Core Insights - DBV Technologies reported a cash balance of $46.4 million as of September 30, 2024, down from $141.4 million at the end of 2023, indicating a net decrease of $95.0 million primarily due to operating activities related to clinical trials [3][4][5] - The company has incurred operating losses and negative cash flows since inception, raising substantial doubt about its ability to continue as a going concern without additional capital [4][6] - DBV expects its cash reserves to last into Q1 2025, but it plans to seek additional financing to support ongoing research and development efforts [5][6] Financial Performance - For the nine months ended September 30, 2024, DBV reported an operating income of $3.6 million, a decrease from $6.9 million in the same period of 2023, attributed to the termination of a collaboration agreement and lower research tax credits [11][12] - Operating expenses increased to $96.4 million for the nine months ended September 30, 2024, compared to $71.4 million in the same period of 2023, driven mainly by research and development costs [12][13] - The net loss for the nine months ended September 30, 2024, was $90.9 million, compared to a net loss of $61.5 million for the same period in 2023, with a net loss per share of $(0.95) [14][16] Cash Flow Analysis - The net cash flow used in operating activities was $(92.2) million for the nine months ended September 30, 2024, compared to $(66.0) million for the same period in 2023 [17] - Cash and cash equivalents decreased by $94.9 million during the nine months ended September 30, 2024, reflecting significant cash outflows [17] Company Overview - DBV Technologies is focused on developing treatment options for food allergies using its proprietary Viaskin technology platform, which aims to modify immune responses through epicutaneous immunotherapy [18] - The company is currently conducting clinical trials for its Viaskin Peanut product aimed at peanut allergies in young children [18][19]

Core Insights - DBV Technologies announced positive regulatory updates for the Viaskin Peanut patch in the U.S. and Europe, including an Accelerated Approval pathway for toddlers aged 1-3 years [1][2][9] - The company plans to initiate a six-month supplemental safety study in toddlers in Q2 2025, which is a prerequisite for the Biologics License Application (BLA) submission [1][4] - The VITESSE Phase 3 study for children aged 4-7 years exceeded enrollment goals, with topline results expected in Q4 2025 [1][8] Regulatory Developments - DBV has received FDA guidance confirming that the Viaskin Peanut patch meets the criteria for Accelerated Approval, addressing a serious condition with meaningful advantages over existing therapies [2][3] - The European Medicines Agency (EMA) has provided scientific advice confirming a registration path for a Marketing Authorization Application (MAA) for the modified patch for ages 1-7 [1][9] Clinical Studies - The COMFORT Toddlers safety study will enroll approximately 300-350 subjects, aiming to build a safety database of around 600 subjects for toddlers [4] - The VITESSE study for children aged 4-7 years enrolled 654 subjects, with plans for a safety study to begin in Q2 2025 [8] Financial Overview - As of September 30, 2024, DBV reported cash and cash equivalents of $46.4 million, down from $66.2 million as of June 30, 2024, primarily due to operating expenses [11] - The company anticipates that its cash reserves will support operations into Q1 2025, with plans to seek additional capital for ongoing research and development [13] Investor Engagement - DBV management will host an investor conference call to discuss these regulatory updates, scheduled for October 22, 2024, at 5:00 PM ET [14]

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]

Core Insights - DBV Technologies has successfully completed the patient screening for the VITESSE Phase 3 clinical trial, which evaluates the Viaskin® Peanut Patch in children aged 4 to 7 with peanut allergies [1][2] - The VITESSE trial is the largest immunotherapy clinical trial for this demographic, involving over 600 subjects across 86 sites in multiple countries [2] - Topline results from the VITESSE study are anticipated by Q4 2025 [1] Company Overview - DBV Technologies is a clinical-stage biopharmaceutical company focused on developing treatments for food allergies and other immunologic conditions [3] - The company utilizes its proprietary Viaskin technology platform to address food allergies through epicutaneous immunotherapy (EPIT™), which aims to desensitize the immune system to allergens [3] - DBV is committed to transforming the care of individuals with food allergies, with ongoing clinical trials for Viaskin Peanut targeting both toddlers and children [3] Operational Highlights - The VITESSE Phase 3 trial is a 12-month study designed to evaluate the efficacy and safety of the Viaskin Peanut Patch [2] - The trial has achieved enrollment ahead of schedule, closing screening a month earlier than expected [2] - DBV Technologies is headquartered in Châtillon, France, with operations in North America [4]

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 (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 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 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 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 ...

[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)