Amoéba Takes Another Decisive Step Forward With The Final Approval Of Its Biocontrol Active Substance By The European Commission

Press release

Chassieu (France), 17 June 2025 - 6.00 p.m. - Amoéba (FR0011051598 - ALMIB), an industrial greentech specialized in the development of natural microbiological solutions based on the patented use of amoebae, is proud to announce the final approval of its biocontrol active substance by the European Commission as a low-risk substance. Following the signing of a major distribution agreement with Koppert[1], Amoéba has thus taken another decisive step towards commercialisation ahead of obtaining the registration for its AXPERA biocontrol solution in the targeted European countries.

This approval is the result of a five-year European validation process, the final administrative stages of which took place in the first half of 2025:

• In January 2025[2], EFSA published on its website the final report of the scientific evaluation of Amoéba's active substance at European level, concluding on its fungicidal efficacy and on its low risk profile for human health and the environment.
• In May 2025, based on this report, the European Commission prepared a draft implementing regulation approving the active substance, which was submitted to a vote by the 27 Member States of the European Union. They voted unanimously in favour of approving the active substance as a low-risk substance[3].
• Today, the implementing regulation is officially published and confirms the entry into force of the approval.

The regulation is available at the following address:

EUR-Lex – Published Regulation

After years of intensive research and development, the active substance ‘Lysate of Willaertia magna' has now been approved at European level, with a confirmed low-risk profile.

Key points about the active substance ‘Lysate of Willaertia magna':

• Low-risk profile: the active substance has been rigorously tested and approved for its low impact on the environment and human health. It thus meets the growing needs of farmers for sustainable solutions that protect both crops and the environment.
• Proven efficacy: field trials have demonstrated its effectiveness in protecting crops against a wide range of pathogens. 
• Sustainability: as a biocontrol solution, it is part of a sustainable development approach, reducing dependence on synthetic chemicals.

As a reminder, in Europe, Amoéba has initiated the application for marketing authorisation for its biocontrol product, under the brandname ‘AXPERA'. The application has been submitted to the nine European Member States targeted as a priority, with a decision expected in late 2025 or early 2026, which will then pave the way for commercialisation.

In the United States, where the active substance has been approved since 2022, the AXPERA biocontrol product is in the final stages of scientific evaluation, with a decision from the US Environmental Protection Agency (US EPA) expected in the coming weeks.

" This European approval is a source of immense pride for Amoeba teams. It rewards more than five years of investment, perseverance and innovation to develop an effective, sustainable and environmentally friendly biocontrol solution. " says Jean-François Doucet, CEO of Amoéba. “This major regulatory recognition validates our scientific approach and our commitment to more sustainable agriculture. It is a milestone that paves the way for the commercialisation of AXPERA in Europe, to meet the specific needs of farmers.”

About Amoéba:

Founded in 2010, Amoéba is a greentech company based in Chassieu (Lyon, France) whose ambition is to become a major player in the treatment of microbiological risk based on the patented use of amoebae in the plant protection and cosmetics sectors.

With know-how that is unique in the world and protected by numerous patents, Amoéba is currently the only company capable of exploiting the full potential of the Willaertia amoeba on an industrial scale and cultivating it in sufficient volumes to offer biological solutions that constitute a viable alternative to the chemical products widely used today. Amoéba is currently focusing on the global biocontrol market for plant protection and on the cosmetics market. As the marketing of plant protection products is subject to obtaining local regulatory authorisations, the Company has carried out the necessary regulatory procedures and filed registration dossiers in Europe and the United States. With regard to the active substance, it has already obtained approval in 2022 in the USA and a positive and definitive report from EFSA in Europe. Product approvals are expected in the coming months.

The cosmetic application does not require prior approval from a competent authority in Europe or the United States. The cosmetic ingredient is already registered on the INCI (International Nomenclature of Cosmetic Ingredients) list, paving the way for it to be marketed worldwide except in China, where local approval is required.

Amoéba is listed on Euronext Growth (ALMIB). The company is a member of the Bpifrance Excellence network and is eligible for the PEA-PME scheme. For more information, visit www.amoeba-nature.com.

Contacts:

Disclaimer

This press release contains certain forward-looking statements concerning Amoéba which are based on its own assumptions and estimates and on information that is currently available to us. However, Amoéba gives no assurance that the estimates contained in such forward-looking statements will be verified, with these estimates subject to numerous risks, including the risks set forth in Amoéba's universal registration document filed with the French Financial Markets Authority (Autorité des Marchés Financiers) on April 17, 2025 under number D.25-0281 and available on the Amoéba website (www.amoeba-nature.com). The forward-looking statements contained in this press release are also subject to risks not yet known to Amoéba or not currently considered material by Amoéba . The occurrence of all or part of such risks could cause Amoéba's actual results, financial conditions, performance, or achievements to be materially different from such forward-looking statements.

[1] See the press release dated 3 June 2025.

[2] See the press release dated 15 January 2025.

[3] See the press release dated 21 May 2025.