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DBV Technologies(DBVT) - 2025 Q1 - Quarterly Results
2025-04-30 20:46
Exhibit 99.1 DBV Technologies (Euronext: DBV – ISIN: FR0010417345 – Nasdaq Stock Market: DBVT – CUSIP: 23306J309), a clinical-stage biopharmaceutical company, today reported financial results for the First Quarter of 2025. The quarterly and three months financial statements were approved by the Board of Directors on April 30, 2025. Financial Highlights for the First Quarter Ended March 31, 2025 The Company's interim condensed consolidated financial statements for the three months ended March 31, 2025, are p ...
DBV Technologies(DBVT) - 2025 Q1 - Quarterly Report
2025-04-30 20:02
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 ____________________ FORM 10-Q ____________________ (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2025 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ______________ to _______________ Commission file number 001-36697 DBV TECHNOLOGIES S.A. (Exact name of registrant a ...
DBV Technologies Reports First Quarter 2025 Financial Results
GlobeNewswire News Room· 2025-04-30 20:00
Châtillon, France, April 30, 2025 The Company's interim condensed consolidated financial statements for the three months ended March 31, 2025, are prepared in accordance with accounting principles generally accepted in the United States ("U.S. GAAP"). DBV Technologies Reports First Quarter 2025 Financial Results Cash and Cash Equivalents DBV Technologies (Euronext: DBV – ISIN: FR0010417345 – Nasdaq Stock Market: DBVT – CUSIP: 23306J309), a clinical-stage biopharmaceutical company, today reported financial r ...
Here's Why Momentum in DBV Technologies (DBVT) Should Keep going
ZACKS· 2025-04-30 13:50
Most of us have heard the dictum "the trend is your friend." And this is undeniably the key to success when it comes to short-term investing or trading. But it isn't easy to ensure the sustainability of a trend and profit from it. The trend often reverses before exiting the trade, leading to a short-term capital loss for investors. So, for a profitable trade, one should confirm factors such as sound fundamentals, positive earnings estimate revisions, etc. that could keep the momentum in the stock alive. Our ...
DBV Technologies announces filing of 2024 Annual Report on Form 10-K and Universal Registration Document
Newsfilter· 2025-04-11 20:30
Châtillon, France, April 11, 2025 DBV Technologies announces filing of 2024 Annual Report on Form 10-K and Universal Registration Document DBV Technologies (TRQX:DBVp), a clinical-stage biopharmaceutical company focused on treatment options for food allergies and other immunologic conditions with significant unmet medical need (the "Company"), today announced: The audited financial statements for the year ended December 31, 2024 were approved by the Board of Directors on April 11, 2025, and present no chan ...
DBV Technologies(DBVT) - 2024 Q4 - Annual Report
2025-04-11 20:05
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 ____________________ FORM 10-K ____________________ (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2024 or □ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _______________ to ______________ Commission file number 001-36697 DBV TECHNOLOGIES S.A. (Exact name of registrant as spe ...
DBV Technologies Announces Financing of up to $306.9 Million (€284.5 Million) to Advance Viaskin® Peanut Patch Through Biologics License Application Submission and U.S. Commercial Launch, if Approved
Newsfilter· 2025-03-28 02:30
Core Viewpoint - DBV Technologies announced a financing of up to $306.9 million (€284.5 million) to support the development and potential commercialization of its Viaskin Peanut patch for treating pediatric peanut allergies, contingent upon FDA approval and successful completion of clinical trials [1][3][4]. Financing Details - The financing includes gross proceeds of $125.5 million (€116.3 million) upon closing and up to $181.4 million (€168.2 million) if all warrants are exercised, with an immediate dilution of 22.4% and a maximal dilution of up to 73.7% for existing shareholders [1][4][7]. - The financing was led by several prominent investors, including MPM BioImpact and Adage Capital Management LP, among others [2]. Development and Regulatory Updates - DBV is advancing the Viaskin peanut patch, having aligned with the FDA on safety exposure data required for a Biologics License Application (BLA) for children aged 4 to 7 years, which accelerates the timeline for submission [3][4]. - The VITESSE Phase 3 study, which is the largest study conducted for peanut allergy in this age range, has enrolled 654 subjects, exceeding the original target of 600, enhancing the study's statistical power to over 90% [3][4]. Use of Proceeds - The proceeds from the financing will be allocated for working capital, continued development of the Viaskin Peanut program, preparation and submission of the BLA, and readiness for a potential U.S. launch [1][5][6]. Financial Position and Future Outlook - The company anticipates that the financing will provide sufficient net working capital to meet obligations over the next 12 months and extend financial visibility into 2028, contingent on the successful commercialization of Viaskin Peanut [11][13]. - Current cash reserves are insufficient to cover operating needs for the next 12 months, highlighting the importance of this financing [8][10]. Shareholder Impact - The financing will significantly alter the shareholding structure, with existing shareholders facing substantial dilution if all warrants are exercised [40][41][43]. - Baker Brothers Investments, a major shareholder, will see its ownership change from 22.82% to 17.14% on a non-diluted basis post-offering, and potentially to 25.15% if all warrants are exercised [32][41][43]. Investor Engagement - DBV Technologies will host an investor conference call to discuss the financing and FDA updates, indicating proactive communication with stakeholders [4][49].
DBV Technologies(DBVT) - 2024 Q4 - Annual Results
2025-03-24 11:01
FDA Approval and Product Development - The FDA has agreed that safety exposure data from the VITESSE Phase 3 study is sufficient to support a Biologics License Application (BLA) for the Viaskin peanut patch in children aged 4-7, eliminating the need for the COMFORT Children supplemental safety study[1] - The BLA submission for the Viaskin peanut patch is now expected in the first half of 2026, potentially accelerating the product launch by approximately one year if approved by the FDA[2] - The VITESSE study enrolled 654 participants, making it the largest Phase 3 clinical trial for peanut allergy in this age group, with over 500 participants expected to be included in the safety database at the time of BLA submission[4] - The COMFORT Toddlers study is expected to initiate in the second quarter of 2025, with a BLA submission for the 1-3 year old indication anticipated in the second half of 2026[5] - The company is focused on developing its proprietary VIASKIN® patch technology for food allergies, with ongoing clinical trials for VIASKIN Peanut targeting peanut allergic toddlers and children[26] - DBV Technologies is committed to transforming the care of food allergic individuals through its epicutaneous immunotherapy (EPIT™) approach[26] Financial Performance - Cash and cash equivalents decreased to $32.5 million as of December 31, 2024, from $141.4 million as of December 31, 2023, reflecting a net cash consumption of $108.9 million primarily due to clinical trial-related expenses[10] - Operating income for the year ended December 31, 2024, was $4.2 million, down from $15.7 million in 2023, a decrease of $11.5 million attributed to the termination of a collaboration agreement and lower research tax credits[15] - Operating expenses increased to $120.7 million for the year ended December 31, 2024, compared to $92.2 million in 2023, driven by a $29.1 million rise in research and development costs[17] - The company recorded a net loss of $113.9 million for the year ended December 31, 2024, compared to a net loss of $72.7 million for the same period in 2023, resulting in a net loss per share of $(1.17)[20] - For the year ended December 31, 2024, the net loss was $113.9 million, compared to a net loss of $72.7 million in 2023, representing a 56.7% increase in losses year-over-year[23] - Operating income decreased to $4.2 million in 2024 from $15.7 million in 2023, indicating a decline of 73.3%[23] - Research and Development expenses rose to $89.3 million in 2024, up from $60.2 million in 2023, reflecting a 48.3% increase[23] - Net cash flows used in operating activities were $(104.5) million in 2024, compared to $(79.7) million in 2023, representing a 31.1% increase in cash outflow[24] - The net cash and cash equivalents at the end of the period decreased to $32.5 million in 2024 from $141.4 million in 2023, a decline of 77.0%[24] Capital and Audit Status - The company has incurred operating losses and negative cash flows from operations since inception, with available cash expected to fund operations only into April 2025[11] - The company intends to seek additional capital to support ongoing research and development efforts and the BLA filing for the Viaskin peanut patch[12] - The company has not yet obtained assurance from its auditors that the financial statements will be certified without qualification, indicating ongoing audit procedures[25] Company Overview - DBV Technologies is headquartered in Châtillon, France, with operations in North America located in Warren, NJ[27] - The company's ordinary shares are traded on Euronext Paris and its ADSs on the Nasdaq Capital Market, indicating its presence in both European and U.S. markets[27]
DBV Technologies Secures Agreement with FDA on Safety Exposure Data Required for BLA for Viaskin® Peanut Patch in 4–7-year-olds, Accelerating the Timeline for a BLA Filing Submission to 1H 2026, & Reports 2024 Unaudited Financial Results...
Newsfilter· 2025-03-24 06:30
Core Insights - DBV Technologies has secured an agreement with the FDA regarding the safety exposure data required for the Biologics License Application (BLA) for the Viaskin® Peanut Patch in children aged 4 to 7 years, which accelerates the timeline for submission to the first half of 2026 [1][2][5] - The company reported unaudited financial results for the full year 2024, indicating significant cash consumption and operating losses [8][11][23] FDA Agreement and BLA Submission - The FDA has agreed that the safety exposure data from the VITESSE Phase 3 study will be sufficient for the BLA, eliminating the need for the COMFORT Children supplemental safety study [2][5] - The BLA submission is now expected in the first half of 2026, potentially accelerating the product launch by approximately one year, pending FDA approval [2][5][6] - The VITESSE study is the largest Phase 3 clinical trial for peanut allergy in this age group, enrolling 654 participants [3][4] Financial Results - Cash and cash equivalents decreased to $32.5 million as of December 31, 2024, from $141.4 million at the end of 2023, reflecting a net cash consumption of $108.9 million primarily due to clinical trial expenses [11][12] - Operating income for 2024 was $4.2 million, down from $15.7 million in 2023, attributed to the termination of a collaboration agreement and a lower research tax credit [17][23] - The company recorded a net loss of $113.9 million for 2024, compared to a net loss of $72.7 million in 2023, resulting in a net loss per share of $(1.17) [23][24] Research and Development - Operating expenses rose to $120.7 million in 2024, up from $92.2 million in 2023, driven by increased research and development costs related to the ongoing VITESSE trial and preparatory activities for supplemental safety studies [19][21] - The company plans to pursue an Accelerated Approval pathway for the Viaskin peanut patch in toddlers aged 1 to 3 years, with a supplemental safety study expected to begin in Q2 2025 [6][30] Company Overview - DBV Technologies is focused on developing treatment options for food allergies using its proprietary Viaskin® patch technology, which aims to modify allergic reactions through epicutaneous immunotherapy [30][31]
DBV Technologies Secures Agreement with FDA on Safety Exposure Data Required for BLA for Viaskin® Peanut Patch in 4–7-year-olds, Accelerating the Timeline for a BLA Filing Submission to 1H 2026, & Reports 2024 Unaudited Financial Results
GlobeNewswire News Room· 2025-03-24 06:30
Core Insights - DBV Technologies has secured an agreement with the FDA regarding the safety exposure data required for the Biologics License Application (BLA) for the Viaskin® Peanut Patch in children aged 4 to 7 years, which accelerates the timeline for submission to the first half of 2026 [1][2][5] - The company reported unaudited financial results for the full year 2024, indicating significant cash consumption and operating losses [8][11][12] FDA Agreement and Clinical Trials - The FDA has agreed that the safety data from the VITESSE Phase 3 study will be sufficient for the BLA, eliminating the need for the COMFORT Children supplemental safety study [2][5][6] - The VITESSE study is the largest Phase 3 clinical trial for peanut allergy in this age group, enrolling 654 participants, and is expected to provide robust safety data [3][4][5] - The BLA submission is now anticipated in the first half of 2026, potentially accelerating the product launch by approximately one year, pending FDA approval [2][5][6] Financial Results - Cash and cash equivalents decreased to $32.5 million as of December 31, 2024, from $141.4 million at the end of 2023, reflecting a net cash consumption of $108.9 million primarily due to clinical trial expenses [11][12][15] - Operating income for 2024 was $4.2 million, down from $15.7 million in 2023, attributed to the termination of a collaboration agreement and a lower Research Tax Credit [16][22] - The company recorded a net loss of $113.9 million for 2024, compared to a net loss of $72.7 million in 2023, with a net loss per share of $(1.17) [22][23][26] Research and Development - Operating expenses rose to $120.7 million in 2024, up from $92.2 million in 2023, driven by increased research and development costs related to the ongoing VITESSE trial and preparatory activities for supplemental safety studies [18][21][26] - The company plans to pursue an Accelerated Approval pathway for the Viaskin peanut patch in toddlers aged 1 to 3 years, with a BLA submission expected in the second half of 2026 [6][29]