Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company developing and delivering novel therapies for the management of central nervous system (CNS) disorders, today announced it is joining advocacy organizations around the world to help raise awareness of Alzheimer’s disease (AD) and to stand in solidarity with all those affected by this condition and their families during Alzheimer’s Disease Awareness Month. November marks Alzheimer’s Disease Awareness Month, an important time to know the facts about this illness that affects millions.

On November 2, Axsome’s headquarters at One World Trade Center, New York City, will be lit in teal as part of the Alzheimer’s Foundation of America’s (AFA) “Light the World in Teal” campaign. More than 1,000 structures around the world to “Go Teal” as part of this campaign. The color teal is used by the AFA as a symbol of awareness and support for this devastating illness. Throughout the month, AFA also encourages people to “Go Teal” by dressing in the color to show support for AD awareness. You can learn more about the AFA’s awareness campaign and find resources and networks for AD support at their website here.

AD is a progressive neurodegenerative disorder characterized by cognitive decline, and behavioral and psychological symptoms including agitation. AD is the most common form of dementia and afflicts an estimated 6 million individuals in the United States, a number that is anticipated to increase to approximately 14 million by 2050.1 It is a leading cause of death in older adults, and exacts an emotional, physical, and financial toll on the entire family of those who are diagnosed. These facts highlight the significant need for additional research into innovative treatment approaches to help people with AD and their loved ones live better lives.

For more information about AD as well as to learn more about organizations and their affiliates that provide resources and support networks for Alzheimer’s communities, please read more here:

  • Alzheimer’s Foundation of America (AFA) (https://alzfdn.org/). AFA provides support, services and education to individuals, families and caregivers affected by Alzheimer’s disease and related dementias nationwide, and funds research for better treatment and a cure.
  • Alzheimer’s Association (https://www.alz.org/). The Alzheimer's Association leads the way to end Alzheimer's and all other dementia by accelerating global research, driving risk reduction and early detection, and maximizing quality care and support.
  • UsAgainstAlzheimer's (https://www.usagainstalzheimers.org/). UsAgainstAlzheimer’s was founded in 2010 to disrupt and diversify the movement to cure Alzheimer’s. Through urgent and inclusive mobilization, UsAgainstAlzheimer’s works to dramatically increase funding for Alzheimer’s and dementia research.
  • CaringKind (https://www.caringkindnyc.org/). CaringKind is New York City’s leading expert on Alzheimer’s and dementia caregiving. With over 40 years of experience, CaringKind works directly with community partners to develop the information, tools and training to support individuals and families affected by dementia.
  • Alzheimer’s Orange County (https://www.alzoc.org/). Since 1982, Alzheimer’s Orange County has been Orange County’s center for Alzheimer’s resources. They are dedicated to providing quality care and support services to the thousands of residents of Orange County who are affected by Alzheimer’s disease or other related dementia, and also partnering with local researchers to populate clinical trials to help find a cure.

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 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 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. Alzheimer’s Association. 2020 Alzheimer’s Disease Facts and Figures. Alzheimers Dement 2020;16(3):391+.
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