SUNY Upstate Medical University

NEW YORK, Oct. 29, 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 seven presentations from across its broad portfolio of innovative neuroscience products and product candidates at Psych Congress 2024, being held Oct. 29 - Nov. 2, 2024, in Boston, Massachusetts. Details for the presentations are as follows: Major Depressive Disorder Title: AXS-05 (Auvelity®) in Major Depressive Disorder: Pooled Data from Two Six-Week Controlled Trials (GEMINI and ASCEND)Presentation Date and Time: Thursday, Oct. 31, 1:30 - 3 p.m. and Friday, Nov. 1, 1:30 - 3 p.m. ETLead Author: Craig Chepke, MD, SUNY Upstate Medical UniversityPoster Number: 171 Title: Effects of AXS-05 (Auvelity®) in Improving Anhedonia and Interest-Activity Symptoms of MDD and the Associated Improvements in Functional Impairment Presentation Date and Time: Thursday, Oct. 31, 1:30 - 3 p.m. and Friday, Nov. 1, 1:30 - 3 p.m. ETLead Author: Roger McIntyre, MD, Professor of Psychiatry and Pharmacology at the University of TorontoPoster Number: 172 Title: Real-World Treatment Experiences and Expectations by Symptom Severity in Patients with Major Depressive DisorderPresentation Date and Time: Thursday, Oct. 31, 1:30 - 3 p.m. and Friday, Nov. 1, 1:30 - 3 p.m. ETLead Author: Roger McIntyre, MD, Professor of Psychiatry and Pharmacology at the University of TorontoPoster Number: 198 Alzheimer’s Disease Agitation Title: Clinical Profile of AXS-05 in Treating Alzheimer’s Disease-Related Agitation: Results from The Phase 2/3 Development ProgramPresentation Date and Time: Thursday, Oct. 31, 1:30 - 3 p.m. and Friday, Nov. 1, 1:30 - 3 p.m. ETLead Author: Jeffrey Cummings, MD, ScD, Vice Chair of Research, UNLV Department of Brain HealthPoster Number: 45 OSA and Narcolepsy Title: Solriamfetol for Excessive Daytime Sleepiness in Patients with Narcolepsy and OSA Reporting Anxiety and Depression in the Real-World SURWEY StudyPresentation Date and Time: Thursday, Oct. 31, 1:30 - 3 p.m. and Friday, Nov. 1, 1:30 - 3 p.m. ETLead Author: Ulf Kallweit, MD, Assistant Professor of Neurology at the University Witten/Herdecke, GermanyPoster Number: 20 Cognition Title: Effects of Solriamfetol on Cognition in Obstructive Sleep Apnea with Excessive Daytime Sleepiness and Impaired Cognition in the SHARP Clinical TrialPresentation Date and Time: Thursday, Oct. 31, 1:30 - 3 p.m. and Friday, Nov. 1, 1:30 - 3 p.m. ETLead Author: Yaroslav Winter, MD, Mainz Comprehensive Epilepsy and Sleep Medicine Center, department of neurology, Johannes Gutenberg-University, Mainz, GermanyPoster Number: 92 Title: Effects of Solriamfetol on Cognition in Patients with Excessive Daytime Sleepiness Associated with Narcolepsy in the Real-World SURWEY StudyPresentation Date and Time: Thursday, Oct. 31, 1:30 - 3 p.m. and Friday, Nov. 1, 1:30 - 3 p.m. ETLead Author: Yaroslav Winter, MD, Mainz Comprehensive Epilepsy and Sleep Medicine Center, department of neurology, Johannes Gutenberg-University, Mainz, GermanyPoster Number: 164 About Axsome Therapeutics 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 www.axsome.com. 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 continued commercial success of the Company’s Sunosi® and Auvelity® 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; 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 the Company’s 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; 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 circumstance. Investors:Mark JacobsonChief Operating Officer(212) 332-3243mjacobson@axsome.com Media:Darren OplandDirector, Corporate Communications(929) 837-1065dopland@axsome.com

A total of 12 presentations including 6 original posters to showcase MTPA's latest ALS research JERSEY CITY, N.J., Oct. 17, 2024 /PRNewswire/ -- Mitsubishi Tanabe Pharma America, Inc. (MTPA) today announced that twelve presentations following expansive research in amyotrophic lateral sclerosis (ALS) will be shared as part of the Northeast Amyotrophic Lateral Sclerosis Consortium (NEALS) 2024 Annual Meeting, being held virtually October 21-24. "We are excited to present our latest data in ALS research, from preclinical studies to extensive real-world data on RADICAVA® (edaravone) at this year's meeting," said Gustavo A. Suarez Zambrano, M.D., Vice President of Medical Affairs, MTPA. "Our unwavering commitment to ALS research drives us to provide valuable insights to patients, healthcare practitioners and researchers alike, with the ultimate goal of providing treatment options to help improve the lives of those affected by this disease." RADICAVA ORS Results: A presentation will examine the impact of RADICAVA ORS on survival and function in ALS patients, using data from the Pooled Resource Open-Access ALS Clinical Trials (PRO-ACT) database. For this analysis, patients were propensity score-matched with participants from studies MT-1186 A01-A04. Additionally, multiple presentations will explore RADICAVA ORS through multi-center, phase 3b, double-blind, parallel group studies, including a comparison of daily dosing to the U.S. Food and Drug Administration (FDA)-approved on/off regimen, evaluated over 48 weeks (MT-1186-A02) and up to 96 weeks (MT-1186-A04). Safety data from the phase 3 open-label safety extension study (MT-1196-A03) and a post-marketing safety analysis will also be presented. Analysis of Long-term Function and Survival of Radicava ORS® (Oral Edaravone)-Treated Patients With Amyotrophic Lateral Sclerosis vs Propensity Score–Matched PRO-ACT Historical Controls (Stephen Apple, M.D.; MTPA) Poster Session: 4:00 p.m. - 6:00 p.m. ET, Wednesday, October 23 Phase 3b Study MT-1186-A02 to Investigate the Superiority of Daily Dosing vs the FDA-approved On/Off Regimen of Oral Edaravone in Patients with ALS (Alejandro Salah, M.D., Ph.D., MBA, MHA; MTPA) Poster Session: 4:00 p.m. - 6:00 p.m. ET, Wednesday, October 23 Phase 3b Study MT-1186-A04 Extension Study to Evaluate the Continued Efficacy and Safety of Radicava ORS® (Oral Edaravone) for up to an Additional 48-Weeks in Patients With Amyotrophic Lateral Sclerosis (Stephen Apple, M.D.; MTPA) Poster Session: 4:00 p.m. - 6:00 p.m. ET, Wednesday, October 23 Phase 3, Open-Label, Safety Extension Study of Oral Edaravone Administered Over 96 Weeks in Patients with ALS (MT-1186-A03) (Alejandro Salah, M.D., Ph.D., MBA, MHA; MTPA) Poster Session: 4:00 p.m. - 6:00 p.m. ET, Wednesday, October 23 Summary of the US Safety Data for Radicava ORS®: Findings From the Postmarketing Pharmacovigilance (Stephen Apple, M.D.; MTPA) Poster Session: 4:00 p.m. - 6:00 p.m. ET, Wednesday, October 23 Real World Data: Data will be presented from an evaluation of treatment patterns, clinical outcomes and survival rates of RADICAVA-treated individuals living with ALS from the ALS/Motor Neuron Disease (MND) Natural History Consortium (NHC) registry. Additionally, a preliminary analysis will examine the treatment combinations in people with ALS enrolled in the OPTUM claims database. Other presentations include two studies focused on point-of-care quality classifications and at-home telespirometry, evaluating erect and supine slow vital capacity in individuals with ALS, as well as an observational study, Track-ALS, assessing participant compliance and the usability of digital health technologies (DHTs) to remotely monitor ALS progression. Treatment Patterns and Survival Benefit of Edaravone–Treated People With Amyotrophic Lateral Sclerosis in the ALS/MND Natural History Consortium (Stephen Apple, M.D.; MTPA) Poster Session: 4:00 p.m. - 6:00 p.m. ET, Wednesday, October 23 Preliminary Analysis of Treatment Combinations in Patients With Amyotrophic Lateral Sclerosis Enrolled in an US-Based Administrative Claims Database (Malgorzata Ciepielewska, M.S.; MTPA) Poster Session: 4:00 p.m. - 6:00 p.m. ET, Wednesday, October 23 Smartphone Application-Mediated Supervised At-Home Telespirometry Erect and Supine Slow Vital Capacity (eSVC/sSVC) Measurements in Subjects With Amyotrophic Lateral Sclerosis Identify Statistically Significant Differences in eSVC/sSVC Decline as Function of Non-Invasive Ventilation Treatment Status [NCT05106569] (Eufrosina I. Young, M.D.; SUNY Upstate Medical University) Poster Session: 4:30 p.m. - 6:30 p.m. ET, Tuesday, October 22 Smartphone Application–Mediated, Supervised, At-Home Telespirometry Vital Capacity Measurements in Amyotrophic Lateral Sclerosis: Comparison of American Thoracic Society/European Respiratory Society Point-of-Care Quality Assessment Algorithms Implemented for Slow Vital Capacity and Forced Vital Capacity [NCT05106569] (Eufrosina I. Young, M.D.; SUNY Upstate Medical University) Poster Session: 4:30 p.m. - 6:30 p.m. ET, Tuesday, October 22 Compliance of Home-based Remote Digital Monitoring to Assess ALS progression (Track-ALS) (Katie Terrebonne; Emory University) Poster Session: 4:30 p.m. - 6:30 p.m. ET, Tuesday, October 22 Preclinical Data: Two preclinical studies will be presented, showcasing the effects of edaravone. The first study examines its impact on spinal motor neurons derived from induced pluripotent stem cells (iPSC) taken from a person with ALS carrying the A382T mutation in TDP-43. The second study investigates the role of edaravone on the modulation of glutamate-mediated hyperexcitability in spinal motor neurons using an ALS animal model. Transcriptomic Signature Induced by Edaravone in Motor Neurons From an ALS Patient With a TDP-43 Mutation (Satsuki Mikuriya, M.S.; MTPA) Poster Session: 4:00 p.m. - 6:00 p.m. ET, Wednesday, October 23 Edaravone Reduces the Enhanced Glutamatergic Transmission Onto Motor Neurons in the Spinal Cord of a Mouse Model of Amyotrophic Lateral Sclerosis (Alejandro Salah, M.D., Ph.D., MBA, MHA; MTPA) Poster Session: 4:00 p.m. - 6:00 p.m. ET, Wednesday, October 23 About RADICAVA® (edaravone) and RADICAVA ORS® (edaravone) The U.S. Food and Drug Administration (FDA) approved RADICAVA® (edaravone) on May 5, 2017, and the oral formulation RADICAVA ORS ® (edaravone) on May 12, 2022, for the treatment of amyotrophic lateral sclerosis (ALS). In 2024, the FDA recognized RADICAVA ORS with Orphan Drug Exclusivity based on the major contribution to patient care of the innovative oral formulation. RADICAVA is administered in 28-day cycles by intravenous (IV) infusion. It takes 60 minutes to receive each 60 mg dose. For the initial cycle, the treatment is infused daily for 14 consecutive days, followed by a two-week drug-free period. All cycles thereafter are infused daily for 10 days within a 14-day period, followed by a two-week drug-free period. RADICAVA ORS is taken daily for 14 consecutive days followed by a 14-day drug-free period for the initial treatment cycle. For subsequent treatment cycles, RADICAVA ORS is taken for 10 days within a 14-day period followed by a 14-day drug-free period. RADICAVA ORS should be taken in the morning after overnight fasting. Patients should not eat or drink (except water) within one hour after taking RADICAVA ORS.1 Edaravone was discovered and developed for ALS by Mitsubishi Tanabe Pharma Corporation (MTPC) and commercialized in the U.S. by Mitsubishi Tanabe Pharma America, Inc. (MTPA). The MTPC group companies began researching ALS in 2001 through an iterative clinical platform over a 13-year period. In 2015, edaravone was approved as RADICUT® for the treatment of ALS in Japan and South Korea. Marketing authorizations were subsequently granted in Canada (October 2018), Switzerland (January 2019), Indonesia (July 2020), Thailand (April 2021), Malaysia (December 2021) and Brazil (February 2024). Marketing authorization for RADICAVA® Oral Suspension was granted in Canada (November 2022) and Switzerland (May 2023), and RADICUT® Oral Suspension 2.1% was granted regulatory approval in Japan in December 2022. To date, in the U.S., RADICAVA and RADICAVA ORS have been used to treat over 16,000 people with ALS, with over 2.0-million days of therapy, and have been prescribed by over 2,400 HCPs.2-4 IMPORTANT SAFETY INFORMATION Hypersensitivity Reactions RADICAVA (edaravone) and RADICAVA ORS (edaravone) are contraindicated in patients with a history of hypersensitivity to edaravone or any of the inactive ingredients of this product. Hypersensitivity reactions (redness, wheals, and erythema multiforme) and cases of anaphylaxis (urticaria, decreased blood pressure, and dyspnea) have occurred with RADICAVA. Patients should be monitored carefully for hypersensitivity reactions. If hypersensitivity reactions occur, discontinue RADICAVA or RADICAVA ORS, treat per standard of care, and monitor until the condition resolves. Sulfite Allergic Reactions RADICAVA and RADICAVA ORS contain sodium bisulfite, a sulfite that may cause allergic-type reactions, including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown but occurs more frequently in asthmatic people. Adverse Reactions The most common adverse reactions (≥10%) reported in RADICAVA-treated patients were contusion (15%), gait disturbance (13%), and headache (10%). In an open label study, fatigue was also observed in 7.6% of patients receiving RADICAVA ORS. Pregnancy Based on animal data, RADICAVA and RADICAVA ORS may cause fetal harm. To report suspected adverse reactions or product complaints, contact Mitsubishi Tanabe Pharma America, Inc., at 1-888-292-0058. You may also report suspected adverse reactions to the FDA at 1-800-FDA-1088 or . INDICATION RADICAVA and RADICAVA ORS are indicated for the treatment of amyotrophic lateral sclerosis (ALS). For more information, including full Prescribing Information, please visit . About Mitsubishi Tanabe Pharma America, Inc. Based in Jersey City, N.J., Mitsubishi Tanabe Pharma America, Inc. (MTPA) is a wholly-owned subsidiary of Mitsubishi Tanabe Pharma Corporation (MTPC). It was established by MTPC to develop and advance our pipeline as well as commercialize approved pharmaceutical products in North America. For more information, please visit or follow us on X (formerly Twitter), Facebook and LinkedIn. About Mitsubishi Tanabe Pharma Corporation Mitsubishi Tanabe Pharma Corporation (MTPC), the pharma arm of Mitsubishi Chemical Group (MCG), is one of the oldest pharmaceutical companies in the world, founded in 1678. MTPC is headquartered in Doshomachi, Osaka, the birthplace of Japan's pharmaceutical industry. MCG has positioned health care as its strategic focus in its management policy, "Forging the future". MTPC sets the MISSION of "Creating hope for all facing illness". To that end, MTPC is working on the disease areas of central nervous system, immuno-inflammation, diabetes and kidney, and cancer. MTPC is focusing on "precision medicine" to provide drugs with high treatment satisfaction and additionally working to develop "around the pill solutions" to address specific patient concerns based on therapeutic medicine, including prevention of diseases, pre-symptomatic disease care, prevention of aggravation and prognosis. For more information, go to . Media inquiries: [email protected] 1 RADICAVA and RADICAVA ORS Prescribing Information. Jersey City, NJ: Mitsubishi Tanabe Pharma America, Inc.; 2022. 2 Data on file. Mitsubishi Tanabe Pharma America, Inc. 3 Data on file. Mitsubishi Tanabe Pharma America, Inc. 4 Data on file. Mitsubishi Tanabe Pharma America, Inc. SOURCE Mitsubishi Tanabe Pharma America WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

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 (MOSEICTM 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, 22nd Floor New York, NY 10007 Tel: 212-332-3243 Email: mjacobson@axsome.com Media: Darren Opland Director, Corporate Communications Axsome Therapeutics, Inc. One World Trade Center, 22nd Floor New York, NY 10007 Tel: 929-837-1065 Email: dopland@axsome.com