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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, 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 2.02.

Results of Operations and Financial Condition

On April 30, 2025, DBV Technologies S.A. (the “Company”) issued a press release announcing financial results and business highlights for the fiscal quarter ended March 31, 2025. 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

No.

   Description
99.1    Press Release issued April 30, 2025
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 30, 2025   DBV TECHNOLOGIES S.A.
    By:  

/s/ Virginie Boucinha

    Name:   Virginie Boucinha
    Title:   Chief Financial Officer
EX-99.1 2 d947872dex991.htm EX-99.1 EX-99.1

Exhibit 99.1   

 

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DBV Technologies Reports First Quarter 2025 Financial Results

DBV Technologies (Euronext: DBV – ISIN: FR0010417345 – Nasdaq Stock Market: DBVT – CUSIP: 23306J309), a clinical-stage biopharmaceutical company, today reported financial results for the First Quarter of 2025. The quarterly and three months financial statements were approved by the Board of Directors on April 30, 2025.

Financial Highlights for the First Quarter Ended March 31, 2025

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

Cash and Cash Equivalents

Our Condensed Consolidated Financial Statements have been prepared assuming the Company will continue as a going concern. The going concern assumption contemplates the realization of assets and satisfaction of liabilities in the normal course of business.

Cash and cash equivalents amounted to $13.0 million as of March 31, 2025, compared to $32.5 million as of December 31, 2024, a net decrease of $19.5 million. This decrease includes $19.7 million of cash used in operating activities, mainly in external clinical trial related expenses, notably progress on subject enrollment in the VITESSE Phase 3 clinical trial, as well as Regulatory and Manufacturing activities to support ongoing clinical trials.

On March 27, 2025, the company announced a financing of up to $306.9 million (€284.5 million), to Advance Viaskin® Peanut Patch through Biologics License Application submission (BLA) and U.S. Commercial Launch, if approved. The financing included gross proceeds of $125.5 million (€116.3 million) received on April 7, 2025. With the receipt of the aforementioned proceeds, and based on its current operations, plans, and assumptions examined by the Board on March 23, 2025, the


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Company estimates that its cash and cash equivalents are sufficient to fund its operations into June 2026.

The Company has incurred operating losses and negative cash flows from operations since inception. The Company does not generate product revenue and continues to prepare for the potential launch of its first product in the United States and in the European Union, if approved.

These condensed consolidated financial statements do not include any adjustments to the carrying amounts and classification of assets, liabilities, and reported expenses that may be necessary if the Company was unable to continue as a going concern.

 

In millions of USD

(unaudited)

 

   U.S. GAAP      
   three months ended 
March 31, 
    2025      2024 
Net cash & cash equivalents at the beginning of the period    32.5    141.4

Net cash flow used in operating activities

   (19.7)    (34.7)

Net cash flow provided by / (used in) investing activities

   (0.4)    (2.1)

Net cash flow provided by / (used in) financing activities

      (0.1)

Effect of exchange rate changes on cash & cash equivalents

   0.5    (3.0)

Net cash & cash equivalents at the end of the period

   13.0    101.5
           

Operating Income

Operating income amounted to $0.8 million for the three months ended March 31, 2025, compared with $1.4 million for the same period in 2024 due to a lower French Research Tax Credit entitlement as a greater proportion of study activities were carried out in North America and are therefore not eligible for this tax credit.

 

In millions of USD

(unaudited)

 

  U.S. GAAP       
  three months ended March 31,
 

2025

 

  

2024

 

Research tax credits

  0.8    1.4

Other operating income

    

Operating income

  0.8    1.4
          

Operating Expenses


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Operating expenses amounted to $27.4 million for the three months ended March 31, 2025, compared with $30 million for the three months ended March 31, 2024, a decrease of $2.6 million. This decrease is primarily driven by lower General & Administrative expenses, notably $2.2 million expenses associated with office moves in France and the U.S that occurred in 2024.

 

In millions of USD   U.S. GAAP
  three months ended March 31,
(unaudited)   2025   2024

Research & Development

  (21.5)   (21.4)

Sales & Marketing

  (0.3)   (0.8)

General & Administrative

  (5.6)   (7.8)

Operating expenses

  (27.4)   (30.0)

Net Loss and Net Loss Per Share

The Company recorded a net loss of $27.1 million for the three months ended March 31, 2025, compared to a net loss of $27.3 million for the three months ended March 31, 2024.

On a per share basis, net loss (based on the weighted average number of shares outstanding over the period) was $(0.26) for the three months ended March 31, 2025 vs. $(0.28) for the three months ended March 31, 2024.

 

    U.S. GAAP
    three months ended March 31,
     2025   2024

Net (loss) (in millions of USD)

  (27.1)   (27.3)

Basic / diluted net (loss) per share (USD/share)

  (0.26)   (0.28)

CONDENSED CONSOLIDATED STATEMENTS OF FINANCIAL POSITION


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U.S. GAAP

    
In millions of USD     March 31, 2025    December 31, 
2024 

Assets

   50.6    65.7

of which cash & cash equivalents

   13.0    32.5

Liabilities

   47.7    38.3

Shareholders’ equity

   2.9    27.4
           

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

 

     U.S. GAAP     
     three months ended March 31,
In millions of USD    2025    2024

Operating income

   0.8    1.4

Research & Development

   (21.5)    (21.4)

Sales & Marketing

   (0.3)    (0.8)

General & Administrative

   (5.6)    (7.8)

Operating expenses

   (27.4)    (30.0)

Financial income/(expenses)

   (0.5)    1.3

Income tax

     

Net loss

   (27.1)    (27.3)
Basic/diluted net loss per share attributable to shareholders    (0.26)    (0.28)
           

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

 

     U.S. GAAP     
     three months ended
March 31,
In millions of USD    2025    2024

Net cash flows (used) in operating activities

   (19.7)    (34.7)

Net cash flows (used) in investing activities

   (0.4)    (2.1)

Net cash flows (used) in financing activities

      (0.1)
Effect of exchange rate changes on cash & cash equivalents (U.S. GAAP presentation)    0.5    (3.0)

Net increase / (decrease) in cash & cash equivalents

   (19.5)    (39.8)
Net cash & cash equivalents at the beginning of the period    32.5    141.4
Net cash & cash equivalents at the end of the period    13.0    101.5
           


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About DBV Technologies

DBV Technologies is a clinical-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 technology platform, Viaskin, 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 platform 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 Viaskin Peanut 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).

Forward Looking Statements

This press release may contain forward-looking statements and estimates, including statements regarding DBV’s financial condition, forecast of its cash runway, the therapeutic potential of Viaskin® Peanut patch and EPIT™, designs of DBV’s anticipated clinical trials, DBV’s planned regulatory and clinical efforts including timing and results of communications with regulatory agencies, 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 French Autorité des Marchés Financiers (“AMF”), DBV’s filings and reports 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, 2024, filed with the SEC on April 11, 2025, and future filings and reports made with the AMF and 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.


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Viaskin is a registered trademark and EPIT is a trademark of DBV Technologies.

DBV Investor Relations Contact

Katie Matthews

DBV Technologies

katie.matthews@dbv-technologies.com

DBV Media Contact

Angela Marcucci

DBV Technologies

angela.marcucci@dbv-technologies.com