Axsome Therapeutics Inc AXSM

NEW YORK, May 16, 2022 /PRNewswire/ – Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company developing and delivering novel therapies for the management of central nervous system (CNS) disorders, is supporting the National Alliance on Mental Illness (NAMI) during Mental Health Awareness Month this May to raise awareness of and support for people living with depression and other mental health conditions. NAMI is the nation's largest grassroots mental health organization.

Recent figures indicate a high and growing prevalence of mental illness, with a significant percentage of those afflicted not receiving treatment:

• 1 in 5 U.S. adults and 1 in 6 youth aged 6-17 experience mental illness each year.¹
• Suicide is the second leading cause of death among people aged 10-34.²
• Between 2020 and 2021, calls to the NAMI HelpLine (1-800-950-NAMI, or 6264) about depression and anxiety increased by 80%, calls about suicide increased by 185%, and calls about mental health crises increased by 251%.³
• Among adults with mental illness, only 46% received treatment in 2020, a number that is even lower among Black (37%), Hispanic/Latinx (35%), and Asian Americans (21%).¹

NAMI's mental health education, advocacy, and support options for individuals and their families can be accessed at www.nami.org.

Tips and resources from the National Institute of Mental Health to help take care of your mental health are available at  https://www.nimh.nih.gov/health/topics/caring-for-your-mental-health.

Resources and tools to help support those affected by depression are available at www.talkdepressettling.com.

"Axsome stands in solidarity with the millions of people affected by mental illness and is proud to participate in NAMI's 2022 'Together for Mental Health' campaign in observance of Mental Health Awareness Month," said Herriot Tabuteau, MD, Chief Executive Officer of Axsome. "We look forward to continuing our work to bring national awareness and dialogue to mental health and address the pressing need for new and effective treatments to help those living with depression and other mental health conditions."

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 newly acquired Sunosi product; 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 Company's NDA submission for AXS-05 in MDD or the timing of such approval; 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 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 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 product candidates, if approved; the Company's anticipated capital requirements, including the amount of capital required for the continued commercialization of Sunosi and for the Company's commercial launch of its product candidates, 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 COVID-19; 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 Contact:
Mark Jacobson
Chief Operating Officer
Axsome Therapeutics, Inc.
22 Cortlandt Street, 16th Floor
New York, NY 10007
Tel: 212-332-3243
Email: mjacobson@axsome.com
www.axsome.com

References

1. Substance Abuse and Mental Health Services Administration. (2021). Results from the 2020 National Survey on Drug Use and Health. Retrieved from https://www.samhsa.gov/data/
2. Centers for Disease Control and Prevention (CDC). (2019). WISQARS Leading Causes of Death Reports. Retrieved from: https://www.cdc.gov/injury/wisqars/index.html
3. National Alliance on Mental Illness. (2 May 2022). Press Release.  

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SOURCE Axsome Therapeutics Inc