Amoéba reaches a determining milestone with the positive and definitive conclusions of the EFSA

Press release

• Receipt of the final conclusions validating the efficacy and low-risk profile of Amoéba's biocontrol active substance;
• This validation, coupled with the Memorandum of Understanding signed with Koppert, world leader in biocontrol, paves the way for the upcoming launch of AXPERA, the new innovative biofungicide solution developed by Amoéba;
• Organisation of a videoconference open to all on Wednesday 18 December at 6pm.

To register and take part in this videoconference, click on the link below:

I would like to take part in the videoconference

Chassieu (France), 16 December 2024 – 8.00 am - Amoéba (FR0011051598 - ALMIB) has taken a decisive step forward with the recognition by the European Food Safety Authority (EFSA) in its assessment report of the efficacy and low-risk profile of its biocontrol substance[1]. These conclusions from the EFSA, which come just after the signing of a Memorandum of Understanding (MoU) with Koppert[2], a world leader in biocontrol, now pave the way for the transformation of Amoéba into an industrial and commercial company.

Amoéba announces that on the afternoon of Friday 13 December 2024, it received from the EFSA the final conclusions of the assessment of its active substance at European level. This report highlights in particular:

• 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.

Amoéba now has until 3 January 2025 to withdraw the confidential data from the report. The EFSA will then publish the final report, whose conclusions will remain unchanged, on its website. The European Commission will then have 6 months to approve the active substance, in accordance with the usual administrative procedures.

Jean-Baptiste EBERST, Amoéba's Director of Regulatory Affairs, said: "The finalisation of the EFSA assessment represents a major step forward for Amoéba. This validation confirms not only the efficacy of our solution, but also its positive contribution to sustainable agriculture. These conclusions are the culmination of six years work of dedicated teamwork and collaboration with Austria, the rapporteur member state, and the EFSA."

Amoéba will now be able to launch the application procedure for the marketing authorization for its biocontrol products, under the name "AXPERA". The application will be submitted to the eight European Member States targeted as a priority[4], with a decision expected in 2025.

The EFSA and Koppert: a sequence that embodies Amoéba's change of dimension

This major announcement comes on the heels of the signing, on Thursday 12 December 2024, of an ambitious Memorandum of Understanding (MoU) between Amoéba and Koppert, the world leader in biocontrol, who intend to combine their expertise to bring a range of innovative biofungicides to market.

Amoéba could thus benefit from Koppert's know-how, experience and power in order to make the most of the approval of its substance.

The definitive confirmation by the EFSA of the strengths of its active substance combined with the promising prospects of its association with Koppert constitute a major milestone in the history of Amoéba, which will become an industrial and commercial company from 2025.

Jean-François DOUCET, Chief Executive Officer of Amoéba, added: "This decision rewards the unwavering commitment of our teams to developing and securing recognition for the full potential of our active substance, and is a source of great pride for our employees. We would also like to thank the various stakeholders supporting our approach, in particular Bpifrance and our main shareholder Nice & Green, for their confidence and their financial and strategic support.”

Benoit Villers, Chairman of the Board of Directors of Amoéba, concludes: "We have just experienced a perfectly extraordinary sequence in 24 hours with these two consecutive major milestones, which constitute excellent news for our shareholders, who have always believed in the potential of the company. Amoéba, in close collaboration with Koppert, is now preparing to provide its customers with concrete, effective and environmentally-friendly solutions. We are opening a new chapter in the history of Amoéba.”

Organisation of a videoconference open to all

As part of these two major announcements, Benoit Villers and Jean-François Doucet, respectively Chairman of the Board of Directors and Chief Executive Officer of Amoéba, will present the company's strategy and outlook and answer investors' questions during a video conference open to the public on Wednesday 18 December 2024 at 6 pm.

To register and take part in this videoconference, click on the link below:

I would like to take part in the videoconference

The conference will include a question and answer session. You can now send your questions to amoeba@actus.fr

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:

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.

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

[2] See the press release dated 12 December 2024.

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

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