Medesis Pharma S.A.

Regulatory Filings • Sep 21, 2021

TREATMENT OF ALZHEIMER'S DISEASE: ANSM AUTHORIZES MEDESIS PHARMA PHASE II CLINICAL TRIAL

Montpellier, September 21, 2021 at 6:00 p.m. - MEDESIS PHARMA, a pharmaceutical biotechnology company r (Sun) dug can in a la Soconial (1 delment) (Any, endoling he announism of online and institution of or louis do or Alzheimer's disease, authorization from the French Medicines Agency (ANSM) for the conduct of a Phase II clinical trial of its NanoLithium program.

NanoLithium program: the added value of Aonys proprietary technology

The drug candidate developed by Medesis Pharma is NanoLithium: a formulation of lithium in its innovative microemulsion technology, Aonys. If allows the activity to be obtained with very low doses of limim. Lihium. Lihium and elderly patients. The significant added value of the drug candidate NanoLithium consists in the administration of a dose of lithium much lower than the usual dose of conventional lithium (dose divided by 70), thanks to Aonys.

NanoLithium, which efficacy has been demonstrated in several preclinical studies of Alzheimer's disease, carried out in the Laboratory of Neuropharmacology at McGill University in Montreal and outcomes published in several scientific publications.

Phase II clinical study: a treatment of behavioral and psychological symptoms associated with Alzheimer's disease

Medesis Pharma will conduct a Phase II clinical study whose primary objective is the treatment and psychological symptoms' quality of life memory os, difficulty planing or soving or soving or soving problems, conversations misplaced objects, social withdrawal, and offen changes n mood and personality The cinined for a further 9 months to demonstrate a change in the overall course of the disease.

The clinical study will be conducted in 6 CHUs in France: Montpeller, Toulouse, Marseille, Lille, Lyon and Paris and plans to include 68 patients. Medesis Pharma plans to intitiate pre-inclusion of patients in the last quarter of 2021, for a first administration of the drug in early 2022. The first outcomes could thus be obtained during the summer of 2022.

Medesis Pharma is driven by the possibility of offering non invasions adapted to patients; NanoLithium is administered in the mouth once a day. Derived from a widely available asset and accessible administration techniques, the selling price of the potential drug is expected to be low and could represent a sustainable and global treatment approach across the world, regardless of social protection systems.

The design of the study, submited at the ANSM, was prepared with Professor Jacques of Marchers (Jacques)
Touchon (former Described) (Aladicine of Montpellier and President of clinical trials in Alzheimer's disease 'Clinical Trials on Alzheimer's Disease conference '), and Professor Audrey Gabelle from the University Hospital of Montpellier (Neurologist, Head of the Memor Resource Research Center, and of the
Rare and Early Dementia Reference Center, of the Behavioral N

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 (BB). This innovative approach is being applied for future drugs to treat major diseases that do not have effective treatments: Alzheimer'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 eleven 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 informations : 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