10-Q

Large accelerated filer

Accelerated filer

Non-accelerated filer

Smaller reporting company

Emerging growth company

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 March 31, 2022

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

For the transition period from

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.

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 April 29, 2022, the registrant had

55,096,537 ordinary

shares, nominal value €0.10 per share, outstanding including treasury shares

Table of contents


		Page
Part I	Financial information		1
Item 1	Condensed Consolidated Statements of Financial Position (Unaudited) as of March 31, 2022 and December 31, 2021		1
	Condensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited) for the Three Months Ended March 31, 2022 and 2021		2
	Condensed Consolidated Statements of Cash Flows (Unaudited) for the Three Months Ended March 31, 2022 and 2021		3
	Condensed Consolidated Statements of Changes in Shareholders’ Equity (Unaudited) for the Three Months Ended March 31, 2022 and 2021		4
	Notes to the Financial Statements (Unaudited)	5
Item 2	Management’s Discussion and Analysis of Financial Condition and Results of Operations		15
Item 3	Quantitative and Qualitative Disclosures About Market Risk		20
Item 4	Controls and Procedures		21

Part II	Other Information		22
Item 1	Legal Proceedings		22
Item 1A	Risk Factors		22
Item 2	Unregistered Sales of Equity Securities and Use of Proceeds		22
Item 3	Defaults Upon Senior Securities		22
Item 4	Mine Safety Disclosures		22
Item 5	Other Information		22
Item 6	Exhibits		23

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 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 prospectus are the property of their respective owners. Solely for convenience, the trademarks and trade names in this Quarterly Report on Form 10-Q 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 on Form

10-Q,

or 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 the Securities Act, and Section 21E of the Securities Exchange Act of 1934, as amended, or the 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 ability to continue as a going concern;

•

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 Viaskin

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;

•

the sufficiency of existing capital resources;

•

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.”

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. 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.

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)


		March 31,			December 31,
	Note	2022			2021
Assets
Current assets:
Cash and cash equivalents	3	$	74,107		$	77,301
Other current assets	4		16,329			37,085

Total current assets			90,437			114,386
Property, plant, and equipment, net			17,196			18,146
Right of use assets related to operating leases	5		3,356			7,336
Intangible assets			18			22
Other non-current assets			6,575			6,833

Total non-current assets			27,144			32,338

Total Assets		$	117,581		$	146,723

Liabilities and shareholders’ equity
Current liabilities:
Trade payables	6	$	11,416		$	11,429
Short-term operating leases	5		2,034			3,003
Short-term financial debt			333			510
Current contingencies	8		3,529			4,095
Other current liabilities	6		8,719			12,361

Total current liabilities			26,031			31,397

Long-term operating leases	5		2,268			7,147
Non-current contingencies	8		5,758			6,758
Other non-current liabilities			1,461			2,147

Total current liabilities			9,488			16,052

Total Liabilities		$	35,519		$	47,449

Shareholders’ equity:
Ordinary shares, €0.10 par value; 55,096,537 and 55,095,762 shares authorized, and issued as at March 31, 2022 and December 31, 2021, respectively		$	6,539		$	6,538
Additional paid-in capital			359,478			358,115
Treasury stock, 144,501 and 153,631 ordinary shares as of March 31, 2022 and December 31, 2021, respectively, at cost			(1,193	)		(1,232	)
Accumulated deficit			(275,219	)		(258,528	)
Accumulated other comprehensive income			543			519
Accumulated currency translation effect			(8,086	)		(6,137	)

Total Shareholders’ equity		$	82,062		$	99,274

Total Liabilities and s hareholder’s equity		$	117,581		$	146,723

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

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 March 31,
	Note		2022			2021
Operating income		9	$	2,546		$	2,941

Operating expenses
Research and development expenses				(12,223	)		(22,164	)
Sales and marketing expenses				(464	)		(729	)
General and administrative expenses				(6,630	)		(9,683	)

Total Operating expenses				(19,317	)		(32,575	)

Loss from operations				(16,771	)		(29,634	)

Financial income				152			215

Loss before taxes				(16,619	)		(29,419	)

Income tax				(87	)		(30	)

Net loss			$	(16,706)		$	(29,449)

Foreign currency translation differences, net of taxes				(1,933	)		(8,744	)
Actuarial gains (loss) on employee benefits, net of taxes				24			(85	)

Total comprehensive loss			$	(18,615	)	$	(38,279	)

Basic/diluted net loss per share attributable to shareholders		13	$	(0.30	)	$	(0.54	)

Weighted average number of shares outstanding used in computing per share amounts:				54,932,192			54,880,776

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

DBV Technologies S.A.

Condensed Consolidated Statements of Cash Flows (unaudited)

(amounts in thousands)


		Three months Ended March 31,
	Notes	2022			2021
Net loss for the period
Adjustments to reconcile net loss to net cash used in operating activities:		$	(16,706	)	$	(29,449	)
Depreciation, amortization and accrued contingencies			(599	)		1,483
Retirement pension obligations			(9	)		—
Expenses related to share-based payments			1,363			1,433
Other elements			(3	)		(456	)
Changes in operating assets and liabilities:
Decrease (increase) in trade receivables			—			2,101
Decrease (increase) in other current assets			20,458			(417	)
(Decrease) increase in trade payables			(19	)		(2,567	)
(Decrease) increase in other current and non-current liabilities			(4,118	)		(7,980	)
Change in operating lease liabilities and right of use assets			(1,849	)		(353	)

Net cash flow used in operating activities			(1,483	)		(36,204	)

Cash flows provided by (used in) investing activities:
Acquisitions of property, plant, and equipment			(131	)		(184	)
Proceeds from property, plant and equipment dispositions			3			—
Acquisitions of non-current financial assets			(40	)		(1	)
Proceeds from non-current financial assets			179			—

Net cash flows provided by (used in) investing activities			11			(185	)

Cash flows (used in) provided by financing activities:
(Decrease) in conditional advances			(168	)		(164	)
Treasury shares			40			578
Capital increases, net of transaction costs			—			42
Other cash flows related to financing activities			—			(17	)

Net cash flows (used in) provided by financing activities			(129	)		440

Effect of exchange rate changes on cash and cash equivalents			(1,594	)		(7,944	)

Net decrease in cash and cash equivalents			(3,194	)		(43,893	)

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	$	74,107		$	152,459

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

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


	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	)
Issuance 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

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

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 presented in thousands of U.S. Dollars, except for share and per share data and as otherwise noted. 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

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.

Going concern

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

Since its inception, the Company has primarily funded its operations with equity financings, and, to a lesser extent, public assistance aimed at supporting innovation and payments associated with research tax credits (

Crédit d’Impôt Recherche

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

Following receipt of a Complete Response Letter (“CRL”) from the U.S. Food and Drug Administration (“FDA”) in connection with its Biologics License Application (“BLA”) for Viaskin

™

Peanut, beginning in August 2020, the Company scaled down its other clinical programs and

pre-clinical

spend to focus on Viaskin

™

Peanut. In response, the Company implemented a global restructuring plan to provide operational latitude to progress the clinical development and regulatory review of Viaskin

™

Peanut in the United States and European Union. This restructuring plan was completed in the second half of 2021.

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 CRL. In order to respond to the FDA’s requests and recommendations, the Company defined parallel workstreams primarily in order to generate the

6-month

safety and adhesion clinical data to assess a modified Viaskin Peanut patch and demonstrate the equivalence in allergen uptake between the current and modified patches in the intended patient population.

Following the submission of the adhesion study’s protocol to the FDA, the Company received an Advice/Information Request letter from the FDA in October 2021, requesting a stepwise approach to the modified Viaskin patch development program and provided partial feedback on this protocol. 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 feedback and announced its plan to initiate a pivotal Phase 3 clinical study for a modified Viaskin Peanut patch (mVP) in children ages 4-11. The Company considers this trial as the most straightforward approach to demonstrate effectiveness, safety, and improved adhesion of the modified Viaskin Peanut system. After receiving agreement from the FDA for its change in strategy, the protocol for the new Phase 3 pivotal study of the modified Viaskin Peanut (“mVP”) patch was completed at the end of February 2022

and was submitted to the FDA in April 2022.

The

ompany has been granted a Type C meeting by the FDA

, which is expected to be held

in the second quarter of 2022

to align on the new Phase

study protocol.

The Company has incurred operating losses and negative cash flows from operations since inception. As of the date of the filing, the Company’s available cash and cash equivalents are not projected to be sufficient to support its operating plan for at least the next 12 months. As such, there is substantial doubt regarding the Company’s ability to continue as a going concern.

Based on its current operations, as well as its plans and assumptions as revised pursuant to its change of strategy, announced in December 2021, the Company expects that its balance of cash and cash equivalents of $74.1 million as of March 31, 2022 will be sufficient to fund its operations into the first quarter of 2023.

The Company intends to seek additional capital as it prepares for the new pivotal study and launch of Viaskin Peanut, if approved, and continues other research and development efforts. The Company may seek to finance its future cash needs through a combination of public or private equity or debt financings, collaborations, license and development agreements and other forms of

non-dilutive

financings.

The Company cannot guarantee that it will be able to obtain the necessary financing to meet its needs or to obtain funds at attractive terms and conditions. The ongoing

COVID-19

pandemic has already caused extreme volatility and disruptions in the capital and credit markets. A severe or prolonged economic downturn could result in a variety of risks to the Company, including reduced ability to raise additional capital when needed or on acceptable terms, if at all.

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

These Consolidated Financial Statements do not include any adjustments to the carrying amounts and classification of assets, liabilities, and reported expenses that may be necessary if the Company were unable to continue as a going concern

Accounting Pronouncements adopted in 2022

The Company

has

not adopt 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.

Note 2: Significant Events and Transactions

Clinical programs

Viaskin Peanut for children ages 4-11 - United States Regulatory History and Current Status

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 CRL. 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:

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

‘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 approximately 50% 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

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. The FDA’s explanation was that the results from the allergen uptake studies might affect the design of the STAMP study.

After careful review of the FDA’s information requests and consideration of all other options, 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 feedback. The Company estimated that the FDA’s newly proposed sequential approach would require at least five rounds of exchanges that necessitate FDA alignment prior to initiating STAMP, the

6-month

safety and adhesion study. The Company does not believe this approach to be in the best interest of patients due to the significant time delays associated with FDA review of a resource dependent

(non-PDUFA)

product. As such, in December 2021, the Company announced it plans to initiate a pivotal Phase

—placebo-controlled efficacy trial for a modified Viaskin Peanut patch (mVP) in children ages 4-11. The study will also include updates to the Instructions for Use (IFU). The Company considers this trial the most straightforward to demonstrate effectiveness, safety, and improved adhesion of the modified Viaskin Peanut system. The FDA has confirmed the Company’s change in strategy is agreeable via oral and written exchanges. The protocol for the new Phase 3 pivotal study of the modified Viaskin Peanut (“mVP”) patch was completed at the end of February 2022

and was submitted to the FDA in April 2022. The Company

has been granted a Type C meeting by the FDA in the second quarter of 2022 to align on the new Phase

study protocol.

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

In August 2021, the Company announced it has received from the EMA 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

On June 26, 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 2021 and

top-line

results are expected by the end of the second quarter of 2022.

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 March 31, 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 and comprehensive loss 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.

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 table presents for each reported period, the breakdown of cash and cash equivalents:


	March 31,		December 31,
	2022		2021
Cash		29,145		31,427
Cash equivalents		44,963		45,874

Total cash and cash equivalents as reported in the statements of financial position		74,107		77,301

Bank overdrafts		—		—

Total net cash and cash equivalents as reported in the statements of cash flows		74,107		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.

Note 4 Other Current Assets

Other current assets consisted of the following:


	March 31,		December 31,
	2022		2021
Research tax credit		8,430		28,092
Other tax claims		3,696		3,561
Prepaid expenses		3,386		4,149
Other receivables		817		1,283

Total		16,329		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 three months period ended March 31, 2022, the Company received the reimbursement of the 2019 and 2020 fiscal year research tax credit.

The variance in Research Tax Credit is presented as follow:


	Amount in thousands of US Dollars
Opening research tax credit receivable as of January 1, 2022		28,092
+ Operating revenue		1,569
- Payment received		(20,874	)
- Adjustment and currency translation effect		(358	)

Closing research tax credit receivable as of March 31, 2022		8,430

Of which - Non-current portion		—
Of which - Current portion		8,430

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 rental and 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.

Note 5 Lease contracts

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


	March 31, 2022						December 31, 2021
	Real estate		Other assets		Total		Real estate		Other assets		Total
Current portion		2,159		66		2,225		3,361		77		3,438
Year 2		1,803		18		1,821		3,124		23		3,147
Year 3		605		15		620

SEC Form 10-Q filed by DBV Technologies S.A.