XML 27 R6.htm IDEA: XBRL DOCUMENT v3.3.0.814
Organization and Nature of Operations and Basis of Presentation
9 Months Ended
Sep. 30, 2015
Organization, Consolidation and Presentation of Financial Statements [Abstract]  
Organization, Consolidation and Presentation of Financial Statements Disclosure [Text Block]
1.
Organization and Nature of Operations and Basis of Presentation
 
Description of Business
 
Synthetic Biologics, Inc. (the “Company” or “Synthetic Biologics”) is a clinical-stage company developing therapeutics to protect the gut microbiome while targeting pathogen-specific diseases. The Company’s lead candidates in Phase 2 development include: (1) SYN-004 which is designed to protect the gut microbiome (gastrointestinal (GI) microflora) from the effects of certain commonly used intravenous (IV) beta-lactam antibiotics for the prevention of C. difficile infection (CDI) and antibiotic-associated diarrhea (AAD), and (2) SYN-010 which is intended to reduce the impact of methane-producing organisms in the gut microbiome to treat an underlying cause of irritable bowel syndrome with constipation (IBS-C). In addition, the Company is developing a Phase 2 oral estriol drug, TrimestaTM, for the treatment of relapsing-remitting multiple sclerosis (MS) and cognitive dysfunction in MS, and in collaboration with Intrexon Corporation (NYSE: XON), a preclinical stage monoclonal antibody for the prevention and treatment of Pertussis, and novel discovery stage biotherapeutics for the treatment of phenylketonuria (PKU).
  
Therapeutic Area
 
Product Candidate
 
Status
 
 
 
 
 
Prevention of CDI and AAD
 
SYN-004
 
 
 
 
(oral enzyme)
 
Phase 2
 
 
 
 
 
IBS-C
 
SYN-010
 
 
 
 
(oral compound)
 
Phase 2
 
 
 
 
 
Relapsing-remitting MS
 
Trimesta
 
 
 
 
(oral estriol)
 
Phase 2
 
 
 
 
 
Cognitive dysfunction in MS
 
Trimesta
 
 
 
 
(oral estriol)
 
Phase 2
 
 
 
 
 
Prevention/Treatment of
 
SYN-005
 
 
Pertussis (whooping cough)
 
(monoclonal antibody)
 
Preclinical
 
Basis of Presentation
 
The accompanying consolidated financial statements have been prepared pursuant to the rules and regulations of Securities and Exchange Commission (“SEC”) for interim financial information. Accordingly, they do not include all of the information and notes required by U.S. Generally Accepted Accounting Principles (“GAAP”) for complete financial statements. The accompanying consolidated financial statements include all adjustments, comprised of normal recurring adjustments, considered necessary by management to fairly state our results of operations, financial position and cash flows. The operating results for the interim periods are not necessarily indicative of results that may be expected for any other interim period or for the full year. These consolidated financial statements should be read in conjunction with the consolidated financial statements and notes thereto included in our Annual Report on Form 10-K for the year ended December 31, 2014 (“2014 Form 10-K”) as filed with the SEC. The interim results for the three and nine months ended September 30, 2015, are not necessarily indicative of results for the full year.
 
The consolidated financial statements are prepared in conformity with U.S. GAAP, which requires the use of estimates, judgments and assumptions that affect the amounts of assets and liabilities at the reporting date and the amounts of revenue and expenses in the periods presented. We believe that the accounting estimates employed are appropriate and the resulting balances are reasonable; however, due to the inherent uncertainties in making estimates actual results could differ from the original estimates, requiring adjustments to these balances in future periods.