Form 8-K
8-K — DBV Technologies S.A.
Accession: 0001193125-26-197921
Filed: 2026-04-30
Period: 2026-04-30
CIK: 0001613780
SIC: 2836 (BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES))
Item: Results of Operations and Financial Condition
Item: Financial Statements and Exhibits
Documents
8-K — d132063d8k.htm (Primary)
EX-99.1 (d132063dex991.htm)
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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
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
EX-99.1
Filename: d132063dex991.htm · Sequence: 2
EX-99.1
Exhibit 99.1
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”).
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.
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.
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
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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