Organization and Description of the Business

12 Months Ended

Dec. 31, 2015

Organization and Description of the Business

Organization and Description of the Business

1. Organization and Description of the Business

We are a clinical stage biopharmaceutical company focused on developing and commercializing innovative therapeutics to treat epilepsy and neuropsychiatric disorders. Our clinical stage product candidate, ganaxolone, is a CNS‑selective GABA_A modulator being developed in three different dose forms (IV, oral capsule and oral liquid) intended to provide more treatment options to adult and pediatric patient populations in both acute and chronic care settings. Ganaxolone acts on the GABA_A receptor, a well‑characterized target in the brain known for both anti‑seizure and anti‑anxiety effects through positive allosteric modulation.  Our primary focus to date has been directed towards developing business strategies, raising capital, conducting research and development activities, and conducting preclinical testing and human clinical trials of our product candidates.

Liquidity

We have not generated any product revenues and have incurred operating losses since inception. There is no assurance that profitable operations will ever be achieved, and if achieved, could be sustained on a continuing basis. In addition, development activities, clinical and preclinical testing, and commercialization of our product candidates will require significant additional financing. Our accumulated deficit as of December 31, 2015 was $97.2 million and we expect to incur substantial losses in future periods.  We plan to finance our future operations with a combination of proceeds from the issuance of equity securities, the issuance of additional debt, potential collaborations and revenues from potential future product sales, if any. We have not generated positive cash flows from operations, and there are no assurances that we will be successful in obtaining an adequate level of financing for the development and commercialization of our planned product candidates.

In connection with the closing of a secondary public offering during the fourth quarter of 2015, we issued a total of 5,056,003 shares of common stock resulting in aggregate net proceeds, after underwriting discounts and commissions and other estimated offering expenses, of approximately $28.1 million.   We believe that our cash, cash equivalents and investment balance as of December 31, 2015 is adequate to fund our operations into the second half of 2017.