Karyopharm Therapeutics Inc. (NASDAQ:KPTI) Q4 2023 Earnings Call Transcript

Maury Raycroft: Okay. That’s helpful. And maybe one other question, you plan to report the preliminary results from the monotherapy Phase 2 inject naive myelofibrosis with moderate thrombocytopenia in the second half of this year. Can you talk more about what the strategy is for that study for potential stand-alone monotherapy approval path or more for supplementing the combination filing in late fall?

Reshma Rangwala: Yes, great question. So, one of the unique aspects of selinexor is that when we look at preclinical data obviously clinical data from a relapse refractory myelofibrosis study which is the essential study. And then of course the subgroup data from our Phase 1 selinexor plus ruxolitinib, it all points to very intriguing monotherapy activity. Again, this is unique when you look at other mechanisms or mechanisms of action whether it’s a BET inhibitor or a BCL2 inhibitor those agents by and large do not have that critical monotherapy activity. It’s key that that physicians ultimately have that flexibility in that dosing. And we want to use this Phase 2 study to further investigate this monotherapy activity in this high unmet patient population.

And we’ll have an opportunity to read out some data later this year and really be able to identify whether that activity is meaningful again in that high unmet need patient populations. We’re really looking at this as a proof-of-concept study, potentially we can expand it potentially gets an NCCN, but right now it’s really to double down and better tested this hypothesis that we have with selinexor for again in this drug naive population.

Maury Raycroft: Got it. Okay. Thanks for taking my questions.

Richard Paulson: Thanks, Maury.

Operator: And your next question comes from the line of Jonathan Chang from Leerink Partners. Your line is open.

Jonathan Chang : Hi guys. Thanks for taking my questions. First question, can you speak to the enrollment experience of the Phase 3 SPD triplet study in multiple myeloma? And then second question can you talk about how you’re thinking about your cash position and runway and the converts due to mature in October at 2025. Thank you.

Richard Paulson: Yes thanks Jonathan. For the first part of that I’ll turn to Reshma and then I’ll let Mike touch on the second part of that?

Reshma Rangwala: Yes. Thanks Jonathan for the question. So the enrollment is going well with that SPD. trial home it’s an all oral is the one you mentioned you know SPD really represents the only oral therapy obviously has some unique data pre and post T cell therapies which in this evolving environment is going to be a key attribute for this combination. And there’s a lot of interest in this study both in the U.S. as well as the EU. So we’re driving towards enrollment and look forward to them announcing completion of the enrollment later this year.

Michael Mason : Second, on the second question, yes, we finished 2023 with $192 million in cash. We burned or approximately $88 million in 2023, which gives us a cash runway with or what we’re planning for XPOVIO net revenues here in the U.S. as well as partnership revenues offset by spend over the next couple of years into late 2025. And as far as the convert goes to the convert is due in October 2025 so it certainly gives us some time. It’s a very closely held with the top five holders owning a greater than 85% of the bonds. So we’ll certainly be opportunistic when evaluating our options around that on the convert.

Jonathan Chang : Got it. Thanks for taking my questions.

Richard Paulson: Thanks, Jonathan.

Operator: And your next question comes from the line of Colleen Kusy from Baird. Your line is open.

Colleen Kusy: Great. Good morning. Thanks for taking our questions. Any comments you can offer on 1Q so far? I think you had mentioned last year that the third party reimbursement Foundation wouldn’t be as impactful this year with IRA coming online. So can you just anything notable with the IRE rollout so far this year and any seasonality you’re seeing yet 1Q?

Richard Paulson: Thanks Colleen. I mean I was talking about that at a high level or we just don’t provide comments kind of intra-quarter. So we’ll update on Q1, but we’re progressing in Q1 here we feel very good about being able to deliver our full year guidance.

Colleen Kusy : Great. And then with some exciting label expansion opportunities ahead, can you just make some comments remind us on your IP position for selinexor? When does the composition matter expire? And how long do you think you could be protected beyond that?

Richard Paulson: Yes. Thanks Colin. As you know I think we’ve had some really positive evolution with regards to our IP position. And obviously, we work very hard to make sure we protect our valuable inventions here in the US and globally. Last year in Q3, we were able to achieve kind of almost one-year 342 days of extension to our Composition-of-Matter Patent. So that takes us to July of 2033. And then in Q4 of last year actually we were able to really work with the patent office and enable us to enhance our patents with regard to the polymorphic form of selinexor and in newly issued patents expire in August of 2035. And we really believe that these, polymorphic form used API. It’s differentiated from other forms and really offers clear novel benefits. So you know for us a long runway in front of us with regards to patent protection.

Colleen Kusy: Great. That’s helpful. Thanks for taking my questions.

Richard Paulson: Thanks Colleen.

Operator: And your next question comes from the line of Brian Abrahams from RBC Capital Markets. Your line is open.

Unidentified Analyst: Hi. This is Joe on for Brian. Thanks for taking my question. A question on the new Monotherapy study in MF, I believe you’re allowing add-on therapies in this study. Can you talk about how many patients are expected to go on add-on therapies over the course of the study and also any synergistic benefits you may — you may expect to see with Pacritinib and Momelotinib. Thank you.

Richard Paulson: Yeah. Thanks Joe. When…

Reshma Rangwala: Great. And …

Richard Paulson: Oh sorry. Go ahead, go ahead, Reshma.

Reshma Rangwala: I jumped the gun. I apologize. It’s a great question Joe. So the monotherapy study as you mentioned correctly, does allow the option to add-on different therapies as early as week 12. Now with that said, if the patient is deriving benefit both from an SVR and TSS perspective, we really want them to continue on Selinexor Monotherapy. And as I mentioned earlier, given all of the preclinical and clinical data we really do feel confident that Selinexor Monotherapy is going to drive that benefit across those two endpoints which really suggests that a very small proportion if that is likely going to need an add-on therapy in the form of Momelotinib, Pacritinib or Ruxolitinib. So we’ll wait to see, as the study continues to rollout. And as we see additional patients — we see patients being enrolled on the study. But again, I think it is going to be small proportion patients.