ZENEO®
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CROSSJECT publishes its 2025 financial results and confirms the strengthening of its operational, industrial and financial trajectory
Globenewswire· 2026-03-25 06:20
Core Insights - CROSSJECT has made significant progress in the development and regulatory preparation of ZEPIZURE®, an injectable for managing epileptic seizures, with a focus on its proprietary ZENEO® needle-free auto-injector technology [1][5][6] Financial Performance - For the financial year ending December 31, 2025, CROSSJECT reported operating revenue of €14.9 million, a 12.2% increase from €13.3 million in 2024, primarily driven by BARDA invoicing which rose to €12.1 million from €8.2 million [3][14] - Operating expenses increased slightly to €26.5 million from €26.2 million in 2024, resulting in an operating loss of €11.6 million, an improvement from a loss of €13.0 million in 2024 [15][16] - The net loss for 2025 was €10.4 million, improved from €12.8 million in 2024, reflecting better revenue growth and disciplined expenditure management [16] Funding and Financial Structure - CROSSJECT received increased funding from BARDA, totaling $43.3 million, which supports regulatory and manufacturing activities [2][8] - The company reduced its bank debt by €2.7 million, with borrowings from credit institutions decreasing to €10.2 million from €12.9 million at the end of 2024 [4][18] - As of December 31, 2025, CROSSJECT had available cash of €5.1 million, supplemented by a €2.8 million research tax credit receivable, totaling €7.9 million [3][20] Regulatory and Operational Developments - In 2025, CROSSJECT achieved satisfactory stability results for ZEPIZURE® and produced additional validation batches, preparing for regulatory submissions [6][9] - The company is actively pursuing an Emergency Use Authorization (EUA) application in coordination with BARDA, aiming for commercial deliveries in 2026 and U.S. commercialization in 2027 [5][23] Strategic Direction - CROSSJECT is focusing on the development of its ZENEO® platform, including ZEPIZURE® Junior for pediatric use, and estimates the commercial potential of its emergency medicines portfolio could reach annual peak sales of around €1 billion [10][9] - The company has strengthened its governance and market visibility, with new coverage initiated by financial institutions and preparations for direct commercialization in the U.S. [12][13]
CROSSJECT completes €5 million financing with Vatel Capital
Globenewswire· 2025-11-14 19:46
Core Points - CROSSJECT has completed a €5 million financing round fully subscribed by Vatel Capital, aimed at supporting the development of its injectable product ZEPIZURE for treating epileptic seizures [3][5] - The financing was executed through a reserved issue of convertible bonds with interest rates between 7.5% and 9.5%, convertible at a fixed price of €2.65 per share, representing a conversion premium of 9.8% over a 10-day VWAP and 20.5% over a 20-day VWAP [4][15] - The company is in advanced regulatory development for ZEPIZURE, collaborating with BARDA for Emergency Use Authorization in the U.S. [6][29] Financing Details - The transaction consists of three tranches of convertible bonds totaling €5 million, with varying maturities and interest rates [4][12] - Approximately €4.9 million from this transaction will be used to meet working capital requirements until regulatory objectives for ZEPIZURE are achieved [9] - The company has also secured an additional €11.3 million in R&D funding from BARDA, enhancing financial security for future development stages [7] Regulatory and Development Progress - CROSSJECT is actively submitting data to BARDA and preparing for potential FDA inspections of its production facilities [6] - The company is also advancing its clinical development plan for ZEPIZURE, targeting a second New Drug Application for treating status epilepticus in both adults and children [8] - The net proceeds from the financing will be allocated equally between the development of ZEPIZURE and other R&D activities, including manufacturing investments [9] Share Capital and Dilution Impact - The issuance of convertible bonds could lead to the creation of up to 1,886,790 new ordinary shares, representing approximately 3.52% of the company's share capital on a non-diluted basis [4][15] - The conversion of these bonds may dilute existing shareholders, with potential changes in shareholding percentages outlined in the press release [18][21] - The company is exploring additional financing options to extend its cash runway until it receives initial payments from its U.S. sponsor [9][10] Company Overview - CROSSJECT is a specialty pharmaceuticals company focused on developing emergency medications using its ZENEO® needle-free auto-injector technology [29] - The company is currently in advanced stages of regulatory development for ZEPIZURE, supported by a $60 million contract with BARDA [29][30] - Other products in development include solutions for allergic shocks and adrenal insufficiencies, as well as therapies for various emergency indications [29]
CROSSJECT advances on the development of ZEPIZURE® Junior, its solution for epilepsy crises in children
Globenewswire· 2025-06-11 05:30
Core Insights - CROSSJECT is advancing the development of ZEPIZURE® Junior, a solution for managing epilepsy crises in children, while also progressing with ZEPIZURE® for adults [2][6]. Company Development - CROSSJECT has completed a clinical echography study involving 90 adults and children aged 2-18 to assess anatomical characteristics relevant to the ZENEO® device's drug delivery system [4]. - The company has successfully calibrated the ZENEO® device for pediatric use, confirming its effectiveness in delivering the drug solution at the appropriate penetration depth [4][9]. - Previous studies indicated that children over 8 years old can effectively use the ZENEO® autoinjector [5]. Market Context - According to the CDC, approximately 456,000 children in the U.S. are diagnosed with active epilepsy, highlighting a significant market need for effective treatment solutions [3]. - CROSSJECT aims to establish ZEPIZURE® as the standard of care for pediatric epilepsy, indicating a strategic focus on this demographic [6]. Financial and Regulatory Aspects - CROSSJECT has a $60 million contract with BARDA to support the development of ZEPIZURE®, which underscores the financial backing for its pediatric initiatives [7][8].
Maxim Group initiates the coverage of the CROSSJECT share with a BUY recommendation and a target price of €4.00
Globenewswire· 2025-06-03 05:30
Group 1 - Maxim Group has initiated coverage of CROSSJECT with a BUY recommendation and a target price of €4.00 [2] - The CROSSJECT share price was €1.77 on the date of the research report issuance, May 29, 2025 [3] - CROSSJECT is in advanced regulatory development for ZEPIZURE®, an epileptic rescue therapy, supported by a $60 million contract with BARDA [5][6] Group 2 - CROSSJECT specializes in developing emergency medicines using its needle-free auto-injector ZENEO® platform [5] - The company aims to provide solutions for allergic shocks, adrenal insufficiencies, and other emergency indications [5] - Patrick Alexandre, CEO of CROSSJECT, expressed excitement about the endorsement from Maxim Group and the potential for further developments in the North American market [4]
CROSSJECT provides updates on the EUA filing of ZEPIZURE®
Globenewswire· 2025-05-07 05:30
Core Insights - CROSSJECT is advancing the Emergency Use Authorization (EUA) filing process for ZEPIZURE®, an injectable treatment for epilepsy crises, in collaboration with BARDA [3][5][6] - The company has successfully completed critical aseptic filling steps for ZEPIZURE® and is on track with final assembly and packaging [4][9] - Initial feedback from the FDA is anticipated within one month of the submission, with the final manufacturing data expected to be delivered by June 2025 [5][9] Company Overview - CROSSJECT is a specialty pharmaceuticals company focused on developing emergency medications using its needle-free auto-injector ZENEO® platform [7] - The company has a $60 million contract with BARDA to support the development of ZEPIZURE® [7][8] - Other products in development include solutions for allergic shocks and adrenal insufficiencies, as well as various emergency therapies [7]
Mise à disposition du rapport financier annuel 2024
Globenewswire· 2025-04-30 15:45
Group 1 - The core announcement is that CROSSJECT has made its 2024 annual financial report available to the public and filed it with the French Financial Markets Authority [2][5] - CROSSJECT is a pharmaceutical company specializing in the advanced development and registration of ZEPIZURE®, an emergency solution for managing epilepsy crises [2][3] - The company has secured a $60 million contract from the U.S. Biomedical Advanced Research and Development Authority (BARDA) for the research and development of ZEPIZURE® [3][4] Group 2 - ZEPIZURE® utilizes the award-winning needle-free auto-injector ZENEO®, allowing untrained patients and caregivers to perform intramuscular injections easily and instantly in emergency situations [3] - CROSSJECT is also developing additional products for emergency treatment of allergic shocks, adrenal insufficiencies, opioid overdoses, and asthma attacks [3]