DBVT

You should read the following discussion and analysis of our financial condition and results of operations in conjunction with our unaudited condensed consolidated financial statements and related notes included in Part 1, Item 1 of this Report and with our audited financial statements and related notes thereto for the year ended December 31, 2025, included in our Annual Report on Form 10-K for the year ended December 31, 2025, filed with the Securities and Exchange Commission on March 26, 2026, as amended by the Amendment No. 1 on Form 10-K/A filed with the SEC on April 30, 2026, or the Annual Report. This discussion and other parts of this Report contain forward-looking statements that involve risks and uncertainties, such as statements of our plans, objectives, expectations and intentions. Our actual results could differ materially from those discussed in these forward-looking statements. Factors that could cause such differences are discussed in the section of this Report titled “Special Note Regarding Forward-Looking Statements” and under “Item 1A. Risk Factors” in the Annual Report. Overview We are a late-stage specialty biopharmaceutical company focused on changing the field of immunotherapy by developing a novel technology platform called Viaskin. Our therapeutic approach is based on EPIT, our proprietary method of delivering biologically active compounds to the immune system through intact skin using Viaskin, an epicutaneous patch (i.e., a skin patch). We have generated significant data demonstrating that Viaskin’s mechanism of action is novel and differentiated. Viaskin targets specific antigen-presenting immune cells in the skin, called Langerhans cells, that capture the antigen and migrate to the lymph node in order to activate the immune system without passage of the antigen into the bloodstream, minimizing systemic exposure in the body. We are advancing this unique technology to treat children suffering from food allergies, for whom safety is paramount, since the introduction of the offending allergen into their bloodstream can cause severe or life-threatening allergic reactions, such as anaphylactic shock. We believe Viaskin may offer convenient, self-administered, non-invasive immunotherapy to patients, if approved. Our most advanced product candidate is Viaskin Peanut patch, which has been evaluated as a potential therapy for children with peanut allergy in twelve completed clinical trials, including five Phase 2 trials and five completed Phase 3 trials. The Company is planning for a BLA submission in the third quarter of 2026 for Viaskin Peanut patch as a potential treatment for children 4 through 7 years old. The Company also has an ongoing Phase 3 supplementary safety study of Viaskin Peanut patch in peanut-allergic toddlers ages one through three. Conditional on successful completion of this safety study, the Company is planning for a BLA submission in the second half of 2026 for children ages one to three. The Company has earlier-stage food allergy programs including Viaskin Milk and other autoimmune inflammatory diseases. Recent developments During the second quarter of 2026, the Company continued to advance the key elements supporting the potential commercialization of VIASKIN® Peanut, including regulatory readiness, clinical development, manufacturing and supply-chain preparedness, commercial launch planning and institutional investor engagement. Regulatory Development BLA Submission Update for VIASKIN® Peanut Patch for children aged 4 through7 years On June 29, 2026, the Company announced that it has had ongoing detailed iterative engagement with FDA with the goal of ensuring a complete, efficient, and timely review of the Company’s BLA for children aged 4 through 7 years, and, through this process and based on FDA review, DBV received valuable, actionable input from the FDA, specific to the organization, mapping, and formatting of existing data sets for the CMC and biostatistical elements of the BLA. The Company announced further that it will take the required time to incorporate the FDA’s feedback and anticipates the BLA filing to occur in the third quarter of 2026. The FDA did not request any additional data. Clinical Development Update Initiation of Phase 2 THRIVE Study On June 2, 2026, the Company announced that the first participant had been screened in the Phase 2 THRIVE study evaluating the efficacy and safety of the VIASKIN® Peanut patch in infants aged 6 through 12 months with peanut allergy. THRIVE is a single-arm, open-label study designed to assess the ability of participants to achieve ad lib consumption of dietary peanut following treatment with the VIASKIN® Peanut patch for 36 months. The Company believes the THRIVE study may provide additional information regarding the potential use of the VIASKIN® Peanut patch in younger patient populations. Financing March 2025 PIPE Financing The Company has received the supplemental gross proceeds of $94 million (€81 million) resulting in the full exercise of the ABSA Warrants and BS Warrants issued on its March 2025 PIPE Financing. 18 Manufacturing and supply-chain readiness Letter of intent signed with Fareva Amboise On June 25, 2026, the Company entered into a letter of intent with Fareva in connection with the planned commercial-scale manufacturing of the VIASKIN® Peanut patch. Under the letter of intent, Fareva will undertake manufacturing readiness activities, infrastructure and equipment upgrades and workforce expansion intended to support commercial production of VIASKIN® Peanut patch. The parties are currently negotiating a definitive commercial manufacturing and supply agreement. The planned investment for commercial manufacturing is estimated at $7.5 million, of which up to $5.2 million is expected to be supported by the Company through a combination of an FDA approval-contingent upfront payment and manufacturing-related pricing arrangements. The Company expects these activities to support preparedness for future commercialization of VIASKIN® Peanut patch, if approved. Letter of intent signed with ICS On June 5, 2026, the Company entered into a letter of intent with ICS in connection with future commercialization support and distribution services for the VIASKIN® Peanut patch, if approved, in the United States. Under the letter of intent, the parties agreed to undertake certain preliminary launch readiness and implementation planning activities while continuing negotiations toward a definitive commercial outsourcing services agreement. The contemplated activities include operational planning, systems readiness, distribution infrastructure preparation and other commercialization support services intended to facilitate a potential future product launch, if approved. Manufacturing Supply Agreement (Peanut Source Material) with Fareva La Vallée The Company entered into the MS Agreement with FLV, under which FLV will manufacture and supply the PSM exclusively for DBV Technologies S.A. during the agreement term. The term is effective for a period of eight (8) years and can be renewed for a period of two (2) years. Critical Accounting Policies and Significant Judgments and Estimates Our management’s discussion and analysis of our financial condition and results of operations is based on our unaudited condensed consolidated financial statements, which have been prepared in accordance with generally accepted accounting principles in the United States (“U.S. GAAP”). The preparation of these unaudited condensed consolidated financial statements requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the unaudited condensed consolidated financial statements, as well as the revenue, costs and expenses recognized during the reporting periods. Our estimates are based on our historical experience and on various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions. There have been no new policies or significant changes to our critical accounting policies as disclosed in the critical accounting policies described in the Annual Report. Business Trends and Results of Operations Comparison of the Three Months Ended June 30, 2026 and 2025 The following table summarizes our results of operations, derived from our unaudited condensed consolidated financial statements, which have been prepared in accordance with U.S. GAAP and presented in millions of U.S. dollars, for the three months ended June 30, 2026 and 2025. Three Months Ended June 30, 2026 2025 $ change % of change Operating income 0.7 1.5 (0.7) (51)% Operating expenses Research and development expenses (31.2) (33.7) 2.5 (7)% Sales and marketing expenses (5.5) (0.4) (5.1) 1225% General and administrative expenses (14.6) (8.5) (6.1) 72% Total Operating expenses (51.3) (42.6) (8.7) 21% Financial income (expense) 0.4 (0.6) 1.0 (162)% Income tax (0.2) (0.1) (0.1) 89% Net loss (50.4) (41.9) (8.5) 20% 19 Operating Income The following table summarizes our operating income during the three months ended June 30, 2026 and 2025: Three Months Ended June 30, 2026 2025 $ change % of change Other income 0.7 1.5 (0.7) (51)% Research tax credit 0.7 1.5 (0.7) (51)% Total operating income 0.7 1.5 (0.7) (51)% The Company did not generate Revenue from operating activities. Research tax credit decreased by $0.7 million for the three months ended June 30, 2026, compared to the three months ended June 30, 2025. The accrual is consistent with the prior quarter and reflects the lower level of eligible research activities, as the Company’s focus continues to shift from clinical development toward commercial readiness activities. Operating Expenses Research and Development Expenses The following table summarizes our research and development expenses incurred during the three months ended June 30, 2026 and 2025: Research and Development expenses Three Months Ended June 30, 2026 2025 $ change % of change External clinical-related expenses 16.9 20.2 (3.2) (16)% Employee-related costs 8.1 5.2 3.0 58% Share-based payment expenses 1.3 0.5 0.7 136% Depreciation, amortization and other costs 2.2 1.9 0.4 20% Pre-Commercial Inventory 2.6 6.0 (3.4) (56)% Total Research and Development expenses 31.2 33.7 (2.5) (7)% External clinical-related expenses decreased by $(3.2) million for the three months ended ended June 30, 2026, compared to the three months ended June 30, 2025. The decrease was primarily driven by the completion of the EPOPEX study, while expenditures associated with the VITESSE and COMFORT Toddlers programs remained globally consistent. Employee-related costs increased by $3.0 million for the three months ended ended June 30, 2026, compared to the three months ended June 30, 2025. This increase was mainly driven by hirings to support development, medical affairs, regulatory and quality capabilities. Pre-commercial inventory continues to increase during the period by $2.6 million as June 30, 2026 as the Company progresses with its commercialization readiness activities. The Company expenses Pre-commercial inventory until BLA approval. Sales and Marketing Expenses The following table summarizes our sales and marketing expenses incurred during the three months ended ended June 30, 2026 and 2025: Sales & Marketing expenses Three Months Ended June 30, 2026 2025 $ change % of change External professional services 3.3 0.2 3.1 2046% Employee-related costs 1.9 0.2 1.7 981% Share-based payment expenses 0.3 — 0.3 1443% Depreciation, amortization and other costs 0.1 0.1 — (17)% Total Sales & Marketing expenses 5.5 0.4 5.1 1225% Sales and marketing expenses have increased by $5.1 million during the three months ended June 30, 2026, compared to the three months ended June 30, 2025, primarily reflecting the continued execution of the Company’s commercial launch readiness strategy in the United States. The increase was driven by higher personnel and external costs associated with the expansion of commercial, market access and launch-support capabilities in preparation for a potential launch of VIASKIN® Peanut, if approved. 20 General and Administrative Expenses The following table summarizes our general and administrative expenses incurred during the three months ended June 30, 2026 and 2025: General & Administrative expenses Three Months Ended June 30, 2026 2025 $ change % of change External professional services 4.7 2.6 2.2 85% Employee-related costs 4.3 3.2 1.1 34% Share-based payment expenses 2.1 0.7 1.4 205% Depreciation, amortization and other costs 3.4 2.0 1.4 72% Total General & Administrative expenses 14.6 8.5 6.1 72% General and Administrative expenses increased by $6.1 million for the three months ended June 30, 2026, compared to the three months ended June 30, 2025, primarily reflecting continued scaling of the Company’s corporate infrastructure to support BLA readiness and commercial launch preparedness. Financial Income (Expense) Our financial income was $0.4 million for the three months ended June 30, 2026, compared to a financial expense of $0.6 million for the three months ended June 30, 2025, primarily reflecting higher interest income generated from the investment of available cash following the Company’s 2025 financing transactions, in accordance with its treasury policy. The increase was partially offset by foreign exchange unfavorable effects. Income Tax Our income tax expense was $0.2 million for the three months ended June 30, 2026 and was $0.1 million for the three months ended June 30, 2025. Net Loss Net loss was $50.4 million for the three months ended June 30, 2026, compared to $41.9 million for the three months ended June 30, 2025. Net loss per share (based on the weighted average number of shares outstanding over the period) was $(0.12) and $(0.31) for the three months ended June 30, 2026 and 2025, respectively. This improvement reflects a significantly strengthened equity base following recent financings. Comparison of the Six Months Ended June 30, 2026 and 2025 The following table summarizes our results of operations, derived from our unaudited condensed consolidated financial statements, which have been prepared in accordance with U.S. GAAP and presented in millions of U.S. dollars, for the six months ended June 30, 2026 and 2025. Six Months Ended June 30, 2026 2025 $ change % of change Operating income 1.6 2.2 (0.6) (27)% Operating expenses Research and development expenses (64.6) (55.2) (9.4) 17% Sales and marketing expenses (10.4) (0.7) (9.7) 1426% General and administrative expenses (25.1) (14.1) (11.0) 78% Total Operating expenses (100.1) (69.9) (30.1) 43% Financial income (expense) 0.9 (1.1) 2.0 (184)% Income tax (0.4) (0.1) (0.3) 278% Net loss (98.0) (69.0) (29.0) 42% Operating Income The following table summarizes our operating income during the six months ended June 30, 2026 and 2025: Six Months Ended June 30, 2026 2025 $ change % of change Research tax credit 1.6 2.2 (0.6) (28)% Total Other operating income 1.6 2.2 (0.6) (28)% The Company did not generate Revenue from operating activities. This caption consists of Research Tax Credit (crédit d’impôt recherche, or CIR) that is granted to companies by the French tax authorities in order to encourage them to conduct technical and scientific researches. The Company accrued $1.6 million as of June 30, 2026. This level in tax credit income accrual reflects on a full year basis the expected lower level of eligible experimental activities, as the Company’s focus continues to shift from clinical development toward commercial readiness activities. 21 Operating Expenses Research and Development Expenses The following table summarizes our research and development expenses incurred during the six months ended June 30, 2026 and 2025: Six Months Ended June 30, 2026 2025 $ change % of change External clinical-related expenses 36.6 30.3 6.3 21% Employee-related costs 15.5 9.2 6.3 68% Share-based payment expenses 2.4 1.1 1.2 110% Depreciation, amortization and other costs 4.4 4.3 0.1 3% Pre-Commercial Inventory 5.6 10.3 (4.6) (45)% Total Research and Development expenses 64.6 55.2 9.4 17% External clinical-related expenses increased by $6.3 million for the six months ended June 30, 2026 compared to the six months ended. The increase primarily reflects higher clinical trial activity during the first half of 2026, including COMFORT Toddlers study, and to the acceleration of BLA readiness activities to prepare BLA submission. These higher costs were partially offset by lower external clinical-related expenses in the second quarter 2026, primarily due to the completion of EPOPEX study. Employee-related costs and share based payment expenses respectively increased by $6.3 million and $1.2 million for the six months ended June 30, 2026, compared to the six months ended June 30, 2025 primarily due to reinforcement of Medical Affairs, Quality and Regulatory functions in the United States to support a potential U.S. launch, if approved, and to ensure organizational readiness as the Company approaches commercialization. The Company continued its precommercial inventory build up for $5.6 million in anticipation of potential FDA approval. The Company expenses Pre-commercial inventory until BLA approval. Sales and Marketing Expenses The following table summarizes our sales and marketing expenses incurred during the six months ended June 30, 2026 and 2025: Six Months Ended June 30, 2026 2025 $ change % of change External professional services 6.9 0.3 6.7 2584% Employee-related costs 2.8 0.3 2.5 790% Share-based payment expenses 0.4 — 0.4 1017% Depreciation, amortization and other costs 0.3 0.1 0.2 261% Total Sales & Marketing expenses 10.4 0.7 9.7 1427% Sales and marketing expenses increased by $9.7 million during the six months ended June 30, 2026, compared to the six months ended June 30, 2025. The prior-year period represented an earlier stage of the Company’s commercialization strategy, before FDA alignment on the planned BLA submission pathway and completion of the March 2025 PIPE Financing. Following these milestones, the Company accelerated investments in commercial infrastructure, market access and launch-support functions in the United States to support BLA readiness and preparation for a potential commercialization of VIASKIN® Peanut, if approved. General and Administrative Expenses The following table summarizes our general and administrative expenses incurred during the six months ended June 30, 2026 and 2025: General & Administrative expenses Six Months Ended June 30, 2026 2025 $ change % of change External professional services 6.9 3.6 3.3 91% Employee-related costs 7.8 5.1 2.7 52% Share-based payment expenses 3.2 1.8 1.4 78% Depreciation, amortization and other costs 7.3 3.6 3.7 103% Total General & Administrative expenses 25.1 14.1 11.0 78% General and Administrative expenses increased by $11.0 million for the six months ended June 30, 2026, compared to the six months ended June 30, 2025. The increase reflects the Company’s broader organizational transition following the March 2025 FDA alignment and March 2025 PIPE Financing, which enabled the Company to expand corporate capabilities required to support late-stage regulatory execution, commercial readiness and public-company infrastructure. Other operating expenses also increased mainly driven by the extension of the New Jersey office lease, D&O insurance as well as patents and licenses expenses. 22 Financial Income (Expense) Our financial income was $0.9 million for the six months ended June 30, 2026, compared to a financial expense of $1.1 million for the six months ended June 30, 2025 an increase reflecting interest yield earned on excess cash balances following the March 2025 PIPE Financing. The improvement also reflects the implementation of a foreign exchange risk management strategy intended to reduce exposure to U.S. dollar volatility. Income Tax Our income tax expense was $0.4 million for the six months ended June 30, 2026 compared to $0.1 million for the six months ended June 30, 2025. Net Loss Net loss was $98.0 million for the six months ended June 30, 2026, compared to $69.0 million for the six months ended June 30, 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. Liquidity and Capital Resources Our financing strategy is to maintain financial flexibility to meet working capital requirements including commercial inventory build and manufacturing capacity expansion to support demand of VIASKIN Peanut patches in the United States and Europe, if approved. Financial Condition On June 30, 2026, the Company held $174.9 million in cash and cash equivalents compared to $194.2 million of cash and cash equivalents held on December 31, 2025. Net cash used for operating activities was $101.7 million and $53.6 million for the periods ended June 30, 2026 and June 30, 2025, respectively. The Company’s net cash flows provided by financing activities totaled $89.0 million for the periods ended June 30, 2026 and $117.0 million in June 30, 2025, following the March 2025 PIPE Financing. In addition, the Company's results of operations and financial position are subject to the effects of foreign currency fluctuations, principally between the U.S. dollar and the Euro. The Company's functional currency is the Euro, and a significant portion of its operating expenses, including personnel costs and facility-related expenditures, are denominated in euros. During the six months ended June 30, 2026, the euro depreciated against the U.S. dollar, resulting in a $(5.3) million unfavorable foreign currency translation adjustment recognized in other comprehensive loss and a $(5.6) million unfavorable effect of exchange rate changes on cash and cash equivalents. As the Company continues to expand its U.S.-based operations in preparation for a potential commercial launch, an increasing proportion of its expenditures are denominated in U.S. dollars; however, the Company's euro-denominated cost base remains substantial. Continued appreciation of the euro against the U.S. dollar would increase the U.S. dollar equivalent of the Company's euro-denominated operating expenses and could accelerate the utilization of the Company's cash resources. The Company utilizes foreign exchange swap instruments to manage a portion of this exposure, as described in Note 9 to the condensed consolidated financial statements; however, there can be no assurance that such measures will fully offset the impact of adverse currency movements on the Company's results of operations, cash flows or financial condition. Sources of Liquidity and Material Cash Requirements Since its inception and up to June 30, 2026, the Company has received a total of approximately $1.7 billion in equity financing, almost all of which relates to cash proceeds from capital increases. The Company obtained the following gross proceeds from various financings through the issuance of securities as detailed : In Million dollars Equity capital Before 2023 1,309.7 2023 7.8 2024 — 2025 291.5 2026 94.7 Total 1,703.7 In June 2022, the Company announced an aggregate $194 million private investment in public equity (“PIPE”) financing from the sale of 32,855,669 ordinary shares, as well as pre-funded warrants to purchase up to 28,276,331 ordinary shares. The ordinary shares were sold to the purchasers at a price per ordinary share of €3.00 (corresponding to $3.22), and the pre-funded warrants at a pre-funded price of €2.90 (corresponding to $3.11) per pre-funded warrant, which equals the per share price for the ordinary shares less the remaining €0.10 exercise price for each such pre-funded warrant. In April 2025, the Company completed a PIPE financing generating initial gross proceeds of $125.5 million (€116.3 million), followed by the full exercise of associated warrants in January 2026 after the announcement of positive Phase 3 VITESSE topline results, resulting in additional gross proceeds of $195.4 million (€166.7 million at 1 EUR = $1.17). Of the additional gross proceeds, $100.7 million was received as of December 31, 2025 and the remaining $94.7 million (€81.0 million at the exchange rate of 1 EUR = $1.17) was received in January 2026. In addition, in September 2025, the Company entered into an at-the-market sales agreement (the "Sales Agreement") with Citizens JMP Securities, LLC ("Citizens"), under which the Company could offer and sell, from time to time, at its sole discretion, ADSs having an aggregate offering price of up to $150.0 million through Citizens. Citizens received commissions of up to 3.0% of the gross proceeds of any ADSs sold through Citizens under the Sales Agreement. The ADSs were offered and sold pursuant to the Company's shelf registration statement on Form S-3, which was originally filed with the Securities and Exchange Commission on April 6, 2023. During the fourth quarter of 2025, the Company received approximately $65 million in gross proceeds from the sale of 4,790,552 ADSs under the Sales Agreement, after deducting sales commissions and offering expenses. No sales were made under the Sales Agreement during the six months ended June 30, 2026. The Form S-3 under which the Sales Agreement was established expired in April 23 2026; accordingly, the Company is currently unable to make additional sales under the Sales Agreement until a new registration statement on Form S-3 becomes effective and a new prospectus supplement is filed. The Company also benefits as an SME status from refunds of Research Tax credit (crédit d’impôt recherche) granted to companies by the French tax authorities in order to encourage them to conduct technical and scientific research. Material expenses commitments The Company expects future cash requirements to be driven primarily by the continued advancement of its clinical programs, BLA readiness activities, commercial launch preparedness, manufacturing scale-up initiatives, operating lease obligations and contractual commitments under strategic manufacturing and supply agreements, including arrangements with Sanofi and Fareva. Further information regarding these commitments is provided in Note 14 to the condensed consolidated financial statements. The commitment amounts are based on contractual obligations that incorporate fixed or minimum service commitments, fixed, minimum, or variable pricing mechanisms, and the anticipated timing of the related contractual activities. Future events could cause actual payments to differ from these estimates. The Company continues to monitor geopolitical and macroeconomic developments and, while such conditions may affect future operating costs, supply chains and foreign exchange markets, management does not believe they have had a material impact on the Company's condensed consolidated financial statements as of June 30, 2026. Forward-looking 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 this Form 10‑Q, 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 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 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. Smaller Reporting Company Status We are a smaller reporting company as defined in the Securities Exchange Act of 1934, as amended. We may, and intend to, take advantage of certain of the scaled disclosures available to smaller reporting companies and will be able to take advantage of these scaled disclosures for so long as we are a smaller reporting company. We may be a smaller reporting company in any year in which (i) the market value of our voting and non-voting ordinary shares held by non-affiliates is less than $250.0 million measured on the last business day of our second fiscal quarter or (ii) (a) our annual revenue is less than $100.0 million during the most recently completed fiscal year and (b) the market value of our voting and non-voting ordinary shares held by non-affiliates is less than $700.0 million measured on the last business day of our second fiscal quarter. 24