Good day, ladies and gentlemen, and welcome to the Q2 2018 Xenon Pharmaceuticals Earnings Conference Call. At this time, all participants are in a listen-only mode. Later, we’ll conduct a question-and-answer session, and instructions will follow at that time. [Operator Instructions] As a reminder, this conference may be recorded. I would now like to turn the conference over to your host, Ms. Jodi Regts. Ma’am, you may begin.

Thank you. Good afternoon. Thank you for joining us on our call and webcast to discuss our financial and operating results for our second quarter ended June 30, 2018. Joining me on today’s call are Dr. Simon Pimstone, Xenon’s Chief Executive Officer; and Ian Mortimer, Xenon’s President and Chief Financial Officer. Following this introduction, Simon will provide perspective on Xenon’s progress, and then Ian will review our financial results. After that, we will open up the call to your questions. Please be advised that during this call, we will make a number of statements that are forward-looking, including statements about the sufficiency of our cash to fund operations into at least mid-2020; the timing of IND or IND equivalent submissions with regulatory agencies; the initiation of future clinical trials; the efficacy of our clinical trial design and anticipated enrolment; the potential efficacy, safety profile, future development plans, regulatory success and commercial potential of our and our collaborator’s, product candidates; the timing of and results from ongoing clinical trials and preclinical development activities; our ability to achieve certain milestones in both our proprietary and partner development program; the plans of our collaboration partners and their interactions with regulatory agencies; the results of our research and development efforts; the status and timing of the potential addition of new programs to our pipeline and related to development activities; and the potential to advance XEN007 or other product candidates into Phase 2 or later clinical trials. Forward-looking statements are subject to numerous risks and uncertainties, many of which are beyond our control, including the risks and uncertainties described from time to time in our SEC filings. Our results may differ materially from those projected on today’s call. We undertake no obligation to publicly update any forward-looking statement. Today’s press release summarizing our second quarter results and the accompanying quarterly report on Form 10-Q will be made available under the Investors section of our website at www.xenon-pharma.com and filed with the SEC and on SEDAR. Now, I’d like to turn the call over to Simon.

Thank you, Jodi, and good afternoon, everyone. As I reflect upon the first half of this year, we achieved a number of important milestones and continue to see exciting advancements in Xenon’s clinical stage epilepsy ion channel programs. We enter the second half of the year bolstered by a strong momentum in our clinical stage programs and by significantly strengthened balance sheet. We look forward to exciting catalysts in the near-term, including a readout of our Phase 1b TMS pharmacodynamic data from XEN1101 program, complete Phase 1 readouts from XEN1101 and XEN901 epilepsy programs in the fourth quarter of this year, and advancing both these programs into Phase 2 clinical development. Just briefly, I’d like to touch on our ongoing collaboration with Genentech, before focusing on our proprietary epilepsy programs. As noted on previous calls, Genentech has completed a Phase 1 clinical trial for GDC-0310, which is an oral, selective Nav1.7 small-molecule inhibitor developed for the potential treatment of pain. We look forward to updating you once Genentech’s ongoing preclinical studies are completed and the final results are analyzed by Genentech. We have no further update at this time as this work remains in progress. Now, I’ll turn my attention to our proprietary pipeline of ion channel modulators. Our pipeline includes two proprietary and novel epilepsy product candidates currently in clinical development, XEN1101 and XEN901. Both have unique mechanisms of action, and we believe they contain additional attractive pharmaceutical properties that could yield important therapeutic advances and differentiation from existing antiepileptic drugs. We also added XEN007, a CNS-acting calcium channel inhibitor, containing the active ingredient, flunarizine, to our pipeline earlier this year. We obtained FDA Orphan Drug Designation or ODD for XEN007 for the treatment of hemiplegic migraine, an orphan and often severe disorder associated with migraine. To potentially expedite…

Thanks, Simon. I’ll start by providing an overview of our cash provision, cash runway guidance, and then I’ll provide a few highlights of the financial statements. I am pleased to report that we enter the second half of this year with a significantly strengthened balance sheet and new institutional shareholders who support our strategic goals. Cash and cash equivalents and marketable securities as of June 30, 2018 were $63.3 million. Included in this cash number are the net proceeds of approximately $29 million from the sale of 3.44 million common shares, under our first at-the-market or ATM offering agreement. Subsequent to the end of the quarter, we raised additional net proceeds of approximately $14.7 million from the sale of 1.6 million common shares, and this was under our second ATM offering agreement. Therefore, this $14.7 million is not included in our June 30th cash number. We’re very pleased that after the announcement of our Phase 1 clinical data in May, for both 1101 and 901 that we were able to raise this capital and continue to broaden our institutional shareholder base. In addition to this new equity capital, effective August 3, 2018, we also refinance our term loan agreement with Silicon Valley Bank. This increases our total outstanding borrowings from $12 million to $15.5 million. But more importantly, this extends the interest-only period on the loan from September 30, 2019 to March 31, 2020, and this has obviously a positive impact on our cash runway. Therefore, with the capital raised under the ATM equity offerings and the refined SVB term loan, based on our current assumptions, which include fully supporting the planned clinical development of both XEN1101 and XEN901, we anticipate having sufficient cash to fund operations into at least mid-2020. And this cash runway guidance excludes any revenue generating…

Thank you. [Operator Instructions] Our first question comes from Stephen Willey of Stifel. Your line is open.

Just a quick question for Simon. I guess, when you characterize the activities for 901 that lie ahead of you, I think you keep referencing adult focal seizures and/or rare pediatric forms of epilepsy. So, just kind of curious, if the latter reference means that you’ve made any progress with respect to some of the early juvenile tox studies that need to be done and the formulation switches that we need to be done to move into this patient population?

I appreciate the question, Steve. And you’re absolutely right, referencing both the adult focal and the rare pediatric options. And that is what they remain. As you know, obviously sodium channel modulators are the mainstay of treatment for focal seizures. So, clearly, it remains an opportunity. I think, the critical really gauging piece is going to be the interaction we expect and hope to have with the regulatory agencies, subsequent to having the Phase 1 study completed to determine what in fact will be needed and required to initiate a pediatric study in the EIEE13 infantile epilepsy subgroup. So, work is initiating to help support the pediatric entry as soon as possible. Those studies clearly are gating. Those include, as you referenced, juvenile tox and CMC formulation development. A critical gating item however is of course the regulatory meeting. We expect to submit a request for meeting sometime this year. I don’t know when we’ll have the FDA response by, but we hope to have that as quickly as possible. And then, I think we’ll have a better understanding of whether or not we’re able to move into that pediatric population, hoping to have driven our tox and CMC worked to out to support any pediatric program as quickly as possible. That’s not going to be 2018, Steve; it will be a 2019 timeframe.

Understood. And then, just on 007. Can you maybe just explain a little bit kind of what your options might be, just in terms of the various development strategies that you have in front of you? And I guess, what are some of the decision points that you’re considering, as you consider each of the various options that you have?

It’s a good question, Steve. Clearly, the ODD, as you know, for the molecule, has been obtained for hemiplegic migraine. I would say that’s where the bulk of the work has been done to-date. We understand that condition well. It’s actually a pretty common orphan disorder, 30,000 to 60,000 subjects in the U.S. where the drug would be developed. And so, we are quite far down, I would say, in assessing the opportunity of the drug for hemiplegic migraine, and I think just some months away from maybe finalizing that. But in parallel, there are a couple of other indications which we haven’t yet disclosed publicly, and I don’t think we’ll do so, until we are a bit further along in understanding the potential where the drug, flunarizine, may have significant utility as well in neurological orphan disorders. But, we still are in, I’d say, mapping out what the clinical study would look like and looking at feasibility of the studies. And until we’ve completed that work, and that’s really what’s holding things up at this point. We’re not ready to commit to HM until we completed the planning around a couple of other indications. We should have wrapped up in the coming months, Steve. And then, I think we’ll be making a decision on what the next steps, which we hope would be a Phase 2 program, would look like. So, that’s kind of where we are. Staying a little bit quiet in terms of the indications at this point, only because I think we’ve got a bit more work to do. But, we are looking at specifically two other indications. And we hope to have that looked at and completed that assessment over the coming few months and then a final decision made. We haven’t given guidance on the 007 molecule, but we do expect the next study will be a Phase 2 program. And I think and hope that we would be committing to a Phase 2 program, while I don’t think it will be in 2018, certainly soon thereafter. So, we have work underway, and we hope to have, I’d say, more clarity on this in the coming few months.

Thank you. [Operator Instructions] Next question comes from Maury Raycroft of Jefferies. Your line is open.

Hi. This is Vesna [ph] on for Maury today. Congrats on the progress. And thank you for taking our questions. My first question is a follow-up on Stephen’s question. So, thank you for the additional color on the Phase 2 for 901. I was wondering for the Phase 2 plans for 1101. Have you discussed those with the FDA yet? Are you planning to schedule that meeting? Will it be one or two separate meetings for the two drugs? And also, are you considering a combination arm for the Phase 2 studies, or will it be monotherapy for 1101?

Yes. So, thank you for those questions, good questions. In terms of the combination on arm, we don’t have a combination arm specifically contemplated for 1101 Phase 2. But of course, there’s background treatment. So, effectively, these are generally always combination therapies. But, there are an array of background drugs that can be used. And so, those will be combination, but no combination arm specifically. We’ll have 2 to 3 active arms, monotherapy on background therapy with 1 placebo arm. And then, the first question you asked was, whether we had FDA interactions on 1101 for Phase 2. Not yet. Just to remind you, the Phase 1 is currently being conducted through a CTA in the UK. We certainly are looking at jurisdictions very closely now. And any U.S. development for the Phase 2 would require a FDA submission. We haven’t had an FDA interaction yet for 1101 in preparation for the Phase 2. We expect to make decisions based on geography, actually, in the very, very near term. We don’t expect to have submissions that include both 1101 and 901 together. These are very different drugs, different mechanisms, different questions. The plan for 1101 initially is to go into adults with focal epilepsy, whereas with 901, we’ve got questions around whether we can advance that product without adult data into a pediatric population. So, very different questions for the agency and we expect there will be different meetings.

Yes. I would just add that. Given that both 1101 and 901, the Phase 1 trials were done in Europe, Phase 2 development may start earlier in Europe. So, we could always get a leg up there. In the adult population specifically for 1101, we don’t expect that we would need a pre-IND regulatory interaction very different in the pediatric setting where with specific questions that we’d want guidance on. But, we feel comfortable that the Phase 2 program in adults that we would be initiating for 1101 that we file the IND and then we could go right into initiating that Phase 2 program.

Thank you. That is very helpful. And then, as a follow-up question, if you can give us any additional clarity on your plans for ezogabine, have you discussed this with the regulators? And if you were to conduct a pediatric trial, how big of a trial would it be? When are you planning on doing that? If you can give any additional color, I would appreciate it. Thank you.

I think, our plan is to give sort of more fulsome color once we have some of the boxes checked on our side. So, we have had some preliminary interaction with the FDA. So, we’re very comfortable with that. We’re not at this I think in a position to talk about the details of what a next step program would be for the product. We’ve got some work underway with KOLs and sites to determine sort of feasibility around some of the preliminary discussions we’ve had. We may or may not have to go back to the FDA. I think, we’ll be in a very good position to update the street in the very near term on this. But yes, we have had some preliminary discussions with the FDA. We’re encouraged. We obviously are pursuing this based on preliminary discussions that have been held. But, certainly, we have a number of boxes still to check, which I think we can do in the near term, to determine the next steps. And so, I think that’s really all that we can say at this point in time.

Thank you. I’m showing no further questions. I’d like to turn the call back over to Jodi Regts for any closing remarks.

Thanks everyone for joining us today. We look forward to keeping you updated on our progress. Operator, we will now end the call.

Thank you. Ladies and gentlemen, this does conclude today’s conference. Thank you for your participation and have a wonderful day. You may all disconnect.