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, 2024

☐	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 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.

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 Viaskin

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.

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		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.

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.

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.

DBV Technologies S.A.

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

(amounts in th

ousands, 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.

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.

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.

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.

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 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.

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

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.

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


	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,

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.

Note 5

Lease contracts

Future minimum lease payments under the Company’s operating

leas

es’ 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

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