0001193125-26-197921.txt : 20260430 0001193125-26-197921.hdr.sgml : 20260430 20260430173048 ACCESSION NUMBER: 0001193125-26-197921 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 15 CONFORMED PERIOD OF REPORT: 20260430 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20260430 DATE AS OF CHANGE: 20260430 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: 26927479 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 d132063d8k.htm 8-K 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

April 30, 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 April 30, 2026, DBV Technologies S.A. (the “Company”) issued a press release announcing financial results and business highlights for the fiscal quarter ended March 31, 2026. 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 April 30, 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: April 30, 2026     By:  

/s/ Virginie Boucinha

    Name:   Virginie Boucinha
    Title:   Chief Financial Officer
EX-99.1 2 d132063dex991.htm EX-99.1 EX-99.1

Exhibit 99.1

 

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Press Release

Châtillon, France, April 30, 2026

DBV Technologies Reports First Quarter 2026 Financial Results

 

   

Reported cash and cash equivalents of $229 million as of March 31, 2026 —providing funding into the second quarter of 2027 following the full exercise of the ABSA Warrants and BS Warrants issued in its March 2025 private placement (“PIPE”) financing

 

   

Continued disciplined execution focused on BLA filing in the first half of this year and commercial preparedness for the U.S. launch of the VIASKIN® Peanut Patch for children aged 4 to 7 years, if approved

DBV Technologies (Euronext: DBV – ISIN: FR0010417345 – Nasdaq Capital Market: DBVT) (the “Company”), a late-stage biopharmaceutical company, today reported financial results for the first quarter of 2026. The quarterly and three months unaudited condensed financial statements were approved by the Board of Directors on April 30, 2026.

“The entire DBV team has been operating with exceptional focus and rigor as we progress towards significant milestones in the coming months, including the upcoming Biologics License Application (BLA) submissions for both our Children ages 4-7 and Toddler ages 1-3 programs in first half and second half of this year, respectively.” said Daniel Tassé, Chief Executive Officer of DBV Technologies. “We also plan to initiate a first of its kind study in infants ages 6 through 12 months. This Phase 2 study, previously announced at last year’s American College of Asthma, Allergy, and Immunology, and now called THRIVE, will 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. Across all development programs, we are operating with extreme precision and purpose with the goal of providing practical, non-invasive treatment options to peanut allergy families no matter where they are on their treatment journey.”

Financial Highlights for the First Quarter Ended March 31, 2026

The Company’s interim unaudited condensed consolidated financial statements for the three months ended March 31, 2026, and the comparative period of March 31, 2025, are prepared in accordance with accounting principles generally accepted in the United States (“U.S. GAAP”).


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In the first quarter of 2026, the Company started to execute its plan for growth, building on the key events from 2025, including the receipt of regulatory alignment with the U.S. Food and Drug Administration in the first quarter of 2025 regarding the safety data requirements and positive phase 3 clinical results in the fourth quarter, that will both support the planned BLA submission for the VIASKIN® Peanut Patch in children aged 4 to 7 years in the first half of 2026.

Financial Performance

Operating Income

For the three months ended March 31, 2026, the Company accrued $1 million of French Research Tax Credit (“Crédit d’impôt recherche”). This level reflects the expected lower volume of eligible experimental activities on a full-year basis, as the Company’s focus continues to shift from clinical development toward commercial-readiness activities.

Research and Development Expenses

R&D expenses increased by $12 million for the three months ended March 31, 2026, compared to the three months ended March 31, 2025, driven primarily by:

 

   

Clinical-related expenses driven by the ongoing recruitment for the COMFORT Toddlers study, the VITESSE Open-label extension (OLE), and the acceleration of BLA-readiness activities.

 

   

Investment in Medical Affairs, Quality and Regulatory functions in the United States.

 

   

Continuous Pre-Commercial Inventory build-up in preparation for the launch of the VIASKIN® Peanut Patch for children aged 4 to 7 years in the U.S., if approved.

Selling, General and Administrative (“SG&A”) Expenses

SG&A Expenses increased by $9 million for the three months ended March 31, 2026, compared to the three months ended March 31, 2025, reflecting the Company’s steps towards building U.S. Commercial infrastructure. The Company plans a phased build of launch-readiness capabilities to support the U.S. launch of the VIASKIN® Peanut Patch for children aged 4 to 7, if approved.

Net Loss

Net loss was $47.6 million for the three months ended March 31, 2026, compared to $27.1 million for the three months ended March 31, 2025. Net loss per share (based on the weighted average number of shares* over the period) decreased from $(0.26) to $(0.11) for the three months ended March 31, 2025, and March 31, 2026, respectively. This improvement reflects a significantly strengthened equity base following recent financings.


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Cash Position and Liquidity

On March 31, 2026, the Company held $229 million in Cash and Cash Equivalents compared to $194 million of Cash and Cash Equivalents on December 31, 2025. Net cash used for operating activities was $49 million and $20 million for the periods ended March 31, 2026, and March 31, 2025, respectively. The Company’s net cash flows provided by financing activities totaled $89 million for the periods ended March 31, 2026, following the full exercise of the ABSA Warrants and BS Warrants Issued on its March 2025 PIPE Financing.

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.

These estimates are based on the Company’s current forecasts and exclude any additional expenditures related to programs other than the VIASKIN Peanut or resulting from the potential in licensing or acquisition of additional product candidates or technologies, or any associated development the Company may pursue. The Company may have based these estimates on assumptions that are incorrect, and the Company may end up using its resources sooner than anticipated.

Unaudited condensed Consolidated Statement of Operations

 

(In millions of USD)    US GAAP
Three months ended March 31
 
   2026      2025  

Operating income

     0.9        0.8  

Operating expenses

     

Research and development expenses

     (33.4      (21.5

Sales and marketing expenses

     (4.8      (0.3

General and administrative expenses

     (10.5      (5.6

Total Operating expenses

     (48.8      (27.4

Loss from operations

     (47.9      (26.6

Financial income (expense)

     0.5        (0.5

Loss before taxes

     (47.4      (27.1

Income tax

     (0.2      —   

Net loss

     (47.6      (27.1

Basic/diluted Net loss per share attributable to shareholders*

     (0.11      (0.26

 

*

Following the March 2025 PIPE financing, this weighted-average share count includes the shares underlying the pre-funded warrants, as the remaining cash exercise price for those warrants is considered immaterial.


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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, including the planned Phase 2 THRIVE study in peanut-allergic infants aged 6 through 12 months, 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


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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, the Company’s ability to successfully execute on its growth plans, commercial readiness activities and BLA-related efforts, risks related to the commercialization and launch of the Company’s product candidates, including market acceptance, pricing and reimbursement, and the Company’s ability to obtain additional financing on acceptable terms, if needed, to fund its operations. 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 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, as amended by the Amendment No. 1 on Form 10-K/A filed with the SEC on April 30, 2026, and future filings and reports made with the 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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Document and Entity Information
Apr. 30, 2026
Document And Entity Information [Line Items]  
Document Type 8-K
Document Period End Date Apr. 30, 2026
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 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 And Entity Information [Line Items]  
Security 12b Title Ordinary shares, nominal value €0.10 per share
No Trading Symbol Flag true
Security Exchange Name NASDAQ
ADR [Member]  
Document And Entity 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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