Biotalys NV

Biotalys Secures Product Registration in California for EVOCA®, Strengthening Regulatory Pathway for Its Lead Asset EVOCA NG

Approval in one of the world's most stringent regulatory jurisdictions and important crop protection markets provides important regulatory precedent for Biotalys’ AGROBODY® biocontrols

Ghent, BELGIUM, Sept. 02, 2026 (GLOBE NEWSWIRE) --             Press Release

Biotalys (Euronext Brussels: BTLS), an Agricultural Technology (AgTech) company developing protein-based biocontrol solutions for sustainable crop protection, today announced that the California Department of Pesticide Regulation (CDPR) has granted state registration for EVOCA, the company's first protein-based biofungicide. The approval follows the successful completion of the public consultation process earlier in July and confirms that EVOCA has successfully met the state's stringent regulatory requirements for human health, environmental safety and product efficacy.

California is widely recognized for applying some of the world's most rigorous requirements to crop protection products. Securing approval therefore provides meaningful validation of EVOCA and the underlying AGROBODY platform that supports Biotalys' pipeline.

Carlo Boutton, Chief Executive Officer of Biotalys, commented: "This California registration is an important achievement for Biotalys. Meeting the state's demanding scientific and regulatory standards underscores the potential of our AGROBODY biocontrols, an entirely new class of protein-based crop protection solutions. Our ambition is to offer growers novel, safe and effective biological products that help them protect their crops and produce food more sustainably.

EVOCA NG is one of the lead assets in our refocused strategy and is expected to become our first commercial product. As it is based on the same active ingredient and AGROBODY foundation as EVOCA, the California decision is highly relevant to its further development. It strengthens our confidence in bringing EVOCA NG to U.S. growers in 2029 and gives shareholders greater visibility on our commercialisation pathway and the long-term potential of our platform and pipeline."

California is the largest agricultural state in the United States and one of the world's leading regions for high-value crop production. Together with the product’s registration in Florida earlier this year and the prior regulatory approval by the U.S. Environmental Protection Agency (EPA), the registration in California further builds the strong foundation for Biotalys' future commercial presence and its mission to broaden growers' access to effective biological crop protection solutions.

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. It received EPA approval in the U.S. in December 2025, state approval in Florida and California in 2026, while regulatory review is ongoing in the European Union. 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, Investor Relations & Communications
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.

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 Secures California Registration for EVOCA_2 September 2026
• Press Release_Biotalys verkrijgt productregistratie voor EVOCA in Californië _2 september 2026