TAAR1

The recent approval of Rovi Pharmaceuticals Laboratories' OKEDI/RISVAN (risperidone ISM) has spiked the competition among the other pharmaceutical companies that are developing novel therapies to improve the treatment landscape. RISVAN has the potential to become a blockbuster drug. LAS VEGAS, Aug. 26, 2024 /PRNewswire/ -- Schizophrenia is a severe mental illness affecting about 1% of Americans, cognitive functions, emotional responses, decision-making, and social interaction. Onset typically occurs in late teens to early 20s for men and late 20s to early 30s for women. Currently, as per the WHO, the vast majority of schizophrenia patients around the world are not receiving mental health care. Approximately 50% of people in mental hospitals have a schizophrenia diagnosis, and only 31.3% of people with psychosis receive specialist mental health care. As per DelveInsight analysis, in 2023 the total diagnosed prevalent cases of schizophrenia in the 7MM were found to be approximately 4 million cases out of which the US accounted for nearly 1.5 million cases. It is anticipated that these numbers will rise by 2034 due to several factors, including population growth, improved diagnostic techniques, increased awareness, and reduced stigma around mental health issues prompting more individuals to seek diagnosis, and potentially, environmental stressors contributing to a higher occurrence of the disorder. Schizophrenia treatment involves a blend of medication, psychological counseling, and social support. However, nearly one-third of patients do not respond sufficiently to standard treatments. Relapses, characterized by psychotic symptoms and functional impairments, are significant. Schizophrenia treatment mainly consists of antipsychotic medications that target dopamine neurotransmitters. Second-generation medications are favored because they lower the risk of severe side effects. Long-acting injectable antipsychotics can enhance adherence and improve treatment outcomes. High-dose regimens of specific medications may be advantageous for patients with severe, treatment-resistant schizophrenia. Additionally, hospitalization and electroconvulsive therapy might be necessary for patients who do not respond to medication therapy or during severe episodes. First-generation antipsychotics like chlorpromazine, fluphenazine, haloperidol, and perphenazine are effective in treating positive symptoms such as hallucinations and delusions but do not alleviate negative symptoms or cognitive impairments. Second-generation antipsychotics, including REXULTI/RXULTI (brexpiprazole), CAPLYTA (lumateperone), LATUDA (lurasidone hydrochloride), SAPHRIS (asenapine), ABILIFY MYCITE (aripiprazole tablets with sensor), VRAYLAR/REAGILA (cariprazine), SECUADO (asenapine), INVEGA SUSTENNA/TRINZA/HAYFERA (paliperidone palmitate), ARISTADA/ARISTADA INITIO (aripiprazole lauroxil), PERSERIS (risperidone), FANAPT (iloperidone), and LYBALVI (olanzapine and samidorphan), were developed to address both positive and negative symptoms, as well as cognitive symptoms. Although these medications typically have fewer extrapyramidal side effects, they can cause weight gain, sexual dysfunction, and other metabolic disorders. Additionally, elderly patients using FGAs and SGAs are at an increased risk of developing pneumonia. Learn more about the FDA-approved schizophrenia drugs @ Drugs for Schizophrenia Treatment REXULTI (brexpiprazole) is an oral tablet available in strengths from 0.25 mg to 4 mg, containing various inactive ingredients. While its exact mechanism of action is not fully understood, it work as a partial agonist at serotonin 5-HT1A and dopamine D2 receptors and as an antagonist at serotonin 5-HT2A receptors. REXULTI was first approved in the US in July 2015 for use in adults with MDD and schizophrenia. In January 2022, it received FDA approval for pediatric patients aged 13–17. The EMA approved it in July 2018, and Japan approved it in tablet form in January 2018 and as an oral-disintegrating dose in August 2021. Generic versions of REXULTI have now been approved, which may affect its market presence. Janssen Pharmaceutical's INVEGA SUSTENNA/INVEGA TRINZA/INVEGA HAFYERA (paliperidone palmitate) is an SGA agent that seems to act as a D2 partial agonist and a 5-HT-2A receptor antagonist. INVEGA SUSTENNA is administered monthly, INVEGA TRINZA every three months, and INVEGA HAFYERA twice yearly. Paliperidone is a benzisoxazole derivative. In the EU and Japan, INVEGA SUSTENNA is marketed as XEPLION. In the EU, INVEGA TRINZA is sold as TREVICTA, and in Japan as XEPLION TRI. INVEGA HAFYERA is a long-acting injectable treatment administered in the upper buttocks every six months, providing continuous treatment and symptom control over this period. Additionally, the recent approval of RISVAN (Risperidone ISM) has intensified the competition in the schizophrenia treatment space. Risperidone ISM is a long-acting injectable antipsychotic created and patented by ROVI for treating schizophrenia in adults. From the first injection, it delivers immediate and sustained plasma drug levels without the need for loading doses or additional oral risperidone. This approval is based on the positive outcomes of the pivotal PRISMA-3 study, which assessed the efficacy and safety of Risperidone ISM in patients with schizophrenia. The study's findings demonstrate that the two doses tested (75 mg and 100 mg administered once monthly) successfully met the predetermined primary and secondary efficacy endpoints for treating patients with moderate to severe schizophrenia symptoms. Furthermore, OKEDI (risperidone ISM) was launched in Germany, the UK, and Spain in 2022. The approval was based on the positive results of the pivotal PRISMA-3 study on the efficacy and safety of risperidone ISM in schizophrenia patients. As per the estimates by Delveinsight analysts, this drug has blockbuster potential in the schizophrenia market with medium-fast uptake. To know more about schizophrenia treatment options, visit @ New Treatment for Schizophrenia The schizophrenia market is crowded with so many companies working in the domain. Various potential therapies that are projected to enter during the forecast period include Boehringer Ingelheim's Iclepertin (BI-425809), Sumitomo Pharma/Otsuka's Ulotaront (SEP-363856), Reviva Pharmaceuticals' Brilaroxazine (RP5063), Minerva Neurosciences/Mitsubishi Tanabe Pharma's Roluperidone (MIN-101/MT-210), Karuna Therapeutics (Bristol Myers Squibb)/Royalty Pharma's KarXT (xanomeline-trospium), ACADIA Pharmaceuticals' NUPLAZID (pimavanserin), Teva Pharmaceutical/MedinCell/Royalty Pharma's Olanzapine LAI (mdc-TJK/TV-44749), Neurocrine Biosciences/Mitsubishi Tanabe Pharma's Valbenazine (NBI-98854), Lyndra Therapeutics' LYN-005 (long-acting oral risperidone), Newron Pharmaceuticals' Evenamide (NW-3509), Luye Pharma's LY03010 (ER paliperidone palmitate), and others. Discover which therapies are expected to grab major schizophrenia market share @ Schizophrenia Market Report Iclepertin (BI 425809) is an investigational drug and a glycine transporter 1 (GlyT1) inhibitor aimed at addressing the brain biology related to cognitive symptoms in schizophrenia (CIAS). Abnormalities in glutamatergic signaling downstream of neuronal NMDA receptors contribute to cognitive impairment in this condition. Enhancing NMDA receptor function could potentially improve synaptic plasticity and cognition. Glycine, an essential NMDA receptor co-agonist, is modulated by glycine transporters GlyT-1 and GlyT-2, which are located in presynaptic and astrocyte membranes. These transporters regulate glycine levels by taking it up into nerve terminals and adjacent glial cells, affecting synaptic cleft glycine concentration. By inhibiting these transporters, BI 425809 aims to increase glycine levels, thereby modulating NMDA receptor function. Administered orally, this potent and selective GlyT1 inhibitor is also under investigation for Alzheimer's disease. However, early 2020 Phase II trial results did not support its continued development for this indication, and the focus has now shifted to schizophrenia, with multiple Phase III trials currently underway. Since schizophrenia, patients frequently ignore certain symptoms, such as cognitive impairment. Therefore, if approved, BI-425809 will be the first approved pharmacotherapy for the treatment of CIAS. Ulotaront (SEP-363856), developed by Sumitomo Pharma and Otsuka Pharmaceuticals, is a trace amine-associated receptor 1 (TAAR1) agonist with serotonin 5-HT1A agonist activity. It is a small-molecule oral agent that does not bind to dopamine D2 or serotonin 5-HT2A receptors. Sunovion discovered Ulotaront in collaboration with PsychoGenics using the in vivo phenotypic SmartCube platform and associated artificial intelligence algorithms. Ulotaront is currently in late-stage development for schizophrenia and generalized anxiety disorder (GAD) in Japan and as an adjunctive treatment for major depressive disorder, schizophrenia, and GAD in the US. Top-line results from Phase III DIAMOND 1 and DIAMOND 2 trials in schizophrenia have been released, but the Phase III DIAMOND 3 trial in the US has been halted. Sumitomo Pharma has also stopped a Phase III trial for schizophrenia in Japan and another Phase II/III trial in China, Japan, Taiwan, and the Philippines, citing business strategy reasons. Despite this, two Phase III trials are still ongoing. Recently, Otsuka and Sumitomo revised their licensing agreement, excluding SEP-4199 and SEP-378614. Under this revision, Otsuka gained exclusive rights from SMPA to develop, manufacture, and commercialize ulotaront worldwide. If Otsuka successfully develops and commercializes ulotaront, they will pay up to 30 million USD (approximately 4.5 billion yen) in milestones, along with royalties based on sales, without any upfront payment. Starting January 2024, Otsuka will cover the full cost of studies conducted by both Sumitomo Pharma Group and Otsuka, except for certain studies. KarXT (xanomeline–trospium) is an oral modulator targeting muscarinic receptors found in both the central nervous system (CNS) and various peripheral tissues. This proprietary product combines xanomeline, a novel muscarinic agonist, with trospium, an approved muscarinic antagonist, to preferentially stimulate muscarinic receptors in the CNS. As a dual M1/M4 muscarinic acetylcholine receptor agonist, KarXT aims to improve the positive, negative, and cognitive symptoms of schizophrenia. The US FDA has accepted Karuna Therapeutics' NDA for KarXT for adult schizophrenia treatment, with a PDUFA date of September 26, 2024. Additionally, KarXT is undergoing multiple Phase III trials as an adjunctive treatment with standard-of-care agents for schizophrenia and is being evaluated for psychosis treatment in Alzheimer's disease patients. Following Bristol Myers Squibb's acquisition of Karuna Therapeutics, Karuna is now a wholly-owned subsidiary of BMS. At the Annual Congress of the Schizophrenia International Research Society (SIRS) in April 2024 in Italy, BMS presented promising results from the latest interim analysis of the Phase III EMERGENT-4 open-label extension trial, showing KarXT's efficacy in reducing symptoms in adults with schizophrenia. BMS plans to continue discussions with the US FDA and will release more data from the EMERGENT program later this year. Discover more about drugs for schizophrenia in development @ Schizophrenia Clinical Trials The anticipated launch of these emerging therapies for schizophrenia are poised to transform the market landscape in the coming years. As these cutting-edge therapies continue to mature and gain regulatory approval, they are expected to reshape the schizophrenia market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth. DelveInsight estimates that the market size for schizophrenia is expected to grow from USD 2.6 billion in 2023 with a significant CAGR by 2034. This growth can be attributed to the introduction of upcoming therapies and the rising prevalence of the disease. The anticipated launch of these therapies is also expected to attract new entrants to the Schizophrenia market, resulting in increased competition and innovation. DelveInsight's latest published market report titled as Schizophrenia Market Insight, Epidemiology, and Market Forecast – 2034 will help you to discover which market leader is going to capture the largest market share. The report provides comprehensive insights into the schizophrenia country-specific treatment guidelines, patient pool analysis, and epidemiology forecast to help understand the key opportunities and assess the market's underlying potential. The schizophrenia market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM segmented into: Total Prevalent Cases of Schizophrenia Total Diagnosed Prevalent Cases of Schizophrenia Gender-specific Diagnosed Prevalent Cases of Schizophrenia Severity-specific Diagnosed Prevalent Cases of Schizophrenia The report provides an edge while developing business strategies by understanding trends shaping and driving the 7MM schizophrenia market. Highlights include: 11-year Forecast 7MM Analysis Epidemiology-based Market Forecasting Historical and Forecasted Market Analysis upto 2034 Emerging Drug Market Uptake Peak Sales Analysis Key Cross Competition Analysis Industry Expert's Opinion Access and Reimbursement Download this schizophrenia market report to assess the epidemiology forecasts, understand the patient journeys, know KOLs' opinions about the upcoming treatment paradigms, and determine the factors contributing to the shift in the schizophrenia market. Also, stay abreast of the mitigating factors to improve your market position in the schizophrenia therapeutic space. Related Reports Schizophrenia Pipeline Schizophrenia Pipeline Insight – 2024 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key schizophrenia companies, including Otsuka Pharmaceutical Development & Commercialization, Inc., Gedeon Richter Ltd., Lyndra Therapeutics, Neurocrine Bioscience, Takeda Pharmaceutical Company, Memory Pharmaceuticals, Hoffmann-La Roche, Neurocrine Biosciences, Boehringer Ingelheim, Meiji Seika Pharma Co., Ltd., SK Life Science, Inc., Alkermes, Inc. , Solvay Pharmaceuticals, Mitsubishi Tanabe Pharma Corporation, SyneuRx International (Taiwan) Corp, BioXcel Therapeutics Inc, Cognitive Research Corporation, Amarex Clinical Research, Forum Pharmaceuticals Inc, Amneal Pharmaceuticals, LLC, Recognify Life Sciences, Accutest Research Laboratories (I) Pvt. Ltd., Eli Lilly and Company, Johnson & Johnson Pharmaceutical Research & Development, L.L.C, Janssen, LP, Delpor, Inc., Jiangsu Hansoh Pharmaceutical, Cerevel Therapeutics, LLC, Zogenix, Inc., Luye Pharma, Reviva Pharmaceuticals, Alkermes, Inc., Karuna Therapeutics, Autifony Therapeutics, Neumora Therapeutics, Adex Therapeutics, among others. Schizophrenia Epidemiology Forecast Schizophrenia Epidemiology Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, and schizophrenia epidemiology trends. Dementia Market Dementia Market Insights, Epidemiology, and Market Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key dementia companies, including Hoffmann-La Roche, Forest Laboratories, Inc., Janssen Pharmaceuticals, Inc., Merck and Co., Inc., Novartis, among others. Bipolar Depression Market Bipolar Depression Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key bipolar depression companies, including Intra-Cellular Therapies, Sunovion Pharmaceuticals, COMPASS Pathways, among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP

Total 2Q 2024 net product revenue of $87.2 million, representing 87% year-over-year growth Auvelity® 2Q 2024 net product sales of $65.0 million, representing 135% year-over-year growth Sunosi® 2Q 2024 net product revenue of $22.1 million representing 16% year-over-year growth NDA for AXS-07 in migraine resubmitted Topline results of ADVANCE-2 Phase 3 trial of AXS-05 in Alzheimer’s disease agitation anticipated 2H 2024 Topline results of ACCORD-2 Phase 3 randomized withdrawal trial of AXS-05 in Alzheimer's disease agitation anticipated 2H 2024; target enrollment reached Topline results of FOCUS Phase 3 trial of solriamfetol in ADHD anticipated 2H 2024 SUSTAIN Phase 3 trial of solriamfetol in shift work disorder initiated NDA submission for AXS-14 in fibromyalgia expected 3Q 2024 NEW YORK, Aug. 05, 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 financial results for the second quarter of 2024. “We delivered another robust quarter driven by focused commercial execution and continued pipeline advancement,” said Herriot Tabuteau, MD, CEO of Axsome Therapeutics. “We continue to see strong demand for Auvelity and increased commercial payer coverage by more than 22 million lives as of August 1st. The NDA for AXS-07 in migraine has been resubmitted, and we are tracking to submit the NDA for AXS-14 in fibromyalgia in the third quarter. Trials in four new indications for solriamfetol are now underway, and we remain on track to deliver topline results from the FOCUS Phase 3 trial in ADHD in the second half of this year. For our AXS-05 program in Alzheimer’s disease agitation, the ADVANCE-2 Phase 3 trial continues to progress, and the ACCORD-2 Phase 3 trial has reached target enrollment, positioning us to potentially report topline results for both of these pivotal trials in the second half of the year.” Second Quarter 2024 Financial Highlights Total net product revenue for the second quarter of 2024 was $87.2 million, representing 87% year-over-year growth. Total net product revenue for the comparable period in 2023 was $46.7 million.Auvelity net product sales were $65.0 million for the second quarter of 2024, representing 135% year-over-year growth. Auvelity net product sales for the comparable period in 2023 were $27.6 million.Sunosi net product revenue was $22.1 million for the second quarter of 2024, consisting of $21.5 million in net product sales and $0.6 million in royalty revenue associated with sales in out-licensed territories, representing 16% year-over-year growth. Sunosi net product revenue for the comparable period in 2023 was $19.1 million, consisting of $18.4 million in net product sales and $0.7 million in royalty revenue.Total cost of revenue was $8.1 million for the second quarter of 2024. Total cost of revenue for the comparable period in 2023 was $4.6 million.Research and development (R&D) expenses were $49.9 million for the second quarter of 2024, compared to $20.6 million for the comparable period in 2023. The increase was primarily related to the initiation and continuation of solriamfetol Phase 3 trials in major depressive disorder, ADHD, and binge eating disorder, ongoing trials of AXS-05 and AXS-12, manufacturing costs associated with AXS-07 and AXS-14, post-marketing commitments for Auvelity and Sunosi, and higher personnel costs, including non-cash stock-based compensation, due to organizational growth.Selling, general, and administrative (SG&A) expenses were $103.6 million for the second quarter of 2024, compared to $78.9 million for the comparable period in 2023. The increase was primarily related to commercialization expenses largely driven by field force expansion and higher personnel costs, including non-cash stock-based compensation, due to organizational growth.Net loss for the second quarter of 2024 was $79.3 million or $(1.67) per share, compared to a net loss of $67.2 million or $(1.54) per share for the comparable period in 2023. The net loss in the second quarter of 2024 reflects $26.0 million in non-cash charges.Cash and cash equivalents totaled $315.7 million at June 30, 2024, compared to $386.2 million at December 31, 2023.Shares of common stock outstanding were 47,801,578 at June 30, 2024. Financial Guidance Axsome believes that its current cash is sufficient to fund anticipated operations into cash flow positivity, based on the current operating plan. Commercial Highlights Auvelity Approximately 123,000 prescriptions were written for Auvelity in the second quarter of 2024, representing a 29% sequential increase versus the first quarter of 2024.Payer coverage for Auvelity in the commercial channel increased from 48% of lives covered last quarter to 60% of lives covered as of August 1. The proportion of lives covered in the government channel (Medicare and Medicaid) remains at approximately 100%. Payer coverage for Auvelity across all channels is now at approximately 76% of all covered lives. Axsome expects coverage to continue to expand and evolve. Sunosi Approximately 45,000 prescriptions were written for Sunosi in the U.S. in the second quarter of 2024, representing an 8% increase versus the first quarter of 2024.Sunosi maintains broad payer coverage in the commercial channel with 95% of lives covered. Currently 83% of total lives across all channels are covered. Development Pipeline Axsome is advancing an industry-leading neuroscience pipeline encompassing five innovative, late-stage, patent-protected product candidates for 9 serious psychiatric and neurologic conditions, which affect more than 140 million people in the U.S. alone. Recent and anticipated progress for key pipeline programs is summarized below. AXS-05 AXS-05 (dextromethorphan-bupropion) is Axsome’s novel, oral, investigational NMDA receptor antagonist and sigma-1 agonist being developed for the treatment of Alzheimer’s disease (AD) agitation and smoking cessation. AXS-05 has been granted U.S. Food and Drug Administration (FDA) Breakthrough Therapy designation for AD agitation. Alzheimer’s Disease Agitation: Axsome is conducting the ADVANCE-2 study, a Phase 3, placebo-controlled, parallel group trial evaluating the efficacy and safety of AXS-05 in AD agitation. Patients completing ADVANCE-2 may enter a long-term open label safety extension trial. The Company anticipates topline results from the ADVANCE-2 trial in the second half of 2024.Axsome is also conducting the ACCORD-2 study, a Phase 3, double-blind, placebo-controlled, randomized withdrawal trial evaluating the efficacy and safety of AXS-05 in AD agitation. The enrollment target for the ACCORD-2 trial has been met and the Company now anticipates topline results in the second half of 2024. Smoking Cessation: Axsome plans to initiate a pivotal Phase 2/3 trial of AXS-05 in smoking cessation in 2024. AXS-07 AXS-07 (MoSEIC™ meloxicam-rizatriptan) is Axsome’s novel, oral, rapidly absorbed, multi-mechanistic, investigational medicine being developed for the acute treatment of migraine. Migraine: The Company has resubmitted its New Drug Application (NDA) for AXS-07 for the acute treatment of migraine. The Company expects the NDA resubmission to be designated as Class 2, which would be subject to a six-month review.Axsome is conducting the EMERGE study, a multicenter, Phase 3, single-group trial evaluating the efficacy and safety of AXS-07 for the acute treatment of migraine headache in adults with a prior inadequate response to an oral CGRP inhibitor. The Company anticipates topline results from the EMERGE trial in the second half of 2024. AXS-12 AXS-12 (reboxetine) is Axsome’s novel, oral, potent, investigational highly selective norepinephrine reuptake inhibitor and cortical dopamine modulator being developed for the treatment of narcolepsy. AXS-12 has been granted FDA Orphan Drug designation for narcolepsy. Narcolepsy: Axsome is conducting a Phase 3 open label safety extension trial of AXS-12 with topline results anticipated in the fourth quarter of 2024. AXS-12 has previously met the primary endpoints and demonstrated positive and statistically significant results in the completed SYMPHONY Phase 3 and CONCERT Phase 2 trials in patients with narcolepsy. AXS-14 AXS-14 (esreboxetine) is Axsome’s novel, oral, potent, highly selective investigational norepinephrine reuptake inhibitor being developed for the management of fibromyalgia. Esreboxetine, the SS-enantiomer of reboxetine, is more potent and selective than racemic reboxetine. Fibromyalgia: Pre-submission activities for the Company’s NDA for AXS-14 for the management of fibromyalgia are substantially complete. The Company expects to submit the NDA in the third quarter of 2024. AXS-14 has previously met the primary endpoints and demonstrated positive and statistically significant results in a Phase 3 and in a Phase 2 trial for the management of fibromyalgia. Solriamfetol Solriamfetol is Axsome’s dopamine and norepinephrine reuptake inhibitor and TAAR1 agonist being developed for the treatment of attention deficit hyperactivity disorder (ADHD), major depressive disorder (MDD), binge eating disorder (BED), and excessive sleepiness associated with shift work disorder (SWD). Attention Deficit Hyperactivity Disorder: Axsome is conducting the FOCUS study, a Phase 3, randomized, double-blind, placebo-controlled, multicenter trial evaluating the efficacy and safety of solriamfetol for the treatment of ADHD in adults. The Company anticipates topline results in the second half of 2024.Major Depressive Disorder: Axsome is conducting the PARADIGM study, a Phase 3, randomized, double-blind, placebo-controlled, multicenter trial evaluating the efficacy and safety of solriamfetol for the treatment of MDD. The Company anticipates topline results in 2025.Binge Eating Disorder: Axsome is conducting the ENGAGE study, a Phase 3, randomized, double-blind, placebo-controlled, multicenter trial evaluating the efficacy and safety of solriamfetol for the treatment of BED. The Company anticipates topline results in 2025.Shift Work Disorder: Axsome has initiated the SUSTAIN (Studying Solriamfetol Modulation of TAAR-1, Dopamine, and Norepinephrine in Shift Work Disorder) study, a Phase 3, randomized, double-blind, placebo-controlled, multicenter trial evaluating the efficacy and safety of solriamfetol for the treatment of SWD in adults. The Company anticipates topline results in 2026. Business Update In June 2024, Axsome announced that it has resolved patent litigation with Unichem Laboratories Ltd. (Unichem) seeking approval to market a generic equivalent of Sunosi in the United States. The Company entered into a settlement agreement with Unichem Laboratories Ltd., which permits Unichem to begin selling its generic version of Sunosi on June 30, 2042, or earlier under certain circumstances. The June 30, 2042 date is also subject to potential extension for pediatric exclusivity. Anticipated Milestones Regulatory: AXS-14 for fibromyalgia, NDA submission (3Q 2024) Clinical Trial Topline Results: Phase 3 ADVANCE-2 trial of AXS-05 in Alzheimer’s disease agitation (2H 2024)Phase 3 ACCORD-2 trial of AXS-05 in Alzheimer’s disease agitation (2H 2024)Phase 3 open-label safety extension trial of AXS-12 in narcolepsy (2H 2024)Phase 3 FOCUS trial of solriamfetol in ADHD in adults (2H 2024)Phase 3 EMERGE trial of AXS-07 in patients with migraine with inadequate response to oral CGRP inhibitors (2H 2024)Phase 3 PARADIGM trial of solriamfetol in major depressive disorder (2025)Phase 3 ENGAGE trial of solriamfetol in binge eating disorder (2025)Phase 3 SUSTAIN trial of solriamfetol in shift work disorder (2026) Clinical Trial Initiations and Progress: Pivotal Phase 2/3 trial of AXS-05 in smoking cessation, initiation (2024) Conference Call Information Axsome will host a conference call and webcast today at 8:00 AM Eastern to discuss second quarter 2024 financial results and provide a business update. To participate in the live conference call, please dial (877) 405-1239 (toll-free domestic). The live webcast can be accessed on the Investors page of the Company’s website at axsome.com. A replay of the webcast will be available for approximately 30 days following the live event. 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”. 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. Axsome Therapeutics, Inc.Selected Consolidated Financial Data Axsome Therapeutics, Inc.Consolidated Balance Sheets(In thousands, except share and per share amounts) June 30,2024 December 31,2023 (Unaudited) Assets Current assets: Cash and cash equivalents $315,657 $386,193 Accounts receivables, net 120,342 94,820 Inventories, net 15,220 15,135 Prepaid and other current assets 11,808 8,115 Total current assets 463,027 504,263 Equipment, net 724 846 Right-of-use asset - operating lease 6,071 6,772 Goodwill 12,042 12,042 Intangible asset, net 50,107 53,286 Non-current inventory and other assets 16,255 11,027 Total assets $548,226 $588,236 Liabilities and stockholders’ equity Current liabilities: Accounts payable $61,340 $40,679 Accrued expenses and other current liabilities 116,771 90,501 Operating lease liability, current portion 1,419 1,267 Contingent consideration, current 7,040 6,407 Total current liabilities 186,570 138,854 Contingent consideration, non-current 69,620 73,300 Loan payable, long-term 179,330 178,070 Operating lease liability, long-term 6,829 7,035 Finance lease liability, long-term 3,025 — Total liabilities 445,374 397,259 Stockholders’ equity: Preferred stock, $0.0001 par value per share (10,000,000 shares authorized, none issued and outstanding) — — Common stock, $0.0001 par value per share (150,000,000 shares authorized, 47,801,578 and 47,351,363 shares issued and outstanding at June 30, 2024 and December 31, 2023, respectively) 5 5 Additional paid-in capital 1,086,120 1,026,543 Accumulated deficit (983,273) (835,571)Total stockholders’ equity 102,852 190,977 Total liabilities and stockholders’ equity $548,226 $588,236 Axsome Therapeutics, Inc.Consolidated Statements of Operations (Unaudited)(In thousands, except share and per share amounts) Three months ended June 30, Six months ended June 30, 2024 2023 2024 2023 Revenues: Product sales, net $86,520 $46,017 $160,616 $74,586 License revenue — — — 65,735 Royalty revenue 646 683 1,549 955 Total revenues 87,166 46,700 162,165 141,276 Operating expenses: Cost of revenue (excluding amortization and depreciation) 8,055 4,599 14,352 12,155 Research and development 49,853 20,581 86,683 38,374 Selling, general and administrative 103,554 78,935 202,524 153,126 Loss in fair value of contingent consideration 2,160 6,053 748 5,891 Intangible asset amortization 1,590 1,589 3,179 3,161 Total operating expenses 165,212 111,757 307,486 212,707 Loss from operations (78,046) (65,057) (145,321) (71,431)Interest expense, net (1,299) (2,730) (2,381) (4,994)Loss before income taxes (79,345) (67,787) (147,702) (76,425)Income tax benefit (expense) — 617 — (1,963)Net loss $(79,345) $(67,170) $(147,702) $(78,388)Net loss per common share, basic and diluted $(1.67) $(1.54) $(3.11) $(1.80)Weighted average common shares outstanding, basic and diluted 47,573,229 43,669,820 47,482,602 43,597,131 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

Total 1Q 2024 net product revenue of $75.0 million, representing 160% year-over-year growth Auvelity® 1Q 2024 net product sales of $53.4 million, representing 240% year-over-year growth Sunosi® 1Q 2024 net product revenue of $21.6 million representing 64% year-over-year growth Contract executed with second large group purchasing organization (GPO) for potential coverage of Auvelity Positive pivotal Phase 3 trial results of AXS-12 in narcolepsy announced Topline results of ADVANCE-2 Phase 3 trial of AXS-05 in Alzheimer’s disease agitation and FOCUS Phase 3 trial of solriamfetol in ADHD both anticipated 2H 2024 ACCORD-2 Phase 3 randomized withdrawal trial of AXS-05 in Alzheimer's disease agitation initiated; enrollment completion anticipated mid-year 2024 PARADIGM and ENGAGE Phase 3 trials of solriamfetol in major depressive disorder and binge eating disorder, respectively, initiated NDA resubmission for AXS-07 in migraine and NDA submission for AXS-14 in fibromyalgia both targeted for 2Q 2024 NEW YORK, May 06, 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 financial results for the first quarter of 2024. “The first quarter was marked by strong financial performance for our on-market products which are delivering important and differentiated treatment options for patients living with depression, narcolepsy and obstructive sleep apnea,” said Herriot Tabuteau, MD, CEO of Axsome Therapeutics. “We also significantly advanced our innovative neuroscience pipeline in the quarter. We announced positive Phase 3 results for AXS-12 in narcolepsy, a major step toward making this new medicine available to patients living with this debilitating condition, and we launched two pivotal trials of solriamfetol in major depressive disorder and binge eating disorder. In the coming months we look forward to resubmitting our NDA for AXS-07 in migraine, and to submitting our NDA for AXS-14 in fibromyalgia. Our Phase 3 ADVANCE-2 trial of AXS-05 in Alzheimer’s disease agitation remains on track for completion in the second half of 2024. Further, we added to the robustness of this clinical development program with the initiation of the ACCORD-2 study of AXS-05 in Alzheimer’s disease agitation, a Phase 3 randomized withdrawal trial, for which we expect to complete enrollment mid-year 2024.” First Quarter 2024 Financial Highlights Total net product revenue for the first quarter of 2024 was $75.0 million, representing 160% year-over-year growth. Total net product revenue for the comparable period in 2023 was $28.8 million. Overall total revenue for the first quarter of 2023 was $94.6 million which included a one-time $65.7 million upfront payment received for the out-licensing of Sunosi commercialization rights in Europe and certain countries in the Middle East and North Africa region. Auvelity net product sales were $53.4 million for the first quarter of 2024, representing 240% year-over-year growth. Auvelity net product sales for the comparable period in 2023 were $15.7 million. Sunosi net product revenue was $21.6 million for the first quarter of 2024, consisting of $20.7 million in net product sales and $0.9 million in royalty revenue associated with sales in out-licensed territories, representing 64% year-over-year growth. Sunosi net product revenue for the comparable period in 2023 was $13.2 million, consisting of $12.9 million in net product sales and $0.3 million in royalty revenue. Total cost of revenue was $6.3 million for the first quarter of 2024. Total cost of revenue for the comparable period in 2023 was $7.6 million. The 2023 comparable period includes $5.0 million in out-license fee sharing expense. Research and development (R&D) expenses were $36.8 million for the first quarter of 2024, compared to $17.8 million for the comparable period in 2023, respectively. The increase was primarily related to the initiation and continuation of solriamfetol Phase 3 trials in major depressive disorder, binge eating disorder, and ADHD, ongoing trials of AXS-05 and AXS-12, manufacturing associated with the anticipated NDAs for AXS-07 and AXS-14, post-marketing commitments for Auvelity and Sunosi, and higher personnel costs including non-cash stock-based compensation. Selling, general, and administrative (SG&A) expenses were $99.0 million for the first quarter of 2024, compared to $74.2 million for the comparable period in 2023. The increase was primarily related to commercialization activities for Auvelity and Sunosi specifically around field force expansion and organizational growth, including non-cash stock-based compensation. Net loss for the first quarter of 2024 was $68.4 million or $(1.44) per share, compared to a net loss of $11.2 million, or $(0.26) per share for the comparable period in 2023. The net loss in the first quarter of 2024 reflects $21.0 million in non-cash charges. The 2023 comparable period includes $62.0 million in net gain from the Sunosi out-licensing. Cash and cash equivalents totaled $331.4 million at March 31, 2024, compared to $386.2 million at December 31, 2023. Shares of common stock outstanding were 47,464,575 at March 31, 2024. Financial Guidance ·Axsome believes that its current cash is sufficient to fund anticipated operations into cash flow positivity, based on the current operating plan. Commercial Highlights Auvelity Approximately 95,000 prescriptions were written for Auvelity in the first quarter of 2024, representing a 12% sequential increase versus the fourth quarter of 2023. Payer coverage for Auvelity across all channels is stable at approximately 70% of all covered lives. The proportion of lives covered in the commercial and government (Medicare and Medicaid) channels are approximately 48% and approximately 100%, respectively. Effective May 1, 2024, Axsome has contracted with a second large group purchasing organization (GPO) for potential formulary coverage of Auvelity. Pharmacy benefit managers and health plans under this GPO are now able to make coverage decisions for Auvelity based on the contracted terms. Axsome has now contracted with two of the three largest GPOs for Auvelity. Sunosi Approximately 42,000 prescriptions were written for Sunosi in the U.S. in the first quarter of 2024, representing an 1.6% decrease versus the fourth quarter of 2023. Sunosi maintains broad payer coverage in the commercial channel with 95% of lives covered. Currently 83% of total lives across all channels are covered. Development Pipeline Axsome is advancing an industry-leading neuroscience portfolio encompassing five innovative, late-stage, patent-protected product candidates for 10 serious psychiatric and neurologic conditions, which affect more than 150 million people in the U.S. alone. Recent and anticipated progress for key pipeline programs is summarized below. AXS-05 AXS-05 (dextromethorphan-bupropion) is Axsome’s novel, oral, investigational NMDA receptor antagonist and sigma-1 agonist being developed for Alzheimer’s disease (AD) agitation and smoking cessation. AXS-05 has been granted U.S. Food and Drug Administration (FDA) Breakthrough Therapy designation for AD agitation. Alzheimer’s Disease Agitation: Axsome is conducting the ADVANCE-2 study, a Phase 3, placebo-controlled, parallel group trial to evaluate the efficacy and safety of AXS-05 for the treatment of AD agitation. Patients completing ADVANCE-2 may enter a long-term open label safety extension trial. The Company anticipates completion of ADVANCE-2 in the second half of 2024. Axsome recently initiated the ACCORD-2 study, a Phase 3, double-blind, placebo-controlled, randomized withdrawal trial to evaluate the efficacy and safety of AXS-05 in the treatment of AD agitation. In this study, patients from the Company’s long-term open label safety extension trial are treated with AXS-05 and monitored for treatment response based on the Cohen-Mansfield Agitation Inventory (CMAI). Approximately 140 patients who experience a treatment response are planned to be randomized into the double-blind treatment period, in a 1:1 ratio, to continue treatment with AXS-05 or to switch to placebo, for up to 26 weeks or until a relapse of agitation occurs. The primary endpoint will be the time from randomization to relapse. The company anticipates completion of enrollment in this study around mid-year. ACCORD-2 adds a fourth controlled efficacy trial to the robust development program for AXS-05 in AD agitation, which now includes two parallel group trials (ADVANCE-1 and ADVANCE-2) and two randomized withdrawal trials (ACCORD-1 and ACCORD-2). Smoking Cessation: Axsome plans to initiate a pivotal Phase 2/3 trial in this indication in 2024. AXS-07 AXS-07 (MoSEIC™ meloxicam-rizatriptan) is Axsome’s novel, oral, rapidly absorbed, multi-mechanistic, investigational medicine for the acute treatment of migraine. Migraine: Activities for the resubmission of the Company’s New Drug Application (NDA) for AXS-07 for the acute treatment of migraine are nearing completion. The Company is on track to resubmit the NDA in the second quarter of 2024. No additional clinical efficacy or safety trials have been requested by the FDA for a resubmission of the NDA. The Company expects the NDA resubmission to be designated as Class 2 which would be subject to a six-month review. Axsome is conducting the EMERGE study, a multicenter, Phase 3, single-group trial evaluating the efficacy and safety of AXS-07 in the acute treatment of migraine headache in adults with a prior inadequate response to an oral CGRP inhibitor. The Company anticipates topline results from the EMERGE study in the second half of 2024. AXS-12 AXS-12 (reboxetine) is Axsome’s novel, oral, potent, investigational highly selective norepinephrine reuptake inhibitor and cortical dopamine modulator for the treatment of narcolepsy. AXS-12 has been granted FDA Orphan Drug designation for the treatment of narcolepsy. Narcolepsy: In March 2024, Axsome announced positive topline results from the SYMPHONY trial, a Phase 3, randomized, double-blind, multicenter, placebo-controlled trial of AXS-12 in patients with narcolepsy. AXS-12 achieved the primary endpoint by significantly reducing the frequency of cataplexy attacks as compared to placebo in patients with narcolepsy. AXS-12 also reduced excessive daytime sleepiness severity (EDS), improved cognitive function, reduced overall narcolepsy severity, and improved patient function and quality of life, as compared to placebo. AXS-12 was well tolerated in the trial. A Phase 3 open label safety extension trial of AXS-12 is currently ongoing with completion anticipated in the fourth quarter of 2024. In March 2024, the Company also announced topline results from the CRESCENDO (Characterizing Patient Perspectives on Unmet Needs in Narcolepsy) survey of 203 narcolepsy patients with cataplexy (narcolepsy type 1 or NT1) who are currently receiving treatment. The results demonstrated high rates of persistent symptoms with 77%, 64%, and 74% continuing to experience cataplexy, EDS, and cognitive impairment, respectively, despite being on current treatments. CRESCENDO was conducted by a third-party research firm that worked with Narcolepsy Network to ensure patient privacy. Narcolepsy Network is a national non-profit patient support organization for people with narcolepsy, idiopathic hypersomnia and related sleep disorders. AXS-14 AXS-14 (esreboxetine) is Axsome’s novel, oral, potent, highly selective investigational norepinephrine reuptake inhibitor for the management of fibromyalgia. Esreboxetine, the SS-enantiomer of reboxetine, is more potent and selective than racemic reboxetine. Fibromyalgia: Pre-submission activities for the Company’s NDA for AXS-14 for the management of fibromyalgia are nearing completion. The Company is targeting submission of the NDA in the second quarter of 2024. AXS-14 has previously met the primary endpoints and demonstrated positive and statistically significant results in a Phase 3 and in a Phase 2 trial for the management of fibromyalgia. Solriamfetol Solriamfetol is Axsome’s dopamine and norepinephrine reuptake inhibitor and TAAR1 agonist in development for the treatment of attention deficit hyperactivity disorder (ADHD), major depressive disorder (MDD), binge eating disorder (BED), and excessive sleepiness associated with shift work disorder (SWD). Attention Deficit Hyperactivity Disorder: Axsome is conducting the FOCUS study, a Phase 3, randomized, double-blind, placebo-controlled, multicenter trial to assess the efficacy and safety of solriamfetol for the treatment of ADHD in adults. The Company anticipates topline results from the FOCUS study in the second half of 2024. Major Depressive Disorder: In March 2024, Axsome initiated the PARADIGM study, a Phase 3, randomized, double-blind, placebo-controlled, multicenter trial of solriamfetol for the treatment of MDD. The Company anticipates topline results from the PARADIGM study in 2025. Binge Eating Disorder: In March 2024, Axsome initiated the ENGAGE study, a Phase 3, randomized, double-blind, placebo-controlled, multicenter trial of solriamfetol for the treatment of BED. The Company anticipates topline results from the ENGAGE study in 2025. Shift Work Disorder: The Company is on track initiate a Phase 3 trial of solriamfetol for the treatment of excessive sleepiness (ES) associated with SWD in the second quarter of 2024. Anticipated Milestones Regulatory and Commercial: AXS-07 for migraine, NDA resubmission (2Q 2024) AXS-14 for fibromyalgia, NDA submission (2Q 2024) Clinical Trial Topline Results: Phase 3 ADVANCE-2 trial of AXS-05 for Alzheimer’s disease agitation (2H 2024) Phase 3 open-label safety extension trial of AXS-12 in narcolepsy (2H 2024) Phase 3 FOCUS trial of solriamfetol in ADHD in adults (2H 2024) Phase 3 PARADIGM trial of solriamfetol in major depressive disorder (2025) Phase 3 ENGAGE trial of solriamfetol in binge eating disorder (2025) Phase 3 EMERGE trial of AXS-07 in migraine with inadequate response to oral CGRP inhibitors (2H 2024) Clinical Trial Initiations and Progress: Phase 3 trial of solriamfetol in shift work disorder, initiation (2Q 2024) Phase 3 ACCORD-2 trial of AXS-05 for Alzheimer's disease agitation, enrollment completion (mid-year 2024) Pivotal Phase 2/3 trial of AXS-05 for smoking cessation, initiation (2024) Conference Call Information Axsome will host a conference call and webcast today at 8:00 AM Eastern to discuss first quarter 2024 financial results as well as to provide a corporate update. To participate in the live conference call, please dial (877) 405-1239 (toll-free domestic). The live webcast can be accessed on the "Webcasts & Presentations" page of the "Investors" section of the Company’s website at axsome.com. A replay of the webcast will be available for approximately 30 days following the live event. 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 Therapeutics, Inc. Selected Consolidated Financial Data Axsome Therapeutics, Inc. Consolidated Balance Sheets (In thousands, except share and per share amounts) March 31, December 31, 2024 2023 (Unaudited) Assets Current assets: Cash and cash equivalents $ 331,441 $ 386,193 Accounts receivables, net 101,434 94,820 Inventories, net 15,583 15,135 Prepaid and other current assets 12,032 8,115 Total current assets 460,490 504,263 Equipment, net 812 846 Right-of-use asset - operating lease 6,411 6,772 Goodwill 12,042 12,042 Intangible asset, net 51,697 53,286 Non-current inventory and other assets 14,276 11,027 Total assets $ 545,728 $ 588,236 Liabilities and stockholders’ equity Current liabilities: Accounts payable $ 53,791 $ 40,679 Accrued expenses and other current liabilities 82,716 90,501 Operating lease liability, current portion 1,153 1,267 Contingent consideration, current 6,388 6,407 Total current liabilities 144,048 138,854 Contingent consideration, non-current 70,000 73,300 Loan payable, long-term 178,689 178,070 Operating lease liability, long-term 7,258 7,035 Finance lease liability, long-term 1,697 — Total liabilities 401,692 397,259 Stockholders’ equity: Preferred stock, $0.0001 par value per share (10,000,000 shares authorized, none issued and outstanding) — — Common stock, $0.0001 par value per share (150,000,000 shares authorized, 47,464,575 and 47,351,363 shares issued and outstanding at March 31, 2024 and December 31, 2023, respectively) 5 5 Additional paid-in capital 1,047,959 1,026,543 Accumulated deficit (903,928 ) (835,571 ) Total stockholders’ equity 144,036 190,977 Total liabilities and stockholders’ equity $ 545,728 $ 588,236 Axsome Therapeutics, Inc. Consolidated Statements of Operations (Unaudited) (In thousands, except share and per share amounts) Three months ended March 31, 2024 2023 Revenues: Product sales, net $ 74,096 $ 28,569 License revenue — 65,735 Royalty revenue 903 272 Total revenues 74,999 94,576 Operating expenses: Cost of revenue (excluding amortization and depreciation) 6,297 7,556 Research and development 36,830 17,793 Selling, general and administrative 98,970 74,191 Gain in fair value of contingent consideration (1,412 ) (162 ) Intangible asset amortization 1,589 1,572 Total operating expenses 142,274 100,950 Loss from operations (67,275 ) (6,374 ) Interest expense, net (1,082 ) (2,264 ) Loss before income taxes (68,357 ) (8,638 ) Income tax expense — (2,580 ) Net loss $ (68,357 ) $ (11,218 ) Net loss per common share, basic and diluted $ (1.44 ) $ (0.26 ) Weighted average common shares outstanding, basic and diluted 47,393,563 43,523,631 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