Xenon Pharmaceuticals Inc. (NASDAQ:XENE) Q3 2019 Earnings Conference Call - Final Transcript

Nov 05, 2019 • 04:30 pm ET


Xenon Pharmaceuticals Inc. (NASDAQ:XENE) Q3 2019 Earnings Conference Call - Final Transcript


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Ladies and gentlemen, thank you for standing by, and welcome to the Q3 2019 Xenon Pharmaceuticals Inc Earnings Conference Call. [Operator Instructions]

I would now like to hand the conference over to your speaker today, Ms. Jodi Regts. Ma'am, you may begin.

Jodi Regts

Thank you. Good afternoon. Thanks for joining us on our call and webcast to discuss our financial and operating results from the third quarter of 2019. 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 give an overview of Xenon's clinical programs, 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 2021; the timing of IND or IND-equivalent submissions with regulatory agencies; the initiation of future clinical trials; the efficacy of our clinical trial designs and anticipated data. Today's press release summarizing our third quarter 2019 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 on SEDAR.

I'd now like to turn the call over to Simon.

Simon Pimstone

Thank you, Jodi, and good afternoon, everyone. Today I'll provide an update on each of our clinical stage programs, including XEN496, XEN1101, XEN901 and XEN007, and I'll highlight some of the important milestone events anticipated this year. After Ian's financial commentary and a recap of our recent agreement with Flexion, we'll open the call for questions.

So I'll start with XEN496, a Kv7 potassium channel modulator, we are developing as a treatment for a rare pediatric neuro developmental disorder called KCNQ2 developmental and epileptic encephalopathy or otherwise known as KCNQ2-DEE sometimes referred to as EIEE7. Ezogabine, which is the active ingredient in XEN496 was previously approved by the FDA as an adjuvant treatment for adult partial onset seizures, but was withdrawn from the market for commercial reasons in 2017. There's a strong genetic rationale to suggest that ezogabine maybe efficacious as a treatment for KCNQ2-DEE. This is further supported by non-controlled clinical studies, as well as anecdotal parental and physician feedback suggesting that XEN496 may be well tolerated and reduce seizure burden with potential to improve developmental and cognition or development and cognition in this rare pediatric population.

We recently conducted a survey of patients and caregivers in the KCNQ2-DEE community and the feedback continues to support our rationale for developing XEN496 for this rare pediatric developmental epilepsy disorder. We will be presenting details on our survey work at the upcoming Annual Meeting of the American Epilepsy Society or AES in early December.

We obtained orphan drug designation from the FDA for XEN496 as a treatment for KCNQ2-DEE, in response to our pre-IND briefing package that included our proposal to study XEN496 in infants and children with