Crossject provides strategic update on priorities for 2024

Focusing on regulatory filings and accelerating U.S. commercialization efforts

Contract of up to $155 million with BARDA for U.S. stockpiling continues to advance

Dijon, France February 6, 2024 –530 pm CET Crossject (ISIN: FR0011716265; Euronext: ALCJ), a specialty pharma company developing needle-free auto-injectors for emergency situations, provides a summary of recent milestones reached and an update on its strategic priorities for 2024.

In January 2024, Crossject engaged Syneos Health, a leading fully integrated biopharmaceutical solutions organization, to prepare for the commercial launch of its ZENEO-midazolam autoinjector, proposed name ZEPIZURE, an innovative rescue therapy for epileptic seizures, including those caused by nerve agent exposure, in the United States. Syneos Health has a strong U.S. presence and significant expertise in commercializing new therapies for Crossject, as it approaches filing for regulatory approval.

Crossject is also advancing its licensing and commercialization efforts for ZEPIZURE in other strategic markets and signed in 2023 a licensing agreement with AFT Pharmaceuticals for Australia and New Zealand and a new commercialization agreement for northern Europe.

In 2024, Crossject will especially focus on regulatory approvals for ZEPIZURE and accelerating market access efforts in the United States. Crossject has a senior team in the U.S. and is working in close collaboration with Syneos Health to ensure a smooth and rapid launch of ZEPIZURE upon receiving regulatory approval.

The Company previously signed a $92 million contract with the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response (ASPR) in the U.S. Department of Health and Human Services (HHS), under contract number 75A50122C00031. The contract includes $32 million to advance the development of ZEPIZURE, through U.S. Food and Drug Administration (FDA) approval for status epilepticus. The agreement also includes procurement of $60 million of ZEPIZURE, which will be delivered to the U.S. government (USG), once it is authorized for emergency use by the FDA. Delivery of ZEPIZURE will fulfill a USG requirement for an improved anticonvulsant to treat status epilepticus seizures caused by nerve agent exposure. According to the contract terms, BARDA also has options for post-marketing commitment activities and procurement of additional ZEPIZURE units for up to $63 million. The total contract value, if all options are exercised, is $155 million. The Company is actively engaged with BARDA and the FDA, and discussions are fully focused on ensuring fulfillment of requirements to file for Emergency Use Authorization (EUA) of ZEPIZURE.