Earned final approval by the U.S. EPA and positive recommendation by the Dutch regulator for its first candidate biofungicide EVOCA™, paving the path for its commercial version EVOCA NG
Streamlined leadership and operations to concentrate resources on commercial preparation of EVOCA NG and BioFun-6 in high-value markets
Year-end cash and cash equivalents amounted to €8.0 million, providing a financial runway until end of May 2026; negotiations with investors regarding financing options are well-advanced
Strategic refocus of the company to result in significant reduction of the cash burn until the end of 2028
Management to host a conference call and live webcast at 15:00 CEST / 14:00 GMT / 09:00 AM ET today, details below
Biotalys (Euronext: BTLS), an Agricultural Technology (AgTech) company developing protein-based biocontrols for sustainable crop protection, today announced key business achievements and consolidated financial results for 2025, prepared in accordance with IFRS as adopted by the European Union, and an outlook for 2026. The annual report, including the full financial report, is published on the company's website.
Carlo Boutton, interim CEO of Biotalys, stated: "In 2025, we reached a major value inflection point with the U.S. EPA approval of our first biocontrol, EVOCA, further validating our AGROBODYTM platform. Alongside our regulatory progress, we also established a strategic partnership with AgroFresh, leveraging EVOCA's favorable safety profile in the post-harvest market. As we enter the next phase, we are sharpening our focus on our most advanced biofungicide programs and implementing a streamlined operating model designed to materially reduce our cash burn."
Strategic refocus (post-period)
Early February 2026, Biotalys announced its intention to proceed with a strategic refocus designed to concentrate resources on its highest-priority programs and streamline operations accordingly.
The Biotalys board has in the meantime confirmed this decision and the company is proceeding with a streamlined operational model and suspension of its early-stage activities to reduce operating expenses, while safeguarding the long-term value of its technology platform. Biotalys will prioritise the development and regulatory advancement of its lead biofungicide assets and focus commercial preparation efforts on markets with the highest near-term potential.
Business Highlights
In 2025, Biotalys further advanced its technology platform and product development pipeline, while forging new partnerships to expand commercialisation options for its biocontrols.
Product Pipeline (including post-period information):
In December, Biotalys announced regulatory approval by the U.S. Environmental Protection Agency (EPA) for EVOCA, which helps safely control the fungal diseases Botrytis (grey mold) and powdery mildew for fruit and vegetable growers. In April 2026, the company obtained state registration in Florida, marking the first approval of an AGROBODY biocontrol by a US state.
EVOCA also earned strong support in Europe in 2025. The Dutch Board for the Authorisation of Plant Protection Products (CTGB) recommended the approval of EVOCA's active ingredient throughout the European Union, while the Dutch Institute for Health and Environment (RIVM) confirmed there were no critical areas of concern and proposed its low-risk classification. In the meantime, EFSA has initiated the two-month public consultation period, allowing stakeholders to provide comments on the dossier.
In March 2025, the company released results of initial field trials in both Europe and the United States demonstrating the increased potency of BioFun-6, Biotalys' second biofungicide candidate targeting Botrytis and powdery mildew in high-value fruits and vegetables, by achieving the same level of performance as EVOCA at significantly lower dosage rates. BioFun-6 also performed well across a variety of independent academic trials by University of California-Davis in 2025 (full results here).
Throughout the year, Biotalys continued to advance its first bioinsecticide, BioIns-2, in collaboration with Syngenta Crop Protection resulting in a first research milestone in April 2026. The company also progressed BioFun-7, the R&D program in partnership with the Gates Foundation targeting leafspot disease. As part of its strategic refocus, Biotalys is opening its research programs BioFun-4 (Oomycetes in potatoes and F&V) and BioFun-8 (Alternaria in F&V and specialty crops) for R&D collaboration with third parties.
Key Partnerships (including post-period information):
In May 2025, Biotalys announced a partnership with AgroFresh to protect produce post-harvest and reduce global food waste from fungal decay. The partnership focuses on developing and commercializing sustainable biological solutions to keep high-value and highly perishable crops fresher for longer with less chemical residues.
In early 2026, Biotalys entered into a strategic partnership with 21st.BIO, a leading Danish precision fermentation technology company, to accelerate the production of Biotalys' protein-based biocontrol solutions. This collaboration leverages 21st.BIO's proprietary fermentation platform to support the production of Biotalys' AGROBODY agricultural biocontrol products at commercially competitive costs. The strain engineering and process development for both EVOCA and BioFun-6 is on track to meet the company's commercial timelines.
Operations and Leadership (including post-period information):
In March 2025, the company appointed Toni Bucci to its Board of Directors. A seasoned agriculture and biotech executive, she is providing expert guidance to help the company navigate its path to commercialization and accelerate its impact in sustainable agriculture.
In May, Biotalys appointed Luc Van fraeyenhoven as Chief Financial Officer to provide cost-conscious and operationally sound financial leadership on both long-term strategies and day-to-day finance operations.
In March 2026, the company appointed Carlo Boutton as CEO ad interim while Patrik Haesen in his capacity as permanent representative of shareholder A.I.F. was appointed as Chair of the Audit Committee.
In addition, Biotalys expanded its patent protection. The company obtained a patent for EVOCA in China and in Brazil, under the Patentes Verdes ("Green Technology") initiative to accelerate the examination of patent applications relating to technologies having a positive impact on the environment from the Brazilian National Institute of Industrial Property (INPI). In addition, Biotalys obtained a U.S. patent for one of the active ingredients developed in the BioFun-6 program.
Biotalys earned Top 100 status in Forward Fooding's FoodTech 500 list, which ranks global innovators at the intersection of food, technology and sustainability.
Outlook for 2026
Biotalys will implement its strategic refocus and concentrate resources on its highest-priority programs while streamlining operations accordingly. The company will prioritize the development and regulatory advancement of its lead biofungicide assets and focus commercial preparation efforts on markets with the highest near-term potential.
The EPA approval of EVOCA in the U.S. paves the way for the regulatory submission of the second generation of the biocontrol, EVOCA NG, which Biotalys anticipates will have a significantly shorter regulatory review process as the product contains the same active ingredient. EVOCA NG is expected to be Biotalys' first commercial biofungicide, with a planned launch in the USA in 2029, and in Europe in 2030, targeting a combined market of more than USD 1.1 billion.1
In addition to the recently obtained state registration of EVOCA in Florida, the company expects state registration in California in the second half of this year. In the European Union, Biotalys expects the two-month public consultation phase which initiated yesterday to conclude by end of June. Both the European Food Safety Authority (EFSA) and the Dutch Board for the Authorisation of Plant Protection Products (CTGB) will then review comments, after which the dossier is expected to proceed to the decision phase.
The company plans to progress its BioFun-6 program and expects results from field trials with a second lead candidate by mid this year. Based on the outcome, Biotalys plans additional trials to further establish application modalities. The company will also continue to support the partnered BioFun-7 program with the Gates Foundation as well as BioIns-2 in partnership with Syngenta. In addition, Biotalys will explore research collaborations for its BioFun-4 and BioFun-8 programs.
Biotalys will further finetune its production process and manufacturing plans to achieve commercially competitive manufacturing costs for its product pipeline, supported by its strategic partnership with 21st.BIO. The company expects important progress in this area in the fourth quarter of this year, allowing it to initiate the required regulatory studies for EVOCA NG.
With a cash and cash equivalents balance of €8.0 million at the end of 2025, the company confirms its current financial runway to reach until end of May 2026. Biotalys is in well-advanced negotiations with a number of investors to support the execution of the strategic refocus. Next to an equity injection, the company is also exploring other alternative dilutive and non-dilutive financing options.
Detailed financial review for 2025
In € thousand
