Xenon Pharmaceuticals Inc Q4 2023 Earnings Call Transcript

The following is excerpted from the question-and-answer section of the transcript.

Question: Paul Matteis - Stifel, Nicolaus & Company, Inc. - Analyst : Congrats on the progress. I was wondering if you could give a little bit more color on what you're seeing at the site level as it relates to enrollment in X-TOLE2 and whether things are running a little bit slower than planned recently or if there's any kind of context you can give around the updated timing guidance? And then as it relates to the Nav1.7 program, given the buzz and pain, I was just curious if you could drill down there, how confident are you that you have a compelling lead candidate? And when do you think something like that could be in the clinic? Thanks so much.

Question: Paul Matteis - Stifel, Nicolaus & Company, Inc. - Analyst : Thank you. REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. FEBRUARY 29, 2024 / 9:30PM, XENE.OQ - Q4 2023 Xenon Pharmaceuticals Inc Earnings Call

Question: Leonid Timashev - RBC Capital Markets Wealth Management - Analyst : This is Leonid, on for Brian. Thanks for taking our question. I wanted to ask on MDD and specifically on the investigator-initiated study. I guess curious if you guys feel like you have everything you need to plan your MDD trials based upon your own work or if there's anything specific you're looking for from the investigator-initiated trial. And if you think you'll have some of that data in hand as you go to the FDA to discuss trial design and have the end of Phase 2 meeting? Thanks.

Question: Leonid Timashev - RBC Capital Markets Wealth Management - Analyst : Got it. Thanks.

Question: Tessa Romero - J.P. Morgan Securities LLC - Analyst : Thanks for taking our questions. First one is you gave us a little bit of color tonight on X-TOLE2 enrollment. How is the exact enrollment going? And do you think you might be in a position to guide for enrollment completion sometime this year? And then second question is just, as a follow-up to some of your earlier comments, are you able to give us any further detail on what the next update might be from you on your discovery programs on Nav1.1 and Nav1.7? Could we see something further from you at all before an IND? How should we be thinking about that? Thanks.

Question: Tessa Romero - J.P. Morgan Securities LLC - Analyst : Great. Thanks for taking our questions.

Question: Andrew Tsai - Jefferies LLC - Analyst : Thanks for taking our questions. So maybe the first one, just in the upcoming FDA meeting in April, thanks for sharing some of the planned elements of the MDD study designs. Is there an upside scenario in this meeting that you're hoping for? And then secondly, actually on the Nav1.7, obviously, REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. FEBRUARY 29, 2024 / 9:30PM, XENE.OQ - Q4 2023 Xenon Pharmaceuticals Inc Earnings Call there's a little buzz with Nav1.8 going on. So can you talk about whether you believe 1.7 is a superior target to 1.8? And what -- to you having some of the historical challenges and pitfalls when pursuing that 1.7 that you think you can overcome? Thank you.

Question: Andrew Tsai - Jefferies LLC - Analyst : Thanks so much.

Question: Danielle Brill - Raymond James & Associates, Inc. - Analyst : We have questions on for XEN1101. Is there any update on the pediatric formulation? And what's your current thinking of the ex-US strategy is? Thank you. REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. FEBRUARY 29, 2024 / 9:30PM, XENE.OQ - Q4 2023 Xenon Pharmaceuticals Inc Earnings Call

Question: Danielle Brill - Raymond James & Associates, Inc. - Analyst : Thank you.

Question: Joseph Thome - Cowen & Co., LLC - Analyst : Maybe just one on the three Phase 3 studies for major depressive disorder. I guess are these going to be just three replicate trials or in terms of the patient population enrolled or will you potentially use one of them to examine like an antidepressant unresponsive population or TRD, how should we think about that? And then second, just on the HAM-D measure itself, I guess, is there something mechanistically about 1101 that makes the REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. FEBRUARY 29, 2024 / 9:30PM, XENE.OQ - Q4 2023 Xenon Pharmaceuticals Inc Earnings Call benefit clear on the HAM-D scale versus the MADRS or was it really just what you saw in the Phase 2 and maybe some of that decreased variability in the response that made you go forward with that measure? Thanks.

Question: Joseph Thome - Cowen & Co., LLC - Analyst : Perfect. Thank you.

Question: Brian Skorney - Robert W. Baird & Co. Inc. - Analyst : Also on the Nav1.7 program you're working on, given what seems to be somewhat disparate results from a 1.8 inhibitor, there's been some questions that we've done about differential expression in different tissues, it's not just a clinical design issue here. So I guess, how do you think about expression of Nav1.7 and how does this inform what key indications do you think are the most likely to be pursued for this target, I think, 1.7 preferentially expressed in DRG neurons. So just as you go forward, what do you imagine for the path for clinical development here? REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. FEBRUARY 29, 2024 / 9:30PM, XENE.OQ - Q4 2023 Xenon Pharmaceuticals Inc Earnings Call

Question: Marc Goodman - Leerink Partners LLC - Analyst : Ian, I was curious, as you've dove into the data from MDD, a little bit more on the safety profile, just why do you think the safety profile was just different in that population relative to the epilepsy population? And then, Sherry, maybe you could just give us a sense of R&D spend for this year? Thank you.

Question: Marc Goodman - Leerink Partners LLC - Analyst : Thanks.

Question: Laura Chico - Wedbush Securities Inc. - Analyst : Thanks very much for fitting me in. Just two quick ones and following up on that. Apologies if I missed part of it, but could there be a scenario in which you just do two depression studies, I guess, given the large database and leverage of the epilepsy data set, I'm just trying to understand, could there be a scenario where you don't necessarily need to do three trials? And would that be a discussion point in the end of Phase 2 meeting? And then related to depression, it looks like the timing for the Mount Sinai depression study has been extended based on the clinical trial posting. And I understand this is not a gating item at this point for the trial initiation or FDA discussion. But I guess I'm curious how much relevance does this study actually carry at this point to you? And what's your working assumption in terms of data readout? Thank you.

Question: Laura Chico - Wedbush Securities Inc. - Analyst : Thank you.