Synthetic Biologics (SYN) Misses Q3 EPS by 8c

Synthetic Biologics (NYSE: SYN) reported Q3 EPS of ($0.31), $0.08 worse than the analyst estimate of ($0.23).

"During the third quarter, we remained sharply focused on the advancement of our portfolio of GI-focused clinical programs which leverage the microbiome to improve the health of patients," stated Steven A. Shallcross, Chief Executive and Financial Officer. "We were pleased to announce our clinical trial collaboration with Washington University School of Medicine in St. Louis ("Washington University") to conduct a Phase 1b/2a clinical trial of SYN-004 (ribaxamase). The announcement of this agreement is an important step in our pursuit of a more cost-effective development strategy for our SYN-004 (ribaxamase) program aimed at improving clinical outcomes of high-risk patients who undergo allogeneic hematopoietic cell transplantation (HCT) and receive long courses of intravenous (IV) beta-lactam antibiotics. Looking ahead, we intend to hold a Type-C meeting with the U.S. Food & Drug Administration ("FDA") during the fourth quarter to solidify the clinical protocol parameters for this program with the intention of initiating enrollment during the first quarter of 2020."

Mr. Shallcross continued, "Enrollment in our investigator-sponsored Phase 2b clinical study for SYN-010 in breath-methane positive irritable bowel syndrome with constipation (IBS-C) patients remains ongoing. We anticipate a data readout sometime during the first half of 2020 which we believe will further fortify the established clinical data set for SYN-010 and support regulatory discussions to potentially simplify future registration studies. For our SYN-020 intestinal alkaline phosphatase (IAP) program, preclinical activities and toxicology studies remain on track to support an Investigational New Drug Application (IND) application filing during the first quarter of 2020. We look forward to sharing important updates and progress for this and all our GI and microbiome-focused clinical programs."

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

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