Medesis Pharma S.A.

Regulatory Filings • Nov 22, 2021

Montpellier (France), November 22, 2021 – Medesis Pharma, a pharmaceutical biotechnology company developing drug candidates with Aonys, its proprietary oral nanodroplet active ingredient administration technology, is announcing that it has received approval to conduct a Phase II clinical trial for its NanoManganese® program in Brazil.

NanoManganese program: Aonys proprietary technology adding value

The drug candidate developed by Medesis Pharma is NanoManganese: a Manganese formulation making it possible to obtain a therapeutic activity with very low doses of Manganese, thanks to Medesis Pharma's innovative microemulsion technology Aonys. This product is not an antiviral, but is intended to prevent and/or treat the severe forms of COVID-19.

This drug candidate is based on Medesis Pharma's research into the development of a radioprotection drug to treat people irradiated following a civil or military nuclear accident, as well as cancer treatment with radiotherapy. Preclinical trials have been conducted with the Armed Forces Biomedical Research Institute (IRBA) in France on irradiated animals with very positive results, enabling the animals to survive following a lethal radiation dose.

Similarities can be seen with the severe pulmonary inflammatory lesions observed for both pathologies, triggered in one case by the coronavirus SRAS-Cov-2 and in the other case by nuclear irradiation; these are linked to an excessive autoimmune response. NanoManganese could therefore make it possible to treat and prevent the severe forms of pneumonia and states of respiratory distress caused by COVID-19.

The state of acute respiratory distress observed with the severe forms of COVID-19 has already been recorded with severe forms of other viral diseases (influenza, hepatitis B, cytomegalovirus, rubella, etc.), triggered in all cases by an inflammatory cytokine storm.

Phase II clinical trial: treatment for patients with severe forms of COVID-19

The clinical trial, conducted at eight hospital centers in Brazil, plans to include 120 patients, split between the active treatment (NanoManganese) and a placebo, for a maximum treatment duration of 10 days. This study's results are expected by summer 2022, subject to developments with the epidemic in Brazil.

Positive clinical results would then enable the NanoManganese product to be developed for treating severe forms of viral diseases.

Medesis Pharma is driven by the possibility of offering non-invasive therapeutic innovations adapted for patients; NanoManganese is administered in oral form twice a day. Derived from a widely available active ingredient and accessible administration techniques, the sales price for the potential drug is expected to be low, offering a treatment that would be adapted for use worldwide, regardless of the social protection systems in place in the various countries.

About Medesis Pharma

To advance the treatment of serious diseases without effective treatments, Medesis Pharma creates drug candidates based on its proprietary Aonys® technology for the oral administration of active ingredients in nanodroplet form, enabling active ingredients to be effectively delivered to all cells, with passage through the blood–brain barrier (BBB). This innovative approach is being applied for future drugs to treat major diseases that do not have effective treatments: Alzheimer's Disease, Huntington's Disease, certain resistant cancers and severe respiratory inflammations such as those linked to COVID-19. Medesis Pharma is also developing dedicated treatments for people irradiated following a civil or military nuclear accident.

Medesis Pharma, a French biopharmaceutical company based near Montpellier, has a track record of 15 scientific publications, holds ten patents, reflecting 17 years of research, and is focused specifically on four projects that are moving into Clinical Phase II for neurodegenerative diseases and the treatment of Covid-19. Building on its world-renowned positions, Medesis Pharma is also working on new applications for its technology in partnership with public research laboratories (CNRS, CEA, IRBA), major teaching hospital centers in France, Canada and the United States, as well as private structures such as Transgene

Medesis Pharma's shares are listed on Euronext Growth Paris (FR0010844464 – ALMDP).

For more information: www.medesispharma.com

MEDESIS PHARMA

Tessa Olivato Tel: +33 4 67 03 03 96 contact@medesispharma.com

CALYPTUS Marie Calleux Tel : +33 1 53 65 68 66 medesispharma@calyptus.net