Synthetic Biologics (SYN) Misses Q3 EPS by 3c

Synthetic Biologics (NYSE: SYN) reported Q3 EPS of ($0.08), $0.03 worse than the analyst estimate of ($0.05).

Clinical Programs Update

Prevention of C. difficile (C. diff) Infections – SYN-004 Oral Beta-Lactamase Enzyme

• Clinical drug manufacturing under cGMP guidelines commenced in the third quarter with a vastly improved process utilized by supplier Evonik.
• Preclinical data further validating the SYN-004 approach were presented at two scientific forums – IDWeek and the 54th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC).
• U.S. Notice of Allowance for the first composition of matter patent directly related to SYN-004's unique properties was issued.
• Phase 1a and 1b clinical studies remain on track to initiate within the next 30 days.
• Topline data from Phase 1 studies expected before year-end 2014.

Relapsing-Remitting Multiple Sclerosis (RRMS) – Trimesta™ (oral estriol)

• Expanded efficacy and safety results from the investigator-initiated Phase 2 trial evaluating adjunctive Trimesta in women with RRMS including positive results on cognitive and disability scores at 12 months, attesting to Trimesta's unique neuroprotective properties, were presented at the ACTRIMS-ECTRIMS meeting in Boston in September by the trial's lead investigator.
• A separate Phase 2 trial focused exclusively on cognition utilizing Trimesta with a variety of currently marketed MS drugs, including Copaxone®, Avonex®, Betaseron®, Extavia®, Rebif®, Gilenya®, Aubagio® and Tecfidera®, is enrolling patients at four sites in the United States.
• Active discussions with a number of potential strategic partners may accelerate development of this innovative therapy for relapsing-remitting MS in women.
• MRI brain scan analyses are ongoing to evaluate changes in the brain that correlate with improvements seen in clinical outcomes; topline data expected during the first quarter of 2015.

Constipation-Predominant Irritable Bowel Syndrome (C-IBS) – SYN-010 Statin-Class Oral Compound

• Strengthened Clinical Advisory Board (CAB) to support the development of SYN-010; CAB is comprised of prominent gastrointestinal (GI) key opinion leaders: Mark Pimentel, M.D., (Chair), William Chey, M.D., Gail M. Comer, M.D., Anthony J. Lembo, M.D., and Philip Schoenfeld, M.D., MSEd, MSc.
• In September, announced the SYN-010 statin-class formulation at an IBS Investor Day in New York. Keynote speaker, Dr. Pimentel, provided an overview of the clinical development strategy for clinical candidate SYN-010.
• Anticipating a 505(b)(2) regulatory pathway for SYN-010, a corporate Investigational New Drug (IND) application is expected to be filed with the FDA in the first quarter of 2015 with the initiation of a Phase 2 clinical trial of SYN-010 in C-IBS anticipated in the first half of 2015.

Pertussis (Whooping Cough) – SYN-005 Monoclonal Antibody (mAb) Combination

• SYN-005 was granted U.S. Orphan Drug Designation by the FDA for the treatment of Pertussis.
• Increased awareness of SYN-005's novel mAbs combination designed to target and neutralize pertussis toxin were the topic of an oral presentation at ICAAC. Neutralizing pertussis toxin is anticipated to decrease morbidity and mortality in critically ill infants.
• An IND is expected to be filed in 2015, with plans to initiate a Phase 1 clinical trial in second half of 2015.

For earnings history and earnings-related data on Synthetic Biologics (SYN) click here.

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