DBV Technologies S.A.
For the period ended Mar 31, 2026. Filed Apr 30, 2026.
View on SEC.govAbout this filing
A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Mar 31, 2026 · Filed Apr 30, 2026
DBVT$10.45+6.6%Stored close · as of Nov 6, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2025-09-30; filed 2025-10-28.
0001628280-25-046809
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2026-03-31; filed 2026-04-30.
0001628280-26-028929
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 112 previous paragraphs and 62 current paragraphs.
23 unchanged; 8 reworded; 31 added; 76 removed; 5 previous and 0 current paragraphs rearranged.
Tables are not compared: 12 previous and 8 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 (31)
Current report
Our most advanced product candidate is Viaskin Peanut, which has been evaluated as a potential therapy for children with peanut allergy in twelve clinical trials, including three Phase 2 trials and four completed Phase 3 trials. We have two ongoing Phase 3 trials of Viaskin Peanut in children ages one to three and ages four to seven with peanut allergy. The Company plans to submit a BLA for Viaskin Peanut in children aged 4 to 7 in the first half of 2026. With respect to the toddler program, the COMFORT Toddlers supplemental safety study in peanut allergic children aged 1 to 3, which screened its first subject on June 25, 2025, is ongoing and the Company continues to enroll subjects towards its target of approximately 300 to 350 subjects on active treatment. This would bring the total Viaskin Peanut patch safety database in this age group to approximately 600 subjects, consistent with prior FDA guidance.
Current report
Overview of the First Quarter of 2026
Current report
In the first quarter of 2026, the Company started to execute its plan for the potential U.S. commercialization of the Viaskin Peanut patch for children aged 4 to 7, following regulatory, clinical and financial developments in 2025 that will support a BLA filing and have increased cash and cash equivalents.
Current report
In March 2025, the FDA confirmed the safety data requirements to support the planned Biologics License Application for Viaskin Peanut in children aged 4 to 7 if approved, providing a clear and executable path toward submission. Subsequently, the Company completed its March 2025 PIPE financing. In addition ATM sales in the second half of 2025 materially strengthened the Company’s balance sheet, enabling continued progression toward potential commercialization while maintaining disciplined capital allocation. Finally, in December 2025, the Company reported positive topline results from the Phase 3 VITESSE trial in peanut-allergic children aged 4 to 7 years that enable a BLA filing expected in the first half of 2026.
Current report
The Company’s strategic objective remains to change the field of immunotherapy by developing and commercializing safe, effective, and convenient therapies for patients with food allergies and other immunological conditions while delivering sustained value to shareholders.
Current report
The Company did not generate Revenue from operating activities.
Current report
This caption consists of Research Tax Credit (crédit d’impôt recherche, or CIR) that is granted to companies by the French tax authorities in order to encourage them to conduct technical and scientific researches. The Company accrued $0.9 million as of March 31, 2026. This level in tax credit income accrual reflects on a full year basis the expected lower level of eligible experimental activities, as the Company’s focus continues to shift from clinical development toward commercial readiness activities.
Current report
External clinical-related expenses increased by $10.0 million for the three months ended March 31, 2026 compared to the three months ended March 31, 2025 mainly due to higher clinical trial activity driven by the initiation of patient recruitment for the COMFORT Toddlers study, and to the acceleration of BLA readiness activities to prepare BLA submission.
Current report
Employee-related costs and share based payment expenses respectively increased by $3.3 million and $0.5 million for the three months ended March 31, 2026, compared to the three months ended March 31, 2025 primarily due to reinforcement of Medical Affairs, Quality and Regulatory functions in the United States to support a potential U.S. launch, if approved, and to ensure organizational readiness as the Company approaches commercialization.
Current report
The Company continued its precommercial inventory build up for $3.0 million in anticipation of potential FDA approval.
Current report
Depreciation, amortization and other costs decreased by $0.7 million for the three months ended March 31, 2026, compared to the three months ended March 31, 2025 primarily due to lower depreciation and amortization. Other costs reduced as well in the absence of certain prior-year charges.
Current report
In the third quarter of 2025, the Company appointed a Chief Commercial Officer, marking a key step in establishing a dedicated commercial organization. Since then, efforts have focused on building U.S.‑based commercial, market access and launch‑readiness capabilities designed to support a successful introduction of Viaskin® Peanut in children aged 4 to 7, if approved. The increase in sales and marketing expenses in the first quarter of 2026 reflects the continued build‑out of this commercial infrastructure and the progression toward execution of this strategy.
Current report
General and Administrative expenses increased by $4.9 million for the three months ended March 31, 2026, compared to the three months ended March 31, 2025.
Current report
External professional services increased by $3.1 million for the three months ended March 31, 2026, compared to the three months ended March 31, 2025 primarily due to an accelerated activity in 2026 to support a potential U.S. launch, if approved, and to ensure organizational readiness as the Company approaches commercialization particularly through Investor Relations, Human Resources and Legal activities. This increase in activity is further accentuated given that, in the prior-year period, the Company was containing its costs and expenses during its financing period ended in March 31, 2025.
Current report
Employee-related costs and share-based payments increased by $1.6 million, for the three months ended March 31, 2026, compared to the three months ended March 31, 2025 as the Company continued to scale its organization in preparation for commercial operations. The growth in full time employees was concentrated in Human Resources, Information Solutions, Finance, and Legal and Compliance, reflecting targeted investments in the core infrastructure required to achieve commercial readiness for Viaskin Peanut in North America. These additions were designed to strengthen operational capabilities, enhance organizational maturity, and support the transition toward a potential commercial launch, if approved.
Current report
Depreciation, amortization and other costs increased by $0.3 million for the three months ended March 31, 2026, compared to the three months ended March 31, 2025.
Current report
Our financing strategy is to maintain financial flexibility to meet working capital requirements including commercial inventory build and manufacturing capacity expansion to support demand of VIASKIN Peanut patches in the United States and Europe, if approved.
Current report
In addition, the Company's results of operations and financial position are subject to the effects of foreign currency fluctuations, principally between the U.S. dollar and the Euro. The Company's functional currency is the Euro, and a significant portion of its operating expenses, including personnel costs and facility-related expenditures, are denominated in euros. During the three months ended March 31, 2026, the euro depreciated against the U.S. dollar, resulting in a $(4.4) million unfavorable foreign currency translation adjustment recognized in other comprehensive loss and a $(4.5) million unfavorable effect of exchange rate changes on cash and cash equivalents. As the Company continues to expand its U.S.-based operations in preparation for a potential commercial launch, an increasing proportion of its expenditures are denominated in U.S. dollars; however, the Company's euro-denominated cost base remains substantial. Continued appreciation of the euro against the U.S. dollar would increase the U.S. dollar equivalent of the Company's euro-denominated operating expenses and could accelerate the utilization of the Company's cash resources, which are held primarily in U.S. dollars. The Company utilizes foreign exchange swap instruments to manage a portion of this exposure, as described in Note 8 to the condensed consolidated financial statements; however, there can be no assurance that such measures will fully offset the impact of adverse currency movements on the Company's results of operations, cash flows or financial condition.
Current report
Since its inception and up to March 31, 2026, the Company has received a total of approximately $1.7 billion in equity financing, almost all of which relates to cash proceeds from capital increases. The Company obtained the following gross proceeds from various financings through the issuance of securities as detailed :
Current report
In June 2022, the Company announced an aggregate $194 million private investment in public equity (“PIPE”) financing from the sale of 32,855,669 ordinary shares, as well as pre-funded warrants to purchase up to 28,276,331 ordinary shares. The ordinary shares were sold to the purchasers at a price per ordinary share of €3.00 (corresponding to $3.22), and the pre-funded warrants at a pre-funded price of €2.90 (corresponding to $3.11) per pre-funded warrant, which equals the per share price for the ordinary shares less the remaining €0.10 exercise price for each such pre-funded warrant.
Current report
In April 2025, the Company completed a PIPE financing generating initial gross proceeds of $125.5 million (€116.3 million), followed by the full exercise of associated warrants in January 2026 after the announcement of positive Phase 3 VITESSE topline results, resulting in additional gross proceeds of $195.4 million (€166.7 million at 1 EUR = $1.17). Of the additional gross proceeds, $100.7 million was received as of December 31, 2025 and the remaining $94.7 million (€81.0 million at the exchange rate of 1 EUR = $1.17) was received in January 2026.
Current report
In addition, in September 2025, the Company established an ATM equity program pursuant to which it may offer and sell up to $150.0 million of ADSs, subject to applicable regulatory limits. During the fourth quarter of 2025, the Company raised $65 million in gross proceeds through multiple issuances of ADSs.
Current report
The Company also benefits as an SME status from refunds of Research Tax credit (crédit d’impôt recherche) granted to companies by the French tax authorities in order to encourage them to conduct technical and scientific research.
Current report
Material expenses commitments
Current report
The following table presents our material expenses commitments for future periods:
Current report
The commitment amounts in the table above are associated with contracts that are enforceable and legally binding and that specify all significant terms, including fixed or minimum services to be used, fixed, minimum or variable price provisions, and the approximate timing of the actions under the contracts. Future events could cause actual payments to differ from these estimates.
Current report
Forward-looking
Current report
As of March 31, 2026, Cash & Cash Equivalents are $229.2 million. Based on its current operations, plans, and assumptions, Management estimates that the Company is sufficiently funded to run its operations into the second quarter of 2027.
Current report
These estimates are based on the Company’s current forecasts and exclude any additional expenditures related to programs other than the VIASKIN Peanut or resulting from the potential in licensing or acquisition of additional product candidates or technologies, or any associated development the Company may pursue. The Company may have based these estimates on assumptions that are incorrect, and the Company may end up using its resources sooner than anticipated.
Current report
The Company's net cash used in operating activities increased to $49.1 million for the three months ended March 31, 2026, compared to $19.7 million for the three months ended March 31, 2025, reflecting the acceleration of clinical development activities, the build-out of commercial infrastructure, and the continued expansion of the Company's workforce in preparation for a potential U.S. launch of Viaskin Peanut, if approved. The Company expects its operating cash outflows to remain at elevated levels, and potentially increase further, as it advances toward BLA submission, continues to invest in manufacturing readiness and pre-commercial inventory, and scales its commercial organization. This anticipated trajectory of expenditures has been incorporated into the Company's cash runway estimate described above. However, the rate at which the Company utilizes its cash resources may vary materially from current expectations depending on, among other factors, the timing and scope of regulatory interactions, the pace of clinical enrollment, the timing of manufacturing-related capital commitments, and fluctuations in foreign exchange rates. If the Company's operating cash outflows exceed current projections, the Company may need to seek additional financing earlier than anticipated.
Current report
The Company may expend resources sooner than anticipated and may seek additional resources to execute the corporate strategy either through new or existing financing strategies. As of date of issuance, the remaining financing capacity and Equity securities are:
Removed paragraphs (76)
Previous report
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 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.
Previous report
We also have an ongoing Phase 3 open-label extension to the EPITOPE trial (our completed Phase 3 efficacy and safety trial conducted in peanut-allergic toddlers which met its clinical endpoints), with 3-year results for active-treatment subjects in 2024, and an ongoing Phase 3 supplementary safety study, in peanut-allergic toddlers ages one through three.
Previous report
The Company submitted the protocol for its COMFORT Toddlers supplemental safety study in 1 – 3 years-old to the FDA on November 9, 2023. The Company received comments and queries to the protocol from the FDA on March 11, 2024. On July 30, 2024, the Company announced that it and the FDA had been engaged in ongoing dialogue since May 2023 on the COMFORT Toddlers supplemental safety study in 1 – 3-years-old with a peanut allergy. The study protocol was submitted on November 9, 2023, with comments provided by FDA on March 11, 2024. After March, much of the dialogue between DBV and FDA regarding the COMFORT Toddlers supplemental study had focused on patch wear-time experience, including how prescribers would advise parents and caregivers to manage day-to-day variability in patch wear time. The Company proposed an approach, informed by the EPITOPE efficacy data, that focuses on the user experience during the first 90-days of treatment. The Company submitted to the FDA draft labeling for Section 2 – Dosing and Administration, for a potential Viaskin Peanut Prescribing Information (PI), along with comprehensive supportive data and analyses. Within the first 90-days of treatment (excluding the lead-in dosing period) it is possible to identify those patients who are very likely to have a robust clinical efficacy response based on patch wear time experience (i.e., “Label-in” patients). The proposed PI recommends continuation of treatment for these patients. With the same 90-day approach, patients less likely to have a robust clinical efficacy response, identified by their patch wear-time experience, would be identified as “Label-out” patients. In these instances, the PI would recommend a shared decision-making process, between the health care provider and the parent or caregiver, to determine whether treatment should be discontinued.
Previous report
On October 22, 2024, the Company announced positive regulatory updates for the Viaskin Peanut patch in the United States and Europe. DBV agreed to guidance provided by the FDA on a potential pathway under the Accelerated Approval Program for the Viaskin Peanut patch in toddlers ages 1 – 3 years-old. FDA confirmed that the Company met Accelerated Approval qualifying criterion 1 and 2 . Regarding criterion 3, FDA provided guidance and suggestion regarding the intermediate clinical endpoint, which the Company agreed to in informal discussions with the FDA. The Company formalized the Accelerated Approval guidance provided by FDA via submission of a meeting request and confirmed the general elements of the two study components: the COMFORT Toddlers safety study, to be completed before BLA submission, and the confirmatory effectiveness study, including the third Accelerated Approval criterion regarding the intermediate clinical endpoint. The Company expects that the confirmatory study will be initiated by the time of BLA submission and would run in parallel to commercialization in the United States, if the Viaskin Peanut patch is approved.
Previous report
The Company announced further that it aligned with FDA on a wear time collection methodology in COMFORT Toddlers that provides a practical approach for subjects and families, is intended to generate sufficient data to support a BLA submission, and places wear time into an acceptable clinical hierarchy relative to other study endpoints. On June 25, 2025, the Company announced that the first subject was screened in COMFORT Toddlers supplemental safety study in peanut allergic toddlers 1 – 3 years old. The Company anticipates enrolling approximately 300 – 350 subjects on active treatment into the safety study, which would bring the total Viaskin Peanut patch safety database in toddlers to approximately 600 subjects, consistent with prior FDA guidance. With this path forward, the BLA submission for Viaskin Peanut patch in 1 – 3 years-old under the Accelerated Approval program is anticipated to be supported by:
Previous report
ii. Additional safety data generated in COMFORT Toddlers supplemental safety study, which was initiated in June quarter of 2025.
Previous 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.
Previous report
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.
Previous report
The Company announced further that it sought scientific advice from the EMA regarding the components of a MAA for the Viaskin Peanut patch. Previous advice obtained from two local country regulatory health authorities indicated a potential path for a 1 – 7 year-old registration with one 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 year-old indication for peanut allergy patients using the modified patch, along with a new safety study in 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.
Previous report
Manufacturing and Supply Agreement
Previous report
On August 29, 2025, the Company updated the Supply Agreement with SANOFI, under which SANOFI will manufacture and supply the Viaskin Peanut API exclusively for the Company during the term of the Supply Agreement. The Supply Agreement has an initial term of four years with a possibility to extend for an additional period. The effective date of the Supply Agreement is January 1, 2025.
Previous report
The Supply Agreement includes terms related to manufacturing, quality control, pricing, volume commitments, and supply obligations. The Supply Agreement is designed to secure commercial-scale manufacturing capacity in preparation for a potential Biologics License Application (“BLA”) submission and subsequently, the commercial launch of the Viaskin Peanut patch in the United States, if approved.
Previous report
We have non-cancellable minimum commitments for products and services, subject to the Supply Agreement. Under US GAAP, take-or-pay arrangements are generally considered firm purchase commitments. As of September 30, 2025, we have assessed our ability to meet our performance obligations as per US GAAP requirements (ASC 440-10: Commitments, ASC 450-20: Loss Contingencies and ASC 330-10-35: Inventory and purchase commitments) and confirm to commit to agreed volumes. Hence, we have not recognized on the balance sheet any loss provision.
Previous report
The Company expects to incur expenditures related to support for BLA and PAI preparation, Cold storage rental, over the Supply Agreement term. These expenditures are consistent with the Company’s planned investments to strengthen its supply chain readiness ahead of potential regulatory milestones. The Company believes the Supply Agreement enhances the robustness of its manufacturing network and supports long-term product supply reliability.
Previous report
Research tax credit increased by $1.7 million for the three months ended September 30, 2025, compared to the three months ended September 30, 2024 primarily due to a greater proportion of activities eligible to receive the Research tax credit carried out in the third quarter 2025 than in the third quarter 2024.
Previous report
Research and Development expenses increased by $5.0 million for the three months ended September 30, 2025 compared to the three months ended September 30, 2024.
Previous report
External clinical-related expenses increased by $4.5 million mainly due to (1) the launch of the COMFORT Toddlers study following alignment with the FDA, and (2) regulatory and production activities to support ongoing clinical trials, BLA submission and pre-commercialization activities for Viaskin Peanut in North America.
Previous report
Employee-related costs increased by $0.5 million for the three months ended September 30, 2025 compared to the three months ended September 30, 2024. This increase is mainly due to (1) recruitments made during the third quarter of 2024, mainly based in the United States, for which a full quarter of personnel costs are recognized at end-September 2025, and (2) additional recruitments made during the third quarter 2025.
Previous report
Depreciation, amortization and other costs remain consistent for the three months ended September 30, 2025 compared to the three months ended September 30, 2024.
Previous report
General and Administrative expenses remain consistent for the three months ended September 30, 2025, compared to the three months ended September 30, 2024.
Previous report
External professional services increased by $0.2 million for the three months ended September 30, 2025, compared to the three months ended September 30, 2024 mainly due to financing activities.
Previous report
Employee-related costs, excluding share-based payments, decreased by $0.1 million for the three months ended September 30, 2025, compared to the three months ended September 30, 2024 due to lower full time equivalent on third quarter 2025 compared to 2024.
Previous report
The Share-based payment expenses decreased by $0.8 million mainly due to employees that lost their rights subsequently to their exits.
Previous report
Depreciation, amortization and other costs increased by $0.7 million for the three months ended September 30, 2025, compared to the three months ended September 30, 2024 mainly due to depreciation related to the refurbishment of the Châtillon office and licenses increase following recruitment made in 2025.
Previous report
Comparison of the Nine Months Ended September 30, 2025 and 2024
Previous report
Operating Income
Previous report
During the nine months ended September 30, 2025 we generated an Operating Income of $5.0.million compared to $3.6.million during the nine months ended September 30, 2025.
Previous report
Research tax credit increased by $1.4 million for the nine months ended September 30, 2025, compared to the nine months ended September 30, 2024 primarily due to the fact that more eligible activities have been carried out in the period, including the related costs of the FAREVA platform.
Previous 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, 2025 and 2024:
Previous report
Research and Development expenses increased by $13.4 million for the nine months ended September 30, 2025, compared to the nine months ended September 30, 2024.
Previous report
External clinical-related expenses increased by $11.5 million mainly due to (1) the launch of the COMFORT Toddlers study following alignment with the FDA and (2) regulatory and production activities to support ongoing clinical trials, BLA submission and pre-commercialization activities for Viaskin Peanut in North America.
Previous report
Employee-related costs increased by $0.9 million for the nine months ended September 30, 2025 compared to the nine months ended September 30, 2024. This increase is primarily due to the recruitment carried out during the second quarter of 2024, mainly based in the United States in Medical, Quality and Regulatory Affairs, resulting in a full nine-month impact in 2025 compared to a four to six month impact in 2024.
Previous report
Depreciation, amortization and other costs increased by $1.6 million for the nine months ended September 30, 2025 compared to the nine months ended September 30, 2024. This increase is mainly due to a $1.1 million provision reversal at June 30, 2024, following the termination of the Collaboration Agreement with NESTEC, which reduced last year's charge.
Previous report
Sales and Marketing expenses
Previous report
Sales and Marketing expenses decreased by $0.4 million for the nine months ended September 30, 2025, compared to the nine months ended September 30, 2024, mainly due to (1) lower Sales and Marketing activities, (2) lower sales full time equivalent (following a transfer of assignment between sales and overheads) and (3) lower travel expenses.
Previous report
General and Administrative expenses
Previous report
General and Administrative expenses decreased by $2.3 million for the nine months ended September 30, 2025, compared to the nine months ended September 30, 2024.
Showing the first 40 of 76 passages. Open the source sections for the rest.
Reworded paragraphs (8)
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, 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.
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, 2025, included in our Annual Report on Form 10-K for the year ended December 31, 2025, filed with the Securities and Exchange Commission on March 26, 2026, as amended by the Amendment No. 1 on Form 10-K/A filed with the SEC on April 30, 2026, 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
We are a clinical-stage specialty biopharmaceutical company focused on changing the field of immunotherapy by developing a novel technology platform called Viaskin. Our therapeutic approach is based on epicutaneous immunotherapy (EPIT) our proprietary method of delivering biologically active compounds to the immune system through intact skin using Viaskin, an epicutaneous patch (i.e., a skin patch). We have generated significant data demonstrating that Viaskin’s mechanism of action is novel and differentiated, Viaskin targets specialized antigen-presenting immune cells in the skin, called Langerhans cells, that capture the antigen that accumulates in the outer layer of the skin, and then migrate to the skin-draining lymph nodes in order to activate the immune system without passage of the antigen into the bloodstream, minimizing systemic exposure in the body. We are advancing this unique technology to treat children suffering from food allergies, for whom safety is paramount, since the introduction of the offending allergen into their bloodstream can cause severe or life-threatening allergic reactions, such as anaphylactic shock. We believe Viaskin may offer convenient, self-administered, non-invasive immunotherapy to patients, if approved.
Current wording
We are a late-stage specialty biopharmaceutical company focused on changing the field of immunotherapy by developing a novel technology platform called Viaskin. Our therapeutic approach is based on EPIT, our proprietary method of delivering biologically active compounds to the immune system through intact skin using Viaskin, an epicutaneous patch (i.e., a skin patch). We have generated significant data demonstrating that Viaskin’s mechanism of action is novel and differentiated. Viaskin targets specific antigen-presenting immune cells in the skin, called Langerhans cells, that capture the antigen and migrate to the lymph node in order to activate the immune system without passage of the antigen into the bloodstream, minimizing systemic exposure in the body. We are advancing this unique technology to treat children suffering from food allergies, for whom safety is paramount, since the introduction of the offending allergen into their bloodstream can cause severe or life-threatening allergic reactions, such as anaphylactic shock. We believe Viaskin may offer convenient, self-administered, non-invasive immunotherapy to patients, if approved.
Previous wording
The following table summarizes our results of operations, derived from our unaudited condensed consolidated financial statements, which have been prepared in accordance with U.S. GAAP and presented in thousands of U.S. dollars, for the three months ended September 30, 2025 and 2024.
Current wording
The following table summarizes our results of operations, derived from our unaudited condensed consolidated financial statements, which have been prepared in accordance with U.S. GAAP and presented in millions of U.S. dollars, for the three months ended March 31, 2026 and 2025.
Previous wording
Sales and marketing expenses have increased by $0.7 million during the three months ended September 30, 2025, compared to the three months ended September 30, 2024 mainly due to higher Sales and Marketing activities to prepare support pre-commercialization activities for Viaskin Peanut in North America.
Current wording
Sales and marketing expenses have increased by $4.6 million during the three months ended March 31, 2026, compared to the three months ended March 31, 2025 reflecting the Company’s go‑to‑market strategy.
Previous wording
Our financial income was $1.1 million for the three months ended September 30, 2025, compared to a financial expense of $0.1 million for the three months ended September 30, 2024. This item mainly includes the gains from our investments.
Current wording
Our financial income was $0.5 million for the three months ended March 31, 2026, compared to a financial expense of $0.5 million for the three months ended March 31, 2025. This item mainly includes the interest income on our short term investments.
Previous wording
Our income tax was nil for the three months ended September 30, 2025 and September 30, 2025.
Current wording
Our income tax expense was $0.2 million for the three months ended March 31, 2026 compared to nil for the three months ended March 31, 2025. The income tax expense for the current period relates to the Company’s U.S. subsidiary, which generated taxable income pursuant to the Company’s intercompany transfer pricing arrangements.
Previous wording
Net loss was $33.2 million for the three months ended September 30, 2025, compared to $30.4 million for the three months ended September 30, 2024. Net loss per share (based on the weighted average number of shares outstanding over the period) was $ (0.24) and $ (0.32) for the three months ended September 30, 2025 and 2024, respectively.
Current wording
Net loss was $47.6 million for the three months ended March 31, 2026, compared to $27.1 million for the three months ended March 31, 2025. Net loss per share (based on the weighted average number of shares outstanding over the period) decreased from $(0.26) to $(0.11) for the three months ended March 31, 2025 and March 31, 2026, respectively.
Previous wording
On September 30, 2025, we had $69.8 million in cash and cash equivalents compared to $32.5 million of cash and cash equivalents on December 31, 2024.
Current wording
On March 31, 2026, the Company held $229.2 million in cash and cash equivalents compared to $194.2 million of cash and cash equivalents on December 31, 2025. Net cash used for operating activities was $49.1 million and $19.7 million for the periods ended March 31, 2026 and March 31, 2025, respectively. The Company’s net cash flows provided by financing activities totaled $88.9 million for the periods ended March 31, 2026 and nil in March 31, 2025, following the full Exercise of the ABSA Warrants and BS Warrants Issued on its March 2025 PIPE Financing.
Rearranged previous paragraphs (5)
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The following table summarizes our results of operations, derived from our unaudited condensed consolidated financial statements, which have been prepared in accordance with U.S. GAAP and presented in thousands of U.S. dollars, for the nine months ended September 30, 2025 and 2024.
Previous report — wording carried elsewhere
The following table summarizes our operating income during the nine months ended September 30, 2025 and 2024:
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The following table summarizes our sales and marketing expenses incurred during the nine months ended September 30, 2025 and 2024:
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The following table summarizes our general and administrative expenses incurred during the nine months ended September 30, 2025 and 2024:
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Net loss was $102.1 million for the nine months ended September 30, 2025, compared to $90.9 million for the nine months ended September 30, 2024. Net loss per share (based on the weighted average number of shares outstanding over the period) was $(0.82) and $(0.95) for the nine months ended September 30, 2025 and 2024, respectively.