DBV Technologies S.A.
For the period ended Jun 30, 2026. Filed Jul 16, 2026.
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A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Jun 30, 2026 · Filed Jul 16, 2026
DBVT$10.45+6.6%Stored close · as of Nov 6, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2026-03-31; filed 2026-04-30.
0001628280-26-028929
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2026-06-30; filed 2026-07-16.
0001628280-26-048453
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 62 previous paragraphs and 96 current paragraphs.
33 unchanged; 10 reworded; 45 added; 19 removed; 0 previous and 8 current paragraphs rearranged.
Tables are not compared: 8 previous and 11 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (45)
Current report
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.
Current report
The Company has earlier-stage food allergy programs including Viaskin Milk and other autoimmune inflammatory diseases.
Current report
Recent developments
Current report
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.
Current report
Regulatory Development
Current report
BLA Submission Update for VIASKIN® Peanut Patch for children aged 4 through7 years
Current report
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.
Current report
Clinical Development Update
Current report
Initiation of Phase 2 THRIVE Study
Current report
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.
Current report
Financing
Current report
Manufacturing and supply-chain readiness
Current report
Letter of intent signed with Fareva Amboise
Current report
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.
Current report
Letter of intent signed with ICS
Current report
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.
Current report
Manufacturing Supply Agreement (Peanut Source Material) with Fareva La Vallée
Current report
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.
Current report
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.
Current report
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.
Current report
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.
Current report
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.
Current report
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.
Current report
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.
Current report
Comparison of the Six Months Ended June 30, 2026 and 2025
Current report
Operating Income
Current report
Operating Expenses
Current report
Research and Development Expenses
Current report
Sales and Marketing Expenses
Current report
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.
Current report
General and Administrative Expenses
Current report
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.
Current report
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.
Current report
Financial Income (Expense)
Current report
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.
Current report
Income Tax
Current report
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.
Current report
Net Loss
Current report
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.
Current report
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
Showing the first 40 of 45 passages. Open the source sections for the rest.
Removed paragraphs (19)
Previous report
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.
Previous report
Overview of the First Quarter of 2026
Previous report
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.
Previous report
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.
Previous report
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.
Previous report
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.
Previous report
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.
Previous report
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.
Previous report
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.
Previous report
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.
Previous report
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.
Previous report
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.
Previous report
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.
Previous report
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.
Previous report
The following table presents our material expenses commitments for future periods:
Previous report
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.
Previous report
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.
Previous report
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.
Previous report
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:
Reworded paragraphs (10)
Previous wording
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.
Current wording
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.
Previous wording
The following table summarizes our sales and marketing expenses incurred during the three months ended March 31, 2026 and 2025:
Current wording
The following table summarizes our sales and marketing expenses incurred during the three months ended ended June 30, 2026 and 2025:
Previous wording
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.
Current wording
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.
Previous wording
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.
Current wording
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.
Previous wording
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.
Current wording
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.
Previous wording
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.
Current wording
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.
Previous wording
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.
Current wording
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.
Previous wording
The Company continued its precommercial inventory build up for $3.0 million in anticipation of potential FDA approval.
Current wording
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.
Previous wording
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.
Current wording
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.
Previous wording
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.
Current wording
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.
Rearranged current paragraphs (8)
Current report — wording carried from elsewhere
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.
Current report — wording carried from elsewhere
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.
Current report — wording carried from elsewhere
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.
Current report — wording carried from elsewhere
The following table summarizes our operating income during the six months ended June 30, 2026 and 2025:
Current report — wording carried from elsewhere
The Company did not generate Revenue from operating activities.
Current report — wording carried from elsewhere
The following table summarizes our research and development expenses incurred during the six months ended June 30, 2026 and 2025:
Current report — wording carried from elsewhere
The following table summarizes our sales and marketing expenses incurred during the six months ended June 30, 2026 and 2025:
Current report — wording carried from elsewhere
The following table summarizes our general and administrative expenses incurred during the six months ended June 30, 2026 and 2025: