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Form 8-K

sec.gov

8-K — DBV Technologies S.A.

Accession: 0001193125-26-126671

Filed: 2026-03-26

Period: 2026-03-26

CIK: 0001613780

SIC: 2836 (BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES))

Item: Results of Operations and Financial Condition

Item: Financial Statements and Exhibits

Documents

8-K — d113165d8k.htm (Primary)

EX-99.1 (d113165dex991.htm)

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8-K

8-K (Primary)

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8-K

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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

March 26, 2026

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 registration 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 March 26, 2026, DBV Technologies S.A. (the “Company”) issued a press release announcing financial results and business highlights for the fiscal year ended December 31, 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

Description

99.1

Press Release dated March 26, 2026.

104

Cover Page Interactive Data File (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.

DBV Technologies S.A.

Date: March 26, 2026

By:

/s/ Virginie Boucinha

Name:

Virginie Boucinha

Title:

Chief Financial Officer

EX-99.1

EX-99.1

Filename: d113165dex991.htm · Sequence: 2

EX-99.1

Exhibit 99.1

DBV Technologies Reports Full Year 2025 Financial Results and Business Update

Continued advancing the VIASKIN® Peanut Patch clinical

development programs in peanut-allergic toddlers (1 through 3 years old) and children (4 through 7 years old)

Bolstered executive leadership team in preparation for BLA submission and potential approval

Reported cash and cash equivalents of $194 million as of December 31, 2025, plus additional gross

proceeds of $94 million received on January 16, 2026 —providing funding into the second quarter of 2027

DBV

Technologies (Euronext: DBV – ISIN: FR0010417345 – Nasdaq Capital Market: DBVT) (the “Company”), a late-stage biopharmaceutical company, today reported financial results for the full year 2025. The consolidated

financial statements are prepared under U.S. Generally Acceptable Accounting Principles (“U.S. GAAP”) and International Financial Reporting Standards (“IFRS”) for the purpose of Form

10-K and French “Document d’Enregistrement Universel” containing the Annual Financial Report – were approved by the Board of Directors on March 26, 2026.

“We entered 2025 with a clear set of priorities – strengthening our financial position, advancing our clinical development program (including

completing VITESSE and initiating COMFORT Toddlers), and preparing for the BLA submission and commercialization of the VIASKIN® Peanut Patch in the United States, if

approved,” said Daniel Tassé, Chief Executive Officer of DBV Technologies. “I am pleased with our progress to date in enhancing DBV’s capabilities and building a company ready for launch. Our focus on bringing

the VIASKIN® Peanut Patch to peanut-allergic children ages 1-7 years remains unwavering.”

2025 Operational Highlights

Clinical Execution

Continued to advance clinical program for the VIASKIN®

Peanut Patch across both toddlers and children

Reported positive topline results from the Phase 3 VITESSE trial in peanut-allergic children aged 4 to 7 years

Initiated supplemental safety study, COMFORT Toddlers, for peanut-allergic toddlers aged 1 to 3 years

Announced planned clinical study to assess the efficacy and safety of the VIASKIN® Peanut Patch in achieving ad lib consumption of dietary peanut in peanut-allergic infants 6 through 12 months of age following a minimum of 3 years of treatment

Scientific Engagement

Maintained active engagement with allergy, immunology, and patient advocacy communities through participation in

leading scientific and medical congresses, including American Academy of Allergy, Asthma, and Immunology (AAAAI) Annual Meeting, the European Academy of Allergy and Clinical Immunology (EAACI) Congress, and the American College of Allergy, Asthma,

and Immunology (ACAAI) Annual Scientific Meeting

Leadership Expansion

Bolstered leadership capabilities in preparation for potential commercialization

Appointed Kevin Trapp as Chief Commercial Officer and James Briggs as Chief Human Resources Officer to strengthen

ability to grow, plan, and execute a launch in the United States, if approved

Appointed Philina Lee, Ph.D. to Board of Directors (subject to ratification by the Company’s shareholders

at the next annual meeting of shareholders), adding deep expertise in biotechnology strategy and commercialization

Financial

Position

Announced a private placement financing (”2025 PIPE”) of up to $306.9 million (€284.5

million) on March 27, 2025, to advance the VIASKIN® Peanut Patch through Biologics License Application (”BLA”) submission and U.S. commercial launch, if approved. The 2025

PIPE included gross proceeds of $125.5 million (€116.3 million at the exchange rate of 1 EUR = $1.08) received on April 7, 2025 and $100.7 million as of December 31, 2025 (€85,7 million at the exchange rate of

1 EUR = $1.17) resulting from the exercise of the ABSA Warrants and BS Warrants, following the announcement of the positive VITESSE Topline Results on December 16, 2025

Further strengthened balance sheet through the launch of a $150 million At-the-Market (ATM) program, subsequently subscribed for $65 million as of December 31, 2025

Anticipated 2026 Events

BLA Submission for 4-7 year olds anticipated in the first half of 2026

with potential for Priority Review

Completion of enrollment of COMFORT Toddlers safety study and subsequent topline results readout

BLA submission for 1-3 year olds anticipated in the second half of 2026

under an Accelerated Approval Pathway

Financial Highlights for the Full Year 2025

2025 Financial Highlights are presented under both U.S. GAAP and IFRS. Comments are provided on a U.S. GAAP basis. Differences between U.S. GAAP and IFRS

consolidated financial statements result mainly from the application of lease accounting standards.

Financial Performance

Operating Income

For the year ended December 31,

2025, operating income totaled $5.6 million, increasing from $4.2 million for the year ended December 31, 2024, driven by higher eligible activities to the French Research Tax Credit (crédit d’impôt recherche).

Research and Development Expenses

R&D expenses

increased by $27.3 million for the year ended December 31, 2025, compared to 2024 driven by:

Pre-commercial inventory of $16.1 million, in preparation of the

launch of VIASKIN® Peanut Patch for children aged 4 to 7 years old in the U.S., if approved

External clinical expenses of $6.9 million, with COMFORT Toddlers study ongoing patient enrollment

Employee-related costs of $3.3 million from the addition of Quality and Regulatory resources to support BLA

submission and commercial readiness activities

Selling, General and Administrative Expenses

SG&A Expenses increased by $4.6 million for the year ended December 31, 2025, compared to the year ended December 31, 2024

primarily from Market Research activities and additional roles strengthening operational capabilities towards launch of the VIASKIN® Peanut Patch for children aged 4 to 7 years in the U.S., if

approved.

Net Loss

Net loss was $147.0 million

for the year ended December 31, 2025, compared to $113.9 million for the year ended December 31, 2024. Net loss per share (based on the weighted average number of shares outstanding over the period) was $1.05 and

$1.17 for the year ended December 31, 2025 and 2024, respectively.

Cash Position and Liquidity

On December 31, 2025, DBV held $194.2 million in cash and cash equivalents

compared to $32.5 million of cash and cash equivalents on December 31, 2024.

Net cash used for operating activities was $121.2 million and $104.5 million for the years ended

December 31, 2025, and 2024, respectively.

Net cash flows from financing activities totaled $276.2 million in 2025 and $0.6 million in 2024,

resulting from the 2025 PIPE proceeds and the ATM facility.

Considering the supplemental gross proceeds received from completed ABSA

and BS warrants exercises ($94 million) in January 2026, together with the Company’s existing cash and cash equivalents as of December 31, 2025, and based on current operations, plans, and assumptions, management

has determined that its cash and cash equivalents, are sufficient to fund its operations into the second quarter of 2027.

The going concern assessment is

based on the Company’s current forecasts and exclude any additional expenditure related to other programs than the VIASKIN® Peanut Patch or resulting from the potential in licensing or

acquisition of additional product candidates or technologies, or any associated development the Company may pursue. Assumptions used in the going concern assessment may differ from actual results, and the Company may end up using its resources

sooner than anticipated and seek additional resources to execute the corporate strategy either through new or existing financing strategies.

Audited Consolidated Statement of Operations (In millions of USD)

US GAAP

December 31,

IFRS

December 31,

2025

2024

2025

2024

Operating income

5.6

4.2

5.6

4.2

Operating expenses

Research and development expenses

(116.7

)

(89.3

)

(116.6

)

(89.2

)

Sales and marketing expenses

(3.2

)

(2.7

)

(3.2

)

(2.7

)

General and administrative expenses

(32.8

)

(28.7

)

(32.8

)

(28.7

)

Total Operating expenses

(152.7

)

(120.7

)

(152.6

)

(120.6

)

Loss from operations

(147.1

)

(116.6

)

(147.0

)

(116.5

)

Financial income (expense)

0.6

2.7

0.3

2.4

Loss before taxes

(146.5

)

(113.8

)

(146.6

)

(114.1

)

Income tax

(0.5

)

(0.1

)

(0.5

)

(0.1

)

Net loss

(147.0

)

(113.9

)

(147.1

)

(114.1

)

Basic/diluted Net loss per share attributable to shareholders

(1.05

)

(1.17

)

(1.05

)

(1.18

)

About DBV Technologies

DBV Technologies is a late-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 VIASKIN® patch technology 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® patch 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 the VIASKIN Peanut Patch 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.dbvtechnologies.com and engage with us on X (formerly

Twitter) and LinkedIn.

Forward Looking Statements

This press release contains forward-looking statements, including, without limitation, statements regarding the Company’s financial condition, forecast

of its cash runway, the therapeutic potential of Viaskin® patch, designs of DBV’s anticipated clinical trials, DBV’s planned regulatory and clinical efforts including timing and

results of communications with regulatory agencies, clinical trial data releases and publications, the potential regulatory submissions, regulatory approval, launch and commercialization of the Company’s product candidates, the ability of any

of DBV’s product candidates, if approved, to improve the lives of patients with food allergies, and the Company’s business strategy and goals. These forward-looking statements and estimates are not promises or guarantees and involve

substantial risks and uncertainties. At this stage, the Company’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 the Company’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, 2025, filed with the SEC on March 26, 2026, 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.

VIASKIN is a registered trademark of DBV Technologies.

Investor Contact

Jonathan Neely

DBV Technologies

Jonathan.neely@dbv-technologies.com

Media Contact

Brett Whelan

DBV Technologies

Brett.whelan@dbv-technologies.com

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