Nature of the business and principles and accounting methods (Policies)	9 Months Ended
Sep. 30, 2026
Accounting Policies [Abstract]
Basis of Presentation	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 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 March 26, 2026, as amended by Amendment No. 1 on Form 10-K/A filed with the SEC on April 30, 2026. The condensed consolidated statement of financial position as of December 31, 2025 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, 2025. 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, 2026, or any other future period. The Company presents all financial statement amounts in millions. This presentation has been applied consistently to all periods presented, with prior‑period amounts presented on the same basis. No rounding adjustments were required, and the change did not affect comparability.
Recently Adopted Accounting Pronouncements	Recently Adopted Accounting Pronouncements There have been no recently issued accounting standards which had a material impact on our results of operations, financial condition, or cash flows.
Accounting Pronouncements Issued Not Yet Adopted	Accounting Pronouncements Issued Not Yet Adopted 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. Management evaluated the impact of adopting ASU 2024‑03 and determined that its adoption will result on expanded disclosures on the Company’s consolidated financial statements. In December 2025, the FASB issued ASU 2025‑12, Codification Improvements, which includes a series of technical corrections, clarifications, and minor improvements to existing guidance across various Topics in the FASB Accounting Standards Codification. The amendments are not expected to significantly affect current accounting practices. ASU 2025‑12 is effective for annual and interim reporting periods beginning after December 15, 2026. The Company does not expect the adoption of ASU 2025-12 to have a material impact on its consolidated financial statements. In December 2025, the FASB also issued ASU 2025‑11, Interim Reporting (Topic 270): Narrow‑Scope Improvements, which clarifies the scope and applicability of interim reporting guidance, enhances the organization and navigability of required interim disclosures, and introduces a disclosure principle requiring entities to disclose material events or changes that occur after the most recent annual reporting period. For public business entities, the ASU is effective for interim reporting periods in fiscal years beginning after December 15, 2027 with early adoption permitted. The Company does not expect ASU 2025-11 to have a material impact on its interim consolidated financial statements. In December 2025, the FASB issued ASU 2025‑10, Government Grants (Topic 832): Accounting for Government Grants Received by Business Entities, which establishes authoritative U.S. GAAP guidance for the recognition, measurement, presentation, and disclosure of government grants received by business entities. The amendments are effective for public business entities for annual reporting periods beginning after December 15, 2028, including interim periods within those annual periods, with early adoption permitted. The Company does not expect ASU 2025-10 to have a material impact on its consolidated financial statements. In April 2026, the FASB issued ASU 2026‑01, Equity (Topic 505): Initial Measurement of Paid‑in‑Kind Dividends on Equity‑Classified Preferred Stock. The ASU provides authoritative guidance on the initial measurement of paid‑in‑kind (“PIK”) dividends issued on equity‑classified preferred stock, addressing diversity in practice. Under the amendments, PIK dividends are required to be initially measured based on the PIK dividend rate stated in the preferred stock agreement, typically applied to the liquidation value of the preferred stock outstanding. The guidance does not affect the determination of when PIK dividends are recognized. The ASU is effective for annual reporting periods beginning after December 15, 2026, including interim periods within those fiscal years, with early adoption permitted. The amendments may be applied on either a prospective basis or a modified retrospective basis. The Company does not expect ASU 2026-01 to have a material impact on its consolidated financial statements. In May 2026, the FASB issued ASU 2026‑02, introducing a comprehensive framework for the accounting of environmental credits and related obligations. The standard requires entities to recognize environmental credits as assets only when it is probable that they will be used to settle obligations or otherwise transferred, with all other credits expensed as incurred. Measurement is primarily based on cost, with subsequent accounting depending on the intended use of the credits. The ASU also establishes a liability model for environmental credit obligations, measured based on available credits (funded portion) or the cost or fair value of credits to be acquired (unfunded portion). The guidance is effective for public business entities for fiscal years beginning after December 15, 2027, with early adoption permitted. The Company does not expect ASU 2026-02 to have a material impact on its consolidated financial statements. 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.
Use of estimates	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 estimates and assumptions, developed based on the information available at the time of closing the accounts, particularly relate to: •The assessment of the fair value of equity-settled share-based compensation plans granted to employees and/or executives, which is performed using actuarial models. These models require the Company to use certain calculation assumptions, such as the expected volatility of the share price and the estimated timing of achieving performance conditions over the vesting period of the share-based compensation plan; •The evaluation of the amount of the Research Tax Credit, which is based on eligible internal and external research expenses incurred by the Company during the fiscal year. Only eligible research expenditures are included in the calculation of the Research Tax Credit; •The recoverability of the Company’s net deferred tax assets and related valuation allowance; •The assumptions used in the valuation of right-of-use assets & operating leases; and •The estimate of provisions and contingencies.
Going Concern	Going Concern These condensed consolidated financial statements have been prepared assuming that the Company will continue as a going concern. The going concern assumption contemplates the realization of assets and the satisfaction of liabilities in the normal course of business for at least twelve months from the date of issuance of these condensed consolidated financial statements. The Company has incurred operating losses and negative cash flows from operations since inception and expects operating cash outflows to remain significant as it continues to invest in clinical development, regulatory activities, manufacturing and supply-chain readiness and preparations for the potential commercialization of VIASKIN Peanut patch, if approved. Net cash used in operating & investing activities was $159.4 million for the nine months ended September 30, 2026, compared to $86.7 million for the nine months ended September 30, 2025, reflecting the continued advancement of these activities and the expansion of the Company’s organization. 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 patch in children ages 4 through 7 on September 29, 2026, for which the Company requested Priority Review, and the completion of a sale of $50.0 million in gross proceeds of ADSs under its ATM Program announced by the Company 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 of VIASKIN Peanut patch in children ages 4 through 7, if approved. 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. These estimates are based on the Company’s current forecasts and exclude additional expenditures related to programs other than VIASKIN Peanut patch or resulting from the potential in-licensing or acquisition of additional product candidates or technologies. The timing and amount of the Company’s future cash requirements may differ materially from current estimates depending on, among other factors, the timing and outcome of the regulatory review process, the pace of clinical development activities, manufacturing and supply-chain commitments, commercial readiness activities and foreign exchange rate fluctuations. These condensed consolidated financial statements do not include any adjustments to the carrying amounts and classification of assets and liabilities or reported expenses that may be necessary if the Company were unable to continue as a going concern.
Significant contracts	Significant contracts March 2025 PIPE Financing In March 2025, the Company completed a private investment in public equity financing generating initial gross proceeds of $125.5 million (€116.3 million) received on April 7, 2025 (“March 2025 PIPE Financing”). Following the announcement of positive VITESSE topline results on December 16, 2025, the warrants issued in connection with the March 2025 PIPE Financing were fully exercised, resulting in additional gross proceeds of $195.4 million (€166.7 million at the exchange rate of 1 EUR = $1.17), of which $100.7 million (€85.7 million) was received in the fourth quarter of 2025 and $94.7 million (€81.0 million) was received in January 2026. The pre-funded warrants issued in connection with the March 2025 PIPE Financing were classified as equity under ASC 480 and ASC 815. Upon exercise, the par value of the newly issued common stocks was recorded in “Common stock” and any additional amount, including the exercise price paid and the remaining carrying amount of the warrants, was recorded in “Additional paid-in capital”. No gain or loss was recognized in the Consolidated Statements of Operations and Comprehensive Loss as the warrants were classified as equity from inception. Fareva La Vallée - Manufacturing Infrastructure Agreements The Company entered strategic manufacturing arrangements with Fareva La Vallée ("FLV") to secure dedicated manufacturing capacity for both Peanut Source Material ("PSM") and Peanut Drug Substance ("PDS"), supporting the future commercial supply chain for VIASKIN Peanut. Peanut Source Material On March 17, 2026, the Company entered into a Manufacturing and Supply Agreement (the “MS Agreement”) with FLV, under which FLV will manufacture and supply the VIASKIN PSM, exclusively for the Company during the MS Agreement term. The term is effective for a period of eight (8) years and can be renewed for a period of two (2) years. The MS Agreement is subsequent to the Service Agreement that the Company entered into with FLV on March 18, 2024 (the “PSM Services Agreement”), for the construction of a dedicated production line and facility and the transfer of manufacturing of the PSM to FLV required to produce VIASKIN Peanut patches. The PSM Services Agreement also included binding commercial terms which were incorporated into the MS Agreement. The PSM Services Agreement includes the following services (i) construction activities, (ii) the acquisition of equipment, and (iii) the cGMP qualification of a dedicated PSM production line installed at FLV’s premises. The Company has funded capital expenditures amounting to $4.1 million (at the exchange rate of 1€ = $1.14), granting access to preferential pricing and to an exclusively dedicated PSM production line located at FLV’s facilities, while ownership of the line remains with FLV. 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 Company’s commitments under the agreement include PDS facility services fees capped at $3.9 million (at the exchange rate of 1€ = $1.14), of which the Company funded $3.3 million (at the exchange rate of 1€ = $1.14). These fees, exclude certain capital expenditures directly supported by the Company, and transfer services fees are capped at $3.2 million (at the exchange rate of 1€ = $1.14). The agreement also includes binding commercial terms expected to be incorporated into a future definitive manufacturing and supply agreement. Accounting Treatment Management has concluded that both the PSM and PDS arrangements contain embedded leases within the scope of ASC 842, Leases, based on the following considerations: •Identified asset: The dedicated PSM & PDS production lines are identified assets, and FLV does not have substitution rights. •Control of use: The Company has (i) the right to obtain substantially all of the economic benefits from use of the asset, through exclusive access to the production capacity, and (ii) the right to direct the use of the asset, including decision‑making authority over relevant activities such as production volumes, scheduling, and operating methods. In accordance with ASC 842‑10‑25‑2, the right‑of‑use assets will be recognized at the lease commencement date, defined as the date on which the production lines are made available for use following completion of cGMP qualification. At this stage, the Company has identified the embedded leases, the separation of lease and non‑lease components of the arrangements, and the reclassification of the payment related to the exclusive access right as prepaid rent under ASC 842 (Other non-current assets). Subsequent to September 30, 2026, the first commercial PSM batch was successfully manufactured by FLV and incorporated into the pre-commercial inventory. Accordingly, management expects lease commencement to occur during the fourth quarter of 2026 and amortization of the PSM right-of-use asset to begin during the fourth quarter of 2026. Under the PSM Manufacturing and Supply Agreement, the Company is subject to minimum purchase commitments tied to the commercial supply of PSM. Specifically, if cumulative commercial orders are below 940 kilograms at the end of the 36-month period following delivery of the first commercial batch, the Company may be required to compensate FLV for the shortfall, subject to a contractual cap of $0.6 million (at the exchange rate of 1€ = $1.14). Based on management's operational forecasts as of September 30, 2026, the Company expects to meet the purchase obligations and therefore did not record any liability or accrual related to these commitments

Nature of the business and principles and accounting methods (Policies)

9 Months Ended

Sep. 30, 2026

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 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 March 26, 2026, as amended by Amendment No. 1 on Form 10-K/A filed with the SEC on April 30, 2026. The condensed consolidated statement of financial position as of December 31, 2025 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, 2025.

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, 2026, or any other future period.

The Company presents all financial statement amounts in millions. This presentation has been applied consistently to all periods presented, with prior‑period amounts presented on the same basis. No rounding adjustments were required, and the change did not affect comparability.

Recently Adopted Accounting Pronouncements

There have been no recently issued accounting standards which had a material impact on our results of operations, financial condition, or cash flows.

Accounting Pronouncements Issued Not Yet Adopted

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. Management evaluated the impact of adopting ASU 2024‑03 and determined that its adoption will result on expanded disclosures on the Company’s consolidated financial statements.

In December 2025, the FASB issued ASU 2025‑12, Codification Improvements, which includes a series of technical corrections, clarifications, and minor improvements to existing guidance across various Topics in the FASB Accounting Standards Codification. The amendments are not expected to significantly affect current accounting practices. ASU 2025‑12 is effective for annual and interim reporting periods beginning after December 15, 2026. The Company does not expect the adoption of ASU 2025-12 to have a material impact on its consolidated financial statements.

In December 2025, the FASB also issued ASU 2025‑11, Interim Reporting (Topic 270): Narrow‑Scope Improvements, which clarifies the scope and applicability of interim reporting guidance, enhances the organization and navigability of required interim disclosures, and introduces a disclosure principle requiring entities to disclose material events or changes that occur after the most recent annual reporting period. For public business entities, the ASU is effective for interim reporting periods in fiscal years beginning after December 15, 2027 with early adoption permitted. The Company does not expect ASU 2025-11 to have a material impact on its interim consolidated financial statements.

In December 2025, the FASB issued ASU 2025‑10, Government Grants (Topic 832): Accounting for Government Grants Received by Business Entities, which establishes authoritative U.S. GAAP guidance for the recognition, measurement, presentation, and disclosure of government grants received by business entities. The amendments are effective for public business entities for annual reporting periods beginning after December 15, 2028, including interim periods within those annual periods, with early adoption permitted. The Company does not expect ASU 2025-10 to have a material impact on its consolidated financial statements.

In April 2026, the FASB issued ASU 2026‑01, Equity (Topic 505): Initial Measurement of Paid‑in‑Kind Dividends on Equity‑Classified Preferred Stock. The ASU provides authoritative guidance on the initial measurement of paid‑in‑kind (“PIK”) dividends issued on equity‑classified preferred stock, addressing diversity in practice. Under the amendments, PIK dividends are required to be initially measured based on the PIK dividend rate stated in the preferred stock agreement, typically applied to the liquidation value of the preferred stock outstanding. The guidance does not affect the determination of when PIK dividends are recognized. The ASU is effective for annual reporting periods beginning after December 15, 2026, including interim periods

within those fiscal years, with early adoption permitted. The amendments may be applied on either a prospective basis or a modified retrospective basis. The Company does not expect ASU 2026-01 to have a material impact on its consolidated financial statements.

In May 2026, the FASB issued ASU 2026‑02, introducing a comprehensive framework for the accounting of environmental credits and related obligations. The standard requires entities to recognize environmental credits as assets only when it is probable that they will be used to settle obligations or otherwise transferred, with all other credits expensed as incurred. Measurement is primarily based on cost, with subsequent accounting depending on the intended use of the credits. The ASU also establishes a liability model for environmental credit obligations, measured based on available credits (funded portion) or the cost or fair value of credits to be acquired (unfunded portion). The guidance is effective for public business entities for fiscal years beginning after December 15, 2027, with early adoption permitted. The Company does not expect ASU 2026-02 to have a material impact on its consolidated financial statements.

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.

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 estimates and assumptions, developed based on the information available at the time of closing the accounts, particularly relate to:

•The assessment of the fair value of equity-settled share-based compensation plans granted to employees and/or executives, which is performed using actuarial models. These models require the Company to use certain calculation assumptions, such as the expected volatility of the share price and the estimated timing of achieving performance conditions over the vesting period of the share-based compensation plan;

•The evaluation of the amount of the Research Tax Credit, which is based on eligible internal and external research expenses incurred by the Company during the fiscal year. Only eligible research expenditures are included in the calculation of the Research Tax Credit;

•The recoverability of the Company’s net deferred tax assets and related valuation allowance;

•The assumptions used in the valuation of right-of-use assets & operating leases; and

•The estimate of provisions and contingencies.

Going Concern

These condensed consolidated financial statements have been prepared assuming that the Company will continue as a going concern. The going concern assumption contemplates the realization of assets and the satisfaction of liabilities in the normal course of business for at least twelve months from the date of issuance of these condensed consolidated financial statements.

The Company has incurred operating losses and negative cash flows from operations since inception and expects operating cash outflows to remain significant as it continues to invest in clinical development, regulatory activities, manufacturing and supply-chain readiness and preparations for the potential commercialization of VIASKIN Peanut patch, if approved. Net cash used in operating & investing activities was $159.4 million for the nine months ended September 30, 2026, compared to $86.7 million for the nine months ended September 30, 2025, reflecting the continued advancement of these activities and the expansion of the Company’s organization.

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 patch in children ages 4 through 7 on September 29, 2026, for which the Company requested Priority Review, and the completion of a sale of $50.0 million in gross proceeds of ADSs under its ATM Program announced by the Company 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 of VIASKIN Peanut patch in children ages 4 through 7, if approved. 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.

These estimates are based on the Company’s current forecasts and exclude additional expenditures related to programs other than VIASKIN Peanut patch or resulting from the potential in-licensing or acquisition of additional product candidates or technologies. The timing and amount of the Company’s future cash requirements may differ materially from current estimates depending on, among other factors, the timing and outcome of the regulatory review process, the pace of clinical development activities, manufacturing and supply-chain commitments, commercial readiness activities and foreign exchange rate fluctuations. These condensed consolidated financial statements do not include any adjustments to the carrying amounts and classification of assets and liabilities or reported expenses that may be necessary if the Company were unable to continue as a going concern.

Significant contracts

Significant contracts
March 2025 PIPE Financing

In March 2025, the Company completed a private investment in public equity financing generating initial gross proceeds of $125.5 million (€116.3 million) received on April 7, 2025 (“March 2025 PIPE Financing”). Following the announcement of positive VITESSE topline results on December 16, 2025, the warrants issued in connection with the March 2025 PIPE Financing were fully exercised, resulting in additional gross proceeds of $195.4 million (€166.7 million at the exchange rate of 1 EUR = $1.17), of which $100.7 million (€85.7 million) was received in the fourth quarter of 2025 and $94.7 million (€81.0 million) was received in January 2026.

The pre-funded warrants issued in connection with the March 2025 PIPE Financing were classified as equity under ASC 480 and ASC 815. Upon exercise, the par value of the newly issued common stocks was recorded in “Common stock” and any additional amount, including the exercise price paid and the remaining carrying amount of the warrants, was recorded in “Additional paid-in capital”. No gain or loss was recognized in the Consolidated Statements of Operations and Comprehensive Loss as the warrants were classified as equity from inception.

Fareva La Vallée - Manufacturing Infrastructure Agreements

The Company entered strategic manufacturing arrangements with Fareva La Vallée ("FLV") to secure dedicated manufacturing capacity for both Peanut Source Material ("PSM") and Peanut Drug Substance ("PDS"), supporting the future commercial supply chain for VIASKIN Peanut.

Peanut Source Material

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

The MS Agreement is subsequent to the Service Agreement that the Company entered into with FLV on March 18, 2024 (the “PSM Services Agreement”), for the construction of a dedicated production line and facility and the transfer of manufacturing of the PSM to FLV required to produce VIASKIN Peanut patches. The PSM Services Agreement also included binding commercial terms which were incorporated into the MS Agreement.

The PSM Services Agreement includes the following services (i) construction activities, (ii) the acquisition of equipment, and (iii) the cGMP qualification of a dedicated PSM production line installed at FLV’s premises. The Company has funded capital expenditures amounting to $4.1 million (at the exchange rate of 1€ = $1.14), granting access to preferential pricing and to an exclusively dedicated PSM production line located at FLV’s facilities, while ownership of the line remains with FLV.

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 Company’s commitments under the agreement include PDS facility services fees capped at $3.9 million (at the exchange rate of 1€ = $1.14), of which the Company funded $3.3 million (at the exchange rate of 1€ = $1.14). These fees, exclude certain capital expenditures directly supported by the Company, and transfer services fees are capped at $3.2 million (at the exchange rate of 1€ = $1.14). The agreement also includes binding commercial terms expected to be incorporated into a future definitive manufacturing and supply agreement.

Accounting Treatment

Management has concluded that both the PSM and PDS arrangements contain embedded leases within the scope of ASC 842, Leases, based on the following considerations:

•Identified asset: The dedicated PSM & PDS production lines are identified assets, and FLV does not have substitution rights.

•Control of use: The Company has (i) the right to obtain substantially all of the economic benefits from use of the asset, through exclusive access to the production capacity, and (ii) the right to direct the use of the asset, including decision‑making authority over relevant activities such as production volumes, scheduling, and operating methods.

In accordance with ASC 842‑10‑25‑2, the right‑of‑use assets will be recognized at the lease commencement date, defined as the date on which the production lines are made available for use following completion of cGMP qualification. At this stage, the Company has identified the embedded leases, the separation of lease and non‑lease components of the arrangements, and the reclassification of the payment related to the exclusive access right as prepaid rent under ASC 842 (Other non-current assets). Subsequent to September 30, 2026, the first commercial PSM batch was successfully manufactured by FLV and incorporated into the pre-commercial inventory. Accordingly, management expects lease commencement to occur during the fourth quarter of 2026 and amortization of the PSM right-of-use asset to begin during the fourth quarter of 2026.

Under the PSM Manufacturing and Supply Agreement, the Company is subject to minimum purchase commitments tied to the commercial supply of PSM. Specifically, if cumulative commercial orders are below 940 kilograms at the end of the 36-month period following delivery of the first commercial batch, the Company may be required to compensate FLV for the shortfall, subject to a contractual cap of $0.6 million (at the exchange rate of 1€ = $1.14). Based on management's operational forecasts as of September 30, 2026, the Company expects to meet the purchase obligations and therefore did not record any liability or accrual related to these commitments