DBV Technologies SA

Note 1: The Company

Incorporated in 2002 under the laws of France, DBV Technologies S.A. (“DBV Technologies” or the “Company”) is a clinical-stage specialty biopharmaceutical company focused on changing the field of immunotherapy by developing a novel technology platform called Viaskin. The Company’s therapeutic approach is based on epicutaneous immunotherapy, or EPIT, a proprietary method of delivering biologically active compounds to the immune system through intact skin using Viaskin.

Basis of Presentation

The condensed consolidated financial statements of the Company and its wholly-owned subsidiaries are unaudited and have been prepared in accordance with generally accepted accounting principles in the United States (“U.S. GAAP”) and are presented in

U.S. dollars

. All significant intercompany accounts and transactions between the Company and its subsidiaries have been eliminated on consolidation.

The unaudited condensed consolidated financial statements presented in this Quarterly Report should be read in conjunction with the consolidated financial statements and accompanying notes included in the Company’s Annual Report on

Form 10-K

filed with the SEC on March 7, 2024 (the “ Annual Report”). The condensed consolidated statement of financial position as of December 31, 2023 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, 2023.

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, 2024, or any other future period.

Use of estimates

The preparation of the Company’s condensed consolidated financial statements requires the use of estimates, assumptions and judgments that affect the reported amounts of assets, liabilities, and disclosures of contingent assets and liabilities at the date of the consolidated financial statements and the reported amount of income and expenses during the period. The Company bases its estimates and assumptions on historical experience and other factors that it believes to be reasonable under the circumstances. The Company evaluates its estimates and assumptions on an ongoing basis. The actual results may differ from these estimates.

On an

on-going

basis, management evaluates its estimates, primarily those related to: (1) evaluation of costs and measure of progress of the wind-down activities resulting from the termination of the collaboration agreement with Nestlé Health Science, (2) research tax credits, (3) assumptions used in the valuation of right of use assets—operating lease, (4) impairment of

right-of-use

assets related to leases and property, plant and equipment, (5) recoverability of the Company’s net deferred tax assets and related valuation allowance, (6) assumptions used in the valuation model to determine the fair value and vesting conditions of share-based compensation plan, (7) estimate of contingencies, and (8) estimate of employee benefits obligations.

Going Concern

These Condensed Consolidated Financial Statements have been prepared assuming the Company will continue as a going concern. The going concern assumption contemplates the realization of assets and satisfaction of liabilities in the normal course of business. However, substantial doubt about the Company’s ability to continue as a going concern exists.

Since its inception, the Company has primarily funded its 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). 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.

The Company has incurred operating losses and negative cash flows from operations since inception. As of the date of the filing, our available cash and cash equivalents are 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.

Based on our current operations, as well as our plans and assumptions, we expect that our balance of cash and cash equivalents of $66.2 million as of June 30, 2024 will be sufficient to fund our operations into the first quarter 2025.

The Company intends to seek additional capital as it prepares for the launch of Viaskin Peanut, if approved, and continues 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. The Company may seek to finance its 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.

The Company cannot guarantee that it will be able to obtain the necessary financing to meet its needs or to obtain funds at attractive terms and conditions, including as a result of disruptions to the global financial markets due to 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 the Company, including reduced ability to raise additional capital when needed or on acceptable terms, if at all.

If the Company is not successful in its financing objectives, the Company could have to scale back its operations, notably by delaying or reducing the scope of its research and development efforts or obtain financing through arrangements with collaborators or others that may require the Company to relinquish rights to its product candidates that the Company might otherwise seek to develop or commercialize independently.

These condensed consolidated financial statements do not include any adjustments to the carrying amounts and classification of assets, liabilities, and reported expenses that may be necessary if the Company was unable to continue as a going concern.

Accounting Pronouncements recently adopted

There have been no recently issued accounting standards adopted during the period which had a material impact on the Company’s financial statements.

There are no recently issued accounting standards that are expected to have a material impact on our results of operations, financial condition, or cash flows.

Accounting Pronouncements issued not yet adopted

Other accounting standards that have been issued or proposed by the FASB or other standards-setting bodies that do not require adoption until a future date are not expected to have a material impact on the Company’s Consolidated Financial Statements upon adoption.

Note 2: Significant Events and Transactions

Clinical programs

United States Regulatory History and Current Status

In August 2020, the Company received a Complete Response Letter, or CRL, in which the FDA indicated it could not approve the Viaskin Peanut BLA in its then-current form. The FDA identified concerns regarding the impact of patch-site adhesion on efficacy and indicated the need for patch modifications, followed by completion of a new human factors study. In addition, the FDA indicated that supplementary clinical data would need to be generated to support the modified patch. Finally, the FDA requested additional Chemistry, Manufacturing and Controls, or CMC, data. The FDA did not raise any safety concerns related to Viaskin Peanut.

In January 2021, the Company received written responses from the FDA to questions provided in the Type A meeting request that the Company submitted in October 2020 following receipt of the CRL. The FDA agreed with the Company’s position that a modified Viaskin Peanut patch should not be considered as a new product entity provided the occlusion chamber of the current Viaskin Peanut patch and the peanut protein dose of 250 µg (approximately 1/1000 of one peanut) remains unchanged and performs in the same way it has performed previously.

In March 2021, the Company commenced CHAMP (Comparison of adHesion Among Modified Patches), a Phase 1 trial in healthy adult volunteers to evaluate the adhesion of five modified Viaskin Peanut patches to confirm consistency of efficacy data between the existing and modified patches. The study was completed in the second quarter of 2021 and the Company selected the circular patch for further development, which is larger in size relative to the current patch and circular in shape. In May 2021, the Company submitted a proposed protocol to the FDA for STAMP (Safety, Tolerability, and Adhesion of Modified Patches), a

6-month

safety and adhesion study. On October 14, 2021, in an Advice/Information Request letter, the FDA requested the Company conduct a stepwise, or sequential, approach to the modified Viaskin patch development program by conducting allergen uptake comparison studies (i.e., ‘EQUAL in Adults’, EQUAL) and submitting the data for FDA review and feedback prior to starting the STAMP study.

After careful review of the FDA’s information requests, the Company decided not to pursue the approach to the development plans for Viaskin Peanut as requested by the FDA. The Company estimated that the FDA’s proposed sequential approach would require at least five rounds of exchanges with the FDA to achieve alignment before initiating STAMP, the

6-month

safety and adhesion study. As such, in December 2021, the Company announced its plan to initiate a pivotal Phase 3 placebo-controlled efficacy trial for a modified Viaskin Peanut patch (mVP) in children in the intended patient population. The Company considered this approach the most straightforward to potentially demonstrate effectiveness, safety, and improved in vivo adhesion of the mVP. Following written exchanges with the FDA, the FDA confirmed it was aligned with the Company’s change in strategy.

On September 7, 2022, the Company announced the initiation of VITESSE, a Phase 3 pivotal study of the mVP in children ages

4-7

years with peanut allergy. On September 21, 2022, the Company announced it received from FDA a partial clinical hold letter related to certain design elements of VITESSE.

On December 23, 2022, the Company announced that the FDA lifted the partial clinical hold. The FDA confirmed the Company satisfactorily addressed all clinical hold issues and the VITESSE phase 3 clinical study could proceed with the revised trial protocol. On March 7, 2023, the Company announced that the first patient was screened in the VITESSE study. Screening of the last subject is anticipated by the end of the third quarter of 2024.

In June 2022, the Company announced positive topline results from Part B of EPITOPE, which enrolled 362 subjects ages

1-3

years, of which 244 and 118 were in the active and placebo arms respectively. Enrollment was balance for age and baseline disease characteristics between the active and placebo treatment ar

m

s.

On April 19, 2023, the Company outlined the regulatory pathway for Viaskin Peanut in children

1-3

years old after the FDA confirmed in written responses to the Company’s

Pre-BLA

meeting request that the Company’s EPITOPE phase 3 study met the

pre-specified

criteria for success for the primary endpoint and did not request any additional efficacy study in this age group. The FDA required additional safety data to augment the safety data collected from EPITOPE in support of a BLA.

On July 31, 2023, the Company announced receipt of feedback from FDA on two supplemental safety studies, COMFORT Children and COMFORT Toddlers.

The Company submitted the protocol for its COMFORT Toddlers supplemental safety study in

1-through-3-year-olds

to FDA on November 9, 2023. The Company received comments and queries to the protocol from the FDA on March 11, 2024. Since March, the Company and the FDA have been engaged in ongoing dialogue related to the program. Much of the ongoing dialogue has focused on patch wear-time experience. To address the FDA’s protocol queries, the Company submitted to the FDA on June 28, 2024, a proposed labeling approach, informed by the EPITOPE efficacy data. The proposed labeling approach focuses on the user experience during the first 90 days on treatment. The Company is awaiting feedback on the labeling proposal following FDA review.

The Company also announced on November 9, 2023,

2-

year

results from the ongoing phase 3 open-label extension to the EPITOPE trial, EPOPEX, of Viaskin Peanut in toddlers.

The Company submitted the protocol for its COMFORT Children supplemental safety study in

4-through-7-year-olds

to the FDA on November 29, 2023 and, as of the date of this filing, the Company is still awaiting feedback from the FDA. The Company anticipates that the COMFORT Children safety study will enroll peanut allergic children ages 4 –

7-years

and anticipates the safety study will support the efficacy results from the ongoing VITESSE phase 3 pivotal study.

Viaskin Peanut for children ages

4-11—European

Union Regulatory History and Current Status

On December 20, 2021, the Company announced it withdrew the Marketing Authorization Application (“MAA”) for Viaskin Peanut and formally notified the European Medicines Agency (“EMA”) of our decision. The Company believes data from a second Viaskin Peanut pivotal clinical trial will support a more robust path for licensure of Viaskin Peanut in the EU. The Company intends to resubmit the MAA when that data set is available.

Viaskin Peanut for children ages

1-3

In June 2020, the Company announced that in Part A of the EPITOPE phase 3 clinical study subject in both treatment arms showed consistent treatment effects after 12 months of therapy, as assessed by a double-blind placebo-controlled food challenge and biomarker results. Part A subjects were not included in Part B and the efficacy analyses from Part A were not statistically powered to demonstrate superiority of either dose versus placebo. These results validated the ongoing investigation of the 250 µg dose in this age group, which was the dose studied in Part B of the EPITOPE phase 3 clinical study. Enrollment for Part B of EPITOPE was completed in the first quarter of 2021.

In June 2022, the Company announced positive topline results from Part B of EPITOPE, which enrolled 362 subjects ages 1 to 3 years, of which 244 and 118 were in the active and placebo arms respectively. Enrollment was balanced for age and baseline disease characteristics between the active and placebo treatment arms.

On April 19, 2023, the Company outlined the regulatory pathway for Viaskin Peanut in children

1-3

years old after the FDA confirmed in written responses to the Company’s

Pre-BLA

meeting request that the Company’s EPITOPE phase 3 study met the

pre-specified

criteria for success for the primary endpoint and did not request any additional efficacy study in this age group. The FDA requires additional safety data to augment the safety data collected from EPITOPE in support of a BLA. This new safety study will also generate patch adhesion data and will include updated instructions for use.

On May 10, 2023, the New England Journal of Medicine (“NEJM”) published results from the EPITOPE phase 3 clinical study that demonstrated EPIT with Viaskin Peanut was statistically superior to placebo in desensitizing children to peanut exposure by increasing the peanut dose that triggers allergic symptoms. As stated in an accompanying editorial piece, these data are seen as “very good news” for toddlers with peanut allergy, as there are currently no approved treatment options for peanut-allergic children under the age of 4 years.

In November 2023, the Company announced the interim analyses from the first year of the open-label extension of EPITOPE, called EPOPEX, which showed improvement between months 12 and 24 of treatment with Viaskin Peanut across all efficacy parameters. These data were presented at the annual American College of Allergy, Asthma and Immunology (ACAAI) in November 2023.

The Company submitted the protocol for its COMFORT Toddlers supplemental safety study in

1-through-3-year-olds

to the FDA on November 9, 2023. The Company received comments and queries to the protocol from the FDA on March 11, 2024. Since March, the Company and the FDA have been engaged in ongoing dialogue related to the program. Much of the ongoing dialogue has focused on patch wear-time experience. To address the FDA’s protocol queries, the Company submitted to the FDA on June 28, 2024, a proposed labeling approach, informed by the EPITOPE efficacy data. The proposed labeling approach focuses on the user experience during the first 90 days on treatment. The Company is awaiting feedback on the labeling proposal following FDA review.

Viaskin Peanut for Children ages

4-7

On September 7, 2022, the Company announced the initiation of VITESSE, a Phase 3 pivotal study of the mVP in children ages

4-7

years with peanut allergy. The Company defined initiation as the submission of the trial protocol to selected study sites for subsequent Institutional Review Board (IRB)/Ethics Committee (EC) approval.

On September 21, 2022, the Company announced it received from the FDA a partial clinical hold letter related to certain design elements of VITESSE. The Company announced on December 23, 2022 that the FDA lifted the partial clinical hold. The FDA confirmed the Company satisfactorily addressed all clinical hold issues and the VITESSE phase 3 clinical study could proceed with the revised trial protocol. On March 7, 2023, the Company announced that the first patient was screened in the VITESSE trial. Screening of the last subject is anticipated by the end of the third quarter of 2024.

In July 2023, the Company received Type C Meeting Written Responses from the FDA regarding key study design elements for COMFORT Children. Subsequently, in October 2023, the Company received feedback from the FDA addressing the remaining protocol design elements for COMFORT Children. This feedback included language simplification for how Viaskin should be used.

The Company submitted the protocol for its COMFORT Children supplemental safety study in

4-through-7-year-olds

to the FDA on November 29, 2023 and, as of the date of this filing, the Company is still awaiting feedback from FDA. The Company anticipates that the COMFORT Children safety study will enroll peanut allergic children ages 4 –

7-years

and anticipates the safety study will support the efficacy results from the ongoing VITESSE phase 3 pivotal study. Furthermore, the Company anticipates that the key inclusion criteria for the COMFORT Children study will be based on a physician-diagnosed peanut allergy, peanut-specific IgE and a Skin Prick Test (with no requirement for a DBPCFC). COMFORT Children is anticipated to be initiated towards the end of VITESSE enrollment.

ADS Ratio Change & NASDAQ listing market change

On May 31st 2024, the Company announced plans to change the ratio of its American Depositary Shares (“ADSs”) to its ordinary shares (the “ADS Ratio”), nominal value €0.10 (ten cents) per share, from the current ADS Ratio of one (1) ADS to

one-half

(1/2) of one (1) ordinary share to a new ADS Ratio of one (1) ADS to one (1) ordinary share (the “ADS Ratio Change”). The ADS Ratio Change was effective on June 7, 2024 (the “Effective Date”).

For the Company’s ADS holders, the change in the ADS Ratio had the same effect as a

one-for-two

reverse ADS split and was intended to enable the Company to regain compliance with the Nasdaq minimum bid price requirement. On the Effective Date, registered holders of company ADSs held in certificated form were required on a mandatory basis to surrender their certificated ADSs to the depositary bank for cancellation and received one (1) new ADS in exchange for every two existing ADSs surrendered. The exchange of every two existing ADSs then-held for one (1) new ADS occurred automatically, at the Effective Date, with the then-held ADSs being cancelled and new ADSs being issued by the depositary bank. DBV’s ADSs continued to be traded on the Nasdaq Stock Market under the ticker symbol “DBVT.

No fractional new ADSs were issued in connection with the ADS Ratio Change. Instead, fractional entitlements to new ADSs were aggregated and sold by the depositary bank and the net cash proceeds from the sale of the fractional ADS entitlements (after deduction of fees, taxes and expenses) were distributed to the applicable ADS holders by the depositary bank. The ADS Ratio Change had no impact on DBV’s underlying ordinary shares, and no ordinary shares were issued or cancelled in connection with the ADS Ratio Change.

In addition, to obtain an additional 180 days period to regain compliance with the NASDAQ minimum bid price requirement, the Company applied to transfer its securities from the NASDAQ Global Select Market to the NASDAQ Capital Market (the “NCM”). On June 18, 2024, the Company was notified by the Listing Qualifications Department that NASDAQ granted the Company’s request to transfer the listing of its ADSs from the NASDAQ Global Select Market tier to the NCM tier, and that NASDAQ granted the Company’s request for a second

180-day

period, or until December 16, 2024, to regain compliance with the $1.00 bid price requirement. The Company’s ADSs were transferred to the NCM at the opening of business on June 20, 2024.

Legal Proceedings

From time to time, the Company ma

y

become subject to various legal proceedings and claims that arise in the ordinary course of our business activities. The Company is not currently subject to any material legal proceedings.

Note 3: Cash and Cash Equivalents

The following tables summarize the cash and cash equivalents as of June 30, 2024 and December 31, 2023:

Cash equivalents are convertible into cash on 32 days notice at no or insignificant cost, on demand. They are measured using level 1 fair value measurements.

Note 4: Other Current Assets

Other current assets consisted of the following:

Research tax credit

The variance in Research Tax Credit is presented as follows:

Before currency translation effect, the balance in research tax credit as of June 30, 2024, consisted of $8.9 million research tax credit for the previous fiscal year filed with the tax authorities and yet to be reimbursed, and $2.6 million estimated research tax credit for the first six months of the 2024 fiscal year.

The other tax claims are primarily related to the VAT as well as the reimbursement of VAT that has been requested. Prepaid expenses are comprised primarily of insurance expenses, as well as legal and scientific consulting fees.

Prepaid expenses include $2.2 million relating to the Services Agreement entered by the Company with Fareva La Vallee, dated March 18, 2024, for the construction of a manufacturing line by Fareva La Vallee for the production and supply of peanut source material for the Company.

Note 5: Lease contracts

Future minimum lease payments under the Company’s operating leases’ right of use as of June 30, 2024 and December 31, 2023, are as follows:

The increase in $1.7 million dollars in lease obligations due over 1 year results from the new US headquarter lease.

The Company recognizes rent expense, calculated as the remaining cost of the lease allocated over the remaining lease term on a straight-line basis. Rent expense presented in the consolidated statement of operations and comprehensive loss was:

Supplemental cash flow information related to operating leases is as follows for the period June 30, 2024 and 2023:

Note 6: Trade Payables and Other Current Liabilities

6.1 Trade Payables

Trade payables decreased by $3.5 million as of June 30, 2024, compared to December 31, 2023.

No discounting was performed on the trade payables to the extent that the amounts did not present payment terms longer than one year at the end of each fiscal period presented.

6.2 Other Current Liabilities

The following tables summarize the other current liabilities as of June 30, 2024 and December 31, 2023:

The Employee related liabilities includes short-term debt to employees including social welfare, tax agency obligations and bonus provision. The variance versus year end is due to bonus accruals.

Note 7: Shareholders’ equity

The share capital as of June 30, 2024 is set at the sum of €9,649,308 ($10,978

thousand converted

at historical rates). It is divided into 96,493,078 fully authorized, subscribed and

paid-up

ordinary shares with a par value of €0.10.

Pursuant to the authorization granted by the General Meeting of the Shareholders held on May 16, 2024 (the “SH General Meeting”), the accumulated net losses of DBV Technologies S.A. after appropriation of the net result for the year ended December 31, 2023, have been allocated to additional

paid-in

capita

l

.

Note 8: Share-Based Payments

The Board of Directors has been authorized at the General Meeting of the Shareholders to grant restricted stock units (“RSU”), stock options plan (“SO”), and

non-employee

warrants (

Bons de Souscription d’Actions

or “BSA”).

During the six months ended June 30, 2024, the Company granted 534,000 stock options and 124,000 restricted stock units to employees. There have been no changes in the vesting conditions and method of valuation of the SO and RSUs from that disclosed in Note 12 to the consolidated financial statements included in the Annual Report.

Change in Number of BSA/SO/RSU:

Share-based payments expense reflected in the condensed consolidated statements of operations is as follows:

Note 9: Contingencies

The following tables summarize the contingencies as of June 30, 2024 and December 31, 2023:

The changes in contingencies are as follows:

In May 2026, the Company entered into a Development Collaboration and License Agreement (the “Collaboration Agreement”) with Societe des Produits Nestle S.A. (formerly, NESTEC S.A.) (“NESTEC”) under which the COmpany was responsible for leading the development activities of MAG1C up through a pivotal phase 3 clinical program. On October 30, 2023, the Company signed a Mutual Termination Letter Agreement with NESTEC terminating the Collaboration Agreement (the “Collaboration Agreement”) between the parties. As of June 30, 2024, the accrual for ongoing Clinical study completion totals $0.9 million as compated to $2.1 million as of December 31, 2023 representing our best estimate of the remaining expenses related to the ongoing clinical study.

An amount of $1.8 million reserved for the refurbishment of the previous Montrouge offices was reversed in the second quarter of 2024.

The Company does not hold any plan assets related to long-term employee benefit for any of the periods presented. There have been no significant changes in assumptions for the estimation of the retirement commitments from those disclosed in Note 13 to the consolidated financial statements included in the Annual Report.

Note 10: Operating income

The following table summarizes the operating income during the three and six months ended June 30, 2024 and 2023:

Until the end of 2023, our operating income was composed of both the French Research tax credit (Crédit d’Impôt Recherche, or “CIR”) and the revenue recognized under the Collaboration Agreement with NESTEC. Following the termination of the Collaboration Agreement on October 30, 2023, our operating income is now exclusively generated by the French research tax credit.

The decrease in Research tax credit was primarily due to the fact that a greater proportion of studies activities were carried out in North America and were therefore not eligible to the French Research tax credit.

Note 11: Operating Expenses

The Company had an average of 106 employees during the six months ended June 30, 2024, in comparison with an average of 88 employees during the six months ended June 30, 2023. The increase is mainly due to hiring to support development activities and quality activities.

The following table summarizes the allocation of personnel expenses by function during the three and six months ended June 30, 2024 and 2023:

The following table summarizes the allocation of personnel expenses by nature during the three and six months ended June 30, 2024 and 2023:

The increase in personnel expenses is due to the recruitment of internal resources mostly based in North America to support development activ

it

ies.

Note 12: Commitments

There wereno significant changes in other commitments from those disclosed in Note 17 to the consolidated financial statements included in the Annual Report.

Note 13: Relationships with Related Parties

There wereno new significant related-party transactions during the period nor any changes in the nature of the transactions from those described in Note 18 to the consolidated financial statements included in the Annual Report.

Note 14: Loss Per Share

Basic loss per share is calculated by dividing the net loss attributable to the shareholders of the Company by the weighted average number of ordinary shares outstanding during the period. As the Company was in a loss position for each of the three- and

six-month

periods ended June 30, 2024 and 2023, the diluted loss per share is equal to basic loss per share because the effects of potentially dilutive shares were anti-dilutive as a result of the Company’s net loss.

The following is a summary of the ordinary share equivalents that were excluded from the calculation of diluted net loss per share for each of the three and six months ended June 30, 2024 and 2023 indicated in number of potential shares:

Note 15: Events after the Close of the Period

The Company evaluated subsequent events that occurred after June 30, 2024, through the date the condensed consolidated financial statements were issued after their approval by the Board of Directors on July 30, 2024, and determined that there are no significant events that require adjustments or disclosure in such condensed consolidated financial statements.