Core Viewpoint - The article emphasizes the importance of identifying and maintaining trends in short-term investing, highlighting that sound fundamentals and positive earnings estimates are crucial for sustaining momentum in stock prices [1]. Group 1: Stock Performance - DBV Technologies S.A. (DBVT) has shown a significant price increase of 100.4% over the past 12 weeks, indicating strong investor interest [3]. - The stock has also experienced a price increase of 40.6% over the last four weeks, suggesting that the upward trend is still intact [4]. - Currently, DBVT is trading at 89.5% of its 52-week high-low range, indicating a potential breakout opportunity [4]. Group 2: Fundamental Strength - DBVT holds a Zacks Rank 1 (Strong Buy), placing it in the top 5% of over 4,000 ranked stocks based on earnings estimate revisions and EPS surprises [5]. - The stock has an Average Broker Recommendation of 1 (Strong Buy), reflecting high optimism from the brokerage community regarding its near-term price performance [6]. Group 3: Investment Strategy - The "Recent Price Strength" screen is a useful tool for identifying stocks like DBVT that have the fundamental strength to maintain their recent uptrend [2]. - There are additional stocks that meet the criteria of the "Recent Price Strength" screen, suggesting further investment opportunities [7].

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 ...

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 ...

Market Overview - The S&P 500 experienced a significant drop of approximately 10% in the first five trading days of April 2025 due to tariffs impacting market stability [1] - Investors with available cash may seek opportunities in companies that have shown resilience amid market volatility [1] Alumis (NASDAQ: ALMS) - Alumis shares surged by 64% in the five trading days leading to April 7, 2025, largely due to the announcement of a proposed merger with Acelyrin Inc. [4] - The merger is expected to consolidate strong pipelines and provide a cash runway through 2027, with multiple clinical readouts anticipated [5] - Current stock price is $8.04, with a 12-month price forecast of $26.00, indicating a potential upside of 223.38% [3] DBV Technologies (NASDAQ: DBVT) - DBV Technologies shares increased by 129% year-to-date as of April 7, 2025, and rose by 17% in the five days leading to that date [7] - The company is developing the VIASKIN peanut patch, which aims to desensitize children to peanut allergies, and has received FDA support for its Biologics License Application [8][9] - Current stock price is $7.07, with a 12-month price forecast of $22.50, suggesting a potential upside of 218.25% [6] Corcept Therapeutics (NASDAQ: CORT) - Corcept's relacorilant has shown promise in treating ovarian cancer, with a late-stage trial indicating it may delay cancer progression in patients resistant to existing chemotherapy [10] - The stock price is currently $72.97, with a 12-month price forecast of $143.25, indicating a potential upside of 96.31% [10] - Corcept's shares have increased nearly 50% year-to-date, despite a recent decline in early April [11]

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].

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]

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]

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]

Core Insights - DBV Technologies will participate in the AAAAI/WAO Joint Congress from February 28 to March 3, 2025, in San Diego, CA, showcasing its research on the VIASKIN® peanut patch [1][5] Group 1: Clinical Study Results - Dr. David Fleischer will present Month 60 efficacy and safety results from the PEOPLE study, which involved peanut-allergic children aged 4-11 years treated with the VIASKIN® peanut patch for up to 60 months [2][9] - The percentage of treatment responders increased from 39.1% at PEPITES completion to 73.3% at Month 60, indicating significant improvement in treatment efficacy over time [7] - Approximately 66.7% of participants achieved an eliciting dose (ED) of 1,000 mg of peanut protein at Month 60, compared to 33.3% at PEPITES completion [7] Group 2: Safety and Compliance - Most treatment-emergent adverse events (TEAEs) were mild to moderate local skin reactions, which decreased in frequency and severity over the study period [7] - Treatment compliance remained high at 93.1% over five years, suggesting strong adherence to the treatment regimen [6][7] Group 3: Future Directions - DBV Technologies is committed to completing studies for regulatory submissions targeting toddlers aged 1-3 years and children aged 4-7 years [8] - The company aims to demonstrate the long-term efficacy and safety of the VIASKIN® peanut patch as a potential breakthrough treatment for peanut allergies [6][11]

Core Viewpoint - DBV Technologies has confirmed alignment with the U.S. FDA on an Accelerated Approval pathway for the Viaskin Peanut patch aimed at toddlers aged 1 to 3 years, with key study design elements agreed upon for the upcoming COMFORT Toddlers study, set to begin in Q2 2025, and a Biologics License Application (BLA) submission anticipated in the second half of 2026 [2][3][17]. Regulatory Pathway - The FDA has issued written communication confirming an Accelerated Approval pathway for the Viaskin Peanut patch, which must meet three qualifying criteria: treatment of a serious condition, meaningful advantage over existing therapies, and demonstration of an effect likely to predict clinical benefit [4]. - DBV has received confirmation that the Viaskin Peanut patch meets the first two criteria and that the efficacy data from the Phase 3 EPITOPE study can serve as an intermediate clinical endpoint for the third criterion [5][4]. Study Design and Execution - The COMFORT Toddlers study will be a Phase 3 double-blind, placebo-controlled study designed to generate additional safety and adhesion data for the Viaskin Peanut patch in peanut-allergic toddlers [13]. - The study is expected to enroll approximately 480 subjects across 80-90 study centers in the U.S., Canada, Australia, and Europe, with a six-month study duration followed by an optional 18-month open-label treatment phase [14][13]. Product Development - DBV has made modifications to the Viaskin Peanut patch to enhance caregiver application simplicity and product identification, while maintaining the same device components in contact with the patient's skin [6]. - The commercial Viaskin Peanut patch has been used in 304 subjects with over 234,695 patient-days of therapy, showing no clinically relevant differences in efficacy or safety compared to the clinical patch used in the EPITOPE study [10]. Post-Marketing Study - The FDA has confirmed criteria for a post-marketing confirmatory study, which will assess the effectiveness of the intended commercial Viaskin Peanut patch and must be initiated at the time of BLA submission [9]. - The confirmatory study will include a double-blind, placebo-controlled food challenge and will use the same statistical criteria for success as the EPITOPE Phase 3 efficacy study [11]. Company Overview - DBV Technologies is a clinical-stage biopharmaceutical company focused on developing treatment options for food allergies through its proprietary Viaskin patch technology, which aims to modify allergic reactions by re-educating the immune system [19]. - The company is headquartered in Châtillon, France, with North American operations in Warren, NJ, and its shares are traded on Euronext Paris and the Nasdaq Capital Market [20].