MedinCell S A : Half-Year Report

Published: 2024-12-10 17:14:16 ET MEDCL.PA

HALF-YEAR REPORT

Period from April 1er to September 30 2024

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Contents

HALF-YEARMANAGEMENT REPORT

CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS UNDER IFRS AT

SEPTEMBER 30, 2024

CERTIFICATION BY THE PERSON RESPONSIBLE FOR THE INTERIM FINANCIAL REPORT

STATUTORY AUDITORS' LIMITED REVIEW REPORT

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HALF-YEARLY

BUSINESS

REPORT

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"Our mission is to help improve and protect the health of people around the world. The fair sharing of the value created with all our employees is the cornerstone of our business model. Medincell's long- term viability is an essential condition for achieving our objectives.

Medincell's raison d'être, voted by the Annual General Meeting on September 5, 2019 and enshrined in the articles of association.

Medincell is a clinical and commercial-stage biopharmaceutical licensing company developing long- acting injectable drugs in a wide range of therapeutic areas. Our innovative treatments aim to ensure compliance with medical prescriptions, improve efficacy and accessibility, and reduce their environmental footprint. They combine active ingredients with our proprietary BEPO technology® , which controls the release of a drug at a therapeutic level for several days, weeks or months from the subcutaneous or local injection of a simple, fully bioresorbable deposit measuring just a few millimeters. The first treatment based on BEPO® technology, intended for the treatment of schizophrenia, was approved by the FDA in April 2023, and is now distributed in the United States by TEVA under the name UZEDY® (the BEPO technology® is licensed to TEVA under the name SteadyTeq™). We collaborate with leading pharmaceutical companies and foundations to improve global health through new treatment options. Based in Montpellier, Medincell currently employs over 130 people representing more than 20 different nationalities.

A technology platform opening up a host of opportunities

BEPO® technology makes it possible to control and guarantee the regular delivery of the optimum therapeutic dose of a drug for several days, weeks or months, by means of a simple subcutaneous or local injection of a polymer deposit just a few millimeters in size, entirely bioresorbable. Through this controlled, prolonged release of the active ingredient, Medincell makes medical treatments more efficient, notably by improving compliance with medical prescriptions, and significantly reducing the amount of medication needed for occasional or chronic treatment.

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results were positive, both in terms of efficacy and safety, or because they are now being treated with UZEDY .®

Before entering development, each program undergoes a rigorous selection process, which consists of evaluating and validating its medical interest, economic potential, technical feasibility and the regulatory pathway prior to eventual market launch. This preliminary stage is designed to maximize the chances of success and limit the financial risk. It enables us to draw up a TPP (Target Product Profile), i.e. a set of specifications for the product to be developed, specifying in particular the molecule used, the target indication, the product's duration of action, the dose to be delivered on a regular basis and the regulatory process envisaged. This TPP may evolve during the early stages of product development.

Three-stage product development processes

Each product then follows a similar path in the phases preceding clinical development, when attrition is potentially highest:

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CONCENTRATION OF ACTIVE INGREDIENT

TOXICITY

THERAPEUTIC THRESHOLD

TIME

Expertise in polymers

Polymers are at the heart of BEPO® formulations and Medincell's intellectual property. Mastering their manufacture on a commercial scale and to pharmaceutical quality standards is essential. Medincell is therefore a partner in a joint venture, CM Biomaterials, created in 2015 with Corbion, one of the world's leading manufacturers and suppliers of biopolymers for the pharmaceutical industry. From the formulation stage onwards, the copolymers specific to each product are manufactured in compliance with GMP (Good Manufacturing Practice) standards, i.e. to a level of quality identical to that of marketed pharmaceutical products, and are produced on the same production lines as future marketing batches.

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A strategy of rapid expansion of the product portfolio

The proprietary BEPO® technology can be combined with a wide range of active ingredients for use in different indications. The Company's strategy is to maximize its medical and financial impact by developing a portfolio of products chosen for their potential.

The products selected will be :

In line with its strategy and objectives, Medincell's product portfolio progressed during the first half of the year, with significant advances in several programs that should reach the clinical stage during the 2025-2026 financial year, and the launch of feasibility studies and formulation selection activities for new products, some developed in partnership.

Medincell product portfolio

At the date of publication of this report, the portfolio comprised :

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At the date of this report, the product portfolio and R&D pipeline were as follows:

FORMULATION

PRECLINICAL

CLINICAL - PHASE 3

COMMECIALIZATION

mdc-

Progestin 6 months

Contraception

mdc-

Ivermectin 3 months

Malaria

AbbVie (1/6)

mdc-

Olanzapine 1 month

Schizophrenia

mdc-

Celecoxib - Intra-articular

Postoperative pain

mdc--

UZEDY®

Risperidone 1 & 2 months

Schizophrenia

Several programs, developed alone or in partnership, are currently at the formulation stage, a prerequisite for the selection of a product candidate. These include the first program developed with AbbVie, for which a contract was signed on April 16, 2024. Details of these programs remain confidential for strategic reasons.

In May 2022, TEVA launched preclinical activities with a view to obtaining approval for UZEDY® in a second neuroscience indication, and these activities are still ongoing. In July 2024, TEVA also announced the exploration of an additional indication for UZEDY® in the treatment of bipolar I disorder in adults.

Summary of the main events of the half-year and beyond

April 2024The global health agency Unitaid grants Medincell an additional envelope of up to $6 million over three years to fund the Phase 1 clinical trial of the injectable long-acting treatment mdc-STM. If proven safe, effective and well-tolerated, it could have a significant impact on malaria transmission in vulnerable populations living in the worst-affected areas.

Medincell announces a strategic co-development and licensing agreement with AbbVie to develop a new generation of long-acting injectable therapies.

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May

2024TEVA and Medincell announce positive efficacy results for the Phase 3

SOLARIS trial of TEV-'749 (olanzapine / mdc-TJK), a monthly long-acting

subcutaneous injection for adults with schizophrenia.

Medincell reports on the Phase 3 clinical trial of mdc-CWM, conducted by Arthritis

Innovation Corporation (AIC): the primary endpoint was not met, but encouraging

results were observed on other endpoints. The study also confirmed the safety of

the treatment administered into the joint at the time of surgery.

June

2024TEVA presents new data supporting the switch from Invega Sustenna®

(paliperidone palmitate) to UZEDY® for the treatment of schizophrenia.

Medincell joins the Euronext Tech Leaders index.

H.C. Wainwright & Co. initiates coverage of Medincell with a Buy recommendation.

July

2024Medincell presents data showing the enhanced potential of a monoclonal

antibody against melanoma tumors thanks to BEPO technology®

TEVA provides an update on the pivotal phase 3 clinical trial of long-acting

olanzapine injection (LAI) and on the commercial progress of UZEDY® :

September 2024 Medincell announces advances in the development of its product portfolio and R&D pipeline:

Olanzapine LAI: TEVA announces at Morgan Stanley's Global Healthcare Conference that no PDSS observed after approximately 99% of injections planned for regulatory submission

TEVA presentations at ENCP** 2024:

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November 2024 TEVA presentations at Psych Congress*** 2024:

(post-closing)

• Olanzapine LAI: new positive data from the initial period of the Phase 3

SOLARIS trial, demonstrating, across several baseline indicators, a

significant improvement in social interactions and quality of life between

baseline and week 8 of the study.

• UZEDY® : real-life analyses of UZEDY show high rates of adherence and

use in adults with schizophrenia who have difficulty accessing treatment.

Announcements at TEVA's 3ème quarter earnings conference, November 6, 2024:

*PDDS = Post injection Delirium/Sedation Syndrome

**37th Annual Congress of the European College of Neuropsychopharmacology (ECNP) - September 21-24, 2024, Milan, Italy

*** Psych Congress 2024, from October 29 to November 2, 2024, in Boston, MA (United States)

Main events of the half-year

UZEDY® : Successful US market launch

On April 28, 2023, TEVA and Medincell announced that the U.S. Food and Drug Administration ("FDA") had granted marketing authorization for mdc-MRI in the United States. It has been marketed by partner TEVA since May 2023, under the name UZEDY®.

UZEDY® is intended for the treatment of schizophrenia in adults. Clinical studies have demonstrated that it can provide an effective response to the many challenges inherent in treating this complex disease. Thanks to BEPO® technology, UZEDY® has unique and innovative features which could make it the reference treatment for schizophrenia.

At its quarterly results conferences on May 8, 2024 and July 31, 2024, TEVA confirmed its UZEDY® revenue guidance for 2024 announced at the beginning of the year, i.e. $80 million for the first full year of commercialization. The Medincell partner also announced in July that it was exploring a new indication for UZEDY® for the treatment of bipolar I disorder in adults.

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Disclaimer

Medincell SA published this content on December 10, 2024, and is solely responsible for the information contained herein. Distributed by Public, unedited and unaltered, on December 10, 2024 at 22:13:07.734.