Biotalys NV

Biotalys Provides Regulatory Review Update for EVOCA in the U.S.

Inside information

Ghent, BELGIUM, Aug. 29, 2025 (GLOBE NEWSWIRE) -- Biotalys (Euronext - BTLS) today provides an update on the regulatory approval procedure in the United States of its first protein-based biocontrol product, EVOCA™*.

Biotalys has received further guidance from the U.S. Environmental Protection Agency (EPA) on the regulatory review of EVOCA. The EPA has confirmed that the scientific review of the dossier is progressing, and that all the requests for additional information have been addressed. While the agency continues to work diligently on the review, the company now expects the final steps of the registration procedure to be taken in Q4, rather than by the end of September as previously anticipated.

Kevin Helash, Chief Executive Officer of Biotalys, said: “Biotalys is at the forefront of introducing precision biocontrols, a new class of crop protection solutions that has the potential to disrupt the industry, and create long term value for growers and investors alike. EVOCA is the first product developed using our AGROBODY™ technology platform and has a new mode of action, showcasing our ability to create products that combine the safety and sustainability of biologicals with the performance and reliability growers expect from traditional chemistries. We continue to have a positive dialogue with the EPA and remain optimistic about concluding the review this year towards a favorable outcome for EVOCA.”

The first biocontrol developed on Biotalys’ AGROBODY technology platform, EVOCA helps safely control fungal diseases Botrytis (grey mold) and powdery mildew for fruit and vegetable growers looking to add effective, biodegradable solutions to their spray rotation programs to reduce chemical applications.

* EVOCA™: Pending regulatory review. This product is not currently registered for sale or use in the United States, the European Union, or elsewhere and is not being offered for sale and no assurance can be given if, when and under which conditions registration will be obtained.

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.

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', '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.

Attachments

• Biotalys press release_Regulatory Update _29 August 2025
• Biotalys persbericht_Regelgevende Update _29 augustus 2025