Is accelerated approval absolutely needed, or could NCCN inclusion provide sufficient revenue to address debt and operating needs?

While NCCN inclusion is important and can typically achieve about 50% of peak product revenue, the goal is broader access. Both NCCN and advancing the regulatory pathway (accelerated approval) are occurring positively and are crucial for funding operations and enabling patient access. “if NCCN is all that you achieve, usually products will achieve about 50% of what their peak may be. But obviously, our goal is to enable as broad access as possible. 1 component is NCCN. The other component, as we've talked to, is really continuing to advance down the regulatory pathway.”

What is the stopgap to position the company financially to make it through near-term milestones and into 2027?

The company is working on a range of financing opportunities and strategic alternatives, including direct dialogue with lenders who have historically been supportive. The goal is to enhance liquidity and extend the runway through important milestones in H2 2026. “our lenders have consistently been very, very supportive with us and I don't have any reason to believe that they won't continue to do so. And so I think as we announced, we are working on a range of financing opportunities and strategic alternatives.”

How rapid is the NCCN inclusion given the meeting this week, and what insights does the company have on the likelihood of FDA priority review?

For NCCN, the company has provided all necessary components (ASCO, EHA, JCO publications) and expects inclusion in H2 2026. For priority review, it's a request made at submission, with the FDA having 60 days to review. While no specific insight, the company believes it has a strong package and a need for combination therapy. “this is, you know, a request that we need to make with the FDA at the time that the application is submitted. They have approximately 60 days to review that request, and then they'll provide that update shortly thereafter. So no specific insight, but we do believe that we have a strong package, potentially a differentiating profile, a need for a combination therapy.”

KPTI

Karyopharm (KPTI) Q2 FY26 earnings call: guidance and Q&A

Earnings call· Jun 2026 (Q2 FY26)· Health Care· Aug 13, 2026

Source: earnings call transcript

Executive summary

Karyopharm Q2 FY26 — Myelofibrosis sNDA Submission on Track, Financial Headwinds Addressed

Karyopharm is sharpening its focus on hematology, advancing selinexor's sNDA for myelofibrosis and growing its multiple myeloma business, XPOVIO. The company is actively addressing a near-term liquidity challenge and debt covenant issue while leveraging its established commercial platform for a potential myelofibrosis launch in early 2027. This strategic pivot follows the disappointing results of the XPORT-EC-042 study in endometrial cancer.

Highlights

Selinexor sNDA submission for myelofibrosis is on track for August 2026, with constructive FDA interactions.
The SENTRY study demonstrated statistically significant, rapid, deep, and sustained spleen responses, with an overall survival hazard ratio of 0.43.
XPOVIO U.S. net product revenue was $30.8 million in Q2 FY26, up from $29.7 million in Q2 FY25, showing resilience despite competition.
Selinexor plus ruxolitinib has the potential to generate up to approximately $1 billion in peak annual revenue in the U.S. alone for myelofibrosis.

Concerns

The Phase 3 XPORT-EC-042 study in endometrial cancer did not achieve statistical significance for its primary endpoint, leading to reduced investment in the program.
Total revenue for Q2 FY26 was $33.4 million, down from $37.9 million in the prior year, partly due to reduced reimbursement of development-related expenses.
Net loss was $67 million for the quarter, compared to $37.3 million in the prior year period.
The company expects to fall below its $10 million minimum liquidity covenant if a $15.8 million principal payment due September 10, 2026, is made without additional financing or a waiver.

Guidance & targets

Category	Target	Timeline	Confidence
Full-year 2026 Total Revenue	$130 million to $150 million high materiality	FY26	High
Full-year 2026 U.S. XPOVIO Net Product Revenue	$115 million to $130 million high materiality	FY26	High
Full-year 2026 Combined R&D and SG&A Expenses	$230 million to $245 million high materiality	FY26	High
Selinexor Myelofibrosis Launch	early as the first quarter of 2027 high materiality	Q1 · FY27	Medium
SENTRY-2 60mg Cohort Top-line Data	second half of this year medium materiality	H2 FY26	High

Segment performance

Segment	Revenue	YoY	QoQ	Margin
XPOVIO U.S. Net Product Revenue Strong commercial execution despite an increasingly competitive treatment landscape, reflecting the resilience of the multiple myeloma franchise. Underlying demand: relatively consistent with Q2 FY25Gross to net rate: 26.6%	$30.8 million	up from $29.7 million	—	—

Risks & headwinds

XPORT-EC-042 study failure in endometrial cancer Q2 FY26 results

did not achieve statistical significance for its primary endpoint

Mitigation:Deliberate decision to sharpen focus on hematology (myelofibrosis and multiple myeloma) and meaningfully reduce planned investment in endometrial cancer.

Liquidity covenant breach Near-term (September 2026)

$15.8 million principal payment due September 10, 2026, could cause cash to fall below $10 million minimum liquidity covenant

Mitigation:Actively evaluating a range of financing opportunities and strategic alternatives; direct dialogue with lenders.

Increased third-quarter expenses Q3 FY26

modestly higher than the second quarter

Mitigation:Acknowledged as a unique transition period, with cost structure expected to decline over time, particularly in 2027.

What to watch in Q3 FY26

Selinexor sNDA Submission for Myelofibrosis

August 2026

Current On track for August 2026

Target Submitted

Why it matters

This is a critical regulatory milestone for the company's lead pipeline asset and future growth.

We remain on track to submit our sNDA in August as we complete the final elements of our submission in collaboration with the FDA.

Find out whether KPTI delivers this. Inve re-checks your case every morning.

Q&A highlights

What remains to be done for the sNDA, and how much is already complete, especially given selinexor's existing approval?

The vast majority of the sNDA is complete. The remaining work involves finalizing alignment with the FDA on the confirmatory data piece, specifically using maturing overall survival (OS) data from the ongoing SENTRY trial. The SENTRY study was designed to follow patients for OS, and this data will serve as the confirmatory data set for accelerated approval.

“1 of the key pieces that we are just aligning and finalizing with the FDA is just around the confirmatory data piece, right? So I think as we all appreciate under accelerated approval, we are provided an approval, a label, but we do need to provide clinical benefit at some point in the future. And so right now our discussions really have been focused on using the mature overall survival observed from SENTRY.”

asked by Edward Tenthoff · answered by Reshma Rangwala

2 min read 6 chapters

Detailed narrative

Myelofibrosis sNDA Progress and Regulatory Pathway

Karyopharm is on track to submit its sNDA for selinexor in myelofibrosis in August 2026, following constructive interactions with the FDA. The submission will be based on week 24 SVR35 results, which the FDA indicated appears to qualify as a reasonably likely surrogate endpoint for overall survival.

The company plans to use maturing overall survival data from the ongoing SENTRY trial as confirmatory data for accelerated approval, with the study designed to follow patients for OS.

SENTRY Study Data and Scientific Rationale

The SENTRY study demonstrated statistically significant, rapid, deep, and sustained spleen responses, with a promising overall survival hazard ratio of 0.43. The benefit was consistent across pre-specified patient subgroups, including those on suboptimal ruxolitinib doses, where SVR35 rates were as high as 50% compared to 0% with ruxolitinib alone.

The biological rationale for combining XPO1 and JAK inhibition is compelling, targeting complementary pathways to improve outcomes beyond symptom control.

XPORT-EC-042 Study Results and Strategic Re-focus

The Phase 3 XPORT-EC-042 study in endometrial cancer did not achieve statistical significance for its primary endpoint. Following these results, Karyopharm made a deliberate decision to sharpen its focus on hematology, specifically myelofibrosis and multiple myeloma, where selinexor has the greatest potential to improve patients' lives and create long-term shareholder value.

Investment in the endometrial cancer program will be meaningfully reduced, with greater financial benefit expected in 2027.

Commercial Strategy for Myelofibrosis

Karyopharm is well-positioned to commercialize selinexor in myelofibrosis by leveraging its established hematology platform built through XPOVIO. This includes existing medical and scientific affairs teams, commercial coverage in community and academic hematology, key account capabilities, and market access expertise. The myelofibrosis market structure, with approximately 70% of patients treated in the community setting, aligns well with the company's existing footprint, allowing for efficient resource deployment.

XPOVIO Performance in Multiple Myeloma

XPOVIO U.S. net product revenue was $30.8 million in Q2 FY26, demonstrating strong commercial execution and resilience despite an increasingly competitive treatment landscape. The community setting, representing approximately 60% of the U.S. business, continues to value XPOVIO as a differentiated oral therapy. XPOVIO also holds a unique position in the evolving treatment landscape for T-cell engaging therapies, providing flexibility before and after CAR-T therapy.

Financial Position and Capital Allocation

The company ended Q2 FY26 with $65.4 million in cash, cash equivalents, restricted cash, and investments. Based on the current operating plan, existing liquidity is expected to fund operations into September 2026. A $15.8 million principal payment is due on September 10, 2026, under the Senior Secured Term Loan Facility, which could lead to a liquidity covenant breach if not addressed through additional financing or a waiver.

The company is actively evaluating financing opportunities and strategic alternatives.

Summary of the company's earnings call; see how call summaries are prepared. Not investment advice.