Medincell's Partner Teva Presented New Data on Investigational Olanzapine LAI and UZEDY® at Psych Congress 2026

New Phase 3 analyses of Olanzapine LAI, currently under regulatory review, provided further insights into stabilization, long-term efficacy and treatment-switching strategies

Additional real-world data reinforced UZEDY's clinical and economic benefits in the management of schizophrenia and bipolar I disorder care

MONTPELLIER, France--(BUSINESS WIRE)--Regulatory News:

Medincell's partner Teva presented new data on investigational Olanzapine long-acting injectable (LAI) and UZEDY^®, two treatments utilizing Medincell's proprietary BEPO^® technology, licensed to Teva as SteadyTeq™. The findings were presented at Psych Congress 2026, held from September 15 to 19 in New Orleans, Louisiana.

Teva presented new post hoc analyses from the Phase 3 SOLARIS trial evaluating its investigational once-monthly subcutaneous olanzapine LAI for the treatment of schizophrenia in adults. In the long-term treatment period, 56% of participants achieved stabilization, only 4% of stabilized participants subsequently relapsed, and 21% of participants treated for at least six months met study criteria for remission. Additional analyses also provided insights into potential treatment-switching approaches from oral and short-acting injectable olanzapine regimens.

Olanzapine LAI remains investigational and is not currently approved by any regulatory authority. A PDUFA decision from the U.S. Food and Drug Administration is expected in the fourth quarter of 2026.

Teva also presented new real-world evidence for UZEDY^®, showing favorable treatment continuity among adults with schizophrenia compared with several long-acting injectable antipsychotics and lower healthcare resource utilization compared with once-monthly paliperidone palmitate. Additional analyses evaluated outcomes in adults with bipolar I disorder who switched from oral antipsychotics to UZEDY^®.

Read Teva's full press releases:

• New investigational olanzapine LAI data presented at Psych Congress 2026: https://ir.tevapharm.com/news-and-events/press-releases/press-release-details/2026/Teva-Announces-New-Olanzapine-LAI-TEV-749-Post-Hoc-Data-Highlighting-High-Rates-of-Stabilization-and-Long-Term-Efficacy-as-Once-Monthly-Subcutaneous-Injectable-for-the-Treatment-of-Schizophrenia-in-Adults/default.aspx

• New real-world data on UZEDY® presented at Psych Congress 2026: https://ir.tevapharm.com/news-and-events/press-releases/press-release-details/2026/Teva-Highlights-New-Real-World-Data-Showing-UZEDY-risperidone-Outperforms-Other-Long-Acting-Injectables-in-Keeping-Schizophrenia-Patients-on-Treatment-While-Reducing-Emergency-Care-and-Healthcare-Costs/default.aspx

About Medincell

Medincell (Euronext Paris: MEDCL) 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 enables 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^®.

A New Drug Application (NDA) for Olanzapine LAI as a once-monthly treatment for schizophrenia in adults was submitted to the U.S. FDA in December 2025 by Medincell’s partner, Teva. U.S. FDA accepted Teva’s New NDA for Olanzapine LAI on February 20, 2026. A European Marketing Authorization Application (MAA) 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^® is a trademark of Teva Pharmaceuticals. Medincell’s BEPO^® technology is licensed to Teva as SteadyTeq™, a trademark of Teva Pharmaceuticals.

This press release contains forward-looking statements, including statements regarding Company’s expectations for (i) the timing, progress and outcome of its clinical trials; (ii) the clinical benefits and competitive positioning of its product candidates; (iii) its ability to obtain regulatory approvals, commence commercial production and achieve market penetration and sales; (iv) its future product portfolio; (v) its future partnering arrangements; (vi) its future capital needs, capital expenditure plans and ability to obtain funding; and (vii) prospective financial matters regarding our business. Although the Company believes that its expectations are based on reasonable assumptions, any statements other than statements of historical facts that may be contained in this press release relating to future events are forward-looking statements and subject to change without notice, factors beyond the Company's control and the Company's financial capabilities.

These statements may include, but are not limited to, any statement beginning with, followed by or including words or phrases such as "objective", "believe", "anticipate", “expect”, "foresee", "aim", "intend", "may", "anticipate", "estimate", "plan", "project", "will", "may", "probably", “potential”, "should", "could" and other words and phrases of the same meaning or used in negative form. Forward-looking statements are subject to inherent risks and uncertainties beyond the Company's control that may, if any, cause actual results, performance, or achievements to differ materially from those anticipated or expressed explicitly or implicitly by such forward-looking statements. A list and description of these risks, contingencies and uncertainties can be found in the documents filed by the Company with the Autorité des Marchés Financiers (the "AMF") pursuant to its regulatory obligations, including the Company's universal registration document, filed with the AMF on July 29, 2025, under number D. 25-0580 (the "Universal Registration Document"), as well as in the documents and reports to be published subsequently by the Company. In particular, readers' attention is drawn to the section entitled "Facteurs de Risques" on page 30 et seq. 26 of the Registration Document.

Any forward-looking statements made by or on behalf of the Company speak only as of the date they are made. Except as required by law, the Company does not undertake any obligation to publicly update these forward-looking statements or to update the reasons why actual results could differ materially from those anticipated by the forward-looking statements, including in the event that new information becomes available. The Company's update of one or more forward-looking statements does not imply that the Company will make any further updates to such forward-looking statements or other forward-looking statements. Readers are cautioned not to place undue reliance on these forward-looking statements.

This press release is for information purposes only. The information contained herein does not constitute an offer to sell or a solicitation of an offer to buy or subscribe for the Company's shares in any jurisdiction, in particular in France. Similarly, this press release does not constitute investment advice and should not be treated as such. It is not related to the investment objectives, financial situation, or specific needs of any recipient. It should not deprive the recipients of the opportunity to exercise their own judgment. All opinions expressed in this document are subject to change without notice. The distribution of this press release may be subject to legal restrictions in certain jurisdictions.