Xenon Pharmaceuticals Inc at Goldman Sachs Global Healthcare Conference Transcript

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

Question: Paul Choi - Goldman Sachs Group, Inc - Analyst : And so what we'll maybe do is let Ian kick it off maybe with some high-level remarks for those listening in on the webcast. Maybe just giving a brief background on Xenon, its core competencies, and the markets you're targeting.

Question: Paul Choi - Goldman Sachs Group, Inc - Analyst : Okay, great. Maybe we can start with MDD for which, azetukalner, you had most -- your most recent clinical data with X-NOVA. So can you maybe summarize the results for us, and help us understand what does this data look like in terms of context versus other mid-stage studies because we want to try and keep it like-for-like, not necessarily versus approved agents and at least how does that fit in, at least in the current MDD treatment landscape?

Question: Paul Choi - Goldman Sachs Group, Inc - Analyst : Yes, it will be great.

Question: Paul Choi - Goldman Sachs Group, Inc - Analyst : Okay. I want to touch briefly on something you mentioned, Ian, which is talked about some of the changes for your endpoints in terms of Phase 3. One of the other things that we also have seen in the literature and I think, this is also seen in X-NOVA, is you see differential responses depending on severity of disease. And so can you maybe speak to a little bit to how you're thinking about inclusion, exclusion criteria, where you want to enroll more severe, more depressed population, to increase your probability of technical success here?

Question: Paul Choi - Goldman Sachs Group, Inc - Analyst : Okay. Great. I think one of the things that probably has been most interesting about the Xenon story is that when you laid out your, historically, your preclinical literature in the animal models, the simulations of depression there, the dosing curve performances and severity has translated very well, obviously, in terms of your Phase 2 clinic. REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. JUNE 12, 2024 / 8:00PM, XENE.OQ - Xenon Pharmaceuticals Inc at Goldman Sachs Global Healthcare Conference So the science there, I think, is really elegant. Maybe other things, you talked a little bit about sample size which has yet to be finalized, but just in terms of like maybe what you can paint for us in terms of broad strokes in terms of how you're thinking about powering. Given the recent experience of some other companies or sponsors in the MDD setting have had some issues, both at clinical trial sites as well as with statistical assumptions and placebo performance. Maybe just sort of what is the state of the art, I guess, in terms of MDD trial execution, and staff's plans, maybe if you could frame that for us?

Question: Paul Choi - Goldman Sachs Group, Inc - Analyst : Okay. Maybe to round out our discussion on MDD, obviously, you still have to run Phase 3 programs, but just as you think about longer-term development here, and either combination therapies and just given a polypharmacy approach in depression, just sort of how do you think about other development aspects of MDD here, and maybe looking into adjacent populations such as mixed features and things like that?

Question: Paul Choi - Goldman Sachs Group, Inc - Analyst : Okay. Great. Maybe turning to your lead program in epilepsy and FOS. You talked a little bit about enrollment updates on your last earnings and just maybe when do you think you'd be able to offer more precision on whether enrollment can be completed by year-end versus early next year? Just sort of what visibility you have on the pace of enrollment, and completing that?

Question: Paul Choi - Goldman Sachs Group, Inc - Analyst : Okay. So that's a very nice data for 2025, which would look to be a very interesting year for you guys with data coming out, potentially at some point, either 2Q or mid-'25, broadly speaking, potentially here. So I wanted to ask maybe how you're thinking about data mechanics with regard to top lining results versus balancing, and saving some of the interesting material for medical meeting and just kind of where the thinking is on that? And then sort of what sort of medical meeting or forum might be a potential opportunity for looking at the results in detail.

Question: Paul Choi - Goldman Sachs Group, Inc - Analyst : Okay, great. Assuming clinical success, which I think most investors think is pretty likely here based on your Phase 2 X-TOLE results, can you maybe just remind us what your regulatory package broadly would look like? I think you've indicated that guidance from the FDA or suggestion that X-TOLE could serve as one of your confirmatory trials. With X-TOLE2, you'll have a package put together. But what other things are needed in terms of either a safety database or things like that? Is that adequately sizing, how long do you have to track these patients for in terms of establishing the safety profile? Just maybe some comments there.

Question: Paul Choi - Goldman Sachs Group, Inc - Analyst : Okay. I want to touch maybe briefly just on the competitive landscape because there are other molecules in this class on development, and just good management teams, hopefully are not paranoid, but they do think about the competitive landscape. And so just as you think about your time lines where you're clearly further along versus some of the other drugs in the category, just what do you watch for in terms of the competitive landscape, whether it's Biohaven or who else, and what are you monitoring for? REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. JUNE 12, 2024 / 8:00PM, XENE.OQ - Xenon Pharmaceuticals Inc at Goldman Sachs Global Healthcare Conference

Question: Paul Choi - Goldman Sachs Group, Inc - Analyst : And just how do you monitor companies like whether it's a Biohaven or recently debuted companies like Rapport that are looking into the space as well. REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. JUNE 12, 2024 / 8:00PM, XENE.OQ - Xenon Pharmaceuticals Inc at Goldman Sachs Global Healthcare Conference

Question: Paul Choi - Goldman Sachs Group, Inc - Analyst : Okay. I want to maybe in our remaining time, touch on some corporate matters, just reflecting maybe questions on spend levels versus your cash runway, which as you mentioned, will take you out a few more years, and embeds running Phase 3 programs for both FOS and MDD. But I want to ask just is this sort of burn rate what we should sort of think about for the near to intermediate term, just given you are running so many late-stage programs. And then as FOS completes its pivotal studies here and you get to the commercial stage, maybe either for you or for Chris, how do you think about launching an FOS, whether it's going it alone or partnering and maybe just some comments there?

Question: Paul Choi - Goldman Sachs Group, Inc - Analyst : We have about a minute left, and I just want to touch on the early-stage pipeline, which I think you continue to do obviously very high-quality work in terms of sodium channel drug development and just sort of what time lines are and just sort of how to think about the cadence of INDs for 1.7 as well as to the next Kv7 drug that you mentioned earlier?

Question: Paul Choi - Goldman Sachs Group, Inc - Analyst : Okay, great. We're almost up on time here. So maybe we'll end it on that note. My thanks to Ian and Chris for joining us from Xenon. Thank you very much.