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Sofinnova Industrial Biotech
Biotalys receives approval for large-scale demonstration trials of EVOCA in the Netherlands
Ghent, Belgium, Sept. 02, 2024 (GLOBE NEWSWIRE) -- Press release
Biotalys (Euronext Brussels: BTLS), an Agricultural Technology (AgTech) company developing protein-based biocontrols for sustainable crop protection, today announced it received approval by the Dutch regulator CTGB (College voor de Toelating van Gewasbeschermingsmiddelen en Biociden) for large-scale demonstration trials in greenhouses of its first biofungicide candidate, EVOCA™*. Importantly, the harvested fruits and vegetables can be sold for human consumption.
Jeannette Vriend, Plant protection specialist at Dutch growers association Glastuinbouw Nederland, said: “We are very pleased that this innovative technology can now be tested at large scale by growers. Given the many challenges to adequately control fungal diseases in tomatoes, cucumbers and strawberries, due to a sharply shrinking crop protection product package, we really need the acceleration of new, green solutions. These trials offer an ideal opportunity to properly implement such solutions in these high-value integrated crops.”
The CTGB granted Biotalys the approval to test EVOCA against powdery mildew in 40 hectares of tomatoes, 20 hectares of cucumbers and 10 hectares of strawberries. Produce from these greenhouse trials is allowed to be sold for human consumption, an exemption to standard practices requiring crop destruction when a crop protection product is used that has not yet received regulatory approval.**
Eva Van Hende, Head of Regulatory and Sustainability of Biotalys, said: “The ability to test EVOCA in large-scale demonstration trials while allowing the sale of the harvested produce for consumption reinforces our confidence that the product is safe to use. This decision by the Dutch authority is particularly relevant as the Netherlands is both the rapporteur Member State for our regulatory dossier at the European level and one of the largest exporters of fruits and vegetables worldwide.”
EVOCA is a novel protein-based biofungicide which earned an entirely new resistance classification by the Fungicide Resistance Action Committee (FRAC). The product helps control the fungal diseases botrytis and powdery mildew in fruits and vegetables. Demonstrating strong performance in trials across multiple regions, climates, soil types, production types, pathogen pressure and crops to date, EVOCA is currently under review by the U.S. Environmental Protection Agency (EPA) and the Dutch College voor Toelating van Gewasbeschermingsmiddelen en Biociden (CTGB) in the European Union for regulatory approval. EVOCA will pave the way for EVOCA NG, which is expected to be Biotalys’ first commercial fungicide from its AGROBODY technology platform.
* EVOCA™: Pending Registration. 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.
** Decisions of the CTGB are subject to appeal during a period of six weeks following the publication of the decision.
About Biotalys
Biotalys is an Agricultural Technology (AgTech) company developing protein-based biocontrol solutions for the protection of crops and aiming to provide alternatives to conventional chemical pesticides for a more sustainable and safer food supply. 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 has been listed on Euronext Brussels since July 2021. 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 notices
This announcement is for informational purposes only and is directed only at persons who are located outside the United States. This announcement does not constitute an offer to sell or the solicitation of an offer to buy shares or any other security and shall not constitute an offer, solicitation or sale in the United States or in any jurisdiction in which, or to any persons to whom, such offering, solicitation or sale would be unlawful. The shares have not been, and will not be, registered under the U.S. Securities Act or the securities laws of any state of the United States or any other jurisdiction, and may not be offered or sold within the United States, or to, or for the account or benefit of, U.S. persons, except pursuant to an exemption from, or in a transaction not subject to, the registration requirements of the U.S. Securities Act and applicable state or local securities laws. Accordingly, the shares are being offered and sold (i) in the United States only to qualified institutional buyers in accordance with Rule 144A under the U.S. Securities Act and (ii) in “offshore transactions” to non-U.S. persons outside the United States in accordance with Regulation S under the U.S. Securities Act. There is no assurance that the offering will be completed or, if completed, as to the terms on which it will be completed.
This announcement has been prepared on the basis that any offer of the shares in any Member State of the European Economic Area (the “EEA”) is or will be made pursuant to an exemption under the Prospectus Regulation from the requirement to publish a prospectus for offers of the shares. The expression “Prospectus Regulation” means Regulation (EU) 2017/1129 (as amended or superseded) any implementing measure in each relevant Member State of the EEA.
This announcement is only addressed to and directed at persons in Member States of the EEA who are "qualified investors" within the meaning of Article 2(e) of the Prospectus Regulation, or such other investors as shall not constitute an offer to the public within the meaning of Article 3.1 of the Prospectus Regulation.
The offer, sale and admission to trading of the shares will be made pursuant to an exception under the Prospectus Regulation from the requirement to produce a prospectus for offers or admissions to trading of securities. This press release does not constitute a prospectus within the meaning of the Prospectus Regulation or an offer to the public.
The distribution of this press release into certain jurisdictions may be restricted by law. Persons into whose possession this announcement comes should inform themselves about and observe any such restrictions. Any failure to comply with these restrictions may constitute a violation of the laws of any such jurisdiction.
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.
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