DBV Technologies(DBVT)

Search documents
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 ...
DBV Technologies(DBVT) - 2024 Q2 - Earnings Call Transcript
2024-07-31 02:03
DBV Technologies S.A. (NASDAQ:DBVT) Q2 2024 Earnings Conference Call July 30, 2024 5:30 PM ET Company Participants Katie Matthews – Investor Relations Daniel Tassé – Chief Executive Officer Pharis Mohideen – Chief Medical Officer Virginie Boucinha – Chief Financial Officer Conference Call Participants Jon Wolleben – Citizens JMP Operator Welcome to the DBV Second Quarter Financial Results and Business Update Conference Call. All participants will be in a listen-only mode. [Operator Instructions] After today ...
DBV Technologies Announces Filing of 2024 Half-Year Report ― Conditions for Accessing or Consulting the Report
Newsfilter· 2024-07-30 21:30
DBV Technologies Announces Filing of 2024 Half-Year Report ― Conditions for Accessing or Consulting the Report The 2024 Half-Year Report can be consulted or downloaded from the Company's website (www.dbvtechnologies.com) in the section Investors/Financial Information, and on the AMF website (www.amffrance.org), in French only. by mail : DBV Technologies – 107 avenue de la République 92320 Châtillon, France ; by email: investors@dbv-technologies.com. DBV Technologies is a clinical-stage biopharmaceutical com ...
DBV Technologies Announces Filing of 2024 Half-Year Report ― Conditions for Accessing or Consulting the Report
GlobeNewswire News Room· 2024-07-30 21:30
DBV Technologies Announces Filing of 2024 Half-Year Report ― Conditions for Accessing or Consulting the Report The 2024 Half-Year Report can be consulted or downloaded from the Company's website (www.dbvtechnologies.com) in the section Investors/Financial Information, and on the AMF website (www.amffrance.org), in French only. by mail : DBV Technologies – 107 avenue de la République 92320 Châtillon, France ; by email: investors@dbv-technologies.com. DBV Technologies is a clinical-stage biopharmaceutical com ...
DBV Technologies(DBVT) - 2024 Q2 - Quarterly Results
2024-07-30 20:46
[Q2 and Half-Year 2024 Business and Financial Update](index=1&type=section&id=DBV%20Technologies%20Provides%20Updates%20on%20the%20Viaskin%20Peanut%20Program%20in%20Children%20and%20Toddlers%20and%20Reports%20Second%20Quarter%20and%20Half-Year%202024%20Financial%20Results) [Business and Clinical Program Update](index=1&type=section&id=Business%20Update) DBV Technologies provided key updates on its Viaskin Peanut program, with VITESSE Phase 3 study enrollment on track for completion by the end of Q3 2024 and a new labeling proposal submitted to the FDA for the COMFORT Toddlers study - Enrollment for the VITESSE Phase 3 study in peanut-allergic children aged 4-7 is on track to be completed by the end of Q3 2024[2](index=2&type=chunk)[16](index=16&type=chunk) - A labeling proposal was submitted to the FDA for the COMFORT Toddlers study to address protocol queries regarding patch wear-time, based on EPITOPE efficacy data[2](index=2&type=chunk)[13](index=13&type=chunk) - The company ended Q2 2024 with a cash balance of **$66.2 million**, and its cash runway is extended into Q1 2025 due to cost-saving measures[2](index=2&type=chunk)[5](index=5&type=chunk) [VITESSE Phase 3 Study Update](index=1&type=section&id=VITESSE) Enrollment for the VITESSE Phase 3 pivotal study, evaluating the modified Viaskin® Peanut patch in approximately 600 children aged 4-7 with peanut allergies, is progressing as planned, with the final subject expected to be screened by the end of Q3 2024 across 86 sites globally - The VITESSE trial is evaluating the efficacy and safety of the modified Viaskin® Peanut patch in approximately **600 subjects** aged 4-7, randomized 2:1[16](index=16&type=chunk) - Recruitment is expected to be complete by the end of Q3 2024, with strong momentum from engagement at medical conferences and patient advocacy outreach[2](index=2&type=chunk)[30](index=30&type=chunk) [COMFORT Toddlers Study and FDA Engagement](index=2&type=section&id=COMFORT%20Toddlers) DBV proposed a new labeling approach to the FDA for the Viaskin Peanut patch in toddlers (1-3 years) on June 28th, using a 90-day period to identify patient response likelihood and guide treatment continuation, and is awaiting the FDA's response - DBV submitted a draft labeling proposal to the FDA on June 28th, focusing on dosing and administration to address patch wear-time concerns[2](index=2&type=chunk)[24](index=24&type=chunk) - The proposed approach identifies "Label-in" and "Label-out" patient populations within the first **90 days** of treatment based on their patch wear-time experience to predict clinical efficacy[43](index=43&type=chunk) - DBV has noted increased engagement from the FDA and looks forward to continued dialogue to advance the regulatory pathway for Viaskin Peanut in toddlers[4](index=4&type=chunk) [Financial Highlights](index=3&type=section&id=Financial%20Highlights%20for%20the%20second%20quarter%20Ended%20June%2030%2C%202024) For the first half of 2024, DBV reported a net loss of **$60.5 million** due to increased operating expenses, ending Q2 with **$66.2 million** in cash, raising substantial doubt about its ability to continue as a going concern without additional financing Condensed Consolidated Statements of Operations (U.S. GAAP, in millions of USD) | Metric | Six Months Ended June 30, 2024 | Six Months Ended June 30, 2023 | Three Months Ended June 30, 2024 | Three Months Ended June 30, 2023 | | :--- | :--- | :--- | :--- | :--- | | Revenues | 2.6 | 4.5 | 1.2 | 2.3 | | Operating expenses | (65.0) | (50.7) | (35.0) | (27.4) | | Net loss | (60.5) | (44.8) | (33.1) | (24.2) | | Basic/diluted net loss per share | (0.63) | (0.48) | (0.34) | (0.26) | [Operating Income](index=5&type=section&id=Operating%20Income) Operating income for the first six months of 2024 decreased by **$1.9 million** to **$2.6 million**, primarily due to a lower Research Tax credit entitlement as more study activities were conducted in North America Operating Income Comparison (H1, U.S. GAAP, in millions of USD) | Period | 2024 | 2023 | | :--- | :--- | :--- | | Six months ended June 30 | $2.6 | $4.5 | [Operating Expenses](index=5&type=section&id=Operating%20Expenses) Operating expenses for H1 2024 increased by **$14.3 million** to **$65.0 million**, primarily driven by higher Research & Development costs for clinical trials and a **$3.1 million** rise in employee-related costs due to a headcount increase of **24** - Operating expenses increased by **$14.3 million** in H1 2024 vs H1 2023, mainly from higher R&D costs for the VITESSE and COMFORT clinical trials[7](index=7&type=chunk) - Employee-related costs rose by **$3.1 million** in H1 2024 due to a headcount expansion of **24 employees** to support clinical, regulatory, and quality activities[49](index=49&type=chunk) Operating Expenses Breakdown (H1, U.S. GAAP, in millions of USD) | Expense Category | Six Months Ended June 30, 2024 | Six Months Ended June 30, 2023 | | :--- | :--- | :--- | | Research & Development | (46.8) | (33.7) | | Sales & Marketing | (1.7) | (0.9) | | General & Administrative | (16.4) | (16.1) | | **Total Operating Expenses** | **(65.0)** | **(50.7)** | [Net Loss](index=6&type=section&id=Net%20Loss%20and%20Net%20Loss%20Per%20Share) The company's net loss for the first six months of 2024 widened to **$60.5 million**, or **$(0.63)** per share, from **$44.8 million**, or **$(0.48)** per share, in the same period of 2023 Net Loss and EPS Comparison (H1, U.S. GAAP) | Metric | Six Months Ended June 30, 2024 | Six Months Ended June 30, 2023 | | :--- | :--- | :--- | | Net Loss (in millions USD) | $(60.5) | $(44.8) | | Net Loss Per Share (USD) | $(0.63) | $(0.48) | [Cash Position, Runway, and Going Concern](index=4&type=section&id=Cash%20and%20Cash%20Equivalents) DBV ended Q2 2024 with **$66.2 million** in cash, a decrease from **$141.4 million** at year-end 2023, extending its cash runway into Q1 2025 but raising substantial doubt about its ability to continue as a going concern without additional financing - Cash and cash equivalents were **$66.2 million** as of June 30, 2024, compared to **$141.4 million** as of December 31, 2023[46](index=46&type=chunk) - The company's cash runway is expected to last into Q1 2025 due to cost-saving measures[5](index=5&type=chunk) - There is substantial doubt regarding the company's ability to continue as a going concern, as available cash is not projected to be sufficient for the next **12 months**[34](index=34&type=chunk) - The company plans to seek additional capital to fund its R&D efforts and prepare for the potential launch of Viaskin Peanut[27](index=27&type=chunk) [Corporate Information and Disclosures](index=9&type=section&id=About%20DBV%20Technologies) DBV Technologies is a clinical-stage biopharmaceutical company developing food allergy treatments using its Viaskin platform, with shares traded on Euronext Paris and Nasdaq, and the release includes standard forward-looking statements about inherent risks [Company Overview](index=9&type=section&id=About%20DBV%20Technologies) DBV Technologies is a clinical-stage biopharmaceutical company developing food allergy treatments using its proprietary Viaskin platform for epicutaneous immunotherapy (EPIT), headquartered in France with U.S. operations and dual-listed shares - DBV is a clinical-stage biopharmaceutical company developing treatments for food allergies using its proprietary Viaskin platform, which is based on epicutaneous immunotherapy (EPIT)[40](index=40&type=chunk) - The company is headquartered in France with North American operations in New Jersey, and its shares are dual-listed on Euronext Paris and the Nasdaq[11](index=11&type=chunk) [Forward-Looking Statements](index=10&type=section&id=Forward%20Looking%20Statements) The press release contains forward-looking statements regarding DBV's financial condition, product potential, and clinical/regulatory efforts, which are subject to substantial risks and uncertainties, advising investors to consult SEC filings - The release includes forward-looking statements on financial condition, cash runway, product potential, and clinical/regulatory timing[41](index=41&type=chunk) - These statements involve significant risks related to R&D, clinical trials, and regulatory approvals, and investors are cautioned not to place undue reliance on them[41](index=41&type=chunk)
DBV Technologies Provides Updates on the Viaskin Peanut Program in Children and Toddlers and Reports Second Quarter and Half-Year 2024 Financial Results
GlobeNewswire News Room· 2024-07-30 20:30
The Company has incurred operating losses and negative cash flows from operations since inception. As of July 30th, DBV's available cash and cash equivalents are not projected to be sufficient to support the Company's operating plan for at least the next 12 months. As such, there is substantial doubt regarding its ability to continue as a going concern. The Company intends to seek additional capital as it continues research and development efforts and prepares for the launch of Viaskin Peanut, if approved. ...
DBV Technologies(DBVT) - 2024 Q2 - Quarterly Report
2024-07-30 20:06
DBV Technologies S.A. (Registrant) | --- | --- | --- | |-------|----------------------------------------------------------------------------------------------------------|-------| | By: | /s/ Daniel Tassé | | | | Daniel Tassé | | | | Chief Executive Of icer (Principal Executive Of icer) | | | By: | /s/ Virginie Boucinha | | | | Virginie Boucinha Chief Financial Of icer (Principal Financial and Accounting Of icer) | | Date: July 30, 2024 24 See "Note 2: Significant Events and Transactions – Legal Proceedings ...
DBV Technologies to Report Second Quarter 2024 Financial Results and Business Update on July 30, 2024
Newsfilter· 2024-07-29 05:30
Company Overview - DBV Technologies is a clinical-stage biopharmaceutical company focused on developing treatment options for food allergies and other immunologic conditions with significant unmet medical needs [4] - The company is headquartered in Châtillon, France, with North American operations in Warren, NJ [2] - DBV's ordinary shares are traded on Euronext Paris and its American Depositary Shares (ADSs) are traded on the Nasdaq Global Select Market [2] Technology and Products - DBV Technologies is investigating the use of its proprietary technology platform, Viaskin, to address food allergies through epicutaneous immunotherapy (EPIT™) [4] - The Viaskin platform aims to introduce microgram amounts of biologically active compounds to the immune system via intact skin, seeking to modify the underlying allergy by re-educating the immune system [4] - The company is currently conducting clinical trials for Viaskin Peanut in peanut allergic toddlers and children [4] Upcoming Events - DBV Technologies will host a conference call and live audio webcast on July 30, 2024, at 5:30 p.m. ET to review its second quarter 2024 financial results and provide a business update [1][7] - A live webcast of the call will be available on the company's website, with a replay accessible after the event [6]
DBV Technologies to Report Second Quarter 2024 Financial Results and Business Update on July 30, 2024
GlobeNewswire News Room· 2024-07-29 05:30
DBV Technologies to Report Second Quarter 2024 Financial Results and Business Update on July 30, 2024 Interested participants may access this call via the below teleconferencing numbers and asking to join the DBV Technologies call: A live webcast of the call will be available on the Investors & Media section of the Company's website: https://www.dbv-technologies.com/investor-relations/. A replay of the presentation will also be available on DBV's website after the event. DBV Technologies is a clinical-stage ...
Half-Year Report on the DBV Technologies Liquidity Contract with ODDO BHF
GlobeNewswire News Room· 2024-07-08 20:30
Media Contact Angela Marcucci DBV Technologies angela.marcucci@dbv-technologies.com AMF Regulated Information Montrouge, France, July 8, 2024 Half-Year Report on the DBV Technologies Liquidity Contract with ODDO BHF DBV Technologies (Euronext: DBV – ISIN: FR0010417345 – Nasdaq Stock Market: DBVT), a clinical-stage biopharmaceutical company, today issued the Half-Year report on its liquidity contract with ODDO BHF. Under the liquidity contract between DBV Technologies and ODDO BHF, the following assets appea ...