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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 presents its financial results and key highlights for the first half of 2025
Globenewswire· 2025-09-24 20:00
Core Insights - CROSSJECT reported its financial results for the first half of 2025, highlighting progress in regulatory activities and financial performance [3][4][9]. Financial Performance - The company recorded revenues of €8,038,000 for H1 2025, an increase from €5,766,000 in H1 2024 [13]. - R&D reimbursements from BARDA rose significantly to €6,584,000 in H1 2025, compared to €3,064,000 in H1 2024, reflecting increased R&D activities [13][19]. - The operating loss improved to €5,139,000 in H1 2025 from €6,719,000 in H1 2024, indicating better cost management [14]. - The net loss for the period was €4,868,000, down from €6,402,000 in the same period last year [14]. Regulatory and Development Activities - CROSSJECT continued its regulatory efforts with BARDA to obtain Emergency Use Authorization (EUA) for ZEPIZURE® in the U.S. [4][9]. - The company produced validation batches in collaboration with its CDMO partner EUROFINS, which are part of the EUA dossier [5]. - In September 2025, CROSSJECT secured an €11.3 million extension of R&D funding from the U.S. government [5]. Production and Innovation - The company finalized the development of the ZENEO® Nest module to enhance aseptic filling operations, preparing for increased production volumes [7]. - CROSSJECT maintained a cash position of €6.3 million as of June 30, 2025, down from €7.0 million at the end of 2024, reflecting effective resource management [9]. Strategic Collaborations - The company strengthened its marketing strategy for ZEPIZURE® by collaborating with opinion leaders in epilepsy and emergency medicine [8]. - In preparation for potential FDA inspections, BARDA conducted mock audits during the summer [10].
CROSSJECT remains engaged during the summer break
Globenewswire· 2025-08-04 15:35
Core Points - CROSSJECT is actively working on submitting the ZEPIZURE® dossier for Emergency Use Authorization (EUA) despite the summer break [3][4] - Maintenance operations are ongoing at CROSSJECT's three production sites to ensure optimal conditions for future commercial deliveries [4][9] - Development teams are engaged in preparations for the New Drug Application (NDA) for ZEPIZURE®, including monitoring production and planning additional clinical studies in the United States [5][6] Company Overview - CROSSJECT is a specialty pharmaceutical company focused on emergency products utilizing its ZENEO® needle-free auto-injector technology [3][7] - The company has a $60 million contract with BARDA for the development of ZEPIZURE®, an epileptic rescue therapy [7][8] - The ZENEO® platform allows for easy and instant delivery of emergency medications, targeting various conditions including allergic shocks and adrenal insufficiencies [7]
CROSSJECT announces a successful capital increase of €5.7 million following full exercise of the extension clause
Globenewswire· 2025-06-24 17:00
Core Viewpoint - CROSSJECT successfully completed a capital increase of €5.7 million, which will support the final registration phases of ZEPIZURE®, its emergency treatment for epileptic seizures [2][3][18] Financing Details - The capital increase was achieved through a preferential subscription rights offering, with a gross amount of €5,725,479.20 and a net amount of approximately €5,458,093.69 [2][3] - The subscription price was set at €1.40, reflecting a 22.6% discount to the closing price on June 3, 2025 [3] - Total demand for the offering reached €9.2 million, resulting in an oversubscription rate of 1.84 times the initial offering [9][18] Use of Proceeds - Approximately 60% of the net proceeds will be allocated to the final development phases of ZEPIZURE® and initial production stages [6] - The remaining 40% will finance R&D for other projects, including ZENEO® Adrenaline and ZENEO® Hydrocortisone, and cover general administrative expenses [6] Development Timeline - CROSSJECT is on track for the EUA submission to the FDA and anticipates a confirmation of receipt within one month after submission [5] - The company is also preparing for a second NDA filing for ZEPIZURE® in the second quarter of 2026 [6] Shareholder Impact - Following the capital increase, the company's share capital will amount to €5,032,022.40, comprising 50,320,224 shares [11] - Gemmes Venture, a significant shareholder, subscribed €62,460, reducing its stake from 24.7% to approximately 22.0% post-transaction [12] Legal and Regulatory Framework - The capital increase was authorized by the Supervisory Board and executed in accordance with the resolutions from the Combined General Meeting [8] - The new shares will be listed on Euronext Growth and will be fully assimilated to existing shares upon issuance [26][27]
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].
Launch of a capital increase with preferential subscription rights for nearly 5 million euros
Globenewswire· 2025-06-04 18:22
Group 1 - CROSSJECT is launching a capital increase with preferential subscription rights for an initial total amount of approximately €4.98 million, which may increase to €5.73 million if the extension clause is exercised [3][4][9] - The company aims to use around 60% of the net proceeds for the final development phases of ZEPIZURE® and the initial production stages, while approximately 40% will be allocated to R&D for other projects and general expenses [5][6] - CROSSJECT is on track to submit an Emergency Use Authorization (EUA) application to the FDA and expects to finalize production of validation batches in June 2025 [4][7] Group 2 - The subscription price for the new shares is set at €1.40, representing a 22.6% discount to the closing price on June 3, 2025 [9][16] - Existing shareholders and Vatel Capital have committed to subscribe for approximately €3.7 million, representing 76.4% of the transaction [9][36] - The subscription period is from June 12, 2025, to June 20, 2025, with preferential subscription rights detached on June 10, 2025 [18][24][30] Group 3 - The capital increase will involve the issuance of approximately 3,556,199 new shares, which may increase to 4,089,628 shares if the extension clause is fully exercised [13][15] - The company estimates that the net working capital will be sufficient to meet obligations until the end of 2025, assuming first payments from its American partner [7] - CROSSJECT's share capital currently comprises 46,230,596 fully subscribed shares, with a par value of €0.1 each [12]
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 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]
CROSSJECT’s ZENEO® needle-free autoinjector consistently matches depth of traditional intramuscular injections and exceeds the standards needle length of currently utilized auto-injectors
Globenewswire· 2025-05-15 05:30
Core Insights - CROSSJECT's ZENEO® needle-free auto-injector demonstrates comparable injection depth to traditional 30-mm needles and exceeds the length of many existing auto-injectors, indicating strong clinical and commercial potential [2][3][4] Company Overview - CROSSJECT is a specialty pharmaceuticals company focused on developing emergency medications, particularly through its ZENEO® needle-free auto-injector platform [6] - The company is advancing the regulatory development of ZEPIZURE®, an emergency injectable for epilepsy management, supported by a $60 million contract with BARDA [6][7] Product Performance - In a recent MRI study with 50 healthy subjects, the ZENEO® auto-injector achieved a mean injection depth of 34 mm (±7.5 mm) on bare skin and 28 mm (±8.4 mm) through clothing, both within the intended range for intramuscular injections [4] - The ZENEO® device's performance surpasses that of conventional needle-based auto-injectors, which typically have needle lengths between 11 mm and 25 mm, ensuring rapid and complete dose delivery [4][8] Clinical Validation - The study results align with previous clinical findings, confirming that midazolam injected with ZENEO® is bioequivalent to injections using a 30-mm needle [5] - Local reactions to the treatment were transient and well-tolerated, similar to those experienced with traditional intramuscular injections [5]
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]