DBV Technologies S.A.: Form 10-Q for the period ended Mar 31, 2026

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, which has been evaluated as a potential therapy for children with peanut allergy in twelve clinical trials, including three Phase 2 trials and four completed Phase 3 trials. We have two ongoing Phase 3 trials of Viaskin Peanut in children ages one to three and ages four to seven with peanut allergy. The Company plans to submit a BLA for Viaskin Peanut in children aged 4 to 7 in the first half of 2026. With respect to the toddler program, the COMFORT Toddlers supplemental safety study in peanut allergic children aged 1 to 3, which screened its first subject on June 25, 2025, is ongoing and the Company continues to enroll subjects towards its target of approximately 300 to 350 subjects on active treatment. This would bring the total Viaskin Peanut patch safety database in this age group to approximately 600 subjects, consistent with prior FDA guidance.

Overview of the First Quarter of 2026

In the first quarter of 2026, the Company started to execute its plan for the potential U.S. commercialization of the Viaskin Peanut patch for children aged 4 to 7, following regulatory, clinical and financial developments in 2025 that will support a BLA filing and have increased cash and cash equivalents.

In March 2025, the FDA confirmed the safety data requirements to support the planned Biologics License Application for Viaskin Peanut in children aged 4 to 7 if approved, providing a clear and executable path toward submission. Subsequently, the Company completed its March 2025 PIPE financing. In addition ATM sales in the second half of 2025 materially strengthened the Company’s balance sheet, enabling continued progression toward potential commercialization while maintaining disciplined capital allocation. Finally, in December 2025, the Company reported positive topline results from the Phase 3 VITESSE trial in peanut-allergic children aged 4 to 7 years that enable a BLA filing expected in the first half of 2026.

The Company’s strategic objective remains to change the field of immunotherapy by developing and commercializing safe, effective, and convenient therapies for patients with food allergies and other immunological conditions while delivering sustained value to shareholders.

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. Our significant accounting policies are more fully described in Note 1 of the Notes to the Consolidated Financial Statements in Part I, Item 1 of our Annual Report.

Business Trends and Results of Operations

Comparison of the Three Months Ended March 31, 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 March 31, 2026 and 2025.

Operating Income

The following table summarizes our operating income during the three months ended March 31, 2026 and 2025:

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 $0.9 million as of March 31, 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.

Operating Expenses

Research and Development Expenses

The following table summarizes our research and development expenses incurred during the three months ended March 31, 2026 and 2025:

External clinical-related expenses increased by $10.0 million for the three months ended March 31, 2026 compared to the three months ended March 31, 2025 mainly due to higher clinical trial activity driven by the initiation of patient recruitment for the COMFORT Toddlers study, and to the acceleration of BLA readiness activities to prepare BLA submission.

Employee-related costs and share based payment expenses respectively increased by $3.3 million and $0.5 million for the three months ended March 31, 2026, compared to the three months ended March 31, 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 $3.0 million in anticipation of potential FDA approval.

Depreciation, amortization and other costs decreased by $0.7 million for the three months ended March 31, 2026, compared to the three months ended March 31, 2025 primarily due to lower depreciation and amortization. Other costs reduced as well in the absence of certain prior-year charges.

Sales and Marketing Expenses

The following table summarizes our sales and marketing expenses incurred during the three months ended March 31, 2026 and 2025:

Sales and marketing expenses have increased by $4.6 million during the three months ended March 31, 2026, compared to the three months ended March 31, 2025 reflecting the Company’s go‑to‑market strategy.

In the third quarter of 2025, the Company appointed a Chief Commercial Officer, marking a key step in establishing a dedicated commercial organization. Since then, efforts have focused on building U.S.‑based commercial, market access and launch‑readiness capabilities designed to support a successful introduction of Viaskin® Peanut in children aged 4 to 7, if approved. The increase in sales and marketing expenses in the first quarter of 2026 reflects the continued build‑out of this commercial infrastructure and the progression toward execution of this strategy.

General and Administrative Expenses

The following table summarizes our general and administrative expenses incurred during the three months ended March 31, 2026 and 2025:

General and Administrative expenses increased by $4.9 million for the three months ended March 31, 2026, compared to the three months ended March 31, 2025.

External professional services increased by $3.1 million for the three months ended March 31, 2026, compared to the three months ended March 31, 2025 primarily due to an accelerated activity in 2026 to support a potential U.S. launch, if approved, and to ensure organizational readiness as the Company approaches commercialization particularly through Investor Relations, Human Resources and Legal activities. This increase in activity is further accentuated given that, in the prior-year period, the Company was containing its costs and expenses during its financing period ended in March 31, 2025.

Employee-related costs and share-based payments increased by $1.6 million, for the three months ended March 31, 2026, compared to the three months ended March 31, 2025 as the Company continued to scale its organization in preparation for commercial operations. The growth in full time employees was concentrated in Human Resources, Information Solutions, Finance, and Legal and Compliance, reflecting targeted investments in the core infrastructure required to achieve commercial readiness for Viaskin Peanut in North America. These additions were designed to strengthen operational capabilities, enhance organizational maturity, and support the transition toward a potential commercial launch, if approved.

Depreciation, amortization and other costs increased by $0.3 million for the three months ended March 31, 2026, compared to the three months ended March 31, 2025.

Financial Income (Expense)

Our financial income was $0.5 million for the three months ended March 31, 2026, compared to a financial expense of $0.5 million for the three months ended March 31, 2025. This item mainly includes the interest income on our short term investments.

Income Tax

Our income tax expense was $0.2 million for the three months ended March 31, 2026 compared to nil for the three months ended March 31, 2025. The income tax expense for the current period relates to the Company’s U.S. subsidiary, which generated taxable income pursuant to the Company’s intercompany transfer pricing arrangements.

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 outstanding over the period) decreased from $(0.26) to $(0.11) for the three months ended March 31, 2025 and March 31, 2026, respectively.

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 March 31, 2026, the Company held $229.2 million in cash and cash equivalents compared to $194.2 million of cash and cash equivalents on December 31, 2025. Net cash used for operating activities was $49.1 million and $19.7 million for the periods ended March 31, 2026 and March 31, 2025, respectively. The Company’s net cash flows provided by financing activities totaled $88.9 million for the periods ended March 31, 2026 and nil in March 31, 2025, following the full Exercise of the ABSA Warrants and BS Warrants Issued on its 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 three months ended March 31, 2026, the euro depreciated against the U.S. dollar, resulting in a $(4.4) million unfavorable foreign currency translation adjustment recognized in other comprehensive loss and a $(4.5) 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, which are held primarily in U.S. dollars. The Company utilizes foreign exchange swap instruments to manage a portion of this exposure, as described in Note 8 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 March 31, 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 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 established an ATM equity program pursuant to which it may offer and sell up to $150.0 million of ADSs, subject to applicable regulatory limits. During the fourth quarter of 2025, the Company raised $65 million in gross proceeds through multiple issuances of ADSs.

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 following table presents our material expenses commitments for future periods:

The commitment amounts in the table above are associated with contracts that are enforceable and legally binding and that specify all significant terms, including fixed or minimum services to be used, fixed, minimum or variable price provisions, and the approximate timing of the actions under the contracts. Future events could cause actual payments to differ from these estimates.

Forward-looking

As of March 31, 2026, Cash & Cash Equivalents are $229.2 million. Based on its current operations, plans, and assumptions, Management estimates that the Company is sufficiently funded to run 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.

The Company's net cash used in operating activities increased to $49.1 million for the three months ended March 31, 2026, compared to $19.7 million for the three months ended March 31, 2025, reflecting the acceleration of clinical development activities, the build-out of commercial infrastructure, and the continued expansion of the Company's workforce in preparation for a potential U.S. launch of Viaskin Peanut, if approved. The Company expects its operating cash outflows to remain at elevated levels, and potentially increase further, as it advances toward BLA submission, continues to invest in manufacturing readiness and pre-commercial inventory, and scales its commercial organization. This anticipated trajectory of expenditures has been incorporated into the Company's cash runway estimate described above. However, the rate at which the Company utilizes its cash resources may vary materially from current expectations depending on, among other factors, the timing and scope of regulatory interactions, the pace of clinical enrollment, the timing of manufacturing-related capital commitments, and fluctuations in foreign exchange rates. If the Company's operating cash outflows exceed current projections, the Company may need to seek additional financing earlier than anticipated.

The Company may expend resources sooner than anticipated and may seek additional resources to execute the corporate strategy either through new or existing financing strategies. As of date of issuance, the remaining financing capacity and Equity securities are:

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.

We are a smaller reporting company as defined by Rule 12b-2 of the Exchange Act and are not required to provide the information required under this item.

Disclosure Controls and Procedures

Based on its evaluation as of March 31, 2026, our management, including our Chief Executive Officer and Chief Financial Officer, concluded that our disclosure controls and procedures (as defined in Rule 13a-15(e) under the Exchange Act) were effective to provide reasonable assurance that (i) the information required to be disclosed in our reports filed or submitted under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms, and (ii) such information is accumulated and communicated to our management, including our Chief Executive Officer and Chief Financial Officer, as appropriate, to allow timely decisions regarding required disclosure.

Changes in Internal Control Over Financial Reporting

There were no changes in our internal control over financial reporting identified in management’s evaluation pursuant to Rules 13a-15(d) or 15d-15(d) of the Exchange Act during the period covered by this Quarterly Report on Form 10-Q that materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

Limitation on Effectiveness of Controls and Procedures

Our management, including our Chief Executive Officer and Chief Financial Officer, does not expect that our disclosure controls and procedures or our internal controls will prevent all error and all fraud. A control system, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the control system are met. Further, the design of a control system must reflect the fact that there are resource constraints, and the benefits of controls must be considered relative to their costs. Because of the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that all control issues and instances of fraud, if any, within the Company have been detected. These inherent limitations include the realities that judgments in decision making can be faulty and that breakdowns can occur because of simple error or mistake. Controls can also be circumvented by the individual acts of some persons, by collusion of two or more people, or by management override of the controls. The design of any system of controls is based in part on certain assumptions about the likelihood of future events, and there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions. Over time, controls may become inadequate because of changes in conditions or deterioration in the degree of compliance with policies and procedures. Because of the inherent limitations in a cost-effective control system, misstatements due to error of fraud may occur and not be detected.

Our business is subject to risks and events that, if they occur, could adversely affect our financial condition and results of operations and trading price of our securities. In addition to the other information set forth in this Quarterly Report, you should carefully consider the factors described in Part I, Item 1A. “Risk Factors” of our Annual Report. While management has plans to address these issues, there is no assurance these plans will be successful, which could materially impact our business and financial condition.