Organization and Description of the Business
|6 Months Ended|
Jun. 30, 2020
|Organization and Description of the Business|
|Organization and Description of the Business||
1. Organization and Description of the Business
Trevena, Inc., or the Company, was incorporated in Delaware as Parallax Therapeutics, Inc. on November 9, 2007. The Company began operations in December 2007, and its name was changed to Trevena, Inc. on January 3, 2008. The Company is a biopharmaceutical company focused on the development and commercialization of novel medicines for patients affected by central nervous system, or CNS, disorders. The Company operates in one segment and has its principal office in Chesterbrook, Pennsylvania.
Since commencing operations in 2007, the Company has devoted substantially all of its financial resources and efforts to research and development, including nonclinical studies and clinical trials. The Company has never been profitable and has not yet commenced commercial operation. In late 2017, the Company submitted a new drug application or the NDA, for OLINVYK to the United States Food and Drug Administration, or the FDA. In November 2018, the FDA, issued a complete response letter, or the CRL, which requested the Company to generate additional clinical and nonclinical data. In the CRL, the FDA requested additional clinical data on the QT interval and indicated that the submitted safety database was not of adequate size for the proposed labeling. The FDA also requested certain additional nonclinical data and validation reports. Throughout 2019, the Company completed the additional studies and the nonclinical work requested by the FDA. In February 2020, the Company resubmitted the OLINVYK NDA to address the CRL and in March 2020, the FDA set a Prescription Drug User Fee Act, or PDUFA, goal date of August 7, 2020 for the completion of its review of the NDA. On August 7, 2020, the FDA approved the NDA for OLINVYK.
Since its inception, the Company has incurred losses and negative cash flows from operations. At June 30, 2020, the Company had an accumulated deficit of $425.1 million. The Company’s net loss was $11.9 million and $9.9 million for the six months ended June 30, 2020 and 2019, respectively. The Company follows the provisions of Financial Accounting Standards Board, or FASB, Accounting Standards Codification, or ASC, Topic 205-40, Presentation of Financial Statements—Going Concern, which requires management to assess the Company’s ability to continue as a going concern for one year after the date the financial statements are issued. The Company expects that its existing balance of cash and cash equivalents as of June 30, 2020 is sufficient to fund operations for more than one year after the date of this filling, through year-end 2021. There can be no assurance that the Company will be successful in raising additional capital or that such capital, if available, will be on terms that are acceptable to the Company, or that the Company will be successful in deferring certain operating expenses, or that the COVID-19 pandemic will not have an impact on the Company’s ability to raise capital or fund its operations as planned. If the Company is unable to raise sufficient additional capital or defer sufficient operating expenses, the Company may be compelled to reduce the scope of its operations and planned capital expenditures.
The entire disclosure for organization, consolidation and basis of presentation of financial statements disclosure.
Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef