10-Q

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 10-Q

(Mark One)

☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended June 30, 2022

or

☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from                to

Commission file number 001-36697

DBV TECHNOLOGIES S.A.

(Exact name of registrant as specified in its charter)

France	Not applicable
State or other jurisdiction of incorporation or organization	(I.R.S. Employer Identification No.)
177-181 avenue Pierre Brossolette Montrouge France	92120
(Address of principal executive offices)	(Zip Code)

Registrant’s telephone number, including area code +33 1 55 42 78 78

Securities registered pursuant to Section 12(b) of the Act:    

Title of each class	Trading Symbol(s)	Name of each exchange on which registered
American Depositary Shares, each representing one-half of one ordinary share, nominal value €0.10 per share	DBVT	The Nasdaq Stock Market LLC
Ordinary shares, nominal value €0.10 per share*	n/a	The Nasdaq Stock Market LLC

* Not for trading, but only in connection with the registration of the American Depositary Shares.

Securities registered pursuant to section 12(g) of the Act: None.

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.

☒  Yes            ☐  No

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).

☒  Yes            ☐  No

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

Large accelerated filer	☐	Accelerated filer	☐
Non-accelerated filer	☒	Smaller reporting company	☒
		Emerging growth company	☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.   ☐

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Act).    ☐  Yes    ☒  No

As of August 1st, 2022, the registrant had 94,025,192 ordinary shares, nominal value €0.10 per share, outstanding including treasury shares.

Table of contents

Part I	Financial information	3
Item 1	Condensed Consolidated Statements of Financial Position (Unaudited) as of June 30, 2022 and December 31, 2021	3
	Condensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited) for the Three and Six Months Ended June 30, 2022 and 2021	4
	Condensed Consolidated Statements of Cash Flows (Unaudited) for the Six Months Ended June 30, 2022 and 2021	5
	Condensed Consolidated Statements of Changes in Shareholders’ Equity (Unaudited) for the Six Months Ended June 30, 2022 and 2021	6
	Notes to the Condensed Consolidated Financial Statements (Unaudited)	7
Item 2	Management’s Discussion and Analysis of Financial Condition and Results of Operations	19
Item 3	Quantitative and Qualitative Disclosures About Market Risk	28
Item 4	Controls and Procedures	29
Part II	Other Information	30
Item 1	Legal Proceedings	30
Item 1A	Risk Factors	30
Item 2	Unregistered Sales of Equity Securities and Use of Proceeds	30
Item 3	Defaults Upon Senior Securities	31
Item 4	Mine Safety Disclosures	31
Item 5	Other Information	31
Item 6	Exhibits	32

Unless the context otherwise requires, we use the terms “DBV”, “DBV Technologies,” the “Company,” “we,” “us” and “our” in this Quarterly Report on Form 10-Q, or Quarterly Report, to refer to DBV Technologies S.A. and, where appropriate, its consolidated subsidiaries. “Viaskin™”, “EPIT™” and our other registered and common law trade names, trademarks and service marks are the property of DBV Technologies S.A. or our subsidiaries. All other trademarks, trade names and service marks appearing in this Quarterly Report are the property of their respective owners. Solely for convenience, the trademarks and trade names in this Quarterly Report may be referred to without the ® and ™ symbols, but such references should not be construed as any indicator that their respective owners will not assert their rights thereto.

SPECIAL NOTE REGARDING FORWARD LOOKING STATEMENTS.

This Quarterly Report contains forward-looking statements which are made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended or Securities Act, and Section 21E of the Securities Exchange Act of 1934, as amended, or Exchange Act. These statements may be identified by such forward-looking terminology as “may,” “should,” “expects,” “intends,” “plans,” “anticipates,” “believes,” “estimates,” “predicts,” “potential,” “continue” or variations of these words or similar expressions that are intended to identify forward-looking statements, although not all forward-looking statements contain these words. Any forward-looking statement involves known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to differ materially from any future results, levels of activity, performance or achievements expressed or implied by such forward-looking statement. Forward-looking statements include statements, other than statements of historical fact, about, among other things:

• the impact of the ongoing COVID-19 pandemic, including the emergence of new variant strains of COVID-19, and its effects on our operations, research and development, clinical trials and ability to obtain financing and potential disruption in the operations and business of third-party manufacturers, contract research organizations, or CROs, other service providers and collaborators with whom we conduct business;

• our expectations regarding the timing or likelihood of regulatory filings and approvals, including with respect to our anticipated re-submission of a Biologics License Application, or a BLA, for ViaskinTM Peanut to the U.S. Food and Drug Administration, or the FDA;

• the initiation, timing, progress and results of our pre-clinical studies and clinical trials, and our research and development programs;

• our business model and our other strategic plans for our business, product candidates and technology;

• our ability to manufacture clinical and commercial supplies of our product candidates and comply with regulatory requirements related to the manufacturing of our product candidates;

• our ability to build our own sales and marketing capabilities, or seek collaborative partners, to commercialize Viaskin Peanut and/or our other product candidates, if approved;

• the commercialization of our product candidates, if approved;

• our expectations regarding the potential market size and the size of the patient populations for Viaskin Peanut and/or our other product candidates, if approved, and our ability to serve such markets;

• the pricing and reimbursement of our product candidates, if approved;

• the rate and degree of market acceptance of Viaskin Peanut and/or our other product candidates, if approved, by physicians, patients, third-party payors and others in the medical community;

• our ability to advance product candidates into, and successfully complete, clinical trials;

• the scope of protection we are able to establish and maintain for intellectual property rights covering our product candidates and technology;

• estimates of our expenses, future revenues, capital requirements and our needs for additional financing;

• the potential benefits of strategic collaboration agreements and our ability to enter into strategic arrangements;

• our ability to maintain and establish collaborations or obtain additional grant funding;

• our financial performance; and

• other risks and uncertainties, including those listed under the caption “Risk Factors.”

1

Although we believe that we have a reasonable basis for each forward-looking statement contained in this Quarterly Report, these statements are based on our estimates or projections of the future that are subject to known and unknown risks and uncertainties and other important factors that may cause our actual results, level of activity, performance, experience or achievements to differ materially from those expressed or implied by any forward-looking statement. These risks, uncertainties and other factors are described in greater detail under the caption “Risk Factors” in Part I. Item 1A of our Annual Report on Form 10-K for the year ended December 31, 2021, filed with the Securities and Exchange Commission, or the SEC on March 9, 2022. Additional information is also included on our Current Report on Form 8-K, filed with the SEC on June 13, 2022. As a result of the risks and uncertainties, the results or events indicated by the forward-looking statements may not occur. Undue reliance should not be placed on any forward-looking statement. We qualify all of our forward-looking statements by these cautionary statements.

In addition, any forward-looking statement in this Quarterly Report, including statements that “we believe” and similar statements, reflect our beliefs and opinions on the relevant subject and represents our views only as of the date of this Quarterly Report and should not be relied upon as representing our views as of any subsequent date. These statements are based upon information available to us as of the date of this Quarterly Report and while we believe such information forms a reasonable basis for such statements, such information may be limited or incomplete, and our statements should not be read to indicate that we have conducted an exhaustive inquiry into, or review of, all potentially available relevant information. These statements are inherently uncertain and you are cautioned not to unduly rely upon these statements. We anticipate that subsequent events and developments may cause our views to change. Although we may elect to update these forward-looking statements publicly at some point in the future, we specifically disclaim any obligation to do so, except as required by applicable law. Our forward-looking statements do not reflect the potential impact of any future acquisitions, mergers, dispositions, joint ventures or investments we may make.

2

Part I – Financial Information

Item 1. Financial Statements

DBV Technologies S.A.

Condensed Consolidated Statements of Financial Position (unaudited)

(amounts in thousands, except share and per share data)

		June 30,			December 31,
	Note	2022			2021
Assets
Current assets:
Cash and cash equivalents	3	$	247,971		$	77,301
Other current assets	4		11,981			37,085
Total current assets			259,953			114,386
Property, plant, and equipment, net			15,677			18,146
Right-of-use assets related to operating leases	5		3,146			7,336
Intangible assets			14			22
Other non-current assets			6,189			6,833
Total non-current assets			25,025			32,338
Total Assets		$	284,978		$	146,723
Liabilities and shareholders’ equity
Current liabilities:
Trade payables	6	$	16,341		$	11,429
Short-term operating leases	5		1,968			3,003
Short-term financial debt			156			510
Current contingencies	9		3,189			4,095
Other current liabilities	6		8,778			12,361
Total current liabilities			30,431			31,397
Long-term operating leases	5		1,945			7,147
Non-current contingencies	9		6,421			6,758
Other non-current liabilities	6		1,764			2,147
Total non-current liabilities			10,130			16,052
Total Liabilities		$	40,562		$	47,449
Shareholders’ equity:
Ordinary shares, €0.10 par value; 94,022,679 and 55,095,762 shares authorized, and issued as at June 30, 2022 and December 31, 2021, respectively		$	10,708		$	6,538
Additional paid-in capital			456,447			358,115
Treasury stock, 106,287 and 153,631 ordinary shares as of June 30, 2022 and December 31, 2021, respectively, at cost			(953	)		(1,232	)
Accumulated deficit			(203,050	)		(258,528	)
Accumulated other comprehensive income			743			519
Accumulated currency translation effect			(19,480	)		(6,137	)
Total Shareholders’ equity	7	$	244,416		$	99,274
Total Liabilities and Shareholders’ equity		$	284,978		$	146,723

The accompanying notes are an integral part of these condensed consolidated financial statements.

3

DBV Technologies S.A.

Condensed Consolidated Statements of Operations and Comprehensive Loss (unaudited)

(amounts in thousands, except share and per share data)

		Three Months Ended June 30,						Six Months Ended  June 30,
	Note	2022			2021			2022			2021
Operating income	10	$	1,529		$	(1,488	)	$	4,074		$	1,453
Operating expenses
Research and development expenses			(18,611	)		(20,179	)		(30,834	)		(42,343	)
Sales and marketing expenses			(1,037	)		(1,198	)		(1,500	)		(1,927	)
General and administrative expenses			(5,704	)		(8,269	)		(12,334	)		(17,951	)
Total Operating expenses			(25,352	)		(29,646	)		(44,669	)		(62,221	)
Loss from operations			(23,823	)		(31,134	)		(40,595	)		(60,768	)
Financial income			784			46			936			261
Loss before taxes			(23,039	)		(31,088	)		(39,659	)		(60,507	)
Income tax			—			434			(87	)		404
Net loss		$	(23,039	)	$	(30,654	)	$	(39,746	)	$	(60,103	)
Foreign currency translation differences, net of taxes			(11,394	)		2,788			(13,327	)		(5,956	)
Actuarial gains (losses) on employee benefits, net of taxes			200			48			224			(38	)
Total comprehensive loss		$	(34,234	)	$	(27,818	)	$	(52,849	)	$	(66,097	)
Basic/diluted net loss per share attributable to shareholders	14	$	(0.35	)	$	(0.56	)	$	(0.66	)	$	(1.09	)
Weighted average shares outstanding used in computing per share amounts:			66,047,949			54,904,764			60,490,075			54,892,794

The accompanying notes are an integral part of these condensed consolidated financial statements.

4

DBV Technologies S.A.

Condensed Consolidated Statements of Cash Flows (unaudited)

(amounts in thousands)

		Six Months  Ended June 30,
	Notes	2022			2021
Net loss for the period		$	(39,746	)	$	(60,103	)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation, amortization and accrued contingencies			1,249			8,619
Retirement pension obligations			14			57
Expenses related to share-based payments	8		2,441			2,527
Other elements			(3	)		(843	)
Changes in operating assets and liabilities:
Decrease (increase) in trade receivables			—			2,175
Decrease (increase) in other current assets			23,436			(8,393	)
(Decrease) increase in trade payables			5,894			(3,165	)
(Decrease) increase in other current and non-current liabilities			(3,040	)		(6,608	)
Change in operating lease liabilities and right of use assets			(1,979	)		(769	)
Net cash flow used in operating activities			(11,733	)		(66,503	)
Cash flows used in investing activities:
Acquisitions of property, plant, and equipment, net from proceeds			(369	)		(13	)
Proceeds from property, plant, and equipment dispositions			3			—
Acquisitions of non-current financial assets			(279	)		—
Proceeds from non-current financial assets			426			—
Net cash flows used in investing activities			(218	)		(13	)
Cash flows provided by financing activities:
Decrease in conditional advances			(328	)		(345	)
Treasury shares			279			638
Capital increases, net of transaction costs			195,270			794
Other cash flows related to financing activities			—			(17	)
Net cash flows provided by financing activities			195,221			1,071
Effect of exchange rate changes on cash and cash equivalents			(12,600	)		(5,423	)
Net increase (decrease) in cash and cash equivalents			170,670			(70,868	)
Net Cash and cash equivalents at the beginning of the period			77,301			196,352
Net cash and cash equivalents at the end of the period	3	$	247,971		$	125,484

The accompanying notes are an integral part of these condensed consolidated financial statements.

5

DBV Technologies S.A.

Condensed Consolidated Statements of Changes in Shareholders’ Equity (unaudited)

(amounts in thousands, except share and per share data)

	Ordinary shares
	Number of Shares		Amount		Additional paid-in capital			Treasury stock			Accumulated deficit			Accumulated other comprehensive income (loss)			Accumulated currency translation effect			Total Shareholders’ Equity
Balance at January 1, 2021		54,929,187	$	6,518	$	1,152,042		$	(1,169	)	$	(958,543	)	$	484		$	6,158		$	205,491
Net (loss)		—		—		—			—			(29,449	)		—			—			(29,449	)
Other comprehensive loss		—		—		—			—			—			(85	)		(8,744	)		(8,829	)
Issuance of ordinary shares		7,500		1		42			—			—			—			—			42
Treasury shares		—		—		—			488			—			—			—			488
Share-based payments		—		—		1,433			—			—			—			—			1,433
Balance at March 31, 2021		54,936,687	$	6,519	$	1,153,516		$	(681	)	$	(987,992	)	$	399		$	(2,586	)	$	169,176
Net (loss)		—		—		—			—			(30,654	)		—			—			(30,654	)
Other comprehensive income		—		—		—			—			—			48			2,788			2,836
Issuance of ordinary shares		75,000		9		464			—			—			—			—			473
Insuance of warrants						279															279
Treasury shares		—		—					(185	)		—			—			—			(185	)
Share-based payments		—		—		1,094						—			—			—			1,094
Allocation of accumulated net losses		—		—		(797,823	)		—			797,823			—			—			—
Balance at June 30, 2021		55,011,687	$	6,529	$	357,530		$	(866	)	$	(220,823	)	$	446		$	203		$	143,019

	Ordinary shares
	Number of Shares		Amount		Additional paid-in capital			Treasury stock			Accumulated deficit			Accumulated other comprehensive income (loss)		Accumulated currency translation effect			Total Shareholders’ Equity
Balance at January 1, 2022		55,095,762	$	6,538	$	358,115		$	(1,232	)	$	(258,528	)	$	519	$	(6,137	)	$	99,274
Net (loss)		—		—		—			—			(16,706	)		—		—			(16,706	)
Other comprehensive loss		—		—		—			—			—			24		(1,933	)		(1,909	)
Insuance of ordinary shares		775		1		—			—			—			—		—			1
Treasury shares		—		—		—			40			—			—		—			40
Share-based payments		—		—		1,363			—			—			—		—			1,363
Other changes		—		—		—			—			15					(15	)		—
Balance at March 31, 2022		55,096,537	$	6,539	$	359,478		$	(1,193	)	$	(275,219	)	$	543	$	(8,086	)	$	82,062
Net (loss)		—		—		—			—			(23,039	)		—		—			(23,039	)
Other comprehensive loss		—		—		—			—			—			200		(11,394	)		(11,194	)
Issuance of ordinary shares		38,926,142		4,170		103,007			—			—			—		—			107,176
Issuance of warrants		—		—		88,094			—			—			—		—			88,094
Treasury shares		—		—		—			240			—			—		—			240
Share-based payments		—		—		1,078			—			—			—		—			1,078
Allocation of accumulated net losses		—		—		(95,209	)		—			95,209			—		—			—
Balance at June 30, 2022		94,022,679	$	10,708	$	456,447		$	(953	)	$	(203,050	)	$	743	$	(19,480	)	$	244,416

The accompanying notes are an integral part of these condensed consolidated financial statements.

6

NOTES TO THE FINANCIAL STATEMENTS (UNAUDITED)

Note 1: The Company

Incorporated in 2002 under the laws of France, DBV Technologies S.A. (“DBV Technologies,” or the “Company”, or the “group”) 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 9, 2022 (the “Annual Report”). The condensed consolidated statement of financial position at December 31, 2021 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, 2021.

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, 2022, 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 development activities conducted as part 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, and (7) estimate of contingencies.

Accounting Pronouncements adopted in 2022

The Company has not adopted any new accounting pronouncements in 2022 to date.

Accounting Pronouncements issued not yet adopted

In June 2016, the Financial Accounting Standards Board (“FASB”) issued ASU 2016-13—Financial Instruments—Credit losses, which replaces the incurred loss impairment methodology for financial instruments in current U.S. GAAP with a methodology that reflects expected credit losses and requires consideration of a broader range of reasonable and supportable information to inform credit loss estimates. The FASB has issued ASU 2019-10 which has resulted in the postponement of the effective date of the new guidance for eligible smaller reporting companies to the fiscal year beginning January 1, 2023. The guidance must be adopted using a modified-retrospective approach and a prospective transition approach is required for debt securities for which an other-than-temporary impairment had been recognized before the effective date. The Company is currently evaluating the impact of the guidance on its Consolidated Financial Statements. The Company does not expect this new standard will 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.

7

Note 2: Significant Events and Transactions

Clinical programs

ViaskinTM Peanut for children ages 4-11 in the United States

In January 2021, the Company received written responses from the FDA to questions provided in the Type A meeting request the Company submitted in October 2020 following the Complete Response Letter received in August 2020. The FDA agreed with its 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 order to confirm the consistency of efficacy data between the existing and a modified patch, FDA requested an assessment comparing the uptake of allergen (peanut protein) between the patches in peanut allergic children ages 4-11. The Company named that assessment EQUAL, which stands for Equivalence in Uptake of ALlergen. The FDA also recommended conducting a 6-month, well-controlled safety and adhesion trial to assess a modified Viaskin Peanut patch in the intended patient population. The Company later named this study STAMP, which stands for Safety, Tolerability, and Adhesion of Modified Patches.

Based on the January 2021 FDA feedback, the Company defined three parallel workstreams:

1. Identify a modified Viaskin patch (which the Company calls mVP).

2. Generate the 6-month safety and adhesion clinical data FDA requested via STAMP, which the Company expected to be the longest component of the mVP clinical plan. The Company prioritized the STAMP protocol submission so the Company could begin the study as soon as possible.

3. Demonstrate the equivalence in allergen uptake between the current and modified patches in the intended patient population via EQUAL. The complexity of EQUAL hinged on the lack of established clinical and regulatory criteria to characterize allergen uptake via an epicutaneous patch. To support those exchanges, the Company outlined its proposed approach to demonstrate allergen uptake equivalence between the two patches, and allotted time to generate informative data through two additional studies:

a. PREQUAL, a Phase I study with adult healthy volunteers to optimize the allergen sample collection methodologies and validate the assays we intend to use in EQUAL

b. ‘EQUAL in adults’—a second Phase I study with adult healthy volunteers to compare the allergen uptake of cVP and Mvp;

In March 2021, the Company commenced CHAMP (Comparison of adHesion Among Modified Patches), a trial in healthy adult volunteers to evaluate the adhesion of five modified Viaskin Peanut patches, to identify the one or two best-performing patches, which the Company completed in the second quarter of 2021. Based on the adhesion parameters studied, the Company selected the modified patch to advance to further clinical testing in the intended patient population. All modified Viaskin Peanut patches demonstrated better adhesion performance as compared to the then-current Viaskin Peanut patch, and the Company then selected two modified patches that performed best out of the five modified patches studied for further development. The Company then 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 its proposed STAMP protocol to the FDA, and in October 2021, the Company received an Advice/Information Request letter from the FDA. In this letter, the FDA requested a stepwise approach to the modified Viaskin patch development program and provided partial feedback on the STAMP protocol. Specifically, the FDA requested that the Company conduct allergen uptake comparison studies (i.e., ‘EQUAL in Adults’, EQUAL), and submit the allergen uptake comparison data for FDA review and feedback prior to starting the STAMP study.

After careful review of the FDA’s information requests, in December 2021, the Company decided not to pursue the stepwise approach to the development plans for Viaskin Peanut as requested by the FDA in the October 2021 letter. The Company estimated that the FDA’s newly proposed stepwise approach would require at least five rounds of exchanges that necessitate FDA alignment prior to initiating STAMP, the 6-month safety and adhesion study. As such, in December 2021, the Company announced its plan to initiate a pivotal Phase III placebo-controlled efficacy trial for a modified Viaskin Peanut patch (mVP) in children in the intended patient population. The clinical trial will also include updates to the Instructions for Use (IFU). The Company considers this approach the most straightforward to potentially demonstrate effectiveness, safety, and improved in vivo adhesion of the modified Viaskin Peanut system. The FDA confirmed the Company’s change in strategy is agreeable via oral and written exchanges.

8

The new Phase 3 pivotal study for modified Viaskin Peanut has been named VITESSE (Viaskin Peanut Immunotherapy Trial to Evaluate Safety, Simplicity and Efficacy), which means “speed” in French.

In May 2022, the Company announced that the FDA granted it a Type C meeting to align on the protocol and the study protocol was submitted to the FDA as part of the the Type C meeting briefing package. DBV continues to engage in productive dialogue with the FDA on the key elements of the VITESSE protocol. As previously disclosed, the Company will communicate key elements of the VITESSE trial design and projected timelines once this process has concluded.

Viaskin Peanut for children ages 4-11—European Union Regulatory History and Current Status

In August 2021, the Company announced its receipt from the EMA of the Day 180 list of outstanding issues, which is an established part of the prescribed EMA review process. It is a letter that is meant to include any remaining questions or objections at that stage in the process. The EMA indicated many of their objections and major objections from the Day 120 list of questions had been answered. One major objection remained at Day 180. The Major Objection questioned the limitations of the data, for example, the clinical relevance and effect size supported by a single pivotal study.

In December 2021, the Company announced it has withdrawn the Marketing Authorization Application for Viaskin Peanut and formally notified the EMA of our decision. The initial filing was supported by positive data from a single, placebo-controlled Phase 3 pivotal trial known as PEPITES (V712-301). The decision to withdraw was based on the view of EMA Committee for Medicinal Products for Human Use (CHMP) that the data available to date from a single pivotal study were not sufficient to preclude a Major Objection at Day 180 in the review cycle. The Company believes data from a second Viaskin Peanut pivotal study 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, patients 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 validate the ongoing investigation of the 250 Pg dose in this age group, which is the dose being studied in Part B of the study. Enrollment for Part B of EPITOPE was completed in the first quarter of 2022.

In June 2022, the Company announced that its pivotal Phase III trial EPITOPE, assessing the safety and efficacy of Viaskin™ Peanut 250 µg for the treatment of peanut-allergic toddlers ages 1 to 3 years, met its primary endpoint. Viaskin Peanut demonstrated a statistically significant treatment effect (p<0.001), with 67.0% of subjects in the Viaskin Peanut arm meeting the treatment responder criteria after 12 months, as compared to 33.5% of subjects in the placebo arm (difference in response rates = 33.4 %, 95 % CI = 22.4% - 44.5 %).

DBV intends to further analyze the data from EPITOPE and explore regulatory pathways for Viaskin Peanut in children ages 1 to 3 years, given the high unmet need and absence of approved treatments for this vulnerable population.

Financing

In May 2022, the Company announced that pursuant to the Company’s At-The-Market program established in May 2022 (the “ATM Program”), it had issued and completed sales of new ordinary shares (the “Ordinary Shares”) in form of American Depositary Shares (“ADSs”), for a total gross amount of $15.3 million. In this context, 6,036,238 new Ordinary Shares in form of ADS have been issued through a capital increase without preferential subscription rights of the shareholders reserved to specific categories of persons fulfilling certain characteristics (the “ATM Issuance”), at a unit subscription price of 1.27 dollar per ADS (i.e., a subscription price per Ordinary Share of 2.41 euro based on the USD/EUR exchange rate of 1.0531 dollar for 1 euro, as published by the European Central Bank on May 4, 2022) and each ADS giving the right to receive one-half of one ordinary share of the Company).

In June 2022, the Company announced an aggregate $194 million private investment in public equity (PIPE) financing (corresponding to €181 million on the basis of an exchange rate of $1.0739 = €1.00 published by the European Central Bank on June 8, 2022) from the sale of 32,855,669 ordinary shares, as well as pre-funded warrants to purchase up to 28,276,331 ordinary shares. The ordinary shares were sold to the purchasers at a price per ordinary share of €3.00 (corresponding to $3.22), and the pre-funded warrants were sold to the purchasers at a pre-funded price of €2.90 (corresponding to $3.11) per pre-funded warrant, which equals the per share price for the ordinary shares less the remaining €0.10 exercise price for each such pre-funded warrant. Gross proceeds from the PIPE financing total approximately $194 million (corresponding to €181 million), before deducting private placement expenses.

The ordinary shares, including the ordinary shares issuable upon exercise of the pre-funded warrants from the PIPE financing, have not been registered under the Securities Act of 1933, as amended, and may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements. The Company has agreed to file a registration statement with the Securities and Exchange Commission registering the resale of the ordinary shares, including the ordinary shares underlying the pre-funded warrants. 

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Following the financing operations carried out in the first half of 2022, the Company has cash and cash equivalent to support the Company’s operations several months beyond the projected completion of VITESSE, the planned Phase 3 clinical study of the modified Viaskin™ Peanut patch in peanut allergic children ages 4 years and older.

COVID-19 Pandemic

On March 11, 2020, the World Health Organization declared COVID-19 a pandemic. This global health crisis led many countries to impose national containment measures and travel bans. In view of this exceptional situation, the Company decided to take all measures aimed primarily at guaranteeing the safety of its employees and the continuation of ongoing clinical trials, in compliance with the directives of the authorities in each country. The Company has experienced a decrease in new patients enrolling in the ongoing clinical studies and it has had to adapt the protocols of its clinical trials because patients remain subject to travel restrictions.

The Company has assessed the impact of the uncertainties created by the pandemic. As of June 30, 2022, those uncertainties were taken into account in the assumptions underlying the estimates and judgments used by the Company. The Company continues to update these estimates and assumptions as the situation evolves. The effects of the COVID-19 pandemic are presented in the relevant line items of the condensed consolidated statement of financial position and the condensed consolidated statement of operations according to the function or nature of the income or expense.

Legal Proceedings

A class action complaint was filed on January 15, 2019 in the United States District Court for the District of New Jersey, entitled Travis Ito-Stone v. DBV Technologies, et al., Case No. 2:19-cv-00525. The complaint alleged that the Company and its former Chief Executive Officer, its current Chief Executive Officer, and its former Deputy Chief Executive Officer violated certain federal securities laws, specifically under Sections 10(b) and 20(a) of the Exchange Act, and Rule 10b-5 promulgated thereunder. The plaintiffs seek unspecified damages on behalf of a purported class of purchasers of the Company’s securities between February 14, 2018 and August 4, 2020 and also held the Company’s securities on December 20, 2018 and/or March 16, 2020 and/or August 4, 2020.

A hearing was held on July 29, 2021 in the U.S. District Court for the District of New Jersey where the Court entered an order granting the Company’s Motion to Dismiss the Second Amended Class Action Complaint without prejudice. As the dismissal was without prejudice, the Plaintiffs replead their case by filing a Third Amended Class Action Complaint on September 30, 2021 in the same Court. The company moved to dismiss third amended complaint on December 10, 2021.

On July 29, 2022 the Court entered an order granting the Company’s Motion to Dismiss the Plaintiff’s Third Amended Complaint with prejudice. The Court indicated that the Third Amended Complaint was deficient in a number of ways, failing to allege a violation of the Securities Exchange Act of 1934, and ordered the matter closed. Per court procedural rules, the Plaintiffs have 30 days to appeal the dismissal of the Third Amended.

The Company believes that the allegations contained in the amended complaint are without merit and will continue to defend the case vigorously. The Company believes this complaint will not have a material adverse effect on the Company’s consolidated financial position, results of operations or liquidity.

Note 3: Cash and Cash Equivalents

The following tables summarize the cash and cash equivalents as of June 30, 2022 and December 31, 2021:

	June 30,		December 31,
	2022		2021
Cash		226,674		31,427
Cash equivalents		21,298		45,874
Total cash and cash equivalents as reported in the statements of financial position		247,971		77,301

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

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Note 4 Other Current Assets

Other current assets consisted of the following:

	June 30,		December 31,
	2022		2021
Research tax credit		2,908		28,092
Other tax claims		4,339		3,561
Prepaid expenses		3,773		4,149
Other receivables		961		1,283
Total		11,981		37,085

Research tax credit

In the fiscal year ended December 31, 2021, the Company recovered its Small and Medium-sized Enterprises, or SMEs, status under EU law, and became therefore eligible again for the immediate reimbursement of the Research Tax Credit.

During the six months period ended June 30, 2022, the Company received the reimbursement of the 2019, 2020 and 2021 fiscal year research tax credit.

The variance in Research Tax Credit is presented as follows:

	Amount in thousands of US Dollars
Opening research tax credit receivable as of January 1, 2022		28,092
+ Operating revenue		3,060
- Payment received		(27,119	)
- Adjustment and currency translation effect		(1,125	)
Closing research tax credit receivable as of June 30, 2022		2,908
Of which - Non-current portion		—
Of which - Current portion		2,908

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 also include upfront payments which are recognized over the term of the ongoing clinical studies.

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Note 5 Lease contracts

Future minimum lease payments under the Company’s operating leases’ right of use as of June 30, 2022 and December 31, 2021, are as follows:

	June 30, 2022									December 31, 2021
	Real estate			Other assets			Total			Real estate			Other assets			Total
Current portion		2,104			50			2,154			3,361			77			3,438
Year 2		1,843			19			1,862			3,124			23			3,147
Year 3		284			11			295			2,299			18			2,317
Year 4		—			—			—			771			1			773
Year 5		—			—			—			790			—			790
Thereafter		—			—			—			1,220			—			1,220
Total minimum lease payments		4,231			80			4,311			11,565			119			11,684
Less: Effects of discounting		(363	)		(6	)		(370	)		(1,526	)		(8	)		(1,534	)
Present value of operating lease		3,868			73			3,941			10,039			111			10,150
Less: current portion		(1,922	)		(46	)		(1,968	)		(2,929	)		(74	)		(3,003	)
Long-term operating lease		1,946			27			1,973			7,110			37			7,147
Weighted average remaining lease term (years)		1.79			—						4.14			2.01
Weighted average discount rate		3.14	%		1.29	%					4.84	%		3.32	%

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:

	June 30,
	2022			2021
Operating lease expense		950		1,698
Net termination impact		(1,657	)	—

In January 2022, the company entered into a termination agreement for its U.S. office in Summit, NJ, following the resizing of its facility use. The Company recognized an income of $1.2 million as of June 30, 2022 due to the early termination of its Summit, NJ lease, offset by the payment of a one-time lump sum early termination fee of $1.5 million.

On March 28, 2022, the Company entered into a binding office lease agreement in New Jersey for a lease term of 3 years and 2 months. The lease commencement was based upon delivery of possession of the premises by the Landlord and occurred on April 1, 2022. Right of use and related lease debt will be recorded starting April 1, 2022 for a gross amount of 0.4 million.

Supplemental cash flow information related to operating leases is as follows for the period June 30, 2022 and 2021:

	June 30,
	2022		2021
Cash paid for amounts included in the measurement of lease liabilities		—	—
Operating cash flows from operating leases		1,079	2,077

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Note 6: Trade Payables and Other Current Liabilities

6.1 Trade Payables

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 Liabilities

The following tables summarize the other liabilities as of June 30, 2022 and December 31, 2021:  

	June 30,						December 31,
	2022						2021
	Other current liabilities		Other non-current liabilities		Total		Other current liabilities		Other non-current liabilities		Total
Employee related liabilities		4,135		77		4,212		6,708		247		6,954
Deferred income		3,012		1,687		4,700		4,146		1,900		6,046
Tax liabilities		400		—		400		182		—		182
Other debts		1,231		—		1,231		1,325		—		1,325
Total		8,778		1,764		10,542		12,361		2,147		14,508

The other current liabilities include short-term debt to employees including social welfare and tax agency obligations.

Deferred income primarily includes deferred income from the collaboration agreement with Nestlé Health Science, which amounted to $4.7 million as of June 30, 2022.

Note 7: Shareholders’ equity

The share capital as of June 30, 2022 is set at the sum of €9,402,268 ($10,708,445 converted at historical rates). It is divided into 94,022,679 fully authorized, subscribed and paid-up shares with a par value of €0.10.

Pursuant to the authorization granted by the General Meeting of the Shareholders held on May 12, 2022 (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, 2021 have been allocated to additional paid-in capital.

Pursuant to the authorization granted by the SH General Meeting, the Board of Directors, at its meeting of June 9, 2022 (the “Board General Meeting”):

• decided, within the framework of the Issuance the principle of a capital increase in cash with cancellation of preferential subscription rights, reserved for categories of persons meeting which set out the characteristics included in the 18th resolution of the Board General Meeting, through the issuance of Ordinary Shares and warrants to subscribe for Ordinary Shares, for a maximum amount of 6,113,200 New Ordinary Shares, corresponding to the maximum issue ceiling under the 22nd resolution of the Board General Meeting;

• granted a number of authorizations for the purpose of carrying out the Issuance;

• sub-delegated its authority to the Chief Executive Officer for the purpose of implementing the financing.

The Chief Executive Officer, acting pursuant to the sub-delegations of authority granted by the Board of Directors of the Company on June 8, 2022, after receiving the favorable opinion of the Pricing Committee established by the Board of Directors, has, on June 9, 2022 :

• decided, making use of the 18th resolution of the Board General Meeting, to proceed with a capital increase in cash with cancellation of preferential subscription rights reserved for categories of investors, in accordance with the Article L. 225-128 of French Commercial Code, an amount of € 3,285,566.90, through the issuance of (i) 32,855,669 New Ordinary Shares, to be

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subscribed in cash at a unit price of €2.90 of share premium) and to be fully paid up at the time of subscription, i.e. a capital increase of a nominal amount of €3,285,566.90 together with a share premium of € 95,281,440.10, i.e. a gross amount of the capital increase of € 98,567,007, and (ii) 28,276,331 prefunded warrants to be subscribed in cash by paying up on the date of issue of € 82,001,359.90 corresponding to the prepayment of the subscription price of the new ordinary shares in the event of exercise of the prefunded warrants,

• decided to set the maximum nominal amount of the capital increase resulting from the full exercise of the prefunded warrants at € 2,827,633.10, by issuing a maximum of 28,276,331 ordinary shares, with a value of € 0.10 to be subscribed in cash at the price of € 0.10 euro (without share premium), and to be fully paid up at the time of subscription, i.e. a capital increase of a maximum nominal amount of € 2,827,633.10 (and a share premium corresponding to the amount of the pre-financed price released in advance at the time of the subscription of the prefunded warrants ), being specified that this amount does not take into account the nominal value of the ordinary shares to be issued in order to preserve the rights of the holders of securities giving access to the capital issued or to be issued, in accordance with the legal and regulatory provisions and the contractual stipulations providing for other cases of adjustment if necessary;

• determined the list of beneficiaries (designated within each of the categories of persons defined in the 18th resolution of the Board General Meeting) and the number of New Ordinary Shares and warrants allocated to each of them under the conditions defined in the 18th resolution of the Board General Meeting beneficiaries under the conditions defined in section 5 of the offering circular relating to the Issue.

The Company has assessed the pre-funded warrants for appropriate equity or liability classification. During this assessment, the Company determined the pre-funded warrants are freestanding instruments that do not meet the definition of a liability pursuant to ASC 480 and do not meet the definition of a derivative pursuant to ASC 815.

The 2022 Warrants are classified as a component of permanent equity because they are freestanding financial instruments that are legally detachable and separately exercisable from the shares of common stock with which they were issued, are immediately exercisable, do not embody an obligation for the Company to repurchase its shares, and permit the holders to receive a fixed number of shares of common stock upon exercise. In addition, the 2022 Warrants do not provide any guarantee of value or return.

Accordingly, the pre-funded warrants are classified as equity and accounted for as a component of additional paid-in capital at the time of issuance.

The changes in number of outstanding prefunded warrants are as follows:

	Prefunded warrants
Balance as of December 31, 2021		—
Granted during the period		28,276,331
Forfeited during the period		—
Exercised/released during the period		—
Expired during the period		—
Balance as of June 30, 2022		28,276,331

Note 8: Share-Based Payments

The Board of Directors has been authorized by the SH General Meeting to grant restricted stock units (“RSU”), stock options plan (“SO”), employee warrants (Bons de Souscription de Parts de Créateur d’Entreprise or “BSPCE”) and non-employee warrants (Bons de Souscription d’Actions or “BSA”).

During the six months ended June 30, 2022, the Company granted 19,000 stock options and 3,200 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 13 to the consolidated financial statements included in the Annual Report.

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Stock option fair value assumptions during the six months ended June 30, 2022
Weighted average share price at grant date in €	2.42
Weighted average expected volatility	92.4	%
Weighted average risk-free interest rate	0.86	%
Weighted average expected term (in years)	6
Dividend yield	—
Weighted average fair value of stock options in €	1.81

Change in Number of BSA/SO/RSU:

	Number of outstanding
	BSA		SO			RSUs
Balance as of December 31, 2021		256,693		3,631,210			1,240,520
Granted during the period		—		19,000			3,200
Forfeited during the period		—		(205,728	)		(66,588	)
Exercised/released during the period		—		(2,125	)		(31,910	)
Expired during the period		—		—			—
Balance as of June 30, 2022		256,693		3,442,358			1,145,223

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

		Three Months Ended June 30,						Six Months Ended June 30,
		2022			2021			2022			2021
Research & development	SO		(290	)		(302	)		(665	)		(678	)
	RSU		(185	)		115			(393	)		(136	)
Sales & marketing	SO		(38	)		(63	)		(33	)		(112	)
	RSU		(17	)		(26	)		(16	)		(48	)
General & administrative	SO		(478	)		(709	)		(1,176	)		(1,353	)
	RSU		(70	)		(110	)		(157	)		(201	)
Total share-based compensation (expense)			(1,078	)		(1,094	)		(2,441	)		(2,527	)

Note 9: Contingencies

The following tables summarize the contingencies as of June 30, 2022 and December 31, 2021:

	June 30,		December 31,
	2022		2021
Current contingencies		3,189		4,095
Non-current contingencies		6,421		6,758
Total contingencies		9,610		10,853

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The changes in contingencies are as follows:

	Pension retirement obligations			Collaboration agreement - Loss at completion			Other contingencies			Total
At January 1, 2022		1,008			9,800			45			10,853
Increases in liabilities		14			—			—			14
Used liabilities		—			(108	)		(44	)		(152	)
Reversals of unused liabilities		—			—			—			—
Net interest related to employee benefits, and unwinding of discount		—			—			—			—
Actuarial gains and losses on defined-benefit plans		(224	)		—			—			(224	)
Currency translation effect		(73	)		(807	)		(2	)		(882	)
At June 30, 2022		725			8,885			—			9,610
Of which Current		—			3,189			—			3,189
Of which Non-current		725			5,696			—			6,421

In 2021 and during the first six months of 2022, the Company updated its measurement of progress of the Phase 2 clinical trial (“PII”) conducted as part of the collaboration and license agreement with Nestlé and updated the cumulative income recognized. The Company has recorded an accrual in the amount of the excess between the Company’s current best estimates of costs yet to be incurred and incomes yet to be recognized for the completion of the PII.

There have been no significant changes in assumptions for the estimation of the retirement commitments from those disclosed in Note 14 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, 2022 and 2021:

	Three Months Ended June 30,					Six Months Ended June 30,
	2022		2021			2022		2021
Research tax credit		1,491		1,870			3,060		3,677
Other operating income		37		(3,358	)		1,014		(2,225	)
Total		1,529		(1,488	)		4,074		1,453

As of June 30, 2022, the Company recorded its collaboration agreement’s revenue based on its updated measurement of progress of the Phase II clinical trial conducted as part of the agreement. The accrual recorded in the amount of the difference between the Company’s current best estimates of costs yet to be incurred and revenues yet to be recognized for the completion of the Phase II clinical trial has been updated accordingly.

Note 11: Allocation of Personnel Expenses

The Company had an average of 87 employees during the six months ended June 30, 2022, in comparison with an average of 111 employees during the six months ended June 30, 2021.

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The following table summarizes the allocation of personnel expenses by function during the three and six months ended June 30, 2022 and 2021:

	Three Months Ended June 30,				Six Months Ended June 30,
	2022		2021		2022		2021
Research and Development expenses		3,097		3,393		6,172		8,111
Sales and Marketing expenses		344		518		589		1,036
General and Administrative expenses		2,767		2,999		5,362		6,765
Total personnel expenses		6,208		6,910		12,123		15,912

The following table summarizes the allocation of personnel expenses by nature during the three six months ended June 30, 2022 and 2021:

	Three Months Ended June 30,				Six Months Ended June 30,
	2022		2021		2022		2021
Wages and salaries		3,509		4,382		7,497		8,836
Social security contributions		1,256		1,064		1,507		2,396
Expenses for pension commitments		211		293		509		695
Employer contribution to bonus shares		154		77		170		1,458
Share-based payments		1,078		1,094		2,441		2,527
Total		6,208		6,910		12,123		15,912

The decrease in personnel expenses is mainly due to a decrease in headcount following the full implementation of the new organization.

Note 12: Commitments

There have been no significant changes in other commitments from those disclosed in Note 18 to the consolidated financial statements included in the Annual Report.

Note 13: Relationships with Related Parties

The Company’s related parties consist exclusively of the members of the Board of Directors and the members of the Executive Committee. As of June 30, 2022, the total amount of remuneration granted to the members of the Board of Directors and Executive Committee has not changed significantly since December 31, 2021.

There were no new significant related-party transactions during the period nor any change in the nature of the transactions from those described in Note 19 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, 2022 and 2021, 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.

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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, 2022 and 2021 indicated in number of potential shares:

	Three Months Ended June 30,				Six Months Ended June 30,
	2022		2021		2022		2021
Non-employee warrants		256,693		256,693		256,693		256,693
Stock options		3,442,358		2,594,410		3,442,358		2,594,410
Restricted stock units		1,145,223		1,092,445		1,145,223		1,092,445
Prefunded warrants		28,276,331		—		28,276,331		—

Note 15: Events after the Close of the Period

As previously disclosed, a class action complaint was filed in January 2019 in the U.S. District Court, District of New Jersey, alleging that the Company and certain current and former executive officers violated certain U.S. federal securities laws. Plaintiffs filed a Third Amended Complaint on September 30, 2021. On July 29, 2022 the Court entered an order granting the Company’s Motion to Dismiss the Plaintiff’s Third Amended Complaint with prejudice. The Court indicated that the Third Amended Complaint was deficient in a number of ways, failing to allege a violation of the Securities Exchange Act of 1934, and ordered the matter closed. Per court procedural rules, the Plaintiffs have 30 days to appeal the dismissal of the Third Amended Complaint. The Company believes that the allegations contained in the complaint are without merit and will continue to defend the case vigorously. The Company evaluated no other subsequent events that occurred after June 30, 2022, through the date the condensed consolidated financial statements were issued after their approval by the Board of Directors on July 29, 2022 and determined that there are no significant events that require adjustments or disclosure in such condensed consolidated financial statements.

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Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

You should read the following discussion and analysis of our financial condition and results of operations in conjunction with our unaudited condensed consolidated financial statements and related notes included in Part 1, Item 1 of this Report and with our audited financial statements and related notes thereto for the year ended December 31, 2021, included in our Annual Report on Form 10-K for the year ended December 31, 2021, filed with the Securities and Exchange Commission on March 9, 2022, or the Annual Report. This discussion and other parts of this Report contain forward-looking statements that involve risks and uncertainties, such as statements of our plans, objectives, expectations and intentions. Our actual results could differ materially from those discussed in these forward-looking statements. Factors that could cause such differences are discussed in the section of this Report titled “Special Note Regarding Forward-Looking Statements” and under “Item 1A. Risk Factors” in the Annual Report.

Overview

We are a 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. We have generated significant data demonstrating that Viaskin’s mechanism of action is novel and differentiated, as it targets specific antigen-presenting immune cells in the skin, called Langerhans cells, that capture the antigen and migrate to the lymph node in order to activate the immune system without passage of the antigen into the bloodstream, minimizing systemic exposure in the body. We are advancing this unique technology to treat patients, including infants and children, suffering from food allergies, for whom safety is paramount, since the introduction of the offending allergen into their bloodstream can cause severe or life-threatening allergic reactions, such as anaphylactic shock. We believe Viaskin may offer convenient, self-administered, non-invasive immunotherapy to patients. Our most advanced clinical program is Viaskin Peanut.

ViaskinTM Peanut for children ages 4-11 in the United States

In January 2021, the Company received written responses from the FDA to questions provided in the Type A meeting request the Company submitted in October 2020 following the Complete Response Letter received in August 2020. The FDA agreed with its 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 order to confirm the consistency of efficacy data between the existing and a modified patch, FDA requested an assessment comparing the uptake of allergen (peanut protein) between the patches in peanut allergic children ages 4-11. The Company named that assessment EQUAL, which stands for Equivalence in Uptake of ALlergen. The FDA also recommended conducting a 6-month, well-controlled safety and adhesion trial to assess a modified Viaskin Peanut patch in the intended patient population. The Company later named this study STAMP, which stands for Safety, Tolerability, and Adhesion of Modified Patches

Based on the January 2021 FDA feedback, the Company defined three parallel workstreams:

4. Identify a modified Viaskin patch (which the Company calls mVP).

5. Generate the 6-month safety and adhesion clinical data FDA requested via STAMP, which the Company expected to be the longest component of the mVP clinical plan. The Company prioritized the STAMP protocol submission so the Company could begin the study as soon as possible.

6. Demonstrate the equivalence in allergen uptake between the current and modified patches in the intended patient population via EQUAL. The complexity of EQUAL hinged on the lack of established clinical and regulatory criteria to characterize allergen uptake via an epicutaneous patch. To support those exchanges, the Company outlined its proposed approach to demonstrate allergen uptake equivalence between the two patches, and allotted time to generate informative data through two additional studies:

c. PREQUAL, a Phase I study with adult healthy volunteers to optimize the allergen sample collection methodologies and validate the assays we intend to use in EQUAL

d. ‘EQUAL in adults’—a second Phase I study with adult healthy volunteers to compare the allergen uptake of cVP and Mvp;

In March 2021, the Company commenced CHAMP (Comparison of adHesion Among Modified Patches), a trial in healthy adult volunteers to evaluate the adhesion of five modified Viaskin Peanut patches, to identify the one or two best-performing patches, which the Company completed in the second quarter of 2021. Based on the adhesion parameters studied, the Company selected the modified patch to advance to further clinical testing in the intended patient population. All modified Viaskin Peanut patches demonstrated better adhesion performance as compared to the then-current Viaskin Peanut patch, and the Company then selected two modified patches that performed best out of the five modified patches studied for further development. The Company then selected the circular patch for further development, which is larger in size relative to the current patch and circular in shape.

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In May 2021, the Company submitted its proposed STAMP protocol to the FDA, and in October 2021, the Company received an Advice/Information Request letter from the FDA. In this letter, the FDA requested a stepwise approach to the modified Viaskin patch development program and provided partial feedback on the STAMP protocol. Specifically, the FDA requested that the Company conduct allergen uptake comparison studies (i.e., ‘EQUAL in Adults’, EQUAL), and submit the allergen uptake comparison data for FDA review and feedback prior to starting the STAMP study.

After careful review of the FDA’s information requests, in December 2021, the Company decided not to pursue the stepwise approach to the development plans for Viaskin Peanut as requested by the FDA in the October 2021 letter. The Company estimated that the FDA’s newly proposed stepwise approach would require at least five rounds of exchanges that necessitate FDA alignment prior to initiating STAMP, the 6-month safety and adhesion study. As such, in December 2021, the Company announced its plan to initiate a pivotal Phase III placebo-controlled efficacy trial for a modified Viaskin Peanut patch (mVP) in children in the intended patient population. The clinical trial will also include updates to the Instructions for Use (IFU). The Company considers this approach the most straightforward to potentially demonstrate effectiveness, safety, and improved in vivo adhesion of the modified Viaskin Peanut system. The FDA confirmed the Company’s change in strategy is agreeable via oral and written exchanges.

The new Phase 3 pivotal study for modified Viaskin Peanut has been named VITESSE (Viaskin Peanut Immunotherapy Trial to Evaluate Safety, Simplicity and Efficacy), which means “speed” in French.

In May 2022, the Company announced that the FDA granted it a Type C meeting to align on the protocol and the study protocol was submitted to the FDA as part of the the Type C meeting briefing package. DBV continues to engage in productive dialogue with the FDA on the key elements of the VITESSE protocol. As previously disclosed, the Company will communicate key elements of the VITESSE trial design and projected timelines once this process has concluded.

Viaskin Peanut for children ages 4-11 - European Union Regulatory History and Current Status

In August 2021, the Company announced its receipt from the EMA of the Day 180 list of outstanding issues, which is an established part of the prescribed EMA review process. It is a letter that is meant to include any remaining questions or objections at that stage in the process. The EMA indicated many of their objections and major objections from the Day 120 list of questions had been answered. One major objection remained at Day 180. The Major Objection questioned the limitations of the data, for example, the clinical relevance and effect size supported by a single pivotal study.

In December 2021, the Company announced it has withdrawn the Marketing Authorization Application for Viaskin Peanut and formally notified the EMA of our decision. The initial filing was supported by positive data from a single, placebo-controlled Phase 3 pivotal trial known as PEPITES (V712-301). The decision to withdraw was based on the view of EMA Committee for Medicinal Products for Human Use (CHMP) that the data available to date from a single pivotal study were not sufficient to preclude a Major Objection at Day 180 in the review cycle. The Company believes data from a second Viaskin Peanut pivotal study 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, patients 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 validate the ongoing investigation of the 250 Pg dose in this age group, which is the dose being studied in Part B of the study. Enrollment for Part B of EPITOPE was completed in the first quarter of 2022.

In June 2022, The Company announced that its pivotal Phase III trial EPITOPE, assessing the safety and efficacy of Viaskin™ Peanut 250 µg for the treatment of peanut-allergic toddlers ages 1 to 3 years, met its primary endpoint. Viaskin Peanut demonstrated a statistically significant treatment effect (p<0.001), with 67.0% of subjects in the Viaskin Peanut arm meeting the treatment responder criteria after 12 months, as compared to 33.5% of subjects in the placebo arm (difference in response rates = 33;4 %, 95 % CI = 22.4% - 44.5 %).

DBV intends to further analyze the data from EPITOPE and explore regulatory pathways for Viaskin Peanut in children ages 1 to 3 years, given the high unmet need and absence of approved treatments for this vulnerable population.

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Critical Accounting Policies and Significant Judgments and Estimates

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

There have been no new policies or significant changes to our critical accounting policies as disclosed in the critical accounting policies described in the Annual Report. Our significant accounting policies are more fully described in Note 1 of the Notes to the Condensed Consolidated Financial Statements in Part I, Item 1 of our Annual Report.

Business trends and Results of Operations

Comparison of the Three Months Ended June 30, 2022 and 2021

The following table summarizes our results of operations, derived from our condensed consolidated financial statements, which have been prepared in accordance with U.S. GAAP and presented in thousands of U.S. Dollars, for the three months ended June 30, 2022 and 2021.

	Three months ended June 30,
	2022			2021			$ change			% change
Operating income	$	1,529		$	(1,488	)		3,016			(203	)%
Operating expenses
Research and development expenses		(18,611	)		(20,179	)		1,568			(8	)%
Sales and marketing expenses		(1,037	)		(1,198	)		162			(13	)%
General and administrative expenses		(5,704	)		(8,269	)		2,564			(31	)%
Total Operating expenses		(25,352	)		(29,646	)		4,309			(15	)%
Financial income		784			46			737	*
Income tax		—			434			(434	)		(100	)%
Net loss	$	(23,039	)	$	(30,654	)		7,629			(25	)%
Basic/diluted Net loss per share attributable to shareholders	$	(0.35	)	$	(0.56	)

* Percentage not meaningful

Operating Income

The following table summarizes our operating income during the three months ended June 30, 2022 and 2021:

	Three months ended June 30,
	2022		2021			$ change			% change
Sales		—		—			—			—
Other income		1,529		(1,488	)		3,016			(203	)%
Research tax credit		1,491		1,870			(379	)		(20	)%
Other operating income		37		(3,358	)		3,396			(101	)%
Total operating income		1,529		(1,488	)		3,016			(203	)%

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Our operating income is primarily generated from the French research tax credit (Crédit d’Iimpôt Recherche, or “CIR”), and by the revenue recognized under our collaboration agreement with Nestlé Health Science. We generated operating income of $1.5 million during the three months ended June 30, 2022 compared to $(1.5) million during the three months ended June 30, 2021. The increase in operating income is primarily attributable to the revenue recognized under the Nestlé’s collaboration agreement, as we updated the measurement of progress of the Phase II clinical trial conducted as part of the agreement. During the three months ended June 30, 2021 negative revenue was recognized under the Nestlé’s collaboration agreement due to delays in new patient enrollment.The decrease in research tax credit is attributable to the decline of eligible expenses in connection with Research and Development costs.

Research and Development Expenses

The following table summarizes our research and development expenses incurred during the three months ended June 30, 2022 and 2021:

	Three Months Ended June 30,
Research and Development expenses	2022		2021		$ change			% change
External clinical-related expenses		11,664		9,808		1,856			19	%
Employee-related costs		2,622		3,206		(584	)		(18	)%
Share-based payment expenses		475		187		289			155	%
Depreciation, amortization and other costs		3,850		6,978		(3,128	)		(45	)%
Total Research and Development expenses		18,611		20,179		(1,568	)		(8	)%

Research and Development expenses decreased by $1.6 million for the three months ended June 30, 2022, compared to the three months ended June 30, 2021, primarily due to an increase in external clinical-related expenses following the launch of work on VITESSE protocol. We have also continued to practice financial discipline and implemented further cost containment strategies.

Employee-related costs, excluding share-based payment expenses, decreased by $0.6 million for the three months ended June 30, 2022 compared to the three months ended June 30, 2021 due to the workforce reduction following full implementation of the new organization.

The decrease in depreciation, amortization and other costs was primarily due to the loss at completion recorded on the Phase II clinical trial conducted as part of the Nestlé agreement.

22

Sales and Marketing expenses

The following table summarizes our sales and marketing expenses incurred during the three months ended June 30, 2022 and 2021:

	Three Months Ended June 30,
Sales and Marketing expenses	2022		2021		$ change			% change
External professional services		399		307		92			30	%
Employee-related costs		289		430		(140	)		(33	)%
Share-based payment expenses		55		89		(34	)		(38	)%
Depreciation, amortization and other costs		294		373		(79	)		(21	)%
Total Sales and Marketing expenses		1,037		1,198		(162	)		(13	)%

Sales and marketing expenses amounted to $1 million for the three months ended June 30, 2022, compared to $1.2 million for the three months ended June 30, 2021.

Employee-related costs, excluding share-based payments expenses, decreased by $0.1 million for the three months ended June 30, 2022, compared to the three months ended June 30, 2021 due to the workforce reduction following full implementation of the new organization.

General and Administrative expenses

The following table summarizes our general and administrative expenses incurred during the three months ended June 30, 2022 and 2021:

	Three Months Ended June 30,
General and Administrative expenses	2022		2021		$ change			% change
External professional services		1,771		1,922		(151	)		(8	)%
Employee-related costs		2,220		2,180		40			2	%
Share-based payment expenses		548		819		(271	)		(33	)%
Depreciation, amortization and other costs		1,166		3,348		(2,182	)		(65	)%
Total General and Administrative expenses		5,704		8,269		(2,564	)		(31	)%

General and Administrative expenses decreased by $2.6 million for the three months ended June 30, 2022, compared to the three months ended June 30, 2021 primarily due to a decrease in depreciation, amortization and other costs as we continued to practice financial discipline and implemented further cost containment strategies.

Financial income (expense)

Our financial income was approximately $784,000 for the three months ended June 30, 2022, compared to a financial income of $46,000 for the three months ended June 30, 2021. This item mainly includes foreign exchange income and expenses.

Income tax

Our income tax profit was nil for the three months ended June 30, 2022, compared to $0.1 million for the three months ended June 30, 2021. This profit mainly resulted from U.S. tax refunds.

Net loss

Net loss was $23 million for the three months ended June 30, 2022, compared to $30.7 million for the three months ended June 30, 2021. Net loss per share (based on the weighted average number of shares outstanding over the period) was $0.35 and $0.56 for the three months ended June 30, 2022 and 2021, respectively.

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Business trends and Results of Operations

Comparison of the Six Months Ended June 30, 2022 and 2021

The following table summarizes our results of operations, derived from our condensed consolidated financial statements, which have been prepared in accordance with U.S. GAAP and presented in thousands of U.S. Dollars, for the six months ended June 30, 2022 and 2021.

	Six months ended June 30,
	2022			2021			$ change			% change
Operating income	$	4,074		$	1,453			2,621			180	%
Operating expenses
Research and development expenses		(30,834	)		(42,343	)		11,509			(27	)%
Sales and marketing expenses		(1,500	)		(1,927	)		427			(22	)%
General and administrative expenses		(12,334	)		(17,951	)		5,617			(31	)%
Total Operating expenses		(44,669	)		(62,221	)		17,552			(28	)%
Financial income (expense)		936			261			675			258	%
Income tax		(87	)		404			(491	)		(122	)%
Net loss	$	(39,746	)	$	(60,103	)		20,357			(34	)%
Basic/diluted Net loss per share attributable to shareholders	$	(0.66	)	$	(1.09	)

Operating Income

The following table summarizes our operating income during the six months ended June 30, 2022 and 2021:

	Six months ended June 30,
	2022		2021			$ change			% change
Sales		—		—
Other income		4,074		1,453			2,621			180	%
Research tax credit		3,060		3,677			(617	)		(17	)%
Other operating income		1,014		(2,225	)		3,238			(146	)%
Total operating income		4,074		1,453			2,621			180	%

Our operating income was primarily generated from the French research tax credit (Crédit d’Impôt Recherche or “CIR”) and from revenue recognized under our collaboration agreement with Nestlé Health Science. We generated operating income of $4.1 million during the six months ended June 30, 2022, compared to $1.5 million during the six months ended June 30, 2021.

The increase in operating income is primarily attributable to the revenue recognized under the Nestlé’s collaboration agreement, as we updated the measurement of progress of the Phase II clinical trial conducted as part of the agreement. During the six months ended June 30, 2021 negative revenue was recognized under the Nestlé’s collaboration agreement due to delays in new patient enrollment.The decrease in research tax credit is attributable to the decline in eligible expenses in connection with Research and Development costs.

Research and Development Expenses

The following table summarizes our research and development expenses incurred during the six months ended June 30, 2022 and 2021:

	Six Months Ended June 30,
Research and Development expenses	2022		2021		$ change			% change
External clinical-related expenses		19,014		22,686		(3,672	)		(16	)%
Employee-related costs		5,114		7,297		(2,183	)		(30	)%
Share-based payment expenses		1,058		814		244			30	%
Depreciation, amortization and other costs		5,648		11,546		(5,898	)		(51	)%
Total Research and Development expenses		30,834		42,343		(11,509	)		(27	)%

24

Research and Development expenses decreased by $11.5 million for the six months ended June 30, 2022 compared to the six months ended June 30, 2021 primarily due to a decrease in external clinical-related expenses as main component of the work on clinical studies such as REALISE and EPITOPE has been finalized during the year 2021. We have also continued to practice financial discipline and implemented further cost containment strategies.

Employee-related costs, excluding share-based payments expenses, decreased by $2.2 million for the six months ended June 30, 2022, compared to the six months ended June 30, 2021 due to the workforce reduction following full implementation of the new organization.

Sales and Marketing expenses

The following table summarizes our sales and marketing expenses incurred during the six months ended June 30, 2022 and 2021:

	Six Months Ended June 30,
Sales and Marketing expenses	2022		2021		$ change			% change
External professional services		521		391		130			33	%
Employee-related costs		539		877		(338	)		(39	)%
Share-based payment expenses		49		159		(110	)		(69	)%
Depreciation, amortization and other costs		391		500		(109	)		(22	)%
Total Sales and Marketing expenses		1,500		1,927		(427	)		(22	)%

Sales and marketing expenses decreased by $0.4 million for the six months ended June 30, 2022, compared to the six months ended June 30, 2021, primarily due to a decrease in employee-related costs.

Employee-related costs, excluding share-based payments expenses, decreased by $0.4 million for the six months ended June 30, 2022, compared to the six months ended June 30, 2021 due to the workforce reduction following full implementation of the new organization.

General and Administrative expenses

The following table summarizes our general and administrative expenses incurred during the six months ended June 30, 2022 and 2021:

	Six Months Ended June 30,
General and Administrative expenses	2022		2021		$ change			% change
External professional services		2,879		4,210		(1,330	)		(32	)%
Employee-related costs		4,029		5,211		(1,181	)		(23	)%
Share-based payment expenses		1,333		1,554		(221	)		(14	)%
Depreciation, amortization and other costs		4,093		6,977		(2,884	)		(41	)%
Total General and Administrative expenses		12,334		17,951		(5,617	)		(31	)%

General and Administrative expenses decreased by $5.7 million for the six months ended June 30, 2022, compared to the six months ended June 30, 2021, primarily due to a decrease of depreciation, amortization and other costs.

The decrease in employee-related costs, excluding share-based payment expenses, is directly related to the workforce reduction following full implementation of the new organization.

Financial income (expense)

Our financial income was $0.9 million for the six months ended June 30, 2022, compared to a financial income of $0.3 million for the six months ended June 30, 2021. This item mainly includes foreign exchange income (expense).

Income tax

Our income tax expense was $ 87,000 for the six months ended June 30, 2022. This income tax profit mainly resulted from US tax refunds.

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Net loss

Net loss was $39.7 million for the six months ended June 30, 2022, compared to $60.1 million for the six months ended June 30, 2021. Net loss per share (based on the weighted average number of shares outstanding over the period) was $0.51 and $1.09 for the six months ended June 30, 2022 and 2021, respectively.

Liquidity and Capital Resources

Financial Condition

On June 30, 2022, we had $248 million in cash and cash equivalents compared to $77.3 million of cash and cash equivalents on December 31, 2021. We have incurred operating losses and negative cash flows from operations since our inception. Net cash used for operating activities was $12.3 and $66.5 million for the six months ended June 30, 2022 and 2021, respectively. As of June 30, 2022, we recorded a net loss of $23 million.Our net cash flows provided by financing activities increased to $195.2 million during the six months ended June 30, 2022 from $1.1 million during the six months ended June 30, 2021. Financing activities consisted mainly of our underwritten global offering in the second quarter of 2022.

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. 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.

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

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.

Sources of Liquidity and Material Cash Requirements

We have incurred net losses each year since our inception. Substantially all of our net losses resulted from costs incurred in connection with our development programs and from general and administrative expenses associated with our operations. We have not incurred any bank debt.

As of the date of the filing, our available cash is projected to be sufficient to support our operating plan for at least the next 12 months.

In May 2022, the Company announced that pursuant to the Company’s ATM program, it had issued and completed sales of new Ordinary Shares in the form of ADSs, for a total gross amount of $15.3 million.

In June 2022, the Company announced an aggregate $194 million PIPE financing (corresponding to €181 million on the basis of an exchange rate of $1.0739 = €1.00 published by the European Central Bank on June 8, 2022) from the sale of 32,855,669 Ordinary Shares, as well as pre-funded warrants to purchase up to 28,276,331 Ordinary Shares.

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 to the ongoing COVID-19 pandemic. 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 cash requirements for future periods:

	Material Cash Requirements Due by the period Ended June 30,
	2023		2024		2025		Thereafter		Total
	(Amounts in thousands)
Conditional advances		156		—		—		—		156
Operating leases		2,154		1,862		295		—		4,312
Purchase obligations - Obligations Under the Terms of CRO Agreements		17,057		6,721		4,969		—		30,586
Total		19,367		8,583		5,264		—		35,054

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. The table does not include obligations under agreements that we can cancel without a significant penalty.

Future events could cause actual payments to differ from these estimates.

Conditional advances

In 2014, BpiFrance Financement granted an interest-free Innovation loan to DBV Technologies to help finance the pharmaceutical development of Viaskin™ Milk. This amount was received in a single disbursement on November 27, 2014. In 2020, due to the COVID-19 pandemic, Bpifrance postponed the repayments for a 6-month period. Repayment will end during the third quarter of 2022.

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 $3.5 million cash requirement as of June 30, 2022 which expires March 8, 2024.

We also have facilities in North America that were initially intended to support our U.S. subsidiary as well as future commercialization needs. We lease 3,780 square feet of office space in Tower 49, New York, New York. This lease is for a period of 65 months and expires on February 25, 2023. In light of our global restructuring, the current stage of regulatory interactions regarding Viaskin Peanut, and the ongoing COVID-19 pandemic, we entered into a sublease agreement of this office space in June 2021. The NYC office represents a $0.3 million cash requirement as of June 30, 2022 until the first quarter of 2023.

On March 28, 2022, the Company entered into a binding office lease agreement in New Jersey for a lease term of 3 years and 2 months. The lease commencement was based upon delivery of possession of the premises by the Landlord and occurred on April 1, 2022. The principal offices occupy a 5,799 square meter facility, and represents a $0.4 million cash requirement as of June 30, 2022 which expires May 1, 2025.

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. Expenses associated with the ongoing trials amounted globally to $105.5 million. As of June 30, 2022, the amount we are still obligated to pay in connection with these contracts through 2024 is $30.6 million.

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Summary Statement of Cash Flows

The table below summarizes our sources and uses of cash for the six months ended June 30, 2022 and 2021.

	Six months ended June 30,
(Amounts in thousands of U.S. Dollars)	2022			2021			$ change			% of change
Net cash flow used in operating activities		(11,733	)		(66,503	)		54,770			(82	)%
Net cash flow used in investing activities		(218	)		(13	)		(206	)		1595	%
Net cash flow provided by financing activities		195,222			1,071			194,151				*
Effect of exchange rate changes on cash and cash equivalents		(12,600	)		(5,423	)		(7,177	)		132	%
Net (decrease) increase in cash and cash equivalents		170,670			(70,868	)		241,538			(341	)%

* Percentage not meaningful

Operating Activities

Our net cash flows used in operating activities were $11.7 million and $66.5 million during the six months ended June 30, 2022 and 2021, respectively. Our net cash flows used in operating activities increased by $54.8 million, or 82%, mainly due to cost containment measures and to the workforce reduction following full implementation of the new organization. Cash flows used in operating activities for the six months ended June 30, 2021 included restructuring costs paid for $6.3 million.

Investing Activities

Our net cash flows used in investing activities was approximately $218,000 and $13,000 during the six months ended June 30, 2022 and 2021, respectively.

Financing Activities

Our net cash flows provided by financing activities increased to $195.2 million during the six months ended June 30, 2022 from $1.1 million during the six months ended June 30, 2021. Financing activities consisted mainly of our underwritten global offering in the second quarter of 2022.

Off-Balance Sheet Arrangements

We have not entered into any off-balance sheet arrangements and do not have variable interests in variable interest entities.

Smaller Reporting Company Status

We are a smaller reporting company as defined in the Securities Exchange Act of 1934, as amended. We may, and intend to, take advantage of certain of the scaled disclosures available to smaller reporting companies and will be able to take advantage of these scaled disclosures for so long as we are a smaller reporting company. We may be a smaller reporting company in any year in which (i) the market value of our voting and non-voting ordinary shares held by non-affiliates is less than $250.0 million measured on the last business day of our second fiscal quarter or (ii) (a) our annual revenue is less than $100.0 million during the most recently completed fiscal year and (b) the market value of our voting and non-voting ordinary shares held by non-affiliates is less than $700.0 million measured on the last business day of our second fiscal quarter.

Item 3. Quantitative and Qualitative Disclosures About Market Risk

Our market risks have not changed materially from those disclosed in the Annual Report.

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Item 4. Controls and Procedures

Disclosure Controls and Procedures

Based on its evaluation as of June 30, 2022, our management, including our Chief Executive Officer and Chief Financial Officer,

concluded that our disclosure controls and procedures (as defined in Rule 13a-15(e) under the Exchange Act) were effective to provide

reasonable assurance that (i) the information required to be disclosed in our reports filed or submitted under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms, and (ii) such information is accumulated and communicated to our management, including our Chief Executive Officer and Chief Financial Officer, as appropriate, to allow timely decisions regarding required disclosure.

Changes in Internal Control Over Financial Reporting

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

Limitation on Effectiveness of Controls and Procedures

Our management, including our Chief Executive Officer and Chief Financial Officer, does not expect that our disclosure controls and

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

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PART II – Other information

Item 1. Legal Proceedings

See “Note 2: Significant Events and Transactions – Legal Proceedings” in the notes to the condensed consolidated financial statements included elsewhere in this Report.

Item 1A. Risk Factors

Except as set forth below, there have been no material changes in our risk factors from those disclosed in the Annual Report.

Future sales of ordinary shares or ADSs by existing shareholders could depress the market price of the ADSs.

As of December 31, 2021, 55,095,762 Ordinary Shares were issued and outstanding. Sales of a substantial number of shares of our Ordinary Shares or ADSs in the public market, or the perception that these sales might occur, could depress the market price of our securities and could impair our ability to raise capital through the sale of additional equity securities. A substantial number of our shares are now generally freely tradable, subject, in the case of sales by our affiliates, to the volume limitations and other provisions of Rule 144 under the Securities Act. If holders of these shares sell, or indicate an intent to sell, substantial amounts of our securities in the public market, the trading price of our securities could decline significantly.

In June 2022, we completed a $194 million PIPE financing from the sale of (i) 32,855,669 Ordinary Shares, nominal value €0.10 per share at a price per Ordinary Share of €3.00 (corresponding to $3.22 on the basis of an exchange rate of $1.0739 = €1.00 published by the European Central Bank on June 8, 2022), and (ii) pre-funded warrants to purchase an aggregate of 28,276,331 Ordinary Shares (the “Warrant Shares”) at a pre-funded price per pre-funded warrant of €2.90 (corresponding to $3.11), which equals the per share price of the Ordinary Shares less the exercise price of €0.10 per pre-funded warrant. Each pre-funded warrant has an exercise price of €0.10 per Warrant Share. We entered into a registration rights agreement with the investors pursuant to which we agreed to file a registration statement with the SEC registering the resale of the 32,855,669 Ordinary shares and the 28,276,331 Ordinary shares underlying the pre-funded warrants issued in the PIPE. Upon the effectiveness of this registration statement and subject to certain beneficial ownership limitations contained in the pre-funded warrants, these shares will be freely tradable, without restriction, in the public market. In addition, the exercise of some or all of the pre-funded warrants will increase the number of our outstanding ordinary shares, which may dilute the ownership percentage or voting power of our shareholders.

In addition, we have filed a registration statement with the SEC to register the Ordinary Shares that may be issued under our equity incentive plans. The Ordinary Shares subject to outstanding options under our equity incentive plans, Ordinary Shares reserved for future issuance under our equity incentive plans and Ordinary Shares subject to outstanding warrants will become eligible for sale in the public market in the future, subject to certain legal and contractual limitations. Sales of a large number of the shares issued under these plans in the public market could have an adverse effect on the market price of our securities.

Item 2. Unregistered Sales of Equity Securities and Use of Proceeds

During the six months ended June 30, 2022, we issued the following unregistered securities:

• On March 23, 2022, the issuance of an aggregate of 775 ordinary shares to a non-U.S. employee upon settlement of RSUs;

• On May 19, 2022, the issuance of an aggregate of 5,000 ordinary shares to a non-U.S. employee upon settlement of RSUs;

• On May 24, 2022, the issuance of an aggregate of 26,135 ordinary shares to a non-U.S. employee upon settlement of RSUs;

• Pursuant to the authorization granted by the General Meeting of the Shareholders held on May 12, 2022, the Company offered the opportunity to subscribe for warrants to purchase ordinary shares on May 12, 2022, and on June 9, 2022, the Chief Executive Officer authorized a capital increase for an amount of €3,285,566.90 through the issue of (i) 32,855,669 New Shares with a per value of €0.10 each and (ii) the issuance of 28,276,331 prefunded warrants, with cancellation of shareholders’ preferential subscription rights in favor of Braidwell LP, funds advised by Baker Bros. Advisors LP and BpiFrance Participations SA, existing shareholders of the Company and Venrock Healthcare Capital Partners.

• On June 8, 2022, we entered into a securities purchase agreement with certain institutional and accredited investors pursuant to which we agreed to issue and sell to the investors i) 32,855,669 ordinary shares, nominal value €0.10 per share, at a price per ordinary share of €3.00 (corresponding to $3.22 on the basis of an exchange rate of $1.0739 = €1.00 published by the European Central Bank on June 8, 2022), and (ii) pre-funded warrants to purchase an aggregate of 28,276,331 ordinary shares (the “Warrant Shares”) at a pre-funded price per pre-funded warrant of €2.90 (corresponding to $3.11), which equals the per share price of the ordinary shares less the exercise price of €0.10 per Pre-Funded Warrant. Each Pre-Funded Warrant has an exercise price of €0.10 per Warrant Share. The Pre-Funded Warrants are exercisable at any time after their original issuance and will expire ten years

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following their issuance. The exercise price and number of shares of ordinary shares issuable upon exercise of the warrants may be adjusted in certain circumstances, including stock splits, stock dividends, reclassifications and the like. The pre-funded warrants issued in the PIPE provide that the holder of the pre-funded warrants will not have the right to exercise any portion of its pre-funded warrants if such holder, together with its affiliates, would beneficially own in excess of 9.99% of the number of ordinary shares outstanding immediately after giving effect to such exercise (the “Beneficial Ownership Limitation”). The holder may increase or decrease the Beneficial Ownership Limitation, provided, however, that the holder may only increase the Beneficial Ownership Limitation by (i) obtaining authorization from the French Ministry of Economy in the event the Beneficial Ownership Limitation is being raised above 9.99%, and (ii) by providing 61 days’ notice to the Company, except that in no event will the Beneficial Ownership Limitation exceed 19.99%. The securities issued by us pursuant to the securities purchase agreement and to be issued upon exercise of the warrants were not registered under the Securities Act of 1933, as amended, or the Securities Act, and may not be offered or sold in the United States absent registration or an applicable exemption from registration requirements.

• On June 10, 2022, the issuance of 3,100 ordinary shares to a non-U.S. employee upon exercise of 3,100 SO at an exercise price of 4.16 euros per SO, for aggregate proceeds to the Company of 12,896 euros.

None of the foregoing transactions involved any underwriters, underwriting discounts or commissions, or any public offering. We believe these transactions were exempt from registration under the Securities Act in reliance on Section 4(a)(2) of the Securities Act or Regulation S promulgated under Section 5 of the Securities Act, as transactions by an issuer not involving any public offering or as offerings made to non-U.S. resident employees pursuant to an employee benefit plan established and administered in accordance with the law of a country other than the United States (namely, the Republic of France) and in accordance with that country’s practices and documentation. All recipients had adequate access, through their relationships with us, to information about us. The sales of these securities were made without any general solicitation or advertising.

Item 3. Defaults Upon Senior Securities

None.

Item 4. Mine Safety Disclosures

Not applicable.

Item 5. Other Information

Not applicable.

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Item 6. Exhibits.

Exhibit Index

Exhibit	Description	Incorporated by Reference
		Schedule/ Form		File Number		Exhibit		File Date
1.1	Sales Agreement, dated as of May 2, 2022, by and between DBV Technologies S.A. and Jefferies LLC		Form 8-K		001-36697		1.1		May 2, 2022
3.1	Amended and Restated By-laws (statuts) of the registrant (English translation)
4.1	Terms and Conditions of the Pre-Funded Warrant		Form 8-K		001-36697		Annex II of the Securities Purchase Agreement filed as Exhibit 10.1		June 13, 2022
10.1	Registration Rights Agreement, dated June 8, 2022, by and between DBV Technologies S.A. and the investor parties thereto		Form 8-K		001-36697		10.2		June 13, 2022
10.2	Securities Purchase Agreement, dated June 8, 2022, by and between DBV Technologies S.A. and the investor parties thereto		Form 8-K		001-36697		10.1		June 13, 2022
31.1	Certificate of Chief Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002, as Amended
31.2	Certificate of Chief Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002, as amended
32.1*	Certificate of Chief Executive Officer and Chief Financial Officer pursuant to 18 U.S.C. §1350, as adopted pursuant to Section 906 of the Sarbanes- Oxley Act of 2002, as amended
101.INS	XBRL Instance Document
101.SCH	XBRL Taxonomy Extension Schema Document
101.CAL	XBRL Taxonomy Extension Calculation Linkbase Document
101.DEF	XBRL Taxonomy Extension Definition Linkbase Document
101.LAB	XBRL Taxonomy Extension Labels Linkbase Document
101.PRE	XBRL Taxonomy Extension Presentation Linkbase Document
104	Cover Page Interactive Data File, formatted in Inline XBRL and contained in Exhibit 101.

* Furnished herewith and not deemed to be “filed” for purposes of Section 18 of the Exchange Act, and shall not be deemed to be incorporated by reference into any filing under the Securities Act of 1933, as amended, or the Exchange Act (whether made before or after the date of the Form 10-Q), irrespective of any general incorporation language contained in such filing.

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SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

	DBV Technologies S.A.
	(Registrant)
Date: August 1, 2022	By:	/s/ Daniel Tassé
		Daniel Tassé
		Chief Executive Officer
		(Principal Executive Officer)
Date: August 1, 2022	By:	/s/ Sébastien Robitaille
		Sébastien Robitaille
		Chief Financial Officer
		(Principal Financial and Accounting Officer)

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EX-3.1

Exhibit 3.1

B Y-LAWS

(updated by decision of the CEO on July 12, 2022)

DBV Technologies

Limited Company with share capital of €9,402,267.90

177-181 avenue Pierre Brossolette - 92120 Montrouge, France

Nanterre Trade and Companies Register No. 441 772 522

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I.—CHARACTERISTIC FEATURES OF THE COMPANY

Article 1 - Form

The Company was incorporated in the form of a French Limited Company (Société Anonyme) with a Board of Directors.

Article 2 - Name

The name of the Company is: “DBV Technologies”

Article 3 - Registered office

The registered office is located at: 177-181 avenue Pierre Brossolette - 92120 Montrouge, France

Article 4 - Corporate Purpose

The Company’s corporate purpose in France and in all countries is:

• the development of any innovative medical products, including any drugs, or diagnostic or treatment products;

• the study, research, development, industrial manufacturing, and marketing of said products;

• the use and development of any patents or licenses relating to these products, and generally speaking any commercial, investment or real estate, financial or other transactions that are directly or indirectly related to the corporate purpose in whole or in part, or to any other similar or related purpose, and that may promote the operation and commercial development of the Company.

Article 5 - Term

The Company’s term is ninety-nine years as from its registration in the Trade and Companies Register.

Article 6 - Share capital

The share capital has been set at €9,402,267.90.

It is divided into 94,022,679 ordinary shares with a par value of 10-euro cents (€0.10) each. All of the shares have been fully subscribed, and their full amount paid up in cash.

Article 7 - Changes to the share capital

I. The share capital may be increased either via the issue of new shares, or by increasing the par value of the existing shares.

2

The new shares will be paid for in cash, or via a contribution in kind, offset against liquid and due receivables, or via the incorporation of profits, reserves, or share premiums into the share capital, either as the result of a merger or demerger, or following the exercise of a right attached to transferable securities granting entitlement to the share capital, including payment of the corresponding amounts, where applicable.

The new equity securities will be issued either at their par value, or at that amount plus a share premium.

Only the Extraordinary General Meeting of Shareholders has the power to decide on increasing the share capital, based on a report from the Board of Directors containing the disclosures required by law.

However, the Extraordinary General Meeting of Shareholders may delegate this power to the Board of Directors under the conditions determined by law. The Board of Directors has the requisite powers to perform a capital increase in one or several installments, to determine its terms and conditions, to record its completion, and to amend the By-Laws accordingly within the limits of the powers so granted by the Extraordinary General Meeting of Shareholders.

If the General Meeting of Shareholders decides to increase the share capital, it may delegate the powers required to perform the transaction to the Board of Directors.

If a delegation of power or of authority is used, the Board of Directors will draw up a supplementary report at the next Ordinary General Meeting of Shareholders.

If the capital increase is performed via the incorporation of profits, reserves, or share premiums, the Extraordinary General Meeting of Shareholders will take decisions under the quorum and majority conditions provided for Ordinary General Meetings of Shareholders. In this case, it may decide that rights amounting to fractional shares may neither be traded nor transferred, and that the corresponding equity securities must be sold. The proceeds from the sale will be allocated to the holders in proportion to their rights.

A capital increase by increasing the par value of the shares can only be decided with the shareholders’ unanimous consent, except if it results from the incorporation of profits, reserves, or share premiums into the share capital.

Shareholders will have a preferential right to subscribe to the cash shares issued in order to perform a capital increase, in proportion to the number of shares that they hold. The shares purchased as a result of exercising this right will be shares in the same class as the one for the shares giving rise to said right, together with the shares resulting from the purchase of other transferable securities than shares.

The shareholders may sell all or some of their subscription rights throughout the subscription period. These rights will be tradable if they are stripped from shares that are themselves tradable. Otherwise, they may be sold under the same conditions as the actual shares.

Shareholders may waive their preferential subscription right on an individual basis.

The Extraordinary General Meeting of Shareholders that decides on the capital increase may waive the preferential subscription right under the conditions and limits determined by law, and rule to that effect on the reports prepared by the Board of Directors and the Statutory Auditors under the conditions determined by the laws and regulations in effect.

If the Extraordinary General Meeting of Shareholders, or the Board of Directors in the event of a delegation of authority, has expressly decided to do so, any shares that have not been subscribed on an irrevocable basis will be allotted to shareholders who subscribed to a higher number of shares on a revocable basis than the number to which they were able to subscribe on a preferential basis, in proportion to the subscription rights that they hold, and within the limits of their request, in any event.

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If, for any reason, subscriptions have not absorbed the full amount of the capital increase, the Board of Directors may use the options provided for below, or only some of them, in the order that it determines:

(i) limiting the capital increase to the amount of the subscriptions, subject to the general condition that it amounts to at least three quarters of the increase decided upon, and that this option was not expressly excluded by the Extraordinary General Meeting of Shareholders at the time of issue;

(ii) allocating the balance of the shares if the Extraordinary General Meeting of Shareholders has not decided otherwise;

(iii) opening the subscription process to the public if the Extraordinary General Meeting of Shareholders has expressly authorized it.

If subscriptions have not absorbed the entire capital increase following the exercise of these options, or three-quarters of the increase in the case provided for under (i) above, the capital increase will not be performed.

However, the Board of Directors may automatically limit the capital increase to the amount raised in all cases where the unsubscribed shares account for less than 3% of the capital increase.

In the event of a capital increase with or without preferential subscription rights, the Extraordinary General Meeting of Shareholders may provide that the number of securities may be increased by up to 15% of the initial issue, at the same price as the one used for the initial issue within a period of thirty days following the close of the subscription period.

If the capital increase creates fractions of shares, shareholders who have an insufficient number of subscription or allotment rights must make arrangements to purchase or sell the rights required to obtain the delivery of a whole number of new shares.

II. The Extraordinary General Meeting of Shareholders (or the Board of Directors in the event of a delegation of authority) may also authorize or decide on a capital decrease, subject to the rights of creditors, where applicable.

Decreasing the share capital below the legal limit can only be decided under the condition precedent of a capital increase intended to return the share capital to an amount that is at least equal to the minimum legal threshold, unless the Company turns itself into a company with another legal form. Otherwise, any interested party may apply to the courts to have the Company wound up. The court may not order the Company to be wound up if the amount of the share capital has been restored to the statutory minimum by the day when it rules on the substance of the case.

Article 8 - Financial year

The financial year runs from January 1 to December 31.

II. - ADMINISTRATION OF THE COMPANY

Article 9 - Executive Management exercise method

The executive management of the Company is the responsibility either of the Chairman of the Board of Directors or of another individual appointed by the Board of Directors bearing the title of Chief Executive Officer.

The Board of Directors chooses between the two Executive Management exercise methods based on the unanimous vote of all of its members.

Where responsibility for the Company’s Executive Management is held by the Chairman of the Board of Directors, the following provisions concerning the role of Chief Executive Officer apply.

4

A. The Board of Directors

Article 10 - Composition of the Board of Directors

The Company is governed by a Board of Directors that consists of between 3 and 18 directors.

The Directors are appointed by the General Meeting of Shareholders, deliberating under the quorum and majority conditions for Ordinary General Meetings of Shareholders.

The term of office for the Directors appointed during the term of the company is three (3) years. This term expires at the end of the meeting convened to approve the financial statements for the year just ended, and which is held in the year during which their term of office expires.

By way of exception and in order to allow exclusively for the implementation or maintenance of the staggered terms of office of Directors, the ordinary General Meeting of Shareholders may appoint one or more members of the Board for a term of two (2) years or one (1) year.

The Directors may be dismissed at any time and without any good reason by the General Meeting of Shareholders, deliberating under the quorum and majority conditions for Ordinary General Meetings of Shareholders.

The number of Directors aged over eighty cannot exceed one third of the Board members.

Article 11 - Board Discussions

The Board of Directors meets as often as is required by the Company’s interests at the invitation of the Chairman of the Board of Directors, at the registered office or the place specified in the notice of meeting. The invitation may be issued by any means five days in advance: it may also be issued orally and immediately if all of the Directors and non-voting Board members agree.

The Board of Directors may also make decisions by written consultation of the directors under the conditions provided by law.

If it has not met for over two months, at least one quarter of the members of the Board of Directors may ask the Chairman to convene the Board based on a determined agenda. The Chief Executive Officer or a Director may also ask the Chairman to convene the Board of Directors based on a determined agenda. The Chairman will be bound by any such requests.

An attendance register will be kept, and minutes will be drawn up following each meeting. The Board may only validly take decisions if at least half of its members are present.

Except where the choice of the method for exercising Executive Management is concerned, decisions will be taken based on a majority vote of the Directors present or represented. The Chairman will have a casting vote in the event that the vote is split.

The Directors and any individuals asked to attend the Board of Directors’ meetings are required to exercise discretion with respect to information of a confidential nature, and which is provided as such by the Chairman of the Board of Directors.

Article 12 - The Board’s powers

The Board of Directors determines the Company’s guidelines, and ensures their implementation. Subject to the powers specifically assigned to General Meetings of Shareholders, and within the limits of the corporate purpose, the Board will deal with any matter involving the proper operation of the Company, and settle any matters concerning it through its discussions.

5

The Board of Directors carries out the controls and verifications that it considers appropriate. Every Director will receive all of the information required to fulfill their assignment, and may ask for the disclosure of any documents that they consider useful.

Article 13 - The Chairman of the Board of Directors

The Board of Directors elects a Chairman, who must be a private individual, from among its members, and determines their remuneration, in accordance with applicable law. The Chairman is appointed for a period that may not exceed the length of their term of office as a Director. They are eligible for reelection. The Board of Directors may dismiss the Chairman at any time. Any provisions to the contrary will be considered void.

No one aged 75 or over may be appointed as Chairman. If the incumbent Chairman reaches this age during a financial year, their duties will automatically end following the Ordinary General Meeting of Shareholders convened to approve the financial statements for that financial year.

The Chairman organizes and directs the work undertaken by the Board, and accounts for it at the General Meeting of Shareholders. They ensure that the Company’s bodies operate properly, and especially that the Directors are in a position to fulfill their assignment.

Article 14 - Non-Voting Board Members

The General Meeting of Shareholders may appoint one or two non-voting Board members for the Company who are private individuals, regardless of whether they are shareholders; they will be aged 65 at most on the day of their appointment.

Non-voting Board members are appointed for a period of two (2) years. Their assignment ends after the General Meeting of Shareholders that has approved the financial statements for the year just ended, and held in the year during which their term of office expires.

Non-voting Board members do not receive any remuneration. They may receive allowances determined by the Board of Directors in order to reimburse the expenses that they are required to incur as part of the normal performance of their duties. If the Board delegates a specific assignment to the non-voting Board members or to one of them, they may allocate them an allowance in proportion to the importance of the assignment entrusted to them, as well as a budget for performing said assignment. Non-voting Board members are invited to all of the Board of Directors’ meetings and to all of the General Meeting of Shareholders, and take part in the discussions in an advisory capacity. Non-voting Board members perform a general and permanent advisory and supervisory role at the Company. However, they may not interfere in the management of the Company under any circumstances, or, in general, replace its legal bodies.

B. The Executive Management

Article 15 - Chief Executive Officers and Deputy Chief Executive Officers

The executive management of the Company is the responsibility of a private individual appointed by the Board of Directors bearing the title of Chief Executive Officer, under the Company’s responsibility.

The Board of Directors may appoint one or more private individuals responsible for assisting the Chief Executive Officer, who will bear the title of Deputy Chief Executive Officer, on the recommendation of the Chief Executive Officer. The number of Deputy Chief Executive Officers cannot exceed five.

The Chief Executive Officer may be dismissed by the Board of Directors at any time. The same applies to the Deputy Chief Executive Officers, on the recommendation of the Chief Executive Officer. If the dismissal is not on justified grounds, it may result in the payment of damages and interest.

Where the Chief Executive Officer ceases, or is otherwise prevented from performing their duties, the Deputy Chief Executive Officers will retain their positions and their assignments until a new Chief Executive Officer is appointed, unless the Board decides otherwise.

6

The Board of Directors determines the compensation paid to the Chief Executive Officer and the Deputy Chief Executive Officers, in accordance with applicable law.

Article 16—Powers of the Chief Executive Officer and Deputy Chief Executive Officers

The Chief Executive Officer is granted very extensive powers to act in the Company’s name in all circumstances. They exercise the powers within the limit of the corporate purpose, and subject to those that the law and these By-Laws expressly assign to General Meeting of Shareholders and to the Board of Directors.

They represent the Company in its dealings with third parties. The Company will be committed even by the Chief Executive Officer’s actions that do not relate to the corporate purpose, unless it proves that the third party was aware that the action exceeded that purpose, or could not ignore this fact in view of the circumstances. The sole publication of the By-Laws does not amount to sufficient proof.

The Board of Directors determines the scope and term of the powers granted to the Deputy Chief Executive Officers, with the Chief Executive Officer’s consent. The Deputy Chief Executive Officers have the same powers as the Chief Executive Officer where third parties are concerned.

III. - GENERAL MEETING OF SHAREHOLDERS

Article 17 - General Meeting of Shareholders

The duly constituted General Meeting of Shareholders represents the entire body of shareholders.

Its decisions, which are taken in accordance with the law and the By-Laws, are binding on all of the shareholders, even if they are absent, disagree, or are incapable.

There are three forms of meetings, depending on the purpose of the resolutions put forward:

• Ordinary General Meetings;

• Extraordinary General Meetings;

• Special Meetings that bring together the holders of shares in a given class.

Article 18 - Invitations

The Meetings are convened by the Board of Directors. They may also be convened by the Statutory Auditor or by a court representative, under the conditions and in accordance with the procedures provided for by law.

Meetings are convened by the liquidator(s) during the liquidation period.

The Meetings are held at the registered office or at any other location specified in the notice of meeting.

A notice of meeting is published in the Bulletin des Annonces Légales Obligatoires (French Official Gazette, or BALO) at least thirty-five days before a Meeting is held. In addition to the information relating to the Company, the notice specifies the agenda for the Meeting, and the wording of the draft resolutions that will be put forward. Requests to enter points or draft resolutions on the agenda must be addressed to the Company under the conditions provided for by the regulations in effect.

The Meetings are held at the registered office or at any other location specified in the notice of meeting.

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Subject to specific legal provisions, the invitation is issued at least fifteen days before the date of the Meeting by a notice inserted in a legal gazette published in the Department where the registered office is located, as well as in the BALO.

However, individuals who have held registered shares for at least one month at the date of the last published notice of meeting must be invited on an individual basis, via an ordinary letter (or via registered letter if they make the request and advance the related cost) sent to their last known address. This invitation may also be forwarded via means of electronic telecommunication, instead of by letter, to any shareholder who makes the request beforehand via registered letter with acknowledgment of receipt, in accordance with the legal and regulatory requirements, and provides their email address. The shareholder may expressly ask the Company for the aforementioned means of telecommunication to be replaced by a letter in the future, via registered letter with a request for acknowledgment of receipt.

The notice of meeting must also specify the conditions under which shareholders may vote by post, and the places where, and terms and conditions according to which, they may obtain postal vote forms. Where applicable, the notice of meeting may be sent with a proxy form and a postal vote form under the conditions specified in Article 21. I of these By-Laws, or only with a postal vote form, under the conditions specified in Article 21. II of these By-Laws.

Where a Meeting has been unable to take decisions as a result of failing to achieve the quorum required, a second Meeting will be convened, subject to specific legal provisions, at least ten days in advance, in the forms provided for by the regulations in effect.

Article 19 - Agenda

The agenda for Meetings will be prepared by the person convening the meeting.

One or several shareholders, who represent at least the percentage of the share capital specified by law, and acting in accordance with the legal conditions and timeframes, have the option to request the inclusion of points or draft resolutions on the agenda for the Meeting, via registered letter with a request for acknowledgment of receipt.

The Meeting may not discuss an issue that has not been entered on the agenda, which cannot be altered at the time of the second invitation. However, it may dismiss one or several members of the Board of Directors, and replace them in all circumstances.

Article 20 - Shareholders’ attendance at the Meetings

Any shareholder has the right to attend the Meetings and to participate in the discussions

(i) either in person; or

(ii) by granting a proxy to any private individual or legal entity of their choice; or

(iii) by sending a proxy to the Company with no specified mandate; or

(iv) by voting by post; or

(v) via video-conference, or via another means of telecommunication that complies with the applicable legal and regulatory provisions.

Attendance at General Meetings of Shareholders in any form is conditional on registering or entering the shares under the conditions and according to the timeframes provided for by the regulations in effect.

The final date for returning postal vote forms is determined by the Board of Directors, and announced in the notice of meeting published in the BALO. This date cannot be less than three days before the Meeting.

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Shareholders who have voted by post will no longer have the option to take part in the Meeting directly, or to be represented by a proxy.

In the event that the proxy form and the postal vote form are returned by post, the proxy form will be taken into consideration, subject to the votes expressed in the postal vote form.

Article 21 - Shareholder representation

I. Any shareholder may have themselves represented at Meetings by any private individual or legal entity of their choice, via a proxy form sent to them by the Company:

• either at their request sent to the Company via any means. This request must be received at the registered office at least five days before the Meeting;

• or at the Company’s initiative.

The proxy granted by a shareholder in order to have themselves represented at a Meeting will be signed by the latter, via a secure electronic signature process, where applicable, or via any other reliable identification process that guarantees their link to the deed to which it is attached.

The proxy may be revoked in the same way as the proxies required to appoint a representative.

All of the documents and information provided for by the regulations in effect must be enclosed with any proxy form sent to shareholders by the Company for each Meeting.

The proxy granted by a shareholder will only be valid for a single Meeting, or for any successive meetings convened with the same agenda. It may also be granted for two Meetings, one of which is Ordinary, and the other one of which is Extraordinary, and which are held on the same day, within a period of fifteen days.

II. Any shareholder may vote by post using a voting form sent to them by the Company

• at their request, and addressed in writing. This request must be deposited with or reach the registered office at least six days before the date of the Meeting, or

• at the Company’s initiative, or

• as an appendix to a proxy vote form, under the conditions provided for by the regulations in effect.

All of the documents and information provided for by the regulations in effect must be attached to any postal vote form sent to shareholders by the Company for each Meeting.

The postal vote form sent to a shareholder will only be valid for a single Meeting or for successive Meetings convened with the same agenda.

Article 22 - Attendance sheet

An attendance sheet containing the information specified by law will be kept at each Meeting.

This attendance sheet, duly initialed by the shareholders present and the proxies, and the shareholders attending via video-conference or another means of telecommunication, in accordance with the legal and regulatory requirements, and to which the powers granted to each representative are appended, together with the postal voting forms, will be certified as accurate by the Meeting Bureau.

The Meetings will be chaired by the Chairman of the Board of Directors. Otherwise, the Meeting will elect its own Chairman.

The tellers’ duties will be performed by two shareholders who are present and agree to do so, and who represent the highest number of votes, both on their own behalf and as proxies.

9

The Bureau formed in this way will appoint a secretary, who may be chosen from outside the shareholders.

Article 23 - Quorum

In Ordinary and Extraordinary General Meetings of Shareholders, the quorum will be calculated on the basis of all of the shares that make up the share capital and, in Special General Meetings of Shareholders, of all the shares in the class in question, minus any shares to which no voting rights are attached, in accordance with the provisions of the law.

The voting right attached to the shares is proportional to the percentage of the total share capital that they represent. Each equity share or dividend share will grant entitlement to one vote. Fully paid-up shares for which proof can be provided that they have been registered in the name of the same shareholder for at least two years do not benefit from double voting rights.

In the event of a postal vote, only the forms filled in and received by the Company at least three days before the Meeting is held will be taken into account.

Forms not indicating a vote or expressing an abstention are not considered as expressed votes.

Article 24 - Minutes

The decisions taken at the Meetings will be recorded in minutes that are drawn up in a special ledger held at the registered office, and signed by the members of the Bureau.

Copies or excerpts of the minutes of the decisions will be certified either by the Chairman of the Board of Directors or by the Meeting Secretary. They will be validly certified by the liquidator(s) in the event of liquidation proceedings.

Article 25 - Disclosure of documents

Any shareholder has the right to obtain disclosure of, and the Board of Directors is required to send or make available to them, the documents required to enable them to form an opinion in full knowledge of the facts, and to make an informed judgment on the Company’s management and operations.

The nature of these documents, and the conditions for sending them or making them available to the shareholders are determined by the regulations in effect.

Every shareholder or their representative may seek the assistance of an expert registered on one of the lists drawn up by the courts, in order to exercise their right of disclosure.

The exercise of the right of disclosure entails the right to take copies, except where records are concerned.

Article 26 - Ordinary General Meeting of Shareholders

The Ordinary General Meeting of Shareholders takes all of the decisions that exceed the powers of the Board of Directors and which do not fall within the remit of the Extraordinary General Meeting of Shareholders.

The Meeting is convened at least once a year, within a period of six months following the end of each financial year, in order to approve the financial statements for that year, subject to this period being extended by an order from the Presiding Judge of the Commercial Court ruling at the request of the Board of Directors.

The Meeting is convened on an extraordinary basis every time that this appears to be in the Company’s interests.

10

When convened for the first time, the Ordinary General Meeting of Shareholders may only validly deliberate if the shareholders present, represented, or who have voted by post hold at least one fifth of the shares to which voting rights are attached.

No quorum is required if the meeting is convened for a second time and the original agenda has not been amended.

The Ordinary General Meeting of Shareholders decides by a majority of the votes expressed by the shareholders present, represented or voting by mail. The expressed votes do not include those attached to shares for which the shareholder has not taken part in the vote, has abstained or has voted blank or null.

Article 27 - Extraordinary General Meeting of Shareholders

Only the Extraordinary General Meeting of Shareholders is authorized to amend all of the provisions of the By-Laws, and to specifically decide on turning the Company into a company with another legal form. It cannot, however increase the shareholders’ undertakings, except in the case of transactions resulting from a duly executed reverse share split.

The Extraordinary General Meeting of Shareholders may only validly deliberate if the shareholders present, represented or who have voted by post hold at least one quarter of the shares with voting rights at the time of the first invitation, and one fifth of the shares with voting rights at the time of the second invitation. If the second quorum is not achieved, the second Meeting may be postponed to a date no later than two months after the date on which it was convened.

The Meeting passes resolutions based on a two-thirds majority vote expressed by the shareholders who are present, represented, or have voted by post, or who are attending the Meeting via video-conference or another means of telecommunication, in accordance with the legal and regulatory provisions.

As a legal exemption to the above provisions, a General Meeting of Shareholders that decides on a capital increase via the capitalization of reserves, profits, or share premiums may pass resolutions under the same quorum and majority conditions as an Ordinary General Meeting of Shareholders.

Furthermore, where the Extraordinary General Meeting of Shareholders is required to discuss the approval of a contribution in kind or the granting of a particular benefit, the shares held by the individual making the contribution or the beneficial owner will not be taken into account to calculate the majority. The individual making the contribution or the beneficial owner will not have a vote, either on their own behalf, or as a proxy.

Article 28 - Special Meeting

If there are several share classes, no change may be made to the rights attached to shares in one of these classes without a due vote at an Extraordinary General Meeting of Shareholders open to all shareholders and, furthermore, without an equally compliant vote at a Special Meeting open only to the holders of shares in the class in question.

Special Meetings may only validly discuss matters if the shareholders present, represented, who have voted by post, or who are attending the Meeting via video-conference or via another means of telecommunication in accordance with the legal and regulatory provisions, hold at least one third of the shares with voting rights, where an amendment to those rights is planned, on the first invitation, and one fifth of the shares on the second invitation. Otherwise, the second Special Meeting may be postponed to a date no later than two months after the date on which it was convened.

Special Meetings pass resolutions based on a two-thirds majority of the expressed votes of the shareholders present or represented.

11

IV. - THE COMPANY’S SECURITIES

Article 29 - Payment for the shares

At least 25% of the par value of shares subscribed in cash must be paid at the time of subscription, together with the full share premium, where applicable.

The balance must be paid in one or several installments, as called by the Board of Directors, and within a period of five years from the date on which the capital increase was finalized.

Calls for funds are made known to the shareholders via a notice published in the BALO fifteen (15) days in advance.

If the shareholder does not make the required payments on the amount of the shares to which they have subscribed at the times determined by the Board of Directors, these payments will automatically bear interest payable to the Company at the legal rate determined in Article L. 313-2 of the French Monetary and Financial Code, as from the end of the month following the date when they are due, without any requirement for a court application or letter of notice. Furthermore, shares for which the required payments have not been made at the end of a period of 30 days as from the sending of a letter of notice to the defaulting shareholder, to which no reply has been received, will no longer grant the right to attend General Meetings of Shareholders and to vote at those Meetings, and will be deducted from the quorum calculation. The right to dividends, and the preferential right to subscribe to capital increases attached to the shares will be suspended. These rights will be recovered once the capital and interest amounts due have been paid. The shareholder may then request the payment of dividends that have not expired, and exercise their preferential subscription right, if the determined timeframe for exercising that right has not expired.

The share capital must be fully paid up before any issue of new shares to be paid for in cash.

Article 30 - Form of the shares - Management of the securities accounts

The shares may be in registered or bearer form, if the legislation allows, depending on the shareholder’s choice.

Issued shares give rise to a registration in individual accounts in the name of each shareholder opened by the Company or any authorized intermediary. These accounts are held under the conditions and in accordance with the procedures provided for by the legal and regulatory provisions.

In order to identify the owners of bearer shares, the company may, under the conditions provided for by the legal and regulatory provisions in force, request, at any time, information concerning the owners of its shares and securities conferring immediate or future voting rights at its own General Meetings of Shareholders.

Article 31 - Transfer of the shares

Shares registered on an account are transferred from account to account.

Cash shares are freely tradable as from the completion of the capital increase. Shares resulting from contributions are freely tradable as from the completion of the capital increase, i.e. the date of the Meeting or of the meeting of the Board of Directors acting on a delegation of authority, which approved the contributions, in the event of a contribution in kind during the term of the company.

The transfer of ownership will result from their registration on the purchaser’s account, on the date and under the conditions determined by law and the applicable regulations, where applicable.

The shares will be freely tradable, subject to the provisions provided for by law.

Article 32 - Crossing of thresholds

Any private individual or legal entity referred to in Articles L. 233-7, L. 233-9, and L. 223-10 of the French Commercial Code who comes to directly or indirectly hold a number of shares representing a percentage of the Company’s share capital or voting rights higher than or equal to 2.5% or a multiple of that percentage, either on a stand-alone basis or in concert, must inform the Company of the total

12

number of shares, voting rights, and securities granting access to the share capital or to voting rights immediately or in the future that they hold, via registered letter with a request for an acknowledgment of receipt sent to the registered office within a period of four trading days, prior to the market close as from the point when they crossed said percentage threshold(s).

The disclosure obligation provided for above also applies under the same conditions when each threshold mentioned above is crossed downwards.

If they have not been reported under the conditions specified above, shares or voting rights that exceed the percentage that should have been reported will be stripped of their voting rights at General Meetings of Shareholders at any Meeting that may be held until the expiry of a two-year period following the date when the notice of interest was made compliant, in accordance with Article L. 233-14 of the French Commercial Code, if a failure to report has been observed, and if one or several shareholders holding an interest of at least 2.5% have made a request recorded in the minutes of the General Meeting of Shareholders.

The above reports will apply notwithstanding the reports on the crossing of thresholds provided for by the legal or regulatory provisions in effect.

Article 33 - Rights and obligations attached to the shares

Each share entitles the holder to a share in the Company’s profits and assets, in proportion to the amount of capital that it represents.

Furthermore, each share entitles the holder to vote and be represented at General Meetings of Shareholders under legal and statutory provisions.

Shareholders will only be liable up to the amount of the par value of the shares that they hold; any calls for funds above that amount are prohibited.

Ownership of a share automatically entails adherence to the Company’s By-Laws and to the decisions of the General Meeting of Shareholders.

Heirs, creditors, assigns, or other representatives of a shareholder will not be entitled to request seizure of the Company’s assets or securities, or ask for them to be shared out or sold at auction, nor interfere in administrative acts relating to the Company in order to exercise their rights; they must refer to the company records and to the resolutions of the General Meeting of Shareholders.

Whenever it is necessary to hold several shares in order to exercise a given right, such as in the case of an exchange, reverse share split or allotment of shares, or an increase or decrease in the share capital, or a merger or other corporate transaction, the holders of single shares, or of a lower number of shares than required, may only exercise these rights if they personally arrange for the consolidation, and potentially the purchase or sale of the shares required.

However, in the event of the exchange of securities following a merger or demerger transaction, a capital decrease, a reverse share split or share split, and the mandatory conversion of bearer shares to registered shares, or of the distribution of securities charged to the reserves relating to a capital decrease, or the distribution or allotment of bonus shares, based solely on a decision by the Board of Directors, the Company may sell securities that the beneficiaries have requested to be delivered to them, as long as it has carried out the publication formalities provided for in the regulations at least two years beforehand.

As from the sale, the old securities or the old rights to distributions or allotments will be canceled, as and when required, and their holders will only be able to claim the cash allocation of the net proceeds of the sale of the unclaimed securities.

Article 34 - Beneficial & Bare ownership

The shares are indivisible as regards the Company.

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Joint owners of shares are required to have themselves represented to the Company by just one of them, who will be considered as the sole owner, or by a single proxy; in the event of disagreement, the single proxy may be appointed by a court at the request of the first joint owner to do so.

Unless the Company has been notified of an agreement to the contrary, the beneficial owners of shares will validly represent the bare owners with the Company. Voting rights will be held by the beneficial owner at Ordinary General Meetings of Shareholders and by the bare owner at Extraordinary General Meetings of Shareholders.

Unless otherwise agreed between the parties, the preferential subscription right attached to securities belongs to the bare owner where the shares are encumbered by a usufruct interest.

V. - COMPANY FINANCIAL STATEMENTS

Article 35. - Preparation and approval of the company financial statements

a) The Board of Directors will draw up an inventory and the annual financial statements at the end of each financial year, and will then prepare the management report.

Where applicable, the Board of Directors will prepare and publish the consolidated financial statements, together with the report regarding the management of the Group.

b) The Ordinary General Meeting of Shareholders will approve the annual company financial statements within a period of six months following the financial year-end, after familiarizing itself with the management report and the report prepared by the Statutory Auditors; the consolidated financial statements and the report regarding the management of the Group will be presented at that Meeting, if required.

All information measures will be taken in compliance with the law and the regulations.

Article 36 - Audit of the financial statements

The financial statements will be audited by one or several incumbent, and, where applicable, alternate Statutory Auditors, under the conditions determined by Articles L. 225-218 of the French Commercial Code.

Article 37 - Allocation of the amounts available for distribution

Following the approval of the financial statements, and the recording of the existence of amounts available for distribution, the Ordinary General Meeting of Shareholders will determine the share of these amounts allotted to the shareholders in the form of a dividend; this dividend will be charged to the distributable profit for the year as a priority.

The procedures for paying the dividends or interim dividends are determined by the General Meeting of Shareholders.

Write-down differences are not available for distribution.

If required, the Meeting will allocate the non-distributed portion of the profit for the financial year available for distribution in the proportions that it determines, either to one or several reserves, which may be general or special, which remain at its disposal, or to the “retained earnings” account.

Any losses will be carried forward, unless the Meeting decides to offset them against existing reserves.

14

VI. - LIQUIDATION OF THE COMPANY

Article 38 - Liquidation

Once it has been wound up, the Company will be liquidated under the conditions determined by the French Commercial Code.

Unless the Ordinary General Meeting of Shareholders decides otherwise, the liquidator or liquidators will pursue any ongoing business until it is completed.

The net proceeds of the liquidation, following the settlement of the liabilities and payroll expenses, and repayment to the shareholders of the non-amortized par value of their shares, will be divided between the shareholders, taking the rights of the different share categories into account, where applicable.

Vll - MISCELLANEOUS ITEMS

Article 39 - Powers

All powers will be granted to the bearers of original copies of these By-Laws, or of copies or excerpts certified as original, in order to carry out all formalities.

15

EX-31.1

Exhibit 31.1

Certification by the Chief Executive Officer pursuant to Securities Exchange Act Rules 13a-14(a) and 15d-14(a) as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002

I, Daniel Tassé, certify that:

1. I have reviewed this quarterly report on Form 10-Q of DBV Technologies S.A.;

2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

3. Based on my knowledge, the financial statement, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

4. The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to use by others within those entities, particularly during the period in which this report is being prepared;

b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be signed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

c) Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

d) Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and

5. The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):

a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and

b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the

registrant’s internal control over financial reporting.

Date: August 1, 2022

/s/ Daniel Tassé

Daniel Tassé

Chief Executive Officer

(Principal Executive Officer)

EX-31.2

Exhibit 31.2

Certification by the Chief Financial Officer pursuant to Securities Exchange Act Rules 13a-14(a) and 15d-14(a) as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002

I, Sébastien Robitaille, certify that:

1. I have reviewed this quarterly report on Form 10-Q of DBV Technologies S.A.;

2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statement were made, not misleading with respect to the period covered by this report;

3. Based on my knowledge, the financial statements and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

4. The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

c) Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

d) Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and

5. The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):

a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and

b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

Date: August 1, 2022

/s/ Sébastien Robitaille

Sébastien Robitaille

Chief Financial Officer

(Principal Financial and Accounting Officer)

EX-32.1

Exhibit 32.1

Certification by the Chief Executive Officer and Chief Financial Officer pursuant to 18 U.S.C. 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002

Pursuant to the requirement set forth in Rule 13a-14(b) of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), and Section 1350 of Chapter 63 of Title 18 of the United States Code (18 U.S.C. § 1350), Daniel Tassé, Chief Executive Officer of DBV Technologies S.A. (the “Company”), and Sébastien Robitaille, Chief Financial Officer of the Company, each hereby certifies that, to the best of his knowledge:

1. The Company’s Quarterly Report on Form 10-Q for the period ended June 30, 2022, to which this Certification is attached as Exhibit 32.1 (the “Quarterly Report”), fully complies with the requirements of Section 13(a) and Section 15(d) of the Exchange Act, and

2. The information contained in the Quarterly Report fairly presents, in all material respects, the financial condition and results of operations of the Company.

Date: August 1, 2022

/s/ Daniel Tassé	/s/ Sébastien Robitaille
Daniel Tassé Chief Executive Officer (Principal Executive Officer)	Sébastien Robitaille Chief Financial Officer (Principal Financial and Accounting Officer)

This certificate accompanies the Quarterly Report, is not deemed filed with the Securities and Exchange Commission and is not to be incorporated by reference into any filing of the Company under the Securities Act of 1933, as amended, or the Exchange Act (whether made before or after the date of the Quarterly Report), irrespective of any general incorporation language contained in such filing.

XML

Cover Page - shares	6 Months Ended
	Jun. 30, 2022	Aug. 01, 2022
Document Information [Line Items]
Document Type	10-Q
Amendment Flag	false
Document Period End Date	Jun. 30, 2022
Document Fiscal Year Focus	2022
Document Fiscal Period Focus	Q2
Entity Registrant Name	DBV TECHNOLOGIES S.A.
Entity Central Index Key	0001613780
Entity File Number	001-36697
Current Fiscal Year End Date	--12-31
Entity Current Reporting Status	Yes
Entity Address, Postal Zip Code	92120
Entity Filer Category	Non-accelerated Filer
Entity Interactive Data Current	Yes
Entity Common Stock, Shares Outstanding		94,025,192
Document Quarterly Report	true
Document Transition Report	false
Entity Shell Company	false
Entity Emerging Growth Company	false
Entity Address, Country	FR
Entity Small Business	true
Entity Incorporation, State or Country Code	I0
Entity Address, Address Line One	177-181 avenue Pierre Brossolette
Entity Address, City or Town	Montrouge
City Area Code	33
Local Phone Number	1 55 42 78 78
Entity Tax Identification Number	00-0000000
American Depositary Share [Member]
Document Information [Line Items]
Title of 12(b) Security	American Depositary Shares, each representing one-half of one ordinary share, nominal value €0.10 per share
Trading Symbol	DBVT
Security Exchange Name	NASDAQ
Ordinary Shares [Member]
Document Information [Line Items]
Title of 12(b) Security	Ordinary shares, nominal value €0.10 per share
No Trading Symbol Flag	true
Security Exchange Name	NASDAQ

XML

Condensed Consolidated Statements of Financial Position - USD ($) $ in Thousands	Jun. 30, 2022	Dec. 31, 2021
Current assets:
Cash and cash equivalents	$ 247,971	$ 77,301
Other current assets	11,981	37,085
Total current assets	259,953	114,386
Non-Current assets:
Property, plant, and equipment, net	15,677	18,146
Right-of-use assets related to operating leases	3,146	7,336
Intangible assets	14	22
Other non-current assets	6,189	6,833
Total non-current assets	25,025	32,338
Total Assets	284,978	146,723
Current liabilities:
Trade payables	16,341	11,429
Short-term operating leases	1,968	3,003
Short-term financial debt	156	510
Current contingencies	3,189	4,095
Other current liabilities	8,778	12,361
Total current liabilities	30,431	31,397
Non-Current liabilities
Long-term operating leases	1,945	7,147
Non-current contingencies	6,421	6,758
Other non-current liabilities	1,764	2,147
Total non-current liabilities	10,130	16,052
Total Liabilities	40,562	47,449
Shareholders' equity:
Ordinary shares, €0.10 par value; 94,022,679 and 55,095,762 shares authorized, and issued as at June 30, 2022 and December 31, 2021, respectively	10,708	6,538
Additional paid-in capital	456,447	358,115
Treasury stock, 106,287 and 153,631 ordinary shares as of June 30, 2022 and December 31, 2021, respectively, at cost	(953)	(1,232)
Accumulated deficit	(203,050)	(258,528)
Accumulated other comprehensive income	743	519
Accumulated currency translation effect	(19,480)	(6,137)
Total Shareholders' equity	244,416	99,274
Total Liabilities and Shareholders' equity	$ 284,978	$ 146,723

XML

Condensed Consolidated Statements of Financial Position (Parenthetical) - Common Shares [Member] - € / shares	Jun. 30, 2022	Dec. 31, 2021
Common stock shares par value	€ 0.1	€ 0.1
Common stock shares authorized	94,022,679	55,095,762
Common stock shares issued	94,022,679	55,095,762
Treasury stock, common, shares	106,287	153,631

XML

Condensed Consolidated Statements of Operations and Comprehensive Loss - USD ($) $ in Thousands	3 Months Ended		6 Months Ended
	Jun. 30, 2022	Jun. 30, 2021	Jun. 30, 2022	Jun. 30, 2021
Revenues
Operating income	$ 1,529	$ (1,488)	$ 4,074	$ 1,453
Operating expenses
Research and development expenses	(18,611)	(20,179)	(30,834)	(42,343)
Sales and marketing expenses	(1,037)	(1,198)	(1,500)	(1,927)
General and administrative expenses	(5,704)	(8,269)	(12,334)	(17,951)
Total Operating expenses	(25,352)	(29,646)	(44,669)	(62,221)
Loss from operations	(23,823)	(31,134)	(40,595)	(60,768)
Other Income (expenses)
Financial income	784	46	936	261
Loss before taxes	(23,039)	(31,088)	(39,659)	(60,507)
Income tax	0	434	(87)	404
Net loss	(23,039)	(30,654)	(39,746)	(60,103)
Foreign currency translation differences, net of taxes	(11,394)	2,788	(13,327)	(5,956)
Actuarial gains (losses) on employee benefits, net of taxes	200	48	224	(38)
Total comprehensive loss	$ (34,234)	$ (27,818)	$ (52,849)	$ (66,097)
Basic net loss per share attributable to shareholders	$ (0.35)	$ (0.56)	$ (0.66)	$ (1.09)
Weighted average shares outstanding used in computing per share amounts:	66,047,949	54,904,764	60,490,075	54,892,794
Diluted net loss per share attributable to shareholders	$ (0.35)	$ (0.56)	$ (0.66)	$ (1.09)
Weighted average shares outstanding used in computing per share amounts:	66,047,949	54,904,764	60,490,075	54,892,794

XML

Condensed Consolidated Statements of Cash Flows - USD ($) $ in Thousands	6 Months Ended
	Jun. 30, 2022	Jun. 30, 2021
Statement of Cash Flows [Abstract]
Net loss for the period	$ (39,746)	$ (60,103)
Cash flows used in operating activities:
Depreciation, amortization and accrued contingencies	1,249	8,619
Retirement pension obligations	14	57
Expenses related to share-based payments	2,441	2,527
Other elements	(3)	(843)
Changes in operating assets and liabilities:
Decrease (increase) in trade receivables	0	2,175
Decrease (increase) in other current assets	23,436	(8,393)
(Decrease) increase in trade payables	5,894	(3,165)
(Decrease) increase in other current and non-current liabilities	(3,040)	(6,608)
Change in operating lease liabilities and right of use assets	(1,979)	(769)
Net cash flow used in operating activities	(11,733)	(66,503)
Cash flows used in investing activities:
Acquisitions of property, plant, and equipment, net from proceeds	(369)	(13)
Proceeds from property, plant, and equipment dispositions	3	0
Acquisitions of non-current financial assets	(279)	0
Proceeds from non-current financial assets	426	0
Net cash flows used in investing activities	(218)	(13)
Cash flows provided by financing activities:
Decrease in conditional advances	(328)	(345)
Treasury shares	279	638
Capital increases, net of transaction costs	195,270	794
Other cash flows related to financing activities	0	(17)
Net cash flows provided by financing activities	195,221	1,071
Effect of exchange rate changes on cash and cash equivalents	(12,600)	(5,423)
Net increase (decrease) in cash and cash equivalents	170,670	(70,868)
Net Cash and cash equivalents at the beginning of the period	77,301	196,352
Net cash and cash equivalents at the end of the period	$ 247,971	$ 125,484

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Condensed Consolidated Statements of Changes in Shareholders' Equity $ in Thousands	USD ($)	EUR (€)	Common Shares [Member] USD ($) shares	Additional Paid-in Capital [Member] USD ($)	Treasury Stock [Member] USD ($)	Accumulated Deficit [Member] USD ($)	Accumulated Other Comprehensive income (loss) [Member] USD ($)	Accumulated Currency Translation Effect [Member] USD ($)
Beginning balance at Dec. 31, 2020	$ 205,491		$ 6,518	$ 1,152,042	$ (1,169)	$ (958,543)	$ 484	$ 6,158
Beginning balance (Shares) at Dec. 31, 2020 | shares			54,929,187
Net (loss)	(29,449)					(29,449)
Other comprehensive income (loss)	(8,829)						(85)	(8,744)
Issuance of ordinary shares	42		$ 1	42
Issuance of ordinary shares (Shares) | shares			7,500
Treasury shares	488				488
Share-based payments	1,433			1,433
Ending balance at Mar. 31, 2021	169,176		$ 6,519	1,153,516	(681)	(987,992)	399	(2,586)
Ending balance (Shares) at Mar. 31, 2021 | shares			54,936,687
Beginning balance at Dec. 31, 2020	205,491		$ 6,518	1,152,042	(1,169)	(958,543)	484	6,158
Beginning balance (Shares) at Dec. 31, 2020 | shares			54,929,187
Net (loss)	(60,103)
Issuance of ordinary shares | €		€ 3,285,566,900
Ending balance at Jun. 30, 2021	143,019		$ 6,529	357,530	(866)	(220,823)	446	203
Ending balance (Shares) at Jun. 30, 2021 | shares			55,011,687
Beginning balance at Mar. 31, 2021	169,176		$ 6,519	1,153,516	(681)	(987,992)	399	(2,586)
Beginning balance (Shares) at Mar. 31, 2021 | shares			54,936,687
Net (loss)	(30,654)					(30,654)
Other comprehensive income (loss)	2,836						48	2,788
Issuance of ordinary shares	473		$ 9	464
Issuance of ordinary shares (Shares) | shares			75,000
Issuance of warrants	279			279
Treasury shares	(185)				(185)
Share-based payments	1,094			1,094
Allocation of accumulated net losses				(797,823)		797,823
Ending balance at Jun. 30, 2021	143,019		$ 6,529	357,530	(866)	(220,823)	446	203
Ending balance (Shares) at Jun. 30, 2021 | shares			55,011,687
Beginning balance at Dec. 31, 2021	99,274		$ 6,538	358,115	(1,232)	(258,528)	519	(6,137)
Beginning balance (Shares) at Dec. 31, 2021 | shares			55,095,762
Net (loss)	(16,706)					(16,706)
Other comprehensive income (loss)	(1,909)						24	(1,933)
Issuance of ordinary shares	1		$ 1
Issuance of ordinary shares (Shares) | shares			775
Treasury shares	40				40
Share-based payments	1,363			1,363
Other changes						15		(15)
Ending balance at Mar. 31, 2022	82,062		$ 6,539	359,478	(1,193)	(275,219)	543	(8,086)
Ending balance (Shares) at Mar. 31, 2022 | shares			55,096,537
Beginning balance at Dec. 31, 2021	99,274		$ 6,538	358,115	(1,232)	(258,528)	519	(6,137)
Beginning balance (Shares) at Dec. 31, 2021 | shares			55,095,762
Net (loss)	(39,746)
Issuance of ordinary shares | €		3,285,566,900
Share-based payments | €		€ 95,281,440,100
Ending balance at Jun. 30, 2022	244,416		$ 10,708	456,447	(953)	(203,050)	743	(19,480)
Ending balance (Shares) at Jun. 30, 2022 | shares			94,022,679
Beginning balance at Mar. 31, 2022	82,062		$ 6,539	359,478	(1,193)	(275,219)	543	(8,086)
Beginning balance (Shares) at Mar. 31, 2022 | shares			55,096,537
Net (loss)	(23,039)					(23,039)
Other comprehensive income (loss)	(11,194)						200	(11,394)
Issuance of ordinary shares	107,176		$ 4,170	103,007
Issuance of ordinary shares (Shares) | shares			38,926,142
Issuance of warrants	88,094			88,094
Treasury shares	240				240
Share-based payments	1,078			1,078
Allocation of accumulated net losses				(95,209)		95,209
Ending balance at Jun. 30, 2022	$ 244,416		$ 10,708	$ 456,447	$ (953)	$ (203,050)	$ 743	$ (19,480)
Ending balance (Shares) at Jun. 30, 2022 | shares			94,022,679

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The Company

6 Months Ended

Jun. 30, 2022

Accounting Policies [Abstract]

The Company

Note 1: The Company

Incorporated in 2002 under the laws of France, DBV Technologies S.A. (“DBV Technologies,” or the “Company”, or the “group”) 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 9, 2022 (the “Annual Report”). The condensed consolidated statement of financial position at December 31, 2021 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, 2021.

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, 2022, 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 development activities conducted as part 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, and (7) estimate of contingencies.

Accounting Pronouncements adopted in 2022

The Company has not adopted any new accounting pronouncements in 2022 to date.

Accounting Pronouncements issued not yet adopted

In June 2016, the Financial Accounting Standards Board (“FASB”) issued ASU 2016-13—Financial Instruments—Credit losses, which replaces the incurred loss impairment methodology for financial instruments in current U.S. GAAP with a methodology that reflects expected credit losses and requires consideration of a broader range of reasonable and supportable information to inform credit loss estimates. The FASB has issued ASU 2019-10 which has resulted in the postponement of the effective date of the new guidance for eligible smaller reporting companies to the fiscal year beginning January 1, 2023. The guidance must be adopted using a modified-retrospective approach and a prospective transition approach is required for debt securities for which an other-than-temporary impairment had been recognized before the effective date. The Company is currently evaluating the impact of the guidance on its Consolidated Financial Statements. The Company does not expect this new standard will 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.

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Significant Events and Transactions

6 Months Ended

Jun. 30, 2022

Significant Events And Transactions Disclosure [Abstract]

Significant Events and Transactions

Note 2: Significant Events and Transactions

Clinical programs

ViaskinTM Peanut for children ages 4-11 in the United States

In January 2021, the Company received written responses from the FDA to questions provided in the Type A meeting request the Company submitted in October 2020 following the Complete Response Letter received in August 2020. The FDA agreed with its 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 order to confirm the consistency of efficacy data between the existing and a modified patch, FDA requested an assessment comparing the uptake of allergen (peanut protein) between the patches in peanut allergic children ages 4-11. The Company named that assessment EQUAL, which stands for Equivalence in Uptake of ALlergen. The FDA also recommended conducting a 6-month, well-controlled safety and adhesion trial to assess a modified Viaskin Peanut patch in the intended patient population. The Company later named this study STAMP, which stands for Safety, Tolerability, and Adhesion of Modified Patches.

Based on the January 2021 FDA feedback, the Company defined three parallel workstreams:

1. Identify a modified Viaskin patch (which the Company calls mVP).

2. Generate the 6-month safety and adhesion clinical data FDA requested via STAMP, which the Company expected to be the longest component of the mVP clinical plan. The Company prioritized the STAMP protocol submission so the Company could begin the study as soon as possible.

3. Demonstrate the equivalence in allergen uptake between the current and modified patches in the intended patient population via EQUAL. The complexity of EQUAL hinged on the lack of established clinical and regulatory criteria to characterize allergen uptake via an epicutaneous patch. To support those exchanges, the Company outlined its proposed approach to demonstrate allergen uptake equivalence between the two patches, and allotted time to generate informative data through two additional studies:

a. PREQUAL, a Phase I study with adult healthy volunteers to optimize the allergen sample collection methodologies and validate the assays we intend to use in EQUAL

b. ‘EQUAL in adults’—a second Phase I study with adult healthy volunteers to compare the allergen uptake of cVP and Mvp;

In March 2021, the Company commenced CHAMP (Comparison of adHesion Among Modified Patches), a trial in healthy adult volunteers to evaluate the adhesion of five modified Viaskin Peanut patches, to identify the one or two best-performing patches, which the Company completed in the second quarter of 2021. Based on the adhesion parameters studied, the Company selected the modified patch to advance to further clinical testing in the intended patient population. All modified Viaskin Peanut patches demonstrated better adhesion performance as compared to the then-current Viaskin Peanut patch, and the Company then selected two modified patches that performed best out of the five modified patches studied for further development. The Company then 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 its proposed STAMP protocol to the FDA, and in October 2021, the Company received an Advice/Information Request letter from the FDA. In this letter, the FDA requested a stepwise approach to the modified Viaskin patch development program and provided partial feedback on the STAMP protocol. Specifically, the FDA requested that the Company conduct allergen uptake comparison studies (i.e., ‘EQUAL in Adults’, EQUAL), and submit the allergen uptake comparison data for FDA review and feedback prior to starting the STAMP study.

After careful review of the FDA’s information requests, in December 2021, the Company decided not to pursue the stepwise approach to the development plans for Viaskin Peanut as requested by the FDA in the October 2021 letter. The Company estimated that the FDA’s newly proposed stepwise approach would require at least five rounds of exchanges that necessitate FDA alignment prior to initiating STAMP, the 6-month safety and adhesion study. As such, in December 2021, the Company announced its plan to initiate a pivotal Phase III placebo-controlled efficacy trial for a modified Viaskin Peanut patch (mVP) in children in the intended patient population. The clinical trial will also include updates to the Instructions for Use (IFU). The Company considers this approach the most straightforward to potentially demonstrate effectiveness, safety, and improved in vivo adhesion of the modified Viaskin Peanut system. The FDA confirmed the Company’s change in strategy is agreeable via oral and written exchanges.

The new Phase 3 pivotal study for modified Viaskin Peanut has been named VITESSE (Viaskin Peanut Immunotherapy Trial to Evaluate Safety, Simplicity and Efficacy), which means “speed” in French.

In May 2022, the Company announced that the FDA granted it a Type C meeting to align on the protocol and the study protocol was submitted to the FDA as part of the the Type C meeting briefing package. DBV continues to engage in productive dialogue with the FDA on the key elements of the VITESSE protocol. As previously disclosed, the Company will communicate key elements of the VITESSE trial design and projected timelines once this process has concluded.

Viaskin Peanut for children ages 4-11—European Union Regulatory History and Current Status

In August 2021, the Company announced its receipt from the EMA of the Day 180 list of outstanding issues, which is an established part of the prescribed EMA review process. It is a letter that is meant to include any remaining questions or objections at that stage in the process. The EMA indicated many of their objections and major objections from the Day 120 list of questions had been answered. One major objection remained at Day 180. The Major Objection questioned the limitations of the data, for example, the clinical relevance and effect size supported by a single pivotal study.

In December 2021, the Company announced it has withdrawn the Marketing Authorization Application for Viaskin Peanut and formally notified the EMA of our decision. The initial filing was supported by positive data from a single, placebo-controlled Phase 3 pivotal trial known as PEPITES (V712-301). The decision to withdraw was based on the view of EMA Committee for Medicinal Products for Human Use (CHMP) that the data available to date from a single pivotal study were not sufficient to preclude a Major Objection at Day 180 in the review cycle. The Company believes data from a second Viaskin Peanut pivotal study 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, patients 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 validate the ongoing investigation of the 250 Pg dose in this age group, which is the dose being studied in Part B of the study. Enrollment for Part B of EPITOPE was completed in the first quarter of 2022.

In June 2022, the Company announced that its pivotal Phase III trial EPITOPE, assessing the safety and efficacy of Viaskin™ Peanut 250 µg for the treatment of peanut-allergic toddlers ages 1 to 3 years, met its primary endpoint. Viaskin Peanut demonstrated a statistically significant treatment effect (p<0.001), with 67.0% of subjects in the Viaskin Peanut arm meeting the treatment responder criteria after 12 months, as compared to 33.5% of subjects in the placebo arm (difference in response rates = 33.4 %, 95 % CI = 22.4% - 44.5 %).

DBV intends to further analyze the data from EPITOPE and explore regulatory pathways for Viaskin Peanut in children ages 1 to 3 years, given the high unmet need and absence of approved treatments for this vulnerable population.

Financing

In May 2022, the Company announced that pursuant to the Company’s At-The-Market program established in May 2022 (the “ATM Program”), it had issued and completed sales of new ordinary shares (the “Ordinary Shares”) in form of American Depositary Shares (“ADSs”), for a total gross amount of $15.3 million. In this context, 6,036,238 new Ordinary Shares in form of ADS have been issued through a capital increase without preferential subscription rights of the shareholders reserved to specific categories of persons fulfilling certain characteristics (the “ATM Issuance”), at a unit subscription price of 1.27 dollar per ADS (i.e., a subscription price per Ordinary Share of 2.41 euro based on the USD/EUR exchange rate of 1.0531 dollar for 1 euro, as published by the European Central Bank on May 4, 2022) and each ADS giving the right to receive one-half of one ordinary share of the Company).

In June 2022, the Company announced an aggregate $194 million private investment in public equity (PIPE) financing (corresponding to €181 million on the basis of an exchange rate of $1.0739 = €1.00 published by the European Central Bank on June 8, 2022) from the sale of 32,855,669 ordinary shares, as well as pre-funded warrants to purchase up to 28,276,331 ordinary shares. The ordinary shares were sold to the purchasers at a price per ordinary share of €3.00 (corresponding to $3.22), and the pre-funded warrants were sold to the purchasers at a pre-funded price of €2.90 (corresponding to $3.11) per pre-funded warrant, which equals the per share price for the ordinary shares less the remaining €0.10 exercise price for each such pre-funded warrant. Gross proceeds from the PIPE financing total approximately $194 million (corresponding to €181 million), before deducting private placement expenses.

The ordinary shares, including the ordinary shares issuable upon exercise of the pre-funded warrants from the PIPE financing, have not been registered under the Securities Act of 1933, as amended, and may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements. The Company has agreed to file a registration statement with the Securities and Exchange Commission registering the resale of the ordinary shares, including the ordinary shares underlying the pre-funded warrants. 

Following the financing operations carried out in the first half of 2022, the Company has cash and cash equivalent to support the Company’s operations several months beyond the projected completion of VITESSE, the planned Phase 3 clinical study of the modified Viaskin™ Peanut patch in peanut allergic children ages 4 years and older.

COVID-19 Pandemic

On March 11, 2020, the World Health Organization declared COVID-19 a pandemic. This global health crisis led many countries to impose national containment measures and travel bans. In view of this exceptional situation, the Company decided to take all measures aimed primarily at guaranteeing the safety of its employees and the continuation of ongoing clinical trials, in compliance with the directives of the authorities in each country. The Company has experienced a decrease in new patients enrolling in the ongoing clinical studies and it has had to adapt the protocols of its clinical trials because patients remain subject to travel restrictions.

The Company has assessed the impact of the uncertainties created by the pandemic. As of June 30, 2022, those uncertainties were taken into account in the assumptions underlying the estimates and judgments used by the Company. The Company continues to update these estimates and assumptions as the situation evolves. The effects of the COVID-19 pandemic are presented in the relevant line items of the condensed consolidated statement of financial position and the condensed consolidated statement of operations according to the function or nature of the income or expense.

Legal Proceedings

A class action complaint was filed on January 15, 2019 in the United States District Court for the District of New Jersey, entitled Travis Ito-Stone v. DBV Technologies, et al., Case No. 2:19-cv-00525. The complaint alleged that the Company and its former Chief Executive Officer, its current Chief Executive Officer, and its former Deputy Chief Executive Officer violated certain federal securities laws, specifically under Sections 10(b) and 20(a) of the Exchange Act, and Rule 10b-5 promulgated thereunder. The plaintiffs seek unspecified damages on behalf of a purported class of purchasers of the Company’s securities between February 14, 2018 and August 4, 2020 and also held the Company’s securities on December 20, 2018 and/or March 16, 2020 and/or August 4, 2020.

A hearing was held on July 29, 2021 in the U.S. District Court for the District of New Jersey where the Court entered an order granting the Company’s Motion to Dismiss the Second Amended Class Action Complaint without prejudice. As the dismissal was without prejudice, the Plaintiffs replead their case by filing a Third Amended Class Action Complaint on September 30, 2021 in the same Court. The company moved to dismiss third amended complaint on December 10, 2021.

On July 29, 2022 the Court entered an order granting the Company’s Motion to Dismiss the Plaintiff’s Third Amended Complaint with prejudice. The Court indicated that the Third Amended Complaint was deficient in a number of ways, failing to allege a violation of the Securities Exchange Act of 1934, and ordered the matter closed. Per court procedural rules, the Plaintiffs have 30 days to appeal the dismissal of the Third Amended.

The Company believes that the allegations contained in the amended complaint are without merit and will continue to defend the case vigorously. The Company believes this complaint will not have a material adverse effect on the Company’s consolidated financial position, results of operations or liquidity.

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Cash and Cash Equivalents

6 Months Ended

Jun. 30, 2022

Cash and Cash Equivalents [Abstract]

Cash and Cash Equivalents

Note 3: Cash and Cash Equivalents

The following tables summarize the cash and cash equivalents as of June 30, 2022 and December 31, 2021:

	June 30,		December 31,
	2022		2021
Cash		226,674		31,427
Cash equivalents		21,298		45,874
Total cash and cash equivalents as reported in the statements of financial position		247,971		77,301

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

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Other current assets

6 Months Ended

Jun. 30, 2022

Other Current Assets [Abstract]

Other current assets

Note 4 Other Current Assets

Other current assets consisted of the following:

	June 30,		December 31,
	2022		2021
Research tax credit		2,908		28,092
Other tax claims		4,339		3,561
Prepaid expenses		3,773		4,149
Other receivables		961		1,283
Total		11,981		37,085

Research tax credit

In the fiscal year ended December 31, 2021, the Company recovered its Small and Medium-sized Enterprises, or SMEs, status under EU law, and became therefore eligible again for the immediate reimbursement of the Research Tax Credit.

During the six months period ended June 30, 2022, the Company received the reimbursement of the 2019, 2020 and 2021 fiscal year research tax credit.

The variance in Research Tax Credit is presented as follows:

	Amount in thousands of US Dollars
Opening research tax credit receivable as of January 1, 2022		28,092
+ Operating revenue		3,060
- Payment received		(27,119	)
- Adjustment and currency translation effect		(1,125	)
Closing research tax credit receivable as of June 30, 2022		2,908
Of which - Non-current portion		—
Of which - Current portion		2,908

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 also include upfront payments which are recognized over the term of the ongoing clinical studies.

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Lease contracts

6 Months Ended

Jun. 30, 2022

Lessee Disclosure [Abstract]

Lease contracts

Note 5 Lease contracts

Future minimum lease payments under the Company’s operating leases’ right of use as of June 30, 2022 and December 31, 2021, are as follows:

	June 30, 2022									December 31, 2021
	Real estate			Other assets			Total			Real estate			Other assets			Total
Current portion		2,104			50			2,154			3,361			77			3,438
Year 2		1,843			19			1,862			3,124			23			3,147
Year 3		284			11			295			2,299			18			2,317
Year 4		—			—			—			771			1			773
Year 5		—			—			—			790			—			790
Thereafter		—			—			—			1,220			—			1,220
Total minimum lease payments		4,231			80			4,311			11,565			119			11,684
Less: Effects of discounting		(363	)		(6	)		(370	)		(1,526	)		(8	)		(1,534	)
Present value of operating lease		3,868			73			3,941			10,039			111			10,150
Less: current portion		(1,922	)		(46	)		(1,968	)		(2,929	)		(74	)		(3,003	)
Long-term operating lease		1,946			27			1,973			7,110			37			7,147
Weighted average remaining lease term (years)		1.79			—						4.14			2.01
Weighted average discount rate		3.14	%		1.29	%					4.84	%		3.32	%

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:

	June 30,
	2022			2021
Operating lease expense		950		1,698
Net termination impact		(1,657	)	—

In January 2022, the company entered into a termination agreement for its U.S. office in Summit, NJ, following the resizing of its facility use. The Company recognized an income of $1.2 million as of June 30, 2022 due to the early termination of its Summit, NJ lease, offset by the payment of a one-time lump sum early termination fee of $1.5 million.

On March 28, 2022, the Company entered into a binding office lease agreement in New Jersey for a lease term of 3 years and 2 months. The lease commencement was based upon delivery of possession of the premises by the Landlord and occurred on April 1, 2022. Right of use and related lease debt will be recorded starting April 1, 2022 for a gross amount of 0.4 million.

Supplemental cash flow information related to operating leases is as follows for the period June 30, 2022 and 2021:

	June 30,
	2022		2021
Cash paid for amounts included in the measurement of lease liabilities		—	—
Operating cash flows from operating leases		1,079	2,077

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Trade Payables and Other Current Liabilities

6 Months Ended

Jun. 30, 2022

Payables and Accruals [Abstract]

Trade Payables and Other Current Liabilities

Note 6: Trade Payables and Other Current Liabilities

6.1 Trade Payables

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 Liabilities

The following tables summarize the other liabilities as of June 30, 2022 and December 31, 2021:  

	June 30,						December 31,
	2022						2021
	Other current liabilities		Other non-current liabilities		Total		Other current liabilities		Other non-current liabilities		Total
Employee related liabilities		4,135		77		4,212		6,708		247		6,954
Deferred income		3,012		1,687		4,700		4,146		1,900		6,046
Tax liabilities		400		—		400		182		—		182
Other debts		1,231		—		1,231		1,325		—		1,325
Total		8,778		1,764		10,542		12,361		2,147		14,508

The other current liabilities include short-term debt to employees including social welfare and tax agency obligations.

Deferred income primarily includes deferred income from the collaboration agreement with Nestlé Health Science, which amounted to $4.7 million as of June 30, 2022.

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Shareholders' equity

6 Months Ended

Jun. 30, 2022

Stockholders' Equity Note [Abstract]

Shareholders' equity

Note 7: Shareholders’ equity

The share capital as of June 30, 2022 is set at the sum of €9,402,268 ($10,708,445 converted at historical rates). It is divided into 94,022,679 fully authorized, subscribed and paid-up shares with a par value of €0.10.

Pursuant to the authorization granted by the General Meeting of the Shareholders held on May 12, 2022 (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, 2021 have been allocated to additional paid-in capital.

Pursuant to the authorization granted by the SH General Meeting, the Board of Directors, at its meeting of June 9, 2022 (the “Board General Meeting”):

• decided, within the framework of the Issuance the principle of a capital increase in cash with cancellation of preferential subscription rights, reserved for categories of persons meeting which set out the characteristics included in the 18th resolution of the Board General Meeting, through the issuance of Ordinary Shares and warrants to subscribe for Ordinary Shares, for a maximum amount of 6,113,200 New Ordinary Shares, corresponding to the maximum issue ceiling under the 22nd resolution of the Board General Meeting;

• granted a number of authorizations for the purpose of carrying out the Issuance;

• sub-delegated its authority to the Chief Executive Officer for the purpose of implementing the financing.

The Chief Executive Officer, acting pursuant to the sub-delegations of authority granted by the Board of Directors of the Company on June 8, 2022, after receiving the favorable opinion of the Pricing Committee established by the Board of Directors, has, on June 9, 2022 :

• decided, making use of the 18th resolution of the Board General Meeting, to proceed with a capital increase in cash with cancellation of preferential subscription rights reserved for categories of investors, in accordance with the Article L. 225-128 of French Commercial Code, an amount of € 3,285,566.90, through the issuance of (i) 32,855,669 New Ordinary Shares, to be

subscribed in cash at a unit price of €2.90 of share premium) and to be fully paid up at the time of subscription, i.e. a capital increase of a nominal amount of €3,285,566.90 together with a share premium of € 95,281,440.10, i.e. a gross amount of the capital increase of € 98,567,007, and (ii) 28,276,331 prefunded warrants to be subscribed in cash by paying up on the date of issue of € 82,001,359.90 corresponding to the prepayment of the subscription price of the new ordinary shares in the event of exercise of the prefunded warrants,

• decided to set the maximum nominal amount of the capital increase resulting from the full exercise of the prefunded warrants at € 2,827,633.10, by issuing a maximum of 28,276,331 ordinary shares, with a value of € 0.10 to be subscribed in cash at the price of € 0.10 euro (without share premium), and to be fully paid up at the time of subscription, i.e. a capital increase of a maximum nominal amount of € 2,827,633.10 (and a share premium corresponding to the amount of the pre-financed price released in advance at the time of the subscription of the prefunded warrants ), being specified that this amount does not take into account the nominal value of the ordinary shares to be issued in order to preserve the rights of the holders of securities giving access to the capital issued or to be issued, in accordance with the legal and regulatory provisions and the contractual stipulations providing for other cases of adjustment if necessary;

• determined the list of beneficiaries (designated within each of the categories of persons defined in the 18th resolution of the Board General Meeting) and the number of New Ordinary Shares and warrants allocated to each of them under the conditions defined in the 18th resolution of the Board General Meeting beneficiaries under the conditions defined in section 5 of the offering circular relating to the Issue.

The Company has assessed the pre-funded warrants for appropriate equity or liability classification. During this assessment, the Company determined the pre-funded warrants are freestanding instruments that do not meet the definition of a liability pursuant to ASC 480 and do not meet the definition of a derivative pursuant to ASC 815.

The 2022 Warrants are classified as a component of permanent equity because they are freestanding financial instruments that are legally detachable and separately exercisable from the shares of common stock with which they were issued, are immediately exercisable, do not embody an obligation for the Company to repurchase its shares, and permit the holders to receive a fixed number of shares of common stock upon exercise. In addition, the 2022 Warrants do not provide any guarantee of value or return.

Accordingly, the pre-funded warrants are classified as equity and accounted for as a component of additional paid-in capital at the time of issuance.

The changes in number of outstanding prefunded warrants are as follows:

	Prefunded warrants
Balance as of December 31, 2021		—
Granted during the period		28,276,331
Forfeited during the period		—
Exercised/released during the period		—
Expired during the period		—
Balance as of June 30, 2022		28,276,331

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Share-Based Payments

6 Months Ended

Jun. 30, 2022

Share-based Payment Arrangement [Abstract]

Share-Based Payments

Note 8: Share-Based Payments

The Board of Directors has been authorized by the SH General Meeting to grant restricted stock units (“RSU”), stock options plan (“SO”), employee warrants (Bons de Souscription de Parts de Créateur d’Entreprise or “BSPCE”) and non-employee warrants (Bons de Souscription d’Actions or “BSA”).

During the six months ended June 30, 2022, the Company granted 19,000 stock options and 3,200 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 13 to the consolidated financial statements included in the Annual Report.

Stock option fair value assumptions during the six months ended June 30, 2022
Weighted average share price at grant date in €	2.42
Weighted average expected volatility	92.4	%
Weighted average risk-free interest rate	0.86	%
Weighted average expected term (in years)	6
Dividend yield	—
Weighted average fair value of stock options in €	1.81

Change in Number of BSA/SO/RSU:

	Number of outstanding
	BSA		SO			RSUs
Balance as of December 31, 2021		256,693		3,631,210			1,240,520
Granted during the period		—		19,000			3,200
Forfeited during the period		—		(205,728	)		(66,588	)
Exercised/released during the period		—		(2,125	)		(31,910	)
Expired during the period		—		—			—
Balance as of June 30, 2022		256,693		3,442,358			1,145,223

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

		Three Months Ended June 30,						Six Months Ended June 30,
		2022			2021			2022			2021
Research & development	SO		(290	)		(302	)		(665	)		(678	)
	RSU		(185	)		115			(393	)		(136	)
Sales & marketing	SO		(38	)		(63	)		(33	)		(112	)
	RSU		(17	)		(26	)		(16	)		(48	)
General & administrative	SO		(478	)		(709	)		(1,176	)		(1,353	)
	RSU		(70	)		(110	)		(157	)		(201	)
Total share-based compensation (expense)			(1,078	)		(1,094	)		(2,441	)		(2,527	)

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Contingencies

6 Months Ended

Jun. 30, 2022

Loss Contingency [Abstract]

Contingencies

Note 9: Contingencies

The following tables summarize the contingencies as of June 30, 2022 and December 31, 2021:

	June 30,		December 31,
	2022		2021
Current contingencies		3,189		4,095
Non-current contingencies		6,421		6,758
Total contingencies		9,610		10,853

The changes in contingencies are as follows:

	Pension retirement obligations			Collaboration agreement - Loss at completion			Other contingencies			Total
At January 1, 2022		1,008			9,800			45			10,853
Increases in liabilities		14			—			—			14
Used liabilities		—			(108	)		(44	)		(152	)
Reversals of unused liabilities		—			—			—			—
Net interest related to employee benefits, and unwinding of discount		—			—			—			—
Actuarial gains and losses on defined-benefit plans		(224	)		—			—			(224	)
Currency translation effect		(73	)		(807	)		(2	)		(882	)
At June 30, 2022		725			8,885			—			9,610
Of which Current		—			3,189			—			3,189
Of which Non-current		725			5,696			—			6,421

In 2021 and during the first six months of 2022, the Company updated its measurement of progress of the Phase 2 clinical trial (“PII”) conducted as part of the collaboration and license agreement with Nestlé and updated the cumulative income recognized. The Company has recorded an accrual in the amount of the excess between the Company’s current best estimates of costs yet to be incurred and incomes yet to be recognized for the completion of the PII.

There have been no significant changes in assumptions for the estimation of the retirement commitments from those disclosed in Note 14 to the consolidated financial statements included in the Annual Report.

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Operating Income

6 Months Ended

Jun. 30, 2022

Other Income and Expenses [Abstract]

Operating Income

Note 10: Operating income

The following table summarizes the operating income during the three and six months ended June 30, 2022 and 2021:

	Three Months Ended June 30,					Six Months Ended June 30,
	2022		2021			2022		2021
Research tax credit		1,491		1,870			3,060		3,677
Other operating income		37		(3,358	)		1,014		(2,225	)
Total		1,529		(1,488	)		4,074		1,453

As of June 30, 2022, the Company recorded its collaboration agreement’s revenue based on its updated measurement of progress of the Phase II clinical trial conducted as part of the agreement. The accrual recorded in the amount of the difference between the Company’s current best estimates of costs yet to be incurred and revenues yet to be recognized for the completion of the Phase II clinical trial has been updated accordingly.

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Allocation of Personnel Expenses

6 Months Ended

Jun. 30, 2022

Operating Expenses [Abstract]

Allocation of Personnel Expenses

Note 11: Allocation of Personnel Expenses

The Company had an average of 87 employees during the six months ended June 30, 2022, in comparison with an average of 111 employees during the six months ended June 30, 2021.

The following table summarizes the allocation of personnel expenses by function during the three and six months ended June 30, 2022 and 2021:

	Three Months Ended June 30,				Six Months Ended June 30,
	2022		2021		2022		2021
Research and Development expenses		3,097		3,393		6,172		8,111
Sales and Marketing expenses		344		518		589		1,036
General and Administrative expenses		2,767		2,999		5,362		6,765
Total personnel expenses		6,208		6,910		12,123		15,912

The following table summarizes the allocation of personnel expenses by nature during the three six months ended June 30, 2022 and 2021:

	Three Months Ended June 30,				Six Months Ended June 30,
	2022		2021		2022		2021
Wages and salaries		3,509		4,382		7,497		8,836
Social security contributions		1,256		1,064		1,507		2,396
Expenses for pension commitments		211		293		509		695
Employer contribution to bonus shares		154		77		170		1,458
Share-based payments		1,078		1,094		2,441		2,527
Total		6,208		6,910		12,123		15,912

The decrease in personnel expenses is mainly due to a decrease in headcount following the full implementation of the new organization.

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Commitments

6 Months Ended

Jun. 30, 2022

Commitments and Contingencies Disclosure [Abstract]

Commitments

Note 12: Commitments

There have been no significant changes in other commitments from those disclosed in Note 18 to the consolidated financial statements included in the Annual Report.

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Relationships with Related Parties

6 Months Ended

Jun. 30, 2022

Related Party Transactions [Abstract]

Relationships with Related Parties

Note 13: Relationships with Related Parties

The Company’s related parties consist exclusively of the members of the Board of Directors and the members of the Executive Committee. As of June 30, 2022, the total amount of remuneration granted to the members of the Board of Directors and Executive Committee has not changed significantly since December 31, 2021.

There were no new significant related-party transactions during the period nor any change in the nature of the transactions from those described in Note 19 to the consolidated financial statements included in the Annual Report.

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Loss Per Share

6 Months Ended

Jun. 30, 2022

Earnings Per Share [Abstract]

Loss Per Share

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, 2022 and 2021, 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, 2022 and 2021 indicated in number of potential shares:

 

	Three Months Ended June 30,				Six Months Ended June 30,
	2022		2021		2022		2021
Non-employee warrants		256,693		256,693		256,693		256,693
Stock options		3,442,358		2,594,410		3,442,358		2,594,410
Restricted stock units		1,145,223		1,092,445		1,145,223		1,092,445
Prefunded warrants		28,276,331		—		28,276,331		—

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Events After The Close Of The Period

6 Months Ended

Jun. 30, 2022

Subsequent Events [Abstract]

Events after the Close of the Period

Note 15: Events after the Close of the Period

As previously disclosed, a class action complaint was filed in January 2019 in the U.S. District Court, District of New Jersey, alleging that the Company and certain current and former executive officers violated certain U.S. federal securities laws. Plaintiffs filed a Third Amended Complaint on September 30, 2021. On July 29, 2022 the Court entered an order granting the Company’s Motion to Dismiss the Plaintiff’s Third Amended Complaint with prejudice. The Court indicated that the Third Amended Complaint was deficient in a number of ways, failing to allege a violation of the Securities Exchange Act of 1934, and ordered the matter closed. Per court procedural rules, the Plaintiffs have 30 days to appeal the dismissal of the Third Amended Complaint. The Company believes that the allegations contained in the complaint are without merit and will continue to defend the case vigorously. The Company evaluated no other subsequent events that occurred after June 30, 2022, through the date the condensed consolidated financial statements were issued after their approval by the Board of Directors on July 29, 2022 and determined that there are no significant events that require adjustments or disclosure in such condensed consolidated financial statements.

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The Company (Policies)

6 Months Ended

Jun. 30, 2022

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 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 9, 2022 (the “Annual Report”). The condensed consolidated statement of financial position at December 31, 2021 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, 2021.

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, 2022, or any other future period.

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 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 development activities conducted as part 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, and (7) estimate of contingencies.

Accounting Pronouncements adopted in 2022

Accounting Pronouncements adopted in 2022

The Company has not adopted any new accounting pronouncements in 2022 to date.

Accounting Pronouncements issued not yet adopted

Accounting Pronouncements issued not yet adopted

In June 2016, the Financial Accounting Standards Board (“FASB”) issued ASU 2016-13—Financial Instruments—Credit losses, which replaces the incurred loss impairment methodology for financial instruments in current U.S. GAAP with a methodology that reflects expected credit losses and requires consideration of a broader range of reasonable and supportable information to inform credit loss estimates. The FASB has issued ASU 2019-10 which has resulted in the postponement of the effective date of the new guidance for eligible smaller reporting companies to the fiscal year beginning January 1, 2023. The guidance must be adopted using a modified-retrospective approach and a prospective transition approach is required for debt securities for which an other-than-temporary impairment had been recognized before the effective date. The Company is currently evaluating the impact of the guidance on its Consolidated Financial Statements. The Company does not expect this new standard will 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.

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Cash and Cash Equivalents (Tables)

6 Months Ended

Jun. 30, 2022

Cash and Cash Equivalents [Abstract]

Summary of breakdown of cash and cash equivalents

The following tables summarize the cash and cash equivalents as of June 30, 2022 and December 31, 2021:

	June 30,		December 31,
	2022		2021
Cash		226,674		31,427
Cash equivalents		21,298		45,874
Total cash and cash equivalents as reported in the statements of financial position		247,971		77,301

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Other current assets (Tables)

6 Months Ended

Jun. 30, 2022

Other Current Assets [Abstract]

Summary of Other Current Asset

Other current assets consisted of the following:

	June 30,		December 31,
	2022		2021
Research tax credit		2,908		28,092
Other tax claims		4,339		3,561
Prepaid expenses		3,773		4,149
Other receivables		961		1,283
Total		11,981		37,085

Summary Of Research Tax Credit

The variance in Research Tax Credit is presented as follows:

	Amount in thousands of US Dollars
Opening research tax credit receivable as of January 1, 2022		28,092
+ Operating revenue		3,060
- Payment received		(27,119	)
- Adjustment and currency translation effect		(1,125	)
Closing research tax credit receivable as of June 30, 2022		2,908
Of which - Non-current portion		—
Of which - Current portion		2,908

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Lease contracts (Tables)

6 Months Ended

Jun. 30, 2022

Lessee Disclosure [Abstract]

Summary of Operating Leases Future Minimum Payments Receivable

Future minimum lease payments under the Company’s operating leases’ right of use as of June 30, 2022 and December 31, 2021, are as follows:

	June 30, 2022									December 31, 2021
	Real estate			Other assets			Total			Real estate			Other assets			Total
Current portion		2,104			50			2,154			3,361			77			3,438
Year 2		1,843			19			1,862			3,124			23			3,147
Year 3		284			11			295			2,299			18			2,317
Year 4		—			—			—			771			1			773
Year 5		—			—			—			790			—			790
Thereafter		—			—			—			1,220			—			1,220
Total minimum lease payments		4,231			80			4,311			11,565			119			11,684
Less: Effects of discounting		(363	)		(6	)		(370	)		(1,526	)		(8	)		(1,534	)
Present value of operating lease		3,868			73			3,941			10,039			111			10,150
Less: current portion		(1,922	)		(46	)		(1,968	)		(2,929	)		(74	)		(3,003	)
Long-term operating lease		1,946			27			1,973			7,110			37			7,147
Weighted average remaining lease term (years)		1.79			—						4.14			2.01
Weighted average discount rate		3.14	%		1.29	%					4.84	%		3.32	%

Summary of Rent expenses

Rent expense presented in the consolidated statement of operations and comprehensive loss was:

	June 30,
	2022			2021
Operating lease expense		950		1,698
Net termination impact		(1,657	)	—

Summary of Supplemental cash flow information related to our operating leases

Supplemental cash flow information related to operating leases is as follows for the period June 30, 2022 and 2021:

	June 30,
	2022		2021
Cash paid for amounts included in the measurement of lease liabilities		—	—
Operating cash flows from operating leases		1,079	2,077

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Trade Payables and Other Current Liabilities (Tables)

6 Months Ended

Jun. 30, 2022

Other Liabilities [Abstract]

Summary of Other Liabilities

The following tables summarize the other liabilities as of June 30, 2022 and December 31, 2021:  

	June 30,						December 31,
	2022						2021
	Other current liabilities		Other non-current liabilities		Total		Other current liabilities		Other non-current liabilities		Total
Employee related liabilities		4,135		77		4,212		6,708		247		6,954
Deferred income		3,012		1,687		4,700		4,146		1,900		6,046
Tax liabilities		400		—		400		182		—		182
Other debts		1,231		—		1,231		1,325		—		1,325
Total		8,778		1,764		10,542		12,361		2,147		14,508

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Shareholders' equity (Tables)

6 Months Ended

Jun. 30, 2022

Stockholders' Equity Note [Abstract]

Schedule of Nonvested Share Activity

The changes in number of outstanding prefunded warrants are as follows:

	Prefunded warrants
Balance as of December 31, 2021		—
Granted during the period		28,276,331
Forfeited during the period		—
Exercised/released during the period		—
Expired during the period		—
Balance as of June 30, 2022		28,276,331

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Share-Based Payments (Tables)

6 Months Ended

Jun. 30, 2022

Summary of Stock Options Valuation Assumptions

Stock option fair value assumptions during the six months ended June 30, 2022
Weighted average share price at grant date in €	2.42
Weighted average expected volatility	92.4	%
Weighted average risk-free interest rate	0.86	%
Weighted average expected term (in years)	6
Dividend yield	—
Weighted average fair value of stock options in €	1.81

Summary of RSU Activity

Change in Number of BSA/SO/RSU:

	Number of outstanding
	BSA		SO			RSUs
Balance as of December 31, 2021		256,693		3,631,210			1,240,520
Granted during the period		—		19,000			3,200
Forfeited during the period		—		(205,728	)		(66,588	)
Exercised/released during the period		—		(2,125	)		(31,910	)
Expired during the period		—		—			—
Balance as of June 30, 2022		256,693		3,442,358			1,145,223

Summary of Share-Based Payments Expenses

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

		Three Months Ended June 30,						Six Months Ended June 30,
		2022			2021			2022			2021
Research & development	SO		(290	)		(302	)		(665	)		(678	)
	RSU		(185	)		115			(393	)		(136	)
Sales & marketing	SO		(38	)		(63	)		(33	)		(112	)
	RSU		(17	)		(26	)		(16	)		(48	)
General & administrative	SO		(478	)		(709	)		(1,176	)		(1,353	)
	RSU		(70	)		(110	)		(157	)		(201	)
Total share-based compensation (expense)			(1,078	)		(1,094	)		(2,441	)		(2,527	)

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Contingencies (Tables)

6 Months Ended

Jun. 30, 2022

Loss Contingency [Abstract]

Summary of Current Contingencies and Non-current Contingencies

The following tables summarize the contingencies as of June 30, 2022 and December 31, 2021:

	June 30,		December 31,
	2022		2021
Current contingencies		3,189		4,095
Non-current contingencies		6,421		6,758
Total contingencies		9,610		10,853

Summary of Movement in Provisions

The changes in contingencies are as follows:

	Pension retirement obligations			Collaboration agreement - Loss at completion			Other contingencies			Total
At January 1, 2022		1,008			9,800			45			10,853
Increases in liabilities		14			—			—			14
Used liabilities		—			(108	)		(44	)		(152	)
Reversals of unused liabilities		—			—			—			—
Net interest related to employee benefits, and unwinding of discount		—			—			—			—
Actuarial gains and losses on defined-benefit plans		(224	)		—			—			(224	)
Currency translation effect		(73	)		(807	)		(2	)		(882	)
At June 30, 2022		725			8,885			—			9,610
Of which Current		—			3,189			—			3,189
Of which Non-current		725			5,696			—			6,421

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Operating Income (Tables)

6 Months Ended

Jun. 30, 2022

Other Income and Expenses [Abstract]

Schedule of operating income

The following table summarizes the operating income during the three and six months ended June 30, 2022 and 2021:

	Three Months Ended June 30,					Six Months Ended June 30,
	2022		2021			2022		2021
Research tax credit		1,491		1,870			3,060		3,677
Other operating income		37		(3,358	)		1,014		(2,225	)
Total		1,529		(1,488	)		4,074		1,453

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Allocation of Personnel Expenses (Tables)

6 Months Ended

Jun. 30, 2022

Operating Expenses [Abstract]

Summary of Allocation of Personnel Expenses By Function

The following table summarizes the allocation of personnel expenses by function during the three and six months ended June 30, 2022 and 2021:

	Three Months Ended June 30,				Six Months Ended June 30,
	2022		2021		2022		2021
Research and Development expenses		3,097		3,393		6,172		8,111
Sales and Marketing expenses		344		518		589		1,036
General and Administrative expenses		2,767		2,999		5,362		6,765
Total personnel expenses		6,208		6,910		12,123		15,912

Summary of Allocation of Personnel Expenses By Nature

The following table summarizes the allocation of personnel expenses by nature during the three six months ended June 30, 2022 and 2021:

	Three Months Ended June 30,				Six Months Ended June 30,
	2022		2021		2022		2021
Wages and salaries		3,509		4,382		7,497		8,836
Social security contributions		1,256		1,064		1,507		2,396
Expenses for pension commitments		211		293		509		695
Employer contribution to bonus shares		154		77		170		1,458
Share-based payments		1,078		1,094		2,441		2,527
Total		6,208		6,910		12,123		15,912

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Loss Per Share (Tables)

6 Months Ended

Jun. 30, 2022

Earnings Per Share, Basic [Abstract]

Schedule of Antidilutive Securities Excluded from Computation of Earnings Per Share [Table Text Block]

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, 2022 and 2021 indicated in number of potential shares:

 

	Three Months Ended June 30,				Six Months Ended June 30,
	2022		2021		2022		2021
Non-employee warrants		256,693		256,693		256,693		256,693
Stock options		3,442,358		2,594,410		3,442,358		2,594,410
Restricted stock units		1,145,223		1,092,445		1,145,223		1,092,445
Prefunded warrants		28,276,331		—		28,276,331		—

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Significant Events and Transactions - Additional Information (Detail) € / shares in Units, $ / shares in Units, € in Thousands, $ in Millions		1 Months Ended	6 Months Ended
	Jan. 31, 2020	May 31, 2022 USD ($) $ / shares shares	Jun. 30, 2022 USD ($) $ / shares shares	Jun. 30, 2022 EUR (€) shares	Jun. 30, 2022 € / shares shares	May 31, 2022 € / shares
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Shares Issued, Price Per Share | € / shares					€ 2.9
Proceeds From Issuance Of Common Stock | €				€ 98,567,007
Class of Warrant or Right, Exercise Price of Warrants or Rights | (per share)			$ 3.11		2.9
Class of Warrant or Right, Issue price | € / shares					0.1
American Depositary Shares
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Stock Issued During Period, Shares, New Issues		6,036,238
Shares Issued, Price Per Share | (per share)		$ 1.27				€ 2.41
Stockholders' Equity Note, Stock Split, Conversion Ratio		1.0531
Proceeds From Issuance Of Common Stock | $		$ 15.3
private investment in public equity [Member]
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Stock Issued During Period, Shares, New Issues			32,855,669	32,855,669
Shares Issued, Price Per Share | (per share)			$ 3.22		€ 3
Proceeds From Issuance Of Common Stock			$ 194.0	€ 181,000
Class of Warrant or Right, Number of Securities Called by Warrants or Rights			28,276,331		28,276,331
Private Placement [Member]
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Stockholders' Equity Note, Stock Split, Conversion Ratio			1.0739	1.0739
ViaskinTM Clinical Program For Children Aged Between Four to Eleven [Member]
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Clinical Program Trial Period	6 months

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Cash and Cash Equivalents - Summary of breakdown of cash and cash equivalents (Detail) - USD ($) $ in Thousands	Jun. 30, 2022	Dec. 31, 2021
Cash and Cash Equivalents, at Carrying Value [Abstract]
Cash	$ 226,674	$ 31,427
Cash equivalents	21,298	45,874
Total cash and cash equivalents as reported in the statements of financial position	$ 247,971	$ 77,301

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Other Current Assets - Summary of Other Current Asset (Detail) - USD ($) $ in Thousands	Jun. 30, 2022	Dec. 31, 2021
Other Assets [Abstract]
Research tax credit	$ 2,908	$ 28,092
Other tax claims	4,339	3,561
Prepaid expenses	3,773	4,149
Other receivables	961	1,283
Total	$ 11,981	$ 37,085

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Other current assets - Summary Of Research Tax Credit (Detail) $ in Thousands	6 Months Ended
	Jun. 30, 2022 USD ($)
Tax Credit Carryforward [Line Items]
Opening balance	$ 28,092
Operating revenue	3,060
Payment received	(27,119)
Adjustment and currency translation effect	(1,125)
Closing balance	2,908
Of which - Non-current portion	0
Of which - Current portion	$ 2,908

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Lease contracts - Summary of Operating Leases Future Minimum Payments Receivable (Detail) - USD ($) $ in Thousands	Jun. 30, 2022	Dec. 31, 2021
Current portion	$ 2,154	$ 3,438
Year 2	1,862	3,147
Year 3	295	2,317
Year 4		773
Year 5		790
Thereafter		1,220
Total minimum lease payments	4,311	11,684
Less: Effects of discounting	(370)	(1,534)
Present value of operating lease	3,941	10,150
Less: current portion	(1,968)	(3,003)
Long-term operating leases	1,973	7,147
Real Estate [Member]
Current portion	2,104	3,361
Year 2	1,843	3,124
Year 3	284	2,299
Year 4		771
Year 5		790
Thereafter		1,220
Total minimum lease payments	4,231	11,565
Less: Effects of discounting	(363)	(1,526)
Present value of operating lease	3,868	10,039
Less: current portion	(1,922)	(2,929)
Long-term operating leases	$ 1,946	$ 7,110
Weighted average remaining lease term (years)	1 year 9 months 14 days	4 years 1 month 20 days
Weighted average discount rate	3.14%	4.84%
Other Asset [Member]
Current portion	$ 50	$ 77
Year 2	19	23
Year 3	11	18
Year 4		1
Total minimum lease payments	80	119
Less: Effects of discounting	(6)	(8)
Present value of operating lease	73	111
Less: current portion	(46)	(74)
Long-term operating leases	$ 27	$ 37
Weighted average remaining lease term (years)		2 years 3 days
Weighted average discount rate	1.29%	3.32%

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Lease contracts - Summary of Rent expenses (Detail) - Rent Expenses [Member] - USD ($) $ in Thousands	6 Months Ended
	Jun. 30, 2022	Jun. 30, 2021
Operating lease expense	$ 950	$ 1,698
Net termination impact	$ (1,657)

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Lease contracts - Summary of Supplemental cash flow information related to our operating leases (Detail) - USD ($) $ in Thousands	6 Months Ended
	Jun. 30, 2022	Jun. 30, 2021
Cash Flow, Operating Activities, Lessee [Abstract]
Operating cash flows from operating leases	$ 1,079	$ 2,077

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Lease contracts - Additional Information (Detail) - USD ($) $ in Thousands	6 Months Ended
	Jun. 30, 2022	Dec. 31, 2021
Operating Lease, Right-of-Use Asset	$ 3,146	$ 7,336
NEW JERSEY
Gain on termination of lease	1,200
Early Termination of Lease Offset By The Payment Of A One Time Lump Sum Early Termination Fee	1,500
Operating Lease, Right-of-Use Asset	$ 400
lease agreement for lease term	3 years 2 months

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Trade Payables and Other Current Liabilities - Additional Information (Detail) $ in Millions	Jun. 30, 2022 USD ($)
Nestl Health Science [Member]
Deferred revenues	$ 4.7

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Trade Payables and Other Current Liabilities - Summary of Other Liabilities by Nature (Detail) - USD ($) $ in Thousands	Jun. 30, 2022	Dec. 31, 2021
Schedule Of Other Liabilities, By Nature [Line Items]
Other current liabilities	$ 8,778	$ 12,361
Other non-current liabilities	1,764	2,147
Total	10,542	14,508
Employee related liabilities [Member]
Schedule Of Other Liabilities, By Nature [Line Items]
Other current liabilities	4,135	6,708
Other non-current liabilities	77	247
Total	4,212	6,954
Deferred income [Member]
Schedule Of Other Liabilities, By Nature [Line Items]
Other current liabilities	3,012	4,146
Other non-current liabilities	1,687	1,900
Total	4,700	6,046
Tax Liabilities [Member]
Schedule Of Other Liabilities, By Nature [Line Items]
Other current liabilities	400	182
Other non-current liabilities	0	0
Total	400	182
Other Debts [Member]
Schedule Of Other Liabilities, By Nature [Line Items]
Other current liabilities	1,231	1,325
Other non-current liabilities	0	0
Total	$ 1,231	$ 1,325

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Shareholders' equity - Additional Information (Detail) € / shares in Units, $ in Thousands	3 Months Ended				6 Months Ended
	Jun. 30, 2022 USD ($) shares	Mar. 31, 2022 USD ($)	Jun. 30, 2021 USD ($)	Mar. 31, 2021 USD ($)	Jun. 30, 2022 EUR (€)	Jun. 30, 2021 EUR (€)	Jun. 30, 2022 EUR (€) € / shares shares	Dec. 31, 2021 USD ($)	Dec. 31, 2020 USD ($)
Class of Stock [Line Items]
Share capital | $	$ 244,416	$ 82,062	$ 143,019	$ 169,176				$ 99,274	$ 205,491
Deferred Compensation Arrangement with Individual, Shares Authorized for Issuance	6,113,200						6,113,200
Stock Issued During Period, Value, New Issues	$ 107,176	1	473	42	€ 3,285,566,900	€ 3,285,566,900
Common Stock, Shares Subscribed but Unissued	32,855,669						32,855,669
Shares Issued, Price Per Share | € / shares							€ 2.9
APIC, Share-based Payment Arrangement, Increase for Cost Recognition	$ 1,078	$ 1,363	$ 1,094	$ 1,433	95,281,440,100
Proceeds From Issuance Of Common Stock | €					98,567,007,000
Class of Warrant or Right, Unissued	28,276,331						28,276,331
Warrants and Rights Outstanding | €							€ 82,001,359,900
Prefunded Warrants [Member]
Class of Stock [Line Items]
Stock Issued During Period, Value, New Issues | €					2,827,633,100
Shares Issued, Price Per Share | € / shares							€ 0.1
Class of Warrant or Right, Number of Securities Called by Each Warrant or Right	28,276,331						28,276,331
APIC, Share-based Payment Arrangement, Restricted Stock Unit, Increase for Cost Recognition | €					€ 100
Share Capital
Class of Stock [Line Items]
Share capital	$ 10,708,445						€ 9,402,268,000
Nominal value | € / shares							€ 0.1
Share capital authorized	94,022,679						94,022,679

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Shareholders' equity - Schedule of Nonvested Share Activity (Detail) - Prefunded Warrants [Member]	6 Months Ended
	Jun. 30, 2022 shares
Class of Stock [Line Items]
Balance as of December 31, 2021	0
Granted during the period	28,276,331
Forfeited during the period	0
Exercised/released during the period	0
Expired during the period	0
Balance as of June 30, 2022	28,276,331

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Share-Based Payments - Summary of Stock Options Valuation Assumptions (Detail)	6 Months Ended
	Jun. 30, 2022 $ / shares
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Weighted average share price at grant date in €	$ 2.42
Weighted average risk-free interest rate	0.86%
Weighted average expected term (in years)	6 years
Dividend yield	0.00%
Weighted average fair value of stock options in €	$ 1.81
Weighted average expected volatility	92.40%

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Share-Based Payments - Summary of RSU Activity (Detail)	6 Months Ended
	Jun. 30, 2022 shares
BSA Warrants [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Number of warrants outstanding, Beginning Balance	256,693
Number of warrants outstanding, Exercised/released during the period	0
Number of warrants outstanding, Ending Balance	256,693
Restricted Stock Units [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Number of RSU outstanding, Beginning Balance	1,240,520
Number of RSU outstanding, Granted during the period	3,200
Number of RSU outstanding, Forfeited during the period	(66,588)
Number of RSU outstanding, Exercised during the period	(31,910)
Number of RSU outstanding, Expired during the period	0
Number of RSU outstanding, Ending Balance	1,145,223
Employee Stock Option Member
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Number of stock options outstanding, Beginning Balance	3,631,210
Number of stock options outstanding, Granted during the period	19,000
Number of stock options outstanding, Forfeited during the period	(205,728)
Number of stock options outstanding, Exercised during the period	(2,125)
Number of stock options outstanding, Ending Balance	3,442,358

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Share-Based Payments - Summary of Share-Based Payments Expenses (Detail) - USD ($) $ in Thousands	3 Months Ended		6 Months Ended
	Jun. 30, 2022	Jun. 30, 2021	Jun. 30, 2022	Jun. 30, 2021
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items]
Share-based payments	$ (1,078)	$ (1,094)	$ (2,441)	$ (2,527)
Research & Development expenses [Member] | Employee Stock Option Member
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items]
Share-based payments	(290)	(302)	(665)	(678)
Research & Development expenses [Member] | Restricted Stock Units [Member]
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items]
Share-based payments	(185)	115	(393)	(136)
Sales & Marketing expenses [Member] | Employee Stock Option Member
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items]
Share-based payments	(38)	(63)	(33)	(112)
Sales & Marketing expenses [Member] | Restricted Stock Units [Member]
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items]
Share-based payments	(17)	(26)	(16)	(48)
General & Administrative expenses [Member] | Employee Stock Option Member
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items]
Share-based payments	(478)	(709)	(1,176)	(1,353)
General & Administrative expenses [Member] | Restricted Stock Units [Member]
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items]
Share-based payments	$ (70)	$ (110)	$ (157)	$ (201)

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Share-Based Payments - Additional Information (Detail)	6 Months Ended
	Jun. 30, 2022 shares
Share options [Member]
Share-Based Payments [Line iteam]
Number of stock options outstanding, Granted during the period	19,000
Restricted stock units [Member]
Share-Based Payments [Line iteam]
Number of RSU outstanding, Granted during the period	3,200

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Contingencies - Summary of Current Contingencies and Non-current Contingencies (Detail) - USD ($) $ in Thousands	Jun. 30, 2022	Dec. 31, 2021
Liability, Defined Benefit Plan [Abstract]
Current contingencies	$ 3,189	$ 4,095
Non-current contingencies	6,421	6,758
Total contingencies	$ 9,610	$ 10,853

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Contingencies - Summary of Movement in Contingencies (Detail) - USD ($) $ in Thousands	6 Months Ended
	Jun. 30, 2022	Dec. 31, 2021
Contingencies, Beginning balance	$ 10,853
Increases in liabilities	14
Used liabilities	(152)
Reversals of unused liabilities	0
Net interest related to employee benefits, and unwinding of discount	0
Actuarial gains and losses on defined-benefit plans	(224)
Currency translation effect	(882)
Contingencies, Ending balance	9,610
Of which current	3,189	$ 4,095
Of which non-current	6,421	$ 6,758
Pension retirement obligations [Member]
Contingencies, Beginning balance	1,008
Increases in liabilities	14
Reversals of unused liabilities	0
Actuarial gains and losses on defined-benefit plans	(224)
Currency translation effect	(73)
Contingencies, Ending balance	725
Of which non-current	725
Collaboration agreement -Loss at completion [Member]
Contingencies, Beginning balance	9,800
Increases in liabilities	0
Used liabilities	(108)
Currency translation effect	(807)
Contingencies, Ending balance	8,885
Of which current	3,189
Of which non-current	5,696
Other provisions incl. restructuring [Member]
Contingencies, Beginning balance	45
Increases in liabilities	0
Used liabilities	(44)
Currency translation effect	(2)
Contingencies, Ending balance	$ 0

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Operating Income - Summary of Operating Income (Detail) - USD ($) $ in Thousands	3 Months Ended		6 Months Ended
	Jun. 30, 2022	Jun. 30, 2021	Jun. 30, 2022	Jun. 30, 2021
Other Income and Expenses [Abstract]
Research Tax Credit	$ 1,491	$ 1,870	$ 3,060	$ 3,677
Other operating income	37	(3,358)	1,014	(2,225)
Total	$ 1,529	$ (1,488)	$ 4,074	$ 1,453

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Allocation of Personnel Expenses - Summary of Allocation of Personnel Expenses By Function (Detail) - USD ($) $ in Thousands	3 Months Ended		6 Months Ended
	Jun. 30, 2022	Jun. 30, 2021	Jun. 30, 2022	Jun. 30, 2021
Research and development expenses	$ 18,611	$ 20,179	$ 30,834	$ 42,343
General and administrative expenses	5,704	8,269	12,334	17,951
Total Operating expenses	25,352	29,646	44,669	62,221
Expenses by Function [Member]
Research and development expenses	3,097	3,393	6,172	8,111
Sales and marketing expenses	344	518	589	1,036
General and administrative expenses	2,767	2,999	5,362	6,765
Total Operating expenses	$ 6,208	$ 6,910	$ 12,123	$ 15,912

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Allocation of Personnel Expenses -Summary of Allocation of Personnel Expenses By Nature (Detail) - USD ($) $ in Thousands	3 Months Ended		6 Months Ended
	Jun. 30, 2022	Jun. 30, 2021	Jun. 30, 2022	Jun. 30, 2021
Share-based payments	$ (1,078)	$ (1,094)	$ (2,441)	$ (2,527)
Total Operating expenses	25,352	29,646	44,669	62,221
Expenses by Nature [Member]
Wages and salaries	3,509	4,382	7,497	8,836
Social security contributions	1,256	1,064	1,507	2,396
Expenses for pension commitments	211	293	509	695
Employer contribution to bonus shares	154	77	170	1,458
Share-based payments	1,078	1,094	2,441	2,527
Total Operating expenses	$ 6,208	$ 6,910	$ 12,123	$ 15,912

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Commitments - Additional Information (Detail)	6 Months Ended
	Jun. 30, 2022 USD ($)
Disclosure Of Commitments [Line Items]
Increase (decrease) in other commitments during the period	$ 0

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Relationships with Related Parties - Additional Information (Detail) $ in Thousands	6 Months Ended
	Jun. 30, 2022 USD ($)
Deferred Compensation Arrangement with Individual, Excluding Share-based Payments and Postretirement Benefits [Line Items]
Increase decrease in related party transactions and changes in nature of the transactions	$ 0

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Loss Per Share - Summary of the Common Stock Equivalents Which Were Excluded From the Calculation of Diluted Net Loss Per Share (Detail) - shares	3 Months Ended		6 Months Ended
	Jun. 30, 2022	Jun. 30, 2021	Jun. 30, 2022	Jun. 30, 2021
Non-employee warrants [Member]
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount	256,693	256,693	256,693	256,693
Stock options [Member]
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount	3,442,358	2,594,410	3,442,358	2,594,410
Restricted stock units [Member]
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount	1,145,223	1,092,445	1,145,223	1,092,445
Prefunded warrants [Member]
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount	28,276,331	0	28,276,331	0