UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
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| Item 2.02 | Results of Operation and Financial Condition |
As of March 31, 2023, DBV Technologies S.A. (the “Company”) had approximately $192.3 million of cash and cash equivalents. This amount is unaudited and preliminary, is subject to completion of financial closing procedures that could result in changes to the amount, and does not present all information necessary for an understanding of the Company’s financial condition as of March 31, 2023.
| Item 8.01 | Other Events |
On April 19, 2023, the Company issued a press release to announce the U.S. Food and Drug Administration provided a written response regarding the regulatory path for investigational Viaskin™ Peanut 250 mg patch (DBV712) in toddlers ages 1 - 3 years-old with a confirmed peanut allergy. A copy of the press release is filed as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated in this Item 8.01 by reference.
Forward Looking Statements
This Current Report on Form 8-K and the press release filed as Exhibit 99.1 hereto contain forward-looking statements and estimates, including statements regarding the Company’s clinical development and regulatory plans with respect to Viaskin™ Peanut for the treatment of toddlers ages 1-3 years old, the therapeutic potential of Viaskin™ Peanut as a treatment for peanut-allergic children more broadly, the ability of any of the Company’s product candidates, if approved, to improve the lives of patients with food allergies, designs of the Company’s anticipated clinical trials, safety studies and HF studies, the timing and anticipated results of interactions with regulatory agencies and the Company’s estimates of its cash and cash equivalents as of March 31, 2023. These forward-looking statements and estimates are not promises or guarantees and involve substantial risks and uncertainties, including risks inherent to the clinical development and regulatory process, as well as market conditions and other risks and uncertainties set forth in the Company’s regulatory filings with the Autorité des Marchés Financiers (“AMF”), the Company’s filings and reports with the U.S. Securities and Exchange Commission (“SEC”), and future filings and reports made with the AMF and SEC. 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, the Company undertakes no obligation to update or revise the information contained in this Current Report on Form 8-K and the press release filed as Exhibit 99.1 hereto.
| Item 9.01 | Financial Statements and Exhibits |
(d) Exhibits
| Exhibit No. |
Description | |
| 99.1 | Press Release, dated April 19, 2023 | |
| 104 | Cover Page Interactive Data File (the cover page XBRL tags are 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: April 19, 2023 | DBV TECHNOLOGIES S.A. | |||||
| By: | /s/ Sébastien Robitaille | |||||
| Name: | Sébastien Robitaille | |||||
| Title: | Chief Financial Officer | |||||