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It was by chance, during tests carried out as part of the biocide regulatory dossier, that we discovered the strong antifungal properties of the amoeba Willaertia magna C2c Maky.

Information of the timetable for the other regulatory dossiers:

Chassieu (France), April 6, 2021 – 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 a development phase, has submitted today the application for approval of the biocidal active substance, the living amoeba Willaertia magna C2c Maky, and the biocidal products containing it, to the U.S. Environmental Protection Agency (U.S. EPA).

Amoéba reminds that in August 2019, it had decided to voluntarily withdraw its application for approval of the biocidal active substance, the living amoeba Willaertia magna C2c Maky, and biocidal products containing it, and to submit a new application for approval at a later stage.

During a pre-submission meeting in November 2019 between Amoéba and the U.S. EPA, requests for clarification were raised about the scientific elements that led to the withdrawal of the dossier and the way in which Amoéba planned to respond.

Amoéba was therefore able to submit a new application today, with the additional studies required by the U.S. EPA.

Once the active substance and biocidal product registrations are obtained, expected by mid- 2022 subject to approval by the US EPA, registration (notification and payment of fees) will be required at the state level, which will take about two months (except for California, which requires a full dossier evaluation of about 12 months). Once registration is obtained at the local level, marketing may be possible in the State.

Amoéba thus envisages the first sales of its biocide product in the United States from the second half of 2022, subject to a positive decision by the U.S. EPA.

Information on the timetable for other biocidal and phytosanitary regulatory dossiers:

Amoéba also provides information on the regulatory timetable for the various regulatory dossiers:

Biocide application (biocidal active substance, living Willaertia magna C2c Maky):

  • Europe: the application for approval of the active substance, submitted in 2019 (see Press Release of 12 August 2019), is currently being evaluated by the Maltese authority. Amoéba considers that the evaluation report of the authority could be available mid-2021.
  • Canada: the application for registration of the active substance and biocidal products containing it, submitted in 2019 (see Press Release of 1 February 2019) is currently being evaluated. The extension of the evaluation period (initially estimated at 24 months) is due to a request for additional information from the Canadian agency to which the company has responded. Amoéba estimates that the decision of the Canadian agency could occur before the end of 2021.

Phytosanitary application (biocontrol active substance, lysate of Willaertia magna C2c Maky):

  • Europe: the application for approval of the active substance, submitted in 2020 (see Press Release of 29 May 2020), is currently being evaluated by the Austrian authority. Amoéba considers that the evaluation report of the authority could be available at the end of 2021.
  • United States: the application for registration of the active substance and products containing it, submitted in 2020 (see Press Release of 1 October 2020) is currently being evaluated. The decision of the American agency should occur during 2022.
  • 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 file.

Details of the procedures are available in the Universal Registration Document (URD) filed with the French Financial Markets Authority (Autorité des Marchés Financiers) on 30 April 2020 under number D20-0416, in particular in sub-section 5.4.3. The URD is available on the company’s website and its update, including the above information, will be published in April 2021.

Press release PDF

Press release PDF

Chassieu (France), April 6, 2021 – 8.30 am- 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 a development phase, announces within the development of its biofungicide active substance, the lysate of the amoeba Willaertia magna C2c Maky, that it extends its collaborations with its partners (PHILAGRO and STÄHLER) and other major actors of the plant protection sector (BASF – BAYER – EVERGREEN GARDEN CARE – GOWAN – KWIZDA).

Continued experimentation with partners

PHILAGRO (France) and STÄHLER (Switzerland), the partner companies with which AMOÉBA has already signed term sheets that will lead to the signature of distribution agreements on grapevines (See press releases of December 9 and 18, 2020), will continue their experiments on grapevines but also on other crops.

Biocontrol application tested on other crops and geographical areas

Other agrochemical players, some of whom have already conducted tests in 2020, have decided to take part in this new field trials campaign. BASF – BAYER – EVERGREEN GARDEN CARE – GOWAN – KWIZDA will test the active substance of AMOEBA in different countries and on a wide range of crops (including vines, cereals and vegetables).

With the trials carried out by AMOÉBA itself, a total of more than 200 trials are planned throughout the world (Europe, the Americas, Asia) in 2021. This very large campaign will enable us to deepen our knowledge of the active substance, compare several formulations, broaden our knowledge of the spectrum of activity and generate, in Europe, results that will be used in future marketing authorization applications for formulated biocontrol products.

“This new field trials campaign, in which new agrochemical players will take part, demonstrates the need to act quickly to find alternatives to chemicals. Today’s agriculture, faced with more and more restrictions on the use of plant protection products, has to take up many environmental challenges to meet the expectations of the market and consumers. With 200 trials scheduled, including more than 70 of its own, AMOEBA and its partners are determined to support all the players in the agricultural world in order to bring about a genuine agro-ecological transition“, says Fabrice PLASSON, President and CEO of Amoéba.

PDF Press Release

Chassieu (France), March 26, 2021 – 8.15 am- 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 a development phase, announces today its 2020 annual results.

The Board of Directors, which met on 25 March 2021, approved the corporate and consolidated financial statements of the Amoeba Group for the year ended 31 December 2020.

The Statutory Auditors have carried out their audit work and have not identified any material misstatements that would call into question the conformity of the financial statements. The certification reports are being issued.

2020 results impacted by the cost of regulatory studies

At 31 December 2020, Amoéba’s operating profit was -€ 6,156k compared to – € 5,506k at 31 December 2019.

  • The company did not generate any revenue during the 2020 financial year.
  • Subsidies remain stable compared to 2019. They consist of the Research Tax Credit and reflect the efforts made by the company in terms of research and development on its biocontrolapplication in 2020.
  • Industrial deployment costs are slightly higher than the previous year.
  • Research and Development expenses amounted to €1,612k, down compared to 2019 (€2,634k). This decrease is due to an impairment of development costs for €933k recorded in June 2019 following the withdrawal of the marketing authorization application in the United States and the subsequent postponement of production operations (see press release of 19 August 2019).
  • Marketing and sales expenses (€221k) decreased (€274k in 2019).
  • General and administrative expenses amounted to €3,838k, a €1,262k increase compared to2019. This variance is due to regulatory studies expenses , increased fees incurred for financialoperations and patents management.
  • The financial result mainly includes interest expenses related to bank loans (€1,546k), theOCAPI transaction (€359k) and foreign exchange losses.

The net result thus amounts to -€8,157k compared to -€7,250k at 31 December 2019.

At 31 December 2020, the company’s shareholders’ equity amounted to €2m compared with €4.2m as at 31 December 2019.

The Company’s financial debt amounts to €8.6m and mainly consists of the EIB loan (€5m) and capitalised interest (€2.9m), as well as debts related to lease obligations (€0.7m).

The Company’s cash position at 31 December 2020 was €4,975k compared to €4,761k at 31 December 2019.

A year mainly marked by the development acceleration of the biocontrol application for plant protection and the regulatory dossiers follow up for the biocontrol and biocide applications.

During the year 2020, Amoéba focused on the following main areas:

1. Development accelerating of the biocontrol application for the prevention of plant diseases, in particular through research partnerships with major industrial groups

  • During the year 2020, the Company announced the signature of 8 Material Transfer Agreements (MTA) with De Sangosse, Certis Europe, Stähler Switzerland, BASF, Philagro France & Nichino Europe, Evergreen Garden Care, Syngenta and Bayer. The purpose of these agreements was to supply these companies with various formulations of experimental products containing Amoeba’s active substance: the amoeba lysate Willaertia magna C2c Maky. In return, the agrochemical groups financed and conducted their own field trials to evaluate the performance of these products in preventing diseases on different crops. At the end of the testing period, 2 term sheets were signed with Philagro and Sthäler for the development and marketing of our biocontrol product against grapevine downy mildew in France and Switzerland respectively.
  • The Company confirmed the efficacy of its amoeba lysate Willaertia Magna C2c Maky against grapevine downy mildew during the second field test campaign (see press release of 27 July 2020). It also announced the first efficacy results of its biocontrol solution on several major wheat diseases in its field trials (see press release dated 22 July 2020).
  • On August 11, 2020, the Company announced the publication of a first peer-reviewed scientific paper on its biocontrol application (https://www.mdpi.com/2223-7747/9/8/1013/pdf) in the special issue of Plants “Natural Products for Plant Pest and Disease Control”.
  • On October 1, 2020, the company filed an application for approval of the biocontrol active substance, “Willaertia magna C2c Maky lysate” and products containing it, with the US Environmental Protection Agency (EPA).
  • On 7 December 2020, the Company announced the signature of a research partnership with Gowan, a leading supplier of agricultural inputs (crop protection products, seeds and fertilizers) in the United States. Amoéba and the Gowan group are thus embarking on a targeted research phase which, if successful, could promote the commercial development of Amoéba’s biocontrol solutions in the United States.

2. Follow up of the application for the biocidal application marketing authorisation

  • In Europe: continued discussions with the Maltese authorities and Dutch experts. Following regular discussions and exchanges with the authorities and their experts, the Company expects to receive their evaluation report mid-2021.
  • In the United States: finalization of studies and drafting of conclusions for a submission of the Biocide application planned for April 2021. At the request of the American authorities, additional studies were carried out in 2020. These studies, conducted according to an EPA protocol – in addition to the OECD studies already carried out – have once again demonstrated the harmlessness of the amoeba Willaertia magna C2c Maky. The application for marketing authorisation should be submitted to the EPA on April 2021.

3. Continued research into the knowledge of the amoeba Willaertia Magna C2c Maky

During the year 2020, the company published several scientific articles relating to the knowledge of the Willaertia magna C2c maky amoeba.

4. Transfer of the Company’s shares from the regulated market of Euronext in Paris to Euronext Growth.

At the General Meeting of 24 June 2020, the Company submitted to the vote of its shareholders, who approved it, a project to transfer the listing of its shares from the regulated market of Euronext Paris (compartment C) to the multilateral trading facility Euronext Growth Paris.

This transfer, which was completed on 14 September 2020, aims to enable Amoéba to be listed on a market more suited to its size and market capitalisation, to simplify the Company’s operations and to reduce the costs related to its listing, while allowing it to continue to benefit from the attractions of the financial markets.

5. Securing the company’s financing

  • Renegotiation of the bank financing with the European Investment Bank (EIB) and signature of a contract for the issuance of Warrants to the EIB: On 31 March 2020, the Company signed an amendment to the loan agreement entered into on 6 October 2017 with the EIB for a proposed issuance of 200,000 Share Subscription Warrants (SSW) to the EIB. Under the terms of the amendment, the EIB has agreed to definitively remove the covenant to maintain the initially set up ratio between the amount of its equity capital and that of its assets. The issue of these warrants was approved by the General Meeting of Shareholders on 24 June 2020 and decided on 29 July 2020. The amendment signed between the EIB and Amoéba does not change the contractual maturity of the EIB loan scheduled for 2022.
  • Bond financing:
    • OCAPI 2020 plan
      • The Combined General Meeting of Shareholders of March 13, 2020 approved the implementation of a new contract for the issuance of bonds convertible into shares with an incentive program (OCAPI) between Amoéba and Nice & Green SA. As of December 31, 2020, 234 bonds out of 312 initially planned have already been issued and fully converted, representing the creation of 2,783,957 new shares.
    • New 2021-2022 OCAPI plan
      • On December 16, 2020, the Company signed a new bond financing agreement with Nice & Green for an amount of €23 million. In accordance with the terms of the contract, the Investor has undertaken, except in the case of usual defaults, to subscribe to OCAs in tranches to be quarterly issued according to the following schedule
        • six (6) initial tranches consisting of sixty (60) OCAs;
        • one (1) tranche consisting of forty (40) OCAs; and
        • an additional optional tranche of eighty (80) OCAs.
      • This timescale allows for a regular financing of the Company while limiting the impact on the share price.
      • The issuance by Amoéba of the OCAs and the possible issuance of new shares for which admission to trading will be requested, is intended to ensure the continuity of operations until September 20231 and in particular to finance:
        • (i) current expenses related to the business over the financing period, including operating expenses, research and development activities on the biocontrol application as well as the application processes for the authorisation of the biocidal active substance and the biocontrol substance in Europe and the United States
        • (ii) the repayment of the EIB loan and accrued capitalised interests amounting to €11.8 million scheduled for November 2022.

Impact of the Covid 19 health crisis on the Society’s development

From the beginning of April 2020, the production of the Company’s active substance continued under normal operating conditions. The health crisis had no impact on the preparation and monitoring of ongoing regulatory dossiers. The company made limited use of the partial activity mechanism and did not apply for a state guaranteed loan.

The Company does not market its products and does not currently recognise any significant turnover. The Covid-19 crisis therefore had little impact on its income statement.

Recent developments and prospects

As a reminder, the Company does not currently market any product and is awaiting marketing authorisations according to the schedules below:

The application procedures for the market authorisation of the biocidal and the biocontrol applications are detailed in the Universal Registration Document filed with the “Autorité des Marchés Financiers on 30 April 2020 under number D20-0416, in particular in subsection 5.4.3 “Product registration procedures”.

The company, in partnership with leading agrochemical companies, is preparing to carry out a third field tests campaign of its biocontrol product in 2021. These tests should focus on cereal diseases.

In addition to existing applications (biocide and biocontrol), Amoéba is receiving numerous requests to integrate its solution into new fields. A strict scientific evaluation of these opportunities is carried out permanently by our laboratory and external expert laboratories.

At the date of the accounts closing, the Company has sufficient net working capital to meet its obligations and cash requirements over the next twelve months, considering it should respect its commitments until September 2023. The financial statements for the year ended 31 December 2020 were prepared by the Board of Directors on a going concern basis in light of the business and cash flow forecasts.

Next meeting :

General Meeting of Shareholders: 27 May 2021

Amoéba announces the signature of a Material Transfer Agreement (MTA) with GOWAN COMPANY, a leading supplier of agricultural inputs (crop protection products, seeds and fertilizers) in the USA. 

The purpose of the research partnership is the provision by Amoéba of experimental products containing the amoeba lysate Willaertia magna C2c Maky. In return, GOWAN COMPANY will carry out its own field trials to evaluate the performance of these products in preventing fungal diseases on a range of crops in the US market. 

Amoéba and GOWAN COMPANY are thus embarking on a targeted research phase, which, if successful, could promote the commercial development of Amoéba biocontrol solutions in the USA 

“This research partnership with a US company generating more than $500M in revenue materializes the first step in market engagement of Amoéba biocontrol products. It’s perfectly aligned with the current assessment of our biocontrol dossier by the US authorities”, explains Jean-Luc Souche – Amoéba Biocontrol Business Developer. 

Amoéba appointed Pierre Morgon as non-voting Director with a view to proposing his candidacy as Director at the next General Meeting of Shareholders to be held in 2021. As a non-voting director, he will attend the next meetings of the Board of Directors in an advisory capacity, bringing his extensive experience and expertise to the Company.
Experiences and training
Pierre Morgon has over 30 years of experience in the global Life Sciences industry, especially specialty care, vaccines and immunotherapy, in management positions in multinational companies and as CEO of start-up companies.
He is a lecturer in several MBA programs and life sciences conferences, as well as at the Mass Challenge incubator in Switzerland where he also acts as a mentor for life sciences start-ups.
Currently, Pierre MORGON is CEO of MRGN Advisors, Regional Partner for Switzerland at Mérieux Equity Partners and Senior Vice-President International Business at CanSino Biologics.
He is also Chairman of the Boards of Directors of Theradiag, Eurocine Vaccines, MYCB1 and Health Technology Holding, as well as Non-Executive Director of the Boards of Directors of Vaccitech and Univercells.
He holds a doctorate in pharmacy, a master’s degree in business law and a MBA. He is also an alumnus of ESSEC, INSEAD and IMD.
“I would like to thank Fabrice Plasson for the confidence he has shown in me by asking me to join Amoeba’s Board of Directors. The company is in full expansion and the new applications of its technology in human health represent an exciting opportunity and challenge. I look forward to bringing my experience in life sciences, both in terms of development, partnerships and business development as well as governance” said Pierre MORGON.
“Pierre is a global reference in the field of vaccines and immunotherapies as well as in the entire value chain of the healthcare industry. It is a great pleasure to welcome him to our Board of Directors to benefit from his international vision (Chinese, European and American) in this sector. Pierre is also a recognized director of listed companies in Europe and an investment fund manager, with a perfect understanding of the challenges faced by companies such as Amoeba, which are undergoing strong acceleration,” said Fabrice Plasson, Chairman and CEO of Amoeba.

Amoéba announces the signature of a Letter of Intent (LOI) with PHILAGRO France, concerning the development and marketing of its biocontrol product against vine downy mildew in France.
This signature, with a recognised player in the crop protection market, an entity born from the strategic alliance of three Japanese groups (SUMITOMO Chemical Company, NISSAN Chemical Industries and NIHON NOHYAKU Company), follows on from the partnership announced in April 2020 to evaluate the performance of the biocontrol fungicide containing AMOEBA’s active substance: the amoeba lysate Willaertia magna C2c Maky.
The aim of the LOI is to define the collaboration outlines between the two companies before and after the marketing of the product on the French territory with a view to signing a commercial partnership contract within 12 months.
Amoéba will carry out the regulatory tests necessary for the registration of its product and PHILAGRO will refine the marketing and commercial positioning of the product through field trials.
Amoéba has made an exclusive commitment with PHILAGRO France concerning vine application over a marketing period of several years in France, the leading European market for downy mildew treatment.
“The Philagro team is delighted to be able to work with Amoéba for the development and future marketing of this very promising biocontrol solution in the strategic segment of the vine downy mildew. The two companies share a common vision of the evolution of the French market and high expectations in biocontrol innovations, complementing each other perfectly to make this solution a real technical and commercial success” explains Denis TROALEN, General Manager of PHILAGRO France.
“The choice of PHILAGRO as an exclusive partner is guided by more than 25 years of experience in the service of crop protection, a strong operational positioning in biocontrol and a real capacity for commercial execution in this strategic segment. The human relationship established between our two companies during this 2020 year of field tests has convinced us of the unfailing motivation of the teams to make the most of our product against vine downy mildew in France. “comments Fabrice PLASSON, Chairman and CEO of Amoéba.

Amoéba announces the signature of a Term Sheet with STÄHLER SUISSE SA, for the development and marketing of its biocontrol product against vine downy mildew in Switzerland. 

This signature, with a highly recognized local player in the crop protection market, follows on from the partnership announced in March 2020 to evaluate the performance of the biocontrol fungicide containing AMOEBA’s active substance: the amoeba lysate Willaertia magna C2c Maky. 

The aim of the Term Sheet is to define the terms of the collaboration between the two companies before and after the marketing of the product on the Swiss territory with a view to signing a commercial partnership contract within 12 months. 

Amoéba will carry out the regulatory tests necessary for the registration of its product and STÄHLER will define, through additional field trials, the marketing and commercial positioning of the product. 

Amoéba has made a non-exclusive commitment with STÄHLER concerning the vine application over a marketing period of several years in Switzerland, where vine downy mildew is an important market and the search for sustainable treatment solutions a strong objective for all Swiss agriculture. 

“Vine downy mildew is one of the main diseases in the Swiss vineyard. Its control today requires repeated applications of phytosanitary products. AMOEBA’s biocontrol product was tested for the first time by Stähler Suisse SA in 2020 in 2 trials. The results were very encouraging and it has been decided to continue the testing and development work. The product could become an important tool for the move towards a more ecological viticulture“, explains Simon Gasser, Head of Development and Certification at STÄHLER SUISSE SA. 

“As the Swiss vineyard offers a wide variety of grape varieties, the choice of STÄHLER as a partner was a natural one. As a leading player in its domestic market, specialising in particular in crops such as vines, arboriculture and market gardening, the company is already heavily involved in the development and marketing of biocontrol solutions. Our common goal is to provide local winegrowers with an effective solution for vine protection without impacting the environment “comments Fabrice PLASSON, Chairman and CEO of Amoéba.