Exhibit 99.1

 

 

Axsome Therapeutics Reports Fourth Quarter and Full Year 2018 Financial Results and Provides Business Update

 

Company to host conference call today at 8:00 AM Eastern

 

NEW YORK, March 14, 2019 (Globe Newswire) — Axsome Therapeutics, Inc. (NASDAQ: AXSM), a clinical-stage biopharmaceutical company developing novel therapies for the management of central nervous system (CNS) disorders, today reported financial results for the fourth quarter and year ended December 31, 2018.

 

“In 2018, we advanced our clinical programs and significantly expanded our CNS pipeline through the addition of new internally generated product candidates, and the launch of clinical trials in new indications,” said Herriot Tabuteau, MD, Chief Executive Officer of Axsome. “We have continued this momentum into 2019, reporting positive results from the Phase 2 ASCEND trial of AXS-05 in major depressive disorder, and initiating the Phase 3 MOMENTUM trial of AXS-07 in migraine and the Phase 2 CONCERT trial of AXS-12 in narcolepsy. All in all, we are currently conducting registration or mid-stage clinical trials with our potentially first- or best-in-class product candidates in five different important CNS indications. In addition, our recently completed financings allow us to advance our deep pipeline well beyond data readouts for all ongoing clinical trials. Over the next several quarters, we look forward to topline results from the Phase 3 STRIDE-1 trial of AXS-05 in treatment resistant depression, the Phase 2 trial of AXS-05 in smoking cessation, the Phase 2 CONCERT trial of AXS-12 in narcolepsy, the Phase 3 MOMENTUM trial of AXS-07 in migraine, and the Phase 2/3 ADVANCE-1 trial of AXS-05 in Alzheimer’s disease agitation.”

 

CNS Pipeline Update

 

Axsome is developing a portfolio of differentiated, patent-protected, central nervous system (CNS) product candidates. CNS disorders are distressing for patients, difficult to treat, and often underserved, with many having no approved or satisfactory treatment options. Axsome accelerates the development of new CNS medicines by utilizing proprietary medicinal chemistry and formulation technologies, and novel mechanisms of action, combined with human proof-of-concept data and innovative clinical trial designs. Axsome’s technologies include metabolic inhibition, MoSEIC™ delivery, chiral chemistry and formulation, and proprietary chemical synthesis and analysis. Our CNS pipeline includes three differentiated product candidates in active clinical development.

 

·                  AXS-05: AXS-05 is a novel, oral, investigational NMDA receptor antagonist with multimodal activity, which is being evaluated in four separate indications: treatment resistant depression (TRD), Alzheimer’s disease (AD) agitation, major depressive disorder (MDD), and smoking cessation. AXS-05 consists of dextromethorphan (an NMDA receptor antagonist, sigma-1 receptor agonist, and serotonin and norepinephrine reuptake inhibitor) and bupropion (a norepinephrine and dopamine reuptake inhibitor, which also increases the bioavailability of dextromethorphan). AXS-05 has been granted U.S. Food and Drug Administration (FDA) Fast Track designations for the treatment of TRD and for the treatment of AD agitation.

 

Depression: Axsome is enrolling a Phase 3 trial in TRD (the STRIDE-1 study), and has completed a Phase 2 trial in MDD (the ASCEND study). The Phase 3 STRIDE-1 study is a randomized, double-blind, active-controlled, multicenter trial to assess the efficacy and safety of AXS-05 in TRD, defined as major depressive disorder which has failed to respond to two or more antidepressant treatments. To date, approximately 95% of the target number of subjects have been randomized. Topline results are anticipated in the second quarter of 2019.

 

In January 2019, Axsome announced positive results from the Phase 2 ASCEND study, a randomized, double-blind, active-controlled, multicenter, U.S. trial, in patients with confirmed moderate to severe MDD. In this study, AXS-05 met the prespecified primary endpoint by rapidly, substantially, and statistically significantly reducing depressive symptoms, measured using the Montgomery-Åsberg Depression Rating Scale (MADRS) total score, as compared to the active comparator bupropion. Further details of the study results are expected to be presented at upcoming scientific meetings. Axsome anticipates meeting with the FDA in the second quarter of 2019 to discuss the potential regulatory path for developing AXS-05 for the broader MDD indication.

 

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The following information was filed by Axsome Therapeutics, Inc. (AXSM) on Thursday, March 14, 2019 as an 8K 2.02 statement, which is an earnings press release pertaining to results of operations and financial condition. It may be helpful to assess the quality of management by comparing the information in the press release to the information in the accompanying 10-K Annual Report statement of earnings and operation as management may choose to highlight particular information in the press release.

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