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, 2024

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 92120 France	N/A
(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 May 7, 2024, the registrant had 96,434,369       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 March 31, 2024 and December 31, 2023	3
	Condensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited) for the Three Months Ended March 31, 2024 and 2023	4
	Condensed Consolidated Statements of Cash Flows (Unaudited) for the Three Months Ended March 31, 2024 and 2023	5
	Condensed Consolidated Statements of Changes in Shareholders’ Equity (Unaudited) for the Three Months Ended March 31, 2024 and 2023	6
	Notes to the Condensed Consolidated Financial Statements (Unaudited)	7
Item 2	Management’s Discussion and Analysis of Financial Condition and Results of Operations	18
Item 3	Quantitative and Qualitative Disclosures About Market Risk	23
Item 4	Controls and Procedures	23
Part II	Other Information	24
Item 1	Legal Proceedings	24
Item 1A	Risk Factors	24
Item 2	Unregistered Sales of Equity Securities and Use of Proceeds	24
Item 3	Defaults Upon Senior Securities	24
Item 4	Mine Safety Disclosures	24
Item 5	Other Information	24
Item 6	Exhibits	25

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 (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended, (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:

• 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 design, timing and anticipated results of interactions with regulatory agencies;

• 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 funding;

• our financial performance;

• developments relating to our competitors and our industry, including competing therapies; 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, 2023, filed with the Securities and Exchange Commission, or the SEC on March 7, 2024. 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.

1

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)

			March 31,			December 31,
	Note		2024			2023
Assets
Current assets:
Cash and cash equivalents		3	$	101,525		$	141,367
Other current assets		4		18,037			17,548
Total current assets				119,562			158,915
Property, plant, and equipment, net				12,913			12,623
Right-of-use assets related to operating leases		5		6,551			5,247
Intangible assets				52			58
Other non-current assets				6,818			6,144
Total non-current assets				26,334			24,071
Total Assets			$	145,895		$	182,986
Liabilities and shareholders’ equity
Current liabilities:
Trade payables		6	$	18,076		$	23,302
Short-term operating leases		5		232			1,144
Current contingencies		9		3,153			3,959
Other current liabilities		6		5,023			8,934
Total current liabilities				26,483			37,339
Long-term operating leases		5		6,793			4,526
Non-current contingencies		9		965			935
Other non-current liabilities		6		—			—
Total non-current liabilities				7,758			5,461
Total Liabilities			$	34,241		$	42,799
Shareholders’ equity:
Ordinary shares, €0.10 par value; 96,434,369 and 96,431,770 shares authorized, and issued as of March 31, 2024 and December 31, 2023, respectively			$	10,972		$	10,972
Additional paid-in capital				379,426			377,468
Treasury stock, 262,644 and 222,988 ordinary shares as of March 31, 2024 and December 31, 2023, respectively, at cost				(1,325	)		(1,263	)
Accumulated deficit				(266,207	)		(238,862	)
Accumulated other comprehensive income				683			742
Accumulated currency translation effect				(11,897	)		(8,871	)
Total Shareholders’ equity		7	$	111,654		$	140,187
Total Liabilities and Shareholders’ equity			$	145,895		$	182,986

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 March 31,
	Note		2024			2023
Operating income		10	$	1,407		$	2,194
Operating expenses
Research and development expenses		11		(21,403	)		(16,037	)
Sales and marketing expenses		11		(758	)		(434	)
General and administrative expenses		11		(7,804	)		(6,889	)
Total Operating expenses				(29,964	)		(23,359	)
Loss from operations				(28,558	)		(21,165	)
Financial income(expenses)		13		1,261			605
Loss before taxes				(27,297	)		(20,561	)
Income tax (expense)				(48	)		—
Net loss			$	(27,345	)	$	(20,561	)
Foreign currency translation differences, net of taxes				(3,026	)		3,666
Actuarial gains (losses) on employee benefits, net of taxes				(59	)		(82	)
Total comprehensive loss			$	(30,429	)	$	(16,977	)
Basic/diluted Net loss per share attributable to shareholders		15	$	(0.28	)	$	(0.22	)
Weighted average shares outstanding used in computing per share amounts:				96,176,057			93,970,598

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)

			Three Months Ended March 31,
	Notes		2024			2023
Net loss for the period			$	(27,345	)	$	(20,561	)
Adjustments to reconcile net loss to net cash flow provided by (used in) operating activities:
Depreciation, amortization and accrued contingencies				53			(228	)
Retirement pension obligations				(8	)		(35	)
Expenses related to share-based payments		8		1,958			1,632
Other elements				—			—
Changes in operating assets and liabilities:
Decrease (increase) in other current assets				(835	)		(3,098	)
(Decrease) increase in trade payables				(4,805	)		4,478
(Decrease) increase in other current and non-current liabilities				(3,765	)		(2,989	)
Change in operating lease liabilities and right of use assets				56			(42	)
Net cash flow provided by (used in) operating activities				(34,692	)		(20,841	)
Cash flows provided by (used in) investing activities:
Acquisitions of property, plant, and equipment				(1,335	)		(111	)
Proceeds from property, plant, and equipment dispositions				—			—
Acquisitions of non-current financial assets				(858	)		—
Proceeds from non-current financial assets dispositions				62			153
Net cash flows provided by (used in) investing activities				(2,132	)		42
Cash flows provided by (used in) financing activities:
(Decrease) increase in conditional advances				—			—
Treasury shares				(62	)		(14	)
Net cash flows provided by (used in) financing activities				(62	)		(14	)
Effect of exchange rate changes on cash and cash equivalents				(2,957	)		3,909
Net increase (decrease) in cash and cash equivalents				(39,842	)		(16,905	)
Net Cash and cash equivalents at the beginning of the period				141,367			209,194
Net cash and cash equivalents at the end of the period		3	$	101,525		$	192,289

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, 2023		94,137,145	$	10,720	$	458,221		$	(1,109	)	$	(259,578	)	$	781		$	(14,581	)	$	194,453
Net (loss)		—		—		—			—			(20,561	)		—			—			(20,561	)
Other comprehensive income (loss)		—		—		—			—			—			(82	)		3,666			3,584
Issuance of ordinary shares		10 174		1		(1	)		—			—			—			—			—
Treasury shares		—		—		—			(14	)		—			—			—			(14	)
Share-based payments		—		—		1,632			—			—			—			—			1,632
Balance at March 31, 2023		94,147,319	$	10,721	$	459,852		$	(1,123	)	$	(280,138	)	$	698		$	(10,915	)	$	179,094

	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, 2024		96,431,770	$	10,972	$	377,468		$	(1,263	)	$	(238,862	)	$	742		$	(8,871	)	$	140,187
Net (loss)		—		—		—			—			(27,345	)		—			—			(27,345	)
Other comprehensive income (loss)		—		—		—			—			—			(59	)		(3,026	)		(3,084	)
Issuance of ordinary shares		2,599		3		(3	)		—			—			—			—			—
Treasury shares		—		—		—			(62	)		—			—			—			(62	)
Share-based payments		—		—		1,958			—			—			—			—			1,958
Balance at March 31, 2024		96,434,369	$	10,972	$	379,426		$	(1,325	)	$	(266,207	)	$	683		$	(11,897	)	$	111,654

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

6

NOTES TO THE CONDENSED CONSOLIDATED

FINANCIAL STATEMENTS (UNAUDITED)

Note 1: The Company

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

Basis of Presentation

The condensed consolidated financial statements of the Company and its wholly-owned subsidiaries are unaudited and have been prepared in accordance with generally accepted accounting principles in the United States (“U.S. GAAP”) and are presented in U.S. dollars. All significant intercompany accounts and transactions between the Company and its subsidiaries have been eliminated on consolidation.

The unaudited condensed consolidated financial statements presented in this Quarterly Report should be read in conjunction with the consolidated financial statements and accompanying notes included in the Company’s Annual Report on Form 10-K filed with the SEC on March 7, 2024 (the “Annual Report”). The condensed consolidated statement of financial position as of December 31, 2023 was derived from the audited consolidated financial statements but does not include all disclosures required by U.S. GAAP. The Company’s critical accounting policies are detailed in the Annual Report. The Company’s critical accounting policies have not changed materially since December 31, 2023.

Certain information and footnote disclosures normally included in financial statements prepared in accordance with U.S. GAAP have been condensed or omitted from these interim financial statements. However, these condensed consolidated financial statements include all adjustments, consisting only of normal recurring adjustments, which are, in the opinion of management, necessary to fairly state the results of the interim period. These interim financial results are not necessarily indicative of results to be expected for the full fiscal year ending December 31, 2024, or any other future period.

Use of estimates

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

On an on-going basis, management evaluates its estimates, primarily those related to: (1) evaluation of costs and measure of progress of wind-down activities resulting from the termination of the collaboration agreement with Nestlé Health Science, (2) research tax credits, (3) assumptions used in the valuation of right of use assets—operating lease, (4) impairment of right-of-use assets related to leases and property, plant and equipment, (5) recoverability of the Company’s net deferred tax assets and related valuation allowance, (6) assumptions used in the valuation model to determine the fair value and vesting conditions of share-based compensation plan, (7) estimate of contingencies, and (8) estimate of employee benefits obligations.

Going Concern

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

Since its inception, the Company has primarily funded its operations with equity financings, and, to a lesser extent, public assistance aimed at supporting innovation and payments associated with research tax credits (Crédit d’Impôt Recherche). The Company does not generate product revenue and continues to prepare for the potential launch of its first product in the United States and in the European Union, if approved.

Following receipt of a Complete Response Letter (“CRL”) from the U.S. Food and Drug Administration (“FDA”) in connection with its BLA for Viaskin Peanut, in August 2020, the Company scaled down its other clinical programs and pre-clinical spend to focus on Viaskin Peanut. The Company also initiated a global restructuring plan in June 2020 to provide operational latitude to progress the clinical development and regulatory review of Viaskin Peanut in the United States and European Union.

7

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 sequential 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 in the intended patient population. The Company considers this approach as the most straightforward approach to demonstrate effectiveness, safety, and improved in vivo adhesion of the modified Viaskin Peanut system. After receiving approval 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 has been prepared for FDA submission.

In May 2022, the Company established an At-The-Market (“ATM”) program allowing to offer and sell, including with unsolicited investors who have expressed an interest, a total gross amount of up to $100 million of American Depositary Shares (“ADSs”). The Company’s intent is to use the net proceeds, if any, of sales of ADSs issued under the program, together with its existing cash and cash equivalents, primarily for activities associated with potential approval and launch of Viaskin Peanut, as well as to advance the development of the Company’s product candidates using its Viaskin Platform and for working capital and other general corporate purposes.

In June 2022, the Company announced that its pivotal Phase 3 trial EPITOPE, assessing the safety and efficacy of Viaskin Peanut treatment of peanut-allergic toddlers ages 1 to 3 years, met its primary endpoint, with a statistically significant treatment effect. The Company also indicated continuing productive dialogue with the FDA on the protocol design of VITESSE, a pivotal Phase 3 trial of the modified Viaskin Peanut patch in peanut- allergic children ages 4 to 7 years.

During the same month, the Company announced private placement financing (“PIPE”) amounting to $194 million.

In September 2022, after announcing the initiation of the VITESSE clinical trial, the Company received a partial clinical hold letter from the FDA on its VITESSE Phase 3 clinical study. Within the FDA’s communication, the modifications address design elements, including the statistical analysis of adhesion, minimum daily wear time and technical alignments in methods of categorizing data, to meet study objectives as well as the total number of trial participants on active treatment.

On December 23, 2022, the Company announced the FDA lifted the partial clinical hold and confirmed the Company satisfactorily addressed all clinical hold issues. The FDA stated that the VITESSE phase 3 clinical study may proceed with the revised trial protocol. On March 7, 2023, the Company announced that the first patient was screened in the VITESSE study. Screening of the last patient is anticipated by Q3 2024.

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 our current operations, as well as our plans and assumptions, we expect that our balance of cash and cash equivalents of $101.5 million as of March 31, 2024 will be sufficient to fund our operations until December 31, 2024.

The Company intends to seek additional capital as it prepares for the launch of Viaskin Peanut, if approved, and continues other research and development efforts. The Company will require substantial additional capital to fund its research and development and ongoing operating expenses. These capital requirements are expected to be funded through debt and equity offerings prior to December 31, 2024. The Company may seek to finance its future cash needs through a combination of public or private equity or debt financings, collaborations, license and development agreements and other forms of non-dilutive financings.

The Company cannot guarantee that it will be able to obtain the necessary financing to meet its needs or to obtain funds at attractive terms and conditions, including as a result of disruptions to the global financial markets due to any future pandemics, epidemics or global health crises and conflict in Ukraine or other global political or military crises. The COVID-19 pandemic and conflict in Ukraine 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.

8

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

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

Accounting Pronouncements recently adopted

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

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

Accounting Pronouncements issued not yet adopted

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

Note 2: Significant Events and Transactions

Clinical programs

United States Regulatory History and Current Status

In 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 receipt of the Complete Response Letter. 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, the 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.

In March 2021, the Company commenced CHAMP (Comparison of adHesion Among Modified Patches), a Phase 1 trial in healthy adult volunteers to evaluate the adhesion of five modified Viaskin Peanut patches. The Company completed CHAMP in the second quarter of 2021. 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 the 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 on October 14, 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, in December 2021, the Company decided not to pursue the sequential 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. As such, in December 2021, the Company announced its plan to initiate a pivotal Phase 3 placebo-controlled efficacy trial for a modified Viaskin Peanut patch (mVP) in children in the intended patient population. The Company 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.

On September 7, 2022, the Company announced the initiation of VITESSE, a new Phase 3 pivotal study of the modified Viaskin Peanut (mVP) patch in children ages 4-7 years with peanut allergy. We defined initiation as the submission of the trial protocol to selected study sites for subsequent Institutional Review Board (IRB)/Ethics Committee (EC) approval.

9

On September 21, 2022, the Company announced it received feedback from the U.S. FDA in the form of a partial clinical hold on VITESSE. In the partial clinical hold letter, the FDA specified changes to elements of the VITESSE protocol, acknowledging the intent for the trial to support a future BLA submission. In the following months, we engaged with the FDA to address the feedback provided in the partial clinical hold letter and to finalize the VITESSE protocol. In addition, we continued internal preparations for VITESSE and conducted certain site assessment and start-up activities for prompt study launch once the partial clinical hold was lifted.

On December 23, 2022, the Company announced the FDA lifted the partial clinical hold and confirmed the Company satisfactorily addressed all clinical hold issues. The FDA stated that VITESSE phase 3 clinical study may proceed with the revised trial protocol.

On March 2, 2023, the Company announced the completion of EVOLVE, a 12-week caregiver and patient user experience study of the mVP patch in 50 peanut allergic children ages 4–11-years old. The objective of EVOLVE was to evaluate the Instructions for Use (IFU) and ease of use for the mVP patch. The study concluded that the updated IFU supported correct patch application, which included no lifting of the patch edges or detachment directly after application. Furthermore, EVOLVE concluded that the majority of parents/caregivers reported a positive ease of use experience with the mVP patch. In EVOLVE, DBV also tested the functionality of an electronic patient diary (eDiary) to collect information on activities of daily living and patch adhesion scores. EVOLVE verified that the eDiary tool can be used by caregivers in VITESSE to capture the adhesion data in support of a potential BLA.

On March 7, 2023, the Company announced that the first patient was screened in the VITESSE study. Screening of the last patient is anticipated by the third quarter of 2024.

On April 19, 2023, the Company outlined the regulatory pathway for Viaskin Peanut in children 1-3 years old after the FDA confirmed that the Company’s Phase 3 EPITOPE study meets the pre-specified criteria for success for the primary endpoint, not requesting any additional efficacy study. The FDA required additional safety data to augment the safety data collected from EPITOPE in support of a BLA.

On July 31, 2023, the Company announced receipt of feedback from FDA on the two supplemental safety studies, COMFORT Children and COMFORT Toddlers. The COMFORT Toddlers safety study will enroll peanut allergic toddlers ages 1 – 3-years and will support the efficacy results generated from the EPITOPE Phase 3 pivotal study. The COMFORT Children safety study will enroll peanut allergic children ages 4 – 7-years and will support the efficacy results anticipated from the ongoing VITESSE Phase 3 pivotal study. FDA agreed with a 6-month study duration and a 3:1 randomization (active:placebo) of approximately 400 subjects in the double-blind, placebo-controlled COMFORT Toddlers study. 

The Company submitted the protocol for its COMFORT Toddlers supplemental safety study in 1-through-3-year-olds to FDA on November 9, 2023, and the Company and FDA are still engaged in ongoing dialogue related to the program.

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

On August 2, 2021, the Company announced it received from the European Medicines Agency (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.

On December 20, 2021, the Company announced it withdrew the Marketing Authorization Application (MAA) for Viaskin Peanut and formally notified the EMA of our decision. The initial filing was supported by 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 clinical trial 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 clinical trial will support a more robust path for licensure of Viaskin Peanut in the EU. The Company intends to resubmit the MAA when that data set is available.

Viaskin Peanut for children ages 1-3

In June 2020, the Company announced that in Part A of the EPITOPE phase 3 clinical study, subjects 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 µg dose in this age group, which is the dose being studied in Part B of the EPITOPE phase 3 clinical study. Enrollment for Part B of EPITOPE was completed in the first quarter of 2021.

10

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

The Company 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.

On April 19, 2023, the Company outlined the regulatory pathway for Viaskin Peanut in children 1-3 years old after the FDA confirmed that the Company’s Phase 3 EPITOPE study meets the pre-specified criteria for success for the primary endpoint, not requesting any additional efficacy study. The FDA requires additional safety data to augment the safety data collected from EPITOPE in support of a BLA. This new safety study will also generate patch adhesion data and will include updated instructions for use.

On May 10, 2023, the New England Journal of Medicine (NEJM) published results that demonstrated epicutaneous immunotherapy (EPIT) with VP was statistically superior to placebo in desensitizing children to peanut exposure by increasing the peanut dose that triggers allergic symptoms. As stated in an accompanying editorial piece, these data are seen as “very good news” for toddlers with peanut allergy, as there are currently no approved treatment options for peanut-allergic children under the age of 4 years. Following this publication, the Company confirmed it is advancing regulatory efforts for VP in toddlers ages 1-3 years old with a confirmed peanut allergy.

In November 2023, the Company announced the interim analyses from the first year of the open-label extension of EPITOPE. These data were presented at the annual American College of Allergy, Asthma and Immunology (ACAAI) in November 2023.

The Company submitted the protocol for its COMFORT Toddlers supplemental safety study in 1-through-3-year-olds to FDA on November 9, 2023, and the Company and FDA are still engaged in ongoing dialogue related to the program.

Viaskin Peanut for Children ages 4-7

On September 7, 2022, the Company announced the initiation of VITESSE, a new Phase 3 pivotal study of the modified Viaskin Peanut (mVP) patch in children ages 4-7 years with peanut allergy. The Company defined initiation as the submission of the trial protocol to selected study sites for subsequent Institutional Review Board (IRB)/Ethics Committee (EC) approval.

On September 21, 2022, the Company announced we had received feedback from the FDA in the form of a partial clinical hold on VITESSE. In the partial clinical hold letter, the FDA specified changes to elements of the VITESSE protocol, acknowledging the intent for the trial to support a future BLA submission. In the following months, the Company engaged with the FDA to address the feedback provided in the partial clinical hold letter and to finalize the VITESSE protocol. In addition, the Company continued internal preparations for VITESSE and conducted certain site assessment and start-up activities for prompt study launch once the partial clinical hold was lifted.

On December 23, 2022, the Company announced the FDA lifted the partial clinical hold and confirmed we satisfactorily addressed all clinical hold issues. The FDA stated that VITESSE may proceed with the revised trial protocol.

On March 7, 2023, the Company announced that the first patient was screened in the VITESSE trial. Screening of the last patient is anticipated by the third quarter of 2024.

In July 2023, the Company received Type C Meeting Written Responses from the FDA regarding key study design elements for COMFORT Children. In summary, there was an agreement with the Agency that COMFORT Children will be a Double-Blind, Placebo-Controlled study involving approximately 270 children, randomized at a 3:1 ratio (active to placebo). Participation will not necessitate a food challenge, and patch adhesion data will be generated using the same approach as previously agreed upon with the FDA for the VITESSE phase 3 study.

Subsequently, in October 2023, the Company received feedback from the FDA addressing the remaining protocol design elements for COMFORT Children. This feedback included language simplification for how Viaskin should be used. Furthermore, the key inclusion criteria for the COMFORT Children study will be based on a physician-diagnosed peanut allergy, peanut-specific IgE and a Skin Prick Test (with no requirement for a DBPCFC). The revised protocol design of the safety study was submitted to the FDA in Q4 2023. COMFORT Children is anticipated to be initiated towards the end of VITESSE enrollment. The Company intends that enrollment of the COMFORT Children safety study will be strategically timed to avoid competition with the VITESSE study for the same subjects.

Legal Proceedings

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

Note 3: Cash and Cash Equivalents

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

	March 31,		December 31,
	2024		2023
Cash		15,725		10,530
Cash equivalents		85,800		130,836
Total cash and cash equivalents as reported in the statements of financial position		101,525		141,367

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	March 31,		December 31,
	2024		2023
Bank overdrafts		—		—
Total cash and cash equivalents as reported in the statements of cash flows		101,525		141,367

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,
	2024		2023
Research tax credit		10,066		8,857
Other tax claims		5,725		5,236
Prepaid expenses		1,727		2,103
Other receivables		518		1,353
Total		18,037		17,548

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, 2024		8,857
+ Operating revenue		1,407
- Payment received		—
- Adjustment and currency translation effect		(198	)
Closing research tax credit receivable as of March 31, 2024		10,066
Of which - Non-current portion		—
Of which - Current portion		10,066

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 March 31, 2024 and December 31, 2023, are as follows:

	March 31, 2024									December 31, 2023
	Real estate			Other assets			Total			Real estate			Other assets			Total
Current portion		344			61			405			1,205			71			1,275
Year 2		1,014			—			1,014			65			11			75
Year 3		1,259			—			1,259			421			—			421
Thereafter		6,256			—			6,256			5,515			—			5,515
Total minimum lease payments		8,873			61			8,934			7,205			81			7,295
Less: Effects of discounting		(1,902	)		(7	)		(1,909	)		(1,617	)		(9	)		(1,626	)
Present value of operating lease		6,971			54			7,025			5,588			73			5,670
Less: current portion		(178	)		(54	)		(232	)		(1,072	)		(72	)		(1,144	)
Long-term operating lease		6,793			—			6,793			4,516			1			4,526
Weighted average remaining lease term (years)		7.52			0.01						7.95			—
Weighted average discount rate		5.00	%		0.03	%					4.53	%		2.50	%

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 condensed consolidated statement of operations and comprehensive loss was:

	March 31,
	2024			2023
Operating lease expense / (income)		586			446
Net termination impact		(12	)		(81	)

Supplemental cash flow information related to operating leases is as follows for the period March 31, 2024 and 2023:

	March 31
	2024		2023
Cash paid for amounts included in the measurement of lease liabilities
Operating cash flows for operating leases		501		496

Note 6: Trade Payables and Other 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 Current Liabilities

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

	March 31						December 31,
	2024						2023
	Other current liabilities		Other non- current liabilities		Total		Other current liabilities		Other non- current liabilities		Total
Employee related liabilities		4,629		—		4,629		7,828		—		7,828
Tax liabilities		180		—		180		223		—		223
Other debts		214		—		214		883		—		883
Total		5,023		—		5,023		8,934		—		8,934

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The Employee related liabilities include short-term debt to employees including social welfare and tax agency obligations as of March 31, 2024. The Employee related liabilities included short-term debt to employees including social welfare, tax agency obligations and bonus provision (paid during first quarter 2024) as of December 31, 2023.

Note 7: Shareholders’ equity

The share capital as of March 31, 2024 is set at the sum of €9,643,437 ($10,972 thousands converted at historical rates). It is divided into 96,434,369 fully authorized, subscribed and paid-up ordinary shares with a par value of €0.10.

Note 8: Share-Based Payments

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

During the three months ended March 31, 2024, the Company granted 262,000 stock options and 59,000 restricted stock units to employees.

There have been no changes in the vesting conditions and method of valuation of the SO and RSUs from that disclosed in Note 12 to the consolidated financial statements included in the Annual Report.

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Change in Number of BSA/SO/RSU:

	Number of outstanding
	BSA		SO		RSUs
Balance as of December 31, 2023		244,693		7,129,541		2,021,370
Granted during the period		—		262,000		59,000
Forfeited during the period		—		3,525		13,738
Exercised/released during the period		—		—		2,598
Expired during the period		—		—		—
Balance as of March 31, 2024		244,693		7,388,016		2,064,035

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

	Three Months Ended March 31,
	2024				2023
Research & development		SO	(513	)		(429	)
		RSU	(256	)		(258	)
Sales & marketing		SO	(23	)		(27	)
		RSU	(9	)		(8	)
General & administrative		SO	(1,030	)		(797	)
		RSU	(126	)		(113	)
Total share-based compensation (expense)			(1,958	)		(1,632	)

The $0.3 million increase in share-based compensation expenses is notably due to the increase of number of ordinary share equivalents granted in 2023 impacting the three months ended March 31, 2024, in comparison to the number granted in 2022 impacting the three months ended March 31, 2023.

Note 9: Contingencies

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

	March 31,		December 31,
	2024		2023
Current contingencies		3,153		3,959
Non-current contingencies		965		935
Total contingencies		4,118		4,894

The changes in contingencies are as follows:

	Pension retirement obligations			Other contingencies			Total
At January 1, 2024		935			3,959			4,894
Increases in liabilities		—			—			—
Used liabilities		—			(723	)		(723	)
Reversals of unused liabilities		(8	)		—			(8	)
Net interest related to employee benefits, and unwinding of discount		—			—			—
Actuarial gains and losses on defined-benefit plans		59			—			59
Currency translation effect		(20	)		(82	)		(103	)
At March 31, 2024		965			3,153			4,118

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	Pension retirement obligations		Other contingencies		Total
Of which Current		—		3,153		3,153
Of which Non-current		965		—		965

In May 2016, the Company entered into a Development Collaboration and License Agreement (the “Collaboration Agreement”) with Société des Produits Nestlé S.A. (formerly NESTEC S.A.) (“NESTEC”) under which the Company was responsible for leading the development activities of MAG1C up through a pivotal phase 3 clinical program.

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

As of March 31, 2024, the accrual for ongoing Clinical study completion totals $1.3 million (vs. $2.3 million as of December 31, 2023) representing our best estimate of the remaining expenses related to the ongoing clinical study.

The Company does not hold any plan assets related to long-term employee benefit for any of the periods presented. There have been no significant changes in assumptions for the estimation of the retirement commitments from those disclosed in Note 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 months ended March 31, 2024 and 2023:

	Three Months Ended March 31,
	2024		2023
Research tax credit		1,407		1,765
Other operating income		—		429
Total		1,407		2,194

As of March 31, 2023, other income were recorded according the Collaboration Agreement between the Company and NESTEC.

On October 30, 2023, the Company and NESTEC entered into a Mutual Termination Letter Agreement terminating the Collaboration Agreement, explaining the lack of other income as of March 31, 2024.

Note 11: Operating expenses

The Company had an average of 105 employees during the three months ended March 31, 2024, in comparison with an average of 87 employees during the three months ended March 31, 2023. This increase is mainly due to hiring to support clinical development activities related to ongoing and anticipated clinical trials and to support quality activities.

The following table summarizes the allocation of personnel expenses by function during the three months ended March 31, 2024 and 2023:

	Three Months Ended March 31,
	2024		2023
Research and Development expenses		5,048		4,006
Sales and Marketing expenses		334		165
General and Administrative expenses		3,236		3,100
Total personnel expenses		8,618		7,272

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The following table summarizes the allocation of personnel expenses by nature during the three months ended March 31, 2024 and 2023:

	Three Months Ended March 31,
	2024		2023
Wages and salaries		5,144		4,438
Social security contributions		1,207		699
Expenses for pension commitments		309		258
Employer contribution to bonus shares		—		244
Share-based payments		1,958		1,632
Total		8,618		7,272

The increase in personnel expenses is mainly due to the recruitment of US employees.

Note 12: Financial income (expense)

Our financial income was $1.3 million for the three months ended March 31, 2024, compared to $0.6 million for the three months ended March 31, 2023. This item mainly includes the financial income on our financial assets.

Note 13: Commitments

There has been no significant change in other commitments from those disclosed in Note 17 to the consolidated financial statements included in the Annual Report.

Note 14: Relationships with Related Parties

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 18 to the consolidated financial statements included in the Annual Report.

Note 15: 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 months ended March 31, 2024 and 2023, the diluted loss per share is equal to basic loss per share because the effects of potentially dilutive shares were anti-dilutive as a result of the Company’s net loss.

The following is a summary of the ordinary share equivalents that were excluded from the calculation of diluted net loss per share for each of the three months ended March 31, 2024 and 2023 indicated in number of potential shares:

	Three Months Ended March 31,
	2024		2023
Non-employee warrants		244,693		251,693
Stock options		7,388,016		5,318,569
Restricted stock units		2,064,035		1,583,938
Prefunded warrants		28,276,331		28,276,331

Note 16: Events after the Close of the Period

The Company evaluated subsequent events that occurred after March 31, 2024, through the date the condensed consolidated financial statements were issued after their approval by the Board of Directors on May 7, 2024 and determined that there are no significant events that require adjustments or disclosure in such condensed consolidated financial statements.

On April 22, 2024, the Company moved its headquarters to 107 Avenue de la République in Châtillon in France, which is subject to ratification by the shareholders of the Company at the annual general meeting on May 16, 2024.

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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, 2023, included in our Annual Report on Form 10-K for the year ended December 31, 2023, filed with the Securities and Exchange Commission on March 7, 2024, 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 EPIT, our proprietary method of delivering biologically active compounds to the immune system through intact skin using Viaskin, an epicutaneous patch (i.e., a skin patch). We have generated significant data demonstrating that Viaskin’s mechanism of action is novel and differentiated. Viaskin 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 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, if approved.

Our most advanced product candidate is Viaskin Peanut, which has been evaluated as a potential therapy for children with peanut allergy in eleven clinical trials, including four Phase 2 trials and four completed Phase 3 trials. We also have an ongoing Phase 3 trial of Viaskin Peanut in children ages four to seven with peanut allergy, as well as two planned Phase 3 supplementary safety studies, one in peanut-allergic children ages four through seven, and one in peanut-allergic toddlers, ages one through three.

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 condensed 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 Consolidated Financial Statements in Part I, Item 1 of our Annual Report.

Business trends and Results of Operations

Comparison of the Three Months Ended March 31, 2024 and 2023

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 March 31, 2024 and 2023.

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	Three months ended March 31,
	2024			2023			$ change			% change
Operating income	$	1,407		$	2,194			(787	)		(36	%)
Operating expenses
Research and development expenses		(21,403	)		(16,037	)		(5,366	)		33	%
Sales and marketing expenses		(758	)		(434	)		(324	)		75	%
General and administrative expenses		(7,804	)		(6,889	)		(915	)		13	%
Total Operating expenses		(29,964	)		(23,359	)		(6,605	)		28	%
Financial income		1,261			605			656			108	%
Income tax		(48	)		—			(48	)		—
Net loss	$	(27,345	)	$	(20,561	)		(6,785	)		33	%
Basic/diluted Net loss per share attributable to shareholders	$	(0.28	)	$	(0.22	)

Operating Income

The following table summarizes our operating income during the three months ended March 31, 2024 and 2023:

	Three months ended March 31,				$ change			% change
	2024		2023
Sales		—		—		—			—
Other income		1,407		2,194		(787	)		(36	%)
Research tax credit		1,407		1,765		(358	)		(20	)%
Other operating income		—		429		(429	)		(100	%)
Total operating income		1,407		2,194		(787	)		(36	%)

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

Operating Expenses

Since inception, our operating expenses have consisted primarily of research and development activities, and to a lower extent general and administration sales and marketing activities.

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Research and Development Expenses

The following table summarizes our research and development expenses incurred during the three months ended March 31, 2024 and 2023:

	Three Months Ended March 31,
Research and Development expenses	2024		2023		$ change		% change
External clinical-related expenses		14,026		10,471		3,555		34	%
Employee-related costs		4,278		3,319		959		29	%
Share-based payment expenses		770		687		83		12	%
Depreciation, amortization and other costs		2,329		1,559		770		69	%
Total Research and Development expenses		21,403		16,037		5,366		33	%

Research and Development expenses increased by $5.4 million for the three months ended March 31, 2024, compared to the three

months ended March 31, 2023, primarily due to the increase in external clinical-related expenses for $3.6 million, driven by progress on patient enrollment in VITESSE Phase 3 clinical trial.

Employee-related costs, excluding share-based payments, increased by $1.0 million for the three months ended March 31, 2024 compared to the three months ended March 31, 2023 due to the recruitment of employees to support research and development activities mainly on the VITESSE trial.

Sales and Marketing expenses

The following table summarizes our sales and marketing expenses incurred during the three months ended March 31, 2024 and 2023:

	Three Months Ended March 31,				$ change		% change
Sales and Marketing expenses	2024		2023
Personnel expenses (incl. share-based payment expenses)		334		165		169		102	%
External professional services and other costs		424		269		155		58	%
Total Sales and Marketing expenses		758		434		324		75	%

Sales and marketing expenses have increased by $0.3 million during the three months ended March 31, 2024, compared the three months ended March 31, 2023 to support pre-commercialization activities for Viaskin Peanut in North America.

General and Administrative expenses

The following table summarizes our general and administrative expenses incurred during the three months ended March 31, 2024 and 2023:

	Three Months Ended March 31,				$ change			% change
General and Administrative expenses	2024		2023
External professional services		2,433		1,706		726			43	%
Employee-related costs		2,080		2,190		(111	)		(5	%)
Share-based payment expenses		1,157		910		247			27	%
Depreciation, amortization and other costs		2,135		2,082		53			3	%
Total General and Administrative expenses		7,804		6,889		915			13	%

General and Administrative expenses increased by $0.9 million for the three months ended March 31, 2024, compared to the three months ended March 31, 2023 as a result of external professional services incurred to prepare financing activities as well to perform recruitments.

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Financial income (expense)

Our financial income was $1.3 million for the three months ended March 31, 2024, compared to a financial income of $0.6 million for the three months ended March 31, 2023. This item mainly includes the financial income on our financial assets.

This item mainly includes the financial income on our financial assets, reflecting the rise of Euro short term monetary rates between 2023-Q1 (€STER = 1.89% on December 31, 2022) and 2024-Q1 (€STER = 3.88% on December 31, 2023), where our excess cash is invested.

Income tax

Our income tax profit for the three months ended March 31, 2024 was $48 thousand. We did not have any income tax profit or expense for the three months ended March 31, 2023.

Net loss

Net loss was $27.3 million for the three months ended March 31, 2024, compared to $20.6 million for the three months ended March 31, 2023. Net loss per share (based on the weighted average number of shares outstanding over the period) was $0.28 and $0.22 for the three months ended March 31, 2024 and 2023, respectively.

Liquidity and Capital Resources

Financial Condition

On March 31, 2024, we had $101.5 million in cash and cash equivalents compared to $141.4 million of cash and cash equivalents on December 31, 2023. Based on its current operations, plans and assumptions, the Company expects that its balance of cash and cash equivalents will be sufficient to fund its operations until December 31, 2024.

As of the date of filing, our available cash is not projected to be sufficient to support our operating plan for at least the next 12 months. As such, there is substantial doubt regarding our ability to continue as a going concern.

We have incurred operating losses and negative cash flows from operations since our inception. Net cash used for operating activities was $34.7 million and $20.8 million for the three months ended March 31, 2024 and 2023, respectively. For the three months ended March 31, 2024, we recorded a net loss of $27.3 million. Our net cash flows provided by financing activities was $(0.1) million during the three months ended March 31, 2024 compared to a nil amount during the three months ended March 31, 2023. Our net cash flows used in investing activities was $(2.1) million during the three months ended March 31, 2024, including revamping of the new headquarter for $(1.3) million, compared to $(0.1) million during the three months ended March 31, 2023.

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.

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

In May 2022, we established an At-The-Market (“ATM”) program to offer and sell, including with unsolicited investors who have expressed an interest, a total gross amount of up to $100 million of American Depositary Shares (“ADSs”), each ADS representing one-half of one ordinary share of the Company. The ATM program is intended to be effective through the expiration of the Company’s existing registration statement registering the ADSs to be issued under the ATM program, i.e. until July 16, 2024, unless terminated prior to such date in accordance with the sales agreement or the maximum amount of the program has been reached. The Company’s intent is to use the net proceeds, if any, of sales of ADSs issued under the program, together with its existing cash and cash equivalents, primarily for activities associated with potential approval and launch of Viaskin Peanut, as well as to advance the development of the Company’s product candidates using its Viaskin Platform and for working capital and other general corporate purposes.

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

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. 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.

Operating leases

At the date of filing, our corporate headquarters are located in Châtillon, France. Our principal offices occupy a 2,447 square meter facility, pursuant to a lease agreement dated November, 2023 and represents a $4.5 million cash requirement as of March 31, 2024 until March, 2033. The move of the corporate headquarters to Châtillon, France is subject to ratification by the shareholders of the Company at the annual general meeting on May 16, 2024.

The lease agreement for the office occupying 4,470 square meter facility in Montrouge, France, signed on March 3, 2015, with an effective date of August 1, 2025, expires on May, 2024. Associated lease termination costs were reflected in the Company’s financial accounts in the Annual Report on Form 10-K for the year ended December 31, 2023, filed with the SEC on March 7, 2024.

At the date of filing, our primary U.S. office is located in Warren, New Jersey. In February 2024, we entered into a sublease agreement, commencing on March 19, 2024 and effective for 70 months, for an office of 16,704 square feet in Warren, New Jersey. The Warren office represent a $1.8 million cash requirement as of March 31, 2024 which expires December 31, 2029.

We also have facilities in North America that were intended to support our U.S. operations. We lease 5,799 square feet in Basking Ridge, New Jersey, which commenced on April 1, 2022 and is effective for 38 months.

The Company transitioned to its new offices location in Warren NJ and Châtillon France over the end of the first quarter of 2024. Leases from prior offices located in Basking Ridge NJ and Montrouge, France offices were still active at the time of filing.

There have been no material changes in our operating leases from those disclosed in the Annual Report.

Purchase obligations—Obligations Under the Terms of CRO Agreements

In connection with the launch of our clinical trials for Viaskin Peanut and Viaskin Milk, we signed agreements with several contract research organizations. As of December 31, 2023, expenses associated with the ongoing trials amounted globally to $114.4 millions, and we had non-cancellable contractual obligations with CRO until year ended 2025 amounting to $64.4 millions.

There have been no material changes in our purchase obligations from those disclosed in the Annual Report.

Summary Statement of Cash Flows

The table below summarizes our sources and uses of cash for the three months ended March 31, 2024 and 2023.

	Three months ended March 31,
(Amounts in thousands of U.S. Dollars)	2024			2023			$ change			% of change
Net cash flow provided by (used in) operating activities		(34,692	)		(20,841	)		(13,851	)		66	%
Net cash flow provided by (used in) investing activities		(2,132	)		42			(2,174	)		(5,176	%)
Net cash flow provided by (used in) financing activities		(62	)		(14	)		(47	)		328	%
Effect of exchange rate changes on cash and cash equivalents		(2,957	)		3,909			(6,866	)		(176	%)
Net (decrease) increase in cash and cash equivalents		(39,842	)		(16,905	)		(22,937	)		136	%

Operating Activities

Our net cash flows used in operating activities were $34.7 million and $20.8 million during the three months ended March 31, 2024 and 2023, respectively. The variance of $13.9 million is mainly driven by the increase in (1) external clinical-related expenses by $3.7 million, (2) R&D activities to support clinical trials progress through Regulatory Affairs, Medical Affairs, Manufacturing platform and Supply activities by $6.4 million and (3) internal employees’ compensation increase by $2.5 million with 18 additional employees.

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Investing Activities

Our net cash flows used in investing activities was $(2.1) million during the three months ended March 31, 2024, including revamping of the new offices in Châtillon, France for $(1.3) million, compared to $(0.1) million during the three months ended March 31, 2023.

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

We are a smaller reporting company as defined by Rule 12b-2 of the Exchange Act and are not required to provide the information required under this item.

Item 4. Controls and Procedures

Disclosure Controls and Procedures

Based on its evaluation as of March 31, 2024, 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 Quarterly Report.

Item 1A. Risk Factors

Our business is subject to risks and events that, if they occur, could adversely affect our financial condition and results of operations and trading price of our securities. In addition to the other information set forth in this Quarterly Report, you should carefully consider the factors described in Part I, Item 1A. “Risk Factors” of our Annual Report. There have been no material changes in our risk factors from those disclosed in the Annual Report.

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

During the three months ended March 31, 2024, we issued the following unregistered securities:

• On March 23, 2024, the issuance of an aggregate of 2,599 ordinary shares to US and non-US employees upon settlement of RSUs.;

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

During the three months ended March 31, 2024, none of our directors and officers (as defined in Rule 16a-1(f) under the Securities Exchange Act of 1934, as amended) adopted or terminated any contracts, instructions or written plans for the purchase or sale of the Company’s securities.

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Item 6. Exhibits.

Exhibit Index

		Incorporated by Reference
Exhibit	Description	Schedule/ Form	File Number	Exhibit	File Date
3.1	By-laws (status) of the registrant (English translation)
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 incorporate 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: May 7, 2024	By:	/s/ Daniel Tassé
	Daniel Tassé
	Chief Executive Officer
	(Principal Executive Officer)
Date: May 7, 2024	By:	/s/ Virginie Boucinha
	Virginie Boucinha
	Chief Financial Officer
	(Principal Financial and Accounting Officer)

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