AMOEBA prepares for the commercial launch of  the AXPERA Product Line in the USA with
approval expected by 2025

Chassieu (France), August 28, 2024 – 5:45pm – Amoéba (FR0011051598 – ALMIB), an industrial
greentech specialising in the development of natural microbiological solutions based on the
patented use of amoebae, announces that the US Environmental Protection Agency (US EPA) has
confirmed the admissibility and completeness of the registration dossier for its biocontrol products
in the United States.
On the basis of the approval already obtained in the United States for its biocontrol active substance,
and in order to accelerate its industrial and commercial development, Amoéba announces that in July
2024 it successfully submitted an application for federal market authorization application (MAA) for
its biofungicide products AXPERA GREEN and AXPERA NOA to the US EPA, the US environmental
protection agency.

The US EPA has confirmed the admissibility and completeness of the registration dossier for these
products. The pre-approval assessment has now begun and the authorization decision is expected
within a theoretical timeframe of 7 months. However, as a precaution and taking into account the
generally observed evaluation periods, the conclusions from the US EPA are therefore expected in mid2025.

These conclusions will apply to the entire US territory, excluding California, where the
registration procedure is separate. The US registration application for the plant protection products,
AXPERA GREEN and AXPERA NOA, is based on the required regulatory studies, over 38 field trials
conducted in the United States, in addition to more than 300 trials conducted on this version of the
product outside the US.

In parallel with the evaluation, Amoéba is working in collaboration with Dunham Trimmer, a leading
American consultancy in the biological products market, to prepare the commercial launch of AXPERAbased solutions, including the selection of commercial partners. If the registration timelines are met,
the market authorization would allow the first distribution contracts could be signed by the end of
2025.
This information is in addition to that from the approval authorities in Europe. Now that the collective
review of the active substance dossier by the Member States and the European Food Safety Authority
(EFSA) has been completed, the EFSA must finalize its report concluding the evaluation, and has
confirmed that it should be published by December 2024 at the latest.

About Amoéba:
Founded in 2010, Amoéba is a greentech based in Chassieu (Lyon, France) with the ambition to become a major
player for the treatment of microbiological risk in the crop protection and cosmetic sectors.
Based on the natural properties of a unique, exclusively patented, microorganism, the only one of its kind in the
world, our biological solutions offer a viable alternative to the chemical products that are widely used in the
industry today. Amoéba is currently focused on the global biocontrol market for plant protection and the
cosmetics market. As the market release of phytosanitary products is subject to local regulatory approvals, the
Company has completed the regulatory processes required and in 2022 obtained approval for its active
substance in the United States and its recommendation for approval in Europe, issued by the Austrian authority.
As the cosmetic application does not require prior approval from a relevant authority in Europe and the United
States, the party responsible for bringing the formulated cosmetic product to market must carry out a selfassessment of its safety.
Amoéba is listed on Euronext Growth. The Company is a member of the BPI Excellence network and is eligible
for the PEA-PME scheme. For more information, please visit www.amoeba-nature.com.