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Investor releaseQuarter not tagged2026-07-16

DBV Technologies Reports Second Quarter and Half-Year 2026 Financial Results and Business Update

GlobeNewswire
Châtillon, France, July 16, 2026 DBV Technologies Reports Second Quarter and Half-Year 2026 Financial Results and Business Update Continued productive engagement with the FDA in support of the BLA for the VIASKIN® Peanut Patch in children aged 4 through 7 years, with submission of the BLA anticipated in the third quarter of 2026 Reported cash and cash equivalents of $174.9 million as of June 30, 2026, funding into third quarter of 2027 DBV will host a conference call today, July 16, at 5:00pm ET DBV Technologies (Euronext: DBV – ISIN: FR0010417345 – Nasdaq Stock Market: DBVT – CUSIP: 23306J309), a late-stage biopharmaceutical company, today reported financial results for the Second Quarter and Half-Year of 2026. The quarterly and Half-Year financial statements were approved by the Board of Directors on July 16, 2026. “2026 is an important year for DBV as we continue to prepare to become a commercial company, if approved. I’m happy to report that we have made meaningful progress towards that goal in the first half of the year,” said Daniel Tassé, Chief Executive Officer of DBV Technologies. “Recently, we shared the regulatory progress we’ve made through collaborative engagement with the FDA. We have also made judicious investments in launch readiness, while we continue to execute clinical studies that we expect will add further understanding to the potentially transformative value of the VIASKIN® Peanut Patch.” Half-Year 2026 Operational HighlightsRegulatory and Clinical Execution Continued advancing the BLA submission for the VIASKIN® Peanut Patch in children aged 4 through 7 years. Engaged in detailed and iterative discussions with the U.S. Food and Drug Administration (FDA) to support a complete, efficient and timely review of the BLA, once submitted. The FDA has not requested additional data. DBV is incorporating valuable, actionable feedback from the FDA specific to the organization, mapping and formatting of existing CMC and biostatistical data sets, and now anticipates submitting the BLA in the third quarter of 2026. Recruitment was closed in the second quarter of 2026 for the COMFORT Toddlers supplemental safety study, an important operational milestone in the continued advancement of the VIASKIN® Peanut Patch in toddlers aged 1 through 3 years. Initiated the THRIVE study evaluating the efficacy and safety of the VIASKIN® Peanut Patch in achieving ad…Read full document

Châtillon, France, July 16, 2026 DBV Technologies Reports Second Quarter and Half-Year 2026 Financial Results and Business Update Continued productive engagement with the FDA in support of the BLA for the VIASKIN® Peanut Patch in children aged 4 through 7 years, with submission of the BLA anticipated in the third quarter of 2026 Reported cash and cash equivalents of $174.9 million as of June 30, 2026, funding into third quarter of 2027 DBV will host a conference call today, July 16, at 5:00pm ET DBV Technologies (Euronext: DBV – ISIN: FR0010417345 – Nasdaq Stock Market: DBVT – CUSIP: 23306J309), a late-stage biopharmaceutical company, today reported financial results for the Second Quarter and Half-Year of 2026. The quarterly and Half-Year financial statements were approved by the Board of Directors on July 16, 2026. “2026 is an important year for DBV as we continue to prepare to become a commercial company, if approved. I’m happy to report that we have made meaningful progress towards that goal in the first half of the year,” said Daniel Tassé, Chief Executive Officer of DBV Technologies. “Recently, we shared the regulatory progress we’ve made through collaborative engagement with the FDA. We have also made judicious investments in launch readiness, while we continue to execute clinical studies that we expect will add further understanding to the potentially transformative value of the VIASKIN® Peanut Patch.” Half-Year 2026 Operational HighlightsRegulatory and Clinical Execution Continued advancing the BLA submission for the VIASKIN® Peanut Patch in children aged 4 through 7 years. Engaged in detailed and iterative discussions with the U.S. Food and Drug Administration (FDA) to support a complete, efficient and timely review of the BLA, once submitted. The FDA has not requested additional data. DBV is incorporating valuable, actionable feedback from the FDA specific to the organization, mapping and formatting of existing CMC and biostatistical data sets, and now anticipates submitting the BLA in the third quarter of 2026. Recruitment was closed in the second quarter of 2026 for the COMFORT Toddlers supplemental safety study, an important operational milestone in the continued advancement of the VIASKIN® Peanut Patch in toddlers aged 1 through 3 years. Initiated the THRIVE study evaluating the efficacy and safety of the VIASKIN® Peanut Patch in achieving ad lib consumption of dietary peanut in infants aged 6 through 12 months with peanut allergy after 3-4 years of treatment with the VIASKIN® Peanut Patch. Scientific Engagement Maintained active engagement with allergy, immunology, and patient advocacy communities through participation in leading scientific and medical congresses, including American Academy of Allergy, Asthma, and Immunology (AAAAI) Annual Meeting and the European Academy of Allergy and Clinical Immunology (EAACI) Congress, where DBV presented positive subgroup analyses from the phase 3 VITESSE study. Corporate and Financial Position Funded into third quarter of 2027, to support operations and commercial preparedness, including investment across core functions required to potentially launch and support the long-term success of the VIASKIN® Peanut Patch brand, including Medical Affairs, Sales, Market Access, Marketing, Account Management, and Pharmacovigilance. Enhanced visibility in the European investment community through inclusion in CAC Mid 60 and SBF 120, Euronext Tech leaders, and MSCI EMEA Small Cap indices. Food Allergy Prevalence Rates A recent epidemiologic assessment using a survey based, standardized methodology demonstrated prevalence of peanut allergy remains unchanged statistically relative to historical estimates, despite shifts in clinical practice toward earlier introduction of allergenic foods to diet and earlier diagnosis of peanut allergy. Financial Highlights for the Second Quarter Ended June 30, 2026The Company’s interim condensed consolidated financial statements for the three and six months ended June 30, 2026, and the comparative period of June 30, 2025, are prepared in accordance with accounting principles generally accepted in the United States (“U.S. GAAP”) and Europe (IFRS). Comments are provided on a U.S. GAAP basis. Differences between U.S. GAAP and IFRS condensed consolidated financial statements result mainly from the application of leases and pensions accounting standards. Operating IncomeOperating income amounted to $1.6 million for the six months ended June 30, 2026, including $0.7 million for the three months ended June 30, 2026, compared with $2.2 million and $1.5 million, respectively, for the corresponding periods in 2025. The decrease reflects a lower accrual of French research tax credit income, consistent with the expected reduction in eligible experimental activities on a full-year basis as the Company continues to shift its focus from clinical development toward commercial readiness activities. Operating ExpensesResearch and Development ExpensesR&D expenses amounted to $64.6 million for the six months ended June 30, 2026, including $31.2 million for the three months ended June 30, 2026, compared with $55.2 million and $33.7 million, respectively, for the corresponding periods in 2025: Increased clinical trial activity from COMFORT Toddlers and THRIVE studies, and BLA submission preparation Investment in Medical Affairs, Quality, Pharmacovigilance, and Regulatory functions in the United States. Continued Pre-Commercial Inventory build-up in preparation for the launch of the VIASKIN® Peanut Patch for children aged 4 through 7 years in the U.S., if approved. Selling, General and Administrative (“SG&A”) ExpensesSG&A expenses increased by $11.2 million and $20.7 million for the three and six months ended June 30, 2026, respectively, compared with the corresponding periods in 2025. The Company is building its U.S. commercial infrastructure and conducting pre-marketing activities in preparation for the potential U.S. launch of VIASKIN® Peanut for children aged 4 through 7 years, if approved. Financial Income (Expense)Net financial income amounted to $0.9 million for the six months ended June 30, 2026, including $0.4 million for the three months ended June 30, 2026, compared with a net financial expense of $1.1 million and $0.6 million, respectively, for the corresponding periods in 2025. The improvement primarily reflects higher interest income generated from the investment of cash balances following the equity financing transactions, together with the effects of the Company’s foreign-exchange risk-management activities. Income TaxIncome tax expense amounted to $0.4 million for the six months ended June 30, 2026, including $0.2 million for the three months ended June 30, 2026, compared with $0.1 million for the corresponding periods in 2025. Net Loss and Net Loss Per ShareThe Company recorded a net loss for the six months ended June 30, 2026, of $98.0 million, including $50.4 million for the three months ended June 30, 2026, compared with $69.0 million and $41.9 million for the corresponding periods in 2025. Net loss per share (based on the weighted average number of shares outstanding over the period) decreased from $(0.58) to $(0.23) for the six months ended June 30, 2025, and June 30, 2026, respectively. This improvement reflects a significantly strengthened equity base following recent financings. Cash Position and LiquidityThese condensed consolidated financial statements have been prepared assuming that the Company will continue as a going concern. As of June 30, 2026, the Company had cash and cash equivalents of $174.9 million. Following the revised timing of the anticipated BLA submission from the second to the third quarter of 2026, management updated the Company’s forecasts to reflect the revised timing of related expenditures and activities, including cost-containment measures. Based on its current operations, plans and assumptions, management estimates that the Company has sufficient funding to support its operations for at least twelve months from the date of issuance of these condensed financial statements (Form 10-Q & Half Year Report), into the third quarter of 2027. These estimates are based on the Company’s current forecasts and exclude any additional expenditures related to programs other than the VIASKIN® Peanut Patch or resulting from the potential in licensing or acquisition of additional product candidates or technologies, or any associated development the Company may pursue. The Company may have based these estimates on assumptions that are incorrect, and the Company may end up using its resources sooner than anticipated. The Company's net cash used in operating & investing activities increased to $102.6 million for the six months ended June 30, 2026, compared to $54.0 million for the six months ended June 30, 2025, reflecting continued investments in clinical development activities, manufacturing & supply-chain readiness, commercial launch preparedness, and the expansion of the Company’s workforce in preparation for a potential launch of the VIASKIN® Peanut Patch, if approved. While the Company expects operating cash outflows to remain significant as it advances toward BLA submission and potential commercialization, the Company’s current forecasts incorporate measures intended to align spending with the revised regulatory timeline. The timing and amount of the Company’s future cash requirements may vary materially from current expectations depending on, among other factors, the timing and scope of regulatory interactions, the pace of clinical enrollment, manufacturing-related commitments, commercial readiness activities, foreign exchange rate fluctuations and other factors. The Company may seek additional capital in the future through new or existing financing strategies to support its long-term corporate strategy. Conference Call & WebcastDBV management will host an investor conference call and webcast today, July 16th at 5:00pm ET, to discuss this update. This call is accessible via the below teleconferencing numbers and requesting the DBV Technologies call. United States: +1-877-344-8082International: +1-213-992-4618 UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS About DBV TechnologiesDBV Technologies is a late-stage biopharmaceutical company developing treatment options for food allergies and other immunologic conditions with significant unmet medical need. DBV Technologies is currently focused on investigating the use of its proprietary VIASKIN® patch technology to address food allergies, which are caused by a hypersensitive immune reaction and characterized by a range of symptoms varying in severity from mild to life-threatening anaphylaxis. Millions of people live with food allergies, including young children. Through epicutaneous immunotherapy (EPIT), the VIASKIN® Peanut Patch is designed to introduce microgram amounts of a biologically active compound to the immune system through intact skin. EPIT is a new class of non-invasive treatment that seeks to modify an individual’s underlying allergy by re-educating the immune system to become desensitized to allergen by leveraging the skin’s immune tolerizing properties. DBV Technologies is committed to transforming the care of people with food allergies. The Company’s food allergy programs include ongoing clinical trials of VIASKIN® Peanut Patch in toddlers (1 through 3 years of age) and children (4 through 7 years of age) with peanut allergy. DBV Technologies is headquartered in Châtillon, France, with North American operations in Warren, NJ. The Company’s ordinary shares are traded on segment B of Euronext Paris (DBV, ISIN code: FR0010417345) and the Company’s ADSs (each representing five ordinary shares) are traded on the Nasdaq Capital Market (DBVT – CUSIP: 23306J309). For more information, please visit www.dbv-technologies.com and engage with us on X (formerly Twitter) and LinkedIn. Forward Looking StatementsThis press release may contain forward-looking statements and estimates, including statements regarding DBV’s financial condition, forecast of its estimated cash runway into the third quarter of 2027, the therapeutic potential of VIASKIN® Peanut patch and EPIT, DBV’s planned regulatory and clinical efforts including timing and results of communications with regulatory agencies, plans and expectations with respect to the submission of the BLA for VIASKIN® Peanut Patch for peanut allergic children 4 through 7 years of age in the third quarter of 2026, the continued advancement of the VIASKIN® Peanut patch in toddlers aged 1 through 3 years and infants aged 6 through 12 months, DBV’s commercial launch preparedness activities and the build-out of its commercial infrastructure in the United States, and the ability of any of DBV’s product candidates, if approved, to improve the lives of patients with food allergies. These forward-looking statements and estimates are not promises or guarantees and involve substantial risks and uncertainties. At this stage, DBV’s product candidates have not been authorized for sale in any country. Among the factors that could cause actual results to differ materially from those described or projected herein include uncertainties associated generally with research and development, clinical trials and related regulatory reviews and approvals, and DBV’s ability to successfully execute on its budget discipline measures. A further list and description of risks and uncertainties that could cause actual results to differ materially from those set forth in the forward-looking statements in this press release can be found in DBV’s regulatory filings with the U.S. Securities and Exchange Commission (“SEC”), including in DBV’s Annual Report on Form 10-K for the year ended December 31, 2025, filed with the SEC on March 26, 2026, as amended by the Amendment No. 1 on Form 10-K/A filed with the SEC on April 30, 2026, DBV’s Quarterly Report on Form 10-Q filed with the SEC on July 16, 2026, and future filings and reports made with the SEC by DBV. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements and estimates, which speak only as of the date hereof. Other than as required by applicable law, DBV Technologies undertakes no obligation to update or revise the information contained in this Press Release. VIASKIN is a registered trademark of DBV Technologies. Investor Contact Jonathan NeelyDBV [email protected] Media ContactBrett WhelanDBV [email protected] Attachment PDF Version

Investor releaseQuarter not tagged2026-07-16

DBV Technologies Q2 Earnings Call Highlights

MarketBeat
Interested in DBV Technologies S.A.? Here are five stocks we like better. DBV Technologies is preparing to file a BLA for its VIASKIN Peanut Patch in Q3 2026 and said it may request priority review, with the FDA process still on track and no request for additional clinical data. The company is expanding its peanut allergy program beyond children ages 4 to 7, with recruitment closed for the COMFORT Toddlers safety study, a planned filing for ages 1 to 3 by year-end 2026, and the first infant patient enrolled in the new THRIVE Phase 2 study. DBV is also building commercial readiness for a potential U.S. launch, including market access, patient services, supply chain, and launch operations, and said it has funding into Q3 2027. 3 Biopharmaceutical Stocks Bucking the Sell-Off DBV Technologies (NASDAQ:DBVT) said it is continuing preparations for a planned third-quarter 2026 Biologics License Application submission for its VIASKIN Peanut Patch in children ages 4 through 7, while also building commercial infrastructure ahead of a potential U.S. launch. On a conference call discussing second-quarter and first-half 2026 results, Chief Executive Officer Daniel Tassé said the company is working to “transform the company into a commercial organization” in anticipation of possible FDA approval of the patch. The company’s lead program is aimed at treating peanut allergy in children. → 3 Space Stocks That Could Outshine SpaceX After Its IPO Tassé said DBV is still optimizing its BLA submission through discussions with the FDA, which he characterized as constructive and collaborative. He emphasized that the agency has not asked for additional data. “The work underway is focused on incorporating FDA feedback related to the organization, the mapping, and formatting of existing CMC and biostatistical data sets,” Tassé said. He added that DBV plans to submit an “optimized BLA” in the third quarter of 2026 to support an efficient review. → These 3 Water ETFs Could be Quiet Winners From Infrastructure Spending During the question-and-answer portion of the call, Tassé said DBV plans to request priority review when it files the BLA because the VIASKIN Peanut platform has breakthrough designation, making the company eligible to seek that review pathway. He said the FDA has up to 60 days after filing to accept the application for review and to determine whether priority review will b…Read full document

Interested in DBV Technologies S.A.? Here are five stocks we like better. DBV Technologies is preparing to file a BLA for its VIASKIN Peanut Patch in Q3 2026 and said it may request priority review, with the FDA process still on track and no request for additional clinical data. The company is expanding its peanut allergy program beyond children ages 4 to 7, with recruitment closed for the COMFORT Toddlers safety study, a planned filing for ages 1 to 3 by year-end 2026, and the first infant patient enrolled in the new THRIVE Phase 2 study. DBV is also building commercial readiness for a potential U.S. launch, including market access, patient services, supply chain, and launch operations, and said it has funding into Q3 2027. 3 Biopharmaceutical Stocks Bucking the Sell-Off DBV Technologies (NASDAQ:DBVT) said it is continuing preparations for a planned third-quarter 2026 Biologics License Application submission for its VIASKIN Peanut Patch in children ages 4 through 7, while also building commercial infrastructure ahead of a potential U.S. launch. On a conference call discussing second-quarter and first-half 2026 results, Chief Executive Officer Daniel Tassé said the company is working to “transform the company into a commercial organization” in anticipation of possible FDA approval of the patch. The company’s lead program is aimed at treating peanut allergy in children. → 3 Space Stocks That Could Outshine SpaceX After Its IPO Tassé said DBV is still optimizing its BLA submission through discussions with the FDA, which he characterized as constructive and collaborative. He emphasized that the agency has not asked for additional data. “The work underway is focused on incorporating FDA feedback related to the organization, the mapping, and formatting of existing CMC and biostatistical data sets,” Tassé said. He added that DBV plans to submit an “optimized BLA” in the third quarter of 2026 to support an efficient review. → These 3 Water ETFs Could be Quiet Winners From Infrastructure Spending During the question-and-answer portion of the call, Tassé said DBV plans to request priority review when it files the BLA because the VIASKIN Peanut platform has breakthrough designation, making the company eligible to seek that review pathway. He said the FDA has up to 60 days after filing to accept the application for review and to determine whether priority review will be granted. DBV is currently assuming the full 60-day period, though Tassé said there is a possibility the timeline could be shorter given the level of engagement with the agency. If granted, priority review would mean a six-month review period. → Why ASML’s AI Monopoly Is Still Getting Stronger On chemistry, manufacturing and controls, Tassé said discussions with the FDA are “essentially now completed” and that the agency’s comments do not require changes to how DBV manufactures the product. “There’s nothing that the agency has asked us to do that represents a change in any way, shape, or form to the way we manufacture the product,” he said. Asked what remains before submission, Tassé said the gating items are completing discussions with the FDA on CMC and on the formatting and tabulation of biostatistics tables. Chief Medical Officer Pharis Mohideen said DBV closed recruitment during the second quarter for COMFORT Toddlers, a supplemental safety study evaluating VIASKIN Peanut in toddlers ages 1 to 3. In response to an analyst question, Mohideen said the study includes a six-month treatment period and has no efficacy component. Tassé said DBV still intends to file for the 1-to-3-year-old population by the end of 2026. He noted that EPITOPE, the pivotal trial in that age group, has already been completed and showed efficacy. Mohideen also highlighted additional presentations from the VITESSE Phase 3 study in 4-to-7-year-olds. Data presented earlier this year at the American Academy of Allergy, Asthma & Immunology annual meeting showed consistent treatment effects regardless of baseline eliciting dose and across multiple statistical subgroups, she said. At the European Academy of Allergy and Clinical Immunology Congress, DBV presented data showing that children with asthma, eczema or other food allergies had no difference in VIASKIN treatment effect, according to Mohideen. She said those comorbid conditions are common in the study population and among children seen by allergists for peanut allergy. DBV is also moving into younger patients through THRIVE, a study evaluating VIASKIN Peanut in infants ages 6 through 12 months with peanut allergy. Mohideen said the first subject was enrolled last month at Dr. Doug Mack’s site in Canada. The study is designed to assess efficacy and safety in achieving ad lib consumption of dietary peanut after three to four years of treatment with the patch. Mohideen described the trial as “first-of-its-kind” and said it is aligned with the earlier introduction of allergens into the diet and the identification of food allergies at younger ages. In response to a question, Mohideen said THRIVE is a Phase 2, proof-of-concept study and is not intended as a registration study at this point. Tassé added that DBV chose not to wait until a post-approval Phase 4 setting because the question was “too important and too pressing.” Chief Commercial Officer Kevin Trapp said DBV is investing across market access, patient services, brand readiness, field force planning and launch operations as it prepares for a possible U.S. launch. Trapp said commercial planning is being coordinated across medical affairs, regulatory, pharmacovigilance, quality, supply and manufacturing teams to connect launch readiness with evidence, safety systems, product supply and the regulatory timeline. “Our goal in the end, to ensure a prescriber and patient experience that supports their needs and fits into their daily routines,” Trapp said. He also said DBV is engaging with caregivers, advocates, physicians and payers to better understand barriers to adoption of the peanut patch. The company is reviewing manufacturing capacity, supply chain readiness and related capital requirements that would be needed to support potential peak demand if the product is approved. Discussing market context, Mohideen cited a recent standardized survey-based study led by Dr. Alessandro Fiocchi that reported a 2% prevalence of peanut allergy in U.S. children. She said that estimate is broadly consistent with prior U.S. literature, including an approximately 2.2% prevalence rate reported by Dr. Ruchi Gupta and colleagues in 2018. Trapp said those findings reinforce DBV’s view that the U.S. peanut allergy opportunity has not changed and that peanut allergy remains a persistent population-level issue despite early introduction practices. Tassé said DBV is funded into the third quarter of 2027, supporting operations and commercial preparedness, including investments across functions needed to potentially launch and support VIASKIN Peanut Patch. He said the company is approaching investment decisions with attention to regulatory progress, commercial readiness and disciplined capital allocation. “The first half of 2026 reinforced our conviction in DBV’s future,” Tassé said, citing progress toward BLA submission, completion of COMFORT Toddlers recruitment, expansion of the VIASKIN Peanut clinical program and preparations for commercialization. DBV Technologies SA is a clinical-stage biopharmaceutical company engaged in developing immunotherapies for allergic diseases. The company specializes in epicutaneous immunotherapy, leveraging its proprietary Viaskin platform to deliver biologically active compounds across intact skin without needles or injections. Through this approach, DBV aims to modulate patients’ immune response to specific allergens, offering a potentially safer and more convenient alternative to traditional therapies. The company’s lead product candidate, Viaskin Peanut, is designed for the treatment of peanut allergy in children and adolescents. This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to [email protected]. The article "DBV Technologies Q2 Earnings Call Highlights" was originally published by MarketBeat. View MarketBeat's top stocks for July 2026.

TranscriptFY2026 Q22026-07-16

FY2026 Q2 earnings call transcript

Earnings source - 82 paragraphs
Operator

Please note this event is being recorded. I would now like to turn the conference over to Jonathan Neely, Investor Relations. Please go ahead, sir.

Jonathan Neely

Thank you. This afternoon, DBV Technologies reported financial results for the second quarter and half year of 2026. This update is available in the press releases section of the DBV Technologies website. Before we begin, please note that today's call may include a number of forward-looking statements, including but not limited to comments regarding our forecast of estimated cash runway, clinical and regulatory development plans, the design and conduct of our clinical trials, the timing and results of interactions with regulatory agencies, and the ability of any of our product candidates, if approved, to improve the lives of patients with food allergies. These forward-looking statements are based on assumptions that are subject to risks and uncertainties that could cause the company's actual results to differ significantly from those suggested by these statements. Given these risks and uncertainties, you should not place undue reliance on these forward-looking statements.

Jonathan Neely

Please refer to the company's filings with the SEC and the French AMF for information concerning risk factors that could cause the company's actual results to differ materially from expectations, including any forward-looking statements made on this call. Except as required by law, the company disclaims any obligation to publicly update or revise any forward-looking statements to account for or reflect events or circumstances that occur after this call. Joining me on the call today are Daniel Tassé, our Chief Executive Officer, as well as Pharis Mohideen, our Chief Medical Officer, and Kevin Trapp, our Chief Commercial Officer. I will now pass the call over to Daniel. Daniel.

Daniel Tassé

Thank you, Jonathan, and thank you all for joining us today. 2026 is and will continue to be a pivotal year for DBV. We are working aggressively to transform the company into a commercial organization in anticipation of the potential approval of the VIASKIN Peanut Patch for children aged four through seven by the FDA. It's certainly a tremendous amount of work to move from the clinical to commercial stage. Today, we'd like to walk you through a summary what we've accomplished toward that goal in the first half of the year. Pharis and Kevin have joined me today to help describe how we have advanced our lead program toward BLA submission, continued constructive engagement with FDA, expanded the VIASKIN Peanut clinical program, and strengthened the foundation required to become a commercial stage company. I'll start with the status of the BLA.

Daniel Tassé

As we shared two weeks ago, we continue to optimize our BLA submission for the VIASKIN Peanut Patch in children aged four through seven through our engagement with the FDA, which has been constructive and collaborative. These discussions have been particularly valuable for a novel, first of its kind product like the VIASKIN Peanut Patch. Let me reiterate, the FDA has not requested additional data. The work underway is focused on incorporating FDA feedback related to the organization, the mapping, and formatting of existing CMC and biostatistical data sets. We believe this is the right work to do now, since our objective is a timely and efficient review of the BLA for VP in four to seven, and we plan to submit an optimized BLA in the third quarter of 2026 to support an efficient FDA review.

Daniel Tassé

In addition to these conversations, our progress in the first half 2026 include important developments in our clinical program. Let me invite Pharis Mohideen, our Chief Medical Officer, to tell you a little bit more about that.

Pharis Mohideen

Thank you, Daniel. While much of our team is laser-focused on BLA preparation and submission, we are also working hard to continue to build our scientific platform. Today, I will share an update on four main topics: the COMFORT Toddlers study, the test, THRIVE, and whether or not the prevalence of peanut allergy has changed over the last 10 years. First, let me start with COMFORT Toddlers. I am pleased to say that in the second quarter, we closed recruitment for COMFORT Toddlers, a supplemental safety study evaluating the VIASKIN Peanut Patch in toddlers aged one to three years. This is an important milestone as we look to progress this program. About VITESSE, we presented new data from our phase III study in four to seven-year-olds at the American Academy of Allergy, Asthma & Immunology annual meeting earlier this year.

Pharis Mohideen

This data included additional efficacy assessments demonstrating consistency of the treatment effects regardless of baseline eliciting dose and across multiple statistical subgroups. Last month, at the European Academy of Allergy and Clinical Immunology Congress, we presented VITESSE data showing that subjects with asthma, eczema, and or other food allergies, common comorbid conditions for our study population, had no difference in the VIASKIN treatment effect. This is an important dimension of the treatment of food allergies and peanut allergies since they are often accompanied by other atopic conditions. The population of children we recruited in VITESSE is very typical of the overall peanut allergy population seen in allergists' offices.

Pharis Mohideen

This data reinforces our confidence in the potential role that the VIASKIN Peanut Patch may play, both for allergists who are navigating the everyday complexities of the food allergy population and for families who are looking for a practical treatment that fits into their everyday lives. Also at EAACI, the design elements for THRIVE were presented by Dr. Kirsten Perrett, who is the co-lead investigator, along with Professor Gideon Lack. THRIVE is assessing the efficacy and safety of the VIASKIN Peanut Patch in achieving ad lib consumption of dietary peanut in infants with peanut allergy aged six through 12 months following three to four years of treatment with the VIASKIN Peanut Patch. We are pleased to have shared the first subject was enrolled in this first-of-its-kind study last month at Dr. Doug Mack's site in Canada.

Pharis Mohideen

We believe this study is nicely aligned with earlier introduction of allergens into the diet. Consequently, more patients being identified with a food allergy at an earlier age. Given the positive results of the phase II EPITOPE study in one to three-year-olds, which was published in the New England Journal of Medicine in 2023, we believe that the THRIVE study has the potential to be a landmark study. We pay very close attention to the ever-evolving food allergy treatment landscape. A question that we frequently get is whether the prevalence of peanut allergy has changed. I'd like to take a minute to discuss an important recent publication that informs discussions of the prevalence of IgE-mediated food allergy across children and adults.

Pharis Mohideen

Dr. Alessandro Fiocchi, a leading allergist, and colleagues, conducted a standardized survey-based study of peanut allergy prevalence in children using a methodological approach deemed by the FDA as sufficient to produce evidence of high to medium strength. In the U.S., the study reported a 2% prevalence of peanut allergy in children. That estimate is broadly consistent with prior U.S. literature, including the approximate 2.2% prevalence rate previously reported by Dr. Ruchi Gupta and colleagues in 2018. Importantly, the Gupta data were collected in 2015 and 2016, while the Fiocchi data were collected in 2022 and 2023. These two independent data sets, collected approximately seven years apart, both point to a U.S. pediatric peanut allergy prevalence of approximately 2%. The confidence intervals further support that conclusion. Gupta reported a 95% confidence interval of 2%-2.5%, which overlap with the estimates across each pediatric age group in the Fiocchi paper.

Pharis Mohideen

I'll hand over to Kevin Trapp to put this new prevalence data into a commercial context. Kevin?

Kevin Trapp

Thank you, Pharis. For us, these findings are highly relevant because they reinforce that the opportunity in peanut allergy in the U.S. has not changed. This is an important point. The Fiocchi data reinforces that peanut allergy remains a persistent population-level issue. Despite early introduction, the peanut allergy patient population remains largely consistent. Peanut allergy also remains one of the most common food allergies in children, and it still creates a daily burden for patients, families, and healthcare systems. That is why our work matters and why, as we move toward BLA submission, we're planning now for what it takes to bring VIASKIN Peanut Patch to the market at scale if approved. For commercial, that means focusing on building the infrastructure a successful U.S. launch requires. We are investing across market access, patient services, brand readiness, field force planning, and launch operations.

Kevin Trapp

We have built the launch model around cross-functional execution. Commercial is working closely with medical affairs, our regulatory team, pharmacovigilance, quality, supply, and manufacturing so that the launch planning is connected to the evidence, our safety systems, product supply, and the regulatory timeline. Our goal in the end, to ensure a prescriber and patient experience that supports their needs and fits into their daily routines. It looks simple on the front end but is so complex on the back end. We're also spending real time with the food allergy community, including caregivers, advocates, physicians, and payers to understand where the greatest barriers exist and how DBV can support adoption of the peanut patch. In short, we're doing the work now to drive both a successful launch and the long-term growth of VIASKIN Peanut Patch.

Kevin Trapp

As part of that longer-term planning, we're taking a close look at company operations that would be required to support potential peak demand for the VIASKIN Peanut Patch if approved. We're reviewing what the future would look like for our manufacturing capacity, supply chain readiness, and related capital requirements. We believe the opportunity is significant and that the patch has the potential to transform treatment in a large market with significant unmet need. Our planning must reflect that potential. Daniel, I'll pass it back to you.

Daniel Tassé

Thank you, Kevin. I would like to emphasize Kevin's last point. The planning that we're doing and the foundation we're building reflect our belief in the potential of the VIASKIN Peanut Patch. At the same time, we always approach these investment decisions thoughtfully in alignment with regulatory progress, commercial readiness, and disciplined capital allocation. In closing, the first half of 2026 reinforced our conviction in DBV's future. We are advancing our lead program in four to seven-year-olds towards BLA submission. We have closed recruitment for COMFORT Toddlers supplemental safety study in one to three-year-olds. We are expanding our VIASKIN Peanut clinical program with the very important THRIVE study. We are funded into the third quarter of 2027 to support operations and commercial preparedness, including investments across our core functions required to potentially launch and support the long-term success of the VIASKIN Peanut Patch.

Daniel Tassé

We're doing all of this with a clear purpose, to help children and families living with the daily burden of peanut allergy. I will now pass it over to the operator for questions.

Operator

If you would like to ask a question, please press star one on your telephone keypad now. You will be placed into the queue in the order received. Please be prepared to ask your question when prompted. Once again, if you would like to ask a question, please press star one on your phone now. Our first question comes from Yatin Suneja at Guggenheim.

Yatin Suneja

Hey, guys. Thank you for taking my question, thank you for all the details. Very helpful. Just two quick questions from me.

Daniel Tassé

Yeah.

Yatin Suneja

First is with regard to the filing and the acceptance and the timelines around it. What are your working assumptions? How should we think about the acceptance timelines? Will this be a standard review or a priority review? Then with regard to the CMC readiness and commercial supply, are there any implications from the FDA feedback, any changes in manufacturing dossier or anything you sort of have to do from a launch perspective?

Daniel Tassé

Thanks for those questions, Yatin. Let me start with the first one. The regulatory timelines are we will be asking for priority review given the fact that VIASKIN Peanut, the platform, has a breakthrough designation, thus making us eligible for priority review. As you know, that request is made formally when you file the BLA. We're working closely with the agency on the content of that BLA. That was the purpose of the update a few weeks ago here. After we file, it's up to 60 days for the agency to accept the file for review and share whether or not the sponsor is given priority review. Right now, we're assuming 60 days. Could it be shorter? There's a possibility given how closely we're working with the agency. But the formal timelines are 60 days.

Daniel Tassé

We'll ask for priority review, which would be a six-month review at that point in time. I hope that answers the first half of your question. On CMC, the discussions with the agency on CMC are essentially now completed. We've had all their comments. We're in the process of making the adjustments that they want here. There's nothing that the agency has asked us to do that represents a change in any way, shape, or form to the way we manufacture the product and the way we will describe that in the module three, the CMC section of the BLA.

Yatin Suneja

Got it. One more question, if I may.

Daniel Tassé

Please.

Yatin Suneja

What is now the gating factor or what are some of the things that you need to get either an alignment or you have to complete it on your end? Could you just tell us before you can submit the BLA? Thank you.

Daniel Tassé

There are discussions ongoing, Yatin, as you know, on CMC and also on formatting tabulation of the biostats table. That discussion is also going on in parallel. Completing the discussions with the FDA on CMC and the same completion on biostats are the two gating items right now progressing in parallel.

Yatin Suneja

Thank you very much.

Daniel Tassé

Thank you.

Operator

Our next question comes from Sushila Hernandez of VLK.

Sushila Hernandez

Yes. Thank you for taking my questions. I also have two. Do I understand correctly that you have engaged with the FDA since the last conference call that you organized? If so, have they provided with additional suggestions on the structuring, mapping of the BLA package or on any other fronts?

Daniel Tassé

Yep. Okay. Those are your two questions, Sushila? Sorry about that. Yes. The short answer is yes, the dialogue with the agency is ongoing when dialogue is both talking as well as exchanging emails. Yes, there's been further discussion of what they want, all of which are things that we're accommodating within, again, nothing that is being discussed right now requires incremental data, or we see as being fundamentally problematic in any way. I trust that answers the two halves of your question.

Sushila Hernandez

Yes. Thank you. Then just one more.

Daniel Tassé

Please.

Sushila Hernandez

With the recruitment completed of the safety study in toddlers, could you just remind us for how long you will follow these toddlers before the study is completed?

Daniel Tassé

Pharis, you want to take that one? It's your baby.

Pharis Mohideen

Yeah.

Sushila Hernandez

So with the-

Pharis Mohideen

Yeah.

Sushila Hernandez

Yeah, with the recruitment completed. Oh, sorry. Yeah, go ahead.

Pharis Mohideen

No, it's a six-month safety study. Again, there's no efficacy component to it. We did the food challenge up front to have inclusion/exclusion, it's a six-month treatment period.

Sushila Hernandez

Okay. That's clear. Thank you.

Operator

Our next question comes from Kristen Kluska of Cantor Fitzgerald.

Kristen Kluska

Thanks so much for the updates. Couple questions from me. First, I think most of us on the line probably have never submitted an application before, can you help us just to try to imagine what it's like to reformat things? Why isn't it as simple as just copy and pasting in other areas? Sorry for the basic question, I think it will help since we don't have this experience.

Daniel Tassé

I appreciate that question, Kristen, because it really is critical. Yeah, there's nothing you do in an office that looks like filing a BLA. This is not a ZIP file you attach to an email. This is not a link to some data site when it comes to doing due diligence. It's a massive document that includes literally hundreds of thousands of pages and tests and validations and protocols, all organized in a way that's obviously delineated under the regulations of the CFRs. All of this includes a lot of hyperlinking so that the FDA can easily, or as easily as possible, navigate from one element to the other one.

Daniel Tassé

All of that rigor and structure needs to be done in a way that is formatted to FDA standards, one, for their ease of review, and two, to make sure that, given the size of that file, there's no issues through the FDA IT firewalls. To add to that, the sense of the massiveness of the undertaking, since there's a lot of linkage of something that's in one part of the BLA to another one, a big part of what sponsors do is to verify that all of those linkages work, and that as you change something, you don't change something in a domino document later on. It sounds like a lot of small things, and that's exactly what it is. It's a lot of small things. I don't know if that answers your question here, but it's a massive undertaking. It's all about details.

Kristen Kluska

Yeah. Thank you so much for that additional color.

Daniel Tassé

Yeah.

Kristen Kluska

On COMFORT Toddlers,

Daniel Tassé

Yes.

Kristen Kluska

Are you still planning to file that later this year, or how should we be thinking about that based on the time to collect the safety data?

Daniel Tassé

Yeah, we are still planning to file by the end of the year. Remember, COMFORT is a supplemental safety study. The pivotal-

Kristen Kluska

Yes.

Daniel Tassé

trial is EPITOPE. Let's not forget that that's already completed here. That shows efficacy. We talked about the amount of commonality and overlap in content of the BLA one to three, four to seven. That's obviously part of things we're learning as we work closely with FDA in four to seven. We maintain our objective of filing by the end of the year, as we work through that logistic. Obviously, that will be in dialogue with the FDA, obviously.

Kristen Kluska

Okay. Thank you so much.

Daniel Tassé

I hope that answered your question.

Kristen Kluska

Appreciate it.

Daniel Tassé

Yeah.

Kristen Kluska

It did. Thank you.

Daniel Tassé

Thank you.

Operator

Our next question comes from Jon Wolleben of Citizens Capital.

Jon Wolleben

Hey, thanks for taking the question. A couple on commercial from me. Do you guys have any sense of the average price of Xolair in one-to-seven-year-olds and what pricing bin you guys have been testing with payers?

Daniel Tassé

Kevin, you take that one?

Kevin Trapp

Yeah, Jon, it's Kevin. Yeah, sure. Yeah. As you know, Xolair is IgE and weight-based, so it'll vary across that age range. We've seen prices from around EUR 10,000 into the EUR 30,000s, right, depending on that. We've tested a range of prices. We're not going to finalize anything yet. We've got payer discussions that'll be upcoming here in the next month, advisory boards. The research is being done, and as we get tighter on this, we get closer to launch, we can give you some more ranges.

Jon Wolleben

Okay. When we think about commercial, do you have a sense in your research what proportion of one-to-seven-year-olds with peanut allergy would seek some form of therapy? Digging into that, who would be a likely candidate for VIASKIN Peanut versus who would not be? Any guidance on that?

Kevin Trapp

Yeah. We're working through the segment. Yeah, sure. Yeah. Look, we've done a lot of both parent research and allergist research. I would say that we always see very significant demand as we talk to parents. We know it's not one market. As we continue to look through segmentation and who will activate first, we think there's a number of things in our framework from those that have just been diagnosed or just had a reaction, those that have already sought out immunotherapy but perhaps didn't continue with it for either the burden of frequency of visits or the tolerability. Then there's a group that maybe get farther out in their avoidance at epi, and they may need more education, and they'll be later down the path. We've got our framework, Jon. We're doing a lot of work on kind of segmentation and prioritization.

Kevin Trapp

Again, I think we'll have more to say to that in the second half of the year if we're talking about a commercial day at some point. Is that helpful?

Jon Wolleben

Okay. It'll be more helpful around the commercial day. I appreciate you guys taking the question.

Daniel Tassé

Candor is wonderful. Thanks, Jon.

Operator

As a reminder, if you would like to ask a question, please press star one on your telephone keypad. Our next question comes from Sam Slutsky of LifeSci Capital.

Sam Slutsky

Hey, good evening. Appreciate the question. Just in terms of the THRIVE study, could you remind us what the ultimate goal of that is in terms of are you expecting to eventually get a label change with it, whether it's age groups or just the language around treatment in general? Just what's the end goal of that study, hopefully?

Daniel Tassé

Pharis? I can add to it.

Pharis Mohideen

Yeah. This is a phase II study. It's really almost more of a proof of concept study, Sam. The objective, and this is sort of trampolining off of the one-to-three-year-old success that we saw in EPITOPE at that age group. We're going a little bit younger. As you know, younger patients tend to have a more responsive immune system. The ultimate goal is to see if these patients can get to the point where they can consume peanut ad lib. We have a very broad definition because one size doesn't fit all in this patient population. At this point, we're running the study. It's not really intended to be a registration study. It's a single-arm study. We've not talked to agencies about what this data set could do. We just started recruitment, as I mentioned. It's in its early stages.

Pharis Mohideen

For us, conceptually, it's a natural study to do given the data that we presented with desensitization and sustained unresponsiveness. With the introduction of food allergens earlier, this population absolutely does exist, right? It's early stages, Sam. Again, right now we're going to run the study and see where we end up. If we choose to dialogue with the agencies in the future, we'll have those conversations, but for now, it's open sites recruit and see what the study shows.

Daniel Tassé

I'll add one thing, Sam, if I may. What's not changing here is the duration of treatment, right? We expect kids will be on therapy for three, four, five years. We're trying to do the same thing here in 6-12-month-olds. We could have decided to do this study as part of a phase IV study post-approval. I think the question is too important and too pressing to wait that long. Moreover, we're running this study with obviously some degree of confidence given what we know about our product that is going to show some benefits here. That's why we're calling it a phase II study. It's a question that deserves to be answered, and it does not change the treatment paradigm of using VIASKIN Peanut in toddlers with peanut allergic.

Sam Slutsky

Okay, thanks.

Daniel Tassé

Is that helpful, Sam? Yeah.

Sam Slutsky

Yep.

Daniel Tassé

Thank you.

Operator

This concludes our question and answer session. I would like to turn the conference back over to Daniel Tassé for any closing remarks.

Daniel Tassé

Well, next. Oh, there we go. Okay. Well, thank you. That concludes our call for this afternoon. Again, we are very pleased with our progress towards commercialization, remain committed, as we're answering your questions, at transforming the lives of children and families living the daily burden of food allergy. It is a burden. We think we have a technology that can make a big difference there. We're proud of the work that we're doing and the science that we're pursuing to try to change the life of families. Thank you. Good evening, and we'll talk to you soon.

Operator

This concludes today's conference call. Thank you for attending.

Investor releaseQuarter not tagged2026-07-14

DBV Technologies to Report Second Quarter 2026 Financial Results and Business Update on July 16, 2026

GlobeNewswire
Châtillon, France, July 14, 2026 DBV Technologies to Report Second Quarter 2026 Financial Results and Business Update on July 16, 2026 Company to host investor conference call and webcast at 5:00 p.m. ET DBV Technologies (Euronext: DBV – ISIN: FR0010417345 – Nasdaq Stock Market: DBVT), a late-stage biopharmaceutical company, today announced that the Company will host a conference call and live audio webcast on Thursday, July 16th, at 5:00 p.m. ET to review its second quarter 2026 financial results and provide a business update. Interested participants may access this call via the teleconferencing numbers below and by asking to join the DBV Technologies Second Quarter 2026 Results call: United States: +1-877-344-8082 International: +1-213-992-4618 A live webcast of the call will be available on the Events section of the Company's website here. About DBV TechnologiesDBV Technologies is a late-stage biopharmaceutical company developing treatment options for food allergies and other immunologic conditions with significant unmet medical need. DBV Technologies is currently focused on investigating the use of its proprietary VIASKIN® patch technology to address food allergies, which are caused by a hypersensitive immune reaction and characterized by a range of symptoms varying in severity from mild to life-threatening anaphylaxis. Millions of people live with food allergies, including young children. Through epicutaneous immunotherapy (EPIT), the VIASKIN® Patch is designed to introduce microgram amounts of a biologically active compound to the immune system through intact skin. EPIT is a new class of non-invasive treatment that seeks to modify an individual’s underlying allergy by re-educating the immune system to become desensitized to allergen by leveraging the skin’s immune tolerizing properties. DBV Technologies is committed to transforming the care of food allergic people. The Company’s food allergy programs include ongoing clinical trials of the VIASKIN® Peanut Patch in peanut allergic toddlers (1 through 3 years of age) and children (4 through 7 years of age). DBV Technologies is headquartered in Châtillon, France, with North American operations in Warren, NJ. The Company’s ordinary shares are traded on segment B of Euronext Paris (DBV, ISIN code: FR0010417345) and the Company’s ADSs (each representing five ordinary shares) are traded on the Nasdaq Capital M…Read full document

Châtillon, France, July 14, 2026 DBV Technologies to Report Second Quarter 2026 Financial Results and Business Update on July 16, 2026 Company to host investor conference call and webcast at 5:00 p.m. ET DBV Technologies (Euronext: DBV – ISIN: FR0010417345 – Nasdaq Stock Market: DBVT), a late-stage biopharmaceutical company, today announced that the Company will host a conference call and live audio webcast on Thursday, July 16th, at 5:00 p.m. ET to review its second quarter 2026 financial results and provide a business update. Interested participants may access this call via the teleconferencing numbers below and by asking to join the DBV Technologies Second Quarter 2026 Results call: United States: +1-877-344-8082 International: +1-213-992-4618 A live webcast of the call will be available on the Events section of the Company's website here. About DBV TechnologiesDBV Technologies is a late-stage biopharmaceutical company developing treatment options for food allergies and other immunologic conditions with significant unmet medical need. DBV Technologies is currently focused on investigating the use of its proprietary VIASKIN® patch technology to address food allergies, which are caused by a hypersensitive immune reaction and characterized by a range of symptoms varying in severity from mild to life-threatening anaphylaxis. Millions of people live with food allergies, including young children. Through epicutaneous immunotherapy (EPIT), the VIASKIN® Patch is designed to introduce microgram amounts of a biologically active compound to the immune system through intact skin. EPIT is a new class of non-invasive treatment that seeks to modify an individual’s underlying allergy by re-educating the immune system to become desensitized to allergen by leveraging the skin’s immune tolerizing properties. DBV Technologies is committed to transforming the care of food allergic people. The Company’s food allergy programs include ongoing clinical trials of the VIASKIN® Peanut Patch in peanut allergic toddlers (1 through 3 years of age) and children (4 through 7 years of age). DBV Technologies is headquartered in Châtillon, France, with North American operations in Warren, NJ. The Company’s ordinary shares are traded on segment B of Euronext Paris (DBV, ISIN code: FR0010417345) and the Company’s ADSs (each representing five ordinary shares) are traded on the Nasdaq Capital Market (DBVT – CUSIP: 23306J309). For more information, please visit www.dbvtechnologies.com and engage with us on X (formerly Twitter) and LinkedIn. VIASKIN is a registered trademark of DBV Technologies. Investor Contact Jonathan NeelyDBV [email protected] Media ContactBrett WhelanDBV [email protected] Attachment PDF Version

Investor releaseQuarter not tagged2026-06-03

DBV Technologies Announces the Results of its 2026 Combined General Meeting

GlobeNewswire
Châtillon, France, June 3, 2026 DBV Technologies Announces the Results of its 2026 Combined General Meeting Shareholders approved all proposed resolutions DBV Technologies (Euronext: DBV – ISIN: FR0010417345 – Nasdaq Stock Market: DBVT), a late stage biopharmaceutical company (the “Company”), held its Combined General Meeting (the “General Meeting”). The General Meeting was chaired by Michel de Rosen, Chairman of the Board of Directors (the “Board”). The Company’s shareholders approved all resolutions submitted by the Board. The resolutions and voting results are posted on the Company’s website: 2026 Annual General Meeting | DBV Technologies About DBV TechnologiesDBV Technologies is a late-stage biopharmaceutical company developing treatment options for food allergies and other immunologic conditions with significant unmet medical need. DBV Technologies is currently focused on investigating the use of its proprietary VIASKIN® patch technology to address food allergies, which are caused by a hypersensitive immune reaction and characterized by a range of symptoms varying in severity from mild to life-threatening anaphylaxis. Millions of people live with food allergies, including young children. Through epicutaneous immunotherapy (EPIT), the VIASKIN® patch is designed to introduce microgram amounts of a biologically active compound to the immune system through intact skin. EPIT is a new class of non-invasive treatment that seeks to modify an individual’s underlying allergy by re-educating the immune system to become desensitized to allergen by leveraging the skin’s immune tolerizing properties. DBV Technologies is committed to transforming the care of food allergic people. The Company’s food allergy programs include ongoing clinical trials of the VIASKIN Peanut Patch in peanut allergic toddlers (1 through 3 years of age) and children (4 through 7 years of age). DBV Technologies is headquartered in Châtillon, France, with North American operations in Warren, NJ. The Company’s ordinary shares are traded on segment B of Euronext Paris (DBV, ISIN code: FR0010417345) and the Company’s ADSs (each representing five ordinary shares) are traded on the Nasdaq Capital Market (DBVT – CUSIP: 23306J309). For more information, please visit www.dbv-technologies.com and engage with us on X (formerly Twitter) and LinkedIn. VIASKIN is a registered trademark of DBV Technologies. I…Read full document

Châtillon, France, June 3, 2026 DBV Technologies Announces the Results of its 2026 Combined General Meeting Shareholders approved all proposed resolutions DBV Technologies (Euronext: DBV – ISIN: FR0010417345 – Nasdaq Stock Market: DBVT), a late stage biopharmaceutical company (the “Company”), held its Combined General Meeting (the “General Meeting”). The General Meeting was chaired by Michel de Rosen, Chairman of the Board of Directors (the “Board”). The Company’s shareholders approved all resolutions submitted by the Board. The resolutions and voting results are posted on the Company’s website: 2026 Annual General Meeting | DBV Technologies About DBV TechnologiesDBV Technologies is a late-stage biopharmaceutical company developing treatment options for food allergies and other immunologic conditions with significant unmet medical need. DBV Technologies is currently focused on investigating the use of its proprietary VIASKIN® patch technology to address food allergies, which are caused by a hypersensitive immune reaction and characterized by a range of symptoms varying in severity from mild to life-threatening anaphylaxis. Millions of people live with food allergies, including young children. Through epicutaneous immunotherapy (EPIT), the VIASKIN® patch is designed to introduce microgram amounts of a biologically active compound to the immune system through intact skin. EPIT is a new class of non-invasive treatment that seeks to modify an individual’s underlying allergy by re-educating the immune system to become desensitized to allergen by leveraging the skin’s immune tolerizing properties. DBV Technologies is committed to transforming the care of food allergic people. The Company’s food allergy programs include ongoing clinical trials of the VIASKIN Peanut Patch in peanut allergic toddlers (1 through 3 years of age) and children (4 through 7 years of age). DBV Technologies is headquartered in Châtillon, France, with North American operations in Warren, NJ. The Company’s ordinary shares are traded on segment B of Euronext Paris (DBV, ISIN code: FR0010417345) and the Company’s ADSs (each representing five ordinary shares) are traded on the Nasdaq Capital Market (DBVT – CUSIP: 23306J309). For more information, please visit www.dbv-technologies.com and engage with us on X (formerly Twitter) and LinkedIn. VIASKIN is a registered trademark of DBV Technologies. Investor Contact Jonathan NeelyDBV [email protected] Media ContactBrett WhelanDBV [email protected] Attachment PDF Version

Investor releaseQuarter not tagged2026-05-01

DBV Technologies Reports First Quarter 2026 Financial Results

GlobeNewswire
Châtillon, France, April 30, 2026 DBV Technologies Reports First Quarter 2026 Financial Results Reported cash and cash equivalents of $229 million as of March 31, 2026 —providing funding into the second quarter of 2027 following the full exercise of the ABSA Warrants and BS Warrants issued in its March 2025 private placement (“PIPE”) financing Continued disciplined execution focused on BLA filing in the first half of this year and commercial preparedness for the U.S. launch of the VIASKIN® Peanut Patch for children aged 4 to 7 years, if approved DBV Technologies (Euronext: DBV – ISIN: FR0010417345 – Nasdaq Capital Market: DBVT) (the “Company”), a late-stage biopharmaceutical company, today reported financial results for the first quarter of 2026. The quarterly and three months unaudited condensed financial statements were approved by the Board of Directors on April 30, 2026. “The entire DBV team has been operating with exceptional focus and rigor as we progress towards significant milestones in the coming months, including the upcoming Biologics License Application (BLA) submissions for both our Children ages 4-7 and Toddler ages 1-3 programs in first half and second half of this year, respectively.” said Daniel Tassé, Chief Executive Officer of DBV Technologies. “We also plan to initiate a first of its kind study in infants ages 6 through 12 months. This Phase 2 study, previously announced at last year's American College of Asthma, Allergy, and Immunology, and now called THRIVE, will assess the efficacy and safety of the VIASKIN® Peanut Patch in achieving ad lib consumption of dietary peanut in peanut-allergic infants 6 through 12 months of age following a minimum of 3 years of treatment. Across all development programs, we are operating with extreme precision and purpose with the goal of providing practical, non-invasive treatment options to peanut allergy families no matter where they are on their treatment journey.” Financial Highlights for the First Quarter Ended March 31, 2026 The Company’s interim unaudited condensed consolidated financial statements for the three months ended March 31, 2026, and the comparative period of March 31, 2025, are prepared in accordance with accounting principles generally accepted in the United States (“U.S. GAAP”). In the first quarter of 2026, the Company started to execute its plan for growth, building on the key events…Read full document

Châtillon, France, April 30, 2026 DBV Technologies Reports First Quarter 2026 Financial Results Reported cash and cash equivalents of $229 million as of March 31, 2026 —providing funding into the second quarter of 2027 following the full exercise of the ABSA Warrants and BS Warrants issued in its March 2025 private placement (“PIPE”) financing Continued disciplined execution focused on BLA filing in the first half of this year and commercial preparedness for the U.S. launch of the VIASKIN® Peanut Patch for children aged 4 to 7 years, if approved DBV Technologies (Euronext: DBV – ISIN: FR0010417345 – Nasdaq Capital Market: DBVT) (the “Company”), a late-stage biopharmaceutical company, today reported financial results for the first quarter of 2026. The quarterly and three months unaudited condensed financial statements were approved by the Board of Directors on April 30, 2026. “The entire DBV team has been operating with exceptional focus and rigor as we progress towards significant milestones in the coming months, including the upcoming Biologics License Application (BLA) submissions for both our Children ages 4-7 and Toddler ages 1-3 programs in first half and second half of this year, respectively.” said Daniel Tassé, Chief Executive Officer of DBV Technologies. “We also plan to initiate a first of its kind study in infants ages 6 through 12 months. This Phase 2 study, previously announced at last year's American College of Asthma, Allergy, and Immunology, and now called THRIVE, will assess the efficacy and safety of the VIASKIN® Peanut Patch in achieving ad lib consumption of dietary peanut in peanut-allergic infants 6 through 12 months of age following a minimum of 3 years of treatment. Across all development programs, we are operating with extreme precision and purpose with the goal of providing practical, non-invasive treatment options to peanut allergy families no matter where they are on their treatment journey.” Financial Highlights for the First Quarter Ended March 31, 2026 The Company’s interim unaudited condensed consolidated financial statements for the three months ended March 31, 2026, and the comparative period of March 31, 2025, are prepared in accordance with accounting principles generally accepted in the United States (“U.S. GAAP”). In the first quarter of 2026, the Company started to execute its plan for growth, building on the key events from 2025, including the receipt of regulatory alignment with the U.S. Food and Drug Administration in the first quarter of 2025 regarding the safety data requirements and positive phase 3 clinical results in the fourth quarter, that will both support the planned BLA submission for the VIASKIN® Peanut Patch in children aged 4 to 7 years in the first half of 2026. Financial Performance Operating Income For the three months ended March 31, 2026, the Company accrued $1 million of French Research Tax Credit (“Crédit d’impôt recherche”). This level reflects the expected lower volume of eligible experimental activities on a full-year basis, as the Company’s focus continues to shift from clinical development toward commercial-readiness activities. Research and Development Expenses R&D expenses increased by $12 million for the three months ended March 31, 2026, compared to the three months ended March 31, 2025, driven primarily by: Clinical-related expenses driven by the ongoing recruitment for the COMFORT Toddlers study, the VITESSE Open-label extension (OLE), and the acceleration of BLA-readiness activities. Investment in Medical Affairs, Quality and Regulatory functions in the United States. Continuous Pre-Commercial Inventory build-up in preparation for the launch of the VIASKIN® Peanut Patch for children aged 4 to 7 years in the U.S., if approved. Selling, General and Administrative (“SG&A”) Expenses SG&A Expenses increased by $9 million for the three months ended March 31, 2026, compared to the three months ended March 31, 2025, reflecting the Company’s steps towards building U.S. Commercial infrastructure. The Company plans a phased build of launch-readiness capabilities to support the U.S. launch of the VIASKIN® Peanut Patch for children aged 4 to 7, if approved. Net Loss Net loss was $47.6 million for the three months ended March 31, 2026, compared to $27.1 million for the three months ended March 31, 2025. Net loss per share (based on the weighted average number of shares* over the period) decreased from $(0.26) to $(0.11) for the three months ended March 31, 2025, and March 31, 2026, respectively. This improvement reflects a significantly strengthened equity base following recent financings. Cash Position and Liquidity On March 31, 2026, the Company held $229 million in Cash and Cash Equivalents compared to $194 million of Cash and Cash Equivalents on December 31, 2025. Net cash used for operating activities was $49 million and $20 million for the periods ended March 31, 2026, and March 31, 2025, respectively. The Company’s net cash flows provided by financing activities totaled $89 million for the periods ended March 31, 2026, following the full exercise of the ABSA Warrants and BS Warrants Issued on its March 2025 PIPE Financing. Based on current operations, plans, and assumptions, management has determined that its Cash and Cash Equivalents are sufficient to fund its operations into the second quarter of 2027. These estimates are based on the Company’s current forecasts and exclude any additional expenditures related to programs other than the VIASKIN Peanut or resulting from the potential in licensing or acquisition of additional product candidates or technologies, or any associated development the Company may pursue. The Company may have based these estimates on assumptions that are incorrect, and the Company may end up using its resources sooner than anticipated. Unaudited condensed Consolidated Statement of Operations * Following the March 2025 PIPE financing, this weighted-average share count includes the shares underlying the pre-funded warrants, as the remaining cash exercise price for those warrants is considered immaterial. About DBV Technologies DBV Technologies is a late-stage biopharmaceutical company developing treatment options for food allergies and other immunologic conditions with significant unmet medical need. DBV Technologies is currently focused on investigating the use of its proprietary VIASKIN® patch technology to address food allergies, which are caused by a hypersensitive immune reaction and characterized by a range of symptoms varying in severity from mild to life-threatening anaphylaxis. Millions of people live with food allergies, including young children. Through epicutaneous immunotherapy (EPIT), the VIASKIN® patch is designed to introduce microgram amounts of a biologically active compound to the immune system through intact skin. EPIT is a new class of non-invasive treatment that seeks to modify an individual’s underlying allergy by re-educating the immune system to become desensitized to allergen by leveraging the skin’s immune tolerizing properties. DBV Technologies is committed to transforming the care of food allergic people. The Company’s food allergy programs include ongoing clinical trials of the VIASKIN Peanut Patch in peanut allergic toddlers (1 through 3 years of age) and children (4 through 7 years of age). DBV Technologies is headquartered in Châtillon, France, with North American operations in Warren, NJ. The Company’s ordinary shares are traded on segment B of Euronext Paris (DBV, ISIN code: FR0010417345) and the Company’s ADSs (each representing five ordinary shares) are traded on the Nasdaq Capital Market (DBVT – CUSIP: 23306J309). For more information, please visit www.dbvtechnologies.com and engage with us on X (formerly Twitter) and LinkedIn. Forward Looking Statements This press release contains forward-looking statements, including, without limitation, statements regarding the Company’s financial condition, forecast of its cash runway, the therapeutic potential of Viaskin® patch, designs of DBV’s anticipated clinical trials, including the planned Phase 2 THRIVE study in peanut-allergic infants aged 6 through 12 months, DBV’s planned regulatory and clinical efforts including timing and results of communications with regulatory agencies, clinical trial data releases and publications, the potential regulatory submissions, regulatory approval, launch and commercialization of the Company’s product candidates, the ability of any of DBV’s product candidates, if approved, to improve the lives of patients with food allergies, and the Company’s business strategy and goals. These forward-looking statements and estimates are not promises or guarantees and involve substantial risks and uncertainties. At this stage, the Company’s product candidates have not been authorized for sale in any country. Among the factors that could cause actual results to differ materially from those described or projected herein include uncertainties associated generally with research and development, clinical trials and related regulatory reviews and approvals, the Company’s ability to successfully execute on its growth plans, commercial readiness activities and BLA-related efforts, risks related to the commercialization and launch of the Company’s product candidates, including market acceptance, pricing and reimbursement, and the Company’s ability to obtain additional financing on acceptable terms, if needed, to fund its operations. A further list and description of risks and uncertainties that could cause actual results to differ materially from those set forth in the forward-looking statements in this press release can be found in DBV’s regulatory filings with the U.S. Securities and Exchange Commission (“SEC”), including in DBV’s Annual Report on Form 10-K for the year ended December 31, 2025, filed with the SEC on March 26, 2026, as amended by the Amendment No. 1 on Form 10-K/A filed with the SEC on April 30, 2026, and future filings and reports made with the SEC by DBV. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements and estimates, which speak only as of the date hereof. Other than as required by applicable law, DBV Technologies undertakes no obligation to update or revise the information contained in this Press Release. VIASKIN is a registered trademark of DBV Technologies. Investor Contact Jonathan Neely DBV Technologies [email protected] Media Contact Brett Whelan DBV Technologies [email protected] Attachment PDF Version

Investor releaseQuarter not tagged2026-03-27

DBV Technologies Reports Full Year 2025 Financial Results and Business Update

GlobeNewswire
Châtillon, France, March 26, 2026 DBV Technologies Reports Full Year 2025 Financial Results and Business Update Continued advancing the VIASKIN® Peanut Patch clinical development programs in peanut-allergic toddlers (1 through 3 years old) and children (4 through 7 years old) Bolstered executive leadership team in preparation for BLA submission and potential approval Reported cash and cash equivalents of $194 million as of December 31, 2025, plus additional gross proceeds of $94 million received on January 16, 2026 —providing funding into the second quarter of 2027 DBV Technologies (Euronext: DBV – ISIN: FR0010417345 – Nasdaq Capital Market: DBVT) (the “Company”), a late-stage biopharmaceutical company, today reported financial results for the full year 2025. The consolidated financial statements are prepared under U.S. Generally Acceptable Accounting Principles (“U.S. GAAP”) and International Financial Reporting Standards (“IFRS”) for the purpose of Form 10-K and French “Document d’Enregistrement Universel” containing the Annual Financial Report – were approved by the Board of Directors on March 26, 2026. “We entered 2025 with a clear set of priorities – strengthening our financial position, advancing our clinical development program (including completing VITESSE and initiating COMFORT Toddlers), and preparing for the BLA submission and commercialization of the VIASKIN® Peanut Patch in the United States, if approved,” said Daniel Tassé, Chief Executive Officer of DBV Technologies. “I am pleased with our progress to date in enhancing DBV’s capabilities and building a company ready for launch. Our focus on bringing the VIASKIN® Peanut Patch to peanut-allergic children ages 1-7 years remains unwavering.” 2025 Operational Highlights Clinical Execution Continued to advance clinical program for the VIASKIN® Peanut Patch across both toddlers and children Reported positive topline results from the Phase 3 VITESSE trial in peanut-allergic children aged 4 to 7 years Initiated supplemental safety study, COMFORT Toddlers, for peanut-allergic toddlers aged 1 to 3 years Announced planned clinical study to assess the efficacy and safety of the VIASKIN® Peanut Patch in achieving ad lib consumption of dietary peanut in peanut-allergic infants 6 through 12 months of age following a minimum of 3 years of treatment Scientific Engagement Maintained active engagement with allerg…Read full document

Châtillon, France, March 26, 2026 DBV Technologies Reports Full Year 2025 Financial Results and Business Update Continued advancing the VIASKIN® Peanut Patch clinical development programs in peanut-allergic toddlers (1 through 3 years old) and children (4 through 7 years old) Bolstered executive leadership team in preparation for BLA submission and potential approval Reported cash and cash equivalents of $194 million as of December 31, 2025, plus additional gross proceeds of $94 million received on January 16, 2026 —providing funding into the second quarter of 2027 DBV Technologies (Euronext: DBV – ISIN: FR0010417345 – Nasdaq Capital Market: DBVT) (the “Company”), a late-stage biopharmaceutical company, today reported financial results for the full year 2025. The consolidated financial statements are prepared under U.S. Generally Acceptable Accounting Principles (“U.S. GAAP”) and International Financial Reporting Standards (“IFRS”) for the purpose of Form 10-K and French “Document d’Enregistrement Universel” containing the Annual Financial Report – were approved by the Board of Directors on March 26, 2026. “We entered 2025 with a clear set of priorities – strengthening our financial position, advancing our clinical development program (including completing VITESSE and initiating COMFORT Toddlers), and preparing for the BLA submission and commercialization of the VIASKIN® Peanut Patch in the United States, if approved,” said Daniel Tassé, Chief Executive Officer of DBV Technologies. “I am pleased with our progress to date in enhancing DBV’s capabilities and building a company ready for launch. Our focus on bringing the VIASKIN® Peanut Patch to peanut-allergic children ages 1-7 years remains unwavering.” 2025 Operational Highlights Clinical Execution Continued to advance clinical program for the VIASKIN® Peanut Patch across both toddlers and children Reported positive topline results from the Phase 3 VITESSE trial in peanut-allergic children aged 4 to 7 years Initiated supplemental safety study, COMFORT Toddlers, for peanut-allergic toddlers aged 1 to 3 years Announced planned clinical study to assess the efficacy and safety of the VIASKIN® Peanut Patch in achieving ad lib consumption of dietary peanut in peanut-allergic infants 6 through 12 months of age following a minimum of 3 years of treatment Scientific Engagement Maintained active engagement with allergy, immunology, and patient advocacy communities through participation in leading scientific and medical congresses, including American Academy of Allergy, Asthma, and Immunology (AAAAI) Annual Meeting, the European Academy of Allergy and Clinical Immunology (EAACI) Congress, and the American College of Allergy, Asthma, and Immunology (ACAAI) Annual Scientific Meeting Leadership Expansion Bolstered leadership capabilities in preparation for potential commercialization Appointed Kevin Trapp as Chief Commercial Officer and James Briggs as Chief Human Resources Officer to strengthen ability to grow, plan, and execute a launch in the United States, if approved Appointed Philina Lee, Ph.D. to Board of Directors (subject to ratification by the Company’s shareholders at the next annual meeting of shareholders), adding deep expertise in biotechnology strategy and commercialization Financial Position Announced a private placement financing (”2025 PIPE”) of up to $306.9 million (€284.5 million) on March 27, 2025, to advance the VIASKIN® Peanut Patch through Biologics License Application (”BLA”) submission and U.S. commercial launch, if approved. The 2025 PIPE included gross proceeds of $125.5 million (€116.3 million at the exchange rate of 1 EUR = $1.08) received on April 7, 2025 and $100.7 million as of December 31, 2025 (€85,7 million at the exchange rate of 1 EUR = $1.17) resulting from the exercise of the ABSA Warrants and BS Warrants, following the announcement of the positive VITESSE Topline Results on December 16, 2025 Further strengthened balance sheet through the launch of a $150 million At-the-Market (ATM) program, subsequently subscribed for $65 million as of December 31, 2025 Anticipated 2026 Events BLA Submission for 4-7 year olds anticipated in the first half of 2026 with potential for Priority Review Completion of enrollment of COMFORT Toddlers safety study and subsequent topline results readout BLA submission for 1-3 year olds anticipated in the second half of 2026 under an Accelerated Approval Pathway Financial Highlights for the Full Year 2025 2025 Financial Highlights are presented under both U.S. GAAP and IFRS. Comments are provided on a U.S. GAAP basis. Differences between U.S. GAAP and IFRS consolidated financial statements result mainly from the application of lease accounting standards. Financial Performance Operating Income For the year ended December 31, 2025, operating income totaled $5.6 million, increasing from $4.2 million for the year ended December 31, 2024, driven by higher eligible activities to the French Research Tax Credit (crédit d’impôt recherche). Research and Development Expenses R&D expenses increased by $27.3 million for the year ended December 31, 2025, compared to 2024 driven by: Pre-commercial inventory of $16.1 million, in preparation of the launch of VIASKIN® Peanut Patch for children aged 4 to 7 years old in the U.S., if approved External clinical expenses of $6.9 million, with COMFORT Toddlers study ongoing patient enrollment Employee-related costs of $3.3 million from the addition of Quality and Regulatory resources to support BLA submission and commercial readiness activities Selling, General and Administrative Expenses SG&A Expenses increased by $4.6 million for the year ended December 31, 2025, compared to the year ended December 31, 2024 primarily from Market Research activities and additional roles strengthening operational capabilities towards launch of the VIASKIN® Peanut Patch for children aged 4 to 7 years in the U.S., if approved. Net Loss Net loss was $147.0 million for the year ended December 31, 2025, compared to $113.9 million for the year ended December 31, 2024. Net loss per share (based on the weighted average number of shares outstanding over the period) was $1.05 and $1.17 for the year ended December 31, 2025 and 2024, respectively. Cash Position and Liquidity On December 31, 2025, DBV held $194.2 million in cash and cash equivalents compared to $32.5 million of cash and cash equivalents on December 31, 2024. Net cash used for operating activities was $121.2 million and $104.5 million for the years ended December 31, 2025, and 2024, respectively. Net cash flows from financing activities totaled $276.2 million in 2025 and $0.6 million in 2024, resulting from the 2025 PIPE proceeds and the ATM facility. Considering the supplemental gross proceeds received from completed ABSA and BS warrants exercises ($94 million) in January 2026, together with the Company’s existing cash and cash equivalents as of December 31, 2025, and based on current operations, plans, and assumptions, management has determined that its cash and cash equivalents, are sufficient to fund its operations into the second quarter of 2027. The going concern assessment is based on the Company’s current forecasts and exclude any additional expenditure related to other programs than the VIASKIN® Peanut Patch or resulting from the potential in licensing or acquisition of additional product candidates or technologies, or any associated development the Company may pursue. Assumptions used in the going concern assessment may differ from actual results, and the Company may end up using its resources sooner than anticipated and seek additional resources to execute the corporate strategy either through new or existing financing strategies. Audited Consolidated Statement of Operations (In millions of USD) About DBV Technologies DBV Technologies is a late-stage biopharmaceutical company developing treatment options for food allergies and other immunologic conditions with significant unmet medical need. DBV Technologies is currently focused on investigating the use of its proprietary VIASKIN® patch technology to address food allergies, which are caused by a hypersensitive immune reaction and characterized by a range of symptoms varying in severity from mild to life-threatening anaphylaxis. Millions of people live with food allergies, including young children. Through epicutaneous immunotherapy (EPIT), the VIASKIN® patch is designed to introduce microgram amounts of a biologically active compound to the immune system through intact skin. EPIT is a new class of non-invasive treatment that seeks to modify an individual’s underlying allergy by re-educating the immune system to become desensitized to allergen by leveraging the skin’s immune tolerizing properties. DBV Technologies is committed to transforming the care of food allergic people. The Company’s food allergy programs include ongoing clinical trials of the VIASKIN Peanut Patch in peanut allergic toddlers (1 through 3 years of age) and children (4 through 7 years of age). DBV Technologies is headquartered in Châtillon, France, with North American operations in Warren, NJ. The Company’s ordinary shares are traded on segment B of Euronext Paris (DBV, ISIN code: FR0010417345) and the Company’s ADSs (each representing five ordinary shares) are traded on the Nasdaq Capital Market (DBVT – CUSIP: 23306J309). For more information, please visit www.dbvtechnologies.com and engage with us on X (formerly Twitter) and LinkedIn. Forward Looking Statements This press release contains forward-looking statements, including, without limitation, statements regarding the Company’s financial condition, forecast of its cash runway, the therapeutic potential of Viaskin® patch, designs of DBV’s anticipated clinical trials, DBV’s planned regulatory and clinical efforts including timing and results of communications with regulatory agencies, clinical trial data releases and publications, the potential regulatory submissions, regulatory approval, launch and commercialization of the Company’s product candidates, the ability of any of DBV’s product candidates, if approved, to improve the lives of patients with food allergies, and the Company’s business strategy and goals. These forward-looking statements and estimates are not promises or guarantees and involve substantial risks and uncertainties. At this stage, the Company’s product candidates have not been authorized for sale in any country. Among the factors that could cause actual results to differ materially from those described or projected herein include uncertainties associated generally with research and development, clinical trials and related regulatory reviews and approvals, and the Company’s ability to successfully execute on its budget discipline measures. A further list and description of risks and uncertainties that could cause actual results to differ materially from those set forth in the forward-looking statements in this press release can be found in DBV’s regulatory filings with the French Autorité des Marchés Financiers (“AMF”), DBV’s filings and reports with the U.S. Securities and Exchange Commission (“SEC”), including in DBV’s Annual Report on Form 10-K for the year ended December 31, 2025, filed with the SEC on March 26, 2026, and future filings and reports made with the AMF and SEC by DBV. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements and estimates, which speak only as of the date hereof. Other than as required by applicable law, DBV Technologies undertakes no obligation to update or revise the information contained in this Press Release. VIASKIN is a registered trademark of DBV Technologies. Investor Contact Jonathan Neely DBV Technologies [email protected] Media Contact Brett Whelan DBV Technologies [email protected] Attachment PDF Version

Investor releaseQuarter not tagged2025-10-29

DBV Technologies Reports Third Quarter 2025 Financial Results

GlobeNewswire
Châtillon, France, October 28, 2025 DBV Technologies Reports Third Quarter 2025 Financial Results DBV closes Q3 2025 with a cash and cash equivalents balance of $69.8 million, taking cash runway into the third quarter of 2026 DBV Technologies (Euronext: DBV – ISIN: FR0010417345 – Nasdaq Stock Market: DBVT – CUSIP: 23306J309), a clinical-stage biopharmaceutical company (the "Company"), reported financial results for the third quarter of 2025. The quarterly and nine months unaudited financial statements were approved by the Board of Directors on October 28, 2025. Financial Highlights for the third quarter ended September 30, 2025 The Company’s unaudited interim condensed consolidated financial statements for the nine months ended September 30, 2025, are prepared in accordance with accounting principles generally accepted in the United States (“U.S. GAAP”). Operating Income The increase in Research tax credit during the three and the nine months ended September 30, 2025, is primarily due to the fact that more eligible activities have been carried out in the period, including the related costs of the FAREVA platform. Operating Expenses Operating expenses amounted to $107.0 million for the nine months ended September 30, 2025, compared with $96.4 million for the nine months ended September 30, 2024, an increase by $10.6 million driven mostly by the launch of the COMFORT Toddlers supplemental safety study. Net Loss and Net Loss Per Share The Company recorded a net loss for the nine months ended September 30, 2025, of $102.1 million, compared to a net loss of $90.9 million for the nine months ended September 30, 2024. On a per share basis, net loss (based on the weighted average number of 124,723,638 shares outstanding over the period) was (0.82) USD/share for the nine months ended September 30, 2025. Cash and Cash Equivalents Our Condensed Consolidated Financial Statements have been prepared assuming the Company will continue as a going concern. The going concern assumption contemplates the realization of assets and satisfaction of liabilities in the normal course of business. Cash and cash equivalents amounted to $69.8 million as of September 30, 2025, compared to $32.5 million as of December 31, 2024, a net increase of $37.4 million. On March 27, 2025, the company announced a private placement financing ("2025 PIPE") of up to $306.9 million (€284.5 million), to…Read full document

Châtillon, France, October 28, 2025 DBV Technologies Reports Third Quarter 2025 Financial Results DBV closes Q3 2025 with a cash and cash equivalents balance of $69.8 million, taking cash runway into the third quarter of 2026 DBV Technologies (Euronext: DBV – ISIN: FR0010417345 – Nasdaq Stock Market: DBVT – CUSIP: 23306J309), a clinical-stage biopharmaceutical company (the "Company"), reported financial results for the third quarter of 2025. The quarterly and nine months unaudited financial statements were approved by the Board of Directors on October 28, 2025. Financial Highlights for the third quarter ended September 30, 2025 The Company’s unaudited interim condensed consolidated financial statements for the nine months ended September 30, 2025, are prepared in accordance with accounting principles generally accepted in the United States (“U.S. GAAP”). Operating Income The increase in Research tax credit during the three and the nine months ended September 30, 2025, is primarily due to the fact that more eligible activities have been carried out in the period, including the related costs of the FAREVA platform. Operating Expenses Operating expenses amounted to $107.0 million for the nine months ended September 30, 2025, compared with $96.4 million for the nine months ended September 30, 2024, an increase by $10.6 million driven mostly by the launch of the COMFORT Toddlers supplemental safety study. Net Loss and Net Loss Per Share The Company recorded a net loss for the nine months ended September 30, 2025, of $102.1 million, compared to a net loss of $90.9 million for the nine months ended September 30, 2024. On a per share basis, net loss (based on the weighted average number of 124,723,638 shares outstanding over the period) was (0.82) USD/share for the nine months ended September 30, 2025. Cash and Cash Equivalents Our Condensed Consolidated Financial Statements have been prepared assuming the Company will continue as a going concern. The going concern assumption contemplates the realization of assets and satisfaction of liabilities in the normal course of business. Cash and cash equivalents amounted to $69.8 million as of September 30, 2025, compared to $32.5 million as of December 31, 2024, a net increase of $37.4 million. On March 27, 2025, the company announced a private placement financing ("2025 PIPE") of up to $306.9 million (€284.5 million), to advance Viaskin® Peanut patch through Biologics License Application (”BLA”) submission and U.S. commercial launch, if approved. The 2025 PIPE included gross proceeds of $125.5 million (€116.3 million) received on April 7, 2025. However, it should be noted that the Company may receive an aggregate of up to $181.4 million (€168.2 million) in gross proceeds if all warrants in connection with the 2025 PIPE are exercised, subject to satisfaction of specified conditions. The VITESSE Phase 3 study hitting its primary endpoint will trigger an acceleration of the exercise period of the warrants (topline results are expected in the fourth quarter of 2025). DBV expects that the proceeds of this funding will be used for working capital and general corporate purposes, to finance the continued development of the Viaskin Peanut program in 4-7 years old, to finance the preparation and submission of a potential BLA, and to finance the readiness of a launch of Viaskin peanut in the U.S., if approved. In addition, in September 2025, the Company established an equity offering program (the “ATM Program”), pursuant to which the Company may offer and sell American Depositary Shares ("ADSs"), from time to time through its sale agent, having an aggregate offering price of up to $150.0 million (subject to French regulatory limits). Subsequent to the end of the third quarter, the Company received a total gross amount of approximately $30 million from the issuance of 11,538,460 Ordinary Shares (underlying 2,307,692 ADSs) on October 6, 2025 pursuant to the ATM Program. As of the date of the filing, with the receipt of the aforementioned proceeds, and based on its current operations, plans, and assumptions examined by the Board on October 28, 2025, the Company estimates that its cash and cash equivalents are sufficient to fund its operations into the third quarter of 2026. As such, cash and cash equivalents are not sufficient to fund operations for the next 12 months, and these conditions and events raise substantial doubt about the Company's ability to continue as a going concern. Management is actively pursuing financing options including additional sales under the ATM Program, potential warrant exercises, and strategic transactions. Our Condensed Consolidated Financial Statements do not include any adjustments to the carrying amounts and classification of assets, liabilities, and reported expenses that may be necessary if the Company were unable to continue as a going concern. Given the Company’s historical operating losses and reliance on external financings, the Company may still seek additional capital for future needs through a combination of public or private equity or debt financings, collaborations, licensing agreements, and other funding options. While recent financing events have improved the Company’s financial position, access to additional capital in the future remains subject to market conditions and investor interest. Operating Activities Our net cash flows used in operating activities were $86.0 million and $92.2 million during the nine months ended September 30, 2025 and 2024, respectively. Net cash flows used in operating activities decreased by $6.2 million as our costs and expenses have been contained and payment terms extended during the period covered by this report. Investing Activities Net cash flows used in investing activities were $0.7 million and $1.5 million during the nine months ended September 30, 2025 and 2024, respectively. The variance is primarily explained by capitalized costs for the headquarters move to Châtillon. Financing Activities Net cash flows from financing activities were $117.1 million for the nine months ended September 30, 2025 compared to $(88) thousand for the nine months ended September 30, 2024. This increase is due to the financing operation completed on April 7, 2025. CONDENSED CONSOLIDATED STATEMENTS OF FINANCIAL POSITION (unaudited) CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (unaudited) About DBV Technologies DBV Technologies is a clinical-stage biopharmaceutical company developing treatment options for food allergies and other immunologic conditions with significant unmet medical need. DBV Technologies is currently focused on investigating the use of its proprietary VIASKIN® patch technology, to address food allergies, which are caused by a hypersensitive immune reaction and characterized by a range of symptoms varying in severity from mild to life-threatening anaphylaxis. Millions of people live with food allergies, including young children. Through epicutaneous immunotherapy (EPIT), the VIASKIN® patch is designed to introduce microgram amounts of a biologically active compound to the immune system through intact skin. EPIT is a new class of non-invasive treatment that seeks to modify an individual’s underlying allergy by re-educating the immune system to become desensitized to allergen by leveraging the skin’s immune tolerizing properties. DBV Technologies is committed to transforming the care of food allergic people. The Company’s food allergy programs include ongoing clinical trials of VIASKIN Peanut in peanut allergic toddlers (1 through 3 years of age) and children (4 through 7 years of age). DBV Technologies is headquartered in Châtillon, France, with North American operations in Warren, NJ. The Company’s ordinary shares are traded on segment B of Euronext Paris (Ticker: DBV, ISIN code: FR0010417345) and the Company’s ADSs (each representing five ordinary shares) are traded on the Nasdaq Capital Select Market (Ticker: DBVT – CUSIP: 23306J309). For more information, please visit www.dbv-technologies.com and engage with us on X (formerly Twitter) and LinkedIn. Forward-Looking Statements This press release may contain forward-looking statements and estimates, including statements regarding DBV’s financial condition, forecast of its cash runway, the therapeutic potential of Viaskin® Peanut patch and EPIT™. These forward-looking statements and estimates are not promises or guarantees and involve substantial risks and uncertainties. At this stage, DBV’s product candidates have not been authorized for sale in any country. Among the factors that could cause actual results to differ materially from those described or projected herein include uncertainties associated generally with research and development, clinical trials and related regulatory reviews and approvals, and DBV’s ability to successfully execute on its budget discipline measures. A further list and description of risks and uncertainties that could cause actual results to differ materially from those set forth in the forward-looking statements in this press release can be found in DBV’s regulatory filings with the French Autorité des Marchés Financiers (“AMF”), DBV’s filings and reports with the U.S. Securities and Exchange Commission (“SEC”), including in DBV’s Annual Report on Form 10-K for the year ended December 31, 2024, filed with the SEC on April 11, 2025, as amended by Amendment No. 1 on Form 10-K/A filed with the SEC on April 28, 2025, and as amended further by Amendment No. 2 on Form 10-K/A filed with the SEC on May 14, 2025, DBV's Quarterly Report on Form 10-Q filed with the SEC on October 28, 2025, and future filings and reports made with the AMF and SEC by DBV. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements and estimates, which speak only as of the date hereof. Other than as required by applicable law, DBV Technologies undertakes no obligation to update or revise the information contained in this Press Release. Viaskin is a registered trademark of DBV Technologies. Investor Contact Katie Matthews DBV Technologies [email protected] Media Contact Brett Whelan DBV Technologies [email protected] Attachment PDF Version

Investor releaseQuarter not tagged2025-07-30

DBV Technologies Reports Second Quarter and Half-Year 2025 Financial Results

GlobeNewswire
Châtillon, France, July 29, 2025 DBV Technologies Reports Second Quarter and Half-Year 2025 Financial Results DBV Technologies (Euronext: DBV – ISIN: FR0010417345 – Nasdaq Stock Market: DBVT – CUSIP: 23306J309), a clinical-stage biopharmaceutical company, today reported financial results for the Second Quarter of 2025. The quarterly and half-year financial statements were approved by the Board of Directors on July 29, 2025. Financial Highlights for the Second Quarter Ended June 30, 2025 The Company’s interim condensed consolidated financial statements for the quarter and six months ended June 30, 2025, are prepared in accordance with accounting principles generally accepted in the United States (“U.S. GAAP”) and Europe (IFRS). Operating Income Operating income amounted to $2.2 million for the six months ended June 30, 2025, compared with $2.6 million for the same period in 2024, primarily due to a lower French Research Tax Credit entitlement as a greater proportion of studies activities were carried out in North America and therefore not eligible for the tax credit. Operating Expenses Operating expenses amounted to $69.9 million for the six months ended June 30, 2025, compared with $65.0 million for the six months ended June 30, 2024, an increase by $4.9 million driven mostly by the launch of the COMFORT Toddlers supplemental safety study. Net Loss and Net Loss Per Share The Company recorded a net loss for the six months ended June 30, 2025, of $69.0 million, compared to a net loss of $60.5 million for the six months ended June 30, 2024. On a per share basis, net loss (based on the weighted average number of shares outstanding over the period) was $(0.58) for the six months ended June 30, 2025 compared with $(0.63) for the six months ended June 30, 2024. Cash and Cash Equivalents Our Condensed Consolidated Financial Statements have been prepared assuming the Company will continue as a going concern. The going concern assumption contemplates the realization of assets and satisfaction of liabilities in the normal course of business. Cash and cash equivalents amounted to $103.2 million as of June 30, 2025, compared to $32.5 million as of December 31, 2024, a net increase of $70.7 million. . On March 27, 2025, the company announced a financing of up to $306.9 million (€284.5 million), to advance Viaskin® Peanut patch through Biologics License Application ("BLA")…Read full document

Châtillon, France, July 29, 2025 DBV Technologies Reports Second Quarter and Half-Year 2025 Financial Results DBV Technologies (Euronext: DBV – ISIN: FR0010417345 – Nasdaq Stock Market: DBVT – CUSIP: 23306J309), a clinical-stage biopharmaceutical company, today reported financial results for the Second Quarter of 2025. The quarterly and half-year financial statements were approved by the Board of Directors on July 29, 2025. Financial Highlights for the Second Quarter Ended June 30, 2025 The Company’s interim condensed consolidated financial statements for the quarter and six months ended June 30, 2025, are prepared in accordance with accounting principles generally accepted in the United States (“U.S. GAAP”) and Europe (IFRS). Operating Income Operating income amounted to $2.2 million for the six months ended June 30, 2025, compared with $2.6 million for the same period in 2024, primarily due to a lower French Research Tax Credit entitlement as a greater proportion of studies activities were carried out in North America and therefore not eligible for the tax credit. Operating Expenses Operating expenses amounted to $69.9 million for the six months ended June 30, 2025, compared with $65.0 million for the six months ended June 30, 2024, an increase by $4.9 million driven mostly by the launch of the COMFORT Toddlers supplemental safety study. Net Loss and Net Loss Per Share The Company recorded a net loss for the six months ended June 30, 2025, of $69.0 million, compared to a net loss of $60.5 million for the six months ended June 30, 2024. On a per share basis, net loss (based on the weighted average number of shares outstanding over the period) was $(0.58) for the six months ended June 30, 2025 compared with $(0.63) for the six months ended June 30, 2024. Cash and Cash Equivalents Our Condensed Consolidated Financial Statements have been prepared assuming the Company will continue as a going concern. The going concern assumption contemplates the realization of assets and satisfaction of liabilities in the normal course of business. Cash and cash equivalents amounted to $103.2 million as of June 30, 2025, compared to $32.5 million as of December 31, 2024, a net increase of $70.7 million. . On March 27, 2025, the company announced a financing of up to $306.9 million (€284.5 million), to advance Viaskin® Peanut patch through Biologics License Application ("BLA") submission and U.S. commercial launch, if approved. The financing included gross proceeds of $125.5 million (€116.3 million) received on April 7, 2025. With the receipt of the aforementioned proceeds, and based on its current operations, plans, and assumptions examined by the Board on June 23, 2025, the Company estimates that its cash and cash equivalents are sufficient to fund its operations into the second quarter of 2026. As such, there is substantial doubt regarding our ability to continue as a going concern. However, it should be noted that the Company financing also includes an aggregate of up to $181.4 million (€168.2 million) in gross proceeds if all warrants are exercised, subject to satisfaction of specified conditions. The VITESSE Phase 3 study hitting its primary endpoint will trigger an acceleration of the exercise period of the warrants. DBV expects that the proceeds of this funding will be used for working capital and general corporate purposes, to finance the continued development of the Viaskin Peanut program, to finance the preparation and submission of a potential BLA, and to finance the readiness of a launch of Viaskin peanut in the U.S., if approved. These condensed consolidated financial statements do not include any adjustments to the carrying amounts and classification of assets, liabilities, and reported expenses that may be necessary if the Company was unable to continue as a going concern. These condensed consolidated financial statements do not include any adjustments to the carrying amounts and classification of assets, liabilities, and reported expenses that may be necessary if the Company was unable to continue as a going concern. CONDENSED CONSOLIDATED STATEMENTS OF FINANCIAL POSITION CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS About DBV Technologies DBV Technologies is a clinical-stage biopharmaceutical company developing treatment options for food allergies and other immunologic conditions with significant unmet medical need. DBV Technologies is currently focused on investigating the use of its proprietary technology platform, Viaskin, to address food allergies, which are caused by a hypersensitive immune reaction and characterized by a range of symptoms varying in severity from mild to life-threatening anaphylaxis. Millions of people live with food allergies, including young children. Through epicutaneous immunotherapy (EPIT), the Viaskin platform is designed to introduce microgram amounts of a biologically active compound to the immune system through intact skin. EPIT is a new class of non-invasive treatment that seeks to modify an individual’s underlying allergy by re-educating the immune system to become desensitized to allergen by leveraging the skin’s immune tolerizing properties. DBV Technologies is committed to transforming the care of food allergic people. The Company’s food allergy programs include ongoing clinical trials of Viaskin Peanut in peanut allergic toddlers (1 through 3 years of age) and children (4 through 7 years of age). DBV Technologies is headquartered in Châtillon, France, with North American operations in Warren, NJ. The Company’s ordinary shares are traded on segment B of Euronext Paris (DBV, ISIN code: FR0010417345) and the Company’s ADSs (each representing five ordinary shares) are traded on the Nasdaq Capital Market (DBVT – CUSIP: 23306J309). For more information, please visit www.dbv-technologies.com and engage with us on X (formerly Twitter) and LinkedIn. Forward Looking Statements This press release may contain forward-looking statements and estimates, including statements regarding DBV’s financial condition, forecast of its cash runway and therapeutic potential of Viaskin® Peanut patch and EPIT. These forward-looking statements and estimates are not promises or guarantees and involve substantial risks and uncertainties. At this stage, DBV’s product candidates have not been authorized for sale in any country. Among the factors that could cause actual results to differ materially from those described or projected herein include uncertainties associated generally with research and development, clinical trials and related regulatory reviews and approvals, and DBV’s ability to successfully execute on its budget discipline measures. A further list and description of risks and uncertainties that could cause actual results to differ materially from those set forth in the forward-looking statements in this press release can be found in DBV’s regulatory filings with the French Autorité des Marchés Financiers (“AMF”), DBV’s filings and reports with the U.S. Securities and Exchange Commission (“SEC”), including in DBV’s Annual Report on Form 10-K for the year ended December 31, 2024, filed with the SEC on April 11, 2025, as amended by Amendment No. 1 on Form 10-K/A filed with the SEC on April 28, 2025, and as amended further by Amendment No. 2 on Form 10-K/A filed with the SEC on May 14, 2025, and future filings and reports made with the AMF and SEC by DBV. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements and estimates, which speak only as of the date hereof. Other than as required by applicable law, DBV Technologies undertakes no obligation to update or revise the information contained in this Press Release. Viaskin is a registered trademark of DBV Technologies. Investor Contact Katie Matthews DBV Technologies [email protected] Media Contact Brett Whelan DBV Technologies [email protected] Attachment PDF Version

Investor releaseQuarter not tagged2025-06-12

DBV Technologies Announces the Voting Results of its 2025 Combined General Meeting

GlobeNewswire
Châtillon, France, June 11, 2025 DBV Technologies Announces the Voting Results of its 2025 Combined General Meeting Shareholders approved all proposed resolutions DBV Technologies (Euronext: DBV – ISIN: FR0010417345 – Nasdaq Stock Market: DBVT), a clinical-stage biopharmaceutical company (the “Company”), held its Combined General Meeting (the “General Meeting”). The General Meeting was chaired by Michel de Rosen, Chairman of the Company. The Company’s shareholders approved all resolutions submitted by the Board of Directors. The resolutions and the voting results are posted on the Investors/Annual General Meetings section of the Company’s website: https://dbv-technologies.com/events/2025-annual-general-meeting/. About DBV Technologies DBV Technologies is a clinical-stage biopharmaceutical company developing treatment options for food allergies and other immunologic conditions with significant unmet medical need. DBV is currently focused on investigating the use of its proprietary technology platform, Viaskin™, to address food allergies, which are caused by a hypersensitive immune reaction and characterized by a range of symptoms varying in severity from mild to life-threatening anaphylaxis. Millions of people live with food allergies, including young children. Through epicutaneous immunotherapy (EPIT™), the Viaskin platform is designed to introduce microgram amounts of a biologically active compound to the immune system through intact skin. EPIT is a new class of non-invasive treatment that seeks to modify an individual’s underlying allergy by re-educating the immune system to become desensitized to allergen by leveraging the skin’s immune tolerizing properties. DBV is committed to transforming the care of food allergic people. The Company’s food allergy programs include ongoing clinical trials of Viaskin Peanut in peanut allergic toddlers (1 through 3 years of age) and children (4 through 7 years of age). DBV Technologies is headquartered in Châtillon, France, with North American operations in Warren, NJ. The Company’s ordinary shares are traded on segment B of Euronext Paris (Ticker: DBV, ISIN code: FR0010417345) and the Company’s ADSs (each representing five ordinary shares) are traded on the Nasdaq Capital Market (DBVT – CUSIP: 23306J309). For more information, please visit www.dbv-technologies.com and engage with us on X (formerly Twitter) and LinkedIn.…Read full document

Châtillon, France, June 11, 2025 DBV Technologies Announces the Voting Results of its 2025 Combined General Meeting Shareholders approved all proposed resolutions DBV Technologies (Euronext: DBV – ISIN: FR0010417345 – Nasdaq Stock Market: DBVT), a clinical-stage biopharmaceutical company (the “Company”), held its Combined General Meeting (the “General Meeting”). The General Meeting was chaired by Michel de Rosen, Chairman of the Company. The Company’s shareholders approved all resolutions submitted by the Board of Directors. The resolutions and the voting results are posted on the Investors/Annual General Meetings section of the Company’s website: https://dbv-technologies.com/events/2025-annual-general-meeting/. About DBV Technologies DBV Technologies is a clinical-stage biopharmaceutical company developing treatment options for food allergies and other immunologic conditions with significant unmet medical need. DBV is currently focused on investigating the use of its proprietary technology platform, Viaskin™, to address food allergies, which are caused by a hypersensitive immune reaction and characterized by a range of symptoms varying in severity from mild to life-threatening anaphylaxis. Millions of people live with food allergies, including young children. Through epicutaneous immunotherapy (EPIT™), the Viaskin platform is designed to introduce microgram amounts of a biologically active compound to the immune system through intact skin. EPIT is a new class of non-invasive treatment that seeks to modify an individual’s underlying allergy by re-educating the immune system to become desensitized to allergen by leveraging the skin’s immune tolerizing properties. DBV is committed to transforming the care of food allergic people. The Company’s food allergy programs include ongoing clinical trials of Viaskin Peanut in peanut allergic toddlers (1 through 3 years of age) and children (4 through 7 years of age). DBV Technologies is headquartered in Châtillon, France, with North American operations in Warren, NJ. The Company’s ordinary shares are traded on segment B of Euronext Paris (Ticker: DBV, ISIN code: FR0010417345) and the Company’s ADSs (each representing five ordinary shares) are traded on the Nasdaq Capital Market (DBVT – CUSIP: 23306J309). For more information, please visit www.dbv-technologies.com and engage with us on X (formerly Twitter) and LinkedIn. Viaskin and EPIT are trademarks of DBV Technologies. Investor Contact Katie Matthews DBV Technologies [email protected] Media Contact Angela Marcucci DBV Technologies [email protected] Attachment PDF Version

Investor releaseQuarter not tagged2025-05-01

DBV Technologies Reports First Quarter 2025 Financial Results

GlobeNewswire
Châtillon, France, April 30, 2025 DBV Technologies Reports First Quarter 2025 Financial Results 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 prepared in accordance with accounting principles generally accepted in the United States (“U.S. GAAP”). Cash and Cash Equivalents Our Condensed Consolidated Financial Statements have been prepared assuming the Company will continue as a going concern. The going concern assumption contemplates the realization of assets and satisfaction of liabilities in the normal course of business. Cash and cash equivalents amounted to $13.0 million as of March 31, 2025, compared to $32.5 million as of December 31, 2024, a net decrease of $19.5 million. This decrease includes $19.7 million of cash used in operating activities, mainly in external clinical trial related expenses, notably progress on subject enrollment in the VITESSE Phase 3 clinical trial, as well as Regulatory and Manufacturing activities to support ongoing clinical trials. On March 27, 2025, the company announced a financing of up to $306.9 million (€284.5 million), to Advance Viaskin® Peanut Patch through Biologics License Application submission (BLA) and U.S. Commercial Launch, if approved. The financing included gross proceeds of $125.5 million (€116.3 million) received on April 7, 2025. With the receipt of the aforementioned proceeds, and based on its current operations, plans, and assumptions examined by the Board on March 23, 2025, the Company estimates that its cash and cash equivalents are sufficient to fund its operations into June 2026. The Company has incurred operating losses and negative cash flows from operations since inception. The Company does not generate product revenue and continues to prepare for the potential launch of its first product in the United States and in the European Union, if approved. These condensed consolidated financial statements do not include any adjustments to the carrying amounts an…Read full document

Châtillon, France, April 30, 2025 DBV Technologies Reports First Quarter 2025 Financial Results 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 prepared in accordance with accounting principles generally accepted in the United States (“U.S. GAAP”). Cash and Cash Equivalents Our Condensed Consolidated Financial Statements have been prepared assuming the Company will continue as a going concern. The going concern assumption contemplates the realization of assets and satisfaction of liabilities in the normal course of business. Cash and cash equivalents amounted to $13.0 million as of March 31, 2025, compared to $32.5 million as of December 31, 2024, a net decrease of $19.5 million. This decrease includes $19.7 million of cash used in operating activities, mainly in external clinical trial related expenses, notably progress on subject enrollment in the VITESSE Phase 3 clinical trial, as well as Regulatory and Manufacturing activities to support ongoing clinical trials. On March 27, 2025, the company announced a financing of up to $306.9 million (€284.5 million), to Advance Viaskin® Peanut Patch through Biologics License Application submission (BLA) and U.S. Commercial Launch, if approved. The financing included gross proceeds of $125.5 million (€116.3 million) received on April 7, 2025. With the receipt of the aforementioned proceeds, and based on its current operations, plans, and assumptions examined by the Board on March 23, 2025, the Company estimates that its cash and cash equivalents are sufficient to fund its operations into June 2026. The Company has incurred operating losses and negative cash flows from operations since inception. The Company does not generate product revenue and continues to prepare for the potential launch of its first product in the United States and in the European Union, if approved. These condensed consolidated financial statements do not include any adjustments to the carrying amounts and classification of assets, liabilities, and reported expenses that may be necessary if the Company was unable to continue as a going concern. Operating Income Operating income amounted to $0.8 million for the three months ended March 31, 2025, compared with $1.4 million for the same period in 2024 due to a lower French Research Tax Credit entitlement as a greater proportion of study activities were carried out in North America and are therefore not eligible for this tax credit. Operating Expenses Operating expenses amounted to $27.4 million for the three months ended March 31, 2025, compared with $30 million for the three months ended March 31, 2024, a decrease of $2.6 million. This decrease is primarily driven by lower General & Administrative expenses, notably $2.2 million expenses associated with office moves in France and the U.S that occurred in 2024. Net Loss and Net Loss Per Share The Company recorded a net loss of $27.1 million for the three months ended March 31, 2025, compared to a net loss of $27.3 million for the three months ended March 31, 2024. On a per share basis, net loss (based on the weighted average number of shares outstanding over the period) was $(0.26) for the three months ended March 31, 2025 vs. $(0.28) for the three months ended March 31, 2024. CONDENSED CONSOLIDATED STATEMENTS OF FINANCIAL POSITION CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS About DBV Technologies DBV Technologies is a clinical-stage biopharmaceutical company developing treatment options for food allergies and other immunologic conditions with significant unmet medical need. DBV Technologies is currently focused on investigating the use of its proprietary technology platform, Viaskin, to address food allergies, which are caused by a hypersensitive immune reaction and characterized by a range of symptoms varying in severity from mild to life-threatening anaphylaxis. Millions of people live with food allergies, including young children. Through epicutaneous immunotherapy (EPIT™), the Viaskin platform is designed to introduce microgram amounts of a biologically active compound to the immune system through intact skin. EPIT is a new class of non-invasive treatment that seeks to modify an individual’s underlying allergy by re-educating the immune system to become desensitized to allergen by leveraging the skin’s immune tolerizing properties. DBV Technologies is committed to transforming the care of food allergic people. The Company’s food allergy programs include ongoing clinical trials of Viaskin Peanut in peanut allergic toddlers (1 through 3 years of age) and children (4 through 7 years of age). DBV Technologies is headquartered in Châtillon, France, with North American operations in Warren, NJ. The Company’s ordinary shares are traded on segment B of Euronext Paris (DBV, ISIN code: FR0010417345) and the Company’s ADSs (each representing five ordinary shares) are traded on the Nasdaq Capital Market (DBVT – CUSIP: 23306J309). Forward Looking Statements This press release may contain forward-looking statements and estimates, including statements regarding DBV’s financial condition, forecast of its cash runway, the therapeutic potential of Viaskin® Peanut patch and EPIT™, designs of DBV’s anticipated clinical trials, DBV’s planned regulatory and clinical efforts including timing and results of communications with regulatory agencies, the ability of any of DBV’s product candidates, if approved, to improve the lives of patients with food allergies. These forward-looking statements and estimates are not promises or guarantees and involve substantial risks and uncertainties. At this stage, DBV’s product candidates have not been authorized for sale in any country. Among the factors that could cause actual results to differ materially from those described or projected herein include uncertainties associated generally with research and development, clinical trials and related regulatory reviews and approvals, and DBV’s ability to successfully execute on its budget discipline measures. A further list and description of risks and uncertainties that could cause actual results to differ materially from those set forth in the forward-looking statements in this press release can be found in DBV’s regulatory filings with the French Autorité des Marchés Financiers (“AMF”), DBV’s filings and reports with the U.S. Securities and Exchange Commission (“SEC”), including in DBV’s Annual Report on Form 10-K for the year ended December 31, 2024, filed with the SEC on April 11, 2025, and future filings and reports made with the AMF and SEC by DBV. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements and estimates, which speak only as of the date hereof. Other than as required by applicable law, DBV Technologies undertakes no obligation to update or revise the information contained in this Press Release. Viaskin is a registered trademark and EPIT is a trademark of DBV Technologies. DBV Investor Relations Contact Katie MatthewsDBV [email protected] DBV Media Contact Angela MarcucciDBV [email protected] Attachment PDF Version

Investor releaseQuarter not tagged2025-03-24

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
Châtillon, France, March 24, 2025 DBV Technologies Secures Agreement with FDA on Safety Exposure Data Required for Biologics License Application (BLA) for Viaskin® Peanut Patch in 4 – 7-year-olds, Accelerating the Timeline for a BLA Filing Submission to 1H 2026, and Reports 2024 Unaudited Financial Results1 COMFORT Children supplemental safety study in children 4 – 7-years-old no longer required FDA confirms safety exposure data generated from VITESSE Phase 3 clinical study and VITESSE Open-Label Extension (OLE) are sufficient to support a Biologics License Application (BLA) for Viaskin peanut patch in children 4 – 7-years-old VITESSE topline results on-track for the fourth quarter of 2025 BLA submission for Viaskin peanut patch in children 4 – 7-years-old is now expected in the first half of 2026; DBV anticipates this path may accelerate potential launch, if approved by the FDA, by approximately one year DBV also reports unaudited financial results1 for the full year 2024, including cash and cash equivalents DBV Technologies (Euronext: DBV – ISIN: FR0010417345 – Nasdaq Stock Market: DBVT, the “Company”), a clinical-stage biopharmaceutical company, today announced that in a Written Responses Only to the Company’s Type D IND meeting request, the U.S. Food and Drug Administration (FDA) agreed with the Company’s proposal that the safety exposure data from the VITESSE Phase 3 study for Viaskin peanut patch in 4 – 7-year-olds will be sufficient to support a Biologics License Application (BLA) filing in this age group. As a result, the COMFORT Children supplemental safety study will no longer be required, which accelerates the timeline for a BLA submission of Viaskin® peanut patch in 4 – 7-year-olds with a peanut allergy. The Company also reported unaudited financial results1 for the full year 2024, including cash and cash equivalents. FDA UpdateBased on the Written Responses Only received, DBV will no longer conduct the COMFORT Children 6-month supplemental safety study. The Company will utilize the safety data from the VITESSE participants randomized to active treatment as well as placebo-crossover participants in the VITESSE Open Label Extension (OLE), expediting the BLA submission for the Viaskin peanut patch from the previously anticipated timeline. Accordingly, the Company plans to submit a BLA in the first half of 2026 and anticipates potentially…Read full document

Châtillon, France, March 24, 2025 DBV Technologies Secures Agreement with FDA on Safety Exposure Data Required for Biologics License Application (BLA) for Viaskin® Peanut Patch in 4 – 7-year-olds, Accelerating the Timeline for a BLA Filing Submission to 1H 2026, and Reports 2024 Unaudited Financial Results1 COMFORT Children supplemental safety study in children 4 – 7-years-old no longer required FDA confirms safety exposure data generated from VITESSE Phase 3 clinical study and VITESSE Open-Label Extension (OLE) are sufficient to support a Biologics License Application (BLA) for Viaskin peanut patch in children 4 – 7-years-old VITESSE topline results on-track for the fourth quarter of 2025 BLA submission for Viaskin peanut patch in children 4 – 7-years-old is now expected in the first half of 2026; DBV anticipates this path may accelerate potential launch, if approved by the FDA, by approximately one year DBV also reports unaudited financial results1 for the full year 2024, including cash and cash equivalents DBV Technologies (Euronext: DBV – ISIN: FR0010417345 – Nasdaq Stock Market: DBVT, the “Company”), a clinical-stage biopharmaceutical company, today announced that in a Written Responses Only to the Company’s Type D IND meeting request, the U.S. Food and Drug Administration (FDA) agreed with the Company’s proposal that the safety exposure data from the VITESSE Phase 3 study for Viaskin peanut patch in 4 – 7-year-olds will be sufficient to support a Biologics License Application (BLA) filing in this age group. As a result, the COMFORT Children supplemental safety study will no longer be required, which accelerates the timeline for a BLA submission of Viaskin® peanut patch in 4 – 7-year-olds with a peanut allergy. The Company also reported unaudited financial results1 for the full year 2024, including cash and cash equivalents. FDA UpdateBased on the Written Responses Only received, DBV will no longer conduct the COMFORT Children 6-month supplemental safety study. The Company will utilize the safety data from the VITESSE participants randomized to active treatment as well as placebo-crossover participants in the VITESSE Open Label Extension (OLE), expediting the BLA submission for the Viaskin peanut patch from the previously anticipated timeline. Accordingly, the Company plans to submit a BLA in the first half of 2026 and anticipates potentially accelerating the product launch by approximately one year, subject to FDA approval. “DBV’s alignment with FDA represents a tremendous achievement for food allergy families, clinicians, researchers, and countless external partners that have been working for many years to advance the Viaskin peanut patch in children living with peanut allergy,” said Daniel Tassé, Chief Executive Officer, DBV Technologies. “I thank the FDA and the Review Team for their collaboration and constructive approach during the Type D meeting process, which enabled us to gain clarity expeditiously. DBV is commencing preparations for a BLA submission in the first half of 2026 to be supported by the Phase 3 VITESSE study, which is on-track for readout of topline results in the fourth quarter of 2025. We believe that the Viaskin peanut patch has the potential to change the lives of millions of children living with peanut allergy. This mission drives DBV every day. We will continue to work hard to bring this innovative treatment option to market.” FDA has agreed with DBV’s proposal to support potential licensure of the Viaskin peanut patch in children 4 – 7-years-old with the efficacy, safety and patch wear time data generated from VITESSE, which enrolled 654 participants, making it the largest Phase 3 clinical trial for peanut allergy ever conducted in this age group. This will include safety data from study participants on active treatment for 12-months and the additional crossover study participants on active treatment in the VITESSE OLE. At the time of BLA submission, the safety database will be comprised of more than 500 study participants on Viaskin peanut patch active treatment. “I am extremely pleased to see that FDA agrees that the VITESSE safety exposure data being generated is sufficiently robust to support a BLA in this age group,” said Dr. David Fleischer, FAAAAI, FACAAI, Global Principal Investigator, VITESSE, Professor of Pediatrics at Children’s Hospital Colorado. “This is the largest, most rigorous study ever conducted in peanut allergic children between 4 and 7 years of age. The insights that we will gain from this work are invaluable to the disease space as a whole. Clinicians want to see additional FDA approved treatment options in food allergy so that we may conduct thoughtful conversations with our patients about which option is best for them and their lifestyle. I look forward to the day when the Viaskin peanut patch may be part of those conversations.” As previously communicated, DBV also plans to pursue an Accelerated Approval pathway for the Viaskin peanut patch in toddlers 1 – 3-years-old with a peanut allergy. The COMFORT Toddlers 6-month supplemental safety study is on-track to initiate in the second quarter of 2025 and will recruit approximately 480 study participants. The BLA submission for the 1 – 3-year-old indication is expected in the second half of 2026, subject to the successful completion of the COMFORT Toddlers study. “On behalf of our 6,500 members in the United States and globally, we are pleased to support potential new innovations in food allergy, including the Viaskin peanut patch, that could add to the toolbox allergist-immunologists consider when treating patients,” said Dr. James Tracy, DO, FACAAI, President, American College of Allergy, Asthma, and Immunology (ACAAI). “The ACAAI advocates for the best treatment outcomes for our patients under the care of their clinician. We are encouraged by the robust dataset being generated by the VITESSE Phase 3 study, in which many of our members are currently serving as investigators. We continue to support DBV’s development of the Viaskin peanut program in this 4 – 7-year-old age group. Our community encourages as many treatment options as possible to reach those who are eagerly awaiting.” Unaudited Financial Results1 for Full Year 2024These unaudited financial results1 have been examined by the Board of Directors of the Company on March 23, 2025, and the audited final financial statements are expected to be approved by the Board of Directors on March 28, 2025. The audit procedures by the statutory auditors of the Company on the 2024 consolidated full year financial statements are in progress. Financial results are presented under both U.S. generally accepted accounting principles (“US GAAP”) and the International Financial Reporting Standards (“IFRS”) as adopted by the European Union. Financial statement comments refer to U.S. GAAP financial statements. Differences between US GAAP and IFRS as adopted by the European Union consolidated financial statements result mainly from the discrepancies arising from the application of lease accounting standards. In order to finance its activities, the Company needs to raise additional funds and is actively reviewing potential financing and strategic options with its financial advisors. Cash and Cash EquivalentsCash and cash equivalents amounted to $32.5 million as of December 31, 2024, compared to $141.4 million as of December 31, 2023, a net cash consumption of $108.9 million, mainly driven by external clinical trial-related expenses, in particular those related to subject enrollment in the Company’s ongoing VITESSE Phase 3 clinical trial, with topline results expected by the fourth quarter of 2025 as previously communicated, as well as regulatory and manufacturing activities to support ongoing clinical trials. The Company has incurred operating losses and negative cash flows from operations since inception. As of the date of this press release, the Company’s available cash and cash equivalents will not be sufficient to support its operating plan for the next 12 months. Based on its current operations, plans and assumptions, the Company expects that its cash and cash equivalents will be sufficient to fund its operations only into April 2025. 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 filing of the BLA and launch of Viaskin® Peanut patch, if approved. The Company cannot guarantee that it will successfully obtain the necessary financing to meet its needs or to obtain funds at attractive terms and conditions. If the Company is not successful in its financing objectives, the Company could have to scale back its operations, notably by delaying or reducing the scope of its research and development efforts or obtain financing through arrangements with collaborators or others that may require the Company to relinquish rights to its product candidates that the Company might otherwise seek to develop or commercialize independently or discontinue all or part of its operations. Operating IncomeOperating income amounted to $4.2 million for the year ended December 31, 2024, compared with $15.7 million for the same period in 2023. This decrease by $11.5 million is composed of (1) $7.0 million following the mutual termination of the Development, Collaboration, and License Agreement with with Societé des Produits Nestlé S.A (formerly NESTEC S.A.) (“NESTEC”), and (2) a lower Research Tax Credit (“CIR”). This decrease is due to a corrective CIR filed in 2023 by the Company for $2.9 million for fiscal years 2020, 2021 and 2022 and a greater proportion of study activities carried out in North America in 2024 as compared to 2023, which are not eligible to the CIR. Operating ExpensesOperating expenses amounted to $120.7 million for the year ended December 31, 2024, compared with $92.2 million for the year ended December 31, 2023, an increase of $28.5 million. This increase is primarily driven by research & development costs of $29.1 million resulting from (1) subject enrollment in the Company’s ongoing VITESSE Phase 3 clinical trial, (2) preparatory activities for the Company’s COMFORT supplemental safety studies in anticipation of initiation after FDA alignment, and (3) regulatory and manufacturing activities to support ongoing clinical trials. General and administrative expenses decreased by $0.8 million during the year ended December 31, 2024, compared to the year ended December 31, 2023, primarily due to the positive impact of office moves in France and the U.S. Net Loss Per ShareThe 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 year ended December 31, 2023.On a per share basis, net loss (based on the weighted average number of shares outstanding over the period) was $(1.17) for the year ended December 31, 2024. CONSOLIDATED STATEMENTS OF FINANCIAL POSITION (unaudited) CONSOLIDATED STATEMENTS OF OPERATIONS (unaudited) CONSOLIDATED STATEMENTS OF CASH FLOWS (unaudited) DisclaimerThe unaudited financial results as of and for the year ended December 31, 2024 included inthis press release have been examined by the Board of Directors of the Company on March 23, 2025 and remain subject to any adjustments, and other developments arising between now and the time such financial results are finalized. The Company’s independent auditors have not yet audited nor have they expressed any opinion or any other form of assurance on these unaudited financial results, in particular DBV has not yet obtained assurance from its auditors that the financial statements will be certified without qualification. The audit procedures by the statutory auditors of the Company are in progress. About DBV TechnologiesDBV Technologies is a clinical-stage biopharmaceutical company developing treatment options for food allergies and other immunologic conditions with significant unmet medical need. DBV is currently focused on investigating the use of its proprietary VIASKIN® patch technology to address food allergies, which are caused by a hypersensitive immune reaction and characterized by a range of symptoms varying in severity from mild to life-threatening anaphylaxis. Millions of people live with food allergies, including young children. Through epicutaneous immunotherapy (EPIT™), the VIASKIN® patch is designed to introduce microgram amounts of a biologically active compound to the immune system through intact skin. EPIT is a new class of non-invasive treatment that seeks to modify an individual’s underlying allergy by re-educating the immune system to become desensitized to allergen by leveraging the skin’s immune tolerizing properties. DBV is committed to transforming the care of food allergic people. The Company’s food allergy programs include ongoing clinical trials of VIASKIN Peanut in peanut allergic toddlers (1 through 3 years of age) and children (4 through 7 years of age). DBV Technologies is headquartered in Châtillon, France, with North American operations in Warren, NJ. The Company’s ordinary shares are traded on segment B of Euronext Paris (Ticker: DBV, ISIN code: FR0010417345) and the Company’s ADSs (each representing five ordinary shares) are traded on the Nasdaq Capital Market (Ticker: DBVT; CUSIP: 23306J309). For more information, please visit www.dbv-technologies.com and engage with us on X (formerly Twitter) and LinkedIn. Forward Looking StatementsThis press release may contain forward-looking statements and estimates, including statements regarding the Company’s financial condition, forecast of its cash runway, financing plans, the therapeutic potential of VIASKIN® Peanut patch and EPIT™, designs of DBV’s anticipated clinical trials, DBV’s planned regulatory and clinical efforts including timing and results of communications with regulatory agencies, plans and expectations regarding initiation of the confirmatory study, plans and expectations with respect to the submission of BLAs to FDA, anticipated support for the BLA submission, and the ability of any of DBV’s product candidates, if approved, to improve the lives of patients with food allergies. These forward-looking statements and estimates are not promises or guarantees and involve substantial risks and uncertainties. At this stage, the Company’s product candidates have not been authorized for sale in any country. Among the factors that could cause actual results to differ materially from those described or projected herein include DBV’s ability to obtain necessary financing, uncertainties associated generally with research and development, clinical trials and related regulatory reviews and approvals, and the Company’s ability to successfully execute on its budget discipline measures. The review of potential financial and strategic options may not result in any particular action or transaction being pursued, entered into or consummated, and there is no assurance as to the timing, sequence or outcome of any action or transaction or series of actions or transactions. If the Company is unable to continue as a going concern, it may have to liquidate its assets and may receive less than the value at which those assets are carried on its financial statements, and it is likely that investors will lose all or part of their investment. A further list and description of risks and uncertainties that could cause actual results to differ materially from those set forth in the forward-looking statements in this press release can be found in the Company’s regulatory filings with the French Autorité des Marchés Financiers (“AMF”), the Company’s filings and reports with the U.S. Securities and Exchange Commission (“SEC”), including future filings and reports made with the AMF and SEC by the Company. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements and estimates, which speak only as of the date hereof. Other than as required by applicable law, the Company undertakes no obligation to update or revise the information contained in this press release. Viaskin is a registered trademark and EPIT is a trademark of DBV Technologies. Investor Contact Katie MatthewsDBV [email protected] Media ContactAngela MarcucciDBV [email protected] 1 The financial information published in this press release shall be considered as "données financières estimées" or "estimated financial data", according to AMF Position-Recommendation DOC-2016-05. Attachment PDF Version

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