Xenon Pharmaceuticals Inc Q2 2024 Earnings Call Transcript

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

Question: Paul Matteis - Stifel - Analyst : Hey there, good afternoon. Congrats on all the progress. As it relates to X-TOLE2, I was wondering if by now, you have a good sense of how the patient demographics as it relates to baseline seizure frequency, refractoriness, et cetera, comparing to X-TOLE1. And then just as it relates to your updated timing guidance for top-line, thanks for that. Is the expectation still that you'll complete enrollment around the end of this year, early next year? Thanks so much.

Question: Paul Matteis - Stifel - Analyst : Good to hear. I thank you both very much, Al.

Question: Leo Leung - RBC Capital Markets - Analyst : Hey, it's Leo Leung on for Brian. Thanks for taking my question. I had maybe one and then just a quick clarifying question as well. I guess on the MDD trial, design, I guess is you thinking about howazetukalner might position itself and there's a number of other agents that are and also potentially having effect on anhedonia, I guess, how's those other competitive trials? And I think the Kappa-opioid start to readout. I guess, are you looking for any data there and how they perform on anhedonia to maybe inform and whether you want to change selection for anhedonia or how that might impact market positioning for azetukalner. And then just to clarify, I think you guys said that you're not running ex-US sites for the MDD Phase 3 program. And I think maybe before you had said that you would use both international and US sites. I guess, can you maybe talk about what drove that change, if I heard you guys correctly, and maybe how that might impact any expectations on timing and how quickly you can move? Thanks.

Question: Tessa Romero - J.P. Morgan - Analyst : Good afternoon and thank you for taking our questions. So Ian, you've outlined top-line X-TOLE2 data in the second half of 2025 here. Digging back up on like an earlier question that was asked, maybe asked slightly differently, can you just provide a little bit of an updated view for us on how the pace of enrollment has been going? And just curious, has it been pretty steady since all the sites were activated? Or there -- have you observed any changes due to competitive dynamics or anything else here in the US or globally across sites? And can you just remind us what the split is between US and ex-US sites? And what are the key regions outside the US? Thanks so much.

Question: Dina Ramadane - Bank of America - Analyst : Hi, good afternoon. This is Dina on for Jason. Thank you so much for taking our questions. I just wanted to ask about the next-generation Kv7 asset that's in IND-enabling studies. Could you please provide some more color on the specific drug properties that led you to advance this asset? Is your aim to improve upon azetukalner's profile? Or is this more of a life cycle management play to advance Kv7 into neuropsych opportunities beyond the current epilepsy and MDD set? 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. AUGUST 08, 2024 / 8:30PM, XENE.OQ - Q2 2024 Xenon Pharmaceuticals Inc Earnings Call

Question: Dina Ramadane - Bank of America - Analyst : Got it. Thank you so much. And I guess a quick follow-up to that. You highlighted some additional neuropsych indications. Will we be looking at data from Kv7 competitor in bipolar mania and potentially migraine to inform the indications you plan to assess with this next-gen molecule? It might be a little bit too mature of a question to ask. Thank you.

Question: Dina Ramadane - Bank of America - Analyst : Thank you so much.

Question: Luke Herrmann - Baird - Analyst : Hi, this is Luke on for Brian. Thanks for taking the question on Nav 1.7, can you talk about your biggest learnings from legacy challenges with the mechanism in the past on? And then apologies if this is something you've discussed before, but can you remind us whether you intend to conduct a non human primate studies to get a better idea of the profile before entering the clinic given it seems there's been challenges with translation utilizing rodent models in the past.

Question: Luke Herrmann - Baird - Analyst : Yeah, yeah.

Question: Luke Herrmann - Baird - Analyst : Awesome. Thanks.

Question: Andrew Tsai - Jefferies - Analyst : Hey, good afternoon. Congrats on execution. Thanks for the updates. I wanted to ask on PGTCS. at this time, could it be possible we get data in 2025? Or should we be assuming 2026 at the earliest? And I think you guys have mentioned for how the study is powered to show other drugs show within this indication. So would it be fair to assume a 30% to 40% type placebo-adjusted separation, seizure reductions that could be the bar here. Thank you.

Question: Paul Choi - Goldman Sachs - Analyst : Sorry about that. I just wanted to ask a follow-up on Nav1.7 with regard to development in pain. And can you comment, pending any of the animal model work, what you see as the most logical development focus for that area, whether you focus on an acute development clinical strategy or focusing perhaps on the larger chronic opportunity for us to prosecute them in parallel. Thanks, Ian.

Question: Peyton Bohnsack - TD Cowen - Analyst : Hi guys, thanks for taking our questions. I guess, could you talk a little bit more about the design of the MDD total program? I guess, in terms of just initiating studies and enrollment and the data releases, are you planning on staggering initiation one, two, three? Or are you going to initiate them all at once? And then for the data releases, basically the same question, can it be released all at once? Or will it be done when the study analysis is completed? And then just secondly and real quickly, I apologize if I missed this, is MADRS still being measured in these studies? Thanks.

Question: Peyton Bohnsack - TD Cowen - Analyst : Great. Thank you very much.

Question: Dylan Shindler - Wedbush Securities - Analyst : Thank you very much for taking my questions. This is Dylan on for Laura Chico. And I'm not sure if this is a question for Chris Kenney or Ian. But we noticed within the SCNA -- SCN8A program partnered with Neurocrine. You're also looking at next lead candidate, that's Nav1.2 or Nav1.6 inhibitor for focal epilepsy. And we were wondering if you see positive outcomes with 352. Would this also run through to the broader seizure-related indications?

Question: Dylan Shindler - Wedbush Securities - Analyst : Yeah. Thank you so much for taking the question.

Question: Basma Radwan - Leerink Partners - Analyst : Hi, this is Basma on for Marc. We have a question on X-ACKT. Could you please remind us what we should expect in terms of the efficacy of XEN1101 in the primary generalized seizures? Should we expect an efficacy in line with what we've seen in the focal onset seizures? We also had a question about the dose, the 25 milligram. What work you've done to actually feel comfortable about the use of this dose in this indication and whether you believe this dose will be efficacious or not? Thank you.

Question: Basma Radwan - Leerink Partners - Analyst : Thank you.