Amoéba: AXPERA in Final Authorization Phase in France
Amoéba announces that ANSES has initiated the final phase of the evaluation of its biocontrol product AXPERA, submitted in March 2025. Concurrently, French and Italian agricultural sectors are seeking derogatory authorizations to use the product at the start of their production season.
The evaluation process of the AXPERA market authorization application by ANSES is currently in its final phase. This stage includes a comment period on the draft evaluation report, which began in February and will conclude on March 6, 2026. It will be followed by the signing and official publication of the authorization in France, an administrative phase that may span several weeks. Amoéba indicates that at this stage of the draft report, there are no elements opposing the issuance of the market authorization. All requested uses have been deemed acceptable, and the product's safety profile has been confirmed. Once the French authorization is obtained, other concerned member states will then initiate the national procedure for authorizing the product on their territories.
Derogatory Market Authorizations Sought by French and Italian Agricultural Sectors
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Agricultural sectors in France and Italy have initiated steps to obtain derogatory market authorizations to address emergency phytosanitary situations, similar to the one granted in 2025 in France for the use of AXPERA against vine mildew. The goal is for the sectors to be able to use AXPERA from the start of the production season. Additionally, Amoéba has submitted a new request for an exceptional experimental authorization to Dutch authorities to use AXPERA on multiple crops, including the possibility of consuming the harvests.
Sur la base de ses ressources actuelles, de son plan d'affaires et de la lettre de soutien de son actionnaire de référence, Amoéba estime pouvoir faire face à ses obligations jusqu'au 31 décembre 2026.
Risks mentioned
Autorisation définitive d'AXPERA obtenue tardivement (fin juin 2026) après période d'utilisation des produits, affectant les ventes du semestre
Monétisation de la plateforme cosmétique dont ni la réalisation, ni le calendrier, ni le montant ne sont acquis à ce jour
Besoin de levée de fonds supplémentaire pour assurer continuité d'exploitation jusqu'au 30 septembre 2027 et financer plan de développement
Opportunities identified
Autorisation pérenne AXPERA obtenue en France en juin 2026 ouvre la voie à la commercialisation en plusieurs pays européens
Accord majeur signé avec Syngenta pour distribution exclusive de la solution en céréales dans 27 pays UE, premiers lancements commerciaux attendus Q3 2028
Extension de l'accord de distribution Koppert jusqu'en juin 2031 et potentiel de monétisation de la plateforme cosmétique Willa™ dès 2027
Outlook / guidance
Expected revenue: 1,5 millions d'euros
Management commentary: Building on the outcomes of the various strategic initiatives undertaken since 2023, Amoéba will be able to leverage the ramp-up of its contracts in the agricultural sector from 2027 onwards to achieve revenue of between €1 million and €2 million.
The information presented in this article is provided for informational purposes only and does not constitute an investment recommendation, an incentive to buy or sell a financial asset, or investment advice. Readers are invited to conduct their own research before making any decision.
Investments in the stock market involve risks, including the risk of capital loss. Past performance of an asset or market is no guarantee of future results. Any investment decision should be made taking into account your personal financial situation, objectives and risk tolerance.
