DBV Technologies SA
For the period ended Mar 31, 2025. Filed Apr 30, 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.
Mar 31, 2025 · Filed Apr 30, 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 2024-09-30; filed 2024-11-06.
0001613780-24-000007
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent 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 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 102 previous paragraphs and 77 current paragraphs.
41 unchanged; 22 reworded; 14 added; 32 removed; 7 previous and 0 current paragraphs rearranged.
Tables are not compared: 11 previous and 6 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 (14)
Current report
Currently, we have an ongoing Phase 3 efficacy and safety trial (VITESSE) to evaluate the modified Viaskin Peanut patch in children ages four through seven with peanut allergy. On March 7, 2023, the Company announced that the first subject was screened in the VITESSE study. The Company announced on September 23, 2024 that subject screening was completed in the third quarter of 2024. Topline results are anticipated in the fourth quarter of 2025. On March 24, 2025, the Company announced that in a Written Responses Only to the Company’s Type D IND meeting request the FDA agreed with the Company’s proposal that the safety exposure data from the VITESSE Phase 3 study for Viaskin peanut patch in 4 – 7-year-olds will be sufficient to support a BLA filing in this age group. As a result, the COMFORT Children supplemental safety study will no longer be required and the Company will not conduct the study. The Company will utilize the safety data from the VITESSE subjects randomized to active treatment as well as placebo-crossover subjects in the VITESSE Open Label Extension (OLE). Accordingly, the Company plans to submit a BLA in the first half of 2026 and anticipates potentially accelerating the product launch by approximately one year, subject to FDA approval.
Current report
On December 11, 2024, the Company announced that it reached alignment with FDA on the Accelerated Approval pathway for Viaskin Peanut patch in toddlers 1-3 years-old and on key study design elements for the COMFORT Toddlers study, including study size and wear time collection methodology and analysis. The Company announced further that FDA confirmed criteria for a post-marketing confirmatory study in toddlers 1-3 years-old and that the Company and FDA agreed that the confirmatory study will assess the effectiveness of the intended commercial Viaskin Peanut patch, will include a include a double-blind, placebo-controlled food challenge (DBPCFC) and will use the same statistical criteria for success (i.e., lower bound of the 95% CI > 15%) as used in the EPITOPE and will need to be initiated at the time that the BLA is submitted.
Current 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.
Current report
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 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.
Current 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.
Current report
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 report
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 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 Investors in a private placement (the “2025 PIPE”) the following securities:
Current 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
Current 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
Current 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.
Current 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.
Current report
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.
Removed paragraphs (32)
Previous report
The Company announced further that the COMFORT Children safety study is expected to be initiated in the second quarter of 2025. This study plans to enroll approximately 250 subjects to raise the total number of 4 – 7 years-old on active treatment across the development program to approximately 600, consistent with prior FDA guidance. The VITESSE phase 3 efficacy trial of the Viaskin Peanut patch in peanut allergic children ages 4 – 7 years-old and the COMFORT Children safety study will constitute the core studies for a BLA submission in 4 – 7 years-old.
Previous report
Until the end of 2023, our operating income was composed of both the French research tax credit (Crédit d’Impôt Recherche, or “CIR”) and the revenue recognized under the Collaboration Agreement with NESTEC. Following the termination of the Collaboration Agreement on October 30, 2023, our operating income is now exclusively generated by the French research tax credit which explains why Other operating income was nil for the three months ended September 30, 2024 compared to $1.1 million for the three months ended September 30, 2023.
Previous report
Research and Development expenses increased by $9.9 million for the three months ended September 30, 2024, compared to the three months ended September 30, 2023, due to an increase in external clinical-related expenses of $4.9 million, primarily reflecting progress on subject enrollment in VITESSE Phase 3 clinical trial after the initiation of the study with the first patient screened in March 2023.
Previous report
Depreciation, amortization and other costs increased by $3.6 million for the three months ended September 30, 2024, compared to the three months ended September 30, 2023, due to (1) the termination of the Collaboration Agreement with NESTEC no longer requiring onerous contract provisioning, (2) accruals on CRO activities and (3) Medical, Quality and Regulatory Affairs activities.
Previous report
General and Administrative expenses increased by $1.0 million for the three months ended September 30, 2024, compared to the three months ended September 30, 2023.
Previous report
These increases are partially offset by a decrease in depreciation, amortization and other costs for $1.0 million for the three months ended September 30, 2024, compared to the three months ended September 30, 2023 primarily due to the provision reversal on the Montrouge office revamping following the non-renewal of the related lease agreement.
Previous report
Comparison of the Nine Months Ended September 30, 2024 and 2023
Previous report
Operating Income
Previous report
During the nine months ended September 30, 2024 we generated an Operating Income of $3.6 million compared to $6.9 million during the nine months ended September 30, 2023.
Previous report
Until the end of 2023, our operating income was composed of both the French research tax credit (Crédit d’Impôt Recherche, or “CIR”) and the revenue recognized under the Collaboration Agreement with NESTEC. Following the termination of the Collaboration Agreement on October 30, 2023, our operating income is now exclusively composed of the French research tax credit. Other operating income was nil for the nine months ended September 30, 2024 compared to $1.9 million for the nine months ended September 30, 2023.
Previous report
Research tax credit decreased by $1.3 million for the nine months ended September 30, 2024, compared to the nine months ended September 30, 2023 primarily due to the fact that a greater proportion of clinical studies activities were carried out in North America and were therefore not eligible to the French Research tax credit.
Previous report
Operating Expenses
Previous report
Research and Development Expenses
Previous report
The following table summarizes our R&D expenses incurred during the nine months ended September 30, 2024 and 2023:
Previous report
Research and Development expenses increased by $23.0 million for the nine months ended September 30, 2024, compared to the nine months ended September 30, 2023, essentially due to external clinical-related expenses increasing by $15.5 million from both patient enrollment in VITESSE Phase 3 clinical trial sustainable increase after the initiation of the study with the first patient screened in March 2023 and the preparatory activities for the COMFORT studies in preparation for and anticipation of initiation after FDA alignment.
Previous report
Employee-related costs, excluding share-based payments, increased by $3.3 million for the nine months ended September 30, 2024, compared to the nine months ended September 30, 2023 due to the recruitment of 13 internal resources in Medical, Quality and Regulatory Affairs, mostly based in the U.S.
Previous report
Depreciation, amortization and other costs increased by $3.9 million for the nine months ended September 30, 2024, compared to the nine months ended September 30, 2023, due to (1) l the termination of the Collaboration Agreement with NESTEC, (2) accruals on CRO activities and (3) Medical, Quality and Regulatory Affairs activities.
Previous report
Sales and Marketing expenses
Previous report
Sales and marketing expenses increased by $0.6 million for the nine months ended September 30, 2024, compared to the nine months ended September 30, 2023, primarily to support pre-commercialization activities for Viaskin Peanut in North America.
Previous report
General and Administrative expenses
Previous report
General and Administrative expenses increased by $1.4 million for nine months ended September 30, 2024, compared to the nine months ended September 30, 2023.
Previous report
External professional services increased by $1.8 million for nine months ended September 30, 2024, compared to the nine months ended September 30, 2023, primarily due to one-time costs associated with (1) office moves in France and the U.S, (2) financing activities and (3) trademark and patent activities.
Previous report
This increase is partially offset by a decrease in depreciation, amortization and other costs for $1.4 million for the nine months ended September 30, 2024, compared to the nine months ended September 30, 2023 primarily due to the provision reversal on the Montrouge office revamping.
Previous report
Financial income (expense)
Previous report
Income tax
Previous report
Our income tax expense was $48 thousand for the nine months ended September 30, 2024 compared to $13 thousand for the nine months ended September 30, 2023.
Previous report
Net loss
Previous report
Based on its current operations, plans and assumptions, the Company expects that its balance of cash and cash equivalents will be sufficient to fund its operations into the first quarter 2025.
Previous report
As of the date of filing, our available cash and cash equivalents will not be sufficient to support our operating plan for at least the next 12 months. As such, there is substantial doubt regarding our ability to continue as a going concern.
Previous report
We have incurred operating losses and negative cash flows from operations since our inception. Net cash used for operating activities was $92.2 million and $66.0 million for the nine months ended September 30, 2024 and 2023, respectively. For the nine months ended September 30, 2024, we recorded a net loss of $90.9 million. Our net cash flows provided by financing activities decreased to $(0.1) million during the nine months ended September 30, 2024 from $7.0 million during the nine months ended September 30, 2023 yielded by our ATM.
Previous report
Our financial statements have been prepared on a going concern basis assuming that we will be successful in our financing objectives. As such, no adjustments have been made to the financial statements relating to the recoverability and classification of the asset carrying amounts or classification of liabilities that might be necessary should we not be able to continue as a going concern.
Previous report
Our net cash flows used in operating activities were $92.2 million and $66.0 million during the nine months ended September 30, 2024 and 2023, respectively. Our net cash flows used in operating activities increased by $26.3 million . The variance is mainly driven by the increase in (1) external clinical related expenses by $10.2 million, (2) Regulatory and Manufacturing activities by $9.9 million and (3) internal employees’ compensation increase by $4.8 million as a result of the hiring of 16 additional internal resources.
Reworded paragraphs (22)
Previous wording
Currently, we have an ongoing Phase 3 efficacy and safety trial (VITESSE) to evaluate the modified Viaskin Peanut patch in children ages four through seven with peanut allergy. On March 7, 2023, the Company announced that the first patient was screened in the VITESSE study. The Company announced on September 23, 2024 that subject screening was completed in the third quarter of 2024 and that topline results are anticipated by fourth quarter of 2025. 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 anticipated later this year, as well as two planned Phase 3 supplementary safety studies, one in peanut-allergic children ages four through seven, and one 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, 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.
Previous wording
FDA guidance for Accelerated Approval include three qualifying criteria: 1) that the product candidate treats a serious condition, 2) that the product candidate generally provides a meaningful advantage over available therapies, and 3) that the product candidate demonstrates an effect on an intermediate clinical endpoint that is reasonably likely to predict clinical benefit. FDA confirmed that DBV has met criterion 1 and 2. Regarding criterion 3, FDA has provided guidance and suggestion regarding the intermediate clinical endpoint, which DBV has agreed to in informal discussions with the FDA. The Company intends to formalize the Accelerated Approval guidance provided by FDA via submission of a meeting request to confirm 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. DBV 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 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.
Previous wording
Research tax credit decreased by $0.2 million for the three months ended September 30, 2024, compared to the three months ended September 30, 2023 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 $0.7 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.
Previous wording
Employee-related costs, excluding share-based payments, increased by $1.1 million for the three months ended September 30, 2024, compared to the three months ended September 30, 2023 due to the recruitment of 13 internal resources in Medical, Quality and Regulatory Affairs mostly based in the U.S.
Current 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.
Previous wording
Sales and marketing expenses have decreased by $0.1 million during the three months ended September 30, 2024, compared to the three months ended September 30, 2023 mainly due to the optimization of external professional services.
Current wording
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 wording
External professional services increased by $1.7 million for the three months ended September 30, 2024, compared to the three months ended September 30, 2023 mainly due to (1) one-time costs associated with financing activities, and trademark and patent activities and (2) an accrual reversal that occurred last year and had the effect of reducing the corresponding last year expenses.
Current 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.
Previous wording
Our financial expense was $(0.1) million for the three months ended September 30, 2024, compared to a financial income of $1.5 million for the three months ended September 30, 2023. This item mainly includes the financial income on our financial assets and foreign exchange result.
Current 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.
Previous wording
Our income tax expense was nil for the three months ended September 30, 2024 compared to nil for the three months ended September 30, 2023.
Current 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.
Previous wording
Net loss was $30.4 million for the three months ended September 30, 2024, compared to $16.7 million for the three months ended September 30, 2023. Net loss per share (based on the weighted average number of shares outstanding over the period) was $0.32 and $0.17 for the three months ended September 30, 2024 and 2023, respectively.
Current 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.
Previous wording
On September 30, 2024, we had $46.4 million in cash and cash equivalents compared to $141.4 million of cash and cash equivalents on December 31, 2023.
Current 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.
Previous wording
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 ordinary share of the Company. The ATM program was intended to be effective through the expiration on July 16, 2024 of the Company’s existing registration statement registering the ADSs to be issued under the ATM program. The Company’s intent was to use the net proceeds, if any, of sales of ADSs issued under the program, together with its existing cash and cash equivalents, primarily for activities associated with potential approval and launch of Viaskin Peanut, as well as to advance the development of the Company’s product candidates using its Viaskin Peanut platform and for working capital and other general corporate purposes.
Current wording
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 wording
We intend to 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 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.
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. 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 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.
Previous wording
Our corporate headquarters are located in Châtillon, France. Our principal offices occupy a 2,447 square meter facility, pursuant to a lease agreement dated November, 2023 and represents $5.7 million cash requirement as of September 30, 2024. 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 $6.7 million cash requirement as of March 31, 2025. The lease term ends in March, 2033.
Previous wording
The lease agreement for the office occupying 4,470 square meter facility in Montrouge, France, signed on March 3, 2015, with an effective date of August 1, 2025, expired on May 31, 2024. Associated lease termination costs were reflected in the Company’s financial accounts in the Annual Report.
Current wording
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 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 $1.9 million cash requirement as of September 30, 2024 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 $1.7 million cash requirement as of March 31, 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 $0.1 million cash requirement as of September 30, 2024 which expires April 30, 2025.
Current 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.
Previous wording
There have been no material changes in our operating leases from those disclosed in the Annual Report except the impact of the new lease in Warren NJ for $1.7 million.
Current wording
There have been no material changes in our operating leases from those disclosed in the Annual Report.
Previous 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, 2024 expenses associated with the ongoing trials amounted globally to $162.4 million compared to $114.4 million as of December 31, 2023.
Current 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.
Previous wording
The table below summarizes our sources and uses of cash for the nine months ended September 30, 2024 and 2023.
Current wording
The table below summarizes our sources and uses of cash for the three months ended March 31, 2025 and 2024.
Previous wording
Our net cash flows used in investing activities were $1.5 million and $0.6 million during the nine months ended September 30, 2024 and 2023 respectively. The variance includes capitalized costs for the headquarters move to Châtillon in April 2024 which amounted to $1.8 million.
Current 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.
Previous wording
Our net cash flows from financing activities were $(88) thousand for the nine months ended September 30, 2024 compared to $7.0 million for the nine months ended September 30, 2023 from the ATM.
Current 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.
Rearranged previous paragraphs (7)
Previous report — wording carried elsewhere
On October 22, 2024, the Company announced positive regulatory updates for the Viaskin Peanut patch in the United States and Europe. The Company 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.
Previous report — wording carried 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 nine months ended September 30, 2024 and 2023.
Previous report — wording carried elsewhere
The following table summarizes our operating income during the nine months ended September 30, 2024 and 2023:
Previous report — wording carried elsewhere
The following table summarizes our sales and marketing expenses incurred during the nine months ended September 30, 2024 and 2023:
Previous report — wording carried elsewhere
The following table summarizes our general and administrative expenses incurred during the nine months ended September 30, 2024 and 2023:
Previous report — wording carried elsewhere
Our financial income was $1.9 million for the nine months ended September 30, 2024, compared to a financial income of $3.0 million for the nine months ended September 30, 2023. This item mainly includes financial income on our financial assets and an unfavorable foreign exchange result.
Previous report — wording carried elsewhere
Net loss was $90.9 million for the nine months ended September 30, 2024, compared to $61.5 million for the nine months ended September 30, 2023. Net loss per share (based on the weighted average number of shares outstanding over the period) was $0.95 and $0.65 for the nine months ended September 30, 2024 and 2023, respectively.