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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

May 7, 2024

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.)

 

177-181 avenue Pierre Brossolette

92120 Montrouge 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 one- half of one ordinary share, 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 May 7, 2024, DBV Technologies S.A. (the “Company”) issued a press release announcing financial results and business highlights for the fiscal quarter ended March 31, 2024. 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 May 7, 2024
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: May 7, 2024   DBV TECHNOLOGIES S.A.
    By:  

/s/ Virginie Boucinha

    Name:      Virginie Boucinha
    Title:   Chief Financial Officer

Exhibit 99.1

 

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Montrouge, France, May 7, 2024

DBV Technologies Reports First Quarter 2024 Financial Results and Business Update

 

   

VITESSE enrollment on track to screen last patient by Q3 2024

   

Appointment of Robert Pietrusko, PharmD to Chief Regulatory Officer

   

Q1 2024 closes with a cash balance of $101.5 million

DBV Technologies (Euronext: DBV – ISIN: FR0010417345 – Nasdaq Stock Market: DBVT), a clinical-stage biopharmaceutical company focused on treatment options for food allergies and other immunologic conditions with significant unmet medical need, today reported financial results for the first quarter 2024. The quarterly financial statements were approved by the Board of Directors on May 7, 2024.

Recent Business Developments

Clinical and Regulatory Update

Enrollment for VITESSE, DBV’s Phase 3 pivotal study of the modified Viaskin Peanut patch in children ages 4 through 7 years with peanut allergy passed the halfway point for recruitment in Q1 and continues to be on track to screen the last patient by Q3 2024. VITESSE is a trial evaluating efficacy and safety in approximately 600 subjects (randomized 2:1) with 86 participating sites in US, Canada, Europe, UK and Australia.

We are pleased with VITESSE enrollment rates and thrilled that our sites in Europe and the UK are actively enrolling subjects and have increased the momentum for VITESSE,” said Pharis Mohideen, M.D. Chief Medical Officer at DBV Technologies. “This comes on the heels of the February AAAAI meeting where there was tremendous interest in Viaskin Peanut and standing room only, record breaking attendance at our product theatre “Importance of Early Intervention for Peanut Allergy.”

The Company submitted the protocol for its COMFORT Toddlers supplemental safety study in 1 through 3-year-olds to the FDA on November 9, 2023. The Company and the FDA are engaged in ongoing dialogue related to the program.

Appointment of Robert Pietrusko, Chief Regulatory Officer

DBV has strengthened its regulatory expertise by appointing Robert Pietrusko, PharmD, to the position of Chief Regulatory Officer. Bob brings a wealth of expertise


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to DBV through his more than four decades of biopharmaceutical regulatory experience.

Bob joins DBV from Vor Bio, where he has served as Chief Regulatory Officer since April 2020. He previously served as Senior Vice President of Regulatory Affairs & Quality Assurance at Voyager Therapeutics, Inc., and as Vice President of Global Regulatory Affairs and Quality at ViroPharma Incorporated (acquired by Shire in 2013). He has served in regulatory and quality assurance roles of increasing responsibility at Millennium Pharmaceuticals (acquired by Takeda in 2008) and SmithKline Beecham (part of GlaxoSmithKline).

Bob has led the regulatory effort leading to more than 35 BLA/NDA/MAA approvals globally including in the US across many FDA Divisions at both the Center for Biologics Evaluation and Research (CBER) and the Center for Drug Evaluation and Research (CDER). He is also a leader in regulatory policy through his involvement as Chair of the Regulatory Affairs Committee of the Alliance for Regenerative Medicine (ARM) and an appointed member of the Regulatory Affairs committee of the American Society of Gene and Cell Therapies (ASGCT).

Bob brings to DBV extensive regulatory affairs and quality expertise, and his leadership is an important addition to the company,” stated Daniel Tassé, Chief Executive Officer of DBV Technologies.In addition to his deep understanding of complex development programs, he has a proven track record of shepherding multiple products through the regulatory process to approval across the various divisions of the FDA. Bob’s guidance will be instrumental as we continue the development of Viaskin Peanut in toddlers and children. We are thrilled to welcome him to our team.”

Financial Highlights for the First Quarter Ended March 31, 2024

The Company’s interim condensed consolidated financial statements for the three months ended March 31, 2024, are prepared in accordance with accounting principles in the U.S. (“U.S. GAAP”).

Cash and Cash Equivalents

 

In millions of USD

(unaudited)

  

 

U.S. GAAP

 

  

 

    three months ended March 31    

 


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         2024            2023    
     
Net cash & cash equivalents at the beginning of the period    141,4    209,2
     
Net cash flow used in operating activities    (34,7)    (20,8)
     
Net cash flow provided by / (used in) investing activities    (2,1)    -
     
Net cash flow provided by / (used in) financing activities    (0,1)    -
     
Effect of exchange rate changes on cash & cash equivalents    (3,0)    3,9
     
Net cash & cash equivalents at the end of the period    101,5    192,3

Cash and cash equivalents amount to $101,5 million as of March 31, 2024, compared to $141,4 million as of December 31, 2023, a net decrease by $39,8 million including $34,7 million of net cash flow used in operating activities, mainly external clinical-related expenses explained by progress on patient enrollment in VITESSE Phase 3 clinical trial.

The Company has incurred operating losses and negative cash flows from operations since inception. As of the date of the filing, the Company’s available cash and cash equivalents are not projected to be sufficient to support its operating plan for at least the next 12 months. As such, there is substantial doubt regarding the Company’s ability to continue as a going concern.

Based on our current operations, as well as our plans and assumptions, we expect that our balance of cash and cash equivalents of $101.5 million as of March 31, 2024, will be sufficient to fund our operations until December 31, 2024. The Company intends to seek additional capital as it continues research and development efforts and prepares for the launch of Viaskin Peanut, if approved.

Operating Income

 

In millions of USD

(unaudited)

  

 

U.S. GAAP

 

  
  

 

three months ended March 31

 

  
  

 

    2024    

 

  

 

    2023    

 

  


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Research tax credits

        1,4              1,8        
     

Other operating income

   -    0,4   
     

Operating income

   1,4    2,.2   

Operating income amounts to $1,4 million for the first 3 months ended March 31, 2024, compared with $2,2 million for the same period in 2023, a decrease by $0,8 million mainly resulting from the contract termination with Nestlé Health Science for $0,4 million.

Operating Expenses

 

In millions of USD

(unaudited)

  

 

U.S. GAAP

 

  
  

 

three months ended March 31

 

  
  

 

    2024    

 

       2023       
     

Research & Development

   21,4    16,0   
     

Sales & Marketing

   0,8    0,5   
     

General & Administrative

   7,8    6,9   
     

Operating expenses

   30,0    23,4   

Operating expenses amount to $30 million in the first quarter, compared with $23,4 million at March 31, 2023, an increase of $6,6 million mainly due to the increase in research and development activities in particular VITESSE Phase 3 clinical trial.

Net Loss and Net Loss Per Share

 

   
     U.S. GAAP   
  

 

three months ended March 31

 

  
  

 

   2024   

 

  

 

   2023   

 

    
     

Net income / (loss) (in millions of USD)

   (27,3)    (20,6)   


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

       (0,28)            (0,22)       

Net result for the first three months ended March 31, 2024, is a loss amounting to $27,3 million, compared to a loss amounting to $20,6 million for the first three months ended March 31, 2023.

On a per share basis, net loss (based on the weighted average number of shares outstanding over the period) is $0,28 for the first three months ended March 31, 2024.

CONDENSED CONSOLIDATED STATEMENTS OF FINANCIAL POSITION (unaudited)

 

   

In millions of USD

  

 

U.S. GAAP

 

  

 

  March 31, 2024  

 

  

 

  December 31, 2023  

 

     

Assets

   145,9    183,0
     

of which cash & cash equivalents

   101,5    141,4
     

Liabilities

   34,2    42,8
     

Shareholders’ equity

   111,7    140,2
     

of which net result

   (27,3)    (72,7)

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (unaudited)

 

In millions of USD

  

 

U.S. GAAP

 

     
  

 

   Three months ended March 31   

 

  
  

 

2024

 

  

 

2023

 

  
     

Revenues

   1,4    2,2   
     

Research & Development

   (21,4)    (16,0)   
     

Sales & Marketing

   (0,8)    (0.5)   


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General & Administrative

   (7,8)    (6,9)      
     

Operating expenses

   (30,0)    (23,4)   
     

Financial income/(expenses)

       1,2            0,6       
     

Income tax

   -    -   
     

Net loss

   (27,3)    (20,6)   
     

Basic/diluted net loss per share attributable to shareholders

   (0,28)    (0,22)   

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (unaudited)

 

In millions of USD

  

 

U.S. GAAP

 

  

 

Three months ended March 31

 

  

 

2024

 

  

 

2023

 

     

Net cash flows provided / (used) in operating activities

   (34,7)    (20,8)
     

Net cash flows provided / (used) in investing activities

   (2,1)    -
     

Net cash flows provided / (used) in financing activities

   (0,1)    -
     

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

   (3,0)    3,9
     

Net increase / (decrease) in cash & cash equivalents

   (39,9)    (16,9)
     

Net cash & cash equivalents at the beginning of the period

   141,4    209,2
     

Net cash & cash equivalents at the end of the period

   101,5    192,3

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 is currently focused on investigating the use


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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 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 Montrouge, France, with North American operations in Warren, NJ. The Company’s ordinary shares are traded on segment B of Euronext Paris (Ticker: DBV, ISIN code: FR0010417345) and the Company’s ADSs (each representing one-half of one ordinary share) are traded on the Nasdaq Global Select Market (Ticker: DBVT).

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 cash runway, the therapeutic potential of Viaskin Peanut 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, 2023, filed with the SEC on March 7, 2024, and future


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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.

Viaskin and EPIT are trademarks of DBV Technologies.

Investor Contact

Katie Matthews

DBV Technologies

katie.matthews@dbv-technologies.com

Media Contact

Aurora Krause

DBV Technologies

aurora.krause-ext@dbv-technologies.com

v3.24.1.u1
Document and Entity Information
May 07, 2024
Document Information [Line Items]  
Document Type 8-K
Document Period End Date May 07, 2024
Entity Registrant Name DBV Technologies S.A.
Entity Incorporation State Country Code I0
Entity File Number 001-36697
Entity Tax Identification Number 00-0000000
Entity Address Address Line 1 177-181 avenue Pierre Brossolette
Entity Address Postal Zip Code 92120
Entity Address City Or Town Montrouge
Entity Address Country FR
Country Region 33
City Area Code 1
Local Phone Number 55 42 78 78
Written Communications false
Soliciting Material false
Pre Commencement Tender Offer false
Pre Commencement Issuer Tender Offer false
Entity Emerging Growth Company false
Entity Central Index Key 0001613780
Amendment Flag false
Common Stock [Member]  
Document Information [Line Items]  
Security 12b Title Ordinary shares, nominal value €0.10 per share
No Trading Symbol Flag true
Security Exchange Name NASDAQ
American Depositary Share [Member]  
Document Information [Line Items]  
Security 12b Title American Depositary Shares, each representing one- half of one ordinary share, nominal value €0.10 per share
Security Exchange Name NASDAQ
Trading Symbol DBVT

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