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, announced today it is supporting Alzheimer’s & Brain Awareness Month this June, to help increase awareness and understanding of the challenges Alzheimer’s disease (AD) presents to patients, their caregivers, and their loved ones, and the importance of brain and mental health as cornerstones of overall health.

Alzheimer’s disease 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 nearly 7 million individuals in the United States, a number that is anticipated to increase to approximately 14 million by 2060.1 Additionally, the long duration of the condition exacerbates the impact and burden on individuals and public health.

Axsome is committed to making a meaningful difference in the lives of those affected by Alzheimer’s disease and other central nervous system disorders. In observance of Alzheimer’s & Brain Awareness Month, One World Trade Center, Axsome’s corporate headquarters in New York City, will be illuminated in purple, the color for Alzheimer’s disease awareness, on June 21, 2024, through the building’s Spireworks program.

To learn more about Alzheimer’s disease advocacy and caregiver support organizations and the resources they provide, please visit the following websites:

• 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.
• Alzheimer’s Foundation of America (https://alzfdn.org/). The Alzheimer’s Foundation of America (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.
• Caregiver Action Network (https://www.caregiveraction.org/). Caregiver Action Network (CAN) is the nation’s leading family caregiver organization working to improve the quality of life for the more than 90 million Americans who care for loved ones with chronic conditions, disabilities, or disease, as well as those supporting the living needs of older adults.
• 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 its community partners to develop the information, tools and training to support individuals and families affected by dementia.
• Family Caregiver Alliance (https://www.caregiver.org/). For more than 40 years, Family Caregiver Alliance (FCA) has provided services to family caregivers of adults with physical and cognitive impairments, such as Parkinson’s, stroke, Alzheimer’s and other types of dementia.
• National Alliance for Caregiving (https://www.caregiving.org/). The National Alliance for Caregiving is a non-profit coalition of national organizations who share a vision of a society that values, supports and empowers family caregivers to thrive at home, work and life. Its mission is to build partnerships in research, advocacy, and innovation to make life better for family caregivers.

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. Alzheimer’s Association. 2024 Alzheimer’s Disease Facts and Figures. Alzheimers Dement 2024;20(5).
2. Tractenberg RE, et al. J Neuropsychiatry Clin Neurosci. 2002;14:11-18.
3. Porsteinsson AP,et al. Expert Opin Pharmacother. 2017;18:611-620.
4. Rabins PV, et al. Alzheimers Dement. 2013;9:204-207.