ZENEO® platform
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CROSSJECT Secures Additional BARDA Funding for the Progressive Developmental and FDA Authorization of the ZEPIZURE® (ZENEO® Midazolam)
Globenewswire· 2025-09-22 05:30
Core Points - CROSSJECT has secured an additional $11.3 million in funding from the U.S. Biomedical Advanced Research and Development Authority (BARDA), increasing total funding for the development of ZEPIZURE® (ZENEO® Midazolam) to $43.3 million [2][3] - The new funding will support regulatory and manufacturing activities aimed at achieving FDA Emergency Use Authorization (EUA) and New Drug Application (NDA) [2] - Recent advancements include the completion of validation batches and a facility audit, which are critical for meeting regulatory requirements [3] Company Overview - CROSSJECT is a specialty pharmaceuticals company focused on developing needle-free auto-injectors for emergency situations, with its ZENEO® platform designed for easy and instant drug delivery [4] - The company is in advanced regulatory development for ZEPIZURE®, an epileptic rescue therapy, backed by a $60 million contract with BARDA for the acquisition of 306,000 adult and 54,000 pediatric auto-injectors [3][4] - The ZENEO® platform is versatile, enabling untrained caregivers to administer a range of emergency drugs via intramuscular injection [4]
CROSSJECT prepares for the launch of a capital increase with preferential subscription rights of around 5 million euros in preparation for commercial and production activities linked to EUA approval
Globenewswire· 2025-05-20 05:30
Core Points - CROSSJECT plans to launch a capital increase of approximately 5 million euros, potentially increasing to 5.8 million euros, to support commercial and production activities related to the EUA approval of ZEPIZURE® [2][3][8] - The capital increase aims to provide financial resources for the final development phases of ZEPIZURE® and to initiate production steps, with a significant portion allocated to R&D for other projects [8][10] Offer Details - The capital increase will be executed through the issuance of new shares with preferential subscription rights, as authorized by the Supervisory Board and the Annual General Meeting [4][5] - The net proceeds will be allocated approximately 60% to ZEPIZURE® development and production, and 40% to R&D for other projects, repayment of financial creditors, and general expenses [8][9] Financial Strategy - If the Offer is limited to 75% of the issue, around 3.8 million euros, the allocation will be on a pro rata basis, prioritizing ZEPIZURE® activities [9] - The company estimates that the net working capital from the Offer will be sufficient to meet obligations until the end of 2025, assuming first payments from the US partner [10] Shareholder Support - Gemmes Venture, a 26% reference shareholder, intends to guarantee the Offer in cash up to 75% of the initial amount [11] - Heights Capital Management has indicated its intention to subscribe to the capital increase by offsetting its claim of around 0.5 million euros [12] Company Overview - CROSSJECT is a specialty pharmaceuticals company developing emergency medicines, with ZEPIZURE® in advanced regulatory development and a $60 million contract with BARDA [15][16] - The company utilizes its ZENEO® platform for easy delivery of emergency drugs via intramuscular injection [15]