DBV Technologies S.A.: Form 10-Q for the period ended Sep 30, 2026

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.

Overview

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 epicutaneous immunotherapy, 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.

Our most advanced product candidate is Viaskin Peanut patch, evaluated as a potential immunotherapy for children with peanut allergy in twelve clinical trials, including four Phase 2 trials and five completed Phase 3 trials. We are advancing two separate Viaskin Peanut product candidates in parallel to support two potential BLAs in two distinct age groups: one in toddlers ages one through three with the original, or square, patch, and one in children ages four through seven with the modified, or circular, patch. We submitted the BLA for Viaskin Peanut patch as a potential treatment for children 4 through 7 years old in the third quarter of 2026 and requested Priority Review. We also have an ongoing Phase 3 supplementary safety study of Viaskin Peanut patch in peanut-allergic toddlers ages one through three. We have held discussions with the FDA on how to ensure a timely review of the BLA for Viaksin Peanut for toddlers aged 1 through 3 years following the recent submission of the BLA for Viaskin Peanut for children 4 through 7 years old, including a potential rolling submission of the 1-through-3 BLA. The same review team will review both BLAs. The FDA indicated to us that a review of the BLA for Viaskin Peanut for 1 through 3 year olds initiated shortly after the review of the 4-through-7 BLA would allow the FDA to build on the learnings from its review and the efficiencies expected from the meaningful content overlap of the two BLAs. It would provide us and FDA the opportunity to align on the form, content, and best timing of the components of the submission of the BLA for Viaskin Peanut for 1 through 3 year olds, in support of an efficient review of both BLAs. We will continue the regulatory dialogue with FDA over the next few months and expect to submit the BLA for Viaskin Peanut in toddlers 1 through 3 years old in 2027, and we expect to will provide further update once the regulatory pathway for our toddler program has been finalized.

The Company has earlier-stage food allergy programs including Viaskin Milk and other autoimmune inflammatory diseases.

Recent developments

During the third quarter of 2026, we made significant progress toward the potential commercialization of VIASKIN® Peanut. Following extensive interactions with the FDA during the quarter, we submitted our BLA for VIASKIN Peanut in children ages 4 through 7 years old on September 29, 2026 and requested Priority Review.

In parallel, supported by our strengthened financial resources extended through the refresh of the ATM Program, we accelerated the build-out of our commercial capabilities and continued to advance clinical development, manufacturing and supply-chain readiness and institutional investor engagement, including preparations for FDA inspection, while progressing launch infrastructure.

We are actively working to advance launch infrastructure, including distribution and patient access capabilities to support the launch of VIASKIN Peanut patch in the United States, upon approval..

Regulatory Development

Submission of BLA FDA for the VIASKIN® Peanut Patch in Children Aged 4-7 Years

On June 29, 2026, we announced that we had ongoing detailed iterative engagement with FDA with the goal of ensuring a complete, efficient, and timely review of tour BLA for children aged 4 through 7 years, and, through this process and based on FDA review, we received valuable, actionable input from the FDA, specific to the organization, mapping, and formatting of existing data sets for the CMC and biostatistical elements of the BLA. We announced further that we would take the required time to incorporate the FDA’s feedback and that it anticipated the BLA filing to occur in the third quarter of 2026. The FDA did not request any additional data.

On September 29, 2026, we announced the submission of a BLA to FDA seeking approval of the VIASKIN Peanut patch for the treatment of peanut allergy in children aged 4 through 7 years. The submission is supported by data from the Phase 3 VITESSE study, a randomized, double-blind, placebo-controlled trial, which enrolled 654 children. We requested Priority Review, which, if granted, would reduce the standard review period from ten to six months. The FDA has 60 days from the submission date to determine whether the BLA is sufficiently complete to permit substantive review, following which we anticipate receipt of a PDUFA target action date. The BLA filing represents a significant regulatory milestone and an important step toward the potential commercialization of VIASKIN® Peanut in the United States. There can be no assurance that the FDA will accept the BLA for filing, grant Priority Review, or ultimately approve the VIASKIN® Peanut patch.

Clinical Development Update

Phase 2 THRIVE Study

On June 2, 2026, we announced that the first participant had been screened in the Phase 2 THRIVE study evaluating the efficacy and safety of the VIASKIN® Peanut patch in infants aged 6 through 12 months with peanut allergy. The study has since progressed to eight participating clinical sites and eight enrolled patients. THRIVE is a single-arm, open-label study designed to assess the ability of participants to achieve ad lib consumption of dietary peanut following 36 months of treatment with the VIASKIN® Peanut patch. We believe the THRIVE study may provide additional information regarding the potential use of the VIASKIN® Peanut patch in younger patient populations.

Financing

Shelf Registration Statement, ATM Program Refresh and Sale of $50 million in gross proceeds under ATM Program

On July 27, 2026, we filed an automatically effective shelf registration statement on Form S-3ASR with the SEC. The shelf registration statement permits us to sell, from time to time, ADSs representing ordinary shares and warrants. At the time of filing the shelf registration statement, we also filed a prospectus supplement with the SEC authorizing the sale of up to $150.0 million of ADSs under our existing ATM Program. On August 3, 2026, we announced the sale of $50.0 million in gross proceeds of ADSs to RA Capital Management, L.P. under the ATM Program. In connection with this transaction, we issued 18,288,220 new ordinary shares, underlying 3,657,644 new ADSs, at an at-the-market price of $13.67 per ADS.

March 2025 PIPE Financing

We received the supplemental gross proceeds of $94.7 million (€81 million) resulting in the full exercise of the ABSA Warrants and BS Warrants issued on our March 2025 PIPE Financing. See “Note 2: Significant Events and Transactions - March 2025 PIPE Financing” in the notes to the condensed consolidated financial statements included elsewhere in this Quarterly Report for additional information.

Manufacturing and supply-chain readiness

Amendment to the Letter of intent signed with Fareva Amboise

On September 30, 2026, the Company entered into Amendment No. 1 to its June 25, 2026 Letter of Intent with Fareva Amboise concerning manufacturing readiness activities supporting the future commercial-scale manufacture of the VIASKIN® Peanut patch. The planned investment is estimated at $5.5 million (at the exchange rate of 1€ = $1.14). Under the amendment, the Company's $1.1 million (at the exchange rate of 1€ = $1.14) upfront contribution to this project was modified such that payment is no longer contingent upon FDA approval of the Company's Biologics License Application. Instead, payment is contingent upon the successful completion of an independent Mock Pre-Approval Inspection , including the absence of critical findings or repeat observations and remediation of all findings by February 1, 2027.

In addition, the amendment finalized and secured the workforce expansion component of the project, including training and extended readiness activities. These personnel are dedicated to supporting industrial ramp-up, execution of the remediation plan and commercial manufacturing preparedness. The parties continue to negotiate a definitive commercial manufacturing and supply agreement. The Company expects the amended arrangement to support the timely execution of manufacturing readiness activities and further prepares the Amboise facility for future commercial production of VIASKIN® Peanut, if approved, including activities necessary to support a successful FDA pre-approval inspection.

Services Agreement with Fareva La Vallée - Peanut Drug Substance

On July 8, 2026, the Company entered into a PDS Services Agreement and Binding Commercial Term Sheet with FLV relating to the construction development, installation and qualification of a dedicated PDS manufacturing line, as well as related transfer services for technical and validation batches. The PDS facility services are expected to be completed no later than September 30, 2027, and the transfer services no later than September 1, 2028. The agreement also includes binding commercial terms expected to be incorporated into a future definitive manufacturing and supply agreement.

Letter of intent signed with Integrated Commercialization Solutions

On June 5, 2026, the Company entered into a Letter of Intent with Integrated Commercialization Solutions, LLC ("ICS") in connection with future commercialization support and distribution services for the VIASKIN® Peanut patch in the United States, if approved. Under the letter of intent, the parties agreed to undertake certain preliminary launch readiness and implementation planning activities while continuing negotiations toward a definitive commercial outsourcing services agreement. The contemplated activities include operational planning, systems readiness, distribution infrastructure preparation and other commercialization support services intended to facilitate a potential future product launch, if approved. Management expects execution of the definitive agreement by the end of 2026.

Manufacturing Supply Agreement (Peanut Source Material) with Fareva La Vallée

On March 17, 2026, the Company entered into the MS Agreement with FLV, under which FLV will manufacture and supply the PSM exclusively for DBV Technologies S.A. during the agreement term. The term is effective for a period of eight (8) years and can be renewed for a period of two (2) years.

Critical Accounting Policies and Significant Judgments and Estimates

Our management’s discussion and analysis of our financial condition and results of operations is based on our unaudited condensed consolidated financial statements, which have been prepared in accordance with generally accepted accounting principles in the United States (“U.S. GAAP”). The preparation of these unaudited condensed consolidated financial statements requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the unaudited condensed consolidated financial statements, as well as the revenue, costs and expenses recognized during the reporting periods. Our estimates are based on our historical experience and on various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions.

There have been no new policies or significant changes to our critical accounting policies as disclosed in the critical accounting policies described in the Annual Report.

Business Trends and Results of Operations

Comparison of the Three Months Ended September 30, 2026 and 2025

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 September 30, 2026 and 2025.

Operating Income

The following table summarizes our operating income during the three months ended September 30, 2026 and 2025:

The Company did not generate Revenue from operating activities.

Research tax credit decreased by $1.2 million for the three months ended September 30, 2026, compared to the three months ended September 30,2025. The accrual reflects the lower level of eligible research activities, as the Company’s focus continues to shift from clinical development toward commercial readiness activities.

Operating Expenses

Research and Development Expenses

The following table summarizes our research and development expenses incurred during the three months ended September 30, 2026 and 2025:

External clinical-related expenses increased by $8.2 million for the three months ended September 30, 2026, compared to the three months ended September 30, 2025. The increase was primarily driven by accelerated patient enrollment in COMFORT Toddlers study, with the last patient randomized in August 2026, the ramp-up of expenses associated to THRIVE study, initiated in 2026, and the acceleration of BLA readiness activities to prepare BLA submission. This increase was partially offset by the completion of EPOPEX study and the resulting reduction in associated expenses, as well as lower costs related to VITESSE study after the last patient last visit double-blind placebo-controlled end of 2025.

Employee-related costs and share based payment expenses respectively increased by $2.4 million and $0.8 million for the three months ended September 30, 2026, compared to the three months ended September 30, 2025. This increase is consistent with the reinforcement of Medical Affairs, Quality and

Regulatory functions in the United States, representing 38 new hirings across these functions compared to September 30, 2025, to support a potential U.S. launch, if approved, and to ensure organizational readiness as the Company approaches commercialization.

Following extensive interactions with the FDA, the Company also submitted its BLA for children ages 4 through 7 on September 29, 2026 and requested Priority Review, resulting in the recognition of $4.7 million of previously deferred BLA-related costs, which accounted for the majority of $7.9 million recognized during the period.

Pre-commercial inventory expense increased by $0.9 million, or 24%, reflecting the continued build-up of potential commercial inventory as the Company advances launch readiness for VIASKIN® Peanut. Following the manufacturing ramp-up initiated in the third quarter of 2025, the Company continued to receive inventory produced essentially by its contract manufacturing organizations, to support potential commercial launch requirements. Until BLA approval is obtained, the related manufacturing costs continue to be recognized as research and development expense.

Sales and Marketing Expenses

The following table summarizes our sales and marketing expenses incurred during the three months ended September 30, 2026 and 2025:

For the fourth consecutive quarter, sales and marketing expenses have increased, rising by $4.2 million during the three months ended September 30, 2026, compared to the three months ended September 30, 2025. This reflects the continued execution of the Company’s commercial launch readiness strategy in the United States. The increase was primarily driven by higher personnel-related and external costs associated with the expansion of the Company’s commercial, market access and launch-support capabilities in preparation for the potential U.S. launch of VIASKIN® Peanut, if approved. This expansion included the hiring of 15 U.S.-based employees compared to September 30, 2025, across Market Access and Patient Services (5), Marketing and Market Insights (4), Sales and Commercial Operations (3), and Commercial Leadership and Transformation (3).

General and Administrative Expenses

The following table summarizes our general and administrative expenses incurred during the three months ended September 30, 2026 and 2025:

General and Administrative expenses increased by $6.7 million for the three months ended September 30, 2026, compared to the three months ended September 30, 2025, reflecting continued scaling of the Company’s corporate infrastructure to support BLA readiness and commercial launch preparedness. The increase was driven by $3.3 million of higher share-based compensation expense, related to new CEO grants, together with higher employee-related costs associated with 11 additional employees compared to September 30, 2025.

Other operating expenses also increased mainly driven by the extension of the New Jersey office lease, D&O insurance as well as patents and licenses expenses.

Financial Income (Expense)

Our financial income was $0.6 million for the three months ended September 30, 2026, compared to $1.1 million for the three months ended September 30, 2025, reflecting interest income generated from the investment of available cash.

Income Tax

Our income tax expense was $0.3 million for the three months ended September 30, 2026 and was 0 for the three months ended September 30, 2025.

Net Loss

Net loss was $64.5 million for the three months ended September 30, 2026, compared to $33.2 million for the three months ended September 30, 2025. Net loss per share (based on the weighted average number of shares outstanding over the period) was $0.14 and $0.24 for the three months ended September 30, 2026 and 2025, respectively.

Comparison of the Nine Months Ended September 30, 2026 and 2025

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 nine months ended September 30, 2026 and 2025.

Operating Income

The following table summarizes our operating income during the nine months ended September 30, 2026 and 2025:

The Company did not generate Revenue from operating activities.

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 $3.1 million as of September 30, 2026. This tax credit income accrual reflects the expected level, on a full year basis of eligible experimental activities, as the Company’s focus continues to shift from clinical development toward commercial readiness activities.

Operating Expenses

Research and Development Expenses

The following table summarizes our research and development expenses incurred during the nine months ended September 30, 2026 and 2025:

External clinical-related expenses increased by $15.6 million for the nine months ended September 30, 2026 compared to the nine months ended September 30, 2025. The increase primarily reflects higher clinical trial activity during the first nine month of 2026, mainly driven by accelerated patient enrollment in COMFORT Toddlers study, with the last patient randomized in August 2026, the ramp-up of expenses associated to THRIVE study, initiated in 2026, as well as the acceleration of BLA readiness activities to prepare BLA submission. This increase was partially offset by the completion of EPOPEX study and the resulting reduction in associated expenses, as well as lower costs related to VITESSE study after the last patient last visit double-blind placebo-controlled end of 2025.

Employee-related costs and share based payment expenses respectively increased by $8.7 million and $2.0 million for the nine months ended September 30, 2026, compared to the nine months ended September 30, 2025 primarily due to reinforcement of Medical Affairs, Quality and Regulatory functions in the United States, representing 38 new hirings across these functions compared to September 30, 2025, to support a potential U.S. launch, if approved, and to ensure organizational readiness as the Company approaches commercialization.

Following extensive interactions with the FDA, the Company also submitted its BLA for children ages 4 through 7 on September 29, 2026 and requested Priority Review, resulting in the recognition of $4.7 million of previously deferred BLA-related costs, which accounted for the majority of the increase of $5.3 million compared to September 30, 2025.

Pre-commercial inventory expense decreased by $3.7 million, reflecting the significant manufacturing ramp-up undertaken in 2025 following the March 2025 PIPE financing and alignment with the FDA. During 2026, the Company maintained a more established production cadence while continuing to build potential commercial inventory and advance launch readiness for VIASKIN® Peanut. These costs continue to be recognized as research and development expense prior to BLA approval.

Sales and Marketing Expenses

The following table summarizes our sales and marketing expenses incurred during the nine months ended September 30, 2026 and 2025:

Sales and marketing expenses increased by $13.9 million during the nine months ended September 30, 2026, compared to the nine months ended September 30, 2025. The increase was primarily driven by higher personnel-related and external costs associated with the expansion of the Company’s commercial, market access and launch-support capabilities in preparation for the potential U.S. launch of VIASKIN® Peanut, if approved. This expansion included the hiring of 15 U.S.-based employees compared to September 30, 2025, across Market Access and Patient Services (5), Marketing and Market Insights (4), Sales and Commercial Operations (3), and Commercial Leadership and Transformation (3).

General and Administrative Expenses

The following table summarizes our general and administrative expenses incurred during the nine months ended September 30, 2026 and 2025:

General and Administrative expenses increased by $17.7 million for the nine months ended September 30, 2026, compared to the nine months ended September 30, 2025, reflecting continued investments in corporate infrastructure to support BLA readiness and potential commercial launch preparations.

The increase was mainly driven by $3.7 million in employee-related costs and $4.7 million in share-based payment expenses, attributable to 11 additional employees and new CEO grants. Depreciation, amortization and other costs also rose by $4.9 million primarily due to the extension of the New Jersey office lease, D&O insurance, Director fees, and patents and licenses expenses.

Financial Income (Expense)

Our financial income was $1.5 million for the nine months ended September 30, 2026, compared to nil for the nine months ended September 30, 2025. The increase primarily reflects higher interest income earned on larger average cash and investment balances following financing activities. Financial income for the 2025 comparative period was totally offset by unfavorable foreign exchange effects, which reduced the benefit of interest income earned on investments.

Income Tax

Our income tax expense was $0.7 million for the nine months ended September 30, 2026 compared to $0.1 million for the nine months ended September 30, 2025.

Net Loss

Net loss was $162.5 million for the nine months ended September 30, 2026, compared to $102.1 million for the nine months ended September 30, 2025. Net loss per share (based on the weighted average number of shares outstanding over the period) decreased from $(0.82) to $(0.37) for the nine months ended September 30, 2025 and September 30, 2026, respectively.

Liquidity and Capital Resources

Our financing strategy is to maintain financial flexibility to support regulatory and potential commercial launch activities, including working capital requirements, pre-commercial inventory build and manufacturing capacity expansion to support potential demand for VIASKIN Peanut in the United States and Europe, if approved.

Financial Condition

On September 30, 2026, the Company held $165.7 million in cash and cash equivalents compared to $194.2 million of cash and cash equivalents held on December 31, 2025. Net cash used in operating & investing activities totaled $159.4 million and $86.7 million for the periods ended September 30, 2026 and September 30, 2025, respectively. Net cash provided by financing activities totaled $137.1 million for the periods ended September 30, 2026 and $117.1 million in September 30, 2025, reflecting net proceeds from the first and second tranches of the March 2025 PIPE Financing and drawdowns under the Company's at-the-market equity program.

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, while its reporting currency is the U.S. dollar. The Company incurs operating expenses in both currencies: a significant portion of external costs, including those related to commercial activities, regulatory affairs, and clinical development, are denominated in U.S. dollars.

During the nine months ended September 30, 2026, the euro depreciated against the U.S. dollar, resulting in a $5.5 million unfavorable foreign currency translation adjustment recognized in other comprehensive loss and a $6.2 million unfavorable effect of exchange rate changes on cash and cash equivalents. The U.S. dollar has remained broadly strong against the euro during this period, driven by persistent interest rate differentials and macroeconomic uncertainty, contributing to continued EUR/USD volatility. Continued depreciation of the euro against the U.S. dollar would further reduce the U.S. dollar value of the Company's euro-denominated cash and net assets, potentially accelerating the effective utilization of its liquidity.

The Company utilizes foreign exchange swap instruments to manage a portion of this exposure, as described in Note 9 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.

Sources of Liquidity and Material Cash Requirements

Since its inception and through September 30, 2026, the Company has raised $1,753.7 million in aggregate equity financing to fund its research and development activities, commercial preparedness, and general corporate operations. The following table summarizes the gross proceeds received from each financing transaction through the issuance of securities:

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.

In March 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.

In September 2025, the Company entered into an at-the-market sales agreement (the “Sales Agreement”) with Citizens JMP Securities, LLC (“Citizens”), under which the Company may offer and sell, from time to time and at its sole discretion, ADSs through Citizens. Citizens is entitled to commissions of up to 3.0% of the gross proceeds from ADSs sold under the Sales Agreement. During the fourth quarter of 2025, the Company raised$65.0 million in gross proceeds from the sale of 4,790,552 ADSs under the Sales Agreement.

The shelf-registration statement on Form S-3 under which the Sales Agreement was established expired in April 2026, and in July 2026 the Company filed a new automatically effective shelf registration statement on Form S-3ASR, which includes a base prospectus and a sales agreement prospectus supplement refreshing the ATM Program by filing a prospectus supplement for the sale of up to $150.0 million of ADSs. During the nine months ended September 30, 2026, the Company completed the sale of $50.0 million in gross proceeds of ADSs to RA Capital Management, L.P. under the Sales Agreement. In connection with this transaction, the Company issued 18,288,220 new ordinary shares, underlying 3,657,644 new ADSs, at an at-the-market price of $13.67 per ADS. The additional capital further strengthened the Company’s financial resources as it advanced the BLA submission and continued to invest in clinical development, manufacturing readiness and preparations for the potential commercialization of VIASKIN® Peanut, if approved.

The Company also seeks to optimize the return on its available cash through short-term investments, which generate interest income while preserving liquidity for anticipated operating and strategic requirements. In addition, the Company benefits from refunds of research tax credits (crédit d’impôt recherche) available in France in connection with qualifying research and development activities.

The Company further actively manages excess liquidity through low-risk, interest-bearing investments, generating financial income while preserving flexibility to fund its operating and strategic priorities. The Company also benefits as an SME status from research tax credit (crédit d’impôt recherche) refunds in France related to qualifying research and development activities.

Material expenses commitments

The Company expects future cash requirements to be driven primarily by the continued advancement of its clinical programs, BLA readiness activities, commercial launch preparedness, manufacturing scale-up initiatives, operating lease obligations and contractual commitments under strategic manufacturing and supply agreements, including arrangements with Sanofi and Fareva. Further information regarding these commitments is provided in Note 14 to the condensed consolidated financial statements.

The commitment amounts are based on contractual obligations that incorporate fixed or minimum service commitments, fixed, minimum, or variable pricing mechanisms, and the anticipated timing of the related contractual activities. Future events could cause actual payments to differ from these estimates. The Company continues to monitor geopolitical and macroeconomic developments and, while such conditions may affect future operating costs, supply chains and foreign exchange markets, management does not believe they have had a material impact on the Company's condensed consolidated financial statements as of September 30, 2026.

Forward-looking

As of September 30, 2026, the Company had cash and cash equivalents of $165.7 million. During the third quarter of 2026, the Company achieved significant regulatory and financing milestones, including the submission of its BLA for VIASKIN® Peanut in children ages 4 through 7 on September 29, 2026, for which the Company requested Priority Review, and the sale of $50.0 million in gross proceeds of ADSs under its ATM Program in July 2026. Following the BLA submission, management updated the Company’s operating and liquidity forecasts to reflect the potential regulatory review pathway and the anticipated timing of related clinical, regulatory, manufacturing and commercial readiness activities. The Company’s forecasts incorporate milestone-based spending assumptions designed to align the timing of certain expenditures with potential regulatory developments while continuing to advance activities necessary to support regulatory review and potential commercialization. Based on its current operations, plans and assumptions, the Company estimates that its existing cash and cash equivalents will be sufficient to fund operations into the third quarter of 2027.

As such, Management has concluded that the Company's existing cash and cash equivalents are not sufficient to fund its operations for at least twelve months from the date of issuance of these interim condensed consolidated financial statements. Accordingly, substantial doubt exists about the Company's ability to continue as a going concern within twelve months after the date these condensed consolidated financial statements are issued.

The Company will require additional capital to fund its operations. Management is actively evaluating multiple financing alternatives, including, without limitation, potential additional sales under the Company’s existing ATM Program, equity transactions, warrants exercise and other alternative forms of financing. The Company’s continued advancement through the regulatory review process may provide additional financing opportunities. However, the availability, timing and terms of any additional financing will depend on regulatory developments, market conditions and investors’ interest, lenders and other counterparties, and there can be no assurance that additional financing will be available when needed, on acceptable terms or at all.

Smaller Reporting Company Status

We are currently a “smaller reporting company” as defined in Rule 12b-2 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), and have taken advantage of certain scaled disclosure accommodations available to smaller reporting companies in this and prior filings. However, as of June 30, 2026, the last business day of our second fiscal quarter, the market value of our voting and non-voting ordinary shares held by non-affiliates exceeded $700.0 million. As a result, based on the current SEC reporting framework, we will no longer qualify as a smaller reporting company effective January 1, 2027.

We are a smaller reporting company as defined by Rule 12b-2 of the Exchange Act and are not required to provide the information required under this item.

Disclosure Controls and Procedures

Based on its evaluation as of September 30, 2026, our management, including our Chief Executive Officer and Chief Financial Officer, concluded that our disclosure controls and procedures (as defined in Rule 13a-15(e) under the Exchange Act) were effective to provide reasonable assurance that (i) the information required to be disclosed in our reports filed or submitted under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms, and (ii) such information is accumulated and communicated to our management, including our Chief Executive Officer and Chief Financial Officer, as appropriate, to allow timely decisions regarding required disclosure.

Changes in Internal Control Over Financial Reporting

There were no changes in our internal control over financial reporting identified in management’s evaluation pursuant to Rules 13a-15(d) or 15d-15(d) of the Exchange Act during the period covered by this Quarterly Report on Form 10-Q that materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

Limitation on Effectiveness of Controls and Procedures

Our management, including our Chief Executive Officer and Chief Financial Officer, does not expect that our disclosure controls and procedures or our internal controls will prevent all error and all fraud. A control system, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the control system are met. Further, the design of a control system must reflect the fact that there are resource constraints, and the benefits of controls must be considered relative to their costs. Because of the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that all control issues and instances of fraud, if any, within the Company have been detected. These inherent limitations include the realities that judgments in decision making can be faulty and that breakdowns can occur because of simple error or mistake. Controls can also be circumvented by the individual acts of some persons, by collusion of two or more people, or by management override of the controls. The design of any system of controls is based in part on certain assumptions about the likelihood of future events, and there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions. Over time, controls may become inadequate because of changes in conditions or deterioration in the degree of compliance with policies and procedures. Because of the inherent limitations in a cost-effective control system, misstatements due to error or fraud may occur and not be detected.

Our business is subject to risks and events that, if they occur, could adversely affect our financial condition and results of operations and trading price of our securities. In addition to the other information set forth in this Quarterly Report, you should carefully consider the factors described in Part I, Item 1A. “Risk Factors” of our Annual Report and in Part II, Item 1A of our Quarterly Report on Form 10-Q for the Quarter ended June 30, 2026. There have been no material changes in our risk factors from those disclosed in the Annual Report except as follows:

There is uncertainty regarding our ability to maintain liquidity sufficient to operate our business effectively, which raises substantial doubt about our ability to continue as a going concern.

Our unaudited condensed consolidated financial statements as of September 30, 2026 have been prepared assuming the Company will continue as a going concern for the next twelve months. Our management concluded that our recurring losses from operations, existing unrestricted cash, and cash equivalents raise substantial doubt about our ability to continue as a going concern for the next twelve months after issuance of our financial statements included in this Quarterly Report on Form 10-Q. As of September 30, 2026, we had unrestricted cash, cash equivalents and marketable securities of $165.7 million consisting of cash and investments. Subsequent to September 30, 2026, we raised additional proceeds of approximately $50 million total gross proceeds through the Company’s ATM Program. We do not expect our existing cash and cash equivalents will be sufficient to fund our operations through the next twelve months and we will need to seek additional capital to fund our operations, working capital needs, capital expenditures and other strategic initiatives beyond that time. Although management has been successful in raising capital in the past, there can be no assurance that we will be successful or that any needed financing will be available in the future at terms acceptable to us. As such, we cannot conclude that such plans will be effectively implemented within one year after the date that the financial statements included in this Quarterly Report on Form 10-Q and there is uncertainty regarding our ability to maintain liquidity sufficient to operate our business effectively, which raises substantial doubt about our ability to continue as a going concern.

Relying on third-party manufacturers may result in delays in our clinical development or commercialization efforts.

Developing and commercializing new medicines entails significant risks and expenses. Our clinical trials may be delayed if third-party manufacturers are unable to assure a sufficient quantity of the drug product to meet our study needs. Currently, we have only one manufacturer, Sanofi S.A., or Sanofi, of the API used in our Viaskin product candidates, including Viaskin Peanut patch, such as peanut protein extract and unmodified allergen milk extract. In February 2020, Sanofi announced that it planned to create a new company dedicated to the production and marketing to third parties of API. Subsequently, Sanofi consolidated its API commercial and development activities conducted in six of its European API production sites. While those API sites do not include the site in which the API used in our Viaskin product candidates is produced, there can be no assurances that this transition will not adversely impact our supply of API from Sanofi. If Sanofi does not continue to manufacture the API as required by us in a timely manner, we may not be able to find a substitute manufacturer on a timely basis and our commercialization efforts and clinical trials may be delayed. Notwithstanding contractual protections, Sanofi may be able to utilize knowledge gained through their relationship with us in furtherance of their development of competitive therapies.

In December 2025, Stallergenes Greer announced that it intends to discontinue the commercialization of Palforzia, on July 31, 2026, for business reasons.

• We also expect to rely on Sanofi and on FAREVA for the manufacturing of the patch and on other third-party manufacturers for the manufacturing of commercial supply of Viaskin Peanut, if approved, and any other product for which we obtain regulatory approval. Sanofi may not be able to effectively scale its manufacturing capacity of our API to meet our commercialization needs and we may be unable to establish any agreements with other third-party manufacturers or to do so on acceptable terms. Even if Sanofi is able to meet our commercialization needs or if we are able to establish agreements with other third-party manufacturers, reliance on third-party manufacturers entails additional risks, including:reliance on the third party for regulatory compliance and quality assurance;
• the possible breach of the manufacturing agreement by the third party;
• the possible misappropriation of our proprietary information, including our trade secrets and know-how; and
• the possible termination or non-renewal of the agreement by the third party at a time that is costly or inconvenient for us.

Once regulatory approval is obtained, a marketed product and its manufacturer are subject to continual review. The discovery of previously unknown problems with a product or manufacturer may result in restrictions on the product, manufacturer or manufacturing facility, including withdrawal of the product from the market. Manufacturers of products with which we contract are required to operate in accordance with FDA-mandated cGMPs or comparable GMP requirements in foreign countries. A failure of any of our contract manufacturers to establish and follow cGMPs and to document their adherence to such practices may lead to significant delays in the launch or availability of products based on our product candidates into the market. Moreover, the constituent parts of a combination product retain their regulatory status (as a biologic or medical device, for example) and, as such, we or our contract manufacturers may be subject to additional requirements in the QSR or comparable quality management systems in foreign countries, applicable to medical devices, such as design controls, purchasing controls, and corrective and preventive action. We, our contract manufacturers, any future collaborators and their contract manufacturers could be subject to periodic unannounced inspections by the FDA or other comparable foreign regulatory authorities, to monitor and ensure compliance with cGMP. Despite our efforts to audit and verify regulatory compliance, one or more of our third-party manufacturing vendors may be found on regulatory inspection by the FDA or other comparable foreign regulatory authorities to be noncompliant with cGMP regulations. Failure by third-party manufacturers to comply with applicable regulations could result in sanctions being imposed on us, including shutdown of the third-party vendor, fines, injunctions, civil penalties, revocation or suspension of regulatory approval for any products granted pre-market approvals, invalidation of drug product lots or processes, seizures or recalls of products, operating restrictions, and criminal prosecutions.

We have been informed by FAREVA Amboise (“FAREVA”), our sole contract manufacturer for Viaskin Peanut patches, that the FDA has issued warning letters to FAREVA identifying certain current Good Manufacturing Practice (“cGMP”) deficiencies, including at the FAREVA facility at which our Viaskin Peanut patches are manufactured. We are working collaboratively with FAREVA on its ongoing remediation and mitigation efforts in response to these warning letters. If FAREVA is unable to remediate these deficiencies to the FDA's satisfaction in a timely manner, or if the FDA takes further enforcement action with respect to the FAREVA Amboise facility, our ability to manufacture Viaskin Peanut patches for our clinical trials or, if approved, for commercial supply could be materially and adversely affected. Because FAREVA is currently our sole manufacturer of Viaskin Peanut patches, we do not have an alternative manufacturing source to which we could readily transition, and any interruption or restriction on manufacturing at the FAREVA Amboise facility could significantly delay our clinical development and regulatory timelines, including timing of the filing, acceptance or approval of our anticipated BLA submission for the Viaskin Peanut patch in children ages 4 through 7 years, and could have a material adverse effect on our business, results of operations, and financial condition.

Since the FDA’s warning letters, FAREVA has confirmed that it has responded to the FDA in accordance with applicable regulatory timelines and provided monthly remediation updates.

Our current and anticipated future dependence upon others for the manufacture of our product candidates or products, if approved, may adversely affect our future profit margins and our ability to commercialize any products that receive regulatory approval on a timely and competitive basis.