8-K

Date: July 29, 2025

DBV TECHNOLOGIES S.A.

/s/ Virginie Boucinha

Virginie Boucinha

Chief Financial Officer

0001193125-25-168148.txt : 20250729 0001193125-25-168148.hdr.sgml : 20250729 20250729172826 ACCESSION NUMBER: 0001193125-25-168148 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 16 CONFORMED PERIOD OF REPORT: 20250729 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20250729 DATE AS OF CHANGE: 20250729 FILER: COMPANY DATA: COMPANY CONFORMED NAME: DBV Technologies S.A. CENTRAL INDEX KEY: 0001613780 STANDARD INDUSTRIAL CLASSIFICATION: BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836] ORGANIZATION NAME: 03 Life Sciences EIN: 000000000 STATE OF INCORPORATION: I0 FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-36697 FILM NUMBER: 251163157 BUSINESS ADDRESS: STREET 1: 107 AVENUE DE LA REPUBLIQUE CITY: CHATILLON STATE: I0 ZIP: 92320 BUSINESS PHONE: 33(0)155427878 MAIL ADDRESS: STREET 1: 107 AVENUE DE LA REPUBLIQUE CITY: CHATILLON STATE: I0 ZIP: 92320 8-K 1 d945712d8k.htm 8-K 8-K

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

July 29, 2025

Date of Report (Date of earliest event reported)

DBV Technologies S.A.

(Exact name of registrant as specified in its charter)

France

001-36697

Not applicable

(State or other jurisdiction

of incorporation)

(Commission

File Number)

(IRS Employer

Identification No.)

107 avenue de la République

92320 Châtillon France

Not Applicable

(Address of principal executive offices)

(Zip Code)

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

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

☐	Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐	Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐	Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐	Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

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


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

*	Not for trading, but only in connection with the listing of the American Depositary Shares on The Nasdaq Stock Market LLC.

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).

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. ☐

Item 2.02.

Results of Operations and Financial Condition

On July 29, 2025, DBV Technologies S.A. (the “Company”) issued a press release announcing financial results and business highlights for the fiscal quarter ended June 30, 2025. A copy of the press release is being furnished as Exhibit 99.1 to this Current Report on Form 8-K.

The information contained in Item 2.02 in this Current Report on Form 8-K (including Exhibit 99.1) is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, (the “Exchange Act”) or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.

Item 9.01

Financial Statements and Exhibits

(d) Exhibits


Exhibit No.		Description

99.1		Press Release issued July 29, 2025

104		Cover Page Interactive Data File (the cover page XBRL tags are embedded within the inline XBRL document)

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 hereunto duly authorized.

EX-99.1 2 d945712dex991.htm EX-99.1 EX-99.1

LOGO

DBV Technologies Reports Second Quarter and Half-Year 2025 Financial Results

DBV Technologies (Euronext: DBV – ISIN: FR0010417345 – Nasdaq Stock Market: DBVT – CUSIP: 23306J309), a clinical-stage biopharmaceutical company, today reported financial results for the Second Quarter of 2025. The quarterly and half-year financial statements were approved by the Board of Directors on July 29, 2025.

Financial Highlights for the Second Quarter Ended June 30, 2025

The Company’s interim condensed consolidated financial statements for the quarter and six months ended June 30, 2025, are prepared in accordance with accounting principles generally accepted in the United States (“U.S. GAAP”) and Europe (IFRS).

Operating Income

Operating income amounted to $2.2 million for the six months ended June 30, 2025, compared with $2.6 million for the same period in 2024, primarily due to a lower French Research Tax Credit entitlement as a greater proportion of studies activities were carried out in North America and therefore not eligible for the tax credit.


	U.S. GAAP				U.S. GAAP				IFRS
In millions of USD	six months ended June 30,				three months ended June 30,				six months ended June 30,
(unaudited)	2025		2024		2025		2024		2025		2024
Research tax credit		2.2		2.6		1.5		1.2		2.2		2.6
Other operating income		—		—		—		—		—		—
Operating income		2.2		2.6		1.5		1.2		2.2		2.6

LOGO

Operating Expenses

Operating expenses amounted to $69.9 million for the six months ended June 30, 2025, compared with $65.0 million for the six months ended June 30, 2024, an increase by $4.9 million driven mostly by the launch of the COMFORT Toddlers supplemental safety study.


	U.S. GAAP						U.S. GAAP						IFRS
In millions of USD	six months ended June 30,						three months ended June 30,						six months ended June 30,
(unaudited)	2025			2024			2025			2024			2025			2024
Research & Development		(55.2	)		(46.8	)		(33.7	)		(25.4	)		(55.1	)		(46.7	)

Sales & Marketing		(0.7	)		(1.7	)		(0.4	)		(1.0	)		(0.7	)		(1.7	)

General & Administrative		(14.1	)		(16.4	)		(8.5	)		(8.6	)		(14.1	)		(16.5	)
Operating expenses		(69.9	)		(65.0	)		(42.6	)		(35.0	)		(69.8	)		(64.9	)

Net Loss and Net Loss Per Share

The Company recorded a net loss for the six months ended June 30, 2025, of $69.0 million, compared to a net loss of $60.5 million for the six months ended June 30, 2024.

On a per share basis, net loss (based on the weighted average number of shares outstanding over the period) was $(0.58) for the six months ended June 30, 2025 compared with $(0.63) for the six months ended June 30, 2024.


	U.S. GAAP						U.S. GAAP						IFRS
In millions of USD	six months ended June 30,						three months ended June 30,						six months ended June 30,
(unaudited)	2025			2024			2025			2024			2025			2024
Net (loss) (in millions of USD)		(69.0	)		(60.5	)		(41.9	)		(33.1	)		(69.0	)		(60.6	)
Basic / diluted net (loss) per share (USD/share)		(0.58	)		(0.63	)		(0.31	)		(0.34	)		(0.58	)		(0.63	)

Cash and Cash Equivalents

Our 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.

Cash and cash equivalents amounted to $103.2 million as of June 30, 2025, compared to $32.5 million as of December 31, 2024, a net increase of $70.7 million. .

LOGO

On March 27, 2025, the company announced a financing of up to $306.9 million (€284.5 million), to advance Viaskin^® Peanut patch through Biologics License Application (“BLA”) submission and U.S. commercial launch, if approved. The financing included gross proceeds of $125.5 million (€116.3 million) received on April 7, 2025. With the receipt of the aforementioned proceeds, and based on its current operations, plans, and assumptions examined by the Board on June 23, 2025, the Company estimates that its cash and cash equivalents are sufficient to fund its operations into the second quarter of 2026. As such, there is substantial doubt regarding our ability to continue as a going concern.

However, it should be noted that the Company financing also includes an aggregate of up to $181.4 million (€168.2 million) in gross proceeds if all warrants are exercised, subject to satisfaction of specified conditions. The VITESSE Phase 3 study hitting its primary endpoint will trigger an acceleration of the exercise period of the warrants. DBV expects that the proceeds of this funding will be used for working capital and general corporate purposes, to finance the continued development of the Viaskin Peanut program, to finance the preparation and submission of a potential BLA, and to finance the readiness of a launch of Viaskin peanut in the U.S., if approved.

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.


In millions of USD	U.S. GAAP six months ended June 30,						IFRS six months ended June 30,
(unaudited)	2025			2024			2025			2024
Net cash & cash equivalents at the beginning of the period		32.5			141.4			32.5			141.4
Net cash flow used in operating activities		(53.6	)		(69.8	)		(53.3	)		(68.7	)
Net cash flow provided by / (used in) investing activities		(0.4	)		(1.4	)		(0.4	)		(1.4	)
Net cash flow provided by / (used in) financing activities		117.0			(0.1	)		116.7			(1.1	)
Effect of exchange rate changes on cash & cash equivalents		7.7			(3.9	)		7.7			(3.9	)
Net cash & cash equivalents at the end of the period		103.2			66.2			103.2			66.2

LOGO

CONDENSED CONSOLIDATED STATEMENTS OF FINANCIAL POSITION


In millions of USD	U.S. GAAP				IFRS
(unaudited)	June 30, 2025		December 31, 2024		June 30, 2025		December 31, 2024
Assets		143.4		65.7		143.2		65.5
of which cash & cash equivalents		103.2		32.5		103.2		32.5
Liabilities		57.2		38.3		57.1		38.2
Shareholders’ equity		86.2		27.4		86.2		27.4

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS


	U.S. GAAP						U.S. GAAP						IFRS
In millions of USD	six months ended June 30,						three months ended June 30,						six months ended June 30,
(unaudited)	2025			2024			2025			2024			2025			2024
Operating income		2.2			2.6			1.5			1.2			2.2			2.6
Research & Development		(55.2	)		(46.8	)		(33.7	)		(25.4	)		(55.1	)		(46.7	)
Sales & Marketing		(0.7	)		(1.7	)		(0.4	)		(1.0	)		(0.7	)		(1.7	)
General & Administrative		(14.1	)		(16.4	)		(8.5	)		(8.6	)		(14.1	)		(16.5	)
Operating expenses		(69.9	)		(65.0	)		(42.6	)		(35.0	)		(69.8	)		(64.9	)
Financial income/(expenses)		(1.1	)		2.0			(0.6	)		0.7			(1.3	)		1.8
Income tax		(0.1	)		—			(0.1	)		—			(0.1	)		—
Net loss		(69.0	)		(60.5	)		(41.9	)		(33.1	)		(69.0	)		(60.6	)
Basic/diluted net loss per share attributable to shareholders		(0.58	)		(0.63	)		(0.31	)		(0.34	)		(0.58	)		(0.63	)

LOGO

About DBV Technologies

DBV Technologies is a clinical-stage biopharmaceutical company developing treatment options for food allergies and other immunologic conditions with significant unmet medical need. DBV Technologies is currently focused on investigating the use of its proprietary technology platform, Viaskin, to address food allergies, which are caused by a hypersensitive immune reaction and characterized by a range of symptoms varying in severity from mild to life-threatening anaphylaxis. Millions of people live with food allergies, including young children. Through epicutaneous immunotherapy (EPIT), the Viaskin platform is designed to introduce microgram amounts of a biologically active compound to the immune system through intact skin. EPIT is a new class of non-invasive treatment that seeks to modify an individual’s underlying allergy by re-educating the immune system to become desensitized to allergen by leveraging the skin’s immune tolerizing properties. DBV Technologies is committed to transforming the care of food allergic people. The Company’s food allergy programs include ongoing clinical trials of Viaskin Peanut in peanut allergic toddlers (1 through 3 years of age) and children (4 through 7 years of age).

DBV Technologies is headquartered in Châtillon, France, with North American operations in Warren, NJ. The Company’s ordinary shares are traded on segment B of Euronext Paris (DBV, ISIN code: FR0010417345) and the Company’s ADSs (each representing five ordinary shares) are traded on the Nasdaq Capital Market (DBVT – CUSIP: 23306J309).

For more information, please visit www.dbv-technologies.com and engage with us on X (formerly Twitter) and LinkedIn.

Forward Looking Statements

This press release may contain forward-looking statements and estimates, including statements regarding DBV’s financial condition, forecast of its cash runway and therapeutic potential of Viaskin^® Peanut patch and EPIT. These forward-looking statements and estimates are not promises or guarantees and involve substantial risks and uncertainties. At this stage, DBV’s product candidates have not been authorized for sale in any country. Among the factors that could cause actual results to differ materially from those described or projected herein include uncertainties associated generally with research and development, clinical trials and related regulatory reviews and approvals, and DBV’s ability to successfully execute on its budget discipline measures. A further list and description of risks and uncertainties that could cause actual results to differ materially from those set forth in the forward-looking statements in this press release can be found in DBV’s regulatory filings with the French Autorité des Marchés Financiers (“AMF”), DBV’s filings and reports with the U.S. Securities and Exchange Commission (“SEC”), including in DBV’s Annual Report on Form 10-K for the year ended December 31, 2024, filed with the SEC on April 11, 2025, as amended by Amendment No. 1 on Form 10-K/A filed with the SEC on April 28, 2025, and as amended further by Amendment No. 2 on Form 10-K/A filed with the SEC on May 14, 2025, and future filings and reports made with the AMF and SEC by DBV. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements and estimates, which speak only as of the date hereof. Other than as required by applicable law, DBV Technologies undertakes no obligation to update or revise the information contained in this Press Release.

LOGO

Viaskin is a registered trademark of DBV Technologies.

Investor Contact

Katie Matthews

DBV Technologies

katie.matthews@dbv-technologies.com

Media Contact

Brett Whelan

DBV Technologies

brett.whelan@dbv-technologies.com

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Document and Entity Information	Jul. 29, 2025
Document Information [Line Items]
Document Type	8-K
Document Period End Date	Jul. 29, 2025
Entity Registrant Name	DBV Technologies S.A.
Entity Incorporation State Country Code	I0
Entity File Number	001-36697
Entity Tax Identification Number	00-0000000
Entity Address Address Line 1	107 avenue de la République
Entity Address Postal Zip Code	92320
Entity Address City Or Town	Châtillon
Entity Address Country	FR
Country Region	33
City Area Code	1
Local Phone Number	55 42 78 78
Written Communications	false
Soliciting Material	false
Pre Commencement Tender Offer	false
Pre Commencement Issuer Tender Offer	false
Entity Emerging Growth Company	false
Entity Central Index Key	0001613780
Amendment Flag	false
Common Stock [Member]
Document Information [Line Items]
Security 12b Title	Ordinary shares, nominal value €0.10 per share
No Trading Symbol Flag	true
Security Exchange Name	NASDAQ
American Depositary Share [Member]
Document Information [Line Items]
Security 12b Title	American Depositary Shares, each representing five ordinary shares, nominal value €0.10 per share
Security Exchange Name	NASDAQ
Trading Symbol	DBVT

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