DBV Technologies S.A.
For the period ended Sep 30, 2025. Filed Oct 28, 2025.
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, 2025 · Filed Oct 28, 2025
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 2025-06-30; filed 2025-07-29.
0001613780-25-000016
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2025-09-30; filed 2025-10-28.
0001628280-25-046809
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 109 previous paragraphs and 112 current paragraphs.
53 unchanged; 35 reworded; 23 added; 18 removed; 3 previous and 1 current paragraphs rearranged.
Tables are not compared: 12 previous and 12 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 (23)
Current report
Manufacturing and Supply Agreement
Current report
On August 29, 2025, the Company updated the Supply Agreement with SANOFI, under which SANOFI will manufacture and supply the Viaskin Peanut API exclusively for the Company during the term of the Supply Agreement. The Supply Agreement has an initial term of four years with a possibility to extend for an additional period. The effective date of the Supply Agreement is January 1, 2025.
Current report
The Supply Agreement includes terms related to manufacturing, quality control, pricing, volume commitments, and supply obligations. The Supply Agreement is designed to secure commercial-scale manufacturing capacity in preparation for a potential Biologics License Application (“BLA”) submission and subsequently, the commercial launch of the Viaskin Peanut patch in the United States, if approved.
Current report
We have non-cancellable minimum commitments for products and services, subject to the Supply Agreement. Under US GAAP, take-or-pay arrangements are generally considered firm purchase commitments. As of September 30, 2025, we have assessed our ability to meet our performance obligations as per US GAAP requirements (ASC 440-10: Commitments, ASC 450-20: Loss Contingencies and ASC 330-10-35: Inventory and purchase commitments) and confirm to commit to agreed volumes. Hence, we have not recognized on the balance sheet any loss provision.
Current report
The Company expects to incur expenditures related to support for BLA and PAI preparation, Cold storage rental, over the Supply Agreement term. These expenditures are consistent with the Company’s planned investments to strengthen its supply chain readiness ahead of potential regulatory milestones. The Company believes the Supply Agreement enhances the robustness of its manufacturing network and supports long-term product supply reliability.
Current report
Research and Development expenses increased by $5.0 million for the three months ended September 30, 2025 compared to the three months ended September 30, 2024.
Current report
Depreciation, amortization and other costs remain consistent for the three months ended September 30, 2025 compared to the three months ended September 30, 2024.
Current report
Sales and marketing expenses have increased by $0.7 million during the three months ended September 30, 2025, compared to the three months ended September 30, 2024 mainly due to higher Sales and Marketing activities to prepare support pre-commercialization activities for Viaskin Peanut in North America.
Current report
General and Administrative expenses remain consistent for the three months ended September 30, 2025, compared to the three months ended September 30, 2024.
Current report
Employee-related costs, excluding share-based payments, decreased by $0.1 million for the three months ended September 30, 2025, compared to the three months ended September 30, 2024 due to lower full time equivalent on third quarter 2025 compared to 2024.
Current report
The Share-based payment expenses decreased by $0.8 million mainly due to employees that lost their rights subsequently to their exits.
Current report
Depreciation, amortization and other costs increased by $0.7 million for the three months ended September 30, 2025, compared to the three months ended September 30, 2024 mainly due to depreciation related to the refurbishment of the Châtillon office and licenses increase following recruitment made in 2025.
Current report
Comparison of the Nine Months Ended September 30, 2025 and 2024
Current report
Research and Development expenses increased by $13.4 million for the nine months ended September 30, 2025, compared to the nine months ended September 30, 2024.
Current report
General and Administrative expenses decreased by $2.3 million for the nine months ended September 30, 2025, compared to the nine months ended September 30, 2024.
Current report
Employee-related costs increased by $0.4 million for the nine months ended September 30, 2025, compared to the nine months ended September 30, 2024. This increase is primarily due to recruitment having started during the second quarter of 2024.
Current report
Depreciation, amortization and other costs remain consistent for the nine months ended September 30, 2025, compared to the nine months ended September 30, 2024.
Current report
Our financial income was $4 thousand for the nine months ended September 30, 2025, compared to a financial income of $1.9 million for the nine months ended September 30, 2024. This item includes the net interests yielded by our cash deposits offset by an unfavorable foreign exchange impact.
Current report
In September 2025, the Company entered into a Sales Agreement (the “Sales Agreement”) with Citizens JMP Securities, LLC (“Citizens”), with respect to an equity offering program (the “ATM Offering”) pursuant to which the Company may offer sell American Depositary Shares (“ADS”), from time to time, through Citizens as its sales agent. Pursuant to the Sales Agreement and a prospectus supplement the Company has filed related to the ATM Offering, the Company may offer and sell ADSs having an aggregate offering price of up to $150.0 million (subject to French regulatory limits) from time to time through Citizens. The issuance and sale, if any, of the ADSs by the Company under the Sales Agreement will be made pursuant to the Company’s previously filed and effective registration statement on Form S-3 (Registration Statement No. 333-271166). Sales of the Company’s ADSs, if any, in the ATM Offering may be made in sales deemed to be an “at the market offering” as defined in Rule 415(a)(4) promulgated under the Securities Act from time to time. Subsequent to the end of the third quarter, the Company also received a total gross amount of approximately $30 million from the sale of 11,538,460 Ordinary Shares (underlying 2,307,692 ADSs) received on October 6, 2025 pursuant to the ATM Offering.
Current report
We have non-cancellable minimum commitments for products and services, subject to the Supply Agreement. They are reflected in Note 12.
Current report
On August 29, 2025, the Company updated its Supply Agreement with SANOFI, under which SANOFI will manufacture and supply the Viaskin Peanut API exclusively for the Company during the Supply Agreement term. Under such, the Company has agreed to certain minimum purchase levels and service fees over the initial four-year-term.
Current report
As of September 30, 2025, total payments made during the period under the Agreement are approximately $5.9 million, which were recorded as R&D expenses.
Current report
Future purchase commitments as of September 30, 2025, are as follows and are consistent with the Company’s overall manufacturing and supply strategy in preparation for potential commercial launch activities.
Removed paragraphs (18)
Previous report
Research and Development expenses increased by $8.3 million for the three months ended June 30, 2025 compared to the three months ended June 30, 2024.
Previous report
Sales and marketing expenses have decreased by $0.6 million during the three months ended June 30, 2025, compared to the three months ended June 30, 2024 mainly due to (1) lower Sales and Marketing activities, (2) lower sales headcount (down to 1 employee at the end of June 2024 compared with 2 employees for the same period of the previous year, following a transfer of assignment from sales to overheads) and (3) lower travel expenses.
Previous report
External professional services decreased by $0.6 million for the three months ended June 30, 2025, compared to the three months ended June 30, 2024 mainly due to (1) one-time costs associated with financing activities and (2) lower lease costs following office moves in France and the U.S.
Previous report
Employee-related costs, excluding share-based payments, increased by $0.6 million for the three months ended June 30, 2025, compared to the three months ended June 30, 2024 due to (1) recruitments made during the second quarter of 2024 for which a full quarter of personnel costs are recognized at end-June 2025, and (2) retroactive payment to January 1st of salary increases in the second quarter of 2025 instead of the first quarter 2024.
Previous report
Depreciation, amortization and other costs decreased by $0.1 million for the three months ended June 30, 2025, compared to the three months ended June 30, 2024 mainly due to (1) a lower lease cost in France and (2) a reduction in travel expenses.
Previous report
Our financial expense was $0.6 million for the three months ended June 30, 2025, compared to a financial income of $0.7 million for the three months ended June 30, 2024. This item mainly includes the financial income on our financial assets and foreign exchange result due to the appreciation of EUR vs USD in Q2 2025.
Previous report
Comparison of the Six Months Ended June 30, 2025 and 2024
Previous report
Other operating income was nil for the six months ended June 30, 2025
Previous report
Research and Development expenses increased by $8.4 million for the six months ended June 30, 2025, compared to the six months ended June 30, 2024.
Previous report
General and Administrative expenses decreased by $2.4 million for the six months ended June 30, 2025, compared to the six months ended June 30, 2024.
Previous report
Depreciation, amortization and other costs decreased by $0.6 million mainly due to (1) the reduction in rent in France office following the move to new premises in Châtillon, (2) the reduction in insurance policies and (3) limited travel over the first half of 2025.
Previous report
On March 27, 2025, the Company entered into securities purchase agreements (together, the “Securities Purchase Agreements”) pursuant to which the Company agreed to issue and sell to various investors in a private placement (the “2025 PIPE”) the following securities:
Previous report
•a share capital increase without preferential subscription rights reserved to categories of persons satisfying determined characteristics pursuant to the 24th resolution of the general meeting of shareholders of May 16, 2024 (the "2024 General Meeting") completed on April 7, 2025 for an amount of €38 million, consisting of the issuance of (i) 34,090,004 new shares at a par value of €0.10 (the "New Shares") each with warrants of the Company attached (the "ABSA Warrants", and together with the New Shares, the "ABSA") at a subscription price of €1.1136 per ABSA and (ii) up to 59,657,507 additional new shares, if all the ABSA Warrants attached to the New Shares are exercised (the "ABSA Warrant Shares"); and
Previous report
•the issue through an offering reserved to categories of persons satisfying determined characteristics of 71,005,656 units (the “PFW-BS-PFW”) completed on April 7, 2025 for an amount of €79 million at a subscription price of €1.1136 per PFW-BS-PFW (of which €1.1036 will have been prefunded on the issue date), each PFW-BS-PFW consisting of one pre-funded warrant to subscribe for one share of the Company (the "First Pre-Funded Warrants") and one warrant (the "BS Warrants") to subscribe to one second pre-funded warrants (the "Second Pre-Funded Warrants"), each of which entitles the holder to subscribe for 1.75 shares of the Company (the "Second PFW Shares"), allowing to issue up to 71,005,656 additional new shares if all the First Pre-Funded Warrants are exercised (the "First PFW Shares") and up to 124,259,898 additional new shares if all the Second Pre-Funded Warrants are exercised (the "Second PFW Shares", together with the ABSA Warrant Shares and the First Pre-Funded Warrant Shares, the "Warrant Shares", and together with the New Shares, the "Offered Shares"). The Company has assessed the PFW-BS-PFW will be classified as a component of permanent equity
Previous report
Our corporate headquarters are located in Châtillon, France. Our principal offices occupy a 2,447 square meters facility, pursuant to a lease agreement dated November, 2023 and represents $6.8 million cash requirement as of June 30, 2025. The lease term ends in March, 2033.
Previous report
Our primary U.S. office is located in Warren, New Jersey. In February 2024, we entered into a sublease agreement, commencing on March 19, 2024 and effective for 70 months, for an office of 16,704 square feet in Warren, New Jersey. The Warren office represent a $1.6 million cash requirement as of June 30, 2025 which expires December 31, 2029.
Previous report
We also leased 5,799 square feet intended to support our U.S. operations in Basking Ridge, New Jersey, which commenced on April 1, 2022 and expired May 31, 2025. The Basking Ridge office represents a $26 thousand cash requirement as of June 30, 2025.
Previous report
We have not entered into any off-balance sheet arrangements and do not have variable interests in variable interest entities.
Reworded paragraphs (35)
Previous wording
We also have an ongoing Phase 3 open-label extension to the EPITOPE trial (our completed Phase 3 efficacy and safety trial conducted in peanut-allergic toddlers which met its clinical endpoints), with 3-year results for active-treatment subjects in 2024, as well as a planned Phase 3 supplementary safety study, in peanut-allergic toddlers ages one through three. The Company submitted the protocol for its COMFORT Toddlers supplemental safety study in 1 – 3 years-old to the FDA on November 9, 2023. The Company received comments and queries to the protocol from the FDA on March 11, 2024.
Current wording
We also have an ongoing Phase 3 open-label extension to the EPITOPE trial (our completed Phase 3 efficacy and safety trial conducted in peanut-allergic toddlers which met its clinical endpoints), with 3-year results for active-treatment subjects in 2024, and an ongoing Phase 3 supplementary safety study, in peanut-allergic toddlers ages one through three.
Previous wording
On July 30, 2024, the Company announced that it and the FDA had been engaged in ongoing dialogue since May 2023 on the COMFORT Toddlers supplemental safety study in 1 – 3-years-old with a peanut allergy. The study protocol was submitted on November 9, 2023, with comments provided by FDA on March 11, 2024. After March, much of the dialogue between DBV and FDA regarding the COMFORT Toddlers supplemental study had focused on patch wear-time experience, including how prescribers would advise parents and caregivers to manage day-to-day variability in patch wear time. The Company proposed an approach, informed by the EPITOPE efficacy data, that focuses on the user experience during the first 90-days of treatment. The Company submitted to the FDA draft labeling for Section 2 – Dosing and Administration, for a potential Viaskin Peanut Prescribing Information (PI), along with comprehensive supportive data and analyses. Within the first 90-days of treatment (excluding the lead-in dosing period) it is possible to identify those patients who are very likely to have a robust clinical efficacy response based on patch wear time experience (i.e., “Label-in” patients). The proposed PI recommends continuation of treatment for these patients. With the same 90-day approach, patients less likely to have a robust clinical efficacy response, identified by their patch wear-time experience, would be identified as “Label-out” patients. In these instances, the PI would recommend a shared decision-making process, between the health care provider and the parent or caregiver, to determine whether treatment should be discontinued.
Current wording
The Company submitted the protocol for its COMFORT Toddlers supplemental safety study in 1 – 3 years-old to the FDA on November 9, 2023. The Company received comments and queries to the protocol from the FDA on March 11, 2024. On July 30, 2024, the Company announced that it and the FDA had been engaged in ongoing dialogue since May 2023 on the COMFORT Toddlers supplemental safety study in 1 – 3-years-old with a peanut allergy. The study protocol was submitted on November 9, 2023, with comments provided by FDA on March 11, 2024. After March, much of the dialogue between DBV and FDA regarding the COMFORT Toddlers supplemental study had focused on patch wear-time experience, including how prescribers would advise parents and caregivers to manage day-to-day variability in patch wear time. The Company proposed an approach, informed by the EPITOPE efficacy data, that focuses on the user experience during the first 90-days of treatment. The Company submitted to the FDA draft labeling for Section 2 – Dosing and Administration, for a potential Viaskin Peanut Prescribing Information (PI), along with comprehensive supportive data and analyses. Within the first 90-days of treatment (excluding the lead-in dosing period) it is possible to identify those patients who are very likely to have a robust clinical efficacy response based on patch wear time experience (i.e., “Label-in” patients). The proposed PI recommends continuation of treatment for these patients. With the same 90-day approach, patients less likely to have a robust clinical efficacy response, identified by their patch wear-time experience, would be identified as “Label-out” patients. In these instances, the PI would recommend a shared decision-making process, between the health care provider and the parent or caregiver, to determine whether treatment should be discontinued.
Previous wording
On October 22, 2024, the Company announced positive regulatory updates for the Viaskin Peanut patch in the United States and Europe. DBV agreed to guidance provided by the FDA on a potential pathway under the Accelerated Approval Program for the Viaskin Peanut patch in toddlers ages 1 – 3 years-old. FDA confirmed that the Company has met Accelerated Approval qualifying criterion 1 and 2 . Regarding criterion 3, FDA provided guidance and suggestion regarding the intermediate clinical endpoint, which the Company agreed to in informal discussions with the FDA. The Company formalized the Accelerated Approval guidance provided by FDA via submission of a meeting request and confirmed the general elements of the two study components: the COMFORT Toddlers safety study, to be completed before BLA submission, and the confirmatory effectiveness study, including the third Accelerated Approval criterion regarding the intermediate clinical endpoint. The Company expects that the confirmatory study will be initiated by the time of BLA submission and would run in parallel to commercialization in the United States, if the Viaskin Peanut patch is approved.
Current wording
On October 22, 2024, the Company announced positive regulatory updates for the Viaskin Peanut patch in the United States and Europe. DBV agreed to guidance provided by the FDA on a potential pathway under the Accelerated Approval Program for the Viaskin Peanut patch in toddlers ages 1 – 3 years-old. FDA confirmed that the Company met Accelerated Approval qualifying criterion 1 and 2 . Regarding criterion 3, FDA provided guidance and suggestion regarding the intermediate clinical endpoint, which the Company agreed to in informal discussions with the FDA. The Company formalized the Accelerated Approval guidance provided by FDA via submission of a meeting request and confirmed the general elements of the two study components: the COMFORT Toddlers safety study, to be completed before BLA submission, and the confirmatory effectiveness study, including the third Accelerated Approval criterion regarding the intermediate clinical endpoint. The Company expects that the confirmatory study will be initiated by the time of BLA submission and would run in parallel to commercialization in the United States, if the Viaskin Peanut patch is approved.
Previous wording
The Company announced further that it has aligned with FDA on a wear time collection methodology in COMFORT Toddlers that provides a practical approach for subjects and families, is intended to generate sufficient data to support a BLA submission, and places wear time into an acceptable clinical hierarchy relative to other study endpoints. DBV has initiated study start-up activities and plans to screen the first subject in the second quarter of 2025. The Company anticipates enrolling approximately 300 – 350 subjects on active treatment into the safety study, which would bring the total Viaskin
Current wording
The Company announced further that it aligned with FDA on a wear time collection methodology in COMFORT Toddlers that provides a practical approach for subjects and families, is intended to generate sufficient data to support a BLA submission, and places wear time into an acceptable clinical hierarchy relative to other study endpoints. On June 25, 2025, the Company announced that the first subject was screened in COMFORT Toddlers supplemental safety study in peanut allergic toddlers 1 – 3 years old. The Company anticipates enrolling approximately 300 – 350 subjects on active treatment into the safety study, which would bring the total Viaskin Peanut patch safety database in toddlers to approximately 600 subjects, consistent with prior FDA guidance. With this path forward, the BLA submission for Viaskin Peanut patch in 1 – 3 years-old under the Accelerated Approval program is anticipated to be supported by:
Previous wording
Research tax credit increased by $0.3 million for the three months ended June 30, 2025, compared to the three months ended June 30, 2024 primarily due to a greater proportion of activities eligible to receive the Research tax credit carried out in the second quarter 2025 than in the second quarter 2024, and in particular with the launch of COMFORT Toddlers clinical trial.
Current wording
Research tax credit increased by $1.7 million for the three months ended September 30, 2025, compared to the three months ended September 30, 2024 primarily due to a greater proportion of activities eligible to receive the Research tax credit carried out in the third quarter 2025 than in the third quarter 2024.
Previous wording
External clinical-related expenses increased by $7.0 million mainly due to (1) the launch of the COMFORT Toddlers study following alignment with the FDA, (2) the progress of the VITESSE phase 3 clinical study, and (3) regulatory and production activities to support ongoing clinical trials.
Current wording
External clinical-related expenses increased by $4.5 million mainly due to (1) the launch of the COMFORT Toddlers study following alignment with the FDA, and (2) regulatory and production activities to support ongoing clinical trials, BLA submission and pre-commercialization activities for Viaskin Peanut in North America.
Previous wording
Employee-related costs increased by $0.7 million for the three months ended June 30, 2025 compared to the three months ended June 30, 2024. This increase is due to (1) recruitments made during the second quarter of 2024, mainly based in the United States in Medical, Quality and Regulatory Affairs, for which a full quarter of personnel costs are recognized at end-June 2025, and (2) retroactive payment to January 1st of salary increases in the second quarter of 2025.
Current wording
Employee-related costs increased by $0.5 million for the three months ended September 30, 2025 compared to the three months ended September 30, 2024. This increase is mainly due to (1) recruitments made during the third quarter of 2024, mainly based in the United States, for which a full quarter of personnel costs are recognized at end-September 2025, and (2) additional recruitments made during the third quarter 2025.
Previous wording
General and Administrative expenses decreased by $0.2 million for the three months ended June 30, 2025, compared to the three months ended June 30, 2024.
Current wording
External professional services increased by $0.2 million for the three months ended September 30, 2025, compared to the three months ended September 30, 2024 mainly due to financing activities.
Previous wording
Our financial expense was $1.1 million for the six months ended June 30, 2025, compared to a financial income of $2.0 million for the six months ended June 30, 2024. This item mainly includes financial income on our financial assets and a unfavorable foreign exchange result..
Current wording
Our financial income was $1.1 million for the three months ended September 30, 2025, compared to a financial expense of $0.1 million for the three months ended September 30, 2024. This item mainly includes the gains from our investments.
Previous wording
Our income tax expense was $117 thousands for the three months ended June 30, 2025 and was nil for the three months ended June 30, 2024.
Current wording
Our income tax was nil for the three months ended September 30, 2025 and September 30, 2025.
Previous wording
Net loss was $41.9 million for the three months ended June 30, 2025, compared to $33.1 million for the three months ended June 30, 2024. Net loss per share (based on the weighted average number of shares outstanding over the period) was $ (0.31) and $ (0.34) for the three months ended June 30, 2025 and 2024, respectively.
Current wording
Net loss was $33.2 million for the three months ended September 30, 2025, compared to $30.4 million for the three months ended September 30, 2024. Net loss per share (based on the weighted average number of shares outstanding over the period) was $ (0.24) and $ (0.32) for the three months ended September 30, 2025 and 2024, 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 thousands of U.S. dollars, for the six months ended June 30, 2025 and 2024.
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 thousands of U.S. dollars, for the nine months ended September 30, 2025 and 2024.
Previous wording
The following table summarizes our operating income during the six months ended June 30, 2025 and 2024:
Current wording
The following table summarizes our operating income during the nine months ended September 30, 2025 and 2024:
Previous wording
During the six months ended June 30, 2025 we generated an Operating Income of $2.2.million compared to $2.6.million during the six months ended June 30, 2024.
Current wording
During the nine months ended September 30, 2025 we generated an Operating Income of $5.0.million compared to $3.6.million during the nine months ended September 30, 2025.
Previous wording
Research tax credit decreased by $0.4 million for the six months ended June 30, 2025, compared to the six months ended June 30, 2024 primarily due to the fact that a greater proportion of clinical studies activities were carried out in North America and therefore not eligible for the French Research tax credit.
Current wording
Research tax credit increased by $1.4 million for the nine months ended September 30, 2025, compared to the nine months ended September 30, 2024 primarily due to the fact that more eligible activities have been carried out in the period, including the related costs of the FAREVA platform.
Previous wording
The following table summarizes our R&D expenses incurred during the six months ended June 30, 2025 and 2024:
Current wording
The following table summarizes our R&D expenses incurred during the nine months ended September 30, 2025 and 2024:
Previous wording
External clinical-related expenses increased by $7.0 million mainly due to (1) the launch of the COMFORT Toddlers study following alignment with the FDA, (2) the progress of the VITESSE phase 3 clinical study, and (3) regulatory and production activities to support ongoing clinical trials.
Current wording
External clinical-related expenses increased by $11.5 million mainly due to (1) the launch of the COMFORT Toddlers study following alignment with the FDA and (2) regulatory and production activities to support ongoing clinical trials, BLA submission and pre-commercialization activities for Viaskin Peanut in North America.
Previous wording
Employee-related costs increased by $0.4 million for the six months ended June 30, 2025 compared to the six months ended June 30, 2024. This increase is due to recruitments made during the second quarter of 2024, mainly based in the United States in Medical, Quality and Regulatory Affairs, for which six months of personnel costs are recognized at June 30, 2025 compared with two to three months at June 30, 2024.
Current wording
Employee-related costs increased by $0.9 million for the nine months ended September 30, 2025 compared to the nine months ended September 30, 2024. This increase is primarily due to the recruitment carried out during the second quarter of 2024, mainly based in the United States in Medical, Quality and Regulatory Affairs, resulting in a full nine-month impact in 2025 compared to a four to six month impact in 2024.
Previous wording
Depreciation, amortization and other costs increased by $1.3 million for the six months ended June 30, 2025 compared to the six months ended June 30, 2024. This increase is mainly due to a $1.1 million provision reversal at June 30, 2024, following the termination of the Collaboration Agreement with NESTEC, which reduced last year's charge.
Current wording
Depreciation, amortization and other costs increased by $1.6 million for the nine months ended September 30, 2025 compared to the nine months ended September 30, 2024. This increase is mainly due to a $1.1 million provision reversal at June 30, 2024, following the termination of the Collaboration Agreement with NESTEC, which reduced last year's charge.
Previous wording
The following table summarizes our sales and marketing expenses incurred during the six months ended June 30, 2025 and 2024:
Current wording
The following table summarizes our sales and marketing expenses incurred during the nine months ended September 30, 2025 and 2024:
Previous wording
Sales and Marketing expenses decreased by $1.1 million for the six months ended June 30, 2025, compared to the six months ended June 30, 2024, mainly due to (1) lower Sales and Marketing activities, (2) lower sales headcount (down to 1 employee at June 30, 2024 compared with 2 employees for the same period of the previous year, following a transfer of assignment from sales to overheads) and (3) lower travel expenses.
Current wording
Sales and Marketing expenses decreased by $0.4 million for the nine months ended September 30, 2025, compared to the nine months ended September 30, 2024, mainly due to (1) lower Sales and Marketing activities, (2) lower sales full time equivalent (following a transfer of assignment between sales and overheads) and (3) lower travel expenses.
Previous wording
The following table summarizes our general and administrative expenses incurred during the six months ended June 30, 2025 and 2024:
Current wording
The following table summarizes our general and administrative expenses incurred during the nine months ended September 30, 2025 and 2024:
Previous wording
This decrease derives from decrease in external professional services due to non-recurring costs incurred in the first half of 2024 associated with (1) office relocations in France and the United States, (2) financing activities and (3) activities related to the Company's trademarks and patents.
Current wording
This decrease derives from decrease in external professional services due to non-recurring costs incurred in 2024 associated with (1) office relocations in France and the United States, (2) financing activities and (3) activities related to the Company's and patents.
Previous wording
Our income tax expense was $117 thousand for the six months ended June 30, 2025 compared to $48 thousand for the six months ended June 30, 2024.
Current wording
Our income tax expense was $117 thousand for the nine months ended September 30, 2025, compared to $48 thousand for the nine months ended September 30, 2024.
Previous wording
Net loss was $69.0 million for the six months ended June 30, 2025, compared to $60.5 million for the six months ended June 30, 2024. Net loss per share (based on the weighted average number of shares outstanding over the period) was $(0.58) and $(0.63) for the six months ended June 30, 2025 and 2024, respectively.
Current wording
Net loss was $102.1 million for the nine months ended September 30, 2025, compared to $90.9 million for the nine months ended September 30, 2024. Net loss per share (based on the weighted average number of shares outstanding over the period) was $(0.82) and $(0.95) for the nine months ended September 30, 2025 and 2024, respectively.
Previous wording
On June 30, 2025, we had $103.2 million in cash and cash equivalents compared to $32.5 million of cash and cash equivalents on December 31, 2024.
Current wording
On September 30, 2025, we had $69.8 million in cash and cash equivalents compared to $32.5 million of cash and cash equivalents on December 31, 2024.
Previous wording
The Company financing also includes an aggregate of up to $181.4 million (€168.2 million) in gross proceeds if all warrants are exercised, subject to satisfaction of specified conditions. The VITESSE Phase 3 study hitting its primary endpoint will trigger an acceleration of the exercise period of the warrants. DBV expects that the proceeds of this funding will be used for working capital and general corporate purposes, to finance the continued development of the Viaskin Peanut program, to finance the preparation and submission of a potential Biologics License Application (“BLA”) and, to finance the readiness of a launch of Viaskin peanut in the US, if approved.
Current wording
The Company may also receive an aggregate of up to $181.4 million (€168.2 million) in gross proceeds if all warrants are exercised, subject to satisfaction of specified conditions. The VITESSE Phase 3 study hitting its primary endpoint will trigger an acceleration of the exercise period of the warrants. DBV expects that the proceeds of this funding will be used for working capital and general corporate purposes, to finance the continued development of the Viaskin Peanut program, to finance the preparation and submission of a potential Biologics License Application (“BLA”) and, to finance the readiness of a launch of Viaskin peanut in the US, if approved.
Previous wording
With the receipt of the aforementioned proceeds, and based on its current operations, plans, and assumptions examined by the Board on June 23, 2025, the Company estimates that its cash and cash equivalents are sufficient to fund its operations into the second quarter of 2026. As such, there is substantial doubt regarding our ability to continue as a going concern.
Current wording
As of the date of the filing, with the receipt of the aforementioned proceeds, and based on its current operations, plans, and assumptions examined by the Board on October 28, 2025, the Company estimates that its cash and cash equivalents are sufficient to fund its operations into the third quarter of 2026. These conditions and events raise substantial doubt about the Company’s ability to continue as a going concern within one year after the date that these financial statements are issued.
Previous wording
We cannot guarantee that we will be able to obtain the necessary financing to meet our needs or to obtain funds at attractive terms and conditions, including as a result of disruptions to the global financial markets due any future pandemics, epidemics or global health crises and conflict in Ukraine or other global political or military crises. A severe or prolonged economic downturn could result in a variety of risks to us, including reduced ability to raise additional capital when needed or on acceptable terms, if at all. If we are not successful in our financing objectives, we could have to scale back our operations, notably by delaying or reducing the scope of our research and development efforts or obtain financing through arrangements with collaborators or others that may require us to relinquish rights to our product candidates that we might otherwise seek to develop or commercialize independently.
Current wording
We cannot guarantee that we will be able to obtain the necessary financing to meet our needs or to obtain funds at attractive terms and conditions, including as a result of disruptions to the global financial markets due any future pandemics, epidemics or global health crises and conflicts, other global political or military crises. A severe or prolonged economic downturn could result in a variety of risks to us, including reduced ability to raise additional capital when needed or on acceptable terms, if at all. If we are not successful in our financing objectives, we could have to scale back our operations, notably by delaying or reducing the scope of our research and development efforts or obtain financing through arrangements with collaborators or others that may require us to relinquish rights to our product candidates that we might otherwise seek to develop or commercialize independently.
Previous wording
In preparation of the launch of our clinical trials for Viaskin Peanut, we signed agreements with several contract research organizations. As of June 30, 2025 expenses associated with the ongoing trials amounted globally to $272.7 million compared to $170.3 million as of December 31, 2024.
Current wording
In preparation of the launch of our clinical trials for Viaskin Peanut, we signed agreements with several contract research organizations. As of September 30, 2025 expenses associated with the ongoing trials amounted globally to $279.2 million compared to $170.3 million as of December 31, 2024.
Previous wording
The table below summarizes our sources and uses of cash for the six months ended June 30, 2025 and 2024.
Current wording
The table below summarizes our sources and uses of cash for the nine months ended September 30, 2025 and 2024.
Previous wording
Our net cash flows used in operating activities were $53.6 million and $69.8 million during the six months ended June 30, 2025 and 2024, respectively. Our net cash flows used in operating activities decreased by $16.2 million as our costs and expenses have been contained and payment terms extended during the Company’s financing period.
Current wording
Our net cash flows used in operating activities were $86.0 million and $92.2 million during the nine months ended September 30, 2025 and 2024, respectively. Our net cash flows used in operating activities decreased by $6.2 million as our costs and expenses have been contained and payment terms extended during period covered by this report.
Previous wording
The decrease compared to last year is mainly due to (1) the reduction of external expenses related to completed or expiring clinical trials for $3.4 million, (2) the deferral of Research & Development activities to support clinical trial progress through regulatory affairs, medical affairs, the manufacturing platform and procurement activities for $5.1 million, and (3) deferrals of Sales & Marketing activities, travel expenses and savings on insurance policies.
Current wording
The decrease compared to last year is mainly due to (1) the deferral of Research & Development activities to support clinical trial progress through regulatory affairs, medical affairs, the manufacturing platform and procurement activities for $6.8 million, (2) General and Administration non-recurring costs incurred in 2024 associated with office relocations in France and the United States, financing activities, activities related to the Company's trademarks and patents and savings on insurance policies for $5.0 million, and (3) deferrals of Sales & Marketing activities by $0.8 million. This decrease is partially offset by the launch of the COMFORT Toddlers study following alignment with the FDA for $4.7 million.
Previous wording
Our net cash flows used in investing activities were $0.4 million and $1.4 million during the six months ended June 30, 2025 and 2024 respectively. The variance is primarily explained by capitalized costs for the headquarters move to Châtillon.
Current wording
Our net cash flows used in investing activities were $0.7 million and $1.5 million during the nine months ended September 30, 2025 and 2024 respectively. The variance is primarily explained by capitalized costs for the headquarters move to Châtillon.
Previous wording
Our net cash flows from financing activities were $117.0 million for the six months ended June 30, 2025 compared to $(95) thousand for the six months ended June 30, 2024. This increase is due to the financing operation completed on April 7, 2025.
Current wording
Our net cash flows from financing activities were $117.1 million for the nine months ended September 30, 2025 compared to $(88) thousand for the nine months ended September 30, 2024. This increase is due to the financing operation completed on April 7, 2025.
Rearranged current paragraphs (1)
Current report — wording carried from elsewhere
Purchase Obligations - Obligations Under the Terms of SANOFI Manufacturing and Supply Agreement
Rearranged previous paragraphs (3)
Previous report — wording carried elsewhere
Peanut patch safety database in toddlers to approximately 600 subjects, consistent with prior FDA guidance. With this path forward, the BLA submission for Viaskin Peanut patch in 1 – 3 years-old under the Accelerated Approval program is anticipated to be supported by:
Previous report — wording carried elsewhere
Depreciation, amortization and other costs increased by $0.8 million for the three months ended June 30, 2025 compared to the three months ended June 30, 2024. which comprised a favorable accrual reversal following the termination of the Collaboration Agreement with NESTEC,
Previous report — wording carried elsewhere
Employee-related costs increased by $0.4 million for the six months ended June 30, 2025, compared to the six months ended June 30, 2024. This increase is mainly due to the recruitment carried out during the second quarter of 2024.