BiomEdit Initiates Final Field Safety Trial For Non-Antibiotic Poultry Biologic, Advancing Toward USDA Conditional Licensure

• Pre-licensing commercial manufacturing batches completed successfully and pivotal field safety trial underway as final regulatory requirements before conditional licensure
• Study published in a Nature portfolio journal demonstrates statistically significant improvements in feed conversion and weight gain under sub-clinical necrotic enteritis challenge conditions
• Conditional licensure for BE-101 expected in Q3, 2026 pending final USDA review

Greenfield, IN /PRNewswire/ - BiomEdit, a pioneering animal health biotechnology company, today announced the initiation of the pivotal field safety trial for its lead candidate, BE-101, a non-antibiotic poultry biologic for the prevention of mortality associated with necrotic enteritis (NE) in broiler chickens. The study represents one of the two final regulatory requirements prior to potential conditional licensure by U.S. Department of Agriculture's Center for Veterinary Biologics (USDA CVB).

Two of the three required field safety sites began this month at commercial broiler production complexes testing product from pre-licensing serial manufacturing batches. Upon completion of the field safety trial, and USDA CVB review of the final report and successful testing of product from pre-licensing serial batches, BiomEdit expects conditional licensure in Q3, assuming typical regulatory review timing. Commercial launch readiness is aligned for early Q4, 2026.

BE-101 is a first-of-its-kind probiotic vectored antibody (pvAb™) biologic engineered to neutralize Clostridium perfringens toxins, a primary driver of NE-related mortality and production losses. NE remains one of the most economically significant diseases in broiler production, with global losses estimated at $6 billion annually.

Recent results published in npj Biofilms and Microbiomes, a Nature portfolio journal, demonstrated that BE-101 delivered statistically significant improvements in feed conversion and body weight gain in a commercial-like study under sub-clinical NE challenge conditions. Birds receiving BE-101 achieved a 6- to 7-point improvement in feed conversion ratio at key time points, along with increased finished weight and reduced NE mortality compared to challenged controls. The study also identified corresponding improvements in gut health and host response, helping explain how toxin neutralization translated into production benefits.

"As we continue to meet key milestones on the path toward conditional licensure, we're focused on the day we can bring this non-antibiotic solution to producers facing a disease where new solutions are needed," said Aaron Schacht, CEO of BiomEdit. "Working directly with poultry producers during these field safety trials provides a real-world window into how the product performs on-farm. We're encouraged by the engagement and the opportunity to deliver a practical tool that supports both flock health and production performance."

About BiomEdit
BiomEdit is an animal health biotechnology company leveraging the power of the microbiome and synthetic biology to develop next-generation solutions for livestock and pet health. Founded in 2022, BiomEdit is backed by leading investors including Anterra Capital, Viking Global, Nutreco, AgriZeroNZ, Elevate and Betagro Ventures among others. For more information, visit www.biomedit.com.