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Nature of Business and Basis of Presentation
9 Months Ended
Sep. 30, 2016
Nature of Business and Basis of Presentation  
Nature of Business and Basis of Presentation

Axsome Therapeutics, Inc.

Notes to Consolidated Financial Statements (Unaudited)

 

Note 1. Nature of Business and Basis of Presentation

Axsome Therapeutics, Inc. (“Axsome” or the “Company”) was incorporated on January 12, 2012 in the State of Delaware. The Company is a clinical-stage biopharmaceutical company developing novel therapies for the management of central nervous system (“CNS”) disorders for which there are limited existing treatment options. Axsome’s product candidate portfolio includes two late-stage candidates, AXS-02 and AXS-05. AXS-02 is currently in Phase 3 trials in complex regional pain syndrome (“CRPS”) and knee osteoarthritis (“OA”) associated with bone marrow lesions (“BMLs”) with an additional Phase 3 trial planned in chronic low back pain (“CLBP”) associated with Modic changes (“MCs”). AXS-05 is currently in a Phase 3 trial in treatment resistant depression (“TRD”), and a Phase 2/3 trial in agitation in patients with Alzheimer’s disease (“AD”) is planned.

The accompanying unaudited interim consolidated financial statements have been prepared by the Company in accordance with accounting principles generally accepted in the United States (“U.S. 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 disclosure normally included in financial statements prepared in accordance with U.S. GAAP have been condensed or omitted pursuant to such rules and regulations. These 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/A for the year ended December 31, 2015 filed with the SEC on August 9, 2016.

 

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 nine months ended September 30, 2016 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 for the foreseeable future and may never become profitable. As of September 30, 2016, the Company had an accumulated deficit of $40.3 million.

The Company’s primary sources of cash have been proceeds from its initial public offering and through private placements of its convertible notes. The Company has not yet commercialized any of its product candidates and cannot be sure if it will ever be able to do so. Even if the Company commercializes one or more of its product candidates, it may not become profitable. 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. The Company may continue to incur substantial operating losses even if it begins to generate revenues from its product candidates.

 

As of September 30, 2016, the Company had $33.9 million in cash. The Company currently anticipates its cash, along with the net proceeds from its debt financing in November 2016 (see Note 8 – Subsequent Event) to be sufficient to fund its anticipated operating cash requirements through the end of 2017. The actual amount of cash that the Company will need to operate is subject to many factors, including, but not limited to, the timing, design and conduct of clinical trials for its product candidates. The Company is dependent upon significant future financing to provide the cash necessary to execute its current operations, including the commercialization of any of its product candidates.

 

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