A1XEH4 Crossject SA

CROSSJECT remains engaged during the summer break

CROSSJECT remains engaged during the summer break

Press Release

CROSSJECT remains engaged during the summer break

  • Maintenance operations are being carried out at production sites.
  • Regulatory and development activities are continuing actively.

Dijon, France, August 4, 2025 (5:30 p.m. CET) -- CROSSJECT (ISIN: FR0011716265; Euronext: ALCJ), the specialty pharmaceutical company developing emergency products based on its proprietary ZENEO® needle-free auto-injector technology, remains fully engaged to submitting the ZEPIZURE® dossier for Emergency Use Authorization (EUA).

During the summer break, maintenance operations are being carried out at Crossject's three production sites. These will allow industrial production to resume under the best possible conditions for preparing commercial deliveries.

The latest documents related to the emergency authorization application are currently being collected and included in the file. Exchanges between regulatory teams continue intensively.

Throughout August, the development teams are also working on activities related to the future New Drug Application (NDA) for ZEPIZURE® for the treatment of epilepsy: monitoring production and analyses, reviewing documentation, and preparing for the additional clinical study to be conducted in the United States.

“Although the summer break is a good time to shut down production lines, our teams are organized to ensure the continuity of internal activities and those with our partners that are necessary for the progress of ZEPIZURE® registrations on the US market,” said Patrick Alexandre, Chairman of the Executive Board of CROSSJECT.

About CROSSJECT

CROSSJECT SA (Euronext: ALCJ; ) is an emerging specialty pharmaceuticals company developing medicines for emergency situations harnessing its award-winning needlefree auto-injector ZENEO® platform. CROSSJECT is in advanced regulatory development for ZEPIZURE®, an epileptic rescue therapy, for which it has a $60 million contract* with BARDA. The Company’s versatile ZENEO® platform is designed to enable patients or untrained caregivers to easily and instantly deliver a broad range of emergency drugs via intramuscular injection on bare skin or even through clothing. The Company’s other products in development mainly include solutions for allergic shocks and adrenal insufficiencies, as well as therapies and other emergency indications.

* This project has been supported in whole or in part with federal funds from the US Department of Health and Human Services; Administration for Strategic Preparedness and Response; BARDA, under contract number 75A50122C00031.

For further information, please contact:

Investor Relations

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EN
04/08/2025

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