AXS-05 in Alzheimer's disease agitation data featured in oral plenary session

New data for AXS-07 in migraine demonstrating efficacy in pooled analysis

Presentations on cognitive and wake promoting effects of solriamfetol

NEW YORK, April 15, 2024 (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 presentations highlighting its innovative psychiatry and neurology pipeline at the American Academy of Neurology (AAN) 2024 annual meeting, being held April 13-18, 2024, in Denver, Colorado. The presentations include an oral presentation during the Clinical Trials Plenary Session of data from the ACCORD Phase 3 trial of AXS-05 in Alzheimer's disease agitation (ADA). Presentations related to the AXS-07 clinical program in migraine include new pooled efficacy data from the MOMENTUM and INTERCEPT Phase 3 trials. Additionally, there will be data presentations on cognition and sleep from the solriamfetol clinical program.

Details for the presentations are as follows:

Alzheimer's Disease Agitation

Title: Efficacy and Safety Of AXS-05 in Agitation Associated with Alzheimer's Disease: Results From ACCORD, a Phase 3, Double-Blind, Placebo-Controlled, Relapse Prevention Trial
Presentation Date and Time: Tuesday, April 16 from 9:15 a.m. to 11:30 a.m. Mountain Time
Lead Author: Anton P. Porsteinsson, MD, William B. and Sheila Konar Professor of Psychiatry at the University of Rochester, School of Medicine and Dentistry
Session Name: PL5: Clinical Trials Plenary Session
Program Number: PL5.005

Migraine

Title: Combined Efficacy and Safety of AXS-07 (MOSEIC^TM Meloxicam and Rizatriptan) in Two Phase 3 Clinical Trials
Presentation Date and Time: Tuesday, April 16 from 11:45 a.m. to 12:45 p.m. Mountain Time
Lead Author: Stewert Tepper, MD, Professor of Neurology at the Geisel School of Medicine at Dartmouth
Session Name: P7: Headache: Therapeutics 2
Program Number: P7.002

Title: EMERGE Study: An Open-label Evaluation of the Efficacy and Safety of AXS-07 (MoSEIC meloxicam-rizatriptan) for Migraine in Adults with Prior Inadequate Response to an Oral CGRP Inhibitor
Presentation Date and Time: Tuesday, April 16 from 8 a.m. to 9 a.m. Mountain Time
Lead Author: Peter McAllister, MD, Director of the New England Center for Neurology and Headache
Session Name: P6: Headache: Therapeutics 1
Program Number: P6.006

Cognition

Title: Solriamfetol Improves Cognitive Performance in Preclinical Models of Sleep Apnea and in a Randomized Placebo-controlled Study of Sleep Apnea Participants (SHARP)
Presentation Date and Time: Wednesday, April 17 from 8 a.m. to 9 a.m. Mountain Time
Lead Author: David Gozal, MD, MBA, Marie M. and Harry L. Smith Endowed Chair and the Chairman of the Department of Child Health at the University of Missouri
Session Name: P9: Sleep 2
Program Number: P9.004

Sleep

Title: Solriamfetol for Excessive Sleepiness in Narcolepsy and Obstructive Sleep Apnea: Effect Sizes and Numbers Needed to Treat or Harm
Presentation Date and Time: Wednesday, April 17 from 11:45 a.m. to 12:45 p.m. Mountain Time
Lead Author: Craig Chepke, MD, DFAPA, SUNY Upstate Medical University
Session Name: P10: Sleep 3
Program Number: P10.009

Title: SURWEY Study of Solriamfetol: Initiation, Titration, Safety, Efficacy, and Follow-up Experience for Patients with OSA in Germany
Presentation Date and Time: Wednesday, April 17 from 8 a.m. to 9 a.m. Mountain Time
Lead Author: Yaroslav Winter, MD, University of Medicine Mainz
Session Name: P9: Sleep 2
Program Number: P9.010

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

Source: Axsome Therapeutics, Inc.