Inside Information / Other news releases

Medincell Achieves Major Milestone with U.S. FDA Approval of WELTRUZA™ (olanzapine)

PRESS RELEASE – October 9, 2026 – 1:00 pm – Montpellier, France – Euronext: MEDCL

Medincell will host Investor webcast today to discuss the implications of the approval for the Company and answer questions from analysts.

Webcast Details

• Date: Friday, October 9, 2026
• Time: 4:00 p.m. CEST / 10:00 a.m. ET
• Webcast: https://www.medincell.com/investor-webcast-oct-9-2026/

A replay of the webcast will be available on Medincell's website following the event.

Medincell (Euronext: MEDCL) achieves major milestone with the announcement by its partner Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd, of the U.S. Food and Drug Administration (FDA) approval of WELTRUZA™ (olanzapine) for extended-release injectable suspension, as the first and only once-monthly subcutaneouslong-acting injectable (LAI) formulation of olanzapine for adults with schizophrenia that can help support stabilization for people living with schizophrenia.

WELTRUZA™ does not require loading doses or oral supplementation at treatment initiation and eliminates the need for post- injection monitoring, addressing a major, long-standing gap in schizophrenia care.

The approval of WELTRUZA™ marks the second FDA-approved medicine utilizing Medincell's long-acting injectable technology, following UZEDY® (risperidone) in 2023.

Teva Pharmaceuticals plans to make WELTRUZA™ available in the United States in the coming weeks.

Medincell is entitled to mid- to high-single digit royalties on worldwide net sales of WELTRUZA™. Medincell is also eligible to receive up to $112 million in development and commercial milestones, including a $4 million payment upon U.S. approval and up to $105 million in sales-based commercial milestones upon achievement of specified sales thresholds.

Christophe Douat, CEO of Medincell, said: “Beyond its clinical significance, the FDA approval of WELTRUZA™ represents a major milestone in the execution of Medincell’s Shift to Growth strategy, with the emergence of a second significant growth engine for the Company. This approval provides further validation of our technology and demonstrates our ability to transform innovation into differentiated medicines that create long-term value for patients, partners and shareholders.”

For additional information regarding WELTRUZA™, please refer to Teva Pharmaceuticals' press release: https://ir.tevapharm.com/news-and-events/press-releases/default.aspx

About Medincell

Medincell is a clinical- and commercial-stage innovation-driven biopharmaceutical company developing and licensing long-acting injectable treatments across multiple therapeutic areas. Our innovative treatments are designed to ensure adherence to medical prescriptions, enhance the effectiveness and accessibility of medicines, and reduce their environmental impact. These treatments combine active pharmaceutical ingredients with our proprietary BEPO ® / BEPO® Star technologies, which enable controlled drug delivery at therapeutic levels for several days, weeks, or months following a subcutaneous or local injection of a small, fully bioresorbable depot. Risperidone LAI was the first treatment based on BEPO® technology to receive FDA approval, initially for schizophrenia in April 2023 (one- and two-month dosing), and subsequently for Bipolar I Disorder in October 2025 (one-month dosing). It is marketed in the United States by Teva under the brand name UZEDY®. Olanzapine LAI as a once-monthly treatment for schizophrenia in adults received FDA approval in October 2026 with launch in the United States by Teva under the brand name WELTRUZA™ planned in Q4 2026. A European Marketing Authorization Application (MAA) for Olanzapine LAI was also accepted by EMA in May 2026. Medincell’s investigational pipeline includes numerous innovative therapeutic candidates in various stages of development, from formulation to Phase 3 clinical trials. We collaborate with leading pharmaceutical companies and foundations to advance global health through new treatment options. Headquartered in Montpellier, France, Medincell employs over 150 people representing more than 27 nationalities.

medincell.com UZEDY® and WELTRUZA™ are trademarks of Teva Pharmaceuticals. Medincell’s BEPO ® technology is licensed to Teva as SteadyTeq™, a trademark of Teva Pharmaceuticals.

Contact

David Heuzé
Head of Corporate and Financial Communications, and ESG
david.heuze@Medincell.com / +33 (0)6 83 25 21 86

Grace Kim
Chief Strategy Officer, U.S. Finance
grace.kim@medincell.com / +1 (646) 991-4023

Nicolas Mérigeau / Gaëlle Fromaigeat
Media Relations
Medincell@newcap.eu / +33 (0)1 44 71 94 94

Louis-Victor Delouvrier / Alban Dufumier
Investor Relations France
Medincell@newcap.eu / +33 (0)1 44 71 94 94

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