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Posted On: 09/21/2021 8:45:39 AM
Post# of 154887
BIOMM S.A.
Public Company
CNPJ/MF No. 04.752.991/0001-10
NIRE No. 31.300.016.510
RELEVANT FACT
BIOMM S.A. (“Company” or “Biomm”), in compliance with the provisions of Resolution of the
Brazilian Securities Commission No. 44, of August 23, 2021, continuing the Notice to the Market
dated May 26, 2021 and the Material Fact dated August 02, 2021, hereby informs its shareholders
and the market in general that the National Health Surveillance Agency – ANVISA, approved the
start of one more phase 3 clinical study of the monoclonal antibody leronlimab in the Brazil.
This new clinical study will focus on hospitalized patients who are in a critical condition of COVID19, in need of mechanical and invasive ventilation or using Extracorporeal Membrane Oxygenation
(ECMO). It will be carried out in 22 research centers with 316 patients.
It is worth remembering that the clinical study for patients in the moderate stage of the disease,
already approved by the National Health Surveillance Agency – ANVISA, was subject of the Material
Fact published by the Company on August 2, 2021.
This new clinical trial, with critically ill patients, will also be conducted by the Academic Research
Organization (ARO) of the Hospital Israelita Albert Einstein (HIAE), in collaboration with CytoDyn,
the US company responsible for developing the drug, and BIOMM, exclusive partner for the
commercialization of leronlimab in Brazil.
The Company will keep its shareholders and the market in general updated on the subject of thismaterial fact.
Nova Lima/MG, September 21st, 2021.
Biomm S.A.
Mirna Santiago Vieira
Chief Financial and Investor Relations Officer
Public Company
CNPJ/MF No. 04.752.991/0001-10
NIRE No. 31.300.016.510
RELEVANT FACT
BIOMM S.A. (“Company” or “Biomm”), in compliance with the provisions of Resolution of the
Brazilian Securities Commission No. 44, of August 23, 2021, continuing the Notice to the Market
dated May 26, 2021 and the Material Fact dated August 02, 2021, hereby informs its shareholders
and the market in general that the National Health Surveillance Agency – ANVISA, approved the
start of one more phase 3 clinical study of the monoclonal antibody leronlimab in the Brazil.
This new clinical study will focus on hospitalized patients who are in a critical condition of COVID19, in need of mechanical and invasive ventilation or using Extracorporeal Membrane Oxygenation
(ECMO). It will be carried out in 22 research centers with 316 patients.
It is worth remembering that the clinical study for patients in the moderate stage of the disease,
already approved by the National Health Surveillance Agency – ANVISA, was subject of the Material
Fact published by the Company on August 2, 2021.
This new clinical trial, with critically ill patients, will also be conducted by the Academic Research
Organization (ARO) of the Hospital Israelita Albert Einstein (HIAE), in collaboration with CytoDyn,
the US company responsible for developing the drug, and BIOMM, exclusive partner for the
commercialization of leronlimab in Brazil.
The Company will keep its shareholders and the market in general updated on the subject of thismaterial fact.
Nova Lima/MG, September 21st, 2021.
Biomm S.A.
Mirna Santiago Vieira
Chief Financial and Investor Relations Officer
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