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Medesis Pharma S.A.

Legal Proceedings Report Oct 23, 2023

1512_iss_2023-10-23_f5b4dde3-4795-4d30-8174-8cc467bfd635.pdf

Legal Proceedings Report

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MEDESIS PHARMA PARTICIPATES IN THE 16" INTERNATIONAL CONGRESS "CLINICAL TRIALS ON ALZHEIMER DISEASE" (CTAD) IN BOSTON FROM OCTOBER 24 TO 27, 2023 AND PRESENTS A POSTER ON ITS CURRENT RESEARCH

Montpellier, October 23, 2023 at 6:00 p.m. - MEDESIS PHARMA, a pharmaceutical biotechnology company, developing drug candidates based on its proprietary technology for administering active ingredients in nano micelles orally, Aonys®, will participate in the Clinical Trials on Alzheimer Disease (CTAD), international congress in Boston, and will present a poster entitled "NanoLithium® has a dual potential in Alzheimer's disease: to treat neuropsychiatric symptoms and modify disease course".

The Clinical Trials on Alzheimer's Disease (CTAD) conference is an international congress dedicated to therapeutic trials for Alzheimer's disease. Top research leaders from the pharmaceutical industry and academia are coming together to form partnerships to accelerate the development of effective treatments to fight Alzheimer's disease. At CTAD 2023, the scientific program will once again focus on cutting-edge clinical research, thought-provoking roundtable discussions and symposia on the latest advances in Alzheimer's disease clinical research.

Solène Guilliot, Medical Director & R&D Director of Medesis Pharma, will be present to meet different stakeholders and present a scientific poster describing the mechanism of action of NanoLithium, the non-clinical studies and the objectives of the Phase II clinical trial in course, which should provide first efficacy results in March 2024. This study aims to demonstrate the effect of NanoLithium on behavioral and psychological symptoms in patients with mild to severe Alzheimer's disease and to identify a potential disease-modifying effect.

NanoLithium: Lithium has a pleiotropic effect in neurodegenerative diseases such as Alzheimer's disease, giving it dual potential, as a treatment for neuropsychiatric symptoms associated with the disease on the one hand, and as a modifier of disease on the other hand. The benefits of lithium in Alzheimer's disease have been studied, but its narrow therapeutic index has prevented further development. Medesis Pharma is currently investigating lithium combined with its nanomicelle drug delivery technology, Aonys, which optimizes the bioavailability of the active ingredient.

NanoLi-AD: The ongoing proof-of-concept clinical study of NanoLithium in Alzheimer's disease (NCT05423522) aims to demonstrate the clinical effectiveness of NanoLithium compared to placebo on the progression of neuropsychiatric symptoms between the start of study and the 12th week of treatment. The secondary objectives of the study are to elucidate the potential for disease modification by evaluating the effectiveness of NanoLithium after 9 to 12 months of treatment on the progression of cognitive performance (CDR, MMSE, ADL), the progression of cortical hypometabolism, progression of peripheral biological biomarkers (ß-amyloid protein, neurofilaments, BDNF, pTau protein, and inflammatory cytokines).

All 68 patients in the clinical study distributed across 8 University Hospital Clinical Investigation Centers in France (Toulouse, Montpellier, Marseille, Lille, Limoge, Lyon, Paris and Strasbourg) have been included since October 16, 2023, with the results of the first phase of the study expected in March 2024.

The study was prepared with Professor Maria Soto, Professor of Geriatrics and coordinator of the CMRR at Toulouse University Hospital, President of the French Federation of Memory Centers, national coordinator of the study and with the contribution of Professor Jacques Touchon (former Dean of the Faculty of Medicine of Montpellier) who is also a member of the Scientific Committee of the 'Clinical Trials on Alzheimer's Disease conference'. Both are also members of the Medesis Pharma Scientific Committee.

To learn more about CTAD: https://www.ctad-alzheimer.com/

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 to future drugs to treat major diseases that do not have effective treatments: Alzheimer's disease, Huntington's disease, and resistant cancers.

Medesis Pharma is also developing treatments dedicated to populations contaminated or irraciated after a civil or military nuclear accident.

French biopharmaceutical company based near Montpellier, Medesis Pharma is the author of 15 scientific publications, holds 12 patent families and 72 patents, resulting from 17 years of research.

Medesis Pharma shares are listed on Euronext Growth Paris: FR001844464 - ALMDP

For mor information: www.medesispharma.com

MEDESIS PHARMA Jean Claude Maurel Tel: +33 4 67 03 03 96 [email protected]

CALYPTUS

Marie Calleux Tel : +33 1 53 65 68 66 [email protected]

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