AI Earnings Predictions for Karyopharm Therapeutics Inc. (KPTI)

EX-99.1

2 kpti-ex99_1.htm

EX-99.1

EX-99.1

Exhibit 99.1

Karyopharm Reports Second Quarter 2026 Financial Results and Highlights Continued Progress Toward Myelofibrosis sNDA Submission

– Planned August sNDA Submission for Selinexor in Combination with Ruxolitinib in Myelofibrosis under the Accelerated Approval Pathway Remains on Track –

– Planned sNDA for Selinexor plus Ruxolitinib Supported by Phase 3 SENTRY Results Presented at ASCO and EHA and Published in the Journal of Clinical Oncology; Potential to Become the First Approved Combination Therapy for Patients with Myelofibrosis –

– Total Revenue was $33.4 Million, and U.S. XPOVIO® (selinexor) Net Product Revenue was $30.8 Million for the Second Quarter of 2026 –

– Company Reaffirms Full-Year 2026 Total Revenue Guidance of $130 Million to $150 Million Including U.S. XPOVIO Net Product Revenue Guidance of $115 Million to $130 Million –

– Conference Call Scheduled for Today at 8:00 a.m. ET –

NEWTON, Mass. – August 13, 2026 – Karyopharm Therapeutics Inc. (Nasdaq: KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, today reported financial results for the second quarter of 2026 and provided an update on the Company's myelofibrosis program. Following continued constructive engagement with the U.S. Food and Drug Administration (FDA), the Company remains on track to submit its planned supplemental New Drug Application (sNDA) in August under the Accelerated Approval pathway for selinexor in combination with ruxolitinib for patients with myelofibrosis. Karyopharm intends to request Priority Review at the time of submission.

“Our planned submission under the Accelerated Approval pathway represents the beginning of an important new chapter for Karyopharm and an important milestone for the myelofibrosis community," said Richard Paulson, President and Chief Executive Officer of Karyopharm. "If approved, selinexor plus ruxolitinib would become the first approved combination therapy for patients with myelofibrosis, introducing a novel therapeutic mechanism for the treatment of this disease within the multi-billion-dollar U.S. marketplace. Our planned submission follows productive engagements with the FDA and reflects the speed, focus, urgency and extraordinary commitment of our teams. We look forward to continuing to work closely with the FDA."

"Together with the continued scientific engagement we are seeing across the myelofibrosis community, we believe the strength and consistency of the SENTRY data reinforce the potential of selinexor to fundamentally change the treatment of patients with myelofibrosis," added Mr. Paulson.

Second Quarter 2026 and Recent Company Highlights

XPOVIO Commercial Performance

• U.S. net product revenue was $30.8 million for the quarter ended June 30, 2026 compared to $29.7 million for the quarter ended June 30, 2025.

• Demand for XPOVIO was relatively consistent in the second quarter of 2026 compared to the second quarter of 2025, amidst a highly competitive commercial landscape. The community setting continued to represent approximately 60% of net product revenue.

• Expanded global patient access for selinexor is translating into growth in royalty revenue from Menarini, Antengene and other international partners. Royalty revenue increased to $2.5 million in the second quarter of 2026 compared to $1.6 million in the second quarter of 2025, with selinexor approved in more than 50 ex-U.S. countries and territories.

Research and Development (R&D) Highlights

Myelofibrosis

• Planned sNDA submission under the Accelerated Approval pathway following multiple, productive engagements with the FDA, including Type B and Type C meetings, and received written feedback from the FDA that spleen volume reduction ≥ 35% (SVR35) appears to qualify as a reasonably likely surrogate endpoint (RLSE) to predict overall survival and can be used to support an sNDA submission.

• Results from the Phase 3 SENTRY trial (NCT04562389) in myelofibrosis were presented in a Late-Breaking Oral Presentation at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting and simultaneously published in the peer-reviewed Journal of Clinical Oncology demonstrating rapid, deep and sustained spleen responses, promising overall survival findings and evidence consistent with potential disease modification.

• Additional analyses presented during a Late-Breaking Oral Presentation at the European Hematology Association (EHA) Congress—where the abstract was selected as one of the six best abstracts presented at the meeting—provided additional evidence supporting SVR35 as a potential predictor of overall survival.

• The Company continues active scientific exchange with investigators and treating physicians following the ASCO and EHA presentations and publication of the SENTRY results in the Journal of Clinical Oncology.

• Continue enrolling patients into the 40 mg cohort of the Phase 2 SENTRY-2 trial (NCT05980806), following comp

SEC.gov | Request Rate Threshold Exceeded

U.S. Securities and Exchange Commission

You’ve Exceeded the SEC’s Traffic Limit

Your request rate has exceeded the SEC’s maximum allowable requests per second. Your access to SEC.gov will be limited for 10 minutes.

Current guidelines limit each user to a total of no more than 10 requests per second, regardless of the number of machines used to submit requests. To ensure that SEC.gov remains available to all users, we reserve the right to block IP addresses that submit excessive requests.

The block will be lifted automatically by waiting 10 minutes. Continuing to exceed the SEC’s maximum allowable request rate during the time-out period will extend the duration of the time-out period. To ensure fair access for all users, please reduce the rate of your requests and visit SEC.gov again after the 10 minute time-out period has passed.

For best practices on efficiently downloading information from SEC.gov, including the latest EDGAR filings, visit sec.gov/developer. You can also sign up for email updates on the SEC open data program, including best practices that make it more efficient to download data, and SEC.gov enhancements that may impact scripted downloading processes. For more information, contact opendata@sec.gov.

For more information, please see the SEC’s Web Site Privacy and Security Policy. Thank you for your interest in the U.S. Securities and Exchange Commission.

Reference ID: 0.c706d217.1784334070.ccd1dd9a

More Information

Internet Security Policy

By using this site, you are agreeing to security monitoring and auditing. For security purposes, and to ensure that the public service remains available to users, this government computer system employs programs to monitor network traffic to identify unauthorized attempts to upload or change information or to otherwise cause damage, including attempts to deny service to users.

Unauthorized attempts to upload information and/or change information on any portion of this site are strictly prohibited and are subject to prosecution under the Computer Fraud and Abuse Act of 1986 and the National Information Infrastructure Protection Act of 1996 (see Title 18 U.S.C. §§ 1001 and 1030).

To ensure our website performs well for all users, the SEC monitors the frequency of requests for SEC.gov content to ensure automated searches do not impact the ability of others to access SEC.gov content. We reserve the right to block IP addresses that submit excessive requests. Current guidelines limit users to a total of no more than 10 requests per second, regardless of the number of machines used to submit requests.

If a user or application submits more than 10 requests per second, further requests from the IP address(es) may be limited for a brief period. Once the rate of requests has dropped below the threshold for 10 minutes, the user may resume accessing content on SEC.gov. This SEC practice is designed to limit excessive automated searches on SEC.gov and is not intended or expected to impact individuals browsing the SEC.gov website.

Note that this policy may change as the SEC manages SEC.gov to ensure that the website performs efficiently and remains available to all users.

Note: We do not offer technical support for developing or debugging scripted downloading processes.

8-K

0001503802false00015038022026-02-122026-02-12

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, DC 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of report (Date of earliest event reported): February 12, 2026 Karyopharm Therapeutics Inc. (Exact Name of Registrant as Specified in Charter)

Delaware

001-36167

26-3931704

(State or Other Jurisdiction of Incorporation)

(Commission File Number)

(IRS Employer Identification No.)

85 Wells Avenue, 2nd Floor Newton, Massachusetts

02459

(Address of Principal Executive Offices)

(Zip Code)

Registrant’s telephone number, including area code: (617) 658-0600 (Former Name or Former Address, if Changed Since Last Report) Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

☐

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class

Trading Symbol(s)

Name of each exchange on which registered

Common Stock, $0.0001 par value

KPTI

Nasdaq Global Select Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company

☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Item 2.02

Results of Operations and Financial Condition.

On February 12, 2026, Karyopharm Therapeutics Inc. announced its financial results for the fourth quarter and full year ended December 31, 2025 and that it will conduct a previously announced, publicly available conference call to discuss those results and other company updates. The full text of the press release issued in connection with the announcement is furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference. The information provided under this Form 8-K (including Exhibit 99.1) shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”) or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.

Item 9.01

Financial Statements and Exhibits.

(d) Exhibits

Exhibit 99.1 relating to Item 2.02 shall be deemed to be furnished, and not filed:

Exhibit No.

Description

99.1

Press Release issued by Karyopharm Therapeutics Inc. on February 12, 2026

104

Cover Page Interactive Data File (formatted as Inline XBRL)

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

KARYOPHARM THERAPEUTICS INC.

Date: February 12, 2026

By:

/s/ Michael Mano

Michael Mano

Executive Vice President, Chief Legal Officer and Secretary