DBV Technologies S.A.
For the period ended Jun 30, 2025. Filed Jul 29, 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.
Jun 30, 2025 · Filed Jul 29, 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 2025-03-31; filed 2025-04-30.
0001613780-25-000011
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent 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 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 77 previous paragraphs and 109 current paragraphs.
42 unchanged; 25 reworded; 32 added; 9 removed; 1 previous and 10 current paragraphs rearranged.
Tables are not compared: 6 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 (32)
Current report
ii. Additional safety data generated in COMFORT Toddlers supplemental safety study, which was initiated in June quarter of 2025.
Current report
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 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.
Current report
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 report
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 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.
Current 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.
Current report
Comparison of the Six Months Ended June 30, 2025 and 2024
Current report
Operating Income
Current report
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 report
Other operating income was nil for the six months ended June 30, 2025
Current report
Operating Expenses
Current report
Research and Development Expenses
Current report
The following table summarizes our R&D expenses incurred during the six months ended June 30, 2025 and 2024:
Current 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.
Current report
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 report
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 report
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 report
Sales and Marketing expenses
Current report
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 report
General and Administrative expenses
Current 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.
Current report
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 report
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.
Current 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.
Current report
Financial income (expense)
Current report
Income tax
Current report
Net loss
Current report
On April 7, 2025, the Company received gross proceeds of $125.5 million (€116.3 million) from the issuance of securities including, ABSAs and PFW-BS-PFWs, as described in the Company’s Quarterly Report on Form 10-Q for the Quarter ended March 31, 2025 filed with the SEC on April 30, 2025.
Current report
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 report
This increase is mainly due to the launch of the COMFORT Toddlers study following alignment with the FDA, and the progress of the VITESSE phase 3 clinical study.
Current report
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.
Removed paragraphs (9)
Previous report
Research and Development expenses remain stable for the three months ended March 31, 2025 compared to the three months ended March 31, 2024 in particular for external clinical-related expenses given the continuity of efforts made on VITESSE Phase 3 clinical trial.
Previous report
Sales and marketing expenses have decreased by $0.5 million during the three months ended March 31, 2025, compared to the three months ended March 31, 2024 due operating expenses containment in the first quarter of 2025, including lower bonuses paid in 2025 compared to 2024.
Previous report
General and Administrative expenses decreased by $2.2 million for the three months ended March 31, 2025, compared to the three months ended March 31, 2024.
Previous report
Employee-related costs, excluding share-based payments, decreased by $0.186 million for the three months ended March 31, 2025, compared to the three months ended March 31, 2024 due to lower bonuses paid in 2025 compared to last year.
Previous report
The Company received initial gross proceeds of $125.5 million (€116.3 million) on April 7, 2025, and based on our current operations, plans and assumptions, we estimate that our balance of cash and cash equivalents will be sufficient to fund our operations into June 2026. We further estimate that, following the potential issuance of all Warrant Shares in the financing, representing potential additional gross proceeds of up to $181.4 million (€168.2 million), we could extend our financial visibility into 2028 and through potential commercialization of Viaskin Peanut in the U.S, if approved.
Previous report
In May 2022, we established an At-The-Market (“ATM”) program to offer and sell, including with unsolicited investors who have expressed an interest, a total gross amount of up to $100 million of American Depositary Shares (“ADSs”), each ADS representing one-half of one ordinary share of the Company. The ATM program terminated on July 16, 2024 at the time the Company’s existing registration statement registering the ADSs to be issued under the ATM program expired.
Previous report
Pursuant to the ATM program, the Company issued and completed sales of new Ordinary Shares in the form of ADSs for a total gross amount of $15.3 million on May 4, 2022, and of $7.8 million on June 14, 2023. Respectively, 6,036,238 and 2,052,450 new Ordinary Shares in the form of ADSs were issued through a capital increase without preferential subscription rights of the shareholders reserved to specific categories of persons fulfilling certain characteristics (the “ATM issuance”), at a unit subscription price of $1.27 and $1.90 per ADS, each ADS giving the right to receive one-half of one ordinary share of the Company.
Previous report
The lease agreement for the former office occupying 4,470 square meters facility in Montrouge, France, signed on March 3, 2015, with an effective date of August 1, 2015, expired on May 31, 2024. Associated lease termination costs were reflected in the Company’s financial accounts in the Annual Report.
Previous report
The Company transitioned to its new offices location in Warren NJ and Châtillon France in April 2024.
Reworded paragraphs (25)
Previous wording
You should read the following discussion and analysis of our financial condition and results of operations in conjunction with our unaudited condensed consolidated financial statements and related notes included in Part 1, Item 1 of this Report and with our audited financial statements and related notes thereto for the year ended December 31, 2024, included in our Annual Report on Form 10-K for the year ended December 31, 2024, filed with the Securities and Exchange Commission on April 11, 2025, or the Annual Report. This discussion and other parts of this Report contain forward-looking statements that involve risks and uncertainties, such as statements of our plans, objectives, expectations and intentions. Our actual results could differ materially from those discussed in these forward-looking statements. Factors that could cause such differences are discussed in the section of this Report titled “Special Note Regarding Forward-Looking Statements” and under “Item 1A. Risk Factors” in the Annual Report.
Current wording
You should read the following discussion and analysis of our financial condition and results of operations in conjunction with our unaudited condensed consolidated financial statements and related notes included in Part 1, Item 1 of this Report and with our audited financial statements and related notes thereto for the year ended December 31, 2024, included in our Annual Report on Form 10-K for the year ended December 31, 2024, filed with the Securities and Exchange Commission on April 11, 2025, as amended by Amendment No. 1 on Form 10-K/A filed with the SEC on April 28, 2025, and as amended further by Amendment No. 2 on Form 10-K/A filed with the SEC on May 14, 2025, or the Annual Report. This discussion and other parts of this Report contain forward-looking statements that involve risks and uncertainties, such as statements of our plans, objectives, expectations and intentions. Our actual results could differ materially from those discussed in these forward-looking statements. Factors that could cause such differences are discussed in the section of this Report titled “Special Note Regarding Forward-Looking Statements” and under “Item 1A. Risk Factors” in the Annual Report.
Previous wording
Our most advanced product candidate is Viaskin Peanut, evaluated as a potential immunotherapy for children with peanut allergy in eleven clinical trials, including four Phase 2 trials and four completed Phase 3 trials. We are advancing two separate Viaskin Peanut product candidates in parallel to support two potential Biologics License Applications (BLAs) in two distinct age groups: one in toddlers ages one through three with the original (square) patch, and one in children ages four through seven with the modified (circular) patch.
Current wording
Our most advanced product candidate is the Viaskin Peanut patch, evaluated as a potential immunotherapy for children with peanut allergy in eleven clinical trials, including four Phase 2 trials and four completed Phase 3 trials. We are advancing two separate Viaskin Peanut product candidates in parallel to support two potential Biologics License Applications (BLAs) in two distinct age groups: one in toddlers ages one through three with the original (square) patch, and one in children ages four through seven with the modified (circular) patch.
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. Since 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
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 has 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 has 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 Viaskin Peanut 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 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.
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 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:
Current 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
Previous wording
Depreciation, amortization and other costs increased by $0.6 million for the three months ended March 31, 2025, compared to the three months ended March 31, 2024 primarily as a result of a favorable reversal on accrual by $0.8 million due to the termination of the Collaboration Agreement with NESTEC in October 2023.
Current wording
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 wording
Employee-related costs, excluding share-based payments, decreased by $0.2 million for the three months ended March 31, 2025, compared to the three months ended March 31, 2024 due to lower bonuses paid in 2025 compared to 2024.
Current 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.
Previous wording
External professional services decreased by $1.4 million for the three months ended March 31, 2025, compared to the three months ended March 31, 2024 mainly due to (1) one-time costs associated with financing activities, lower lease costs following office moves in France and the U.S, and trademark and patent activities that all occurred last year, and (2) a containment of costs and expenses during the Company’s financing period ended in March 31, 2025.
Current wording
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 wording
Depreciation, amortization and other costs decreased by $0.6 million for the three months ended March 31, 2025, compared to the three months ended March 31, 2024 as a result of a lower lease cost in France.
Current wording
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 wording
Net loss was $27.1 million for the three months ended March 31, 2025, compared to $27.3 million for the three months ended March 31, 2024. Net loss per share (based on the weighted average number of shares outstanding over the period) was $0.26 and $0.28 for the three months ended March 31, 2025 and 2024, respectively.
Current 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.
Previous wording
Research tax credit decreased by $0.7 million for the three months ended March 31, 2025, compared to the three months ended March 31, 2024 primarily due to a greater proportion of studies activities carried out in North America and therefore not eligible to the French Research tax credit.
Current 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.
Previous wording
Our financial expense was $0.5 million for the three months ended March 31, 2025, compared to a financial income of $1.3 million for the three months ended March 31, 2024. This item mainly includes the financial income on our financial assets and foreign exchange result.
Current 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..
Previous wording
Our income tax expense was nil for the three months ended March 31, 2025 compared to $48 thousand for the three months ended March 31, 2024.
Current 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.
Previous wording
On March 31, 2025, we had $13.0 million in cash and cash equivalents compared to $32.5 million of cash and cash equivalents on December 31, 2024.
Current 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.
Previous wording
On March 27, 2025, the Company announced the 2025 PIPE, as further described below, of up to $306.9 million (€284.5 million), to advance Viaskin® Peanut Patch through BLA submission and U.S. commercial launch, if approved. The financing included gross proceeds of $125.5 million (€116.3 million) received on April 7 2025. With the receipt of the aforementioned proceeds, and based on its current operations, plans, and assumptions examined by the Board on March 23, 2025, the Company estimates that its cash and cash equivalents are sufficient to fund its operations into June 2026.
Current wording
On March 27, 2025, the Company announced the 2025 financing (PIPE), as further described below, of up to $306.9 million (€284.5 million), to advance Viaskin® Peanut Patch through BLA submission and U.S. commercial launch, if approved.
Previous wording
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 Investors in a private placement (the “2025 PIPE”) the following securities:
Current wording
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 wording
We may seek additional capital as we prepare for the launch of Viaskin Peanut, if approved, and continue other research and development efforts. We may seek to finance our future cash needs through a combination of public or private equity or debt financings, collaborations, license and development agreements and other forms of non-dilutive financings.
Current wording
We may seek additional capital as we prepare for the launch of the Viaskin Peanut patch, if approved, and continue other research and development efforts. We may seek to finance our future cash needs through a combination of public or private equity or debt financings, collaborations, license and development agreements and other forms of non-dilutive financings.
Previous wording
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 $6.7 million cash requirement as of March 31, 2025. The lease term ends in March, 2033.
Current wording
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 wording
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 $1.7 million cash requirement as of March 31, 2025 which expires December 31, 2029.
Current wording
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 wording
We also have facilities in North America that were intended to support our U.S. operations. We lease 5,799 square feet in Basking Ridge, New Jersey, which commenced on April 1, 2022 and is effective for 38 months.The Basking Ridge office represents a $26 thousand cash requirement as of March 31, 2025 which expires April 30, 2025.
Current wording
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 wording
In preparation of the launch of our clinical trials for Viaskin Peanut, we signed agreements with several contract research organizations. As of March 31, 2025 expenses associated with the ongoing trials amounted globally to $180.0 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 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.
Previous wording
The table below summarizes our sources and uses of cash for the three months ended March 31, 2025 and 2024.
Current wording
The table below summarizes our sources and uses of cash for the six months ended June 30, 2025 and 2024.
Previous wording
Our net cash flows used in operating activities were $19.7 million and $34.7 million during the three months ended March 31, 2025 and 2024, respectively. Our net cash flows used in operating activities decreased by $15.0 million as our costs and expenses have been contained during the Company’s financing period ended in March 31, 2025.
Current 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.
Previous wording
Our net cash flows used in investing activities were $0.4 million and $2.1 million during the three months ended March 31, 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 $0.4 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.
Previous wording
Our net cash flows from financing activities were $45 thousand for the three months ended March 31, 2025 compared to $(62) thousand for the three months ended March 31, 2024.
Current 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.
Rearranged current paragraphs (10)
Current report — wording carried from 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:
Current report — wording carried from elsewhere
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.
Current report — wording carried from elsewhere
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.
Current report — wording carried from elsewhere
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 report — wording carried from elsewhere
The following table summarizes our results of operations, derived from our unaudited condensed consolidated financial statements, which have been prepared in accordance with U.S. GAAP and presented in thousands of U.S. dollars, for the six months ended June 30, 2025 and 2024.
Current report — wording carried from elsewhere
The following table summarizes our operating income during the six months ended June 30, 2025 and 2024:
Current report — wording carried from elsewhere
The following table summarizes our sales and marketing expenses incurred during the six months ended June 30, 2025 and 2024:
Current report — wording carried from elsewhere
The following table summarizes our general and administrative expenses incurred during the six months ended June 30, 2025 and 2024:
Current report — wording carried from elsewhere
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 report — wording carried from elsewhere
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.
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Previous report — wording carried elsewhere
There have been no material changes in our purchase obligations from those disclosed in our Annual Report.