Aug 13, 2026 earnings call — sNDA filing for myelofibrosis and financing update
Company is on track to submit sNDA in August and has $65.4 million cash to fund operations into September 2026.
Revenue $0.0B (est $0.0B) · EPS $-2.32 (est $-1.37) · Next-quarter revenue outlook $0.1B–$0.1B
Key quotes
"Turning to slide 6, as we announced in July, we remain on track to submit our sNDA in August as we complete the final elements of our submission in collaboration with the FDA."
"Importantly, we're not preparing to build a commercial organization from the ground up. We're leveraging an established hematology platform that we have built over many years through the commercialization of XPOVIO."
"we are actively evaluating a range of financing opportunities and strategic alternatives with the objective of maximizing long-term shareholder value while preserving strategic flexibility as we advance our myelofibrosis program through these important milestones."
Analyst Q&A 5
what needs to be done for sNDA
Q (Edward Tenthoff · Piper Sandler): He asked what still must be done for the sNDA given selinexor is already approved. He asked if the filing is mostly complete and whether any clinical work or site revisits are needed.
A: Management said the vast majority of the sNDA is already put together and ready. They are finalizing the confirmatory data alignment with the FDA, planning to use mature overall survival from SENTRY, and finalizing the statistical analysis plans required before submission. They said they are on track to submit the sNDA in August.
"One of the key pieces that we are just aligning and finalizing with the FDA is just around the confirmatory data piece, right?" — Reshma Rangwala
can NCCN listing fund operations
Q (Ioannis Souroutzidis · Cantor): He asked whether accelerated approval is required or if inclusion in the NCCN compendia could provide enough revenue to address debt and operating needs. He also asked what stopgap would position the company to make it through the near-term milestones, ideally through 2027.
A: Management said NCCN is important and that, historically, NCCN-only outcomes often achieve about 50% of a product's peak. They said their goal is broad access through both NCCN inclusion and continuing the regulatory pathway. On financing, they said lenders have been supportive and they are working on a range of financing opportunities and strategic alternatives with lenders and potential equity investors to enhance liquidity and extend the runway.
"I think we've talked to that previously where, you know, with NCCN in similar situations, if NCCN is all that you achieve, usually products will achieve about 50% of what their peak may be." — Richard Paulson
NCCN meeting and FDA priority review
Q (Brian Abrahams · RBC): He asked if management heard anything emerging from the NCCN meeting that supports confidence in compendia inclusion, and he asked for the process. He also asked whether the FDA has indicated openness to granting priority review.
A: Management said NCCN is an independent body and they submitted components like ASCO, EHA, and Journal of Clinical Oncology manuscripts. They said they hear high interest from opinion leaders and are on track for compendia inclusion in the second half of the year. On priority review, management said a request must be made at submission, the FDA has approximately 60 days to review that request, and there is no specific insight now, though they believe they have a strong package and hope for an expedited PDUFA date.
"They have approximately 60 days to review that request, and then they'll provide that update shortly thereafter." — Reshma Rangwala
term loan waiver and patient access plan
Q (Maurice Raycroft · Jefferies): He asked what the term loan negotiations and potential waiver discussions look like and what updated obligations could be. He also asked the plan for moving clinical study patients to the paid drug if only the NCCN compendia listing is achieved, and what proportion might switch.
A: Management declined to provide detailed negotiation terms but said lenders have been consistently supportive and conversations are productive as they work on a solution. For patient access, they said the Phase III study will continue with patients and clinicians blinded, and the company's focus is to work with sites and investigators to continue patients on the study, using that program as the confirmatory data source.
"But I think, as we mentioned, the lenders have been consistently supportive with us." — Richard Paulson
which data will be in the sNDA
Q (Michael King · Rodman & Renshaw): He asked whether any part of the data set to be submitted could be a major amendment and how they plan to submit the data given recent meetings and analyses. He asked which data points will form the basis of the filing.
A: Management said the sNDA under accelerated approval will be based primarily on the week 24 SVR35 data, which they view as compelling and differentiating. They said they will include SVR kinetics (week 12, 24, 36), overall survival data, the post-hoc relationship between SVR and OS, disease modification data, and safety. They said they will not focus on 48-week data for the filing, though some 48-week follow-up will be provided, and they confirmed inclusion of the pre-specified OS confirmatory analysis in the submission.
"So the sNDA, under the accelerated approval is really going to be based upon the week 24 data." — Reshma Rangwala