Table of Contents

 
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 SeptemberJune 30, 20222023
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 applicable
State or other jurisdiction of
incorporation or organization
 
(I.R.S. Employer
Identification No.)
177-181
avenue Pierre Brossolette
92120 Montrouge France
 
92120N/A
(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)
 
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 €0.10 per share
 
DBVT
 
The Nasdaq Stock Market LLC
Ordinary shares, nominal
value €0.10 per share
*
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
☒    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
☒    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 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 November 3, 2022,July 31, 2023, the registrant
had
94,025,441
96,250,954 ordinary shares, nominal value €0.10 per share, outstanding including treasury shares.
 
 
 

Table of Contents

Table of contents

Part I

 
Financial information
 3

Item 1

 Condensed Consolidated Statements of Financial Position (Unaudited) as of SeptemberJune 30, 20222023 and December 31, 20212022  3
 Condensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited) for the Three and NineSix Months Ended SeptemberJune 30, 20222023 and 20212022  4
 Condensed Consolidated Statements of Cash Flows (Unaudited) for the NineSix Months Ended SeptemberJune 30, 20222023 and 20212022  5
 Condensed Consolidated Statements of Changes in Shareholders’ Equity (Unaudited) for the NineSix Months Ended SeptemberJune 30, 20222023 and 20212022  6
 
Notes to the Condensed Consolidated Financial Statements (Unaudited)
  87

Item 2

 
Management’s Discussion and Analysis of Financial Condition and Results of Operations
  2117

Item 3

 
Quantitative and Qualitative Disclosures About Market Risk
  3324

Item 4

 
Controls and Procedures
  3324

Part II

 
Other Information
  3424

Item 1

 
Legal Proceedings
  3424

Item 1A

 
Risk Factors
  3425

Item 2

 
Unregistered Sales of Equity Securities and Use of Proceeds
  3425

Item 3

 
Defaults Upon Senior Securities
  3525

Item 4

 
Mine Safety Disclosures
  3525

Item 5

 
Other Information
  3525

Item 6

 
Exhibits
  3625

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™“Viaskin™”, “EPIT™“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 contains forward-looking statements which are made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended or Securities Act,(the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended or Exchange Act.(the “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:

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, 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, or a BLA, for ViaskinTM Peanut to the U.S. Food and Drug Administration, or the FDA;

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;interactions with regulatory agencies;

•

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;

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;

1
Table of Contents

our financial performance;

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

•

the impact of the COVID-19 pandemic and its effects on our operations, research and development, 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; and

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

Although we believe that we have a reasonable basis for each forward-looking statement contained in this Quarterly Report, 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, 2021,2022, filed with the Securities and Exchange Commission, or the SEC on March 9, 2022. Additional information is also included on our Current Report on Form 8-K, filed with the SEC on June 13, 2022.2, 2023. 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.

1

In addition, any forward-looking statement in this Quarterly 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 Quarterly 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

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)
       
June 30,
  
December 31,
 
   
Note
   
2023
  
2022
 
Assets
              
Current assets:
              
Cash and cash equivalents  
 
3
 
  $173,961  $209,194 
Other current assets  
 
4
 
   21,578   13,880 
               
Total current assets
       
 
195,539
 
 
 
223,074
 
Property, plant, and equipment, net        14,135   15,096 
Right-of-use
assets related to operating leases
  
 
5
 
   1,832   2,513 
Intangible assets        68   10 
Other
non-current
assets
        5,944   5,824 
               
Total
non-current
assets
       
 
21,979
 
 
 
23,444
 
               
Total Assets
       
$
217,518
 
 
$
246,518
 
               
Liabilities and shareholders’ equity
              
Current liabilities:
              
Trade payables  
 
6
 
  $19,094  $14,473 
Short-term operating leases  
 
5
 
   1,944   1,894 
Current contingencies  
 
9
 
   5,076   3,944 
Other current liabilities  
 
6
 
   7,258   9,210 
               
Total current liabilities
       
 
33,373
 
 
 
29,521
 
               
Long-term operating leases  
 
5
 
   187   1,127 
Non-current
contingencies
  
 
9
 
   15,731   16,680 
Other
non-current
liabilities
  
 
6
 
   3,987   4,735 
               
Total
non-current
liabilities
       
 
19,905
 
 
 
22,543
 
               
Total Liabilities
       
$
53,277
 
 
$
52,064
 
               
Shareholders’ equity:
              
Ordinary shares, €0.10 par value; 96,250,954 and 94,137,145 shares authorized, and issued as
of
 June 30, 2023 and December 31, 2022, respectively
       $10,952  $10,720 
Additional
paid-in
capital
        375,759   458,221 
Treasury stock, 149,972 and 149,793 ordinary shares as of June 30, 2023 and December 31, 2022, respectively, at cost        (1,082)   (1,109) 
Accumulated deficit        (210,940)   (259,578) 
Accumulated other comprehensive income        687   781 
Accumulated currency translation effect        (11,136)   (14,581) 
               
Total Shareholders’ equity
  
 
7
 
  
$
164,240
 
 
$
194,453
 
               
Total Liabilities and Shareholders’ equity
       
$
217,518
 
 
$
246,518
 
               

       
September 30,
  
December 31,
 
   
Note
   
2022
  
2021
 
Assets
              
Current assets:
              
Cash and cash equivalents
  
 
3
 
  $212,670  $77,301 
Other current assets
  
 
4
 
   13,025   37,085 
        
 
 
  
 
 
 
Total current assets
       
 
225,695
 
 
 
114,386
 
Property, plant, and equipment, net
        14,429   18,146 
Right-of-use
assets related to operating leases
  
 
5
 
   2,614   7,336 
Intangible assets
        11   22 
Other non-current assets
        5,368   6,833 
        
 
 
  
 
 
 
Total non-current assets
       
 
22,422
 
 
 
32,338
 
        
 
 
  
 
 
 
Total Assets
       
$
248,117
 
 
$
146,723
 
        
 
 
  
 
 
 
Liabilities and shareholders' equity
              
Current liabilities:
              
Trade payables
  
 
6
 
  $15,369  $11,429 
Short-term operating leases
  
 
5
 
   1,381   3,003 
Short-term financial debt
        —     510 
Current contingencies
  
 
9
 
   3,026   4,095 
Other current liabilities
  
 
6
 
   8,615   12,361 
        
 
 
  
 
 
 
Total current liabilities
       
 
28,391
 
 
 
31,397
 
        
 
 
  
 
 
 
Long-term operating leases
  
 
5
 
   1,423   7,147 
Non-current contingencies
  
 
9
 
   5,272   6,758 
Other non-current liabilities
  
 
6
 
   979   2,147 
        
 
 
  
 
 
 
Total non-current liabilities
       
 
7,674
 
 
 
16,052
 
        
 
 
  
 
 
 
Total Liabilities
       
$
36,065
 
 
$
47,449
 
        
 
 
  
 
 
 
Shareholders’ equity:
              
Ordinary shares, €0.10 par value; 94,025,441 and 55,095,762 shares authorized, and issued as at September 30, 2022 and December 31, 2021, respectively
       $10,709  $6,538 
Additional paid-in capital
        456,884   358,115 
Treasury stock, 137,101 and 153,631 ordinary shares as of September 30, 2022 and December 31, 2021, respectively, at cost
        (1,083)   (1,232) 
Accumulated deficit
        (220,337)   (258,528) 
Accumulated other comprehensive income
        783   519 
Accumulated currency translation effect
        (34,904)   (6,137) 
        
 
 
  
 
 
 
Total Shareholders’ equity
  
 
7
 
  
$
212,052
 
 
$
99,274
 
        
 
 
  
 
 
 
Total Liabilities and Shareholders’ equity
       
$
248,117
 
 
$
146,723
 
        
 
 
  
 
 
 
The accompanying notes are an integral part of these condensed consolidated financial statements.
 
3
Table of Contents
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
September 30,
 
Nine Months Ended

September 30,
       
Three Months Ended June 30,
 
Six Months Ended
June 30,
 
  
Note
  
2022
 
2021
 
2022
 
2021
   
Note
   
2023
 
2022
 
2023
 
2022
 
Operating income
  
10
  
$
2,074
 
 
$
1,323
 
 
$
6,148
 
 
$
2,776
 
  
 
10
 
  
$
2,288
 
 
$
1,529
 
 
$
4,482
 
 
$
4,074
 
  
Operating expenses
                  
Research and development expenses
      (15,096)   (16,320)   (45,930)   (58,663)       (17,616)   (18,611)   (33,653)   (30,834) 
Sales and marketing expenses
      (159)   (1,072)   (1,659)   (2,999)       (516)   (1,037)   (950)   (1,500) 
General and administrative expenses
      (4,839)   (8,299)   (17,173)   (26,250)       (9,231)   (5,704)   (16,120)   (12,334) 
     
 
  
 
  
 
  
 
                 
Total Operating expenses
      (20,094)   (25,691)   (64,762)   (87,912)      
 
(27,364
) 
 
 
(25,352
) 
 
 
(50,723
) 
 
 
(44,669
) 
     
 
  
 
  
 
  
 
                 
Loss from operations
     
 
(18,020
) 
 
 
(24,368
) 
 
 
(58,614
) 
 
 
(85,137
) 
     
 
(25,076
) 
 
 
(23,823
) 
 
 
(46,242
) 
 
 
(40,595
) 
     
 
  
 
  
 
  
 
                 
Financial income
      732   336   1,668   597 
Financial income (expenses)      846   784   1,450   936 
     
 
  
 
  
 
  
 
                 
Loss before taxes
     
 
(17,287
) 
 
 
(24,033
) 
 
 
(56,946
) 
 
 
(84,540
) 
     
 
(24,230
) 
 
 
(23,039
) 
 
 
(44,791
) 
 
 
(39,659
) 
     
 
  
 
  
 
  
 
                 
Income tax (expense)
      —     —     (87)   404 
Income tax      (13)   —   (13)   (87) 
     
 
  
 
  
 
  
 
                 
Net loss
     
$
(17,287
) 
 
$
(24,033
) 
 
$
(57,033
) 
 
$
(84,136
) 
     
$
(24,243
) 
 
$
(23,039
) 
 
$
(44,804
) 
 
$
(39,746
) 
     
 
  
 
  
 
  
 
                 
Foreign currency translation differences, net of taxes
      (15,425)   (3,728)   (28,752)   (9,684)       (221)   (11,394)   3,445   (13,327) 
Actuarial gains (losses) on employee benefits, net of taxes
      41   28   264   (10)       (10)   200   (92)   224 
     
 
  
 
  
 
  
 
                 
Total comprehensive loss
     
$
(32,672
) 
 
$
(27,733
) 
 
$
(85,520
) 
 
$
(93,830
) 
     
$
(24,475
) 
 
$
(34,234
) 
 
$
(41,452
) 
 
$
(52,849
) 
     
 
  
 
  
 
  
 
                 
Basic/diluted net loss per share attributable to shareholders
  
14
  
$
(0.18
) 
 
$
(0.44
) 
 
$
(0.79
) 
 
$
(1.53
) 
  
 
14
 
  
$
(0.26
) 
 
$
(0.35
) 
 
$
(0.48
) 
 
$
(0.66
) 
  
Weighted average shares outstanding used in computing per
sha
re amounts:
      93,905,050   54,947,354   71,779,572   54,911,278 
Weighted average shares outstanding used in computing per share amounts:      94,324,889   66,047,949   94,150,141   60,490,075 
The accompanying notes are an integral part of these condensed consolidated financial statements.
 
4
Table of Contents
DBV Technologies S.A.
Condensed Consolidated Statements of Cash Flows (unaudited)
(amounts in thousands)

 
      
    Nine Months Ended September 30,    
       
Six Months
Ended June 30,
 
  
Notes
   
2022
 
2021
   
Notes
   
2023
 
2022
 
Net loss for the period
       
$
(57,033
) 
 
$
(84,136
) 
     
$
(44,804
) 
 
$
(39,746
) 
Adjustments to reconcile net loss to net cash used in operating activities:
          
Adjustments to reconcile net loss to net cash flow provided by (used in) operating activities:
      
Depreciation, amortization and accrued contingencies
        1,140   9,705       369   1,249 
Retirement pension obligations
        58   127       11   14 
Expenses related to share-based payments
  
 
8
 
   3,416   4,078   
 
8
 
   3,446   2,441 
Other elements
        (3)   1,214       23   (3) 
Changes in operating assets and liabilities:
                
Decrease (increase) in trade receivables
        —     2,174 
Decrease (increase) in other current assets
        20,900   (9,036)       (6,481)   23,436 
(Decrease) increase in trade payables
        5,699   (7,135)       3,419   5,894 
(Decrease) increase in other current and
non-current
liabilities
        (3,405)   (5,497)       (2,913)   (3,040) 
Change in operating lease liabilities and right of use assets
        (2,554)   (946)       535   (1,979) 
Net cash flow used in operating activities
       
 
(31,781
) 
 
 
(89,452
) 
Net cash flow provided by (used in) operating activities
     
 
(46,394
) 
 
 
(11,733
) 
       
 
  
 
           
Cash flows used in investing activities:
          
Acquisitions of property, plant, and equipment
        (742)   —   
Cash flows provided by (used in) investing activities:
      
Acquisitions of property, plant, and equipment, net from proceeds      (275)   (369) 
Proceeds from property, plant, and equipment dispositions
        3   46       —     3 
Acquisition of intangible assets
        —     (8) 
Acquisitions of non-current financial assets
        (149)   —         (27)   (279) 
Proceeds from
non-current
financial assets
        822   3 
Proceeds from
non-current
financial assets dispositions
      4   426 
       
 
  
 
           
Net cash flows used in investing activities
       
 
(66
) 
 
 
41
 
Net cash flows provided by (used in) investing activities
     
 
(299
) 
 
 
(218
) 
       
 
  
 
           
Cash flows provided by financing activities:
          
Cash flows provided by (used in) financing activities:
      
Decrease in conditional advances
        (479)   (518)       —     (328) 
Treasury shares
        149   (359)       27   279 
Capital increases, net of transaction costs
        194,732   794       7,766   195,270 
Other cash flows related to financing activities
        —     (21)       —     —   
       
 
  
 
           
Net cash flows provided by financing activities
       
 
194,403
 
 
 
(103
) 
Net cash flows provided by (used in) financing activities
     
 
7,793
 
 
 
195,221
 
       
 
  
 
           
Effect of exchange rate changes on cash and cash equivalents
        (27,186)   (8,643)       3,668   (12,600) 
       
 
  
 
           
Net increase (decrease) in cash and cash equivalents
       
 
135,369
 
 
 
(98,157
) 
     
 
(35,232
) 
 
 
170,670
 
       
 
  
 
           
Net Cash and cash equivalents at the beginning of the period
        77,301   196,352       209,194   77,301 
       
 
  
 
           
Net cash and cash equivalents at the end of the period
  
 
3
 
  
$
212,670
 
 
$
98,195
 
  
 
3
 
  
$
173,961
 
 
$
247,971
 
       
 
  
 
           
The accompanying notes are an integral part of these condensed consolidated financial statements.
 
5
5
Table of Contents
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, 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 income (loss)   —      —      —     —     —     24    (1,933)   (1,909) 
Issuance of ordinary shares   775    1    —     —     —     —      —     1 
Treasury shares   —      —      —     40   —     —      —     40 
Share-based payments   —      —      1,363   —     —     —      —     1,363 
Other change in equity   —      —      —     —     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 income (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
 
  
Ordinary shares
                     
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
   
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
 
Balance at January 1, 2023
  
 
94,137,145
 
  
$
10,720
 
  
$
458,221
 
 
$
(1,109
) 
 
$
(259,578
) 
 
$
781
 
 
$
(14,581
) 
 
$
194,453
 
Net (loss)
   —      —      —     —     (29,449)   —     —     (29,449)    —      —      —     —     (20,561)   —     —     (20,561) 
Other comprehensive loss
   —      —      —     —     —     (85)   (8,744)   (8,829) 
Other comprehensive income (loss)   —      —      —     —     —     (82)   3,666   3,584 
Issuance of ordinary shares
   7,500    1    42   —     —     —     —     42    10,174    1    (1)   —     —     —     —     —   
Treasury shares
   —      —      —     488   —     —     —     488    —      —      —     (14)   —     —     —     (14) 
Share-based payments
   —      —      1,433   —     —     —     —     1,433    —      —      1,632   —     —     —     —     1,632 
  
 
   
 
   
 
  
 
  
 
  
 
  
 
  
 
                            
Balance at March 31, 2021
  
 
54,936,687
 
  
$
6,519
 
  
$
1,153,516
 
 
$
(681
) 
 
$
(987,992
) 
 
$
399
 
 
$
(2,586
) 
 
$
169,176
 
Balance at March 31, 2023
  
 
94,147,319
 
  
$
10,721
 
  
$
459,852
 
 
$
(1,123
) 
 
$
(280,138
) 
 
$
698
 
 
$
(10,915
) 
 
$
179,094
 
Net (loss)
   —      —      —     —     (30,654)   —     —     (30,654)    —      —      —     —     (24,243)   —     —     (24,243) 
Other comprehensive income
   —      —      —     —     —     48   2,788   2,836 
Other comprehensive income (loss)   —      —      —     —     —     (10)   (221)   (232) 
Issuance of ordinary shares
   75,000    9    464   —     —     —     —     473    2,103,635    231    7,535   —     —     —     —     7,766 
Issuance of warrants
         279           279 
Treasury shares
   —      —        (185)   —     —     —     (185)    —      —      —     42   —     —     —     42 
Share-based payments
   —      —      1,094     —     —     —     1,094    —      —      1,814   —     —     —     —     1,814 
Allocation of accumulated net losses
   —      —      (797,823)   —     797,823   —     —     —      —      —      (93,441)   —     93,441   —     —     —   
  
 
   
 
   
 
  
 
  
 
  
 
  
 
  
 
                            
Balance at June 30, 2021
  
 
55,011,687
 
  
$
6,529
 
  
$
357,530
 
 
$
(866
) 
 
$
(220,823
) 
 
$
446
 
 
$
203
 
 
$
143,019
 
  
 
   
 
   
 
  
 
  
 
  
 
  
 
  
 
 
Net (loss)
   —      —      —     —     (24,033)   —     —     (24,033) 
Other comprehensive income
   —      —      —     —     —     28   (3,728)  (3,701)
Treasury shares
   —      —        56   —     —     —     56 
Share-based payments
   —      —      1,551     —     —     —     1,551 
  
 
   
 
   
 
  
 
  
 
  
 
  
 
  
 
 
Balance at September 30, 2021
  
 
55,011,687
 
  
$
6,529
 
  
$
359,081
 
 
$
(810
) 
 
$
(244,856
) 
 
$
474
 
 
$
(3,526
) 
 
$
116,892
 
  
 
   
 
   
 
  
 
  
 
  
 
  
 
  
 
 
Balance at June 30, 2023
  
 
96,250,954
 
  
$
10,952
 
  
$
375,759
 
 
$
(1,082
) 
 
$
(210,940
) 
 
$
687
 
 
$
(11,136
) 
 
$
164,240
 
The accompanying notes are an integral part of these condensed consolidated financial statements.
 
6
Table of Contents
DBV Technologies S.A.
Condensed Consolidated Statements of Changes in Shareholders’ Equity (unaudited) (continued)
(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, 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) 
Issuance 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
 
   
 
 
   
 
 
   
 
 
  
 
 
  
 
 
  
 
 
   
 
 
  
 
 
 
Net (loss)
   —      —      —     —     (17,287)   —      —     (17,287) 
Other comprehensive loss
   —      —      —     —     —     41    (15,425)   (15,384) 
Issuance of ordinary shares
   2 762    1    (540)   —     —     —      —     (539) 
Treasury shares
   —      —      —     (130)   —     —      —     (130) 
Share-based payments
   —      —      976   —     —     —      —     976 
   
 
 
   
 
 
   
 
 
  
 
 
  
 
 
  
 
 
   
 
 
  
 
 
 
Balance at September 30, 2022
  
 
94 025 441
 
  
$
10,709
 
  
$
456,884
 
 
$
(1,083
) 
 
$
(220,337
) 
 
$
783
 
  
$
(34,904
) 
 
$
212,052
 
   
 
 
   
 
 
   
 
 
  
 
 
  
 
 
  
 
 
   
 
 
  
 
 
 
The accompanying notes are an integral part of these condensed consolidated financial statements.
7
Table of Contents
NOTES TO THE CONDENSED CONSOLIDATED 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™Viaskin
™
. The Company’s therapeutic approach is based on epicutaneous immunotherapy, or EPIT™EPIT
™
, a proprietary method of delivering biologically active compounds to the immune system through intact skin using Viaskin™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 9, 20222, 2023 (the “Annual Report”). The condensed consolidated statement of financial position as of December 31, 20212022 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, 2021.2022.
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, 2022,2023, 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'sCompany’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.contingencies, and (8) estimate of employee benefits obligations.
Accounting Pronouncements adopted in 20222023
The Company has not adopted any new accounting pronouncements in 2022 to date.
Accounting Pronouncements issued not yet adopted
In June 2016, the Financial Accounting Standards Board (“FASB”) issued ASU 2016-13 -
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 impactAdoption of the guidance on its Consolidated Financial Statements. The Company does not expect this new standard willdid not have a material impact on itsthe consolidated financial statements.
In October 2021, the FASB issued ASU
2021-08,
which amends ASC 805 to require acquiring entities to apply Topic 606 to recognize and measure contract assets and contract liabilities in a business combination. This amendment is effective for public business entities for the fiscal years beginning after December 15, 2022, including interim periods within those fiscal years. Adoption of this new standard has no impact on the consolidated financial statements.
7
Table of Contents
Accounting Pronouncements issued not yet adopted
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.

8
Table of Contents
Note 2: Significant Events and Transactions
Clinical programs
Viaskin
TM
Peanut for children ages 4-11 in the United States Regulatory History and Current Status
In January 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 receipt of the Complete Response Letter received in August 2020.Letter. The FDA agreed with its 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 patch, FDA requested an assessment comparing the uptake of allergen (peanut protein) between the patches in peanut allergic children ages
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 a modified Viaskin Peanut patch in the intended patient population. 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 (“mVP”(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:
Phase 1 clinical trials in healthy adult volunteers:
 a.
PREQUAL, a Phase I1 study with adult healthy volunteers to optimize the allergen sample collection methodologies and validate the assays the Company intendswe intend to use in EQUAL
.
The data collection phase of the trial is complete, and the data analysis phase is ongoing.
 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 Phase 1 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 thepatches. The Company completed CHAMP 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 inon October 14, 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. The FDA’s explanation was that the results from the allergen uptake studies might affect the design of the STAMP study.
After careful review of the FDA’s information requests, in December 2021, the Company decided not to pursue the stepwisesequential approach to the development plans for Viaskin Peanut as requested by the FDA in the October 2021 letter.feedback. The Company estimated that the FDA’s newly proposed stepwisesequential 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 III3 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
9
Table of Contents
The
In 2022, the Company announced the new Phase 3 pivotal study for modified Viaskin Peanut has been named VITESSE (Viaskin Peanut Immunotherapy Trial to Evaluate Safety, Simplicity(mVP) patch would be in younger
(4-7
years old) and Efficacy), which means “speed” in French.more sensitive children with peanut allergy.
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 Type C meeting briefing package.
On September 9,7, 2022, the Company announced the initiation of theVITESSE, a new Phase 3 pivotal study usingof the modified Viaskin™Viaskin Peanut Patch,(mVP) patch in peanut-allergic children ages 4
4-7
years with peanut allergy. We defined initiation as the submission of the trial protocol to 7 years.selected study sites for subsequent Institution
al
Review Board (IRB)/Ethics Committee (EC) approval.
On September 21, 2022, the Company announced it received feedback from the U.S. FDA in the form of a partial clinical hold on its VITESSE Phase 3 clinical study.VITESSE. In the partial clinical hold letter, the FDA specifiesspecified changes to elements of the VITESSE protocol, withacknowledging the intent for the trial to support a future BLA submission. In the following months, we engaged with the FDA to address the feedback provided in the partial clinical hold letter and to finalize the VITESSE protocol. In addition, we continued internal preparations for VITESSE and conducted certain site assessment and
start-up
activities for prompt study launch once the partial clinical hold was lifted.
On December 23, 2022, the Company announced the FDA lifted the partial clinical hold and confirmed we satisfactorily addressed all clinical hold issues. The modifications noted withinFDA stated that VITESSE may proceed with the FDA’s communication address design elements, includingrevised trial protocol.
On March 2, 2023, the statistical analysisCompany announced the completion of EVOLVE, a
12-week
caregiver and patient user experience study of the mVP patch in 50 peanut allergic children ages
4–11-years
old. The objective of EVOLVE was to evaluate the Instructions for Use (IFU) and ease of use for the mVP patch. The study concluded that the updated IFU supported correct patch application, which included no lifting of the patch edges or detachment directly after application. Furthermore, EVOLVE concluded that the majority of parents/caregivers reported a positive ease of use experience with the mVP patch. In EVOLVE, DBV also tested the functionality of an electronic patient diary (eDiary) to collect information on activities of daily living and patch adhesion minimum daily wear time and technical alignmentsscores. EVOLVE verified that the eDiary tool can be used by caregivers in methodsVITESSE to capture the adhesion data in support of categorizing data, to meet study objectives as well asa potential BLA.
On March 7, 2023, the total number of trial participants on active treatment. The Company has not yet begunannounced that the screening or recruitment of subjectsfirst patient was screened in the VITESSE study. Screening of the last patient is anticipated in the first half in 2024 and topline results in the first half in 2025.
On April 19, 2023, the Company outlined
the
regulatory path for Viaskin Peanut in children
1-3
years old after the FDA confirmed that the Company’s Phase 3 EPITOPE study meets the
pre-specified
criteria for success for the primary endpoint, not requesting any additional efficacy study. The partial clinical hold is specificFDA requires additional safety data to VITESSEaugment the safety data collected from EPITOPE in support of a BLA. This new safety study will also generate patch adhesion data and does not impact any other ongoing its clinical studies. The Company expects to provide additional updates following consultation with the FDA.will include updated instructions for use.
Viaskin Peanut for children ages 4-11 -
4-11—European
Union Regulatory History and Current Status
In
On August 2, 2021, the Company announced its receiptit received from the EMAEuropean Medicines Agency (“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.
InOn December 20, 2021, the Company announced it had withdrawn the Marketing Authorization Application (“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 PEPITES
(V712-301).
The decision to withdraw was based on the view of EMA Committee for Medicinal Products for Human Use (CHMP) that the data available to date from a single pivotal studyclinical trial 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 studyclinical trial 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 available.
Viaskin Peanut for children ages
1-3
10
Table of Contents
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 demonstrate superiority of either dose versus placebo. These results validate the ongoing investigation of the 250 Pgµg 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 2022.2021.
9
Table of Contents
In June 2022, the Company announced that its pivotal Phase III trialpositive topline results from Part B of EPITOPE, assessing the safety and efficacy of Viaskin™ Peanut 250 µg for the treatment of peanut-allergic toddlerswhich enrolled 362 subjects ages 1 to 3 years, met its primary endpoint. Viaskin Peanut demonstrated a statistically significant treatment effect (p<0.001), with 67.0% of subjectswhich 244 and 118 were in the Viaskin Peanut arm meetingactive and placebo arms respectively. Enrollment was balance for age and baseline disease characteristics between the active and placebo 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 %).arms.
On April 19, 2023,
The
the Company intends to further analyzeannounced it will begin a new safety study after it received confirmation from the FDA that the EPITOPE study meets the
pre-specified
criteria for success for the primary endpoint, with no additional efficacy study requested. This safety study will increase the safety data collected from EPITOPE in support of a BLA. It will also generate patch adhesion data and explorewill include updated instructions for use.
On May 10, 2023, the New England Journal of Medicine (NEJM) published results that demonstrated epicutaneous immunotherapy (EPIT) with VP was statistically superior to placebo in desensitizing children to peanut
exposure
by increasing the peanut dose that triggers allergic symptoms. As stated in an accompanying editorial piece, these data are seen as “very good news” for toddlers with peanut allergy, as there are currently no approved treatment options for peanut-allergic children under the age of 4 years. Following this publication, the Company confirmed it is advancing regulatory pathwaysefforts for VP in toddlers ages
1-3
years old with a confirmed peanut allergy.
Viaskin Peanut for Children ages
4-7
On September 7, 2022, the Company announced the initiation of VITESSE, a new Phase 3 pivotal study of the modified Viaskin Peanut (mVP) patch in children ages 1
4-7
years with peanut allergy. We defined initiation as the submission of the trial protocol to 3 years, givenselected study sites for subsequent Institutional Review Board (IRB)/Ethics Committee (EC) approval.
On September 21, 2022, the high unmet needCompany announced we had received feedback from the FDA in the form of a partial clinical hold on VITESSE. In the partial clinical hold letter, the FDA specified changes to elements of the VITESSE protocol, acknowledging the intent for the trial to support a future BLA submission. In the following months, we engaged with the FDA to address the feedback provided in the partial clinical hold letter and absenceto finalize the VITESSE protocol. In addition, we continued internal preparations for VITESSE and conducted certain site assessment and
start-up
activities for prompt study launch once the partial clinical hold was lifted.
On December 23, 2022, the Company announced the FDA lifted the partial clinical hold and confirmed we satisfactorily addressed all clinical hold issues. The FDA stated that VITESSE may proceed with the revised trial protocol.
On March 7, 2023, the Company announced that the first patient was screened in the VITESSE trial. Screening of approved treatments for this vulnerable population.the last patient is anticipated in the first half in 2024 and topline results in the first half in 2025.
Financing

In May 2022,June 2023, 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
the
form of American Depositary Shares (“ADSs”), for a total gross amount of $15.3 million.$7.8 million, under the
At-The-Market
(“ATM”) program established in May 2022. In this context, 6,036,2382,052,450 new Ordinary Shares in
the
form of ADS have been issued through a capital increase without preferential subscription rights of the shareholders reserved to specific categories of persons fulfilling certain characteristics (the “ATM Issuance”), at a unit subscription price of 1.271.90 dollar per ADS (i.e., a subscription price per Ordinary Share of 2.413.52 euro based on the USD/EUR exchange rate of 1.05311.0809 dollar for 1 euro, as published by the European Central Bank on May 4, 2022)June 14, 2023) 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 $1.0739 = €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. The ordinary shares were sold to the purchasers at a price per ordinary share of €3.00 (corresponding to $3.22), and the
pre-funded
warrants were sold to the purchasers at a
pre-funded
price of €2.90 (corresponding to $3.11) per
pre-funded
warrant, which equals the per share price for the ordinary shares less the remaining €0.10 exercise price for each such
pre-funded
warrant. Gross proceeds from the PIPE financing total approximately $194 million (corresponding to €181 million), before deducting private placement expenses.
The ordinary shares, including the ordinary shares issuable upon exercise of the pre-funded warrants from the PIPE financing, have not been registered under the Securities Act of 1933, as amended, and may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements. In connection with the PIPE financing, the Company entered into a registration rights agreement (the “Registration Rights Agreement”), pursuant to which the Company filed has a registration statement with the Securities and Exchange Commission (the “SEC”) registering the resale of 59,269,629 ordinary shares issued in the PIPE financing, including ordinary shares underlying the pre-funded warrants.
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 September 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, and Comprehensive Loss.
Legal Proceedings
A class action complaint was filed on January 15, 2019From time to time, the Company may become subject to various legal proceedings and claims that arise in the United States District Court for the Districtordinary course of New Jersey, entitled Travis Ito-Stone v. DBV Technologies, et al., Case No. 2:19-cv-00525.our business activities. The complaint alleged that the Company and its former Chief Executiveis not currently subject to any material legal proceedings.
10
11
Table of Contents
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 Complaint. The Plaintiffs failed to file an appeal of the dismissal of the Third Amended Complaint within the 30-day period and this matter is resolved with finality.
12
Table of Contents
Note 3: Cash and Cash Equivalents
The following tables summarize the cash and cash equivalents as of SeptemberJune 30, 20222023 and December 31, 2022:
2021:
 
  
September 30,
   
December 31,
   
June 30,
   
December 31,
 
  
2022
   
2021
   
2023
   
2022
 
Cash
   167,916    31,427    24,111    30,104 
Cash equivalents
   44,754    45,874    149,850    179,090 
  
 
   
 
         
Total cash and cash equivalents as reported in the statements of financial position
  
 
212,670
 
  
 
77,301
 
  
 
173,961
 
  
 
209,194
 
  
 
   
 
         
Bank overdrafts   —      —   
        
Total cash and cash equivalents as reported in the statements of cash flows
  
 
173,961
 
  
 
209,194
 
Cash equivalents are immediately convertible into cash at no or insignificant cost, on demand. They are measured using level 1 fair value measurements.
Note 4 Other Current Assets
Other current assets consisted of the following:

 
  
September 30,
   
December 31,
 
  
2022
   
2021
   
June 30,
2023
   
December 31,
2022
 
Research tax credit
   4,094    28,092    9,662    5,792 
Other tax claims
   3,636    3,561    5,851    3,903 
Prepaid expenses
   4,107    4,149    4,494    2,680 
Other receivables
   1,188    1,283    1,571    1,504 
  
 
   
 
         
Total
  
 
13,025
 
  
 
37,085
 
  
 
21,578
 
  
 
13,880
 
  
 
   
 
         
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 nine months period ended September 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:
follows:
   
Amount in
thousands of US
Dollars
 
Opening research tax credit receivable as of January 1, 20222023
28,092
+ Operating revenue
4,467
- Payment received
(26,386) 
- Adjustment and currency translation effect
(2,079) 
  
 
5,792
+ Operating revenue3,741 
- Payment received
—  
- Adjustment and currency translation effect130
Closing research tax credit receivable as of SeptemberJune 30, 2022
2023
  
 
4,0949,662
 
   
 
Of which -
Non-current
portion
   —  
Of which - Current portion
  
4,094
9,662
1
3
TableBefore currency translation effect, the balance in research tax credit as of ContentsJune 30, 2023, consisted of $5.8 million research tax credit for the 2022 fiscal year filed with the tax authorities and yet to be reimbursed, and $3.7 million estimated research tax credit for the first six months of the 2023 fiscal year.
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
Table of Contents
Note 5 Lease contracts
Future minimum lease payments under the Company'sCompany’s operating leases’ right of use as of SeptemberJune 30, 20222023 and December 31, 2021,2022, are as follows:
 
   
September 30, 2022
  
December 31, 2021
 
   
Real estate
  
Other
assets
  
Total
  
Real estate
  
Other
assets
  
Total
 
Current portion
   1,504   34   1,538   3,361   77   3,438 
Year 2
   1,874   18   1,891   3,124   23   3,147 
Year 3
   103   6   109   2,299   18   2,317 
Year 4
   —     —     —     771   1   773 
Year 5
   —     —     —     790   —     790 
Thereafter
   —     —     —     1,220   —     1,220 
   
 
 
  
 
 
  
 
 
  
 
 
  
 
 
  
 
 
 
Total minimum lease payments
  
 
3,481
 
 
 
58
 
 
 
3,538
 
 
 
11,565
 
 
 
119
 
 
 
11,684
 
Less: Effects of discounting
   (729)   (5)   (734)   (1,526)   (8)   (1,534) 
   
 
 
  
 
 
  
 
 
  
 
 
  
 
 
  
 
 
 
Present value of operating lease
  
 
2,752
 
 
 
52
 
 
 
2,804
 
 
 
10,039
 
 
 
111
 
 
 
10,150
 
Less: current portion
   (1,350)   (31)   (1,381)   (2,929)   (74)   (3,003) 
   
 
 
  
 
 
  
 
 
  
 
 
  
 
 
  
 
 
 
Long-term operating lease
  
 
1,402
 
 
 
22
 
 
 
1,423
 
 
 
7,110
 
 
 
37
 
 
 
7,147
 
   
 
 
  
 
 
  
 
 
  
 
 
  
 
 
  
 
 
 
Weighted average remaining lease term (years)
   1.80   —         4.14   2.01     
Weighted average discount rate
   3.50%   0.9%       4.84%   3.32%     
   
June 30, 2023
  
December 31, 2022
 
   
Real estate
  
Other
assets
  
Total
  
Real estate
  
Other
assets
  
Total
 
Current portion   1,886   74   1,961   1,972   79   2,051 
Year 2   291   43   334   1,168   74   1,243 
Year 3   —     —     —     65   6   71 
Thereafter   —     —     —     —     —     —   
                          
Total minimum lease payments
  
 
2,177
 
 
 
118
 
 
 
2,295
 
 
 
3,204
 
 
 
160
 
 
 
3,364
 
Less: Effects of discounting   (153)   (10)   (163)   (325)   (17)   (343) 
                          
Present value of operating lease
  
 
2,024
 
 
 
107
 
 
 
2,131
 
 
 
2,879
 
 
 
143
 
 
 
3,021
 
Less: current portion   (1,873)   (72)   (1,944)   (1,823)   (71)   (1,894) 
                          
Long-term operating lease
  
 
151
 
 
 
36
 
 
 
187
 
 
 
1,055
 
 
 
72
 
 
 
1,127
 
                          
Weighted average remaining lease term (years)   0.95   —         1.40   —       
Weighted average discount rate   2.90%   2.50%       3.00%   2.45%     
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 condensed consolidated statement of operations and comprehensive loss was:​​​​​​​

 
   
September 30,
 
  
2022
   
2021
 
Operating lease expense
   1,373    2,480 
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 have been recorded starting April 1, 2022 for a gross amount
of
$
0.4 million.
1
4
Table of Contents
   
June 30,
 
   
2023
   
2022
 
Operating lease expense / (income)   1,543    950 
Net termination impact   (920)    (1,657) 
Supplemental cash flow information related to operating leases is as follows for the period SeptemberJune 30, 20222023 and 2022:
2021:
 
  
September 30,
   
June 30,
 
2022
   
2021
   
2023
   
2022
 
Cash paid for amounts included in the measurement of lease liabilities
   —      —         
Operating cash flows from operating leases
   1,533    2,845 
Operating cash outflows related to operating leases   963    1,079 
Note 6: Trade Payables and Other Current Liabilities
6.1 Trade Payables
Trade payables increased by $4.6 million as of June 30, 2023, compared to December 31, 2022.
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.
12
Table of Contents
6.2 Other Liabilities
The following tables summarize the other liabilities as of SeptemberJune 30, 20222023 and December 31, 2022:
2021:
 
   
September 30,
   
December 31,
 
   
2022
   
2021
 
   
Other current
liabilities
   
Other non-
current
liabilities
   
Total
   
Other current
liabilities
   
Other non-
current
liabilities
   
Total
 
Employee related liabilities
   4,666    54    4,719    6,708    247    6,954 
Deferred income
   2,911    926    3,836    4,146    1,900    6,046 
Tax liabilities
   405    —      405    182    —      182 
Other debts
   634    —      634    1,325    —      1,325 
   
 
 
   
 
 
   
 
 
   
 
 
   
 
 
   
 
 
 
Total
  
 
8,615
 
  
 
979
 
  
 
9,594
 
  
 
12,361
 
  
 
2,147
 
  
 
14,508
 
   
 
 
   
 
 
   
 
 
   
 
 
   
 
 
   
 
 
 
   
June 30,
   
December 31,
 
   
2023
   
2022
 
   
Other
 current

liabilities
   
Other
 non-current

liabilities
   Total   
Other
 current

liabilities
   
Other
 non-current

liabilities
   Total 
Employee related liabilities   4,374    —      4,374    5,872    45    5,917 
Deferred income   2,264    3,987    6,251    2,137    4,690    6,828 
Tax liabilities   187    —      187    69    —      69 
Other debts   433    —      433    1,131    —      1,131 
                               
Total
  
 
7,258
 
  
 
3,987
 
  
 
11,245
 
  
 
9,210
 
  
 
4,735
 
  
 
13,945
 
                               
The other currentEmployee related liabilities include short-term debt to employees including social welfare and tax agency obligations.
Deferred income primarily includes deferred income from the collaboration agreement with Nestlé Health Science, which amounted to $3.8 million as of September 30, 2022.
Science.
Note 7: Shareholders’ equity
The share capital as of SeptemberJune 30, 20222023 is set at the sum of €9,402,544€9,625,095.40 ($10,708,72510,952 thousands converted at historical rates). It is divided into 94,025,44196,250,954 fully authorized, subscribed and
paid-up
ordinary shares with a par value of €0.10.
Pursuant to the authorization granted by the General Meeting of the Shareholders held on MayApril 12, 20222023 (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, 20212022, 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 PIPE financing 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;
1
5
Table of Contents
granted a number of authorizations for the purpose of carrying out the
i
ssuance;
sub-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 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 PIPE financing. 
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 September 30, 2022
28,276,331
1
6
Table of Contents
Note 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”), and
non-employee
warrants (
Bons de Souscription d’Actions
or “BSA”).
During the ninesix months ended SeptemberJune 30, 2022,2023, the Company granted 154,50059,200 stock options and 69,90035,800 restricted 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 12 to the consolidated financial statements included in the Annual Report. 
Change in Number of BSA/SO/RSU:
   
Number of outstanding
 
   
BSA
   
SO
   
RSUs
 
Balance as of December 31, 2022
  
 
251,693
 
  
 
5,306,569
 
  
 
1,589,081
 
Granted during the period   —      59,200    35,800 
Forfeited during the period   —      (75,200)    (54,444) 
Exercised/released during the period   —      —      (61,359) 
Expired during the period   —      —      —   
                
Balance as of June 30, 2023
  
 
251,693
 
  
 
5,290,569
 
  
 
1,509,078
 
                
13
Table of Contents
Share-based payments expense reflected in the condensed consolidated statements of operations is as follows:
       
Three Months
Ended June 30,
  
Six Months
Ended June 30,
 
       
2023
  
2022
  
2023
  
2022
 
Research & development   SO    (465)   (290)   (894)   (665) 
    RSU    (271)   (185)   (529)   (393) 
Sales & marketing   SO    (27)   (38)   (54)   (33) 
    RSU    (8)   (17)   (17)   (16) 
General & administrative   SO    (925)   (478)   (1,722)   (1,176) 
    RSU    (118)   (70)   (231)   (157) 
                       
Total share-based compensation (expense)
       
 
(1,814
) 
 
 
(1,078
) 
 
 
(3,446
) 
 
 
(2,441
) 
                       
Note 9: Contingencies
The following tables summarize the contingencies as of June 30, 2023 and December 31, 2022:
   
June 30,
   
December 31,
 
   
2023
   
2022
 
Current contingencies   5,076    3,944 
Non-current
contingencies
   15,731    16,680 
           
Total contingencies
  
 
20,807
 
  
 
20,625
 
           
The changes in contingencies are as follows:
   
Pension
retirement
obligations
   
Collaboration
agreement -
Loss at
completion
   
Other
contingencies
   
Total
 
At January 1, 2023
  
 
790
 
  
 
19,835
 
  
 
—  
 
  
 
20,625
 
Increases in liabilities   11    —      780    791 
Used liabilities   —      —      —      —   
Reversals of unused liabilities   —      (1,083)    —      (1,083) 
Net interest related to employee benefits, and unwinding of discount   —      —      —      —   
Actuarial gains and losses on defined-benefit plans   93    —      —      93 
Currency translation effect   15    366    —      381 
                     
At June 30, 2023
  
 
909
 
  
 
19,118
 
  
 
780
 
  
 
20,807
 
                     
Of which Current
  
 
—  
 
  
 
4,296
 
  
 
780
 
  
 
5,076
 
Of which
Non-current
  
 
909
 
  
 
14,822
 
  
 
—  
 
  
 
15,731
 
The Company does not hold any plan assets related to long-term employee benefit for any of the periods presented. There have been no significant changes in assumptions for the estimation of the retirement commitments from those disclosed in Note 13 to the consolidated financial statements included in the Annual Report.
Stock option fair value assumptions during the nine months ended September 30, 2022
Weighted average share price at grant date in €
4.3
Weighted average expected volatility
93.6% 
Weighted average risk-free interest rate
0.89% 
Weighted average expected term (in years)
6
Dividend yield
—  
Weighted average fair value of stock options in €
3.3
Change in Number of BSA/SO/RSU:
   
Number of outstanding
 
   
BSA
   
SO
   
RSUs
 
Balance as of December 31, 2021
  
 
256,693
 
  
 
3,631,210
 
  
 
1,240,520
 
Granted during the period
   —      154,500    69,900 
Forfeited during the period
   —      (238,715)    (92,326) 
Exercised/released during the period
   —      (5,613)    (32,159) 
Expired during the period
   (5,000)    —      —   
   
 
 
   
 
 
   
 
 
 
Balance as of September 30, 2022
  
 
251,693
 
  
 
3,541,383
 
  
 
1,185,936
 
   
 
 
   
 
 
   
 
 
 
Share-based payments exp
e
nses reflected in the condensed consolidated statements of operations is as
follows:
   
Three Months Ended
September 30,
  
Nine Months Ended
September 30,
 
   
2022
  
2021
  
2022
  
2021
 
Research & development
   SO    (337)   (273)   (1,002)   (952) 
    RSU    (201)   (660)   (594)   (795) 
Sales & marketing
   SO    30   (60)   (3)   (172) 
    RSU    20   (27)   4   (75) 
General & administrative
   SO    (423)   (439)   (1,599)   (1,791) 
    RSU    (66)   (92)   (223)   (293) 
        
 
 
  
 
 
  
 
 
  
 
 
 
Total share-based compensation (expense)
       
 
(976
) 
 
 
(1,551
) 
 
 
(3,416
) 
 
 
(4,078
) 
        
 
 
  
 
 
  
 
 
  
 
 
 
1
7
Table of Contents
Note 9: Contingencies
The following tables summarize the contingencies as of September 30, 2022 and December 31, 2021:
   
September 30,
   
December 31,
 
   
2022
   
2021
 
Current contingencies
   3,026    4,095 
Non-current contingencies
   5,272    6,758 
   
 
 
   
 
 
 
Total contingencies
  
 
8,298
 
  
 
10,853
 
   
 
 
   
 
 
 
The changes in contingencies are as follows:
   
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
   58    —      —     58 
Used liabilities
   —      (889)    (43)   (932) 
Reversals of unused liabilities
   —      —      —     —   
Net interest related to employee benefits, and unwinding of discount
   —      —      —     —   
Actuarial gains and losses on defined-benefit plans
   (264)    —      —     (264) 
Currency translation effect
   (123)    (1,291)    (3)   (1,417) 
   
 
 
   
 
 
   
 
 
  
 
 
 
At September 30, 2022
  
 
678
 
  
 
7,620
 
  
 
—  
 
 
 
8,298
 
   
 
 
   
 
 
   
 
 
  
 
 
 
Of which Current
  
 
—  
 
  
 
3,026
 
  
 
—  
 
 
 
3,026
 
Of which
Non-current
  
 
678
 
  
 
4,594
 
  
 
—  
 
 
 
5,272
 
In 20212022 and during the first ninesix months of 2022,2023, the Company updated its measurement of progress of the Phase 2 clinical trial (“PII”) conducted as part of the collaboration and license agreement with Nestlé Health Sciences and updated the cumulative income recognized. The Company hasrecognized a reversal of $1.1 million of the loss for completion recorded an accrual in the amount of the excess between the Company’s current best estimates of costs yet to be incurred and incomesincome yet to be recognized for the completion of the PII.
There have been no significant changes in assumptionsThe other contingencies mainly consisted of a provision for the estimation of the retirement commitments from those disclosed in Note 14refurbishment amounting to the consolidated financial statements includedbest estimate of costs to be incurred in case the Annual Report.Montrouge office lease agreement is not renewed at its July 2024 term.
14
Table of Contents
Note 10: Operating income
The following table summarizes the operating income during the three and six months ended SeptemberJune 30, 20222023 and 2021:2022:
   
Three Months Ended
June 30,
   
Six Months Ended
June 30,
 
   
2023
   
2022
   
2023
   
2022
 
Research tax credit   1,975    1,491    3,741    3,060 
Other operating income   312    37    741    1,014 
                     
Total
  
 
2,288
 
  
 
1,529
 
  
 
4,482
 
  
 
4,074
 
                     
The increase in operating income was primarily due to the increase in the research and development costs eligible to research tax credit in France.
   
Three Months Ended
September 30,
   
Nine Months Ended
September 30,
 
   
2022
   
2021
   
2022
   
2021
 
Research tax credit
   1,407    1,647    4,467    5,324 
Other operating income
   668    (324)    1,681    (2,549) 
   
 
 
   
 
 
   
 
 
   
 
 
 
Total
  
 
2,074
 
  
 
1,323
 
  
 
6,148
 
  
 
2,776
 
   
 
 
   
 
 
   
 
 
   
 
 
 
As of September 30, 2022, theThe Company recorded its collaboration agreement’s revenuerecognizes as other operating income accrued revenues based on its updated measurement of progress of
1
8
Table of Contents
the Phase II2 clinical trial conducted as part of the agreement. The accrualcollaboration agreement with Nestlé. Moreover, the loss for completion recorded in the amount of the difference between the Company’s current best estimates of costs yet to be incurred and revenues yet to be recognized for the completion of the Phase II2 clinical trial has beenwas updated accordingly.accordingly as of June 30, 2023 (see note 9 related to contingencies).
Note 11: Allocation of Personnel Expenses
The Company had an average of 8588 employees during the ninesix months ended SeptemberJune 30, 2022,2023, in comparison with an average of 10587 employees during the ninesix months ended SeptemberJune 30, 2021.2022.
The following table summarizes the allocation of personnel expenses by function during the three and ninesix months ended SeptemberJune 30, 20222023 and 2021:2022:
 
   
Three Months Ended
September 30,
   
Nine Months Ended
September 30,
 
   
2022
   
2021
   
2022
   
2021
 
Research and Development expenses
   3,186    4,161    9,357    12,272 
Sales and Marketing expenses
   138    492    727    1,528 
General and Administrative expenses
   1,598    2,583    6,961    9,347 
   
 
 
   
 
 
   
 
 
   
 
 
 
Total personnel expenses
  
 
4,922
 
  
 
7,236
 
  
 
17,045
 
  
 
23,148
 
   
 
 
   
 
 
   
 
 
   
 
 
 
   
Three Months
Ended June 30,
   
Six Months
Ended June 30,
 
   
2023
   
2022
   
2023
   
2022
 
Research and Development expenses   4,014    3,097    8,020    6,172 
Sales and Marketing expenses   208    344    373    589 
General and Administrative expenses   2,858    2,767    5,958    5,362 
                     
Total personnel expenses
  
 
7,079
 
  
 
6,208
 
  
 
14,351
 
  
 
12,123
 
                     
The following table summarizes the allocation of personnel expenses by nature during the three and ninesix months ended SeptemberJune 30, 20222023 and 2021:2022:

 
   
Three Months Ended
September 30,
   
Nine Months Ended
September 30,
 
   
2022
   
2021
   
2022
   
2021
 
Wages and salaries
   3,505    3,793    11,001   12,629 
Social security contributions
   634    1,110    2,141   3,505 
Expenses for pension commitments
   214    286    723   981 
Employer contribution to bonus shares
   (406)    497    (236)   1,955 
Share-based payments
   976    1,551    3,416   4,078 
   
 
 
   
 
 
   
 
 
  
 
 
 
Total
  
 
4,922
 
  
 
7,236
 
  
 
17,045
 
 
 
23,148
 
   
 
 
   
 
 
   
 
 
  
 
 
 
   
Three Months
Ended June 30,
   
Six Months
Ended June 30,
 
   
2023
   
2022
   
2023
   
2022
 
Wages and salaries   4,078    3,509    8,516    7,497 
Social security contributions   1,185    1,256    1,884    1,507 
Expenses for pension commitments   246    211    504    509 
Employer contribution to bonus shares   (244)    154    —    170 
Share-based payments   1,814    1,078    3,446    2,441 
                     
Total
  
 
7,079
 
  
 
6,208
 
  
 
14,351
 
  
 
12,123
 
                     
The decreaseincrease in personnel expenses iswas mainly due to a decrease in headcount followingrecruitment of US employees partially offset by the full implementationdeparture of
non-US
employees, and the new organization.increase of charges related to share-base payments.
Note 12: Commitments
There have beenwere no significant changes in other commitments from those disclosed in Note 1817 to the consolidated financial statements included in the Annual Report.
15
Table of Contents
Note 13: Relationships with Related Parties
The Company’s related parties consist exclusively consisted of the members of the Board of Directors and the members of the Executive Committee. As of SeptemberJune 30, 2022,2023, the total amount of remuneration granted to the members of the Board of Directors and Executive Committee has not significantly changed significantly since December 31, 2021.2022.
There were no new significant related-party transactions during the period nor any changechanges in the nature of the transactions from those described in Note 1918 to the consolidated financial statements included in the Annual Report.
1
9
Table of Contents
Note 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 threethree- and nine months
six-month
periods ended SeptemberJune 30, 20222023 and 2021,2022, 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.
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 SeptemberJune 30, 20222023 and 20212022 indicated in number of potential shares:
 
  
Three Months Ended
September 30,
   
Nine Months Ended
September 30,
 
  
2022
   
2021
   
2022
   
2021
   
Three Months Ended
June 30,
   
Six Months Ended
June 30,
 
  
2023
   
2022
   
2023
   
2022
 
Non-employee warrants
   251,693    256,693    251,693    256,693    251,693    256,693    251,693    256,693 
Stock options
   3,541,383    2,585,710    3,541,383    2,585,710    5,290,569    3,442,358    5,290,569    3,442,358 
Restricted stock units
   1,185,936    1,104,145    1,185,936    1,104,145    1,509,078    1,145,223    1,509,078    1,145,223 
Prefunded warrants
   28,276,331    —      28,276,331    —      28,276,331    28,276,331    28,276,331    28,276,331 
Note 15: Events after the Close of the Period
The Company evaluated subsequent events that occurred after SeptemberJune 30, 2022,2023, through the date the condensed consolidated financial statements were issued after their approval by the Board of Directors on November 3, 2022July 28, 2023, and determined that there are no significant events that require adjustments or disclosure in such condensed consolidated financial statements.
 
16
20

Table of Contents

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, 2021,2022, included in our Annual Report on Form 10-K for the year ended December 31, 2021,2022, filed with the Securities and Exchange Commission on March 9, 2022,2, 2023, 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.Viaskin, an epicutaneous patch (i.e., a skin patch). We have generated significant data demonstrating that Viaskin’s mechanism of action is novel and differentiated, as itViaskin 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. We believe Viaskin may offer convenient, self-administered, non-invasive immunotherapy to patients. patients, if approved.

Our most advanced clinical program is Viaskin Peanut.

Viaskin
TM
Peanut, which has been evaluated as a potential therapy for children ages 4-11with peanut allergy in the United States
In January 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 Complete Response Letter received in August 2020. The FDA agreed with its 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 patchnine clinical trials, including four Phase 2 trials 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 patch, FDA requested an assessment comparing the uptake of allergen (peanut protein) between the patches in peanut allergic children ages 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 a modified Viaskin Peanut patch in the intended patient population. 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 (“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 the Company intends 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
21
Table of Contents
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.
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 ittrials. We recently completed a Type C meeting to align on the protocol and the study protocol was submitted to the FDA as part of the Type C meeting briefing package.
On September 9, 2022, the Company announced the initiation of the Phase 3 study, using the modified Viaskin™ Peanut Patch, in peanut-allergic children ages 4 to 7 years.
On September 21, 2022, the Company announced it received feedback from the U.S. FDA in the form of a partial clinical hold on its VITESSE Phase 3 clinical study. In the partial clinical hold letter, the FDA specifies changes to elements of the VITESSE protocol with the intent for the trial to support a future BLA submission. The modifications noted within the FDA’s communication address design elements, including the statistical analysis of adhesion, minimum daily wear time and technical alignments in methods of categorizing data, to meet study objectives as well as the total number of trial participants on active treatment. The Company has not yet begun the screening or recruitment of subjects in the VITESSE study. The partial clinical hold is specific to VITESSE and does not impact any other ongoing its clinical studies. The Company expects to provide additional updates following consultation with the FDA.
22
Table of Contents
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 had withdrawn the Marketing Authorization Application 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 PEPITES (V712-301). The decision to withdraw was based on the view of EMA 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 support a more robust path for licensure of Viaskin Peanut in the EU. The Company intendschildren ages one to resubmit the MAA when that data set is available.
three with peanut allergy and we also have an ongoing Phase 3 trial of Viaskin Peanut forin children ages 1-3
In June 2020,four to seven with peanut allergy.

On March 7, 2023, 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 investigationscreening of the 250 Pg dosefirst patient in this age group, which is the dose being studied in Part BVITESSE. Screening of the study. Enrollment for Part B of EPITOPE was completedlast patient is anticipated in the first quarter of 2022.

In June 2022, The Company announced that its pivotal Phase III trial EPITOPE, assessing the safetyhalf in 2024 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 statistically significant treatment effect (p<0.001), with 67.0% of subjectstopline results in the Viaskin Peanut arm meetingfirst half in 2025.

On April 19, 2023, the treatment responder criteria after 12 months, as compared to 33.5% of subjects inCompany outlined 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 pathwayspath for Viaskin Peanut in children 1-3 years old after the FDA confirmed that the Company’s Phase 3 EPITOPE study meets the pre-specified criteria for success for the primary endpoint, not requesting any additional efficacy study. The FDA requires additional safety data to augment the safety data collected from EPITOPE in support of a BLA. This new safety study will also generate patch adhesion data and will include updated instructions for use.

On May 10, 2023, the New England Journal of Medicine (NEJM) published results that demonstrated epicutaneous immunotherapy (EPIT) with VP was statistically superior to placebo in desensitizing children to peanut exposure by increasing the peanut dose that triggers allergic symptoms. As stated in an accompanying editorial piece, these data are seen as “very good news” for toddlers with peanut allergy, as there are currently no approved treatment options for peanut-allergic children under the age of 4 years. Following this publication, the Company confirmed it is advancing regulatory efforts for VP in toddlers ages 1 to 31-3 years given the high unmet need and absence of approved treatments for this vulnerable population.

old with a confirmed peanut allergy.

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 unaudited 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 unaudited 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 unaudited condensed 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 Consolidated Financial Statements in Part I, Item 1 of our Annual Report.

17

Business trends and Results of Operations

Comparison of the Three Months Ended SeptemberJune 30, 20222023 and 2021

2022

The following table summarizes our results of operations, derived from our unaudited 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 SeptemberJune 30, 20222023 and 2021.

23
Table of Contents
   
Three months ended
September 30,
         
   
2022
   
2021
   
$ change
   
% change
 
Operating income
  
$
2,074
 
  
$
1,323
 
  
 
751
 
  
 
57
% 
Operating expenses
        
Research and development expenses
   (15,096)    (16,320)    1,224    (8%) 
Sales and marketing expenses
   (159)    (1,072)    913    (85%) 
General and administrative expenses
   (4,839)    (8,299)    3,460    (42%) 
  
 
 
   
 
 
   
 
 
   
 
 
 
Total Operating expenses
   (20,094)    (25,691)    5,597    (22%) 
  
 
 
   
 
 
   
 
 
   
 
 
 
Financial income
   732    336    396    118% 
  
 
 
   
 
 
   
 
 
   
 
 
 
Income tax
   —      —      —      —   
  
 
 
   
 
 
   
 
 
   
 
 
 
Net loss
  
$
(17,287
) 
  
$
(24,033
) 
  
 
6,745
 
  
 
(28
%) 
  
 
 
   
 
 
   
 
 
   
 
 
 
Basic/diluted Net loss per share attributable to shareholders
  
$
(0.18
) 
  
$
(0.44
) 
    
2022.

   Three months ended June 30,         
   2023   2022   $ change   % change 

Operating income

  $2,288   $1,529    759    50% 

Operating expenses

        

Research and development expenses

   (17,616)    (18,611)    995    (5)% 

Sales and marketing expenses

   (516)    (1,037)    520    (50)% 

General and administrative expenses

   (9,231)    (5,704)    (3,527)    62% 
  

 

 

   

 

 

   

 

 

   

 

 

 

Total Operating expenses

   (27,364)    (25,352)    (2,012)    8% 
  

 

 

   

 

 

   

 

 

   

 

 

 

Financial income (expenses)

   846    784    62    8% 
  

 

 

   

 

 

   

 

 

   

 

 

 

Income tax

   (13)    —      (13)    —   
  

 

 

   

 

 

   

 

 

   

 

 

 

Net loss

  $(24,243)   $(23,039)    (1,204)    5% 
  

 

 

   

 

 

   

 

 

   

 

 

 

Basic/diluted Net loss per share attributable to shareholders

  $(0.26)   $(0.35)     

Operating Income

The following table summarizes our operating income during the three months ended SeptemberJune 30, 20222023 and 2021:

   
Three months ended
September 30,
   
$ change
   
% change
 
   
2022
   
2021
 
Sales
   —      —      —      —   
Other income
   2,074    1,323    751    57% 
Research tax credit
  
 
1,407
 
  
 
1,647
 
   (240)    (15%) 
Other operating income
  
 
668
 
  
 
(324
) 
   992    (306%) 
  
 
 
   
 
 
   
 
 
   
 
 
 
Total operating income
  
 
2,074
 
  
 
1,323
 
  
 
751
 
  
 
57
% 
  
 
 
   
 
 
   
 
 
   
 
 
 
2022:

   Three months ended June 30,         
   2023   2022   $ change   % change 

Sales

   —      —      —      —   

Other income

   2,288    1,529    759    50% 

Research tax credit

   1,975    1,491    484    32% 

Other operating income

   312    37    275    734% 
  

 

 

   

 

 

   

 

 

   

 

 

 

Total operating income

   2,288    1,529    759    50% 
  

 

 

   

 

 

   

 

 

   

 

 

 

Our operating income is primarily generated from the French research tax credit (

Crédit d’Iimpôd’Impôt Recherche
, or “CIR”), and by the revenuerevenues recognized underas part of our collaboration agreement with Nestlé Health Science. We generated operating income of $2.1$2.3 million during the three months ended SeptemberJune 30, 20222023 compared to $ 1.3$1.5 million during the three months ended SeptemberJune 30, 2021. 2022.

The increase in operating income iswas primarily attributabledue to the revenue recognized underincrease by $0.5 million in French research tax credit as the Nestlé’s collaboration agreement,eligible employee-related costs increased to support research and development activities (1) after the initiation of the VITESSE trial with the first patient screened in March 2023, and (2) as part of the new safety study for toddlers after the FDA confirmed additional safety data is required for BLA.

In addition, other operating income increased by $0.3 million for the three months ended June 30, 2023, compared to the three months ended June 30, 2022, after we updated the measurement of progress of the Phase II2 clinical trial conducted as part of the agreement. During the three months ended September 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 decrease in eligible costs in connection with Research and Development costs.

agreement.

Operating Expenses

Research and Development Expenses

The following table summarizes our research and development expenses incurred during the three months ended SeptemberJune 30, 20222023 and 2021:2022:

18

   
Three Months Ended
September 30,
         
Research and Development expenses
  
2022
   
2021
   
$ change
   
% change
 
External clinical-related expenses
   11,136    8,633    2,503    29% 
Employee-related costs
   2,648    3,228    (581)    (18%) 
Share-based payment expenses
   538    933    (395)    (42%) 
Depreciation, amortization and other costs
   774    3,526    (2,752)    (78%) 
  
 
 
   
 
 
   
 
 
   
 
 
 
Total Research and Development expenses
  
 
15,096
 
  
 
16,320
 
  
 
(1,224
) 
  
 
(8
%) 
  
 
 
   
 
 
   
 
 
   
 
 
 
   Three Months Ended June 30,         
Research and Development expenses  2023   2022   $ change   % change 

External clinical-related expenses

   11,421    11,664    (243)    (2)% 

Employee-related costs (excl. share-based payments)

   3,278    2,622    656    25% 

Share-based payment expenses

   736    475    261    55% 

Depreciation, amortization and other costs

   2,181    3,850    (1,669)    (43)% 
  

 

 

   

 

 

   

 

 

   

 

 

 

Total Research and Development expenses

   17,616    18,611    (995)    50% 
  

 

 

   

 

 

   

 

 

   

 

 

 

Research and Development expenses decreased by $1.2 million for the three months ended September 30, 2022, compared to the three

24
Table of Contents
months ended September 30, 2021, primarily due to a decrease in depreciation, amortization and following the loss at completion recorded on the Phase II clinical trial conducted as part of the Nestlé agreement for the three months ended September 30, 2021. The increase in external clinical-related expenses is driven by 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 $1.0 million for the three months ended SeptemberJune 30, 20222023, compared to the three months ended SeptemberJune 30, 2021 mostly2022, primarily due to EUR/USD exchange variationthe reversal of $1.1 million of the loss at completion recorded as other costs on the Phase 2 clinical trial conducted as part of the collaboration agreement with Nestlé. During the three months ended June 30, 2022, the loss at completion was impacted by additional clinical and workforce reduction.
25
Tableproduction costs following increasing timing to achieve upcoming milestones. During the three months ended June 30, 2023, there were no changes to the timing to completion.

In addition external clinical expenses decreased by $0.2 million as a result of Contents

differences in phasing of on-going clinical trials between the three months ended June 30, 2022 and the three months ended June 30, 2023.

Decreases in impacts of the loss at completion and in external clinical-related expenses were partially offset by the increase by $0.7 million in employee-related costs (excl. share-based payments) to support research and development activities (1) after the initiation of the VITESSE trial with the first patient screened in March 2023, and (2) as part of the new safety study for toddlers after the FDA confirmed additional safety data is required for BLA.

Sales and Marketing expenses

The following table summarizes our sales and marketing expenses incurred during the three months ended SeptemberJune 30, 20222023 and 2021:

   
Three Months Ended
September 30,
   
$ change
   
% change
 
Sales and Marketing expenses
  
2022
   
2021
 
Personnel expenses
   138    492    (354)    (72%) 
External professional services and other costs
   20    580    (559)    (96%) 
  
 
 
   
 
 
   
 
 
   
 
 
 
Total Sales and Marketing expenses
  
 
159
 
  
 
1,072
 
  
 
(913
) 
  
 
(85
%) 
  
 
 
   
 
 
   
 
 
   
 
 
 
2022:

   Three Months Ended June 30,         
Sales and Marketing expenses  2023   2022   $ change   % change 

External professional services

   80    399    (319)    (80)% 

Employee-related costs (excl. share-based payments)

   173    289    (116)    (40)% 

Share-based payment expenses

   35    55    (20)    (36)% 

Depreciation, amortization and other costs

   229    294    (65)    (22)% 
  

 

 

   

 

 

   

 

 

   

 

 

 

Total Sales and Marketing expenses

   516    1,037    (520)    (50)% 
  

 

 

   

 

 

   

 

 

   

 

 

 

Sales and marketing expenses amounted to $0.2decreased by $0.5 million for the three months ended SeptemberJune 30, 2022, compared to $1.1 million for the three months ended September 30, 2021.

Employee-related costs decreased by $0.3 million for the three months ended September 30, 2022,2023, compared to the three months ended SeptemberJune 30, 20212022, due to the workforce reduction following full implementationa decrease of the new organization.
external professional services and employee-related costs.

General and Administrative expenses

The following table summarizes our general and administrative expenses incurred during the three months ended SeptemberJune 30, 20222023 and 2021:

   
Three Months Ended
September 30,
   
$ change
   
% change
 
General and Administrative expenses
  
2022
   
2021
 
External professional services
   1,292    2,216    (924)    (42%) 
Employee-related costs
   1,110    2,052    (942)    (46%) 
Share-based payment expenses
   488    530    (42)    (8%) 
Depreciation, amortization and other costs
   1,949    3,501    (1,552)    (44%) 
  
 
 
   
 
 
   
 
 
   
 
 
 
Total General and Administrative expenses
  
 
4,839
 
  
 
8,299
 
  
 
(3,460
) 
  
 
(42
%) 
  
 
 
   
 
 
   
 
 
   
 
 
 
2022:

   Three Months Ended June 30,         
General and Administrative expenses  2023   2022   $ change   % change 

External professional services

   3,806    1,771    2,034    115% 

Employee-related costs (excl. share-based payments)

   1,814    2,220    (405)    (18)% 

Share-based payment expenses

   1,043    548    496    91% 

Depreciation, amortization and other costs

   2,568    1,166    1,402    120% 
  

 

 

   

 

 

   

 

 

   

 

 

 

Total General and Administrative expenses

   9,231    5,704    3,527    62% 
  

 

 

   

 

 

   

 

 

   

 

 

 

General and Administrative expenses decreasedincreased by $3.5 million for the three months ended SeptemberJune 30, 2022,2023, compared to the three months ended SeptemberJune 30, 2021 primarily2022, mainly due to one-time costs associated with financing activities, organizational planning, market research and planning activities. In addition, we recorded a decrease in depreciation, amortization and otherprovision amounting to $0.7 million as of June 30, 2023, as our best estimate of costs as we continued to practice financial discipline and implemented further cost containment strategies.be incurred if the Montrouge office lease agreement is not renewed at its July 2024 terms.

19

Financial income (expense)

Our financial income was approximately $0.7$0.8 million for the three months ended SeptemberJune 30, 2022,2023, compared to a financial income of $0.3$0.8 million for the three months ended SeptemberJune 30, 2021.2022. This item mainly includes foreign exchange income.

the financial income on our financial assets.

Income tax

We did not have any

Our income tax profit or expense was nil for the three months ended SeptemberJune 30, 2022 nor 2021.

2023 and June 30, 2022.

Net loss

Net loss was $17.3$24.2 million for the three months ended SeptemberJune 30, 2022,2023, compared to $24.0$23 million for the three months ended SeptemberJune 30, 2021.2022. Net loss per share (based on the weighted average number of shares outstanding over the period) was $0.18$0.26 and $0.44$0.35 for the three months ended SeptemberJune 30, 2023 and 2022, and 2021, respectively.

26
Table of Contents
Business trends and Results of Operations

Comparison of the NineSix Months Ended SeptemberJune 30, 20222023 and 2021

2022

The following table summarizes our results of operations, derived from our unaudited condensed consolidated financial statements, which have been prepared in accordance with U.S. GAAP and presented in thousands of U.S. Dollars, for the ninesix months ended SeptemberJune 30, 20222023 and 2021.

   
Nine months ended
September 30,
   
$ change
   
% change
 
   
2022
   
2021
 
Operating income
  
$
6,148
 
  
$
2,776
 
  
 
3,373
 
  
 
122
% 
Operating expenses
        
Research and development expenses
   (45,930)    (58,663)    12,733    (22)% 
Sales and marketing expenses
   (1,659)    (2,999)    1,340    (45)% 
General and administrative expenses
   (17,173)    (26,250)    9,077    (35)% 
  
 
 
   
 
 
   
 
 
   
 
 
 
Total Operating expenses
   (64,762)    (87,912)    23,150    (26)% 
  
 
 
   
 
 
   
 
 
   
 
 
 
Financial income
   1,668    597    1,071    179% 
  
 
 
   
 
 
   
 
 
   
 
 
 
Income tax (expense)
   (87)    404    (491)    (122)% 
  
 
 
   
 
 
   
 
 
   
 
 
 
Net loss
  
$
(57,033
) 
  
$
(84,136
) 
  
 
27,103
 
  
 
(32
)% 
  
 
 
   
 
 
   
 
 
   
 
 
 
Basic/diluted Net loss per share attributable to shareholders
  
$
(0.79
) 
  
$
(1.53
) 
    
2022.

   Six months ended June 30,         
   2023   2022   $ change   % change 

Operating income

  $4,482   $4,074    407    10% 

Operating expenses

        

Research and development expenses

   (33,653)    (30,834)    (2,819)    9% 

Sales and marketing expenses

   (950)    (1,500)    551    (37)% 

General and administrative expenses

   (16,120)    (12,334)    (3,786)    31% 
  

 

 

   

 

 

   

 

 

   

 

 

 

Total Operating expenses

   (50,723)    (44,669)    (6,054)    14% 
  

 

 

   

 

 

   

 

 

   

 

 

 

Financial income (expense)

   1,450    936    515    55% 
  

 

 

   

 

 

   

 

 

   

 

 

 

Income tax

   (13)    (87)    74    (85)% 
  

 

 

   

 

 

   

 

 

   

 

 

 

Net loss

  $(44,804)   $(39,746)    (5,058)    13% 
  

 

 

   

 

 

   

 

 

   

 

 

 

Basic/diluted Net loss per share attributable to shareholders

  $(0.48)   $(0.66)     
  

 

 

   

 

 

   

 

 

   

 

 

 

Operating Income

The following table summarizes our operating income during the ninesix months ended SeptemberJune 30, 20222023 and 2021:

   
Nine months ended
September 30,
   
$ change
   
% change
 
   
2022
   
2021
 
Sales
   —      —       
Other income
   6,148    2,776    3,373    122% 
Research tax credit
  
 
4,467
 
  
 
5,324
 
  
 
(857
) 
  
 
(16
%) 
Other operating income
  
 
1,681
 
  
 
(2,549
) 
  
 
4,230
 
  
 
(166
%) 
  
 
 
   
 
 
   
 
 
   
 
 
 
Total operating income
  
 
6,148
 
  
 
2,776
 
  
 
3,373
 
  
 
122
% 
  
 
 
   
 
 
   
 
 
   
 
 
 
2022:

   Six months ended June 30,         
   2023   2022   $ change   % change 

Sales

   —      —       

Other income

   4,482    4,074    407    10% 

Research tax credit

   3,741    3,060    680    22% 

Other operating income

   741    1,014    (273)    (27)% 
  

 

 

   

 

 

   

 

 

   

 

 

 

Total operating income

   4,482    4,074    407    10% 
  

 

 

   

 

 

   

 

 

   

 

 

 

Our operating income was primarily generated fromconsisted of the French research tax credit (

Crédit d’Impôt Recherche
, or “CIR”), and from revenuerevenues recognized underas part of our collaboration agreement with Nestlé Health Science. We generated operating income of $6.1$4.5 million during the ninesix months ended SeptemberJune 30, 2022,2023 compared to $2.8$4.1 million during the ninesix months ended SeptemberJune 30, 2021.
2022.

The increase in operating income is primarily attributablewas due to the revenue recognized underincrease by $0.7 million in the Nestlé’s collaboration agreement,French research tax credit as both eligible employee-related costs and eligible external clinical-related expenses increased to support research and development activities (1) after the initiation of the VITESSE trial with the first patient screened in March 2023, and (2) as part of the new safety study for toddlers after the FDA confirmed additional safety data is required for BLA.

20

The increase in research tax credit was partially offset by the decrease by $0.3 million in other operating income for the six months ended June 30, 2023, compared to the six months ended June 30, 2022, after we updated the measurement of progress of the Phase II2 clinical trial conducted as part of the agreement. During the nine months ended September 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.

27
Table of Contents
agreement.

Operating Expenses

Research and Development Expenses

The following table summarizes our research and developmentR&D expenses incurred during the ninesix months ended SeptemberJune 30, 20222023 and 2021:

   
Nine Months Ended
September 30,
         
   
2022
   
2021
   
$ change
   
% change
 
Research and Development expenses
        
External clinical-related expenses
   30,150    31,319    (1,169)    (4%) 
Employee-related costs
   7,761    10,525    (2,764)    (26%) 
Share-based payment expenses
   1,596    1,747    (151)    (9%) 
Depreciation, amortization and other costs
   6,423    15,072    (8,649)    (57%) 
  
 
 
   
 
 
   
 
 
   
 
 
 
Total Research and Development expenses
  
 
45,930
 
  
 
58,663
 
  
 
(12,733
) 
  
 
(22
%) 
  
 
 
   
 
 
   
 
 
   
 
 
 
2022:

   Six Months Ended June 30,         
Research and Development expenses  2023   2022   $ change   % change 

External clinical-related expenses

   21,892    19,014    2,878    15% 

Employee-related costs (excl. share-based payments)

   6,598    5,114    1,484    29% 

Share-based payment expenses

   1,423    1,058    365    34% 

Depreciation, amortization and other costs

   3,741    5,648    (1,908)    (34)% 
  

 

 

   

 

 

   

 

 

   

 

 

 

Total Research and Development expenses

   33,653    30,834    2,819    9% 
  

 

 

   

 

 

   

 

 

   

 

 

 

Research and Development expenses decreased by $12.7 million for the nine months ended September 30, 2022 compared to the nine months ended September 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, decreasedincreased by $2.8 million for the ninesix months ended SeptemberJune 30, 2022,2023, compared to the ninesix months ended SeptemberJune 30, 20212022, primarily due to the workforce reduction following full implementationincrease by $2.9 million and by $1.5 million in external clinical-related expenses and in employee-related costs (excl. share-based payments) respectively, to support research and development activities (1) after the initiation of the VITESSE trial with the first patient screened in March 2023, and (2) as part of the new organization.
The decreasesafety study for toddlers after the FDA confirmed additional safety data is required for BLA.

Increases in depreciation, amortizationboth external clinical-related expenses and otheremployee-related costs was primarily due towere partially offset by the reversal of $1.1 million of the loss at completion recorded as other costs on the Phase II2 clinical trial conducted as part of the collaboration agreement with Nestlé agreement.

. During the six months ended June 30, 2022, the loss at completion was impacted by additional clinical and production costs following increasing timing to achieve upcoming milestones. During the six months ended June 30, 2023, there were no changes to the timing to completion.

Sales and Marketing expenses

The following table summarizes our sales and marketing expenses incurred during the ninesix months ended SeptemberJune 30, 20222023 and 2021:

   
Nine Months Ended
September 30,
         
   
2022
   
2021
   
$ change
   
% change
 
Sales and Marketing expenses
        
Personnel expenses
   727    1,528    (801)    (52%) 
External professional services and other costs
   932    1,471    (538)    (37%) 
  
 
 
   
 
 
   
 
 
   
 
 
 
Total Sales and Marketing expenses
  
 
1,659
 
  
 
2,999
 
  
 
(1,340
) 
  
 
(45
%) 
  
 
 
   
 
 
   
 
 
   
 
 
 
2022:

   Six Months Ended June 30,         
Sales and Marketing expenses  2023   2022   $ change   % change 

External professional services

   348    521    (173)    (33)% 

Employee-related costs (excl. share-based payments)

   303    539    (237)    (44)% 

Share-based payment expenses

   70    49    21    41% 

Depreciation, amortization and other costs

   229    391    (162)    (41)% 
  

 

 

   

 

 

   

 

 

   

 

 

 

Total Sales and Marketing expenses

   950    1,500    (551)    (37)% 
  

 

 

   

 

 

   

 

 

   

 

 

 

Sales and marketing expenses decreased by $1.3$ 0.6 million for the ninesix months ended SeptemberJune 30, 2022,2023, compared to the ninesix months ended SeptemberJune 30, 2021,2022, primarily due to a decrease inof external professional services and employee-related costs.

Personnel expenses, decreased by $0.8 million for the nine months ended September 30, 2022, compared to the nine months ended September 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 ninesix months ended SeptemberJune 30, 20222023 and 2021:2022:

   Six Months Ended June 30,         
General and Administrative expenses  2023   2022   $ change   % change 

External professional services

   5,512    2,879    2,633    91% 

Employee-related costs (excl. share-based payments)

   4,005    4,029    (25)    (1)% 

Share-based payment expenses

   1,954    1,333    620    47% 

Depreciation, amortization and other costs

   4,650    4,093    557    14% 
  

 

 

   

 

 

   

 

 

   

 

 

 

Total General and Administrative expenses

   16,120    12,334    3,786    31% 
  

 

 

   

 

 

   

 

 

   

 

 

 

21

   
Nine Months Ended
September 30,
         
   
2022
   
2021
   
$ change
   
% change
 
General and Administrative expenses
        
External professional services
   4,171    6,425    (2,255)    (35%) 
Employee-related costs
   5,139    7,263    (2,124)    (29%) 
Share-based payment expenses
   1,822    2,084    (263)    (13%) 
Depreciation, amortization and other costs
   6,042    10,478    (4,436)    (42%) 
  
 
 
   
 
 
   
 
 
   
 
 
 
Total General and Administrative expenses
  
 
17,173
 
  
 
26,250
 
  
 
(9,077
) 
  
 
(35
%) 
  
 
 
   
 
 
   
 
 
   
 
 
 
28
Table of Contents

General and Administrative expenses decreasedincreased by $9.1$3.8 million for the ninesix months ended SeptemberJune 30, 2022,2023, compared to the ninesix months ended SeptemberJune 30, 2021, primarily2022, mainly due to one-time costs associated with financing activities, organizational planning, market research and planning activities. In addition, we recorded a decreaseprovision amounting to $0.7 million as of depreciation, amortization and other costs. We have continuedJune 30, 2023, as our best estimate of costs to practice financial discipline and implemented further cost containment strategies.

The decrease in employee-related costs, excluding share-based payment expenses,be incurred if the Montrouge office lease agreement is directly related to the workforce reduction following full implementation of the new organization
.
not renewed at its July 2024 terms.

Financial income (expense)

Our financial income was $1.7$1.5 million for the ninesix months ended SeptemberJune 30, 2022,2023, compared to a financial income of $0.6$0.9 million for the ninesix months ended SeptemberJune 30, 2021.2022. This item mainly includes foreign exchangefinancial income (expense).

on our financial assets.

Income tax

Our income tax expense was $87,000nil for the ninesix months ended SeptemberJune 30, 2022, compared to a US Tax income of $404,000 for the nine months ended September2023 and June 30, 2021.

2022.

Net loss

Net loss was $57.0$ 44.8 million for the ninesix months ended SeptemberJune 30, 2022,2023, compared to $84.1$39.7 million for the ninesix months ended SeptemberJune 30, 2021.2022. Net loss per share (based on the weighted average number of shares outstanding over the period) was $0.79$0.48 and $1.53$0.66 for the ninesix months ended SeptemberJune 30, 2023 and 2022, and 2021, respectively.

Liquidity and Capital Resources

Financial Condition

On SeptemberJune 30, 2022,2023, we had $212.7$174 million in cash and cash equivalents compared to $77.3$209.2 million of cash and cash equivalents on December 31, 2021.2022. We have incurred operating losses and negative cash flows from operations since our inception. Net cash used for operating activities was $31.8$ 46.4 million and $89.5$11.7 million for the ninesix months ended SeptemberJune 30, 2023 and 2022, and 2021, respectively. For the nine months ended SeptemberAs of June 30, 2022,2023, we recorded a net loss of $57$ 44.8 million. Our net cash flows provided by financing activities increaseddecreased to $194.4$7.8 million during the ninesix months ended SeptemberJune 30, 20222023 from $(0.1)$195.2 million during the ninesix months ended SeptemberJune 30, 2021. Financing activities consisted mainly2022 due to more important financing operations in first semester of 2022 (May 2022 ATM and June 2022 PIPE) compared to 2023 (June 2023 ATM).

Our condensed consolidated financial statements have been prepared on a going concern basis assuming that based on our current operations, as well as our plans and assumptions, we expect that our balance of cash and cash equivalents at closing date will be sufficient to fund our operations for at least the next 12 months. As such, no adjustments have been made to the condensed consolidated 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 global offeringnet 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.

Payments associated with Research tax credits (Crédit d’Impôt Recherche) contribute to fund our short-term cash requirements. We intend to seek additional capital as we prepare for the second quarterlaunch of 2022.

Viaskin Peanut, if approved, and continue other research and development efforts. 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.

In May 2022, we established an At-The-Market (“ATM”) program to offer and sell, including with unsolicited investors who have expressed an interest, a total gross amount of up to $100 million of American Depositary Shares (“ADSs”), each ADS representing one-half of one ordinary share of the Company. The ATM program is intended to be effective through the expiration of the Company’s existing registration statement registering the ADSs to be issued under the ATM program, i.e. until July 16, 2024, unless terminated prior to such date in accordance with the sales agreement or the maximum amount of the program has been reached. The Company’s intent is to use the net proceeds, if any, of sales of ADSs issued under the program, together with its existing cash and cash equivalents, primarily for activities associated with potential approval and launch of Viaskin Peanut, as well as to advance the development of the Company’s product candidates using its Viaskin Peanut platform and for working capital and other general corporate purposes.

Pursuant to the ATM program, the Company issued and completed sales of new Ordinary Shares in the form of ADSs for a total gross amount of $15.3 million on May 4, 2022, and of $7.8 million on June 14, 2023. Respectively, 6,036,238 and 2,052,450 new Ordinary Shares in the form of ADSs were issued through a capital increase without preferential subscription rights of the shareholders reserved to specific categories of persons fulfilling certain characteristics (the “ATM issuance”), at a unit subscription price of $1.27 and $1.90 per ADS, each ADS giving the right to receive one-half of one ordinary share of the Company.

22

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. 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.
29
Table of Contents
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.
The following table presents our material cash requirements for future periods:
   
Material Cash Requirements Due by the period
Ended
September 30,
 
   
2023
   
2024
   
2025
   
Thereafter
   
Total
 
   
(Amounts in thousands)
 
Operating leases
   1,381    1,423    —      —      2,804 
Purchase obligations - Obligations Under the Terms of CRO Agreements
   12,411    36,234    7,805    —      56,450 
  
 
 
   
 
 
   
 
 
   
 
 
   
 
 
 
Total
   13,791    37,657    7,805    —      59,254 
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 ended 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 3, 2015, and represents a $3$0.8 million cash requirement as of SeptemberJune 30, 20222023 which expires July 31, 2024.

Our primary U.S. office is located in Basking Ridge, New Jersey. In 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,2022, we entered into a subleaselease agreement, commencing on April 1, 2022 and effective for 38 months, for an office of this5,799 square feet in Basking Ridge, New Jersey. The Basking Ridge office space in June 2021. The NYC office representsrepresent a $0.2$0.1 million cash requirement as of SeptemberJune 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 September 30, 20222023 which expires MayJune 1, 2025.
30
Table of Contents

There have been no material changes in our operating leases from those disclosed in the Annual Report.

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

There have been no material changes in our purchase obligations from those disclosed in the ongoing trials amounted globally to $125.9 million. As of September 30, 2022, the amount we are still obligated to pay in connection with these contracts through 2025 is $56.4 million.

31
Table of Contents
Annual Report.

Summary Statement of Cash Flows

The table below summarizes our sources and uses of cash for the ninesix months ended SeptemberJune 30, 20222023 and 2021.

   
Nine months ended
September 30,
       
(Amounts in thousands of U.S. Dollars)
  
2022
  
2021
  
$ change
  
% of change
 
Net cash flow used in operating activities
   (31,781)   (89,452)   57,671   (64%) 
Net cash flow used in investing activities
   (66)   41   (107)   (262%) 
Net cash flow provided by financing activities
   194,403   (103)   194,506   * 
Effect of exchange rate changes on cash and cash equivalents
   (27,186)   (8,643)   (18,543)   215% 
  
 
 
  
 
 
  
 
 
  
 
 
 
Net (decrease) increase in cash and cash equivalents
  
 
135,369
 
 
 
(98,157
) 
 
 
233,527
 
 
 
(238
%) 
  
 
 
  
 
 
  
 
 
  
 
 
 
*
Percentage not meaningful
2022.

   Six months ended June 30,         
(Amounts in thousands of U.S. Dollars)  2023   2022   $ change   % of change 

Net cash flow used in operating activities

   (46,394)    (11,733)    (34,661)    295% 

Net cash flow used in investing activities

   (299)    (218)    (80)    37% 

Net cash flow provided by financing activities

   7,793    195,222    (187,429)    (96)% 

Effect of exchange rate changes on cash and cash equivalents

   3,668    (12,600)    16,268    (129)% 
  

 

 

   

 

 

   

 

 

   

 

 

 

Net (decrease) increase in cash and cash equivalents

   (35,232)    170,670    (205,903)    (121)% 
  

 

 

   

 

 

   

 

 

   

 

 

 

Operating Activities

Our net cash flows used in operating activities were $31.8$46.4 million and $89.5$11.7 million during the ninesix months ended SeptemberJune 30, 2023 and 2022, and 2021, respectively. During the nine months period ended September 30, 2022, we received $21.1 million of research tax credit’s reimbursement for the 2019, 2020 and 2021 fiscal year. Excluding research tax credit reimbursement, ourOur net cash flows used in operating activities decreasedincreased by $31.3$ 34.7 million, or 35%, mainly due to cost containment measures andthe repayment in 2022 of the research tax credit receivable relating to fiscal years 2019 to 2021 for €24.8 million (corresponding to $28.1 million on the basis of 2021 closing exchange rate). The increase is also explained by the change in trade payables during the six months period ended June 30, 2023 compared to the workforce reduction following full implementation of the new organization

.
Cashsix months period ended June 30, 2022.

Investing Activities

Our net cash flows used in operatinginvesting activities forwere $0.3 million and $0.2 million during the ninesix months ended SeptemberJune 30, 2021 included restructuring costs paid for $0.7 million.

2023 and 2022, respectively.

Financing Activities

Our net cash flows provided by financing activities increased to $194.4was $ 7.8 million during the ninesix months ended SeptemberJune 30, 2023 that consisted of the ATM in June 2023 compared to $195.2 million during the six months ended June 30, 2022, from $103,000 duringthat consisted of the nine months ended September 30, 2021. Financing activities consisted mainly of our global offering inMay 2022 ATM and the second quarter of 2022.June 2022 PIPE.

23

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.

32
Table of Contents

Item 3. Quantitative and Qualitative Disclosures About Market Risk

Our market risks have not changed materially from those disclosed in item 7A

We are a smaller reporting company as defined by Rule 12b-2 of the Annual Report.

Exchange Act and are not required to provide the information required under this item.

Item 4. Controls and Procedures

Disclosure Controls and Procedures

Based on its evaluation as of SeptemberJune 30, 2022,2023, 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'sSEC’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'smanagement’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.

33
Table of Contents

PART II – Other information

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.

24

Item 1A. Risk Factors

Except as

Our business is subject to risks and events that, if they occur, could adversely affect our financial condition and results of operations and trading price of our securities. In addition to the other information set forth below, therein this Quarterly Report, you should carefully consider the factors described in Part I, Item 1A. “Risk Factors” of our Annual Report. 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. Pursuant to a registration rights agreement (the “Registration Rights Agreement”) with the investors, the Company filed a registration statement with the SEC registering the resale of 59,269,629 ordinary shares issued in the PIPE financing, including ordinary shares underlying the pre-funded warrants. The Company also filed a registration statement with the SEC registering the resale of 11,593,170 ordinary shares by Entities affiliated with Baker Bros. Advisors, issued in the PIPE financing, including ordinary shares underlying the pre-funded warrants. As a result, subject to certain beneficial ownership limitations contained in the pre-funded warrants, these shares are 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

During the ninesix months ended SeptemberJune 30, 2022,2023, we issued the following unregistered securities:

On March 23, 2022, the issuance of an aggregate of 775 ordinary shares to 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
34
Table of Contents

 
Shares”) at a pre-funded price per pre-funded warrant•

On March 23, 2023, the issuance of €2.90 (corresponding to $3.11), which equals the per share pricean aggregate of the10,174 ordinary shares lessto U.S. and non-U.S. employees upon settlement of RSUs;

•

On May 19, 2023, the exercise priceissuance of €0.10 per Pre-Funded Warrant. Each Pre-Funded Warrant has an exercise priceaggregate of €0.10 per Warrant Share. The Pre-Funded Warrants are exercisable at any time after their original issuance and will expire ten years following their issuance. The exercise price and number of shares of2,500 ordinary shares issuableto a non-U.S. employee upon exercisesettlement of RSUs;

•

On May 22, 2023, 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 holderissuance of the pre-funded warrants will not have the right to exercise any portionan aggregate of its pre-funded warrants if such holder, together with its affiliates, would beneficially own in excess of 9.99% of the number of14,364 ordinary shares outstanding immediately after giving effect to such exercise (the “Beneficial Ownership Limitation”). The holder may increase or decreasenon-U.S. employees upon settlement of RSUs; and

•

On May 24, 2023, the Beneficial Ownership Limitation, provided, however, that the holder may only increase the Beneficial Ownership Limitation by (i) obtaining authorization from the French Ministryissuance 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 exercisean aggregate 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. Pursuant to the Registration Rights Agreement, the Company filed a registration statement with the Securities and Exchange Commission registering the resale of 59,269,62934,321 ordinary shares issued in the PIPE financing, including ordinary shares underlying the pre-funded warrants.to U.S. and non-U.S. employees upon settlement of RSUs.

On June 10, 2022, the issuance of 3,100 ordinary shares to a non-U.S. employee upon exercise of 3,100 SO at an exercise price of 4.16 euros per SO, for aggregate proceeds to the Company of 12,896 euros.
On July 8, 2022, the issuance of 2,513 ordinary shares to a U.S. employee upon exercise of 2,513 SO at an exercise price of 4.16 euros per SO, for aggregate proceeds to the Company of 10,454 euros.
On September 23, 2022, the issuance of an aggregate of 249 ordinary shares to a non-U.S. employee upon settlement of RSUs.

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

None.

Item 4. Mine Safety Disclosures

Not applicable.

Item 5. Other Information

Not applicable.

35
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-Q    001-36697    3.1    5/04/23 
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        

25

Exhibit

Description

Incorporated by Reference
      
Incorporated by Reference
Exhibit
Schedule/
Form		 
Description
File
Number		 
Schedule/
Form
Exhibit 
File
Number

Date		 
Exhibit
File
Date
    3.1By-laws (status) of the registrant (English translation)
  31.1Certificate of Chief Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002, as Amended
  31.2Certificate 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.INSXBRL Instance Document
101.SCHXBRL Taxonomy Extension Schema Document
101.CALXBRL 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 incorporate language contained in such filing.

36
Table of Contents

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrationregistrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

  
DBV Technologies S.A.
  (Registrant)
Date: November 3, 2022
July 31, 2023		  
By:
 

/s/ Daniel Tassé

 
  Daniel Tassé
  
Chief Executive Officer
  
(Principal Executive Officer)
Date: November 3, 2022
July 31, 2023		  
By:
 

/s/ Sébastien Robitaille

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

26

37