Amoéba announces the publication of its Interim Financial Report for 2022.
Chassieu, October 3, 2022, 5.45 pm, AMOEBA (FR0011051598-ALMIB) – producer of a biological biocide capable of eliminating the risk in water and human wounds, and of a biocontrol product for plant protection, still in the testing phase, announces today that it has published its Interim Financial Report for 2022.
AMOEBA’s shareholders are informed that the interim financial report for the 2022 financial year (ending on December 31st, 2022), filed today with the Autorité des Marchés Financiers (AMF), can be found at the company website: https://amoeba-nature.com/en/investor/financial-documents/.
This report includes:
• Interim Activity Report
• Condensed Interim Financial Statements
• Certification of the person responsible for the interim financial report
• Statutory Auditors’ Review Report on the interim financial information
Amoéba announces its half-year results for 2022
Chassieu (France), September 29, 2022 – 6:00 pm – AMOÉBA (FR0011051598 – ALMIB), producer of a biological biocide capable of eliminating bacterial risk in water and human wounds, and of a biocontrol product for plant protection, still in the development phase, today announced its half- yearly results for 2022.
The Board of Directors, which met on 29 September 2022, approved the Company’s consolidated accounts for the first half of 2022.
The Statutory Auditor has carried out a limited review at the Company’s request of the consolidated financial statements for the six months ended 30 June 2022 and has not identified any material misstatements that would call into question their conformity.
The half-year report is being issued and will be available on the company’s website (www.amoeba- nature.com) in the next few days.
Operational results in line with 2021 and financial debt restructuring
The operating result for the six months to 30 June 2022 was a loss of K€2,860, compared with a loss of K€2,884 in the first half of 2021. No significant impairment was recorded during the periods presented.
- The company did not generate any revenue during the first half of 2022.
- Industrial deployment costs were €130k higher than the previous year.
- Research and Development expenses net of grants were €1,055k, compared to €819k in H12021.
- Marketing and sales expenses are up 71% on the previous year (€192k at 30 June 2022 versus €112k at 30 June 2021
- General and administrative expenses were down at 30 June 2022 to €1,097k, or -30% compared to the previous year.
- The financial result mainly includes interest expenses related to bank loans of €1,549k (compared to €1,434k in the first half of 2021) and changes in the fair value of financial derivatives of €335k (compared to €154k in 2021).
The net result for the first half of the year is therefore -€4,726k.The Company’s cash position at 30 June 2022 was €2,752k compared to €7,274k at 31 December 2021.
The decrease in cash is explained by :• cash flow from operations of – €2,682k;
• cash flow from investment activities of -€40k;
• cash flows from financing activities of – €1,802k, mainly due to the issue of bonds for €5,760kin the first half of 2022 and the full repayment of the EIB loan for €6,070k.As at 30 June 2022, the Company’s shareholders’ equity amounted to €3.7m compared to €0.2m as at 31 December 2021.The Company’s financial debt amounted to €4.8m. It is mainly made up of the OCAPI loan (€4.3 million) and debts linked to rental obligations (€0.4 million), the EIB loan having been fully repaid on 30 June 2022.
A first semester mainly marked by the progress of regulatory marketing files, the continued development of the biocontrol application and the early repayment of the EIB loanDuring the first half of 2022, Amoéba focused on the following main areas:
1. Follow-up of the marketing authorisation applications for the biocontrol and biocideapplications
used in accordance with good plant protection practice and under realistic conditions of use.
• Biocidal application
On 03 May 2022, the Company announced that the MCCAA (Malta Competition and Consumer Affairs Authority), the competent authority of the reporting Member State (Malta) evaluating the application for approval of the biocidal active substance “Willaertia magna C2c Maky”, recommended its non-approval for biocidal use in cooling towers in Europe.
On the basis of the application dossier for approval of the biocidal active substance “Willaertia magna C2c Maky”, the Maltese authority concluded in its draft report that the active substance is not likely to meet the approval criteria, considering that the innate efficacy has not been sufficiently demonstrated and that a Trojan horse effect cannot be excluded under realistic conditions of use. However, a few weeks later, the US EPA issued a favourable pre-notification for the use of the amoeba Willaertia Magna C2c Maky in closed cooling systems (see below “Recent developments and prospects”) in the United States.
2.Further development of the biocontrol application and launch of a new massive field trial campaign for 2022
In the first half of 2022, the company has started a new field trial campaign for its biocontrol product, focusing on :
- Trials for the European marketing authorisation of the selected formulation on grapevine downy mildew
- After the excellent results obtained in 2021, the intensification of the powdery mildew programme on vines
- Intensification of the programme against mildew and powdery mildew on market garden crops in order to prepare future MA applications
- Continuation of the cereals programme, in particular against rusts, septoria and fusarium head blight.
- Trials on new targets: in particular apple scab, a major subject, following promising results obtained in climatic chambers.
- Continued evaluation against soybean rust and coffee rust FinancingThe Company announced the issuance of the fourth and fifth tranches of 60 bonds convertible into shares in the framework of its bond financing with an incentive programme concluded with Nice & Green.In addition, Amoéba finalised the restructuring of its debt by prepaying the entire EIB loan.
3.Financing
The Company announced the issuance of the fourth and fifth tranches of 60 bonds convertible into shares in the framework of its bond financing with an incentive programme concluded with Nice & Green.In addition, Amoéba finalised the restructuring of its debt by prepaying the entire EIB loan.
4.Changes in governance
The General Meeting of Shareholders of 24 May 2022 ratified the appointment as directors of Mr Philippe DUJARDIN to replace Mr Pascal REBER, who resigned and Mrs Sylvie GUINARD, replacing Mrs Claudine VERMOT-DESROCHES, who has resigned.
Mr Philippe DUJARDIN and Ms Sylvie GUINARD will hold office for the remainder of their predecessors’ term of office, i.e. until the end of the Ordinary General Meeting of shareholders to be held in 2023 to approve the financial statements for the year ending 31 December 2022.
In addition, the General Meeting of Shareholders of 24 May 2022 ratified the appointment of Mr Pascal REBER as Censeur.
Mr Pascal REBER will exercise the said functions for a period of three (3) years, i.e. until the end of the Ordinary General Meeting of Shareholders to be held in 2024 to approve the accounts for the financial year ending 31 December 2023.
Impact of the COVID-19 health crisis and the war in Ukraine on the accounts at 30 June 2022
At the date of this half-yearly report, the Company considers that its activities have not been significantly impacted by the health crisis.
The production of the active substance necessary to carry out the field tests could continue under normal operating conditions. The health crisis had no impact on the preparation and monitoring of current regulatory dossiers. The Company made limited use of the partial activity mechanism and did not request an EMP.
The Company does not yet market its products and does not recognise any significant turnover to date. The Covid-19 crisis had little impact on its income statement.
The Company has no activities in Russia or Ukraine. However, the Company’s activities could be impacted by the direct or indirect consequences of the conflict, which it is not possible to quantify precisely at this time.
Recent developments and prospects
Following the US EPA’s preliminary favourable decision on the use of the amoeba Willaertia Magna C2c Maky in closed cooling systems (see press release of 10 August 2022), Amoeba is currently refining its market analysis on this restricted type of system in order to evaluate its commercialization potential.
On 29 September 2022, the company has received from the United States Environmental Protection Agency (US EPA) a positive pre-decisional determination following its assessment of the application dossier for the use of the Lysate of Willaertia magna C2c Maky as a biocontrol active ingredient (biopesticide) in agriculture. The US EPA has concluded that the Lysate of Willaertia magna C2c Maky has a low toxic profile for human health and the environment, and that its “mode of action contributes to its attractiveness as viable alternative to conventional pesticides making it a valuable addition to the pesticide tool kit”. Therefore, the EPA is proposing to grant the unconditional registration of lysate of Willaertia magna C2c Maky as a new active ingredient and supports a pesticidal food use and non- food use.
The Company is pursuing its project to set up its first biocontrol plant. This plant would be located in France and should be operational in 2024 to satisfy the start of the marketing of biocontrol products. It should represent an estimated investment of between 15 and 17 million euros for which Amoéba will have to seek new financing from the 4th quarter of 2022.
At the date of closing of the accounts, the Company has sufficient net working capital to meet its obligations and cash requirements over the next twelve months, as the Company believes it can meet its commitments.
Amoéba announces that the US EPA is about to approve its biocontrol solution for use in agriculture
Lyon (France), September 29th, 2022 – 17h45 – AMOÉBA (FR0011051598 – ALMIB), producer of a biological biocide capable of eliminating bacterial risk in water and human wounds, and of a biocontrol product for plant protection, still in development phase, informs that the United States Environmental Protection Agency (US EPA) has made a positive pre-decisional determination following its assessment of the application dossier for the use of the Lysate of Willaertia magna C2c Maky as a biocontrol active ingredient (biopesticide) in agriculture.
The US EPA has concluded that the Lysate of Willaertia magna C2c Maky has a low toxic profile for human health and the environment, and that its “mode of action contributes to its attractiveness as viable alternative to conventional pesticides making it a valuable addition to the pesticide tool kit”. Therefore, the EPA is proposing to grant the unconditional registration of lysate of Willaertia magna C2c Maky as a new active ingredient and supports a pesticidal food use and non-food use. The US EPA also propose an exemption from the requirement of a tolerance for lysate of Willaertia magna C2c Maky and no pre-harvest interval when the products are applied according to EPA-approved label instructions and good agricultural practices.
Based on the last administrative steps required by the US EPA to finalize the procedure, the issuance of the marketing authorization of the products is expected by the end of 2022 at the latest.
“2022 is definitely the year of transition for Amoéba, with this third positive regulatory announcement that confirms the path to turnover generation as early as 2024.
The US EPA is taking a position in favor of the conversion or substitution of chemical molecules by Amoéba’s biological products, first by issuing a favorable opinion for the biocide last August (see Press Release dated Aug 10th, 2022) and today for the biocontrol solution, recognising Amoéba as a major player in the development of alternatives to pesticides.
Amoeba is now a viable solution recognized by the European and American authorities capable of reducing the use of chemical pesticides. The imminent access to a market of more than $8 billion, combined with the verified efficacy of our product through 480 field tests, positions Amoeba as the future world leader in biocontrol.
In anticipation of these favorable decisions, Amoéba has entered into an industrialization phase by simultaneously expanding its production site in Chassieu and building a new plant dedicated to biocontrol. By the end of 2022, the regulatory uncertainties will be definitively lifted to make way for Amoeba’s new development plan for commercialization. Once again, I would like to congratulate the Amoéba teams who have worked towards this success”, says Fabrice Plasson, CEO of Amoéba.
Amoéba announces the issuance of the sixth tranche of 60 bonds convertible into shares.
Chassieu (France), September 15, 2022– 5.45 pm – AMOEBA (FR0011051598 – ALMIB), producer of a biological biocide capable of eliminating bacterial risk in water and human wounds, and a biocontrol product for plant protection, still in a development phase, announces the issuance of the sixth tranche of bonds convertible into shares (“OCAs”) of its new bond financing with incentive program, namely 60 OCAs numbered from 301 to 360 fully issued to Nice & Green S.A.
This issue is part of the agreement entered into with Nice & Green S.A. on December 16, 2020 with a view to setting up a bond financing with a profit-sharing program through the issuance of 480 OCAs with a nominal value of EUR 50,000 each, representing a total nominal amount of the bond issue of EUR 24,000,000 (the “Issuance Agreement”).
The Chairman and Chief Executive Officer of the Company, using the sub-delegation granted to him by the Board of Directors at its meeting on June 24, 2021, decided to issue on September 15, 2022, 60 OCAs numbered from 301 to 360 to the benefit of Nice & Green S.A. corresponding to the sixth tranche of the bond financing.
As provided for in the issuance agreement, these OCAs were fully subscribed at a price equal to 96% of their nominal value, representing a sixth tranche of OCAs for a total net amount of EUR 2,880,000.
As a reminder, the Company maintains on its website a monitoring table of the OCAs and the number of Amoéba shares in circulation (see Investors section / Regulatories information / Other information).
As an indication, the theoretical impact of the issue of this sixth tranche of OCAs is presented in the tables below in accordance with the OCA conversion formulas on the basis of 92% of the lowest volume-weighted average trading price of the Amoéba share at closing (as published by Bloomberg) over the six (6) trading days immediately preceding September 15, 2022, namely 0.9295 euros.
– Impact of the issue on the share of shareholders’ equity per share (calculation based on Amoéba’s shareholders’ equity as at december 31, 2021, prepared in accordance with International Financial Reporting Standards (IFRS) adjusted for capital increases completed up to September 15, 2022 i. e. 11,445,684 euros and the number of shares comprising the Company’s share capital as at September 15, 2022, i. e. 42,472,936 shares) :
(*) amount of shareholders’ equity at 31 december 2021 prepared in accordance with IFRS international financial standards and adjusted for capital increases completed until September 15, 2022
(**) assuming:
- the full exercise of the business creator share subscription warrants and share subscription warrants issued and allocated by Amoéba, exercisable or not, giving the right to subscribe for 200,000 new shares
- the definitive allocation of the conditional rights to receive 25,000 free shares fully subject to a condition of uninterrupted presence.
– Impact of the issue on the participation of a shareholder holding 1% of Amoéba’s share capital prior to the issue of the sixth tranche (calculation based on the number of shares comprising Amoéba’s share capital as at September 15, 2022, i.e. 42,472,936 shares) :
(*) assuming:
- the full exercise of the business creator share subscription warrants and share subscription warrants issued and allocated by Amoéba, exercisable or not, giving the right to subscribe for 200,000 new shares
- the definitive allocation of the conditional rights to receive 25,000 free shares fully subject to a condition of uninterrupted presence.
“The objectives of the financing programme with Nice & Green SA were to develop our biocontrol application worldwide on field crops, to continue the examination of our regulatory dossiers and to restructure the company’s debt while strengthening its equity (see press release of 21 December 2020). To date, even before the end of the programme, I am pleased to note that these objectives have been achieved with, in particular, the implementation of 194 field trials between 2021 and 2022, the positive recommendation from Austria for the approval of our biocontrol active substance and the full early repayment of our loan from the EIB. Amoéba can now look forward to a new phase in its development and financing with the construction of a dedicated biocontrol plant and the search for new opportunities based on the use of the amoeba Willaertia magna C2c Maky,” said Fabrice Plasson, Chairman and CEO of Amoéba.
Amoéba informs that the US EPA has made a positive pre-decisional determination for the use of Amoéba’s biocide in closed cooling systems
Lyon (France), August 10th, 2022 – 17h45 – AMOÉBA (FR0011051598 – ALMIB), producer of a biological biocide capable of eliminating bacterial risk in water and human wounds, and of a biocontrol product for plant protection, still in development phase, informs that the United States Environmental Protection Agency (US EPA) has made a positive pre-decisional determination following its assessment of the application dossier for the use of Willaertia magna C2c Maky as a biocidal active ingredient in cooling systems.
The US EPA has concluded that the amoeba Willaertia magna C2c Maky and the BIOMEBA products containing it can be authorized on the United States territory for a biocidal use in closed cooling systems, for the control of microbial slime (bioslime), microbially induced corrosion and general microbial flora in cooling towers waters.
Based on the last administrative steps required by the US EPA to finalize the procedure, the issuance of the marketing authorization of the products is expected by the end of 2022 at the latest.
“This is historic news that has just been sent to us by the US EPA. Amoéba has been legitimized in its application for the use of a microorganism in the treatment of bacterial risk in water. We will now refine our analysis of the market potential for this type of closed systems. We hope that the pragmatism of North American regulatory agencies will one day inspire European agencies. This decision adds a very positive note to the worldwide interest already in place for our biocontrol application and will influence the company’s future development.”, says Fabrice Plasson, CEO of Amoéba.
Amoéba announces the issuance of the fifth tranche of 60 bonds convertible into shares.
Chassieu (France), June 13, 2022– 5.45 pm – AMOEBA (FR0011051598 – ALMIB), producer of a biological biocide capable of eliminating bacterial risk in water and human wounds, and a biocontrol product for plant protection, still in a development phase, announces the issuance of the fifth tranche of bonds convertible into shares (“OCAs”) of its new bond financing with incentive program, namely 60 OCAs numbered from 241 to 300 fully issued to Nice & Green S.A.
This issue is part of the agreement entered into with Nice & Green S.A. on December 16, 2020 with a view to setting up a bond financing with a profit-sharing program through the issuance of 480 OCAs with a nominal value of EUR 50,000 each, representing a total nominal amount of the bond issue of EUR 24,000,000 (the “Issuance Agreement”).1
The Chairman and Chief Executive Officer of the Company, using the sub-delegation granted to him by the Board of Directors at its meeting on June 24, 2021, decided to issue on June 13, 2022, 60 OCAs numbered from 241 to 300 to the benefit of Nice & Green S.A. corresponding to the fifth tranche of the bond financing.
As provided for in the issuance agreement, these OCAs were fully subscribed at a price equal to 96% of their nominal value, representing a fifth tranche of OCAs for a total net amount of EUR 2,880,000.
As a reminder, the Company maintains on its website a monitoring table of the OCAs and the number of Amoéba shares in circulation (see Investors section / Regulatories information / Other information).
As an indication, the theoretical impact of the issue of this fifth tranche of OCAs is presented in the tables below in accordance with the OCA conversion formulas on the basis of 92% of the lowest volume-weighted average trading price of the Amoéba share at closing (as published by Bloomberg) over the six (6) trading days immediately preceding June 13, 2022, namely 0.555 euros.
– Impact of the issue on the share of shareholders’ equity per share (calculation based on Amoéba’s shareholders’ equity as at december 31, 2021, prepared in accordance with International Financial Reporting Standards (IFRS) adjusted for capital increases completed up to June 13, 2022 i. e. 5,493,684 euros and the number of shares comprising the Company’s share capital as at June 13, 2022, i. e. 29,717,637 shares) :
(*) amount of shareholders’ equity at 31 december 2021 prepared in accordance with IFRS international financial standards and adjusted for capital increases completed until June 13, 2022
(**) assuming:
- the full exercise of the business creator share subscription warrants and share subscription warrants issued and allocated by Amoéba, exercisable or not, giving the right to subscribe for 200,000 new shares
- the definitive allocation of the conditional rights to receive 25,000 free shares fully subject to a condition of uninterrupted presence.
- the conversion of 4 bonds issued on tranche 3 and 60 bonds issued on Tranche 4 and not yet converted at june 13, 2022
– Impact of the issue on the participation of a shareholder holding 1% of Amoéba’s share capital prior to the issue of the fifth tranche (calculation based on the number of shares comprising Amoéba’s share capital as at June 13, 2022, i.e. 29,717,637 shares) :
(*) assuming:
- the full exercise of the business creator share subscription warrants and share subscription warrants issued and allocated by Amoéba, exercisable or not, giving the right to subscribe for 200,000 new shares
- the definitive allocation of the conditional rights to receive 25,000 free shares fully subject to a condition of uninterrupted presence.
- the conversion of 4 bonds issued on tranche 3 and 60 bonds issued on tranche 4 and not yet converted at June 13, 2022.
Amoéba updates the regulatory calendar for both the biocide and biocontrol applications in the US.
Lyon (France), May 30, 2022 – 17h45 – AMOÉBA (FR0011051598 – ALMIB), producer of a biological biocide capable of eliminating bacterial risk in water and human wounds, and of a biocontrol product for plant protection, still in development phase, updates the regulatory calendar for both the biocide and biocontrol applications in the US.
Application for authorization of the biocide in the United States
The application for approval of the biocidal active substance, the living amoeba Willaertia magna C2c Maky, and biocidal products containing it, filed in April 2021 with the U.S. Environmental Protection Agency (U.S. EPA), is still under review. The conclusions were, according to the legal deadline announced by the authority, expected by mid-2022. The U.S. EPA has requested an extension of the assessment period: the conclusions of the assessment should now be available in the second half of 2022.
Application for authorization of the biocontrol in the United States
The application for approval of the biocontrol active substance, the lysate of Willaertia magna C2c Maky, and the biocontrol products containing it, filed in October 2020 with the U.S. Environmental Protection Agency (EPA), is still under review. The conclusions were, according to the legal deadline announced by the authority, expected by the end of May 2022. The U.S. EPA has requested an extension of the assessment period: the conclusions of the assessment should now be available in the second half of 2022.
Ordinary and extraordinary general meeting to be held on 24 May 2022 – Modalities through which the preparatory documents will be made available
The company’s shareholders are invited to attend the ordinary and extraordinary general
meeting which will be held on: Tuesday 24 may 2022 – 9 am at the company registered office – 38 Avenue des Frères Montgolfier- 69680 CHASSIEU.
The notice of the meeting as a notice of convocation, including the agenda and the planned
resolutions, was published in the BALO (Bulletin of obligatory legal announcements) of 18 april, 2022.
The documents stipulated by article R.225-83 of the French commercial code are available to
shareholders from the moment that the assembly is convened, in line with the applicable regulatory
requirements:
• Any registered shareholder can, until the fifth day (inclusive) before the assembly, ask the
company to send him these documents. For holders of bearer shares, this right can only be
exercised upon presentation of a statement of participation in the accounts of bearer shares
held by the authorised intermediary;
• Any shareholder can consult these documents at the company’s headquarters during the 15
days preceding the date of the meeting.
For information, electronic voting via the VOTACCESS secure voting platform for the General Meeting
of Tuesday, May 24, 2022 will be open from May 6, 2022 until Monday, May 23, 2022 at 3:00 pm (Paris
time). Shareholders wishing to use this platform can consult the access conditions in the notice of
meeting and on the company’s website (https://amoeba-nature.com/investisseur/assembleegenerale).
In the context of the coronavirus epidemic (COVID-19), the procedures for holding the Shareholders’
Meeting may change depending on health and/or legal requirements. Shareholders are invited to
regularly consult the section dedicated to the Shareholders’ Meeting on the Company’s website
(https://www.amoeba-nature.com/Investors/General-assembly).
The results of the votes on resolutions will be posted on the Company’s website.
Amoeba announces that the Maltese authority recommends the non-approval of the biocidal active substance for the European territory
Lyon (France), May 3rd, 2022 – 17h45 – AMOÉBA (FR0011051598 – ALMIB), producer of a biological biocide capable of eliminating bacterial risk in water and human wounds, and of a biocontrol product
for plant protection, still in development phase, announces that the MCCAA (Malta Competition and
Consumer Affairs Authority), the competent authority of the reporting Member State (Malta)
evaluating the application for approval of the biocidal active substance “Willaertia magna C2c Maky”,
recommends its non-approval for a biocidal use in cooling towers in Europe.
On the basis of the application for approval of the biocidal active substance “Willaertia magna C2c
Maky”, the Maltese authority concluded in its draft report that the active substance is not likely to
fulfill the approval criteria, considering that the innate efficacy was not sufficiently demonstrated and
that a Trojan horse effect cannot be excluded under realistic conditions of application and use.
Malta therefore recommends to the other EU Member States and to the European Chemicals Agency
(ECHA) that the substance should not be approved and therefore not included in the list of authorized
biocidal active substances.
The Maltese draft assessment report will now be discussed at the European level between Member
States under the aegis of ECHA, before a decision by the European Commission in mid-2023.
“The Trojan Horse effect is purely hypothetical and has never been characterized as a danger.
Regarding the efficacy, European regulations require at the stage of the active substance approval to
demonstrate the capacity of the substance to produce a sufficient effect on a relevant target organism:
the studies conducted by Amoeba have largely shown this ability of Willaertia magna C2c Maky against
legionella. Again, the evaluators question the methodology of our studies while the biocidal standards
are exclusively developed for chemicals and do not exist for microorganisms, creating a barrier to
access the biocidal market for this type of natural substance. The recommendation of non-approval by
Malta is hence an outcome tinged with misunderstanding. “, declares Jean-Baptiste EBERST, Regulatory Director at Amoéba.
“At the dawn of the greatest environmental and health challenges, the unfavorable decision of the
Maltese authority causes disappointment and dismay to Amoeba and its teams. This conclusion goes
against the objectives of the European Commission, which has just published its roadmap on the
restriction of harmful chemicals. Nevertheless, we have just secured Amoéba on a more than €12
billion market thanks to the positive recommendation on biocontrol, which is a major step forward for
a Greentech. Our plant in Chassieu, already 100% dedicated to biocontrol, will provide us with
biocontrol active substance for the years to come. We are also convinced by the strong potential of the
amoeba and are pursuing our development and research in other application areas.” states Fabrice
Plasson, CEO of Amoéba.
Pending application for authorization of its biocide in the United States and Canada
Amoéba reminds that the application for approval of the biocidal active substance, the living amoeba
Willaertia magna C2c Maky, and biocidal products containing it, filed in April 2021 with the U.S.
Environmental Protection Agency (U.S. EPA), is still under review. The conclusions are expected by mid2022.
In Canada, the application for registration of the active substance and biocidal products containing it,
submitted in 2019, is under evaluation. The decision of the Canadian agency could be communicated
in 2022.
Continued development of the biocontrol application
At the same time, Amoéba continues to develop its biocontrol application, especially through
collaborations with its partners and other major players in the plant protection sector through new
field trial campaigns.
In Europe, the Austrian authority has recommended in April 2022 the approval of the biocontrol active
substance.
In the United States, the application for approval of the active substance and products containing it,
also submitted in 2020, is being evaluated.
Finally, in Brazil, an experimental permit was obtained in February 2021, allowing the Company to
initiate field trials on soybean, coffee and banana. Such trials in Brazil are required for an application
for approval.
Amoéba: Austria recommends the approval of the biocontrol active substance for the European territory
Lyon (France), April 25th, 2022 -5.45 pm – AMOEBA (FR0011051598 – AMEBA), producer of a biological biocide capable of eliminating bacterial risk in water and human wounds, and of a biocontrol product for plant protection, still in the testing phase, announces that AGES (Agentur für Gesundheit und Ernährungssicherheit[1]) the competent authority of the Rapporteur Member State (Austria) in charge of the application for approval of the biocontrol active substance “Lysate of Willaertia magna C2c Maky”, recommends its approval for use in plant protection on the European territory.
In its draft assessment report, AGES concludes that the active substance is expected to fulfill the approval criteria, confirming the efficacy of the active substance and its absence of harmful effects on human health and the environment when used in accordance with good plant protection practices and under realistic conditions of use.
Based on this conclusion, Austria recommends to the other EU Member States and to the European Food Safety Agency (EFSA) the approval of this active substance and its inclusion on the list of approved phytopharmaceutical active substances.
In its draft assessment report, Austria also recommends:
- that the active substance ” Lysate of Willaertia magna C2c Maky ” should be classified as a low-risk substance. This classification allows, in particular, an accelerated evaluation of the products containing the active substance (according to the regulations, 120 days instead of 365 days) and a longer period of authorization of the active substance before renewal (15 years instead of 10 years).
- that the establishment of a maximum residue level[2] for “Lysate of Willaertia magna C2c Maky” should not be required, based on the non-toxicological profile of the substance.
At this stage, the recommendation for approval is not subject to any restriction.
The major steps to come before the commercialization of products containing the biocontrol active substance “Lysate of Willaertia magna C2c Maky” on the European territory are as follows:
“The recommendation of approval by Austria is a major step for Amoéba, leading to the future commercialization of our biocontrol products. The positive recommendation confirms both the performance of our substance, the expertise of our teams and the quality of the partners we are working with on this application. The fluent evaluation also shows the importance of the communication between the authority and the applicant, before the submission and during the evaluation, which the Austrian authority has greatly facilitated”, says Jean-Baptiste EBERST, Regulatory Director at Amoéba.
“The positive decision of Austria for the use of the active substance Willaertia magna C2c Maky in biocontrol application is a major success for Amoéba, and rewards the unfailing dedication of our teams. This positive conclusion sets the stage for great opportunities and strongly encourages us to explore the full potential of this substance in different fields of application. With this first success, we are looking forward to the decision of Malta regarding the use of the substance in biocidal application with optimism.” declares Fabrice PLASSON, CEO of Amoéba.
[1] Agency for Health and Food Safety – Austria
[2] MRL, regulatory threshold of pesticide residue concentration, beyond which the marketing of a food product is no longer authorized