New Hope for Toddlers with Peanut Allergies: DBV Launches Critical Safety Trial

Rhea-AI Filing Summary

DBV Technologies announced a significant milestone in its clinical research program with the first subject screening in the COMFORT Toddlers Supplemental Safety Study, focusing on peanut-allergic children aged 1-3 years old. This development marks an important step in the company's research into peanut allergy treatments.

The company, which trades on Nasdaq under symbol DBVT through American Depositary Shares (each representing five ordinary shares), filed this 8-K to report the initiation of this clinical study. The announcement was made via press release on June 25, 2025.

Key filing details:

• The study specifically targets toddlers between 1-3 years old with peanut allergies
• The filing includes two exhibits: the press release (99.1) and Cover Page Interactive Data File
• The document was signed by CFO Virginie Boucinha

Positive

• DBV Technologies initiated COMFORT Toddlers Supplemental Safety Study, expanding clinical trials to peanut-allergic children aged 1-3 years old, potentially broadening their addressable market

Negative

• None.

8-K Event Classification

2 items: 8.01, 9.01

2 items

Item 8.01 Other Events Other

Voluntary disclosure of events the company deems important to shareholders but not covered by other items.

Item 9.01 Financial Statements and Exhibits Exhibits

Financial statements, pro forma financial information, and exhibit attachments filed with this report.

Understanding 8-K Material Events →

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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

June 25, 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 8.01. Other Events

On June 25, 2025, DBV Technologies S.A. issued a press release entitled “DBV Technologies Announces First Subject Screened in COMFORT Toddlers Supplemental Safety Study in Peanut Allergic Toddlers 1 - 3 Years Old.” The full text of the press release is attached as Exhibit 99.1 to this Current Report on Form 8-K and incorporated herein by reference.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits

Exhibit No.		Description
99.1		Press Release Issued June 25, 2025
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.

Date: June 25, 2025				DBV TECHNOLOGIES S.A.
				By:		/s/ Virginie Boucinha
				Name:		Virginie Boucinha
				Title:		Chief Financial Officer

FAQ

What was the purpose of DBVT's 8-K filing on June 25, 2025?

DBVT filed an 8-K to announce the initiation of their COMFORT Toddlers Supplemental Safety Study, specifically reporting that the first subject has been screened in their clinical trial for peanut allergic toddlers aged 1-3 years old.

Who signed DBVT's June 2025 8-K filing?

The 8-K filing was signed by Virginie Boucinha, who serves as the Chief Financial Officer of DBV Technologies S.A.

What exhibits were included in DBVT's June 2025 8-K filing?

The 8-K filing included two exhibits: Exhibit 99.1 (Press Release Issued June 25, 2025) and Exhibit 104 (Cover Page Interactive Data File embedded within the Inline XBRL document).

What securities does DBVT have registered on the Nasdaq Stock Market?

DBVT has two securities registered: American Depositary Shares (ADS) trading under symbol DBVT (each ADS representing five ordinary shares with €0.10 nominal value), and ordinary shares (not for trading, only in connection with the ADS listing).

Is DBVT considered an emerging growth company as of June 2025?

Based on the unchecked box in the filing, DBVT is not classified as an emerging growth company under Rule 405 of the Securities Act of 1933 or Rule 12b-2 of the Securities Exchange Act of 1934.