Axsome Therapeutics, Inc. (NASDAQ:AXSM) Q3 2018 Earnings Conference Call Transcript

Nov 09, 2018 • 08:00 am ET

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Axsome Therapeutics, Inc. (NASDAQ:AXSM) Q3 2018 Earnings Conference Call Transcript

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Presentation
Operator
Operator

Good morning, ladies and gentlemen and welcome to Axsome Therapeutics Third Quarter 2018 Financial Results Conference Call. Currently, all participants are in a listen-only mode. (Operator Instructions) As a reminder, today's conference call is being recorded. I would now like to turn the conference over to your host, Mark Jacobson, SVP of Operations at Axsome Therapeutics. Please go ahead.

Executive
Mark Jacobson

Thank you, operator. Good morning and thank you all for joining us on today's conference call to discuss Axsome Therapeutics 2018 third quarter financial results. A press release providing a corporate update and details of the Company's financial results for the third quarter ended September 30, 2018 crossed the wire a short time ago and is available on our website at www.axsome.com.

(Forward Looking Cautionary Statements)

Joining me on the call today are Dr. Herriot Tabuteau, CEO, Nick Pizzie, CFO and Dr. Cedric O'Gorman, SVP of Clinical Development and Medical Affairs. Dr. Tabuteau will first provide a pipeline update and a review of upcoming milestones, Cedric will then provide further detail on the progress of our clinical studies and Nick will review our third quarter financial results. We will then open the call for questions.

I shall now turn over the call to Herriot.

Executive
Herriot Tabuteau

Thank you, Mark. Good morning everyone and thank you all for joining us today. The past several months have been a highly productive period for Axsome. We advanced our ongoing clinical trials, broadened our CNS pipeline with the announcement of a new product candidate, extended our cash runway in front of upcoming clinical catalysts and position our non-core CNS product candidates for enhanced value creation.

We have continued to highlight our technology at a number of medical conferences and held two R&D key opinion leader events to further the understanding of the important diseases we are targeting and the potential of our product candidates to addressing them. Our growing CNS portfolio now includes AXS-05, AXS-07, AXS-09 and AXS-012. We continue to successfully advance the ongoing clinical trials with our lead CNS product candidate AXS-05 in treatment resistant depression, Alzheimer's disease agitation, major depressive disorder and smoking cessation treatment. AXS-05 possess novel mechanisms of action including glutamatergic, monoaminergic and anti-inflammatory properties.

We are pleased to announce that a) that we now expect the final results from the STRIDE-1 Phase 3 trial of AXS-05, a treatment resistant depression in the first quarter of 2019. This is a change from our prior guidance of the first half of 2019, the acceleration and timeline results from our decision to forgo the previously planned second interim analysis for this trial in favor of a final analysis. Foregoing the second interim analysis preserve statistical power and with a lower than expected observed dropout rate enables a reduction in the total planned number of subjects for the trial.

Moving on to Alzheimer's disease agitation, for the Phase 2-3 trial of AXS-05 and Alzheimer's disease agitation we are on track to report the results of the planned interim analysis for futility this quarter. With regards to