Axsome Therapeutics Joins the Global Narcolepsy Community in Raising Awareness on World Narcolepsy Day

NEW YORK, Sept. 21, 2023 (GLOBE NEWSWIRE) -- 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 the global narcolepsy advocacy community, including more than 20 global patient advocacy organizations across six continents, to raise awareness of the impact that narcolepsy has on World Narcolepsy Day, Sept. 22, 2023.

In support of World Narcolepsy Day, Axsome is sponsoring several awareness events:

• On Sept. 21 at 6 p.m. Eastern Time, Axsome is sponsoring a virtual panel where an international group of experts will discuss narcolepsy around the world, organized by Wake Up Narcolepsy. Registration and details for the panel event can be found here.
• On Sept. 29-Oct. 1, Axsome is a sponsor of and is attending "Thrive Together," Narcolepsy Network's 37th Annual Conference, a multi-day event to learn, engage, and connect with people with narcolepsy and their supporters, being held in Denver, Colo. More details about the conference can be found here.

Axsome is committed to developing innovative therapies that make an impact on the lives of people suffering from CNS disorders, including those with narcolepsy and other sleep disorders. As part of that mission, Axsome's works closely with advocacy and other patient groups to support their efforts to provide a network and resources for patients and their families and to raise awareness of these conditions globally.

Narcolepsy is a serious and debilitating neurological condition that affects one out of 2000 people including an estimated 185,000 people in the U.S. alone. It has been shown to occur in people of any race and most commonly shows up in people aged 15-30. Narcolepsy has been shown to interfere with thinking and emotional and social functioning and is associated with increased risk of work- or driving-related accidents including a 1.5x higher mortality rate. These statistics highlight the significant public health burden that narcolepsy represents, as well as a need for improvements in access to treatments.

For more information about narcolepsy, World Narcolepsy Day, as well as additional resources for patients, please learn more about the following organizations and their affiliates:

• Wake Up Narcolepsy (https://www.wakeupnarcolepsy.org/): a nonprofit organization dedicated to driving narcolepsy awareness, education and research towards improved treatments and a cure.
• Narcolepsy Network (https://narcolepsynetwork.org/): is a national patient support organization dedicated to education, support and assistance, advocacy, and resources for people with narcolepsy.
• Sleep Research Society (https://sleepresearchsociety.org/): an organization for scientific investigators who educate and research sleep and circadian science.
• Sleep Consortium (https://sleepconsortium.org/): a non-profit organization created to accelerate next generation research, disease understanding, and therapy development for those living with Central Disorders of Hypersomnolence (CDoH) and related diseases.
• National Sleep Foundation (https://www.thensf.org/): an independent nonprofit, dedicated to improving overall health and well-being by advancing sleep health.
  

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 Jacobson
Chief Operating Officer
Axsome Therapeutics, Inc.
One World Trade Center, 22^nd Floor
New York, NY 10007
Tel: 212-332-3243
Email: [email protected]
www.axsome.com

Media:

Darren Opland
Director, Corporate Communications
Axsome Therapeutics, Inc.
One World Trade Center, 22^nd Floor
New York, NY 10007
Tel: 929-837-1065
Email: [email protected]
www.axsome.com