Follow the Money to Bio/Pharmaceutical Opportunities
Spotlight on Synthetic Biologics, Inc.

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Follow the Money to Bio/Pharmaceutical Opportunities highlights a newly funded bio/pharmaceutical company. This includes important insights into the featured company’s product pipeline, manufacturing and business relationships, and likely sourcing opportunities.

Synthetic Biologics, formerly known as Adeona Pharmaceuticals, is a U.S. public bio/pharmaceutical company that develops late-stage, orally available, small molecule drugs for the treatment of neurological and fibrotic diseases. It plans to raise $25 million in a secondary public offering, as reported in the PharmSource Lead Sheet on November 17, 2016.

Corporate Highlights

  • Synthetic Biologics was first incorporated in Delaware in 1986 under the name Sheffield Pharmaceuticals.
  • Corporate Headquarters: Rockville, MD – approximately 5,365 square feet of office space
  • Facility: Ann Arbor, MI – administrative and finance office
  • As of March 8, 2016, they had 27 employees
  • Stock Exchange: NYSE
  • Stock Symbol: SYN

Sourcing Opportunities

  • Synthetic Biologics plans to use the proceeds to fund the clinical development of its pipeline, including:
    • SYN-010 – To complete a Phase II study:
      • For treatment of irritable bowel syndrome with constipation
      • Dosage Form: Oral – Solid
      • Nature of API: Chemical – Normal potency
      • Therapeutic Area: Gastrointestinal
    • SYN-004 – To complete a Phase IIb study:
      • For treatment of C. difficile infections and antibiotic-associated diarrhea
      • Dosage Form: Capsule
      • Nature of API: Biologic – Protein – Enzyme; Biologic – Protein – Recombinant
      • Therapeutic Area: Gastrointestinal; Antibacterial
  • The company contracts with contract research organizations (CROs) to conduct clinical trials.
  • Synthetic Biologics does not own or operate manufacturing facilities and currently has no plans to build their own. They currently rely on third party contract manufacturers for all required raw materials, API and finished product for preclinical studies and clinical trials.
  • Synthetic Biologics has no sales, marketing and distribution capabilities.

Business Relationships

  • In August 2015, Synthetic Biologics and Intrexon Corporation entered into an Exclusive Channel Collaboration (ECC) for the development and commercialization of biotherapeutics for the treatment of phenylketonuria. Under the terms of the agreement, Synthetic Biologics paid a $3 million access fee to use Intrexon’s technology, and will pay up to $27 million in milestone payments.
  • In July 2013, Synthetic Biologics and FUJIFILM Diosynth Biotechnologies UK Limited (Fujifilm) initiated the manufacturing process of SYN-004 for the treatment of C. difficile infections. Fujifilm used its pAVEway™ platform for production cell line yields and biological activity of the enzyme product.
  • In August 2012, Synthetic Biologics and Intrexon Corporation entered into a second worldwide exclusive collaboration where Synthetic Biologics intended to develop and commercialize a series of monoclonal antibody therapies targeting three infectious disease indications utilizing Intrexon’s genetic, protein-based and cell-based engineering technologies. Synthetic Biologics issued Intrexon approximately 3.6 million shares of its common stock as a technology access fee upon execution of the agreement.1

Drug Product Pipeline

Product Candidate Indication Dosage Form Status Next Anticipated Step
SYN-010 Irritable bowl syndrome with constipation Oral – Solid Phase II Initiate a Phase III trial
SYN-004 C. difficile infections and antibiotic-associated diarrhea Capsule Phase IIb Results expected in Q1 of 2017

Finances

(In $ thousands) 2015 2014
Revenues
R&D Expenditures
32,906
14,489
General & Administrative Expenditures
8,074
6,013
Total Operating Expenses
40,980
20,502

1Synthetic Biologics, Inc. 3/10/16 10-K, SEC.gov

Contact Information

Synthetic Biologics, Inc. Key Officers
9605 Medical Center Drive, Suite 270 Jeff Riley, President & CEO
Rockville, MD 20850 USA John Monahan, PhD, EVP, R&D
Phone: +1-301-417-4364 Joseph Sliman, MD, SVP, Clinical & Regulatory Affairs
Fax: +1-301-417-4367 Amy Sloan, VP, Regulatory Affairs
Web: www.syntheticbiologics.com Maureen Early, VP, Commercial

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Scotty is a Research Analyst at PharmSource. He holds a BS degree in Biology from George Mason University and an MPH degree from Eastern Virginia Medical School. He’s experienced in data collection, analysis and management, and has done laboratory analysis and safety program development.

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