Synthetic Biologics (SYN) Misses Q1 EPS by 11c

Synthetic Biologics (NYSE: SYN) reported Q1 EPS of ($0.13), $0.11 worse than the analyst estimate of ($0.02).

"During the first quarter of 2021 we remained diligently focused on advancing our portfolio of GI and microbiome-focused clinical programs and were pleased to announce the commencement of clinical trials for our SYN-004 and SYN-020 programs," said Steven A. Shallcross, Chief Executive Officer of Synthetic Biologics. "Enrollment in the SYN-004 Phase 1b/2a clinical trial in allogeneic hematopoietic cell transplant (HCT) recipients is underway at the Washington University School of Medicine in St. Louis ("Washington University") and the first patient of the first antibiotic cohort was dosed earlier this year. We believe SYN-004 has the potential to address an important and underserved patient population, and may significantly improve outcomes for allogeneic HCT recipients by preventing downstream complications often associated with disruption of the gut microbiome by intravenous ("IV") beta-lactam antibiotics. If enrollment proceeds as planned, we anticipate announcing topline data from the first antibiotic cohort during the fourth quarter of 2021, pandemic conditions permitting."

Mr. Shallcross continued, "We were also very excited to announce the initiation of a Phase 1a single-ascending-dose clinical trial of our SYN-020 IAP program during the first quarter of 2021. To date, three out of a total of four cohorts have been dosed and we remain on track to report topline data from this study during the third quarter of 2021, pandemic conditions permitting. A second Phase 1a multiple-ascending-dose study is also expected to begin enrollment during the third quarter of 2021 with topline data expected early next year. Both studies are designed to support the advancement of SYN-020 in multiple potential therapeutic indications, including celiac disease, nonalcoholic fatty liver disease ("NAFLD") and age-related metabolic and inflammatory diseases. We are very excited about the potential for this program to be a long-term value driver for our Company and look forward to sharing important updates."

Mr. Shallcross concluded, "While we remain focused on the execution of our clinical development activities, we were also able raise net proceeds of approximately $66 million as well as $8.0 million in proceeds from the cash exercise of warrants, significantly strengthening our balance sheet and financial position. As a result of these activities, our current cash position is approximately $76.9 million. Importantly, our fortified balance sheet will fully fund our SYN-004 and SYN-020 clinical programs through proof-of-concept clinical studies, and help accelerate our other ongoing activities."

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

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