Regulatory News:

Medincell (Paris:MEDCL):

Christophe Douat, CEO, and Richard Malamut, CMO, will present Medincell's portfolio and R&D pipeline at the Jefferies Global Healthcare Conference on June 6 at 1:00pm ET (19h00 CEST) at the Marriott Marquis Hotel in New York City

Investors can access the presentation remotely, either live or on replay, following this link:

1X1 meetings with the management team may be arranged by directly contacting MedinCell:

“Our American strategy initiated last summer is already paying off. Top US investors, who have fully understood Medincell's short- and long-term potential, are on board. They are essential partners of our accelerating growth.”, said Christophe Douat, CEO of Medincell.

"With the successful launch of Teva-partnered UZEDY® and positive phase 3 results for mdc-TJK, a potentially first-mover LAI olanzapine product with no black-box warning for severe schizophrenia, our well-validated BEPO technology continues to attract strong alliances including the recently announced major partnership with AbbVie. With additional early- and late-stage pipeline programs, encouraging data on Ph3 mdc-CWM, and additional upcoming catalysts - we look forward to sharing our progress and plans with fundamental investors," said Grace Kim, Medincell Head of US Financial Strategy.

Medincell has recently reached the commercial stage with the market launch by Teva of UZEDY® for the treatment of schizophrenia. UZEDY is the first innovative product based on Medincell’s long-acting injectable (LAI) BEPO® technology approved by US FDA.

Teva has recently confirmed the annual revenue guidance for UZEDY, projecting approximately $80 million for 2024. This revenue estimate is in line with Medincell's anticipated earnings from UZEDY, as the company is set to receive royalties from sales and could earn up to $105 million in commercial milestones.

In parallel, Medincell is developing a portfolio of innovative treatments also using the BEPO technology. This notably includes the following candidate treatments:

2 candidates in clinical Phase 3:

  • mdc-TJK (in partnership with Teva): potentially, the first long-acting injectable olanzapine with a favorable safety profile that could enable a large adoption for treatment of patients with more severe forms of schizophrenia. Positive efficacy results have recently been announced. (press release)
  • mdc-CWM (in partnership with AIC): an innovative sustained-release formulation of a non-steroidal anti-inflammatory drug celecoxib aiming at facilitating patient recovery after total knee replacement and decreasing the need for potentially addictive opioids. The encouraging results of the first phase 3 presented recently have paved the way for the next stages of regulatory development. (press release)

2 candidates in preclinical stage:

  • mdc-WWM: 6-month active subcutaneous contraceptive
  • mdc-STM: Global Health program to fight malaria

10 programs in formulation stage:

  • Among them, the first program selected with AbbVie as part of a strategic co-development and licensing agreement, recently announced (press release), to develop next-generation of long-acting injectable therapies. Medincell and AbbVie will co-develop up to six innovative long-acting injectable products and AbbVie will responsible their commercialization. Medincell received the upfront payment of $35 million and is eligible to receive up to $1.9 billion in development and commercial milestones, as well as royalties on worldwide sales.

About Medincell

Medincell is a clinical- and commercial-stage biopharmaceutical licensing company developing long-acting injectable drugs in many therapeutic areas. Our innovative treatments aim to guarantee compliance with medical prescriptions, to improve the effectiveness and accessibility of medicines, and to reduce their environmental footprint. They combine active pharmaceutical ingredients with our proprietary BEPO® technology which controls the delivery of a drug at a therapeutic level for several days, weeks or months from the subcutaneous or local injection of a simple deposit of a few millimeters, entirely bioresorbable. 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® (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 more than 140 people representing more than 25 different nationalities.

UZEDY® and SteadyTeq™ are trademarks 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 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 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.

David Heuzé Head of Corporate and Financial Communications, and ESG / +33 (0)6 83 25 21 86

Grace Kim Head of US Financial Strategy & IR / +1 (646) 991-4023

Nicolas Mérigeau/ Arthur Rouillé Media Relations / +33 (0)1 44 71 94 94

Louis-Victor Delouvrier/Alban Dufumier Investor Relations France / +33 (0)1 44 71 94 94

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