X4 Pharmaceuticals, Inc. (NASDAQ:XFOR) Q4 2022 Earnings Call Transcript

Unidentified Analyst : Hi, good morning team. This is on for Mayank. A couple quick questions from us. First, can you remind us how you’re thinking about the timeline for potential EU filing for mavorixafor as well as WHIM syndrome?

Paula Ragan: Sure, Murray, can you take that?

Murray Stewart: Yes, so obviously, we want to use the same dataset. So within the next six to 12 months, we’ll be filing in EU following on from the NDA filing.

Unidentified Analyst : Okay, perfect. And then maybe as we you know, switch to the U.S. launch here. Can you give us an update on any commercial or launch preparation activities, including how you’re thinking about the Salesforce engaging with different patient advocacy groups, et cetera? Thank you very much.

Paula Ragan: Sure. Thanks, Mark, would you like to take that?

Mark Baldry : Sure, thanks. Yes. While we progress against our regulatory timelines, on the commercial side, we’re starting to — I’m a pretty pragmatic guy, so we’re starting to prepare the market, prepare the product and prepare the company for a successful launch. So we’re out with a small field team right now learning about the physicians and where we might be seeing WHIM patients, we’re educating on WHIM disease and really trying to encourage earlier diagnosis as we know that the earlier patients are diagnosed the better outcomes for them. So that’s where we are right now.

Unidentified Analyst : And then maybe one quick follow-up, how much of that work is there overlap with the chronic neutropenia population? You know, as you think about the future, obviously acknowledging a little bit earlier days in that program?

Paula Ragan: Mark, go ahead.

Mark Baldry: Yes, WHIM syndrome it is a form of chronic neutropenia. So everything we’re learning today is really helpful foundation for us as we as we think about our strategies in chronic neutropenia and another primary, immune deficiency. So, everything we’re doing now, I think, is teaching us about the unmet need, and primary immune deficiency and this can all be a help helpful for us as we as we build our plans.

Unidentified Analyst : Excellent. Thanks so much for taking our questions.

Operator: Our next question comes from Kristen Kluska of Cantor Fitzgerald, please go ahead.

Kristen Kluska: Hi, good morning, everybody. Thanks for taking our questions. So sounds like you’re planning to have a potentially robust conference attendance this year with data but similar to how we learned new insights on WHIM syndrome, genotype phenotype, patient identification, unmet need and other factors for both CN and WHIM. Do you think we could learn additional data regarding the market opportunity at these conferences? Again, in addition to some data disclosures this year?

Paula Ragan: I think, Kristen it’s a great question. So we actually have been publishing our market analyses and we’ve done some excellent work on ICD 10 codes with respect to current neutropenia. And as we generate even more deep and more refined analyses along those lines, we’ll certainly look forward to publishing that data. Not specific plans yet, but the team is working very hard to make sure we are defining the right population for treatment and that unmet need and alignment of course with market potential, so stay tuned.

Kristen Kluska: Okay, thanks. And in light of the WHIM syndrome data that you presented at the end of last year, curious if you’re getting any read through in terms of getting patients and investigators excited about enrolling and also the potential in the CN program?

Paula Ragan: I definitely think there’s crosswalk for excitement. But I’m going to turn that over to Murray to expand on that.

Murray Stewart: The investigators, the PI’s have been seeing the data and they’re very excited by the data in WHIM and already they’re thinking about wanting to enroll in the CN study. So I think they can see the link between neutropenia between WHIM and CN. And they’re excited about mavorixafor, I mean, historically, they’ve gotten GCSF, which has its limitations. And I think that excited to see a potential oral therapy for WHIM and CN.