MedinCell provides additional information regarding the new drug application for mdc-IRM

1/2 MedinCell provides additional information regarding the new drug application for mdc-IRM Euronext: MEDCL • Montpellier - France • April 19, 2022 • 11:45 pm (CEST) As announced, Teva recently received a Complete Response Letter (“CRL”) from the U.S. Food and Drug Administration (“FDA”) regarding the New Drug Application (NDA) for TV-46000/mdc-IRM. Christophe Douat, CEO of MedinCell, said “We fully trust that our partner, Teva, will remedy this quickly given the positive results of the Phase 3 studies. Teva remains confident in MedinCell’s technology for the development of extended- release injectable products.” A Complete Response Letter is issued when the FDA determines that it cannot approve the application in its current form. Where possible, the FDA will recommend corrective actions that the applicant might take to place the application in condition for approval. Dr. Richard Malamut, President of MedinCell’s Medical Advisory Board, said “CRLs are a common part of the FDA regulatory process and resubmission after addressing identified deficiencies frequently leads to approval”. Teva remains committed to the development of extended -release injectable risperidone and other products based on MedinCell’s technology. About MedinCell MedinCell is a pharmaceutical company at premarketing stage that develops a portfolio of long -acting injectable products in various therapeutic areas by combining its proprietary BEPO ® technology with active ingredients already known and m arketed. Through the controlled and extended release of the active pharmaceutical ingredient, MedinCell makes medical treatments more efficient, particularly thanks to improved compliance, i.e. compliance with medical prescriptions, and to a significant re duction in the quantity of medication required as part of a one-off or chronic treatment. The BEPO® technology makes it possible to control and guarantee the regular delivery of a drug at the optimal therapeutic dose for several days, weeks or months start ing from the subcutaneous or local injection of a simple deposit of a few millimeters, fully bioresorbable. MedinCell collaborate with tier one pharmaceuticals companies and foundations to improve Global Health through new therapeutic options. Based in Montpellier, MedinCell currently employs more than 140 people representing over 25 different nationalities. www.medincell.com Contacts MedinCell David Heuzé Head of communication [email protected] +33 (0)6 83 25 21 86 NewCap Louis-Victor Delouvrier / Olivier Bricaud Investor Relations [email protected] +33 (0)1 44 71 94 94 NewCap Nicolas Merigeau Media Relations [email protected] +33 (0)1 44 71 94 94 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 belie ves 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", “e xpect”, "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 registration document, registered with the AMF on September 4, 2018, under number I. 18 -062 (the "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 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 o ne 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 invest ment 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 jurisdiction s. Persons who come to know about this press rel ease are encouraged to inquire about, and required to comply with, these restrictions. 2/2

The release as fetched from its publisher. medincell.com ↗