Quarterly report pursuant to Section 13 or 15(d)

Organization and Description of Business

v3.19.2
Organization and Description of Business
6 Months Ended
Jun. 30, 2019
Accounting Policies [Abstract]  
Organization and Description of Business
1. Organization and Description of Business
Organization and Business
ContraFect Corporation (the “Company”) is a clinical-stage biotechnology company focused on biologic therapeutic products for life-threatening infectious diseases, particularly those treated in hospital-based settings. The Company intends to address multi-drug resistant infections using its therapeutic product candidates from its portfolio of direct lytic agents (DLAs), including lysins and amurin peptides. The Company’s most advanced product candidate is exebacase, a lysin which targets
Staph aureus
, including methicillin-resistant strains, which causes serious infections such as bacteremia, pneumonia and osteomyelitis.
Staph aureus
is also a frequent cause of biofilm-associated infections of heart valves (endocarditis), prosthetic joints, indwelling devices and catheters. These infections result in significant morbidity and mortality despite current antibiotic therapy. The Company has completed a Phase 2 superiority design study of exebacase as a treatment for
Staph aureus
bacteremia, including endocarditis. The study evaluated and compared the safety, tolerability, efficacy and pharmacokinetics of exebacase when used in addition to standard-of-care (SOC) antibiotics to SOC antibiotics alone. The Company intends to initiate a Phase 3 trial of exebacase based on the positive data generated from the Phase 2 study.
The Company has incurred losses from operations since inception as a research and development organization and has an accumulated deficit of $196.4 million as of June 30, 2019. For the six months ended June 30, 2019, the Company used $16.1 million of cash in operations. The Company expects operating losses and negative cash flows to continue at significant levels in the future as it continues its clinical trials. Without additional funding, the Company believes it will not have sufficient funds to meet its obligations within the next twelve months from the date of issuance of these consolidated financial statements. These factors raise substantial doubt about the Company’s ability to continue as a going concern. The Company plans to continue to fund its operations through public or private debt and equity financings, but there can be no assurances that such financing will continue to be available to the Company on satisfactory terms, or at all. As such, under the requirements of ASC
205-40,
management may not consider the potential for future capital raises in its assessment of the Company’s ability to meet its obligations for the next twelve months. If the Company is unable to obtain funding, the Company would be forced to delay, reduce or eliminate its research and development programs, which could adversely affect its business prospects, or the Company may be unable to continue operations.
The consolidated financial statements have been prepared assuming that the Company will continue as a going concern, which contemplates continuity of operations, the realization of assets and the satisfaction of liabilities and commitments in the normal course of business.