Axsome Therapeutics, Inc. (NASDAQ:AXSM) Q2 2020 Earnings Conference Call - Final Transcript

Aug 10, 2020 • 08:00 am ET

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Axsome Therapeutics, Inc. (NASDAQ:AXSM) Q2 2020 Earnings Conference Call - Final Transcript

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Presentation
Operator
Operator

Good morning and welcome to the Axsome Therapeutics Conference Call. [Operator Instructions]

Now, I'd like to turn the conference over to your host, Mark Jacobson, Chief Operating Officer 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. Our earnings press release providing a corporate update and details of the company's financial results for the second quarter of 2020 crossed the wire a short time ago and is available on our website at axsome.com.

During today's call, we will be making certain forward-looking statements. These statements may include statements regarding, among other things, the efficacy, safety and intended utilization of our investigational agents; our clinical and non-clinical plans; our plans to present or report additional data; the anticipated conduct and the source of future clinical trials; regulatory plans; future research and development plans; and possible intended use of cash and investments. These forward-looking statements are based on current information, assumptions and expectations that are subject to change and involve risks and uncertainties that may cause actual results to differ materially from those contained in the forward-looking statements.

These and other risks are described in our periodic filings made with the Securities and Exchange Commission, including our quarterly and annual reports. You are cautioned not to place undue reliance on these forward-looking statements, which are only made as of today's date, and the company disclaims any obligation to update such statements.

Joining me on the call today are Dr. Herriot Tabuteau, Chief Executive Officer; Nick Pizzie, Chief Financial Officer; Dave Marek, Chief Commercial Officer; and Dr. Cedric O'Gorman, Senior Vice President of Clinical Development and Medical Affairs. Herriot will first provide an overview of the company and then review recent developments and upcoming milestones. Following Herriot, Nick will review our financial results. We will then open the line for questions.

I shall now turn the call over to Herriot.

Executive
Herriot Tabuteau

Thank you, Mark. Good morning, everyone, and thank you all for joining Axsome Therapeutics second quarter 2020 financial results and business update conference call.

Over the past several months, we continue to advance our AXS-05 and AXS-07 product candidates towards NDA submissions in major depressive disorder and migraine respectively. Across our broad development pipeline, we achieved several important clinical and regulatory milestones, including two FDA breakthrough therapy designations. I will provide a pipeline update, highlight the achievements in the quarter and will then review our upcoming milestones.

Starting with AXS-05 in depression, this morning, in addition to our regular quarterly financial results press release, we issued a separate press release focused solely on the progress in our depression program, including the generation of new clinical data. We remain on track to submit the NDA for AXS-05 in the treatment of major depressive disorder, or MDD, in the fourth quarter. To that end, we have completed a successful pre-NDA meeting with the FDA for AXS-05 in MDD. In addition, we have completed enrollment in the Phase 3 open-label safety trial of AXS-05