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Organization and Nature of Operations and Basis of Presentation
12 Months Ended
Dec. 31, 2013
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 other diseases. The Company is developing an oral treatment to reduce the impact of methane producing organisms on constipation-predominant irritable bowel syndrome (C-IBS), an oral biologic to protect the GI microflora from the effects of IV antibiotics for the prevention of C. diff infection, 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 has two legacy programs. The Company is developing an oral estriol drug for the treatment of relapsing-remitting multiple sclerosis (MS) and cognitive dysfunction in MS. The Company has also partnered the development of a treatment for fibromyalgia.
 
Therapeutic Area
 
Product Candidate
 
Status
 
 
 
 
 
Relapsing-remitting MS
 
Trimesta
  (oral estriol)
 
Topline results to be presented by lead principal investigator at American Academy of Neurology Annual Meeting in April 2014
 
 
 
 
 
Cognitive dysfunction in MS
 
Trimesta
  (oral estriol)
 
Patient enrollment underway in Phase II clinical trial
 
 
 
 
 
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
 
 
 
 
 
C. difficile infection prevention
 
SYN-004
   (oral enzyme)
 
SYN-004, second generation candidate in preclinical;
Intend to initiate Phase Ia and Ib clinical trials
during 2nd half of 2014
 
 
 
 
 
Pertussis
 
SYN-005
   (monoclonal antibody)
 
Preclinical; Intend to report additional topline results from large animal study during 2nd quarter of 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; Collaboration with Intrexon
 
 
 
 
 
Fibromyalgia
 
Effirma
   (oral flupirtine)
 
Partnered with Meda AB
 
In addition, the Company is seeking development partners for its zinc-based intellectual property and assets including, AEN-100.
 
Basis of Presentation and Corporate Structure
 
As of December 31, 2013, the Company had eight subsidiaries, Pipex Therapeutics, Inc. (“Pipex Therapeutics”), Effective Pharmaceuticals, Inc. (“EPI”), Solovax, Inc. (“Solovax”), CD4 Biosciences, Inc. (“CD4”), Epitope Pharmaceuticals, Inc. (“Epitope”), Healthmine, Inc. (“Healthmine”), Putney Drug Corp. (“Putney”) and Synthetic Biomics, Inc. (“Synthetic Biomics”). As of December 31, 2013, Pipex Therapeutics, EPI, Healthmine and Putney are wholly owned, and Solovax, CD4, Epitope and Synthetic Biomics are majority-owned.
 
For financial reporting purposes, the outstanding common stock of the Company is that of Synthetic Biologics, Inc. All statements of operations, equity and cash flows for each of the entities are presented as consolidated. All subsidiaries were formed under the laws of the State of Delaware on January 8, 2001, except for EPI, which was incorporated in Delaware on December 12, 2000, Epitope which was incorporated in Delaware in January of 2002, Putney which was incorporated in Delaware in November of 2006, Healthmine which was formed in Delaware in December of 2007 and Synthetic Biomics which was incorporated in Nevada in December of 2013.
 
On March 8, 2012, the Company sold all of its interest in Adeona Clinical Laboratory, LLC (the “Lab”) to Hartlab, LLC, an entity controlled by the Lab’s former owner, in consideration for (i) the immediate assignment of the Lab’s outstanding accounts receivable up through the date of closing, plus (ii) $700,000 payable pursuant to the terms of a two-year non-recourse promissory note secured by all the assets of the Lab. Accordingly, this business has been presented in the consolidated financial statements as discontinued operations. During September 2013, the note receivable and associated interest receivable were deemed uncollectible. Accordingly, the Company recorded bad debt expense of $763,000. This transaction is described in more detail in Note 3 - Discontinued Operations of Adeona Clinical Laboratory.