The following is excerpted from the question-and-answer section of the transcript.
(Questions from industry analysts are provided in full, but answers are omitted - download the transcript to see the full question-and-answer session)
Question: Serge Belanger - Needham & Company, LLC - Analyst
: Great. Thank you. I guess let's start off with -- 1101 was kind of designed as a follow-on to ezogabine. Ezogabine was a product that had, I think,
significant potential but was kind of held back because of the safety, tolerability issues. Maybe if you just want to highlight how 1101 is different
and given the data you've seen so far with X-TOLE, how satisfied you are with the profile of this compound relative to what you had seen with the
ezogabine?
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APRIL 11, 2022 / 2:15PM, XENE.OQ - Xenon Pharmaceuticals Inc at Needham Healthcare Conference (Virtual)
Question: Serge Belanger - Needham & Company, LLC - Analyst
: Okay. The X-TOLE trial results have been out for around six months. You presented the data to the AES meeting in December, and I'm sure you
plan on publishing it maybe this year. What has been the feedback from the epilepsy community from this data set?
Question: Serge Belanger - Needham & Company, LLC - Analyst
: Okay. And I think the big catalyst now is the upcoming FDA meeting, and I guess the regulatory update that will follow that. But I guess, what are
your expectations going into this regulatory meeting? I know one of the big questions you'd probably get is whether the FDA will accept the X-TOLE
study as one of the pivotal trials. I guess do you expect to get clear guidance on that question?
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APRIL 11, 2022 / 2:15PM, XENE.OQ - Xenon Pharmaceuticals Inc at Needham Healthcare Conference (Virtual)
Question: Serge Belanger - Needham & Company, LLC - Analyst
: Okay. And then I think you've given a broad overview of the Phase 3 plans, maybe explore a couple of doses. Any changes in terms of the patient
population? I know in the X-TOLE trial, you evaluated the drug in a very severe patient population. Do you expect to make any changes for that in
the Phase 3 trial?
Question: Serge Belanger - Needham & Company, LLC - Analyst
: Okay. So based on the FDA feedback, that will determine whether both of these Phase 3 trials will be identical or not? Is that how we should think
about it? Or you're also meeting with the European agency. I guess that could also determine what that second Phase 3 trial may look like?
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APRIL 11, 2022 / 2:15PM, XENE.OQ - Xenon Pharmaceuticals Inc at Needham Healthcare Conference (Virtual)
Question: Serge Belanger - Needham & Company, LLC - Analyst
: Okay. And these meetings will take place sometime in the second quarter, and we should expect that the trials will be underway sometime in the
second half?
Question: Serge Belanger - Needham & Company, LLC - Analyst
: Great. Maybe let's talk about the market opportunity in adult focal epilepsy. I guess based on the X-TOLE trial, now you got a better idea of where
1101 can play in the treatment paradigm?
Question: Serge Belanger - Needham & Company, LLC - Analyst
: Okay. And looking at the European market opportunities, it's set up kind of the same way where Vimpat and Keppra are in the class of minor kind
of the first -- have a first treatment role and then you move on to some of the newer branded products?
Question: Serge Belanger - Needham & Company, LLC - Analyst
: Okay. Moving on to depression, I think besides the X-TOLE trial results in 2021, your plans to expand into depression, I think, was another important
development for the company last year. Maybe we'll start off talking about the scientific and mechanistic rationale of using 1101 for depression?
Question: Serge Belanger - Needham & Company, LLC - Analyst
: Okay. And then just thinking about safety, tolerability, obviously the threshold, very different from a refractory epilepsy patient population versus
one in depression. So how do you think about that and how do you manage that for -- as you evaluate the product in depression?
Question: Serge Belanger - Needham & Company, LLC - Analyst
: Okay. And you've also mentioned potential plans to expand to new indications, potential announcements this year. This will be another epilepsy
-- more epilepsy indications or are you still looking beyond epilepsy for these new indications?
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APRIL 11, 2022 / 2:15PM, XENE.OQ - Xenon Pharmaceuticals Inc at Needham Healthcare Conference (Virtual)
Question: Serge Belanger - Needham & Company, LLC - Analyst
: Okay. And just a wrap up for our 1101 conversation, maybe just cover the IP of the program?
Question: Serge Belanger - Needham & Company, LLC - Analyst
: Great. So I guess in the last few minutes we have remaining, I just wanted to cover the 496 program. So this is a pediatric formulation of ezogabine.
So maybe talk some of the differences between this formulation versus ezogabine and what that means for the IP also of the program.
Question: Serge Belanger - Needham & Company, LLC - Analyst
: Okay. And just -- KCNQ2, what kind of market opportunity does that represent for 496?
Question: Serge Belanger - Needham & Company, LLC - Analyst
: Okay. And like you said, the EPIK trial is enrolling. And I think you've started giving broad guidance on when we could see a readout?
Question: Serge Belanger - Needham & Company, LLC - Analyst
: Okay. And maybe just to finish off here. Well, first, let's -- maybe just a financial overview in terms of the cash balance, the cash runway, and the
OpEx projections, and then maybe let's wrap it up afterwards, which is a highlight of the upcoming catalyst.
Question: Serge Belanger - Needham & Company, LLC - Analyst
: Okay.
Question: Serge Belanger - Needham & Company, LLC - Analyst
: Great. Well, I want to thank you both for spending time with us this morning. Very much appreciate it.
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