v3.26.1
Nature of Business and Basis of Presentation
6 Months Ended
Jun. 30, 2026
Organization, Consolidation and Presentation of Financial Statements [Abstract]  
Nature of Business and Basis of Presentation

Note 1. Nature of Business and Basis of Presentation

Axsome Therapeutics, Inc. (“Axsome” or the “Company”), based in New York, New York, is a biopharmaceutical company dedicated to the development and commercialization of innovative medicines to improve the brain health of individuals living with central nervous system (“CNS”) conditions. Axsome has a broad and diverse commercial portfolio of four U.S. Food and Drug Administration (“FDA”) approved treatments for major depressive disorder, agitation associated with dementia due to Alzheimer’s disease (AADDAD), excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea, and migraine. Additionally, Axsome is advancing a deep pipeline of numerous novel product candidates in early- to late-stage development targeting a range of serious, underserved conditions across psychiatry and neurology that collectively impact over 150 million people in the United States.

SUNOSI® is a novel, oral, dopamine and norepinephrine reuptake inhibitor (DNRI), trace amine-associated receptor 1 (TAAR1) agonist, and 5-HT1A agonist approved in the United States, the European Union, and Canada for the treatment of excessive daytime sleepiness in adult patients with obstructive sleep apnea or narcolepsy. SUNOSI was approved by the FDA in March 2019, by the European Commission in January 2020, and by Health Canada in May 2021. The Company acquired the U.S. rights to SUNOSI in May 2022 and, in November 2022, acquired worldwide ex-U.S. rights, excluding certain Asian markets. In February 2023, the Company announced a licensing transaction with Atnahs Pharma UK Limited (“Pharmanovia”) to market SUNOSI in Europe and certain countries in the Middle East / North Africa.

AUVELITY® (dextromethorphan-bupropion), also referred to as “AXS-05”, was developed by the Company and approved by the FDA in August 2022 as the first and only oral, N-methyl-D-aspartate (NMDA) receptor antagonist for the treatment of major depressive disorder in adults (MDD). The Company initiated the commercial availability of AUVELITY in October 2022. In April 2026, the FDA approved AUVELITY for the treatment of AADDAD. The Company initiated the commercial launch of AUVELITY for the treatment of AADDAD in June 2026.

SYMBRAVO® (MoSEICTM meloxicam-rizatriptan) is a novel, oral, rapidly absorbed, multi-mechanistic, selective COX-2 inhibitor and 5-HT1B/1D agonist that was developed by the Company and approved by the FDA in January 2025 for the acute treatment of migraine with or without aura in adults. The Company initiated the commercial availability of SYMBRAVO in June 2025.

In November 2025, the Company acquired global rights to AXS-17, a novel oral GABAA receptor α2,3 subtype-selective positive allosteric modulator (PAM). The Company plans to evaluate AXS-17 as a potential treatment for epilepsy. In December 2025, the Company acquired global rights to deuterium-stabilized S-bupropion. In the first quarter of 2026, the Company acquired AXS-20, a selective PDE10A inhibitor. The Company plans to initially develop AXS-20 in schizophrenia and Tourette syndrome.

The Company refers herein to AUVELITY, SUNOSI, SYMBRAVO (also referred to as “AXS-07”), AXS-12, AXS-14, AXS-17, AXS-20 and its programs to develop additional indications for AXS-05 and solriamfetol as the Company’s products.

The accompanying unaudited interim consolidated financial statements have been prepared by the Company in accordance with accounting principles generally accepted in the United States (“GAAP”) for interim information and pursuant to the rules and regulations of the Securities and Exchange Commission (the “SEC”) for reporting on Form 10-Q. Accordingly, certain information and footnote disclosures normally included in financial statements prepared in accordance with GAAP have been condensed or omitted pursuant to such rules and regulations. These unaudited interim consolidated financial statements should be read in conjunction with the audited financial statements and related notes included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025, filed with the SEC on February 23, 2026.

In the opinion of management, the unaudited interim consolidated financial statements reflect all adjustments, which are normal recurring adjustments, necessary for the fair presentation of the financial information for the interim periods. The results of operations for the three and six months ended June 30, 2026 are not necessarily indicative of the operating results for the full fiscal year or any future period.

Liquidity and Capital Resources

The Company has incurred operating losses since its inception and expects to continue to incur operating losses and may never become profitable. As of June 30, 2026, the Company had an accumulated deficit of $1,421.8 million.

The Company’s primary sources of cash have been proceeds from the sales of AUVELITY, SUNOSI, and SYMBRAVO, the issuance and sale of its common stock in public offerings, and the issuance of debt. The Company’s ability to achieve profitability depends on a number of factors, including its ability to obtain regulatory approval for its product candidates, successfully complete any post-approval regulatory obligations and successfully commercialize its product candidates alone or in partnership with third parties. The Company may continue to incur substantial operating losses even as it continues to generate revenues from its products.

The Company believes its existing cash will be sufficient to fund its anticipated operating cash requirements for at least twelve months following the date of this filing. During that time, the Company expects that its expenses will increase primarily due to the commercialization of AUVELITY, SUNOSI, and SYMBRAVO while continuing to further develop the Company’s pipeline assets. The Company may use a combination of public and private equity offerings, debt financings, other third-party funding, strategic alliances, licensing arrangements or marketing and distribution arrangements if market conditions are favorable or as a result of other strategic considerations to finance its future cash needs.

The Company’s common stock is listed on The Nasdaq Global Market and trades under the symbol “AXSM.”