CROSSJECT Reports Strong Financial Milestones for H1 2025
CROSSJECT Captures Financial Progress in H1 2025
In an encouraging unveiling of its financial results, CROSSJECT has reflected a strong financial footing and strategic advancements during the first half of the year. With a cash position of €6.3 million, the company demonstrates exceptional resource control, despite a slight decrease from €7.0 million at the end of the previous year.
Investment in Research and Development
Investment in research and development (R&D) remained stable, with CROSSJECT reporting a significant increase in reimbursements from the U.S. Biomedical Advanced Research and Development Authority (BARDA), rising from €3.1 million to €6.5 million. This uptick aligns with the company's efforts on regulatory development and batch manufacturing associated with the registration of its innovative product, ZEPIZURE®.
Regulatory Development Progress
CROSSJECT continues to make headway with its regulatory activities alongside BARDA, aiming for swift regulatory approvals for ZEPIZURE® in the United States. In this context, the company, in collaboration with its contract development and manufacturing organization (CDMO) partner EUROFINS, produced validation batches in June that are crucial for the Emergency Use Authorization (EUA) application.
Operational Highlights in H1 2025
Throughout the first half of 2025, CROSSJECT has embraced multiple operational efforts towards obtaining important regulatory approvals. The company's partnership with BARDA has intensified during the summer of 2025, focusing on drafting detailed submissions and preparing for potential FDA inspections through mock audits.
Strategic Growth and Funding Initiatives
In September, CROSSJECT secured an additional €11.3 million extension in R&D funding under its existing government contract. This funding is vital as it supports the ongoing development and validation of ZEPIZURE®, designed to provide emergency treatment options for those suffering from epileptic seizures.
Financial Performance Overview
For the first half of 2025, CROSSJECT reported an operating loss of €5.1 million, which is an improvement from the €6.7 million loss reported for the same timeframe in the previous year. The decrease in loss can be attributed to increased BARDA reimbursements and effective management of total operating expenses, which rose to €13.2 million compared to €12.5 million last year.
Net Loss Insights
The net loss for the company amounted to €4.9 million, marking a notable improvement from €6.4 million in H1 2024. Such positive trends indicate the company's strategic focus and commitment towards enhancing financial stability while pushing forward with its product developments.
Future Directions and Innovations
As CROSSJECT moves beyond its current financial period, it is committed to further refining its portfolio and expanding production capabilities. The recent introduction of ZENEO® Nest, a module to expedite aseptic filling operations, showcases CROSSJECT's dedication to innovation and readiness for increased production volumes.
Looking ahead, CROSSJECT also continues to solidify its market position in the United States. By fostering collaborations with key opinion leaders in epilepsy and emergency medicine, the company aims to enhance the visibility and efficacy of ZEPIZURE® in emergency medical situations.
Patrick ALEXANDRE, the Chairman of the Executive Board at CROSSJECT, expressed gratitude towards BARDA for its unwavering support and diligence in the review process, contributing to essential funding which will further expedite the registration of ZEPIZURE®.
Frequently Asked Questions
What financial position did CROSSJECT achieve in H1 2025?
CROSSJECT reported a cash position of €6.3 million in H1 2025, showing effective resource management.
How much did R&D reimbursements increase for CROSSJECT?
R&D reimbursements increased substantially to €6.5 million, compared to €3.1 million the previous year.
What is ZEPIZURE® and its relevance to CROSSJECT?
ZEPIZURE® is an innovative product by CROSSJECT for emergency treatment of seizures, currently in the regulatory approval phase with BARDA.
What operational steps is CROSSJECT taking for FDA approval?
CROSSJECT has been actively engaging with BARDA to refine submission documents and prepare for FDA audits through mock inspections.
What are CROSSJECT's future plans for production?
CROSSJECT intends to enhance production capabilities through innovations like the ZENEO® Nest module, ensuring readiness for increased product demand.
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