GlobeNewswire Inc | May 7, 2021 07:00AM EDT

May 07, 2021

NEW YORK, May 07, 2021 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM) is joining Mental Health America (MHA) and other advocacy organizations in observing May is Mental Health Month, by raising awareness of and supporting people living with depression, anxiety, and other mental health conditions. MHA is the nations leading community-based nonprofit organization dedicated to addressing the needs of those living with mental illness and promoting overall mental health.

Recent data from the Centers for Disease Control (CDC) and from MHA indicate a striking increase in the prevalence of mental health conditions in the U.S., including a more than 4-fold increase in symptoms of depression compared to prior to the COVID-19 pandemic:

-- The prevalence of depression symptoms increased from 6.5% in 2019 to a high of 30.2% of U.S. adults in December 2020 [1,2]; -- The prevalence of anxiety symptoms increased from 8.1% in 2019 to a high of 36.9% of U.S. adults in December 2020 [1,2]; -- Of the nearly 3 million people who took an MHA mental health screening during the past 12 months, approximately 1 million were experiencing depression, and hundreds of thousands more were experiencing either anxiety or psychosis [3]; and -- Prior to the COVID-19 pandemic,an estimated 1 in 5adults in the U.S. reported living with a mental health condition, including depression, anxiety, bipolar disorder, schizophrenia, and post-traumatic stress disorder [4]. Research shows that estimate has grown to at least 2 in 5 adults [5].

These findings highlight the need, more than ever, to promote mental health awareness, increase access to care, and provide support for those living with mental health conditions.

Individuals living with mental health conditions are not alone. The following organizations are committed to providing support and resources to people living with mental health conditions, and to those looking to prioritize their mental health:

-- 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. -- 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. -- Anxiety and Depression Association of America (ADAA) ( https://adaa.org). ADAAs mission focuses on improving quality of life for those with anxiety, depression, OCD, PTSD, and co-occurring disorders through education, practice, and research.

As part of Axsomes commitment to depression education, resources and tools are available at www.talkdepressettling.com to help support those affected by depression.

About Axsome Therapeutics, Inc.

Axsome Therapeutics, Inc. is a biopharmaceutical company developing novel therapies for the management of central nervous system (CNS) disorders for which there are limited treatment options. For the many people facing unsatisfactory treatments for CNS disorders, Axsome accelerates the invention and adoption of life-changing medicines. For more information, please visit the Companys website at www.axsome.com. The Company may occasionally disseminate material, nonpublic information on the company website.

References

-- Terlizzi EP, Schiller JS. Estimates of mental health symptomatology, by month of interview: United States, 2019. National Center for Health Statistics. (2021). Retrieved from https://www.cdc.gov/nchs/data/nhis/mental-health-monthly-508.pdf. -- US Census Bureau Household Pulse Survey 2020-2021. Retrieved from https://www.cdc.gov/nchs/covid19/pulse/mental-health.htm. -- Mental Health America. (2021). Mental Health Month 2021 Toolkit. Retrieved from https://mhanational.org/sites/default/files/MHM 2021 - Foreword and Intro.pdf. -- Substance Abuse and Mental Health Services Administration. (2020). Results from the 2019 National Survey on Drug Use and Health. Retrieved from https://www.samhsa.gov/data/. -- Czeisler M, et al. Mental Health, Substance Use, and Suicidal Ideation During the COVID-19 Pandemic United States, June 2430, 2020. Retrieved from https://www.cdc.gov/mmwr/volumes/69/wr/mm6932a1.htm?s_cid=mm6932a1_w.

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 Companys 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 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 expenses), futility analyses and receipt of interim results, which are not necessarily indicative of the final results of our ongoing clinical trials, 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, but not limited to, whether potential filing issues or issues identified by FDA during the substantive review may impact the potential approvability of the Companys NDA submission for AXS-05 in MDD or the timing of such approval, and whether the FDA will agree with the Companys discontinuation of the bupropion treatment arm of the ADVANCE study in accordance with the independent data monitoring committees recommendations); the successful submission of and approval by the FDA of an 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 potential for the ASCEND clinical trial, combined with the GEMINI clinical trial results, to provide a basis for approval of AXS-05 for the treatment of major depressive disorder and accelerate its development timeline and commercial path to patients; the Companys 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 Companys research and development programs and collaborations; the success of the Companys license agreements; the acceptance by the market of the Companys product candidates, if approved; the Companys anticipated capital requirements, including the amount of capital required for the Companys commercial launch of its product candidates, and the potential impact on the Companys anticipated cash runway; as well as unforeseen circumstances or other disruptions to normal business operations arising from or related to COVID-19; and other factors, including general economic conditions and regulatory developments, not within the Companys 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 Contact:Mark JacobsonChief Operating OfficerAxsome Therapeutics, Inc.22 Cortlandt Street, 16th FloorNew York, NY 10007Tel: 212-332-3243Email: mjacobson@axsome.comwww.axsome.com