DBV Technologies SA
For the period ended Mar 31, 2025. Filed Apr 30, 2025.
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A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Mar 31, 2025 · Filed Apr 30, 2025
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Notes to the Condensed Consolidated Financial Statements (Unaudited)
Note 1: The Company
Incorporated in 2002 under the laws of France, DBV Technologies S.A. (“DBV Technologies” or the “Company”) is a clinical-stage specialty biopharmaceutical company focused on changing the field of immunotherapy by developing a novel technology platform called Viaskin. The Company’s therapeutic approach is based on epicutaneous immunotherapy (“EPIT”), a proprietary method of delivering biologically active compounds to the immune system through intact skin using Viaskin.
Basis of Presentation
The condensed consolidated financial statements of the Company and its wholly-owned subsidiaries are unaudited and have been prepared in accordance with generally accepted accounting principles in the United States (“U.S. GAAP”) and are presented in U.S. dollars. All significant intercompany accounts and transactions between the Company and its subsidiaries have been eliminated on consolidation.
The unaudited condensed consolidated financial statements presented in this Quarterly Report should be read in conjunction with the consolidated financial statements and accompanying notes included in the Company’s Annual Report on Form 10-K filed with the SEC on April 11, 2025 (the “ Annual Report”). The condensed consolidated statement of financial position as of December 31, 2024 was derived from the audited consolidated financial statements but does not include all disclosures required by U.S. GAAP. The Company’s critical accounting policies are detailed in the Annual Report. The Company’s critical accounting policies have not changed materially since December 31, 2024.
Certain information and footnote disclosures normally included in financial statements prepared in accordance with U.S. GAAP have been condensed or omitted from these interim financial statements. However, these condensed consolidated financial statements include all adjustments, consisting only of normal recurring adjustments, which are, in the opinion of management, necessary to fairly state the results of the interim period. These interim financial results are not necessarily indicative of results to be expected for the full fiscal year ending December 31, 2025, or any other future period.
Use of Estimates
The preparation of the Company’s condensed consolidated financial statements requires the use of estimates, assumptions and judgments that affect the reported amounts of assets, liabilities, and disclosures of contingent assets and liabilities at the date of the condensed consolidated financial statements and the reported amount of income and expenses during the period. The Company bases its estimates and assumptions on historical experience and other factors that it believes to be reasonable under the circumstances. The Company evaluates its estimates and assumptions on an ongoing basis. The actual results may differ from these estimates.
On an on-going basis, management evaluates its estimates, primarily those related to: (1) research tax credits, (2) assumptions used in the valuation of right of use assets—operating lease, (3) impairment of right-of-use assets related to leases and property, plant and equipment, (4) recoverability of the Company’s net deferred tax assets and related valuation allowance, (5) assumptions used in the valuation model to determine the fair value and vesting conditions of share-based compensation plan, 6) estimate of contingencies and provisions, and (7) estimate of employee benefits obligations.
Going Concern
These Condensed Consolidated Financial Statements have been prepared assuming the Company will continue as a going concern. The going concern assumption contemplates the realization of assets and satisfaction of liabilities in the normal course of business.
The Company has incurred operating losses and negative cash flows from operations since inception. The Company does not generate product revenue and continues to prepare for the potential launch of its first product in the United States and in the European Union, if approved.
Since its inception, the Company has primarily funded its operations through equity financings, as well as public assistance and Research Tax Credit.. Prior to 2022, the Company underwent restructuring efforts, scaled down certain clinical programs, and engaged with regulatory authorities to advance Viaskin Peanut’s approval process in the United States and European Union. In 2022, the Company secured a private placement financing of $194 million and lifted a partial clinical hold from the FDA on its VITESSE Phase 3 clinical study.
On April 7, 2025, the Company received gross proceeds of $125.5 million (€116.3 million) from the issuance of the ABSA and PFW-BS-PFW, as described in Note 15. With the receipt of the aforementioned proceeds, and based on its current operations, plans, and assumptions examined by the Board of Directors (“Board”) on March 23, 2025, the Company estimates that its cash and cash equivalents are sufficient to fund its operations into June 2026.
Given the Company’s historical operating losses and reliance on external financings, the Company may still seek additional capital for future needs through a combination of public or private equity or debt financings, collaborations, licensing agreements, and other funding options. While recent financing events have improved the Company’s financial position, access to additional capital in the future remains subject to market conditions and investor interest.
Accounting Pronouncements Recently Adopted
There have been no recently issued accounting standards adopted during the period which had a material impact on the Company’s financial statements.
There are no recently issued accounting standards that are expected to have a material impact on our results of operations, financial condition, or cash flows.
Accounting Pronouncements issued not yet adopted
In December 2023, the FASB issued ASU 2023-09, Income Taxes Topic 740 — Improvements to Income Tax Disclosures which enhances the transparency and usefulness of income tax disclosures. This amendment requires disclosure of disaggregated information about the Company’s effective tax rate reconciliation as well as information on income taxes paid. The disclosure requirements will be applied on a prospective basis, with the option to apply it retrospectively. For SEC filers, this ASU 2023-09 is effective for fiscal years beginning after December 15, 2024. The Company is currently evaluating the impact the adoption of this ASU will have on its consolidated financial statements and related disclosures.
In November 2024, the FASB issued ASU 2024-03, Income Statement - Reporting Comprehensive Income Topic 220 — Expense Disaggregation Disclosures. The guidance requires disclosure of additional information about specific expense categories in the notes to financial statements at interim and annual reporting periods. The disclosure requirements will be applied on a prospective basis, with the option to apply it retrospectively. For SEC filers, this ASU is effective for fiscal years beginning after December 15, 2026 and interim periods within fiscal years beginning after December 15, 2027. The Company is currently evaluating the impact the adoption of this ASU 2024-03 will have on its consolidated financial statements and related disclosures.
Other accounting standards that have been issued or proposed by the FASB or other standards-setting bodies that do not require adoption until a future date are not expected to have a material impact on the Company’s Consolidated Financial Statements upon adoption.
Note 2: Significant Events and Transactions
Clinical Programs
United States Regulatory History and Current Status
In August 2019, we announced the submission of a BLA to the FDA for Viaskin Peanut for the treatment of peanut allergy in children four to 11 years of age.
In August 2020, the Company received a Complete Response Letter (“CRL”) in which the FDA indicated it could not approve the Viaskin Peanut BLA in its then-current form. The FDA did not raise any safety concerns related to Viaskin Peanut.
In January 2021, the Company received written responses from the FDA to questions provided in the Type A meeting request that the Company submitted in October 2020 following receipt of the CRL.
In March 2021, the Company commenced CHAMP (Comparison of adHesion Among Modified Patches), a Phase 1 trial in healthy adult volunteers. . In May 2021, the Company submitted a proposed protocol to the FDA for STAMP (Safety, Tolerability, and Adhesion of Modified Patches)a 6-month safety and adhesion study which was to be conducted concurrently with DBV’s allergen uptake comparison studies (i.e., ‘EQUAL in Adults’, EQUAL). On October 14, 2021, in an Advice/Information Request letter, the FDA requested the Company conduct a stepwise, or sequential, approach to the modified Viaskin patch development program by conducting EQUAL first and submitting the data for FDA review and feedback prior to starting the STAMP study.
In December 2021, the Company decided not to pursue the sequential approach requested by the FDA and instead announced its plan to initiate a pivotal Phase 3 placebo-controlled efficacy trial for a modified Viaskin Peanut patch (mVP) in children in the intended patient population. Following written exchanges with the FDA, the FDA confirmed it was aligned with the Company’s strategy.
On September 7, 2022, the Company announced the initiation of VITESSE, a Phase 3 pivotal study of the mVP in children ages 4-7 years with peanut allergy. On September 21, 2022, the Company announced it received from FDA a partial clinical hold letter related to certain design elements of VITESSE.
On December 23, 2022, the Company announced that the FDA lifted the partial clinical hold 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.
In June 2022, the Company announced positive topline results from Part B of EPITOPE.
On April 19, 2023, the Company outlined the regulatory pathway for Viaskin Peanut in children 1 –3 years old after the FDA confirmed in written responses to the Company’s Pre-BLA meeting request that the Company’s EPITOPE phase 3 study met the pre-specified criteria for success for the primary endpoint and did not request an additional efficacy study in this age group. The FDA required additional safety data to augment the safety data collected from EPITOPE in support of a BLA.
On July 31, 2023, the Company announced receipt of feedback from FDA ontwo supplemental safety studies, COMFORT Children and COMFORT Toddlers.
On November 9, 2023, the Company submitted the protocol for its COMFORT Toddlers supplemental safety study in 1 –3 years-old to FDA. 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 Company also announced on November 9, 2023, 2-year results from the ongoing phase 3 open-label extension to the EPITOPE trial, EPOPEX, of Viaskin Peanut in toddlers.
On October 22, 2024, the Company announced positive regulatory updates for the Viaskin Peanut patch in the United States and Europe. DBV had 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 thetwo 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.
The Company announced further that it has aligned with FDA on a wear time collection methodology in COMFORT Toddlers intended to generate sufficient data to support a BLA submission. 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:
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 double-blind, placebo-controlled food challenge (DBPCFC), 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.
The Company submitted the protocol for its COMFORT Children supplemental safety study in ages 4-through-7-years-old to the FDA on November 29, 2023. 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 participants randomized to active treatment as well as placebo-crossover participants 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.
Viaskin Peanut —European Union Regulatory History and Current Status
In November 2020, we announced that our Marketing Authorization Application, or MAA, for Viaskin Peanut, submitted under the name “Abylqis®”, had been validated by the European Medicines Agency, or EMA. The validation of the MAA confirmed that the submission was sufficiently complete to begin the formal review process for Viaskin Peanut to treat peanut allergies in children ages four to 11 years. Following the MAA validation, the EMA’s Committee for Medicinal Products for Human Use, or CHMP, reviews the application and provides a recommendation to the European Commission, on whether to grant a marketing authorization.
On August 2, 2021, we announced we had received from the EMA the Day 180 list of outstanding issues, which is an established part of the prescribed EMA review process. The EMA identifiedone Major Objection remained at Day 180n questioning the limitations of the data, for example, the clinical relevance and effect size supported by a single pivotal study.
On December 17, 2021, we announced we had withdrawn the MAA for Viaskin Peanut, submitted under the name “Abylqis”, and formally notified the EMA of our decision.
On October 22, 2024, the Company announced it received scientific advice from EMA on an indication for ages 1 – 7 years-old in Europe regarding the components of a MAA for the Viaskin Peanut patch. Previous advice obtained fromtwo local country regulatory health authorities indicated a potential path for a 1 – 7 year-old registration withone patch, the modified patch. The EMA recently confirmed through scientific advice that the completed EPITOPE study in 1 – 3 years-old, and a positive VITESSE study in 4 – 7 years-old, could constitute an MAA submission for a 1 – 7 years-old indication for peanut allergy patients using the modified patch, along with a new safety study in toddlers ages 1 – 3 years-old with the modified patch. Timing for the initiation of this new safety study to satisfy the important EU market is currently being planned.
The Company intends to resubmit the MAA when that data set is available.
Viaskin Peanut for Children Ages 1 – 3
In June 2020, the Company announced that in Part A of the EPITOPE phase 3 clinical study subject in both treatment arms showed consistent treatment effects after 12 months of therapy, as assessed by a double-blind placebo-controlled food challenge and biomarker results. Part A subjects were not included in Part B and the efficacy analyses from Part A were not statistically powered to demonstrate superiority of either dose versus placebo.
In June 2022, the Company announced positive topline results from Part B of EPITOPE.
On April 19, 2023, the Company outlined the regulatory pathway for Viaskin Peanut in children 1 – 3 years old after the FDA confirmed in written responses to the Company’s Pre-BLA meeting request that the Company’s EPITOPE phase 3 study met the pre-specified criteria for success for the primary endpoint and did not request any additional efficacy study in this age group. The FDA requires additional safety data to augment the safety data collected from EPITOPE in support of a BLA. This new safety study will also generate patch adhesion data and will include updated instructions for use.
On May 10, 2023, the New England Journal of Medicine (“NEJM”) published results from the EPITOPE phase 3 clinical study that demonstrated EPIT with Viaskin Peanut was statistically superior to placebo in desensitizing children to peanut exposure by increasing the peanut dose that triggers allergic symptoms. As stated in an accompanying editorial piece, these data are seen as “very good news” for toddlers with peanut allergy.
In November 2023, the Company announced the interim analyses from the first year of the open-label extension of EPITOPE, called EPOPEX, which showed improvement between months 12 and 24 of treatment with Viaskin Peanut across all efficacy parameters. These data were presented at the annual American College of Allergy, Asthma and Immunology (ACAAI) in November 2023.
On November 9, 2023, the Company submitted the protocol for its COMFORT Toddlers supplemental safety study in 1 – 3 years-old to FDA. The Company received comments and queries to the protocol from the FDA on March 11, 2024.
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 criteria 1 and 2. Regarding criterion 3, FDA has provided guidance and suggestion regarding the intermediate clinical endpoint, which the Company has 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 thetwo 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.
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:
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 double-blind, placebo-controlled food challenge (DBPCFC), 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.
Viaskin Peanut for Children Ages 4 – 7
On September 7, 2022, the Company announced the initiation of VITESSE, a Phase 3 pivotal study of the mVP in children ages 4-7 years with peanut allergy. The Company defined initiation as the submission of the trial protocol to selected study sites for subsequent Institutional Review Board (IRB)/Ethics Committee (EC) approval.
On September 21, 2022, the Company announced it received from the FDA a partial clinical hold letter related to certain design elements of VITESSE. The Company announced on December 23, 2022 that the FDA lifted the partial clinical hold.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.
In July 2023, the Company received Type C Meeting Written Responses from the FDA regarding key study design elements for COMFORT Children. Subsequently, in October 2023, the Company received feedback from the FDA addressing the remaining protocol design elements for COMFORT Children.
The Company submitted the protocol for its COMFORT Children supplemental safety study in 4--7-years-old to the FDA on November 29, 2023.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 participants randomized to active treatment as well as placebo-crossover participants 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.
Financing
On March 27, 2025, the Company announced a financing of up to $306.9 million (€284.5 million), to advance the Viaskin Peanut Patch through BLA submission and U.S. commercial launch, if approved. The financing includes gross proceeds of $125.5 million (€116.3 million) received on April 7, 2025, and up to $181.4 million (€168.2 million) in potential additional gross proceeds that may be received if all the 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 some of the warrants. The ABSA Warrants (defined below) will be exercisable from their respective date of issue until the earlier of (i) April 7, 2027 and (ii) 30 days following the publication by the Company of a press release announcing that the ongoing VITESSE trial of Viaskin Peanut in children 4-7 years old met the primary endpoint defined in the VITESSE study protocol, it being specified that (i) the primary measure of treatment effect will be the difference in response rates at Month 12 between active and placebo treatment groups, (ii) the primary analysis will be based on a 2-sided confidence interval (“CI”) for the difference in response rates, and (iii) the primary analysis must be positive according to the success criterion (lower bound of the 2-sided 95% CI of the difference in response rates ≥15%) (the “ABSA Warrant Exercise Period”). The exercise of one (1) ABSA Warrant will give the holder the right to subscribe to one point seventy-five (1.75) ABSA Warrant Shares at a price of €1.5939 per ABSA Warrant.
The financing resulted in an immediate dilution of 22.4% and a maximal dilution of up to 73.7% of existing shareholders (on a non-diluted basis) if all the warrants in the Offering are exercised in full.
The financing consists of:
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
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 ofone pre-funded warrant to subscribe forone share of the Company (the "First Pre-Funded Warrants") andone warrant (the "BS Warrants") to subscribe toone 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"),
(together, the "Offering").
The net proceeds from the issue of the ABSA and the PFW-BS-PFW, together with existing cash and cash equivalents, will be mainly used by the Company in the following order of priority (i) for working capital and general corporate purposes, (ii) to finance the continued development of the Viaskin Peanut program, (iii) to finance the preparation and submission of a potential BLA and, (iv) to finance the readiness of a launch of Viaskin Peanut in the U.S., if approved.
The ordinary shares, including the ordinary shares issuable upon exercise of the warrants from the Offering, have not been registered under the Securities Act of 1933, as amended, and may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements. The Company has agreed to file a registration statement with the Securities and Exchange Commission registering the resale of the ordinary shares, including the ordinary shares underlying the warrants issued as part of the Offering.
Taking into account the net proceeds of $125.5 million (€116.3 million) received on April 7, 2025 from the issuance of the ABSA and the PFW-BS-PFW and based on its current operations, plans and assumptions, the Company estimates that it has sufficient balance of cash & cash equivalents to fund its operations into June 2026.
Legal Proceedings
From time to time, the Company may become subject to various legal proceedings and claims that arise in the ordinary course of our business activities. The Company is not currently subject to any material legal proceedings.
Note 3: Cash and Cash Equivalents
The following tables summarize the cash and cash equivalents as of March 31, 2025 and December 31, 2024:
| March 31, 2025 | December 31, 2024 | |
|---|---|---|
| Cash | 12,962 | 32,456 |
| Cash equivalents | — | — |
| Total cash and cash equivalents as reported in the statements of financial position | 12,962 | 32,456 |
Note 4: Other Current Assets
Other current assets consisted of the following:
| March 31, 2025 | December 31, 2024 | |
|---|---|---|
| Research tax credit | 4,917 | 3,980 |
| Other tax claims | 6,015 | 4,452 |
| Prepaid expenses | 3,875 | 1,541 |
| Other receivables | 1,380 | 1,959 |
| Total | 16,186 | 11,932 |
Research tax credit
The variance in Research Tax Credit is presented as follows:
| Amount in thousands of US dollars | |
|---|---|
| Opening research tax credit receivable as of January 1, 2025 | 3,980 |
| + Operating revenue | 753 |
| - Adjustment and currency translation effect | 184 |
| Closing research tax credit receivable as of March 31, 2025 | 4,917 |
| Of which - Non-current portion | — |
| Of which - Current portion | 4,917 |
Before currency translation effect, the balance in research tax credit as of March 31, 2025, consisted of $4.0 million research tax credit for the previous fiscal year filed with the tax authorities. The estimated research tax credit for the first three months of the 2025 fiscal year amounts to $0.8 million.
The other tax claims are primarily related to the VAT as well as the reimbursement of VAT that has been requested. Prepaid expenses are comprised primarily of insurance expenses, as well as legal and scientific consulting fees.
Note 5: Lease contracts
Future minimum lease payments under the Company’s operating leases’ right of use as of March 31, 2025 and December 31, 2024, are as follows:
| March 31, 2025 · December 31, 2024 | ||||||||
|---|---|---|---|---|---|---|---|---|
| Real Estate · Other assets · Total · Real Estate · Other assets · Total | ||||||||
| Current portion | 1,015 | 76 | 1,091 | 810 | 26 | 836 | ||
| Year 2 | 1,259 | 56 | 1,315 | 1,222 | 7 | 1,228 | ||
| Year 3 | 1,267 | 7 | 1,274 | 1,230 | 7 | 1,237 | ||
| Thereafter | 4,990 | 7 | 4,997 | 5,127 | 9 | 5,136 | ||
| Total minimum lease payments | 8,531 | 146 | 8,677 | 8,388 | 49 | 8,437 | ||
| Less: Effects of discounting | (1,430) | (13) | (1,443) | (1,463) | (23) | (1,486) | ||
| Present value of lease liabilities | 7,101 | 133 | 7,234 | 6,925 | 26 | 6,951 | ||
| Less: current portion | (643) | (66) | (709) | (648) | (6) | (654) | ||
| Long-term lease liabities | 6,459 | 66 | 6,525 | 6,278 | 20 | 6,297 | ||
| Weighted average remaining lease term (years) | 7.34 | 0.04 | 7.49 | 0.02 | ||||
| Weighted average discount rate | 5.06% | 0.09% | 5.02% | 0.02% | ||||
The Company recognizes rent expense, calculated as the remaining cost of the lease allocated over the remaining lease term on a straight-line basis. Rent expense presented in the consolidated statement of operations and comprehensive loss was:
| March 31, | |||
|---|---|---|---|
| 2025 | 2024 | ||
| Operating lease expense / (income) | 288 | 586 | |
| Net termination impact | 49 | ||
| Net restructuring impact | (1) | (7) | |
Supplemental cash flow information related to operating leases is as follows for the period March 31, 2025 and 2024:
| March 31, | ||
|---|---|---|
| 2025 | 2024 | |
| Cash paid for amounts included in the measurement of lease liabilities | ||
| Operating cash flows used in operating leases | 96 | 501 |
Note 6: Trade Payables and Other Liabilities
6.1 Trade Payables
Trade payables increased by $12.1 million as of March 31, 2025, compared to December 31, 2024.
No discounting was performed on the trade payables to the extent that the amounts did not present payment terms longer than one year at the end of each fiscal period presented.
6.2 Other Liabilities
The following tables summarize the other liabilities as of March 31, 2025 and December 31, 2024:
| March 31, 2025 · December 31, 2024 | ||||||
|---|---|---|---|---|---|---|
| Other current liabilities · Other non-current liabilities · Total · Other current liabilities · Other non-current liabilities · Total | ||||||
| Employee related liabilities | 4,844 | — | 4,844 | 7,294 | — | 7,294 |
| Tax liabilities | 332 | — | 332 | 188 | — | 188 |
| Other debts | 272 | — | 272 | 846 | — | 846 |
| Total | 5,447 | — | 5,447 | 8,328 | — | 8,328 |
The Employee related liabilities include short-term debt to employees including social welfare, tax agency obligations and bonus provision. The variance versus year end is due to bonus accruals.
Note 7: Shareholders’ equity
The share capital as of March 31, 2025 is set at the sum of €10,285,887 ($11,652 thousand converted at historical rates). It is divided into 102,858,868 fully authorized, subscribed and paid-up ordinary shares with a par value of €0.10.
Note 8: Share-Based Payments
The Board of Directors has been authorized at the General Meeting of the Shareholders to grant restricted stock units (“RSU”), stock options plan (“SO”), and non-employee warrants (Bons de Souscription d’Actions or “BSA”).
During the three months ended March 31, 2025, the Company granted neither stock optionsnor restricted stock units to employees.
There have been no changes in the vesting conditions and method of valuation of the SO and RSUs from that disclosed in Note 12 to the consolidated financial statements included in the Annual Report.
Change in Number of BSA/SO/RSU:
| Number of outstanding | |||
|---|---|---|---|
| BSA · SO · RSUs | |||
| Balance as of December 31, 2024 | 244,693 | 10,444,803 | 2,813,366 |
| Granted during the period | — | — | — |
| Forfeited during the period | — | (3,725) | (36,350) |
| Exercised/released during the period | — | — | (20,467) |
| Expired during the period | — | — | — |
| Balance as of March 31, 2025 | 244,693 | 10,441,078 | 2,756,549 |
Share-based payments expense reflected in the condensed consolidated statements of operations is as follows:
| Three Months Ended March 31, | |||
|---|---|---|---|
| 2025 · 2024 | |||
| Research & development | SO | (382) | (513) |
| RSU | (199) | (256) | |
| Sales & marketing | SO | (12) | (23) |
| RSU | (6) | (9) | |
| General & administrative | SO | (997) | (1,030) |
| RSU | (105) | (126) | |
| Total share-based compensation (expense) | (1,701) | (1,958) | |
Note 9: Contingencies
The following tables summarize the contingencies as of March 31, 2025 and December 31, 2024:
| March 31, 2025 | December 31, 2024 | |
|---|---|---|
| Current contingencies | 82 | 122 |
| Non-current contingencies | 780 | 838 |
| Total contingencies | 861 | 961 |
The changes in contingencies are as follows:
| Pension retirement obligations | Other contingencies | Total | |
|---|---|---|---|
| At January 1, 2025 | 838 | 122 | 961 |
| Increases in liabilities | 34 | 21 | 55 |
| Used liabilities | — | (63) | (63) |
| Reversals of unused liabilities | — | — | — |
| Net interest related to employee benefits, and unwinding of discount | — | — | — |
| Actuarial gains and losses on defined-benefit plans | (132) | — | (132) |
| Currency translation effect | 39 | 1 | 41 |
| At March 31, 2025 | 780 | 82 | 861 |
| Of which current | — | 82 | 82 |
| Of which non-current | 780 | — | 780 |
The Company does not hold any plan assets related to long-term employee benefit for any of the periods presented. There have been no significant changes in assumptions for the estimation of the retirement commitments from those disclosed in Note 13 to the consolidated financial statements included in the Annual Report.
Note 10: Operating income
The following table summarizes the operating income during the three and nine months ended March 31, 2025 and 2024:
| Three Months Ended March 31, | ||
|---|---|---|
| 2025 | 2024 | |
| Research tax credit | 753 | 1,407 |
| Other operating income | — | — |
| Total | 753 | 1,407 |
The decrease in Research tax credit was primarily due to the fact that a greater proportion of studies activities were carried out in North America and were therefore not eligible to the French Research tax credit.
Note 11: Operating Expenses
The Company had an average of 106 employees during the three months ended March 31, 2025, in comparison with an average of 105 employees during the three months ended March 31, 2024. The increase is mainly due to hiring to support development activities and quality activities.
The following table summarizes the allocation of personnel expenses by function during the three months ended March 31, 2025 and 2024:
| Three Months Ended March 31, | ||
|---|---|---|
| 2025 | 2024 | |
| Research and Development expenses | 4,630 | 5,048 |
| Sales & Marketing expenses | 155 | 334 |
| General & Administrative expenses | 2,996 | 3,236 |
| Total personnel expenses | 7,782 | 8,618 |
The following table summarizes the allocation of personnel expenses by nature during the three months ended March 31, 2025 and 2024:
| Three Months Ended March 31, | ||
|---|---|---|
| 2025 | 2024 | |
| Wages and salaries | 4,677 | 5,144 |
| Social security contributions | 1,370 | 1,207 |
| Expenses for pension commitments | 34 | 309 |
| Share-based payments | 1,702 | 1,958 |
| Total | 7,782 | 8,618 |
The decrease in personnel expenses is primarily due to lower bonuses paid in 2025 compared to last year.
Note 12: Commitments
There were no significant changes in other commitments from those disclosed in Note 17 to the consolidated financial statements included in the Annual Report.
Note 13: Relationships with Related Parties
There were no new significant related-party transactions during the period nor any changes in the nature of the transactions from those described in Note 18 to the consolidated financial statements included in the Annual Report.
Note 14: Loss Per Share
Basic loss per share is calculated by dividing the net loss attributable to the shareholders of the Company by the weighted average number of ordinary shares outstanding during the period. As the Company was in a loss position for each of the three-month periods ended March 31, 2025 and 2024, the diluted loss per share is equal to basic loss per share because the effects of potentially dilutive shares were anti-dilutive as a result of the Company’s net loss.
The following is a summary of the ordinary share equivalents that were excluded from the calculation of diluted net loss per share for each of the three months period ended March 31, 2025 and 2024 indicated in number of potential shares:
| Three Months Ended March 31, | ||
|---|---|---|
| 2025 | 2024 | |
| Non-employee warrants | 244,693 | 244,693 |
| Stock options | 10,492,903 | 7,388,016 |
| Restricted stock units | 3,087,872 | 2,064,035 |
| Prefunded warrants | 22,266,331 | 28,276,331 |
Note 15: Events after the Close of the Period
On March 27, 2025, the company announced a financing of up to $306.9 million (€284.5 million), to advance Viaskin® Peanut Patch through biologics license application submission and U.S. commercial launch, if approved. The financing includes gross proceeds of $125.5 million (€116.3 million) received on April 7, 2025 and up to $181.4 million (€168.2 million) in potential additional gross proceeds that may be received if all the warrants are exercised, subject to satisfaction of specified conditions.
On April 15, 2025, the Company received the 2024 Research Tax Credit (Crédit d’Impôt Recherche) in the amount of $4.0 M in cash.
Note 16: Reportable segment disclosure
| Three Months Ended March 31, | ||
|---|---|---|
| 2025 | 2024 | |
| Clinical studies | 6,802 | 8,173 |
| BLA & Regulatory | 1,385 | 1,480 |
| Medical Affairs & Other Medical | 1,958 | 2,664 |
| Research & Innovation | 744 | 190 |
| Manufacturing & Supply and Quality | 10,594 | 8,896 |
| Sales & Marketing | 262 | 758 |
| General & Administrative | 5,626 | 7,804 |
| Total expenses | 27,371 | 29,965 |
The Company operates and is managed asone operating segment driving expenses for the development of Viaskin Peanut. The Company’s R&D organization is primarily responsible for the development and registration efforts of Viaskin Peanut. The Company’s technical operations group is responsible for the development of manufacturing processes, supplying clinical drug product. The Company is also supported by corporate staff functions.
The Company’s Chief Executive Officer as the CODM manages and allocates resources to the operations of the total company by assessing the overall level of resources available and how to best allocate them to support the Company’s long-term company-wide strategic goals. In making this decision, the CODM uses consolidated financial information for the purposes of evaluating performance, allocating resources, setting incentive compensation targets and planning and forecasting for future periods.
The CODM's analysis includes a comparison to budgeted results. Segment assets provided to the CODM are consistent with those reported on the Consolidated Statement of Financial Position with particular emphasis on the Company's available liquidity including cash, cash equivalents.
The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.