Core Insights - Karyopharm Therapeutics is focused on redefining the treatment paradigm for myelofibrosis with the Phase 3 SENTRY trial evaluating selinexor in combination with ruxolitinib, with top-line data expected in the second half of 2025 [1][2] - The company has made key leadership changes, appointing Lori Macomber as CFO and Brendan Strong as SVP of Investor Relations and Corporate Communications [1][20] - Preliminary unaudited total revenue for 2024 is estimated at approximately $145 million, with U.S. XPOVIO net product revenue expected to be around $113 million [1][12] Company Objectives and Strategy - The primary strategic goal for 2025 is to deliver transformative results from the SENTRY trial, aiming to establish selinexor as the first all-oral combination therapy for myelofibrosis [2][15] - The company is committed to high-quality clinical trial execution and is on track to complete enrollment in the SENTRY trial by the first half of 2025 [2][21] Financial Performance - Demand for XPOVIO remained consistent in 2024 compared to 2023, with growth in the second half of the year offsetting earlier declines due to increased competition [5] - The company expects total revenue of approximately $30 million for Q4 2024 and $145 million for the full year, with U.S. XPOVIO net product revenue projected at $29 million for Q4 and $113 million for the full year [12][20] Clinical Development Highlights - The SENTRY trial has updated its co-primary endpoint to absolute mean change in total symptom score (Abs-TSS) and increased the sample size to approximately 350 patients to enhance statistical power [4][19] - Updated clinical data from the Phase 2 trials of selinexor in combination with pomalidomide and dexamethasone showed a median progression-free survival of 18.4 months [5][11] Regulatory and Market Expansion - Karyopharm has expanded global patient access for selinexor with favorable reimbursement decisions in multiple countries, increasing approvals to over 45 countries [5][12] - The company is engaged with the FDA regarding the evolving treatment landscape in endometrial cancer and plans to provide updates on its Phase 3 XPORT-EC-042 trial in early 2025 [8][17] Pipeline and Future Catalysts - The company is preparing for a rapid launch of selinexor following the SENTRY trial results and aims to maintain its commercial foundation in the competitive multiple myeloma market [2][21] - Key upcoming milestones include reporting topline results from the SENTRY trial and updates on the XPORT-MM-031 trial [21][22]

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 ...

Company Overview - Karyopharm Therapeutics Inc. is a commercial-stage pharmaceutical company focused on pioneering novel cancer therapies [3] - The company is recognized for its lead compound, XPOVIO® (selinexor), which is an oral exportin 1 (XPO1) inhibitor approved in the U.S. for three oncology indications [3] - Karyopharm has received regulatory approvals for its products in various international markets, including Europe, the United Kingdom, and China [3] Upcoming Events - The senior management team of Karyopharm will participate in a fireside chat at the Piper Sandler 36th Annual Healthcare Conference on December 3, 2024, at 11:30 a.m. ET in New York [1] - A live webcast of the event will be available on the company's investor website and can be replayed after the event [2] Product Pipeline - Karyopharm has a focused pipeline targeting multiple high unmet need cancers, including multiple myeloma, endometrial cancer, myelofibrosis, and diffuse large B-cell lymphoma (DLBCL) [3]

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 (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]

Core Insights - Karyopharm Therapeutics reported third quarter 2024 total revenue of $38.8 million, with U.S. XPOVIO® (selinexor) net product revenue of $29.5 million, reflecting continued growth in a competitive market [1][14][4] - The company has narrowed its full-year 2024 total revenue guidance to a range of $145.0 million to $155.0 million, with U.S. XPOVIO net product revenue guidance set at $110.0 million to $115.0 million [1][11][12] - A significant change in the Phase 3 SENTRY trial for myelofibrosis has been made, with the Absolute Change in Total Symptom Score (Abs-TSS) replacing TSS50 as a co-primary endpoint, expected to enhance the evaluation of treatment efficacy [1][6][3] Financial Performance - Total revenue for Q3 2024 was $38.8 million, an increase from $36.0 million in Q3 2023 [14] - U.S. XPOVIO net product revenue for Q3 2024 was $29.5 million, compared to $30.2 million in Q3 2023, indicating a slight decline year-over-year [14][21] - License and other revenue increased to $9.3 million in Q3 2024 from $5.8 million in Q3 2023, primarily due to milestone-related revenue from Menarini [15] Research and Development Highlights - The SENTRY trial's sample size has been increased to approximately 350 patients to enhance statistical power, with top-line data readout expected in the second half of 2025 [7] - Preliminary data from the SENTRY-2 Phase 2 trial of selinexor monotherapy in JAKi naïve patients is anticipated to be presented in late 2024 or early 2025 [7] - Long-term follow-up data from the SIENDO study indicated a significant improvement in quality-adjusted time without symptoms or toxicity for patients with advanced or recurrent TP53 wild-type endometrial cancer [8] Market and Competitive Landscape - Karyopharm continues to experience quarter-over-quarter demand growth for XPOVIO, particularly in community settings, which account for approximately 60% of overall net product revenues [5] - The company has expanded global patient access for selinexor with favorable reimbursement decisions in France and Italy, along with regulatory approvals in several countries [6] Financial Outlook - Karyopharm expects full-year 2024 total revenue to be between $145.0 million and $155.0 million, with U.S. XPOVIO net product revenue guidance adjusted to $110.0 million to $115.0 million [11][12] - R&D and SG&A expenses are projected to be in the range of $255.0 million to $265.0 million for 2024 [12] - 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 [21]

-- Conference Call Scheduled for Tuesday, November 5, 2024, at 8:00 a.m. ET --NEWTON, Mass., Oct. 31, 2024 /PRNewswire/ -- Karyopharm Therapeutics Inc. (Nasdaq: KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, today announced it will report third quarter 2024 financial results on Tuesday, November 5, 2024. Karyopharm's management team will host a conference call and audio webcast at 8:00 a.m. ET on Tuesday, November 5, 2024, to discuss the financial results and other compa ...