Axsome Therapeutics Hosts Frontiers in Brain Health R&D Day Reviewing Industry-Leading Late-Stage CNS Pipeline

Comprehensive review of broad pipeline targeting Alzheimer's disease agitation, depression, narcolepsy, fibromyalgia, ADHD, and smoking cessation, with new data analyses

Presentations by expert clinicians and key opinion leaders

Company to webcast its R&D Day event today at 11:00 AM Eastern

NEW YORK, July 21, 2025 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ:AXSM), a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) disorders, will host its Frontiers in Brain Health R&D Day today in New York City to review its industry-leading CNS pipeline.

The Frontiers in Brain Health R&D Day will feature presentations from the following six leading expert clinicians and key opinion leaders, who will discuss the psychiatric and neurological conditions targeted by the company's pipeline, and present clinical data from the pipeline programs:

• Andrea Chadwick, MD, MSc, FASA, Kasumi Arakawa Professor of Anesthesiology, Pain, and Perioperative Medicine and Director of the Fibromyalgia and Centralized Pain Exploration (FACE) Lab; University of Kansas Medical Center. Dr. Chadwick will provide an overview of fibromyalgia and of the previously completed Phase 2 and Phase 3 clinical trials of AXS-14 in the indication.
• Jeffrey Cummings, MD, ScD, Joy Chambers-Grundy Professor of Brain Science, Chair of the Chambers-Grundy Center for Transformative Neuroscience, and Clinical Professor Neurology, UNLV Department of Brain Health. Dr. Cummings will provide an overview of Alzheimer's disease (AD) agitation and discuss the results of the ADVANCE and ACCORD Phase 3 trials of AXS-05 in the indication.
• Andrew Cutler, MD, Clinical Associate Professor of Psychiatry, SUNY Upstate Medical University. Dr Cutler will provide an overview of attention deficit hyperactivity disorder (ADHD), major depressive disorder (MDD) with excessive daytime sleepiness (EDS), and excessive sleepiness associated with shift work disorder (SWD), and discuss the results of the FOCUS and PARADIGM Phase 3 trials of solriamfetol in ADHD and MDD, respectively.
• Susan McElroy, MD, Professor of Psychiatry & Behavioral Neuroscience and Chief Research Officer and Director of Psychopharmacology Research at the Lindner Center of HOPE, University of Cincinnati. Dr. McElroy will provide an overview of binge eating disorder (BED).
• Stewart J. Tepper, MD, Vice President at The New England Institute for Neurology and Headache and Professor Neurology, Geisel School of Medicine at Dartmouth. Dr. Tepper will provide an overview of migraine and will discuss results from the MOMENTUM and INTERCEPT Phase 3 trials of SYMBRAVO^® in the acute treatment of migraine with and without aura.
• Michael Thorpy, MD, Professor of Neurology and Director of the Sleep-Wake Disorders Center at the Montefiore Medical Center, Albert Einstein College of Medicine. Dr. Thorpy will provide an overview of narcolepsy and will discuss the results of the clinical trial program of AXS-12 in the indication.

The presenters and the management team will be available to answer questions at the end of the presentations. To access the event, please click here.

Webcast Information

This event is intended for institutional investors and sell-side analysts. To register for the live webcast, please click here. The live webcast and a replay of the event will also be publicly available on the "Webcasts & Presentations" page of the "Investors" section of the Company's website at www.axsome.com.

About Axsome Therapeutics

Axsome Therapeutics is a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) conditions. We deliver scientific breakthroughs by identifying critical gaps in care and develop differentiated products with a focus on novel mechanisms of action that enable meaningful advancements in patient outcomes. Our industry-leading neuroscience portfolio includes FDA-approved treatments for major depressive disorder, excessive daytime sleepiness associated with narcolepsy and obstructive sleep apnea, and migraine, and multiple late-stage development programs addressing a broad range of serious neurological and psychiatric conditions that impact over 150 million people in the United States. Together, we are on a mission to solve some of the brain's biggest problems so patients and their loved ones can flourish. For more information, please visit us at www.axsome.com and follow us on LinkedIn and X.

Forward Looking Statements

Certain matters discussed in this press release are "forward-looking statements". The Company 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 commercial success of the Company's SUNOSI^®, AUVELITY^®, and SYMBRAVO^® products and the success of the Company's efforts to obtain any additional indication(s) with respect to solriamfetol and/or AXS-05; the Company's ability to maintain and expand payer coverage; the success, timing and cost of the Company's ongoing clinical trials and anticipated clinical trials for the Company's current product candidates, including statements regarding the timing of initiation, pace of enrollment and completion of the trials (including the Company's ability to fully fund the Company's disclosed clinical trials, which assumes no material changes to the Company's currently projected revenues or expenses), futility analyses and receipt of interim results, which are not necessarily indicative of the final results of the Company's 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 the Company's current product candidates; the Company's ability to fund additional clinical trials to continue the advancement of the Company's product candidates; the timing of and the Company's ability to obtain and maintain U.S. Food and Drug Administration ("FDA") or other regulatory authority approval of, or other action with respect to, the Company's product candidates, including statements regarding the timing of any NDA submission; 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 Company's ability to successfully resolve any intellectual property litigation, and even if such disputes are settled, whether the applicable federal agencies will approve of such settlements; 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 commercialization of SUNOSI, AUVELITY, and SYMBRAVO 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; the Company's ability to convert sales to recognized revenue and maintain a favorable gross to net sales; unforeseen circumstances or other disruptions to normal business operations arising from or related to domestic political climate, 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 circumstances.

Investors:

Mark Jacobson

Chief Operating Officer

(212) 332-3243

[email protected]

Media:

Darren Opland

Director, Corporate Communications

(929) 837-1065

[email protected]