X4 Pharmaceuticals, Inc. (NASDAQ:XFOR) Q3 2023 Earnings Call Transcript

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Swayampakula Ramakanth: Thank you. Good morning, Paula and Adam. A lot of my questions have been answered just looking into the Phase 3 study in CN disorders. What’s the label you’re looking for? Or once we get into the application stage? And also, do you foresee either increasing the size of the trial as the trial progresses so that you maintain a certain number of patients in these individual populations so that you can get a broad label?

Adam Mostafa: So regarding the label based on the previous label for GCSF, for example, we should see a label that addresses the reductions of infections in the patient populations that we include in this trial. And so we haven’t finalized the label yet with the FDA, obviously, but this is what we think could be happening, and we’re looking at this reduced infection rate. With regards to in this…

Paula Ragan: Yes, I think he was just asking about subpopulation, I mean similar to GCSF, subpopulations were kind of catch as you catch can, but it’s based on the inclusion. And then the label covered all the variable patient populations.

Adam Mostafa: Yes. The trial again is powered 90% for our primary endpoint. So we’re planning to have this study executed as with the sample size, and we’re confident that we should be able to hit our primary endpoint with the current sample size.

Swayampakula Ramakanth: Okay. Thank you. Thanks for taking my question.

Operator: Thank you. Next question comes from the line of David Bautz with Zacks Small Cap Research. Please go ahead.

David Bautz: Hey, good morning, everyone. Thanks for the update this morning. Just one question for me. I’m curious what type of doctor ends up typically making the diagnosis for WHIM? And I guess what I’m trying to get at is how are you sure that you’re reaching the correct physician population with your outreach program?

Mark Baldry: Yes, it’s a great question. And because of the variable presentation of the disease, These patients have a different journey, diagnostic journey, depending on their symptoms. So some of the patients end up under the care of immunologists, and some of the patients end up under the care of a hematologist or a hemoc. So this is what we’ve been focused on for the past few months, is really looking at the data, engaging with key institutions, and learning about who are the physicians most likely to have these patients, so that once we get approved, we know where to prioritize our efforts. We’ve also been complementing this with our digital marketing, which I talked about earlier in the presentation. And this is an efficient way of extending our reach.

David Bautz: Okay, great. Thanks for that.

Operator: Thank you. This concludes today’s question-and-answer session. I would now like to turn the floor over to Paula Ragan for closing comments.

Paula Ragan: Well, thank you very much again today for joining the call. We look forward to providing continued updates in the future as we make our exciting progress as a company. Have a great day.

Operator: Thank you. This concludes today’s teleconference. You may disconnect your lines at this time. Thank you for your participation.

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