Xenon Pharmaceuticals Inc Q1 2025 Earnings Call Transcript

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

Question: Paul Matteis - Stifel Nicolaus - Analyst : We were just wondering, from the top line epilepsy data in early 2026, how quickly could you file assuming that's positive. And then just a second question, you guys talked about tracking some key metrics. Could you provide any color on what those are and, yeah, just like kind of what those metrics are and how they compare to the Phase 2b.

Question: Tessa Romero - JPMorgan Chase & Co. - Analyst : Hi and team, good afternoon guys, and thanks so much for taking our question. Following up here, can you provide any quantification on how many patients you still need to recruit for X-TOLE2, any numbers you can put around it for us, and what are you specifically focused on to ensure you meet this guidance or is it really just par for the course here we noticed on clinicaltrials.gov that it seems like some additional trial sites have recently been added. And finally, can you talk to what the screen failure rate is coming out to be and is that similar to what you saw in X-TOLE2? Thanks so much.

Question: Brian Abrahams - RBC Capital Markets. - Analyst : Hey, good evening. Thanks for taking my questions. Really two for me, I guess. First, do you have any sense as to the reasons behind the slight timeline slippage, for X-TOLE2, are there kind of implications on kind of competitive dynamics there and any learnings, that you can apply to patient finding in the in the commercial setting. And then secondly on the Mount Sinai study, it seems like in a more mild population, I don't think they had a AMD entry criteria there. There were fairly robust effects as good or even better than what you saw in your study. Any thoughts on how that might impact, I guess, your your Phase 3 plan in terms of your entry criteria or any modifications there or to the powering of your Phase 3s and MDD given what you're seeing coming out of Mount Sinai. Thanks.

Question: Brian Skorney - Baird Equity Research - Analyst : Hey, good afternoon, guys. Thank you for taking the question. I guess also to follow up on the IST studies as well, maybe you could just kind of walk through the details around the FMRI, primary endpoint, what the neuroimaging expectations were here originally, what the thought process on making that the primary was, and, what we've seen versus other active MDD drugs that are approved on some neuroimaging end points.

Question: Myles Minter - William Blair - Analyst : Hey everyone, thanks for taking the question. Just on, the powering, I think you've said it's, for X-TOLE to 99% powered at 25 mg dose, 90% at 15 Ms, for that 360 patient target enrollment. And we did some work. I think if you look at Phase 2, going to Phase 3, the placebo doesn't really change in FOS studies, but the drug effect comes down, and I think it was about a 7% on -- On that medium, seizure frequency. So just wondering, given your comments that you powered this study based on what you saw in exile, which was better than we expected, do you assume some sort of REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. MAY 12, 2025 / 8:30PM, XENE.OQ - Q1 2025 Xenon Pharmaceuticals Inc Earnings Call effect size erosion going in a Phase 3? And if you do, are you going to take this as an opportunity to maybe increase enrollment beyond that 360 patient number? Just wondering how you think about that.

Question: Andrew Tsai - Jefferies - Analyst : Hey, thanks for the updates. My best wishes to share. I believe that's your last earnings call at Xenon. For X-TOLE2, is the general guidance still to revise the data timing guidance to a specific time point over time, such as a specific month or by chance could you plan to press release or announce when you do in fact complete enrollment? And then secondly, we know back in the X-TOLE there was a stronger efficacy differential for patients who are on fewer AEDs at baseline. Any color on the enrolled, Phase 3 X-TOLE2 and 3 base, patient type in terms of the number of prior and concomitant AEDs there on that baseline.

Question: Joseph Thorne - TD Cowen - Analyst : Hi there. Good evening. Thank you for taking my questions. Maybe the first one on the inclusion of the bipolar 1 patients. Maybe if you could just give us a little bit more detail as to why you decided to include both bipolar 1 and bipolar 2 patients in the study, especially given the biohaven data that came out earlier this year. And then maybe just a second question on the sini Phase 2, obviously it's small, but I think in that study, the patients were taking two pills of 10 mg, I guess assuming. And then obviously your Phase 2, it was 20 mg once a day. Do you think there's anything in sort of that two tablets versus one tablet that could have led to the the greater results here? And are you thinking about changing anything relative to that? Obviously, no, it's a small study, but thank you.