Axsome Therapeutics, Inc. announced that AXS-12 (reboxetine), a highly selective and potent norepinephrine reuptake inhibitor and cardiac dopamine modulator, achieved the primary endpoint and significantly reduced the frequency of cataplexy attacks as compared to placebo in patients with narcolepsy in the SYMPHONY Phase 3 trial. AXS-12 has been granted U.S. Food and Drug Administration (FDA) Orphan Drug Designation for the treatment of narcolepsy. The forward-looking statements include risks and uncertainties, including, but not limited to, the continued commercial success of Sunosi®?

and Auvelity®? products and the success of efforts to obtain any additional indication(s) with respect to solriamfetol and/or AXS-05; the success, timing and cost of ongoing clinical trials and anticipated clinical trials for current product candidates, including statements regarding the timing of initiation, pace of enrollment and completion of the trials (including ability to fully fund disclosed clinical trials, which assumes no material changes to currently projected revenues or expenses), futility analyses and receipt of interim results, which are not necessarily indicative of the final results of ongoing clinical trials, and/or data readouts, and the number or type of studies or nature of results necessary to support the filing of a new drug application ("NDA") for any of current product candidates; ability to fund additional clinical trials to continue the advancement of product candidates; the timing of and maintain U.S. food and Drug Administration ("FDA") or other regulatory authority approval of, or other action with respect to, product candidates, including statements regarding The timing of any NDA submission; whether issues identified by FDA in the complete response letter may impact the potential approvability of the Company's NDA for AXS-07 for the acute treatment of migraine in adults with or without aura, purant to special protocol assessment for the MOMENTUM clinical trial; the Company's ability to successfully defend its intellectual property or obtain the necessary licenses at a cost acceptable to the Company, if at all; the successful implementation of the Company's research and development programs and collaborations; the success of the Company's license agreements; the acceptance by the market of the Company's products and product candidates, if approved; the Company's anticipated capital requirements, including the amount of capital required for the continued commercialization of Sunosi and Auvelity and for the Company's commercial launch of its other product candidates, if approved, and the potential impact on the Company's anticipated cash run.