9] - Total revenue for the three months ended September 30, 2024, was $38.783 million, an increase from $36.009 million in the same period of 2023, representing a growth of 7.7%[31] - Product revenue, net for the nine months ended September 30, 2024, was $83.554 million, down from $86.955 million in the same period of 2023, a decrease of 3.5%[31] Expenses - R&D expenses for Q3 2024 were $36.1 million, slightly up from $35.6 million in Q3 2023, driven by increased clinical trial costs[13] - SG&A expenses for Q3 2024 decreased to $27.6 million from $30.8 million in Q3 2023 due to cost reduction initiatives[14] - Research and development expenses for the three months ended September 30, 2024, were $36.134 million, compared to $35.553 million in the same period of 2023, an increase of 1.6%[31] Net Loss - The company reported a net loss of $32.1 million for Q3 2024, an improvement from a net loss of $34.5 million in Q3 2023[17] - The company reported a net loss of $32.072 million for the three months ended September 30, 2024, compared to a net loss of $34.506 million for the same period in 2023, reflecting an improvement of 7.1%[31] Cash and Investments - Cash and investments as of September 30, 2024, totaled $133.9 million, down from $192.4 million at the end of 2023[17] - The company had cash, cash equivalents, and investments of $133.526 million as of September 30, 2024, compared to $191.443 million as of December 31, 2023, a reduction of 30.2%[32] Assets and Liabilities - Total assets decreased to $189.476 million as of September 30, 2024, from $240.438 million as of December 31, 2023, a decline of 21.2%[32] - Total liabilities as of September 30, 2024, were $349.123 million, down from $376.644 million as of December 31, 2023, a decrease of 7.3%[32] Clinical Trials and Safety - The Phase 3 SENTRY trial will now use Abs-TSS as a co-primary endpoint, expected to read out top-line data in 2H 2025[6] - The treatment discontinuation rate due to adverse reactions in patients with multiple myeloma receiving XVd was 19%[26] - Fatal adverse reactions in the BOSTON trial occurred in 6% of patients within 30 days of the last treatment[26] Product Approval - Karyopharm's lead compound, XPOVIO, is approved in the U.S. and has received regulatory approvals in various international markets, including Europe and China[28]

– Achieves Third Quarter 2024 Total Revenue of $38.8 Million and U.S. XPOVIO® (selinexor) Net Product Revenue of $29.5 Million; Continued Regulatory and Reimbursement Approvals Globally –– Following FDA Alignment, Absolute Change in Total Symptom Score (Abs-TSS) Will Replace TSS50 as a Co-Primary Endpoint in Phase 3 SENTRY Trial in JAKi Naïve Myelofibrosis (MF); Expected Top-line Data Read-out Remains on Track for 2H 2025 –– Narrows Full-Year 2024 Total Revenue Guidance Range to $145.0 Million to $155.0 Mil ...