UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM
10-Q

(Mark One)

QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended March 31, 2021

June 30, 2022

or

TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from                to

Commission file number
001-36697

DBV TECHNOLOGIES S.A.

(Exact name of registrant as specified in its charter)

France
 
Not applicableapplicable

State or other jurisdiction of

incorporation or organization

 

(I.R.S. Employer

Identification No.)

177-181
avenue Pierre Brossolette

Montrouge France

 
92120
(Address of principal executive offices)
 
(Zip Code)

Registrant’s telephone number, including area code +33 1 55 42 78 78

Securities registered pursuant to Section 12(b) of the Act:

Title of each class

 

Trading

Symbol(s)

 

Name of each exchange

on which registered

American Depositary Shares, each representing
one-half
of one ordinary share, nominal value €0.10 per share
 
DBVT
 
The Nasdaq Stock Market LLC
Ordinary shares, nominal value €0.10 per share*
 
n/a
 
The Nasdaq Stock Market LLC

*

Not for trading, but only in connection with the registration of the American Depositary Shares.

Securities registered pursuant to section 12(g) of the Act: None.

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.
☒  Yes            ☐  No

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation
S-T
232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).
☒  Yes            ☐  No

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a
non-accelerated
filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,”
and “emerging
“emerging growth company” in Rule
12b-2
of the Exchange Act.

Large accelerated filer   Accelerated filer 
Non-accelerated filer
   Smaller reporting company 
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.   ☐

Indicate by check mark whether the registrant is a shell company (as defined in Rule
12b-2
of the Act).    ☐  Yes    ☒  No


As of April 30, 2021,August 1
st
, 2022, the registrant had 54,936,687 94,025,192
ordinary shares, nominal value €0.10 per share, outstanding.

outstanding including treasury shares.


Table of Contents

Unless the context otherwise requires, we use the terms “DBV”, “DBV Technologies,” the “Company,” “we,” “us” and “our” in this Quarterly Report on
Form 10-Q,
or Quarterly Report, to refer to DBV Technologies S.A. and, where appropriate, its consolidated subsidiaries. “Viaskin
”, “EPIT
” and our other registered and common law trade names, trademarks and service marks are the property of DBV Technologies S.A. or our subsidiaries. All other trademarks, trade names and service marks appearing in this Quarterly Report are the property of their respective owners. Solely for convenience, the trademarks and trade names in this Quarterly Report may be referred to without the 
®
 and 
 symbols, but such references should not be construed as any indicator that their respective owners will not assert their rights thereto.

Table of Contents

SPECIAL NOTE REGARDING FORWARD LOOKING STATEMENTS.

This Quarterly Report on Form 10-Q (“Form 10-Q”) contains forward-looking statements which are made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”),or Securities Act, and Section 21E of the Securities Exchange Act of 1934, as amended, (the “Exchange Act”).or Exchange Act. These statements may be identified by such forward-looking terminology as “may,” “should,” “expects,” “intends,” “plans,” “anticipates,” “believes,” “estimates,” “predicts,” “potential,” “continue” or variations of these words or similar expressions that are intended to identify forward-looking statements, although not all forward-looking statements contain these words. Any forward-looking statement involves known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to differ materially from any future results, levels of activity, performance or achievements expressed or implied by such forward-looking statement. Forward-looking statements include statements, other than statements of historical fact, about, among other things:

statements regarding

the impact of the ongoing
COVID-19
pandemic, including the emergence of new variant strains of
COVID-19,
and its effects on our operations, research and development, and clinical trials and ability to obtain financing and potential disruption in the operations and business of third-party manufacturers, contract research organizations, or CROs, other service providers and collaborators with whom we conduct business;

our expectations regarding the timing or likelihood of regulatory filings and approvals, including with respect to our anticipated re-submission of a Biologics License Application for ViaskinTM Peanut to the U.S. Food and Drug Administration;

our expectations regarding the timing or likelihood of regulatory filings and approvals, including with respect to our anticipated
re-submission
of a Biologics License Application, or a BLA, for Viaskin
TM
Peanut to the U.S. Food and Drug Administration, or the FDA;
the initiation, timing, progress and results of our
pre-clinical
studies and clinical trials, and our research and development programs;

the sufficiency of existing capital resources;

the implementation of our global restructuring plan,

our business model and our other strategic plans for our business, product candidates and technology;

our ability to manufacture clinical and commercial supplies of our product candidates and comply with regulatory requirements related to the manufacturing of our product candidates;

our ability to build our own sales and marketing capabilities, or seek collaborative partners, to commercialize Viaskin Peanut and/or our other product candidates, if approved;

the commercialization of our product candidates, if approved;

our expectations regarding the potential market size and the size of the patient populations for Viaskin Peanut and/or our other product candidates, if approved, and our ability to serve such markets;

the pricing and reimbursement of our product candidates, if approved;

the rate and degree of market acceptance of Viaskin Peanut and/or our other product candidates, if approved, by physicians, patients, third-party payors and others in the medical community;

our ability to advance product candidates into, and successfully complete, clinical trials;

the scope of protection we are able to establish and maintain for intellectual property rights covering our product candidates and technology;

estimates of our expenses, future revenues, capital requirements and our needs for additional financing;

the potential benefits of strategic collaboration agreements and our ability to enter into strategic arrangements;

our ability to maintain and establish collaborations or obtain additional grant funding;

our financial performance;

and

developments relating to our competitors and our industry, including competing therapies; and

other risks and uncertainties, including those listed under the caption “Risk Factors.”

1

Table of Contents
Although we believe that we have a reasonable basis for each forward-looking statement contained in this Quarterly Report, on Form 10-Q, these statements are based on our estimates or projections of the future that are subject to known and unknown risks and uncertainties and other important factors that may cause our actual results, level of activity, performance, experience or achievements to differ materially from those expressed or implied by any forward-looking statement. These risks, uncertainties and other factors are described in greater detail under the caption “Risk Factors” in Part I. Item 1A of our Annual Report on Form
10-K
for the year ended December 31, 2020,2021, filed with the Securities and Exchange Commission, (“SEC”)or the SEC on March 17, 2021.9, 2022. Additional information is also included on our Current Report on Form
8-K,
filed with the SEC on June 13, 2022. As a result of the risks and uncertainties, the results or events indicated by the forward-looking statements may not occur. Undue reliance should not be placed on any forward-looking statement.

We qualify all of our forward-looking statements by these cautionary statements.

In addition, any forward-looking statement in this AnnualQuarterly Report, including statements that “we believe” and similar statements, reflect our beliefs and opinions on the relevant subject and represents our views only as of the date of this annual reportQuarterly Report and should not be relied upon as representing our views as of any subsequent date. These statements are based upon information available to us as of the date of this Quarterly Report and while we believe such information forms a reasonable basis for such statements, such information may be limited or incomplete, and our statements should not be read to indicate that we have conducted an exhaustive inquiry into, or review of, all potentially available relevant information. These statements are inherently uncertain and you are cautioned not to unduly rely upon these statements. We anticipate that subsequent events and developments may cause our views to change. Although we may elect to update these forward-looking statements publicly at some point in the future, we specifically disclaim any obligation to do so, except as required by applicable law. Our forward-looking statements do not reflect the potential impact of any future acquisitions, mergers, dispositions, joint ventures or investments we may make.

2

Table of Contents

Part I – Financial Information

Item 1. Financial Statements

DBV Technologies S.A.

Condensed Consolidated Statements of Financial Position (unaudited)

(amounts in thousands, except share and per share data)

       March 31,  December 31, 
   Note   2021  2020 

Assets

     

Current assets :

     

Cash and cash equivalents

   3   $152,459  $196,352 

Trade receivables

     —     2,230 

Other current assets

     7,349   8,792 
    

 

 

  

 

 

 

Total current assets

     159,809   207,375 

Property, plant, and equipment, net

     21,526   24,792 

Right-of-use assets related to operating leases

     9,168   10,104 

Intangible assets

     32   41 

Other non-current assets

     30,870   29,935 
    

 

 

  

 

 

 

Total non-current assets

     61,596   64,871 
    

 

 

  

 

 

 

Total Assets

    $221,405  $272,246 
    

 

 

  

 

 

 

Liabilities and shareholders’ equity

     

Current liabilities:

     

Trade payables

   4   $17,176  $20,338 

Short-term operating leases

     3,314   3,708 

Short-term financial debt

     701   724 

Current contingencies

   6    4,246   5,016 

Other current liabilities

   4    13,394   22,926 
    

 

 

  

 

 

 

Total current liabilities

     38,831   52,713 
    

 

 

  

 

 

 

Long-term operating leases

     9,533   10,496 

Long-term financial debt

     350   543 

Non-current contingencies

   6    2,229   2,527 

Other non-current liabilities

     1,286   475 
    

 

 

  

 

 

 

Total non-current liabilities

     13,398   14,042 
    

 

 

  

 

 

 

Total Liabilities

    $52,229  $66,754 
    

 

 

  

 

 

 

Shareholders’ equity :

     

Ordinary shares, €0.10 par value; 54,936,687 and 54,929,187 shares authorized, and issued as at March 31, 2021 and December 31, 2020, respectively, and 4,100,663 and 4,029,763 shares outstanding as at March 31, 2021 and December 31, 2020, respectively

    $6,519  $6,518 

Additional paid-in capital

     1,153,516   1,152,042 

Treasury stock, 60,588 and 112,302 ordinary shares as of March 31, 2021 and December 31, 2020, respectively, at cost

     (681  (1,169

Accumulated deficit

     (987,992  (958,543

Accumulated other comprehensive income

     399   484 

Accumulated currency translation effect

     (2,586  6,158 
    

 

 

  

 

 

 

Total Shareholders’ equity

    $169,176  $205,491 
    

 

 

  

 

 

 

Total Liabilities and Shareholder’s equity

    $221,405  $272,246 
    

 

 

  

 

 

 

      
June 30,
  
December 31,
 
   
Note
  
2022
  
2021
 
Assets
            
Current assets:
            
Cash and cash equivalents
  
3
  $247,971  $77,301 
Other current assets
  
4
   11,981   37,085 
      
 
 
  
 
 
 
Total current assets
     
 
259,953
 
 
 
114,386
 
Property, plant, and equipment, net
      15,677   18,146 
Right-of-use
assets related to operating leases
  
5
   3,146   7,336 
Intangible assets
      14   22 
Other non-current assets
      6,189   6,833 
      
 
 
  
 
 
 
Total non-current assets
     
 
25,025
 
 
 
32,338
 
      
 
 
  
 
 
 
Total Assets
     
$
284,978
 
 
$
146,723
 
      
 
 
  
 
 
 
Liabilities and shareholders’ equity
            
Current liabilities:
            
Trade payables
  
6
  $16,341  $11,429 
Short-term operating leases
  
5
   1,968   3,003 
Short-term financial debt
      156   510 
Current contingencies
  
9
   3,189   4,095 
Other current liabilities
  
6
   8,778   12,361 
      
 
 
  
 
 
 
Total current liabilities
     
 
30,431
 
 
 
31,397
 
      
 
 
  
 
 
 
Long-term operating leases
  
5
   1,945   7,147 
Non-current contingencies
  
9
   6,421   6,758 
Other non-current liabilities
  
6
   1,764   2,147 
      
 
 
  
 
 
 
Total non-current liabilities
     
 
10,130
 
 
 
16,052
 
      
 
 
  
 
 
 
Total Liabilities
     
$
40,562
 
 
$
47,449
 
      
 
 
  
 
 
 
Shareholders’ equity:
            
Ordinary shares, €0.10 par value; 94,022,679 and 55,095,762 shares authorized, and issued as at June 30, 2022 and December 31, 2021, respectively
     $10,708  $6,538 
Additional paid-in capital
      456,447   358,115 
Treasury stock, 106,287 and 153,631 ordinary shares as of June 30, 2022 and December 31, 2021, respectively, at cost
      (953  (1,232
Accumulated deficit
      (203,050  (258,528
Accumulated other comprehensive income
      743   519 
Accumulated currency translation effect
      (19,480  (6,137
      
 
 
  
 
 
 
Total Shareholders’ equity
  
7
  
$
244,416
 
 
$
99,274
 
      
 
 
  
 
 
 
Total Liabilities and Shareholders’ equity
     
$
284,978
 
 
$
146,723
 
      
 
 
  
 
 
 
The accompanying notes are an integral part of these condensed consolidated financial statements.

3

DBV Technologies S.A.

Condensed Consolidated Statements of Operations and Comprehensive Loss (unaudited)

(amounts in thousands, except share and per share data)

      Three Months Ended March
31,
 
   Note  2021  2020 

Operating income

  7  $2,941  $4,720 

Operating expenses

     

Research and development expenses

     (22,164  (27,532

Sales and marketing expenses

     (729  (7,297

General and administrative expenses

     (9,683  (11,113
    

 

 

  

 

 

 

Total Operating expenses

     (32,575  (45,942
    

 

 

  

 

 

 

Loss from operations

     (29,634  (41,222
    

 

 

  

 

 

 

Financial income

     215   309 
    

 

 

  

 

 

 

Loss before taxes

     (29,419  (40,913
    

 

 

  

 

 

 

Income tax

     (30  —   
    

 

 

  

 

 

 

Net loss

    $(29,449 $(40,913
    

 

 

  

 

 

 

Other comprehensive loss

     

Foreign currency translation differences, net of taxes

     (8,744  (6,064

Actuarial (losses) gains on employee benefits, net of taxes

     (85  189 
    

 

 

  

 

 

 

Comprehensive loss

    $(38,279 $(46,788
    

 

 

  

 

 

 

Basic/diluted Net loss per share attributable to shareholders

  11  $(0.54 $(0.79

Weighted average shares outstanding used in computing per share amounts:

     54,880,776   51,802,524 

      
Three Months Ended June 30,
  
Six Months Ended 
June 30,
 
   
Note
  
2022
  
2021
  
2022
  
2021
 
Operating income
  
10
  
$
1,529
 
 
$
(1,488
 
$
4,074
 
 
$
1,453
 
Operating expenses
                    
Research and development expenses
      (18,611  (20,179  (30,834  (42,343
Sales and marketing expenses
      (1,037  (1,198  (1,500  (1,927
General and administrative expenses
      (5,704  (8,269  (12,334  (17,951
      
 
 
  
 
 
  
 
 
  
 
 
 
Total Operating expenses
     
 
(25,352
 
 
(29,646
 
 
(44,669
 
 
(62,221
      
 
 
  
 
 
  
 
 
  
 
 
 
Loss from operations
     
 
(23,823
 
 
(31,134
 
 
(40,595
 
 
(60,768
      
 
 
  
 
 
  
 
 
  
 
 
 
Financial income
      784   46   936   261 
      
 
 
  
 
 
  
 
 
  
 
 
 
Loss before taxes
     
 
(23,039
 
 
(31,088
 
 
(39,659
 
 
(60,507
      
 
 
  
 
 
  
 
 
  
 
 
 
Income tax
      —     434   (87  404 
      
 
 
  
 
 
  
 
 
  
 
 
 
Net loss
     
$
(23,039
 
$
(30,654
 
$
(39,746
 
$
(60,103
      
 
 
  
 
 
  
 
 
  
 
 
 
Foreign currency translation differences, net of taxes
      (11,394  2,788   (13,327  (5,956
Actuarial gains (losses) on employee benefits, net of taxes
      200   48   224   (38
      
 
 
  
 
 
  
 
 
  
 
 
 
Total comprehensive loss
     
$
(34,234
 
$
(27,818
 
$
(52,849
 
$
(66,097
      
 
 
  
 
 
  
 
 
  
 
 
 
Basic/diluted net loss per share attributable to shareholders
  
14
  
$
(0.35
 
$
(0.56
 
$
(0.66
 
$
(1.09
Weighted average shares outstanding used in computing per share amounts:
      66,047,949   54,904,764   60,490,075   54,892,794 
The accompanying notes are an integral part of these condensed consolidated financial statements.

4

DBV Technologies S.A.

Condensed Consolidated Statements of Cash Flows (unaudited)

(amounts in thousands)

       Three Months Ended March 31, 
   Notes   2021  2020 

Net loss for the period

    $(29,449 $(40,913

Adjustments to reconcile net loss to net cash used in operating activities:

     

Depreciation, amortization and accrued contingencies

     1,483   1,548 

Retirement pension obligations

     —     109 

Expenses related to share-based payments

     1,433   3,073 

Other elements

     (456  419 

Changes in operating assets and liabilities:

     

Decrease (increase) in inventories and work in progress

     —     (2,402

Decrease (increase) in trade receivables

     2,101   —   

Decrease (increase) in other current assets

     (417  122 

(Decrease) increase in trade payables

     (2,567  (3,212

(Decrease) increase in other current and non-current liabilities

     (7,980  (8,382

Change in operating lease liabilities and right of use assets

     (353  (45

Net cash flow used in operating activities

     (36,204  (49,683
    

 

 

  

 

 

 

Cash flows used in investing activities:

     

Acquisitions of property, plant, and equipment, net from proceeds

     (184  (816

Acquisitions of intangible assets

     —     (114

Acquisitions of non-current financial assets

     (1  —   
    

 

 

  

 

 

 

Net cash flows used in investing activities

     (185  (930
    

 

 

  

 

 

 

Cash flows provided by financing activities:

     

(Decrease) increase in conditional advances

     (164  7 

Treasury shares

     578   (412

Capital increases, net of transaction costs

     42   151,023 

Other cash flows related to financing activities

     (17  (7
    

 

 

  

 

 

 

Net cash flows provided by financing activities

     440   150,611 
    

 

 

  

 

 

 

Effect of exchange rate changes on cash and cash equivalents

     (7,944  (5,811
    

 

 

  

 

 

 

Net (decrease) / increase in cash and cash equivalents

     (43,893  94,187 
    

 

 

  

 

 

 

Net Cash and cash equivalents at the beginning of the period

     196,352   193,255 
    

 

 

  

 

 

 

Net cash and cash equivalents at the end of the period

   3   $152,459  $287,442 
    

 

 

  

 

 

 

      
Six Months 
Ended June 30,
 
   
Notes
  
2022
  
2021
 
Net loss for the period
     
$
(39,746
 
$
(60,103
Adjustments to reconcile net loss to net cash used in operating activities:
         
Depreciation, amortization and accrued contingencies
      1,249   8,619 
Retirement pension obligations
      14   57 
Expenses related to share-based payments
  
8
   2,441   2,527 
Other elements
      (3  (843
Changes in operating assets and liabilities:
            
Decrease (increase) in trade receivables
      —     2,175 
Decrease (increase) in other current assets
      23,436   (8,393
(Decrease) increase in trade payables
      5,894   (3,165
(Decrease) increase in other current and
non-current
liabilities
      (3,040  (6,608
Change in operating lease liabilities and right of use assets
      (1,979  (769
Net cash flow used in operating activities
     
 
(11,733
 
 
(66,503
      
 
 
  
 
 
 
Cash flows used in investing activities:
            
Acquisitions of property, plant, and equipment, net from proceeds
      (369  (13
Proceeds from property, plant, and equipment dispositions
      3   —   
Acquisitions of non-current financial assets
      (279  —   
Proceeds from
non-current
financial assets
      426   —   
      
 
 
  
 
 
 
Net cash flows used in investing activities
     
 
(218
 
 
(13
      
 
 
  
 
 
 
Cash flows provided by financing activities:
            
Decrease in conditional advances
      (328  (345
Treasury shares
      279   638 
Capital increases, net of transaction costs
      195,270   794 
Other cash flows related to financing activities
      —     (17
      
 
 
  
 
 
 
Net cash flows provided by financing activities
     
 
195,221
 
 
 
1,071
 
      
 
 
  
 
 
 
Effect of exchange rate changes on cash and cash equivalents
      (12,600  (5,423
      
 
 
  
 
 
 
Net increase (decrease) in cash and cash equivalents
     
 
170,670
 
 
 
(70,868
      
 
 
  
 
 
 
Net Cash and cash equivalents at the beginning of the period
      77,301   196,352 
      
 
 
  
 
 
 
Net cash and cash equivalents at the end of the period
  
3
  
$
247,971
 
 
$
125,484
 
      
 
 
  
 
 
 
The accompanying notes are an integral part of these condensed consolidated financial statements.

5

DBV Technologies S.A.

Condensed Consolidated Statements of Changes in Shareholders’ Equity (unaudited)

(amounts in thousands, except share and per share data)

  Ordinary shares                   
  Number of
Shares
  Amount  Additional
paid-in

capital
  Treasury
stock
  Accumulated
deficit
  Accumulated
other

comprehensive
income
(loss)
  Accumulated
currency
translation
effect
  Total
Shareholders’
Equity
 

Balance at January 1, 2020

  47,028,510  $5,645  $1,003,595  $(230 $(798,988 $108  $(16,945 $193,186 

Net (loss)

  —     —     —     —     (40,913  —     —     (40,913

Other comprehensive income (loss)

  —     —     —     —     —     189   (6,064  (5,875

Issuance of ordinary shares

  7,898,677   873   150,150   —     —     —     —     151,023 

Treasury shares

  —     —     —     (832  —     —     —     (832

Share-based payments

  —     —     3,073    —     —     —     3,073 
 

 

 

  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

 

Balance at March 31, 2020

  54,927,187  $6,518  $1,156,818  $(1,062 $(839,901 $297  $(23,009 $299,662 
  Ordinary shares                   
  Number of
Shares
  Amount  Additional
paid-in
capital
  Treasury
stock
  Accumulated
deficit
  Accumulated
other
comprehensive

gain
(loss)
  Accumulated
currency
translation
effect
  Total
Shareholders’
Equity
 

Balance at January 1, 2021

  54,929,187  $6,518  $1,152,042  $(1,169 $(958,543 $484  $6,158  $205,491 

Net (loss)

  —     —     —     —     (29,449  —     —     (29,449

Other comprehensive (loss)

  —     —     —     —     —     (85  (8,744  (8,829

Issuance of ordinary shares

  7 500   1   42   —     —     —     —     42 

Treasury shares

  —     —     —     488   —     —     —     488 

Share-based payments

  —     —     1,433   —     —     —     —     1,433 
 

 

 

  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

 

Balance at March 31, 2021

  54,936,687  $6,519  $1,153,516  $(681 $(987,992 $399  $(2,586 $169,176 

   
Ordinary shares
                    
   
Number of
Shares
   
Amount
   
Additional
paid-in
capital
  
Treasury
stock
  
Accumulated
deficit
  
Accumulated
other
comprehensive
income (loss)
  
Accumulated
currency
translation
effect
  
Total
Shareholders’
Equity
 
Balance at January 1, 2021
  
 
54,929,187
 
  
$
6,518
 
  
$
1,152,042
 
 
$
(1,169
 
$
(958,543
 
$
484
 
 
$
6,158
 
 
$
205,491
 
Net (loss)
   —      —      —     —     (29,449  —     —     (29,449
Other comprehensive loss
   —      —      —     —     —     (85  (8,744  (8,829
Issuance of ordinary shares
   7,500    1    42   —     —     —     —     42 
Treasury shares
   —      —      —     488   —     —     —     488 
Share-based payments
   —      —      1,433   —     —     —     —     1,433 
   
 
 
   
 
 
   
 
 
  
 
 
  
 
 
  
 
 
  
 
 
  
 
 
 
Balance at March 31, 2021
  
 
54,936,687
 
  
$
6,519
 
  
$
1,153,516
 
 
$
(681
 
$
(987,992
 
$
399
 
 
$
(2,586
 
$
169,176
 
Net (loss)
   —      —      —     —     (30,654  —     —     (30,654
Other comprehensive income
   —      —      —     —     —     48   2,788   2,836 
Issuance of ordinary shares
   75,000    9    464   —     —     —     —     473 
Insuance of warrants
             279                   279 
Treasury shares
   —      —          (185  —     —     —     (185
Share-based payments
   —      —      1,094       —     —     —     1,094 
Allocation of accumulated net losses
   —      —      (797,823  —     797,823   —     —     —   
   
 
 
   
 
 
   
 
 
  
 
 
  
 
 
  
 
 
  
 
 
  
 
 
 
Balance at June 30, 2021
  
 
55,011,687
 
  
$
6,529
 
  
$
357,530
 
 
$
(866
 
$
(220,823
 
$
446
 
 
$
203
 
 
$
143,019
 
   
Ordinary shares
                     
   
Number of
Shares
   
Amount
   
Additional
paid-in
capital
  
Treasury
stock
  
Accumulated
deficit
  
Accumulated
other
comprehensive
income (loss)
   
Accumulated
currency
translation
effect
  
Total
Shareholders’
Equity
 
Balance at January 1, 2022
  
 
55,095,762
 
  
$
6,538
 
  
$
358,115
 
 
$
(1,232
 
$
(258,528
 
$
519
 
  
$
(6,137
 
$
99,274
 
Net (loss)
   —      —      —     —     (16,706  —      —     (16,706
Other comprehensive loss
   —      —      —     —     —     24    (1,933  (1,909
Insuance of ordinary shares
   775    1    —     —     —     —      —     1 
Treasury shares
   —      —      —     40   —     —      —     40 
Share-based payments
   —      —      1,363   —     —     —      —     1,363 
Other changes
   —      —      —     —     15        (15  —   
   
 
 
   
 
 
   
 
 
  
 
 
  
 
 
  
 
 
   
 
 
  
 
 
 
Balance at March 31, 2022
  
 
55,096,537
 
  
$
6,539
 
  
$
359,478
 
 
$
(1,193
 
$
(275,219
 
$
543
 
  
$
(8,086
 
$
82,062
 
Net (loss)
   —      —      —     —     (23,039  —      —     (23,039
Other comprehensive loss
   —      —      —     —     —     200    (11,394  (11,194
Issuance of ordinary shares
   38,926,142    4,170    103,007   —     —     —      —     107,176 
Issuance of warrants
   —      —      88,094   —     —     —      —     88,094 
Treasury shares
   —      —      —     240   —     —      —     240 
Share-based payments
   —      —      1,078   —     —     —      —     1,078 
Allocation of accumulated net losses
   —      —      (95,209  —     95,209   —      —     —   
   
 
 
   
 
 
   
 
 
  
 
 
  
 
 
  
 
 
   
 
 
  
 
 
 
Balance at June 30, 2022
  
 
94,022,679
 
  
$
10,708
 
  
$
456,447
 
 
$
(953
 
$
(203,050
 
$
743
 
  
$
(19,480
 
$
244,416
 
The accompanying notes are an integral part of these condensed consolidated financial statements.

6

NOTES TO THE FINANCIAL STATEMENTS (UNAUDITED)

Note 1: The Company

Incorporated in 2002 under the laws of France, DBV Technologies S.A. (“DBV Technologies,” or the “Company”, or the “group”) is a clinical-stage specialty biopharmaceutical company focused on changing the field of immunotherapy by developing a novel technology platform called Viaskin
. The Company’s therapeutic approach is based on epicutaneous immunotherapy, or EPIT
, a proprietary method of delivering biologically active compounds to the immune system through intact skin using Viaskin
.

Basis of Presentation

The condensed consolidated financial statements of the Company and its wholly-owned subsidiaries are unaudited and have been prepared in accordance with generally accepted accounting principles in the United States (“U.S. GAAP”) and are presented in U.S. dollars. All significant intercompany accounts and transactions between the Company and its subsidiaries have been eliminated on consolidation.

The unaudited condensed consolidated financial statements presented in this Quarterly Report should be read in conjunction with the consolidated financial statements and accompanying notes included in the Company’s Annual Report on Form
10-K
filed with the SEC on March 17, 20219, 2022 (the “Annual Report”). The condensed consolidated statement of financial position at December 31, 20202021 was derived from the audited consolidated financial statements but does not include all disclosures required by U.S. GAAP. The Company’s critical accounting policies are detailed in the Annual Report. The Company’s critical accounting policies have not changed materially since December 31, 2020.

2021.

Certain information and footnote disclosures normally included in financial statements prepared in accordance with U.S. GAAP have been condensed or omitted from these interim financial statements. However, these condensed consolidated financial statements include all adjustments, consisting only of normal recurring adjustments, which are, in the opinion of management, necessary to fairly state the results of the interim period. These interim financial results are not necessarily indicative of results to be expected for the full fiscal year ending December 31, 2021,2022, or any other future period.

Use of estimates

The preparation of the Company’s condensed consolidated financial statements requires the use of estimates, assumptions and judgments that affect the reported amounts of assets, liabilities, and disclosures of contingent assets and liabilities at the date of the consolidated financial statements and the reported amount of income and expenses during the period. The Company bases its estimates and assumptions on historical experience and other factors that it believes to be reasonable under the circumstances. The Company evaluates its estimates and assumptions on an ongoing basis. The actual results may differ from these estimates.

On an
on-going
basis, management evaluates its estimates, primarily those related to: (1) evaluation of costs and measure of progress of the development activities conducted as part of the collaboration agreement with Nestlé Health Science, (2) research tax credits, (3) assumptions used in the valuation of right of use assets - assets—operating lease, (4) impairment of
right-of-use
assets related to leases and property, plant and equipment, (5) recoverability of the Company’s net deferred tax assets and related valuation allowance, (6) assumptions used in the valuation model to determine the fair value and vesting conditions of share-based compensation plan, and (7) estimate of contingencies.

Going concern

Since its inception, the Company has primarily funded its operations with equity financings, and, to a lesser extent, public assistance aimed at supporting innovation and payments associated with research tax credits (Crédit dImpôt Recherche). 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.

Following receipt of a Complete Response Letter (“CRL”) from the U.S. Food and Drug Administration (“FDA”) in connection with its Biologics License Application (“BLA”) for Viaskin Peanut, beginning in August 2020, the Company scaled down its other clinical programs and pre-clinical spend to focus on Viaskin Peanut. The Company also initiated a global restructuring plan in June 2020 to provide operational latitude to progress the clinical development and regulatory review of Viaskin Peanut in the United States and European Union. Based on guidance received from the FDA in January 2021, the Company’s plans to implement such guidance, and expected cost savings from implementation of the global restructuring plan, the Company expects that its current balance of cash and cash equivalents of $152.5 million as of March 31, 2021 will be sufficient to fund its operations for at least the next 12 months.

The Company intends to seek additional capital as it prepares for the launch of Viaskin Peanut, if approved, and continues other research and development efforts. The Company may seek to finance its future cash needs through a combination of public or private equity or debt financings, collaborations, license and development agreements and other forms of non-dilutive financings. As a result of disruptions to the global financial markets as a result of the ongoing COVID-19 pandemic, the Company cannot guarantee that it will be able to obtain the necessary financing to meet its needs or to obtain funds at attractive terms and conditions. The ongoing COVID-19 pandemic has already caused extreme volatility and disruptions in the capital and credit markets. A severe or prolonged economic downturn could result in a variety of risks to the Company, including reduced ability to raise additional capital when needed or on acceptable terms, if at all.

Accounting Pronouncements adopted in 2021

Effective January 1, 2021, the2022

The Company has not adopted ASU 2019-12, Income Taxes (Topic 740)—Simplifying the Accounting for Income Taxes, which is intendedany new accounting pronouncements in 2022 to simplify accounting for income taxes. It removes certain exceptions to the general principles in Topic 740 and amends existing guidance to improve consistent application. The adoption of ASU 2019-12 did not have a material impact on the Company’s financial position or results of operations.

date.

Accounting Pronouncements issued not yet adopted

In June 2016, the Financial Accounting Standards Board (“FASB”) issued ASU2016-13 -
2016-13—Financial Instruments -
Instruments—Credit losses, which replaces the incurred loss impairment methodology for financial instruments in current U.S. GAAP with a methodology that reflects expected credit losses and requires consideration of a broader range of reasonable and supportable information to inform credit loss estimates. The FASB has issued ASU
2019-10
which has resulted in the postponement of the effective date of the new guidance for eligible smaller reporting companies to the fiscal year beginning January 1, 2023. The guidance must be adopted using a modified-retrospective approach and a prospective transition approach is required for debt securities for which an other-than-temporary impairment had been recognized before the effective date. The Company is currently evaluating the impact of the guidance on its Consolidated Financial Statements. The Company does not expect this new standard will have a material impact on its consolidated financial statements.

In January 2017, the FASB issued ASU 2017-04, Simplifying the Test for Goodwill Impairment, which modifies the goodwill impairment test and requires an entity to write down the carrying value of goodwill for the amount by which the carrying amount of a reporting unit exceeds its fair value. The FASB has issued ASU 2019-10 which has resulted in the postponement of the effective date of the new guidance for eligible smaller reporting companies to the fiscal year beginning January 1, 2023. The Company does not expect this new standard will have a material impact on its consolidated financial statements.

Other accounting standards that have been issued or proposed by the FASB or other standards-setting bodies that do not require adoption until a future date are not expected to have a material impact on the Company’s Consolidated Financial Statements upon adoption.


7

Table of Contents

Note 2: Significant Events and Transactions

Clinical programs

Viaskin
TM
Peanut for children ages
4-11

In January 2020, the Company announced positive topline results of the three-year, open-label extension of its Phase III PEPITES trial, or PEOPLE trial, evaluating the long-term efficacy and safety of investigational Viaskin Peanut in peanut-allergic children ages 4 to 11 years. The results demonstrated long-term clinical benefit as shown by an increase in eliciting dose (“ED”), which may decrease the chance of reacting to an accidental peanut exposure. After three years, the Company observed that 75.9% (107/141) of patients had increased their ED from baseline, and 51.8% (73/141) of patients reached an ED of at least 1,000 mg peanut protein by year three. The safety profile of Viaskin Peanut was consistent with that observed

in the clinical program to date in over 1,000 patients. During the PEOPLE trial, the most common adverse events were mild to moderate skin reactions localized to the administration site, and there was no epinephrine use deemed related to treatment. No treatment related serious adverse events were reported. One patient experienced one case of mild anaphylaxis that was determined by the investigator to be possibly related to treatment and resolved without anti-anaphylactic treatment. Treatment compliance remained high throughout the study at a mean of 98% over three years of treatment. Low discontinuations due to adverse events were observed.

United States

In February 2020, the FDA announced an Allergenic Products Advisory Committee meeting to be held on May 15, 2020 to discuss the Biologics License Application (BLA) for Viaskin Peanut. On March 16, 2020, the Company announced that the FDA had informed us that during its ongoing review of the Company’s BLA for Viaskin Peanut, it had identified questions regarding efficacy, including the impact of patch-site adhesion. Therefore, the Advisory Committee meeting to discuss the BLA originally scheduled on May 15, 2020 was cancelled.

On August 4, 2020, the Company announced that FDA has issued a Complete Response Letter in which the FDA indicated it could not approve the Viaskin Peanut BLA in its current form. The FDA identified concerns regarding the impact of patch-site adhesion on efficacy and indicated the need for patch modifications, and subsequently a new human factor study. The FDA also indicated that supplementary clinical data would need to be generated to support the modified patch. In addition, the FDA requested additional Chemistry, Manufacturing and Controls, or CMC, data. The FDA did not raise any safety concerns related to Viaskin Peanut.

On January 13, 2021, the Company received written responses from the FDA to questions provided in the Type A meeting request the Company submitted in October 2020 following the CRL. The Company believes the FDA feedback provides a well-defined regulatory path forward. In exchanges with the FDA, the Company proposed potential resolutions to two main concerns identified by the FDAComplete Response Letter received in the CRL: the impact of patch adhesion and the need for patch modifications.August 2020. The FDA agreed with the Company’sits position that a modified Viaskin Peanut patch should not be considered as a new product entity provided the occlusion chamber of the current Viaskin Peanut patch and the peanut protein dose of 250 µg (approximately 1/1000 of one peanut) remains unchanged and performs in the same way it has performed previously. In order to confirm the consistency of efficacy data between the existing and a modified patches, thepatch, FDA has

requested an assessment comparing the uptake of allergen (peanut protein) between the patches in peanut allergic children ages 4 to 11 years.

4-11.
The Company named that assessment EQUAL, which stands for Equivalence in Uptake of ALlergen. The FDA also recommended conducting a
6-month,
well-controlled safety and adhesion trial to assess thea modified Viaskin Peanut patch in the intended patient population.

On November 2, 2020, The Company later named this study STAMP, which stands for Safety, Tolerability, and Adhesion of Modified Patches

.
Based on the January 2021 FDA feedback, the Company defined three parallel workstreams:
1.
Identify a modified Viaskin patch (which the Company calls mVP).
2.
Generate the
6-month
safety and adhesion clinical data FDA requested via STAMP, which the Company expected to be the longest component of the mVP clinical plan. The Company prioritized the STAMP protocol submission so the Company could begin the study as soon as possible.
3.
Demonstrate the equivalence in allergen uptake between the current and modified patches in the intended patient population via EQUAL. The complexity of EQUAL hinged on the lack of established clinical and regulatory criteria to characterize allergen uptake via an epicutaneous patch. To support those exchanges, the Company outlined its proposed approach to demonstrate allergen uptake equivalence between the two patches, and allotted time to generate informative data through two additional studies:
a.
PREQUAL, a Phase I study with adult healthy volunteers to optimize the allergen sample collection methodologies and validate the assays we intend to use in EQUAL
b.
‘EQUAL in adults’—a second Phase I study with adult healthy volunteers to compare the allergen uptake of cVP and Mvp;
In March 2021, the Company commenced CHAMP (Comparison of adHesion Among Modified Patches), a trial in healthy adult volunteers to evaluate the adhesion of five modified Viaskin Peanut patches, to identify the one or two best-performing patches, which the Company completed in the second quarter of 2021. Based on the adhesion parameters studied, the Company selected the modified patch to advance to further clinical testing in the intended patient population. All modified Viaskin Peanut patches demonstrated better adhesion performance as compared to the then-current Viaskin Peanut patch, and the Company then selected two modified patches that performed best out of the five modified patches studied for further development. The Company then selected the circular patch for further development, which is larger in size relative to the current patch and circular in shape.
In May 2021, the Company submitted its proposed STAMP protocol to the FDA, and in October 2021, the Company received an Advice/Information Request letter from the FDA. In this letter, the FDA requested a stepwise approach to the modified Viaskin patch development program and provided partial feedback on the STAMP protocol. Specifically, the FDA requested that the Company conduct allergen uptake comparison studies (i.e., ‘EQUAL in Adults’, EQUAL), and submit the allergen uptake comparison data for FDA review and feedback prior to starting the STAMP study.
After careful review of the FDA’s information requests, in December 2021, the Company decided not to pursue the stepwise approach to the development plans for Viaskin Peanut as requested by the FDA in the October 2021 letter. The Company estimated that the FDA’s newly proposed stepwise approach would require at least five rounds of exchanges that necessitate FDA alignment prior to initiating STAMP, the
6-month
safety and adhesion study. As such, in December 2021, the Company announced its plan to initiate a pivotal Phase III placebo-controlled efficacy trial for a modified Viaskin Peanut patch (mVP) in children in the intended patient population. The clinical trial will also include updates to the Instructions for Use (IFU). The Company considers this approach the most straightforward to potentially demonstrate effectiveness, safety, and improved in vivo adhesion of the modified Viaskin Peanut system. The FDA confirmed the Company’s change in strategy is agreeable via oral and written exchanges.
8

Table of Contents
The new Phase 3 pivotal study for modified Viaskin Peanut has been named VITESSE (Viaskin Peanut Immunotherapy Trial to Evaluate Safety, Simplicity and Efficacy), which means “speed” in French.
In May 2022, the Company announced that the FDA granted it a Type C meeting to align on the protocol and the study protocol was submitted to the FDA as part of the the Type C meeting briefing package.
DBV continues to engage in productive dialogue with the FDA on the key elements of the VITESSE protocol. As previously disclosed, the Company will communicate key elements of the VITESSE trial design and projected timelines once this process has concluded.
Viaskin Peanut for children ages
4-11—European
Union Regulatory History and Current Status
In August 2021, the Company announced its receipt from the EMA of the Day 180 list of outstanding issues, which is an established part of the prescribed EMA review process. It is a letter that is meant to include any remaining questions or objections at that stage in the process. The EMA indicated many of their objections and major objections from the Day 120 list of questions had been answered. One major objection remained at Day 180. The Major Objection questioned the limitations of the data, for example, the clinical relevance and effect size supported by a single pivotal study.
In December 2021, the Company announced it has withdrawn the Marketing Authorization Application or MAA, for Viaskin Peanut had been validated by the European Medicines Agency, or EMA. The validation of the MAA confirmed that the submission was sufficiently complete to begin the formal review process for Viaskin Peanut to treat peanut allergies in children ages 4 to 11 years. The Company received the first set of questions fromand formally notified the EMA duringof our decision. The initial filing was supported by positive data from a single, placebo-controlled Phase 3 pivotal trial known as PEPITES
(V712-301).
The decision to withdraw was based on the first quarterview of 2021, which were consistent with the Company’s expectations and prefiling conversations with the EMA. The Company did not receive questions about the impact of adhesion on efficacy. The EMA’sEMA Committee for Medicinal Products for Human Use will provide(CHMP) that the data available to date from a recommendationsingle pivotal study were not sufficient to preclude a Major Objection at Day 180 in the European Commission, or EC, on whether to grantreview cycle. The Company believes data from a marketing authorization when its review of thesecond Viaskin Peanut pivotal study will support a more robust path for licensure of Viaskin Peanut in the EU. The Company intends to resubmit the MAA when that data set is complete.

available.

Viaskin Peanut for children ages
1-3

On

In June 26, 2020, the Company announced that in Part A, patients in both treatment arms showed consistent treatment effects after 12 months of therapy, as assessed by a double-blind placebo-controlled food challenge and biomarker results. Part A subjects were not included in Part B and the efficacy analyses from Part A were not statistically powered to demonstrate superiority of either dose versus placebo. These results validate the ongoing investigation of the 250 mgPg dose in this age group, which is the dose being studied in Part B of the study. Enrollment for Part B of EPITOPE was completed in the first quarter of 2021.

Financing

On February 4, 2020,2022.

In June 2022, the Company announced that its pivotal Phase III trial EPITOPE, assessing the closingsafety and efficacy of an underwritten global offeringViaskin
Peanut 250 µg for the treatment of an aggregatepeanut-allergic toddlers ages 1 to 3 years, met its primary endpoint. Viaskin Peanut demonstrated a statistically significant treatment effect (p<0.001), with 67.0% of 7,500,000subjects in the Viaskin Peanut arm meeting the treatment responder criteria after 12 months, as compared to 33.5% of subjects in the placebo arm (difference in response rates = 33.4 %, 95 % CI = 22.4% - 44.5 %).
DBV intends to further analyze the data from EPITOPE and explore regulatory pathways for Viaskin Peanut in children ages 1 to 3 years, given the high unmet need and absence of approved treatments for this vulnerable population.
Financing
In May 2022, the Company announced that pursuant to the Company’s
At-The-Market
program established in May 2022 (the “ATM Program”), it had issued and completed sales of new ordinary shares (the “Ordinary Shares”) in (i) a public offering of 4,535,581 ordinary shares in the form of 9,071,162 American Depositary Shares (“ADSs”), for a total gross amount of $15.3 million. In this context, 6,036,238 new Ordinary Shares in form of ADS have been issued through a capital increase without preferential subscription rights of the United States, Canada andshareholders reserved to specific categories of persons fulfilling certain countries outside Europecharacteristics (the “ATM Issuance”), at a public offeringunit subscription price of $10.251.27 dollar per ADS (on(i.e., a subscription price per Ordinary Share of 2.41 euro based on the USD/EUR exchange rate of 1.0531 dollar for 1 euro, as published by the European Central Bank on May 4, 2022) and each ADS giving the right to receive
one-half
of one ordinary share of the Company).
In June 2022, the Company announced an aggregate $194 million private investment in public equity (PIPE) financing (corresponding to €181 million on the basis of an exchange rate of $1.0999$1.0739 = €1.00), and (ii) an offering exclusively addressed to qualified investors in Europe (including France)€1.00 published by the European Central Bank on June 8, 2022) from the sale of 2,964,41932,855,669 ordinary shares, as well as
pre-funded
warrants to purchase up to 28,276,331 ordinary shares. The ordinary shares were sold to the purchasers at an offeringa price of €18.63 per ordinary share (together,of €3.00 (corresponding to $3.22), and the “Global Offering”).

On March 2, 2020,

pre-funded
warrants were sold to the Company announced thatpurchasers at a
pre-funded
price of €2.90 (corresponding to $3.11) per
pre-funded
warrant, which equals the underwriters partially exercised their option to purchase 338,687 additionalper share price for the ordinary shares inless the form of 677,374 ADSs at an offeringremaining €0.10 exercise price of $10.25 per ADS,for each such
pre-funded
warrant. Gross proceeds from the PIPE financing total approximately $194 million (corresponding to €181 million), before deducting commissions and estimated offering expenses (the “Option”). private placement expenses.
The Option closed on March 4, 2020.

Consequently, following partial exercise of the Option, the total number of ordinary shares sold in the global offering was 7,838,687 ordinary shares, including 4,874,268the ordinary shares in issuable upon exercise of

the form of 9,748,536 ADSs, bringing the total gross proceeds pre-funded warrants
from the global offering to $160.7 millionPIPE financing, have not been registered under the Securities Act of 1933, as amended, and net proceeds of $150.0 million.

Restructuring

The Company initiated a global restructuring plan in June 2020 to provide operational latitude to progress in the clinical development and regulatory review of investigational Viaskin Peanutmay not be offered or sold in the United States and European Union.except pursuant to an effective registration statement or an applicable exemption from the registration requirements. The Company expects full implementationhas agreed to file a registration statement with the Securities and Exchange Commission registering the resale of the organization-wide costs reduction measures to be completed byordinary shares, including the secondordinary shares underlying

the pre-funded warrants.

9

Following the financing operations carried out in the first half of 2021.

The following table summarizes restructuring activities as2022, the Company has cash and cash equivalent to support the Company’s operations several months beyond the projected completion of March 31, 2021 includedVITESSE, the planned Phase 3 clinical study of the modified Viaskin

Peanut patch in current contingenciespeanut allergic children ages 4 years and other current liabilities in the statement of financial position:

Restructuring
liabilities

Restructuring liability - January 1, 2021

9,387

Amounts paid

(4,854

Other effect including currency translation effect

(220

Restructuring liability - March 31, 2021

4,313

of which current contingencies

1,511

of which other current liabilities

2,803

older.

COVID-19
Pandemic

On March 11, 2020, the World Health Organization declared
COVID-19
a pandemic. This global health crisis led many countries to impose national containment measures and travel bans. In view of this exceptional situation, the Company decided to take all measures

aimed primarily at guaranteeing the safety of its employees and the continuation of ongoing clinical trials, in compliance with the directives of the authorities in each country. The Company has experienced a decrease in new patients enrolling in the ongoing clinical studies and it has had to adapt the protocols of its clinical trials because patients remain subject to travel restrictions.

The Company has assessed the impact of the uncertainties created by the pandemic. As of March 31, 2021,June 30, 2022, those uncertainties were taken into account in the assumptions underlying the estimates and judgments used by the Company. The Company continues to update these estimates and assumptions as the situation evolves. The effects of the
COVID-19
pandemic are presented in the relevant line items of the condensed consolidated statement of financial position and the condensed consolidated statement of operations according to the function or nature of the income or expense.


Legal Proceedings

A class action complaint was filed on January 15, 2019 in the United States District Court for the District of New Jersey, entitled Travis
Ito-Stone
v. DBV Technologies, et al., Case No.
2:19-cv-00525.
The complaint alleged that the Company and its former Chief Executive Officer, its current Chief Executive Officer, and its former Deputy Chief Executive Officer violated certain federal securities laws, specifically under Sections 10(b) and 20(a) of the Exchange Act, and Rule
10b-5
promulgated thereunder. The plaintiffs seek unspecified damages on behalf of a purported class of purchasers of the Company’s securities between February 14, 2018 and August 4, 2020 and also held the Company’s securities on December 20, 2018 and/or March 16, 2020 and/or August 4, 2020.

A hearing was held on July 29, 2021 in the U.S. District Court for the District of New Jersey where the Court entered an order granting the Company’s Motion to Dismiss the Second Amended Class Action Complaint without prejudice. As the dismissal was without prejudice, the Plaintiffs replead their case by filing a Third Amended Class Action Complaint on September 30, 2021 in the same Court. The company moved to dismiss third amended complaint on December 10, 2021.
On July 29, 2022 the Court entered an order granting the Company’s Motion to Dismiss the Plaintiff’s Third Amended Complaint with prejudice. The Court indicated that the Third Amended Complaint was deficient in a number of ways, failing to allege a violation of the Securities Exchange Act of 1934, and ordered the matter closed. Per court procedural rules, the Plaintiffs have 30 days to appeal the dismissal of the Third Amended.
The Company believes that the allegations contained in the amended complaint are without merit and will continue to defend the case vigorously.The Company believes this complaint will not have a material adverse effect on the Company’s consolidated financial position, results of operations or liquidity.

Note 3: Cash and Cash Equivalents

The following table presents for each reported period,tables summarize the breakdown of cash and cash equivalents:

   March 31,   December 31, 
   2021   2020 

Cash

   58,069    42,341 

Cash equivalents

   94,390    154,011 
  

 

 

   

 

 

 

Total cash and cash equivalents as reported in the statements of financial position

   152,459    196,352 
  

 

 

   

 

 

 

equivalents as of June 30, 2022 and December 31, 2021:

   
June 30,
   
December 31,
 
   
2022
   
2021
 
Cash
   226,674    31,427 
Cash equivalents
   21,298    45,874 
   
 
 
   
 
 
 
Total cash and cash equivalents as reported in the statements of financial position
  
 
247,971
 
  
 
77,301
 
   
 
 
   
 
 
 
Cash equivalents are immediately convertible into cash at no or insignificant cost, on demand. They are measured using level 1 fair value measurements.


10

Note 4 Other Current Assets
Other current assets consisted of the following:
   
June 30,
   
December 31,
 
   
2022
   
2021
 
Research tax credit
   2,908    28,092 
Other tax claims
   4,339    3,561 
Prepaid expenses
   3,773    4,149 
Other receivables
   961    1,283 
   
 
 
   
 
 
 
Total
  
 
11,981
 
  
 
37,085
 
   
 
 
   
 
 
 
Research tax credit
In the fiscal year ended December 31, 2021, the Company recovered its Small and
Medium-sized
Enterprises, or SMEs, status under EU law, and became therefore eligible again for the immediate reimbursement of the Research Tax Credit.
During the six months period ended June 30, 2022, the Company received the reimbursement of the 2019, 2020 and 2021 fiscal year research tax credit.

The variance in Research Tax Credit is presented as follows:
Amount in
thousands of US
Dollars
Opening research tax credit receivable as of January 1, 2022
28,092
+ Operating revenue
3,060
- Payment received
(27,119
- Adjustment and currency translation effect
(1,125
Closing research tax credit receivable as of June 30, 2022
2,908
Of
which -
Non
-current
portion
—  
Of
which - Current
portion
2,908
The other tax claims are primarily related to the VAT as well as the reimbursement of VAT that has been requested. Prepaid expenses are comprised primarily of insurance expenses, as well as legal and scientific consulting fees. Prepaid expenses also include upfront payments which are recognized over the term of the ongoing clinical studies.

11

Note 5 Lease contracts
Future minimum lease payments under the Company’s operating leases’ right of use as of June 30, 2022 and December 31, 2021, are as follows:
   
June 30, 2022
  
December 31, 2021
 
   
Real estate
  
Other

assets
  
Total
  
Real estate
  
Other
assets
  
Total
 
Current portion
   2,104   50   2,154   3,361   77   3,438 
Year 2
   1,843   19   1,862   3,124   23   3,147 
Year 3
   284   11   295   2,299   18   2,317 
Year 4
   —     —     —     771   1   773 
Year 5
   —     —     —     790   —     790 
Thereafter
   —     —     —     1,220   —     1,220 
   
 
 
  
 
 
  
 
 
  
 
 
  
 
 
  
 
 
 
Total minimum lease payments
  
 
4,231
 
 
 
80
 
 
 
4,311
 
 
 
11,565
 
 
 
119
 
 
 
11,684
 
Less: Effects of discounting
   (363  (6  (370  (1,526  (8  (1,534
   
 
 
  
 
 
  
 
 
  
 
 
  
 
 
  
 
 
 
Present value of operating lease
  
 
3,868
 
 
 
73
 
 
 
3,941
 
 
 
10,039
 
 
 
111
 
 
 
10,150
 
Less: current portion
   (1,922  (46  (1,968  (2,929  (74  (3,003
   
 
 
  
 
 
  
 
 
  
 
 
  
 
 
  
 
 
 
Long-term operating lease
  
 
1,946
 
 
 
27
 
 
 
1,973
 
 
 
7,110
 
 
 
37
 
 
 
7,147
 
   
 
 
  
 
 
  
 
 
  
 
 
  
 
 
  
 
 
 
Weighted average remaining lease term (years)
   1.79   —         4.14   2.01     
Weighted average discount rate
   3.14  1.29      4.84  3.32    
The Company recognizes rent expense, calculated as the remaining cost of the lease allocated over the remaining lease term on a straight-line basis. Rent expense presented in the consolidated statement of operations and comprehensive loss was:
  
June 30,

  
   
2022
 
2021
  
Operating lease expense
   950
 
 
1,698
  
Net termination impact
   (1,657
  
In January 2022, the company entered into a termination agreement for its U.S. office in Summit, NJ, following the resizing of its facility use. The Company recognized an income of $1.2 million as of June 30, 2022 due to the early termination of its Summit, NJ lease, offset by the payment of a
one-time
lump sum early termination fee of $1.5 million.
On March 28, 2022, the Company entered into a binding office lease agreement in New Jersey for a lease term of 3 years and 2 months. The lease commencement was based upon delivery of possession of the premises by the Landlord and occurred on April 1, 2022. Right of use and related lease debt will be recorded starting April 1, 2022 for a gross amount of 0.4 million.

Supplemental cash flow information related to operating leases is as follows for the period June 30, 2022 and 2021:
  
June 30,

 
   
2022
 
2021
 
Cash paid for amounts included in the measurement of lease liabilities
   —   
 
Operating cash flows from operating leases
   1,079 
2,077
 

12

Note 4:6: Trade Payables and Other Current Liabilities

4.1

6.1 Trade Payables

No discounting was performed on the trade payables to the extent that the amounts did not present payment terms longer than one year at the end of each fiscal period presented.

4.2

6.2 Other Current Liabilities

Other current

The following tables summarize the other liabilities consistedas of the following:

   March 31,   December 31, 
   2021   2020 

Employee related liabilities

   9,245    16,661 

Deferred income

   3,378    4,687 

Tax liabilities

   312    580 

Other debts

   460    999 
  

 

 

   

 

 

 

Total

   13,394    22,926 
  

 

 

   

 

 

 
June 30, 2022 and December 31, 2021:

   
June 30,
   
December 31,
 
   
2022
   
2021
 
   
Other current
liabilities
   
Other non-current

liabilities
   Total   
Other current
liabilities
   
Other non-current

liabilities
   Total 
Employee related liabilities
   
4,135
    
77
    4,212    6,708    247    6,954 
Deferred income
   
3,012
    
1,687
    4,700    4,146    1,900    6,046 
Tax liabilities
   
400
    —      400    182    —      182 
Other debts
   
1,231
    —      1,231    1,325    —      1,325 
   
 
 
   
 
 
   
 
 
   
 
 
   
 
 
   
 
 
 
Total
  
 
8,778
 
  
 
1,764
 
  
 
10,542
 
  
 
12,361
 
  
 
2,147
 
  
 
14,508
 
   
 
 
   
 
 
   
 
 
   
 
 
   
 
 
   
 
 
 
The other current liabilities include short-term debt to employees including employee termination allowance and benefits as part of the restructuring (refer to Note 2, “Significant Events and Transactions of the Period – Restructuring”), bonus accruals, and social welfare and tax agency obligations.

obligations

.
Deferred income primarily includes deferred income from the collaboration agreement with Nestlé Health Science, which amounted to $3.4$4.7 million as of MarchJune 30, 2022.
Note 7: Shareholders’ equity
The share capital as of June 30, 2022 is set at the sum of €9,402,268 ($10,708,445 converted at historical rates). It is divided into 94,022,679 fully authorized, subscribed and
paid-up
shares with a par value of €0.10.
Pursuant to the authorization granted by the General Meeting of the Shareholders held on May 12, 2022 (the “SH General Meeting”), the accumulated net losses of DBV Technologies S.A. after appropriation of the net result for the year ended December 31, 2021.

2021 have been allocated to additional
paid-in
capital
.
Pursuant to the authorization granted by the SH General Meeting, the Board of Directors, at its meeting of June 9, 2022 (the “Board General Meeting”):
decided, within the framework of the Issuance the principle of a capital increase in cash with cancellation of preferential subscription rights, reserved for categories of persons meeting which set out the characteristics included in the 18
th
resolution of the Board General Meeting, through the issuance of Ordinary Shares and warrants to subscribe for Ordinary Shares, for a maximum amount of 6,113,200 New Ordinary Shares, corresponding to the maximum issue ceiling under the 22
nd
resolution of the Board General Meeting;
granted a number of authorizations for the purpose of carrying out the Issuance;
s
u
b-delegated
its authority to the Chief Executive Officer for the purpose of implementing the financing.
The Chief Executive Officer, acting pursuant to the
sub-delegations
of authority granted by the Board of Directors of the Company on June 8, 2022, after receiving the favorable opinion of the Pricing Committee established by the Board of Directors, has, on June 9, 2022 :
decided, making use of the 18
th
resolution of the Board General Meeting, to proceed with a capital increase in cash with cancellation of preferential subscription rights reserved for categories of investors, in accordance with the Article L.
225-128
of French Commercial Code, an amount of € 3,285,566.90, through the issuance of (i)
32,855,669
New Ordinary Shares, to be
13

subscribed in cash at a unit price of €2.90 of share premium) and to be fully paid up at the time of subscription, i.e. a capital increase of a nominal amount of €3,285,566.90 together with a share premium of € 95,281,440.10, i.e. a gross amount of the capital increase of € 98,567,007, and (ii) 28,276,331 prefunded warrants to be subscribed in cash by paying up on the date of issue of € 82,001,359.90 corresponding to the prepayment of the subscription price of the new ordinary shares in the event of exercise of the prefunded warrants,

decided to set the maximum nominal amount of the capital increase resulting from the full exercise of the prefunded warrants at € 2,827,633.10, by issuing a maximum of 28,276,331 ordinary shares, with a value of € 0.10 to be subscribed in cash at the price of € 0.10 euro (without share premium), and to be fully paid up at the time of subscription, i.e. a capital increase of a maximum nominal amount of € 2,827,633.10 (and a share premium corresponding to the amount of the
pre-financed
price released in advance at the time of the subscription of the prefunded warrants ), being specified that this amount does not take into account the nominal value of the ordinary shares to be issued in order to preserve the rights of the holders of securities giving access to the capital issued or to be issued, in accordance with the legal and regulatory provisions and the contractual stipulations providing for other cases of adjustment if necessary;
determined the list of beneficiaries (designated within each of the categories of persons defined in the 18
th
resolution of the Board General Meeting) and the number of New Ordinary Shares and warrants allocated to each of them under the conditions defined in the 18th resolution of the Board General Meeting beneficiaries under the conditions defined in section 5 of the offering circular relating to the Issu
e
.
The Company has assessed the
pre-funded
warrants for appropriate equity or liability classification. During this assessment, the Company determined the
pre-funded
warrants are freestanding instruments that do not meet the definition of a liability pursuant to ASC 480 and do not meet the definition of a derivative pursuant to ASC 815.
The 2022 Warrants are classified as a component of permanent equity because they are freestanding financial instruments that are legally detachable and separately exercisable from the shares of common stock with which they were issued, are immediately exercisable, do not embody an obligation for the Company to repurchase its shares, and permit the holders to receive a fixed number of shares of common stock upon exercise. In addition, the 2022 Warrants do not provide any guarantee of value or return.
Accordingly, the
pre-funded
warrants are classified as equity and accounted for as a component of additional
paid-in
capital at the time of issuance.
The changes in number of outstanding prefunded warrants
are
as follows:
Prefunded
warrants
Balance as of December 31, 2021
—  
Granted during the period
28,276,331
Forfeited during the period
—  
Exercised/released during the period
—  
Expired during the period
—  
Balance as of June 30, 2022
28,276,331

Note 5:8: Share-Based Payments

The Board of Directors has been authorized by the SH General Meeting of the Shareholders to grant restricted stock units (“RSU”), stock options plan (“SO”), employee warrants (
Bons de Souscription de Parts de Créateur d’Entreprise
or “BSPCE”) and
non-employee
warrants (
Bons de Souscription d’Actions
or “BSA”).

During the threesix months ended March 31, 2021,June 30, 2022, the Company granted 75,60019,000 stock options and 24,9003,200 restricted stock.

stock units to employees. There have been no changes in the vesting conditions and method of valuation of the SO and RSUs from that disclosed in Note 1413 to the consolidated financial statements included in the Annual Report.

1
4

Stock optionsoption fair value assumptions during the threesix months ended March 31, 2021

June 30, 2022
 

Weighted average share price at grant date in €

   9.32.42 

Weighted average expected volatility

   90.992.4

Weighted average risk-free interest rate

   (0.360.86)

Weighted average expected term (in years)

   6 

Dividend yield

   —   

Weighted average fair value of stock-optionsstock options in €

   6.91.81 

Change in Number of BSA/BCE/SO/RSU

   Number of outstanding 
   BSA   BCE   SO  RSUs 

Balance as of December 31, 2020

   218,008    5,500    2,610,510   1,118,745 

Granted during the period

   —      —      75,600   24,900 

Forfeited during the period

   —      —      (15,400  (13,700

Exercised/released during the period

   —      (500   —     —   

Expired during the period

   —      —      —     —   
  

 

 

   

 

 

   

 

 

  

 

 

 

Balance as of March 31, 2021

   218,008    5 000    2,670,710   1,129,945 
  

 

 

   

 

 

   

 

 

  

 

 

 
RSU:


Reconciliation of the share-based

   
Number of outstanding
 
   
BSA
   
SO
   
RSUs
 
Balance as of December 31, 2021
  
 
256,693
 
  
 
3,631,210
 
  
 
1,240,520
 
Granted during the period
   —      19,000    3,200 
Forfeited during the period
   —      (205,728   (66,588
Exercised/released during the period
   —      (2,125   (31,910
Expired during the period
   —      —      —   
   
 
 
   
 
 
   
 
 
 
Balance as of June 30, 2022
  
 
256,693
 
  
 
3,442,358
 
  
 
1,145,223
 
   
 
 
   
 
 
   
 
 
 
Share-based payments expenses withreflected in the condensed consolidated statements of operations

   Three Months Ended
March 31,
 
   2021   2020 

Research and development

   SO    (376   (876
   RSU    (251   (392

Sales and marketing

   SO    (49   (598
   RSU    (22   (2

General and administrative

   SO    (644   (1,071
   RSU    (91   (133
    

 

 

   

 

 

 

Total share-based compensation expense

     (1,433   (3,073
    

 

 

   

 

 

 

o

p
erations is as follow
s
:
       
Three Months
Ended June 30,
  
Six Months
Ended June 30,
 
       
2022
  
2021
  
2022
  
2021
 
Research & development
   SO    (290  (302  (665  (678
    RSU    (185  115   (393  (136
Sales & marketing
   SO    (38  (63  (33  (112
    RSU    (17  (26  (16  (48
General & administrative
   SO    (478  (709  (1,176  (1,353
    RSU    (70  (110  (157  (201
        
 
 
  
 
 
  
 
 
  
 
 
 
Total share-based compensation (expens
e
)
       
 
(1,078
 
 
(1,094
 
 
(2,441
 
 
(2,527
        
 
 
  
 
 
  
 
 
  
 
 
 
Note 6:9: Contingencies

Current

The following tables summarize the contingencies as of June 30, 2022 and non-currentDecember 31, 2021:
         
   
June 30,
   
December 31,
 
   
2022
   
2021
 
Current contingencies
   3,189    4,095 
Non-current contingencies
   6,421    6,758 
   
 
 
   
 
 
 
Total contingencies
  
 
9,610
 
  
 
10,853
 
   
 
 
   
 
 
 
15

The changes in contingencies break downare as follows:

   March 31,   December 31, 
   2021   2020 

Current contingencies

   4,246    5,016 

Non-current contingencies

   2,229    2,527 
  

 

 

   

 

 

 

Total contingencies

   6,474    7,542 
  

 

 

   

 

 

 

The table below shows movements in contingencies:

   Pension retirement
obligations
   Collaboration
agreement -
Loss at
completion
   Other contingencies  Total 

At January 1, 2021

   937    3,956    2,649   7,542 

Increases in liabilities

   —      —      —     —   

Used liabilities

   —      (434   (515  (949

Reversals of unused liabilities

   —      —      —     —   

Net interest related to employee benefits, and unwinding of discount

   —      —      —     —   

Actuarial gains and losses on defined-benefit plans

   85    —      —     85 

Other effects including currency translation effect

   (44   (164   4   (204
  

 

 

   

 

 

   

 

 

  

 

 

 

At March 31, 2021

   978    3,358    2,139   6,474 
  

 

 

   

 

 

   

 

 

  

 

 

 

Of which current

   —      2,107    2,139   4,246 

Of which non-current

   978    1,251    —     2,229 


                 
   
Pension
retirement
obligations
   
Collaboration
agreement -
Loss at
completion
   
Other
contingencies
   
Total
 
                 
At January 1, 2022
  
 
1,008
 
 
 
9,800
 
 
 
45
 
 
 
10,853
 
Increases in liabilities
   14   —     —     14 
Used liabilities
   —     (108  (44  (152
Reversals of unused liabilities
   —     —     —     —   
Net interest related to employee benefits, and unwinding of discount
   —     —     —     —   
Actuarial gains and losses on defined-benefit plans
   (224  —     —     (224
Currency translation effect
   (73  (807  (2  (882
   
 
 
  
 
 
  
 
 
  
 
 
 
At June 30, 2022
  
 
725
 
 
 
8,885
 
 
 
—  
 
 
 
9,610
 
   
 
 
  
 
 
  
 
 
  
 
 
 
Of which Current
   —     
3,189
   —     
3,189
 
Of which
Non-current
   
725
   
5,696
   —     
6,421
 
In 20202021 and during the first threesix months of 2021,2022, the ongoing COVID-19 pandemic impactedCompany updated its measurement of progress of the Company’s currentPhase 2 clinical trials, including its Phase II clinical trial (“PII”) conducted as part of the development activities pursuant to the collaboration and license agreement with Nestlé Health Science.and updated the cumulative income recognized. The Company experienced a decrease in new patients enrolling in this Phase II clinical trial and modified the protocols of the clinical trial. As a result of these delays, the Company expects to incur additional clinical and production costs related to the Phase II clinical trial. Starting the last quarter of the fiscal year 2020,has recorded an accrual in the amount of the differenceexcess between the Company’s current best estimates of costs yet to be incurred and revenuesincomes yet to be recognized for the completion of the Phase II clinical trial has been recorded.

PII.

Other contingencies are primarily composed of the estimated expenses to be incurred as part of the employee-related costs related to restructuring, as well as estimated cost of refurbishing lease premises (Refer to Note 2, “Significant Events and Transactions—Restructuring contingencies).

There have been no significant changes in assumptions for the estimation of the retirement commitments from those disclosed in Note 1514 to the consolidated financial statements included in the Annual Report.

Note 7:10: Operating income

The following table summarizes the operating income is broken down induring the following manner:

   Three Months Ended March 31, 
   2021   2020 

Research tax credit

   1,807    2,902 

Other operating income

   1,133    1,818 
  

 

 

   

 

 

 

Total

   2,941    4,720 
  

 

 

   

 

 

 

three and six months ended June 30, 2022 and 2021:

                 
   
Three Months Ended
June 30,
   
Six Months Ended
June 30,
 
   
2022
   
2021
   
2022
   
2021
 
Research tax credit
   1,491    1,870    3,060    3,677 
Other operating income
   37    (3,358   1,014    (2,225
   
 
 
   
 
 
   
 
 
   
 
 
 
Total
  
 
1,529
 
  
 
(1,488
  
 
4,074
 
  
 
1,453
 
   
 
 
   
 
 
   
 
 
   
 
 
 
As of March 31, 2021,June 30, 2022, the Company recorded its collaboration contract’s incomeagreement’s revenue based on its updated measurement of progress of the Phase II clinical trial conducted as part of the collaboration and license agreement with Nestlé Health Science.agreement. The accrual recorded in the amount of the difference between the Company’s current best estimates of costs yet to be incurred and incomerevenues yet to be recognized for the completion of the Phase II clinical trial has been updated accordingly.

Note 8:11: Allocation of Personnel Expenses

The Company had an average of 12187 employees during the threesix months ended March 31, 2021,June 30, 2022, in comparison with an average of 311111 employees during the threesix months ended March 31, 2020.

AllocationJune 30, 2021.

1
6

Table of Personnel ExpensesContents
The following table summarizes the allocation of personnel expenses by Function:

   

Three Months Ended March

31,

 
   2021   2020 

Research and development expenses

   4,718    10,204 

Sales and marketing expenses

   518    4,197 

General and administrative expenses

   3,766    4,283 
  

 

 

   

 

 

 

Total personnel expenses

   9,002    18,684 
  

 

 

   

 

 

 

Allocationfunction during the three and six months ended June 30, 2022 and 2021:


                 
   
Three Months
Ended June 30,
   
Six Months

Ended June 30,
 
   
2022
   
2021
   
2022
   
2021
 
                 
Research and Development expenses
   3,097    3,393    6,172    8,111 
Sales and Marketing expenses
   344    518    589    1,036 
General and Administrative expenses
   2,767    2,999    5,362    6,765 
   
 
 
   
 
 
   
 
 
   
 
 
 
Total personnel expenses
  
 
6,208
 
  
 
6,910
 
  
 
12,123
 
  
 
15,912
 
   
 
 
   
 
 
   
 
 
   
 
 
 
The following table summarizes the allocation of Personnel Expensespersonnel expenses by Nature:

   

Three months Ended March

31,

 
   2021   2020 

Wages and salaries

   4,454    12,872 

Social security contributions

   1,332    663 

Expenses for pension commitments

   402    915 

Employer contribution to bonus shares

   1,381    1,162 

Share-based payments

   1,433    3,073 
  

 

 

   

 

 

 

Total personnel expenses

   9,002    18,684 
  

 

 

   

 

 

 

nature during the three six months ended June 30, 2022 and 2021:


                 
   
Three Months
Ended June 30,
   
Six Months

Ended June 30,
 
   
2022
   
2021
   
2022
   
2021
 
                 
Wages and salaries
   3,509    4,382    7,497    8,836 
Social security contributions
   1,256    1,064    1,507    2,396 
Expenses for pension commitments
   211    293    509    695 
Employer contribution to bonus shares
   154    77    170    1,458 
Share-based payments
   1,078    1,094    2,441    2,527 
   
 
 
   
 
 
   
 
 
   
 
 
 
Total
  
 
6,208
 
  
 
6,910
 
  
 
12,123
 
  
 
15,912
 
   
 
 
   
 
 
   
 
 
   
 
 
 
The decrease in personnel expenses is mainly due to a decreaseddecrease in headcount as well as reductions in accrued bonuses, retention measures and share-based compensation expenses, partly as a resultfollowing the full implementation of the 2020 global restructuring plan.

new organization.

Note 9:12: Commitments

There have been no0 significant changes in other commitments from those disclosed in Note 1918 to the consolidated financial statements included in the Annual Report.

Note 10:13: Relationships with Related Parties

The Company’s related parties consist exclusively of the members of the Board of Directors and the members of the Executive Committee. As of June 30, 2022, the total amount of remuneration granted to the members of the Board of Directors and Executive Committee has not changed significantly since December 31, 2021.
There were no0 new significant related-party transactions during the period nor any change in the nature of the transactions from those described in Note 2019 to the consolidated financial statements included in the Annual Report.

Note 11:14: Loss Per Share

Basic loss per share is calculated by dividing the net loss attributable to the shareholders of the Company by the weighted average number of ordinary shares outstanding during the period. As the Company was in a loss position for each of the three monthsand six month periods ended March 31,June 30, 2022 and 2021, and 2020, the diluted loss per share is equal to basic loss per share because the effects of potentially dilutive shares were anti-dilutive as a result of the Company’s net loss.

1
7

Table of Contents
The following is a summary of the ordinary share equivalents that were excluded from the calculation of diluted net loss per share for each of the three and six months ended March 31,June 30, 2022 and 2021 and 2020 indicated in number of potential shares:

   Three Months Ended March 31, 
   2021   2020 

Non-employee warrants

   225,008    225,008 

Employee warrants

   75,000    82,500 

Stock-options

   2,670,710    2 835,635 

Restricted stock units

   1,129,945    696,895 

   
Three Months Ended

June 30,
   
Six Months Ended

June 30,
 
   
2022
   
2021
   
2022
   
2021
 
Non-employee warrants
   256,693    256,693    256,693    256,693 
Stock options
   3,442,358    2,594,410    3,442,358    2,594,410 
Restricted stock units
   1,145,223    1,092,445    1,145,223    1,092,445 
Prefunded warrants
   28,276,331    —      28,276,331    —   

Note 12:15: Events after the Close of the Period

As previously disclosed, a class action complaint was filed in January 2019 in the U.S. District Court, District of New Jersey, alleging that the Company and certain current and former executive officers violated certain U.S. federal securities laws. Plaintiffs filed a Third Amended Complaint on September 30, 2021. On July 29, 2022 the Court entered an order granting the Company’s Motion to Dismiss the Plaintiff’s Third Amended Complaint with prejudice. The Court indicated that the Third Amended Complaint was deficient in a number of ways, failing to allege a violation of the Securities Exchange Act of 1934, and ordered the matter closed. Per court procedural rules, the Plaintiffs have 30 days to appeal the dismissal of the Third Amended Complaint. The Company believes that the allegations contained in the complaint are without merit and will continue to defend the case vigorously. The Company evaluated no other subsequent events that occurred after March 31, 2021,June 30, 2022, through the date the condensed consolidated financial statements were issued after their approval by the Board of Directors on April 30, 2021July 29, 2022 and determined that there are no significant events that require adjustments or disclosure in such condensed consolidated financial statements.

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Item 2.

Management’s Discussion and Analysis of Financial Condition and Results of Operations

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations
You should read the following discussion and analysis of our financial condition and results of operations in conjunction with our unaudited condensed consolidated financial statements and related notes included in Part 1, Item 1 of this Report and with our audited financial statements and related notes thereto for the year ended December 31, 2020,2021, included in our Annual Report on Form
10-K
for the year ended December 31, 2020,2021, filed with the Securities and Exchange Commission on March 17, 2021,9, 2022, or the Annual Report. This discussion and other parts of this Report contain forward-looking statements that involve risks and uncertainties, such as statements of our plans, objectives, expectations and intentions. Our actual results could differ materially from those discussed in these forward-looking statements. Factors that could cause such differences are discussed in the section of this Report titled “Special Note Regarding Forward-Looking Statements” and under “Item 1A. Risk Factors” in the Annual Report.

Overview

We are a clinical-stage specialty biopharmaceutical company focused on changing the field of immunotherapy by developing a novel technology platform called Viaskin. Our therapeutic approach is based on epicutaneous immunotherapy, or EPIT
TM
, our proprietary method of delivering biologically active compounds to the immune system through intact skin using Viaskin. We have generated significant data demonstrating that Viaskin’s mechanism of action is novel and differentiated, as it targets specific antigen-presenting immune cells in the skin, called Langerhans cells, that capture the antigen and migrate to the lymph node in order to activate the immune system without passage of the antigen into the bloodstream, minimizing systemic exposure in the body. We are advancing this unique technology to treat patients, including infants and children, suffering from food allergies, for whom safety is paramount, since the introduction of the offending allergen into their bloodstream can cause severe or life-threatening allergic reactions, such as anaphylactic shock.

On We believe Viaskin may offer convenient, self-administered,

non-invasive
immunotherapy to patients. Our most advanced clinical program is Viaskin Peanut.
Viaskin
TM
Peanut for children ages
4-11
in the United States
In January 13, 2021, the Company received written responses from the FDA to questions provided in the Type A meeting request the Company submitted in October 2020 following the CRL. We believe the FDA feedback provides a well-defined regulatory path forward. In exchanges with the FDA, we proposed potential resolutions to two main concerns identified by the FDAComplete Response Letter received in the CRL: the impact of patch adhesion and the need for patch modifications.August 2020. The FDA agreed with ourits position that a modified Viaskin Peanut patch should not be considered as a new product entity provided the occlusion chamber of the current Viaskin Peanut patch and the peanut protein dose of 250 µg (approximately 1/1000 of aone peanut) remains unchanged and performs in the same way it has performed previously. In order to confirm the consistency of efficacy data between the existing and a modified patches, thepatch, FDA has requested an assessment comparing the uptake of allergen (peanut protein) between the patches in peanut allergic children ages 4 to 11 years.
4-11.
The Company named that assessment EQUAL, which stands for Equivalence in Uptake of ALlergen. The FDA also recommended conducting a
6-month,
well-controlled safety and adhesion trial to assess thea modified Viaskin Peanut patch in the intended patient population. WeThe Company later named this study STAMP, which stands for Safety, Tolerability, and Adhesion of Modified Patches
Based on the January 2021 FDA feedback, the Company defined three parallel workstreams:
4.
Identify a modified Viaskin patch (which the Company calls mVP).
5.
Generate the
6-month
safety and adhesion clinical data FDA requested via STAMP, which the Company expected to be the longest component of the mVP clinical plan. The Company prioritized the STAMP protocol submission so the Company could begin the study as soon as possible.
6.
Demonstrate the equivalence in allergen uptake between the current and modified patches in the intended patient population via EQUAL. The complexity of EQUAL hinged on the lack of established clinical and regulatory criteria to characterize allergen uptake via an epicutaneous patch. To support those exchanges, the Company outlined its proposed approach to demonstrate allergen uptake equivalence between the two patches, and allotted time to generate informative data through two additional studies:
c.
PREQUAL, a Phase I study with adult healthy volunteers to optimize the allergen sample collection methodologies and validate the assays we intend to use in EQUAL
d.
‘EQUAL in adults’—a second Phase I study with adult healthy volunteers to compare the allergen uptake of cVP and Mvp;
In March 2021, the Company commenced CHAMP (Comparison of adHesion Among Modified Patches), a trial in healthy adult volunteers to evaluate the adhesion of five modified Viaskin Peanut patches, to identify the one or two best-performing patches, which the Company completed in the second quarter of 2021. Based on the adhesion parameters studied, the Company selected the modified patch to advance to further clinical testing in the intended patient population. All modified Viaskin Peanut patches demonstrated better adhesion performance as compared to the then-current Viaskin Peanut patch, and the Company then selected two modified patches that performed best out of the five modified patches studied for further development. The Company then selected the circular patch for further development, which is larger in size relative to the current patch and circular in shape.
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Table of Contents
In May 2021, the Company submitted its proposed STAMP protocol to the FDA, and in October 2021, the Company received an Advice/Information Request letter from the FDA. In this letter, the FDA requested a stepwise approach to the modified Viaskin patch development program and provided partial feedback on the STAMP protocol. Specifically, the FDA requested that the Company conduct allergen uptake comparison studies (i.e., ‘EQUAL in Adults’, EQUAL), and submit the protocolsallergen uptake comparison data for FDA review and feedback prior to starting the STAMP study.
After careful review of the FDA’s information requests, in December 2021, the Company decided not to pursue the stepwise approach to the development plans for Viaskin Peanut as requested by the FDA in the October 2021 letter. The Company estimated that the FDA’s newly proposed stepwise approach would require at least five rounds of exchanges that necessitate FDA alignment prior to initiating STAMP, the
6-month
safety and adhesion study. As such, in December 2021, the Company announced its plan to initiate a pivotal Phase III placebo-controlled efficacy trial for a modified Viaskin Peanut patch (mVP) in children in the intended patient population. The clinical trial will also include updates to the Instructions for Use (IFU). The Company considers this approach the most straightforward to potentially demonstrate effectiveness, safety, and improved in vivo adhesion of the modified Viaskin Peanut system. The FDA confirmed the Company’s change in strategy is agreeable via oral and written exchanges.
The new Phase 3 pivotal study for modified Viaskin Peanut has been named VITESSE (Viaskin Peanut Immunotherapy Trial to Evaluate Safety, Simplicity and Efficacy), which means “speed” in French.
In May 2022, the Company announced that the FDA granted it a Type C meeting to align on the protocol and the allergen uptake study protocol was submitted to the FDA for review and comments before initiatingas part of the trials. We will address details about a new human factor, or HF, validation study and additional CMC datathe Type C meeting briefing package.
DBV continues to engage in subsequent interactionsproductive dialogue with the FDA

During on the first quarterkey elements of the VITESSE protocol. As previously disclosed, the Company will communicate key elements of the VITESSE trial design and projected timelines once this process has concluded.

Viaskin Peanut for children ages
4-11
- European Union Regulatory History and Current Status
In August 2021, we received the first setCompany announced its receipt from the EMA of the Day 180 list of outstanding issues, which is an established part of the prescribed EMA review process. It is a letter that is meant to include any remaining questions or objections at that stage in the process. The EMA indicated many of their objections and major objections from the Day 120 list of questions fromhad been answered. One major objection remained at Day 180. The Major Objection questioned the European Medicines Agency, or EMA, regardinglimitations of the data, for example, the clinical relevance and effect size supported by a single pivotal study.
In December 2021, the Company announced it has withdrawn the Marketing Authorization Application or MAA, for Viaskin Peanut and formally notified the EMA of our decision. The initial filing was supported by positive data from a single, placebo-controlled Phase 3 pivotal trial known as a treatment for peanut allergy in children ages 4-11..PEPITES
(V712-301).
The questions were consistent with our expectations and prefiling conversations withdecision to withdraw was based on the EMA. We did not receive questions about the impactview of adhesion on efficacy. The EMA’sEMA Committee for Medicinal Products for Human Use (CHMP) that the data available to date from a single pivotal study were not sufficient to preclude a Major Objection at Day 180 in the review cycle. The Company believes data from a second Viaskin Peanut pivotal study will providesupport a recommendationmore robust path for licensure of Viaskin Peanut in the EU. The Company intends to resubmit the European Commission, or EC, on whetherMAA when that data set is available.
Viaskin Peanut for children ages
1-3
In June 2020, the Company announced that in Part A, patients in both treatment arms showed consistent treatment effects after 12 months of therapy, as assessed by a double-blind placebo-controlled food challenge and biomarker results. Part A subjects were not included in Part B and the efficacy analyses from Part A were not statistically powered to grantdemonstrate superiority of either dose versus placebo. These results validate the ongoing investigation of the 250 Pg dose in this age group, which is the dose being studied in Part B of the study. Enrollment for Part B of EPITOPE was completed in the first quarter of 2022.
In June 2022, The Company announced that its pivotal Phase III trial EPITOPE, assessing the safety and efficacy of Viaskin
Peanut 250 µg for the treatment of peanut-allergic toddlers ages 1 to 3 years, met its primary endpoint. Viaskin Peanut demonstrated a marketing authorization when its reviewstatistically significant treatment effect (p<0.001), with 67.0% of subjects in the Viaskin Peanut MAA is complete.

arm meeting the treatment responder criteria after 12 months, as compared to 33.5% of subjects in the placebo arm (difference in response rates = 33;4 %, 95 % CI = 22.4% - 44.5 %).

DBV intends to further analyze the data from EPITOPE and explore regulatory pathways for Viaskin Peanut in children ages 1 to 3 years, given the high unmet need and absence of approved treatments for this vulnerable population.
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Table of Contents
Critical Accounting Policies and Significant Judgments and Estimates

Our management’s discussion and analysis of our financial condition and results of operations is based on our condensed consolidated financial statements, which have been prepared in accordance with generally accepted accounting principles in the United States, or U.S. GAAP. The preparation of these condensed consolidated financial statements requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the consolidated financial statements, as well as the revenue, costs and expenses recognized during the reporting periods. Our estimates are based on our historical experience and on various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions.

There have been no new policies or significant changes to our critical accounting policies as disclosed in the critical accounting policies described in the Annual Report. Our significant accounting policies are more fully described in Note 1 of the Notes to the Condensed Consolidated Financial Statements in Part I, Item 1 of thisour Annual Report.

Business trends and Results of Operations
Comparison of the Three Months Ended June 30, 2022 and 2021
The following table summarizes our results of operations, derived from our condensed consolidated financial statements, which have been prepared in accordance with U.S. GAAP and presented in thousands of U.S. Dollars, for the three months ended March 31, 2021June 30, 2022 and 2020:

   Three Months Ended
March 31,
 
   2021   2020 

Operating income

  $2,941   $4,720 

Operating expenses

    

Research and development expenses

   (22,164   (27,532

Sales and marketing expenses

   (729   (7,297

General and administrative expenses

   (9,683   (11,113

Restructuring expenses

   —      —   
  

 

 

   

 

 

 

Total Operating expenses

   (32,575   (45,942
  

 

 

   

 

 

 

Financial income

   215    309 
  

 

 

   

 

 

 

Income tax

   (30   —   
  

 

 

   

 

 

 

Net loss

  $(29,449  $(40,913
  

 

 

   

 

 

 

Basic/diluted Net loss per share attributable to shareholders

  $(0.54  $(0.79

Comparison of the three months ended March 31, 2021 to the three months ended March 31, 2020

2021.

   
Three months ended June 30,
         
   
2022
   
2021
   
$ change
   
% change
 
Operating income
  
$
1,529
 
  
$
(1,488
  
 
3,016
 
  
 
(203
)% 
Operating expenses
                    
Research and development expenses
   (18,611   (20,179   1,568    (8)% 
Sales and marketing expenses
   (1,037   (1,198   162    (13)% 
General and administrative expenses
   (5,704   (8,269   2,564    (31)% 
   
 
 
   
 
 
   
 
 
   
 
 
 
Total Operating expenses
   (25,352   (29,646   4,309    (15)% 
   
 
 
   
 
 
   
 
 
   
 
 
 
Financial income
   784    46    737     
   
 
 
   
 
 
   
 
 
   
 
 
 
Income tax
   —      434    (434   (100)% 
   
 
 
   
 
 
   
 
 
   
 
 
 
Net loss
  
$
(23,039
  
$
(30,654
  
 
7,629
 
  
 
(25
)% 
   
 
 
   
 
 
   
 
 
   
 
 
 
Basic/diluted Net loss per share attributable to shareholders
  
$
(0.35
  
$
(0.56
          
*
Percentage not meaningful
Operating Income

We generated

The following table summarizes our operating income of $2.9 million during the three months ended March 31, 2021 compared to $4.7 million during the three months ended March 31, 2020, a decreaseJune 30, 2022 and 2021:
   
Three months ended June 30,
         
   
2022
   
2021
   
$ change
   
% change
 
Sales
   —      —      —      —   
Other income
   1,529    (1,488   3,016    (203)% 
Research tax credit
  
 
1,491
 
  
 
1,870
 
  
 
(379
  
 
(20
)% 
Other operating income
  
 
37
 
  
 
(3,358
  
 
3,396
 
  
 
(101
)% 
   
 
 
   
 
 
   
 
 
   
 
 
 
Total operating income
  
 
1,529
 
  
 
(1,488
  
 
3,016
 
  
 
(203
)% 
   
 
 
   
 
 
   
 
 
   
 
 
 
21

Table of 37.7%. ThisContents
Our operating income was mainlyis primarily generated from the French research tax credit (cré
Cr
é
dit d’impô
d
Iimp
ô
t recherche)
Recherche
, or CIR,“CIR”), and by the revenue recognized under our collaboration agreement with Nestlé Health Science.

   Three Months Ended March 31   % change 
   2021   2020   2021 vs 2020 

Sales

   —      —     

Other income

   2,941    4,720    (37.7)% 

Research tax credit

   1,807    2,902    (37.7)% 

Other operating income

   1,133    1,818    (37.6)% 
  

 

 

   

 

 

   

 

 

 

Total operating income

   2,941    4,720    (37.7)% 
  

 

 

   

 

 

   

 

 

 

We generated operating income of $1.5 million during the three months ended June 30, 2022 compared to $(1.5) million during the three months ended June 30, 2021. The decreaseincrease in operating income is primarily attributable to the decrease ofrevenue recognized under the CIR,Nestlé’s collaboration agreement, as eligible expenses have declined in correlation with Research and Development costs.

As of March 31, 2021, we recorded our collaboration contract income based on our updated the measurement of progress of the Phase II clinical trial conducted as part of the agreement. During the three months ended June 30, 2021 negative revenue was recognized under the Nestlé’s collaboration agreement due to delays in new patient enrollment.The decrease in research tax credit is attributable to the decline of eligible expenses in connection with Research and license agreement with Nestlé Health Science. The accrual recorded in the amount of the difference between our current best estimates of costs yet to be incurredDevelopment costs.

Research and income yet to be recognized for the completion of the Phase II clinical has been updated accordingly.

Operating Expense

Development Expenses

The following table summarizes our operating expense excluding restructuringresearch and development expenses incurred during the three months ended March 31, 2021June 30, 2022 and 2020:

   Three months Ended
March 31
   % change 
   2021   2020   2021 vs 2020 

Research and development expenses

   22,164    27,532    (19.5)% 

Sales and marketing expenses

   729    7,297    (90.0)% 

General and administrative expenses

   9,683    11,113    (12.9)% 
  

 

 

   

 

 

   

 

 

 

Total operating expenses

   32,575    45,942    (29.1)% 
  

 

 

   

 

 

   

 

 

 
2021:

Operating

   
Three Months Ended June 30,
         
Research and Development expenses
  
2022
   
2021
   
$ change
   
% change
 
External clinical-related expenses
   11,664    9,808    1,856    19
Employee-related costs
   2,622    3,206    (584   (18)% 
Share-based payment expenses
   475    187    289    155
Depreciation, amortization and other costs
   3,850    6,978    (3,128   (45)% 
  
 
 
   
 
 
   
 
 
   
 
 
 
Total Research and Development expenses
  
 
18,611
 
  
 
20,179
 
  
 
(1,568
  
 
(8
)% 
  
 
 
   
 
 
   
 
 
   
 
 
 
Research and Development expenses for the three months ended March 31, 2021 were $32.6 million compared to $45.9decreased by $1.6 million for the three months ended March 31, 2020. The $13.4 million decrease in operating expenses is mainly attributableJune 30, 2022, compared to a decrease in personnel expenses directly related to the workforce reduction we implemented as part of our 2020 global restructuring plan. Personnel expenses decreased by $9.7 million, or 52%, to $9.0 million during the three months ended March 31,June 30, 2021, from $18.7primarily due to an increase in external clinical-related expenses following the launch of work on VITESSE protocol. We have also continued to practice financial discipline and implemented further cost containment strategies.
Employee-related costs, excluding share-based payment expenses, decreased by $0.6 million for the three months ended March 31, 2020. Average headcount decreased 61% between the two periods, from 311 FTEs forJune 30, 2022 compared to the three months ended March 31, 2020June 30, 2021 due to and 121 FTEs for the three months ended March 31, 2021. By function,workforce reduction following full implementation of the personnel expenses, including share-based payment expenses, decreased as follows:

   

Three Months Ended March

31,

   % change 
   2021   2020   2021 vs 2020 

Research and development expenses

   4,718    10,204    (53.8)% 

Sales and marketing expenses

   518    4,197    (87.7)% 

General and administrative expenses

   3,766    4,283    (12.1)% 
  

 

 

   

 

 

   

 

 

 

Total personnel expenses

   9,002    18,684    (51.8)% 
  

 

 

   

 

 

   

 

 

 

new organization.

The decrease in depreciation, amortization and other operating expensescosts was primarily due to the budget discipline measures taken by DBV. In particular,loss at completion recorded on the Phase II clinical trial conducted as part of the Nestlé agreement.
22

Table of Contents
Sales and Marketing expenses
The following table summarizes our sales and marketing consulting fees dropped by 96.8% or $2.6 million, from $2.7expenses incurred during the three months ended June 30, 2022 and 2021:
   
Three Months Ended June 30,
         
Sales and Marketing expenses
  
2022
   
2021
   
$ change
   
% change
 
External professional services
   399    307    92    30
Employee-related costs
   289    430    (140   (33)% 
Share-based payment expenses
   55    89    (34   (38)% 
Depreciation, amortization and other costs
   294    373    (79   (21)% 
  
 
 
   
 
 
   
 
 
   
 
 
 
Total Sales and Marketing expenses
  
 
1,037
 
  
 
1,198
 
  
 
(162
  
 
(13
)% 
  
 
 
   
 
 
   
 
 
   
 
 
 
Sales and marketing expenses amounted to $1 million for the three months ended March 31, 2020June 30, 2022, compared to $1.2 million for the three months ended June 30, 2021.
Employee-related costs, excluding share-based payments expenses, decreased by $0.1 million for the three months ended June 30, 2022, compared to the three months ended June 30, 2021 due to the workforce reduction following full implementation of the new organization.
General and Administrative expenses
The following table summarizes our general and administrative expenses incurred during the three months ended June 30, 2022 and 2021:
   
Three Months Ended June 30,
         
General and Administrative expenses
  
2022
   
2021
   
$ change
   
% change
 
External professional services
   1,771    1,922    (151   (8)% 
Employee-related costs
   2,220    2,180    40    2
Share-based payment expenses
   548    819    (271   (33)% 
Depreciation, amortization and other costs
   1,166    3,348    (2,182   (65)% 
  
 
 
   
 
 
   
 
 
   
 
 
 
Total General and Administrative expenses
  
 
5,704
 
  
 
8,269
 
  
 
(2,564
  
 
(31
)% 
  
 
 
   
 
 
   
 
 
   
 
 
 
General and Administrative expenses decreased by $2.6 million for the three months ended June 30, 2022, compared to the three months ended June 30, 2021 primarily due to a decrease in depreciation, amortization and other costs as we continued to practice financial discipline and implemented further cost containment strategies.
Financial income (expense)
Our financial income was approximately $784,000 for the three months ended June 30, 2022, compared to a financial income of $46,000 for the three months ended June 30, 2021. This item mainly includes foreign exchange income and expenses.
Income tax
Our income tax profit was nil for the three months ended June 30, 2022, compared to $0.1 million for the three months ended March 31, 2021 and general and administrative fees decreased by 43.5% or $1.7 million,June 30, 2021. This profit mainly resulted from $4.0U.S. tax refunds.
Net loss
Net loss was $23 million for the three months ended March 31, 2020June 30, 2022, compared to $2.3$30.7 million for the three months ended March 31,June 30, 2021.

As a result of the ongoing COVID-19 pandemic, we also experienced a decrease in other expenses, in particular tradeshows and travel expenses.

Restructuring

We initiated a global restructuring plan in June 2020 to provide operational latitude to progress in the clinical development and regulatory review of investigational Viaskin Peanut in the United States and European Union.

We expect full implementation of the restructuring plan to result in a reduction of more than 200 jobs, resulting in a remaining global team of 90 individuals dedicated to the pursuit of innovation and scientific development of novel therapies.

As of March 31, 2021, we had 104 employees. We expect full implementation of the organization-wide costs reduction measures to be completed by the second half of 2021.

The restructuring costs, which were $23.6 million as of December 31, 2020, were mainly comprised of payroll expenses, restructuring-related consulting and legal fees, as well as impairment of facilities and right of use assets following resizing of facilities.

During the three months ended March 31, 2021, the restructuring liability evolved as presented below:

Restructuring
liabilities

Restructuring liability - January 1, 2021

9,387

Amounts paid

(4,854

Other effect including currency translation effect

(220

Restructuring liability - March 31, 2021

4,313

of which current contingencies

1,511

of which other current liabilities

2,803

They were no restructuring costs for three months ended March 31, 2021 and 2020.

Financial income

Our financial income was $0.2 million for the three months ended March 31, 2021 and 2020. This item mainly includes foreign exchange income.

Net loss

Net loss was $29.4 million for the three months ended March 31, 2021, compared to $40.9 million for the three months ended March 31, 2020. Net loss per share (based on the weighted average number of shares outstanding over the period) was $0.54$0.35 and $0.79$0.56 for the three months ended June 30, 2022 and 2021, respectively.

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Table of Contents
Business trends and Results of Operations
Comparison of the Six Months Ended June 30, 2022 and 2021
The following table summarizes our results of operations, derived from our condensed consolidated financial statements, which have been prepared in accordance with U.S. GAAP and presented in thousands of U.S. Dollars, for the six months ended June 30, 2022 and 2021.
   
Six months ended June 30,
         
   
2022
   
2021
   
$ change
   
% change
 
Operating income
  
$
4,074
 
  
$
1,453
 
  
 
2,621
 
  
 
180
Operating expenses
        
Research and development expenses
   (30,834   (42,343   11,509    (27)% 
Sales and marketing expenses
   (1,500   (1,927   427    (22)% 
General and administrative expenses
   (12,334   (17,951   5,617    (31)% 
  
 
 
   
 
 
   
 
 
   
 
 
 
Total Operating expenses
   (44,669   (62,221   17,552    (28)% 
  
 
 
   
 
 
   
 
 
   
 
 
 
Financial income (expense)
   936    261    675    258
  
 
 
   
 
 
   
 
 
   
 
 
 
Income tax
   (87   404    (491   (122)% 
  
 
 
   
 
 
   
 
 
   
 
 
 
Net loss
  
$
(39,746
  
$
(60,103
  
 
20,357
 
  
 
(34
)% 
  
 
 
   
 
 
   
 
 
   
 
 
 
Basic/diluted Net loss per share attributable to shareholders
  
$
(0.66
  
$
(1.09
    
  
 
 
   
 
 
   
 
 
   
 
 
 
Operating Income
The following table summarizes our operating income during the six months ended June 30, 2022 and 2021:
   
Six months ended June 30,
         
   
2022
   
2021
   
$ change
   
% change
 
Sales
   —      —       
Other income
   4,074    1,453    2,621    180
Research tax credit
  
 
3,060
 
   3,677    (617   (17)% 
Other operating income
  
 
1,014
 
   (2,225   3,238    (146)% 
  
 
 
   
 
 
   
 
 
   
 
 
 
Total operating income
  
 
4,074
 
  
 
1,453
 
  
 
2,621
 
  
 
180
  
 
 
   
 
 
   
 
 
   
 
 
 
Our operating income was primarily generated from the French research tax credit (
Crédit d’Impôt Recherche
or “CIR”) and from revenue recognized under our collaboration agreement with Nestlé Health Science. We generated operating income of $4.1 million during the six months ended June 30, 2022, compared to $1.5 million during the six months ended June 30, 2021.
The increase in operating income is primarily attributable to the revenue recognized under the Nestlé’s collaboration agreement, as we updated the measurement of progress of the Phase II clinical trial conducted as part of the agreement. During the six months ended June 30, 2021 negative revenue was recognized under the Nestlé’s collaboration agreement due to delays in new patient enrollment.The decrease in research tax credit is attributable to the decline in eligible expenses in connection with Research and Development costs.
Research and Development Expenses
The following table summarizes our research and development expenses incurred during the six months ended June 30, 2022 and 2021:
   
Six Months Ended June 30,
         
Research and Development expenses
  
2022
   
2021
   
$ change
   
% change
 
External clinical-related expenses
   19,014    22,686    (3,672   (16)% 
Employee-related costs
   5,114    7,297    (2,183   (30)% 
Share-based payment expenses
   1,058    814    244    30
Depreciation, amortization and other costs
   5,648    11,546    (5,898   (51)% 
  
 
 
   
 
 
   
 
 
   
 
 
 
Total Research and Development expenses
  
 
30,834
 
  
 
42,343
 
  
 
(11,509
  
 
(27
)% 
  
 
 
   
 
 
   
 
 
   
 
 
 
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Research and Development expenses decreased by $11.5 million for the six months ended June 30, 2022 compared to the six months ended June 30, 2021 primarily due to a decrease in external clinical-related expenses as main component of the work on clinical studies such as REALISE and EPITOPE has been finalized during the year 2021. We have also continued to practice financial discipline and implemented further cost containment strategies.
Employee-related costs, excluding share-based payments expenses, decreased by $2.2 million for the six months ended June 30, 2022, compared to the six months ended June 30, 2021 due to the workforce reduction following full implementation of the new organization.
Sales and Marketing expenses
The following table summarizes our sales and marketing expenses incurred during the six months ended June 30, 2022 and 2021:
   
Six Months Ended June 30,
         
Sales and Marketing expenses
  
2022
   
2021
   
$ change
   
% change
 
External professional services
   521    391    130    33
Employee-related costs
   539    877    (338   (39)% 
Share-based payment expenses
   49    159    (110   (69)% 
Depreciation, amortization and other costs
   391    500    (109   (22)% 
  
 
 
   
 
 
   
 
 
   
 
 
 
Total Sales and Marketing expenses
  
 
1,500
 
  
 
1,927
 
  
 
(427
  
 
(22
)% 
  
 
 
   
 
 
   
 
 
   
 
 
 
Sales and marketing expenses decreased by $0.4 million for the six months ended June 30, 2022, compared to the six months ended June 30, 2021, primarily due to a decrease in employee-related costs.
Employee-related costs, excluding share-based payments expenses, decreased by $0.4 million for the six months ended June 30, 2022, compared to the six months ended June 30, 2021 due to the workforce reduction following full implementation of the new organization.
General and Administrative expenses
The following table summarizes our general and administrative expenses incurred during the six months ended June 30, 2022 and 2021:
   
Six Months Ended June 30,
         
General and Administrative expenses
  
2022
   
2021
   
$ change
   
% change
 
External professional services
   2,879    4,210    (1,330   (32)% 
Employee-related costs
   4,029    5,211    (1,181   (23)% 
Share-based payment expenses
   1,333    1,554    (221   (14)% 
Depreciation, amortization and other costs
   4,093    6,977    (2,884   (41)% 
  
 
 
   
 
 
   
 
 
   
 
 
 
Total General and Administrative expenses
  
 
12,334
 
  
 
17,951
 
  
 
(5,617
  
 
(31
)% 
  
 
 
   
 
 
   
 
 
   
 
 
 
General and Administrative expenses decreased by $5.7 million for the six months ended June 30, 2022, compared to the six months ended June 30, 2021, primarily due to a decrease of depreciation, amortization and other costs.
The decrease in employee-related costs, excluding share-based payment expenses, is directly related to the workforce reduction following full implementation of the new organization
.
Financial income (expense)
Our financial income was $0.9 million for the six months ended June 30, 2022, compared to a financial income of $0.3 million for the six months ended June 30, 2021. This item mainly includes foreign exchange income (expense).
Income tax
Our income tax expense was $ 87,000 for the six months ended June 30, 2022. This income tax profit mainly resulted from US tax refunds.
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Net loss
Net loss was $39.7 million for the six months ended June 30, 2022, compared to $60.1 million for the six months ended June 30, 2021. Net loss per share (based on the weighted average number of shares outstanding over the period) was $0.51 and $1.09 for the six months ended June 30, 2022 and 2021, respectively.
Liquidity and Capital Resources
Financial Condition
On June 30, 2022, we had $248 million in cash and cash equivalents compared to $77.3 million of cash and cash equivalents on December 31, 2021. We have incurred operating losses and negative cash flows from operations since our inception. Net cash used for operating activities was $12.3 and $66.5 million for the six months ended June 30, 2022 and 2021, respectively. As of June 30, 2022, we recorded a net loss of $23 million.Our net cash flows provided by financing activities increased to $195.2 million during the six months ended June 30, 2022 from $1.1 million during the six months ended June 30, 2021. Financing activities consisted mainly of our underwritten global offering in the second quarter of 2022.
We may seek to finance our future cash needs through a combination of public or private equity or debt financings, collaborations, license and development agreements and other forms of
non-dilutive
financings. A severe or prolonged economic downturn could result in a variety of risks to us, including reduced ability to raise additional capital when needed or on acceptable terms, if at all.
If we are not successful in our financing objectives, we could have to scale back our operations, notably by delaying or reducing the scope of our research and development efforts or obtain financing through arrangements with collaborators or others that may require us to relinquish rights to our product candidates that we might otherwise seek to develop or commercialize independently.
Our financial statements have been prepared on a going concern basis assuming that we will be successful in our financing objectives. As such, no adjustments have been made to the financial statements relating to the recoverability and classification of the asset carrying amounts or classification of liabilities that might be necessary should we not be able to continue as a going concern.
Sources of Liquidity and Material Cash Requirements
We have incurred net losses each year since our inception. Substantially all of our net losses resulted from costs incurred in connection with our development programs and from general and administrative expenses associated with our operations. We have not incurred any bank debt.
As of the date of the filing, our available cash is projected to be sufficient to support our operating plan for at least the next 12 months.
In May 2022, the Company announced that pursuant to the Company’s ATM program, it had issued and completed sales of new Ordinary Shares in the form of ADSs, for a total gross amount of $15.3 million.
In June 2022, the Company announced an aggregate $194 million PIPE financing (corresponding to €181 million on the basis of an exchange rate of $1.0739 = €1.00 published by the European Central Bank on June 8, 2022) from the sale of 32,855,669 Ordinary Shares, as well as
pre-funded
warrants to purchase up to 28,276,331 Ordinary Shares.
We cannot guarantee that we will be able to obtain the necessary financing to meet our needs or to obtain funds at attractive terms and conditions, including as a result of disruptions to the global financial markets due to the ongoing
COVID-19
pandemic. A severe or prolonged economic downturn could result in a variety of risks to us, including reduced ability to raise additional capital when needed or on acceptable terms, if at all.
26

Table of Contents
The following table presents our material cash requirements for future periods:
   
Material Cash Requirements Due by the period Ended
June 30,
 
   
2023
   
2024
   
2025
   
Thereafter
   
Total
 
                     
   
(Amounts in thousands)
 
Conditional advances
   156    —      —      —      156 
Operating leases
   2,154    1,862    295    —      4,312 
Purchase obligations - Obligations Under the Terms of CRO Agreements
   17,057    6,721    4,969    —      30,586 
   
 
 
   
 
 
   
 
 
   
 
 
   
 
 
 
Total
   19,367    8,583    5,264    —      35,054 
The commitment amounts in the table above are associated with contracts that are enforceable and legally binding and that specify all significant terms, including interest on long-term debt, fixed or minimum services to be used, fixed, minimum or variable price provisions, and the approximate timing of the actions under the contracts. The table does not include obligations under agreements that we can cancel without a significant penalty.
Future events could cause actual payments to differ from these estimates.
Conditional advances
In 2014, BpiFrance Financement granted an interest-free Innovation loan to DBV Technologies to help finance the pharmaceutical development of Viaskin
Milk. This amount was received in a single disbursement on November 27, 2014. In 2020, due to the
COVID-19
pandemic, Bpifrance postponed the repayments for a
6-month
period. Repayment will end during the third quarter of 2022.
Operating leases
Our corporate headquarters are located in Montrouge, France. Our principal offices occupy a 4,470 square meter facility, pursuant to a lease agreement dated March 31, 20213, 2015 and 2020, respectively.

represents a $3.5 million cash requirement as of June 30, 2022 which expires March 8, 2024.

We also have facilities in North America that were initially intended to support our U.S. subsidiary as well as future commercialization needs. We lease 3,780 square feet of office space in Tower 49, New York, New York. This lease is for a period of 65 months and expires on February 25, 2023. In light of our global restructuring, the current stage of regulatory interactions regarding Viaskin Peanut, and the ongoing
COVID-19
pandemic, we entered into a sublease agreement of this office space in June 2021. The NYC office represents a $0.3 million cash requirement as of June 30, 2022 until the first quarter of 2023.
On March 28, 2022, the Company entered into a binding office lease agreement in New Jersey for a lease term of 3 years and 2 months. The lease commencement was based upon delivery of possession of the premises by the Landlord and occurred on April 1, 2022. The principal offices occupy a 5,799 square meter facility, and represents a $0.4 million cash requirement as of June 30, 2022 which expires May 1, 2025.
Purchase obligations - Obligations Under the Terms of CRO Agreements
In connection with the launch of our clinical trials for Viaskin Peanut and Viaskin Milk, we signed agreements with several contract research organizations. Expenses associated with the ongoing trials amounted globally to $105.5 million. As of June 30, 2022, the amount we are still obligated to pay in connection with these contracts through 2024 is $30.6 million.
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Table of Contents
Summary Statement of Cash Flows

The table below summarizes our sources and uses of cash for the threesix months ended March 21, 2021June 30, 2022 and 2020.

   Three Months Ended
March 31,
   % change 
(Amounts in thousands of U.S. Dollars)  2021   2020   2021 vs 2020 

Net cash flow used in operating activities

   (36,204   (49,683   (27.1)% 

Net cash flow used in investing activities

   (185   (930   (80.1)% 

Net cash flow provided by financing activities

   440    150,611    (99.7)% 

Effect of exchange rate changes on cash and cash equivalents

   (7,944   (5,811   (36.7)% 
  

 

 

   

 

 

   

 

 

 

Net (decrease) increase in cash and cash equivalents

   (43,893   94,187    (146.6)% 
  

 

 

   

 

 

   

 

 

 

2021.

   
Six months ended June 30,
         
(Amounts in thousands of U.S. Dollars)
  
2022
   
2021
   
$ change
   
% of change
 
Net cash flow used in operating activities
   (11,733   (66,503   54,770    (82)% 
Net cash flow used in investing activities
   (218   (13   (206   1595
Net cash flow provided by financing activities
   195,222    1,071    194,151      
Effect of exchange rate changes on cash and cash equivalents
   (12,600   (5,423   (7,177   132
  
 
 
   
 
 
   
 
 
   
 
 
 
Net (decrease) increase in cash and cash equivalents
  
 
170,670
 
  
 
(70,868
  
 
241,538
 
  
 
(341
)% 
  
 
 
   
 
 
   
 
 
   
 
 
 
*
Percentage not meaningful
Operating Activities

Our net cash flows used in operating activities were $36.2$11.7 million and $49.7$66.5 million during the threesix months ended March 31,June 30, 2022 and 2021, and 2020, respectively. Our net cash flows used in operating activities decreasedincreased by $13.5$54.8 million, or 27.2%82%, mainly due to the budget disciplinecost containment measures we took, in particular the decrease in personnel expenses, which was directly relatedand to the workforce reduction we implemented as partfollowing full implementation of our global restructuring plan. the new organization
.
Cash flows used in operating activities for the threesix months ended March 31,June 30, 2021 included $4.9 million in restructuring amounts paid.

costs paid for $6.3 million.

Investing Activities

Our net cash flows used in investing activities were $0.2 millionwas approximately $218,000 and $0.9 million$13,000 during the threesix months ended March 21,June 30, 2022 and 2021, and 2020, respectively. Those investments were mainly for our industrial machinery and equipment, which are commissioned in order to support the commercialization of Viaskin Peanut, if approved.

Financing Activities

Our net cash flows provided by financing activities decreasedincreased to $0.4$195.2 million during the threesix months ended March 21, 2021June 30, 2022 from $150.6$1.1 million during the threesix months ended March 21, 2020.June 30, 2021. Financing activities consisted mainly of our underwritten global offering in the firstsecond quarter of 2020.

Based on our current assumptions, we expect that our current cash and cash equivalents will support our operations until the second half of 2022

Contractual Obligations and Other Commitments

There have been no material changes in our contractual obligations and commitments from those disclosed in the Annual Report.

2022.

Off-Balance
Sheet Arrangements

We have not entered into any
off-balance
sheet arrangements and do not have variable interests in variable interest entities.

Smaller Reporting Company Status

We are a smaller reporting company as defined in the Securities Exchange Act of 1934, as amended. We may, and intend to, take advantage of certain of the scaled disclosures available to smaller reporting companies and will be able to take advantage of these scaled disclosures for so long as we are a smaller reporting company. We may be a smaller reporting company in any year in which (i) the market value of our
voting and non-voting ordinary shares
held
by non-affiliates is
less than $250.0 million measured on the last business day of our second fiscal quarter or (ii) (a) our annual revenue is less than $100.0 million during the most recently completed fiscal year and (b) the market value of our
voting and non-voting ordinary shares
held by non-affiliates is less
than $700.0 million measured on the last business day of our second fiscal quarter.

Item 3.

Quantitative and Qualitative Disclosures About Market Risk

Item 3. Quantitative and Qualitative Disclosures About Market Risk
Our market risks have not changed materially from those disclosed in Item 7A of the Annual Report.

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Table of Contents
Item 4.

Controls and Procedures

Item 4. Controls and Procedures
Disclosure Controls and Procedures

Based on theirits evaluation as of March 31, 2021,June 30, 2022, our management, including our Chief Executive Officer and Chief Financial Officer,
concluded that our disclosure controls and procedures (as defined in Rule
13a-15(e)
under the Exchange Act) were effective to provide
reasonable assurance that (i) the information required to be disclosed in our reports filed or submitted under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms, and (ii) such information is accumulated and communicated to our management, including our Chief Executive Officer and Chief Financial Officer, as appropriate, to allow timely decisions regarding required disclosure.

Changes in Internal Control Over Financial Reporting

There were no changes in our internal control over financial reporting identified in management’s evaluation pursuant to Rules
13a-15(d)
or
15d-15(d)
of the Exchange Act during the period covered by this Quarterly Report on Form
10-Q
that materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

Limitation on Effectiveness of Controls and Procedures

Our management, including our Chief Executive Officer and Chief Financial Officer, does not expect that our disclosure controls and

procedures or our internal controls will prevent all error and all fraud. A control system, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the control system are met. Further, the design of a control system must reflect the fact that there are resource constraints, and the benefits of controls must be considered relative to their costs. Because of the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that all control issues and instances of fraud, if any, within the Company have been detected. These inherent limitations include the realities that judgments in decision making can be faulty and that breakdowns can occur because of simple error or mistake. Controls can also be circumvented by the individual acts of some persons, by collusion of two or more people, or by management override of the controls. The design of any system of controls is based in part on certain assumptions about the likelihood of future events, and there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions. Over time, controls may become inadequate because of changes in conditions or deterioration in the degree of compliance with policies and procedures. Because of the inherent limitations in a cost-effective control system, misstatements due to error of fraud may occur and not be detected.

29

PART II – Other information

Item 1.

Legal Proceedings

Item 1. Legal Proceedings
See “Note 2: Significant Events and Transactions – Legal Proceedings” in the notes to the condensed consolidated financial statements included elsewhere in this Report.

Item 1A.

Risk Factors

There

Item 1A. Risk Factors
Except as set forth below, there have been no material changes in our risk factors from those disclosed in the Annual Report.

Future sales of ordinary shares or ADSs by existing shareholders could depress the market price of the ADSs.
As of December 31, 2021, 55,095,762 Ordinary Shares were issued and outstanding. Sales of a substantial number of shares of our Ordinary Shares or ADSs in the public market, or the perception that these sales might occur, could depress the market price of our securities and could impair our ability to raise capital through the sale of additional equity securities. A substantial number of our shares are now generally freely tradable, subject, in the case of sales by our affiliates, to the volume limitations and other provisions of Rule 144 under the Securities Act. If holders of these shares sell, or indicate an intent to sell, substantial amounts of our securities in the public market, the trading price of our securities could decline significantly.
In June 2022, we completed a $194 million PIPE financing from the sale of (i) 32,855,669 Ordinary Shares, nominal value €0.10 per share at a price per Ordinary Share of €3.00 (corresponding to $3.22 on the basis of an exchange rate of $1.0739 = €1.00 published by the European Central Bank on June 8, 2022), and
(ii) pre-funded
warrants to purchase an aggregate of 28,276,331 Ordinary Shares (the “Warrant Shares”) at a
pre-funded
price per
pre-funded
warrant of €2.90 (corresponding to $3.11), which equals the per share price of the Ordinary Shares less the exercise price of €0.10 per
pre-funded
warrant. Each
pre-funded
warrant has an exercise price of €0.10 per Warrant Share. We entered into a registration rights agreement with the investors pursuant to which we agreed to file a registration statement with the SEC registering the resale of the 32,855,669 Ordinary shares and the 28,276,331 Ordinary shares underlying the
pre-funded
warrants issued in the PIPE. Upon the effectiveness of this registration statement and subject to certain beneficial ownership limitations contained in the
pre-funded
warrants, these shares will be freely tradable, without restriction, in the public market. In addition, the exercise of some or all of the
pre-funded
warrants will increase the number of our outstanding ordinary shares, which may dilute the ownership percentage or voting power of our shareholders.
In addition, we have filed a registration statement with the SEC to register the Ordinary Shares that may be issued under our equity incentive plans. The Ordinary Shares subject to outstanding options under our equity incentive plans, Ordinary Shares reserved for future issuance under our equity incentive plans and Ordinary Shares subject to outstanding warrants will become eligible for sale in the public market in the future, subject to certain legal and contractual limitations. Sales of a large number of the shares issued under these plans in the public market could have an adverse effect on the market price of our securities.
Item 2.

Unregistered Sales of Equity Securities and Use of Proceeds

Item 2. Unregistered Sales of Equity Securities and Use of Proceeds
During the threesix months ended March 31, 2021, we granted 75,600 stock options and 24,900 restricted stock units to employees in France and in the United States.

During the three months ended March 31, 2021,June 30, 2022, we issued 7,500the following unregistered securities:

On March 23, 2022, the issuance of an aggregate of 775 ordinary shares followingto a
non-U.S.
employee upon settlement of RSUs;
On May 19, 2022, the issuance of an aggregate of 5,000 ordinary shares to a
non-U.S.
employee upon settlement of RSUs;
On May 24, 2022, the issuance of an aggregate of 26,135 ordinary shares to a
non-U.S.
employee upon settlement of RSUs;
Pursuant to the authorization granted by the General Meeting of the Shareholders held on May 12, 2022, the Company offered the opportunity to subscribe for warrants to purchase ordinary shares on May 12, 2022, and on June 9, 2022, the Chief Executive Officer authorized a capital increase for an amount of €3,285,566.90 through the issue of (i) 32,855,669 New Shares with a per value of €0.10 each and (ii) the issuance of 28,276,331 prefunded warrants, with cancellation of shareholders’ preferential subscription rights in favor of Braidwell LP, funds advised by Baker Bros. Advisors LP and BpiFrance Participations SA, existing shareholders of the Company and Venrock Healthcare Capital Partners.
On June 8, 2022, we entered into a securities purchase agreement with certain institutional and accredited investors pursuant to which we agreed to issue and sell to the investors i) 32,855,669 ordinary shares, nominal value €0.10 per share, at a price per ordinary share of €3.00 (corresponding to $3.22 on the basis of an exchange rate of $1.0739 = €1.00 published by the European Central Bank on June 8, 2022),
and (ii) pre-funded warrants
to purchase an aggregate of 28,276,331 ordinary shares (the “Warrant Shares”) at
a pre-funded price
per pre-funded warrant
of €2.90 (corresponding to $3.11), which equals the per share price of the ordinary shares less the exercise price of €0.10
per Pre-Funded Warrant.
Each Pre-Funded Warrant
has an exercise price of €0.10 per Warrant Share.
The Pre-Funded Warrants
are exercisable at any time after their original issuance and will expire ten years
30

Table of Contents
following their issuance. The exercise price and number of shares of ordinary shares issuable upon exercise of the warrants may be adjusted in certain circumstances, including stock splits, stock dividends, reclassifications and the like. The
pre-funded
warrants issued in the PIPE provide that the holder of the
pre-funded
warrants will not have the right to exercise any portion of its
pre-funded
warrants if such holder, together with its affiliates, would beneficially own in excess of 9.99% of the number of ordinary shares outstanding immediately after giving effect to such exercise (the “Beneficial Ownership Limitation”). The holder may increase or decrease the Beneficial Ownership Limitation, provided, however, that the holder may only increase the Beneficial Ownership Limitation by (i) obtaining authorization from the French Ministry of Economy in the event the Beneficial Ownership Limitation is being raised above 9.99%, and (ii) by providing 61 days’ notice to the Company, except that in no event will the Beneficial Ownership Limitation exceed 19.99%. The securities issued by us pursuant to the securities purchase agreement and to be issued upon exercise of the warrants were not registered under the Securities Act of 1933, as amended, or the Securities Act, and may not be offered or sold in the United States absent registration or an applicable exemption from registration requirements.
On June 10, 2022, the issuance of 3,100 ordinary shares to a
non-U.S.
employee warrants byupon exercise of 3,100 SO at an employee in France,exercise price of 4.16 euros per SO, for aggregate proceeds to the Company of $42,000.

12,896 euros.

None of the foregoing transactions involved any underwriters, underwriting discounts or commissions, or any public offering. We believe these transactions were exempt from registration under the Securities Act in reliance on Section 4(a)(2) of the Securities Act or Regulation S promulgated under Section 5 of the Securities Act, as transactions by an issuer not involving any public offering or as offerings made to
non-U.S.
resident employees pursuant to an employee benefit plan established and administered in accordance with the law of a country other than the United States (namely, the Republic of France) and in accordance with that country’s practices and documentation. All recipients had adequate access, through their relationships with us, to information about us. The sales of these securities were made without any general solicitation or advertising.

Item 3.

Defaults Upon Senior Securities

Item 3. Defaults Upon Senior Securities
None.

Item 4.

Mine Safety Disclosures

Item 4. Mine Safety Disclosures
Not applicable.

Item 5.

Other Information

Item 5. Other Information
Not applicable.

31

Table of Contents

Item 6. Exhibits.

Exhibit Index

Exhibit

  

Description

  Incorporated by Reference 
      Schedule
/ Form
   File
Number
   Exhibit   File
Date
 
    3.1  By-laws (statuts) of the registrant (English translation)   10-K    001-36697    3.1    3/17/2021 
  31.1  Certificate of Chief Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002, as Amended        
  31.2  Certificate of Chief Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002, as amended        
  32.1*  Certificate of Chief Executive Officer and Chief Financial Officer pursuant to 18 U.S.C. §1350, as adopted pursuant to Section 906 of the Sarbanes- Oxley Act of 2002, as amended        
101.INS  XBRL Instance Document        
101.SCH  XBRL Taxonomy Extension Schema Document        
101.CAL  XBRL Taxonomy Extension Calculation Linkbase Document        
101.DEF  XBRL Taxonomy Extension Definition Linkbase Document��       
101.LAB  XBRL Taxonomy Extension Labels Linkbase Document        
101.PRE  XBRL Taxonomy Extension Presentation Linkbase Document        

Exhibit
  
Description
  
Incorporated by Reference
 
      
Schedule/
Form
   
File
Number
   
Exhibit
   
File
Date
 
1.1  Sales Agreement, dated as of May 2, 2022, by and between DBV Technologies S.A. and Jefferies LLC   Form
8-K
    
001-36697
    1.1    
May 2,
2022
 
 
3.1  Amended and Restated By-laws (statuts) of the registrant (English translation)        
4.1  Terms and Conditions of the Pre-Funded Warrant   Form
8-K
    
001-36697
    





Annex II of
the
Securities
Purchase
Agreement
filed as
Exhibit 10.1
 
 
 
 
 
 
 
   
June 13,
2022
 
 
10.1  Registration Rights Agreement, dated June 8, 2022, by and between DBV Technologies S.A. and the investor parties thereto   Form 8-K    
001-36697
    10.2    
June 13,
2022
 
 
10.2  Securities Purchase Agreement, dated June 8, 2022, by and between DBV Technologies S.A. and the investor parties thereto   Form
8-K
    
001-36697
    10.1    
June 13,
2022
 
 
31.1  Certificate of Chief Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002, as Amended        
31.2  Certificate of Chief Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002, as amended        
32.1*  Certificate of Chief Executive Officer and Chief Financial Officer pursuant to 18 U.S.C. §1350, as adopted pursuant to Section 906 of the Sarbanes- Oxley Act of 2002, as amended        
101.INS  XBRL Instance Document        
101.SCH  XBRL Taxonomy Extension Schema Document        
101.CAL  XBRL Taxonomy Extension Calculation Linkbase Document        
101.DEF  XBRL Taxonomy Extension Definition Linkbase Document        
101.LAB  XBRL Taxonomy Extension Labels Linkbase Document        
101.PRE  XBRL Taxonomy Extension Presentation Linkbase Document        
104  Cover Page Interactive Data File, formatted in Inline XBRL and contained in Exhibit 101.        
*

Furnished herewith and not deemed to be “filed” for purposes of Section 18 of the Exchange Act, and shall not be deemed to be incorporated by reference into any filing under the Securities Act of 1933, as amended, or the Exchange Act (whether made before or after the date of the Form
10-Q),
irrespective of any general incorporation language contained in such filing.

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Table of Contents

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 thereunto duly authorized.

  DBV Technologies S.A.
(Registrant)
Date: May 5, 2021
August 1, 2022  By: 

/s/ Daniel Tassé

  Daniel Tassé
  Chief Executive Officer)Officer
  (Principal Executive Officer)
Date: May 5, 2021August 1, 2022  By: 

/s/ Sébastien Robitaille

  Sébastien Robitaille
  Chief Financial Officer
  (Principal Financial and Accounting Officer)

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