ImmuCell Has Decided To Pause Further Investment In Re-Tain

In seeking FDA approval to bring its innovative Re-Tain® product to market, ImmuCell received Complete Letters from the FDA for four of the five Technical Sections required for NADA approval. It pursued a two-pronged manufacturing approach to reduce capital expenditure and limit technical risk for the remaining fifth Technical Section pertaining to manufacturing. ImmuCell manufactured the active pharmaceutical ingredient using a proprietary process in its own facility and hired an experienced contract manufacturer with FDA approvals for animal health products for the aseptic filling of the product into syringes. ImmuCell passed FDA inspection of its own facility in 2024. It is ImmuCell's understanding that the FDA is now declining to approve the NADA because the contract manufacturer has not satisfactorily addressed inspectional deficiencies.

After considering the practical implications of the resulting delays, including the pending expiration of ImmuCell's contract with the manufacturer in March 2026, ImmuCell has decided to pause further investment in Re-Tain® and increase its investment in its market leading First Defense® franchise, which it believes to have significant revenue and profit growth capacity.