Core Insights - Biotalys has made significant progress in its mission to bring sustainable precision biocontrols to market, particularly with its first biocontrol candidate, EVOCA, which is advancing through the regulatory approval process in the U.S. and Europe [2][4][7] - The company has established a strategic partnership with AgroFresh to develop post-harvest biobased solutions, addressing challenges in the supply chain for fresh produce [3][5][10] - Financial results for the first half of 2025 show an operating loss of €8.1 million, with cash and cash equivalents at €15.7 million, providing a financial runway into May 2026 [9][6][18] Regulatory Developments - Biotalys is collaborating closely with the EPA in the U.S. and the CTGB in Europe to expedite the regulatory review of EVOCA, with expectations for final steps in the registration process by Q4 2025 [4][7] - Positive evaluations from the CTGB and RIVM have paved the way for the peer review phase in Europe, with no critical concerns identified regarding EVOCA's active ingredient [7] Research and Development Updates - Research and development expenses increased to €6.5 million in H1 2025, primarily due to higher external costs, while net cash used in operations was €6.1 million, slightly lower than the previous year [11][18] - Biotalys is advancing its pipeline with multiple programs, including BioFun-6, which has shown strong efficacy in trials, and is collaborating with various academic and industry partners to further develop its product candidates [10][19] Corporate Highlights - The leadership team has been expanded with experienced executives, including the appointment of a new Chief Financial Officer and a new board member with extensive industry experience [10] - Biotalys has strengthened its patent position, obtaining patent protection for EVOCA in Brazil and China, and has been recognized in the FoodTech 500 list, ranking 32 [10][19]

Core Viewpoint - Biotalys NV has received a transparency notification from Sofinnova Partners SAS regarding its shareholding, indicating that Sofinnova now holds 9.93% of Biotalys' voting rights as of June 11, 2025 [1][2]. Company Information - Biotalys is an Agricultural Technology (AgTech) company focused on developing protein-based biocontrol solutions aimed at sustainable crop protection, providing alternatives to conventional chemical pesticides [5]. - The company utilizes its AGROBODY™ technology platform to create a diverse pipeline of product candidates targeting key crop pests and diseases throughout the agricultural value chain [5]. - Founded in 2013 as a spin-off from the VIB (Flanders Institute for Biotechnology), Biotalys has been listed on Euronext Brussels since July 2021 and is based in Ghent, Belgium [5]. Shareholding Details - As of June 11, 2025, Sofinnova Partners SAS holds 3,719,820 shares of Biotalys, which corresponds to 9.93% of the total voting rights [2][6]. - The previous notification indicated that Sofinnova held 4,226,962 voting rights, showing a decrease in their holdings [3]. - The threshold crossed by Sofinnova was 10%, with a total denominator of 37,470,062 shares [6].

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]