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DBV Technologies to Participate in Upcoming AAAAI/WAO Joint Congress
Newsfilter· 2025-02-25 21:01
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]
DBV Confirms Alignment with U.S. FDA on Accelerated Approval Pathway for the Viaskin® Peanut Patch in Toddlers 1 – 3 Years-Old
GlobeNewswire News Room· 2024-12-11 21:05
Châtillon, France, December 11th, 2024 DBV Confirms Alignment with U.S. FDA on Accelerated Approval Pathway for the Viaskin® Peanut Patch in Toddlers 1 – 3 Years-Old DBV and FDA aligned on key study design elements for the COMFORT Toddlers study in 1 – 3 year-olds, including study size and wear time collection methodology and analysis COMFORT Toddlers study on-track to initiate in 2Q 2025Viaskin Peanut patch BLA submission for the Toddlers indication anticipated for 2H 2026 FDA confirmed criteria for post- ...
DBV Technologies(DBVT) - 2024 Q3 - Quarterly Results
2024-11-06 22:19
Exhibit 99.1 Press Release DBV Announces Positive Regulatory Updates for the Viaskin® Peanut Patch in the United States and Europe • DBV to pursue an Accelerated Approval pathway for toddlers ages 1 – 3 years-old • BLA submission under Accelerated Approval is subject to completion of a six-month supplemental safety study in toddlers to be initiated in Q2 2025 • VITESSE Phase 3 study evaluating the Viaskin Peanut patch in children ages 4 – 7 years-old exceeded enrollment goals; Topline results on track for 4 ...
DBV Technologies(DBVT) - 2024 Q3 - Quarterly Report
2024-11-06 21:34
Financial Performance - Operating income for the three months ended September 30, 2024, was €1,072,000, down from €2,372,000 for the same period in 2023, representing a decrease of approximately 54.8%[11] - Net loss for the nine months ended September 30, 2024, was €90,903,000, compared to a net loss of €61,540,000 for the same period in 2023, reflecting an increase in loss of approximately 47.6%[13] - Total comprehensive loss for the nine months ended September 30, 2024, was €91,138,000, compared to €62,111,000 for the same period in 2023, an increase of approximately 46.9%[11] - Basic/diluted net loss per share attributable to shareholders for the three months ended September 30, 2024, was €0.32, compared to €0.17 for the same period in 2023, indicating a worsening of 88.2%[11] - Net loss for Q3 2024 was $30,442 million, an increase of 81.9% from a net loss of $16,736 million in Q3 2023[77] - Net loss increased to $90.9 million for the nine months ended September 30, 2024, compared to a net loss of $61.5 million for the same period in 2023, resulting in a net loss per share of $0.95[98] Assets and Liabilities - Total current assets decreased from €158,915,000 on December 31, 2023, to €68,759,000 on September 30, 2024, a decline of approximately 56.7%[7] - Total liabilities decreased from €42,799,000 on December 31, 2023, to €39,021,000 on September 30, 2024, a reduction of about 8.5%[8] - Total shareholders' equity dropped from €140,187,000 on December 31, 2023, to €54,034,000 on September 30, 2024, a decrease of approximately 61.5%[9] - Cash and cash equivalents decreased significantly from €141,367,000 at the beginning of the period to €46,441,000 at the end of the period, a decline of about 67.1%[13] - The company reported a total shareholders' equity of $54.034 million, down from $79.095 million as of June 30, 2024, reflecting a net loss of $30.442 million for the quarter[16] Research and Development - Research and development expenses increased to €23,662,000 for the three months ended September 30, 2024, compared to €13,795,000 for the same period in 2023, an increase of about 71.5%[11] - The company is preparing for the potential launch of its first product, Viaskin Peanut, in the U.S. and EU, pending regulatory approval[21] - The company initiated the VITESSE Phase 3 pivotal study for the modified Viaskin Peanut patch in children aged 4-7 years, with topline results anticipated by the fourth quarter of 2025[25] - The Company plans to enroll approximately 300-350 subjects in the COMFORT Toddlers safety study, bringing the total safety database for the Viaskin Peanut patch in toddlers to approximately 600 subjects[37] - The Company submitted the protocol for the COMFORT Children supplemental safety study for ages 4-7 years to the FDA, expecting to enroll around 250 subjects, raising the total to approximately 600 in this age group[30] Cash Flow and Financing - The company reported a net cash flow used in operating activities of €92,222,000 for the nine months ended September 30, 2024, compared to €65,967,000 for the same period in 2023, reflecting an increase in cash outflow of about 39.8%[13] - The company plans to seek additional capital to support its research and development efforts and the launch of Viaskin Peanut, which may involve debt and equity offerings[21] - The company has established an At-The-Market program to raise up to $100 million through the sale of American Depositary Shares[101] - The net cash flow from financing activities decreased to $(0.1) million for the nine months ended September 30, 2024, compared to $7.0 million in the same period of 2023[109] Regulatory and Compliance - The company received a Complete Response Letter from the FDA in August 2020 regarding the Viaskin Peanut BLA, necessitating patch modifications and additional clinical data[25] - The Company announced positive regulatory updates for the Viaskin Peanut patch in the U.S. and Europe, with guidance from the FDA on a potential pathway under the Accelerated Approval Program for toddlers aged 1-3 years[35] - The Company has been engaged in ongoing dialogue with the FDA regarding the COMFORT Toddlers supplemental safety study for children aged 1-3 years with peanut allergies[26] - The Company intends to resubmit the Marketing Authorization Application (MAA) for Viaskin Peanut once the necessary data set is available[32] Operational Expenses - Total operating expenses increased by 52.1% to $31,401 million in Q3 2024 from $20,642 million in Q3 2023[77] - Total operating expenses for the nine months ended September 30, 2024, were $96.37 million, an increase of 35.0% compared to $71.37 million in 2023[88] - General and administrative expenses increased by $1.04 million to $7.22 million for the three months ended September 30, 2024, a 16.8% increase from $6.18 million in 2023[83] - Personnel expenses increased to $8,331 million in Q3 2024 from $6,724 million in Q3 2023, a rise of 24%[63] Other Financial Metrics - The estimated research tax credit for the first nine months of the 2024 fiscal year amounts to $3,640 thousand, compared to $4,978 thousand for the same period in 2023[61] - Research tax credit decreased by $1.34 million to $3.64 million for the nine months ended September 30, 2024, a 26.9% decrease from $4.98 million in 2023[89] - Financial income decreased to $1.9 million for the nine months ended September 30, 2024, down from $3.0 million in the same period of 2023[96] Management and Governance - The report was signed by Daniel Tassé, Chief Executive Officer, and Virginie Boucinha, Chief Financial Officer, on November 6, 2024[124]
DBV Technologies Reports Third Quarter 2024 Financial Results
GlobeNewswire News Room· 2024-11-06 21:30
Châtillon, France, November 6, 2024 DBV Technologies Reports Third Quarter 2024 Financial Results DBV closes Q3 2024 with a cash balance of $46.4 million; cash runway into Q1 2025 DBV Technologies (Euronext: DBV – ISIN: FR0010417345 – Nasdaq Stock Market: DBVT – CUSIP: 23306J200), a clinical-stage biopharmaceutical company, today reported financial results for the third quarter of 2024. The quarterly and nine months financial statements were approved by the Board of Directors on November 6, 2024. Financial ...
DBV Announces Positive Regulatory Updates for the Viaskin® Peanut Patch in the United States and Europe
GlobeNewswire News Room· 2024-10-22 20:45
Châtillon, France, October 22, 2024 DBV Announces Positive Regulatory Updates for the Viaskin® Peanut Patch in the United States and Europe DBV to pursue an Accelerated Approval pathway for toddlers ages 1 – 3 years-old BLA submission under Accelerated Approval is subject to completion of a six-month supplemental safety study in toddlers to be initiated in Q2 2025VITESSE Phase 3 study evaluating the Viaskin Peanut patch in children ages 4 – 7 years-old exceeded enrollment goals; Topline results on track fo ...
DBV Technologies to Participate in Upcoming ACAAI 2024 Congress
GlobeNewswire News Room· 2024-10-18 20:30
Core Insights - DBV Technologies will participate in the ACAAI Annual Scientific Meeting from October 24 to 28, 2024, in Boston, focusing on peanut allergy treatment [1][2] - The company has completed enrollment for its VITESSE trial in children aged 4 to 7 years, highlighting its commitment to addressing unmet medical needs in food allergies [3][5] - DBV's lead product, the Viaskin® Peanut patch, aims to reduce allergic reactions to peanuts through a non-invasive epicutaneous delivery system [4][5] Company Activities - DBV is sponsoring the 33rd Annual FIT Bowl, a competition testing knowledge in allergy, asthma, and immunology, scheduled for October 26, 2024 [2] - The company will host a booth at the ACAAI Exhibit Hall from October 25 to 28, 2024, to engage with attendees [2] - DBV is a Benefactor Level Corporate Council Member for the 2024 ACAAI [2] Product Information - The Viaskin® Peanut patch is designed to deliver microgram quantities of peanut antigen to re-educate the immune system, although its safety and efficacy have not yet been established by regulatory agencies [4][5] - The patch represents a new class of treatment known as epicutaneous immunotherapy (EPIT™), which aims to modify allergic responses through the skin [5][6] Clinical Trials - DBV is conducting ongoing clinical trials for the Viaskin Peanut patch in toddlers aged 1 to 3 years and children aged 4 to 7 years [5][6] - The company emphasizes the importance of addressing the significant unmet medical need in food allergies, particularly for young children [3][5]
DBV Technologies Completes Screening for the VITESSE Phase 3 Clinical Trial
GlobeNewswire News Room· 2024-09-23 20:30
Châtillon, France, September 23, 2024 DBV Technologies Completes Screening for the VITESSE Phase 3 Clinical Trial In Q3 2024, DBV exceeded its recruitment goal and successfully closed the screening process for the VITESSE Phase 3 study evaluating the Viaskin® Peanut Patch in peanut allergic children ages 4 – 7 years old Topline results of VITESSE data are expected by Q4 2025 DBV Technologies (Euronext: DBV – ISIN: FR0010417345 – Nasdaq Stock Market: DBVT), a clinical-stage biopharmaceutical company, today a ...
DBV Technologies to Participate in the H.C. Wainwright 26th Annual Global Investment Conference
GlobeNewswire News Room· 2024-09-04 20:30
Châtillon, France, September 4, 2024 DBV Technologies to Participate in the H.C. Wainwright 26th Annual Global Investment Conference DBV Technologies (Euronext: DBV – ISIN: FR0010417345 – Nasdaq Stock Market: DBVT), a clinical-stage biopharmaceutical company, today announced that Daniel Tassé, Chief Executive Officer, will participate in a fireside chat at the H.C. Wainwright 26th Annual Global Investment Conference on Monday, September 9, 2024, at 3:00 pm ET, in New York City. A live webcast of the present ...
Information regarding the total number of voting rights and total number of shares of the Company as of July 31, 2024
Newsfilter· 2024-08-02 20:30
Information regarding the total number of voting rights and total number of shares of the Company as of July 31, 2024 (Article 223-16 of the General Regulations of the Autorité des Marchés Financiers) Market : NYSE Euronext Paris ISIN Code: FR 0010417345 Date Total number of shares Total number of voting rights 07/31/2024 96,498,927 Total gross of voting rights: 96,498,927 Total net* of voting rights: 96,214,457 * Net total = total number of voting rights attached to shares – shares without voting rights At ...