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Organization and Nature of Operations and Basis of Presentation
6 Months Ended
Jun. 30, 2014
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 biotechnology company focused on the development of novel anti-infective biologic and drug candidates targeting specific pathogens that cause serious infections and diseases. The Company is developing an oral biologic to protect the gastrointestinal (GI) microflora from the effects of intravenous (IV) antibiotics for the prevention of C. diff infection, an oral treatment to reduce the impact of methane producing organisms on constipation-predominant irritable bowel syndrome (C-IBS), a series of monoclonal antibodies for the treatment of Pertussis and Acinetobacter infections, and a biologic targeted at the prevention and treatment of a root cause of a subset of IBS. In addition, the Company is developing an oral estriol drug for the treatment of relapsing-remitting multiple sclerosis (MS) and cognitive dysfunction in MS.
 
Therapeutic Area
 
Product Candidate
 
Status
 
 
 
 
 
Relapsing-remitting MS
 
Trimesta
(oral estriol)
 
Patient follow-up is complete in the Phase II trial and topline results were reported in April 2014. The lead principal investigator from University of California, Los Angeles (UCLA) is scheduled to present additional Phase II clinical outcome data, including more detailed results on improvements in cognitive and disability measures at the ACTRIMS-ECTRIMS Joint Meeting in September 2014
 
 
 
 
 
Cognitive dysfunction in MS
 
Trimesta
(oral estriol)
 
Patient enrollment underway in Phase II clinical trial
 
 
 
 
 
C. difficile infection prevention
 
SYN-004
(oral enzyme)
 
SYN-004, second generation candidate in preclinical studies; Intend to initiate Phase Ia and Ib clinical trials
during 2nd half of 2014
 
 
 
 
 
Constipation-predominant irritable bowel syndrome (C-IBS)
 
SYN-010
(oral compound)
 
Planning for in vivo studies underway; Intend to initiate Phase II clinical trial during 2nd half of 2014; Collaboration with Cedars-Sinai Medical Center
 
 
 
 
 
Pertussis
 
SYN-005
(monoclonal antibody)
 
Positive preclinical research findings reported in
April 2014; Collaborations with Intrexon and
The University of Texas at Austin
 
 
 
 
 
Acinetobacter infection
 
SYN-001
(monoclonal antibody)
 
Discovery; Collaboration with Intrexon
 
 
 
 
 
IBS
 
SYN-007
(biologic)
 
Discovery; We are still evaluating the option;
Collaboration with Intrexon
 
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, 2013 (“2013 Form 10-K”) as filed with the SEC. The interim results for the three and six months ended June 30, 2014, 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.  
 
Change in Filing Status
 
On June 30, 2014, the Company exceeded the $75.0 million public float threshold to trigger accelerated filer status with the SEC. Consequently the Company is no longer a Smaller Reporting Company (SRC) and the Company’s auditors must provide an auditor attestation on our internal controls to be included in the Company’s Form 10-K for the year ending December 31, 2014. Such Form 10-K will continue to provide scaled SRC-level disclosures; the larger reporting company disclosures will commence in the Company’s Form 10-Q for the three months ended March 31, 2015.