Biotalys Achieves Critical Manufacturing Milestone for First Commercial Biofungicide EVOCA® NG

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Pilot production campaign delivers more than 15-fold improvement in production efficiency, paving the way for scale-up

Biotalys (Euronext: BTLS), an Agricultural Technology (AgTech) company developing protein-based biocontrol solutions for sustainable crop protection, today announced the successful completion of a pilot production campaign for EVOCA NG, the company’s first AGROBODY® commercial product candidate.

Conducted in partnership with 21st.BIO, a leading precision fermentation technology provider, the campaign successfully demonstrated the consistency and scalability of Biotalys’ manufacturing process for EVOCA NG across five consecutive production batches. This important manufacturing achievement provides critical material and process validation data to support product registrations activities, while further advancing the company’s readiness for future commercial-scale production and market launch.

“This is a key milestone in the transition of EVOCA NG from development to commercialisation,”said Carlo Boutton, Chief Executive Officer of Biotalys. “Five consecutive production batches demonstrate the robustness and reproducibility of our manufacturing approach. Through our collaboration with 21st.BIO, we have also achieved a more than 15-fold improvement in production efficiency compared with EVOCA. We are now ready to move into the next phase towards commercialisation: scaling up production with contract manufacturing organisations.”

EVOCA NG is developed on Biotalys’ proprietary AGROBODY technology platform to help fruit and vegetable growers effectively control the key fungal diseases Botrytis (grey mold) and powdery mildew. Expected to be Biotalys’ first commercial biofungicide, EVOCA NG is planned for registration in both the U.S. and E.U. in 2029, targeting a combined market of approximately USD 1.1 billion1.

EVOCA NG has the same bioactive ingredient as EVOCA, the first-generation product that received EPA approval in the U.S. in December 2025 and state approval in Florida and California in 2026. Regulatory review of EVOCA in the E.U. is ongoing, with the European Food Safety Authority (EFSA) expected to finalise its review by the end of this year or early next year following the recent submission of additional data. The regulatory progress of EVOCA paves the way for EVOCA NG, for which Biotalys expects a significantly shorter regulatory trajectory in both the U.S. and E.U. through equivalency or amendment procedures.