Form 8-K
8-K — DBV Technologies S.A.
Accession: 0001193125-26-306222
Filed: 2026-07-16
Period: 2026-07-16
CIK: 0001613780
SIC: 2836 (BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES))
Item: Results of Operations and Financial Condition
Item: Financial Statements and Exhibits
Documents
8-K — d156695d8k.htm (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
July 16, 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 July 16, 2026, DBV Technologies S.A. (the “Company”) issued a press release announcing financial results and business highlights for the fiscal quarter ended June 30, 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 July 16, 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: July 16, 2026
By:
/s/ Virginie Boucinha
Name:
Virginie Boucinha
Title:
Chief Financial Officer
EX-99.1
EX-99.1
Filename: d156695dex991.htm · Sequence: 2
EX-99.1
Exhibit 99.1
Press Release
Châtillon, France, July 16, 2026
DBV Technologies Reports Second Quarter and Half-Year 2026 Financial Results and Business Update
•
Continued productive engagement with the FDA in support of the BLA for the VIASKIN® Peanut Patch in children aged 4 through 7 years, with submission of the BLA anticipated in the third quarter of 2026
•
Reported cash and cash equivalents of $174.9 million as of June 30, 2026, funding into third quarter of
2027
•
DBV will host a conference call today, July 16, at 5:00pm ET
DBV Technologies (Euronext: DBV – ISIN: FR0010417345 – Nasdaq Stock Market: DBVT – CUSIP: 23306J309), a late-stage biopharmaceutical
company, today reported financial results for the Second Quarter and Half-Year of 2026. The quarterly and Half-Year financial statements were approved by the Board of Directors on July 16, 2026.
“2026 is an important year for DBV as we continue to prepare to become a commercial company, if approved. I’m happy to report that we have made
meaningful progress towards that goal in the first half of the year,” said Daniel Tassé, Chief Executive Officer of DBV Technologies. “Recently, we shared the regulatory progress we’ve made
through collaborative engagement with the FDA. We have also made judicious investments in launch readiness, while we continue to execute clinical studies that we expect will add further understanding to the potentially transformative value of the
VIASKIN® Peanut Patch.”
Half-Year 2026 Operational Highlights
Regulatory and Clinical Execution
•
Continued advancing the BLA submission for the VIASKIN®
Peanut Patch in children aged 4 through 7 years.
•
Engaged in detailed and iterative discussions with the U.S. Food and Drug Administration (FDA) to support a
complete, efficient and timely review of the BLA, once submitted. The FDA has not requested additional data.
•
DBV is incorporating valuable, actionable feedback from the FDA specific to the organization, mapping and
formatting of existing CMC and biostatistical data sets, and now anticipates submitting the BLA in the third quarter of 2026.
•
Recruitment was closed in the second quarter of 2026 for the COMFORT Toddlers supplemental safety study, an
important operational milestone in the continued advancement of the VIASKIN® Peanut Patch in toddlers aged 1 through 3 years.
•
Initiated the THRIVE study evaluating the efficacy and safety of the VIASKIN® Peanut Patch in achieving ad lib consumption of dietary peanut in infants aged 6 through 12 months with peanut allergy after 3-4 years of treatment with
the VIASKIN® Peanut Patch.
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 and the European Academy of Allergy and Clinical Immunology (EAACI) Congress, where DBV presented positive subgroup
analyses from the phase 3 VITESSE study.
Corporate and Financial Position
•
Funded into third quarter of 2027, to support operations and commercial preparedness, including investment across
core functions required to potentially launch and support the long-term success of the VIASKIN® Peanut Patch brand, including Medical Affairs, Sales, Market Access, Marketing, Account
Management, and Pharmacovigilance.
•
Enhanced visibility in the European investment community through inclusion in CAC Mid 60 and SBF 120, Euronext
Tech leaders, and MSCI EMEA Small Cap indices.
Food Allergy Prevalence Rates
•
A recent epidemiologic assessment using a survey based, standardized methodology demonstrated prevalence
of peanut allergy remains unchanged statistically relative to historical estimates, despite shifts in clinical practice toward earlier introduction of allergenic foods to diet and earlier diagnosis of peanut allergy.
Financial Highlights for the Second Quarter Ended June 30, 2026
The Company’s interim condensed consolidated financial statements for the three and six months ended June 30, 2026, and the comparative period of
June 30, 2025, are prepared in accordance with accounting principles generally accepted in the United States (“U.S. GAAP”) and Europe (IFRS). Comments are provided on a U.S. GAAP basis. Differences between U.S. GAAP and IFRS
condensed consolidated financial statements result mainly from the application of leases and pensions accounting standards.
Operating Income
Operating income amounted to $1.6 million for the six months ended June 30, 2026, including $0.7 million for the three months ended
June 30, 2026, compared with $2.2 million and $1.5 million, respectively, for the corresponding periods in 2025.
The decrease reflects a
lower accrual of French research tax credit income, consistent with the expected reduction in eligible experimental activities on a full-year basis as the Company continues to shift its focus from clinical development toward commercial readiness
activities.
Operating Expenses
Research and Development
Expenses
R&D expenses amounted to $64.6 million for the six months ended June 30, 2026, including $31.2 million for the three
months ended June 30, 2026, compared with $55.2 million and $33.7 million, respectively, for the corresponding periods in 2025:
•
Increased clinical trial activity from COMFORT Toddlers and THRIVE studies, and BLA submission preparation
•
Investment in Medical Affairs, Quality, Pharmacovigilance, and Regulatory functions in the United States.
•
Continued Pre-Commercial Inventory
build-up in preparation for the launch of the VIASKIN® Peanut Patch for children aged 4 through 7 years in the U.S., if approved.
Selling, General and Administrative (“SG&A”) Expenses
SG&A expenses increased by $11.2 million and $20.7 million for the three and six months ended June 30, 2026, respectively, compared with the
corresponding periods in 2025. The Company is building its U.S. commercial infrastructure and conducting pre-marketing activities in preparation for the potential U.S. launch of VIASKIN® Peanut for children aged 4 through 7 years, if approved.
Financial Income (Expense)
Net financial income amounted to $0.9 million for the six months ended June 30, 2026, including $0.4 million for the three months ended
June 30, 2026, compared with a net financial expense of $1.1 million and $0.6 million, respectively, for the corresponding periods in 2025. The improvement primarily reflects higher interest income generated from the investment
of cash balances following the equity financing transactions, together with the effects of the Company’s foreign-exchange risk-management activities.
Income Tax
Income tax expense amounted to $0.4 million for the six months ended June 30, 2026, including $0.2 million for the three months ended
June 30, 2026, compared with $0.1 million for the corresponding periods in 2025.
Net Loss and Net Loss Per Share
The Company recorded a net loss for the six months ended June 30, 2026, of $98.0 million, including $50.4 million for the three months ended
June 30, 2026, compared with $69.0 million and $41.9 million for the corresponding periods in 2025.
Net loss per share (based on the
weighted average number of shares outstanding over the period) decreased from $(0.58) to $(0.23) for the six months ended June 30, 2025, and June 30, 2026, respectively. This improvement reflects a significantly strengthened equity base
following recent financings.
Cash Position and Liquidity
These condensed consolidated financial statements have been prepared assuming that the Company will continue as a going concern.
As of June 30, 2026, the Company had cash and cash equivalents of $174.9 million. Following the revised timing of the anticipated BLA submission
from the second to the third quarter of 2026, management updated the Company’s forecasts to reflect the revised timing of related expenditures and activities, including cost-containment measures. Based on its current operations, plans and
assumptions, management estimates that the Company has sufficient funding to support its operations for at least twelve months from the date of issuance of these condensed financial statements (Form
10-Q & Half Year Report), into the third 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 Patch 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.
The Company’s net cash used in operating & investing activities increased to
$102.6 million for the six months ended June 30, 2026, compared to $54.0 million for the six months ended June 30, 2025, reflecting continued investments in clinical development activities, manufacturing & supply-chain
readiness, commercial launch preparedness, and the expansion of the Company’s workforce in preparation for a potential launch of the VIASKIN® Peanut Patch, if approved. While the Company
expects operating cash outflows to remain significant as it advances toward BLA submission and potential commercialization, the Company’s current forecasts incorporate measures intended to align spending with the revised regulatory timeline.
The timing and amount of the Company’s future cash requirements may vary materially from current expectations depending on, among other factors,
the timing and scope of regulatory interactions, the pace of clinical enrollment, manufacturing-related commitments, commercial readiness activities, foreign exchange rate fluctuations and other factors. The Company may seek additional capital in
the future through new or existing financing strategies to support its long-term corporate strategy.
Conference Call & Webcast
DBV management will host an investor conference call and webcast today, July 16th at 5:00pm ET, to discuss this update. This call is accessible via the below
teleconferencing numbers and requesting the DBV Technologies call.
United States: +1-877-344-8082
International: +1-213-992-4618
UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
In millions of USD
(unaudited)
U.S. GAAP
U.S. GAAP
IFRS
six months ended
June 30,
three months
ended June 30,
six months
ended June 30,
2026
2025
2026
2025
2026
2025
Operating income
1.6
2.2
0.7
1.5
1.6
2.2
Research & Development
(64.6
)
(55.2
)
(31.2
)
(33.7
)
(64.5
)
(55.1
)
Sales & Marketing
(10.4
)
(0.7
)
(5.5
)
(0.4
)
(10.4
)
(0.7
)
General & Administrative
(25.1
)
(14.1
)
(14.6
)
(8.5
)
(25.1
)
(14.1
)
Operating expenses
(100.1
)
(69.9
)
(51.3
)
(42.6
)
(99.9
)
(69.8
)
Financial income/(expense)
0.9
(1.1
)
0.4
(0.6
)
0.8
(1.3
)
Income tax
(0.4
)
(0.1
)
(0.2
)
(0.1
)
(0.4
)
(0.1
)
Net loss
(98.0
)
(69.0
)
(50.4
)
(41.9
)
(98.0
)
(69.0
)
Basic/diluted net loss per share attributable to shareholders
(0.23
)
(0.58
)
(0.12
)
(0.31
)
(0.23
)
(0.58
)
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® Peanut 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
people with food allergies. The Company’s food allergy programs include ongoing clinical trials of VIASKIN® Peanut Patch in toddlers (1 through 3 years of age) and children (4
through 7 years of age) with peanut allergy.
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
estimated cash runway into the third quarter of 2027, the therapeutic potential of VIASKIN® Peanut patch and EPIT, DBV’s planned regulatory and clinical efforts including timing and
results of communications with regulatory agencies, plans and expectations with respect to the submission of the BLA for VIASKIN® Peanut Patch for peanut allergic children 4 through 7 years of
age in the third quarter of 2026, the continued advancement of the VIASKIN® Peanut patch in toddlers aged 1 through 3 years and infants aged 6 through 12 months, DBV’s commercial launch
preparedness activities and the build-out of its commercial infrastructure in the United States, and the ability of any of DBV’s product candidates, if approved, to improve the lives of patients with
food allergies. 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 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, DBV’s Quarterly Report on Form 10-Q filed with the SEC on July 16, 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
Jul. 16, 2026
Document And Entity Information [Line Items]
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- Definition
Name of the Exchange on which a security is registered.
+ References
Reference 1: http://www.xbrl.org/2003/role/presentationRef
-Publisher SEC
-Name Exchange Act
-Number 240
-Section 12
-Subsection d1-1
+ Details
Name:
dei_SecurityExchangeName
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- Definition
Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as soliciting material pursuant to Rule 14a-12 under the Exchange Act.
+ References
Reference 1: http://www.xbrl.org/2003/role/presentationRef
-Publisher SEC
-Name Exchange Act
-Number 240
-Section 14a
-Subsection 12
+ Details
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- Definition
Trading symbol of an instrument as listed on an exchange.
+ References
No definition available.
+ Details
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dei_TradingSymbol
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Data Type:
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Balance Type:
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- Definition
Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as written communications pursuant to Rule 425 under the Securities Act.
+ References
Reference 1: http://www.xbrl.org/2003/role/presentationRef
-Publisher SEC
-Name Securities Act
-Number 230
-Section 425
+ Details
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- Details
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- Details
Name:
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