CROSSJECT presents its financial results and key highlights for the first half of 2025

Press release

CROSSJECT presents its financial results and key highlights for the first half of 2025

•         Cash position: €6.3 million, compared to €7.0 million as of December 31 2024, demonstrating the Company's excellent control of its resources. 

•         Stable R&D investments and a €3.1 million increase in R&D reimbursements from BARDA1  for the first half of 2024, to €6.5 million, in line with the focus on regulatory development and batch manufacturing related to the registration of ZEPIZURE®.

•         The company continued to make progress toward BARDA's submission of its Emergency Use Authorization (EUA) application for ZEPIZURE®. 

Dijon, France, September 24, 2025 10:00 p.m. CET -- CROSSJECT (ISIN: FR0011716265; Euronext: ALCJ), a specialty pharmaceutical company developing products for emergency situations based on its proprietary ZENEO® needle-free auto-injector technology, today announced its financial results for the first half of the year ended June 30, 2025, and provided an update on its business highlights for the first half of 2025.

During this period, CROSSJECT continued its regulatory activities in conjunction with the U.S. Biomedical Advanced Research and Development Authority (BARDA) with the aim of obtaining regulatory approvals for ZEPIZURE® in the United States as soon as possible. 

In this context, in June, and as announced in May 2025, CROSSJECT and its CDMO partner EUROFINS produced the validation batches, the data from which form part of the EUA dossier, and organized the manufacture of batches so that they would be available at the time of the EUA evaluation. 

Beyond the reference period ending June 30, 2025, CROSSJECT is continuing  its activities related to the registration of ZEPIZURE®, in particular:

•             The company and BARDA used the summer period to draft and review the detailed,

•             In September, BARDA conducted mock audits to prepare the company for potential FDA inspections. 

In addition, in September, the Company obtained an €11.3 million extension of R&D funding under its contract with the U.S. government.

Other significant events also occurred after the close of the financial year:

•             The company obtained a new credit line of €750,000 from a new banking partner,

•             The company obtained renewal of its ISO 13485 certification for all of its sites (Dijon and Gray),

•             The company also saw its Good Manufacturing Practices (GMP) certificate extended.

In the current macroeconomic context, the company and its advisors believe that it is not currently exposed to any impact from increases in European customs duties on shipments to the United States destined for BARDA.

We would also like to point out that, in preparation for the increase in production volumes when its product portfolio is commercialized, the company finalized the development and introduction of its ZENEO® Nest module, the latest innovation from the ZENEO® Factory, during the first half of the year. ZENEO® Nest facilitates and accelerates aseptic filling operations on high-speed automated lines available at many CDMOs. 

Finally, as part of its direct marketing strategy in the United States, the Company continued to strengthen the potential of ZEPIZURE® in collaboration with opinion leaders in epilepsy and emergency medicine.

"Throughout 2025, CROSSJECT continued to make decisive progress toward filing the EUA application for ZEPIZURE®. We express our gratitude to BARDA for its diligence and consistency in reviewing the data and its attention to our manufacturing tool. Pragmatic and committed to secure the registration of ZEPIZURE® as quickly as possible, BARDA also granted us a major increase (of more than $11 million) in its contribution", said Patrick ALEXANDRE, Chairman of the Executive Board of CROSSJECT. 

See also Appendices 1 (income statement), 2 (balance sheet assets) and 3 (balance sheet liabilities).

1 Contract No. 75A50122C00031 with the Department of Health and Human Services; Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority.

About CROSSJECT

CROSSJECT SA (Euronext: ALCJ;www.crossject.com) is an emerging specialty pharmaceuticals company developing medicines for emergency situations harnessing its award-winning needle-free 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 include mainly 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 more information, please contact : 

Investor relations Press contact

investors@crossject.com melanie.voisard@buzzetcompagnie.com

1

Income statement H1 2025 vs H1 2024

Accounts approved by the Executive Board on 24 September 2025 and presented to the Supervisory Board on the same day.

For the first half of 2025, CROSSJECT's operating loss amounted to €5.1 million, an improvement of €1.5 million compared to the loss of €6.7 million for the same period in 2024. This positive change reflects:

•        A sharp increase in reimbursements from BARDA, amounting to €6.5 million in the first half of 2025, compared with €3.1 million in 2024. These reimbursements reflect a concentration and acceleration of BARDA's R&D activities, including the manufacture of multiple batches during the period related to the ZEPIZURE® application. The coverage ratio of our operating expenses is higher than previously. 

•        Good control of total operating expenses, which rose to €13.2 million compared with €12.5 million in the first half of 2024.

The company's net loss amounted to €4.9 million in the first half of 2025, compared with €6.4 million in the first half of 2024.

As part of its multiple activities, and as evidenced by the extension recently obtained from BARDA and its new bank financing, the company continues to continuously evaluate its dilutive and nondilutive financing options.

2

Assets, 30 June 2025 vs 31 December 2024 

FIXED ASSETS

CURRENT ASSETS

3

 Liabilities and Shareholders’ Equity - 30 June 2025 vs 31 December 2024

SHAREHOLDERS’ EQUITY

LIABILITIES