Biotalys Achieves First U.S. State Registration for EVOCA in Florida

Regulatory Process also Advancing in Key Markets California and Europe

Ghent, BELGIUM, April 27, 2026 (GLOBE NEWSWIRE) -- Press release 

Biotalys (Euronext: BTLS), an Agricultural Technology (AgTech) company developing protein-based biocontrols for sustainable crop protection, today announced that its innovative biofungicide EVOCA™ has achieved state registration in Florida. This marks the first approval of an AGROBODY™ biocontrol by a U.S. state, underscoring a significant milestone for the company and the broader biocontrol sector.

The Florida Department of Agriculture accepted EVOCA with the broad label previously approved by the U.S. Environmental Protection Agency (EPA). This state recognition confirms the product’s robust regulatory profile and its potential to support sustainable agriculture in the region, in particular in controlling the key fungal diseases Botrytis and powdery mildew in fruits and vegetables.

Carlo Boutton, interim CEO of Biotalys, commented: “We are proud to see EVOCA obtain state registration in Florida, as it sets the stage for the future of our protein-based biocontrol solutions. Florida is the second largest U.S. state for the production of key fruits and vegetables such as strawberries, tomatoes and bell peppers that face significant challenges from diseases like Botrytis and powdery mildew. The first state-level approval for our novel biocontrol underscores our commitment to providing innovative tools to growers locally and validates our technology for continued product developments. We look forward to advancing sustainable crop protection and supporting growers with science-driven solutions that meet market demands both in terms of efficacy and sustainability.”

Regulatory progress in California and Europe

In California, the largest agricultural state in the U.S., the Department of Pesticide Regulation (DPR) is progressing its review of EVOCA and its Human Health Assessment Branch has now accepted the EPA-approved label. The next administrative steps are in process, and approval is currently projected for the second half of 2026, further validating the safety and efficacy of Biotalys’ technology.

Regulatory review of EVOCA in the European Union is also advancing with the two-month public consultation phase expected to be initiated this week. 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.

About EVOCA

EVOCA is a protein-based AGROBODY biocontrol that helps safely control the fungal diseases Botrytis (grey mold) and powdery mildew for fruit and vegetable growers. An approval of EVOCA paves the way for the regulatory submission of EVOCA NG, the product’s next generation version containing the same active ingredient. EVOCA NG is expected to be Biotalys’ first commercial biofungicide, with a planned launch in the U.S. in 2029 and in Europe in 2030, targeting a combined market of around USD 1.1 billion¹.

About Biotalys

Biotalys is an Agricultural Technology (AgTech) company developing precision biocontrol solutions based on proteins for the protection of crops in both the pre- and post-harvest markets. The company provides novel solutions that bridge the efficacy and scale of chemistry with the environmental advantages of biological solutions. Based on its novel AGROBODY™ technology platform, Biotalys is developing a strong and diverse pipeline of effective product candidates with a favorable safety profile that aim to address key crop pests and diseases across the whole value chain, from soil to plate. Biotalys was founded in 2013 as a spin-off from the VIB (Flanders Institute for Biotechnology) and is listed on Euronext Brussels. The company is based in the biotech cluster in Ghent, Belgium. More information can be found on www.biotalys.com.

For further information, please contact:

Toon Musschoot, Head of IR & Communication
T: +32 (0)9 274 54 00
E: IR@biotalys.com

Important Notice

Biotalys, its business, prospects and financial position remain exposed and subject to risks and uncertainties. A description of and reference to these risks and uncertainties can be found in the annual report on the consolidated annual accounts published on the company’s website. Biotalys plans to publish its annual report for the full year 2025 on 29 April 2026.

Biotalys does not have sufficient working capital to cover the working capital needs for a period of at least 12 months as of the date hereof and only has a cash runway until end of May 2026. Biotalys is in well-advanced negotiations with a number of investors to support the sharpened portfolio. Next to an equity injection, the company is also exploring other alternative dilutive and non-dilutive financing options.

This announcement contains statements which are "forward-looking statements" or could be considered as such. These forward-looking statements can be identified by the use of forward-looking terminology, including the words ‘aim’, 'believe', 'estimate', 'anticipate', 'expect', 'intend', “have the potential”, 'may', 'will', 'plan', 'continue', 'ongoing', 'possible', 'predict', 'plans', 'target', 'seek', 'would' or 'should', and contain statements made by the company regarding the intended results of its strategy. By their nature, forward-looking statements involve risks and uncertainties and readers are warned that none of these forward-looking statements offers any guarantee of future performance. Biotalys’ actual results may differ materially from those predicted by the forward-looking statements. Biotalys makes no undertaking whatsoever to publish updates or adjustments to these forward-looking statements, unless required to do so by law.

¹ Source: Kynetec 2020; Biotalys

Attachments

• Press release_Biotalys Announces EVOCA State Registration in Florida_v27 April 2026
• Persbericht_Biotalys kondigt staatsregistratie van EVOCA aan in Florida_v27 april 2026