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NEW YORK, May 28, 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 that data from its industry-leading portfolio of novel products for CNS disorders will be presented at the 2024 American Society of Clinical Psychopharmacology (ASCP) Annual Meeting, being held May 28-31, 2024, in Miami Beach, Florida. The presentations include new data from post-hoc analyses of Auvelity® showing improvements in anhedonic symptoms that strongly correlate with improvements in daily function in patients with major depressive disorder (MDD) and data on the clinical profile of AXS-05 in treatment of Alzheimer’s disease agitation. Details for the presentation are as follows: Major Depressive Disorder Title: Effects of AXS-05 (Dextromethorphan-Bupropion) in Improving Anhedonia and Interest-Activity Symptoms of MDD and the Associated Improvements in Functional ImpairmentPresentation Date and Time: Wednesday, May 29, 11:15 a.m. – 1 p.m.Lead Author: Roger McIntyre, MD, Professor of Psychiatry and Pharmacology at the University of TorontoPoster Number: W17Location: Salon 4 Title: Real-World AXS-05 Patient Characteristics in Major Depressive DisorderPresentation Date and Time: Wednesday, May 29, 11:15 a.m. – 1 p.m.Lead Author: Andrew Muzyk, MD, Associate Professor of the Practice of Medical Education at Duke UniversityPoster Number: W40Location: Salon 4 Alzheimer’s Disease Agitation Title: Clinical Profile of AXS-05 (Dextromethorphan-Bupropion) in Treating Alzheimer’s Disease Agitation (ADA): Results From The Phase 2/3 Development ProgramPresentation Date and Time: Wednesday, May 29, 11:15 a.m. – 1 p.m.Lead Author: Jeffrey Cummings, MD, ScD, Vice Chair of Research, UNLV Department of Brain HealthPoster Number: W47Location: Salon 4 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: Thursday, May 30, 12:30 p.m. – 2:15 p.m.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 Poster Number: T38Location: Salon 4 About AUVELITY®AUVELITY is a novel, oral, NMDA receptor antagonist with multimodal activity approved for the treatment of MDD in adults. AUVELITY is a proprietary extended-release oral tablet containing dextromethorphan HBr (45 mg) and bupropion HCl (105 mg). The dextromethorphan component of AUVELITY is an antagonist of the NMDA receptor (an ionotropic glutamate receptor) and a sigma-1 receptor agonist. These actions are thought to modulate glutamatergic neurotransmission. The bupropion component of AUVELITY is an aminoketone and CYP2D6 inhibitor which serves to increase and prolong the blood levels of dextromethorphan. The exact mechanism of action of Auvelity in the treatment of depression is unclear. AUVELITY received Breakthrough Therapy designation from the FDA for the treatment of MDD. INDICATION AND IMPORTANT SAFETY INFORMATION WHAT IS AUVELITY (aw-VEHL-ah-tee)? It is a prescription oral medicine used to treat adults with major depressive disorder (MDD). It is not known if Auvelity is safe and effective for use in children. Auvelity is not approved for uses other than the treatment of MDD. The ingredients in Auvelity, bupropion and dextromethorphan, are the same ingredients found in some other medicines approved for other uses. WHAT IS THE MOST IMPORTANT INFORMATION I SHOULD KNOW ABOUT AUVELITY? Auvelity and other antidepressant medicines may increase suicidal thoughts and actions in some children, adolescents, and young adults, especially within the first few months of treatment or when the dose is changed. Auvelity is not for use in children. You should pay close attention to any new or sudden changes in mood, behavior, thoughts, or feelings or if you develop suicidal thoughts or actions. This is very important when starting or changing the dose of an antidepressant medicine. Call your healthcare provider (HCP) or get emergency help right away if you or your loved one have any of the following symptoms, especially if they are new, worse, or worry you: suicidal thoughts or actionsnew or worsening depression or anxietyagitation or restlessnesstrouble sleeping (insomnia)acting aggressive, being angry violentan extreme increase in activity and talking (mania)panic attacksnew or worsening irritabilityacting on dangerous impulsesother unusual changes in behavior or mood Do not take Auvelity if you: have or had a seizure disorder.have or had an eating disorder like anorexia or bulimia.have recently and suddenly stopped drinking alcohol or use medicines called benzodiazepines, barbiturates, or anti-seizure medicines, and you have recently suddenly stopped taking them.are taking a monoamine oxidase inhibitor (MAOI), have stopped taking an MAOI in the last 14 days, or are being treated with the antibiotic linezolid or intravenous methylene blue. Ask your HCP or pharmacist if you are unsure whether you take an MAOI. Do not start taking an MAOI until you have stopped taking Auvelity for at least 14 days.are allergic to dextromethorphan, bupropion, or any other ingredients in Auvelity. Auvelity may cause serious side effects. Ask your HCP how to recognize the serious side effects below and what to do if you think you have one: Seizures. There is a risk of seizures during treatment with Auvelity. The risk is higher if you take higher doses of Auvelity, have certain medical problems, or take Auvelity with certain other medicines. Do not take Auvelity with other medicines unless your healthcare provider tells you to. If you have a seizure during treatment with Auvelity, stop taking Auvelity and call your HCP right away. Do not take Auvelity again if you have a seizure. Increases in blood pressure (hypertension). Some people may get high blood pressure during treatment with Auvelity. Your HCP should check your blood pressure before you start taking and during treatment with Auvelity. Manic episodes. Manic episodes may happen in people with bipolar disorder who take Auvelity. Symptoms may include: greatly increased energyracing thoughtsunusually grand ideastalking more or faster than usualsevere trouble sleepingreckless behaviorexcessive happiness or irritability Unusual thoughts or behaviors. One of the ingredients in Auvelity (bupropion) can cause unusual thoughts or behaviors, including delusions (believing you are someone else), hallucinations (seeing or hearing things that are not there), paranoia (feeling that people are against you), or feeling confused. If this happens to you, call your HCP. Eye problems (angle-closure glaucoma). Auvelity may cause a type of eye problem called angle-closure glaucoma in people with certain other eye conditions. You may want to undergo an eye examination to see if you are at risk and receive preventative treatment if you are. Call your HCP if you have eye pain, changes in your vision, or swelling or redness in or around the eye. Dizziness. Auvelity may cause dizziness which may increase your risk for falls. Serotonin syndrome. A potentially life-threatening problem called serotonin syndrome can happen when you take Auvelity with certain other medicines. Call your HCP or go to the nearest hospital emergency room right away if you have any of the following signs and symptoms: agitationhallucinationsconfusioncomafast heartbeatblood pressure changesdizzinesssweatingflushinghigh body temperature (hyperthermia)shaking (tremors), stiff muscles, or muscle twitchingloss of coordinationseizuresnausea, vomiting, diarrhea COMMON SIDE EFFECTS The most common side effects of Auvelity include dizziness, headache, diarrhea, feeling sleepy, dry mouth, sexual function problems, and excessive sweating.These are not all the possible side effects of Auvelity. Tell your doctor if you have any side effects. You can report side effects at 1-800-FDA-1088 or www.fda.gov/medwatch. BEFORE USING Tell your HCP about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.It is important to tell your HCP if you are taking: other medicines containing bupropion or dextromethorphanmedicines to treat depression, anxiety, psychotic or thought disorders, including selective serotonin reuptake inhibitors (SSRIs) and tricyclic antidepressantstheophyllinecorticosteroidsoral diabetes medicines or use insulin to control your blood sugarmedicines to control appetite (anorectic)nicotine medicines to help you stop smokingstreet (illicit) drugsbenzodiazepines, sedative-hypnotic (sleep medicines), or opiates If you are unsure if you take any of these medicines, ask your HCP. They can tell you if it is safe to take Auvelity with your other medicines.Tell your HCP if you are pregnant or plan to become pregnant. Auvelity may harm your unborn baby if you take it during pregnancy. Auvelity is not recommended during pregnancy. Your HCP will prescribe another treatment for females who plan to become pregnant.One of the ingredients in Auvelity passes into your breast milk. Do not breastfeed during treatment with Auvelity and for 5 days after the final dose. Tell your HCP about all your medical conditions, including if you: have problems with your liver or kidneys.have diabetes, heart disease, or high blood pressure.have a history of seizure, stroke, eating disorder, head injury, or have a tumor in your brain or spinal cord.have a history of alcohol or drug abuse.have a history of seizure, eating disorder, or abuse alcohol or drugs.have low blood sugar, low blood sodium levels, or a history of falls.you take certain other medicines that could interact with Auvelity.have or had a condition known as bipolar disorder, a family history of bipolar disorder, suicide, or depression.have high pressure in the eye (glaucoma). Review the list below with your HCP. Auvelity may not be right for you if: you drink a lot of alcohol.you abuse prescription or street drugs.you are pregnant or plan to become pregnant.you are breastfeeding or plan to breastfeed. HOW TO TAKE Auvelity is available by prescription only.Take Auvelity exactly as instructed by your HCP.Take Auvelity 1 time a day for 3 days, then increase your dose to 2 times a day (taken at least 8 hours apart). Do not take more than 2 Auvelity tablets in 24 hours.If you miss a dose, do not take an extra dose. Wait and take your next dose at the regular time. Do not take more than 1 dose of Auvelity at a time.Do not change your dose or stop taking Auvelity without talking to your HCP.Swallow Auvelity tablets whole. Do not crush, chew, or divide the tablets.Do not give Auvelity to other people.If you take too much Auvelity call your HCP or seek medical advice promptly. LEARN MORE For more information about Auvelity, call 866-496-2976 or visit Auvelity.com.This summary provides basic information about Auvelity but does not include all information known about this medicine. Read the information that comes with your prescription each time your prescription is filled. This information does not take the place of talking with your doctor. Be sure to talk to your doctor or other HCP about Auvelity and how to take it. Your HCP is the best person to help you decide if Auvelity is right for you. AUV CON BS 10/2022 Please see full Prescribing Information, including Boxed Warning for suicidal thoughts and behaviors, and Medication Guide. 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

HMTM is designed for early intervention to modify the underlying disease process and slow progression of Alzheimer’s disease HMTM has a benign safety pro approximately 3000 subjects studied in trials and has shown no increased risk of amyloid related imaging abnormalities HMTM holds potential to be the first oral, anti-tau therapy requiring minimal testing and treatment monitoring for the treatment of Alzheimer’s disease ABERDEEN, Scotland--(BUSINESS WIRE)-- TauRx Pharmaceuticals Ltd., a global leader in tau-based research in Alzheimer’s disease (AD), presented the 24-month data from its Phase 3 LUCIDITY trial of hydromethylthionine mesylate (HMTM) at the AD/PD™ 2024 Alzheimer's & Parkinson's Diseases Conference in Lisbon, Portugal. This press release features multimedia. View the full release here: Co-founder and CEO, Professor Claude Wischik (Photo: Business Wire) New 24-month data show sustained benefits across the disease spectrum from early to moderate dementia. Analyses comparing the study participants to closely matched real world data and meta-analytical controls, showed significantly reduced disease progression in participants in the LUCIDITY trial. In the early disease subgroup there was a significant reduction in transition to the dementia stage of AD. HMTM is a tau aggregation inhibitor designed to reduce tau pathology in AD. LUCIDITY compared change in standard cognitive and functional outcomes and brain volume loss in participants with early stage to moderate AD treated with HMTM at a 16 mg/day dose with a control group over 12 months, followed by an open label phase where everyone received 16 mg/day HMTM for a further 12 months. Blood based biomarker data announced last year showed that HMTM 16 mg/day produced a 95% reduction in change in blood concentration of neurofilament light chain (NfL) relative to the control group (p=0.0291). NfL in blood provides a measure of progression of neurodegeneration in the brain. From the data shared today, participants at the early stage of AD receiving HMTM 16 mg/day remained significantly above baseline to 18 months and only returned to baseline values after 24 months. Within this subgroup, progression of symptoms to the dementia stage of the disease was significantly less than in the control group. Additionally, further analysis of this subgroup shows that the control group declined significantly below their baseline despite the switch to 16 mg/day after 12 months in the open label phase (p=0.0308 for the observed cases difference in ADAS-Cog13, being a more accurate measure for early disease). Commenting on the results, Professor Claude Wischik, CEO and Executive Chairman of TauRx, explains, “The new data show that benefit can be maintained over 24-months and highlight the importance of starting HMTM treatment early in the disease process. The results are also consistent with earlier research showing that HMTM combines two independent modes of action: inhibition of tau aggregation pathology in the brain and a second symptomatic activity. We were surprised to find that the blood concentration of active drug follows an atypical pro 12 months reaching levels sufficient for symptomatic activity even at a very low dose. “There is strong evidence HMTM impacts the underlying tau pathology of AD. When we compared our results with natural history real world data, such as from the Alzheimer’s disease Neuroimaging Initiative1 database and meta-analytic controls from placebo arms of multiple AD trials in similar patient populations, we found statistically significant differences in cognitive and functional outcomes supporting the benefits of HMTM2. With the combination of a strong safety pro accessibility offered by an orally administered drug, HMTM presents as a unique potential treatment option for patients and physicians.” Professor Alistair Burns, Emeritus Professor of Old Age Psychiatry at the University of Manchester and previously England’s National Clinical Director for Dementia, observed, "We have reached an exciting time in the field of Alzheimer’s disease treatment. After no new therapies for a generation, we are on the threshold of having a range of new treatments, including a tau-targeted oral therapy, which have the real potential to slow the disease process. This is great news for people with Alzheimer's disease, their families and carers." In light of data shared, HMTM has prospective broad applicability for a wide demographic contributing to equity of access to new treatment options. TauRx has initiated regulatory engagement in the UK and the US for intended product approval. Other territories will follow in line with plans to scale commercialisation of HMTM. For additional information, please visit: or . References: 1. ADNI, ; 2. P-values for difference in ADAS-Cog11 at 24 months was p=0.035 and for whole brain volume MRI at 24 months 0.004 when results of HMTM treatment group arm is compared to matched ADNI. P-values for all results comparing HMTM treatment with placebo arms of other studies over 18 months were p<0.0001. TAU PATHOLOGY IN ALZHEIMER’S Through dedicated research programs, it is understood that certain age-related factors lead to misfolding and aggregation of tau proteins, and the subsequent formation of tau tangles in Alzheimer’s. Pathological aggregation of tau protein disrupts and damages neuronal function. The process begins many years before symptoms of dementia are seen. Tau pathology has been proven to correlate with the clinical decline (loss of memory and ability to care for oneself) commonly seen in people with Alzheimer’s, establishing it as an important target for treatment. HMTM is primarily a tau aggregation inhibitor, which effectively crosses the blood brain barrier to target the source of this damaging process. Its secondary pharmacological action is symptomatic through increasing acetylcholine levels in parts of the brain essential for memory functions. ABOUT LUCIDITY Completed in June 2023, LUCIDITY was a double-blind randomised controlled Phase III clinical trial comparing change over 12 months in cognitive, functional and brain atrophy outcomes at HMTM doses of 16 mg/day, 8 mg/day and methylthioninium chloride (MTC) at a dose of 4 mg twice weekly as a control in a 4:1:4 randomisation, with a subsequent 12 month blinded open-label extension phase in which all participants received 16 mg/day. MTC 8mg/week was used in the control group to maintain study blinding for slight urinary colouration, which is a known harmless side effect of the drug. Measurements of ADAS-Cog11, ADCS-ADL23, and whole brain volume MRI were taken at 12 and 24 months compared to baseline. ABOUT TAURx PHARMACEUTICALS LTD TauRx was founded in 2002 in Singapore, with primary research facilities and operations based in Aberdeen, UK. The company has dedicated the past two decades to developing treatments and diagnostics for Alzheimer’s and other neurodegenerative diseases due to pathological aggregation of tau and other proteins. Alzheimer’s disease is a leading cause of disability and death throughout the world and is one of the most important global public health issues. TauRx will contribute to addressing this unmet need with data from LUCIDITY and pursuit of regulatory approvals in line with its overall plans to make HMTM available for people living Alzheimer’s. Future research is planned for other related neurodegenerative diseases.