DBV Technologies S.A.
For the period ended Sep 30, 2026. Filed Oct 28, 2026.
View on SEC.govAbout this filing
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.
Sep 30, 2026 · Filed Oct 28, 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 2026-06-30; filed 2026-07-16.
0001628280-26-048453
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2026-09-30; filed 2026-10-28.
0001628280-26-067930
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 96 previous paragraphs and 111 current paragraphs.
46 unchanged; 33 reworded; 29 added; 16 removed; 1 previous and 3 current paragraphs rearranged.
Tables are not compared: 11 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 (29)
Current report
During the third quarter of 2026, we made significant progress toward the potential commercialization of VIASKIN® Peanut. Following extensive interactions with the FDA during the quarter, we submitted our BLA for VIASKIN Peanut in children ages 4 through 7 years old on September 29, 2026 and requested Priority Review.
Current report
In parallel, supported by our strengthened financial resources extended through the refresh of the ATM Program, we accelerated the build-out of our commercial capabilities and continued to advance clinical development, manufacturing and supply-chain readiness and institutional investor engagement, including preparations for FDA inspection, while progressing launch infrastructure.
Current report
We are actively working to advance launch infrastructure, including distribution and patient access capabilities to support the launch of VIASKIN Peanut patch in the United States, upon approval..
Current report
Submission of BLA FDA for the VIASKIN® Peanut Patch in Children Aged 4-7 Years
Current report
On September 29, 2026, we announced the submission of a BLA to FDA seeking approval of the VIASKIN Peanut patch for the treatment of peanut allergy in children aged 4 through 7 years. The submission is supported by data from the Phase 3 VITESSE study, a randomized, double-blind, placebo-controlled trial, which enrolled 654 children. We requested Priority Review, which, if granted, would reduce the standard review period from ten to six months. The FDA has 60 days from the submission date to determine whether the BLA is sufficiently complete to permit substantive review, following which we anticipate receipt of a PDUFA target action date. The BLA filing represents a significant regulatory milestone and an important step toward the potential commercialization of VIASKIN® Peanut in the United States. There can be no assurance that the FDA will accept the BLA for filing, grant Priority Review, or ultimately approve the VIASKIN® Peanut patch.
Current report
Shelf Registration Statement, ATM Program Refresh and Sale of $50 million in gross proceeds under ATM Program
Current report
On July 27, 2026, we filed an automatically effective shelf registration statement on Form S-3ASR with the SEC. The shelf registration statement permits us to sell, from time to time, ADSs representing ordinary shares and warrants. At the time of filing the shelf registration statement, we also filed a prospectus supplement with the SEC authorizing the sale of up to $150.0 million of ADSs under our existing ATM Program. On August 3, 2026, we announced the sale of $50.0 million in gross proceeds of ADSs to RA Capital Management, L.P. under the ATM Program. In connection with this transaction, we issued 18,288,220 new ordinary shares, underlying 3,657,644 new ADSs, at an at-the-market price of $13.67 per ADS.
Current report
On September 30, 2026, the Company entered into Amendment No. 1 to its June 25, 2026 Letter of Intent with Fareva Amboise concerning manufacturing readiness activities supporting the future commercial-scale manufacture of the VIASKIN® Peanut patch. The planned investment is estimated at $5.5 million (at the exchange rate of 1€ = $1.14). Under the amendment, the Company's $1.1 million (at the exchange rate of 1€ = $1.14) upfront contribution to this project was modified such that payment is no longer contingent upon FDA approval of the Company's Biologics License Application. Instead, payment is contingent upon the successful completion of an independent Mock Pre-Approval Inspection , including the absence of critical findings or repeat observations and remediation of all findings by February 1, 2027.
Current report
In addition, the amendment finalized and secured the workforce expansion component of the project, including training and extended readiness activities. These personnel are dedicated to supporting industrial ramp-up, execution of the remediation plan and commercial manufacturing preparedness. The parties continue to negotiate a definitive commercial manufacturing and supply agreement. The Company expects the amended arrangement to support the timely execution of manufacturing readiness activities and further prepares the Amboise facility for future commercial production of VIASKIN® Peanut, if approved, including activities necessary to support a successful FDA pre-approval inspection.
Current report
Services Agreement with Fareva La Vallée - Peanut Drug Substance
Current report
On July 8, 2026, the Company entered into a PDS Services Agreement and Binding Commercial Term Sheet with FLV relating to the construction development, installation and qualification of a dedicated PDS manufacturing line, as well as related transfer services for technical and validation batches. The PDS facility services are expected to be completed no later than September 30, 2027, and the transfer services no later than September 1, 2028. The agreement also includes binding commercial terms expected to be incorporated into a future definitive manufacturing and supply agreement.
Current report
External clinical-related expenses increased by $8.2 million for the three months ended September 30, 2026, compared to the three months ended September 30, 2025. The increase was primarily driven by accelerated patient enrollment in COMFORT Toddlers study, with the last patient randomized in August 2026, the ramp-up of expenses associated to THRIVE study, initiated in 2026, and the acceleration of BLA readiness activities to prepare BLA submission. This increase was partially offset by the completion of EPOPEX study and the resulting reduction in associated expenses, as well as lower costs related to VITESSE study after the last patient last visit double-blind placebo-controlled end of 2025.
Current report
Employee-related costs and share based payment expenses respectively increased by $2.4 million and $0.8 million for the three months ended September 30, 2026, compared to the three months ended September 30, 2025. This increase is consistent with the reinforcement of Medical Affairs, Quality and
Current report
Following extensive interactions with the FDA, the Company also submitted its BLA for children ages 4 through 7 on September 29, 2026 and requested Priority Review, resulting in the recognition of $4.7 million of previously deferred BLA-related costs, which accounted for the majority of $7.9 million recognized during the period.
Current report
Pre-commercial inventory expense increased by $0.9 million, or 24%, reflecting the continued build-up of potential commercial inventory as the Company advances launch readiness for VIASKIN® Peanut. Following the manufacturing ramp-up initiated in the third quarter of 2025, the Company continued to receive inventory produced essentially by its contract manufacturing organizations, to support potential commercial launch requirements. Until BLA approval is obtained, the related manufacturing costs continue to be recognized as research and development expense.
Current report
General and Administrative expenses increased by $6.7 million for the three months ended September 30, 2026, compared to the three months ended September 30, 2025, reflecting continued scaling of the Company’s corporate infrastructure to support BLA readiness and commercial launch preparedness. The increase was driven by $3.3 million of higher share-based compensation expense, related to new CEO grants, together with higher employee-related costs associated with 11 additional employees compared to September 30, 2025.
Current report
Comparison of the Nine Months Ended September 30, 2026 and 2025
Current report
Following extensive interactions with the FDA, the Company also submitted its BLA for children ages 4 through 7 on September 29, 2026 and requested Priority Review, resulting in the recognition of $4.7 million of previously deferred BLA-related costs, which accounted for the majority of the increase of $5.3 million compared to September 30, 2025.
Current report
Pre-commercial inventory expense decreased by $3.7 million, reflecting the significant manufacturing ramp-up undertaken in 2025 following the March 2025 PIPE financing and alignment with the FDA. During 2026, the Company maintained a more established production cadence while continuing to build potential commercial inventory and advance launch readiness for VIASKIN® Peanut. These costs continue to be recognized as research and development expense prior to BLA approval.
Current report
Sales and marketing expenses increased by $13.9 million during the nine months ended September 30, 2026, compared to the nine months ended September 30, 2025. The increase was primarily driven by higher personnel-related and external costs associated with the expansion of the Company’s commercial, market access and launch-support capabilities in preparation for the potential U.S. launch of VIASKIN® Peanut, if approved. This expansion included the hiring of 15 U.S.-based employees compared to September 30, 2025, across Market Access and Patient Services (5), Marketing and Market Insights (4), Sales and Commercial Operations (3), and Commercial Leadership and Transformation (3).
Current report
The increase was mainly driven by $3.7 million in employee-related costs and $4.7 million in share-based payment expenses, attributable to 11 additional employees and new CEO grants. Depreciation, amortization and other costs also rose by $4.9 million primarily due to the extension of the New Jersey office lease, D&O insurance, Director fees, and patents and licenses expenses.
Current report
Our financial income was $1.5 million for the nine months ended September 30, 2026, compared to nil for the nine months ended September 30, 2025. The increase primarily reflects higher interest income earned on larger average cash and investment balances following financing activities. Financial income for the 2025 comparative period was totally offset by unfavorable foreign exchange effects, which reduced the benefit of interest income earned on investments.
Current report
Since its inception and through September 30, 2026, the Company has raised $1,753.7 million in aggregate equity financing to fund its research and development activities, commercial preparedness, and general corporate operations. The following table summarizes the gross proceeds received from each financing transaction through the issuance of securities:
Current report
The shelf-registration statement on Form S-3 under which the Sales Agreement was established expired in April 2026, and in July 2026 the Company filed a new automatically effective shelf registration statement on Form S-3ASR, which includes a base prospectus and a sales agreement prospectus supplement refreshing the ATM Program by filing a prospectus supplement for the sale of up to $150.0 million of ADSs. During the nine months ended September 30, 2026, the Company completed the sale of $50.0 million in gross proceeds of ADSs to RA Capital Management, L.P. under the Sales Agreement. In connection with this transaction, the Company issued 18,288,220 new ordinary shares, underlying 3,657,644 new ADSs, at an at-the-market price of $13.67 per ADS. The additional capital further strengthened the Company’s financial resources as it advanced the BLA submission and continued to invest in clinical development, manufacturing readiness and preparations for the potential commercialization of VIASKIN® Peanut, if approved.
Current report
The Company also seeks to optimize the return on its available cash through short-term investments, which generate interest income while preserving liquidity for anticipated operating and strategic requirements. In addition, the Company benefits from refunds of research tax credits (crédit d’impôt recherche) available in France in connection with qualifying research and development activities.
Current report
The Company further actively manages excess liquidity through low-risk, interest-bearing investments, generating financial income while preserving flexibility to fund its operating and strategic priorities. The Company also benefits as an SME status from research tax credit (crédit d’impôt recherche) refunds in France related to qualifying research and development activities.
Current report
As of September 30, 2026, the Company had cash and cash equivalents of $165.7 million. During the third quarter of 2026, the Company achieved significant regulatory and financing milestones, including the submission of its BLA for VIASKIN® Peanut in children ages 4 through 7 on September 29, 2026, for which the Company requested Priority Review, and the sale of $50.0 million in gross proceeds of ADSs under its ATM Program in July 2026. Following the BLA submission, management updated the Company’s operating and liquidity forecasts to reflect the potential regulatory review pathway and the anticipated timing of related clinical, regulatory, manufacturing and commercial readiness activities. The Company’s forecasts incorporate milestone-based spending assumptions designed to align the timing of certain expenditures with potential regulatory developments while continuing to advance activities necessary to support regulatory review and potential commercialization. Based on its current operations, plans and assumptions, the Company estimates that its existing cash and cash equivalents will be sufficient to fund operations into the third quarter of 2027.
Current report
As such, Management has concluded that the Company's existing cash and cash equivalents are not sufficient to fund its operations for at least twelve months from the date of issuance of these interim condensed consolidated financial statements. Accordingly, substantial doubt exists about the Company's ability to continue as a going concern within twelve months after the date these condensed consolidated financial statements are issued.
Current report
The Company will require additional capital to fund its operations. Management is actively evaluating multiple financing alternatives, including, without limitation, potential additional sales under the Company’s existing ATM Program, equity transactions, warrants exercise and other alternative forms of financing. The Company’s continued advancement through the regulatory review process may provide additional financing opportunities. However, the availability, timing and terms of any additional financing will depend on regulatory developments, market conditions and investors’ interest, lenders and other counterparties, and there can be no assurance that additional financing will be available when needed, on acceptable terms or at all.
Removed paragraphs (16)
Previous 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.
Previous report
BLA Submission Update for VIASKIN® Peanut Patch for children aged 4 through7 years
Previous 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.
Previous 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.
Previous 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.
Previous 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.
Previous report
Comparison of the Six Months Ended June 30, 2026 and 2025
Previous report
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 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.
Previous 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.
Previous 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.
Previous report
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 :
Previous report
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.
Previous report
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.
Previous report
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.
Previous report
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.
Reworded paragraphs (33)
Previous wording
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.
Current wording
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 epicutaneous immunotherapy, 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 specialized antigen-presenting immune cells in the skin, called Langerhans cells, that capture the antigen that accumulates in the outer layer of the skin, and then migrate to the skin-draining lymph nodes 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.
Previous wording
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 wording
Our most advanced product candidate is Viaskin Peanut patch, evaluated as a potential immunotherapy for children with peanut allergy in twelve clinical trials, including four Phase 2 trials and five completed Phase 3 trials. We are advancing two separate Viaskin Peanut product candidates in parallel to support two potential BLAs in two distinct age groups: one in toddlers ages one through three with the original, or square, patch, and one in children ages four through seven with the modified, or circular, patch. We submitted the BLA for Viaskin Peanut patch as a potential treatment for children 4 through 7 years old in the third quarter of 2026 and requested Priority Review. We also have an ongoing Phase 3 supplementary safety study of Viaskin Peanut patch in peanut-allergic toddlers ages one through three. We have held discussions with the FDA on how to ensure a timely review of the BLA for Viaksin Peanut for toddlers aged 1 through 3 years following the recent submission of the BLA for Viaskin Peanut for children 4 through 7 years old, including a potential rolling submission of the 1-through-3 BLA. The same review team will review both BLAs. The FDA indicated to us that a review of the BLA for Viaskin Peanut for 1 through 3 year olds initiated shortly after the review of the 4-through-7 BLA would allow the FDA to build on the learnings from its review and the efficiencies expected from the meaningful content overlap of the two BLAs. It would provide us and FDA the opportunity to align on the form, content, and best timing of the components of the submission of the BLA for Viaskin Peanut for 1 through 3 year olds, in support of an efficient review of both BLAs. We will continue the regulatory dialogue with FDA over the next few months and expect to submit the BLA for Viaskin Peanut in toddlers 1 through 3 years old in 2027, and we expect to will provide further update once the regulatory pathway for our toddler program has been finalized.
Previous wording
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 wording
On June 29, 2026, we announced that we had ongoing detailed iterative engagement with FDA with the goal of ensuring a complete, efficient, and timely review of tour BLA for children aged 4 through 7 years, and, through this process and based on FDA review, we 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. We announced further that we would take the required time to incorporate the FDA’s feedback and that it anticipated the BLA filing to occur in the third quarter of 2026. The FDA did not request any additional data.
Previous wording
Initiation of Phase 2 THRIVE Study
Current wording
Phase 2 THRIVE Study
Previous wording
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 wording
On June 2, 2026, we 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. The study has since progressed to eight participating clinical sites and eight enrolled patients. THRIVE is a single-arm, open-label study designed to assess the ability of participants to achieve ad lib consumption of dietary peanut following 36 months of treatment with the VIASKIN® Peanut patch. We believe the THRIVE study may provide additional information regarding the potential use of the VIASKIN® Peanut patch in younger patient populations.
Previous wording
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 wording
We received the supplemental gross proceeds of $94.7 million (€81 million) resulting in the full exercise of the ABSA Warrants and BS Warrants issued on our March 2025 PIPE Financing. See “Note 2: Significant Events and Transactions - March 2025 PIPE Financing” in the notes to the condensed consolidated financial statements included elsewhere in this Quarterly Report for additional information.
Previous wording
Letter of intent signed with Fareva Amboise
Current wording
Amendment to the Letter of intent signed with Fareva Amboise
Previous wording
Letter of intent signed with ICS
Current wording
Letter of intent signed with Integrated Commercialization Solutions
Previous wording
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 wording
On June 5, 2026, the Company entered into a Letter of Intent with Integrated Commercialization Solutions, LLC ("ICS") in connection with future commercialization support and distribution services for the VIASKIN® Peanut patch in the United States, if approved. 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. Management expects execution of the definitive agreement by the end of 2026.
Previous wording
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 wording
On March 17, 2026, 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.
Previous wording
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 wording
Research tax credit decreased by $1.2 million for the three months ended September 30, 2026, compared to the three months ended September 30,2025. The accrual reflects the lower level of eligible research activities, as the Company’s focus continues to shift from clinical development toward commercial readiness activities.
Previous wording
The following table summarizes our sales and marketing expenses incurred during the three months ended ended June 30, 2026 and 2025:
Current wording
The following table summarizes our sales and marketing expenses incurred during the three months ended September 30, 2026 and 2025:
Previous wording
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 wording
For the fourth consecutive quarter, sales and marketing expenses have increased, rising by $4.2 million during the three months ended September 30, 2026, compared to the three months ended September 30, 2025. This reflects the continued execution of the Company’s commercial launch readiness strategy in the United States. The increase was primarily driven by higher personnel-related and external costs associated with the expansion of the Company’s commercial, market access and launch-support capabilities in preparation for the potential U.S. launch of VIASKIN® Peanut, if approved. This expansion included the hiring of 15 U.S.-based employees compared to September 30, 2025, across Market Access and Patient Services (5), Marketing and Market Insights (4), Sales and Commercial Operations (3), and Commercial Leadership and Transformation (3).
Previous wording
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 wording
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.
Previous wording
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 wording
Our financial income was $0.6 million for the three months ended September 30, 2026, compared to $1.1 million for the three months ended September 30, 2025, reflecting interest income generated from the investment of available cash.
Previous 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.
Current wording
Our income tax expense was $0.3 million for the three months ended September 30, 2026 and was 0 for the three months ended September 30, 2025.
Previous 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.
Current wording
Net loss was $64.5 million for the three months ended September 30, 2026, compared to $33.2 million for the three months ended September 30, 2025. Net loss per share (based on the weighted average number of shares outstanding over the period) was $0.14 and $0.24 for the three months ended September 30, 2026 and 2025, respectively.
Previous wording
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 wording
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 nine months ended September 30, 2026 and 2025.
Previous wording
The following table summarizes our operating income during the six months ended June 30, 2026 and 2025:
Current wording
The following table summarizes our operating income during the nine months ended September 30, 2026 and 2025:
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 $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.
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 $3.1 million as of September 30, 2026. This tax credit income accrual reflects the expected level, on a full year basis of eligible experimental activities, as the Company’s focus continues to shift from clinical development toward commercial readiness activities.
Previous wording
The following table summarizes our research and development expenses incurred during the six months ended June 30, 2026 and 2025:
Current wording
The following table summarizes our research and development expenses incurred during the nine months ended September 30, 2026 and 2025:
Previous 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.
Current wording
External clinical-related expenses increased by $15.6 million for the nine months ended September 30, 2026 compared to the nine months ended September 30, 2025. The increase primarily reflects higher clinical trial activity during the first nine month of 2026, mainly driven by accelerated patient enrollment in COMFORT Toddlers study, with the last patient randomized in August 2026, the ramp-up of expenses associated to THRIVE study, initiated in 2026, as well as the acceleration of BLA readiness activities to prepare BLA submission. This increase was partially offset by the completion of EPOPEX study and the resulting reduction in associated expenses, as well as lower costs related to VITESSE study after the last patient last visit double-blind placebo-controlled end of 2025.
Previous 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.
Current wording
Employee-related costs and share based payment expenses respectively increased by $8.7 million and $2.0 million for the nine months ended September 30, 2026, compared to the nine months ended September 30, 2025 primarily due to reinforcement of Medical Affairs, Quality and Regulatory functions in the United States, representing 38 new hirings across these functions compared to September 30, 2025, to support a potential U.S. launch, if approved, and to ensure organizational readiness as the Company approaches commercialization.
Previous wording
The following table summarizes our sales and marketing expenses incurred during the six months ended June 30, 2026 and 2025:
Current wording
The following table summarizes our sales and marketing expenses incurred during the nine months ended September 30, 2026 and 2025:
Previous wording
The following table summarizes our general and administrative expenses incurred during the six months ended June 30, 2026 and 2025:
Current wording
The following table summarizes our general and administrative expenses incurred during the nine months ended September 30, 2026 and 2025:
Previous wording
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 wording
General and Administrative expenses increased by $17.7 million for the nine months ended September 30, 2026, compared to the nine months ended September 30, 2025, reflecting continued investments in corporate infrastructure to support BLA readiness and potential commercial launch preparations.
Previous wording
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 wording
Our income tax expense was $0.7 million for the nine months ended September 30, 2026 compared to $0.1 million for the nine months ended September 30, 2025.
Previous wording
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 wording
Net loss was $162.5 million for the nine months ended September 30, 2026, compared to $102.1 million for the nine months ended September 30, 2025. Net loss per share (based on the weighted average number of shares outstanding over the period) decreased from $(0.82) to $(0.37) for the nine months ended September 30, 2025 and September 30, 2026, respectively.
Previous wording
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.
Current wording
Our financing strategy is to maintain financial flexibility to support regulatory and potential commercial launch activities, including working capital requirements, pre-commercial inventory build and manufacturing capacity expansion to support potential demand for VIASKIN Peanut in the United States and Europe, if approved.
Previous 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.
Current wording
On September 30, 2026, the Company held $165.7 million in cash and cash equivalents compared to $194.2 million of cash and cash equivalents held on December 31, 2025. Net cash used in operating & investing activities totaled $159.4 million and $86.7 million for the periods ended September 30, 2026 and September 30, 2025, respectively. Net cash provided by financing activities totaled $137.1 million for the periods ended September 30, 2026 and $117.1 million in September 30, 2025, reflecting net proceeds from the first and second tranches of the March 2025 PIPE Financing and drawdowns under the Company's at-the-market equity program.
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 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.
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, while its reporting currency is the U.S. dollar. The Company incurs operating expenses in both currencies: a significant portion of external costs, including those related to commercial activities, regulatory affairs, and clinical development, are denominated in U.S. dollars.
Previous wording
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
Current wording
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 may offer and sell, from time to time and at its sole discretion, ADSs through Citizens. Citizens is entitled to commissions of up to 3.0% of the gross proceeds from ADSs sold under the Sales Agreement. During the fourth quarter of 2025, the Company raised$65.0 million in gross proceeds from the sale of 4,790,552 ADSs under the Sales Agreement.
Previous wording
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.
Current wording
We are currently a “smaller reporting company” as defined in Rule 12b-2 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), and have taken advantage of certain scaled disclosure accommodations available to smaller reporting companies in this and prior filings. However, as of June 30, 2026, the last business day of our second fiscal quarter, the market value of our voting and non-voting ordinary shares held by non-affiliates exceeded $700.0 million. As a result, based on the current SEC reporting framework, we will no longer qualify as a smaller reporting company effective January 1, 2027.
Rearranged current paragraphs (3)
Current report — wording carried from elsewhere
Regulatory functions in the United States, representing 38 new hirings across these functions compared to September 30, 2025, to support a potential U.S. launch, if approved, and to ensure organizational readiness as the Company approaches commercialization.
Current report — wording carried from elsewhere
During the nine months ended September 30, 2026, the euro depreciated against the U.S. dollar, resulting in a $5.5 million unfavorable foreign currency translation adjustment recognized in other comprehensive loss and a $6.2 million unfavorable effect of exchange rate changes on cash and cash equivalents. The U.S. dollar has remained broadly strong against the euro during this period, driven by persistent interest rate differentials and macroeconomic uncertainty, contributing to continued EUR/USD volatility. Continued depreciation of the euro against the U.S. dollar would further reduce the U.S. dollar value of the Company's euro-denominated cash and net assets, potentially accelerating the effective utilization of its liquidity.
Current report — wording carried from elsewhere
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 previous paragraphs (1)
Previous report — wording carried elsewhere
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.