Press release - regulated informationGhent, Belgium, Sept. 18, 2025 (GLOBE NEWSWIRE) -- Substantial progress in both the U.S. and Europe in the regulatory review of Biotalys’ first candidate biofungicide EVOCA™*Patent protection for EVOCA in Brazil and China, and for a BioFun-6 lead candidate in the U.S.Strategic partnership with AgroFresh to expand into post-harvest segmentLeadership team expanded with proven industry executives Cash and cash equivalents amounted to €15.7 million as of the end of June 202 ...

Core Insights - Biotalys is progressing with the regulatory approval of its first protein-based biocontrol product, EVOCA, with the U.S. EPA confirming that the scientific review is ongoing and all additional information requests have been addressed [2][3] - The company now anticipates that the final steps of the registration procedure will occur in Q4 2025, a delay from the previous expectation of completion by the end of September [2] - EVOCA is designed to control fungal diseases such as Botrytis and powdery mildew, providing biodegradable solutions for fruit and vegetable growers [3] Company Overview - Biotalys is an AgTech company focused on developing precision biocontrol solutions based on proteins for crop protection in pre- and post-harvest markets [5] - The company utilizes its AGROBODY technology platform to create products that combine the efficacy of traditional chemical solutions with the environmental benefits of biological alternatives [5] - Founded in 2013 as a spin-off from the VIB, Biotalys is headquartered in Ghent, Belgium, and is listed on Euronext Brussels [5]

Core Insights - Biotalys is making significant progress in the regulatory approval of its first protein-based biocontrol product, EVOCA™, in both the United States and Europe [2][3][4] Regulatory Developments - The US Environmental Protection Agency (EPA) is expected to complete the scientific review of EVOCA's dossier by the end of summer 2025, with a regulatory decision projected by September 30, 2025 [3] - In Europe, the Dutch authorities have provided positive evaluations of EVOCA's regulatory dossier, classifying its active ingredient as low risk, which is crucial for its approval process [4][5] Product Information - EVOCA™ is designed to control fungal diseases such as Botrytis and powdery mildew, offering biodegradable solutions for fruit and vegetable growers [6] - The product is based on Biotalys' AGROBODY™ technology platform, which has the potential to develop additional protein-based biocontrol solutions [6][8] Future Outlook - A regulatory decision in the European Union is anticipated in the second half of 2026, contingent upon the provision of additional data during the peer review phase [5] - The approval of EVOCA would represent a major milestone for Biotalys and validate its innovative technology platform [6]