AMOEBA: Amoéba announces the publication of the EFSA's final report confirming its positive and definitive conclusions

Press release

Chassieu (France), 15 January 2025 - 5.45 pm - Amoéba (FR0011051598 - ALMIB), an industrial greentech specialising in the development of natural microbiological solutions based on the patented use of amoebae, announces that the European Food Safety Authority (EFSA) has published the final assessment report on Amoéba's biocontrol active substance[1].

As a reminder, Amoéba received on 13 December 2024[2] the positive and definitive conclusions of the EFSA, which validated the efficacy and low-risk profile of its biocontrol active substance.

The EFSA has just published the final report on its website, and its conclusions remain unchanged:

• A proven fungicidal efficacy;
• A low risk profile for human and animal health, as well as for ecosystems and environmental organisms;
• The criteria for exemption from a maximum residue level[3] have been met.

EFSA's final report can be consulted at the following address: https://efsa.onlinelibrary.wiley.com/doi/full/10.2903/j.efsa.2025.9194.

The European Commission now has a maximum of 6 months to ratify the approval of the active substance, in accordance with the usual administrative provisions.

Heading for the market

Amoéba will now be able to launch the marketing authorisation application procedure for its biocontrol products in Europe, under the name "AXPERA". The application will be submitted to the eight European Member States targeted as a priority[4]. A decision is expected by the end of 2025, paving the way for commercialisation.

As a reminder, in 2024 Amoéba submitted an application for federal market authorization application for its "AXPERA" range in the United States (with the exception of California, where the procedure is separate). The US EPA's (US Environmental Protection Agency) conclusions are expected in mid-2025.

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 growing 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 the cosmetics market. As the marketing of plant protection products is subject to obtaining local regulatory approvals, the Company has taken the necessary regulatory steps and in 2022 obtained approval for its active substance in the USA as well as the recommendation for approval in Europe issued by the Austrian authority. Cosmetic applications do not require prior approval from a competent authority in Europe or the United States.

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:

Amoéba	Actus finance & communication		Droit Devant Agency
Chief Executive Officer Jean-François DOUCET [phone] [e-mail]	Investor relations Pierre JACQUEMIN-GUILLAUME [phone] [e-mail]	Financial press relations Serena BONI [phone] [e-mail]	Business and general public press relations Laëtitia PINTO [phone] [e-mail]

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 29, 2024 under number D24-0352 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.

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[1] Scientific name:Willaertia magna C2c Maky lysate.

[2] See the press release dated 16 December 2024.

[3] Highest level of a pesticide residue legally tolerated in or on food.

[4] Belgium, France, Germany, Greece, Italy, Netherlands, Portugal, Spain.

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https://www.actusnews.com/documents_communiques/ACTUS-0-89558-amoeba_cp-efsa-publication_vfin-eng.pdf
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