AMOEBA (EPA:ALMIB) - AMOEBA FILES THE APPLICATION FOR THE AUTHORIZATION OF ITS BIOCONTROL SOLUTION IN THE U.S.A.

Transparency directive : regulatory news

01/10/2020 18:00

PRESS RELEASE

AMOEBA FILES THE APPLICATION FOR THE AUTHORIZATION OF ITS BIOCONTROL SOLUTION
                                 IN THE U.S.A.

Chassieu, October 1, 2020, 6.00 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,
informs that the application for approval of its biocontrol active substance
"lysate of Willaertia magna C2c Maky" and products containing it was submitted
today to the competent authority of the United States, the Environmental
Protection Agency (EPA). The biocontrol solution, developed by Amoéba, is
intended for use as a fungicide in agriculture.

A dossier meeting regulatory requirements

This application for approval is partly based on the studies carried out for
the European dossier (see Press Release of May 29, 2020). Additional toxicity
studies, required by the U.S. pesticide regulation, have been conducted and
have confirmed the absence of hazard to human and animal health.

A possible approval in 2022

Being a naturally occurring substance, the biocontrol active ingredient is a
biopesticide and the application for approval will be evaluated by the
Biopesticides and Pollution Prevention Division (BPPD). The approval process
will take between 18 and 24 months, with a decision expected in 2022. The main
steps are as follows:

1) Initial 21-day Content Screen : the EPA verifies whether the application is
sufficiently complete, which takes 21 days.

2) Preliminary Technical Screen : a preliminary technical review is conducted
within 90 days of Step 1) to determine if the data is accurate and complete,
consistent with the proposed labelling and if, subject to a full review, could
lead to the acceptance of the application. If the information is considered
insufficient by the EPA at this stage, the applicant has 10 business days to
provide the required information.

3) In-Depth Review of Data : Upon successful completion of the Preliminary
Technical Screen stage, the application is subject to a thorough review. If,
during this in-depth review, the EPA determines that there are data gaps or
that additional data are required to complete the review, the EPA will notify
the applicant. The applicant will be given 75 days to make corrections or to
provide additional data.

Ultimately, if the EPA considers that the substance can be used in a plant
protection product without posing unreasonable risks to human health and the
environment, then it issues a federal marketing authorization. Once
registration of the product is obtained at the federal level, registration
(notification and payment of fees) is required by local regulations in most
states and takes approximately one to two months (except in California, which
requires an evaluation of the complete file in approximately 12 months). Once
registration has been obtained at the local level, marketing is possible in the
state.

The Company is therefore considering a marketing approval in the United States
for products containing the biocontrol active substance "lysate of Willaertia
magna C2c Maky" in 2022.

Research partnerships on biocontrol applications

Amoéba is currently and until mid-October exchanging with each partner having
signed a material transfer contract (see press release of April 29, 2020) all
the respective technical results of their field trials. The analysis of product
performance will be used as a basis for discussions on future commercial
collaborations. For obvious reasons of competition, the partners should not
release their results publicly.

About AMOEBA:
Amoéba's ambition is to become a major player in the treatment of bacterial
risk in the fields of water, healthcare and plant protection. Our biological
solution is an alternative to chemical products widely used today. Amoéba is
currently focusing on the market of industrial cooling towers estimated at
EUR1.7Bn (1) on a global chemical biocide market for water treatment, evaluated
at EUR21Bn (2) and on the biocontrol market for plant protection estimated
globally at EUR1.6Bn (4). In the future, the Company is looking at developing
new applications such as chronic wound care, estimated at EUR 751 million (3)
in the USA. Sales of associated products with healthcare, biocides and crop
protection are subject to the Company being granted local regulatory market
authorizations. The Company is currently in a trial phase for biocidal and
plant protection applications and does not market any products.

Created in 2010, based in Chassieu (Lyon, France) with a subsidiary in Canada
and in the United States, Amoéba is quoted on Euronext Growth Paris. The
Company is a member of the BPIfrance Excellence network and is eligible for the
PEA-PME SME equity savings plan setup. More information on
www.amoeba-biocide.com.

(1): Amoéba data combined from sources: DRIRE 2013, Eurostat, ARHIA 2013
(2): Sources combined by Amoéba from water treaters, Freedonia, Eurostat et
     MarketsandMarkets
(3): BCC Research, "Markets for Advanced Wound Management Technologies,"
     Wellesley, MA, 2017
(4): Biopesticides Worldwide Market 2013, CPL, Wallingford, UK

Contacts:

Amoéba
Valérie FILIATRE
General Manager
+33 4 26 69 16 00
valerie.filiatre@amoeba-biocide.com

Investors and Media Relations
Grégory BOSSON / Mathieu CALLEUX
Agence Calyptus
+33(0)1 53 65 37 90
amoeba@calyptus.net

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 Universal
Registration Document of AMOEBA filed with the French Financial Markets
Authority (Autorité des Marchés Financiers) on April 30, 2020 under number
D20-0416 (a copy of which is available on www.amoeba-biocide.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 forward-looking statements.

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AMOEBA (EPA:ALMIB) - AMOEBA FILES THE APPLICATION FOR THE AUTHORIZATION OF ITS BIOCONTROL SOLUTION IN THE U.S.A.

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