AXSM Axsome Therapeutics Inc

Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company developing and delivering novel therapies for the management of central nervous system (CNS) disorders, today is joining the global community of mental health advocates, including Mental Health America, during May’s Mental Health Month to raise awareness of the importance of mental health as a key element of overall health.

Axsome is committed to the millions of individuals living with mental health conditions, their loved ones, and the healthcare providers involved in their wellness journeys. In support of Mental Health Month and this year’s theme of “Where to Start,” Axsome is sharing educational resources for those impacted by mental health conditions.

“As we enter Mental Health Month this May, we welcome Axsome in joining Mental Health America in promoting awareness, providing vital resources and education, and advocating for the mental health and well-being of all,” said Schroeder Stribling, President and CEO, Mental Health America. “This year’s theme for Mental Health Month is ‘Where to Start: Mental Health in a Changing World.’ In a world that is constantly evolving, it can be overwhelming to navigate the various challenges and changes happening around us. The pressures of work, relationships, and societal factors can significantly impact our mental well-being, sometimes even more than we realize. Mental Health America’s resources focus on these all-encompassing factors and offer guidance for Where to Start on individuals’ own mental health journeys.”

Additionally, the One World Trade Center building, Axsome’s headquarters in New York City, will be illuminated in green, the color for mental health awareness, on May 1 as part of Mental Health America’s “Light Up Green” initiative, and through the building’s Spireworks program.

Mental health conditions are extremely prevalent in the U.S., affecting more than an estimated 46% of the population, half of whom develop conditions by early adolescence.1 In addition, 8.3% of adults (21 million) in the past year had a major depressive episode, characterized by at least one period of two weeks or longer when for most of the day nearly every day, they felt depressed or lost interest or pleasure in daily activities.2 For individuals impacted by mental health but unsure “where to start” to take care of their own well-being, Mental Health America is providing resources to help individuals Learn, Act, and Advocate for their wellness journey which can be found here.

To learn more about mental health advocacy organizations and the resources they provide, please visit the following websites:

• Anxiety and Depression Association of America (ADAA) (https://adaa.org). ADAA’s mission focuses on improving quality of life for those with anxiety, depression, OCD, PTSD, and co-occurring disorders through education, practice, and research.
• The Depression and Bipolar Support Alliance (DBSA) (https://www.dbsalliance.org). DBSA is a leading national peer-focused mental health organization, whose mission is to provide hope, help, support, and education for individuals who live with mood disorders.
• Mental Health America (MHA) (https://www.mhanational.org). MHA's work is driven by its commitment to promote mental health as a critical part of overall wellness, including prevention services for all; early identification and intervention for those at risk; and integrated care, services, and support for those who need them, with recovery as the goal. Resources provided by the MHA include a free online mental health screen, which can be found at MHAscreening.org, to help identify signs of mental health problems.
• National Alliance on Mental Illness (NAMI) (https://www.nami.org/). NAMI is the nation’s largest grassroots mental health organization dedicated to building better lives for the millions of Americans affected by mental illness.
• The Mental Health Coalition (MHC) (https://www.thementalhealthcoalition.org/). The Mental Health Coalition (MHC) is a collective of organizations working to destigmatize mental health and empower access to vital resources and necessary support for all. MHC members collaborate and align synergies to create even greater outcomes than they could individually. MHC has independent efforts in addition to the Coalition’s collaborative programs, including Safe Online Standards (SOS) and more.

If you or someone you know is in crisis, the 988 Suicide & Crisis Lifeline (https://988lifeline.org/) is a free confidential support service available 24 hours a day, 7 days a week across the United States. When people call, text, or chat 988, they will be connected to trained counselors that are part of the existing Lifeline network. These trained counselors will listen, understand how their problems are affecting them, provide support, and connect them to resources if necessary.

About Axsome Therapeutics, Inc.

Axsome Therapeutics, Inc. is a biopharmaceutical company developing and delivering novel therapies for central nervous system (CNS) conditions that have limited treatment options. Through development of therapeutic options with novel mechanisms of action, we are transforming the approach to treating CNS conditions. At Axsome, we are committed to developing products that meaningfully improve the lives of patients and provide new therapeutic options for physicians. For more information, please visit the Company’s website at axsome.com. The Company may occasionally disseminate material, nonpublic information on the company website.

Forward Looking Statements

Certain matters discussed in this press release are “forward-looking statements”. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. In particular, the Company’s statements regarding trends and potential future results are examples of such forward-looking statements. The forward-looking statements include risks and uncertainties, including, but not limited to, the continued commercial success of our Sunosi® and Auvelity® products and the success of our efforts to obtain any additional indication(s) with respect to solriamfetol and/or AXS-05; the success, timing and cost of our ongoing clinical trials and anticipated clinical trials for our current product candidates, including statements regarding the timing of initiation, pace of enrollment and completion of the trials (including our ability to fully fund our disclosed clinical trials, which assumes no material changes to our currently projected revenues or expenses), futility analyses and receipt of interim results, which are not necessarily indicative of the final results of our 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 our current product candidates; our ability to fund additional clinical trials to continue the advancement of our product candidates; the timing of and our ability to obtain and maintain U.S. Food and Drug Administration (“FDA”) or other regulatory authority approval of, or other action with respect to, our 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, pursuant to our 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 runway; unforeseen circumstances or other disruptions to normal business operations arising from or related to geo-political conflicts or a global pandemic and other factors, including general economic conditions and regulatory developments, not within the Company’s control. The factors discussed herein could cause actual results and developments to be materially different from those expressed in or implied by such statements. The forward-looking statements are made only as of the date of this press release and the Company undertakes no obligation to publicly update such forward-looking statements to reflect subsequent events or circumstance.

Axsome Contacts:

Investors:Mark JacobsonChief Operating OfficerAxsome Therapeutics, Inc.One World Trade Center, 22nd FloorNew York, NY 10007Tel: 212-332-3243Email: mjacobson@axsome.com www.axsome.com

Media:Darren OplandDirector, Corporate CommunicationsAxsome Therapeutics, Inc.One World Trade Center, 22nd FloorNew York, NY 10007Tel: 929-837-1065Email: dopland@axsome.com www.axsome.com

References:

1. Kessler RC et al. (2005) Lifetime prevalence and age-of-onset distributions of DSM-IV disorders in the National Comorbidity Survey Replication. Arch Gen Psychiatry. 62(6):593-602.
2. Substance Abuse and Mental Health Services Administration. (2022). Key substance use and mental health indicators in the United States: Results from the 2021 National Survey on Drug Use and Health (HHS Publication No. PEP22-07-01-005, NSDUH Series H-57). Rockville, MD: Center for Behavioral Health Statistics and Quality, Substance Abuse and Mental Health Services Administration. Retrieved from https://www.samhsa.gov/data/report/2021-nsduh-annual-national-report.