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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

October 30, 2023

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 1.02

Termination of a Material Definitive Agreement

As previously announced, on May 27, 2016, DBV Technologies S.A. (the “Company”) entered into a Development Collaboration and License Agreement (the “Collaboration Agreement”) with Société des Produits Nestlé S.A. (formerly NESTEC S.A.) (“NESTEC”). The Collaboration Agreement related to an exclusive global collaboration with Nestlé Health Science for the development and, if approved, commercialization of MAG1C, a ready-to-use and standardized atopy patch test tool for the diagnosis of CMPA (non-mediated IgE) in infants .

Under the terms of the Collaboration Agreement, the Company was responsible for leading the development activities of MAG1C up through a pivotal Phase 3 clinical program, and if the appropriate regulatory approvals were received, Nestlé Health Science would support the commercialization of MAG1C globally. The Company was eligible to receive up to €100.0 million in potential development, clinical, regulatory and commercial milestones, including an upfront payment of €10.0 million received in July 2016.

On October 30, 2023, the Company and NESTEC entered into a Mutual Termination Letter Agreement terminating the Collaboration Agreement. Each party remains responsible for its own costs and expenses related to its respective wind-down activities. Any and all licenses and sublicenses, granted by either party to the other party under the Collaboration Agreement, including, without limitation, any licenses to intellectual property, were revoked and terminated.

The foregoing description of the Collaboration Agreement is not complete and is qualified in its entirety by reference to the full text of such agreement, a copy of which was filed as Exhibit 4.14 to the Form 20-F filed by the Company on March 22, 2017 and is incorporated by reference herein, and the Mutual Termination Letter Agreement, a copy of which will be filed as an exhibit to the Company’s Annual Report on Form 10-K for the year ended December 31, 2023.

Item 2.02 Results of Operations and Financial Condition

On October 31, 2023, the Company issued a press release announcing financial results and business highlights for the fiscal quarter ended September 30, 2023. 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 October 31, 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: October 31, 2023     DBV TECHNOLOGIES S.A.
    By:  

/s/ Sébastien Robitaille

    Name: Sébastien Robitaille
    Title: Chief Financial Officer

Exhibit 99.1

 

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DBV Technologies Receives Requested Feedback from FDA on Protocol Design Elements for COMFORT Safety Studies and Reports Third Quarter 2023 Financial Results

 

  ●  

DBV has received written feedback from the U.S. Food and Drug Administration (FDA) clarifying design elements for both the COMFORT Toddlers and COMFORT Children supplemental safety studies.

 
  ●  

Both supplemental safety studies will have harmonized, simplified protocol language on how the product should be used.

 
  ●  

The COMFORT Toddlers study will apply the same eligibility criteria as EPITOPE, DBV’s successful Phase 3 efficacy study in toddlers 1-3 years.

 
  ●  

DBV will submit the final protocol for COMFORT Toddlers to FDA expeditiously and anticipates the first subject enrolled in Q1 2024.

 
  ●  

DBV closes Q3 2023 with a cash balance of $149 million.

 
  ●  

The Company will host a conference call and live audio webcast on Tuesday, October 31st at 5:00pm.

 

DBV Technologies (Euronext: DBV – ISIN: FR0010417345 – Nasdaq Stock Market: DBVT), a clinical-stage biopharmaceutical company, today announced the receipt of written feedback from the U.S. Food and Drug Administration (FDA) regarding the remaining study design elements for the COMFORT (Characterization of the Optimal Management of FOod Allergy Relief and Treatment) supplemental safety studies. The Company also reported financial results for the third quarter of 2023. The quarterly financial statements were approved by the Board of Directors on October 31, 2023.

Recent Business Developments

Following DBV’s request for clarification after receipt of Type C Meeting feedback in July 2023, the FDA provided Written Responses on protocol design elements for the COMFORT supplemental safety studies. Both COMFORT Toddlers and COMFORT Children protocol will have harmonized language guiding how the product will be used in the trials, such as, “Each DBV712 250 µg epicutaneous system is intended to

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be worn for a full day (24 hours).” These instructions are simpler and more concise relative to previously used protocol language.

Further to this approach, both supplemental safety studies will seek to enroll populations that are closely aligned with their respective Phase 3 efficacy studies, as is feasible. For COMFORT Toddlers, eligibility criteria will be the same as in EPITOPE (Phase 3 efficacy study in 1-3-year-olds) as reliance on peanut specific-IgE and skin prick test alone does not ensure a Regulatory-level of assurance of peanut allergy or a similar peanut allergic patient population relative to EPITOPE. Thus, COMFORT Toddlers will include a double-blind, placebo-controlled food challenge (DBPCFC) as part of the Inclusion criteria.

For COMFORT Children, key inclusion criteria will remain peanut specific-IgE and skin prick test as these criteria are well established from previously conducted DBV studies (PEPITES and REALISE), as well as from the medical literature, and are expected to support enrollment of a similar study population relative to VITESSE (Phase 3 efficacy study in 4-7-year-olds). Therefore, a DBPCFC will not be required for COMFORT Children.

The size and duration of both supplemental safety studies remains unchanged from previous communications. These protocol design elements ensure closer alignment between the supplemental safety studies and their respective efficacy studies, which should ultimately support a more robust future BLA submission package for each indication.

“We are very pleased with the engagement and clarity of the feedback received from the FDA,” stated Pharis Mohideen, Chief Medical Officer of DBV Technologies. “With a clear regulatory path forward, we will submit to FDA the final protocols for the COMFORT studies. We remain confident that this work will support a Biologics License Application (BLA) in both age groups and potentially bring this novel, much needed therapy to a vulnerable patient population.”

DBV will implement the FDA’s feedback and expects to submit the final COMFORT Toddlers protocol design to the Agency in the coming weeks. DBV anticipates the first subject will be enrolled in Q1 2024. The initiation of COMFORT Children is expected after the start of COMFORT Toddlers and in alignment with VITESSE recruitment.

 

  

 

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Financial Highlights for the Third Quarter and the Nine Months Ended September 30, 2023

The Company’s interim consolidated financial statements for the nine months ended September 30, 2023 are prepared in accordance with accounting principles in the U.S. (“U.S. GAAP”). Unless otherwise indicated, the financial figures presented in the Q3 Financial Highlights comply with U.S. GAAP consolidated financial statements. The financial figures are commented for the nine months ended September 30, 2023 under U.S. GAAP.

Cash and Cash Equivalents

 

   
(in millions of USD)  

 

U.S. GAAP

 

 

Nine months ended September 30, 

 

 

2023 

  

 

2022 

     

Net cash & cash equivalents at the beginning of the period

   209.2    77.3 
     

Net cash flow used in operating activities

   (66.0)    (31.8) 
     

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

   (0.6)    (0.1) 
     

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

   7.0    194.4 
     

Effect of exchange rate changes on cash & cash equivalents

   (0.4)    (27.2) 
     

Net cash & cash equivalents at the end of the period

   149.1    212.7 

Cash and cash equivalents amount to $149.1 million as of September 30, 2023, compared to $209.2 million as of December 31, 2022, which is a net decrease by $60.1 million mainly due to the following:

 

  (1)

$66.0 million of cash used for operations, mainly driven by the initiation of the VITESSE trial with the first patient screened in March 2023.

 

   

Cash used for operations in the nine months ended September 30, 2023, increased by $34.2 million compared to the nine months ended September 30, 2022. The Company received 24.8 million euros (corresponding to $28.1 million on the basis of 2021 closing exchange rate) during the nine months

 

  

 

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ended September 30, 2022, for reimbursement of 2019, 2020, and 2021 French research tax credits.

 

  (2)

$7.0 million net proceeds from the issuance and sale of new ordinary shares in the form of American Depositary Shares (“ADSs”) on June 16, 2023, and pursuant to the At-The-Market (“ATM”) program established in May 2022.

 

   

Cash provided by financing activities decreased by $187.4 million in the nine months ended September 30, 2023, compared to the nine months ended September 30, 2022. The Company issued and sold new ordinary shares in the form of ADSs for a total gross amount of $7.8 million in June 2023 compared to $15.3 million in May 2022, and completed a private placement financing (“PIPE”) amounting to a total gross amount of $194.0 million in June 2022.

 

  (3)

$0.4 million negative impact of changes in exchange rates. The Company’s treasury position, stated in U.S. Dollars, has been impacted by an appreciation of Euro against U.S. Dollar during the nine months ended September 30, 2023.

Operating Income

 

     
In millions of USD  

 

U.S. GAAP

  

 

U.S. GAAP

 

 

Three months ended September 30,

  

 

Nine months ended September 30,

 

 

2023

  

 

2022

  

 

2023

  

 

2022

         

Research tax credits

   1.2   1.4   5.0   4.5
         

Other operating income

   1.1   0.7   1.9   1.7
         

Operating income

   2.4   2.1   6.9   6.1

Operating income amounts to $6.9 million for the nine months ended September 30, 2023, compared to $6.1 million for the nine months ended September 30, 2022, which is an increase by $0.8 million due to:

 

  (1)

$0.5 million increase in research tax credit estimate as costs eligible to the French tax credit increased to support research and development activities (a) after the initiation of VITESSE with the first patient screened in March 2023, and (b) as part of the new safety study for toddlers after the FDA confirmed in April 2023 additional safety data is required for BLA submission.

 

  

 

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  (2)

$0.2 million increase in other operating income that consists of revenues recognized in advance as part of the Development, Collaboration, and Licensing Agreement (“the Agreement”) with Nestlé Health Science.

On October 30th, 2023, Nestle Health Science and the Company agreed to terminate, as of the effective date of signature, the Development, Collaboration and License Agreement, which set out the terms for the development of a standardized atopy patch test tool for the diagnosis of Cow’s Milk Protein Allergy (non-IgE-mediated) in infants and children. Additionally, the parties agreed to end the APTITUDE study conducted as part of the collaboration due to enrollment difficulties and not as a result of any safety issues.

Operating Expenses

 

In millions of USD  

 

U.S. GAAP

  

 

U.S. GAAP

 

 

Three months ended September 30,

  

 

Nine months ended September 30,

 

 

2023

  

 

2022

  

 

2023

  

 

2022

         

Research & Development

   13.8   15.1   47.4   45.9
         

Sales & Marketing

   0.7   0.2   1.6   1.7
         

General & Administrative

   6.2   4.8   22.3   17.2
         

Operating expenses

   20.6   20.1   71.4   64.8

Operating expenses amount to $71.4 million for the nine months ended September 30, 2023, compared to $64.8 million for the nine months ended September 30, 2022, which is an increase by $6.6 million mainly due to:

 

  (1)

The increase by $1.5 million in research and development expenses is driven by clinical - related expenses mainly to support (i) the VITESSE trial with the first patient screened in March 2023, and (ii) the new safety study for toddlers after the FDA confirmed additional safety data is required for BLA.

 

  

 

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  (2)

The increase by $5.1 million in general and administrative expenses related to:

 

  a.

one-time costs associated with financing activities, organizational planning, market research, and planning activities;

  b.

recruitments to support general and administrative activities with a nine-month impact at end of September 2023 compared to a one or few months impact at end of September 2022; and

  c.

a provision of costs to be incurred if the Montrouge office lease agreement is not renewed at its July 2024 term expiration.

 

  (3)

Slightly offset by the decrease by $0.1 million in sales and marketing expenses due to a decrease of external professional services and employee-related costs.

Net Loss and Net Loss Per Share

 

    

 

U.S. GAAP

 

   U.S. GAAP
 

 

 Three months ended September 30, 

 

    Nine months ended September  30, 
 

 

2023

 

   2022   2023   2022
         

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

   (16.7)   (17.3)   (61.5)   (57.0)
         

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

   (0.17)   (0.18)   (0.65)   (0.79)

Net result for the nine months ended September 30, 2023, is a loss amounting to $61.5 million, compared to a loss amounting to $57.0 million for the nine months ended September 30, 2022.

On a per share basis, net loss (based on the weighted average number of shares outstanding over the period) is $0.65 for the nine months ended September 30, 2023.

Conference Call Information

 

  

 

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DBV will host a conference call and live audio webcast on Tuesday, October 31st, at 5:00 p.m. ET to report third quarter 2023 financial results and provide a business update.

Participants may access this call via the below teleconferencing numbers and asking to join the DBV Technologies call:

 

  ●   United States: 1-844-481-2866
  ●   International: 1-412-317-1859

A live webcast of the call will be available on the Investors & Media section of the Company’s website: https://www.dbv-technologies.com/investor-relations/. A replay of the presentation will also be available on DBV’s website after the event.

CONDENSED CONSOLIDATED STATEMENTS OF FINANCIAL POSITION

(unaudited)

 

In millions of USD  

 

U.S. GAAP

 

 

 

  September 30, 2023  

 

     December 31, 2022  
     

Assets

   189.8   246.5
     

of which cash & cash equivalents

   149.1   209.2
     

Liabilities

   45.8   52.1
     

Shareholders’ equity

   144.0   194.5
     

of which net result

   (61.5)   (96.3)

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (unaudited)

 

     
In millions of USD  

 

U.S. GAAP

 

   U.S. GAAP
 

 

 Three months ended September 30, 

 

    Nine months ended  September 30, 
 

 

2023

 

   2022   2023   2022
         

Revenues

   2.4   2.1   6.9   6.1
         

Research & Development

   (13.8)   (15.1)   (47.4)   (45.9)

 

  

 

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Sales & Marketing

   (0.7)   (0.2)   (1.6)   (1.7)
         

General & Administrative

   (6.2)   (4.8)   (22.3)   (17.2)
         

Operating expenses

   (20.6)   (20.1)   (71.4)   (64.8)
         

Financial income/(expenses)

       1.5           0.7           3.0           1.7    
         

Income tax

   -   -   0.0   (0.1)
         

Net loss

   (16.7)   (17.3)   (61.5)   (57.0)
         

Basic/diluted net loss per share attributable to shareholders

   (0.17)   (0.18)   (0.65)   (0.79)

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOW (unaudited)

 

In millions of USD  

 

U.S. GAAP

 

 

 

  Nine months ended September 30,  

 

 

 

2023

 

   2022
     

Net cash flows provided / (used) in operating activities

   (66.0)   (32.0)
     

Net cash flows provided / (used) in investing activities

   (0.6)   (0.1)
     

Net cash flows provided / (used) in financing activities

   7.0   194.4
     

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

   (0.4)   (27.2)
     

Net increase / (decrease) in cash & cash equivalents

   (60.1)   135.4
     

Net cash & cash equivalents at the beginning of the period

   209.2   77.3
     

Net cash & cash equivalents at the end of the period

   149.1   212.7

 

  

 

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About DBV Technologies

DBV Technologies is developing Viaskin™, an investigational proprietary technology platform with broad potential applications in immunotherapy. Viaskin is based on epicutaneous immunotherapy, or EPIT™, and is DBV Technologies’ method of delivering biologically active compounds to the immune system through intact skin. With this new class of non-invasive product candidates, the Company is dedicated to safely transforming the care of food allergic patients. DBV Technologies’ food allergies programs include ongoing clinical trials of Viaskin Peanut. DBV Technologies has global headquarters in Montrouge, France, and North American operations in Basking Ridge, 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).

Forward Looking Statements

This press release may contain forward-looking statements and estimates, including statements regarding DBV’s forecast of its cash runway, designs of DBV’s anticipated clinical trials, DBV’s planned regulatory and clinical efforts including timing and results of communications with regulatory agencies, 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 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, 2022, filed with the SEC on March 2, 2023, 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.

Investor Contact

Katie Matthews

DBV Technologies

+1 857-529-2563

katie.matthews@dbv-technologies.com

Media Contact

Angela Marcucci

 

  

 

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DBV Technologies

+1 646-842-2393

angela.marcucci@dbv-technologies.com

Viaskin and EPIT are trademarks of DBV Technologies.

 

  

 
v3.23.3
Document and Entity Information
Oct. 30, 2023
Document Information [Line Items]  
Document Type 8-K
Document Period End Date Oct. 30, 2023
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
Amendment Flag false
Entity Central Index Key 0001613780
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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