What changed in this filing

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Item 7. Management’s Discussion and Analysis

2025-04-11 compared with 2024-03-07 · 117 added, 123 removed, 237 unchanged (50% of the section changed)

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You should read this discussion and analysis of our financial condition and consolidated results of operations together with the consolidated financial statements, related notes and other financial information included in this Annual Report on Form 10-K.

Some of the information contained in this discussion and analysis or set forth elsewhere in this Annual Report on Form 10-K, including statements of our plans, objectives, expectations and

intentions, contain forward-looking statements that involve risks and uncertainties.

Some of the information contained in this discussion and analysis or set forth elsewhere in this Annual Report on Form 10-K, including statements of our plans, objectives, expectations and intentions, contain forward-looking statements that involve risks and uncertainties.

As a result of many factors, including those factors set forth in the “Risk Factors” section of this Annual Report on Form 10-K, our actual results could differ materially from the results described in or implied by the forward-looking statements contained in the following discussion and analysis.

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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, or EPITTM, 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).

Our therapeutic approach is based on epicutaneous immunotherapy, or 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.

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Financial Overview

Since our inception, we have primarily funded our operations with equity financings, and, to a lesser extent, public assistance aimed at supporting innovation and payments associated with research tax credits (Crédit d’Impôt Recherche).

We do not generate product revenue and continue to prepare for the potential launch of our first product in the United States and in the European Union, if approved.

Based on its current operations, the Company expects that its balance of cash and cash equivalents of $141.4 million as of December 31, 2023 will be sufficient to fund its operations until December 31, 2024.

The Company has incurred operating losses and negative cash flows from operations since inception.

As of the date of the filing, our available cash is not projected to be sufficient to support our operating plan for at least the next 12 months.

As such, there is substantial doubt regarding our ability to continue as a going concern.

We intend to seek additional capital as we prepare for the launch of Viaskin Peanut, if approved, and continue other research and development efforts.

The Company will require substantial additional capital to fund its research and development and ongoing operating expenses.

These capital requirements are expected to be funded through debt and equity offerings before December 31, 2024.

We intend to seek additional capital as we prepare for the launch of Viaskin Peanut, if approved, and continue other research and development efforts.

Subsequent to December 31, 2024, the Company raised additional proceeds in a private placement financing (the “2025 PIPE”) consisting of i) a share capital increase without preferential subscription rights reserved to categories of persons satisfying determined characteristics pursuant to the 24th resolution of the general meeting of shareholders of May 16, 2024 (the "2024 General Meeting") completed on April 7 2025 for an amount of €38 million, consisting of the issuance of (i) 34,090,004 new shares at a par value of €0.10 (the "New Shares") each with warrants of the Company attached (the "ABSA Warrants", and together with the New Shares, the "ABSA") at a subscription price of €1.1136 per ABSA and (ii) up to 59,657,507 additional new shares, if all the ABSA Warrants attached to the New Shares are exercised (the "ABSA Warrant Shares");

and ii) the issue through an offering reserved to categories of persons satisfying determined characteristics of 71,005,656 units (the “PFW-BS-PFW”) completed on April 7, 2025 for an amount of €79 million at a subscription price of €1.1136 per PFW-BS-PFW (of which €1.1036 will have been prefunded on the issue date), each PFW-BS-PFW consisting of one pre-funded warrant to subscribe for one share of the Company (the "First Pre-Funded Warrants") and one warrant (the "BS Warrants") to subscribe to one second pre-funded warrants (the "Second Pre-Funded Warrants"), each of which entitles the holder to subscribe for 1.75 shares of the Company (the "Second PFW Shares"), allowing to issue up to 71,005,656 additional new shares if all the First Pre-Funded Warrants are exercised (the "First PFW Shares") and up to 124,259,898 additional new shares if all the Second Pre-Funded Warrants are exercised (the "Second PFW Shares", together with the ABSA Warrant Shares and the First Pre-Funded Warrant Shares, the "Warrant Shares", and together with the New Shares, the "Offered Shares").

The Company received initial net proceeds of $125.5 million (€116.3 million) on April 7, 2025, and based on our current operations, plans and assumptions, we estimate that our balance of cash and cash equivalents will be sufficient to fund our operations into June 2026.

We further estimate that, following the potential issuance of all Warrant Shares in the financing, representing potential additional gross proceeds of up to $181.4 million (€168.2 million), we could extend our financial visibility into 2028 and through potential commercialization of Viaskin Peanut in the U.S, if approved.

We imay needadditional capital as we prepare for the launch of Viaskin Peanut, if approved, and continue other research and development efforts.

We may seek to finance our future cash needs through a combination of public or private equity or debt financings, collaborations, license and development agreements and other forms of non-dilutive financings.

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• experience any delays or encounter issues with any of the above.

Our financial statements have been prepared on a going concern basis assuming that we will be successful in our financing objectives.

As such, no adjustments have been made to the financial statements relating to the recoverability and classification of the asset carrying amounts or classification of liabilities that might be necessary should we not be able to continue as a going concern.

Our Consolidated Financial Statements have been prepared assuming the Company will continue as a going concern.

The going concern assumption contemplates the realization of assets and satisfaction of liabilities in the normal course of business.

The Company has incurred operating losses and negative cash flows from operations since inception.

The Company does not generate product revenue and continues to prepare for the potential launch of its first product in the United States and in the European Union, if approved.

Since its inception, the Company has primarily funded its operations through equity financings, as well as public assistance and research tax credit.

Prior to 2022, the Company underwent restructuring efforts, scaled down certain clinical programs, and engaged with regulatory authorities to advance Viaskin Peanut’s approval process in the United States and European Union.

In 2022, the Company secured a private placement financing of $194 million and lifted a partial clinical hold from the FDA on its VITESSE Phase 3 clinical study.

On April 7, 2025, the Company received gross proceeds of $125.5 million (€116.3 million) from the issuance of the ABSA and PFW-BS-PFW, as described in Note 20.

With the receipt of the aforementioned proceeds, and based on its current operations, plans, and assumptions examined by the Board on March 23, 2025, the Company estimates that its cash and cash equivalents are sufficient to fund its operations into June 2026.

Furthermore, should all Warrant Shares be issued, representing potential additional gross proceeds of up to $181.4 million (€168.2 million), the Company estimates that it could extend its financial visibility into 2028, covering the period through the potential commercialization of Viaskin Peanut in the U.S., if approved.

Given the Company’s historical operating losses and reliance on external financings, the Company may still seek additional capital for future needs through a combination of public or private equity or debt financings, collaborations, licensing agreements, and other funding options.

While recent financing events have improved the Company’s financial position, access to additional capital in the future remains subject to market conditions and investor interest.

Business Trends

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The following table provides a breakdown of our direct Research and Development expenses for our two lead development programs, as well as expenses not allocated to the programs and share-based compensation expenses included in Research and Development expenses, for the years ended December 31, 2024 and 2023, respectively:

Year Ended December 31,

(thousands of U.S.

Research and development expenses related to Viaskin Peanut (1)

As a percentage of research and development expenses, excluding share-based compensation Expense (2)

Viaskin Peanut(1) 80,479 60,329

As a percentage of research and development expenses, excluding share- 93 % 105 %

based compensation Expense(2)

Research and development expenses related to Viaskin Milk(1) 3,638 6,019

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Total research and development expenses, excluding share-based compensation expense

86,999 57,727

Share-based compensation expenses included in research and development expenses 2,343 2,496

Total research and development expenses 89,343 60,223

Excludes employee share-based compensation expense after $19,9 millions loss on completion accrual reversal as of December 2023.

(1) Excludes employee share-based compensation expense after $19.9 million loss on completion accrual reversal as of December 2023.

(2) If we exclude MAG1C impact the percentage of research and development expenses related to Viaskin Peanut in 2023 would be 84%.

(3) If we exclude MAG1C impact the percentage of research and development expenses related to Viaskin Milk in 2023 would be 8%.

We cannot determine with certainty the duration and completion costs of the current or future clinical trials of our product candidates or if, when, or to what extent we will generate revenue from the commercialization and

sale of any of our product candidates that obtain regulatory approval.

We may never succeed in achieving regulatory approval for any of our product candidates.

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If a company meets certain criteria in terms of sales, headcount or assets to be considered a Small and Medium-sized Enterprises, or SMEs, under EU law, immediate payment of the CIR can be requested.

We no longer benefited from the immediate reimbursement of the CIR due to the loss of the SME status under EU law for the fiscal year ending December 31, 2019 and 2020.

The CIRs were to be refunded three years after the tax declaration in the event we could not offset it against corporate income tax due.

Beginning in the fiscal year ending December 31, 2021, we recovered our SME status, and became therefore eligible again for the immediate reimbursement of the CIR.

During the fiscal year ending December 31, 2022, the Company received the reimbursement of the 2019, 2020 and 2021 fiscal year research tax credits for a total amount of $26.1 million.

During the fiscal year ending December 31, 2023, the Company received the reimbursement of the 2022 fiscal year research tax credits for a total amount of $5.9 million.

After two consecutive years in 2019 and 2020 without the SME status, we recovered our SME

status, beginning in the fiscal year ending December 31, 2021, and became therefore eligible again for the immediate reimbursement of the CIR.

During the fiscal year ended December 31, 2023, the Company received the reimbursement of the 2022 fiscal year research tax credit for a total amount of $5.9 million.

During the fiscal year ended December 31, 2024, the Company received the reimbursement of the 2023 fiscal year research tax credit for a total amount of $8.7million, including 2020, 2021 and 2022 complementary research tax credit made during the fiscal year ended December 31, 2023.

Collaboration Agreement with Nestlé Health Science

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Under the terms of the Collaboration Agreement, the Company was responsible for leading the development activities of MAG1C up through a pivotal Phase 3 clinical program, and if the appropriate regulatory approvals were received, Nestlé Health Science would support the commercialization of MAG1C globally.

The Company was eligible to receive up to €100.0 millions ($105.0 millions at December 31, 2023 closing exchange rate) in potential development, clinical, regulatory and commercial milestones, including an upfront payment of €10.0 millions received in July 2016.

The Company was eligible to receive up to €100.0 million ($105.0 million at December 31, 2023 closing exchange rate) in potential development, clinical, regulatory and commercial milestones, including an upfront payment of €10.0 million received in July 2016.

On October 30, 2023, the Company and NESTEC entered into a Mutual Termination Letter Agreement terminating the Collaboration Agreement.

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Any and all licenses and sublicenses, granted by either party to the other party under the Collaboration Agreement, including, without limitation, any licenses to intellectual property, were revoked and terminated.

Consequently, since signing the Mutual Termination Letter Agreement and as of December 31 , 2023, we recorded the following :

Loss on completion accrual reversal $19,9 millions (Other Operating Income);

Deferred revenue accrual reversal $6.9 millions (Operating Expenses);

Accrual for ongoing Clinical study completion $2.3 millions (Operating Expenses).

This accrual represents our best estimate of the remainder expenses related to the ongoing clinical study which will be incurred after December 31, 2023 and until the end of the study.

Consequently, since signing the Mutual Termination Letter Agreement and as of December 31, 2023, we had recorded the following:

• Loss on completion accrual reversal of $19.9 million (Other Operating Income);

• Deferred revenue accrual reversal of $6.9 million (Operating Expenses);

• An Accrual of $2.3 million for the remaining expenses related to the ongoing clinical study fully expensed in 2024.

Operating Expenses

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Research and Development expenses comprise clinical trials direct costs as well as salaries, share-based payments and benefits for internal Research and Development personnel.

Consultants, costs of clinical trials

costs related to manufacturing clinical study materials, sponsored research, clinical trials insurance, other external costs, depreciation (of Research and Development equipments and other depreciation related to Research and Development like loss on completion on MAG1C study), and facility costs related to the development of drug candidates.

Consultants, costs of clinical trials costs related to manufacturing clinical study materials, sponsored research, clinical trials insurance, other external costs, depreciation (of Research and Development equipment and other costs related to Research and Development like loss on completion on MAG1C study until December 31, 2023), and facility costs related to the development of drug candidates.

The Company records upfront, non-refundable payments made to outside vendors, or other payments made in advance of services performed or goods being delivered, as prepaid expenses, which are expensed as services are performed or the goods are delivered.

Certain Research and Development projects are, or have been, partially funded by collaboration agreements, The Company records the related reimbursement of research and development costs under these agreements as income in the period in which such costs are incurred.

Certain Research and Development projects are, or have been, partially funded by collaboration agreements.

The Company records the related reimbursement of research and development costs under these agreements as income in the period in which such costs are incurred.

Sales and Marketing

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Finance Income (Expense)

Our cash and cash equivalents have been deposited primarily in savings and deposit accounts with a short term remaining maturity at the date of purchase or less, refundable within one month, for which the risk of changes in value is considered to be insignificant.

Our cash and cash equivalents have been deposited primarily in savings and deposit accounts with a short term remaining maturity at the date of purchase or less, refundable within 32 days or less, for which the risk of changes in value is considered to be insignificant.

Savings and deposit accounts generate a limited amount of interest income, with very low counterparty risks.

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GAAP, for the years ended December 31, 2024 and 2023:

(Dollar amounts presented in thousands, except per share amounts)

2024 2023 $ change % of change

Operating income 4,151 15,728 (11,577) (74) %

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General and administrative expenses (28,739) (29,500) 762 (3) %

Restructuring income (expenses)

Total Operating expenses (120,740) (92,161) (28,579) 31 %

Loss from operations (116,589) (76,432) (40,157) 53 %

Financial income (expense) 2,726 3,714 (987) (27) %

Loss before taxes (113,863) (72,719) (41,144) 57 %

Income tax (55) (7) (49) 721 %

Net loss (113,918) (72,726) (41,192) 57 %

Basic/diluted Net loss per share attributable to shareholders (1.17) (0.76) — —

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The following table summarizes our operating income for the years presented:

(Dollar amounts presented in thousands)

2024 2023 $ change % of change

Sales — — — —

Other income 4,151 15,728 (11,577) (74) %

Research tax credit 4,146 8,766 (4,620) (53) %

Other operating (loss) income

Other operating income 5 6,962 (6,957) (100) %

Total operating income 4,151 15,728 (11,577) (74) %

We generated operating income of $15.7 millions for the year ended December 31, 2023 compared to $4.8 millions for the year ended December 31, 2022.

The increase in operating income is due to the increase in research tax credit and the revenue recognition of $6.9 millions related to the deferred revenue following the termination of the Collaboration Agreement with Nestlé.

Research tax credit increased by $3.0 millions for the year ended December 31, 2023 compared to the year ended December 31, 2022 as a result of the extension of the eligible expense base to include clinical supplies.

A corrective Research tax credit was filed by the Company for $2.9 millions for 2020, 2021 and 2022 fiscal year research tax credit during the year ended December 31, 2023.

Other operating income increased by $7.8 millions for the year ended December 31, 2023 compared to the year ended December 31, 2022 mainly due the reversal of deferred revenue following the Mutual Termination Letter Agreement, effective October 30, 2023, of the Collaboration Agreement between the Company and Nestlé Health Science.

We generated operating income of $4.2 million for the year ended December 31, 2024 compared to $15.7 million for the year ended December 31, 2023.

The decrease in operating income is due to a lower Research Tax Credit.

and nil revenue recognition from January 1, 2024 onward due to the termination of the Collaboration Agreement with NESTEC.

The decrease of theResearch Tax Credit.

by $(4.6) million for the year ended December 31, 2024 compared to the year ended December 31, 2023 is mainly due to a corrective Research Tax Credit.

filed in 2023 by the Company for $2.9 million for 2020, 2021 and 2022 fiscal year and a greater proportion of clinical study activities carried out in North America in 2024 compared to 2023 not eligible for the Research Tax Credit.

Other operating income decreased by $(7.0) million for the year ended December 31, 2024 compared to the year ended December 31, 2023 mainly due to the reversal of deferred revenue following the Mutual Termination Letter Agreement, effective October 30, 2023, of the Collaboration Agreement between the Company and NESTEC.

Operating Expenses

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The following table summarizes our research and development expenses for the years presented:

(Dollar amounts presented in thousands)

2024 2023 $ change % of change

Research and Development expenses

External clinical-related expenses 62,448 49,044 13,404 27 %

Employee-related costs excl.

share-based payment expenses

Employee-related costs 17,213 14,401 2,812 20 %

Share-based payment expenses 2,343 2,496 (153) (6) %

Depreciation and amortization (719) (13,658) 12,939 (95) %

Other costs 8,058 7,940 118 1 %

Total Research and Development expenses 89,342 60,223 29,120 48 %

Our research and development expenses consisted primarily of external costs, such as startup fees paid to investigators, consultants, central laboratories and CROs in connection with our clinical trials, and costs related to acquiring and manufacturing clinical study materials.

Research and Development expenses decreased by $15.3 millions for the year ended December 31, 2023 compared to the year ended December 31, 2022 mainly as a result of :

loss on completion accrual net reversal $17,6 millions (compared to a $10.4 millions depreciation as of December 31, 2022) resulting from Nestlé Collaboration Agreement termination, that offset;

the global increase of $11.3 million in research and development expenses.

External clinical-related expenses increased by $6.8 millions for the year ended December 31, 2023 compared to the year ended December 31, 2022, reflecting intensified Research and Development activities (1) after the initiation of the VITESSE trial with the first patient screened in March 2023, and (2) as part of the new safety study for toddlers and children after the FDA confirmed additional safety data is required for BLA.

Employee-related costs, excluding share-based payment expenses, increased by $3.6 million for the year ended December 31, 2023 compared to the year ended December 31, 2022 due to the workforce increase to support research and development activities on VITESSE trial and the new safety study for toddlers and children.

Research and Development expenses increased by $29.1 million for the year ended December 31, 2024 compared to the year ended December 31, 2023, mainly due to external clinical-related expenses increasing by $13.4 million from both an increase in participant enrollment in the VITESSE Phase 3 clinical trial and the preparatory activities for the COMFORT studies.

Employee-related costs, excluding share-based payments, increased by $2.8 million for the year ended December 31, 2024 compared to the year ended December 31, 2023 due to the recruitment of 12 full-time employees (“FTE”) in Medical, Quality and Regulatory Affairs, mostly based in the U.S.

Depreciation, amortization and other costs increased by $12.9 million for the year ended December 31, 2024 compared to the year ended December 31, 2023, mainly due to (1) the termination of the Collaboration Agreement with NESTEC that explained the accrual net reversal in 2023, (2) accruals reversals on CRO activities, and (3) Medical, Quality and Regulatory Affairs activities.

Sales and Marketing Expenses

The following table summarizes our sales and marketing expenses for the years presented:

(Dollar amounts presented in thousands)

Sales and marketing expenses

2024 2023 $ change % of change

Sales & Marketing expenses

External professional services and other costs 1,770 1,684 86 5 %

Employee-related costs incl.

share-based payment expenses 890 754 136 18 %

External professional services and other costs

Total Sales and marketing expenses

Sales and marketing expenses primarily included payroll for the U.S.

and European employees as well as fees related to pre- commercialization activities for Viaskin Peanut in North America.

Sales and Marketing expenses increased by $0.8 million for the year ended December 31, 2023 compared to the year ended December 31, 2022, primarily due to an increase in fees related to pre-commercialization activities for Viaskin Peanut in North America.

Employee-related costs (including share-based payments expenses) related to payroll for the U.S.

and European employees, decreased by $0.2 million for the year ended December 31, 2023 compared to the year ended December 31, 2022, due to employee departure in the US.

External professional services and other costs increased by $1.0 million for the year ended December 31, 2023 compared to the year ended December 31, 2022, mainly due to an increase in fees related to pre-commercialization activities for Viaskin Peanut in North America.

Total Sales & Marketing expenses 2,659 2,438 222 9 %

Sales and marketing expenses increased by $0.2 million for the year ended December 31, 2024 compared to the year ended December 31, 2023, primarily to support pre-commercialization activities for Viaskin Peanut in North America.

General and Administrative Expenses

The following table summarizes our general and administrative expenses for the years presented:

(Dollar amounts presented in thousands)

General and administrative expenses

External professional services fees

Employee-related costs excl.

share-based payment expenses

2024 2023 $ change % of change

General & Administrative expenses

External professional services 10,052 8,750 1,302 15 %

Employee-related costs 8,981 8,201 780 10 %

Share-based payment expenses 2,161 3,388 (1,227) (36) %

Depreciation, amortization and other costs 7,545 9,161 (1,617) (18) %

Total General and administrative expenses

General and administrative expenses increased by $5.2 millions for the year ended December 31, 2023, compared to the year ended December 31, 2022.

The source of this increase is threefold (1) an increase by $2.8 millions of external professional services fees incurred in our financing activities, (2) an increase by $0.9 million in employee-related costs to support General and Administrative activities, and (3) an increase by $0.8 million in depreciation, amortization and other costs mainly due to Montrouge office revamping which will be departed for a new location in Q2 of 2024.

The workforce dedicated to general and administrative activities increased from 27 employees in 2022 to 34 employees in 2023.

Total General & Administrative expenses 28,739 29,500 (762) (3) %

General and administrative expenses decreased by $(0.8) million for the year ended December 31, 2024, compared to the year ended December 31, 2023.

External professional services increased by $1.3 million for the year ended December 31, 2024, compared to the year ended December 31, 2023, primarily due to one-time costs associated with (1) office moves in France and the U.S, (2) financing activities and (3) trademark and patent activities.

This increase is offset by a decrease in Depreciation, amortization and other costs by $(1.6) million for the year ended December 31, 2024, compared to the year ended December 31, 2023 primarily due to the accrual reversal on the Montrouge office revamping.

Financial income (loss)

Our financial income was $3.7 millions in 2023 and $0.4 million in 2022, and primarily includes the financial income on our financial assets and foreign exchange gains.

Our income tax expense was $7,000 for the year ended December 31, 2023, compared to a US Tax income of $70,000 for the year ended December 31, 2022.

Our financial income was $2.7 million in 2024 and $3.7 million in 2023, and primarily includes the financial income on our financial assets and foreign exchange gains.

Our income tax expense was $55 thousand for the year ended December 31, 2024, compared to an income tax expense of $7 thousand for the year ended December 31, 2023.

Net loss was $113.9 million for the year ended December 31, 2024, compared to $72.7 million for the year ended December 31, 2023.

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Financial Condition

On December 31, 2023, we held $141.4 millions in cash and cash equivalents compared to $209.2 millions of cash and cash equivalents on December 31, 2022..

Net cash used for operating activities was $79.6 and

$55.7 million for the years ended December 31, 2023 and 2022, respectively.

On December 31, 2024, we held $32.5 million in cash and cash equivalents compared to $141.4 million of cash and cash equivalents on December 31, 2023.

Net cash used for operating activities was $104.5 million and $79.7 million for the years ended December 31, 2024 and 2023, respectively.

As of December 31, 2024, we recorded a net loss of $113.9 million.

Our net cash flows provided by financing activities totaled $7.1 million in 2023, mainly consisting of the proceeds from our ATM program.

Our net cash flows provided by financing activities totaled $0.6 million in 2024 and $6.8 million in 2023, mainly consisting of the proceeds from our ATM program.,

Sources of Liquidity and Material Cash Requirements

Based on its current operations, plans and assumptions as revised pursuant to 2023 announcements related to EPITOPE Phase 3 study topline results and VITESSE Phase 3 partial clinical hold lift, the Company expects that its balance of cash and cash equivalents of $141.4 million as of December 31, 2023 will be sufficient to fund its operations until December 31, 2024.

As of the date of the filing, our available cash is not projected to be sufficient to support our operating plan for at least the next 12 months.

As such, there is substantial doubt regarding our ability to continue as a going concern.

We fund short-term cash requirements primarily from payments associated with research tax credits ( Crédit d’Impôt Recherche ).

In May 2022, we established an At-The-Market (“ATM”) program to offer and sell, including with unsolicited investors who have expressed an interest, a total gross amount of up to $100 million of American Depositary Shares (“ADSs”), each ADS representing one-half of one ordinary share of the Company The ATM program is intended to be effective through the expiration of the Company’s existing registration statement registering the ADSs to be issued under the ATM program, i.e.

Subsequent to December 31, 2024, the Company raised additional proceeds in the 2025 PIPE of initial net proceeds of $125.5 million (€116.3 million) received on April 7, 2025, and based on our current operations, plans and assumptions, we estimate that our balance of cash and cash equivalents will be sufficient to fund our operations into June 2026.

The ATM program is intended to be effective through the expiration of the Company’s existing registration statement registering the ADSs to be issued under the ATM program, i.e.

until July 16, 2024, unless terminated prior to such date in accordance with the sales agreement or the maximum amount of the program has been reached.

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During the years ended December 31, 2023 and 2022, we obtained the following financing on the public markets by issuance of securities, net of commissions and estimated offering expenses:

Equity capital

(Amounts in thousands of U.S.

Equity capital Bank loan Other debt Total

2022 194,446 — — 194,446

2023 6,921 — — 6,921

Total 201,367 — — 201,367

We have incurred net losses each year since our inception.

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We have not incurred any bank debt.

We intend to seek additional capital as we prepare for the launch of Viaskin Peanut, if approved, and continue other research and development efforts.

We may seek additional capital as we prepare for the launch of Viaskin Peanut, if approved, and continue other research and development efforts.

future pandemics, epidemics or global health crises and conflict in Ukraine or other global political or military crises.

The COVID-19 pandemic and the conflict in Ukraine caused extreme volatility and disruptions in the capital and credit markets.

We cannot guarantee that we will be able to obtain the necessary financing to meet our needs or to obtain funds at attractive terms and conditions, including as a result of disruptions to the global financial markets due any future pandemics, epidemics or global health crises and conflict in Ukraine or other global political or military crises.

A severe or prolonged economic downturn could result in a variety of risks to us, including reduced ability to raise additional capital when needed or on acceptable terms, if at all.

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The following table presents our material expenses commitments for future periods:

Material expenses Commitments Due by the

Year Ended December 31,

Material Cash Requirements Due by the Year Ended December 31,

2025 2026 2027 Thereafter Total

(Amounts in thousands)

Operating leases 836 1,228 1,237 5,136 8,437

Purchase obligations—Obligations Under the Terms of CRO commitments

Purchase obligations - Obligations Under the Terms of CRO Agreements 8,439 1,541 502 48 10,530

Total 9,275 2,769 1,739 5,184 18,967

The commitment amounts in the table above are associated with contracts that are enforceable and legally binding and that specify all significant terms, including interest on long-term debt, fixed or minimum services to be used, fixed, minimum or variable price provisions, and the approximate timing of the actions under the contracts.

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Operating leases

Our corporate headquarters are located in Montrouge, France.

Our principal offices occupy a 4,470 square meter facility, pursuant to a lease agreement dated March 3, 2015 and represents a $1.1 million cash requirement as of December 31, 2023 until July, 2024.

In November, 2023, the Company entered into new agreements to relocate its headquarters in Chatillon, France:

In November 2023, the Company entered into new agreements to relocate its headquarters in Châtillon, France:

• a short term lease agreement for the fitting works of the new offices,

• a lease agreement starting April 16, 2024 with a minimum duration of six years.

Our corporate headquarters represents a $6.3 million cash requirement as of December 31, 2024 until April 2033.

In light of the current stage of regulatory interactions regarding Viaskin Peanut, we achieved the resizing of our facility use in North America to support our U.S.

subsidiary as well as future commercialization needs, explaining partially operating leases costs as of December 31, 2024 and December 31, 2023:

• Our primary U.S.

office is located in Basking Ridge, New Jersey.

In March 2022, we entered into a lease agreement, commencing on April 1, 2022 and effective for 38 months, for an office of 5,799 square feet in Basking Ridge, New Jersey.

office is located in Warren, New Jersey.

In February 2024, we entered into a lease agreement commencing on March 19, 2024 and effective for 70 months, for an office of 16,704 square feet.

The office represents a $1.8 million cash requirement as of December 31, 2024 which expires December 1, 2029.

• We also have facilities located in Basking Ridge, New Jersey initially intended to support our U.S.

In March 2022, we entered into a lease agreement, commencing on April 1, 2022 and effective for 38 months, for an office of 579 square feet.

The Basking Ridge office represent a $0.1 million cash requirement as of December 31, 2024 which expires June 1, 2025.

In light of the current stage of regulatory interactions regarding Viaskin Peanut, we achieved the resizing of our facility use in North America that was initially intended to support our U.S.

subsidiary as well as future commercialization needs, explaining partially operating leases costs as of December 31, 2023 and December 31, 2022 :

In January 2022, we concluded a termination agreement for our 21,548 square feet commercial facility in Summit, New Jersey.

A one-time lump sum early termination fee of $1.5 million was paid in 2022 and offset by the recognition of an income of $1.2 million due to the early termination of this lease.

In June 2021, we entered into a sublease agreement of our 3,780 square feet office space in Tower 49, New York, New York that both expire in the first quarter of 2023, simultaneously with the lease term.

Purchase obligations—Obligations Under the Terms of CRO Agreements

In connection with the launch of our clinical trials for Viaskin Peanut and Viaskin Milk, we signed agreements with several contract research organizations.

As of December 31, 2023, expenses associated with the ongoing trials amounted globally to $114.4 million, and we had non-cancellable contractual obligations with CRO until year ended 2025 amounting to $44.2 million.

As of December 31, 2024, expenses associated with the ongoing trials amounted globally to $170.3 million, and we had non-cancellable contractual obligations with CRO until the year ended 2026 amounting to $10.0 million.

The table below summarizes our sources and uses of cash for the years ended December 31, 2024 and 2023.

(Amounts in thousands of U.S.

Net cash flows used in operating activities

Net cash flows used in investing activities

Net cash flows provided by financing activities

Dollars) 2024 2023 $ change % of change

Net cash flow used in operating activities (104,474) (79,653) (24,821) 31 %

Net cash flow used in investing activities (757.0) (808.3) 51.304 (6) %

Net cash flow provided by financing activities 587 6,767 (6,180) (91) %

Effect of exchange rate changes on cash and cash equivalents (4,268) 5,867 (10,135) (173) %

Net (decrease) increase in cash and cash equivalents (108,913) (67,827) (41,085) 61 %

Percentage not meaningful

Operating Activities

Our net cash flows used in operating activities were $79.7 millions and $55.7 millions in 2023 and 2022 respectively.

Our net cash flows used in operating activities increased by $24.0 millions, or 43%, mainly due to the collection in 2022 of the research tax credit receivable relating to fiscal years 2019 to 2021 for €24.8 millions (corresponding to $28.1 millions on the basis of 2021 closing exchange rate).

Our net cash flows used in operating activities were $104.5 million and $79.7 million in 2024 and 2023 respectively.

Our net cash flows used in operating activities increased by $24.8 million or 31% The variance is mainly driven by the increase in external clinical related expenses by $11.9 million and in Regulatory and Manufacturing activity-related expenses by $10.5 million.

Investing Activities

Our net cash flows used in investing activities were $0.8 million and $0.1 million in 2023 and 2022 respectively.

Our net cash flows used in investing activities were $0.8 million in 2024 and $0.8 million in 2023.

Financing Activities

Our net cash flows resulting from financing activities decreased to $6.8 millions in 2023 from $194.1 millions in 2022.

For the year ended December 31, 2023, financing activities are primarily composed of the ATM in June 2023 compared to $194.4 millions during for the year ended December 31, 2022 (that consisted of our May 2022 ATM and June 2022 PIPE offering in second quarter of 2022).

Our net cash flows resulting from financing activities were $0.6 million in 2024 and $6.8 million in 2023 from the ATM.

Consistent with customary practice in the French securities market, we entered into a liquidity agreement ( contrat de liquidité ) with Natixis on April 13, 2012.

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Some of the accounting methods and policies used in preparing our financial statements under U.S.

GAAP are based on complex and subjective

assessments by our management or on estimates based on past experience and assumptions deemed realistic and reasonable based on the facts and circumstances concerned.

GAAP are based on complex and subjective assessments by our management or on estimates based on past experience and assumptions deemed realistic and reasonable based on the facts and circumstances concerned.

The actual value of our assets, liabilities and shareholders’ equity and of our earnings could differ from the value derived from these estimates if conditions changed and these changes had an impact on the assumptions adopted.

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Consequently, as of the signing of the Mutual Termination Letter Agreement and as of December 31, 2023, we recorded the following:

Loss on completion accrual reversal $19,9 millions;

Deferred revenue accrual reversal $6.9 millions;

Accrual for ongoing Clinical study completion $2.3 millions.

This accrual represents our best estimate of the remainder expenses related to the ongoing clinical study which will be incurred after December 31, 2023 and until the end of the study.

Clinical studies costs committed beyond December 31 2023 are to be settled by DBV.

Our estimation of costs yet to be incurred for the completion of the study contains uncertainties as they require management to make assumptions and to apply judgment to estimate future cost and timelines to finish the study.

These estimates are subjective and our ability to achieve current best estimates may be affected by factors.

A $2.3 millions provision representing our current best estimates of costs yet to be incurred for the completion of the study was booked as of December 31, 2023.

• Loss on completion accrual reversal $19,9 million;

• Deferred revenue accrual reversal $6.9 million;

• Accrual for ongoing Clinical study completion of $2.3 million as of December 31, 2023.

This updated accrual of $22 thousand represents our best estimate of the remainder expenses related to the ongoing clinical study which will be incurred after December 31, 2024 and until the end of the study.

Share-Based Compensation

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We estimated the following assumptions for the calculation of the fair value of our stock options:

Assumptions per

Assumptions per year ended December 31,

Stock options per grant date 2024 2023

24 unchanged sentences

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 7. Management’s Discussion and Analysis