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Amoéba

Regulatory Filings Jul 13, 2023

1107_iss_2023-07-13_36e5d8ae-1f47-4be0-b135-ffa120ba512d.pdf

Regulatory Filings

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Press release

AMOEBA: Regulatory timetable for Europe's biocontrol application on track

Chassieu (France), July 13th, 2023 - 08h30 - AMOÉBA (FR0011051598 – ALMIB) an industrial biotech in pre-commercialization* specialized in the treatment of microbiological risk, developing a biocontrol agent for the treatment of plants in agriculture and a biological biocide for the treatment of industrial water, confirms that the regulatory timetable for the biocontrol active substance application is in line with the Company's forecasts.

The EFSA, the European Food Safety Agency, mentions on its website a Risk Assessment Deadline on July 19, 2023. As this date was assigned by default when the peer-review of dossier was initiated in December 2022, it does not take into account any delay by the authorities.

The Company had anticipated this possible delay in its forecasts: the regulatory timetable for its biocontrol applications in Europe, as published in the Universal Registration Document 2022 filed with the AMF on April 18, 2023 under the number D23-0296 and available on the Company's website, is still valid and is recalled below:

  • Risk assessment phase ending with EFSA's peer-review report containing its conclusions: expected to be finalized in the second half of 2023.
  • Risk management phase ending with the publication of the implementing regulation containing the European Commission's decision in the Official Journal of the EU: expected to be finalized in the first half of 2024.

As applications for approval of formulated products can be submitted before definitive approval of the active substance, the forecast timetable for formulated products is also in line with the Company's forecasts.

Adress : 38 Avenue des Frères Montgolfier, 69680 CHASSIEU Société Anonyme au capital de 993 199,26 € RCS Lyon 523 877 215

About AMOÉBA:

Amoéba's ambition is to become a major player in the treatment of microbiological risk in the water, plant protection and health sectors. Based on the natural properties of the amoeba Willaertia magna C2c Maky, our biological solution is a viable alternative to the chemical products widely used in the industry today. Amoeba is currently focused on the closed system industrial cooling tower market in the United States estimated at €200 million (1) and on the global biocontrol market for plant protection estimated at €3 billion (2), out of a global market for chemical fungicides estimated at €21 billion (3). The commercialization of the associated biocides and phytosanitary products is subject to local regulatory approvals.

*At the end of 2022, Amoeba obtained approval of its active substance for biocidal use in closed cooling system and for biocontrol use in the United States. The substance has also been recommended for biocontrol use in Europe by the Austrian authority in the same year. The company is currently in a pre-commercialization phase for biocidal and plant protection applications and is expected to market its products by 2025. Founded in 2010 and based in Chassieu (Lyon, France), 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.

(1): Amoéba data (2): IBMA data (3): Amoeba data

Contacts:

Amoéba Valérie FILIATRE Deputy General Manager +33 4 26 69 16 00 [email protected]

Calyptus Investor & Press Relations Nicolas HELIN / Mathieu CALLEUX +33 1 53 65 37 90 /91 [email protected]

Disclaimer

This press release contains certain forward-looking statements concerning AMOEBA which are based on its own assumptions and hypothesis and on information that are available to us. However, AMOEBA gives no assurance that the estimates contained in such forward-looking statements will be verified, which estimates are subject to numerous risks including the risks set forth in the reference document of AMOEBA filed with the French Financial Markets Authority (Autorité des Marchés Financiers) on April 18, 2023 under number D23-0296 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 AMOEBA or not currently considered material by AMOEBA. The occurrence of all or part of such risks could cause actual results, financial conditions, performance, or achievements of AMOEBA to be materially different from such forwardlooking statements.

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